
[Federal Register Volume 80, Number 180 (Thursday, September 17, 2015)]
[Rules and Regulations]
[Pages 56169-56356]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-21921]



[[Page 56169]]

Vol. 80

Thursday,

No. 180

September 17, 2015

Part III





Department of Health and Human Services





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Food and Drug Administration





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21 CFR Parts 11, 16, 117, et al.





Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based 
Preventive Controls for Food for Animals; Final Rule

  Federal Register / Vol. 80 , No. 180 / Thursday, September 17, 2015 / 
Rules and Regulations  

[[Page 56170]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 11, 16, 117, 500, 507, and 579

[Docket No. FDA-2011-N-0922]
RIN 0910-AG10


Current Good Manufacturing Practice, Hazard Analysis, and Risk-
Based Preventive Controls for Food for Animals

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA or we) is adding 
regulations for the Current Good Manufacturing Practice, Hazard 
Analysis, and Risk-Based Preventive Controls for Food for Animals. 
These regulations will, for the first time, establish requirements for 
the current good manufacturing practice (CGMP) for food for animals. In 
addition, we are adding requirements for certain domestic and foreign 
animal food facilities to establish and implement hazard analysis and 
risk-based preventive controls for food for animals. We are taking this 
action to provide greater assurance that animal food is safe and will 
not cause illness or injury to humans and animals and to implement new 
statutory provisions in the FDA Food Safety Modernization Act (FSMA). 
The rule is intended to build an animal food safety system for the 
future that makes modern science- and risk-based preventive controls 
the norm across all sectors of the animal food system.

DATES: This rule is effective November 16, 2015, except for paragraph 
(2) of the definition of ``qualified auditor'' in Sec.  507.3, and 
Sec. Sec.  507.12(a)(1)(ii), 507.105(a)(2), 507.105(c), 
507.110(d)(2)(ii), 507.130(d), 507.135(d), 507.175(c)(2), and 
507.175(c)(13). FDA will publish a document in the Federal Register 
announcing the effective dates of paragraph (2) of the definition of 
``qualified auditor'' in Sec.  507.3, Sec. Sec.  507.12(a)(1)(ii), 
507.105(a)(2), 507.105(c), 507.110(d)(2)(ii), 507.130(d), 507.135(d), 
507.175(c)(2), and 507.175(c)(13). Certain provisions have later 
compliance dates as discussed in section LIII ``Effective and 
Compliance Dates.''

FOR FURTHER INFORMATION CONTACT: Jeanette Murphy, Center for Veterinary 
Medicine (HFV-200), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-402-6246, email: jenny.murphy@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

Table of Contents

Executive Summary
Purpose and Coverage of the Rule
Summary of the Major Provisions of the Rule
Costs and Benefits
I. Background
    A. FDA Food Safety Modernization Act
    B. Stages in the Rulemaking for the Animal Food Preventive 
Controls Rule
    C. Summary of the Major Provisions of Proposed Rule for 
Preventive Controls for Food for Animals
    D. Draft Risk Assessment
    E. Public Comments
II. Legal Authority
    A. Current Good Manufacturing Practice Regulations
    B. Hazard Analysis and Risk-Based Preventive Controls
III. General Comments on the Proposed Rule
IV. Definitions in the Section 415 Registration Regulations (21 CFR 
Part 1, Subpart H)
    A. Definitions That Impact a Determination of Whether an 
Establishment Is a ``Farm''
    B. Proposed Revisions to the Definition of Farm
    C. Proposed Revisions to Definitions of Harvesting, Holding, 
Manufacturing/Processing, Mixed-Type Facility, and Packing
    D. Comments on Feed Mills Associated With Fully Vertically 
Integrated Farming Operations
V. Comments on the Organizing Principles for How the Status of a 
Food as a Raw Agricultural Commodity or as a Processed Food Affects 
the Requirements Applicable to a Farm Under Sections 415 and 418 of 
the FD&C Act
VI. Rulemaking Required by Section 103(c) of FSMA: On-Farm 
Activities
    A. Section 103(c)(1)(C) of FSMA
    B. Comments on Qualitative Risk Assessment of On-Farm Activities 
Outside of the Farm Definition
    C. Comments Regarding an Exemption for Small and Very Small Farm 
Mixed-Type Facilities Under Section 421 of the FD&C Act
VII. Subpart A: Comments on Proposed Sec.  507.1--Applicability and 
Status
    A. Comments on Proposed Sec.  507.1(a)--Applicability
    B. Comments on Proposed Sec.  507.1(b)--Prohibited Act
    C. Comments on Proposed Sec.  507.1(c)--Specific CGMP 
Requirements
    D. Comments on Proposed Sec.  507.1(d)--Human Food Facilities 
That Manufacture Animal Food
VIII. Subpart A: Comments on Proposed Sec.  507.3--Definitions
    A. Definitions We Proposed To Establish in Part 507
    B. Comments Asking FDA To Establish Additional Definitions or 
Otherwise Clarify Terms Not Defined in the Rule
    C. Additional Definitions To Clarify Terms Not Defined in the 
Proposed Rule
IX. Subpart A: Comments on Qualifications of Individuals Who 
Manufacture, Process, Pack, or Hold Animal Food
    A. Applicability and Qualifications of All Individuals Engaged 
in Manufacturing, Processing, Packing, or Holding Animal Food (Final 
Sec.  507.4(a), (b), and (d))
    B. Additional Requirements Applicable to Supervisory Personnel 
(Final Sec.  507.4(c))
X. Subpart A: Comments on Proposed Sec.  507.5--Exemptions
    A. General Comments on the Proposed Exemptions
    B. Proposed Sec.  507.5(a)--Exemption for Facilities Not 
Required To Register Under Section 415 Regulations
    C. Proposed Sec.  507.5(b)--Exemption Applicable to Food Subject 
to 21 CFR part 113--Thermally Processed Low-Acid Foods Packaged in 
Hermetically Sealed Containers
    D. Proposed Sec.  507.5(c)--Exemption Applicable to Activities 
Subject to Standards for Produce Safety in Section 419 of the FD&C 
Act
    E. Proposed Sec.  507.5(d)--Exemption Applicable to a Qualified 
Facility
    F. Proposed Sec.  507.5(e) and (f)--Exemptions Applicable to On-
Farm Low-Risk Activity/Animal Food Combinations Conducted by a Small 
or Very Small Business
    G. Proposed Sec.  507.5(g)--Exemption Applicable to Facilities 
Solely Engaged in Storage of Raw Agricultural Commodities Other Than 
Fruits and Vegetables Intended for Further Distribution or 
Processing
    H. Proposed Sec.  507.5(h)--Exemption Applicable to the Holding 
or Transportation of One or More Raw Agricultural Commodities
    I. Comments Requesting Additional Exemptions
XI. Subpart A: Comments on Proposed Sec.  507.7--Requirements That 
Apply to a Qualified Facility
    A. Comments on Submission of a Certification Statement
    B. General Comments on Requirements That Apply to a Qualified 
Facility
    C. Proposed Sec.  507.7(a)--Documentation To Be Submitted
    D. Proposed Sec.  507.7(b)--Procedure for Submission
    E. Proposed Sec.  507.7(c)--Frequency of Determination and 
Submission
    F. Proposed Sec.  507.7(d)--Notification to Consumers (Final 
Sec.  507.7(e))
    G. Proposed Sec.  507.7(e)--Records (Final Sec.  507.7(f))
XII. Subpart A: Comments on Proposed Sec.  507.10--Applicability of 
Part 507 to a Facility Solely Engaged in the Storage of Unexposed 
Packaged Animal Food
XIII. Subpart A: Comments on Proposed Sec.  507.12--Applicability of 
Part 507 to the Holding and Distribution of Human Food By-Products 
for Use as Animal Food
XIV. Subpart B: General Comments on Proposed Subpart B--Current Good 
Manufacturing Practice
XV. Subpart B: Comments on Proposed Sec.  507.14--Personnel
    A. Proposed Sec.  507.14(a)(1)--Personal Cleanliness (Final 
Sec.  507.14(b)(1))

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    B. Proposed Sec.  507.14(a)(2)--Hand Washing (Final Sec.  
507.14(b)(2))
    C. Proposed Sec.  507.14(a)(3)--Unsecured Jewelry and Other 
Objects (Final Sec.  507.14(b)(3))
    D. Proposed Sec.  507.14(a)(4)--Storing Clothing and Personal 
Belongings (Final Sec.  507.14(b)(4))
    E. Proposed Sec.  507.14(a)(5)--Taking Other Necessary 
Precautions (Final Sec.  507.14(b)(5))
XVI. Subpart B: Comments on Proposed Sec.  507.17--Plant and Grounds
    A. Proposed Sec.  507.17(a)--Grounds Surrounding an Animal Food 
Plant
    B. Proposed Sec.  507.17(b)(1)--Adequate Space Between 
Equipment, Walls, and Stored Materials
    C. Proposed Sec.  507.17(b)(2)--Dripping and Condensation
    D. Proposed Sec.  507.17(b)(3)--Ventilation
    E. Proposed Sec.  507.17(b)(4)--Lighting
    F. Proposed Sec.  507.17(b)(5)--Glass
    G. Proposed Sec.  507.17(b)(6)--Outdoor Storage
XVII. Subpart B: Comments on Proposed Sec.  507.19--Sanitation
    A. Proposed Sec.  507.19(a)--Buildings
    B. Proposed Sec.  507.19(b)--Cleaning
    C. Proposed Sec.  507.19(b)(1)--Wet Cleaning
    D. Proposed Sec.  507.19(b)(2)--Wet Processing
    E. Proposed Sec.  507.19(c)--Cleaning Compounds and Sanitizing 
Agents
    F. Proposed Sec.  507.19(d)(1)--Toxic Materials
    G. Proposed Sec.  507.19(d)(2)--Identification, Use, and Storage 
of Toxic Materials
    H. Proposed Sec.  507.19(e)--Pest Control
    I. Proposed Sec.  507.19(f)--Trash and Garbage
XVIII. Subpart B: Comments on Proposed Sec.  507.20--Water Supply 
and Plumbing
    A. Proposed Sec.  507.20(a)--Water Supply
    B. Proposed Sec.  507.20(b)--Plumbing
    C. Proposed Sec.  507.20(c)--Sewage
    D. Proposed Sec.  507.20(d)--Toilet Facilities
    E. Proposed Sec.  507.20(e)--Hand-Washing Facilities
XIX. Subpart B: Comments on Proposed Sec.  507.22--Equipment and 
Utensils
    A. Proposed Sec.  507.22(a)(1)--Plant Equipment and Utensils
    B. Proposed Sec.  507.22(a)(2)--Design of Equipment and Utensils
    C. Proposed Sec.  507.22(a)(3)--Equipment Installation
    D. Proposed Sec.  507.22(a)(4)--Animal Food Contact Surfaces
    E. Proposed Sec.  507.22(a)(5)--Non-Animal Food Contact 
Equipment (Final Sec.  507.22(a)(1))
    F. Proposed Sec.  507.22(b)--System Design and Construction
    G. Proposed Sec.  507.22(c)--Monitoring Cold Storage 
Temperatures
    H. Proposed Sec.  507.22(d)--Instruments
    I. Proposed Sec.  507.22(e)--Compressed Air
XX. Subpart B: Comments on Proposed Sec.  507.25--Plant Operations
    A. Proposed Sec.  507.25(a)(1)--CGMPs
    B. Proposed Sec.  507.25(a)(2)--Identifying Contents of 
Containers
    C. Proposed Sec.  507.25(a)(3)--Labeling of Finished Product 
(Final Sec.  507.27(b))
    D. Proposed Sec.  507.25(a)(4)--Animal Food Packaging Material 
(Final Sec.  507.25(a)(3))
    E. Proposed Sec.  507.25(a)(5)--Responsibility for Overall Plant 
Cleanliness (Final Sec.  507.25(a)(4))
    F. Proposed Sec.  507.25(a)(6)--Contamination Precautions (Final 
Sec.  507.25(a)(5))
    G. Proposed Sec.  507.25(a)(7)--Testing Procedures (Final Sec.  
507.25(a)(6))
    H. Proposed Sec.  507.25(a)(8)--Contaminated Product (Final 
Sec.  507.25(a)(7))
    I. Proposed Sec.  507.25(a)(9)--Protecting Against Contamination 
(Final Sec.  507.25(a)(8))
    J. Proposed Sec.  507.25(b)(1)--Raw Materials and Ingredients
    K. Proposed Sec.  507.25(b)(1)(i)--Shipping Containers
    L. Proposed Sec.  507.25(b)(1)(ii)--Raw Materials
    M. Proposed Sec.  507.25(b)(1)(iii)--Raw Materials
    N. Proposed Sec.  507.25(b)(2)--Raw Materials Susceptible to 
Mycotoxins
    O. Proposed Sec.  507.25(b)(3)--Raw Materials and Rework (Final 
Sec.  507.25(b)(1)(iii))
    P. Proposed Sec.  507.25(b)(4)--Frozen Raw Materials (Final 
Sec.  507.25(b)(3))
    Q. Proposed Sec.  507.25(c)(1)--Appropriate Conditions for 
Animal Food
    R. Proposed Sec.  507.25(c)(2)--Control of Undesirable 
Microorganisms
    S. Proposed Sec.  507.25(c)(3)--Work-in-Process and Rework
    T. Proposed Sec.  507.25(c)(4)--Processing Steps
    U. Proposed Sec.  507.25(c)(5)--Processing Operations
    V. Proposed Sec.  507.25(c)(6)--Controlling Water Activity (aw)
    W. Proposed Sec.  507.25(c)(7)--Controlling pH
    X. Proposed Sec.  507.25(c)(8)--Ice
XXI. Subpart B: Comments on Proposed Sec.  507.27--Holding and 
Distribution
    A. Proposed Sec.  507.27(a)--Holding and Distribution
    B. Proposed Sec.  507.27(a)(1)--Containers
    C. Proposed Sec.  507.27(a)(2)--Protection From Contamination
    D. Proposed Sec.  507.27(a)(3)--Labeling of Animal Food Held for 
Distribution (Final Sec.  507.27(b))
    E. Proposed Sec.  507.27(b)--Shipping Containers (Final Sec.  
507.27(c))
    F. Proposed Sec.  507.27(c)--Returned Animal Food (Final Sec.  
507.27(d))
    G. Proposed Sec.  507.27(d)--Unpackaged Bulk Animal Food (Final 
Sec.  507.27(e))
XXII. Subpart B: Comments on Proposed Sec.  507.28--Holding and 
Distribution of Human Food By-Products for Use as Animal Food
    A. Proposed Sec.  507.28(a)--Contamination
    B. Proposed Sec.  507.28(a)(1)--Containers
    C. Proposed Sec.  507.28(a)(2)--Protection From Contamination
    D. Proposed Sec.  507.28(a)(3)--Labeling
    E. Proposed Sec.  507.28(b)--Shipping Containers
XXIII. Subpart C: Comments on Overall Framework for Hazard Analysis 
and Risk-Based Preventive Controls
XXIV. Subpart C: Comments on Proposed Sec.  507.31--Food Safety Plan
    A. Proposed Sec.  507.31(a)--Requirement for a Food Safety Plan
    B. Proposed Sec.  507.31(b)--Preparation of the Food Safety Plan 
by a Preventive Controls Qualified Individual
    C. Proposed Sec.  507.31(c)--Contents of a Food Safety Plan
    D. Proposed Sec.  507.31(d)--Records
    E. Comments on Potential Requirements for Submission of a 
Facility Profile to FDA
XXV. Subpart C: Comments on Proposed Sec.  507.33--Hazard Analysis
    A. Proposed Sec.  507.33(a)--Requirement for a Written Hazard 
Analysis
    B. Proposed Sec.  507.33(b)--Hazard Identification
    C. Proposed Sec.  507.33(c) and (d)--Evaluation of Whether a 
Hazard Requires a Preventive Control
XXVI. Subpart C: Comments on Proposed Sec.  507.36--Preventive 
Controls (Final Sec.  507.34)
    A. Proposed Sec.  507.36(a)--Requirement To Identify and 
Implement Preventive Controls (Final Sec.  507.34(a))
    B. Proposed Sec.  507.36(b)--Requirement for Written Preventive 
Controls (Final Sec.  507.34(b))
    C. Proposed Sec.  507.36(c)(1)--Process Controls (Final Sec.  
507.34(c)(1))
    D. Proposed Sec.  507.36(c)(2)--Sanitation Controls (Final Sec.  
507.34(c)(2))
    E. Proposed Sec.  507.36(c)(3)--Supply-Chain Controls (Final 
Sec.  507.34(c)(3))
    F. Proposed Sec.  507.36(c)(4)--Recall Plan (Final Sec.  
507.34(c)(4))
    G. Proposed Sec.  507.36(c)(5)--Other Controls (Final Sec.  
507.34(c)(5))
XXVII. Subpart C: Circumstances in Which the Owner, Operator, or 
Agent in Charge of a Manufacturing/Processing Facility Is Not 
Required To Implement a Preventive Control (Final Sec. Sec.  507.36 
and 507.37)
XXVIII. Subpart C: Comments on Proposed Sec.  507.38--Recall Plan
    A. Proposed Sec.  507.38(a)--Requirement for a Written Recall 
Plan
    B. Proposed Sec.  507.38(b)--Procedures That Describe the Steps 
To Be Taken, and Assign Responsibility for Taking Those Steps
XXIX. Comments on Proposed Sec.  507.39--Preventive Control 
Management Components
    A. Proposed Sec.  507.39(a)--Flexible Requirements for 
Monitoring, Corrective Actions and Corrections, and Verification
    B. Proposed Sec.  507.39(b)--Applicability of Preventive Control 
Management Components to Supply-Chain Program
    C. Proposed Sec.  507.39(c)--Recall Plan is Not Subject to 
Preventive Control Management Components
XXX. Subpart C: Comments on Proposed Sec.  507.40--Monitoring
    A. Our Tentative Conclusion To Require Monitoring of the 
Performance of Preventive Controls
    B. Proposed Sec.  507.40(a) and (b)--Flexibility in Requirements 
for Monitoring
    C. Proposed Sec.  507.40(c)--Records
XXXI. Subpart C: Comments on Proposed Sec.  507.42--Corrective 
Actions and Corrections
    A. Proposed Sec.  507.42(a)(1)(i)--Requirement To Establish and 
Implement Corrective Action Procedures

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    B. Proposed Sec.  507.42(a)(2)--Content of Corrective Action 
Procedures
    C. Proposed Sec.  507.42(b)--Corrective Action in the Event of 
an Unanticipated Problem
    D. Proposed Sec.  507.42(c)--Corrections
    E. Proposed Sec.  507.42(d)--Records
XXXII. Subpart C: Comments on Proposed Sec.  507.45--Verification
    A. Flexibility in Requirements for Verification
    B. Proposed Sec.  507.45(a)--Verification Activities
    C. Proposed Sec.  507.45(b)--Documentation of Verification 
Activities
    D. Comments on Potential Requirements Regarding Complaints
XXXIII. Subpart C: Comments on Proposed Sec.  507.47--Validation
    A. Flexibility in the Requirements To Validate Preventive 
Controls
    B. Proposed Sec.  507.47(b)(1)--When Validation Must Be 
Performed and Role of Preventive Controls Qualified Individual in 
Validation
    C. Proposed Sec.  507.47(b)(2)--What Validation Must Include
    D. Proposed Sec.  507.47(b)(3)--Preventive Controls for Which 
Validation Is Not Required
XXXIV. Subpart C: Comments on Proposed Sec.  507.49--Verification of 
Implementation and Effectiveness
    A. Flexibility in the Requirements To Conduct Activities To 
Verify Implementation and Effectiveness
    B. Proposed Sec.  507.49(a)(1)--Calibration
    C. Comments Directed to Proposed Requirements for Both Product 
Testing (Proposed Sec.  507.49(a)(2) and (b)(2)) and Environmental 
Monitoring (Proposed Sec.  507.49(a)(3) and (b)(3))
    D. Proposed Sec.  507.49(a)(2)--Product Testing
    E. Proposed Sec.  507.49(a)(3)--Environmental Monitoring
    F. Proposed Sec.  507.49(a)(4)--Review of Records
    G. Proposed Sec.  507.49(b)--Written Procedures
XXXV. Subpart C: Comments on Proposed Sec.  507.50--Reanalysis
    A. Proposed Sec.  507.50(a)--Circumstances Requiring Reanalysis
    B. Proposed Sec.  507.50(b)--Timeframe To Complete Reanalysis
    C. Proposed Sec.  507.50(c)--Requirement To Revise the Written 
Food Safety Plan or Document Why Revisions Are Not Needed
    D. Proposed Sec.  507.50(d) --Requirement for Oversight of 
Reanalysis by a Preventive Controls Qualified Individual
    E. Proposed Sec.  507.50(e)--Reanalysis on the Initiative of FDA
XXXVI. Subpart C: Comments on Proposed Sec.  507.51--Modified 
Requirements That Apply to a Facility Solely Engaged in the Storage 
of Unexposed Packaged Animal Food
    A. Proposed Sec.  507.51(a)--Modified Requirements for Unexposed 
Refrigerated Packaged Animal Food That Requires Time/Temperature 
Controls
    B. Proposed Sec.  507.51(b)--Records
XXXVII. Subpart C: Comments on Proposed Sec.  507.53--Requirements 
Applicable to a Preventive Controls Qualified Individual and a 
Qualified Auditor
    A. Proposed Sec.  507.53(a) and (b)--What a Preventive Controls 
Qualified Individual or Qualified Auditor Must Do or Oversee
    B. Proposed Sec.  507.53(c)--Qualification Requirements
    C. Proposed Sec.  507.53(d)--Records
XXXVIII. Subpart C: Comments on Proposed Sec.  507.55--
Implementation Records
XXXIX. Subpart D: Comments on Proposed New Provisions for Withdrawal 
of a Qualified Facility Exemption
    A. Proposed Sec.  507.60--Circumstances That May Lead FDA To 
Withdraw a Qualified Facility Exemption
    B. Proposed Sec.  507.62--Issuance of an Order To Withdraw a 
Qualified Facility Exemption
    C. Proposed Sec.  507.65--Contents of an Order To Withdraw a 
Qualified Facility Exemption
    D. Proposed Sec.  507.67--Compliance With, or Appeal of, an 
Order To Withdraw a Qualified Facility Exemption
    E. Proposed Sec.  507.69--Procedure for Submitting an Appeal
    F. Proposed Sec.  507.71--Procedure for Requesting an Informal 
Hearing
    G. Proposed Sec.  507.73--Requirements Applicable to an Informal 
Hearing
    H. Proposed Sec.  507.85--Reinstatement of a Qualified Facility 
Exemption That Was Withdrawn
    I. Conforming Amendment to 21 CFR Part 16
    J. Other Comments on the Withdrawal Provisions
XL. Subpart E: General Comments on Proposed Requirements Applicable 
to a Supply-Chain Program
XLI. Subpart E: Comments on Requirement To Establish and Implement a 
Supply-Chain Program
    A. Requirement for a Written Supply-Chain Program (Final Sec.  
507.105(a)(1) and (b))
    B. Circumstances That Do Not Require a Written Supply-Chain 
Program (Final Sec.  507.105(a)(2))
    C. Exemption for Animal Food Supplied for Research or Evaluation 
(Final Sec.  507.105(a)(3))
    D. Additional Requirements for Non-Suppliers (Final Sec.  
507.105(c))
    E. Proposed General Requirements for the Supply-Chain Program 
That We Are Not Including in the Final Rule (Proposed Sec.  
507.37(a)(4) and (5))
XLII. Subpart E: Comments on General Requirements for the Supply-
Chain Program
    A. Description of What the Supply-Chain Program Must Include 
(Final Sec.  507.110(a))
    B. Appropriate Supplier Verification Activities ((Final Sec.  
507.110(b))
    C. Purpose of Supplier Verification Activities for Raw Materials 
and Other Ingredients (Final Sec.  507.110(c))
    D. Factors That Must Be Considered When Approving Suppliers and 
Determining Appropriate Supplier Verification Activities for Raw 
Materials and Other Ingredients (Final Sec.  507.110(d))
    E. Supplier Non-Conformance (Final Sec.  507.110(e))
XLIII. Subpart E: New Requirement Specifying the Responsibilities of 
the Receiving Facility (Final Sec.  507.115)
XLIV. Subpart E: Comments on Using Approved Suppliers and 
Determining Appropriate Supplier Verification Activities
    A. Using Approved Suppliers (Final Sec.  507.120)
    B. Determining Appropriate Verification Activities (Final Sec.  
507.125)
XLV. Subpart E: Comments on Conducting Supplier Verification 
Activities for Raw Materials and Other Ingredients
    A. Requirement To Conduct One or More Supplier Verification 
Activities (Final Sec.  507.130(a))
    B. Requirement for an Onsite Audit as a Verification Activity 
When a Hazard Has a Reasonable Probability of Resulting in Serious 
Adverse Health Consequences or Death to Humans or Animals (Final 
Sec.  507.130(b))
    C. Alternative Verification Activity When the Supplier Is a 
Qualified Facility (Final Sec.  507.130(c))
    D. Alternative Verification Activity When the Supplier Is a 
Produce Farm That Is Not a ``Covered Farm'' for the Purposes of the 
Future Produce Safety Rule (Final Sec.  507.130(d))
    E. Alternative Verification Activity When the Supplier Is a 
Shell Egg Producer That Has Less Than 3,000 Laying Hens (Final Sec.  
507.130(e))
    F. Independence of Persons Who Conduct Supplier Verification 
Activities (Final Sec.  507.130(f))
XLVI. Subpart E: Comments on Onsite Audit
    A. Requirements Applicable to an Onsite Audit (Final Sec.  
507.135(a) and (b))
    B. Substitution of Inspection by FDA or an Officially Recognized 
or Equivalent Food Safety Authority
    C. Onsite Audit by a Third-Party Auditor Accredited for the 
Purposes of Section 808 of the FD&C Act
XLVII. Subpart E: Comments on Records Documenting the Supply-Chain 
Program
    A. Applicability of the Recordkeeping Requirements of Subpart F 
(Final Sec.  507.175(a))
    B. Requirement To Review Records of the Supply-Chain Program 
(Final Sec.  507.175(b))
    C. Documentation Demonstrating Use of the Written Procedures for 
Receiving Raw Materials and Other Ingredients (Final Sec.  
507.175(c)(5))
    D. Documentation of the Conduct of an Onsite Audit (Final Sec.  
507.175(c)(7))
    E. Documentation of Sampling and Testing (Final Sec.  
507.175(c)(8))
    F. Documentation of Other Appropriate Supplier Verification 
Activity (Final Sec.  507.175(c)(10))
    G. Documentation of an Alternative Verification Activity for a 
Supplier That Is a Farm That Is Not a ``Covered Farm'' for the 
Purposes of the Future Produce Safety Rule (Final Sec.  
507.175(c)(13))
XLVIII. Subpart F: Comments on Proposed New Recordkeeping 
Requirements
    A. Proposed Sec.  507.200--Records Subject to the Requirements 
of Subpart F and Requirements for Official Review

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    B. Proposed Sec.  507.202--General Requirements Applying to 
Records
    C. Proposed Sec.  507.206--Additional Requirements Applying to 
the Food Safety Plan
    D. Proposed Sec.  507.208--Requirements for Record Retention
    E. Proposed Sec.  507.212--Use of Existing Records
    F. Final Sec.  507.215--Special Requirements Applicable to a 
Written Assurance
XLIX. Comments by Foreign Governments and Foreign Businesses
L. Editorial and Conforming Changes
LI. Comments on FSMA's Rulemaking Provisions
    A. Comments on Section 418(m) of the FDA&C Act Regarding 
Modified Requirements for Facilities Solely Engaged in the 
Production of Food for Animals Other Than Man
    B. Comments on Requirements in Section 418(n)(3) of the FD&C Act 
Regarding Content
LII. Comments on Proposed Conforming Amendments
LIII. Effective and Compliance Dates
    A. Effective and Compliance Dates for Part 507
    B. Effective Dates for Conforming Amendments
    C. Delayed Effective Dates for Provisions That Refer to the 
Forthcoming Rules for Produce Safety and Third-Party Certification
LIV. Compliance and Enforcement
LV. Executive Order 13175
LVI. Economic Analysis of Impacts
LVII. Analysis of Environmental Impact
LVIII. Paperwork Reduction Act of 1995
LIX. Federalism
LX. References

Executive Summary

Purpose and Coverage of the Rule

    This rule is part of FDA's implementation of FSMA, which intends to 
better protect public (human and animal) health by, among other things, 
adopting a modern, preventive, and risk-based approach to food safety 
regulation. This rule establishes new requirements for the production 
of animal food by registered food facilities in two ways.
    First, this rule creates new CGMP regulations that specifically 
address the manufacturing, processing, packing, and holding of food for 
animals. These requirements apply to establishments that are required 
to register with FDA as a food ``facility.'' Second, this rule creates 
new requirements for certain domestic and foreign facilities to 
establish and implement hazard analysis and risk-based preventive 
controls for food for animals. As with the CGMPs, these requirements 
apply to establishments that are required to register with FDA as a 
food facility. This portion of the rule requires registered animal food 
facilities to maintain a food safety plan, perform a hazard analysis, 
and institute preventive controls for the mitigation of those hazards, 
unless an exemption applies. Facilities must also monitor their 
controls, conduct verification activities to ensure the controls are 
effective, take appropriate corrective actions, and maintain records 
documenting these actions.
    This final rule is the result of significant stakeholder 
engagement, beginning before the proposed rule. In response to 
extensive stakeholder input on the proposed rule, we revised key 
provisions in a supplemental notice of proposed rulemaking. After the 
supplemental notice of proposed rulemaking, we conducted even more 
outreach to the stakeholder community to ensure that the risk-based, 
preventive requirements in this final rule are practical and protective 
of public (human and animal) health.

Summary of the Major Provisions of the Rule

    The final rule establishes CGMP provisions to ensure the safety and 
suitability of animal food. Specifically, the rule establishes 
requirements in the following areas:
     Personnel;
     Plant and grounds;
     Sanitation;
     Water supply and plumbing;
     Equipment and utensils;
     Plant operations;
     Holding and distribution; and
     Holding and distribution of human food by-products for use 
as animal food.
    We have added flexibility and clarity to the CGMPs in response to 
comments. These CGMPs establish baseline standards for producing safe 
animal food that take into consideration the unique aspects of the 
animal food industry and provide flexibility for the wide diversity in 
types of animal food facilities. In addition, the CGMPs in this final 
regulation allow human food facilities subject to and in compliance 
with CGMPs for human food and in compliance with all applicable FDA 
human food safety requirements to only follow the specific CGMPs for 
the holding and distribution of human food by-products for use as 
animal food, as long as they do not further process the by-product. 
Under this final rule, all other requirements of part 507, including 
the hazard analysis, preventive controls and supply-chain program 
provisions, would not apply to these by-products of human food 
production.
    The final rule implements the requirements of FSMA for covered 
facilities to establish and implement a food safety system that 
includes a hazard analysis and risk-based preventive controls. 
Specifically, the rule establishes requirements for:
     A written food safety plan;
     Hazard analysis;
     Preventive controls;
     Monitoring;
     Corrective actions and corrections;
     Verification;
     Supply-chain program;
     Recall plan; and
     Associated records.
    We have added flexibility and clarity to these provisions in 
response to comments. Although there are similarities between these 
requirements of FSMA and the requirements of food safety systems known 
as Hazard Analysis and Critical Control Point (HACCP) systems, not 
every provision in FSMA is identical to the provisions of HACCP 
systems, and we have revised much of our terminology to distinguish 
FSMA's requirements for hazard analysis and risk-based preventive 
controls from HACCP requirements. A facility subject to the rule must 
conduct a hazard analysis to identify and evaluate known or reasonably 
foreseeable hazards for each type of animal food manufactured, 
processed, packed, or held at the facility to determine whether there 
are any hazards requiring preventive controls. The first step of a 
hazard analysis is hazard identification, which must consider known or 
reasonably foreseeable hazards, including biological, chemical, and 
physical hazards. The hazard analysis must consider hazards that may be 
present in the animal food because they occur naturally, are 
unintentionally introduced, or are intentionally introduced for 
purposes of economic gain. We continue to believe that hazards that may 
be intentionally introduced for economic gain will need preventive 
controls in rare circumstances, usually in cases where there has been a 
pattern of economically motivated adulteration in the past. 
Economically motivated adulteration that affects product integrity or 
quality, for example, but not animal food safety, is out of the scope 
of this rule.
    A facility subject to the rule must identify and implement 
preventive controls to provide assurances that any hazards requiring a 
preventive control will be significantly minimized or prevented and the 
animal food manufactured, processed, packed, or held by the facility 
will not be adulterated. The rule establishes preventive control 
management components (monitoring, corrective actions and corrections, 
and verification) as appropriate to ensure the

[[Page 56174]]

effectiveness of the preventive controls. One way we have clarified the 
risk-based flexibility of these requirements is by clearly stating in 
the final rule that a facility must take into account the nature of the 
preventive control and the facility's food safety system when 
considering which activities are appropriate for that facility.
    We have also added flexibility and made risk-based modifications 
for specific preventive control management components. For example, the 
final rule allows flexibility for the specific records required to 
document monitoring of refrigeration controls during storage of an 
animal food that requires time/temperature control for safety. These 
records can be either affirmative records demonstrating temperature is 
controlled or ``exception records'' demonstrating loss of temperature 
control. As another example, the rule includes tailored, less 
burdensome requirements for corrections. A correction is defined in 
this rule as an action to identify and correct a problem that occurred 
during the production of animal food, without other actions associated 
with a corrective action procedure (such as actions to reduce the 
likelihood that the problem will recur, evaluate all affected food for 
safety, and prevent affected animal food from entering commerce). The 
final rule clarifies that corrections must be taken in a timely manner 
and must be recorded when appropriate, but they do not, for example, 
need to be included in a written plan or accompanied by a reanalysis of 
the written food safety plan.
    As a third example, the final rule provides flexibility for which 
verification activities must occur. In general, a facility is required 
to conduct verification activities, as appropriate to the nature of the 
preventive control and its role in the facility's food safety system, 
including validation, verification of monitoring, verification of 
corrective actions, verification of implementation and effectiveness, 
and reanalysis. Validation is not required for all controls. For 
example, the rule specifies that validation is not required for certain 
types of preventive controls (i.e., sanitation controls, supply-chain 
controls, and the recall plan) and provides flexibility for the 
facility to not validate other preventive controls with a written 
justification based on factors such as the nature of the hazard, and 
the nature of the preventive control and its role in the facility's 
food safety system. Product testing and environmental monitoring are 
listed as possible verification activities, but, like other preventive 
control management components in general, they are only required as 
appropriate to the animal food, facility, the nature of the preventive 
control, and the preventive control's role in the facility's food 
safety system. In many cases, neither product testing nor environmental 
monitoring will be appropriate. For example, there would be little or 
no benefit to product testing or environmental monitoring in facilities 
that pack or hold raw agricultural commodities that are rarely consumed 
unprocessed, such as soybeans.
    A facility must reanalyze the food safety plan as a whole at least 
once every 3 years. The final rule provides the flexibility for a 
facility to only reanalyze the applicable portion of the food safety 
plan under certain other circumstances, such as when a facility becomes 
aware of new information about potential hazards associated with an 
animal food.
    The final rule also adds flexibility to the preventive controls 
requirements and recognizes the reality of modern distribution chains 
by not requiring a manufacturing/processing facility to implement a 
preventive control in certain circumstances when the hazard requiring a 
preventive control will be controlled by another entity in the 
distribution chain. For example, if a facility's customer (or another 
entity in the distribution chain) will control the hazard, then that 
facility can rely on its customer to provide written assurance that the 
identified hazard will be controlled by an entity in the distribution 
chain, with flexibility for how the customer provides that written 
assurance depending on whether the customer, or an entity subsequent to 
the customer, will control the hazard. We have identified four specific 
circumstances in which a manufacturing/processing facility can rely on 
another entity in the distribution chain to control a hazard, with 
practical solutions explained further in section XXVII. We also have 
provided flexibility for a facility to establish, document, and 
implement an alternative system that ensures adequate control, at a 
later distribution step, of the hazards in the food product distributed 
by a manufacturing/processing facility such that the facility would not 
need to implement a preventive control.
    We revised the proposed provisions for a supplier program to add 
flexibility, recognizing that the receiving facility and the supplier 
may be separated by several entities in a supply chain. We are allowing 
entities such as distributors, brokers, and aggregators to determine, 
conduct, and document appropriate supplier verification activities as a 
service to the receiving facility, provided that the receiving facility 
reviews and assesses applicable documentation provided by the other 
entity and documents that review and assessment. However, because the 
approval of suppliers is ultimately the responsibility of the receiving 
facility, the rule specifies that only a receiving facility can approve 
suppliers. To improve clarity and readability we redesignated the 
proposed provisions into eight distinct sections of regulatory text in 
a newly established subpart E (Supply-Chain Program).
    Each facility subject to the rule must have a recall plan for an 
animal food with a hazard requiring a preventive control.
    Many activities required by the final rule must be conducted (or 
overseen) by a preventive controls qualified individual, a new term we 
are coining here. A preventive controls qualified individual is a 
qualified individual who has successfully completed certain training in 
the development and application of risk-based preventive controls or is 
otherwise qualified through job experience to develop and apply a food 
safety system.
    The rule establishes several exemptions (including modified 
requirements in some cases) from the requirements for hazard analysis 
and risk-based preventive controls. All of these exemptions are 
expressly authorized by FSMA. A facility that manufactures, processes, 
packs, or holds food and that is required to register with FDA would be 
required to comply with the requirements for hazard analysis and risk-
based preventive controls unless it is covered by an exemption, as 
shown in the following table.

[[Page 56175]]



  Proposed Exemptions From the New Requirements for Hazard Analysis and
                     Risk-Based Preventive Controls
------------------------------------------------------------------------
     Who or what is exempt from the
  requirements for hazard analysis and                Notes
     risk-based preventive controls
------------------------------------------------------------------------
``Qualified Facility'' as defined by     Modified requirements apply--
 FSMA:                                    i.e., a qualified facility is
Business with average annual sales of     required to:
 <$500,000 and at least half the sales    Notify FDA about its
 to consumers or local retailers or       status and either:
 restaurants (within the same state or   [cir] Notify FDA that it is
 within 275 miles); or                    addressing hazards through
 Very small business, which the   preventive controls and
 rule defines as a business (including    monitoring; or
 any subsidiaries or affiliates)         [cir] Notify FDA that it
 averaging less than $2,500,000,          complies with applicable non-
 adjusted for inflation, per year,        Federal food safety
 during the 3-year period preceding the   regulations, and notify
 applicable calendar year in sales of     consumers of the name and
 animal food plus the market value of     complete business address of
 animal food manufactured, processed,     the facility where the animal
 packed, or held without sale (e.g.,      food was manufactured or
 held for a fee or supplied to a farm     processed.
 without sale)                            The notification is in
                                          the form of an attestation,
                                          and must be submitted every 2
                                          years, during the same
                                          timeframe as the facility is
                                          required to update its
                                          facility registration.
 Low-risk, on-farm activities    Small and very small on-farm
 performed by small business (<500 full-  businesses conducting only the
 time equivalent employees).              specified low-risk activities
                                          are exempt from the
                                          requirements for hazard
                                          analysis and risk-based
                                          preventive controls.
-or-
 Low-risk, on-farm activities    We define the low-risk, on-farm
 performed by a very small business       activities that qualify for
 (dollar threshold of $2,500,000, as      the exemption, including the
 described previously).                   specific animal foods to which
                                          they relate (such as re-
                                          packing roughage products, or
                                          cracking grains).
Activities that are subject to the        The exemption applies
 ``low-acid canned food'' requirements    only with respect to
 of part 113 (21 CFR part 113).           microbiological hazards
                                          regulated under part 113.
                                          The facility must be
                                          in compliance with part 113.
Activities of a facility that are        These activities will be
 subject to section 419 of the Federal    established in FDA's
 Food, Drug, and Cosmetic Act             forthcoming rule for produce
 (Standards for Produce Safety) (21       safety.
 U.S.C. 350h).
Facilities that are solely engaged in    A facility that stores raw
 the storage of raw agricultural          agricultural commodities that
 commodities (other than fruits and       are fruits and vegetables is
 vegetables) intended for further         not exempt.
 distribution or processing.
A facility solely engaged in the         Modified requirements apply for
 storage of unexposed packaged animal     the storage of unexposed
 food that does not require time/         packaged animal food that
 temperature control to significantly     requires time/temperature
 minimize or prevent the growth of, or    control to significantly
 toxin production by, pathogens.          minimize or prevent the growth
                                          of, or toxin production by,
                                          pathogens.
------------------------------------------------------------------------

    The rule includes procedures for withdrawing a qualified facility 
exemption, in the event of an active investigation of a foodborne 
illness outbreak that is directly linked to the facility, or if FDA 
determines that it is necessary to protect the public (human and 
animal) health and prevent or mitigate a foodborne illness outbreak 
based on relevant conditions or conduct associated with the qualified 
facility. The final rule provides procedures for a facility to appeal 
an order to withdraw a qualified facility exemption, for a facility to 
request an informal hearing, for the conduct of an informal hearing, 
for an appeal, for revoking an order to withdraw a qualified facility 
exemption, and for reinstating an exemption that was withdrawn.
    The rule finalizes recordkeeping provisions associated with the new 
provisions for hazard analysis and risk-based preventive controls. 
These records allow facilities to show, and FDA to determine, 
compliance with the new requirements. To meet these requirements, a 
facility may use existing records as appropriate.

Costs and Benefits

    This final regulation requires domestic and foreign facilities to 
adopt a food safety plan, perform a hazard analysis, and to institute 
preventive controls for the mitigation of those hazards identified as 
requiring a preventive control. It also includes requirements for 
facilities to institute risk-based environmental monitoring, product 
testing, and a supply-chain program as appropriate to the animal food, 
the facility and the nature of the preventive controls, as well as a 
requirement to institute controls to help prevent hazards associated 
with economically motivated adulteration. The total annualized costs 
are estimated at $139.0 to $170.7 million per year (over 10 years at a 
7 percent discount rate), and $135.6 to $166.7 million per year (over 
10 years at a 3 percent discount rate). The total annualized benefits 
to pets are estimated at $10.1-$138.0 million.

                                       Estimated Total Costs and Benefits
                                                   [Millions]
----------------------------------------------------------------------------------------------------------------
                                                                           Total  annualized   Total  annualized
                                       One-time             Annual          cost at 7% \1\      cost at 3% \1\
----------------------------------------------------------------------------------------------------------------
Total Costs.....................    $135.6 to $160.1    $119.7 to $147.9    $139.0 to $170.7    $135.6 to $166.7
Total Benefits to Pets..........             \2\ N/A     $10.1 to $138.0     $10.1 to $138.0     $10.1 to $138.0
----------------------------------------------------------------------------------------------------------------
\1\ Total annualized cost equal to annualized one-time cost plus annual cost.
\2\ N/A = Not applicable


[[Page 56176]]


                   Table of Abbreviations and Acronyms
------------------------------------------------------------------------
     Abbreviation/Acronym                    What it means
------------------------------------------------------------------------
AAFCO........................  Association of American Feed Control
                                Officials.
AFSS.........................  Animal Feed Safety System.
BAM..........................  Bacteriological Analytical Method.
Bioterrorism Act.............  Public Health Security and Bioterrorism
                                Preparedness and Response Act of 2002
                                (Pub. L. 107-188).
CCP..........................  Critical Control Point.
CFR..........................  Code of Federal Regulations.
CGMP.........................  Current Good Manufacturing Practice.
Codex........................  Codex Alimentarius Commission.
CPG..........................  Compliance Policy Guide.
CVM..........................  Center for Veterinary Medicine.
EPA..........................  U.S. Environmental Protection Agency.
EU...........................  European Union.
FDA..........................  U.S. Food and Drug Administration.
FD&C Act.....................  Federal Food, Drug, and Cosmetic Act.
FOIA.........................  Freedom of Information Act.
FSIS.........................  Food Safety and Inspection Service of the
                                U.S. Department of Agriculture.
FSIS Validation Guidelines...  FSIS' Compliance Guidelines on HACCP
                                Systems Validation.
FSMA.........................  FDA Food Safety Modernization Act.
FSPCA........................  Food Safety Preventive Controls Alliance.
FSVP.........................  Foreign Supplier Verification Programs.
GAP..........................  Good Agricultural Practices.
GFSI.........................  Global Food Safety Initiative.
GRAS.........................  Generally Recognized as Safe.
HACCP........................  Hazard Analysis and Critical Control
                                Point.
HHS..........................  U.S. Department of Health and Human
                                Services.
ISO..........................  International Organization for
                                Standardization.
LACF.........................  Thermally processed low-acid foods
                                packaged in hermetically sealed contain
                                (commonly called ``low-acid canned
                                foods'').
N/A..........................  Not Applicable.
NACMCF.......................  The National Advisory Committee on
                                Microbiological Criteria for Foods
                                (advisory committee chartered under the
                                USDA).
NIFA.........................  National Institute of Food and
                                Agriculture of the U.S. Department of
                                Agriculture.
OMB..........................  Office of Management and Budget.
PAS..........................  British Standards Institute ``Publically
                                Available Specification 222:2011''.
PFP..........................  Partnership for Food Protection.
PHS..........................  Public Health Service Act.
PRA..........................  Paperwork Reduction Act.
PSA..........................  Protein Surveillance Assignment.
RA...........................  Risk Assessment.
RAC..........................  Raw Agricultural Commodity.
RFR..........................  Reportable Food Registry.
Section 103(c)(1)(C) draft RA  Draft Qualitative Risk Assessment of Risk
                                of Activity/Food Combinations for
                                Activities (Outside the Farm Definition)
                                Conducted in a Facility Co-Located on a
                                Farm.
Section 103(c)(1)(C) RA......  Qualitative Risk Assessment of Risk of
                                Activity/Food Combinations for
                                Activities (Outside the Farm Definition)
                                Conducted in a Facility Co-Located on a
                                Farm (Final).
TCS..........................  Time/Temperature Control for Safe Animal
                                Food.
USDA.........................  U.S. Department of Agriculture.
------------------------------------------------------------------------

I. Background

A. FDA Food Safety Modernization Act

    The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353), 
signed into law by President Obama on January 4, 2011, is intended to 
allow FDA to better protect public (human and animal) health by helping 
to ensure the safety and security of the food supply. FSMA enables us 
to focus more on preventing food safety problems rather than relying 
primarily on reacting to problems after they occur. The law also 
provides new enforcement authorities to help achieve higher rates of 
compliance with risk-based, prevention-oriented safety standards and to 
better respond to and contain problems when they do occur. In addition, 
the law contains important new tools to better ensure the safety of 
imported foods and encourages partnerships with State, local, tribal, 
and territorial authorities. A top priority for FDA are those FSMA-
required regulations that provide the framework for industry's 
implementation of preventive controls and enhance our ability to 
oversee their implementation for both domestic and imported animal 
food. To that end, we proposed the seven foundational rules listed in 
table 1 and requested comments on all aspects of these proposed rules.

    Table 1--Published Foundational Rules for Implementation of FSMA
------------------------------------------------------------------------
              Title                  Abbreviation         Publication
------------------------------------------------------------------------
Current Good Manufacturing        2013 proposed rule  78 FR 64736,
 Practice and Hazard Analysis      for preventive      October 29, 2013.
 and Risk-Based Preventive         controls for
 Controls for Food for Animals.    animal food.

[[Page 56177]]

 
Current Good Manufacturing        2013 proposed rule  78 FR 3646,
 Practice and Hazard Analysis      for preventive      January 16, 2013.
 and Risk-Based Preventive         controls for
 Controls for Human Food.          human food.
Standards for the Growing,        2013 proposed       78 FR 3504,
 Harvesting, Packing, and          produce safety      January 16, 2013.
 Holding of Produce for Human      rule.
 Consumption.
Foreign Supplier Verification     2013 proposed FSVP  78 FR 45730, July
 Programs (FSVP) for Importers     rule.               29, 2013.
 of Food for Humans and Animals.
Accreditation of Third-Party      2013 proposed       78 FR 45782, July
 Auditors/Certification Bodies     third-party         29, 2013.
 to Conduct Food Safety Audits     certification
 and to Issue Certifications.      rule.
Focused Mitigation Strategies To  2013 proposed       78 FR 78014,
 Protect Food Against              intentional         December 24,
 Intentional Adulteration.         adulteration rule   2013.
                                   (human food only).
Sanitary Transportation of Human  2014 proposed       79 FR 7006,
 and Animal Food.                  sanitary            February 5, 2014.
                                   transportation
                                   rule.
------------------------------------------------------------------------

    We also issued a supplemental notice of proposed rulemaking for the 
rules listed in table 2 and requested comments on specific issues 
identified in each supplemental notice of proposed rulemaking.

 Table 2--Published Supplemental Notices of Proposed Rulemaking for the
              Foundational Rules for Implementation of FSMA
------------------------------------------------------------------------
              Title                  Abbreviation         Publication
------------------------------------------------------------------------
Current Good Manufacturing        2014 supplemental   79 FR 58476,
 Practice and Hazard Analysis      notice.             September 29,
 and Risk-Based Preventive                             2014.
 Controls for Food for Animals.
Current Good Manufacturing        2014 supplemental   79 FR 58524,
 Practice and Hazard Analysis      human preventive    September 29,
 and Risk-Based Preventive         controls notice.    2014.
 Controls for Human Food.
Standards for the Growing,        2014 supplemental   79 FR 58434,
 Harvesting, Packing, and          produce safety      September 29,
 Holding of Produce for Human      notice.             2014.
 Consumption.
Foreign Supplier Verification     2014 supplemental   79 FR 58574,
 Programs (FSVP) for Importers     FSVP notice.        September 29,
 of Food for Humans and Animals.                       2014.
------------------------------------------------------------------------

    As FDA finalizes these seven foundational rulemakings, we are 
putting in place a framework for food safety that is modern and brings 
to bear the most recent science on provisions to enhance food safety, 
that is risk-based and focuses effort where the hazards are reasonably 
likely to occur, and that is flexible and practical given our current 
knowledge of food safety practices. To achieve this, FDA has engaged in 
a great deal of outreach to the stakeholder community to find the right 
balance in these regulations of flexibility and accountability.
    Since FSMA was enacted in 2011, we have been involved in 
approximately 600 engagements on FSMA and the proposed rules, including 
public meetings, Webinars, listening sessions, farm tours, and 
extensive presentations and meetings with various stakeholder groups 
(Refs. 1 and 2). As a result of this stakeholder dialogue, FDA decided 
to issue the four supplemental notices of proposed rulemaking to share 
our thinking on key issues and get additional stakeholder input on 
those issues. As we move forward into the next phase of FSMA 
implementation, we intend to continue this dialogue and collaboration 
with our stakeholders, through guidance, education, training, and 
assistance, to ensure that everyone understands and engages in their 
role in food safety. FDA believes these seven foundational final rules, 
when implemented, will fulfill the paradigm shift toward prevention 
that was envisioned in FSMA and be a major step forward for food safety 
that will protect consumers into the future.

B. Stages in the Rulemaking for the Animal Food Preventive Controls 
Rule

    With regard to this rulemaking, we published proposed provisions in 
the 2013 proposed animal food preventive controls rule and we published 
new and re-proposed provisions in the 2014 supplemental notice. In the 
2014 supplemental notice, we reopened the comment period only with 
respect to specific proposed provisions. In addition, we emphasized 
that the re-proposed provisions we included in the regulatory text were 
based on a preliminary review of the comments.
    In this document, we use the broad term ``proposed animal food 
preventive controls rule'' to refer to the complete proposed regulatory 
text, including both the proposed provisions we published in the 2013 
proposed animal food preventive controls rule and the new and re-
proposed provisions we published in the 2014 supplemental notice. We 
use the narrow terms ``2013 proposed preventive controls rule for 
animal food'' and ``2014 supplemental notice'' to refer to specific 
text published in the Federal Register of October 29, 2013 (78 FR 
64736) and September 29, 2014 (79 FR 58476), respectively. We use the 
terms ``final preventive controls rule for animal food'' and ``this 
rule'' to refer to the regulations we are establishing as a result of 
this rulemaking.

C. Summary of the Major Provisions of Proposed Rule for Preventive 
Controls for Food for Animals

    As part of our implementation of new statutory provisions in FSMA, 
we proposed to add, in newly established part 507, regulations for 
CGMPs. In addition, we proposed to add requirements for certain 
domestic and foreign facilities to establish and implement hazard 
analysis and risk-based preventive controls for food for animals. As 
directed by FSMA (see section 418 of the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) (21 U.S.C. 350g)), these new provisions would 
apply to domestic and foreign facilities that are required to register 
under section 415 of the FD&C Act (21 U.S.C. 350d) and our regulation 
for Registration of Food Facilities (21 CFR part 1, subpart H; the 
section 415 registration regulations). As directed by FSMA (see section 
418(l) and (m) of the FD&C Act), we proposed to establish

[[Page 56178]]

modified requirements for certain facilities. We requested comment on 
all aspects of the proposed requirements, including an opportunity for 
public comment on potential requirements for product testing, 
environmental monitoring, a supplier program, and hazards that may be 
intentionally introduced for purposes of economic gain.
    We proposed to establish the requirements for CGMPs, for hazard 
analysis and risk-based preventive controls, and related requirements 
in new 21 CFR 507 as shown in table 3:

               Table 3--Proposed Subparts in New Part 507
------------------------------------------------------------------------
              Subpart                               Title
------------------------------------------------------------------------
A.................................  General Provisions.
B.................................  Current Good Manufacturing Practice.
C.................................  Hazard Analysis and Risk-Based
                                     Preventive Controls.
D.................................  Withdrawal of an Exemption
                                     Applicable to a Qualified Facility.
E.................................  Reserved.
F.................................  Requirements Applying to Records
                                     That Must be Established and
                                     Maintained.
------------------------------------------------------------------------

D. Draft Risk Assessment

    We issued for public comment a ``Draft Qualitative Risk Assessment 
of Risk of Activity/Animal Food Combinations for Activities (Outside 
the Farm Definition) Conducted in a Facility Co-Located on a Farm'' 
(the section 103(c)(1)(C) draft risk assessment (RA)) (78 FR 64428, 
October 29, 2013). The purpose of the section 103(c)(1)(C) draft RA was 
to provide a science-based risk analysis of those activity/animal food 
combinations that would be considered low risk when conducted in a 
facility co-located on a farm. We used the tentative conclusions of the 
section 103(c)(1)(C) draft RA to propose to exempt food facilities that 
are small or very small businesses that are engaged only in specific 
types of on-farm manufacturing, processing, packing, or holding 
activities from the requirements for hazard analysis and risk-based 
preventive controls. We are including the final risk assessment (the 
section 103(c)(1)(C) RA) in the docket established for this document 
(Ref. 3).

E. Public Comments

    We received more than 2400 public submissions on the 2013 proposed 
preventive controls rule for animal food, and more than 140 public 
submissions on the 2014 preventive controls supplement notice, each 
containing one or more comments. We received submissions from diverse 
members of the public, including animal food facilities (including 
facilities co-located on a farm); farms; cooperatives; coalitions; 
trade organizations; consulting firms; law firms; academia; public 
health organizations; public advocacy groups; consumers; pet owners, 
consumer groups; Congress, Federal, State, local, and foreign 
Government Agencies; and other organizations. Some submissions included 
signatures and statements from multiple individuals. Comments address 
virtually every provision of the proposed animal preventive controls 
rule. In the remainder of this document, we describe these comments, 
respond to them, and explain any revisions we made to the proposed 
preventive controls rule for animal food.
    Some comments address issues that are outside the scope of this 
rule. For example, some comments ask for more inspections of pet food 
facilities. Other comments express concern about the use of 
bioengineered animal food ingredients, and ask that animal foods 
containing such ingredients not be used in pet food. Other comments 
have concerns with FDA's general obligations for the outcome of 
regulations it issues and implements, general concerns with FDA's 
regulation and oversight of industry, concerns about banning specific 
products or imports from specific countries, testing procedures at the 
borders, and concerns about animal food marketing. We do not discuss 
such comments in this document.

II. Legal Authority

    The proposed rule contained an explanation of its legal basis under 
authorities in FSMA, the FD&C Act, and the Public Health Service Act 
(the PHS Act). After considering comments received in response to the 
2013 proposed rule and the 2014 supplemental notice, we made changes in 
the final rule. The legal authorities relied on for the final rule are 
generally the same as in the proposed rule unless otherwise described.

A. Current Good Manufacturing Practice Regulations

    The CGMP regulations finalized in this document establish current 
good manufacturing practice requirements for the manufacturing, 
processing, packing and holding of animal food. FDA's legal authority 
to require current good manufacturing practice derives from sections 
402(a)(3) and (4) and 701(a) of the FD&C Act (21 U.S.C. 342(a)(3) and 
(4), and 371(a)). Section 402(a)(3) of the FD&C Act provides that a 
food is adulterated if it consists in whole or in part of any filthy, 
putrid, or decomposed substance, or if it is otherwise unfit for food. 
Section 402(a)(4) of the FD&C Act provides that a food is adulterated 
if it has been prepared, packed, or held under insanitary conditions 
whereby it may have become contaminated with filth, or whereby it may 
have been rendered injurious to health. Under section 701(a) of the 
FD&C Act, FDA is authorized to issue regulations for the efficient 
enforcement of the FD&C Act. The CGMP regulations we are establishing 
are necessary to prevent animal food from containing filthy, putrid, or 
decomposed substances, being otherwise unfit for food, or being 
prepared, packed, or held under insanitary conditions whereby it may 
have become contaminated with filth, or whereby it may have been 
rendered injurious to health.
    In addition to the FD&C Act, FDA's legal authority for establishing 
CGMP requirements derives from the PHS Act to the extent such measures 
are related to communicable disease. Authority under the PHS Act is 
derived from the provisions of sections 311, 361, and 368 (42 U.S.C. 
243, 264, and 271) that relate to communicable disease. The PHS Act 
authorizes the Secretary to make and enforce such regulations as ``are 
necessary to prevent the introduction, transmission, or spread of 
communicable diseases from foreign countries into the States * * * or 
from one State * * * into any other State'' (section 361(a) of the PHS 
Act). (See sec. 1, Reorg. Plan No. 3 of 1966 at 42 U.S.C. 202 for 
transfer of authority from the Surgeon General to the Secretary.) The 
CGMP regulations are necessary to prevent the spread of communicable 
disease.
    The CGMP regulations finalized in this document include limited 
labeling requirements. These requirements are partly to help prevent 
accidental co-mingling or mix-ups of products at the facility, which 
could result in contaminated animal food. Thus, FDA's legal authority 
for these requirements derives from its authority to require current 
good manufacturing practice. The labeling requirements also are 
intended to enable animal producers and owners, and facilities 
receiving the animal food for further manufacture, to use the animal 
food appropriately. Accordingly, the requirements are supported by 
section 403(a)(1) of the FD&C Act, which states that a food is 
misbranded if its labeling is false or misleading in any particular, 
and by section 403(i) of the FD&C Act, which states that a food is 
misbranded unless

[[Page 56179]]

its label bears the common or usual name of the food or its 
ingredients.

B. Hazard Analysis and Risk-Based Preventive Controls

    Section 103 of FSMA, Hazard Analysis and Risk-Based Preventive 
Controls, amends the FD&C Act to create a new section 418, which 
mandates rulemaking. Section 418(n)(1)(A) of the FD&C Act requires that 
the Secretary issue regulations ``to establish science-based minimum 
standards for conducting a hazard analysis, documenting hazards, 
implementing preventive controls, and documenting the implementation of 
the preventive controls. . . .'' Section 418(n)(1)(B) of the FD&C Act 
requires that the regulations define the terms ``small business'' and 
``very small business,'' taking into consideration the study of the 
food processing sector required by section 418(l)(5) of the FD&C Act. 
Further, section 103(e) of FSMA creates a new section 301(uu) in the 
FD&C Act (21 U.S.C. 331(uu)) to prohibit ``(t)he operation of a 
facility that manufactures, processes, packs, or holds food for sale in 
the United States if the owner, operator, or agent in charge of such 
facility is not in compliance with section 418 (of the FD&C Act).''
    In addition to rulemaking requirements, section 418 contains 
requirements applicable to the owner, operator, or agent in charge of a 
facility required to register under section 415. Section 418(a) is a 
general provision that requires the owner, operator, or agent in charge 
of a facility to evaluate the hazards that could affect food 
manufactured, processed, packed, or held by the facility, identify and 
implement preventive controls, monitor the performance of those 
controls, and maintain records of the monitoring. Section 418(a) 
specifies that the purpose of the preventive controls is to ``prevent 
the occurrence of such hazards and provide assurances that such food is 
not adulterated under section 402 (of the FD&C Act). . . .'' In 
addition to the general requirements in section 418(a) of the FD&C Act, 
sections 418(b) to (i) contain more specific requirements applicable to 
facilities. These include hazard analysis (section 418(b)), preventive 
controls (section 418(c)), monitoring (section 418(d)), corrective 
actions (section 418(e)), verification (section 418(f)), recordkeeping 
(section 418(g)), a written plan and documentation (section 418(h)), 
and reanalysis of hazards (section 418(i)).
    Section 103(c)(2)(C) of FSMA requires that the Secretary adopt a 
final rule with respect to the requirements under sections 418 and 421 
of the FD&C Act from which the Secretary may issue exemptions or 
modifications of the requirements for certain types of facilities. 
Sections 418(j) to (m) of the FD&C Act and sections 103(c)(1)(D) and 
(g) of FSMA provide authority for certain exemptions and modifications 
to the requirements of section 418 of the FD&C Act. These include 
provisions related to low-acid canned food (section 418(j)); activities 
of facilities subject to section 419 of the FD&C Act (Standards for 
Produce Safety) (section 418(k)); qualified facilities (section 
418(l)); facilities that are solely engaged in the production of food 
for animals other than man, the storage of raw agricultural commodities 
(other than fruits and vegetables) intended for further distribution or 
processing, or the storage of packaged foods that are not exposed to 
the environment (section 418(m)); and facilities engaged only in 
certain low-risk on-farm activities on certain foods conducted by small 
or very small businesses (section 103(c)(1)(D) of FSMA). In sections X, 
XI, XII, and XXXVI we discuss provisions that implement these 
exemptions and modified requirements.
    In the supplemental notice, we included potential requirements for 
a supplier program, environmental monitoring, and product testing. We 
are including provisions for such activities in the final rule. Section 
418(o)(3) of the FD&C Act provides supplier verification activities and 
an environmental monitoring program as examples of preventive controls. 
Section 418(f)(4) of the FD&C Act provides for the use of environmental 
and product testing programs as part of required verification that the 
preventive controls are effectively and significantly minimizing or 
preventing the occurrence of identified hazards.
    In certain circumstances, the final rule does not require a 
manufacturing/processing facility to implement a preventive control for 
a hazard requiring a preventive control. Instead, the facility is 
permitted to rely on a subsequent entity in the distribution chain to 
significantly minimize or prevent the hazard. In such a circumstance, a 
facility must disclose in documents accompanying the animal food, that 
the food is ``not processed to control [identified hazard].'' This 
requirement is supported by sections 418 and 701(a) of the FD&C Act (21 
U.S.C. 350g and 371(a)). The requirement that facilities apply 
preventive controls to significantly minimize or prevent hazards is 
fundamental to the public health benefits of the rule. To accommodate 
the realities of modern food production, the rule allows a facility to 
rely on a subsequent entity in the distribution chain rather than 
requiring that facility to apply the control. An animal food may pass 
through multiple entities in the distribution chain before it reaches 
consumers. Further, ordinarily it is not apparent from visual 
examination of the animal food whether a hazard requiring a preventive 
control has been addressed. Consequently, without labeling, a facility 
might not know that a facility upstream in the supply chain has not 
applied a preventive control and is relying on a downstream entity to 
do so. Therefore, the agency concludes that information that animal 
food has not been processed to control an identified hazard is 
necessary for a facility to fulfil its obligation under section 418 
when a facility is relying on a subsequent entity to control the 
hazard. The agency also concludes that such labeling is necessary for 
the efficient enforcement of the FD&C Act because the labelling is 
critical for FDA to hold facilities responsible for their obligations 
under this regulatory scheme. Further, when the hazard can cause a 
communicable disease, FDA concludes that the requirement is necessary 
to prevent the spread of communicable disease from one state into 
another state and relies on sections 311, 361, and 368 of the PHS Act.
    FDA concludes that the provisions in subpart C and related 
requirements in subparts A, E and F should be applicable to activities 
that are intrastate in character. Facilities are required to register 
under section 415 of the FD&C Act regardless of whether the food from 
the facility enters interstate commerce (Sec.  1.225(b) (21 CFR 
1.225(b))). The plain language of section 418 of the FD&C Act applies 
to facilities that are required to register under section 415 (section 
418(o)(2) of the FD&C Act) and does not exclude a facility from the 
requirements because food from such a facility is not in interstate 
commerce. Further, the prohibited act provision associated with section 
418 (section 301(uu) of the FD&C Act) does not require interstate 
commerce for a violation.
    FDA also is issuing the provisions in subpart C and related 
requirements in subparts A, E and F, under sections 402(a)(3) and (4), 
and 701(a) of the FD&C Act to the extent such requirements are 
necessary to prevent animal food from being held under insanitary 
conditions whereby it may become contaminated with filth or rendered 
injurious to health, or being unfit for food. FDA also is finalizing 
those provisions under sections 311, 361, and 368 of the PHS Act 
relating to communicable disease to the extent

[[Page 56180]]

those provisions are necessary to prevent the interstate spread of 
communicable disease.

III. General Comments on the Proposed Rule

    (Comment 1) Several comments ask us to develop guidance to 
accompany the rule, particularly with respect to the new requirements 
for hazard analysis and risk-based preventive controls. For example, 
comments ask us to provide guidance on topics such as hazard analysis, 
environmental monitoring, and validation. Some of these comments ask 
that drafts of the guidance first be made available for public comment. 
Some of these comments request that the guidance be available as soon 
as possible and before the rule becomes effective. Some comments 
request guidance specific to small businesses. Several comments suggest 
FDA revisit some current compliance policy guidances in light of FSMA 
and the proposed rules.
    Other comments emphasize the importance of education and outreach 
and ask us to provide support for ongoing education and outreach, 
including an active role in providing needed instructional examples and 
lessons learned from current investigations and foodborne outbreaks. 
Some comments ask us to convene a scientific workgroup that includes 
experts in food and laboratory science, public health, proficiency 
testing, quality control, and other areas on at least an annual basis 
to assess what hazards should be addressed in food safety plan. Other 
comments ask us to engage universities and extension in education and 
training efforts.
    Some comments ask that funding and information on funding for 
training be provided. Other comments assert that we must make available 
adequate resources to support outreach and technical assistance 
delivered by State regulatory Agencies, as well as Cooperative 
Extension programs and non-governmental organizations that work 
directly with farmers and facilities.
    (Response 1) We are developing several guidance documents, 
including general guidance on hazard analysis and preventive controls, 
as well as guidance for complying with the CGMP requirements of subpart 
B (Ref. 4). We will develop and issue this guidance in accordance with 
our good guidance practices regulation, which establishes criteria for 
when we issue a guidance document as an initial draft, invite public 
comment, and prepare a final version of the guidance document that 
incorporates suggested changes, when appropriate (Sec.  10.115(g)) (21 
CFR 10.115(g)). The public may submit comments on any guidance document 
at any time (Sec.  10.115(g)(5)). In addition, we intend to review 
current guidance documents and make a determination whether they need 
to be withdrawn or revised based on this final rule.
    We agree with comments that stress the importance of education and 
outreach. A central element of our strategy to gain industry compliance 
is to help make available to facilities subject to this rule the 
education and technical assistance they need to understand and 
implement the requirements (Ref. 5). Within the Agency we are 
establishing a Food Safety Technical Assistance Network and seeking 
funding to increase FDA staffing to provide a central source of 
information to support industry understanding and implementation of 
FSMA standards (Ref. 5). This will allow us to respond in a timely and 
consistent way to industry questions on preventive controls technical 
and compliance issues (Ref. 5).
    We also are working in collaboration with the Food Safety 
Preventive Controls Alliance (FSPCA) to develop training materials and 
establish training and technical assistance programs (Refs. 5 and 6). 
The Alliance includes members from FDA, State food protection Agencies, 
the food (human and animal) industry, and academia. It is funded by a 
grant to the Illinois Institute of Technology's Institute for Food 
Safety and Health, a nationally recognized leader in food safety. In 
addition to developing a standardized preventive controls training 
curriculum, the FSPCA is developing selected sections of model food 
safety plans for several food types that will provide needed 
instructional examples. Although we have provided funding to the FSPCA 
to develop a standardized preventive controls training curriculum, we 
are unable to fund training for individual groups who might need 
particular training materials.
    We also are partnering with the National Institute of Food and 
Agriculture (NIFA) of the U.S. Department of Agriculture (USDA) to 
administer the FSMA-mandated National Food Safety Training, Education, 
Extension, Outreach, and Technical Assistance Program, a grant program 
to provide technical assistance for FSMA compliance to owners and 
operators of small and medium-size farms and small food processors 
(Ref. 7). Such efforts will help ensure widespread voluntary compliance 
by encouraging greater understanding and adoption of established food 
safety standards, guidance, and protocols.
    (Comment 2) Some comments ask us to explain how we will enforce the 
rule, particularly with respect to coordination with State and local 
authorities and with other Federal Agencies. For example, some comments 
ask whether FDA or the States will pay for inspections, whereas other 
comments ask us to coordinate inspection of imports with USDA's Food 
Safety and Inspection Service (FSIS) or ask us to combine our 
inspections with those of USDA where possible. Some comments express 
concern about the time gap between the effective date of this rule and 
the time it will take to incorporate applicable provisions into State 
law.
    (Response 2) We are working through the Partnership for Food 
Protection (PFP) (a group of dedicated professionals from Federal, 
State, local, tribal, and territorial governments with roles in 
protecting the food supply and public health) to develop and implement 
a national Integrated Food Safety System consistent with FSMA's 
emphasis on establishing partnerships for achieving compliance (see 
section 209(b) of FSMA). For an example of our current thinking on 
establishing partnerships for achieving compliance, see the ``best 
practices'' document made available by PFP (Ref. 8). This ``best 
practices'' document provides information to FDA field and State 
programs on a variety of issues, including how to coordinate compliance 
activities. Our document entitled ``Operational Strategy for 
Implementing FSMA'' also recognizes the importance of developing 
operational partnerships with States and other government counterparts 
to optimize the effectiveness, efficiency, and consistency of FSMA 
implementation domestically (Ref. 9).
    We are implementing a new inspection paradigm focused on whether 
firms are implementing systems that effectively prevent food 
contamination, requiring fundamentally different approaches to food 
safety inspection and compliance (Ref. 10). This new paradigm involves 
a major reorientation and retraining, for which we are seeking funding, 
of more than 2,000 FDA inspectors, compliance officers, and other staff 
involved in food safety activities, as well as thousands of State, 
local, and tribal inspectors (Ref. 10).
    (Comment 3) Some comments ask us to reevaluate the proposed animal 
food preventive controls rule, compare it with existing programs, and 
identify a mechanism for integrating compliance verification with 
existing industry and

[[Page 56181]]

governmental programs. These comments note that many handlers/
processors use and understand voluntary food safety management systems 
such as HACCP and HACCP-based certification programs and ask us why we 
proposed to create a separate inspection framework for FSMA, without 
integrating that inspection framework with existing programs.
    (Response 3) We decline this request. As previously discussed, we 
are establishing this rule as required by section 103 of FSMA (78 FR 
64736 at 64743 through 64745 and 64817 through 64818). However, where 
compliance with this rule mirrors compliance with existing regulatory 
requirements, there is no need to duplicate existing records, which may 
be supplemented as necessary to include all of the required 
information. (See also Response 2 regarding implementation of a 
national Integrated Food Safety System.)
    (Comment 4) Some comments ask us to make the various rules we are 
establishing to implement FSMA consistent with each other. One comment 
specifically asks us to harmonize the human and animal food preventive 
controls final rules to avoid confusion by firms that produce both 
human and animal food.
    (Response 4) We have aligned the provisions of the various rules to 
the extent practicable. For example, we use the same definitions of 
``farm'' and the same terms used in the definition of ``farm'' (i.e., 
packing, holding, and manufacturing/processing) in this rule, the human 
food preventive controls rule, and the proposed produce safety rule. 
However, the statutory direction is not the same for all the rules, and 
this difference in statutory direction does lead to some differences 
between the rules. For example, section 418(l) of the FD&C Act (which 
relates to this rule) provides for modified requirements for facilities 
that are very small businesses in addition to facilities that satisfy 
criteria for sales to qualified end-users, but section 419(f) of the 
FD&C Act (which relates to the proposed produce safety rule) only 
provides for modified requirements for direct farm marketing.
    Likewise, we have worked to align the provisions of this rule with 
the provisions of the Foreign Supplier Verification Program (FSVP) 
rule. Again, however, there are statutory differences that lead to some 
differences between the rules. For example, section 805 of the FD&C Act 
(21 U.S.C. 348a), applies to an importer, whereas section 418 of the 
FD&C Act applies to a facility that is required to register under 
section 415 of the FD&C Act. Except in the circumstance where an 
importer is also a manufacturer/processor, an importer must conduct a 
hazard analysis as part of the foreign supplier verification 
requirements, whereas a facility that is a manufacturer/processor must 
conduct a hazard analysis to determine whether the requirements of the 
animal food preventive controls rule apply to it. As another example, 
section 805 of the FD&C Act does not provide an exemption for small or 
very small entities, whereas section 418 of the FD&C Act provides an 
exemption for ``qualified facilities,'' which include very small 
businesses.
    To the extent possible, we have attempted to harmonize the animal 
food preventive controls final rule with the human food preventive 
controls final rule. The CGMP (subpart B) requirements address the 
manufacturing, processing, packing, and holding practices at animal 
food plants, but are similar to those for human food, where 
appropriate. Furthermore, Sec.  507.1(d) contains provisions for a 
human food facility that also manufactures, processes, packs, or holds 
animal food. This is intended to reduce confusion and increase 
flexibility for facilities that produce both human and animal food.
    (Comment 5) Some comments express concern that we will enforce the 
rule more strictly for domestic facilities than for foreign facilities, 
e.g., because we lack the funds and manpower to enforce the rule for 
foreign facilities. Other comments assert that it is unprecedented for 
importing countries to regulate the production processes in exporting 
countries and that no scientific evidence supports such regulation. 
These comments express concern that this regulatory requirement will 
greatly increase trading costs and might constitute a barrier to trade 
for exporting countries.
    (Response 5) We intend to enforce this rule in a consistent manner 
to ensure that imported and domestically produced animal foods are in 
full compliance with the requirements of this rule. We note that the 
forthcoming FSVP rule will require importers to help ensure that animal 
food imported into the United States is produced in compliance with 
processes and procedures, including reasonably appropriate risk-based 
preventive controls, that provide the same level of public (human and 
animal) health protection as those required under this rule. The 
implementation of these supplier verification programs by U.S. 
importers will thus provide assurances that imported animal food is in 
compliance with this regulation.
    We disagree that we are seeking to ``regulate the production 
processes in exporting countries'' inappropriately. This rule provides 
for a flexible set of principles and a framework for hazard analysis 
and risk-based preventive controls to be applied to a given production 
process in order to ensure the production of safe animal food destined 
for the United States. Mandating that a finished animal food is 
manufactured under general methods applicable to all animal foods 
(e.g., good manufacturing practices) is a widely accepted regulatory 
practice and fundamentally different than mandating that animal food be 
produced in a certain way. We note that other countries have adopted 
animal food safety regulations that mandate certain principles and 
conditions be applied to animal food manufacturing. Because the 
requirements being implemented by FDA under this regulation are 
flexible and not prescriptive, we do not agree that this regulation 
will significantly increase costs or impede trade.
    We also disagree that there is no scientific evidence supporting 
this rule. In the 2013 proposed preventive controls rule for human and 
animal food, we provided an extensive background discussing the 
scientific evidence upon which this rule is based (78 FR 3646 at 3659 
through 3667, January 16, 2013 and 78 FR 64736 at 64745, October 29, 
2013). In addition, the Appendix to the 2013 proposed preventive 
controls rule provided additional scientific information on activities 
such as product testing and environmental monitoring to support their 
role in ensuring safe food and how these align with international 
standards such as those of Codex Alimentarius (78 FR 64736 at 64834 
through 64836).
    (Comment 6) Many comments from pet owners are generally supportive 
of the rule; however, some request additional regulations and oversight 
for pet food. Many comments state that pet food should meet the same 
standards as human food. Some comments request that pet food be 
required to be tested for safety.
    (Response 6) The CGMP requirements in subpart B are intended to 
serve as baseline standards for producing safe animal food across all 
types of animal food facilities, including pet food facilities. For 
discussion of the relevance of the CGMP requirements to pet food, see 
Response 163. Many pet food facilities (as well as facilities producing 
other animal food) will be subject to the preventive controls 
requirements of subpart C. These provisions require the pet food 
manufacturer to identify and evaluate

[[Page 56182]]

potential hazards for the pet food to determine whether a preventive 
control is required (see Sec.  507.33). These could be hazards to the 
pet consuming the pet food or the person handling the pet food (e.g., 
Salmonella). The preventive controls provisions also include 
requirements for product testing for pathogens or other hazards and 
environmental monitoring for pathogens under certain circumstances (see 
Sec.  507.49), in order to help ensure the safety of the pet (animal) 
food. Currently, low-acid canned animal food in a hermetically sealed 
container (such as canned pet food) is subject to the requirements of 
Sec.  500.23 (21 CFR 500.23) and part 113 to control microbiological 
hazards.
    (Comment 7) Some comments request communication and coordination 
with state regulators throughout the FSMA implementation phase. Some 
comments specifically request training of FDA staff and regulatory 
partners to inspect animal food facilities because there are 
differences between animal food and human food facilities. Some 
comments request that inspectors receive training on the broad range of 
animal food manufacturing. At least one comment requests we establish a 
national advisory committee to provide ongoing input throughout FSMA 
implementation and enforcement. Some comments request that we provide 
methods for communication with State and other regulatory partners, 
including possibly a call center or other direct-contact resource for 
regulators and industry to obtain information on FSMA.
    (Response 7) As discussed in Response 1, we are working in 
collaboration with the FSPCA to develop training materials and programs 
to be used by industry and regulators. The training will be specific to 
human or animal food and will include information on developing a food 
safety plan tailored to each facility's unique hazards. We will 
consider these and other recommendations for the content of such 
training as part of that collaborative effort.
    As discussed in Responses 1 and 2, we are working through two 
working groups (FSCPA and PFP) that involve State and local regulators 
in order to implement this final rule. We will continue to work through 
these groups, as well as use other methods of communication and 
coordination (e.g., arranged teleconference meetings with the States 
(i.e., 50-State calls) to collaborate with State and local regulatory 
officials to implement this final rule. We will consider these 
recommendations as we communicate with State and local regulatory 
partners during the implementation of this final rule.
    (Comment 8) Some comments request that this final rule have a 
provision similar to the proposed produce safety rule that allows a 
state or foreign country to request a variance from the rule's 
requirements due to procedures, processes, and practices that ensure a 
product is not adulterated.
    (Response 8) We are implementing these regulations according to the 
statutory direction of FSMA. A variance request and review process is 
specified for produce in section 419(c)(2) of the FD&C Act; however, 
there are no similar provisions in FSMA directing FDA to create a 
variance process for facilities subject to the preventive controls 
regulations and we therefore are declining to do so.
    (Comment 9) Some comments ask us to take a ``BASE'' approach to 
implementing FSMA. These comments describe this approach as follows: B 
stands for borders, a critical area where FDA should be focusing its 
attention and resources; A stands for audits, recognizing that FDA will 
need to actively audit states and foreign suppliers; S stands for 
standard, representing the standards FDA will set by which firms will 
be audited; and E stands for education, ensuring that all stakeholders 
know their roles and responsibilities required by the rules.
    (Response 9) While we do not intend to follow the BASE approach 
described in the comment, we expect that some of our implementation 
efforts will be similar to the approach described. For discussion of 
our implementation planning, see Responses 1 and 2. To the extent this 
comment is referring to animal food from foreign suppliers presented 
for import, this is a subject of the forthcoming FSVP rule.
    (Comment 10) Some comments requested exceptions or reduced 
requirements that were not previously proposed. One comment requests a 
narrower scope of requirements for facilities involved in the 
production of chemicals used as food additives or in accordance with 
generally recognized as safe (GRAS) standards.
    (Response 10) We decline these requests. The CGMPs in subpart B and 
preventive controls in subpart C are written to serve as baseline 
standards for producing safe animal food across all types of animal 
food facilities, including those producing food additives or other 
ingredients.

IV. Definitions in the Section 415 Registration Regulations (21 CFR 
Part 1, Subpart H)

A. Definitions That Impact a Determination of Whether an Establishment 
Is a ``Farm''

    The 2013 proposed rule for human food preventive controls contained 
a description (78 FR 3646 at 3675 through 3676) of the current legal 
and regulatory framework that governs the determination of when an 
establishment is required to register as a food facility in accordance 
with the section 415 registration regulations. That description focused 
on the framework that governs whether an establishment that grows and 
harvests crops or raises animals satisfies the definition of ``farm,'' 
because the facility registration requirements of section 415 of the 
FD&C Act do not apply to ``farms.'' Under that framework, a key factor 
in whether an establishment falls within the definition of ``farm,'' 
even with respect to crops it grows and harvests itself, is whether the 
activities conducted by the establishment fall within definitions of 
``harvesting,'' ``packing,'' or ``holding'' (which are within the 
``farm'' definition). Another key factor is whether activities 
conducted by the establishment fall within the definition of 
manufacturing/processing (which have been outside the ``farm'' 
definition).
    In the 2014 supplemental human preventive controls notice, comments 
were described regarding proposed revisions to the definitions of 
``farm,'' ``harvesting,'' ``packing'' and ``holding,'' as well as 
comments regarding the triggers for an activity to be considered 
manufacturing/processing (79 FR 58524 at 58530 through 58538). 
Additional revisions were proposed to the definitions of ``farm,'' 
``harvesting,'' ``packing'' and ``holding'' to address these comments.
    Even after the revisions we proposed in the 2014 supplemental human 
preventive controls notice, some comments assert that the overall 
``farm'' definition still presents an unrealistic and incomplete 
understanding of how most farms in America are structured with regard 
to their physical location(s) and business models. See table 4 for 
revised definitions that are being finalized in the human food 
preventive controls for the section 415 registration regulations and 
the section 414 recordkeeping regulations.
    In section IV of the final rule for preventive controls for human 
food, published elsewhere in this issue of the Federal Register, 
comments on the proposed changes to the section 415

[[Page 56183]]

registration regulations and to the section 414 recordkeeping 
regulations are discussed.

    Table 4--Revisions to the Proposed Definitions in the Section 415
 Registration Regulations and the Section 414 Recordkeeping Regulations
------------------------------------------------------------------------
                  Definition                            Revision
------------------------------------------------------------------------
Farm.........................................   A farm is an
                                                ``operation'' rather
                                                than an
                                                ``establishment.``
                                                There are two
                                                types of farms: (1)
                                                Primary production farm;
                                                and (2) secondary
                                                activities farm.
Primary production farm......................   A primary
                                                production farm is
                                                ``under one management''
                                                rather than ``under one
                                                ownership.''
                                                Although a
                                                primary production farm
                                                continues to be ``in one
                                                general physical
                                                location,'' we have
                                                clarified that ``one
                                                general physical
                                                location is ``not
                                                necessarily
                                                contiguous.''
                                                A primary
                                                production farm is an
                                                operation devoted to the
                                                growing of crops, the
                                                harvesting of crops, the
                                                raising of animals
                                                (including seafood), or
                                                any combination of these
                                                activities. Although
                                                some primary production
                                                farms both grow and
                                                harvest crops, other
                                                primary production farms
                                                grow crops but do not
                                                harvest them, and other
                                                primary production farms
                                                harvest crops but do not
                                                grow them.
                                                Treatment to
                                                manipulate the ripening
                                                of raw agricultural
                                                commodities (RACs), and
                                                packaging and labeling
                                                the treated RACs,
                                                without additional
                                                manufacturing/
                                                processing, is within
                                                the ``farm'' definition.
                                                We added an
                                                example of drying/
                                                dehydrating RACs to
                                                create a distinct
                                                commodity that would
                                                fall within the ``farm''
                                                definition (i.e., drying/
                                                dehydrating grapes to
                                                produce raisins), as
                                                well as an example of
                                                additional manufacturing/
                                                processing that would
                                                cause an operation that
                                                dries/dehydrates RACs to
                                                create a distinct
                                                commodity to fall
                                                outside the ``farm''
                                                definition (i.e.,
                                                slicing).
                                                We added an
                                                example of additional
                                                manufacturing/processing
                                                that can cause an
                                                operation that packages
                                                and labels RACs to fall
                                                outside the ``farm''
                                                definition (i.e.,
                                                irradiation).
Secondary activities farm....................   A ``secondary
                                                activities farm'' is an
                                                operation, not located
                                                on a primary production
                                                farm, devoted to
                                                harvesting (such as
                                                hulling or shelling),
                                                packing, and/or holding
                                                of RACs, provided that
                                                the primary production
                                                farm(s) that grows,
                                                harvests, and/or raises
                                                the majority of the RACs
                                                harvested, packed, and/
                                                or held by the secondary
                                                activities farm owns, or
                                                jointly owns, a majority
                                                interest in the
                                                secondary activities
                                                farm.
                                                A secondary
                                                activities farm may also
                                                conduct those additional
                                                activities allowed on a
                                                primary production farm.
Harvesting...................................   We added
                                                additional examples of
                                                harvesting activities.
Holding......................................   We added
                                                additional examples of
                                                holding activities.
Manufacturing/Processing.....................   We added
                                                additional examples of
                                                manufacturing/processing
                                                activities.
------------------------------------------------------------------------

B. Proposed Revisions to the Definition of Farm

    In the human food proposed preventive controls rule, we proposed to 
revise the ``farm'' definition to (1) Provide for on-farm packing and 
holding of RACs to remain within the farm definition regardless of 
ownership of the RACs; (2) include, within the ``farm'' definition, a 
description of packing activities that include packaging RACs grown or 
raised on a farm without additional manufacturing/processing; and (3) 
provide for drying/dehydrating RACs to create a distinct commodity 
(such as the on-farm drying of grapes to produce raisins), and 
packaging and labeling such commodities, without additional 
manufacturing/processing, to remain within the farm definition. See 
section IV.B of the final rule for preventive controls for human food, 
published elsewhere in this issue of the Federal Register, for a full 
discussion of comments and responses on the proposed revisions to the 
farm definition.
    In the final rule for preventive controls for human food, published 
elsewhere in this issue of the Federal Register, we have revised the 
definition of farm to replace the term ``under one ownership'' with the 
term ``under one management.'' As discussed in section IV.B of the 
final rule for preventive controls for human food, although the 
original phrase ``under one ownership'' was not referring to a single 
owner, the ``farm'' definition should reflect modern business models 
(such as cooperatives, on-farm packinghouses under ownership by 
multiple growers, food aggregators, and food hubs) and use language 
that the modern farming community understands. The term ``under one 
management'' refers to the control structure of the business, that is, 
the management of the business entity that is the farm operation. Thus, 
for example, a primary production farm that hires another company as a 
contract harvester to perform harvesting services on the primary 
production farm's behalf is not ``under one management'' with the 
primary production farm just because the primary production farm is 
directing the contractor's activities performed on the primary 
production farm's behalf. The primary production farm and the contract 
harvester have separate and independent management structures because 
they are separate and independent businesses. (See Response 25 in the 
final rule for preventive controls for human food). As another example, 
if a poultry processing company contracts with a primary production 
farm to raise chickens on the poultry processor's behalf, the poultry 
processor and the primary production farm are not ``under one 
management,'' even if their contract strictly controls almost all 
aspects of the raising of the poultry. The poultry processor and the 
primary production farm have separate and independent management 
structures because they are separate and independent businesses.
    In the final rule for preventive controls for human food, we also 
revised the farm definition to add a new category: A ``secondary 
activities farm.'' (See Response 25 in the final rule for preventive 
controls for human food). An important limitation on the types of 
operations that fit within this category is that they must be majority 
owned (or majority jointly owned) by the primary production farm(s) 
that grows, harvests, and/or raises the majority of the RACs the 
secondary activities farm harvests, packs, and/or holds. Thus, both 
product and majority ownership must link a secondary activities farm to 
a primary production farm(s).
    For example, a primary production farm may own a majority interest 
in a separate business that holds RACs and processes them into animal 
food (e.g., a feed mill). If the majority of the RACs held by the feed 
mill come from the primary production farm that owns the feed mill's 
majority interest, the feed

[[Page 56184]]

mill is a secondary activities farm and may manufacture/process animal 
food within the farm definition, but only to the extent that the animal 
food manufactured is consumed at the feed mill or on another farm whose 
``one management'' is the same management as the feed mill. However, if 
the feed mill in this example manufactures/processes animal food that 
is consumed on farms that are not under the same management as the feed 
mill, that manufacturing/processing is outside the farm definition, the 
feed mill is subject to registration under section 415 of the FD&C Act, 
and its manufacturing/processing of animal food for consumption on 
farms not under the same management is subject to the requirements of 
this rule.
    To further clarify, a feed mill that is not majority owned by a 
primary production farm(s) cannot be a secondary activities farm. Also, 
a feed mill that does not receive more than half of the RACs it holds 
from primary production farm(s) that own a majority interest in the 
feed mill cannot be a secondary activities farm. For example, a feed 
mill owned by a poultry processing company will be required to register 
as a food facility, unless the feed mill otherwise meets the definition 
of ``farm.'' When a feed mill is owned by a company such as a poultry 
processor, it is not majority owned by the primary production farm(s) 
that supply the majority of the RACs it holds, and therefore the feed 
mill cannot be a secondary activities farm.

C. Proposed Revisions to Definitions of Harvesting, Holding, 
Manufacturing/Processing, Mixed-Type Facility, and Packing

    See section VIII. for a discussion of comments and responses and 
revisions to the definitions in part 507 of harvesting, holding, 
manufacturing/processing, mixed-type facility, and packing. For a 
discussion of comments and responses to these definitions in the 
section 415 registration regulations and the section 414 recordkeeping 
regulations, see section IV.C through IV.G of the final rule for 
preventive controls for human food, published elsewhere in this issue 
of the Federal Register.

D. Comments on Feed Mills Associated With Fully Vertically Integrated 
Farming Operations

    In the 2014 supplemental notice for animal food, we requested 
comment on whether feed mills that are part of fully vertically 
integrated farming operations, including cooperatives that fit this 
model, that meet the farm definition should be required to register 
under section 415 of the FD&C Act (and thus would be subject to the 
rule). For comments that supported applying the final preventive 
controls rule to feed mills that are part of fully vertically 
integrated farming operations, we requested input on how the farm 
definition should be modified. If they were required to register, we 
also requested comment on whether there should be exemptions from 
registration under section 415 based on size, such as number of animals 
being fed or the amount of animal food being fed (based on tonnage, 
monetary value, or some other factor). Lastly, since there would be no 
total annual sales figure for the animal food produced by these feed 
mills, we requested comment on how to value the animal food being fed 
to animals for purposes of determining whether the feed mill would be a 
qualified facility (proposed Sec.  507.7) and in particular a very 
small business.
    (Comment 11) Some comments generally agree with our recognition 
that there are different types of farm models for raising animals but 
request additional clarification on what we mean by a fully vertically 
integrated farming operation and the depth of integration within an 
operation.
    (Response 11) Feed mills that are part of fully vertically 
integrated farming operations, or certain cooperative farming 
operations that meet the definition of a farm (see Sec.  1.227, as 
revised by the final rule for preventive controls for human food 
published elsewhere in this Federal Register), are not subject to this 
final rule because they are not required to register under section 415 
of the FD&C Act (see Sec.  507.5(a)). Because expanding on the 
characteristics of a fully integrated farming operation is beyond the 
scope of this rule, we decline to further clarify the fully vertically 
integrated farming operation farming model discussed in the 2014 
supplemental notice.
    (Comment 12) Some comments do not support modifying the farm 
definition to subject feed mills that are part of fully vertically 
integrated farming operations to the requirements of this final rule. 
These comments state that these feed mills are currently making safe 
animal food and that some are following industry best practices that 
would meet or exceed the requirements of our proposed CGMPs. Some 
comments also state that these feed mills are producing a narrower 
range of animal food when compared to independent feed mills because 
these integrated feed mills typically provide animal food to a single 
species and therefore utilize fewer ingredients, resulting in less 
chance of harmful error. Some comments note that for large farming 
operations, feeding of the animals is overseen by dedicated 
individuals, such as a nutritionist, which ensures an extra layer of 
oversight for the safety of animal food.
    Some comments express concern that feed mills associated with 
contract farming operations (contract feed mills) will be treated 
differently because, as proposed in the 2013 proposed rule, they would 
need to comply with the rule unlike the feed mills that are part of 
fully vertically integrated farming operations. These comments 
recommend modifications to the farm definition to incorporate the 
contract feed mills into the farm definition, resulting in the contract 
feed mills no longer being required to register under section 415 and 
therefore no longer being subject to the requirements of this rule. 
Some comments (including ones that support and ones that oppose 
modifying the farm definition) generally agree there is no evidence 
that the safety of animal food varies depending on whether a feed mill 
is associated with vertically integrated or contract farming. These 
comments also state that the farm definition as proposed has the 
potential to create disparity in regulatory requirements that feed 
mills must follow based solely on the type of farming model with which 
they are associated (i.e., some will be subject to CGMP and preventive 
controls requirements, while some will be subject to neither).
    Some comments support modifying the farm definition to subject feed 
mills that are part of fully vertically integrated farming operations 
to the requirements of this final rule, and some of those comments also 
support providing an exclusion if it is limited to small on-farm animal 
food mixers. Other comments contend that some of the feed mills that 
are part of fully vertically integrated farming operations produce 
large volumes of animal food that feed a substantial portion of the 
U.S. food-producing animal population and that these feed mills should 
be subject to the final rule to ensure continual production of safe 
animal food. Some comments state concern that the feed mills that are 
part of fully vertically integrated farming operations could introduce 
food safety hazards into the human food supply because they are not 
being adequately controlled due to the feed mills' exemption from this 
rule.
    Comments that support modifying the farm definition to subject feed 
mills that are part of fully vertically integrated farming operations 
to the requirements of this final rule recommend that any exemption 
from this final rule

[[Page 56185]]

applicable to farms be limited based on the volume of the animal feed 
produced or animal equivalency units.
    (Response 12) The farm definition in 21 CFR part 1 has been 
modified based on other comments received to both the 2014 supplemental 
notice for human food preventive controls and to the 2014 supplemental 
notice for animal food preventive controls (see section IV.B of the 
final rule for preventive controls for human food published elsewhere 
in this issue of the Federal Register). However, feed mills that are 
part of fully vertically integrated farming operations still meet the 
definition of farm. As a result, they are not required to register as a 
food facility under section 415 and are not subject to the requirements 
of this rule including CGMPs (subpart B) and Hazard Analysis and Risk-
Based Preventive Controls (subpart C), and supply-chain program 
(subpart E). We remain concerned that this leaves a gap in the 
protection of public (human and animal) health because these feed mill 
operations manufacture significant amounts of animal food. While some 
of these feed mills may be voluntarily implementing some type of animal 
food safety measures, not all feed mills that are part of vertically 
integrated farming operations do. In addition, the voluntary measures 
adopted by some feed mills may not meet the standards of the food 
safety requirements in this rule. Moreover, we do not and cannot 
enforce compliance with purely voluntary practices. Finally, we 
recognize that other feed mills not part of a ``farm'' as defined in 
part 1 will have to comply with the requirements of this rule (unless 
they qualify for an exemption). As we have previously stated, we do not 
have evidence that the safety of animal food varies depending on 
whether a feed mill is part of vertically integrated or contract 
farming. Therefore, we intend to publish a proposed rule that would 
require some feed mill operations that currently are part of a farm to 
comply with the CGMPs (subpart B) of this rule.
    The animal food CGMP requirements help ensure that animal food is 
protected from contamination during manufacturing, processing, packing, 
and holding (see sections XIV to XXII for further discussion of the 
animal food CGMP). By implementing these CGMPs, we believe that feed 
mills not currently covered by this rule would be able to provide a 
baseline level of animal food safety, thus further protecting the 
public (human and animal) health. We will continue to review the 
comments received from the 2014 supplemental proposed rule and other 
available data in considering a proposed rule for feed mills that are 
part of fully vertically integrated farming operations that are not 
required to register under section 415, but produce a large volume of 
animal food. One reason we are not finalizing new food safety 
requirements for feed mills that are part of fully integrated farming 
operations in this rulemaking is that we need more information to help 
guide the scope of the requirements. As part of the future rulemaking 
process we will seek input on the best way to subject vertically 
integrated feed mills that produce large volumes of animal food to food 
safety requirements while avoiding overburdening on-farm feed mixers 
that produce a small amount of food for a small number of animals. The 
proposed rulemaking would not change the applicability of subpart C, 
``Hazard Analysis and Risk-Based Preventive Controls,'' for feed mills 
that are part of a farm. Because farms meeting the definition of Sec.  
1.227 are not required to register under section 415 of the FD&C Act, 
Sec.  507.5(a) exempts them from compliance with subpart C, as required 
by FSMA.

V. Comments on the Organizing Principles for How the Status of a Food 
as a Raw Agricultural Commodity or as a Processed Food Affects the 
Requirements Applicable to a Farm Under Sections 415 and 418 of the 
FD&C Act

    In the 2014 supplemental notice (79 FR 58476 at 58482), we referred 
to the 2014 supplemental human preventive controls notice that 
discussed comments on the organizing principles that formed the basis 
for proposed revisions to section 415 registration regulations and the 
section 414 recordkeeping regulations (79 FR 58524 at 58538). We also 
explained how its proposed revisions to the ``farm'' definition would 
require FDA to reconsider those organizing principles (79 FR 58524 at 
58538).
    For discussion of comments, see section V of the final rule for 
preventive controls for human food, published elsewhere in this issue 
of the Federal Register.

VI. Rulemaking Required by Section 103(c) of FSMA: On-Farm Activities

A. Section 103(c)(1)(C) of FSMA

    We previously described provisions of FSMA that direct us to 
conduct a science-based risk analysis to cover specific types of on-
farm packing, holding, and manufacturing/processing activities that 
would be outside the ``farm'' definition and, thus, subject to the 
requirements for hazard analysis and risk-based preventive controls 
(see section 103(c)(1)(C)) of FSMA and 78 FR 64736 at 64751 and 64752 
through 64754). Consistent with this statutory direction, we developed 
the section 103(c)(1)(C) draft RA and made it available for public 
comment (Ref. 11 and 78 FR 64428). We are including the final risk 
assessment (the section 103(c)(1)(C) RA) in the docket established for 
this document (Ref. 3).
    We previously described provisions of FSMA that direct us to 
consider the results of the science-based risk analysis and exempt 
facilities that are small or very small businesses from the 
requirements for hazard analysis and risk-based preventive controls (or 
modify these requirements, as we determine appropriate), if such 
facilities are engaged only in specific types of on-farm activities 
that we determine to be low risk involving specific animal foods that 
we determine to be low risk (see section 103(c)(1)(D) of FSMA and 78 FR 
64736 at 64751, 64753 through 64754, and 64763 through 64764). In 
section X.F, we discuss the provisions we are establishing in Sec.  
507.5(e) and (f), based on the results of the section 103(c)(1)(C) RA, 
to exempt farm mixed-type facilities that are small or very small 
businesses from requirements for hazard analysis and risk-based 
preventive controls if the only activities that the business conducts 
that are subject to those requirements are low-risk activity/animal 
food combinations.
    We also previously described provisions of FSMA that direct us to: 
(1) Identify high risk-facilities and allocate resources to inspect 
facilities according to the known safety risks of the facilities (as 
determined by several factors) and immediately increase the frequency 
of inspection of all facilities (see the discussion of section 421 of 
the FD&C Act at 78 FR 64736 at 64754) and (2) consider a possible 
exemption from or modification of requirements of section 421 of the 
FD&C Act as we deem appropriate (see the discussion of section 
103(c)(1)(D) of FSMA at 78 FR 64736 at 64744). We tentatively concluded 
that we should not exempt or modify the frequency requirements under 
section 421 based solely upon whether a facility only engages in low-
risk activity/animal food combinations and is a small or very small 
business and requested comment on this tentative conclusion.

B. Comments on Qualitative Risk Assessment of On-Farm Activities 
Outside of the Farm Definition

    (Comment 13) Some comments address the qualitative nature of the 
section 103(c)(1)(C) draft RA and assert

[[Page 56186]]

that it is based on professional judgment rather than data. These 
comments ask us to update the section 103(c)(1)(C) draft RA when more 
data become available. Some comments assert that we should not rely on 
data from the Food Processing Sector Study (Ref. 12), but instead 
collect data from large-scale surveys of actual farm mixed-type 
facilities and their activities. Other comments ask us to collect, 
analyze, and interpret data about the levels of hazards from animal 
food samples taken from small and very small mixed-type facilities and 
use consumption to estimate the likelihood of exposure to hazards in 
animal food from such facilities. Some comments ask us to consult with 
subject matter experts to ensure that the final risk assessment 
reflects sufficient geographic diversity.
    (Response 13) We have acknowledged the limitations of the section 
103(c)(1)(C) draft RA (Ref. 11 and 78 FR 64428; see section I.F in that 
document). Rather than limit public input to subject matter experts, we 
requested comment from all interested persons, and received a number of 
comments about activity/animal food combinations conducted on farms and 
farm mixed-type facilities, including comments from diverse geographic 
areas comprising both areas where farms and farm mixed-type facilities 
tend to be small and where they tend to be large. We disagree that we 
need to conduct large scale surveys, or enter into agreements with 
agencies/organizations, to collect additional information in light of 
the previous opportunity for broad public input regarding the activity/
animal food combinations conducted on farms and farm mixed-type 
facilities.
    (Comment 14) Some comments assert that we should revise the section 
103(c)(1)(C) draft RA and then make it available for additional public 
comment before finalizing the rule.
    (Response 14) We subjected the section 103(c)(1)(C) draft RA to 
peer review in accordance with the requirements of the Final 
Information Quality Bulletin for Peer Review (issued by the Office of 
Management and Budget to implement the Information Quality Act (Pub. L. 
106-554)) before we made it available for broader public comment during 
a time period that exceeded 10 months. The additional iterative process 
recommended by these comments is not necessary and would go beyond the 
processes we routinely apply for public input on a risk assessment.

C. Comments Regarding an Exemption for Small and Very Small Farm Mixed-
Type Facilities Under Section 421 of the FD&C Act

1. Request for Comment on Data Submission Requirements
    We requested comment on whether we should establish data submission 
requirements that would allow us to identify types of facilities in 
order to exempt them from the inspection frequencies, or modify the 
inspection frequencies that apply to them, under section 421 of the 
FD&C Act. We provided examples of such data elements, including 
identification of a facility as a farm mixed-type facility, annual 
monetary value of sales, number of employees, and animal food category/
activity type. We also requested comment on any other criteria that may 
be appropriate for the purposes of allocating inspection resources to 
these facilities.
    Comments did not support these data submission requirements. We are 
not establishing any data submission requirements that would allow us 
to identify types of facilities in order to exempt them from the 
inspection frequencies, or modify the inspection frequencies that apply 
to them, under section 421 of the FD&C Act.
2. Request for Comment on an Exemption From the Requirements of Section 
421 of the FD&C Act
    We received no comments that disagreed with our tentative 
conclusion that we should not exempt or modify the frequency 
requirements under section 421 based solely upon whether a facility 
only engages in low-risk activity/animal food combinations and is a 
small or very small business. We are not establishing any exemption 
from, or modification to, the frequency requirements under section 421 
for facilities that only engage in low-risk activity/animal food 
combinations and are a small or very small business.

VII. Subpart A: Comments on Proposed Sec.  507.1--Applicability and 
Status

    We proposed in Sec.  507.1 to establish the significance of this 
part in determinations of whether animal food is adulterated. We also 
proposed a provision relevant to FSMA's statutory provisions for a 
prohibited act under section 301(uu) of the FD&C Act. We proposed that 
animal food covered by specific CGMPs would also be subject to those 
requirements. For facilities required to comply with CGMPs and 
preventive controls for both the proposed preventive controls rule for 
animal food and the proposed preventive controls rule for human food, 
we proposed that the facility must comply with either rule for the 
animal food, as long as the food safety plan addresses hazards unique 
to animal food. Some comments support the proposed provisions without 
change. Some comments that support the proposed provisions ask us to 
clarify how we will interpret the provisions.
    In the following paragraphs, we discuss comments that ask us to 
clarify the proposed requirements, disagree with, or suggest one or 
more changes to, the proposed requirements. After considering these 
comments, we have revised the proposed requirements along with 
editorial and conforming changes as shown in table 31.

A. Comments on Proposed Sec.  507.1(a)--Applicability

    We proposed that the criteria and definitions in part 507 apply in 
determining whether a food is adulterated: (1) Within the meaning of 
section 402(a)(3) of the FD&C Act in that the food has been 
manufactured under such conditions that it is unfit for food; or (2) 
Within the meaning of section 402(a)(4) of the FD&C Act in that the 
food has been prepared, packed, or held under insanitary conditions 
whereby it may have become contaminated with filth, or whereby it may 
have been rendered injurious to health. We also proposed that the 
criteria and definitions in part 507 also apply in determining whether 
an animal food is in violation of section 361 of the PHS Act.
    (Comment 15) Some comments note that FSMA granted FDA mandatory 
recall authority for adulterated food. These comments express concern 
that theoretically we could use a violation of the requirements for 
hazard analysis and risk-based preventive controls to determine that 
food is adulterated, thereby providing the basis for a mandatory recall 
of that food. These comments raise three issues relevant to how we will 
apply Sec.  507.1(a), with consequences for a potential mandatory 
recall of food.
    First, these comments note that the regulatory text stating that 
the ``criteria and definitions'' apply in making a determination of 
adulteration appears to encompass the entirety of the rule. As a 
result, farms or facilities that violate any of the requirements in the 
proposed rules, including components not directly related to the safety 
of the food (such as recordkeeping requirements), could face a risk 
that we would deem their food adulterated.
    Second, these comments assert that the regulatory text suggests 
that we

[[Page 56187]]

would not automatically consider a food adulterated as a result of a 
violation of the proposed rule, because it states that the criteria and 
definitions ``apply in determining'' whether a food will be considered 
adulterated, rather than that the food ``is'' adulterated.
    Third, these comments state that it is not clear how the exemption 
applicable to qualified facilities is included in the ``criteria and 
definitions'' used in making a determination of adulteration. These 
comments ask us to clarify that we will not just automatically assume 
that qualified facilities are selling adulterated food because they are 
by definition exempt from the requirements for hazard analysis and 
risk-based preventive controls.
    (Response 15) The comments are correct that the criteria and 
definitions ``apply in determining'' whether an animal food will be 
considered adulterated, rather than that the animal food ``is'' 
adulterated. In determining whether an animal food that is 
manufactured, processed, packed, or held in violation of part 507 
(including a violation of the recordkeeping requirement) is 
adulterated, we would consider the totality of the available data and 
information about the violation and the animal food before reaching a 
conclusion that the animal food is adulterated.
    Although this rule does not address the mandatory recall provisions 
of FSMA, the statutory provisions establish two basic criteria. (See 
section 423(a) of the FD&C Act (21 U.S.C. 3501).) First, we must 
determine that there is a ``reasonable probability'' that the animal 
food is adulterated under section 402 of the FD&C Act. A violation of 
part 507 would be relevant to determining whether an animal food is 
adulterated under section 402 of the FD&C Act. Second, we must 
determine that there is a reasonable possibility that the use of, or 
exposure to, that animal food will cause serious adverse health 
consequences or death to humans or animals. Not all animal food that is 
adulterated has a reasonable probability of causing serious adverse 
health consequences or death to humans or animals. For examples of 
animal food contamination with a reasonable probability of causing 
serious adverse health consequences or death to humans or animals, see 
the annual reports of the Reportable Food Registry (RFR) (Refs. 13, 14, 
15, and 16).
    A facility that is exempt from any requirement of part 507, 
including the requirements for hazard analysis and risk-based 
preventive controls, would not be in violation of part 507 if it did 
not comply with provisions that it is not subject to.

B. Comments on Proposed Sec.  507.1(b)--Prohibited Act

    We proposed that the operation of a facility that manufactures, 
processes, packs, or holds animal food for sale in the United States is 
a prohibited act under section 301(uu) of the FD&C Act if the owner, 
operator, or agent in charge of such facility is required to comply 
with, and is not in compliance with, section 418 of the FD&C Act or 
subparts C, D, or F of part 507 and Sec.  507.7 (proposed Sec.  
507.1(b)).
    (Comment 16) Some comments from State regulatory Agencies note that 
this new provision is not covered under the applicable state statute 
and that making any changes to the state statute can be a lengthy 
process that takes up to 3 years to complete.
    (Response 16) See Response 2 for a discussion of our approach to 
working with our food safety partners in the States.

C. Comments on Proposed Sec.  507.1(c)--Specific CGMP Requirements

    We proposed Sec.  507.1(c) would establish that animal food covered 
by specific current good manufacturing practice regulations also be 
subject to the requirement of those regulations. We received no 
comments that disagreed with our proposal, and are finalizing the 
proposed provision without change.

D. Comments on Proposed Sec.  507.1(d)--Human Food Facilities That 
Manufacture Animal Food

    We proposed in Sec.  507.1(d) that a facility that would be 
required to comply with subpart B of part 507 and would be required to 
comply with subpart B of proposed part 117 for human food, may choose 
to comply with part 117 for the animal food. We also proposed that a 
facility that would be required to comply with subpart C of part 507 
and would be required to comply with subpart C of proposed part 117 for 
human food, may choose to comply with part 117 for the animal food as 
long as the food safety plan also addressed hazards that are reasonably 
likely to occur in the animal food. We also proposed that when applying 
the requirements of part 117 to animal food, the term ``food'' in part 
117 would include animal food.
    Based on comments received in the 2014 supplemental notice, we 
proposed in Sec.  507.12 that human food by-products held by the human 
food processor for distribution for use as animal food without 
additional manufacturing/processing by the human food processor would 
only need to comply with proposed Sec.  507.28 in part 507 and proposed 
Sec.  117.95 in part 117 (79 58476 at 58487 to 58489). (See section 
XIII for a discussion of comments received on proposed Sec.  507.12.) 
We are finalizing the proposed provisions in 507.1(d) with the 
exceptions in Sec.  507.12.
    For further discussion of comments on applicability and status, see 
section VIII in the final rule for preventive controls for human food 
published elsewhere in this issue of the Federal Register.

VIII. Subpart A: Comments on Proposed Sec.  507.3--Definitions

    We proposed definitions in the preventive controls rule for animal 
food to be consistent with the proposed preventive controls rule for 
human food with some minor differences and clarifications applicable to 
animal food (e.g., adding ``animal'' before ``food''). Some comments 
support one or more of these proposed definitions without change. For 
example, some comments state that they support the proposed definitions 
for ``microorganism'' and ``subsidiary'' with no suggested revisions. 
Some comments support our proposal in the 2014 supplemental notice to 
use the phrase ``chemical (including radiological)'' in the definition 
of ``hazard,'' noting that doing so is consistent with FSMA, current 
industry practice, and Codex and global HACCP standards. Some comments 
that support a proposed definition suggest alternative or additional 
regulatory text, such as adding examples to make the definition 
clearer. Some comments that support a proposed definition ask us to 
clarify how we will interpret the definition. Comments generally ask 
that we maintain consistency of terms among the FSMA rules to avoid 
confusion and ensure regulatory compliance.
    We did not receive comment on the following terms and therefore, 
are finalizing them as proposed: ``calendar day,'' ``FDA,'' ``pest,'' 
``water activity,'' and ``you.''
    We removed some proposed definitions because the final rule does 
not use them. The proposed definitions that are removed in this final 
rule are ``batter,'' ``blanching,'' ``packaging,'' ``quality control 
operation,'' ``safe moisture level,'' ``should,'' and ``significant 
hazard.''
    In the following sections, we discuss comments that ask us to 
clarify proposed definitions or that disagree with, or suggest one or 
more changes to, a proposed definition. After considering these 
comments, we have revised the proposed requirements with editorial

[[Page 56188]]

and conforming changes as shown in table 31.
    We also discuss definitions for additional terms (i.e., ``audit,'' 
``correction,'' ``full-time equivalent employee,'' ``hazard requiring a 
preventive control,'' ``qualified facility exemption,'' ``raw 
agricultural commodity,'' ``supply-chain-applied control,'' ``unexposed 
packaged animal food,'' and ``written procedures for receiving raw 
materials and other ingredients'') that we are establishing in the 
final rule to simplify the regulatory text throughout the regulations 
and improve clarity. We also discuss a new name (i.e., ``preventive 
controls qualified individual'') for the definition of a term that we 
had proposed to name ``qualified individual,'' and are establishing a 
new definition for the term ``qualified individual.'' Finally, we also 
discuss definitions that comments ask us to add, but that we did not 
add, to the final rule.

A. Definitions We Proposed To Establish in Part 507

1. Adequate
    We proposed to define the term ``adequate'' to mean that which is 
needed to accomplish the intended purpose in keeping with good public 
health practice.
    (Comment 17) Some comments express concern that there is no 
standard or definition for ``good public health practice'' and, for 
animal food establishments, the term ``good public health practice'' 
creates more uncertainty than it removes. The comments request that we 
remove from the definition the term ``good public health practice.'' 
Other comments ask us to develop guidance on thresholds and processes 
that qualify as ``adequate.'' Other comments assert that the word 
``adequate'' must be used in combination with the word ``reasonable'' 
to properly describe the intended measures and precautions.
    (Response 17) We disagree that there is no standard for ``good 
public health practice.'' However, we have revised the definition to 
add after public ``(human and animal)'' to clarify it includes both. 
Our intent in using the term ``adequate'' is to provide flexibility for 
an animal food establishment to comply with the requirement in a way 
that is most suitable for its establishment. We decline the request to 
develop guidance to explicitly address ``thresholds'' or to describe 
processes that qualify as adequate. The CGMPs and preventive controls 
requirements established in this rule are broadly applicable procedures 
and practices rather than very specific procedures and practices where 
additional interpretation from FDA might be appropriate.
2. Affiliate and Subsidiary
    We proposed to define the term ``affiliate'' to mean any facility 
that controls, is controlled by, or is under common control with 
another facility. We proposed to define the term ``subsidiary'' to mean 
any company which is owned or controlled directly or indirectly by 
another company. These proposed definitions would incorporate the 
definition in section 418(l)(4)(A) and (D) of the FD&C Act and would 
make the meanings of these terms clear when used in the proposed 
definition of ``qualified facility.''
    (Comment 18) Some comments ask us to clarify that a facility that 
has no material connection with another food processing operation would 
not be considered as an ``affiliate'' of that operation.
    (Response 18) It is not clear what the comments mean by ``no 
material connection with another food processing operation.'' To the 
extent that a facility does not control, is not controlled by, or is 
not under common control with another facility, we agree that the 
facility would not be considered an affiliate of that food processing 
operation.
    (Comment 19) Some comments assert that the definitions of 
``affiliate'' and ``subsidiary'' fail to account for the legal 
differences between a piece of property (i.e., a facility) and a 
business entity or person. These comments ask us to consider amending 
the proposed definition of ``qualified facility'' to clarify what sales 
to include in determining whether a facility so qualifies.
    (Response 19) See Response 57.
3. Animal Food
    We proposed to define the term ``animal food'' to mean food for 
animals other than man that includes pet food, animal feed, and raw 
materials and ingredients.
    (Comment 20) Several comments voice concerns about including within 
the definition of animal food the term ``raw materials.'' The main 
concern is whether firms producing raw materials for animal food must 
register and create animal food safety plans. The comments fear firms 
would dispose of the raw material products due to the high cost of 
developing and maintaining safety plans, and disposal of those raw 
material products would have a significant economic impact due to a 
considerable increase in the cost of animal food in the United States.
    (Response 20) We decline to change the definition. We do not expect 
that the inclusion of the term ``raw materials'' in the definition for 
animal food will change current practices, noting that a facility 
producing raw materials for animal food is already required to 
register. The definition of ``animal food'' is intended to clarify that 
the rule refers to ``food for animals'' and not ``food derived from 
animals.''
4. Critical Control Point
    We proposed to define the term ``critical control point'' (CCP) to 
mean a point, step, or procedure in a food process at which control can 
be applied and is essential to prevent or eliminate a food safety 
hazard or reduce such hazard to an acceptable level.
    (Comment 21) Some comments oppose the use of ``critical control 
point'' in the rule because the term is confusing and not understood by 
the relevant industry in the context of FSMA and the required 
preventive controls. The comments suggest critical control point is a 
HACCP term and not appropriate for use in this rule where the scope is 
defined differently by the statute.
    (Response 21) We decline to modify or remove the definition as 
these comments request because we believe the term is helpful to 
industry. The proposed definition matches the statutory definition in 
section 418(o)(1) of the FD&C Act and is consistent with definitions in 
the Federal HACCP regulations for seafood, juice, and meat and poultry 
(parts 123 and 120 (21 CFR part 123 and 120) and 9 CFR part 417 
respectively). By specifying that a point, step, or procedure in an 
animal food safety process would reduce a hazard to an ``acceptable 
level,'' the definition provides flexibility for a facility to 
determine an appropriate level in a particular circumstance.
    (Comment 22) Some comments request that we define the term 
``control point.'' The comments suggest defining this term as a point, 
step, or procedure in the production of an animal food at which a 
control may be applied.
    (Response 22) We decline this request. We define ``critical control 
point'' as a point, step, or procedure in a food process at which 
control can be applied and is essential to prevent or eliminate a food 
safety hazard or reduce such hazard to an acceptable level. Also, 
``control point'' is not a term used in the regulatory text of the rule 
and therefore does not need to be defined.
5. Environmental Pathogen
    We proposed to define the term ``environmental pathogen'' to mean a

[[Page 56189]]

pathogen capable of surviving and persisting within the manufacturing, 
processing, packing, or holding environment such that food for animals 
may be contaminated and may result in foodborne illness if that animal 
food is not treated to significantly minimize or prevent the 
environmental pathogen. We also proposed to specify that environmental 
pathogen does not include the spores of pathogenic sporeformers. By 
``pathogenic sporeformers,'' we mean ``pathogenic sporeforming 
bacteria,'' and we are substituting the term ``pathogenic sporeforming 
bacteria'' for ``pathogenic sporeformers'' in the definition of 
``environmental pathogen'' to make that clearer.
    (Comment 23) Some comments ask us to include Salmonella spp. and 
Listeria monocytogenes in the regulatory text as examples of 
environmental pathogens. Other comments believe the definition is too 
broad because it would include any pathogen that is capable of 
surviving or persisting in the environment, and the definition should 
be limited to the pathogenic bacteria that are more appropriate for 
protecting animal food safety.
    (Response 23) We agree that Salmonella spp. and L. monocytogenes 
are useful examples of environmental pathogens and have added these two 
examples to the proposed definition, which had not included examples. 
Adding these two examples to the definition does not mean that these 
two pathogens are the only environmental pathogens that a facility must 
consider in its hazard analysis. New environmental pathogens can emerge 
at any time, and other pathogens can also be environmental pathogens. 
Salmonella spp in pet food have been involved in foodborne illness 
outbreaks in humans (78 FR 64736 at 64747). In addition, there have 
been recalls of pet food found to contain L. monocytogenes, though no 
human or animal illnesses were associated with these recalls to date 
(Refs. 17 and 18).
    (Comment 24) Some comments ask us to clarify the meaning of the 
term ``persisting'' as used in the definition, such as whether it means 
that a sanitation process will not remove the microorganism.
    (Response 24) We use the term ``persisting'' to mean that a 
pathogen can get established if cleaning is not adequate. Once a 
pathogen gets established, appropriate sanitation measures can remove 
the pathogen. However, sanitation procedures necessary to eliminate an 
environmental pathogen that has become established generally are more 
aggressive than routine sanitation procedures.
6. Facility
    We proposed to define the term ``facility'' to mean a domestic 
facility or a foreign facility that is required to register under 
section 415 of the FD&C Act in accordance with the requirements of part 
1, subpart H. Comments directed to the meaning of the term ``facility'' 
address its meaning as established in the section 415 registration 
regulations, rather than this definition established in part 507.
    For a discussion of comments on definitions in part 1, see section 
IV of the final rule for preventive controls for human food published 
elsewhere in this issue of the Federal Register.
7. Farm
    We proposed to define the term ``farm'' by reference to the 
definition of that term in Sec.  1.227(b) rather than by repeating the 
full text of the ``farm'' definition in part 507. For a discussion of 
comments to the farm definition and of the ``farm'' definition that we 
are establishing in Sec.  1.227, see section IV of the final rule for 
preventive controls for human food published elsewhere in this issue of 
the Federal Register.
8. Food
    We proposed to define the term ``food'' to mean food as defined in 
section 201(f) of the FD&C Act and to include raw materials and 
ingredients. Under section 201(f), the term ``food'' means: (1) 
Articles used for food or drink for man or other animals, (2) chewing 
gum, and (3) articles used for components of any such article.
    (Comment 25) Some comments ask us to include examples in the 
definition. These comments also ask us to clarify whether the 
definition applies to food for human consumption, animal consumption, 
or both.
    (Response 25) We decline the request to include examples in the 
definition. There are many examples of food and adding a limited list 
of examples could be confusing rather than helpful. Although the 
definition of food includes food for both human consumption and animal 
consumption, the provisions of the rule are clearly directed to food 
for animal consumption.
    (Comment 26) Some comments ask us to consider fundamental and 
important differences between food additives and GRAS substances and 
finished food. These comments explain that food additives and GRAS 
substances may be synthesized using various chemical and biochemical 
processes, or may be extracted, hydrolyzed or otherwise modified from 
their natural sources, and result in food safety hazards that are quite 
different from finished food preparations. These comments also explain 
that food additives and GRAS substances are often produced using 
processes that minimize microbial contamination hazards and are almost 
always used in food products that undergo further downstream 
processing. These comments assert that food additives and GRAS 
substances generally present a significantly lower public health hazard 
compared to finished food and should be regulated accordingly.
    (Response 26) Substances such as food additives and GRAS substances 
are food and are subject to the requirements of this rule. Both the 
CGMP requirements in subpart B and the requirements for hazard analysis 
and risk-based preventive controls in subparts C and E provide 
flexibility to address all types of food. (As discussed in section XL, 
the final rule establishes the requirements for a supply-chain program 
in subpart E, rather than within subpart C as proposed. As a result, 
this document refers to subparts C and E when broadly referring to the 
requirements for preventive controls.) A manufacturer of a food 
additive or GRAS substance has flexibility to comply with the 
requirements of the rule based on the nature of the production 
processes and the outcome of the hazard analysis for that animal food 
substance.
9. Food-Contact Surfaces
    We proposed to define ``food-contact surfaces'' to mean those 
surfaces that contact animal food and those surfaces from which 
drainage, or other transfer, onto the food or onto surfaces that 
contact the food ordinarily occurs during the normal course of 
operations. ``Food-contact surfaces'' include food-contact surfaces of 
utensils and equipment.
    (Comment 27) Several comments state that the terms ``drainage'' and 
``utensils'' are not widely used or understood within animal feed and 
pet food industry and that the definition for ``food-contact surfaces'' 
should be revised by deleting ``drainage, or other,'' and by replacing 
``utensils'' with ``tools.''
    (Response 27) We decline these requests. See our discussion of the 
term ``utensils'' in Response 169. We believe the term ``drainage'' is 
commonly understood.
10. Harvesting
    We proposed to define the term ``harvesting'' to apply to farms and 
farm

[[Page 56190]]

mixed-type facilities and to mean activities that are traditionally 
performed by farms for the purpose of removing RACs from the place they 
were grown or raised and preparing them for use as food. We proposed 
that harvesting be limited to activities performed on RACs on a farm, 
and that harvesting does not include activities that transform a RAC 
into a processed food. The proposed definition included examples of 
activities that would be harvesting.
    In this final rule, we added or modified several examples of 
harvesting (see Response 28). As noted in table 31, we have reorganized 
the listed examples of harvesting to present them in alphabetical 
order.
    We are defining the term ``harvesting'' to apply to farms and farm 
mixed-type facilities and to mean activities that are traditionally 
performed on farms for the purpose of removing RACs from the place they 
were grown or raised and preparing them for use as animal food. The 
definition includes examples of activities that are harvesting, as 
described in this section. Harvesting is also limited to activities 
performed on RACs, or on processed foods created by drying/dehydrating 
a RAC without additional manufacturing/processing, on a farm.
    (Comment 28) Some comments ask us to provide more examples of 
harvesting activities, in the regulatory text and in guidance. Examples 
of the requested activities include braiding; bunching; cutting the 
edible portion of the crop from the plant; hydro-cooling; maintaining 
hydration of product; refrigerating; removing foliage; removing free 
water from (e.g. spinning); removing or trimming roots; trimming the 
tops of bunches of allium crops such as leeks, chives, or garlic and 
root crops such as carrots, beets, turnips, parsnips, etc. to prepare 
them for sale; and trimming the lower stems of harvested herb crops 
such as parsley, basil, or cilantro, or the lower stems of leafy 
greens. Other comments ask us to specify that harvesting also 
encompasses seed conditioning (i.e., cleaning the seed, including 
removal of leaves, stems, and husks to prepare for marketing), ripening 
(artificial or natural) of fruit, and waxing or coating of RACs.
    (Response 28) We have added or modified several examples of 
harvesting in the regulatory text (i.e., cutting (or otherwise 
separating) the edible portion of the RAC from the crop plant, removing 
or trimming part of the RAC (e.g., foliage, husks, roots or stems) and 
field coring and hulling). In table 1 in the Appendix to the 2014 
supplemental notice (79 FR 58476 at 58520 through 58521), we provided a 
more extensive list of examples of harvesting activities, including 
examples that are not in the regulatory text. We have classified some 
of these activities in more than one way (see 79 FR 58476 at 58520 
through 58521). For example, trimming of outer leaves from RACs can be 
a harvesting activity, as well as a manufacturing/processing activity. 
Artificial ripening of fruit is manufacturing/processing (not 
harvesting), but is now within the ``farm'' definition.
    (Comment 29) Some comments ask us to periodically review the list 
of harvesting activities to ensure that it reflects current practices.
    (Response 29) If particular activities present questions in the 
future about whether the activity is a harvesting activity within the 
``farm'' definition, or a manufacturing/processing activity that is 
outside the ``farm'' definition, we will consider issuing guidance or 
updating any existing guidance to clarify our recommended 
classification of the activity.
    (Comment 30) Some comments note that the proposed definition for 
``harvesting'' seems to be much more inclusive than FDA's original 
proposed regulation, but is significantly more restrictive than the 
current regulation in part 1 because it excludes future technological 
developments. The comment further notes as technology and harvesting 
techniques advance, the risk of tying the definition to traditional 
activities will have a negative effect on agriculture's ability to 
adapt. Furthermore, harvesting is merely the first step in transforming 
a RAC into processed food.
    (Response 30) The comment did not make a specific request or 
provide any suggestions as to how future technological developments 
should be handled; therefore, we are finalizing the definition with the 
changes previously described.
11. Hazard
    We proposed to define the term ``hazard'' to mean any biological, 
chemical (including radiological), or physical agent that is reasonably 
likely to cause illness or injury in humans or animals in the absence 
of its control.
    (Comment 31) Some comments express concern that the rule would 
refer to four levels of ``hazard,'' i.e., ``hazard,'' ``known or 
reasonably foreseeable hazard,'' ``significant hazard,'' and ``serious 
adverse health consequences or death to humans or animals'' hazard. 
These comments ask us to provide sufficient clarity to be able to 
distinguish between these types of hazards and to provide examples in 
guidance as to how these terms will be applied in determining 
compliance with the rule. Other comments express concern that the 
definitions do not establish a meaningful distinction between 
``hazard'' and ``significant hazards'' and do not sufficiently 
distinguish between the hazards identified in the first and second 
steps of the hazard analysis (first narrowing hazards to ``known or 
reasonably foreseeable hazards'' and then narrowing the ``known or 
reasonably foreseeable hazards'' to ``significant hazards'').
    (Response 31) The rule uses three of these terms (i.e., ``hazard,'' 
``known or reasonably foreseeable hazard,'' and the proposed term 
``significant hazard'') to establish a tiered approach to the 
requirements for hazard analysis and risk-based preventive controls. 
The term ``hazard'' is the broadest of these three terms--any 
biological, chemical (including radiological), or physical agent has 
the potential to cause illness or injury. To conduct its hazard 
analysis, a facility starts by first narrowing down the universe of all 
potential hazards to those that are ``known or reasonably foreseeable'' 
for each type of food for animals manufactured, processed, packed, or 
held at its facility. The outcome of the facility's hazard analysis is 
a determination of ``significant hazards,'' i.e., the subset of those 
known or reasonably foreseeable hazards that require a preventive 
control.
    To make this clearer, we have: (1) Revised the proposed definitions 
of ``hazard'' and (2) changed the term ``significant hazard'' to 
``hazard requiring a preventive control'' (formerly ``significant 
hazard''). See Responses 32 and 62.
    The rule does not define the term ``serious adverse health 
consequences or death to humans or animals'' hazard. However, the 
requirements for a supply-chain program refer to a hazard for which 
there is a reasonable probability that exposure to the hazard will 
result in serious adverse health consequences or death to humans or 
animals (see Sec.  507.130(b)). For additional information on how we 
interpret ``serious adverse health consequences or death to humans or 
animals,'' see our guidance regarding the RFR (Refs. 19 and 20), which 
addresses statutory requirements regarding ``reportable foods.'' As 
explained in that guidance, a ``reportable food'' is an article of food 
for which there is a reasonable probability that the use of, or 
exposure to, such article of food will cause serious adverse health 
consequences or

[[Page 56191]]

death to humans or animals. The guidance includes examples of 
circumstances under which food might be reportable.
    (Comment 32) Some comments assert that the distinction between the 
definitions of ``hazard'' and ``significant hazard'' is not discernable 
because the proposed definition of ``hazard'' currently takes into 
account whether or not a ``hazard'' is or is not controlled. These 
comments ask us to delete the phrase ``in the absence of its control'' 
from the definition of ``hazard'' to clarify that hazards are simply 
the agents that are reasonably likely to cause illness or injury. 
Likewise, other comments assert that any hazard that is ``reasonably 
likely to cause illness or injury in the absence of its control'' will, 
if known or reasonably foreseeable, likely be controlled by any 
knowledgeable person.
    (Response 32) We have deleted the phrase ``in the absence of its 
control'' from the definition of ``hazard.'' We agree that deleting 
this phrase from the definition of ``hazard'' will more clearly 
distinguish between the terms ``hazard'' and ``hazard requiring a 
preventive control'' that we are establishing in this rule.
    We also replaced the phrase ``that is reasonably likely to cause 
illness or injury'' with ``that has the potential to cause illness or 
injury'' to more clearly distinguish ``hazard'' from ``known or 
reasonably foreseeable hazard.'' This increases the alignment of the 
definition of ``hazard'' in this rule with the Codex definition of 
``hazard.''
    (Comment 33) Some comments ask us to include ``in the intended 
species'' in the definition of ``hazard.''
    (Response 33) We decline this request. During the hazard analysis 
the facility must identify and evaluate, based on experience, illness 
data, scientific reports, and other information, known or reasonably 
foreseeable hazards for each type of animal food manufactured, 
processed, packed, or held at the facility to determine whether there 
are hazards requiring a preventive control (Sec.  507.33(a)). During 
the hazard evaluation, the facility must consider the effect of the 
intended or reasonably foreseeable use on the safety of the finished 
animal food for the intended animal (Sec.  507.33(d)(8)).
12. Holding
    We proposed to define ``holding'' to mean storage of food, 
including activities performed incidental to storage of a food (e.g., 
activities performed for the safe or effective storage of that food and 
activities performed as a practical necessity for the distribution of 
that food (such as blending of the same RAC and breaking down 
pallets)), but not including activities that transform a RAC into a 
processed food. We proposed that holding facilities could include 
warehouses, cold-storage facilities, storage silos, grain elevators, 
and liquid-storage tanks.
    (Comment 34) Some comments ask us to provide more examples of 
holding activities, in the regulatory text and in guidance. Examples of 
the requested activities include fumigating RACs; application of 
chemicals (including fungicides, sanitizers, and anti-oxidants); and 
``coating'' grain RACs with diatomaceous earth to control insects. 
According to these comments, these activities are incidental to storage 
and do not transform RACs into processed food. Other comments wanted 
examples of holding of human-food by-products destined for animal food 
(for example wet pasta that dries naturally while being held).
    (Response 34) We have added or modified several examples of holding 
in the regulatory text (i.e., fumigating animal food during storage, 
and drying/dehydrating RACs when the drying/dehydrating does not create 
a distinct commodity (such as drying/dehydrating hay or alfalfa)). In 
table 1 in the Appendix to the 2014 supplemental notice (79 FR 58476 at 
58520 through 58521), we provided a more extensive list of examples of 
holding activities, including examples that are not in the regulatory 
text. We have previously classified some of these activities in more 
than one way (see 79 FR 58476 at 58520 through 58521) depending on when 
the activity occurs. For example, sorting, culling, and grading RACs 
can be either a holding activity or a packing activity. Drying/
dehydrating RACs is holding when the drying/dehydrating does not create 
a distinct commodity, but is manufacturing/processing when the drying/
dehydrating creates a distinct commodity (see section IV). Holding of 
certain human food by-products for use as animal food is discussed in 
sections XIII and XXII.
    (Comment 35) Some comments ask us to clarify that mixing or 
blending intact RACs is considered ``holding'' regardless of whether 
the RACs are the same or different.
    (Response 35) We use the term ``blending'' when referring to RACs 
such as grain and when the RACs are the same. For example, we consider 
the activity of ``blending'' different lots of the same grain to meet a 
customer's quality specifications to be a practical necessity for 
product distribution and, thus, to be within the definition of 
``holding'' (see 79 FR 58476 at 58483). However, we use the term 
``mixing'' when the RACs are different. For example, we consider the 
activity of ``mixing'' corn and oats in the production of animal food 
to be manufacturing/processing, because mixing two different foods is 
``making food from one or more ingredients'' (which is our definition 
of ``manufacturing/processing'') and the animal food produced by mixing 
corn and oats is a processed food.
    We classify ``mixing'' intact RACs that does not create a processed 
animal food as incidental to, and therefore part of, ``packing'' or 
``holding'' as applicable. For example, mixing heads or bunches of 
lettuce does not create a processed food, because the mixing has not 
created a distinct commodity, but only a set of mixed RACs. On the 
other hand, mixing that creates a processed animal food is not 
``packing'' or ``holding.'' The definitions of both ``packing'' and 
``holding'' are limited so that they do not include activities that 
transform a RAC into processed animal food. Some kinds of mixing of 
RACs does create a distinct commodity (for example, mixing corn and 
oats to make animal food). In such cases, the mixing is manufacturing/
processing and is not within the farm definition.
    (Comment 36) Some comments ask us to clarify whether the expanded 
definition of holding that we proposed in the 2014 supplemental human 
preventive controls notice would mean that a warehouse that both stores 
and fumigates a RAC to prevent pest infestation would be exempt from 
the requirements for hazard analysis and risk-based preventive controls 
for a facility solely engaged in the storage of RACs (other than fruits 
and vegetables) for further distribution or processing (Sec.  507.5).
    (Response 36) Fumigating RACs to prevent pest infestation would be 
within the definition of ``holding'' and therefore would not prevent a 
facility that stores RACs (other than fruits and vegetables) from being 
eligible for the exemption in Sec.  507.5(g), provided that the 
facility does not conduct other activities not classified as 
``holding.'' However, a threshold question for any facility solely 
engaged in the storage of RACs is whether the stored RACs are fruits or 
vegetables.
    (Comment 37) Some comments ask us to clarify whether there is a 
timeframe associated with holding and to better distinguish between 
``holding'' and ``storage.''
    (Response 37) There is no timeframe (maximum or minimum) associated 
with holding. The definition of holding

[[Page 56192]]

states ``Holding means storage of food'' and, thus, there is no 
distinction between ``holding'' and ``storing.''
    (Comment 38) Some comments ask us to clarify how the definition of 
holding relates to practices, such as fumigation, on almond hull 
stockpiles held on a farm, a farm mixed-type facility or off-farm.
    (Response 38) Practices that are incidental to storage of food, 
such as fumigation of almond hull stockpiles, are holding, regardless 
of whether they are conducted on-farm, on a farm mixed-type facility, 
or off-farm.
    (Comment 39) Some comments ask us to clarify that value added 
activities (such as repacking and blast freezing) conducted in 
facilities such as warehouses would be considered holding when product 
is not exposed to the environment.
    (Response 39) We consider the activities described in these 
comments to be activities performed as a practical necessity for the 
distribution of the food and, thus, to be within the definition of 
holding.
    (Comment 40) Several comments do not support the proposed 
definition of ``holding'' stating that the definition would exempt 
grain receiving and storage facilities that are the primary suppliers 
of the main ingredient in many animal foods including distiller's 
products. Some comments ask us to clarify what is a practical 
necessity.
    (Response 40) Section 418(m) of the FD&C Act provides us with the 
authority to exempt certain facilities from the requirements of section 
418, or to modify those requirements. We proposed to use this authority 
to exempt facilities that solely engage in the storage (holding) of 
RACs (other than fruits and vegetables) intended for further 
distribution or processing. We tentatively concluded that there would 
not be significant public (human and animal) health benefit to be 
gained by having these facilities subject to the requirements of 
subpart C. Outbreaks of illness associated with feeding RACs to animals 
have not been traced back to storage facilities solely engaged in the 
storage of RACs, therefore we think it is appropriate to exempt them 
from the requirements of subparts C and E of the final rule. Such 
facilities remain subject to the requirements of section 402 of the 
FD&C Act that the animal food being held is not adulterated.
    The revised definition of ``holding'' encompasses activities 
performed as a practical necessity for the distribution of RACs, such 
as blending of the same RAC and breaking down pallets. Sampling for 
grading or quality control purposes, repacking, and drying grains and 
oilseeds would also be considered performed as a practical necessity 
for the distribution of animal food within the definition of 
``holding.''
13. Known or Reasonably Foreseeable Hazard
    We proposed to define the term ``known or reasonably foreseeable 
hazard'' to mean a biological, chemical (including radiological), or 
physical hazard that has the potential to be associated with the 
facility or the food.
    (Comment 41) Some comments support the definition as proposed, 
noting that it implies that the implementation of a preventive control 
be based both on the severity and likelihood of the hazard, can help to 
distinguish between the requirements of this rule and HACCP 
requirements, and provides for the proper consideration of both the 
food and the facility when determining whether a hazard is ``known or 
reasonably foreseeable.'' Other comments ask us to modify the 
definition to specify that the term means a hazard ``that is known to 
be, or has the potential to be, associated with the facility or the 
food'' to better align with the term as FDA proposed to define it in 
the proposed FSVP rule. (See 79 FR 58574 at 58595.)
    (Response 41) We have revised the definition as requested by the 
comments to better align with the proposed FSVP rule.
    (Comment 42) Some comments ask us to revise the definition so that 
it addresses a hazard that is known to be, or has the potential to be, 
associated with a food, the facility in which it is manufactured/
processed, or the location or type of farm on which it is grown or 
raised. These comments assert that the type of farm may affect those 
hazards that are known or reasonably foreseeable.
    (Response 42) We decline this request, which appears related to 
another difference between the definition proposed in this rule and the 
definition of this term in the proposed FSVP rule. The proposed FSVP 
rule would define ``known or reasonably foreseeable hazard'' as a 
hazard that is known to be, or has the potential to be, associated with 
a food or the facility ``in which it is manufactured/processed.'' (See 
79 FR 58574 at 58595.) In this rule, we do not need to specify that the 
applicable facility is the one ``in which the food is manufactured/
processed'' because this rule applies to the owner, operator, or agent 
in charge of the facility in which the food is manufactured, processed, 
packed, or held, and that applicability does not need to be repeated in 
each provision. To the extent that this comment is expressing concern 
about raw materials or other ingredients that a facility would receive 
from a farm, those concerns would be considered in the facility's 
hazard analysis, which would include a hazard evaluation that considers 
factors such as those related to the source of raw materials and other 
ingredients (see Sec.  507.33(d)(3)).
14. Lot
    We proposed to define ``lot'' to mean the food produced during a 
period of time indicated by a specific code.
    (Comment 43) Some comments state that many animal food processors 
operate on a batch-production basis rather than a continuous-production 
basis and request that we take this into account with respect to the 
definition of ``lot.'' Other comments suggest replacing ``lot'' with 
``lot identifier'' where ``lot identifier'' means a unique identifier 
for each lot, batch or production run that enables the manufacturer to 
trace accurately the complete manufacturing and distribution history of 
the product. Other comments ask us to modify the proposed definition so 
that it is not limited by a period of time and suggest using an 
approach that would allow for a lot to be defined by either time or by 
a specific identifier. Other comments express the view that the 
individual operators should be able to define their lot designations 
and make these definitions available to FDA upon request.
    (Response 43) Although the term ``lot'' is associated with a period 
of time, an establishment has flexibility to determine the code, with 
or without any indication of time in the code. For example, a code 
could be based on a date, time of day, production characteristic (such 
as origin, variety, and type of packing), combination of date/time/
production characteristic, or any other method that works best for the 
establishment. To clarify that the rule does not require that time be 
``indicated'' by the code, and emphasize the establishment's 
flexibility to determine the code, we have revised ``period of time 
indicated by a specific code'' to ``period of time and identified by an 
establishment's specific code.''
15. Manufacturing/Processing
    We proposed to define ``manufacturing/processing'' to mean making 
food from one or more ingredients, or synthesizing, preparing, 
treating, modifying, or manipulating food, including food crops or 
ingredients. We proposed that examples of manufacturing/processing 
activities would be cutting, peeling, trimming,

[[Page 56193]]

washing, waxing, eviscerating, rendering, cooking, baking, freezing, 
cooling, pasteurizing, homogenizing, mixing, formulating, bottling, 
milling, grinding, extracting juice, distilling, labeling, or 
packaging. For farms and farm mixed-type facilities, manufacturing/
processing would not include activities that are part of harvesting, 
packing, or holding. In this rule, we add more examples to include, 
``artificial ripening,'' ``boiling,'' ``canning,'' ``drying/dehydrating 
raw agricultural commodities to create a distinct commodity (such as 
drying/dehydrating grapes to produce raisins),'' ``evaporating,'' 
``extruding,'' and ``pelleting.'' We also alphabetize the list of 
examples.
    (Comment 44) Some comments express concern that some activities 
included in the definition of ``manufacturing/processing'' overlap with 
activities (such as trimming, washing, and cooling) included in the 
definition of ``harvesting.''
    (Response 44) We acknowledge that there is some overlap in the 
activities that the regulatory text lists as examples of both 
``manufacturing/processing'' and ``harvesting,'' because some 
activities can occur during more than one operation (see table 1 in the 
Appendix to the 2014 supplemental notice (79 FR 58476 at 58520 through 
58521)). For example, ``cutting'' lettuce from the crop plant occurs 
on-farm in the field where the lettuce is harvested, and ``cutting'' 
the core of the lettuce from the rest of the harvested lettuce occurs 
in a fresh-cut processing facility. An important consequence of the 
multiple revisions we have made to the ``farm'' definition in this 
rulemaking is that there are fewer situations in which classification 
of a particular activity is the only trigger for an operation to be 
subject to the section 415 registration requirements. For example, the 
revised ``farm'' definition no longer classifies the packing and 
holding of others' RACs to be a manufacturing/processing activity that 
triggers the registration requirement. As another example, the revised 
``farm'' definition specifies three manufacturing/processing activities 
that are within the ``farm'' definition. We conclude that the overlap 
in the examples of activities listed in the definitions of 
``harvesting'' and ``manufacturing/processing'' does not create 
problems with determining the status of an operation as a ``farm'' or a 
``facility'' and we are retaining examples in both definitions because 
doing so reflects current practices on farms and in manufacturing/
processing facilities.
16. Microorganisms
    We proposed to define the term ``microorganisms'' to mean yeasts, 
molds, bacteria, viruses, protozoa, and microscopic parasites, 
including species having animal or human health significance. We also 
proposed that the term ``undesirable microorganisms'' includes those 
microorganisms that are of animal or human health significance, that 
subject food to decomposition, that indicate that food is contaminated 
with filth, or that otherwise may cause food to be adulterated. We have 
revised the definition to replace ``includes species having animal or 
human health significance'' with ``and includes species that are 
pathogens,'' and replacing ``'undesirable microorganisms''' includes 
those microorganisms that are of animal or human health significance'' 
with ``'undesirable microorganisms''' includes those microorganisms 
that are pathogens.''
    (Comment 45) Some comments express concern that the term 
``undesirable microorganisms'' includes microorganisms that subject 
food to decomposition. These comments assert that the definition would 
expand regulation beyond food safety and ask us to clarify that 
decomposition means a degradation of product that is only relevant when 
it affects the safety of the product, rather than simple spoilage.
    (Response 45) We have not modified the regulatory text of this 
longstanding definition of the term ``undesirable microorganisms'' 
regarding microorganisms that subject food to decomposition. The 
regulations established by this rule are designed to prevent the growth 
of undesirable microorganisms. The scope of the definition of 
``undesirable microorganisms'' is not limited to microorganisms of 
public health significance because these regulations are also concerned 
with sanitation, decomposition, and filth (51 FR 22458 at 22460, June 
19, 1986).
17. Mixed-Type Facility
    We proposed to define ``mixed-type facility'' to mean an 
establishment that engages in both activities that are exempt from 
registration under section 415 of the FD&C Act and activities that 
require the establishment to be registered. We proposed that an example 
of such a facility is a ``farm mixed-type facility,'' which is an 
establishment that grows and harvests crops or raises animals and may 
conduct other activities within the farm definition, but also conducts 
activities that require the establishment to be registered. As a 
conforming change associated with the revisions to the ``farm'' 
definition, we have revised the example of a ``farm mixed-type 
facility'' to specify that it is an establishment that is a farm, but 
also conducts activities outside the farm definition that require the 
establishment to be registered. (See section IV of the final rule for 
preventive controls for human food published elsewhere in this addition 
of the Federal Register.)
    (Comment 46) Some comments ask us to revise the definition to 
exclude those establishments that only conduct low-risk activities 
specified in the exemptions for on-farm, low-risk activity/animal food 
combinations (Sec.  507.5(e) and (f)).
    (Response 46) We decline this request. Whether a particular 
establishment that falls within the definition of ``mixed-type 
facility'' is subject to the requirements for hazard analysis and risk 
based preventive controls is governed by the exemptions established in 
this rule.
18. Monitor
    We proposed to define the term ``monitor'' to mean to conduct a 
planned sequence of observations or measurements to assess whether a 
process, point, or procedure is under control and to produce an 
accurate record for use in verification.
    (Comment 47) Some comments assert that our proposed definition of 
monitor is directed to the narrow circumstance of monitoring that would 
be applied to a CCP under the National Advisory Committee on 
Microbiological Criteria for Foods (advisory committee chartered under 
the USDA) (NACMCF) HACCP guidelines and the Codex HACCP Annex. These 
comments also assert that, using such definitions, monitoring would not 
apply to control measures for which parameters cannot be established 
and that are not amenable to documentation. These comments suggest that 
we use a definition of monitoring consistent with that provided in ISO 
22000:2005 (conducting a planned sequence of observations or 
measurements to assess whether control measures are operating as 
intended) to clarify that monitoring may be conducted where appropriate 
for preventive controls that are not CCPs. (ISO is an abbreviation for 
``International Organization for Standardization.'' ISO develops and 
publishes International Standards.) According to these comments, an 
advantage of this definition is that it also would clarify the 
difference between monitoring activities (observations conducted during 
the

[[Page 56194]]

operation of a control measure to ensure that it is under control) and 
verification activities (to evaluate performance of a control measure).
    (Response 47) We have revised the definition of monitor to mean to 
conduct a planned sequence of observations or measurements to assess 
whether control measures are operating as intended. We agree that the 
revised definition, which reflects an international standard, more 
effectively communicates that monitoring also applies to controls that 
are not at CCPs and may apply to control measures for which parameters 
cannot be established. However, we disagree that this definition 
signals that it is not possible to obtain documentation when monitoring 
preventive controls that are not at CCPs, such as for controls that are 
not process controls and do not involve parameters and maximum or 
minimum values, or combinations of values, to which a parameter must be 
controlled to significantly minimize or prevent a hazard requiring a 
preventive control. For example, it is possible to monitor that a 
specific sanitation control activity has taken place, such as the 
cleaning of a piece of equipment to prevent cross-contact.
    The requirement for documenting monitoring in records is 
established by the requirements for monitoring, not by the definition 
of monitor. As discussed in section XXX.C, we have made several 
revisions to the regulatory text, with associated editorial changes, to 
clarify that monitoring records may not always be necessary.
19. Packaging (When Used as a Verb)
    We proposed to define ``packaging (when used as a verb)'' as 
placing food into a container that directly contacts the food and that 
the consumer receives.
    Based on comments received to the proposed rule for preventive 
controls for human food, we have decided not to establish the 
definition ``packaging (when used as a verb)'' in part 507. For a 
discussion of those comments received to the human food preventive 
controls rule, see section IX.C.20 in the final rule for preventive 
controls for human food published elsewhere in this issue of the 
Federal Register.
20. Packing
    We proposed to define ``packing'' as placing food into a container 
other than packaging the food, including activities performed 
incidental to packing a food (e.g., activities performed for the safe 
or effective packing of that food (such as sorting, culling and 
grading)), but not including activities that transform a raw 
agricultural commodity, as defined in section 201(r) of the FD&C Act, 
into a processed food as defined in section 201(gg). We have revised 
the definition to clarify that packing includes ``re-packing.''
    For comments on the definition of ``packing,'' see section IV.G of 
the final rule for preventive controls for human food, published 
elsewhere in this addition of the Federal Register.
    We are finalizing the definition as proposed, with the addition of 
another example of an activity performed for the safe or effective 
packing of the food, i.e., weighing or conveying incidental to packing 
or repacking, and the addition of ``animal'' in front of food.
21. Pathogen
    We proposed to define the term ``pathogen'' to mean a microorganism 
of public (human or animal) health significance.
    (Comment 48) Some comments ask us to revise the definition to mean 
a ``microorganism of such severity and exposure that it would be deemed 
of public health significance'' because the significance of pathogens 
to public health depends on the organism's severity and the nature of 
exposure.
    (Response 48) We decline this request. Our purpose in defining the 
term pathogen was to simplify the regulations, including our 
longstanding CGMP regulations for human food, by substituting a single 
term (i.e., ``pathogen'') for a more complex term (i.e., 
``microorganism of public health (human and animal) significance'') 
throughout the regulations. These comments fail to explain how we have 
interpreted the current term ``microorganism of public health 
significance'' in a way that does not take into account factors such as 
the severity of illness and the route of exposure.
22. Plant
    We proposed to define the term ``plant'' to mean the building or 
establishment or parts thereof, used for or in connection with the 
manufacturing, processing, packing, or holding of animal food.
    (Comment 49) Some comments state that it would not be helpful to 
use ``plant'' interchangeably with ``establishment'' when referring to 
a business that is not required to register. These comments ask us to 
consistently use one of these terms and to define a term that would 
mean ``a business that is not required to register'' to help 
distinguish such businesses from ``facilities.''
    (Response 49) We agree that it is appropriate to consistently use 
one term when referring to a business entity. However, we disagree that 
it is necessary to establish a definition for a business entity that is 
not required to register. A business that meets the definition of 
``facility'' is required to register; a business that is not required 
to register is simply a business that does not meet the definition of 
``facility.''
    To address these comments, we have revised provisions of the rule 
in three ways. First, we have revised the definition of ``plant'' to 
focus it on the building, structure, or parts thereof, used for or in 
connection with the manufacturing, processing, packing, or holding of 
animal food, rather than on the ``building or establishment.'' Second, 
we have revised applicable provisions of part 507 to use 
``establishment'' rather than ``plant'' when focusing on a business 
entity rather than on buildings or other structures. Third, we have 
revised provisions that use the terms ``plant,'' ``establishment,'' or 
both to conform to the definition of ``plant'' and the described usage 
of ``establishment.'' For example, Sec.  507.14 establishes 
requirements for ``the management of the establishment'' rather than 
``plant management,'' because ``establishment'' is the term focusing on 
the business entity. As another example, Sec.  507.17(a)(1) establishes 
requirements for properly storing equipment, removing litter and waste, 
and cutting weeds or grass within the immediate vicinity of the 
``plant'' rather than within the immediate vicinity of the ``plant 
buildings or structures,'' because the defined term ``plant'' focuses 
on the buildings and structures, and it is not necessary to repeat 
``buildings and structures'' when the term ``plant'' is used.
23. Preventive Controls
    We proposed to define the term ``preventive controls'' to mean 
those risk-based, reasonably appropriate procedures, practices, and 
processes that a person knowledgeable about the safe manufacturing, 
processing, packing, or holding of food would employ to significantly 
minimize or prevent the hazards identified under the hazard analysis 
that are consistent with the current scientific understanding of safe 
food manufacturing, processing, packing, or holding at the time of the 
analysis.
    (Comment 50) Some comments ask us to clarify the meaning of 
``current scientific understanding'' because scientific understanding 
can vary depending on the risk profile of a commodity.
    (Response 50) By ``current scientific understanding,'' we mean to 
emphasize

[[Page 56195]]

that scientific information changes over time and a facility needs to 
keep current regarding safe handling and production practices such that 
the facility has the information necessary to apply appropriate 
handling and production practices.
24. Preventive Controls Qualified Individual
    We proposed to define the term ``qualified individual'' to mean a 
person who has successfully completed training in the development and 
application of risk-based preventive controls at least equivalent to 
that received under a standardized curriculum recognized as adequate by 
FDA, or is otherwise qualified through job experience to develop and 
apply a food safety system. We have changed the proposed term 
``qualified individual'' to ``preventive controls qualified 
individual'' because we are establishing a new definition for 
``qualified individual,'' with a meaning distinct from ``preventive 
controls qualified individual.'' To minimize the potential for 
confusion, for when the term ``qualified individual'' refers to the 
proposed meaning of the term and when the term ``qualified individual'' 
refers to the meaning of that term as finalized in this rule, in the 
remainder of this document we use the new term ``preventive controls 
qualified individual'' whenever we mean ``a person who has successfully 
completed training in the development and application of risk-based 
preventive controls at least equivalent to that received under a 
standardized curriculum recognized as adequate by FDA or is otherwise 
qualified through job experience to develop and apply a food safety 
system,'' even though the proposed rule used the term ``qualified 
individual.'' Likewise, we use the new term ``preventive controls 
qualified individual'' for the proposed term ``qualified individual'' 
when describing the comments to the proposed rule, even though those 
comments use the term ``qualified individual.''
    In the following paragraphs, we discuss comments on this proposed 
definition. (See also our discussion in section XXXVII.B of the 
requirements applicable to the preventive controls qualified individual 
(Sec.  507.53(c)).)
    (Comment 51) Some comments assert that the proposed definition of 
preventive controls qualified individual is ambiguous.
    (Response 51) The comments provide no basis for asserting that this 
definition is ambiguous. The proposed definition includes a performance 
standard (qualified to develop and apply a food safety system), two 
criteria for how a person can become qualified (specialized training or 
job experience), and a description of the type of applicable training 
(development and application of risk-based preventive controls at least 
equivalent to that received under a standardized curriculum). The 
proposed definition provides flexibility for how an individual can 
become qualified, but this flexibility does not make the definition 
ambiguous.
    (Comment 52) Some comments ask us to expand the definition so that 
it includes a team of preventive controls qualified individuals, not 
just a single person.
    (Response 52) We decline this request. The definition applies to 
each preventive controls qualified individual that a facility relies on 
to satisfy the requirements of the rule without limiting the number of 
such preventive controls qualified individuals. The requirements of the 
rule make clear that a facility may rely on more than one preventive 
controls qualified individual (see, e.g., Sec.  507.53(a)).
    (Comment 53) Several comments state that there is a lack of 
specificity about what constitutes appropriate training and experience 
to qualify as a ``preventive controls qualified individual.'' Another 
comment asks us to clarify how the qualification of the ``preventive 
controls qualified individual'' will be assessed. One comment asks how 
the resume and experience of preventive controls qualified individuals 
in other countries will be evaluated by FDA to determine that they meet 
the required qualifications.
    (Response 53) As discussed further in Response 395, we do not 
expect to directly assess the qualifications (whether obtained by 
training or by job experience) of persons who function as preventive 
controls qualified individuals. Instead, we intend to focus our 
inspections of both domestic and foreign facilities on the adequacy of 
the food safety plan prepared by the preventive controls qualified 
individual (or under their oversight). As necessary and appropriate, we 
will consider whether deficiencies we identify in the food safety plan 
suggest that the preventive controls qualified individual may not have 
adequate training or experience to carry out the required functions. If 
the food safety plan suggests the preventive controls qualified 
individual does not have adequate training or experience, we will 
perform a more in-depth review of the preventive controls qualified 
individual's training or experience, including any associated 
documentation.
    See also our discussion in section XXXVII.B about the requirements 
applicable to the preventive controls qualified individual (Sec.  
507.53(c)).
25. Qualified Auditor
    We proposed to define the term ``qualified auditor'' to mean a 
person who is a preventive controls qualified individual as defined in 
this part and has technical expertise obtained by a combination of 
training and experience appropriate to perform the auditing function as 
required by Sec.  507.53(c)(2). As discussed in Response 399, we have 
revised the definition to specify that ``qualified auditor'' means a 
person who is a ``qualified individual'' as that term is defined in 
this final rule, rather than a ``preventive controls qualified 
individual,'' because some auditors may be auditing businesses (such as 
produce farms) that are not subject to the requirements for hazard 
analysis and risk-based preventive controls, and it would not be 
necessary for such an auditor to be a ``preventive controls qualified 
individual.'' We also have clarified that the technical expertise is 
obtained through education, training, or experience (or a combination 
thereof) necessary to perform the auditing function to align the 
description of applicable education, training, and experience with the 
description of applicable education, training, and experience in the 
definition of ``qualified individual'' (see Sec.  507.3).
    (Comment 54) Some comments ask us to revise the definition of 
qualified auditor to include persons who have technical expertise 
obtained by a combination of training, experience, or education 
appropriate to perform audits. Some comments ask us to recognize that 
training and/or experience can make a person a qualified auditor; the 
comments state that people with experience performing audits likely 
have applicable training but might not have completed a specific 
regimen of courses. Some comments maintain that we should recognize the 
role of the education of a potential qualified auditor, as well as 
training and experience to meet the criteria.
    (Response 54) We agree that a qualified auditor might obtain the 
necessary auditing expertise in part through education, as well as 
through training and experience, and we have revised the definition of 
qualified auditor accordingly. The revised definition states that a 
qualified auditor has technical expertise obtained through education, 
training, or experience (or the combination thereof).

[[Page 56196]]

    (Comment 55) Some comments that support the proposed definition ask 
us to revise the definition to specify certain individuals who would be 
considered qualified auditors, such as FDA inspectors, properly trained 
Federal auditors, and State and private auditors operating under a 
contract with the Federal Government.
    (Response 55) We have revised the regulatory text to specify that 
examples of potential qualified auditors include: (1) A government 
employee, including a foreign government employee and (2) an audit 
agent of a certification body that is accredited in accordance with 
regulations in part 1, subpart M (i.e., regulations in our forthcoming 
third-party certification rule implementing section 808 of the FD&C Act 
(21 U.S.C. 348d)). Although we agree that it is useful to include 
examples of individuals who would have the appropriate qualifications, 
the example of an audit agent of a certification body that has been 
accredited in accordance with our regulations in our forthcoming third-
party certification rule adds context about the standard for such 
individuals. Because paragraph (2) of the new provision refers to 
provisions in a future third-party certification rule, we will publish 
a document in the Federal Register announcing the effective date of 
paragraph (2) when we finalize the third-party certification rule.
26. Qualified End-User
    We proposed to define the term ``qualified end-user'' to mean, with 
respect to an animal food, the consumer of the food (where the term 
consumer does not include a business); or a restaurant or retail food 
establishment (as those terms are defined in Sec.  1.227(b)) that: (1) 
Is located (a) in the same State as the qualified facility that sold 
the food to such restaurant or establishment; or (b) is not more than 
275 miles from such facility; and (2) is purchasing the food for sale 
directly to consumers at such restaurant or retail food establishment. 
We have revised the definition of ``qualified end-user'' to add ``or 
the same Indian reservation'' to clarify for purposes of this rule that 
``in the same State'' under section 418(l)(4)(B)(ii)(I) of the FD&C Act 
includes both within a State and within the reservation of a Federally-
Recognized Tribe.
    (Comment 56) One comment requests the term ``restaurant'' be 
removed from the proposed definition of ``qualified end-user'' and 
replaced with the appropriate definitional terms for ``restaurant'' 
provided in Sec.  1.227: Pet shelters, kennels, and veterinary 
facilities in which animal food is provided to animals. The comment 
also suggests we modify the definition of ``qualified end-user'' to be 
reflective of the customer who is the purchaser of the animal food.
    (Response 56) We decline these requests. The definition of 
``qualified end-user'' is consistent with the definition in section 
418(l)(4)(B) of the FD&C Act. As discussed in Response 81, we decline 
to define consumer.
27. Qualified Facility
    We proposed to define ``qualified facility'' by incorporating the 
description of ``qualified facility'' in section 418(l)(1) of the FD&C 
Act with editorial changes to improve clarity. That definition includes 
two types of facilities: (1) A facility that is a very small business 
as defined in this rule and (2) a facility to which certain statutory 
criteria apply regarding the average monetary value of animal food sold 
by the facility and the entities to which the animal food was sold.
    For the second type of facility, to represent accurately the 
language of section 418(l) of the FD&C Act, we have changed ``animal 
food'' to ``food.''
    Some comments discuss issues related to the definition of very 
small business. See section VIII.A.36 for the discussion of the 
definition of very small business.
    (Comment 57) Some comments assert that the definitions of 
``affiliate'' and ``subsidiary'' in the definition of ``qualified 
facility'' fail to account for the legal differences between a piece of 
property (i.e., a facility) and a business entity or person. These 
comments ask us to consider revising the proposed definition of 
``qualified facility'' to clarify what sales to include in determining 
whether a facility so qualifies.
    (Response 57) We have not revised the proposed definition of 
``qualified facility'' as requested by these comments. The sales to be 
included when a facility determines whether it meets the definition of 
a qualified facility are the sales of animal food by a business entity 
meeting the ``very small business'' definition or food by a business 
entity meeting the other qualified facility definition, each of which 
includes the parent company and all its subsidiaries and affiliates. 
The total sales are applicable to each entity, whether it is the 
parent, the subsidiary or the affiliate. We intend to address issues 
such as these in guidance as directed by section 418(l)(2)(B)(ii) of 
the FD&C Act.
    (Comment 58) Some comments ask us to clarify who will determine 
whether a particular facility is a qualified facility.
    (Response 58) Any facility that determines that it satisfies the 
criteria for a ``qualified facility'' must notify FDA of that 
determination (see Sec.  507.7) and, thus, the first determination will 
be made by the facility itself. During inspection, the investigator 
could ask to see the records that support the facility's determination 
to verify the facility's determination.
    In this rule, we remove the term ``quality control operation'' 
because the term is very broad within the animal food industry and may 
not be specific to animal food safety.
28. Receiving Facility
    We proposed to define the term ``receiving facility'' to mean a 
facility that is subject to subpart C of this part and that 
manufactures/processes a raw material or ingredient that it receives 
from a supplier.
    (Comment 59) Some comments ask us to modify the definition to 
specify that the receiving facility could receive the raw material or 
ingredient directly from a supplier or by means of an intermediary 
entity. These comments assert that without this added regulatory text 
the proposed definition implies that the material or ingredient must be 
received directly from the supplier.
    (Response 59) We decline this request. As discussed in section 
XLII.B and C, the two parties that are critical to the supplier 
verification program are the receiving facility and the supplier, even 
if there are entities in the supply chain between the two. The 
definition of receiving facility does not preclude the participation of 
intermediary entities in the supply chain, and the rule does provide 
for such participation (see Sec.  507.115). However, the definition of 
receiving facility does highlight the fact that a receiving facility 
must have a link to a supplier.
29. Rework
    We proposed to define ``rework'' to mean clean, unadulterated food 
that has been removed from processing for reasons other than insanitary 
conditions or that has been successfully reconditioned by reprocessing 
and that is suitable for use as food. In this rule, we add ``animal'' 
before food for clarity.
    (Comment 60) Several comments request that we replace 
``insanitary'' with ``unclean'' as the former term is not utilized in 
the animal food industry. Other comments state that the proposed 
definition for ``rework'' is too narrow and does not represent its use 
in animal food production.
    (Response 60) We decline this request. The word ``insanitary'' is 
used in the FD&C Act and human food

[[Page 56197]]

regulations, including the Current Good Manufacturing Practice in 
Manufacturing, Packing, or Holding Human Food (currently 21 CFR part 
110 and updated and included in the final rule for preventive controls 
for human food (21 CFR part 117) published elsewhere in this Federal 
Register). Because of the use of the term in the FD&C Act and various 
FDA regulations, we think industry is familiar with the word 
``insanitary'' and it is an appropriate word to use in this final rule.
    We disagree that the definition of the term ``rework'' is too 
narrow. The definition allows the flexibility for an establishment to 
consider clean, unadulterated animal food that was never adulterated or 
was successfully reconditioned to be rework.
30. Sanitize
    We proposed to define ``sanitize'' to mean to adequately treat 
cleaned food-contact surfaces by a process that is effective in 
destroying vegetative cells of microorganisms of animal or human health 
significance, and in substantially reducing numbers of other 
undesirable microorganisms, but without adversely affecting the product 
or its safety for animals or humans.
    (Comment 61) Several comments request that we replace the term 
``sanitize'' with ``clean,'' as the former term is not utilized in the 
animal food industry. Other comments ask us to modify the definition 
because the destruction of all microorganisms of animal or human health 
concern is not always practical, and because the terminology 
``adversely affecting the product or its safety for animal or humans'' 
is ambiguous. Others ask us to revise the definition to state that 
``adequate'' or ``adequately'' means to reduce the presence of 
organisms of concern sufficient to help prevent illness through 
cleaning and sanitizing using EPA registered/FDA regulated food use 
antimicrobials and other means such as heat, ozone, etc. Some comments 
ask us to clarify that the ``cleaning'' should be appropriate to the 
specific food system and method used for sanitizing, and that cleaning 
should only be required when the sanitizing process alone would not be 
effective without a prior cleaning step.
    Some comments express concern about whether the proposed definition 
of ``sanitize'' would preclude the continued, routine use of dry 
cleaning methods with no sanitizing step. These comments note that 
adding routine aqueous-based cleaning and sanitizing procedures could 
create a public health risk in certain operations such as low moisture 
food production. These comments also note that dry cleaning procedures 
can result in equipment that, while sanitary, is neither visibly clean 
nor suitable for aqueous chemical sanitizers.
    (Response 61) When the destruction of microorganisms is required, 
we use the terms ``sanitize'' or ``sanitizing,'' to differentiate from 
``cleaning'' or ``sanitation,'' which is consistent with how these 
terms are used throughout our current regulations for human food. 
Therefore, we believe that ``sanitize'' is a word that is commonly 
understood by industry and is used in this final rule in a way that is 
consistent with how it is used in our other regulations relating to 
food.
    We consider that systems such as steam systems clean the surfaces, 
as well as sanitize them and, thus, satisfy the definition of 
``sanitize.'' The definition of ``sanitize'' does not preclude the 
continued use of dry cleaning methods with no sanitizing step because 
the definition describes the meaning of the term ``sanitize'' without 
establishing any requirement for when equipment must be sanitized.
    We have revised the definition so that it means adequately treating 
``surfaces'' rather than ``food-contact surfaces.'' As a technical 
matter, adequately treating any surface--regardless of whether it is a 
food-contact surface--by a process that is effective in destroying 
vegetative cells of pathogens, and in substantially reducing numbers of 
other undesirable microorganisms, but without adversely affecting the 
product or its safety for animals or humans, is ``sanitizing'' the 
surface. Clarifying this technical meaning of the term ``sanitize'' 
imposes no requirements to sanitize surfaces other than animal food-
contact surfaces; the requirements for sanitizing surfaces are 
established by provisions such as Sec.  507.19(b)(2), not by the 
definition of the term ``sanitize.''
31. Significant Hazard (Hazard Requiring a Preventive Control)
    We proposed to define the term ``significant hazard'' to mean a 
known or reasonably foreseeable hazard for which a person knowledgeable 
about the safe manufacturing, processing, packing, or holding of animal 
food would, based on the outcome of a hazard analysis, establish 
controls to significantly minimize or prevent the hazard in an animal 
food. The rule would use the term ``significant hazard'' rather than 
``hazard reasonably likely to occur'' to reduce the potential for a 
misinterpretation that all necessary preventive controls must be 
established at CCPs (79 FR 58476 at 58477 through 58478).
    (Comment 62) Comments support using a term other than ``hazard 
reasonably likely to occur'' and agree that using a term other than 
``hazard reasonably likely to occur'' throughout the rule will reduce 
the potential for a misinterpretation that all necessary preventive 
controls must be established at CCPs.
    Some comments support the regulatory text of the proposed 
definition of the term ``significant hazard.'' These comments state 
that the proposed regulatory text more closely aligns with the 
principles in FSMA (``reasonably foreseeable'' and ``significantly 
minimize or prevent'') and provides operators the flexibility to 
implement a range of preventive controls that are commensurate with the 
risk and probability posed by a specific hazard. Some comments agree 
that the proposed regulatory text can clarify the difference between 
HACCP rules and the animal preventive controls rule. Some comments 
state that the proposed regulatory text plainly reflects the concept 
that significant hazards are those hazards to be addressed through the 
very broad category of preventive controls, and the rule is explicit 
that preventive controls may be controls other than CCPs. Some comments 
state that the definition reflects the risk-based nature (i.e., both 
the severity of a potential hazard and the probability that the hazard 
will occur) of the requirements and provides additional flexibility so 
that facilities can take into account the nature of the preventive 
control in determining when and how to establish and implement 
appropriate preventive control management components. Some comments 
support including the phrase ``based on the outcome of a hazard 
analysis'' in the definition because it ensures that identification of 
significant hazards will be risk based. Some comments ask us to be 
clear about FDA's expectations concerning a hazard analysis conducted 
by those involved in animal food production. Some comments ask us to 
preserve in the final definition two key aspects that grant the animal 
food industry the flexibility that it needs: (1) The logical conclusion 
that not all hazards will have the same impact or will even constitute 
``significant hazards'' at all, depending on the facility's products 
and position in the supply chain and (2) the fact that a ``person 
knowledgeable about the safe manufacturing, processing, packing, or 
holding of food'' must be knowledgeable about the specific food 
produced at that

[[Page 56198]]

facility and in that specific sector of the food industry.
    Some of the comments that support the regulatory text of the 
proposed definition nonetheless express concern about the term 
``significant hazard.'' Some of these comments express concern that a 
facility may not recognize hazards that need to be controlled because 
they do not rise to the commonly understood meaning of ``significant.'' 
Other comments express concern that the adjective ``significant'' is 
subject to many interpretations and suggest that the term ``hazard 
requiring control'' would be more straightforward, accurate, and 
suitable.
    Other comments express concern that the term ``significant hazard'' 
could cause confusion because it has implications in HACCP systems. For 
example, ``significant hazard'' is often used in the context of CCPs 
and preventive controls are not necessarily established at CCPs. Some 
of these comments suggest that we eliminate the term and instead use 
the full regulatory text of the proposed definition in place of 
``significant hazard'' throughout the regulations. Other comments 
suggest using a term such as ``food safety hazard'' or ``actionable 
hazard'' instead of ``significant hazard to avoid a term that has HACCP 
implications. Other comments state that the term ``significant hazard'' 
has implications for facilities that follow the Codex HACCP Annex and 
express concern that foreign facilities would be especially likely to 
be confused by the term ``significant hazard.''
    Some comments ask us to ensure that the term ``significant hazard'' 
is used consistently and express the view that some regulatory text 
refers to a ``hazard'' or ``known and reasonably foreseeable hazard'' 
where ``significant hazard'' should instead be used. As discussed in 
Comment 31, some comments express concern that the rule would refer to 
multiple levels of hazard and ask us to provide sufficient clarity to 
be able to distinguish between these types of hazards.
    (Response 62) We have changed the term ``significant hazard'' to 
``hazard requiring a preventive control.'' The new term uses the 
explicit language of FSMA (i.e., ``preventive control''), is consistent 
with the specific suggestion of one comment (i.e., hazard requiring a 
control''), and is not commonly associated with HACCP systems. We 
decline the request to use the term ``food safety hazard'' because that 
term already is established in Federal HACCP regulations for seafood 
and meat/poultry, and the comments are particularly concerned about 
using a term that has implications for HACCP systems. We also decline 
the request to use the term ``actionable hazard,'' because the term 
``actionable'' is associated with violations at a food processing 
plant.
    We reviewed the full regulatory text of proposed subpart C and 
replaced ``significant hazard'' with ``hazard requiring a preventive 
control'' in most cases. See table 31.
    We also reviewed the full regulatory text of proposed subpart C to 
evaluate whether there were any circumstances where the regulatory text 
should more appropriately refer to ``hazard requiring a preventive 
control'' rather than ``hazard'' or ``known or reasonably foreseeable 
hazard.'' The term ``known or reasonably foreseeable hazard'' appears 
only once, in the requirement for a facility to conduct a hazard 
analysis (Sec.  507.33(a)). We are retaining ``known or reasonably 
foreseeable hazard'' in that requirement because it is necessary to 
implement the tiered approach to the requirements for hazard analysis 
and risk-based preventive controls (see Response 31). To reinforce this 
tiered approach, and emphasize that the facility only conducts a hazard 
analysis for known or reasonably foreseeable hazards, we revised 
``hazard'' to ``known or reasonably foreseeable hazard'' in two 
additional provisions in the requirements for hazard identification 
(see the introductory regulatory text for Sec.  507.33(b)(1) and (2)).
    In our review of the full regulatory text of proposed subpart C, we 
did not identify any circumstances where we believe it is appropriate 
and necessary to specify ``hazard requiring a preventive control'' in 
place of ``hazard.'' It is not necessary for the regulatory text of 
requirements for preventive controls, the supply-chain program, the 
recall plan, corrective actions, and verification to specify ``hazard 
requiring a preventive control'' every time that the requirements use 
the term ``hazard'' because the context of the requirement establishes 
the applicability to ``hazards requiring a preventive control.'' 
Although we acknowledge that using ``hazard requiring a preventive 
control'' in place of ``hazard'' throughout applicable provisions of 
proposed subpart C would emphasize the tiered approach to the 
requirements for hazard analysis and risk-based preventive controls, 
doing so would make the regulatory text unnecessarily bulky and awkward 
and would be inconsistent with comments that ask us to make the 
regulatory text understandable (see Comment 13 in section III of the 
final rule for preventive controls for human food, published elsewhere 
in this issue of the Federal Register).
    (Comment 63) Some comments ask us to allow facilities to continue 
to implement existing controls outside the framework of this rule 
(i.e., outside the framework that requires preventive control 
management components as appropriate to ensure the effectiveness of the 
preventive controls, taking into account the nature of the preventive 
control and its role in the food safety system) when a hazard addressed 
by the existing controls does not rise to the level of ``significant 
hazard.''
    Other comments express concern that the term ``significant hazard'' 
may create a disincentive for facilities to voluntarily implement 
preventive controls for hazards that only pose a remote risk or are 
very rarely encountered, because implementing preventive controls for 
hazards of very low probability and severity may be misinterpreted as 
requiring preventive controls applicable to a ``significant hazard'' 
even if the hazard does not meet the definition of ``significant 
hazard'' established in the rule. Some comments ask us to revise the 
definition to provide facilities with the flexibility and discretion to 
establish appropriate preventive controls for hazards that do not rise 
to the criteria of a ``significant hazard,'' as well as ensuring that 
preventive controls that address remote or very unlikely hazards not be 
subject to the preventive control management requirements for a 
``significant hazard.''
    (Response 63) We have revised the definition to specify that the 
term ``hazard requiring a preventive control'' applies when a 
knowledgeable person would, based on the outcome of a hazard analysis, 
``establish one or more preventive controls'' rather than ``establish 
controls.'' By narrowing ``controls'' to ``one or more preventive 
controls,'' we mean to signify that the proposed term ``significant 
hazard'' (which we now refer to as ``hazard requiring a preventive 
control'') only applies to those controls that the facility establishes 
to comply with the requirements of subparts C and E for hazard analysis 
and risk-based preventive controls. A facility that establishes other 
controls (such as those that the comments describe as ``prerequisite 
programs,'' or controls directed to hazards of very low probability and 
severity) for hazards that are not, based on the outcome of the 
facility's hazard analysis, ``hazards requiring a preventive control'' 
would not need to establish preventive control management components 
for such controls. However, some controls

[[Page 56199]]

previously established in ``prerequisite programs'' would be considered 
``preventive controls.'' We provide some flexibility for facilities 
with respect to how they manage preventive controls, and the preventive 
control management components may be different for hazards that have 
been managed as ``prerequisite programs'' compared to those managed 
with CCPs. A facility that is concerned about the potential for an 
investigator to disagree during inspection that certain controls are 
not directed to ``hazards requiring a preventive control'' could, for 
example, include information relevant to its classification of those 
other controls in its hazard analysis, whether by merely listing the 
``other controls'' or by providing a brief explanation why such 
controls are not ``preventive controls'' as that term is defined in 
this rule.
    (Comment 64) Some comments assert that the proposed definition of 
``significant hazard'' is tautological because it essentially 
establishes a ``significant hazard'' to be a known or reasonably 
foreseeable hazard (i.e., the type of hazards identified in the first 
step of the analysis) for which preventive controls should be 
implemented. These comments assert that the proposed definition of 
``significant hazard'' would collapse the second step of hazard 
analysis into the first, which in turn would lead to the unintended 
consequence of facilities identifying the same hazards in the second 
step as in the first. Some comments ask us to revise the definition to 
include evaluation of severity and probability, because these concepts 
are integral for making a proper determination of whether a hazard is 
significant. Other comments ask us to revise the definition to better 
reflect the risk-based approach that preventive controls be implemented 
to control hazards that have a higher probability of resulting in 
public health consequence in the absence of control.
    (Response 64) We have revised the definition of ``significant 
hazard'' (which we now refer to as ``hazard requiring a preventive 
control'') to specify that the hazard analysis includes an assessment 
of the severity of the illness or injury if the hazard were to occur 
and the probability that the hazard will occur in the absence of 
preventive controls. By specifying that the determination of a 
``significant hazard'' is based on the outcome of a hazard analysis, 
the proposed definition did, as requested by the comments, include the 
risk-based nature of the determination. However, explicitly adding that 
the hazard analysis is based on probability and severity (i.e., risk) 
makes the risk-based nature of the determination clearer.
    We disagree that the proposed definition was tautological and would 
collapse the second step of hazard analysis into the first. A facility 
begins its hazard analysis by narrowing down the universe of all 
potential hazards to those that are ``known or reasonably foreseeable'' 
for each type of animal food manufactured, processed, packed, or held 
at its facility. The outcome of the facility's hazard analysis is a 
determination of a subset of those known or reasonably foreseeable 
hazards, i.e., those hazards requiring a preventive control. To the 
extent that these comments are asserting that the tautology was created 
by the phrase ``in the absence of its control'' in the proposed 
definition of ``hazard,'' we have deleted that phrase from the final 
definition of ``hazard.''
    We decline the request to repeat in the definition of ``hazard 
requiring a preventive control'' the requirement for the types of 
information that a facility would consider in conducting its hazard 
analysis. The requirements for hazard analysis clearly specify that a 
facility must conduct its hazard analysis based on experience, illness 
data, scientific reports, and other information (see Sec.  507.33(a)).
    (Comment 65) Some comments that broadly address the overall 
framework for the new requirements for hazard analysis and risk-based 
preventive controls ask us to consistently refer to ``the nature of the 
preventive control'' (rather than simply to ``the preventive control'') 
when communicating the flexibility that a facility has in identifying 
preventive controls and associated preventive control management 
components. Other comments that broadly address the overall framework 
for the new requirements for hazard analysis and risk-based preventive 
controls ask us to emphasize that the requirements for preventive 
control management components convey not only that the application of a 
particular element is appropriate (i.e., capable of being applied), but 
also necessary for food safety. Some comments recommend that we do so 
by specifying that preventive control management components take into 
account the role of the preventive control in the food safety system.
    (Response 65) We agree with these comments and have revised the 
definition of ``hazard requiring a preventive control'' to specify that 
preventive control management components are established as appropriate 
to ``the nature of the preventive control and its role in the 
facility's food safety system.''
    (Comment 66) Some comments assert that the problem is how to 
separate the hazards addressed by ``HACCP'' from those addressed by 
CGMPs. These comments suggest that control measures that are 
implemented for hazards from ingredients and food-contact packaging 
material, and from production and process, be called CCPs and that 
control measures that are implemented for hazards from personnel, 
equipment, and the plant be called preventive controls.
    (Response 66) The facility must control hazards through the 
application of CGMPs and preventive controls as appropriate to the 
hazard. Although some preventive controls will be established at CCPs, 
and ``CCP'' is a term commonly used in HACCP systems, this rule 
establishes requirements for hazard analysis and risk-based preventive 
controls, not ``HACCP,'' and this rule provides that preventive 
controls include controls at CCPs, if there are any CCPs, as well as 
controls, other than those at CCPs, that are also appropriate for 
animal food safety (see Sec.  507.34(a)(2)).
    Under the rule, some hazards may be addressed by CGMPs and others 
by preventive controls. For example, a facility could control a 
physical hazard such as metal by using screens and magnets under CGMPs 
and then use a metal detector as a preventive control.
    (Comment 67) Some comments express concern that the term 
``significant hazard'' may lead to misunderstanding by medium and 
smaller processors and ask how businesses with limited food safety 
experience will understand the difference between a food safety hazard 
that is ``reasonably likely to occur'' (and, thus, must be controlled 
by a full HACCP Plan) and a ``significant hazard'' that can be 
controlled by a preventive control plan.
    (Response 67) It will not be necessary for an animal food processor 
to understand the difference between a hazard that is ``reasonably 
likely to occur'' in the concept of HACCP requirements and a ``hazard 
requiring a preventive control'' in the context of this rule. FDA does 
not have any HACCP regulations that apply to animal food.
    (Comment 68) Some comments ask us to concur that ``temporal 
hazards'' in some food products (specifically, aflatoxin, pesticides, 
and radiological contamination) do not represent ``significant 
hazards'' that require monitoring and verification activities on an 
ongoing basis. These comments also ask us to acknowledge that in many

[[Page 56200]]

cases the testing done by FDA and others is sufficient for protecting 
public health and that it is not necessary to require ongoing 
monitoring by individual facilities in order to comply with the rule.
    (Response 68) We decline these requests because such a 
determination should be facility specific. However, we have revised the 
considerations for the hazard evaluation to clarify that in making the 
determination as to what hazards require preventive controls, the 
facility can consider factors such as the temporal nature of the hazard 
(see Sec.  507.33 and section XXV). In determining the appropriate 
preventive control management components, the facility can take into 
account the nature of the preventive control and its role in the 
facility's food safety system (see Sec.  507.39(a)).
32. Significantly Minimize
    We proposed to define the term ``significantly minimize'' to mean 
to reduce to an acceptable level, including to eliminate. We did not 
receive comment and are finalizing it as proposed.
33. Small Business
    We proposed to define the term ``small business'' to mean, for the 
purposes of part 507, a business employing fewer than 500 persons. We 
conducted a Food Processing Sector Study as required by section 
418(l)(5) of the FD&C Act (Ref. 12) and used the results of the study 
in defining the term ``small business.'' (78 FR 64736 at 64758 through 
64759.) We made the results of the Food Processing Sector Study 
available in Docket No. FDA-2011-N-0922 and requested public comment on 
that study.
    (Comment 69) Some comments express concern that the Food Processing 
Sector Study is not comprehensive. Some comments assert that FDA did 
not sufficiently collaborate with USDA, and that FDA significantly 
underestimated the number of mixed-use facilities, particularly by 
neglecting to count farms that perform the processing steps on RACs to 
become a processed food. Other comments assert that the Food Processing 
Sector Study is woefully inadequate and must be undertaken again to 
comply with the law.
    (Response 692) We previously acknowledged the limitations of the 
Food Processing Sector Study (78 FR 64736 at 64758 through 64759). We 
have revised and extended the results of our earlier study by expanding 
our data sources and by including representatives from USDA's Economic 
Research Service, USDA's Agricultural Marketing Service and the 
American Farm Bureau to help oversee the revised study. The revised 
Food Processing Sector Study is available in the docket of this rule 
(Ref. 21).
    Our original analysis was based on the merger of Dun & Bradstreet 
data and FDA's Food Facility Registration data to help us estimate the 
number of manufacturing facilities that are also classified as farms. 
We have updated that data source and added data sources. To better 
account for farms that perform processing activities, we included 
Census of Agriculture (Ag Census) data both to provide a count of total 
U.S. farms and to estimate the number of farms conducting food 
processing activities, to the extent that the data identifies 
processing activities. We also included the Agricultural Resource 
Management Survey (ARMS) data because it included questions about some 
processing activities for select commodities.
    Both the Ag Census and ARMS are silent about many processing 
activities. Therefore, we also obtained estimates from commodity 
specialists at trade associations, USDA, and universities with in-depth 
knowledge of the processing activities for specific agricultural 
commodities.
    (Comment 70) Some comments ask us to explain how to calculate the 
number of full-time equivalent employees, e.g., with respect to 
temporary workers, seasonal workers, and part-time workers. Other 
comments say it is unclear whether fewer than 500 full-time equivalent 
employees means those involved in the entire business or those involved 
only in the animal food-related portions of the business, noting that 
the term ``business'' is unclear (i.e., whether business means a 
corporation and all its subsidiaries or only the portion of the 
business related to animal food be it animal feed, pet food and/or 
ingredients).
    (Response 70) As previously discussed, we proposed to establish the 
same definition for small business as that which has been established 
by the U.S. Small Business Administration under 13 CFR part 121 for 
most food manufacturers, and the limit of 500 employees would include 
all employees of the business rather than be limited to the employees 
at a particular facility (78 FR 64736 at 64759). We will base the 
calculation on ``full-time equivalent employees'' and use the same 
approach to calculating full-time equivalent employees for the purpose 
of this rule as we used to calculate full-time equivalent employees in 
the section 414 recordkeeping regulations (see Sec.  1.328). This 
approach is similar to the approach the Agency used to calculate the 
small business exemption for nutrition labeling of food (Sec.  
101.9(j)(18)(iv)(D)). Under this approach, the number of full-time 
equivalent employees is determined by dividing the total number of 
hours of salary or wages paid directly to employees of the business 
entity claiming the exemption and of all of its subsidiaries and 
affiliates by the number of hours of work in 1 year, 2,080 hours (i.e., 
40 hours x 52 weeks).
    The calculation for the number of employees affects exemptions 
(i.e., the exemptions for on-farm, low-risk activity/animal food 
combinations in Sec.  507.5(e) and (f), which apply only to small and 
very small businesses), not just compliance dates. Therefore, we are 
establishing the definition of ``full-time equivalent employee'' in the 
definitions for this rule (Sec.  507.3) and modifying the definition of 
``small business'' to use the term ``500 full-time equivalent 
employees'' rather than ``500 persons.''
    (Comment 71) Some comments assert that there should be no exemption 
from compliance with this rule based on total annual sales or number of 
employees, noting that all companies regardless of size should have 
food safety programs in place.
    (Response 71) The definition of ``small business'' is relevant to 
the exemptions for on-farm, low-risk activity/animal food combinations 
for manufacturing/processing, packing, and holding animal food by 
mixed-type facilities. This exemption is a risk-based exemption, 
because it only applies to activity/animal food combinations that are 
low-risk and, thus, should not affect animal food safety.
34. Supplier
    We proposed to define the term ``supplier'' to mean the 
establishment that manufactures/processes the food, raises the animal, 
or harvests the food that is provided to a receiving facility without 
further manufacturing/processing by another establishment, except for 
further manufacturing/processing that consists solely of the addition 
of labeling or similar activity of a de minimis nature.
    As discussed in section IV.B of the final rule for preventive 
controls for human food, published elsewhere in this issue of the 
Federal Register, we have revised the ``farm'' definition to explicitly 
include business models in which one operation grows crops but does not 
harvest them, and another operation, not under the same management, 
harvests crops but does not grow them. This revision represents a 
change from the existing and proposed

[[Page 56201]]

``farm'' definitions, which describe a ``farm'' as an entity ``devoted 
to the growing and harvesting of crops'' (emphasis added). We proposed 
the ``supplier'' definition in the context of a single business entity 
``devoted to the growing and harvesting of crops'' (emphasis added). We 
used the term ``harvesting,'' rather than ``growing,'' to reflect the 
last stage of production on a farm, except for packing.
    Because the proposed ``supplier'' definition contemplated that the 
same business entity that grows crops also harvests them, we have 
revised the ``supplier'' definition so that the grower remains the 
supplier when the harvester is under separate management. Specifically, 
``supplier'' is now defined to include an establishment that ``grows'' 
food rather than an establishment that ``harvests'' food. Doing so 
focuses the requirements for the supply-chain program (see subpart E) 
on the entity that produces the food, rather than on the entity that 
removes the food from the growing area, when the grower and the 
harvester are not under the same management. Doing so also simplifies 
the determination of who the supplier is in complex business models, 
such as when a ``handler'' arranges for harvest by another business 
entity.
    (Comment 72) Some comments assert that the definition of supplier 
is not workable because the status of warehouses and brokers is unclear 
in the definition. Other comments ask us to modify the definition to 
specify, in addition to the proposed definition, that the supplier 
could be an intermediary entity that takes responsibility on behalf of 
the receiving facility to ensure that the food meets the requirements 
of this part.
    (Response 72) As discussed in section XL, we agree that the role of 
intermediaries in the supply chain is critical and we have added 
options for entities other than the receiving facility to perform 
certain supplier verification activities, provided that the receiving 
facility reviews and assesses the documentation produced by the other 
entity and documents that review and assessment. However, this does not 
mean that these entities take on the role of the supplier. As discussed 
in Response 59 and in section XL, we believe it is important to 
supplier verification to retain the identities of two parties 
involved--the receiving facility and the supplier. Therefore, we are 
retaining our definition of supplier, with the minor change previously 
discussed.
    (Comment 73) Some comments regarding RACs ask us to modify the 
definition of supplier in the case of comingled RACs, such that the 
supplier would be the person immediately back from the receiving 
facility in the supply chain provided that this entity (presumably a 
warehouse or aggregator) voluntarily complies with the requirements of 
subpart C of this part. One comment asks us to clarify in our 
definition that the supplier must be the establishment that controls 
the hazard in question.
    (Response 73) We decline this request. As discussed in section XL, 
we recognize that doing supplier verification with comingled products 
will be a challenge. However, we believe it is important that there be 
a link between the receiving facility (which is manufacturing/
processing the animal food) and the supplier (who controlled the 
hazard(s) in the animal food). We are allowing an entity such as an 
aggregator or distributor to perform some verification activities, so 
the outcome requested by these comments will be achieved while 
maintaining the identities of the two primary parties in the supplier 
verification relationship (see Response 492).
    (Comment 74) One comment asks us to clarify that the proposed 
definition of supplier does not include sources of processing aids or 
chemicals required for post-harvest treatments and packing processes 
(including waxes, fungicides, detergents and sanitizers).
    (Response 74) As defined, the supplier is the establishment growing 
the food, not those establishments providing inputs (such as waxes, 
fungicides, detergents and sanitizers) to that entity.
35. Validation and Verification
    We proposed to define the term ``validation'' to mean that element 
of verification focused on collecting and evaluating scientific and 
technical information to determine whether the food safety plan, when 
properly implemented, will effectively control the identified hazards. 
We proposed to define the term ``verification'' to mean those 
activities, other than monitoring, that establish the validity of the 
food safety plan and that the system is operating according to the 
plan.
    (Comment 75) Some comments ask us to revise the definitions of 
``validation'' and ``verification'' to be consistent with the Codex 
definitions. Codex defines ``validation'' to mean obtaining evidence 
that a control measure or combination of control measures, if properly 
implemented, is capable of controlling the hazard to a specified 
outcome. Codex defines ``verification'' to mean the application of 
methods, procedures, tests and other evaluations, in addition to 
monitoring, to determine whether a control measure is or has been 
operating as intended (Ref. 22).
    Some comments ask us to more clearly distinguish between 
``validation'' and ``verification.'' Some comments assert that 
validation is not an element of verification as stated in our proposed 
definition and suggest that we clearly separate requirements for 
validation from requirements for verification, e.g., by moving the 
proposed requirements for verification to a distinct section in the 
regulatory text.
    (Response 75) We have explained how our proposed definitions for 
``validation'' and ``verification'' align with a variety of widely 
recognized definitions, including definitions established by Codex, the 
NACMCF HACCP guidelines, and Federal HACCP (78 FR 64736 at 64758). We 
disagree that validation is not an element of verification, but 
acknowledge it is not necessary to say so within the definition of 
``validation.'' Although we have moved the details of the requirements 
for validation from its proposed location within the requirements for 
verification (i.e., proposed Sec.  507.45(a)) to a separate section 
(Sec.  507.47), we did so as an editorial change to improve clarity and 
readability rather than as a substantive change to signal that 
validation is not an element of verification (see table 8, 79 FR 58476 
at 58504).
    We agree that validation can apply to a specific control measure as 
specified in the Codex definition. We also agree that validation can 
apply to a combination of control measures as specified in the Codex 
definition. The food safety plan is one example of a combination of 
control measures.
    Although we likewise agree that verification can apply to a 
specific control measure as specified in the Codex definition, we 
disagree that to be consistent with the Codex definition we should 
adopt a definition that excludes the application of verification to the 
food safety plan. It is well established that some verification 
measures, such as testing for a pathogen, verify that multiple control 
measures operated as intended.
    To more clearly distinguish between ``validation'' and 
``verification,'' the definition of ``validation'' we are establishing 
in this rule specifies that validation means obtaining and evaluating 
scientific and technical evidence that a control measure, combination 
of control measures, or the food safety plan as a whole, when properly 
implemented, is capable of effectively controlling the identified

[[Page 56202]]

hazards (emphasis added). We also made conforming changes associated 
with the revised definition of ``validation'' in the requirements for 
validation (see Sec.  507.47(b)(2)). The definition of ``verification'' 
we are establishing in this rule specifies that verification means the 
application of methods, procedures, tests and other evaluations, in 
addition to monitoring, to determine whether a control measure or 
combination of control measures is or has been operating as intended 
and to establish the validity of the food safety plan as a whole 
(emphasis added). Consistent with the request of the comments, the 
definition of ``verification'' uses the Codex description of 
verification as the application of methods, procedures, tests and other 
evaluations, in addition to monitoring.
36. Very Small Business
    We proposed to define the term ``very small business'' to mean, for 
the purposes of proposed part 507, a business that has less than 
$2,500,000 in total annual sales of food for animals, adjusted for 
inflation. As discussed in the proposed rule, we conducted a Food 
Processing Sector Study as required by section 418(l)(5) of the FD&C 
Act (Ref. 12) and used the results of the study in defining the term 
``very small business'' (78 FR 64736 at 64758 through 64760). We made 
the results of the Food Processing Sector Study available in Docket No. 
FDA-2011-N-0922. Some comments support defining ``very small business'' 
as a business that has less than $2,500,000 in total annual sales of 
animal food, adjusted for inflation. Other comments disagree or offer 
alternative recommendations.
    (Comment 76) Some comments ask us to clarify how to classify the 
size of a business that does not take ownership or directly sell food 
(e.g., warehouses and contract manufacturers) to determine status as a 
qualified facility. Some comments recommend modifications to the 
proposed very small business definition based on a discussion of 
certain farming models in the 2014 supplemental notice for animal food 
(79 FR 58476 at 58482). These comments express concern that the 
proposed definition of very small business would not account for animal 
food that is not ``sold,'' but is manufactured and then distributed to 
another entity without a sale, such as in the contract farming model 
discussed in the 2014 supplemental notice.
    Other comments recommend modifications to the definition to use the 
value or volume of animal food manufactured and distributed in 
establishing whether a facility is a very small business. The comments 
state that this would account for the animal food manufactured by feed 
mills servicing contract farms. Some of these comments state that the 
value of food produced by feed mills operating under this contract 
model often exceeds the $2,500,000 threshold of the proposed very small 
business definition. They state that because this proposed definition 
only includes sales, it would allow large facilities to be considered 
very small businesses (as they would have no or a very small amount of 
actual sales).
    Other comments request that we modify the proposed definition to 
specify that animal food produced for contract farms is not included in 
``sales'' in the definition for very small business; thereby allowing 
these feed mills to be very small businesses, which would result in 
qualified facility status.
    Some comments ask us to specify that the monetary threshold for the 
definition be based on average sales during a 3-year period on a 
rolling basis because otherwise firms may be subject to significant 
changes in status from year to year. These comments also ask us to 
clarify that the sales are to be evaluated retrospectively, not 
prospectively.
    (Response 76) We have revised the definition of very small business 
to specify that it is based on an average during the 3-year period 
preceding the applicable calendar year in sales of animal food plus the 
market value of animal human food manufactured, processed, packed, or 
held without sale (e.g., held for a fee or supplied to a farm without 
sale). The applicable calendar year is the year after the 3 calendar 
years used to determine whether a facility is a very small business. 
The most recent applicable calendar year is the current year. For 
example, on June 3, 2024, 2024 is the most recent applicable calendar 
year and is the applicable calendar year when the 3 calendar years used 
to determine whether a facility is a very small business are 2021 to 
2023. The exception is when 3 calendar years of records are not 
available, such as when a facility begins business after the compliance 
date for very small businesses. In such situations the applicable 
calendar year refers to the year during which the calculation is made 
but is not preceded by 3 calendar years used to determine whether a 
facility is a very small business.
    As a companion change, we are explicitly requiring that a facility 
determine and document its status as a qualified facility on an annual 
basis by no later than July 1 of each calendar year (see Sec.  
507.7(c)(1)). Although this requirement was implicit in the proposed 
requirement that a facility must resubmit a notification to FDA if its 
status changes as a qualified facility (proposed Sec.  507.7(c)(2), 
which we are finalizing as Sec.  507.7(c)(3)), we are making this 
requirement explicit to clarify the responsibility of the facility to 
affirmatively determine its status when the calendar years that apply 
to the 3-year average change. The July 1 deadline for a facility to 
determine its status provides facilities with 6 months to make the 
determination after the end of the previous 3 calendar years.
    We also are establishing an earlier compliance date for the 
financial records that a facility maintains to support its status as a 
very small business. Specifically, the compliance date for a facility 
to retain records to support its status as a qualified facility is 
January 1, 2017. Even with this earlier compliance date for these 
records, we realize that although the calculation for ``very small 
business'' in the regulatory text is based on 3 calendar years, a 
facility will only be required to have 2 calendar years of records as 
of the general compliance date for very small businesses. Specifically, 
by December 16, 2019 a facility that begins retaining applicable 
financial records on January 1, 2017, would only have such records for 
2 previous calendar years. Therefore, it would be reasonable for a 
facility to make the calculation based on the 2 previous calendar 
years. If a facility has records for 3 previous calendar years, the 
facility could make the calculation based on the longer time period. 
During inspection in 2019, when a facility has records for the 
preceding 2 calendar years, but not for the preceding 3 previous 
calendar years, we will accept records for the preceding 2 calendar 
years as adequate to support status as a qualified facility based on 
calculating an average for those two years. We note that in some 
situations, a shorter time period is sufficient to determine that a 
facility is not a very small business. For example, a facility with 
sales exceeding $7,500,000 for the preceding calendar year cannot 
qualify as a very small business because no amount of sales from other 
years will reduce average sales below the threshold of $2,500,000.
    The available financial records for a facility that begins 
operations between January 1, 2018 and September 17, 2019 would not 
cover even 2 complete calendar years by September 17, 2019. During the 
first 3 calendar years of such a facility's operation, it would be 
reasonable for a facility to make the calculation based on records it 
has (i.e., for 1 or 2 preceding calendar years), and

[[Page 56203]]

we will accept records for the preceding 1 or 2 years as adequate to 
support status as a qualified facility in these circumstances.
    When a facility does not begin operations until after January 1, 
2019, it would be reasonable for the facility to rely on a projected 
estimate of revenue (or market value) when it begins operations. We 
would evaluate the credibility of the projection considering factors 
such as the facility's number of full-time equivalent employees. After 
the facility has records for 1 or 2 preceding calendar years, it would 
be reasonable for the facility to make the calculation based on records 
it has (i.e., for 1 or 2 preceding calendar years) and we will accept 
records for the preceding 1 or 2 years as adequate to support status as 
a qualified facility in these circumstances.
    We agree with the comments that state the animal food distributed, 
but not ``sold,'' by feed mills operating under contract farming 
agreements (and required to register as a food facility under section 
415 of the FD&C Act) should be included in determining whether a 
facility is a very small business. In addition to annual sales of 
animal food, the market value of the animal food supplied to a farm(s) 
without sale must be included when determining if a business is a very 
small business for purposes of this rule.
    The qualified facility exemption of Sec.  507.7 applicable to very 
small businesses is intended to enable these businesses to comply with 
modified requirements because they have fewer resources to direct to 
full compliance with subpart Cs and E of the rule and they provide a 
small volume of animal food for consumption. Many of the businesses 
that have feed mills that provide animal food under contract farming 
agreements are extensive and sophisticated businesses, such as some 
large-scale meat and poultry operations. Such businesses are not the 
intended beneficiaries of the qualified facility exemption because they 
should have adequate resources, such as personnel, equipment, and 
expertise, to implement the requirements of subparts C and E at their 
feed mills. In addition, many of these feed mills manufacture and 
distribute a large volume of animal food yearly. These were some of the 
factors we considered when we revised the proposed definition of a very 
small business to include the market value of the animal food that is 
manufactured, processed, packed, or held without sales or supplied to a 
farm without sales.
    (Comment 77) Some comments support the proposed dollar threshold of 
$2,500,000, noting that it would provide sufficient flexibility to 
companies that receive the exemption to allow them to continue to 
operate. Some comments say there should be no exemption from compliance 
with this rule based on total annual sales or number of employees and 
that all companies regardless of size should have food safety programs 
in place. Several comments request different dollar amounts for 
determining the threshold.
    Some comments propose that the threshold should be $1,000,000, a 
figure that would provide greater coverage than the $2,500,000 proposed 
threshold and also would simplify compliance with all FSMA rules for 
animal food facilities. Other comments suggest the definition for a 
very small business should mean, for purposes of part 507, a business 
that has less than $1,000,000 in total annual sales of animal food, 
adjusted for inflation, and distributes less than 5,000 tons of animal 
food annually. Several comments urge us to consider applying a $500,000 
threshold to the value of animal feed produced by a facility, not just 
the value of animal food that is sold. The comments state that the 
vertically integrated structure of some livestock and poultry 
operations means that some animal feed produced at large operations may 
never be sold because the company supplies feed to contract operations 
raising animals owned by the company.
    Other comments suggest ensuring sufficient flexibility for a 
diverse array of animal food businesses and that we should establish an 
outright exemption from the rule for businesses with, at the very most, 
$100,000 or less in annual average monetary value of animal food sold 
over the previous 3-year period, adjusted for inflation. Another 
comment suggests a threshold of $250,000. Other comments recommend 
defining a very small business as one with less than $10,000 in annual 
sales believing that a rule encompassing virtually all ingredient and 
feed manufacturing and distribution facilities will encourage large 
firms to continue to do business with very small firms. One comment 
suggested excluding the value of donated by-product in the calculation 
of total annual sales of animal food.
    (Response 77) We are establishing a $2,500,000 threshold for the 
definition of ``very small business.'' Under section 418(l)(1)(A) and 
(B) of the FD&C Act, a very small business is a qualified facility; 
under the exemption authorized in section 418(l)(2) of the FD&C Act, a 
qualified facility is subject to modified requirements rather than the 
requirements for hazard analysis and risk-based preventive controls. We 
have acknowledged that a $2,500,000 threshold exempts a greater portion 
of the animal food supply than thresholds of either $500,000 or 
$1,000,000 (79 FR 58476 at 58502), but reaffirm that under the 
$2,500,000 threshold the businesses that would be exempt from the 
requirements for hazard analysis and risk-based preventive controls 
would represent a small portion of the potential risk of foodborne 
illness; businesses that fall within this definition of ``very small 
business,'' collectively, produce less than 0.6 percent of the animal 
food supply (Ref. 3). In addition, most of these facilities will be 
subject to the CGMP requirements in subpart B; the only exemptions from 
those CGMP requirements are the exemptions in Sec.  507.5(a) (which 
applies to farms and activities of ``farm mixed-type facilities'' that 
fall within the definition of ``farm''), and in Sec.  507.5(h) (which 
applies to: (1) The holding or transportation of one or more RACs; (2) 
hulling, shelling, and drying nuts and hulls (without manufacturing/
processing); and (3) the ginning of cotton (without manufacturing/
processing)). Facilities subject to and in compliance with human food 
CGMPs and applicable FDA human food safety requirements that process 
human food and ``donate'' or sell the human food by-products without 
further processing for use as animal food are only subject to certain 
provisions in subpart B for those by-products. This applies whether 
they are a qualified facility or not. They are not subject to the 
requirements of subparts C and E for the human food by-products used 
for animal food.
    (Comment 78) Some comments ask us to only include the total annual 
sales of food in the United States, adjusted for inflation, for foreign 
facilities that export food to the United States.
    (Response 78) We decline this request. The purpose of the 
definition of ``very small business'' is principally to enable such 
businesses to comply with modified requirements, because they have 
fewer resources to direct to full compliance with the rule. A foreign 
business that sells more than the threshold dollar amount of animal 
food has more resources than the businesses being excluded, even if 
less than that threshold dollar amount reflects sales to the United 
States. Likewise, a domestic business that sells more than the 
threshold dollar amount of food has more resources than the businesses 
being excluded, even if that domestic business exports some of its food 
and, as a result, less than that threshold dollar amount reflects sales 
within the United States.

[[Page 56204]]

    (Comment 79) Some comments ask us to base the threshold on the 
total ``volume of product'' or ``amount of product'' handled or sold. 
These comments assert that an approach using product volume or amount 
would be more risk based because it would correlate more closely to 
consumer exposures than dollar amounts, which can be skewed by product 
values.
    (Response 79) We acknowledge that dollar amounts can be skewed by 
product values but nonetheless disagree that we should base the 
threshold on the total ``volume of product'' or ``amount of product'' 
handled or sold. We see no practical way to identify a threshold based 
on volume or amount of product that could be applied across all product 
sectors, and the comments provide no suggestions for how their 
recommendation could be carried out.
    (Comment 80) Some comments express concern that establishing a 
threshold based on U.S. dollars would place domestic firms at a 
disadvantage relative to foreign firms whose sales are often 
denominated in currencies valued lower than the dollar and often 
reflect much lower costs for factors such as land, labor, and 
environmental compliance. These comments ask us to base the threshold 
on an alternate measure, such as number of employees, or to calculate 
the sales of foreign very small businesses using an appropriate measure 
of purchasing power parity, if there is a straightforward way to do so.
    (Response 80) We decline these requests. As previously discussed, 
we use dollar estimates to evaluate the percent of all food produced in 
the United States that would not be covered by the rule (79 FR 58476 at 
58502). We acknowledge that the definition of ``small business'' is 
based on number of employees, and that two exemptions (i.e., the 
exemptions in Sec.  507.5(e) and (f) for on-farm, low-risk activity 
animal food combinations) apply to small businesses. However, the 
exemptions for on-farm, low-risk activity animal food combinations are 
limited to a narrow sector of the animal food industry, whereas the 
exemption applicable to a very small business will apply to all sectors 
of the animal food industry.
    We do not know of a straightforward way to calculate the sales of 
foreign very small businesses using an appropriate measure of 
purchasing power parity and, thus, are basing the threshold only on 
U.S. dollars.

B. Comments Asking FDA To Establish Additional Definitions or Otherwise 
Clarify Terms Not Defined in the Rule

    Some comments ask us to define certain terms such as 
``associated,'' ``contaminate,'' ``directly linked,'' ``integrated 
operator,'' ``material to the safety of food,'' ``written,'' and 
``necessary.'' We believe that it is not necessary to define these and 
certain other new terms proposed by the comments. We discuss in this 
section of this document comments that ask us to establish other new 
terms or clarify terms in the rule not defined.
1. Consumer/Final Consumer/Customer
    (Comment 81) A few comments request that we define consumer as the 
animal consuming the food. Some comments ask us to define ``customer'' 
as the purchaser of the animal food. Other comments ask us to define 
``final consumer'' to mean a person that feeds animals under the 
control or ownership of that person. The comments suggest ``final 
consumer'' could be used in the animal food rule to help clarify the 
meaning of qualified end user.
    (Response 81) We decline these requests. We stated that for 
purposes of the proposed rule, the term consumer refers to the person 
purchasing the animal food to feed to an animal(s), as well as the 
animal(s) consuming the food (78 FR 64736 at 64756 through 64757). To 
limit the definition of consumer to the animal consuming the food would 
be inconsistent with how that term is used throughout FSMA and would 
create confusion. Therefore, ``consumer'' also includes the person 
purchasing the animal food.
2. Corrections
    (Comment 82) Some comments assert that clearly distinguishing 
between the terms ``corrective actions'' and ``corrections'' will be 
imperative for industry to comply with the rule and for regulators to 
enforce the rule. Some comments ask us to use the ISO definitions of 
``corrective actions'' and ``corrections.'' (According to ISO 
22000:2005 definition 3.13, a ``correction'' is action to eliminate a 
detected non conformity; according to ISO 22000:2005 definition 3.14, 
corrective action is action to eliminate the cause of a detected non 
conformity or other undesirable situation.) Other comments ask us to 
eliminate the term ``correction'' and instead revise the rule to 
clarify the type of situation in which ``corrective actions'' are 
neither necessary nor appropriate. As an example, these comments 
suggest that the proposed provisions for corrections could refer to 
``prompt actions taken in response to minor and isolated deviations 
that do not directly impact product safety.''
    Other comments agree with the concept of simple ``corrections'' but 
assert that the term ``corrections'' is unnecessary and could be 
confusing because different facilities may use the term differently. 
These comments explain that sometimes ``correction'' is used to refer 
to the action taken to fix a deviation, and may or may not be part of 
an overall corrective action taken to identify the root cause of the 
deviation and to prevent a similar occurrence. These comments suggest 
that the provisions explain that prompt actions taken to address minor 
and isolated deviations are not subject to the same requirements as 
corrective actions to address potentially systemic concerns, without 
defining the term ``corrections.''
    (Response 82) We are defining the term ``correction'' to mean an 
action to identify and correct a problem that occurred during the 
production of animal food, without other actions associated with a 
corrective action procedure (such as actions to reduce the likelihood 
that the problem will recur, evaluate all affected animal food for 
safety, and prevent affected animal food from entering commerce). We 
agree that clearly distinguishing between the terms ``corrective 
actions'' and ``corrections'' will be important for both industry and 
regulators. We acknowledge that one way to distinguish between 
``corrective actions'' and actions that we would consider 
``corrections'' could be to avoid the term ``corrections'' and instead 
say what we mean each time the rule uses the term ``corrections.'' 
However, after reviewing the full regulatory text of proposed subpart 
C, we concluded that it was not practical to do so, because the term 
``corrections'' was used more often in a title or a cross-reference 
than in a provision where the full text of what we mean by the term 
``corrections'' is necessary to communicate a requirement. Our 
definition of ``corrections'' focuses on the first step in a 
``corrective action procedure'' (i.e., identify and correct the 
problem) and also specifies those aspects of a corrective action 
procedure that do not apply to a correction (i.e., actions to reduce 
the likelihood that the problem will recur, evaluate all affected 
animal food for safety, and prevent affected animal food from entering 
commerce). (A note to the ISO 22000:2005 definition of corrective 
action indicates that it includes cause analysis and is taken to 
prevent recurrence.) We believe that this definition will be adequate 
to

[[Page 56205]]

distinguish ``corrective actions'' from ``corrections.''
    As an example, if a facility applies sanitation controls for an 
environmental pathogen such as Salmonella spp. and animal food residue 
is observed on ``clean'' equipment prior to production, corrections 
would involve re-cleaning and sanitizing the equipment before it is 
used. Because the observation of animal food residue was made prior to 
production of animal food, no animal food is affected, and no actions 
are needed with respect to animal food. Although there are actions that 
can be taken to prevent reoccurrence, such as retraining sanitation 
personnel, these types of situations may reoccur from time to time.
3. Crop
    (Comment 83) Some comments request we define a new term ``crop'' to 
mean the edible or inedible cultivated or harvested plants.
    (Response 83) We decline this request. The term ``crop'' has a 
common meaning, and it is not necessary to establish a meaning for this 
term in this rule.
4. Establishment
    (Comment 84) Several comments request we establish a definition for 
establishment as it is used in the supplier definition. Also, the 
comments suggest that we replace in the definition of farm the term 
``establishment'' with ``operation.''
    (Response 84) Comments concerning the meaning of the term 
``establishment'' as it relates to the ``supplier'' definition are 
addressed in section XL pertaining to subpart E, the supply-chain 
program. Comments directed to the meaning of the term ``establishment'' 
as it relates to the farm definition are addressed in section IV.A and 
B of the final rule for preventive controls for human food, published 
elsewhere in this issue of the Federal Register.
5. Parameter and Value as Used in the Requirements for Process Controls
    (Comment 85) Some comments ask us to define the terms ``parameter'' 
and ``value'' used in the requirements for preventive controls (Sec.  
507.34). These comments ask us to define ``parameter'' as a measurable 
attribute and ``value'' as a specific measurement.
    (Response 85) We decline this request. Both of these terms are used 
in the context of process controls and both have common meanings when 
associated with process controls. Therefore, it is not necessary for 
the rule to define them.
6. Prerequisite Program
    (Comment 86) Some comments ask that we adapt the definition of 
prerequisite program from the ISO's food safety standard, ISO 
22000:2005, noting that the ISO definition is: Basic practices and 
procedures in animal food production that are necessary for the 
manufacture, handling and provision of safe end products and safe food 
for animal consumption.
    (Response 86) We do not use the term ``prerequisite program'' in 
the regulations established by this rulemaking and do not find it 
necessary to define it. We understand that some facilities may refer to 
practices and procedures such as CGMPs, training, or certain controls 
for hazards as a ``prerequisite program.''
7. Qualified Facility Exemption
    (Comment 873) Some comments note that some of the terminology 
associated with the exemption for qualified facilities in the 
preventive controls rule is different from terminology associated with 
an exemption in the proposed produce safety rule. These comments point 
out that the exemption in the proposed produce safety rule refers to 
``qualified exemptions'' (Sec.  112.5), whereas the exemption in the 
proposed animal preventive controls rule refers to ``exemptions'' and 
``qualified facilities'' (Sec.  507.5(d)).
    (Response 873) We have added a definition for the term ``qualified 
facility exemption,'' to mean an exemption applicable to a qualified 
facility under Sec.  507.5(d) (see the regulatory text in Sec.  507.3). 
We also have made conforming changes throughout the rule to use the 
term ``qualified facility exemption'' when it applies. (See table 31).
8. Qualified Investigator
    (Comment 88) Once comment proposes a new term ``qualified 
investigator'' where the term ``qualified investigator'' means an FDA 
or state commissioned investigator that has successfully completed a 
formal training course on inspections; CGMPs; hazard analysis and 
preventive controls for animal food facilities, both animal feed and 
pet food, and has demonstrated an understanding of the differences 
between pet food and animal feed manufacturing facilities.
    (Response 88) We decline this request. Our inspectors will be 
trained on the requirements of this part.
9. Reanalysis
    (Comment 89) Some comments request we define the term reanalysis to 
mean a reassessment of the validity of a preventive control or food 
safety plan to control a hazard.
    (Response 89) We decline this request. Section 418(i) of the FD&C 
Act sets the requirement for conducting a reanalysis, which is in the 
regulatory text in Sec.  507.50, including how often and under what 
circumstances a reanalysis of the food safety plan must be performed, 
and how to handle the results. Therefore, we have determined that a 
definition of ``reanalysis'' is not necessary. For a discussion of the 
reanalysis requirement, see section XXXV.
10. Risk Assessment
    (Comment 90) Some comments request that we add a new term ``risk 
assessment'' and define this term as a scientifically based process 
consisting of hazard identification, hazard characterization, exposure 
assessment, and risk characterization.
    (Response 90) We do not use the term ``risk assessment'' in the 
regulations established by this rulemaking and do not find it necessary 
to define it. As directed by section 103(c) of FSMA, we issued for 
public comment a draft risk assessment, as described in section I.D and 
are including the final risk assessment in the docket established for 
this rule.
    The definition proposed by the comment is similar to the 
requirements for the hazard analysis of Sec.  507.33. The term ``hazard 
analysis'' comes from section 418 of the FD&C Act. For discussion of 
hazard analysis, see section XXV.
11. Undesirable Microorganisms
    (Comment 91) Some comments request we define a new term 
``undesirable microorganisms'' as those microorganisms that are of 
animal or human health significance, thereby rendering the animal food 
unfit for consumption or distribution.
    (Response 91) We decline this request. See Response 45.
12. Unexposed Packaged Animal Food
    As discussed in section XXXVI, some comments ask us to clarify that 
modified requirements for packaged animal food that is not exposed to 
the environment only apply to such animal food that requires time/
temperature controls for safety (TCS animal food). To do so, we are 
defining the term ``unexposed packaged animal food'' to mean packaged 
animal food that is not exposed to the environment and using this term 
throughout the rule. Doing so simplifies the regulatory text and makes 
it clearer.

[[Page 56206]]

C. Additional Definitions To Clarify Terms Not Defined in the Proposed 
Rule

1. Audit
    As already noted, some comments ask us to make the various rules we 
are establishing to implement FSMA consistent with each other, and we 
have worked to align the provisions of this rule with the provisions of 
the FSVP rule to the extent practicable. (See Comment 4 and Response 
4.) To align these provisions, we are establishing in this final rule a 
definition of ``audit'' analogous to the definition of ``audit'' we 
proposed for the FSVP rule. For the purposes of this rule, ``audit'' 
means the systematic, independent, and documented examination (through 
observation, investigation, records review, discussions with employees 
of the audited entity, and, as appropriate, sampling and laboratory 
analysis) to assess a supplier's food safety processes and procedures.
2. Full-Time Equivalent Employee
    As discussed in Response 70, we have established a definition for 
``full-time equivalent employee'' as a term used to represent the 
number of employees of a business entity for the purpose of determining 
whether the business qualifies for the small business exemption. The 
number of full-time equivalent employees is determined by dividing the 
total number of hours of salary or wages paid directly to employees of 
the business entity and of all of its subsidiaries and affiliates by 
the number of hours of work in 1 year, 2,080 hours (i.e., 40 hours x 52 
weeks). If the result is not a whole number, round down to the next 
lowest whole number.
3. Qualified Individual
    As discussed in section IX.A, we are clarifying in new Sec.  
507.4(b)(1) that each individual engaged in manufacturing, processing, 
packing, or holding animal food (including temporary and seasonal 
personnel) or in the supervision thereof must have the education, 
training, or experience (or combination thereof) necessary to 
manufacture, process, pack, or hold safe animal food as appropriate to 
the individual's assigned duties. To better align with the FSVP rule, 
we use the term ``qualified individual'' in new Sec.  507.4 and are 
defining the term ``qualified individual'' to mean a person who has the 
education, training, or experience (or a combination thereof) necessary 
to manufacture, process, pack, or hold safe animal food as appropriate 
to the individuals assigned duties. A qualified individual may be, but 
is not required to be, an employee of the establishment.
4. Raw Agricultural Commodity
    We have added a definition of the term ``raw agricultural 
commodity'' to have the meaning given in section 201(r) of the FD&C 
Act. We decided to define this term in the rule to simplify the 
provisions in part 507 that refer to raw agricultural commodities.
5. Supply-Chain-Applied Control
    We have added a definition of the term ``supply-chain-applied 
control'' to mean a preventive control for a hazard in a raw material 
or other ingredient when the hazard in the raw material or other 
ingredient is controlled before its receipt. We decided to define this 
term in the rule to simplify the provisions in part 507, and in this 
document, that refer to preventive controls applied by a supplier 
before receipt by a receiving facility.
6. Written Procedures for Receiving Raw Materials and Other Ingredients
    We have added a definition of the term ``written procedures for 
receiving raw materials and other ingredients'' to mean written 
procedures to ensure that raw materials and other ingredients are 
received only from suppliers approved by the receiving facility (or, 
when necessary and appropriate, on a temporary basis from unapproved 
suppliers whose raw materials or other ingredients are subjected to 
adequate verification activities before acceptance for use). We decided 
to define this term in the rule to simplify the provisions in part 507, 
and in this document, that refer to these procedures.

IX. Subpart A: Comments on Qualifications of Individuals Who 
Manufacture, Process, Pack, or Hold Animal Food

    In the 2013 proposed preventive controls rule for animal food we 
proposed that personnel responsible for identifying sanitation failures 
or animal food contamination should have a background of education or 
experience, or a combination thereof, to provide a level of competency 
necessary for production of clean and safe animal food. Animal food 
handlers and supervisors should receive appropriate training in proper 
food handling techniques and food-protection principles and should be 
informed of the danger of poor personal hygiene and insanitary 
practices. We asked if the recommendations should be requirements for 
employee education and training (78 FR 64736 at 64778). In addition, we 
requested comment on how best to implement section 418(o)(3) of the 
FD&C Act and the recommendations of the CGMP Working Group for human 
food with respect to training (78 FR 64736 at 64778). We requested 
comment on whether the rule should specify that each person engaged in 
animal food manufacturing, processing, packing, or holding (including 
temporary and seasonal personnel and supervisors) must receive training 
as appropriate to the person's duties; specifying the frequency of 
training (e.g., upon hiring and periodically thereafter); specify that 
training include the principles of animal food hygiene and animal food 
safety, including the importance of employee health and personal 
hygiene, as applied at the facility; and specify that records document 
required training of personnel and, if so, specify minimum requirements 
for the documentation (e.g., the date of the training, the type of 
training, and the person(s) trained). We also requested comment on 
whether to establish some or all of the potential requirements for 
education and training in subpart B, subpart C, or both.
    In the following paragraphs, we discuss comments that respond to 
our requests for comment on potential requirements for education and 
training and whether to establish any requirements in subpart B, 
subpart C, or both. After considering these comments, we are 
establishing requirements for the qualifications of individuals engaged 
in manufacturing, processing, packing, or holding animal food, as well 
as the associated recordkeeping requirements in new Sec.  507.4 in 
subpart A. The regulatory text makes clear that these requirements, 
established in subpart A, apply to individuals engaged in 
manufacturing, processing, packing, or holding animal food regardless 
of whether the individuals conduct these activities under the framework 
of the CGMPs established in subpart B or the framework for hazard 
analysis and risk-based preventive controls established in subparts C, 
D, and E. The regulatory text also makes clear that the qualification 
requirements apply to the recordkeeping requirements of subpart F. See 
table 5 for a description of these provisions.

[[Page 56207]]



 Table 5--Provisions for Qualifications of Individuals Who Manufacture,
                    Process, Pack or Hold Animal Food
------------------------------------------------------------------------
                                    Proposed
   Final section designation         section           Description
                                   designation
------------------------------------------------------------------------
507.4(a)(1)....................             N/A  Applicability to
                                                  individuals who
                                                  manufacture, process,
                                                  pack, or hold animal
                                                  food subject to
                                                  subparts B and F.
507.4(a)(2)....................             N/A  Applicability to
                                                  individuals who
                                                  manufacture, process,
                                                  pack, or hold animal
                                                  food subject to
                                                  subparts C, D, E, or
                                                  F.
507.4(b)(1)....................       507.14(b)  Each individual engaged
                                                  in manufacturing,
                                                  processing, packing,
                                                  or holding animal food
                                                  must have the
                                                  education, training,
                                                  or experience (or
                                                  combination thereof)
                                                  necessary to
                                                  manufacture, process,
                                                  pack, or hold safe
                                                  animal food as
                                                  appropriate to the
                                                  individual's assigned
                                                  duties.
507.4(b)(2)....................       507.14(b)  Required training in
                                                  the principles of
                                                  animal food hygiene
                                                  and animal food
                                                  safety, including the
                                                  importance of employee
                                                  health and personal
                                                  hygiene.
507.4(c).......................       507.14(c)  Additional
                                                  qualifications of
                                                  supervisory personnel.
507.4(d).......................        507.4(d)  Records of required
                                                  training. The required
                                                  records are subject to
                                                  the recordkeeping
                                                  requirements of
                                                  subpart F.
------------------------------------------------------------------------

A. Applicability and Qualifications of All Individuals Engaged in 
Manufacturing, Processing, Packing, or Holding Animal Food (Final Sec.  
507.4(a), (b), and (d))

    (Comment 92) Some comments prefer that we continue to only provide 
recommendations for education and training and allow the animal food 
industry to determine the appropriate level of specific employee 
training that may be needed. Some comments say that we should allow 
facilities to conduct employee training in a flexible manner, with the 
facility determining the training content and frequency that is 
appropriate for the duties of a given employee as they relate to 
ensuring the safe production and distribution of animal food.
    Some comments recommend that employees be trained ``initially'' and 
``periodically thereafter'' but ask that we recognize the seasonal 
nature of a facility's workforce. Some comments ask that the training 
include the principles of animal food hygiene and animal food safety, 
including the importance of employee health and personal hygiene as 
applied at the facility.
    Some comments ask that training requirements be established in 
subpart B so that the requirements would also apply to establishments 
that manufacture, process, pack, or hold animal food, including 
establishments that are not subject to FSMA's requirements for hazard 
analysis and risk-based preventive controls. Some comments that 
recommend establishing the training requirement in subpart B assert 
that training is more appropriately considered a prerequisite program 
than a preventive control that would belong in subpart C.
    Other comments ask that the training and related recordkeeping 
requirements for the facility's preventive controls qualified 
individuals be established under subpart C because this is directly 
related to the facility's food safety plan. Other comments ask that 
training requirements be established in both subpart B and subpart C. 
Other comments say that including requirements for education and 
training in both subparts B and C would be confusing.
    (Response 92) We are establishing a series of requirements for the 
qualifications of individuals engaged in manufacturing, processing, 
packing, or holding animal food in new Sec.  507.4. First, to clarify 
how these qualification requirements apply to establishments subject to 
subparts B and F, we are requiring that the management of an 
establishment ensure that all individuals who manufacture, process, 
pack, or hold animal food subject to subparts B and F are qualified to 
perform their assigned duties (Sec.  507.4(a)(1)). To clarify how these 
qualification requirements apply to facilities, we are requiring that 
the owner, operator, or agent in charge of a facility must ensure that 
all individuals who manufacture, process, pack, or hold animal food 
subject to subparts C, D, E, or F are qualified to perform their 
assigned duties (Sec.  507.4(a)(2)).
    We are not requiring training specific to the person's assigned 
duties. Each establishment engaged in the manufacturing, processing, 
packing and holding of food for animal consumption would already have 
procedures in place to ensure that all individuals who manufacture, 
process, pack, or hold animal food know how to do their jobs. However, 
to emphasize that we expect all individuals who conduct such activities 
to know how to do their jobs, we are specifying that each individual 
engaged in manufacturing, processing, packing, or holding animal food 
(including temporary and seasonal personnel) or in the supervision 
thereof must have the education, training, or experience (or 
combination thereof) necessary to manufacture, process, pack, or hold 
safe animal food as appropriate to the individual's assigned duties 
(Sec.  507.4(b)(1)). To better align with the forthcoming FSVP rule, we 
are using the term ``qualified individual'' in new Sec.  507.4(b)(1) 
and are defining the term ``qualified individual'' to mean a person who 
has the education, training, or experience (or combination thereof) 
necessary to manufacture, process, pack, or hold safe animal food as 
appropriate to the individual's assigned duties. A qualified individual 
may be, but is not required to be, an employee of the establishment. 
See the discussion of the term ``preventive controls qualified 
individual'' in section VIII.A.10, including a discussion of how we 
have changed the proposed term ``qualified individual'' to ``preventive 
controls qualified individual'' because we are establishing a new 
definition for ``qualified individual,'' with a meaning distinct from 
``preventive controls qualified individual.''
    We also are requiring that each individual engaged in 
manufacturing, processing, packing, or holding animal food (including 
temporary and seasonal personnel) or in the supervision thereof, 
receive training in the principles of animal food hygiene and animal 
food safety, including the importance of employee health and personal 
hygiene, as appropriate to the animal food, the facility and the 
person's assigned duties (see Sec.  507.4(b)(2)). Records that document 
this required training must be established and maintained and are 
subject to the recordkeeping requirements of subpart F (Sec.  
507.4(d)). The rule does not specify the frequency

[[Page 56208]]

of the required training. We expect that production employees will 
receive training before working in production operations. We expect 
that most facilities will also provide some form of refresher training.
    We disagree that we should continue to only provide recommendations 
for education and training. Although the comments express concern about 
overly prescriptive requirements that may not consider variables that 
would affect an establishment's training program (such as training 
course content, training provider, effectiveness of the course and 
instructor and frequency of training per topic, an employee's type and 
length of experience, nature of formal education, and the animal food 
product type and point in the animal food supply chain at which the 
employee works with the animal food product), the training requirement 
we are establishing in the rule provides flexibility for each 
establishment to provide training, and determine the scope and 
frequency of the training, in a way that works best for the 
establishment.
    We agree that it is appropriate to establish training requirements 
so that the requirements apply to all establishments that manufacture, 
process, pack, or hold animal food, including establishments that are 
not subject to FSMA's requirements for hazard analysis and risk-based 
preventive controls, and we are establishing the qualification and 
training requirements in subpart A to clarify the applicability of 
these requirements to all establishments and facilities subject to part 
507. Although we agree that employees in facilities that are subject to 
the requirements for hazard analysis and risk-based preventive controls 
need to understand their responsibilities under the facility's food 
safety plan, we are setting forth a training requirement focused on the 
principles of animal food hygiene and animal food safety. We consider 
training in the principles of animal food hygiene and animal food 
safety, including the importance of employee health and personal 
hygiene, to be fundamental to the concept of CGMPs. We agree that 
establishing a training requirement in both subpart B and subpart C 
could be confusing.
    (Comment 93) Some comments agree that training should be documented 
and assert that those records should show the date of training, a 
description of the training, and the name of the person trained. 
However, comments ask that we allow flexibility in the way these 
records are kept. Other comments assert that requiring that records 
document required training of personnel is burdensome, arbitrary, and 
capricious.
    (Response 93) The rule requires that records that document training 
required by Sec.  507.4(b)(2) be established and maintained without 
prescribing any content of those records. Although one approach to 
documenting training would be to provide the date of training, a 
description of the training, and the name of the person trained, the 
rule provides flexibility for each establishment to document its 
training in a way that works best for that establishment. We disagree 
that requiring records to document required training is burdensome, 
arbitrary, and capricious in light of the flexibility provided by the 
rule for the content of training records.
    (Comment 94) Some comments agree that any requirements should 
include training appropriate to the person's duties but emphasize that 
the decision as to what is appropriate to the person's assigned duties 
should be determined by the establishment.
    (Response 94) The requirement for employees to receive training in 
the principles of animal food hygiene and animal food safety, including 
the importance of employee health and personal hygiene, as appropriate 
to the person's assigned duties, provides flexibility for the 
establishment to provide training that is appropriate for its employees 
in light of each person's assigned duties. However, the rule does not 
require training specific to the person's assigned duties.
    (Comment 95) Some comments assert that the training requirement 
would be an unreasonable burden for small businesses and that companies 
may incur substantial cost for the time that workers would be in 
training rather than in production. Some comments ask us to provide 
non-specific training recommendations for smaller processors that need 
flexibility to control the cost of training. Some comments assert that 
the training and education requirements must be accessible and flexible 
enough to allow employers to bring in temporary help when demand is 
high without causing a delay in hiring.
    (Response 95) All employees will need enough training to do their 
job and understand the importance of hygiene for animal food safety. 
The training offered does not need to be expensive (e.g., offsite 
training or off-the-shelf purchased training) and we expect that much 
of the training will be provided in-house by knowledgeable employees. 
As discussed in Response 1, the FSPCA is developing a preventive 
controls training curriculum. These training materials will be 
available online, and we expect these training materials to be useful 
to small businesses to use for in-house training.

B. Additional Requirements Applicable to Supervisory Personnel (Final 
Sec.  507.4(c))

    We proposed that responsibility for ensuring compliance by all 
personnel with all requirements of this subpart must be clearly 
assigned to competent supervisory personnel in Sec.  507.14(c). We are 
finalizing this provision in Sec.  507.4(c). We are correcting ``all 
requirements of this subpart'' to ``all requirements of this part.'' As 
a conforming change for consistency with the provisions of Sec.  
507.4(b), we are replacing the phrase ``competent supervisory 
personnel'' with the phrase ``supervisory personnel who have the 
education, training, or experience (or a combination thereof) necessary 
to supervise the production safe animal food.''

X. Subpart A: Comments on Proposed Sec.  507.5--Exemptions

    We proposed to establish a series of exemptions from the 
requirements for hazard analysis and preventive controls that would be 
established in subpart C, with modified requirements in some cases.
    Some comments support one or more of the proposed exemptions 
without change. For example, some comments note that the exemptions are 
specified in FSMA and, thus, reflect the intent of Congress. Some 
comments state that some exemptions (i.e., those for products already 
subject to our regulations for the control of microbiological hazards 
for low-acid canned foods (LACF)) make sense because they are risk-
based. Other comments that support one or more of the proposed 
exemptions ask us to clarify particulars associated with these 
exemptions or expand the scope of some of these exemptions. Other 
comments ask us to include additional exemptions in the rule.
    In the remainder of this section, we discuss comments that ask us 
to clarify the proposed exemptions or that disagree with, or suggest 
one or more changes to, the proposed exemptions. We also discuss 
comments that ask us to include additional exemptions in the rule. 
After considering these comments, we have revised the proposed 
exemptions as shown in table 6 with editorial and conforming changes as 
shown in table 31. A key conforming change that affects all proposed 
exemptions from the requirements of subpart C is that the final 
exemptions are from the requirements of subpart E,

[[Page 56209]]

as well as subpart C. As discussed in section XL, the final rule 
establishes the requirements for a supply-chain program in subpart E, 
rather than within subpart C as proposed.

                                  Table 6--Revisions to the Proposed Exemptions
----------------------------------------------------------------------------------------------------------------
             Section                          Exemption                              Modification
----------------------------------------------------------------------------------------------------------------
507.5(e)........................  From the requirements of subpart    Changes consequential to the
                                   C for on-farm packing or holding   revised ``farm'' definition--i.e., no
                                   of food by a small or very small   longer identifying any packing or holding
                                   business if the only packing and   activities for any RACs.
                                   holding activities subject to      Clarification that the modified
                                   section 418 of the FD&C Act that   requirements do not apply to on-farm
                                   the business conducts are the      packing or holding of food by a very small
                                   specified low-risk packing or      business if the only packing and holding
                                   holding activity/animal food       activities subject to section 418 of the
                                   combinations.                      FD&C Act that the business conducts are
                                                                      the listed low-risk packing or holding
                                                                      activity/animal food combinations.
                                                                      Updated animal food categories
                                                                      consistent with the animal food categories
                                                                      included in table 1 in the section
                                                                      103(c)(1)(C) RA.
                                                                      Additions of low-risk packing or
                                                                      holding activity/animal food combinations
                                                                      as a result of an updated risk assessment.
507.5(f)........................  From the requirements of subpart    Changes consequential to the
                                   C for on-farm manufacturing/       revised ``farm'' definition--i.e.:
                                   processing activities conducted    No longer distinguishing between
                                   by a small or very small           manufacturing/processing activities
                                   business for distribution into     conducted on a farm mixed-type facility's
                                   commerce if the only               own RACs and manufacturing/processing
                                   manufacturing/processing           activities conducted on food other than
                                   activities subject to section      the farm mixed-type facility's own RACs;
                                   418 of the FD&C Act that the       and
                                   business conducts are the          Eliminating activities, conducted
                                   specified low-risk manufacturing/  on others' RACs, that would no longer be
                                   processing activity/animal food    classified as manufacturing/processing and
                                   combinations.                      instead would be classified as harvesting,
                                                                      packing, or holding.
                                                                      Clarification that the modified
                                                                      requirements do not apply to on-farm
                                                                      manufacturing/processing activities
                                                                      conducted by a very small business for
                                                                      distribution into commerce, if the only
                                                                      manufacturing/processing activities
                                                                      subject to section 418 of the FD&C Act
                                                                      that the business conducts are the listed
                                                                      low-risk manufacturing/processing activity/
                                                                      animal food combinations.
                                                                      Updated animal food categories
                                                                      consistent with the animal food categories
                                                                      included in table 1 in the section
                                                                      103(c)(1)(C) RA.
                                                                      Additions of low-risk
                                                                      manufacturing/processing activity/animal
                                                                      food combinations as a result of an
                                                                      updated risk assessment.
507.5(h)........................  From the requirements of subpart   Change from an exemption for specific
                                   B for the holding and              activities (i.e., holding and
                                   transportation of RACs.            transportation of RACs) to facilities
                                                                      solely engaged in those activities.
----------------------------------------------------------------------------------------------------------------

A. General Comments on the Proposed Exemptions

    (Comment 96) Some comments ask us to provide the same flexibility 
for foreign small businesses as for domestic small businesses.
    (Response 96) The exemptions apply to both foreign small businesses 
and domestic small businesses.
    (Comment 97) Some comments ask us to clarify whether an 
establishment that is exempt from the requirements for hazard analysis 
and risk-based preventive controls in subpart C remains subject to the 
CGMP requirments in subpart B.
    (Response 97) An establishment that is exempt from the requirements 
for hazard analysis and risk-based preventive controls in subparts C 
and E remains subject to the CGMP requirements in subpart B, unless 
that establishment is specifically exempt from subpart B under Sec.  
507.5(a) (which applies to farms and activities of ``farm mixed-type 
facilities'' that fall within the definition of ``farm''); or Sec.  
507.5(h) (which applies to: (1) Establishments solely engaged in the 
holding or transportation of one or more RACs; (2) hulling, shelling, 
and drying nuts and hulls (without manufacturing/processing, such as 
grinding shells or roasting nuts); and (3) ginning of cotton (without 
manufacturing/processing, such as extracting oil from cottonseed)).
    (Comment 98) Some comments request that we clearly articulate what 
activities are not covered and why; as well as what activities we are 
specifically exempting and why. This comment requests clarification 
about the differences between the categories of ``not covered'' and 
``exempt.''
    (Response 98) We use the terms ``not covered'' and ``exempt'' 
interchangeably to describe what animal food operations or activities 
within an operation are not required to comply with all or parts of 
this rule. Farms, for example, are ``not covered'' by this rule, as 
established in Sec.  507.5, which lists certain exemptions. As another 
example, a business meeting the very small business criteria is a 
qualified facility subject to the requirements of Sec.  507.7, but 
``exempt'' from the requirements of subparts C and E (see Sec.  
507.5(d)). Whether a particular exemption applies to an animal food 
operation depends on the type of operation and the activities it is 
conducting. We believe the exemptions as codified provide enough 
specificity for a facility to determine whether it must comply with or 
is exempt from this final regulation, or certain provisions of the 
final regulation.
    (Comment 99) One comment expressed the opinion that exemptions 
should be driven by risk of activities rather than by whether they are 
conducted on or off a farm.
    (Response 99) Consistent with the statutory direction in section 
103(c) of FSMA, including conducting a qualitative risk assessment, we 
have finalized exemptions for on-farm activity/animal food combinations 
conducted by farm-mixed-type facilities that are small or very small 
businesses as discussed further in sections VI and X.

B. Proposed Sec.  507.5(a)--Exemption for Facilities Not Required To 
Register Under Section 415 Regulations

    We proposed that this part does not apply to establishments, 
including ``farms'' (as defined in Sec.  1.227 of this

[[Page 56210]]

chapter), that are not required to register under section 415 of the 
FD&C Act. However, we proposed that subpart B would apply to the 
packaging, packing, and holding of dried commodities if a ``farm'' or 
``farm mixed-type facility'' dries/dehydrates raw agricultural 
commodities that are produce to create a distinct commodity.
    After reviewing all of the comments concerning raw agricultural 
commodities as discussed elsewhere in this final rule, we have removed 
the requirement that subpart B would apply to the packaging, packing, 
and holding of dried commodities from a ``farm'' or ``farm mixed-type 
facility'' that dries/dehydrates RACs that are produce to create a 
distinct commodity. We have made this change because produce RACs are 
not typically dried or dehydrated to create distinct animal food 
commodities, as they are to create human food commodities (e.g., 
drying/dehydrating grapes to make raisins).
    (Comment 100) One comment requests that we provide clarity and 
examples for animal food facilities that are exempt from facility 
registration and therefore exempt from compliance with part 507 because 
they are considered restaurants or retail food establishments.
    (Response 100) Our food facility registration requirements are 
found in 21 CFR part 1, subpart H. Specifically, ``restaurant'' and 
``retail food establishment'' are defined in 1.227(b). Additional 
information may be found in our ``Guidance for Industry: Questions and 
Answers Regarding Food Facility Registration (Sixth Edition)'' (Ref. 
23). As discussed in section I.E. of the final rule for preventive 
controls for human food published elsewhere in this issue of the 
Federal Register, we are addressing the requirements of section 102(c) 
of FSMA in a separate rulemaking and issued a separate proposed rule to 
amend the definition of ``retail food establishment'' in the section 
415 registration regulations and the section 414 recordkeeping 
regulations (80 FR 19160, April 9, 2015).

C. Proposed Sec.  507.5(b)--Exemption Applicable to Food Subject to 21 
CFR Part 113--Thermally Processed Low-Acid Foods Packaged in 
Hermetically Sealed Containers

    We proposed that activities in animal food facilities that are 
regulated under and are in compliance with Sec.  500.23 and part 113 
would be exempt from subpart C only with respect to microbiological 
hazards regulated under part 113. We further proposed that the 
facilities must comply with subparts C and F with regard to all other 
potential hazards and must comply with subparts A and B. We requested 
comment on the criteria that should be used to determine whether a 
facility is in compliance with Sec.  500.23 and part 113 (78 FR 64736 
at 64762).
    (Comment 101) Some comments express concern that the partial 
exemption for products subject to part 113 could generate confusion for 
both regulators and regulated facilities. These comments also assert 
that the partial exemption for products subject to part 113 would 
generate duplicative recordkeeping requirements under the two rules.
    (Response 101) We acknowledge the potential for confusion and 
expect any confusion to decrease over time as both regulators and 
facilities gain experience with the new requirements. We also expect 
that in most instances a facility that is subject to Sec.  500.23 and 
part 113, and that evaluates potential microbiological hazards as part 
of its hazard analysis, would conclude that the potential hazards are 
controlled by the targeted requirements of part 113 and conclude there 
are no significant microbiological hazards that require preventive 
controls to significantly minimize or prevent the hazards.
    We disagree that the partial exemption for products subject to part 
113 would generate duplicative recordkeeping requirements. The 
requirements of part 113 to control biological hazards are different 
from the requirements of subparts C and E to conduct a hazard 
evaluation for chemical and physical hazards, and implement preventive 
controls and associated preventive control management components to 
address significant chemical and physical hazards. Likewise, the 
records associated with the control of biological hazards under part 
113 are not the same as the records associated with a hazard analysis, 
preventive controls, and associated preventive control management 
components for control of chemical and physical hazards. However, to 
the extent that a facility determines that existing records required by 
part 113 can be used to comply with the requirements of subparts C and 
E, a facility may rely on those records (see Sec.  507.212).
    (Comment 102) Some comments ask us to provide guidance to industry 
and the regulatory community regarding the criteria that will be used 
to determine when a facility is ``in compliance with'' part 113.
    (Response 102) As an example, an LACF manufacturing facility that 
has ongoing problems controlling biological hazards may be better able 
to address biological hazards by preparing and implementing a written 
food safety plan. As with facilities subject to our HACCP regulations, 
we expect that situations in which enforcement actions to ensure 
compliance with part 113 are insufficient to correct problems, and lead 
to a facility losing its exemption from the requirements of subparts C 
and E, will be rare and will depend on very specific circumstances. 
Therefore, at this time we do not anticipate issuing guidance on when 
violations of part 113 could lead to this outcome.

D. Proposed Sec.  507.5(c)--Exemption Applicable to Activities Subject 
to Standards for Produce Safety in Section 419 of the FD&C Act

    We proposed that subpart C would not apply to activities of a 
facility that are subject to section 419 of the FD&C Act (Standards for 
Produce Safety) of the FD&C Act (21 U.S.C. 350h).
    (Comment 103) Some comments request that we broaden the exemption 
to operations that handle culls of raw, intact, fresh produce. One 
comment requested that fresh citrus be considered a low risk product or 
excluded from the rule entirely. This comment requested that culls 
should not be considered a by-product of fresh citrus production.
    (Response 103) We decline these requests. We have included a 
provision under Sec.  507.12 that exempts by-products of off-farm 
packing and holding of RACs for animal food use from most of part 507 
if ``the human food facility is subject to and in compliance with Sec.  
117.8 of part 117, and in compliance with all applicable human food 
safety requirements of the Federal Food, Drug, and Cosmetic Act and 
implementing regulations.'' The human food facility also must not 
further manufacture or process the by-products intended for use as 
animal food. The resulting animal food must be held and distributed in 
accordance with the CGMPs for the holding and distribution of human 
food by-products for use as animal food in Sec.  507.28 and Sec.  
117.95. Thus, facilities subject to and in compliance with Sec.  117.8 
and applicable safety requirements of the FD&C Act and its implementing 
regulations, that pack or hold produce culls off-farm for use as animal 
food (without manufacturing or processing the culls) would be exempt 
from part 507, except for the limited holding and distribution CGMPs in 
Sec.  507.28. Facilities that manufacture or process culls of raw, 
intact, fresh produce for use as animal food would be subject to part 
507. Activities, such as packing fresh citrus, of a facility that is 
subject to section 419 of the FD&C Act are exempt from subparts C.

[[Page 56211]]

E. Proposed Sec.  507.5(d)--Exemption Applicable to a Qualified 
Facility

    We proposed that subpart C would not apply to a qualified facility, 
except as provided by subpart D (Withdrawal of an Exemption Applicable 
to a Qualified Facility), and that qualified facilities would be 
subject to the requirements in Sec.  507.7.
    (Comment 104) Some comments support the proposed exemption for a 
qualified facility. Other comments oppose this proposed exemption, 
asserting that it is not risk based and expressing concern that 
qualified facilities would cause significant food safety problems. Some 
comments ask us to strictly construct and narrowly apply the exemptions 
to as few businesses as possible.
    Some comments do not agree that qualified facilities should be 
subject to modified requirements because even the modified requirements 
are burdensome. Some comments assert that qualified facilities having 
an average annual value of animal food sold during the previous 3-year 
period of $10,000 or less should be exempt from all requirements 
related to hazard analysis and risk-based preventive controls, 
including modified requirements. One comment does not specify an amount 
of annual sales of animal food, but states that whether a facility is a 
qualified facility should be based on whether the facility has caused 
any reported injury or illness to humans or animals.
    (Response 104) The exemption for qualified facilities, including 
the criteria for being a qualified facility and the applicability of 
modified requirements, is expressly directed by section 418(l) of the 
FD&C Act. In defining ``very small business'' to mean a business 
(including any subsidiaries or affiliates) averaging less than 
$2,500,000, adjusted for inflation, per year, during the 3-year period 
preceding the applicable calendar year in sales of animal food plus the 
market value of animal food manufactured, processed, packed, or held 
without sale (e.g., held for a fee or supplied to a farm without sale), 
we constructed this exemption to apply to businesses that, 
collectively, produce less than 2 percent of the dollar value of animal 
food produced in the United States. This is comparable to the 
percentage of the human food supply that is exempt under the definition 
of very small business for human food (see section XI.B of the final 
rule for preventive controls for human food published elsewhere in this 
issue of the Federal Register). As previously discussed in section 
VIII.A.36, the businesses that will be exempt from the requirements for 
hazard analysis and risk-based preventive controls, and will instead be 
subject to other requirements, will produce a small portion of the 
animal food at potential risk of causing foodborne illness (see the 
discussion at 79 FR 58476 at 58502).
    (Comment 105) Some comments assert that a qualified facility should 
be exempt from the CGMP requirements of subpart B, as well as the 
requirements for hazard analysis and risk-based preventive controls in 
subpart C.
    (Response 105) The exemption for qualified facilities is expressly 
directed by section 418(l) of the FD&C Act and is limited to an 
exemption from the requirements for hazard analysis and risk-based 
preventive controls in subparts C and E. The comments provide no basis 
for why new statutory requirements for hazard analysis and risk-based 
preventive controls should in any way impact CGMP requirements that 
apply to the manufacturing, processing, packing, and holding of animal 
food. CGMPs provide the basic requirements for ensuring production of 
safe animal food. Following the CGMPs is essential to properly address 
public (human and animal) health risks from very small facilities that 
are provided an exemption from subparts C and E in order to minimize 
the burden on such facilities.
    (Comment 106) Some comments ask us to provide that a qualified 
facility may voluntarily choose to comply with the requirements for 
hazard analysis and preventive controls.
    (Response 106) A qualified facility may voluntarily choose to 
comply with the requirements for hazard analysis and risk-based 
preventive controls without a specific provision authorizing it to do 
so. One way that a qualified facility could comply voluntarily would be 
to simply not submit the attestation that it is a qualified facility 
(see Sec.  507.7(b) for the requirement for a qualified facility to 
submit an attestation regarding its status as a qualified facility). 
When we inspect the facility, we would inspect the facility for 
compliance with the requirements for hazard analysis and risk-based 
preventive controls. Another way for a facility to voluntarily comply 
would be to submit the attestation, and specify that it will satisfy 
the statutory documentation requirement through documentation of its 
food safety practices rather than documentation that it is in 
compliance with non-Federal food safety law.
    (Comment 107) Some comments ask us to specify in guidance that a 
qualified facility is not required to prepare and implement a food 
safety plan.
    (Response 107) We intend to recommend in guidance how a qualified 
facility could comply with the requirements in Sec.  507.7 without 
satisfying all of the requirements in subparts C and E.

F. Proposed Sec.  507.5(e) and (f)--Exemptions Applicable to On-Farm 
Low-Risk Activity/Animal Food Combinations Conducted by a Small or Very 
Small Business

    As discussed in section VI.A, consistent with the statutory 
direction in section 103(c) of FSMA, including conducting a qualitative 
risk assessment, we proposed three exemptions for on-farm activity/food 
combinations conducted by farm-mixed-type facilities that are small or 
very small businesses (proposed Sec. Sec.  507.5(e), (f)(1), and 
(f)(2)).
1. General Comments on the Proposed Exemptions Applicable to On-Farm 
Low-Risk Activity/Animal Food Combinations Conducted by a Small or Very 
Small Business
    (Comment 108) Some comments assert that conducting a low-risk 
activity/food combination should be sufficient to qualify any facility 
for exemption from subpart C, regardless of whether the activity is 
conducted on-farm or off-farm, or meets the economic threshold for a 
small or very small business.
    (Response 108) The statute provides specific direction for those 
facilities that can qualify for this exemption. (See sections 418(l) 
and 418(o)(2) of the FD&C Act.) See also Response 104 in this final 
rule, and Responses 220 and 222 in the final rule for preventive 
controls for human food published elsewhere in this issue of the 
Federal Register.
    (Comment 109) Some comments state that the exemptions for farming 
activities are confusing.
    (Response 109) The activity/animal food combinations listed in 
Sec.  507.5(e) are directed to an exemption for packing and holding 
activities, whereas the activity/animal food combinations listed in 
Sec.  507.5(f) are directed to an exemption for manufacturing/
processing activities. Although these exemptions are more complex than 
other exemptions (e.g., because they are directed to specific 
activities conducted on specific animal foods), the final ``farm'' 
definition has simplified them to the extent practicable. For example, 
under the ``farm'' definition in the 2013 proposed human preventive 
controls rule, whether an activity was packing or manufacturing/
processing depended, in part, on whether the RACs being packed

[[Page 56212]]

were the farm's own RACs or others' RACs. In contrast, under the 
``farm'' definition established in the final rule for preventive 
controls for human food published elsewhere in this Federal Register, 
packing RACs is a ``packing'' activity, regardless of ownership of the 
RACs being packed.
    (Comment 110) Some comments note a distinction between the 
exemptions for on-farm low-risk activity/animal food combinations 
conducted by small and very small businesses and the exemption for 
qualified facilities. Specifically, the comments state that a farm 
mixed-type facility that only conducts low-risk activity/animal food 
combinations (such as grinding grains) would be exempt from the 
requirements of subpart C, whereas an off-farm qualified facility 
grinding grains, while exempt from the requirements of subpart C, would 
nonetheless be subject to the requirements for a qualified facility in 
Sec.  507.7. These comments ask whether it would be better for a farm 
or farm mixed-type facility that satisfies criteria for a small or very 
small business, and also satisfies criteria for a qualified facility, 
to classify itself as a small or very small business or to classify 
itself as a qualified facility.
    (Response 110) In light of the final ``farm'' definition, these 
comments no longer apply with respect to activities within the farm 
definition.
    For activities conducted by a farm mixed-type facility, we 
acknowledge that the exemptions provided by Sec.  507.5(e) and (f) for 
on-farm low-risk activity/animal food combinations are different from 
the exemption provided by Sec.  507.5(a) for a qualified facility. A 
farm mixed-type facility that only conducts low-risk activity/animal 
food combinations listed in Sec.  507.5(e) and (f) is fully exempt from 
the requirements of subparts C and E, and is not subject to the 
requirements for a qualified facility in Sec.  507.7, even if that farm 
mixed-type facility is also a very small business (and, thus, also is a 
qualified facility). To make this clear, we have revised proposed Sec.  
507.5(e) to specify that Sec.  507.7 does not apply to on-farm packing 
or holding of animal food by a very small business if the only packing 
and holding activities subject to section 418 of the FD&C Act that the 
business conducts are the listed low-risk packing or holding activity/
animal food combinations. Likewise, we have revised proposed Sec.  
507.5(f) to specify that Sec.  507.7 does not apply to on-farm 
manufacturing/processing activities conducted by a very small business 
for distribution into commerce, if the only manufacturing/processing 
activities subject to section 418 of the FD&C Act that the business 
conducts are the listed low-risk manufacturing/processing activity/
animal food combinations.
    With these changes, a farm mixed-type facility that is a very small 
business and that only conducts the low-risk activity/animal food 
combinations listed in Sec.  507.5(e) and/or (f) may find it 
advantageous to classify itself as a very small business eligible for 
the exemption in Sec.  507.5(e) and/or (f) rather than as a qualified 
facility, which would be subject to the requirements in Sec.  507.7.
    (Comment 111) Some comments ask for a process to keep the list of 
low-risk activity/food combinations up to date, such as through 
guidance.
    (Response 111) We decline this request. The exemptions established 
in this rule are binding, whereas any list of additional activity/
animal food combinations established in a guidance document would not 
be binding. We established the list of activity/animal food 
combinations included in these exemptions through an extensive public 
process, including a request for comments on the section 103(c)(1)(C) 
draft RA. From this time forward, the process available to a person who 
wishes us to consider an additional activity/animal food combination is 
to submit a citizen petition in accordance with 21 CFR 10.30.
2. Proposed Sec.  507.5(e)--Exemption Applicable to On-Farm Low-Risk 
Packing or Holding Activity/Animal Food Combinations Conducted by a 
Small or Very Small Business
    We proposed that subpart C would not apply to on-farm packing or 
holding of animal food by a small or very small business if the only 
packing and holding activities subject to section 418 of the FD&C Act 
that the business conducts are low-risk packing or holding activity/
animal food combinations on animal food not grown, raised, or consumed 
on that farm mixed-type facility or another farm or farm mixed-type 
facility under the same ownership.
    (Comment 112) Many comments state that it is common practice among 
farms to hold RACs from farms under different ownership and that 
classifying establishments as being within the ``farm'' definition, or 
outside the ``farm'' definition, based on who owns the RACs being 
packed is not a risk-based classification.
    (Response 112) We proposed a revised definition of ``farm'' in the 
2014 preventive controls supplemental notice for human food to include 
packing and holding of RACs grown on another farm not under the same 
ownership (79 FR 58524 at 58531 through 58532). As a consequential 
change in light of the final ``farm'' definition established in the 
final rule for preventive controls for human food published elsewhere 
in this Federal Register, the exemption no longer identifies any 
packing or holding activities for any RACs (whether the farm's own RACs 
or others' RACs), because an on-farm establishment would no longer be 
subject to the requirements for hazard analysis and risk-based 
preventive controls (subpart C) when it packs or holds RACs, regardless 
of whether it is packing and holding its own RACs or others' RACs. In 
light of the change in the ``farm'' definition, we have revised the 
section 103(c)(1)(C) RA, starting with the list of on-farm activity/
animal food combinations outside the farm definition in table 1, to 
exclude packing and holding of RACs.
3. Proposed Sec.  507.5(f)--Exemption Applicable to On-Farm Low-Risk 
Manufacturing/Processing Activity/Animal Food Combinations Conducted by 
a Small or Very Small Business
    We proposed that subpart C would not apply to on-farm low-risk 
manufacturing/processing activities conducted by a small or very small 
business if the only manufacturing/processing activities subject to 
section 418 of the FD&C Act that the business conducts are those listed 
in the proposed exemption. The proposed exemption specified those 
activity/animal food combinations that would be exempt when conducted 
on a farm mixed-type facility's own RACs and those activity/animal food 
combinations that would be exempt when conducted on animal food other 
than the farm mixed-type facility's own RACs for distribution into 
commerce.
    As a consequential change in light of the final ``farm'' 
definition, the final exemption no longer distinguishes between 
manufacturing/processing activities conducted on a farm mixed-type 
facility's own RACs and manufacturing/processing activities conducted 
on animal food other than the farm mixed-type facility's own RACs. As 
another consequential change, the exemption has been revised to 
eliminate activities, conducted on others' RACs, which no longer are 
classified as manufacturing/processing and instead are classified as 
harvesting, packing, or holding. In addition, we have revised the final 
exemption to list animal food categories consistent with the animal 
food categories included in table 1 in the section 103(c)(1)(C) RA 
(Ref. 3), modified in response to revisions of the ``farm'' definition. 
(See Response 112.) In constructing

[[Page 56213]]

categories of animal food based upon the new ``farm'' definition, we 
grouped together processed grain products (e.g., flour, grits, etc.) 
and grain by-products (e.g., brewers' grain, distillers' grain, and 
corn gluten meal). The category does not include culled products from 
processing grain for human food such as misshapen pasta. Pasta used in 
animal food falls under a new category (any other animal food that does 
not require time/temperature control for safety) that was added to 
include the wide range of possibilities for animal food that was 
originally processed to be human food, as well as other types of animal 
food not listed separately.
    (Comment 113) Some comments ask us to include in the exemption a 
single list of low-risk manufacturing/processing activity/food 
combinations applicable to farm mixed-type facilities conducting 
activities on their own RACs and farm mixed-type facilities conducting 
activities on other's RACs.
    (Response 113) These comments no longer apply. As a consequence of 
the ``farm'' definition established by the final rule for preventive 
controls for human food published elsewhere in this Federal Register, 
the exemption no longer distinguishes between manufacturing/processing 
activities conducted on a farm mixed-type facility's own RACs and 
manufacturing/processing activities conducted on animal food other than 
the farm mixed-type facility's own RACs.
    (Comment 114) Some comments ask us to include manufacturing of 
animal food from low risk ingredients as additional activity/animal 
food combinations in the exemption. Other comments support our 
conclusion that manufacturing animal food ready for consumption is not 
a low risk activity.
    (Response 114) We evaluated manufacturing of animal food as one of 
the activity/animal food combinations within the qualitative risk 
assessment (Ref. 3). The 103(c)(1)(C) RA explains why we determined 
that manufacturing animal food ready for consumption is not a low-risk 
activity/animal food combination.

G. Proposed Sec.  507.5(g)--Exemption Applicable to Facilities Solely 
Engaged in Storage of Raw Agricultural Commodities Other Than Fruits 
and Vegetables Intended for Further Distribution or Processing

    We proposed that subpart C would not apply to facilities that are 
solely engaged in the storage of RACs (other than fruits and 
vegetables) intended for further distribution or processing. In the 
following paragraphs, we discuss comments that ask us to clarify how 
the proposed exemption would apply to specific circumstances.
    (Comment 115) Some comments ask whether this proposed exemption 
(proposed Sec.  507.5(g)) would apply to facilities such as peanut 
buying points or bean elevators and assert that such commodities are 
analogous to grains and the activities conducted at such facilities are 
analogous to those performed by grain elevators.
    (Response 115) We classify peanuts and beans (such as kidney beans, 
lima beans, and pinto beans) within the category of ``fruits and 
vegetables''; we classify soybeans as grain (see the discussion of 
grains at 78 FR 64736 at 64764 and 79 FR 58476 at 5848, and fruits and 
vegetables at 78 FR 3646 at 3690 and proposed Sec. Sec.  112.1 and 
112.2 in the proposed produce safety rule). The exemption for 
facilities solely engaged in storage of RACs intended for further 
distribution or processing does not apply to facilities that store 
fruit and vegetable RACs and, thus, does not apply to facilities such 
as peanut buying points and bean elevators. As discussed in section 
IV.B, we have revised the ``farm'' definition to provide that an 
operation devoted only to the harvesting (such as hulling or shelling), 
packing, and/or holding of RACs is within the ``farm'' definition, 
provided that the farms that grow or raise the majority of the RACs 
harvested, packed, and/or held by the operation own, or jointly own, a 
majority interest in the operation. With this revision, some operations 
dedicated to holding RACs, including fruit and vegetable RACs, will be 
within the ``farm'' definition.
    Peanut buying points and bean elevators that do not meet the 
revised farm definition are storing RACs that are ``fruits and 
vegetables'' and do not meet the criteria for exemption under Sec.  
507.5(g). However, we would not expect such facilities to need an 
extensive food safety plan. A facility that appropriately determines 
through its hazard analysis that there are no hazards requiring 
preventive controls would document that determination in its written 
hazard analysis but would not need to establish preventive controls and 
associated management components.
    (Comment 116) One comment states that genetically modified food 
should be added to the list of hazards that are seen as potential risks 
for animals.
    (Response 116) We decline this request. We have not seen evidence 
that foods derived from genetically engineered plants differ from other 
foods in any meaningful or uniform way, or that, as a class, such foods 
present different or greater safety concerns than their non-genetically 
engineered counterparts. We have a voluntary consultation process for 
foods derived from genetically engineered plants through which we 
engage with the developers of genetically engineered plants to help 
ensure the safety of the derived foods. Foods that have undergone this 
consultation process are as safe as foods from conventionally bred 
plants. Foods derived from genetically engineered plants, irrespective 
of the method of development, are subject to the same food safety and 
other regulatory requirements as foods derived from conventionally-bred 
plants. Therefore genetically engineered foods do not need to be 
singled out as a hazard.
    (Comment 117) Some comments assert that the exemption for storage 
of raw agricultural commodities (other than fruits and vegetables) 
should extend to those distinct and physically separate portions of 
oilseed processing facilities that are devoted solely to RAC storage. 
According to these comments, in the overwhelming majority of cases the 
inclusion of a separate RAC storage area in the same building as the 
oilseed processing area will not introduce additional risk either to 
the processing area or to the operations that take place there and that 
storage areas, whether standing alone as a separate facility or 
incorporated into a larger processing facility, store RACs safely. 
These comments ask us to recognize that storage activities may include 
grain drying to standardize moisture levels and preserve product 
quality.
    (Response 117) The activities included within the definition of 
holding include activities that are performed as a practical necessity 
for the distribution of RACs. In the 2014 supplemental notice, we 
explained that facilities that conduct operations similar to those 
conducted at grain elevators and silos, such as some facilities that 
hold oilseeds, may satisfy the criteria for exemption if activities 
other than storage are performed as a practical necessity for the 
distribution of RACs (see 79 FR 58476 at 58483 and the definition of 
``holding'' in Sec.  507.3). Examples of holding activities include 
drying/dehydrating RACs when the drying/dehydrating does not create a 
distinct commodity (see Sec.  507.3). Thus, the specific example of 
drying grains to standardize moisture levels and preserve product 
quality would fall within the definition of holding as a practical 
necessity for the distribution of RACs. A facility that stores 
oilseeds, and dries them as a practical necessity for the distribution 
of RACs, would be covered by the exemption in Sec.  507.5(g).

[[Page 56214]]

    However, we decline the request to modify the exemption in Sec.  
507.5(g) to also apply to distinct and physically separate storage 
areas that are used solely for storage of RACs (other than fruits and 
vegetables) intended for further distribution or processing. To the 
extent that the comments are asking us to do so to provide for 
facilities that conduct activities as a practical necessity for the 
distribution of RACs to be eligible for the exemption, doing so is not 
necessary in light of the definition of holding. To the extent that the 
comments are asking us to do so to provide for facilities that conduct 
manufacturing/processing activities in addition to holding activities, 
we disagree that doing so would be consistent with the statutory 
direction in FSMA. As previously discussed, section 418(m) of the FD&C 
Act provides in relevant part that we may by regulation exempt or 
modify the requirements for compliance under section 418 of the FD&C 
Act with respect to facilities that are solely engaged in the storage 
of RACs (other than fruits and vegetables) intended for further 
distribution or processing (78 FR 64736 at 64764). The plain meaning of 
``solely'' is only, completely, entirely; without another or others; 
singly; alone (Ref. 24). Facilities that conduct manufacturing/
processing activities in addition to holding activities are not 
``solely'' engaged in the storage of RACs (other than fruits and 
vegetables) intended for further distribution and processing.
    (Comment 118) Some comments request that the language of Sec.  
507.5(g) explicitly state that the exemption from subpart C would apply 
to facilities that are solely engaged in the packing and holding of raw 
agricultural commodities (other than fruits and vegetables) intended 
for further distribution or processing. These comments indicate that 
packing is frequently involved when a facility distributes raw 
agricultural commodities that they have been holding. They cite the 
Sec.  110.19(a) exemption from the human food CGMP regulation for 
establishments ``engaged solely in the harvesting, storage, or 
distribution of one or more `raw agricultural commodities' '' and 
remark that in application of the regulation, the activity of packing 
has been encompassed within the term ``distribution.'' In addition, 
some comments ask that the exemption proposed in Sec.  507.5(g) be 
extended to an exemption from subpart B, as well as from subpart C.
    (Response 118) We decline the request to add the term ``packing'' 
to Sec.  507.5(g). As discussed in Response 117, the activities 
included within the definition of holding include activities that are 
performed as a practical necessity for the distribution of RACs. Under 
Sec.  507.5(h), subpart B does not apply to the holding or 
transportation of one or more RACs. (See section X.H.)

H. Proposed Sec.  507.5(h)--Exemption Applicable to the Holding or 
Transportation of One or More Raw Agricultural Commodities

    We proposed to provide that subpart B would not apply to the 
holding or transportation of one or more RACs as defined in section 
201(r) of the FD&C Act.
    (Comment 119) Some comments ask us to include the term ``packing'' 
in Sec.  507.5(h) to say ``Subpart B of this part does not apply to the 
packing and holding or transportation of one or more raw agricultural 
commodities as defined in section 201(r) of the Federal Food, Drug, and 
Cosmetic Act.''
    (Response 119) We decline the request to add the term ``packing'' 
to Sec.  507.5(h). As discussed in Response 117, the activities 
included within the definition of holding include activities that are 
performed as a practical necessity for the distribution of RACs.
    (Comment 120) Some comments ask us to clarify that CGMP 
requirements (such as using protective coverings where necessary and 
appropriate (Sec.  507.17(c)) do not apply to the bulk outdoor storage 
of RACs for further processing.
    (Response 120) We are returning to the longstanding approach that 
the exemption applies to establishments ``solely engaged'' in specific 
activities. Under the exemption we are establishing in Sec.  
507.5(h)(1), those activities are holding and transportation of RACs. 
We explain why in the following paragraphs.
    These comments appear to interpret the proposed exemption in a way 
that goes beyond the longstanding ``RAC exemption'' in the human food 
CGMPs in Sec.  110.19 and is inconsistent with the intent in updating 
Sec.  110.19 to adjust and clarify what activities fall within this 
exemption based on experience and changes in related areas of the law 
since issuance of this exemption from the CGMPs (78 FR 64736 at 64764 
and 78 FR 3646 at 3710). The suggestion of these comments, i.e., that 
CGMPs should not apply to the holding of RACS in a facility that 
manufactures, processes, or packs RACs--would not make sense in some 
circumstances and would create complex situations for establishments 
(in determining how to comply with the CGMP requirements) and for 
regulators (in determining how to enforce the CGMP requirements). For 
example, it does not make sense for the part of a facility that holds 
RACs prior to processing to be exempt and the parts of the facility 
that are processing the RACs and storing them after processing to be 
covered. Likewise, it does not make sense for part of a transportation 
vehicle to be covered and part to be exempt.
    By revising the proposed ``RAC exemption'' so that it applies only 
to establishments ``solely engaged'' in the storage or transportation 
of RACs, we are providing for a predictable framework for interpreting 
exemptions for facilities ``solely engaged'' in other activities. For 
example, as discussed in Comment 117, comments ask us to expand the 
exemption (in Sec.  507.5(g)) from the requirements for hazard analysis 
and risk-based preventive controls for facilities that are ``solely 
engaged'' in the storage of RACs (other than fruits and vegetables) 
intended for further distribution or processing to also apply to 
distinct and physically separate storage areas that are used solely for 
storage of such RACs. In our response, we noted that facilities that 
conduct manufacturing/processing activities in addition to holding 
activities are not ``solely engaged'' in the storage of such RACs (see 
Response 117). In addition, as discussed in Comment 146, comments ask 
us to apply the exemption (in Sec.  507.10) from the requirements for 
hazard analysis and risk-based preventive controls for facilities that 
are ``solely engaged'' in the storage of unexposed packaged food to 
storage areas of facilities that also engage in food processing 
activities, e.g., for distributors that are engaged in limited food 
processing, such as blending seeds to make bird food. In our response, 
we noted that such distributors are not ``solely'' engaged in the 
storage of unexposed packaged animal food (see Response 146).
    The exemption we are establishing in this rule for establishments 
solely engaged in the storage or transportation of RACs remains 
consistent with our announced intent to adjust and clarify what 
activities fall within this exemption based, in part, on changes in 
related areas of the law since this exemption from the CGMP 
requirements was first issued. As discussed in section IV of the final 
rule for preventive controls for human food, published elsewhere in 
this issue of the Federal Register, we have made a number of changes to 
the ``farm'' definition, including changes that provide for an 
operation devoted to harvesting, packing, and/or holding of RACs to be 
a ``farm'' (i.e., a ``secondary activities

[[Page 56215]]

farm'') (and, thus, be exempt from the CGMP requirements under Sec.  
507.5(a)) even though the operation does not grow RACs (see Sec.  
507.3). With this revised ``farm'' definition, some establishments 
solely engaged in the ``storage'' of RACs will be exempt from the CGMP 
requirements because they are a ``farm.'' For further discussion on 
this provision, see section XI.J in the final rule for preventive 
controls for human food.

I. Comments Requesting Additional Exemptions

    (Comment 121) Some comments request additional exemptions from the 
requirements for hazard analysis and risk-based preventive controls in 
subpart C, the CGMP requirements of subpart B, or both.
    (Response 121) We believe that our CGMP regulations, coupled with 
implementation of FSMA's directives to focus more on preventing food 
safety problems than on reacting to problems after they occur, will 
play an important role in increasing animal food safety. We did not 
propose any exemptions or exceptions from the requirements of subpart C 
other than those authorized by section 103 of FSMA (78 FR 64736 at 
64743 through 64744). We drew on our experience with the CGMP 
regulation for human food and changes in related areas of the FD&C Act 
since issuance of the CGMP regulation (78 FR 3646 at 3709 through 3711) 
to adjust and clarify what activities fall within a longstanding 
exclusion related to raw agricultural commodities (see Sec.  110.19) 
and to modify the CGMPs for human food by-products for use as food for 
animals.
    (Comment 122) Some comments state that facilities that hull, shell, 
and dry tree nuts without further processing could be characterized as 
establishments engaged solely engaged in the harvesting, storage, or 
distribution of one or more raw agricultural commodities. These 
comments express an expectation that since hulled or shelled dried nuts 
retain their raw agricultural commodity status, that facilities 
hulling, shelling and drying tree nuts without further processing would 
qualify for exemption under both proposed Sec. Sec.  507.5(g) and 
507.5(h).
    (Response 122) Hulling and shelling of tree nuts (such as walnuts, 
almonds, and pistachios) are harvesting activities that are within the 
``farm'' definition when conducted on a farm or farm mixed-type 
facility. Drying/dehydrating RACs without creating a distinct commodity 
(such as drying walnuts and hulls) is a holding activity that also is 
within the ``farm'' definition when conducted on a farm or farm mixed-
type facility. As discussed in section IV.B of the final rule for 
preventive controls for human food (published elsewhere in this issue 
of the Federal Register) we have revised the ``farm'' definition to 
provide that an operation, not conducted on a Primary Production Farm, 
devoted to the harvesting (such as hulling or shelling), packing, and/
or holding of RACs is within the ``farm'' definition (as a ``secondary 
activities farm''), provided that the primary production farm(s) that 
grow or raise the majority of the RACs harvested, packed, and/or held 
by the secondary activities farm own, or jointly own, a majority 
interest in the operation. Non-farm facilities dedicated to the 
hulling, shelling, and drying of nuts and hulls perform the same 
activities as those performed by farms. When done on a primary 
production farm or by a secondary activities farm, those activities 
would not be subject to CGMPs. Furthermore, these activities do not 
transform the RAC into a processed food. Therefore, we have added 
regulatory text in Sec.  507.5(h) to provide an exemption from subpart 
B for hulling, shelling, and drying nuts and hulls (without further 
manufacturing/processing) by a non-farm hulling/shelling/drying 
facility because of the similarity in the activities of a farm-owned 
operation and a non-farm owned facility. However, non-farm facilities 
are not exempt from subparts C and E under Sec.  507.5(g) as they are 
not solely engaged in the storage of raw agricultural commodities. A 
facility that appropriately determines through its hazard analysis that 
there are no hazards requiring preventive controls would document that 
determination in its written hazard analysis but would not need to 
establish preventive controls and associated management components.
    (Comment 123) Some comments state that ginning cotton to separate 
cotton fiber from cotton seed is a low-risk harvesting activity. 
Comments further note that since cotton seed used as animal food is a 
by-product from the production of cotton lint, the cotton seed coming 
from a ginning facility would not qualify as a human food by-product. 
The comments request that facilities whose entire operation consists of 
receiving and ginning cotton without further processing the cotton 
seeds be exempt from both subpart C under Sec.  507.5(g) and subpart B 
under Sec.  507.5(h).
    (Response 123) Ginning cotton is a harvesting activity that is 
within the ``farm'' definition when conducted on a farm or farm mixed-
type facility. Drying/dehydrating the cottonseed without further 
processing is a holding activity that also is within the ``farm'' 
definition when conducted on a farm or farm mixed-type facility. (See 
Response 122 for a discussion on modification to the farm definition). 
When done on a primary production farm or by a secondary activities 
farm, these activities (ginning, drying, dehydrating) would not be 
subject to CGMPs, and these activities do not transform the RAC into a 
processed food. Therefore, we have added regulatory text in Sec.  
507.5(h)(2) to provide an exemption from subpart B for the ginning of 
cotton (without further manufacturing/processing) by a non-farm cotton 
ginning facility because of the similarity between a farm-owned 
operation and a non-farm owned facility (See Response 122). However, 
non-farm facilities are not exempt from subparts C and E under Sec.  
507.5(g) as they are not solely engaged in the storage of raw 
agricultural commodities. A facility that appropriately determines 
through its hazard analysis that there are no hazards requiring 
preventive controls would document that determination in its written 
hazard analysis but would not need to establish preventive controls and 
associated management components.

XI. Subpart A: Comments on Proposed Sec.  507.7--Requirements That 
Apply to a Qualified Facility

    As previously discussed (78 FR 64736 at 64765), sections 
418(l)(2)(A) and (B) of the FD&C Act provide that a qualified facility 
must submit two types of documentation to us. The first type of 
required documentation relates to food safety practices at the 
facility, with two options for satisfying this documentation 
requirement. Under the first option, the qualified facility may choose 
to submit documentation that demonstrates that it has identified 
potential hazards associated with the animal food being produced, is 
implementing preventive controls to address the hazards, and is 
monitoring the preventive controls to ensure that such controls are 
effective. Alternatively, under the second option, the qualified 
facility may choose to submit documentation (which may include 
licenses, inspection reports, certificates, permits, credentials, 
certification by an appropriate agency (such as a State department of 
agriculture), or other evidence of oversight), that the facility is in 
compliance with State, local, county, or other applicable non-Federal 
food safety law. The second type of required

[[Page 56216]]

documentation relates to whether the facility satisfies the definition 
of a qualified facility.
    If a qualified facility does not prepare documentation 
demonstrating that it has identified potential hazards associated with 
the animal food being produced, is implementing preventive controls to 
address the hazards, and is monitoring the preventive controls to 
ensure that such controls are effective, it must provide notification 
to consumers of certain facility information by one of two procedures, 
depending on whether an animal food packaging label is required on the 
animal food.
    Consistent with the statutory direction of section 418(l) of the 
FD&C Act, we proposed the following requirements for qualified 
facilities: (1) Submission of certain documentation (proposed Sec.  
507.7(a)); (2) procedures for submission of the documentation (proposed 
Sec.  507.7(b)); (3) the frequency of the submissions (proposed Sec.  
507.7(c)); (4) notification to consumers in certain circumstances 
(proposed Sec.  507.7(d)); and (5) applicable records that a qualified 
facility must maintain (proposed Sec.  507.7(e)).
    In the 2013 proposed preventive controls rule for animal food, we 
tentatively concluded that a certified statement would be acceptable 
for the purposes of satisfying the submission requirements of proposed 
Sec.  507.7(a). We also requested comment on the efficiency and 
practicality of submitting the required documentation using the 
existing mechanism for registration of food facilities, with added 
features to enable a facility to identify whether or not the facility 
is a qualified facility.
    Some comments support one or more of the proposed requirements 
without change. For example, some comments state that our proposed 
interpretation of the statutory term ``business address'' is consistent 
with our use of the term ``business address'' in our regulations 
regarding information that must be included in a prior notice for 
imported food (Sec.  1.281). Some comments that support the proposed 
provisions suggest alternative or additional regulatory text or ask us 
to clarify how we will interpret the provision.
    In this section, we discuss comments that ask us to clarify the 
proposed requirements or that disagree with, or suggest one or more 
changes to, the proposed requirements. We also address comments 
discussing our tentative conclusion regarding the submission of 
certified statements to FDA, including submitting certified statements 
using the existing mechanism for registration of food facilities. After 
considering these comments, we have revised the proposed requirements 
as shown in table 7 with editorial and conforming changes as shown in 
table 31.
    As discussed in Response 76, we have revised the definition of very 
small business to specify that it is based on an average (of sales plus 
market value of animal food held without sale) during the 3-year period 
preceding the applicable calendar year and, as a companion change, we 
are explicitly requiring that a facility determine and document its 
status as a qualified facility on an annual basis (see Sec.  
507.7(c)(1)).

                    Table 7--Revisions to the Proposed Requirements for Qualified Facilities
----------------------------------------------------------------------------------------------------------------
               Section                       Description                            Revision
----------------------------------------------------------------------------------------------------------------
507.7(a).............................  Documentation to be       Specify that the submitted
                                        submitted.               documentation is an ``attestation.``
                                                                 Add ``tribal'' as an example of
                                                                 applicable non-Federal food safety law.
507.7(b).............................  Procedure for            Update details regarding the electronic and
                                        submission.              paper submission of a form specific to the
                                                                 attestation requirement.
507.7(c).............................  Frequency of              New requirement to determine and
                                        determination and        document status as a qualified facility on an
                                        submission.              annual basis no later than July 1 of each
                                                                 calendar year.
                                                                 Specify that a facility that begins
                                                                 manufacturing, processing, packing, or holding
                                                                 animal food after September 17, 2019 must
                                                                 submit the attestation before beginning such
                                                                 operations.
                                                                 Specify that a facility must notify FDA
                                                                 of a change in status from ``not a qualified
                                                                 facility'' to ``qualified facility'' by July 31
                                                                 of the applicable calendar year.
                                                                 Specify that when the status of a
                                                                 facility changes from ``qualified facility'' to
                                                                 ``not a qualified facility'' based on the
                                                                 annual determination, the facility must notify
                                                                 FDA of that change in status using Form FDA
                                                                 3942b by July 31 of the applicable calendar
                                                                 year.
                                                                 Specify that the required biennial
                                                                 submissions of the attestations must be made
                                                                 during a timeframe that will coincide with the
                                                                 required biennial updates to facility
                                                                 registration.
507.7(d).............................  Timeframe for            When the status of a facility changes from
                                        compliance with the      ``qualified facility'' to ``not a qualified
                                        requirements of          facility,'' the facility must comply with
                                        subparts C and E.        subparts C and E no later than December 31 of
                                                                 the applicable calendar year unless otherwise
                                                                 agreed to by FDA and the facility.
507.7(e).............................  Notification to          Conforming changes associated with the term
                                        consumers.               ``attestation.``
507.7(f).............................  Records................  Conforming changes associated with the term
                                                                 ``attestation.``
----------------------------------------------------------------------------------------------------------------

A. Comments on Submission of a Certification Statement

    (Comment 124) Some comments ask us to clarify the distinction 
between the documentation that would be submitted to FDA and the 
records that a qualified facility relies on to support the submitted 
documentation.
    Some comments agree with our tentative conclusion to use certified 
statements to satisfy the proposed submission requirements, noting that 
it would save time and money and reduce the paperwork burden on 
qualified facilities. Some comments ask us to revise the proposed 
requirements to make this use of certified statements explicit in the 
regulatory text.
    Other comments disagree with our tentative conclusion to use 
certified statements to satisfy the submission requirements. These 
comments focus on the importance of actual copies of documents in 
determining compliance with the documentation requirements and assert 
that proof of qualification requires more than a checked box in an 
online registration database. Some comments ask us to require that a 
qualified facility affirm that it has the original documents on file 
and available for FDA inspection. Other comments assert that requiring 
qualified facilities to submit copies of the actual documentation would 
enable us to

[[Page 56217]]

easily review food safety plans or inspection reports and to target our 
compliance and enforcement activities to those qualified facilities 
that pose a greater risk because of inadequate prevention measures or 
deficient inspections.
    (Response 124) We are affirming our tentative decision that we will 
not require a qualified facility to submit to FDA as part of its 
attestation the underlying documentation that establishes its 
compliance. We agree that the underlying records are needed to 
determine compliance with the documentation requirements and that a 
qualified facility must retain the documents it is relying on to 
support its attestation and make them available to us during 
inspection. We also agree that the regulatory text needs to be explicit 
regarding the required documentation and that we need to clearly 
distinguish between the documentation that would be submitted to FDA 
and the records that a qualified facility relies on to support the 
submitted documentation. Therefore, we have made the following three 
revisions to the proposed regulatory text.
    First, we have revised proposed Sec.  507.7(a) to specify that the 
submitted documentation is an ``attestation.'' Second, we have revised 
proposed Sec.  507.7(b) to update details regarding the electronic and 
paper submission of a form specific to this attestation requirement. 
Third, we have revised proposed Sec.  507.7(e) (final Sec.  507.7(f)) 
to specify that you must maintain those records relied upon to support 
the ``attestations'' that are required by Sec.  507.7(a).
    We acknowledge that requiring submission of the actual 
documentation would enable us to easily review food safety plans or 
inspection reports and to target our compliance activities based on 
information that we see in those food safety plans or inspection 
reports. However, as discussed in Response 245, we are not requiring 
that other facilities submit a ``facility profile'' that would allow us 
to more broadly review food safety plans and target our compliance 
activities based on information that we see in those food safety plans 
and will instead explore other mechanisms to achieve the goals we 
described in the 2013 proposed preventive controls rule for animal food 
for a facility profile.

B. General Comments on Requirements That Apply to a Qualified Facility

    (Comment 125) Some comments assert that the proposed requirements 
would create a costly burden for qualified facilities (e.g., 
registering and making submissions to FDA) that would not be imposed on 
other types of exempted facilities. Some of these comments question 
whether the exemption for qualified facilities is meaningful in light 
of the significant burden imposed by the proposed requirements. Some 
comments contrast the proposed requirement for qualified facilities to 
submit documentation to FDA with proposed requirements for all other 
facilities to simply establish and maintain applicable records.
    (Response 125) The submission requirements that we are establishing 
in this rule for qualified facilities reflect the statutory framework 
for qualified facilities (section 418(l)(2)(B) of the FD&C Act). 
Although the submission requirements only apply to qualified 
facilities, the reporting burden associated with submission of an 
attestation is much lower than the recordkeeping burden for facilities 
that are subject to the requirements for hazard analysis and risk-based 
preventive controls (see section LVIII).
    (Comment 126) Some comments ask us to minimize setting different 
standards even though the requirements reflect express statutory 
provisions.
    (Response 126) These comments appear to be referring to the 
statutory provisions of section 418(n)(3)(C) of the FD&C Act, which 
specify that the regulations we establish to implement section 418 of 
the FD&C Act acknowledge differences in risk and minimize, as 
appropriate, the number of separate standards that apply to separate 
foods. We disagree that the statutory provisions of section 
418(n)(3)(C) are directly relevant to the submission requirements of 
this rule for qualified facilities. The requirements for qualified 
facilities, but not other facilities, to submit documentation to FDA 
reflect different regulatory requirements. The different regulatory 
requirements are directed at different facilities, and do not set 
separate standards for particular animal foods. Regardless, even if the 
statutory provisions of section 418(n)(3)(C) were relevant to the 
submission requirements of qualified facilities, provisions of this 
rule that reflect express statutory provisions would not conflict with 
the statutory direction in section 418(n)(3)(C).
    (Comment 127) Some comments emphasize that the requirements need to 
ensure adequate protection of public health and state that we should 
maintain and exercise oversight of qualified facilities. Some comments 
ask that we provide enough specificity so that qualified facilities 
know and understand their food safety responsibilities towards 
consumers.
    (Response 127) A facility that satisfies criteria to be a qualified 
facility continues to be responsible to produce animal food that will 
not be adulterated under section 402 of the FD&C Act. Such a facility 
is also subject to the requirements of section 421 of the FD&C Act 
regarding frequency of inspection of all facilities and to the new 
administrative tools provided by FSMA, such as for suspension of 
registration (section 415 of the FD&C Act) and for mandatory recall 
(section 423 of the FD&C Act). As discussed in Response 77, we expect 
that most qualified facilities will be subject to the CGMP requirements 
of subpart B. When they are inspected, we will be ensuring they are in 
compliance with the CGMP requirements once the applicable compliance 
date is reached.
    (Comment 128) Some comments ask which exemption a farm mixed-type 
facility should follow if it satisfies criteria for a qualified 
facility (Sec.  507.5(d)), as well as criteria for a very small 
business that only conducts on-farm low-risk activity/animal food 
combinations (specified in Sec.  507.5(e) and (f)) and one comment 
suggests that FDA should allow such a facility to choose which 
exemption to follow.
    (Response 128) We describe these comments in more detail in Comment 
110. A farm mixed-type facility that is a very small business and that 
only conducts the low-risk activity/animal food combinations listed in 
Sec.  507.5(e) and (f) may find it advantageous to classify itself as a 
very small business eligible for the exemption in Sec.  507.5(e) and 
(f) (which is not subject to the requirements in Sec.  507.7) rather 
than as a qualified facility (which is subject to the requirements in 
Sec.  507.7).
    (Comment 129) Some comments express concern about State access to 
the records that a qualified facility maintains to support its 
attestations, particularly when a State would conduct an inspection for 
compliance with part 507 under contract to FDA. These comments express 
concern about the time and resources necessary to verify the status of 
a facility as a qualified facility and note that previous mechanisms 
whereby we provide information to States in advance of inspection have 
been slow. These comments also express concern that if the state must 
verify the ``qualified facility'' status of all firms, including those 
that are not FDA contracts, this could delay their ability to conduct 
timely inspections and increase inspection time, reducing the number of 
inspections conducted.
    (Response 129) We are sensitive to the time required for various 
inspection

[[Page 56218]]

activities and intend to communicate with States regarding our 
expectations for how to verify whether a facility is a qualified 
facility.
    (Comment 130) Some comments point out that the proposed procedures 
for submission are silent on the process and timeframe for our review 
and approval of the submitted documentation and ask us to clarify this 
process and timeframe. Other comments ask us to clarify the 
consequences to a facility if its submission is found to be 
insufficient.
    (Response 130) We will not be approving the submitted attestations. 
Instead, we intend to use the information to determine whether the 
facility should be inspected for compliance with the requirements for 
hazard analysis and risk-based preventive controls, or for compliance 
with the requirements for a qualified facility. During the inspection, 
we would ask to see the records that the facility maintains to support 
any submitted attestations.
    (Comment 131) Some comments ask us to clarify whether a foreign 
facility would need to submit documentation of its status as qualified 
facility. These comments note that a foreign facility also would be 
required to provide information to an importer and assert that 
submitting information to both FDA and an importer would be a 
duplication of effort. These comments ask us to allow a foreign 
facility that is a qualified facility to submit information to either 
FDA or the importer, rather than to both FDA and the importer.
    (Response 131) We decline this request. Documentation submitted to 
an importer would not reach FDA and, thus, could not satisfy the 
requirements of this rule. We are requiring submission of an 
attestation, on a form that can be submitted either electronically or 
on paper, rather than submission of the underlying information.

C. Proposed Sec.  507.7(a)--Documentation To Be Submitted

1. Section 507.7(b)(1)--Documentation That the Facility Is a Qualified 
Facility
    We proposed that a qualified facility must submit documentation 
that the facility is a qualified facility. We also proposed that for 
the purpose of determining whether a facility satisfies the definition 
of a qualified facility, the baseline year for calculating the 
adjustment for inflation is 2011. As discussed in Response 124, we have 
revised the provision to specify that the documentation that must be 
submitted is an attestation.
    (Comment 132) Some comments ask us to clarify the documentation 
required to certify that an operation is a qualified facility. Some 
comments ask us to explicitly state that the documentation must include 
financial and sales records of the business and its subsidiaries or 
affiliates. Some comments ask us to clarify the types of records that 
would be required to be submitted by foreign establishments to support 
the classification of a foreign establishment as a ``qualified 
facility.''
    (Response 132) The submission to FDA will be an attestation rather 
than the records that the qualified facility relies on to support the 
attestation; however, you must maintain those records relied upon to 
support the ``attestations'' (see Sec.  507.7(f)). As previously 
discussed, consistent with section 418(l)(2)(B)(ii) of the FD&C Act, we 
intend to issue guidance on the records that a facility could retain to 
demonstrate that it is a qualified facility (78 FR 64736 at 64767). As 
discussed in Response 124, we have revised the regulatory text to 
provide for qualified facilities to submit an attestation that the 
facility is in compliance with State, local, county, tribal, or other 
applicable non-Federal food safety law. We intend to focus on records 
demonstrating that a facility is a very small business (i.e., financial 
records demonstrating that a business averages less than $2,500,000 
adjusted for inflation, per year, during the 3-year period preceding 
the applicable calendar year in sales of animal food plus the market 
value of animal food manufactured, processed, packed, or held without 
sale (e.g., held for a fee or supplied to a farm without sale)) rather 
than records demonstrating that the average annual monetary value of 
the food manufactured, processed, packed or held at such facility that 
is sold directly to qualified end-users during a 3-year period exceeded 
the average annual monetary value of the food sold by the facility to 
all other purchasers. We expect that financial records demonstrating 
that a business is a very small business will be less burdensome for a 
qualified facility to maintain and require fewer resources for FDA to 
review.
    During an inspection, we expect the facility to be able to show us 
how the facility is complying with the applicable food safety 
regulation (including relevant licenses, inspection reports, 
certificates, permits, credentials, or certifications), and producing 
safe animal food.
    (Comment 133) Some comments ask how the adjustment for inflation 
will be calculated and how regulators such as the states will get this 
information.
    (Response 133) We intend to use the Federal calculation for the 
Gross Domestic Product price deflator, as provided by the Bureau of 
Economic Analysis, to adjust for inflation. We will make the inflation-
adjusted dollar value to the baseline very small business cutoffs (e.g. 
$2,500,000 in 2011) available on our Internet site. We will update the 
values for the very small business exemptions and qualifications 
annually using this calculation.
2. Proposed Sec.  507.7(a)(2)(i)--First Option for Documentation: Food 
Safety Practices.
    We proposed two options for satisfying the statutory documentation 
requirement in section 418(l)(2)(B)(i) of the FD&C Act. Under the first 
option (the food safety practices option), a qualified facility could 
submit documentation demonstrating that it has identified the potential 
hazards associated with the animal food being produced, is implementing 
preventive controls to address the hazards, and is monitoring the 
performance of the preventive controls to ensure that such controls are 
effective. As discussed in Response 124, we have revised the provision 
to specify that the submission is an attestation.
    (Comment 134) Some comments assert that the rule is vague about 
what the applicable documentation should include and how exhaustive it 
should be. Some comments ask whether documentation (such as a food 
safety plan) must address all operations at the establishment or only 
those that trigger the registration of the establishment as a facility. 
Some comments ask us to clarify the difference between having 
documentation to support food safety practices and attesting that the 
facility has such documentation. Other comments ask whether a qualified 
facility would need to have records documenting a risk analysis and 
monitoring.
    (Response 134) If a qualified facility submits an attestation 
regarding its food safety practices, the documentation that the 
facility maintains for review during inspection must specify that the 
facility has identified the potential hazards associated with the 
animal food being produced, is implementing preventive controls to 
address the hazards, and is monitoring the performance of the 
preventive controls to ensure that such controls are effective (see 
Sec.  507.7(a)(2)(i)). For example, a qualified facility that produces 
raw dog food might have documentation specifying that it has determined 
that Salmonella is a hazard requiring a preventive control, describing 
the process that will

[[Page 56219]]

control Salmonella, describing sanitation controls to prevent 
contamination of raw dog food with Salmonella, and describing an 
environmental monitoring program to verify that its sanitation controls 
are effective. Likewise, a qualified facility that makes a custom 
cattle food might have documentation specifying that it has determined 
that metal objects are a hazard requiring a preventive control and 
supporting the use of a magnet to remove metal objects from the cattle 
food, with procedures for monitoring the magnet's use if applicable.
    As discussed in Response 124, a qualified facility that chooses the 
food safety practices option for complying with the submission 
requirements of this rule will attest to that by checking a statement 
on a form. In contrast, a food safety plan (or other documentation) 
that the qualified facility relies on to support the attestation will 
be a record subject to the recordkeeping requirements of subpart F.
3. Proposed Sec.  507.7(a)(2)(ii)--Second Option for Documentation: 
Compliance With Other Applicable Non-Federal Food Safety Law
    Under the second option for satisfying the statutory documentation 
requirement, a qualified facility could submit documentation that it is 
in compliance with State, local, county, or other applicable non-
Federal food safety law, including relevant laws and regulations of 
foreign countries. As discussed in Response 124, we have revised the 
provision to specify that the submission is an attestation. We also 
have revised the provision to add ``tribal'' as an example of 
applicable non-Federal food safety law to clarify for purposes of this 
rule that a qualified facility could submit an attestation that it is 
in compliance with tribal food safety law.
    (Comment 135) Some comments object to the proposed provision. These 
comments point out that State and local requirements are inconsistent 
and assert that such requirements are not sufficiently rigorous to 
substitute for the FSMA requirement to conduct a hazard analysis and 
establish and execute a documented food safety plan. One comment 
asserts that the state laws may not provide the same level of 
protection to consumers.
    (Response 135) The provision reflects the express statutory 
direction of section 418(l)(2)(B)(i)(II) of the FD&C Act. Most of these 
qualified facilities are subject to the CGMP requirements of subpart B 
and a facility that satisfies criteria to be a qualified facility 
continues to be responsible to produce animal food that will not be 
adulterated under section 402 of the FD&C Act.
    (Comment 136) Some comments ask us to specify that a qualified 
facility must document compliance with all applicable non-Federal food 
safety laws. One comment asks what evaluation FDA will conduct of any 
non-Federal food safety law before determining that compliance with 
such law constitutes compliance under FSMA for a qualified facility.
    (Response 136) We decline this request. Section 418(l)(2)(B)(i)(II) 
of the FD&C Act refers to apply to compliance with ``State, local, 
county, or other applicable non-Federal food safety law'' (emphasis 
added). As discussed in Response 132, we have revised the regulatory 
text to provide for qualified facilities to submit an attestation that 
the facility is in compliance with State, local, county, or other 
applicable non-Federal food safety law During an inspection, we expect 
the facility to be able to show us how the facility is complying with 
the applicable food safety regulation (including relevant licenses, 
inspection reports, certificates, permits, credentials, or 
certifications), and producing safe animal food.
    (Comment 137) Some comments ask us to provide resources to the 
States to implement the proposed provision. These comments also ask us 
to develop and implement a strategic plan to provide resources (e.g. 
training, guidance) to State and local inspection agencies in advance 
of the anticipated increased burden on State and local inspection 
programs that will be created by the provision.
    (Response 137) We do not believe that specific training for State 
or other government counterparts is necessary for the purposes of 
inspecting a qualified facility that attested to having documentation 
from a non-Federal regulatory authority. The State or other government 
counterpart would merely examine applicable documentation (such as a 
license, inspection report, certificate, permit, credentials, or 
certification by an appropriate agency (such as a State department of 
agriculture)), which is specified in the provision. After inspecting 
such documentation, the State or other government counterpart would 
focus on inspection for compliance with CGMPs.

D. Proposed Sec.  507.7(b)--Procedure for Submission

    We proposed that the documentation must be submitted to FDA either 
electronically or by mail. As discussed in Response 124, we have 
revised the regulatory text to update details regarding the electronic 
and paper submission of a specific form. We are developing paper and 
electronic versions of Form FDA 3942b, which is an information 
collection provision that is subject to review by OMB under the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3501 to 3520). We intend to 
make the paper Form FDA 3942b available in the near future and invite 
comments consistent with procedures for approval of the form by OMB.
    (Comment 138) Some comments recommend that any interface for 
electronic submission of certification statements post adequate notice 
of requirements the facility must meet and warnings detailing potential 
penalties (e.g., for fraudulent submission).
    (Response 138) We intend that the electronic submission system will 
operate in a manner similar to the existing electronic submission 
system for registration of food facilities, including a certification 
statement advising the person signing the form that, under 18 U.S.C. 
1001, anyone who makes a materially false, fictitious, or fraudulent 
statement to the U.S. Government is subject to criminal penalties. We 
intend to include a similar certification statement on paper forms that 
will be available for qualified facilities that choose to submit by 
paper rather than through the electronic system. The electronic and 
paper submission forms will focus on the attestation statements rather 
than on other requirements to which the facility is subject. The Small 
Entity Compliance Guide that we will issue in accordance with section 
212 of the Small Business Regulatory Enforcement Fairness Act (Pub. L. 
104-121) will be better suited to helping qualified facilities 
understand the requirements of the rule than information presented on a 
submission form.

E. Proposed Sec.  507.7(c)--Frequency of Determination and Submission

    We proposed that the documentation must be: (1) Submitted to FDA 
initially within 90 days of the applicable compliance date and (2) 
resubmitted at least every 2 years, or whenever there is a material 
change to the information applicable to determining the status of a 
facility.
    (Comment 139) Some comments assert that the proposed timeframe of 
90 days to submit the required documentation would not provide 
sufficient time to gather and submit the required documentation and ask 
us to extend the timeframe, e.g., to 120 or 180 days.
    (Response 139) We are retaining the proposed timeframe for the 
initial

[[Page 56220]]

submission (within 90 days of the applicable compliance date). The only 
documentation that the qualified facility will need to submit is an 
attestation, which does not need to be gathered. Importantly, however, 
documentation supporting the attestation must be available for 
inspection by September 17, 2019. As discussed in Response 76, the 
compliance date for a facility to retain records to support its status 
as a qualified facility is January 1, 2017. As a companion change, we 
are explicitly requiring that a facility determine and document its 
status as a qualified facility on an annual basis by no later than July 
1of each calendar year (see Sec.  507.7(c)(1)).
    In addition, we have revised proposed Sec.  507.7(c)(1) (which we 
are finalizing as Sec.  507.7(c)(2)(i)(A), (B), and (C)) to specify the 
timeframe for the initial submission for three distinct circumstances: 
(A) By December 16, 2019 for a facility that begins manufacturing, 
processing, packing, or holding animal food before September 17, 2019; 
(B) Before beginning operations, for a facility that begins 
manufacturing, processing, packing or holding animal food after 
September 17, 2019; or (C) By July 31 of the applicable calendar year, 
when the status of a facility changes from ``not a qualified facility'' 
to ``qualified facility'' based on the annual determination required by 
paragraph (c)(1) of this section. See the discussion in Response 76 
regarding the approach we intend to take in a number of circumstances 
that could lead to a facility having records to support its status as a 
qualified facility for fewer than 3 preceding calendar years.
    We have revised the provision to specify that the required biennial 
submissions of the attestations must be made during a timeframe that 
will coincide with the required biennial updates to facility 
registration (see section 102 of FSMA), i.e., during the period 
beginning on October 1 and ending on December 31, beginning in 2020. In 
determining that 2020 would be the first year for the required biennial 
submissions of the attestations, we first considered that the first 
submission of an attestation would be approximately December 2019 for 
qualified facilities that are operating as of the date of this final 
rule (i.e., approximately 90 days after the date of publication of this 
rule). For qualified facilities that do not begin operations until 
after December 2019, the first biennial submission will be required in 
a timeframe less than 2 years, but once the qualified facility has made 
its first submission the subsequent biennial submissions will all be at 
2-year intervals. Coordinating the biennial submissions of the required 
attestations with the biennial registration will reduce the cumulative 
economic impact on the animal food industry of complying with two 
separate requirements because qualified facilities that choose to 
submit electronically will be able to submit electronically while 
accessing the same electronic portal used for facility registration.
    (Comment 140) Some comments ask us to include an option within the 
system to notify us when a facility's status as a ``qualified 
facility'' changes, e.g., because its business expands or changes.
    (Response 140) Notifying us when there is a material change in the 
facility's status from ``qualified facility'' to ``not a qualified 
facility'' is a requirement rather than an option. We included this 
requirement in the proposed rule, and are establishing it in this final 
rule. We made editorial changes to the provision to make this clearer.
    We also established a series of dates associated with the 
facility's change in status from ``qualified facility'' to ``not a 
qualified facility.'' First, we are specifying that when the status of 
a facility changes from ``qualified facility'' to ``not a qualified 
facility'' based on the required annual determination, the facility 
must notify FDA of that change in status using Form FDA 3942b by July 
31 of the applicable calendar year (see Sec.  507.7(c)(3)). We have 
provided the facility with flexibility to wait until July 1 of a given 
calendar year to determine whether its status changes (see Sec.  
507.7(c)(1)); 30 days is an adequate timeframe to submit the form 
notifying us of the change in status.
    Second, we are specifying that when the status of a facility 
changes from ``qualified facility'' to ``not a qualified facility,'' 
the facility must comply with subparts C and E no later than December 
31 of the applicable calendar year unless otherwise agreed to by FDA 
and the facility (see Sec.  507.7(d)). In essence, this provision can 
provide a facility with up to a full year to comply with the full 
requirements for hazard analysis and risk-based preventive controls 
when the facility determines its change in status early in the calendar 
year. A facility that does not determine that change in status until 
the required date of July 1 would still have 6 months to comply with 
the full requirements for hazard analysis and risk-based preventive 
controls. As we have done in the case of a qualified exemption being 
withdrawn (see Sec.  507.65(d)(1)), we are providing flexibility for a 
facility to comply in an alternative timeframe if agreed to by FDA and 
the facility.
    (Comment 141) One comment asks us to specify that the required 
attestations be submitted every 5 years rather than every 2 years. This 
comment asserts that doing so would be consistent with the statutory 
direction of section 201 of FSMA (Targeting of Inspection Resources) 
for non-high risk food facilities. This comment also asserts that we 
did not provide specific reasons for the proposed 2-year timeframe and 
that resubmitting the attestations every 2 years will increase cost in 
time and labor.
    (Response 141) We decline the request. The rule requires 
resubmission whenever there is a material change to the information 
that changes the status of a facility as a qualified facility. 
Therefore, if the facility's sales change its status, so that it is no 
longer a qualified facility, the rule requires that facility to notify 
us when its status changes. (Note that the definition of very small 
business established in this rule bases the threshold dollar amount for 
a very small business on an average (of sales plus the market value of 
animal food held without sale) during the 3-year period preceding the 
applicable calendar year, rather than on annual sales plus market 
value. A biennial submission is adequate to otherwise require a 
qualified facility to affirmatively attest that it continues to satisfy 
the criteria for being a qualified facility. A biennial submission is 
not overly burdensome, because a facility can coordinate its biennial 
submission with its biennial update to its facility registration. The 
suggested 5-year submission based on the targeted inspection frequency 
for non-high risk animal food facilities implies that all qualified 
facilities produce such animal foods, which is not the case.

F. Proposed Sec.  507.7(d)--Notification to Consumers (Final Sec.  
507.7(e))

    We proposed that a qualified facility that does not submit 
documentation of its food safety practices must provide notification to 
consumers as to the name and complete business address of the facility 
where the animal food was manufactured or processed (including the 
street address, or P.O. Box, city, state, and zip code for domestic 
facilities, and comparable full address information for foreign 
facilities).
    (Comment 142) One comment recommends that information giving the 
location of the manufacturing site, and not just the corporation 
contact information, be provided on the animal food labels. Other 
comments state that specifically for pet food and pet treats, the 
manufacturer should be required to include the co-packer information on

[[Page 56221]]

the product labels to include the co-packer's name, private label 
contact information, address, and co-packer's contact information 
(phone and/or email).
    (Response 142) Section 418(l)(7) of the FD&C Act specifically 
mandates for a qualified facility that ``the name and business address 
of the facility where the food was manufactured or processed,'' not the 
corporate contact information, be included on a label for a food for 
which a food packaging label is required. It does not require co-packer 
information. The statute makes no requirements for non-qualified 
facilities.

G. Proposed Sec.  507.7(e)--Records (Final Sec.  507.7(f))

    We proposed that a qualified facility must maintain those records 
relied upon to support the required documentation. We also proposed 
that the records that a qualified facility must maintain would be 
subject to the requirements that would be established in subpart F of 
this rule. As discussed in Response 124, after considering comments we 
have revised the rule to specify that a qualified facility must 
maintain those records relied upon to support the required attestations 
(rather than the required documentation).
    (Comment 143) Some comments ask us to explicitly specify that we 
have access to documents that establish a facility as a qualified 
facility. Some comments assert that a facility may reasonably assume 
that records such as financial records would not be available to us 
because such records are excluded from the records that we have access 
to under the Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002 (the Bioterrorism Act), and as provided by Sec.  
1.362.
    (Response 143) The rule explicitly specifies that we have access to 
records that are required by the rule (see Sec.  507.200). If a 
facility relies on financial records to demonstrate its status as a 
qualified facility, we will have access to those financial records. The 
exemption referred to by the comments for financial records (Sec.  
1.362) is narrowly targeted to records required by the section 414 
recordkeeping regulations and does not apply to records required by 
this preventive controls rule for animal food.

XII. Subpart A: Comments on Proposed Sec.  507.10--Applicability of 
Part 507 to a Facility Solely Engaged in the Storage of Unexposed 
Packaged Animal Food

    We proposed that subpart C would not apply to a facility solely 
engaged in the storage of packaged animal food that is not exposed to 
the environment and does not require time/temperature control to ensure 
the safety of the animal food (proposed Sec.  507.10(a)). We also 
proposed that a facility solely engaged in the storage of packaged 
animal food that is not exposed to the environment but requires time/
temperature control for safety would be subject to the modified 
requirements that would be established in proposed Sec.  507.48 of 
subpart C (proposed Sec.  507.10(b)).
    Some comments support these proposed provisions without change. For 
example, one comment expresses the view that a facility solely engaged 
in the storage of packaged animal food that does not require time/
temperature control for safety does not need to conduct its own hazard 
analysis, nor establish and implement preventive controls because there 
would be no hazards to trigger such activities. Other comments that 
support the proposed provisions ask us to clarify some aspects of the 
provisions or to clarify how the provisions will apply in particular 
circumstances. Other comments that support the proposed provisions ask 
us to broaden them.
    In the following paragraphs, we discuss comments that disagree 
with, or suggest one or more changes to, the proposed provisions. After 
considering these comments, we have revised the proposed requirements 
as shown in table 8 with editorial and conforming changes as shown in 
table 31. A key conforming change that affects Sec.  507.10 is that it 
includes an exemption from the requirements of subpart E, as well as 
subpart C. As discussed in section XL, the final rule establishes the 
requirements for a supply-chain program in subpart E, rather than 
within subpart C as proposed.

   Table 8--Revisions to the Proposed Applicability of Subpart C to a
Facility Solely Engaged in the Storage of Unexposed Packaged Animal Food
------------------------------------------------------------------------
            Section                Description            Revision
------------------------------------------------------------------------
507.10(b).....................  Applicability of   Clarification that
                                 modified           Sec.   507.51 of
                                 requirements in    subpart C only
                                 Sec.   507.51 of   applies to those
                                 subpart C.         unexposed packaged
                                                    animal foods that
                                                    require time/
                                                    temperature control
                                                    to significantly
                                                    minimize or prevent
                                                    the growth of, or
                                                    toxin production by,
                                                    pathogens.
------------------------------------------------------------------------

    (Comment 144) Some comments ask us to clarify that temperature 
controls should be implemented when determined to be necessary by the 
facility or preventive controls qualified individual. Some comments ask 
us to clarify that if a facility stores both TCS food and non-TCS food 
(i.e., unexposed packaged animal food that does not require time/
temperature control for safety), then the modified requirements only 
apply for the portion of the facility that holds the TCS foods.
    (Response 144) We have revised Sec.  507.10(b) to clarify that a 
facility solely engaged in the storage of unexposed packaged animal 
food, including unexposed packaged animal food that requires time/
temperature control to significantly minimize or prevent the growth of, 
or toxin production by, pathogens is subject to the modified 
requirements in Sec.  507.51 of subpart C of this part for any 
unexposed packaged food that requires time/temperature control to 
significantly minimize or prevent the growth of, or toxin production 
by, pathogens.
    (Comment 145) Some comments ask us to revise the regulatory text to 
be explicit that frozen unexposed packaged food is not a TCS food 
subject to modified requirements.
    (Response 145) We decline this request. In the 2013 proposed animal 
food preventive controls rule, we tentatively concluded that it would 
be rare for a frozen animal food to be a TCS food (78 FR 64736 at 
64802), and we affirm that conclusion in this document. However, 
specifying in the regulatory text that a frozen animal food is not a 
TCS food would require us to conclude that a frozen animal food would 
``never'' (rather than ``rarely'') be a TCS food, and we lack 
information to support ``never.''
    (Comment 146) Some comments ask us to apply the exemption to 
storage areas of facilities that also engage in food processing 
activities, e.g., for distributors that are engaged in limited food 
processing, such as blending seeds to make bird food. These comments

[[Page 56222]]

assert that the intent of the term ``solely'' is to make clear that a 
facility that conducts an activity subject to the exemption does not 
escape responsibility for complying with the requirements for hazard 
analysis and risk-based preventive controls when conducting activities 
that are not exempt.
    (Response 146) We disagree with the comment's interpretation of the 
term ``solely.'' The plain meaning of ``solely'' is only, completely, 
entirely; without another or others; singly; alone (Ref. 24). The 
facility described in the comment is not ``solely'' engaged in the 
storage of unexposed packaged animal food.
    Such a facility must conduct a hazard analysis that addresses all 
activities conducted by the facility. The preventive controls that the 
facility would establish and implement would depend on the facility, 
the animal food, and the outcome of the facility's hazard analysis and 
any preventive control management components associated with a 
facility's preventive controls would be established as appropriate to 
ensure the effectiveness of the preventive controls, taking into 
account the nature of the preventive control and its role in the 
facility's food safety system. A facility that stores unexposed 
packaged animal food that is not a TCS animal food could, for example, 
determine that no preventive controls and associated management 
components would be necessary. A facility that stores unexposed 
refrigerated packaged TCS animal food could, for example, determine 
that preventive controls and management components patterned after the 
modified requirements in Sec.  507.51 are adequate to address 
significant hazards associated with that animal food.
    (Comment 147) Some comments ask us to allow a facility to designate 
a storage area as a separate facility for purposes of compliance with 
the requirements for hazard analysis and risk-based preventive 
controls. In the comments' view, an area solely engaged in the storage 
of unexposed packaged food could fall within the exemption in Sec.  
507.10 even though other areas would be subject to the requirements for 
hazard analysis and risk-based preventive controls.
    (Response 147) We disagree that a designated storage area in an 
establishment that conducts manufacturing, processing, or packing in 
addition to storage can fall within the exemption for facilities 
``solely engaged in . . . storage.'' The statute provides authority for 
us to exempt or modify the requirements for compliance with respect to 
``facilities'' that are solely engaged in the storage of packaged foods 
that are not exposed to the environment (section 418(m) of the FD&C 
Act). The statute defines ``facility'' as a domestic facility or a 
foreign facility that is required to register under section 415 of the 
FD&C Act (section 418(o)(2) of the FD&C Act). The section 415 
registration regulations define facility as ``any establishment, 
structure, or structures under one ownership at one general physical 
location . . .'' The comment's interpretation that we could view 
``areas'' of registered facilities to be ``facilities that are solely 
engaged in the storage of packaged foods that are not exposed to the 
environment'' is inconsistent with the statutory and regulatory 
framework under sections 415 and 418 of the FD&C Act.
    (Comment 148) Some comments ask us to consider an alternative to 
the exemption for unexposed packaged foods when a facility conducts 
manufacturing, processing, packing, or holding activities in addition 
to storing unexposed packaged food. Specifically, these comments ask us 
to recognize that the minimal risks of storing unexposed packaged foods 
can be addressed through a combination of compliance with the modified 
requirements for TCS foods (if applicable) and the CGMPs in subpart B 
and state that doing so would be consistent with our discussion in the 
2013 proposed animal food preventive controls rule.
    (Response 148) These comments appear to suggest the outcome of a 
facility's hazard analysis and food safety plan for storing unexposed 
packaged animal food, i.e., that the only significant hazards are the 
potential for growth of pathogens in refrigerated unexposed packaged 
animal foods and that the preventive controls and preventive control 
management components specified in the modified requirements for TCS 
animal food are adequate to address such hazards. It is the 
responsibility of the facility's preventive controls qualified 
individual to identify the significant hazards associated with the 
facility and the animal food it stores, as well as the appropriate 
preventive controls and preventive control management components. 
However, we agree that in some cases the approach suggested in these 
comments would be appropriate.
    (Comment 149) Some comments assert that it is difficult to identify 
TCS foods. These comments ask us to work with industry and professional 
organizations to develop guidance on when the modified requirements 
apply.
    (Response 149) This document does not include guidance on whether 
specific animal foods are TCS foods. We will consider including 
guidance on animal foods that are TCS foods in the implementing 
guidances we are developing (see Response 1). A facility solely engaged 
in storage of unexposed packaged animal food can work with the 
manufacturer of the food to identify TCS food. Alternatively, such a 
facility could simply treat any refrigerated food as a TCS food.

XIII. Subpart A: Comments on Proposed Sec.  507.12--Applicability of 
Part 507 to the Holding and Distribution of Human Food By-Products for 
Use as Animal Food.

    We proposed to add provisions for human food by-products for use as 
animal food. We proposed that the requirements of this part would not 
apply to by-products of human food production that are packed or held 
by that human food facility for distribution as animal food if: the 
facility is subject to and in compliance with subpart B of part 117 
(the CGMPs in the proposed preventive controls rule for human food) and 
in compliance with all other applicable human food safety requirements 
of the FD&C Act and implementing regulations; and the facility does not 
further manufacture or process the by-products intended for use as 
animal food. Proposed Sec.  507.12(b) would require that once the 
animal food was separated from the human food, the facility would need 
to comply with proposed Sec. Sec.  507.28 and 117.95 of part 117 for 
the holding and distribution of that animal food. We also proposed 
Sec.  117.95 be added to the proposed preventive controls rule for 
human food and asked for comment on whether the requirements should be 
placed in both Sec.  117.95 and Sec.  507.28.
    Section 507.12 does not apply to human food by-products when 
contamination or other adulteration has occurred that is materially 
related to food safety. We handle requests for diversion of these 
products for animal food use on a case-by-case basis. Additional 
information on diversion of contaminated or adulterated food for animal 
food use is available in compliance policy guidances (CPG) CPG Sec. 
675.100 ``Diversion of Contaminated Food for Animal Use'' and CPG Sec. 
675.200 ``Diversion of Adulterated Food to Acceptable Animal Feed Use'' 
(Refs. 25 and 26). We asked for comment on whether we should include 
regulations for these types of requests.
    Many comments generally support the concept that certain human food 
by-products intended for use as animal food which do not undergo 
further processing by the human food

[[Page 56223]]

manufacturer only need to comply with proposed Sec.  507.28 for holding 
and distribution of human food by-products for use as animal food. Some 
of these comments note that human food by-products are an important 
source of animal food. Other comments agree but request changes and/or 
additional exemptions.
    We have modified Sec.  507.12 to clarify that the requirements of 
part 507 do not apply to off-farm packing and holding of RACs packed or 
held by a human food facility for distribution as animal food provided 
certain conditions are met. For off-farm packing and holding of produce 
(as defined in part 112 of this chapter), if the human food facility is 
subject to and in compliance with Sec.  117.8 of part 117 of this 
chapter and in compliance with all applicable human food safety 
requirements of the FD&C Act and implementing regulations, and the 
human food facility does not further manufacture or process the by-
products intended for use as animal food, then the requirements of part 
507 do not apply to the by-products.
    (Comment 150) Some comments request that the proposed provisions be 
included in both this rule and the final rule for preventive controls 
for human food so that it would be easier for human food processors to 
understand the requirements for human food by-products intended for use 
as animal food. One comment does not support placing these provisions 
in both of the final rules, preferring that all animal food provisions 
be in part 507, and that part 117 should pertain only to human food.
    (Response 150) Section 117.95--``Holding and distribution of human 
food by-products for use as animal food'' is established in this rule. 
Section 117.95 will appear in 21 CFR part 117, preventive controls for 
human food. The by-products holding and distribution provisions also 
will appear in Sec.  507.28, the animal food CGMPs. The requirements of 
Sec.  117.95 and Sec.  507.28 are identical and appear in both places 
for the convenience of the facilities to which the provisions would 
apply.
    (Comment 151) Two comments state it must be clear in the rule that 
not only by-products but also products which are already authorized for 
food like gelatin or collagen must be authorized for food for animals, 
without further requirements and additional CGMP implementation.
    (Response 151) We understand this comment to be stating that a 
human food product that also may be used as an animal food should not 
be required to comply with part 507 if it is in compliance with human 
food requirements. We agree with this comment. A facility that 
manufactures and sells a food just for human consumption is not subject 
to part 507, even if the purchaser of that food may use it for animal 
food.
    If a facility manufactures, processes, packs, or holds human food 
and animal food, and is subject to subpart C of part 117, it can comply 
with subpart C of part 117 for the animal food, but needs to address 
any hazards unique to the animal food that require a preventive 
control, if applicable. Except as provided by Sec.  507.12 for human 
food by-products, if a facility is required to comply with subpart B of 
part 507 and also subpart B of part 117 because the facility 
manufactures, processes, packs, or holds human food and animal food, 
then the facility may comply with the requirements in subpart B of part 
117, instead of subpart B of part 507, as to the manufacturing, 
processing, packing, and holding of animal food at that facility (see 
the regulatory text for Sec.  507.1(d)).
    (Comment 152) Some comments request that facilities regulated by 
the United States Department of Agriculture (USDA) Food Safety and 
Inspection Service (FSIS) not be required to comply with part 507 for 
animal-derived human food by-products intended for use as animal food. 
Some comments state the requirements are duplicative and are 
unnecessary because FSIS food safety requirements are already in place, 
and that oftentimes the FSIS establishment is unaware of what purpose 
or animal species the purchaser will use the by-product for as animal 
food.
    (Response 152) Only animal food facilities that are required to 
register as a food facility under section 415 of the FD&C Act are 
required to comply with this rule. Establishments regulated exclusively 
throughout by FSIS under the Federal Meat Inspection Act, the Poultry 
Products Inspection Act, or the Egg Products Inspection Act, i.e., 
establishments handling only meat, poultry, or certain egg products, 
are exempt from registration under section 415 of the FD&C Act (see 
Sec.  1.226(g) (21 CFR 1.226(g))). Therefore, these establishments are 
not subject to this rule.
    (Comment 153) Some comments state we did not provide support for 
the tentative conclusion that animal-derived by-products carry 
different risks than other by-products, and therefore did not provide a 
basis for why animal-derived by-products should be subject to all of 
part 507 while other human food by-products are subject to only Sec.  
507.28.
    (Response 153) As explained in Response 152, animal-derived by-
products from establishments that are not required to register as food 
facilities would not be subject to part 507.
    Facilities may be jointly regulated by FDA and FSIS if they produce 
some products that are under FDA jurisdiction and some that are under 
FSIS jurisdiction. Such facilities may be required to register as a 
food facility under section 415 of the FD&C Act. Examples of facilities 
jointly regulated by FDA and FSIS include FSIS establishments that also 
process animal food (such as certain pet food), and facilities that 
process meat and nonmeat products (such as frozen entrees, some of 
which contain meat and are regulated by FSIS, and some of which do not 
contain meat but which contain seafood or vegetables that are regulated 
by FDA).
    FSIS establishments that are required to register with FDA because 
they also process FDA-regulated human food, must follow Sec. Sec.  
507.28 and 117.95 for the holding and distribution of their FDA-
regulated human food by-products for use as animal food, if the 
establishments meet the requirements of Sec.  507.12(a). FSIS 
establishments that are required to register with FDA because they also 
process FDA-regulated animal food must comply with the provisions in 
the preventive controls rule for animal food (part 507).
    (Comment 154) Some comments assert that requiring FSIS-regulated 
establishments to comply with part 507 would result in more by-products 
being diverted to other disposal methods which might have an economic 
or environmental impact.
    (Response 154) We do not agree that compliance with part 507 will 
likely result in substantially less use of human food by-products as 
animal food because it applies only to those establishments that are 
required to register under section 415 of the FD&C Act. Furthermore, 
other disposal methods for these products may be more cost prohibitive 
than compliance with these regulations.
    (Comment 155) One comment requests the wording in proposed Sec.  
507.12 be revised to explicitly exclude animal-derived human food by-
products for use as animal food because of pathogen risk.
    (Response 155) Animal-derived human food by-products have a long 
history of use in the animal food industry. These human food by-
products typically are sold from the human food facility to an animal 
food manufacturer/processor, such as a pet food manufacturer, that uses 
the by-products as an ingredient in a finished animal food. These 
manufacturers/processors are required to comply with

[[Page 56224]]

part 507 and must address any potential pathogens. Furthermore, 21 CFR 
589.2000 prohibits the use of mammalian protein in the manufacture of 
animal food given to ruminant animals, such as cows, sheep, and goats, 
and regulations issued under the Swine Health Protection Act (7 U.S.C. 
3801 et seq.) are intended to ensure that food waste containing meat 
does not contain active disease organisms that pose a risk to swine who 
eat it (see 9 CFR part 166).
    (Comment 156) A few comments state that USDA, not FDA, should issue 
any regulations concerning the food safety of animal-derived by-
products intended for use as animal food.
    (Response 156) The FD&C Act gives FDA certain authority to regulate 
food, which includes food for animals. As explained in section XV of 
the 2013 proposed preventive controls rule for animal food, the FD&C 
Act authorizes FDA to issue CGMP and preventive controls regulations to 
enhance the safety of animal food, including human food by-products 
that are intended for use as animal food. We decline to address what 
USDA's role in animal food safety should be as is it out of the scope 
of this rulemaking.
    (Comment 157) One comment suggests an alternative approach to 
animal-derived human food by-products. The comment suggests that we 
consider a provision that would allow the purchaser to take legal 
responsibility for evaluating and mitigating risk associated with by-
products intended for use as animal food if both parties agree.
    (Response 157) For facilities subject to subpart C, the supply-
chain program in subpart E is required when the receiving facility's 
hazard analysis identifies a hazard requiring a supply-chain-applied 
control and the receiving facility's manufacturing/processing will not 
control the hazard. However, when a manufacturer/processor identifies a 
hazard requiring a preventive control, but can demonstrate and document 
that the hazard will be controlled by an entity in its distribution 
chain (e.g., its customer), then the manufacturer/processor is not 
required to implement a preventive control (see Sec. Sec.  507.36 and 
507.37). For a discussion of these provisions, see section XXVII. For 
facilities exempt from the requirements of subpart C, we are aware that 
parties may enter into purchase contracts that include specifications 
or information for the animal food purchased.
    (Comment 158) The comments support seafood, dietary supplements, 
and infant formula by-products intended for use as animal food without 
further processing be subject only to the holding and distribution 
provisions in proposed Sec.  507.28.
    (Response 158) We agree with these comments. We did not receive 
comments indicating by-products from these human foods have specific 
problems if used as animal food. Facilities that process seafood, 
dietary supplements, and infant formula that meet the requirements of 
Sec.  507.12(a) must follow the requirements of Sec.  507.28 and Sec.  
117.95 for human food by-products for use as animal food.
    (Comment 159) Some comments state that all human food by-products, 
including those further processed, should only have to comply with the 
holding and distribution requirements in proposed Sec.  507.28. Other 
comments support the requirement that human food by-products which are 
further processed should be required to comply with all of proposed 
part 507. Some comments request clarification about what constitutes 
further processing.
    (Response 159) We decline the request to exempt human food by-
products that are further processed from the requirements of part 507 
because following CGMPs for the processing will help ensure the animal 
food's safety and because processing can introduce hazards requiring 
preventive controls. Further processing includes any manufacturing/
processing as defined in Sec.  507.3 and includes activities such as 
cooking, freezing, pelleting, and milling. Some passive activities such 
as dewatering by holding a by-product in a container with a screened 
bottom which allows water to escape, or holding in a perforated 
container which allows natural drying to occur are not considered 
further processing. Holding by-products at particular temperature to 
facilitate easier transportation of the by-products is not considered 
further processing; however, cooking or freezing a by-product to 
prevent deterioration or adulteration is considered further processing. 
Facilities holding human food by-products for use as animal food must 
follow the requirements of Sec.  507.28.
    (Comment 160) Some comments state we should not include diversion 
requests for contaminated or adulterated human food to animal food in 
the regulations; that the information contained in the guidance 
documents should remain in guidance and be handled on a case-by-case 
basis. However, some comments request that the existing compliance 
policy guidances be reviewed and updated and provide suggested changes.
    (Response 160) We have not included regulations for diversion of 
contaminated or adulterated human food for animal food use in this 
final rule. We will continue to handle diversion requests on an 
individual basis. We will consider reviewing and revising the current 
compliance policy guidances, CPG Sec. 675.100, ``Diversion of 
Contaminated Food for Animal Use'' and CPG Sec. 675.200, ``Diversion of 
Adulterated Food to Acceptable Animal Feed Use'' (Refs. 25 and 26).
    (Comment 161) One comment requests clarification on whether these 
provisions would apply to retail outlets such as grocery stores or 
bakeries. One comment asserts that when a pig farmer gets outdated milk 
from a dairy processing bottling plant after the plant takes it back 
from grocery stores that the dairy processor (the human food 
manufacturer) would be exempt from the animal food preventive controls 
final rule.
    (Response 161) Retail food establishments such as grocery stores 
and bakeries are not required to register as food facilities (see 
Sec. Sec.  1.226(c) and 1.227(b)(11)) and as a result are not required 
to comply with part 507. However, the products they distribute for 
animal food must not be adulterated.
    If milk has been returned to a processing plant because it is 
contaminated or adulterated, the facility must follow our compliance 
policy guidances for requests to divert human food for use as animal 
food (Refs. 25 and 26). If the returned milk is not contaminated or 
adulterated, but is returned for a quality reason, the facility must 
follow the holding and distribution requirements of Sec.  507.28 and 
Sec.  117.95, but would be exempt from the other provisions in subpart 
B and subpart C of part 507.
    (Comment 162) One comment requests clarification on whether a 
facility that is producing human food by-products intended for animal 
food that fall under proposed Sec.  507.12 has to state in its food 
safety plan that Sec.  507.12 applies.
    (Response 162) If the human food processor meets the requirements 
in Sec.  507.12(a), the facility only needs to comply with Sec.  507.28 
and Sec.  117.95, for the holding and distribution of the human food 
by-products for use as animal food. The facility does not need to 
include this information in its food safety plan for the human food, 
but may choose to include it so that employees and other individuals 
viewing the food safety plan understand what regulatory requirements 
the human food processor is applying to those human food by-products 
intended for animal food.

[[Page 56225]]

XIV. Subpart B: General Comments on Proposed Subpart B--Current Good 
Manufacturing Practice

    In the 2014 supplemental proposed rule we revised the proposed 
CGMPs to be more appropriate for the animal food industry. Following 
are comments on the proposed CGMP requirements.
    (Comment 163) Some comments state that the risks for pet food, 
especially with respect to pathogens, are different than the risks for 
livestock feed, and therefore FDA should issue two sets of CGMPs. Some 
comments say that CGMPs for pet food should be modeled after the human 
food CGMPs because of the high level of care people provide and demand 
for their pets, pets may eat or sleep with humans, and pet owners often 
store pet food close to human food.
    (Response 163) We believe the single set of CGMPs can serve as 
baseline standards for producing safe animal food across all types of 
animal food facilities and animal food. We considered the diverse needs 
of industry and the ultimate goal of animal food safety as we finalized 
the CGMP regulations. We believe the final requirements are flexible 
enough to be applied appropriately in various animal food production 
settings. For example, Sec.  507.19(b) contains requirements for the 
cleaning of animal food-contact surfaces of equipment and utensils to 
protect against contamination of animal food. We do not specify exactly 
how this is to be done (except some requirements for cleaning with wet 
processing of animal food), knowing that what constitutes adequate 
cleaning will depend on the plant and the animal food. (See Response 
182).
    As discussed in the 2013 proposed rule for preventive controls for 
animal food, in 2003 we introduced the concept of the Animal Feed 
Safety System (AFSS) which was intended to address the safety of all 
animal food at all stages of production and use. After obtaining input 
from the general public, State regulatory officials, industry, 
veterinarians, and consumers, the AFSS working group began developing a 
proposed rule for process controls for animal food, prior to FSMA, that 
was intended to apply to all animal food (including pet food, livestock 
feed, and raw materials and other ingredients) (78 FR 64736 at 64740).
    When we revised the proposed CGMPs in the 2014 supplemental notice, 
we not only consulted the human food CGMPs and their development 
history, but also reviewed the draft AFSS process controls proposed 
rule. We also reviewed CGMPs developed by organizations such as the 
British Standards Institute's Publicly Available Specification (PAS) 
222 and the Association of American Feed Control Officials (AAFCO) 
model GMPs for feed and feed ingredients (which are adopted by many 
states for regulation of animal food) (Refs. 27 and 28). Both PAS 222 
and AAFCO GMPs apply to pet food and other animal food such as feed for 
livestock. Many of the raw materials and other ingredients used in 
making finished animal food are used by multiple types of animal food 
manufacturers producing a variety of animal food products. It would not 
be feasible to enforce different sets of standards for pet food and 
livestock feed in a plant supplying the same ingredients to a pet food 
manufacturer and a livestock feed manufacturer. We expect our CGMP 
requirements to be applied appropriately in all facilities 
manufacturing and processing animal food.
    (Comment 164) Some comments say that CGMP requirements for animal 
food in general are not appropriate for some products used in animal 
food. Comments provide examples such as rendered products, which are 
thermally processed before being used as ingredients in animal food; 
humic products because raw mined materials are low risk; and oilseed 
products because they have not been associated with any significant 
food safety risks and are intermediate ingredients that will undergo a 
subsequent kill step.
    (Response 164) We understand that some ingredients utilized in the 
production of animal food may pose a low risk. Nevertheless, facilities 
that are required to register under section 415 of the FD&C Act and are 
suppliers of ingredients used in animal food will be required to meet 
the CGMP requirements being finalized in this rule. We believe these 
CGMPs provide a great deal of flexibility in establishing baseline 
standards for safely manufacturing, processing, packing, or holding the 
wide diversity of ingredients used in animal food.
    (Comment 165) One comment suggests that a new section be added at 
the end of subpart B that would eliminate the need to comply with the 
CGMPs if a facility showed that the hazard analysis and risk-based 
preventive controls required by subpart C had been properly conducted, 
implemented and validated.
    (Response 165) We decline this request. The requested change is 
counter to the intent of this regulation, that the CGMPs in subpart B 
provide baseline safety and sanitation standards, while hazards 
specific to a facility and the animal food it produces are identified 
and controlled under subpart C. We consider CGMPs to be a prerequisite 
program important for effective preventive controls, and believe that 
the CGMPs being finalized in this rule provide enough flexibility for a 
facility to use CGMPs to address certain hazards so they do not become 
hazards that would require a preventive control.
    (Comment 166) One comment from a foreign government says that 
minimum requirements for recordkeeping and traceability, which are 
recommended in the CODEX Code of Practice on Good Animal Feeding, might 
be appropriate in subpart B so that they would apply to establishments 
exempt from subpart C.
    (Response 166) We agree that traceability and associated 
recordkeeping are important tools for a facility to use for tracing 
animal food in the event of a recall or foodborne illness outbreak. 
Recordkeeping requirements currently exist in the Bioterrorism Act, and 
implementing regulations in part 1 subpart J for persons who 
manufacture, process, pack, transport, distribute, receive, hold, or 
import food in the United States. In addition, the responsible party at 
any food facility required to register under section 415 of the FD&C 
Act (domestic and foreign) is subject to the RFR requirements under 
section 417 of the FD&C Act. Section 417 requires under certain 
circumstances that the responsible party notify the previous source and 
subsequent recipient of the article of reportable food, providing 
traceability.
    (Comment 167) Some comments request that we use the term 
``adulteration'' instead of ``contamination'' in subpart B of the final 
rule because ``adulteration'' of food is the regulatory standard for 
action, whereas contamination is currently undefined. These comments 
state that the term contamination should carry a different meaning than 
in part 117 because what is considered a contaminant in human food may 
differ from what is considered a contaminant in animal food.
    (Response 167) We decline this request. Section 402(a)(3) and (4) 
of the FD&C Act were added to expand our bases for initiating 
enforcement proceedings against adulterated food, particularly to allow 
us to act where a food has been prepared, packed, or held under 
insanitary conditions, whereby it may have become contaminated. In 
other words, a food need not be shown to contain contaminants to be 
adulterated; a showing that the food was prepared, packed, or held 
under

[[Page 56226]]

conditions whereby it may become contaminated is sufficient to prove 
adulteration. Thus, the word ``contamination'' serves a necessary 
purpose in the context of adulteration. The CGMPs in this final rule 
are intended to help protect against the contamination of animal food, 
so that it will not become adulterated.
    The word ``contamination'' is used widely in FDA regulations, 
including our Current Good Manufacturing Practice for Medicated Feeds 
(21 CFR part 225), Thermally Processed Low-Acid Foods Packaged in 
Hermetically Sealed Containers (21 CFR part 113), and the Current Good 
Manufacturing Practice in Manufacturing, Packing, or Holding Human Food 
(21 CFR part 110, and updated and included in the final rule for 
preventive controls for human food, 21 CFR part 117, published 
elsewhere in this Federal Register). In addition, ``contamination'' is 
used in Codex Good Practices for the Feed Industry and PAS 222 (Ref. 
27). Because of the wide use of the term throughout current FDA 
regulations and in international standards, we conclude that industry 
is familiar with the word ``contamination'' and it is an appropriate 
word to use in this final rule.
    We recognize that it may not always be possible to prevent 
contamination of animal food. Therefore, we have changed the regulatory 
text throughout subpart B to stress that the goal of the regulations is 
to ``protect against'' or ``minimize'' the contamination of animal 
food. We recognize that what is considered contamination of human food 
may not be considered contamination in animal food.
    (Comment 168) Some comments object to the use of the terms 
``sanitize'' and ``sanitation'' in the CGMPs, saying that the 
destruction of microorganisms is not always necessary in animal food 
facilities and therefore ``cleaning'' or ``housekeeping'' should be 
used instead of ``sanitizing.'' Some of these comments also ask that we 
change the title of proposed Sec.  507.19 from ``Sanitation'' to 
``Cleaning and Housekeeping.''
    (Response 168) We decline this request. We use the term 
``sanitation'' in a general way that we believe is well understood by 
the animal food industry and does not mean the destruction of 
microorganisms. For example, the term ``sanitation'' is defined in PAS-
222 (Ref. 27). When the destruction of vegetative cells of pathogens 
and substantial reduction of numbers of other undesirable 
microorganisms is required, we use the terms ``sanitize'' or 
``sanitizing,'' not ``sanitation,'' which is consistent with how these 
terms are used throughout our current regulations for human and animal 
food. The only requirement for sanitizing in subpart B is in regards to 
wet processing (see regulatory text for Sec.  507.19(b)(2)). Therefore, 
we believe that ``sanitation'' is a word that is commonly understood by 
industry and is used in this final rule in a way that is consistent 
with how it is used in our other regulations relating to human and 
animal food.
    (Comment 169) Some comments request that we use ``tools'' instead 
of ``utensils'' in the CGMPs to better fit the terminology used in the 
animal food industry.
    (Response 169) We decline this request. We recognize that 
``utensil'' is not commonly used in the animal food industry; however, 
we believe it is well understood. The term ``utensil'' is used in PAS-
222 and Codex Good Practices for the Feed Industry, as well as in the 
CGMPs for human food in part 110 and in the revised CGMPs in the final 
rule for preventive controls for human food, part 117 (Refs. 27 and 
29). Further, because ``tools'' is broadly used to refer to such things 
as construction equipment, software, educational material, and even 
laws and regulations, we believe it is not a good substitute for 
``utensils.''
    (Comment 170) A number of comments request that wherever we require 
measures to protect against contamination of animal food, animal food-
contact surfaces, and animal food-packaging materials, that we delete 
animal food-contact surfaces and animal food-packaging materials 
because the focus should be solely on the animal food.
    (Response 170) We decline this request. While the ultimate goal of 
the CGMP requirements is to protect against contamination of animal 
food, we believe that protecting animal food-contact surfaces and 
animal food-packaging material from contamination is a necessary step 
to achieve this goal because the surfaces and packaging can be a source 
of contamination.

XV. Subpart B: Comments on Proposed Sec.  507.14--Personnel

    We proposed that plant management must take all reasonable measures 
and precautions to ensure that all persons working in direct contact 
with animal food, animal food-contact surfaces, and animal food-
packaging materials conform to hygienic practices to the extent 
necessary to protect against the contamination of animal food. We are 
finalizing this provision with the discussed changes in Sec.  
507.14(a). We have changed ``plant'' to ``establishment'' for clarity. 
We are finalizing the proposed list of methods for maintaining 
cleanliness that were proposed in Sec.  507.14(a)(1) through (5) in new 
Sec.  507.14(b)(1) through (5). We have added paragraph (b) to read: 
``the methods for conforming to hygienic practices and maintaining 
cleanliness include.''
    (Comment 171) Some comments ask us to remove ``all'' because it is 
too extreme and prescriptive.
    (Response 171) We have revised the regulatory text to delete 
``all''. We disagree that the term ``all'' is too extreme and 
prescriptive, but conclude that the term ``all'' is not necessary to 
communicate the intent of the requirement.

A. Proposed Sec.  507.14(a)(1)--Personal Cleanliness (Final Sec.  
507.14(b)(1))

    We proposed that the methods for maintaining cleanliness include 
maintaining adequate personal cleanliness. We did not receive comments 
specific to this provision and are finalizing it as proposed.

B. Proposed Sec.  507.14(a)(2)--Hand Washing (Final Sec.  507.14(b)(2))

    We proposed that the methods for maintaining cleanliness include 
washing hands thoroughly in an adequate hand-washing facility as 
necessary and appropriate to prevent contamination.
    (Comment 172) One comment disagrees with FDA's decision to revise 
the language from the 2013 proposed rule by removing the parenthetic 
statement about sanitizing hands if necessary to protect against 
contamination with undesirable organisms. The comment recommends that 
FDA add a qualifying statement that if hand washing facilities are not 
readily available, the use of hand sanitizers is permitted.
    (Response 172) We decline this request. We deleted the parenthetic 
statement because we did not intend to require hand sanitizing after 
hand washing. We are providing flexibility for plant management to 
determine if hand sanitizing after washing is necessary to protect 
against contamination of animal food with undesirable microorganisms. 
We recognize that there may be some situations where hand washing 
facilities are not readily available. The use of waterless hand 
cleaners (including hand sanitizers) may be adequate under these 
circumstances.

[[Page 56227]]

C. Proposed Sec.  507.14(a)(3)--Unsecured Jewelry and Other Objects 
(Final Sec.  507.14(b)(3))

    We proposed that personnel be required to remove or secure jewelry 
and other objects that might fall into animal food, equipment, or 
containers.
    (Comment 173) One comment says this requirement is unnecessary 
since the proposed CGMPs contain numerous other provisions that require 
facilities to protect against the adulteration of products. The focus 
placed on jewelry and other items that may potentially fall into 
products is unwarranted due to the limited risk of such occurrences.
    (Response 173) We believe that a specific provision to protect 
against jewelry and other personal items falling into animal food is 
appropriate, and is not redundant to other requirements in the CGMPs 
that are intended to protect against adulteration of animal food.

D. Proposed Sec.  507.14(a)(4)--Storing Clothing and Personal 
Belongings (Final Sec.  507.14(b)(4))

    We proposed requiring personnel to store clothing and other 
personal belongings in areas other than where animal food is exposed or 
where equipment or utensils are cleaned.
    (Comment 174) One comment says that the requirement is not 
practical or necessary to ensure the safety of animal food. The comment 
states that the temperature in a facility can be highly variable, so it 
would be unreasonable to require an employee to store clothing outside 
of areas where animal food is exposed.
    (Response 174) We understand that personnel may need layers of 
clothing in certain plants that are exposed to varying temperatures. 
However, when clothing is removed, it needs to be stored away from 
exposed animal food so it does not become a source of contamination. We 
believe storing clothing and other personal belongings in areas other 
than where animal food is exposed is a reasonable protection.

E. Proposed Sec.  507.14(a)(5)--Taking Other Necessary Precautions 
(Final Sec.  507.14(b)(5))

    We proposed that personnel must take any other necessary 
precautions to protect against the contamination of animal food, animal 
food-contact surfaces, or animal food-packaging materials.
    (Comment 175) One comment requests that we provide examples in a 
guidance document for the requirement to take ``any other necessary 
precautions to protect against contamination of animal food, animal 
food contact surfaces, or animal food packaging materials.''
    (Response 175) We believe this provision indicates that the listed 
requirements are not meant to be exhaustive and provides needed 
flexibility for the diverse animal food industry to implement 
precautions specific to their operations to protect against the 
contamination of animal food. We will consider providing examples in 
any future guidance.

XVI. Subpart B: Comments on Proposed Sec.  507.17--Plant and Grounds

A. Proposed Sec.  507.17(a)--Grounds Surrounding an Animal Food Plant

    We proposed that the grounds surrounding an animal food plant under 
the control of the operator must be kept in a condition that will 
protect against the contamination of animal food, including provisions 
to keep areas from being a harborage for pests, maintaining areas so 
they are not a source of contamination, adequately draining areas, and 
treating and disposing of waste so it is not a source of contamination.
    (Comment 176) One comment says that the term ``surrounding'' the 
plant is too ambiguous, and that we should specify the distance from a 
plant that must be controlled to prevent animal food contamination.
    (Response 176) We decline to specify a distance from the plant 
because the area that could impact plant operations is highly variable 
from plant to plant. We have replaced the word ``surrounding'' with the 
word ``around,'' meaning the grounds of the plant under control of the 
plant management that could impact plant operations.
    (Comment 177) Some comments say that the requirements are highly 
prescriptive and should be more flexible. Other comments state that the 
general language that requires the grounds to be kept in a condition 
that will protect against the contamination of animal food is 
sufficient and that the specific requirements should be 
recommendations.
    (Response 177) The specific requirements provide the baseline 
expectations we have for plants to maintain their grounds in a way that 
does not result in the contamination of animal food. The specific 
requirements are common to most plants and provide necessary 
information to the plant management about what it must do to comply 
with this final rule. However, the requirements do not preclude a plant 
from addressing unique circumstances that could lead to the 
contamination of animal food.

B. Proposed Sec.  507.17(b)(1)--Adequate Space Between Equipment, 
Walls, and Stored Materials

    We proposed that the buildings, structures, fixtures, and other 
physical facilities of the plant must be suitable in size, 
construction, and design to facilitate cleaning, maintenance, and pest 
control to reduce the potential for contamination of animal food, 
animal food-contract surfaces, and animal food-packaging materials. We 
also proposed that the plant must provide adequate space between 
equipment, walls, and stored materials to permit employees to perform 
their duties and to allow cleaning and maintenance of equipment.
    (Comment 178) Two comments disagree with this requirement. One 
comment says that the focus is on equipment design and not protecting 
against animal food contamination. The other comment suggests 
simplifying the requirement to provide access between equipment and 
walls.
    (Response 178) We believe protecting animal food from contamination 
requires proper plant design. We decline the request to change the 
requirement by deleting the reference to stored materials because we do 
not agree that stored materials should be allowed to prevent employees 
from performing their duties or inhibit the cleaning and maintenance of 
equipment. We did modify the language in paragraph (b) to replace 
``buildings, structures, fixtures, and other physical facilities of the 
plant'' with ``the plant'' because the plant would include its 
buildings, structures, fixtures, and physical facilities.

C. Proposed Sec.  507.17(b)(2)--Dripping and Condensation

    We proposed that the plant must be constructed in a manner such 
that drip or condensate from fixtures, ducts, and pipes does not serve 
as a source of contamination.
    (Comment 179) One comment asks that we allow for facilities to be 
``constructed or maintained,'' rather than ``constructed'' only, to 
ensure that drip or condensate does not serve as a source of animal 
food contamination. Another comment asks that the requirement be 
deleted, since it is generally not relevant and is redundant to the 
opening statement in proposed paragraph (b). Other comments say that 
requirements pertaining to the construction of buildings and structures 
are too prescriptive and should specify only that the plant be 
constructed in such a manner as to protect against adulteration of 
animal food.

[[Page 56228]]

    (Response 179) We decline the requests to revise or delete this 
requirement. The requirements in (b)(1) to (5) are some of the specific 
requirements that we believe are needed to meet the general requirement 
in paragraph (b) that the plant be designed and constructed to reduce 
the potential for contamination. We believe it is important to specify 
that fixtures, ducts, and pipes be constructed so that they do not 
serve as a source of contamination because condensate and drip may 
serve as a source of contamination. As specified in Sec.  507.20(b)(3), 
plumbing must be maintained to avoid being a source of contamination to 
animal food. In addition, as specified in 507.19(a), the fixtures and 
physical facilities of the plant must be kept in good repair to prevent 
animal food from becoming adulterated. This would include fixtures, 
ducts, and pipes. Thus, we agree that one way to manage dripping and 
condensation is through maintenance or repair to the plumbing or 
structure, and do not intend that existing plants must be redesigned or 
reconstructed.

D. Proposed Sec.  507.17(b)(3)--Ventilation

    We proposed that the plant must provide adequate ventilation or 
control equipment to minimize vapors (for example, steam) and fumes in 
areas where they may contaminate animal food, and locate and operate 
fans and other air-blowing equipment in a manner that minimizes the 
potential for contaminating animal food.
    (Comment 180) One comment says that while steam is a key 
manufacturing component, it is unlikely to be a source of potentially 
hazardous contaminants. Several comments state that steam is not 
commonly used in animal food processing, and should not be specified in 
the rule, or language stating ``where appropriate and necessary'' 
should be included in the regulatory text. Other comments suggest 
additional alternative language.
    (Response 180) We agree that not all plants use steam and the 
phrase ``where appropriate and necessary'' provides that distinction 
and have added it to the regulatory text. We also recognize that animal 
food facilities commonly rely on natural ventilation. As a result, we 
have added the parenthetical (mechanical or natural) to the regulatory 
text to read: ``Provide adequate ventilation (mechanical or natural) . 
. .''

E. Proposed Sec.  507.17(b)(4)--Lighting

    We proposed that the plant must provide adequate lighting in hand-
washing areas, toilet rooms, areas where animal food is received, 
manufactured, processed, packed, or held, and areas where equipment or 
utensils are cleaned. We received no comments on this provision and are 
finalizing it as proposed.

F. Proposed Sec.  507.17(b)(5)--Glass

    We proposed that the plant must provide safety-type light bulbs, 
fixtures, and skylights, or other glass items suspended over exposed 
animal food in any step of preparation, to protect against the 
contamination of animal food in case of glass breakage. We did not 
receive specific comments on this paragraph. However, for clarity, we 
have replaced the term ``safety-type'' with ``shatter-resistant.''

G. Proposed Sec.  507.17(b)(6)--Outdoor Storage

    We proposed that animal food stored outdoors in bulk be protected 
by any effective means, including using protective coverings, 
controlling areas over and around the bulk animal food to eliminate 
harborages for pests, and checking on a regular basis for pests and 
pest infestation.
    (Comment 181) Several comments say that protecting animal food 
stored outdoors is better addressed in proposed Sec.  507.19 
(Sanitation). One comment says that at livestock facilities and farms 
animal food such as hay, silage, grain, human food by-products, and 
other commodities are commonly stored outside with no cover. Another 
comment requests that the regulation be revised to recommend rather 
than require the provisions.
    (Response 181) While we disagree with the recommendation to move 
this requirement to Sec.  507.19 (Sanitation), we moved it from 
proposed paragraph (b) to new paragraph (c) in Sec.  507.17 because 
paragraph (b) pertains to buildings and structures and this requirement 
is about animal food stored outside of the building or structure. We 
have revised the regulatory text in paragraph (c)(1) to read ``Using 
protective coverings where necessary and appropriate'' to account for 
the situations that may not require protective coverings. In addition, 
we have added checking for product condition related to the safety of 
the animal food in paragraph (c)(3) to ensure that if the animal food 
is not covered, animal food safety is maintained. We decline to specify 
under what circumstance protective coverage is required (such as, to 
protect against adverse weather conditions) since there could be 
several reasons for needing protective coverage to help protect against 
contamination of the animal food.

XVII. Subpart B: Comments on Proposed Sec.  507.19--Sanitation

A. Proposed Sec.  507.19(a)--Buildings

    We proposed that buildings, structures, fixtures, and other 
physical facilities of the plant must be kept clean and in good repair 
to prevent animal food from becoming contaminated. We received no 
comments on this provision, however we are replacing ``contaminated'' 
with the broader standard ``adulterated'' as proposed in the 2013 
proposed preventive controls rule for animal food.

B. Proposed Sec.  507.19(b)--Cleaning

    We proposed that animal food-contact and non-contact surfaces of 
utensils and equipment must be cleaned and maintained and utensils and 
equipment stored as necessary and appropriate to protect against the 
contamination of animal food, animal food-contact surfaces, or animal 
food-packaging materials, and that when necessary, equipment be 
disassembled for thorough cleaning.
    (Comment 182) Two comments state that the proposed provision is too 
prescriptive because of the requirement to disassemble equipment for 
cleaning when necessary.
    (Response 182) We believe the language provides flexibility for 
plants to prevent contamination of animal food contact and non-contact 
surfaces of utensils and equipment. The language ``when necessary'' 
provides the plant the option whether to disassemble the equipment for 
cleaning based on the manufacturer's knowledge and experience of when 
this cleaning procedure is necessary to protect against the 
contamination of animal food, animal food-contact surfaces, or animal 
food-packaging materials.

C. Proposed Sec.  507.19(b)(1)--Wet Cleaning

    We proposed that when it is necessary to wet-clean animal food-
contact surfaces used for manufacturing, processing, packing, or 
holding low-moisture animal food, the surfaces must be thoroughly dried 
before subsequent use.
    (Comment 183) One comment states that ``low-moisture animal food'' 
is not defined, so for clarity we should either define it or replace it 
with ``safe moisture level animal food'' because ``safe moisture 
level'' is already defined in the proposed rule.
    (Response 183) We agree that the term ``low-moisture'' is not well 
known when applied to the animal food industry as a whole and we have 
removed the term. We believe that in most cases, animal

[[Page 56229]]

food contact surfaces must be thoroughly dried after wet cleaning 
because the moisture could provide an environment for growth of 
undesirable microorganisms. However, we also understand that in some 
situations, for example in wet processing areas, it would not be 
necessary to dry surfaces thoroughly before subsequent use in order to 
protect against contamination. Therefore, we have inserted ``when 
necessary,'' so that the requirement is appropriate for all types of 
animal food facilities.
    (Comment 184) Two comments note that the proposed rule includes 
explicit requirements for wet cleaning, but none for dry cleaning. One 
comment suggests adding language to paragraph (b) for dry cleaning, 
including vacuuming or sweeping. The second comment suggests adding 
language for dry cleaning when used solely for low-moisture feed 
ingredients.
    (Response 184) We decline these requests. The regulatory text in 
paragraph (b) requires that utensils and equipment be cleaned and 
maintained, but it does not specify the exact procedures. Adequate 
cleanout of so-called dry feeds has been an important CGMP requirement 
applicable to medicated feed for more than 40 years and, as such, some 
of the animal food industry is well aware of this practice. The dry 
cleaning procedures suggested in the comments would be allowable 
methods of cleaning and maintaining where appropriate to protect 
against the contamination of animal food. We do not believe additional 
language is necessary in the regulatory text for dry cleaning. The 
provisions in paragraph (b)(1) for wet cleaning are in addition to the 
more general requirements in paragraph (b) to help ensure that water 
from the wet-cleaning process does not result in subsequent 
contamination of animal food.

D. Proposed Sec.  507.19(b)(2)--Wet Processing

    We proposed that in wet processing, when cleaning and sanitizing is 
necessary to protect against the introduction of undesirable 
microorganisms into animal food, all animal food-contact surfaces must 
be cleaned and sanitized before use and after any interruption during 
which the animal food-contact surfaces may have become contaminated.
    (Comment 185) One comment says the proposed requirements for 
cleaning in wet processing areas should be more flexible and suggests 
the additional wording ``as necessary to protect against adulteration 
of animal food.''
    (Response 185) We believe this requirement is sufficiently flexible 
because it applies only when necessary to protect against the 
introduction of undesirable microorganisms into animal food.

E. Proposed Sec.  507.19(c)--Cleaning Compounds and Sanitizing Agents

    We proposed that cleaning compounds and sanitizing agents must be 
safe and adequate under the conditions of use. We received no comments 
on this provision and are finalizing it as proposed.

F. Proposed Sec.  507.19(d)(1)--Toxic Materials

    We proposed that only certain toxic materials may be used or stored 
in a plant where animal food is manufactured, processed, or exposed, 
i.e., those that are required to maintain clean and sanitary 
conditions, those necessary for use in laboratory testing procedures, 
those necessary for plant and equipment maintenance and operation, and 
those necessary for use in the plant's operations.
    (Comment 186) Some comments say that the proposed regulation would 
require an absolute prohibition of any potentially toxic materials that 
are stored but not used by an animal food plant. The comments note that 
animal food plants that hold and distribute materials such as 
fertilizers and pesticides would either need to discontinue this 
practice or construct new storage buildings, which may be expensive. 
Several comments suggest alternative language to allow toxic materials 
to be held and distributed in a way that would not require significant 
physical improvements to the plant.
    (Response 186) We agree that it might be common for an animal food 
plant to have toxic materials not identified in paragraph (d)(1), such 
as fertilizers or other non-plant chemicals, as part of its business 
inventory. However, we disagree with the comments that state the 
provisions in the rule would require new investments in storage 
buildings. The intent of the provision is to keep toxic chemical 
categories not listed in paragraph (d)(1) out of the plant area so 
animal food is not exposed. We revised the regulatory text to add 
paragraph (d)(3), which reads ``Other toxic materials (such as 
fertilizers and pesticides not included in paragraph (d)(1) of this 
section) must be stored in an area of the plant where animal food is 
not manufactured, processed, or exposed.'' We expect that this will 
result in toxic materials not identified in paragraph (d)(1) being 
separated from animal food either by sufficient space or a sufficient 
physical barrier such that they are not able to contaminate the animal 
food. With this clarification, we do not believe that establishments 
will need to make significant investments to their buildings and 
structures to comply with these requirements.

G. Proposed Sec.  507.19(d)(2)--Identification, Use, and Storage of 
Toxic Materials

    We proposed that toxic materials described in paragraph (d)(1) of 
this section (for example, cleaning compounds, sanitizing agents, and 
pesticide chemicals) must be identified, used, and stored in a manner 
that protects against the contamination of animal food, animal food-
contact surfaces, or animal food-packaging materials.
    (Comment 187) A number of comments object to the use of ``toxic'' 
in proposed paragraph (d)(2). Several comments suggest that ``cleaning 
materials'' rather than ``toxic cleaning compounds'' be used in 
paragraph (d)(2) because any substance may be considered ``toxic'' if 
handled or used inappropriately. One comment asks that the term ``toxic 
materials'' be deleted and requirements established instead for the 
control of substances that are not approved for use in animal food.
    (Response 187) We decline the request. The term ``toxic'' is 
important to specify that this paragraph applies to toxic cleaning 
compounds. The term ``cleaning compounds'' would be too general and 
might include materials that would not need to be handled as specified 
in these requirements to protect against the contamination of animal 
food. For example, water could be considered a cleaning compound, but 
it is not considered toxic at regular use levels and we would not 
expect a plant to treat its use of cleaning water in a manner 
consistent with this requirement. We decline the request to substitute 
``substances that are not approved for use in animal food'' for ``toxic 
materials.'' Not all animal food ingredients have been or must be 
preapproved by the Agency before being used to produce animal food. 
Additionally, ingredients that have not been approved by the Agency 
would not necessarily be toxic.

H. Proposed Sec.  507.19(e)--Pest Control

    We proposed that effective measures must be taken to exclude pests 
from the manufacturing, processing, packing, and holding areas and to 
protect against the contamination of animal food by pests. The use of 
insecticides and rodenticides in the plant is permitted only under 
precautions and restrictions that will

[[Page 56230]]

protect against the contamination of animal food, animal food-contact 
surfaces, and animal food-packaging materials. We received no comments 
on this provision. We have replaced the words ``insecticides and 
rodenticides'' with ``pesticides'' for simplicity and because we have 
defined pest as ``any objectionable animals or insects including birds, 
rodents, flies, and larvae.'' Thus, pests are not limited to insects 
and rodents.

I. Proposed Sec.  507.19(f)--Trash and Garbage

    We proposed that trash and garbage must be conveyed, stored, and 
disposed of in a way that protects against the contamination of animal 
food, animal food-contact surfaces, animal food-packaging materials, 
water supplies, and ground surfaces, and minimizes the potential for 
the trash and garbage to become an attractant and harborage or breeding 
place for pests. We received no comments on this provision; however we 
are removing the term ``garbage.'' (See Response 227).

XVIII. Subpart B: Comments on Proposed Sec.  507.20--Water Supply and 
Plumbing

A. Proposed Sec.  507.20(a)--Water Supply (Final Sec.  507.20(a)(1)-
(4))

    We proposed that the water supply must be adequate for the 
operations and must be derived from a suitable source. Running water at 
a suitable temperature, and under suitable pressure as needed, must be 
provided in all areas where required for the manufacturing or 
processing of animal food, for the cleaning of equipment, utensils, and 
animal food-packaging materials, or for employee hand-washing 
facilities. Water that contacts animal food, animal food-contact 
surfaces, or animal food-packaging materials must be safe for its 
intended use. Water may be reused for washing, rinsing, or conveying 
animal food if it does not increase the level of contamination of the 
animal food.
    (Comment 188) One comment suggests that we develop an enforcement 
plan for water quality that takes into account the intended use of the 
animal food being manufactured. Another comment says that many of the 
details contained in this paragraph of the proposed regulation should 
be handled as guidance rather than regulation.
    (Response 188) We believe that the details contained in this 
paragraph should remain requirements because they are important to 
helping ensure the safety of animal food and to provide the regulated 
facility with information about what is expected of the water supply 
for the plant and the animal food being manufactured, processed, packed 
or held. We will consider including water supply in any future 
guidance.
    (Comment 189) Two comments say that that the requirements 
pertaining to the water supply are overly prescriptive and we should 
require only that the water supply be adequate for the operations. Two 
comments suggest that the requirement about the reuse of water be 
reworded to provide more clarification on the recycling of water within 
the plant.
    (Response 189) We believe the source of the water is relevant to 
ensuring that animal food is protected from contamination. We also 
believe specifying that water be safe for its intended use, and that it 
be provided at a suitable temperature and pressure where it is needed 
for manufacturing, processing, cleaning, and hand washing helps protect 
against animal food contamination. With respect to reuse of water, we 
believe our statement that water may be reused for washing, rinsing, or 
conveying animal food if it does not increase the level of 
contamination of the animal food allows flexibility for recycling water 
within the plant. Additional clarification could have the unintended 
effect of reducing flexibility.

B. Proposed Sec.  507.20(b)--Plumbing

    We proposed that plumbing be designed, installed, and maintained to 
carry adequate quantities of water to required locations throughout the 
plant; properly convey sewage and liquid disposable waste from the 
plant; avoid being a source of contamination to animal food, animal 
food-contact surfaces, or animal food-packaging materials, water 
supplies, equipment, or utensils, or creating an unsanitary condition; 
provide adequate floor drainage in all areas where floors are subject 
to flooding-type cleaning or where normal operations release or 
discharge water or other liquid waste on the floor; and ensure there is 
no backflow or cross-connections between piping for water for 
processing and for waste water.
    (Comment 190) One comment says we are proposing to establish 
specific requirements for plumbing design, installation, and 
maintenance that are not necessary to prevent the adulteration of 
animal food, and suggests deleting the plumbing design section 
entirely. Two comments say that floor drains are not the only way to 
remove water or other fluids from floors, and suggest we allow other 
options such as vacuuming, mopping, or fans.
    (Response 190) We decline these requests. We believe these are 
basic and necessary requirements for helping ensure production of safe 
animal food. The regulatory text requires adequate floor drainage for 
areas where floors are subject to flooding-type cleaning or where 
normal operations release or discharge water or other liquid waste on 
the floor. Plants that do not perform these activities as part of their 
normal operations would not be expected to have floor drainage and 
vacuuming or mopping may be adequate.

C. Proposed Sec.  507.20(c)--Sewage

    We proposed that sewage must be disposed of through an adequate 
sewerage system or through other adequate means.
    (Comment 191) Some comments say that the requirement to provide an 
adequate sewer system is covered by the requirement in proposed Sec.  
507.20(b)(2) for plumbing and that one of the requirements should be 
deleted to eliminate this redundancy.
    (Response 191) The requirement in paragraph (b)(2) is intended to 
make sure the plumbing in the plant is sufficient to remove sewage and 
liquid disposable waste from the points at which it is generated within 
the plant, while the requirement in paragraph (c) is intended to make 
sure that the sewage and liquid disposable waste created by the plant 
is delivered to a wastewater system, such as a sewer or septic system, 
which has a capacity adequate to ensure that this wastewater does not 
contaminate the animal food.

D. Proposed Sec.  507.20(d)--Toilet Facilities

    We proposed that each plant must provide employees with adequate, 
readily accessible toilet facilities, and that the toilet facilities be 
kept clean and not be a potential source of contamination of animal 
food, animal food-contact surfaces, or animal food-packaging materials.
    (Comment 192) Some comments suggest adding ``as appropriate'' to 
the requirement to provide adequate toilet facilities for plant 
employees.
    (Response 192) We decline this request. We understand that there 
may be an exception where toilet facilities are not inside a plant, but 
we believe it is important that toilet facilities are available near 
the plant for employee use, and the requirement as proposed provides 
this flexibility.

E. Proposed Sec.  507.20(e)--Hand-Washing Facilities

    We proposed that each plant must provide hand-washing facilities

[[Page 56231]]

designed to ensure that an employee's hands are not a source of 
contamination of animal food, animal food-contact surfaces, or animal 
food-packaging materials.
    (Comment 193) Some comments suggest adding the words ``as 
appropriate'' to the requirement to provide flexibility for those 
plants that may not need hand-washing facilities. Another comment asks 
that we add an option that allows for the use of hand sanitizing in 
plants that may not need hand-washing facilities.
    (Response 193) We understand that there may not be running water in 
every plant, but we believe it is important that hand-washing 
facilities be available to employees. We understand that in some cases 
hand-washing facilities might consist of waterless hand cleaners 
(including hand sanitizers).

XIX. Subpart B: Comments on Proposed Sec.  507.22--Equipment and 
Utensils

A. Proposed Sec.  507.22(a)(1)--Plant Equipment and Utensils

    We proposed that all plant equipment and utensils must be designed 
and of such material and workmanship to be adequately cleanable, and 
must be properly maintained.
    (Comment 194) Some comments suggest that this be a recommendation 
rather than a requirement because it is too prescriptive and applies to 
all equipment in a plant, rather than only to equipment used in the 
production of animal food.
    (Response 194) We decline this request. We believe that all plant 
equipment with the potential to contaminate animal food must be 
cleanable and maintained. To clarify this requirement, we have added 
language stating that this requirement applies to equipment and 
utensils used in manufacturing, processing, packing, and holding animal 
food, as well as equipment and utensils that do not come in contact 
with animal food but could still serve as a source of contamination of 
animal food.

B. Proposed Sec.  507.22(a)(2)--Design of Equipment and Utensils

    We proposed that the design, construction, and use of equipment and 
utensils must preclude the contamination of animal food with 
lubricants, fuel, metal fragments, contaminated water, or any other 
contaminants.
    (Comment 195) Some comments say that this requirement is too 
prescriptive because equipment and utensils are designed and 
constructed by entities independent of the animal food manufacturers/
processers. Some comments also say that we should clarify that we are 
not requiring the use of food-grade lubricants.
    (Response 195) We understand that plants do not normally design and 
construct the equipment they use. However, we believe it is the plant's 
responsibility to select equipment and utensils that when used will not 
adulterate animal food. We have revised the text to clarify that the 
presence of non-food grade lubricants, fuel, metal fragments, 
contaminated water, or other contaminants in animal food may render it 
adulterated. We also have revised the wording for easier reading. We 
are not requiring that only food grade lubricants be used in the plant, 
but food grade lubricants must be used on equipment that comes in 
contact with animal food. When a non-food grade lubricant is used on 
non-food contact equipment, it must not adulterate the animal food. We 
have added the term ``non-food grade'' for lubricants to clarify this.

C. Proposed Sec.  507.22(a)(3)--Equipment Installation

    We proposed that equipment should be installed and maintained in 
such a way as to facilitate the cleaning of the equipment and adjacent 
spaces. This provision has been revised to be a requirement, not a 
recommendation as it is a requirement, not guidance.
    (Comment 196) One comment suggests that we combine proposed 
Sec. Sec.  507.22(a)(1) and 507.22(a)(3).
    (Response 196) We decline this request. The first provision 
requires that equipment be properly designed and constructed, and the 
second requires that it be installed in a way that facilitates cleaning 
and maintenance. We have revised the wording in (a)(3) for clarity.

D. Proposed Sec.  507.22(a)(4)--Animal Food Contact Surfaces

    We proposed that animal food-contact surfaces must be made of 
materials that withstand the environment of their use and the action of 
animal food, and, if applicable, the action of cleaning compounds, and 
sanitizing agents; be made of nontoxic materials; and maintained to 
protect animal food from being contaminated.
    (Comment 197) Some comments ask us to specify that food-contact 
surfaces must be designed to withstand cleaning procedures.
    (Response 197) We have revised the regulatory text to include 
cleaning procedures. For example animal food-contact surfaces must be 
designed to withstand the actions of scrubbing utensils that could 
damage the equipment.

E. Proposed Sec.  507.22(a)(5)--Non-Animal Food Contact Equipment 
(Final Sec.  507.22(a)(1))

    We proposed that equipment in the animal food in manufacturing/
processing area, that does not come into contact with animal food must 
be constructed in such a way that it can be kept in a clean condition.
    (Comment 198) One comment says that this requirement should be 
deleted because it is highly prescriptive, redundant to proposed 
paragraph (a)(1), and not performance based or necessary. Further, the 
comment states FDA's focus should be on whether the area is adequately 
cleaned, not on whether equipment that does not come in contact with 
animal food is properly designed.
    (Response 198) We disagree that the requirement is too 
prescriptive. However, we agree that there is some redundancy between 
proposed paragraphs (a)(1) and (a)(5). We have removed proposed 
paragraph (a)(5) and have modified the regulatory text in paragraph 
(a)(1) as discussed in section XIX.A.

F. Proposed Sec.  507.22(b)--System Design and Construction

    We proposed that holding, conveying, manufacturing, and processing 
systems, including gravimetric, pneumatic, closed, and automated 
systems, must be designed, constructed, and maintained in a way that 
does not contaminate animal food.
    (Comment 199) Several comments suggest that this requirement be 
revised or deleted to allow plants the flexibility to maintain their 
equipment in a manner that is appropriate for their facility, and 
because it is redundant to proposed Sec.  507.22(a)(1) through (4).
    (Response 199) We decline to revise or eliminate this provision. 
The requirements in Sec.  507.22(a) are specific to individual pieces 
of equipment. The requirement in Sec.  507.22(b) is meant to address 
entire systems that may contain multiple pieces of equipment. While an 
individual piece of equipment may be designed, constructed and 
maintained so that it protects against the contamination of animal 
food, when that piece of equipment becomes part of a system, its use in 
the system must be in a manner that protects against the contamination 
of animal food. (See Response 167.)

[[Page 56232]]

G. Proposed Sec.  507.22(c)--Monitoring Cold Storage Temperatures

    We proposed that each freezer and cold storage compartment used to 
hold animal food must be fitted with an accurate temperature-monitoring 
device.
    (Comment 200) Some comments state requiring monitoring devices for 
each compartment goes too far. Facilities should have flexibility in 
controlling temperatures in freezers and cold storage compartments. One 
comment says this requirement should not require the use of continuous 
temperature-monitoring devices.
    (Response 200) We believe that a temperature-measuring device for 
each compartment is necessary because the temperature may be different 
in each compartment. We have replaced the term ``temperature -
monitoring device'' with ``temperature-measuring device'' as we do not 
intend the establishment to use a continuous monitoring device or 
temperature recording device.

H. Proposed Sec.  507.22(d)--Instruments

    We proposed that instruments and controls used for measuring, 
regulating, or recording temperatures, pH, aw, or other 
conditions that control or prevent the growth of undesirable 
microorganisms in animal food must be accurate, precise, adequately 
maintained, and adequate in number for their designated uses. We 
received no comments on this provision and are finalizing it as 
proposed.

I. Proposed Sec.  507.22(e)--Compressed Air

    We proposed that compressed air or other gases mechanically 
introduced into animal food or used to clean animal food-contact 
surfaces or equipment must be used in such a way so animal food is not 
contaminated. We received no comments on this provision and are 
finalizing it as proposed with the revision ``to protect against the 
contamination of animal food.'' (See Response 167.)

XX. Subpart B: Comments on Proposed Sec.  507.25--Plant Operations

A. Proposed Sec.  507.25(a)(1)--CGMPs

    We proposed that plant management must ensure that all operations 
in the manufacturing, processing, packing, and holding of animal food 
are conducted in accordance with the CGMP requirements of this subpart. 
We received no comments on this provision. We are revising paragraph 
(a) to read ``Management of the establishment must ensure that:'' based 
on the definition of ``plant'' (see section VIII.A.23).

B. Proposed Sec.  507.25(a)(2)--Identifying Contents of Containers

    We proposed that plant management must ensure that containers 
holding animal food, including raw materials, other ingredients, or 
rework, accurately identify the contents.
    (Comment 201) Some comments suggest that we revise the proposed 
requirements by clarifying that the contents of containers, not the 
containers themselves, are accurately identified, and that we clarify 
that bulk silos and bins are not required to be placarded, because this 
is impractical and not industry practice.
    (Response 201) We agree that the animal food in the containers is 
what must be identified and have clarified the language in the 
regulatory text to require management to ensure animal food, including 
raw materials, other ingredients, or rework is accurately identified. 
We recognize that a variety of systems are used by establishments to 
identify animal food within the plant including labeling, computer 
systems, paper records, chalkboards, and other methods. It is necessary 
that plant personnel be able to accurately identify animal food, 
including raw materials, other ingredients, or rework within the plant 
so that animal food is not commingled, substituted, or incorrectly 
formulated in a manner that results in adulterated animal food.

C. Proposed Sec.  507.25(a)(3)--Labeling of Finished Product (Final 
Sec.  507.27(b))

    We proposed that plant management must ensure that the labeling for 
finished animal food product contains information and instructions for 
safely using the product for the intended animal species.
    (Comment 202) Many comments suggest that instead of specifying that 
labeling for the finished animal food product contains information and 
instructions for safely using the product for the intended animal 
species we specify only that labeling for finished animal food products 
conforms to requirements in existing FDA regulations. One comment asks 
that we clarify that finished product means the product that the animal 
receives.
    (Response 202) We decline the request. We do not intend ``finished 
animal food product'' to mean only product that the animal receives. A 
finished animal food product could be ready-to-eat animal food or it 
could be an ingredient or mixture of ingredients that will be further 
processed, mixed, or blended before it is suitable for feeding to 
animals.
    Labeling containing information and instructions for safe use is 
important for both the person feeding the animal(s) and the downstream 
facilities that may use an ingredient or mixture of ingredients to 
further process, mix, or blend into an animal food product. Some animal 
food products may pose a food safety concern for some species for which 
the food is not intended, or may pose a food safety concern for an 
intended species if not used properly. For example, the manufacturer of 
a copper product might include the use levels for food for different 
species or a labeling statement specifying the maximum safe level of 
copper in an animal food intended for sheep.
    We have moved this requirement to paragraph (b) in Sec.  507.27 
``Holding and Distribution.'' We believe that this move helps to 
clarify that the labeling is intended for finished animal food leaving 
the plant. We have renumbered the other requirements in this section 
accordingly.

D. Proposed Sec.  507.25(a)(4)--Animal Food Packaging Material (Final 
Sec.  507.25(a)(3))

    We proposed that plant management must ensure that animal food-
packaging materials are safe and suitable.
    (Comment 203) One comment suggests that instead of requiring that 
animal food-packaging materials are safe and suitable, we require that 
they are safe and suitable for the intended use.
    (Response 203) We disagree that this clarification is needed 
because the intended use is inherent in the current wording of this 
regulation.

E. Proposed Sec.  507.25(a)(5)--Responsibility for Overall Plant 
Cleanliness (Final Sec.  507.25(a)(4))

    We proposed that plant management must ensure that overall 
cleanliness of the plant is under the supervision of one or more 
competent individuals assigned responsibility for this function.
    (Comment 204) One comment suggests that we require that the 
competent individuals responsible for overall cleanliness of the plant 
be ``qualified competent individuals.''
    (Response 204) As discussed in Response 92, we expect all 
individuals who perform activities required under part 507 to know how 
to do their jobs; thus, we are establishing new Sec.  507.4(b), which 
specifies that all individuals who perform activities required under 
part 507 must be ``qualified individuals'' as that term is defined in 
Sec.  507.3 (i.e., a person who has the necessary education, training, 
and experience to perform an activity required under part 507). A 
qualified individual may be, but is not required to be, an employee of 
the establishment.

[[Page 56233]]

F. Proposed Sec.  507.25(a)(6)--Contamination Precautions (Final Sec.  
507.25(a)(5))

    We proposed that plant management must ensure that reasonable 
precautions are taken so that plant operations do not contribute to the 
contamination of animal food, animal food-contact surfaces, and animal 
food packaging materials. We received no comments on this provision. We 
did replace the term ``reasonable'' with the term ``adequate'' to be 
more consistent with the rest of the regulatory text in subpart B.

G. Proposed Sec.  507.25(a)(7)--Testing Procedures (Final Sec.  
507.25(a)(6))

    We proposed that plant management must ensure that chemical, 
microbial, or extraneous-material testing procedures are used where 
necessary to identify sanitation failures or possible animal food 
contamination.
    (Comment 205) Some comments say that the need for chemical, 
microbial, or extraneous-material testing should be determined by a 
facility when identifying hazards and controls under subpart C, and 
therefore it should not be required under CGMPs. One comment says that 
it should be deleted because it is already addressed under the testing 
provisions in subpart C.
    (Response 205) The CGMP regulations in subpart B are intended to 
establish baseline requirements that apply to all plants that 
manufacture, process, pack, or hold animal food (and thus are required 
to register as food facilities in accordance with Sec.  415 of the FD&C 
Act). Using testing procedures, where necessary, to identify sanitation 
failures or to identify contaminated animal food may be an important 
component of manufacturing, processing, packing, or holding animal 
food. This type of testing may be independent of the requirements of 
subpart C, hazard analysis and risk based preventive controls, and 
therefore we have included it in the CGMP regulations. The provision 
provides flexibility for management to determine when testing is 
required by providing that testing be used ``where necessary.''

H. Proposed Sec.  507.25(a)(8)--Contaminated Product (Final Sec.  
507.25(a)(7))

    We proposed that plant management must ensure that animal food that 
has become contaminated to the extent that it is adulterated is 
rejected, disposed of, or if permissible, treated or processed to 
eliminate the adulteration. If disposed of, it must be done in a manner 
that protects against the contamination of other animal food. Whatever 
methods are used to dispose of adulterated animal food, the methods 
should comply with state and local requirements.
    (Comment 206) One comment requests that if we require 
reconditioning of an animal found to be adulterated, that we clarify 
that such a requirement does not apply to grains subject to the review 
inspection provisions provided for by 7 CFR 800.125 and 800.135.
    (Response 206) In most cases, grains subject to the review 
inspection provisions provided for by 7 CFR 800.125 and 800.135 are 
RACs that are being held or transported and subpart B (including Sec.  
507.25(a)(7)) would not apply to the grains (see Sec.  507.5(h)). In 
addition this provision only applies to animal food that has actually 
been found to be adulterated. The provisions provided for by 7 CFR 
800.125 and 800.135 are administered by USDA's Federal Grain Inspection 
Service and relate to their mission of facilitating the marketing of 
grains and related commodities.

I. Proposed Sec.  507.25(a)(9)--Protecting Against Contamination (Final 
Sec.  507.25(a)(8))

    We proposed that plant management must ensure that all animal food 
manufacturing, processing, packing, and holding is conducted under such 
conditions and controls as are necessary to minimize the potential for 
the growth of undesirable microorganisms or for the contamination of 
animal food.
    (Comment 207) Some comments suggest that we remove the requirement 
to minimize the potential for the growth of undesirable microorganisms, 
so that the requirement would be to minimize contamination of animal 
food or protecting against adulteration of animal food.
    (Response 207) We decline this request. In addition to other 
contaminants, we conclude that it is important for an establishment to 
address undesirable microorganisms because they are a common source of 
contamination (78 FR 64736 at 64747).

J. Proposed Sec.  507.25(b)(1)--Raw Materials and Ingredients

    We proposed that raw materials and ingredients must be inspected to 
ensure that they are suitable for manufacturing/processing into animal 
food and handled under conditions that protect against contamination 
and minimize deterioration. We are revising the phrase ``raw materials 
and ingredients'' to read ``raw materials and other ingredients'' to 
make it clear that raw materials are ingredients.
    (Comment 208) Some comments ask that we insert ``as appropriate and 
necessary'' into the requirement to inspect raw materials and 
ingredients to ensure that they are suitable for manufacturing/
processing into animal food. Another comment says that ``minimize 
deterioration'' and ``deterioration'' are highly subjective and should 
be deleted.
    (Response 208) We decline the requests. However, we have revised 
the regulatory text by replacing ``inspected'' with ``examined.'' We 
believe that the use of the word ``examined'' provides more clarity for 
the animal food industry because the term ``inspected'' often implies a 
regulatory activity. We believe such an examination is necessary to 
protect against contamination of animal food. An examination of raw 
materials and other ingredients may include basic activities such as a 
simple visual examination of the product (e.g., looking for broken 
bags), or performing a chemical or microbial analysis. Deterioration of 
animal food includes the loss of palatability or nutritive value 
typically associated with the animal food and we believe this could be 
a safety concern because animals are often fed the same food containing 
the same ingredients for prolonged periods of time. As a result, food 
refusal or consumption of animal food containing fewer nutrients than 
the animal food is expected to provide may result in poor animal 
productivity or health issues. Furthermore, deterioration can indicate 
that the animal food has been held under conditions that would also 
support the growth of undesirable microorganisms.

K. Proposed Sec.  507.25(b)(1)(i)--Shipping Containers

    We proposed that shipping containers (for example, totes, drums, 
and tubs) and bulk vehicles holding raw materials and other ingredients 
must be inspected upon receipt to determine whether contamination or 
deterioration of animal food has occurred.
    (Comment 209) Some comments say that inspection of shipping 
containers should be as appropriate and necessary, or at a frequency 
appropriate and necessary.
    (Response 209) We decline this request. We have revised the 
regulatory text by replacing ``inspected'' with ``examined.'' We 
believe this change better conveys our intent that incoming containers 
consistently be checked to make sure there is no gross visible 
contamination or deterioration of animal food.

[[Page 56234]]

L. Proposed Sec.  507.25(b)(1)(ii)--Raw Materials

    We proposed that raw materials must be cleaned as necessary to 
minimize soil or other contamination.
    (Comment 210) Many comments say that it is not always necessary to 
minimize soil contamination of raw materials because livestock 
routinely ingest soil when consuming pasture plants, hay, and other 
feeds without adverse consequences. Recommendations are to delete 
reference to soil or else insert ``as appropriate.''
    (Response 210) We agree. We have revised the regulatory text to 
remove the words ``soil or other'' from the requirement.

M. Proposed Sec.  507.25(b)(1)(iii)--Raw Materials

    We proposed that raw materials and ingredients must be stored under 
conditions that will protect against contamination and deterioration.
    (Comment 211) One comment suggests that the requirement that raw 
materials be stored under conditions that will protect against 
contamination and deterioration be qualified to say ``unreasonable 
contamination'' and ``excessive deterioration'' to be more appropriate 
for raw materials that will be rendered. One comment asks that we 
delete ``and deterioration.'' Another comment suggests that a new 
section be added to require that air flow be controlled so that 
contamination does not spread from the raw material areas into the 
finished product areas of the plant.
    (Response 211) We believe the rule as proposed is clear, and that 
the qualifiers suggested do not help reduce subjectivity and may create 
confusion about what is considered unreasonable or excessive. We 
decline to add a requirement that specifically addresses air flow, 
because ventilation is addressed in Sec.  507.17(b)(3). Also, the broad 
language requires that raw materials and other ingredients must be 
stored under conditions that will protect against contamination, which 
would include protection from airborne contaminants. We have 
determined, however, that it is logical from a food safety standpoint 
to include rework in this provision. Therefore, we have incorporated 
proposed Sec.  507.25(b)(3) into this requirement.

N. Proposed Sec.  507.25(b)(2)--Raw Materials Susceptible to Mycotoxins

    We proposed that raw materials and ingredients susceptible to 
contamination with mycotoxins or other natural toxins must be evaluated 
and used in a manner that does not result in animal food that can cause 
injury or illness to animals or humans.
    (Comment 212) Several comments suggest that we eliminate this 
requirement because this activity belongs in subpart C, not subpart B. 
Other comments say that the requirement could be interpreted to mean 
that every load of incoming cereal grains must be evaluated for 
mycotoxins, which would not always be necessary. Other suggestions are 
to remove ``evaluated'' from the requirement, leaving only the 
requirement that raw materials and ingredients susceptible to mycotoxin 
contamination be used in a manner that does not result in harm to 
humans or animals.
    (Response 212) We are locating requirements that are common to most 
establishments and plants and serve as a baseline for animal food 
safety in subpart B, current good manufacturing practice. Also, we do 
not intend that every load of grain received must be tested before it 
can be used. We intend for ``evaluation'' to be broad and flexible 
enough to consider any information that allows the plant to use the raw 
materials and other ingredients in a manner that does not result in 
harm to humans or animals. For example, an evaluation could be based on 
a general review of the weather conditions during the growing season 
and whether it could result in mycotoxins.
    (Comment 213) One comment disagrees with our decision in the 2014 
supplemental proposed rule to remove a requirement in Sec.  
507.25(b)(2) of the 2013 proposed rule for preventive controls for 
animal food that raw materials and ingredients not contain 
microorganisms injurious to human or animal health. This comment says 
that we should have modified the regulatory text to require that raw 
materials that are expected to contain levels of microorganisms that 
may be injurious to animal or human health, such as materials to be 
rendered, be stored and handled in a way that prevents contaminating 
the facility and finished product, and that the materials be treated 
(e.g., heat treated) during manufacturing operations so that they no 
longer contain levels that would cause the product to be adulterated.
    (Response 213) Incoming raw materials and other ingredients may 
contain microorganisms injurious to human or animal health. As we 
stated in the 2014 supplemental notice for animal food, we proposed to 
remove this requirement because we did not intend that incoming raw 
materials and other ingredients must be tested for pathogens. Instead, 
we have included requirements that are meant to minimize the growth of 
undesirable microorganisms, and protect animal food from the 
contamination with undesirable microorganisms from raw materials and 
other ingredients, including those that may be injurious to human or 
animal health. We believe these requirements are sufficient to help 
ensure the safety of animal food.

O. Proposed Sec.  507.25(b)(3)--Raw Materials and Rework (Final Sec.  
507.25(b)(1)(iii))

    We proposed that raw materials and ingredients and all rework must 
be held in containers designed and constructed in a way that protects 
against contamination, and must be held under conditions, e.g., 
appropriate temperature and relative humidity, that will minimize the 
potential for growth of undesirable microorganisms and in a manner that 
prevents the animal food from becoming adulterated.
    (Comment 214) Some comments say that requiring that rework be held 
under conditions that will minimize the potential for growth of 
undesirable microorganisms is too prescriptive, and suggest that the 
requirement be modified to require that all rework must be held in a 
manner that prevents the animal food from becoming adulterated. Some 
comments say that this requirement should be addressed in subpart C 
rather than subpart B.
    (Response 214).We disagree that the requirement should be addressed 
in subpart C instead of subpart B because we consider this to be a 
baseline requirement that should apply to all establishments that 
manufacture, process, pack, or hold animal food. However, we have 
decided that proposed paragraph (b)(3) contains requirements that are 
similar to proposed Sec.  507.25(b)(1)(iii). We have moved this 
provision and included it in paragraph (b)(1)(iii) in the final rule.

P. Proposed Sec.  507.25(b)(4)--Frozen Raw Materials (Final Sec.  
507.25(b)(3))

    We proposed that raw materials and ingredients, if frozen, must be 
kept frozen. If thawing is required prior to use, it must be done in a 
manner that minimizes the potential for the growth of undesirable 
microorganisms.
    (Comment 215) One comment says that the requirement to keep frozen 
raw materials frozen or thaw them in a manner that minimizes the 
potential for the growth of undesirable microorganisms is redundant to 
other requirements in Sec.  507.25(b)(1) and therefore should be 
deleted.

[[Page 56235]]

    (Response 215) We decline this request. The requirements in Sec.  
507.25(b)(1) and 507.25(b)(1)(iii) address raw material and other 
ingredient inspection, storage and handling in general. This 
requirement speaks specifically to the storage and handling of frozen 
raw materials. We believe it is important for those establishments that 
use frozen raw material to thaw that material safely to minimize the 
potential for the growth of undesirable microorganisms during the 
thawing process.

Q. Proposed Sec.  507.25(c)(1)--Appropriate Conditions for Animal Food

    We proposed that animal food must be maintained under conditions, 
e.g., appropriate temperature and relative humidity, that will minimize 
the potential for growth of undesirable microorganisms and prevent the 
animal food from becoming adulterated during manufacturing, processing, 
packing, and holding.
    (Comment 216) Some comments say that the requirement to hold and 
manufacture products at a temperatures and relative humidity that will 
minimize the potential for growth of undesirable microorganisms should 
be deleted because it is not relevant to most animal food facilities. 
With this deletion, the requirement would be that animal food be 
maintained under conditions that would prevent the animal food from 
becoming adulterated during manufacturing, processing, packing, and 
holding.
    (Response 216) Temperature and relative humidity are examples of 
conditions and may not apply to all plants and animal food. This 
requirement is important for animal food safety in plants that produce 
animal food that must be handled under specific processing, packing or 
holding conditions to prevent the growth of undesirable microorganisms 
and adulteration.

R. Proposed Sec.  507.25(c)(2)--Control of Undesirable Microorganisms

    We proposed that measures taken during manufacturing, processing, 
packing, and holding of animal food to significantly minimize or 
prevent the growth of undesirable microorganisms (for example, heat 
treating, freezing, refrigerating, irradiating, controlling pH, or 
controlling aw) must be adequate to prevent adulteration of 
animal food.
    (Comment 217) Most of the comments say that measures to 
significantly minimize or prevent the growth of undesirable 
microorganisms should be addressed under subpart C, and that this 
requirement should be removed from the CGMPs. One comment recommends 
deleting only the examples of measures that might be taken. Another 
comment recommends deleting the term ``significantly'' as this term is 
not defined and is difficult to quantify.
    (Response 217) We disagree that the requirement should be addressed 
in subpart C instead of subpart B. We consider controlling undesirable 
microorganisms to be a baseline requirement that should apply to all 
establishments that manufacture, process, pack, or hold animal food. We 
also decline the request to remove the examples of measures that can be 
used to significantly minimize or prevent the growth of undesirable 
microorganisms because they are examples of practical solutions already 
used by industry. We decline to delete the term ``significantly.'' The 
term ``significantly minimize'' is defined in Sec.  507.3 and means to 
reduce to an acceptable level, including to eliminate.

S. Proposed Sec.  507.25(c)(3)--Work-in-Process and Rework

    We proposed that work-in-process and rework must be handled in such 
a way that it is protected against contamination and the growth of 
undesirable microorganisms.
    (Comment 218) Some comments request that we delete ``and the growth 
of undesirable microorganisms'' and require only that work-in-process 
and rework be handled in such a way that it is protected against 
adulteration.
    (Response 218) We decline this request. Because undesirable 
microorganisms are a common source of contamination of animal food, 
including work-in-process and rework, we have decided to specify that 
establishments must protect against the growth of undesirable 
microorganisms, as well as other contamination.

T. Proposed Sec.  507.25(c)(4)--Processing Steps

    We proposed that steps such as cutting, drying, defatting, 
grinding, mixing, extruding, pelleting, and cooling, must be performed 
in a way that protects against the contamination of animal food.
    (Comment 219) One comment suggests that we revise the requirement 
to say that steps be performed in a way that protects against animal 
food adulteration rather than protects against animal food 
contamination. Another comment suggests that the requirement be deleted 
because it is redundant to other requirements in the proposed rule.
    (Response 219) As discussed in Response 167, we believe 
contamination is the better word to use in this context. These specific 
requirements provide a level of detail that we believe is important 
because these activities are common in the animal food industry and can 
contribute to the contamination of animal food. We believe that this 
requirement for these activities is not redundant to other requirements 
in this final rule.

U. Proposed Sec.  507.25(c)(5)--Processing Operations

    We proposed that filling, assembling, packaging, and other 
operations must be performed in such a way that protects against the 
contamination of animal food and the growth of undesirable 
microorganisms.
    (Comment 220) One comment requests that we delete ``and the growth 
of undesirable microorganisms'' and require only that operations be 
performed in such a way that the animal food is protected against 
adulteration. Another comment suggests that the requirement be deleted 
because it is redundant, but does not identify the redundant section.
    (Response 220) As discussed in Response 167, we believe 
contamination is the better word to use in this context. These specific 
requirements, including the requirement for the protection against the 
growth of undesirable microorganisms, provide a level of detail that we 
believe is important because these activities are common in the animal 
food industry and can contribute to the contamination of animal food. 
We believe that these requirements for these activities are not 
redundant with other requirements in this final rule.

V. Proposed Sec.  507.25(c)(6)--Controlling Water Activity 
(aw)

    We proposed that animal food that relies on the control of water 
activity for preventing the growth of undesirable microorganisms must 
be processed to and maintained at a safe moisture level.
    (Comment 221) Some comments request that we delete the requirement 
because controlling water activity belongs in subpart C, not in the 
CGMP regulations. Another comment says that controlling moisture level 
is not sufficient and the requirement should be revised to require that 
animal food that relies on the control of water activity for preventing 
the growth of undesirable microorganisms be processed to and maintained 
at a suitable water activity, not a safe moisture level. We also 
received comments asserting that water activity may not be the only 
factor responsible for preventing the growth of undesirable

[[Page 56236]]

microorganisms in dry products and that we should modify the regulatory 
text to take into account other synergistic barriers for microbial 
growth and toxin formation.
    (Response 221) We disagree that controlling water activity belongs 
in subpart C. While not all animal food establishments rely on the 
control of water activity for preventing the growth of undesirable 
microorganisms in their animal food, we have determined it is important 
to have this requirement in CGMP regulations for those establishments 
that do, considering the potential public health significance of 
undesirable microorganisms. We agree that the term ``safe water 
activity level'' is more commonly understood by the animal food 
industry than ``safe moisture level'' and we have revised the 
regulatory text accordingly. We agree with the comment that water 
activity may not be the only factor responsible for preventing growth 
of undesirable microorganisms in certain animal food and have revised 
the regulatory text to clarify that such products rely ``principally'' 
on the control of water activity.

W. Proposed Sec.  507.25(c)(7)--Controlling pH

    We proposed that animal food that relies principally on the control 
of pH for preventing the growth of undesirable microorganisms must be 
monitored and maintained at the appropriate pH.
    (Comment 222) Some comments request that we delete this proposed 
requirement because controlling pH belongs in subpart C, not in subpart 
B. One comment also says that it is too prescriptive and duplicative of 
protections against adulteration in other proposed sections of subpart 
B.
    (Response 222) We decline the request. While not all animal food 
establishments principally rely on the control of pH for preventing the 
growth of undesirable microorganisms in their animal food, we have 
determined it is important to have this requirement in the CGMP 
regulations for those establishments that do, considering the potential 
public health significance of undesirable microorganisms.

X. Proposed Sec.  507.25(c)(8)--Ice

    We proposed that when ice is used in contact with animal food, it 
must be made from water that is safe and must be used only if it has 
been manufactured in accordance with current good manufacturing 
practice as outlined in this subpart.
    (Comment 223) One comment suggests that this requirement be deleted 
because ice is rarely used in the manufacturing/processing of animal 
food.
    (Response 223) We decline this request. We have established this 
requirement to help ensure that when ice is used for the manufacture of 
animal food, the ice is made from water that is safe so that it does 
not contaminate the animal food it contacts.

XXI. Subpart B: Comments on Proposed Sec.  507.27--Holding and 
Distribution

A. Proposed Sec.  507.27(a)--Holding and Distribution

    We proposed that animal food held for distribution must be held 
under conditions that will protect against contamination and minimize 
deterioration.
    (Comment 224) A few comments request that we remove ``minimize 
deterioration'' from this requirement. These comments say that although 
deterioration may lead to animals refusing food, an animal's refusal of 
food does not necessarily mean that the food has deteriorated. The 
comments suggest that we instead use the phrase ``ensure product 
integrity throughout the intended shelf life,'' or that we clarify the 
definition of deterioration if we do not remove it.
    (Response 224) We decline this request. We believe it is important 
that animal food be held and distributed in manner that does not lead 
to deterioration. Deterioration of animal food includes the loss of 
palatability or nutritive value typically associated with the animal 
food and we believe this could be a safety concern because animals are 
often fed the same food containing the same ingredients for prolonged 
periods of time. As a result, food refusal or consumption of animal 
food containing fewer nutrients than the animal food is expected to 
provide may result in poor animal productivity or health issues. 
Furthermore, deterioration can indicate that the animal food has been 
held under conditions that would also support the growth of undesirable 
microorganisms.

B. Proposed Sec.  507.27(a)(1)--Containers

    We proposed that containers used for holding animal food for 
distribution must be designed, constructed of appropriate material, 
cleaned, and maintained to prevent contamination of animal food.
    (Comment 225) A few comments request that the terms ``designed'' 
and ``constructed of appropriate material,'' which may have different 
interpretations, be replaced by ``fit for purpose'' a term recognized 
by the animal food industry.
    (Response 225) We decline the request. We believe the terms 
``designed'' and ``constructed of appropriate material'' are well 
understood by the animal food industry and ``fit for purpose'' does not 
improve clarity.
    (Comment 226) A few comments note containers used to hold animal 
food may include bins, totes or other intermediate storage containers, 
each of which may require differing levels and frequency of cleaning. 
Some of these comments ask that we add the phrase ``where necessary'' 
when discussing cleaning to provide flexibility.
    (Response 226) We agree that containers used to hold animal food 
will require different cleaning methods and frequency of cleaning. 
These differences may result from the types of containers used, the 
amount and type of animal food held, the frequency at which containers 
are reused, as well as other factors. As a result, we agree that it is 
appropriate to include language that indicates that different methods 
and frequencies of cleaning may be appropriate to protect against 
contamination of the animal food and we have revised the regulatory 
text to add ``as necessary'' after cleaned.

C. Proposed Sec.  507.27(a)(2)--Protection From Contamination

    We proposed that animal food held for distribution must be held in 
a way that prevents contamination from sources such as trash and 
garbage.
    (Comment 227) A few comments request that the phrase ``from sources 
such as trash and garbage'' be deleted. A few comments request that the 
term ``garbage'' not be used because some products that may be 
considered garbage may actually be suitable for use as animal food. 
Some of these comments suggested alternative language.
    (Response 227) We agree in part with this comment. The mistaken 
inclusion of trash or garbage into animal food could be a potential 
source of contamination. The terms ``trash'' and ``garbage'' are 
intended in their general sense and refer to items that are not 
suitable for animal food, or are not intended for animal food. However, 
under the Swine Health Protection Act, ``garbage'' as defined by the 
act is prohibited for use as food for swine, unless it is treated to 
kill disease organisms. For this reason, and because the terms can be 
considered synonyms, we are removing the term ``garbage'' throughout 
subpart B to avoid confusion.

[[Page 56237]]

D. Proposed Sec.  507.27(a)(3)--Labeling of Animal Food Held for 
Distribution (Final Sec.  507.27(b))

    We proposed that labeling identifying the product by the common or 
usual name must be affixed to or accompany the animal food.
    (Comment 228) Some comments support the labeling requirement 
because accurate identification of animal food throughout the 
distribution chain is an important food safety step and loss of 
identity can have serious animal and human health implications. One 
comment suggests that this requirement be revised to specify that the 
proposed labeling be required during holding and distribution of both 
packaged animal food and bulk animal food. One comment says that FDA's 
primary interest should be identification, not labeling, because 
labeling for animal food being held for distribution in bulk is 
impractical. The comment also notes that plants may use a central 
computer system or other method to identify animal food location. A few 
comments suggest that we should require that animal food held for 
distribution be labeled as required by regulations for finished 
products.
    (Response 228) We agree that animal food may be identified in the 
plant through methods other than labeling. We expect that while animal 
food is being processed in the plant that the animal food is accurately 
identified as required in Sec.  507.25(a)(2) of this final rule.
    We have moved the requirement that labeling must include 
information and instructions for safely using the animal food product 
for the intended animal species from proposed Sec.  507.25(a)(3) 
``Plant operations'' in the 2014 supplemental proposed rule to Sec.  
507.27(b) of ``Holding and distribution'' to clarify that this labeling 
information must be included when the product is ready for 
distribution. We think that placing the labeling requirements for 
animal food products ready for distribution under ``Holding and 
distribution'' will help reduce confusion and make these requirements 
for labeling for distribution easier to find in the final rule. 
Labeling that meets applicable FDA labeling regulations must accompany 
or be affixed to the animal food and that the labeling must include, 
when applicable, information and instructions for safely using the 
product for the intended animal species. We have added the 
clarification that it is ``when applicable,'' understanding that not 
all animal food product will need information on its safe use. We have 
deleted the requirement that labeling that identifies the product by 
the common or usual name must be affixed to or accompany the animal 
food in this section because it is already covered by current FDA 
regulations.

E. Proposed Sec.  507.27(b)--Shipping Containers (Final Sec.  
507.27(c))

    We proposed that shipping containers (for example, totes, drums, 
and tubs) and bulk vehicles used to distribute animal food must be 
inspected prior to use to ensure the container or vehicle will not 
contaminate the animal food.
    (Comment 229) Some comments state that the requirement to inspect 
shipping containers is not practical because containers are frequently 
reused without intervening cleaning or because the animal food is 
distributed in dedicated containers or vehicles. One comment says that 
it is pointless to inspect the containers when the product being 
distributed may be decayed and may be dumped on the ground for the 
animals to eat. Other comments state that sometimes nobody is available 
to inspect the vehicle when third-party transportation is used and that 
third-party transportation vehicles may already contain animal food or 
by-products because they are used to pick up from several facilities. 
Some comments say that contractual provisions specify how third-party 
shipping container may be used, and therefore inspection prior to each 
load would not be necessary to manage this risk.
    (Response 229) Though we disagree with the comments, we are 
revising the regulatory text in Sec. Sec.  507.27 and 507.28 to replace 
the word ``inspected'' with ``examined''. We believe that the use of 
the word ``examined'' provides more clarity for the animal food 
industry because the term ``inspected'' often implies a regulatory 
activity. This does not mean that the shipping container must be 
cleaned prior to each use. The plant or facility is responsible for 
examining shipping containers and bulk vehicles that it uses to 
transport the animal food (e.g., the facility transports the animal 
food, or arranges with a third-party to distribute the animal food to 
the facility's customer). We expect the plant or facility personnel 
involved in the process of loading the product into the shipping 
container or vehicle to be aware of the condition of the shipping 
container or vehicle, and consider whether its condition would 
contaminate the animal food. This examination could include viewing the 
shipping container or vehicle to observe whether there are any unusual 
residues in it that may contaminate the animal food, or it could be 
simply knowing what the shipping container or vehicle had previously 
been used for and because of that, whether the container needed to be 
cleaned prior to use. We do not expect a plant or facility to examine 
the shipping container or bulk vehicle when a customer transports the 
animal food or arranges for a third-party to pick up the animal food. 
However, a plant or facility may choose to examine a customer's 
shipping container or bulk vehicle as a business decision to ensure 
that shipping container or bulk vehicle will not lead to the 
contamination or adulteration of the animal food.

F. Proposed Sec.  507.27(c)--Returned Animal Food (Final Sec.  
507.27(d))

    We proposed that animal food returned from distribution must be 
assessed for animal food safety to determine the appropriate 
disposition. Returned animal food must be identified as such and 
segregated until assessed. We received no comments on this requirement 
and are finalizing it as proposed.

G. Proposed Sec.  507.27(d)--Unpackaged Bulk Animal Food (Final Sec.  
507.27(e))

    We proposed that unpackaged or bulk animal food must be held in a 
manner that does not result in cross contamination with other animal 
food. We received no comment on this requirement and are finalizing it 
as proposed with one wording change. We have added the term ``unsafe'' 
to modify cross contamination to make it clear that this requirement 
applies to cross contamination that would result in unsafe animal food.

XXII. Subpart B: Comments on Proposed Sec.  507.28--Holding and 
Distribution of Human Food By-Products for Use as Animal Food

    We proposed to add provisions for human food by-products for use as 
animal food. We proposed that the requirements of this part (with the 
exception of proposed Sec.  507.28) would not apply to by-products of 
human food production that are packed and held by that facility for 
distribution as animal food if certain requirements were met (see 
discussion in section XIII). The facility would only need to comply 
with proposed Sec.  507.28 of this part and proposed Sec.  117.95 of 
part 117 (which contains identical requirements).

A. Proposed Sec.  507.28(a)--Contamination

    We proposed that human food by-products held for distribution as 
animal food must be held under conditions that will protect against 
contamination.

[[Page 56238]]

    (Comment 230) Multiple comments request that the term ``human food 
by-products,'' not ``animal food,'' be used throughout Sec. Sec.  
507.28 and 117.95 (of part 117). These comments note that it is 
important to make clear that human food by-products do not change from 
human food to animal food until they are transferred to someone with 
the intent to use it as an animal food.
    (Response 230) We disagree that human food by-products are not 
animal food until they have been transferred to someone with the intent 
to use it as animal food. Furthermore, we think that the use of the 
term ``human food by-products'' would be more confusing here because 
not all human food by-products are intended for use as animal food. 
However, we have revised the regulatory text to use the term ``human 
food by-products for use as animal food'' throughout this section to 
differentiate it from other requirements in parts 117 and 507. The 
purpose of these provisions in Sec. Sec.  507.28 and 117.95 is to 
ensure that when the processer is holding and distributing human food 
by-products for use as animal food, the by-products are recognized as 
human food by-products for use as animal food by all employees and 
treated as such.

B. Proposed Sec.  507.28(a)(1)--Containers

    We proposed that containers used to hold animal food before 
distribution must be designed, constructed of appropriate material, 
cleaned, and maintained to prevent the contamination of animal food.
    (Comment 231) Some comments state that the provisions about 
containers are too prescriptive because by-products may be held and 
conveyed in ways that do not use containers (such as using storage 
silos, augers, pipes, chutes or conveyor belts to convey product 
directly to transportation vehicles). Some comments request 
clarification on cleaning the containers because they are frequently 
reused for holding by-product without intervening cleaning procedures.
    (Response 231) We agree that human food by-products for use as 
animal food may be held and conveyed using equipment instead of 
containers. We have revised the regulatory text to add ``equipment'' in 
addition to containers, and have added the words ``convey'' and 
``cleaned as necessary'' (see regulatory text for Sec. Sec.  
507.28(a)(1) and 117.95(a)(1)). We expect containers and equipment to 
be cleaned at a frequency that protects against contamination of human 
food by-products for use as animal food by contaminants that could be 
harmful to the public (human and animal) health. This may not require 
cleaning after each use.

C. Proposed Sec.  507.28(a)(2)--Protection From Contamination

    We proposed that animal food held for distribution must be held in 
a way to prevent contamination from sources such as trash and garbage. 
As discussed in Response 227, we have revised the regulatory text to 
remove the term garbage. We did not receive additional comments related 
to this paragraph and are finalizing the proposed language with changes 
previously discussed. (See Responses 227 and 230.)

D. Proposed Sec.  507.28(a)(3)--Labeling

    We proposed that labeling identifying the product by the common or 
usual name must be affixed to or accompany animal food.
    (Comment 232) Some comments state that by-products only need to be 
reasonably identified while they are being held by the facility and 
state that once they are ready for distribution, they should be labeled 
in conformance with applicable regulatory requirements. One comment 
states that what is considered the ``common and usual name'' varies 
between the human food industry, the animal food industry, producers 
and regulators. This comment suggests that FDA work with regulatory 
partners to provide guidance on the proper ``common and usual name'' of 
by-products to promote consistency.
    (Response 232) We agree in part with these comments. As with animal 
food subject to all of part 507, we expect that while human food by-
product for use as animal food is being held in the human food 
facility, it is accurately identified. (See Response 201.) We have 
revised the regulatory text to clarify that the human food by-product 
for use as animal food must be accurately identified while held in the 
human food facility (see Sec.  507.28(a)(3) of the final rule). We 
retained the requirement that when the human food by-product for use as 
animal food is distributed, it must have labeling that identifies the 
common or usual name of the product affixed to or accompanying it (see 
Sec.  507.28(b) of the final rule).
    Our CPG Sec. 665.100 discusses common or usual names for animal 
food ingredients (Ref. 25). There are also industry and other 
regulatory resources that may assist facilities in determining the 
common or usual name of the animal food. For example, USDA maintains 
the National Nutrient Database for Standard Reference, a database that 
includes a list of names for human food items (Ref. 30). We will take 
into consideration these comments when determining whether to issue 
additional guidance about the common or usual name of animal food.
    (Comment 233) One comment requests that FDA require human food 
manufacturers to document the recipient's intended use of the by-
products so the by-products do not become ingredients of human food. 
This comment also requests that these by-products be required to be 
labeled with the statement ``For Use as Animal Feed Only.''
    (Response 233) We decline these requests. Human food is produced 
under human food regulations, such as CGMPs, and HACCP regulations for 
juice and seafood, and facilities must meet the applicable requirements 
for food that is manufactured, processed, packed, or held to ensure the 
safety of that human food. This requirement in Sec.  507.28 is meant 
only for human food by-products for use as animal food that are only 
held and distributed (i.e. not further processed). Human food by-
products may be used as human food ingredients as long as they are in 
compliance with the applicable human food regulations. However, we 
would not object if a facility labels the human food by-products for 
use as animal food ``For Use as Animal Food Only.''

E. Proposed Sec.  507.28(b)--Shipping Containers

    We proposed that shipping containers (for example, totes, drums, 
and tubs) and bulk vehicles used to distribute animal food must be 
inspected prior to use to ensure the container or vehicle will not 
contaminate the animal food. This provision is paragraph (c) of this 
section in the final rule.
    (Comment 234) We received the same comments on Sec.  507.28(c) as 
Sec.  507.27(c). (See Comment 229.)
    (Response 234) We are revising the regulatory text in Sec. Sec.  
507.28(c) and 117.95(c). (See Response 229.)

XXIII. Subpart C: Comments on Overall Framework for Hazard Analysis and 
Risk-Based Preventive Controls

    In the 2014 supplemental notice for preventive controls for animal 
food, we proposed a series of changes to proposed subpart C and 
reopened the comment period specifically with respect to these changes. 
The proposed changes included: (1) Eliminating the term ``hazard 
reasonably likely to occur'' throughout proposed subpart C (and, thus, 
deleting the definition we had proposed for this term); (2) adding a 
new defined term, ``significant hazard,'' and, in general, using this 
new term instead of ``hazard reasonably likely to occur'' throughout 
the re-

[[Page 56239]]

proposed regulations; (3) defining ``known or reasonably foreseeable 
hazard'' in place of ``reasonably foreseeable hazard'' and clarifying 
that the new term means a hazard ``that has the potential to be 
associated with the facility or the food'' rather than ``a potential . 
. . hazard that may be associated with the facility or the food''; and 
(4) providing additional flexibility to address concerns about 
rewriting existing plans or programs to conform with the requirement of 
the preventive controls rule.
    We received many comments on the overall framework for hazard 
analysis and risk-based preventive controls. We discuss each of these 
comments in the discussion of the specific regulatory text applicable 
to each comment. We show highlights of the changes we made after 
considering these comments in table 9.

Table 9--Revisions to the Overall Framework for Hazard Analysis and Risk-
                        Based Preventive Controls
------------------------------------------------------------------------
            Section                Description            Revision
------------------------------------------------------------------------
507.3.........................  Definition of      Revise the proposed
                                 ``significant      term ``significant
                                 hazard``.          hazard'' to ``hazard
                                                    requiring a
                                                    preventive control''
                                                    and revise the
                                                    definition to
                                                    emphasize the role
                                                    of risk in
                                                    determining whether
                                                    a hazard requires a
                                                    preventive control.
507.3.........................  Definition of      Define the term
                                 ``corrections``.   ``correction'' to
                                                    distinguish
                                                    ``corrections'' from
                                                    ``corrective
                                                    actions.''
507.34(c)(1), 507.39(a),        Flexibility in     Clarify that
 507.40, 507.45(a), 507.47(a),   preventive         preventive control
 507.49(a), 507.49(b).           controls and       management
                                 preventive         components depend on
                                 control            the role of a
                                 management         preventive control
                                 components for     in the facility's
                                 monitoring,        food safety system,
                                 corrective         as well as the
                                 actions and        nature of the
                                 corrections, and   preventive control.
                                 verification.
507.33(b)(1)..................  Hazard             Emphasize that the
507.33(b)(2)..................   identification.    hazard
                                                    identification
                                                    focuses on known or
                                                    reasonably
                                                    foreseeable hazards
                                                    (rather than on all
                                                    hazards).
507.40(c)(2)..................  Monitoring         Provide for the use
                                 records.           of ``exception
                                                    records'' for
                                                    monitoring
                                                    preventive controls.
507.42(a).....................  Corrective action  Clarify that
                                 procedures.        corrective action
                                                    procedures depend on
                                                    the nature of the
                                                    hazard.
507.42(c).....................  Corrections......  Provide for
                                                    additional
                                                    circumstances when
                                                    corrections, rather
                                                    than corrective
                                                    actions, are
                                                    warranted.
507.47(c).....................  Preventive         Clarify that a list
                                 controls that do   of preventive
                                 not require        controls that do not
                                 validation.        require validation
                                                    is not an exhaustive
                                                    list.
507.49(a)(5)..................  Activities to      Clarify that there
                                 verify             could be alternative
                                 implementation     verification
                                 and                activities of
                                 effectiveness.     implementation and
                                                    effectiveness other
                                                    than those that we
                                                    specify in the rule.
507.49(b).....................  Written            Clarify that written
                                 procedures for     procedures for
                                 verification of    verification of
                                 implementation     implementation and
                                 and                effectiveness are
                                 effectiveness.     established and
                                                    implemented as
                                                    appropriate to the
                                                    role of the
                                                    preventive control
                                                    in the facility's
                                                    food safety system,
                                                    as well as
                                                    appropriate to the
                                                    facility, the animal
                                                    food, and the nature
                                                    of the preventive
                                                    control.
507.50(b).....................  Reanalysis.......  Provide for
                                                    reanalysis of an
                                                    applicable portion
                                                    of the food safety
                                                    plan (rather than
                                                    the complete food
                                                    safety plan) in
                                                    specified
                                                    circumstances.
------------------------------------------------------------------------

XXIV. Subpart C: Comments on Proposed Sec.  507.31--Food Safety Plan

    We proposed requirements for a food safety plan. Some comments 
support the proposed requirements without change. Some comments that 
support the proposed provisions suggest alternative or additional 
regulatory text or ask us to clarify how we will interpret the 
provision.
    In the following sections, we discuss comments that ask us to 
clarify the proposed requirements, or disagree with, or suggest one or 
more changes to the proposed requirements. After considering these 
comments, we are finalizing the provisions as proposed, with editorial 
and conforming changes as shown in table 31.
    We proposed that the food safety plan be under the oversight of one 
or more ``qualified individuals.'' As discussed in section VIII.A.24, 
we have changed the proposed term ``qualified individual'' to 
``preventive controls qualified individual'' because we are 
establishing a new definition for ``qualified individual,'' with a 
meaning distinct from ``preventive controls qualified individual.'' To 
minimize the potential for confusion for when the term ``qualified 
individual'' refers to the proposed meaning of the term and when the 
term ``qualified individual'' refers to the meaning of that term as 
finalized in this rule, in the remainder of this document we substitute 
the new term ``preventive controls qualified individual'' for the 
proposed term ``qualified individual,'' even though the proposed rule 
used the term ``qualified individual.'' Likewise, we substitute the new 
term ``preventive controls qualified individual'' for the proposed term 
``qualified individual'' when describing the comments to the proposed 
rule, even though those comments use the term ``qualified individual.''
    We proposed that several other provisions of subpart C be under the 
oversight of a ``qualified individual'' (now ``preventive controls 
qualified individual''), and also proposed requirements that would 
apply to the ``qualified individual'' (now ``preventive controls 
qualified individual''). See, e.g., Sec. Sec.  507.47, 507.49, 507.50, 
507.51, 507.53, and 507.55). As discussed in the preceding paragraph, 
in the remainder of this document, we substitute the new term 
``preventive controls qualified individual'' for the proposed term 
``qualified individual,'' when describing these proposed provisions and 
the comments to these proposed provisions.

A. Proposed Sec.  507.31(a)--Requirement for a Food Safety Plan

    We proposed that you must prepare, or have prepared, and implement 
a written food safety plan.
    (Comment 235) Some comments ask us to develop a final preventive 
controls

[[Page 56240]]

rule with separate requirements for food safety plans for manufacturers 
of livestock food and for manufactures of food for other animal 
species.
    (Response 235) We decline this request. The required elements of 
the food safety plan listed in Sec.  507.31(c) apply to each type of 
animal food manufactured at a facility. Animal food types or production 
method types may be grouped together if the hazards, preventive 
controls, parameters, and management components (monitoring, corrective 
actions and corrections, and verification) necessary to ensure the 
effectiveness of the preventive controls are essentially identical. We 
have provided additional flexibility within the required elements of 
the food safety plan in the final rule. Therefore the same requirements 
for a food safety plan are applicable to a facility that makes food for 
livestock and one that makes food for other animal species.
    (Comment 236) Some comments ask us to add regulatory text to this 
section stating that an existing written food safety plan, including 
any plan intended to satisfy the requirements of a foreign jurisdiction 
or that complies with existing standards developed by other 
organizations (such as PAS 222 (Ref. 27)), satisfies the requirements 
of this section if it contains the information specified by Sec.  
507.31(c).
    (Response 236) To the extent that an existing food safety plan 
includes all required information, a facility can use such plans to 
meet the requirements of this rule. We expect that many existing plans 
will need only minor supplementation to fully comply with these 
requirements. Relying on existing records, with supplementation as 
necessary to satisfy the requirements of the preventive controls rule, 
is acceptable (see Sec.  507.212).
    (Comment 237) Some comments agree with our previous statements that 
facilities should be able to group animal food types or production 
method types if hazards, control measures, parameters, and required 
procedures, such as monitoring, are identical (78 FR 64736 at 64779). 
Some comments ask us to emphasize that each facility needs only one 
food safety plan, regardless of how many animal species it makes food 
for, or how many different types of food it makes. These comments 
further state that facilities are under the impression that any given 
facility will need multiple food safety plans if they make many food 
types or make food for multiple animal species.
    (Response 237) We are requiring that a facility have a written food 
safety plan that covers all types of animal food it manufactures, 
processes, packs, or holds and all of the animal species for which the 
food is intended. We recognize that, to the extent that the controls 
are the same, there may be common controls that broadly apply to some 
or all of a facility's animal food products. However, any product-, 
process-, or animal species-specific differences must be carefully 
delineated and observed in practice.
    In some facilities with limited types of animal food products or 
animal species for which the food is intended, the written food safety 
plan may contain a single set of procedures that addresses all of the 
products produced. For other facilities, there may not be a practical 
way to group the products and the written food safety plan may need to 
contain more than one set of procedures to address all of its products.
    (Comment 238) Some comments ask us to emphasize that ``written'' 
means ``any type of recordable and reproducible format'' (e.g., as 
paper or electronic documents). Some comments ask us to specify that 
the components of the food safety plan need not be in a single document 
or stored in one place.
    (Response 238) A ``written'' food safety plan can be either a paper 
document or an electronic document, as provided for by Sec.  
507.202(a). The final rule specifies that required information (which 
would include the food safety plan) does not need to be kept in one set 
of records (see Sec.  507.212(b)), and a food safety plan may be 
prepared as a set of documents kept in different locations within the 
facility (e.g., based on where they will be used), provided that each 
set of documents is onsite. As provided in the recordkeeping 
provisions, electronic records are considered to be onsite if they are 
accessible from an onsite location.
    (Comment 239) Some comments ask us to provide that the food safety 
plan be handled at the corporate level rather than the facility level 
if a corporation owns many facilities.
    (Response 239) A corporation may designate an individual at the 
corporate level as the owner, operator, or agent in charge of a 
particular facility. In addition, an employee of the corporation, 
whether at headquarters or at another facility owned by the 
corporation, may provide input into a particular facility's food safety 
plan. As previously discussed, the food safety plan does need to be 
facility specific (see the discussion of the facility-based nature of 
the food safety plan in the 2013 proposed preventive controls rule for 
animal food, 78 FR 64736 at 64780). For example, even if a corporation 
makes similar products at two separate facilities, it is unlikely that 
the two facilities have exactly the same equipment and layout. 
Procedural instructions must be tailored to the equipment being used, 
and the layout of a facility may affect its approach to preventive 
controls.
    (Comment 240) Some comments assert that a food safety plan should 
only be required for high-risk processing facilities because adhering 
to CGMPs is sufficient for low-risk facilities. Some comments assert 
that FSMA does not authorize us to require farms to develop food safety 
plans.
    (Response 240) We decline the request to establish additional 
exemptions based on risk, other than the exemptions for on-farm low-
risk activity/animal food combinations provided by section 103(c)(1)(D) 
of FSMA (Sec.  507.5(e) and (f)). The applicability of the requirements 
of the preventive controls rule to facilities that are required to 
register is required by the statute (see the definition of facility in 
section 418(o)(2) of the FD&C Act). Section 418(h) of the FD&C Act 
requires that a facility prepare and implement a food safety plan, 
unless an exemption applies. Neither FSMA nor this rule establishes an 
exemption for ``low-risk'' facilities, including ``low-risk'' 
facilities that are regularly inspected by State, local, or tribal 
government Agencies. A farm is not subject to this rule for activities 
within the ``farm'' definition. A farm mixed-type facility that is a 
small or very small business and only conducts the low-risk activity/
animal food combinations specified in Sec.  507.5(e) and (f) is exempt 
from the requirements of subparts C and E, including the requirement 
for a food safety plan.
    (Comment 241) Some comments ask us to clarify that a food safety 
plan is not required when a facility is exempt as a qualified facility 
(Sec.  507.7(a)) or as a facility solely engaged in the storage of 
packaged food that is not exposed to the environment (Sec.  507.10)
    (Response 241) A qualified facility is exempt from the requirements 
of subparts C and E, including the requirement to prepare and implement 
a food safety plan, and is instead subject to the requirements in Sec.  
507.7. Likewise, a facility solely engaged in the storage of packaged 
animal food that is not exposed to the environment and does not require 
time/temperature control to significantly minimize or prevent the 
growth of, or toxin production by, pathogens is exempt from the 
requirements of subparts C and E, including the requirement to prepare 
and implement a food safety plan. See Response 242 for unexposed, 
packaged TCS animal food.

[[Page 56241]]

    (Comment 242) Some comments ask us to clarify that a food safety 
plan is not required for facilities that store unexposed, refrigerated, 
packaged TCS animal foods.
    (Response 242) We agree that a facility ``solely engaged'' in the 
storage of unexposed, refrigerated, packaged TCS animal food is exempt 
from the requirements of subparts C and E, including the requirement to 
prepare and implement a food safety plan, and instead is subject to the 
modified requirements in Sec.  507.51 (see Sec.  507.10). However, if a 
facility engages in other activities in addition to the storage of 
unexposed, refrigerated, packaged TCS animal food, the exemption does 
not apply. In such a case, the facility must prepare and implement a 
food safety plan. However, the modified requirements of Sec.  507.51 
can be informative with respect to what the food safety plan could 
include regarding the storage of unexposed, refrigerated, packaged TCS 
animal food.

B. Proposed Sec.  507.31(b)--Preparation of the Food Safety Plan by a 
Preventive Controls Qualified Individual

    We proposed that the food safety plan must be prepared, or its 
preparation overseen, by one or more preventive controls qualified 
individuals.
    (Comment 243) Some comments ask us to provide for a group of 
qualified individuals to prepare, or oversee the preparation of, a food 
safety plan.
    (Response 243) The proposed regulatory text included in the 2014 
supplemental notice provides for the food safety plan to be prepared, 
or its preparation overseen, by one or more preventive controls 
qualified individuals, and we are finalizing it as proposed.

C. Proposed Sec.  507.31(c)--Contents of a Food Safety Plan

    We proposed that the written food safety plan must include the 
written hazard analysis, preventive controls (including the supplier 
program and recall plan), procedures for monitoring the implementation 
of the preventive controls, corrective action procedures, and 
verification procedures. As discussed in more detail in section XL, we 
have revised the phrase ``supplier program'' to ``supply-chain 
program'' throughout the regulatory text. In the remainder of this 
document, we use the phrase ``supply-chain program'' in section 
headings and when referring to the provisions of the final rule. We 
continue to use the term ``supplier program'' when describing the 
proposed provisions and the comments regarding the proposed provisions.
    (Comment 244) Some comments ask us to specify that sanitation 
controls must be in the food safety plan. Some comments ask us to 
require that the food safety plan include the qualifications of the 
preventive controls qualified individual.
    (Response 244) Sanitation controls are one type of preventive 
control. As appropriate to the facility and the animal food (e.g., to 
control hazards such as environmental pathogens), sanitation controls 
for cleanliness of animal food-contact surfaces and prevention of cross 
contamination are required to be in the food safety plan (Sec.  
507.34(c)(2)).
    We are requiring that you document all applicable training taken by 
the preventive controls qualified individual (see Sec.  507.53(d)). 
This documentation must be established and maintained (see Sec.  
507.55(a)(6)).

D. Proposed Sec.  507.31(d)--Records

    We proposed that the food safety plan is a record that is subject 
to the recordkeeping requirements of subpart F. We received no comments 
that disagreed with this proposed requirement and are finalizing it as 
proposed.

E. Comments on Potential Requirements for Submission of a Facility 
Profile to FDA

    We requested comment on whether to require submission to FDA of a 
subset of the information that would be in a food safety plan (78 FR 
64736 at 64809). This information, which could be referred to as a 
``facility profile,'' could be submitted through an electronic form 
using a menu selection approach at the same time as facility 
registration and updated biennially simultaneously with the required 
biennial update of the food facility registration. We described 
potential benefits to having a facility's food safety plan in advance 
of an inspection, such as aiding in the efficient oversight of 
preventive controls by allowing us to better target inspectional 
activities to facilities that produce foods that have an increased 
potential for contamination (particularly with biological hazards). We 
noted that facilities could benefit from our advance preparation 
through interaction with better-informed investigators and potentially 
reduced inspection time. We requested comment on the utility and 
necessity of such an approach and on the specific types of information 
that would be useful in developing a facility profile. We also 
requested comment on any additional benefits that might be obtained 
from using such an approach and any potential concerns with this 
approach.
    We noted that we had previously announced an opportunity for public 
comment on the proposed collection of additional food facility profile 
information on a voluntary basis from firms that complete the FDA food 
facility registration process (Federal Register of May 11, 2012, 77 FR 
27779). In contrast to the voluntary submission of food facility 
profile information described in that document, in the 2013 proposed 
preventive controls rule for animal food we requested comment on 
whether the submission of such information should be required.
    (Comment 245) Some comments state that submission of a facility 
profile would be useful and support requiring such a submission. 
However, most of the comments that addressed our request for comments 
on such a submission express concern. Some comments assert that 
requiring submission of a facility profile is outside of FDA's 
statutory authority under FSMA. Other comments assert that submitting a 
facility profile would not advance food safety goals or have a 
commensurate benefit to food safety. Some comments express concern 
about protection of confidential information. Other comments express 
concerns that we would misinterpret the submitted information in the 
absence of discussion with the facility. Some comments assert that 
receiving and evaluating the submitted information would be too time-
consuming for FDA, whereas other comments assert that submitting the 
information would be too time-consuming for the facility. Some comments 
state that a subset of the information that would be submitted could be 
found in the Establishment Inspection Reports. Some comments assert 
that we could use information already available through the RFR to 
identify facilities that have needed to address a serious food safety 
violation and target our inspectional resources to those facilities. 
Some comments state that a facility profile is a not a static document 
and would be very difficult to keep up to date. Other comments state 
that such a profile would be of limited or no use to FDA because 
information regarding hazards and preventive controls is best assessed 
in the context of a full food safety plan and related documentation. 
These comments further state that food safety plans will constantly 
evolve as facilities undertake new activities and refine their 
processes; a profile would present only a static picture of the food 
safety measures in place at a given time; FDA has already implemented 
changes to the

[[Page 56242]]

registration process that require facilities to provide more 
information about the activities at the facility. One comment asks us 
to refrain from requiring written or electronic submission of facility 
profiles.
    (Response 245) We have decided that we will not establish a 
requirement for submission of a facility profile. We will explore other 
mechanisms to achieve the goals we described in the 2013 proposed 
preventive controls rule for animal food.

XXV. Subpart C: Comments on Proposed Sec.  507.33--Hazard Analysis

    We proposed requirements for hazard analysis, including hazard 
identification and hazard evaluation. Some comments support the 
proposed requirements without change. For example, some comments 
support our proposal for the hazard analysis to address ``known or 
reasonably foreseeable hazards'' because this is consistent with Codex. 
Other comments agree that the hazard analysis should address both the 
severity of the potential hazard and the probability that the hazard 
will be present in an animal food product. Other comments state that 
testing for environmental pathogens may be impractical in certain 
situations for facilities in chemical plants that also produce food 
additives and that the proposed requirements for hazard evaluation make 
it clear that in such facilities environmental monitoring would not be 
required. Some comments that support the proposed provisions suggest 
alternative or additional regulatory text or ask us to clarify how we 
will interpret the provision.
    In the following sections, we discuss comments that ask us to 
clarify the proposed requirements or that disagree with, or suggest one 
or more changes to, the proposed requirements. After considering these 
comments, we have revised the proposed requirements as shown in table 
10 with editorial and conforming changes as shown in table 31.

  Table 10--Revisions to the Proposed Requirements for Hazard Analysis
------------------------------------------------------------------------
            Section                Description            Revision
------------------------------------------------------------------------
507.33(a)(1)..................  Requirement for a  Specify that a
                                 hazard analysis.   facility must
                                                    ``conduct a hazard
                                                    analysis'' to
                                                    identify and
                                                    evaluate known or
                                                    reasonably
                                                    foreseeable hazards,
                                                    rather than merely
                                                    specify that a
                                                    facility must
                                                    ``identify and
                                                    evaluate'' known or
                                                    reasonably
                                                    foreseeable hazards.
507.33(a)(2)..................  Requirement for    Clarify that the
                                 the hazard         hazard analysis must
                                 analysis to be     be written,
                                 written.           regardless of its
                                                    outcome.
507.33(b)(1) and (b)(2).......  Hazard             Emphasize that the
                                 identification.    hazard
                                                    identification
                                                    focuses on known or
                                                    reasonably
                                                    foreseeable hazards
                                                    (rather than on all
                                                    hazards).
507.33(b)(1)(ii)..............  Hazard             Replace
                                 identification.    ``imbalances''
                                                    with'' deficiencies
                                                    or toxicities'' and
                                                    provide examples of
                                                    these hazards.
507.33(b)(1)(iii).............  Hazard             Add examples of
                                 identification.    physical hazards.
507.33(c)(2)..................  Hazard evaluation  Provide that hazard
                                                    evaluation does not
                                                    need to include an
                                                    evaluation of
                                                    environmental
                                                    pathogens whenever
                                                    finished animal food
                                                    is exposed to the
                                                    environment prior to
                                                    packaging if the
                                                    packaged food
                                                    includes a control
                                                    measure (such as a
                                                    formulation lethal
                                                    to the pathogen)
                                                    that would
                                                    significantly
                                                    minimize the
                                                    pathogen.
507.33(d)(10).................  Hazard evaluation  Provide an example of
                                                    ``other relevant
                                                    factor'' that the
                                                    hazard evaluation
                                                    must consider (the
                                                    example is the
                                                    temporal (e.g.,
                                                    weather-related)
                                                    nature of some
                                                    hazards (e.g.,
                                                    levels of some
                                                    natural toxins)).
------------------------------------------------------------------------

A. Proposed Sec.  507.33(a)--Requirement for a Written Hazard Analysis

    We proposed that you must identify and evaluate, based on 
experience, illness data, scientific reports, and other information, 
known or reasonably foreseeable hazards for each type of animal food 
manufactured, processed, packed, or held at your facility to determine 
whether there are significant hazards. We also proposed that the hazard 
analysis must be written.
    As discussed in Response 62, we have revised the term ``significant 
hazard'' to ``hazard requiring a preventive control.'' In addition, we 
have revised the regulatory text to specify that the outcome of a 
hazard analysis is to determine whether there are any hazards requiring 
a preventive control.
    (Comment 246) Some comments ask us to specify that the rule 
requires a written hazard analysis even if the hazard analysis 
concludes that no hazards exist.
    (Response 246) As proposed, the regulatory text would require a 
written hazard analysis even if the hazard analysis concludes that no 
hazards exist. To make this clearer, we have made two revisions to the 
regulatory text. First, we have revised the regulatory text to specify 
that a facility must ``conduct a hazard analysis'' to identify and 
evaluate known or reasonably foreseeable hazards, rather than merely 
specify that a facility must ``identify and evaluate'' known or 
reasonably foreseeable hazards. Second, we have revised the regulatory 
text to specify that the hazard analysis must be written regardless of 
its outcome.
    (Comment 247) Some comments assert that a facility should not be 
able to conclude that no hazard exists in its production process and 
that any such conclusion reached should be a ``red flag'' to FDA 
investigators.
    (Response 247) The purpose of a hazard analysis is to identify and 
evaluate known or reasonably foreseeable hazards to determine whether 
there are any hazards requiring a preventive control. If a facility 
appropriately determines, under the oversight of a preventive controls 
qualified individual, that no such hazards exist, then that is the 
outcome of its hazard analysis, and the facility must document that 
outcome in its written hazard analysis.
    We expect that there will be many circumstances in which a facility 
appropriately determines that certain biological, chemical, or physical 
hazards are not hazards requiring a preventive control that must be 
addressed in the food safety plan. The provisions of the rule that 
allow a facility to appropriately determine that a particular hazard is 
not a hazard requiring a preventive control in certain animal food 
products are not equivalent to an exemption from the rule. For example, 
a facility that appropriately determines that there are no hazards 
requiring a preventive control associated with its animal food products

[[Page 56243]]

must document that determination in its written hazard analysis (Sec.  
507.33); however, no preventive controls, including supplier 
verification activities, and associated management components would be 
required in such a situation. There are several types of animal food 
products for which a facility may determine that there are no hazards 
requiring a preventive control. Such products include, but are not 
limited to: alfalfa cubes, vegetable oils, and molasses.
    However, we agree that our investigators should take appropriate 
steps to evaluate a facility's hazard analysis when the outcome is that 
there are no hazards requiring a preventive control. We expect that our 
investigators would both review the facility's written hazard analysis 
and discuss the outcome with the facility. During the initial stages of 
implementation, we also expect that our investigators will ask subject 
matter experts in our Center for Veterinary Medicine (CVM) to review 
such a hazard analysis. Over time, as our investigators gain experience 
with appropriate determinations that there are no hazards requiring a 
preventive control, we expect that there will be fewer circumstances in 
which our investigators would consult CVM about such an outcome.
    (Comment 248) Some comments ask us to require that the hazard 
analysis be re-evaluated every 3 years and updated as needed.
    (Response 248) The written hazard analysis is one component of the 
food safety plan, and the food safety plan is subject to reanalysis at 
least once every 3 years, and sooner under certain circumstances (see 
Sec.  507.50).
    (Comment 249) Some comments ask us to modify the provision to 
specify that the hazard analysis identify and evaluate known or 
reasonably foreseeable hazards for each type of animal food 
manufactured, processed, packed, or held at the facility, including 
hazards in the raw materials and ingredients used in the animal food 
(emphasis added).
    (Response 249) We decline this request. Other provisions in the 
requirements for hazard analysis specify that the hazard evaluation 
must consider raw materials and ingredients (see Sec.  507.33(d)(3)). 
It is not necessary to repeat the specific requirements associated with 
the hazard evaluation in the provision that directs each facility to 
conduct a hazard analysis.
    (Comment 250) Some comments state that the standard for hazard 
analysis in the preventive controls rule should both align with the 
reproposed requirements for hazard analysis set forth in the 
supplemental FSVP notice and be consistent with the statutory standard 
for hazard analysis in section 418(b)(1) of the FD&C Act.
    (Response 250) We have aligned the requirements of the animal food 
preventive controls rule and the proposed FSVP rule to the extent 
practicable, consistent with the applicable statutory requirements.

B. Proposed Sec.  507.33(b)--Hazard Identification

    We proposed that the hazard identification must consider hazards 
that include biological, chemical, and physical hazards. We proposed 
examples of biological hazards (e.g., microbiological hazards such as 
parasites, environmental pathogens, and other pathogens) and chemical 
hazards (e.g., radiological hazards and substances such as pesticide 
and drug residues, natural toxins, decomposition, unapproved food or 
color additives, and nutrient imbalances).
    In the preamble for the 2013 proposed preventive controls rule for 
animal food, we explained that nutrient imbalance hazards can result 
from excessive levels of a nutrient in animal food resulting in 
toxicity to the animal, or a nutrient deficiency in the animal food 
that can compromise the health of an animal and provided examples (78 
FR 64736 at 64782). These nutrient imbalance hazards are of particular 
concern for animals that consume one animal food type as their sole 
source of nutrition. Because different species have different 
nutritional needs, certain quantities of a nutrient that are needed by 
one species of animal could pose a health risk to another species of 
animal.
    In the preamble for the 2013 proposed preventive controls rule for 
animal food we also provided examples of physical hazards (e.g., 
stones, glass, or metal fragments that could inadvertently be 
introduced into animal food) (78 FR 64736 at 64782) but did not include 
these examples in the proposed regulatory text.
    We also proposed that the hazard identification must consider 
hazards that may be present in the animal food if they occur naturally 
or may be unintentionally introduced. In the 2014 preventive controls 
supplemental notice for animal food we proposed to add that the hazard 
analysis also must consider hazards that may be intentionally 
introduced for purposes of economic gain (proposed Sec.  
507.33(b)(2)(iii)).
    (Comment 251) As discussed in Comment 62, some comments express 
concern that the rule would refer to multiple levels of hazards (i.e., 
``hazard,'' ``known or reasonably foreseeable hazard,'' and 
``significant hazard'' (which we now refer to as ``hazard requiring a 
preventive control'') and ask us to provide sufficient clarity to be 
able to distinguish between these types of hazards.
    (Response 251) As discussed in Response 62, we have revised the 
requirements for hazard identification to emphasize that the hazard 
identification focuses on known or reasonably foreseeable hazards 
(rather than on all hazards).
    (Comment 252) Some comments ask us to include examples of physical 
hazards in the regulatory text.
    (Response 252) We have added stones, glass, and metal fragments as 
examples of physical hazards in the regulatory text. This is consistent 
with the regulatory text for biological and chemical hazards, even 
though the hazards listed in section 418(b)(1) of the FD&C Act include 
examples of chemical and biological hazards but do not include examples 
of physical hazards.
    (Comment 253) Some comments ask us to separately list some hazards 
(such as parasites and drug residues) rather than include them as 
examples of biological hazards and chemical hazards.
    (Response 253) We decline this request. Although section 
418(b)(1)(A) of the FD&C Act lists such items separately, we believe it 
is clearer to acknowledge that some of the hazards listed in the 
statute are in fact a subset of the broader categories of biological 
and chemical hazards.
    (Comment 254) Some comments ask us to rephrase the requirement for 
hazard identification to specify ``The hazard analysis must identify 
hazards'' rather than ``The hazard identification must consider 
hazards.''
    (Response 254) We decline this request. The provision is directed 
to the first step of a hazard analysis, i.e., hazard identification, 
rather than to the overall hazard analysis (which is addressed in Sec.  
507.33(a)). The purpose of the hazard identification is to consider the 
types of hazards listed as a step in determining whether there are any 
hazards requiring a preventive control; the suggestion of the comments 
implies that such hazards will always be identified. As discussed in 
Response 247, the outcome of a hazard analysis for an animal food 
product could be that there are no hazards requiring a preventive 
control.
    (Comment 255) Some comments ask us to revise the chemical hazard 
examples by replacing the term ``nutrient imbalances'' with ``nutrient 
deficiencies or toxicities.''

[[Page 56244]]

    (Response 255) We agree that the suggested revision adds clarity 
and have modified the regulatory text to replace ``nutrient 
imbalances'' with ``nutrient deficiencies or toxicities,'' and provide 
examples, such as ``inadequate thiamine in cat food,'' ``excessive 
vitamin D in dog food'', and ``excessive copper in food for sheep.''
    (Comment 256) Some comments assert that nutrient imbalances should 
not be addressed in an animal food safety plan because they pose no 
threat to humans.
    (Response 256) We disagree with these comments. The preventive 
controls rule for animal food is intended to protect animal health, as 
well as human health. Section 418 of the FD&C Act, which authorizes the 
preventive controls rules, applies to facilities registered under 
section 415 of the FD&C Act, which includes facilities that 
manufacture, process, pack, and hold animal food.
    (Comment 257) Some comments assert that while serious, ongoing 
imbalances of nutrients such as copper and selenium must be avoided 
with checks and balances, and perhaps product testing, there could be a 
multitude of other incidents that could occur without serious 
consequences and to address every possible scenario, by species, when 
the Agency is aware of a limited number of rare cases, is unreasonable. 
Some comments state that the notion that nutrient deficiencies or 
toxicities for animals are hazards likely to occur in the manufacture 
of animal food seems like a poor fit in this set of food safety 
regulations.
    (Response 257) The Agency has a history of animal food incidents 
resulting in recall of animal food and in animal illnesses and deaths 
from nutrient deficiencies or toxicities.
    From 2012 to 2014, FDA received multiple reports through its RFR 
that were attributable to animal food associated with nutrient 
deficiencies or toxicities. For example, during the 2010/2011 reporting 
period, 3.57 percent of 224 primary (industry and voluntary) RFR 
entries were associated with nutrient deficiencies or toxicities in 
animal food. During the 2012/2013 period, 2.97 percent of 202 entries 
were attributable to nutrient imbalances or toxicities in animal food 
(Refs. 14 and 16). Reports included low levels of thiamine in cat food; 
high levels of vitamin D in dog food; low levels of vitamin D in food 
for swine; high levels of vitamin D in food for guinea pigs, fish, and 
other animal species; high levels of calcium and phosphorus in food for 
broiler chickens and turkeys causing the death of several hundred young 
birds (Refs. 13 to 16); high levels of salt in food for broilers; high 
levels of protein/urea in food for cattle; and high levels of copper in 
food for sheep. Many of these animal foods with nutrient imbalances 
(deficiencies or toxicities) resulted in a recall of the affected 
animal food (Refs. 31 to 39).
    Moreover, an analysis of thiamin levels in randomly selected 
commercial canned cat foods was conducted during a period from December 
2012 through January 2013 (Ref. 40). The study found 13.3 percent of 
the cat foods tested fell below the minimum set for thiamine by AAFCO 
and 15.6 percent were below the recommended allowance of the National 
Research Council.
    We also disagree with the implication that facilities must address 
every possible hazard. Facilities must identify and evaluate known or 
reasonably foreseeable hazards for each type of animal food 
manufactured, processed, packed, or held at the facility to determine 
whether there are any hazards requiring a preventive control.
    (Comment 258) Some comments suggest that nutrient imbalances should 
be addressed through CGMPs.
    (Response 258) We disagree with these comments. We consider 
nutrient deficiencies and toxicities to be a type of chemical hazard 
that are appropriately addressed through preventive controls. If a 
facility identifies a nutrient deficiency or toxicity as a hazard that 
is known or reasonably foreseeable in an animal food and is a hazard 
that requires a preventive control, the facility must implement 
preventive controls for that hazard. The facility has flexibility in 
determining what preventive controls it needs to implement to control 
the hazard. Preventive controls for identified nutrient toxicity or 
deficiency hazards can include CGMPs, but the specific CGMP needs to be 
included in the food safety plan (or for a qualified facility, the 
documentation supporting an attestation under Sec.  507.7(a)(2)).
    (Comment 259) Some comments ask us to consider revising the 
proposed rule to include food allergens in animal food much in the same 
way that they have been proposed in the human food rule.
    (Response 259) We decline this request. We are not aware of 
evidence indicating that foodborne allergens pose a significant health 
risk to animals (78 FR 64736 at 64771). Animals with actual food 
allergies typically have digestive disorders or dermatologic 
conditions, not the anaphylactic reaction that humans have to the major 
food allergens (defined in section 201(qq) of the FD&C Act).
    (Comment 260) Some comments assert that physical hazards in animal 
food are not likely to cause any serious injuries to humans as the 
contaminant is not assimilated into edible tissue.
    (Response 260) We disagree with these comments. The rule defines 
the term hazard to include a physical agent that has the potential to 
cause injury or illness in animals, as well as humans. Physical hazards 
in animal food can cause illness or injury in animals.
    (Comment 261) Some comments ask us to delete ``decomposition'' from 
the list of chemical hazards in this provision.
    (Response 261) We decline this request. As discussed previously, 
decomposition of animal food consists of microbial breakdown of the 
normal food product tissues and the subsequent enzyme-induced chemical 
changes. These changes are manifested by abnormal odors, taste, 
texture, color, etc., and can lead to reduced food intake or rejection 
of the food by the intended animal species, resulting in illness or 
death (see 78 FR 64736 at 64782).
    (Comment 262) Some comments assert that we should not require all 
food safety plans to specifically address the likelihood of 
radiological hazards.
    (Response 262) The rule only requires that a facility consider 
whether radiological hazards are known or reasonably foreseeable, and 
we have described situations where radiological hazards could be 
considered to be known or reasonably foreseeable. A facility that 
appropriately determines that no radiological hazards are known or 
reasonably foreseeable would document that determination in its written 
hazard analysis but would not need to establish preventive controls and 
associated preventive control management components to address 
radiological hazards.
    (Comment 263) Some comments assert that predictable intentional 
hazards should be in the food safety plan but unexpected intentional 
hazards should be part of a food defense plan.
    (Response 263) This rule only requires a facility to consider 
intentionally introduced hazards when such hazards are introduced for 
purposes of economic gain. Hazards that may be intentionally introduced 
by acts of terrorism are the subject of the 2013 proposed intentional 
adulteration rule (78 FR 78014, December 24, 2013), which applies only 
to human foods.
    (Comment 264) Some comments disagree that the animal food 
preventive controls rule should address hazards that are intentionally 
introduced for purposes of economic gain (economically motivated 
adulteration).

[[Page 56245]]

Some of these comments assert that economically motivated adulteration 
is not a good fit for the hazard analysis and preventive controls 
framework because it is, in all but the rarest of circumstances, an 
issue of product integrity and quality, whereas food safety systems are 
designed and built to prevent or mitigate food safety hazards. Some 
comments state that traditional food safety hazards are primarily both 
identified and addressed at the facility level, but economically 
motivated adulteration is typically handled by the corporate parent 
company, where supply-chain management programs are typically located. 
These comments also assert that food safety-related economically 
motivated adulteration is extremely rare and that predicting 
economically motivated adulteration to prevent it is extremely 
difficult. Some comments assert there will be no measurable benefit to 
food safety by imposing requirements to consider economically motivated 
adulteration as part of a food safety plan and that doing so will 
consume limited resources without a corresponding increase in consumer 
protection. Other comments assert that there is no need to require a 
facility to identify hazards intentionally introduced for purposes of 
economic gain because the misbranding and adulteration provisions of 
the FD&C Act already sufficiently provide safeguards against economic 
gain.
    (Response 264) We agree with the comments that state that the 
requirement to consider hazards intentionally introduced for purposes 
of economic gain is narrow. Such hazards will be identified in rare 
circumstances, usually in cases where there has been a pattern of 
economically motivated adulteration in the past. In addition, we define 
hazards to only include those agents that have the potential to cause 
illness or injury. Economically motivated adulteration that affects 
product integrity or quality, for example, but not animal food safety, 
is out of the scope of this rule. We continue to believe that there is 
benefit in taking this preventive approach to economically motivated 
adulteration and not relying solely on enforcing the preexisting 
misbranding and adulteration provisions of the FD&C Act after a 
violation occurs.
    As discussed in sections XL through XLVII, we are finalizing 
supply-chain program provisions. It is consistent with the framework of 
this rule for a facility to address hazards requiring a preventive 
control that may be intentionally introduced for purposes of economic 
gain through the facility's supply-chain program.
    (Comment 265) Some comments express concern about identifying 
hazards that may be intentionally introduced for purposes of economic 
gain because there are potentially an unlimited number of unknown or 
yet-to-be identified hazards that could be intentionally introduced for 
purposes of economic gain by an unscrupulous supplier. These comments 
disagree with our attempt to narrow the field of potential scenarios 
for economically motivated adulteration to circumstances where there 
has been a pattern of such adulteration in the past.
    Some comments assert that our attempt to narrow the field of 
potential scenarios for economically motivated adulteration is both too 
broad and too narrow at the same time. These comments assert that our 
attempt is too broad, because we expect facilities to consider patterns 
of adulteration from the past ``even though the past occurrences may 
not be associated with the specific supplier or the specific food 
product'' and a requirement to consider every potential product and 
potential supplier makes the task open ended. These comments further 
assert that our attempt is too narrow, because a focus on patterns of 
adulteration in the past is unlikely to reveal potential future 
instances of economically motivated adulteration and because those 
intending to defraud purchasers for economic gain are trying to avoid 
detection. According to these comments, once an animal food safety 
related instance of economically motivated adulteration is uncovered, 
perpetrators quickly move to carry out their fraudulent activities in a 
different way. Some comments assert that there are alternative ways to 
control hazards that may be intentionally introduced for purposes of 
economic gain without specific regulatory requirements, such as by 
having an effective supplier approval program with appropriate 
qualification and verification activities; through business-to-business 
relations, expectations, and contracts; and through a vulnerability 
assessment and control plan tailored specifically to economically 
motivated adulteration.
    (Response 265) We disagree that the requirement is too broad. A 
facility must conduct a hazard analysis for each type of animal food 
manufactured, processed, packed, or held at the facility. There is no 
requirement to consider every potential product or potential supplier. 
We also disagree that the requirement is too narrow. Some individuals 
intending to defraud purchasers for economic gain will develop entirely 
novel ways of adulterating food to suit their purposes. We agree that 
these circumstances may not lend themselves to the preventive approach 
required here. We encourage, but do not mandate, that facilities adopt 
other measures they deem appropriate to mitigate the risks of 
economically motivated adulteration that this rulemaking does not 
address. Still, the repeated use of melamine over the years, in animal 
foods and in foods for people, demonstrates that patterns of 
economically motivated adulteration can emerge and should be considered 
as part of a hazard analysis.
    (Comment 266) Some comments ask us to limit the requirement to 
identify hazards that may be introduced for purposes of economic gain 
to only those hazards that pose a risk to public health for which there 
has been a pattern in the past. Some comments assert that in those few 
instances where a hazard was intentionally introduced the underlying 
intention was to defraud rather than to cause harm, and the food safety 
hazard was an unintended consequence. Some comments ask us to focus the 
hazard identification solely on inbound products, because it is obvious 
that hazards introduced by the facility itself will not be prevented 
through a hazard analysis. Some comments ask us to narrow the scope of 
the requirement by specifying that facilities focus on three 
situations: (1) Situations in which there has been a pattern of similar 
adulteration in the past; (2) animal foods or ingredients for which 
quality assurance methods may not sufficiently characterize the animal 
food or ingredient to assure its identity, and; (3) animal foods or 
ingredients for which there are substitutes that are likely to be 
harmful that would be considered obvious to one skilled in food 
science.
    (Response 266) We decline to make the changes suggested in these 
comments because they are unnecessary. Because of our definition of 
hazard, the requirement is already limited to economically motivated 
adulteration that is reasonably likely to cause illness or injury. 
Under the final rule, a facility does not need to identify a hazard 
related to economically motivated adulteration when there is no risk to 
public health or when the economically motivated adulteration is not 
known or reasonably foreseeable.
    We agree that the three circumstances suggested by the comments are 
an appropriate focus for facilities who seek guidance on how to 
approach the requirements, but decline the request to specify these 
limitations of the scope in the regulatory text. As already noted, some 
comments assert that our attempt to narrow the field of potential 
scenarios for economically motivated adulteration

[[Page 56246]]

is both too broad and too narrow at the same time. (See Comment 265.) 
Although we continue to believe that the instances in which a facility 
will identify a hazard intentionally introduced for economic gain will 
be rare, we also consider that limiting the scope of the requirement in 
the regulatory text would be both prejudging the future and 
inconsistent with the public health objectives of this rule.
    (Comment 267) Some comments ask us to allow implementation of the 
major provisions in FSMA before establishing requirements to address 
economically motivated adulteration. These comments assert that 
economically motivated adulteration requires a completely different 
paradigm than unintentional adulteration. In addition, because 
economically motivated adulteration is typically addressed through 
product specifications, supplier relationships, and good business 
practices, implementation of these other provisions of the animal food 
preventive controls rule are likely to have a positive effect on 
preventing economically motivated adulteration.
    (Response 267) We disagree that economically motivated adulteration 
requires a completely different paradigm than unintentional 
adulteration. Hazards intentionally introduced for economic gain are 
addressed here with the same preventive framework as every other 
hazard. As such, we do not see a compelling reason to delay 
implementation of the requirements to address economically motivated 
adulteration.

C. Proposed Sec.  507.33(c) and (d)--Evaluation of Whether a Hazard 
Requires a Preventive Control

    We proposed that the hazard analysis must include an evaluation of 
the identified hazards to assess the severity of the illness or injury 
if the hazard were to occur and the probability that the hazard will 
occur in the absence of preventive controls; and environmental 
pathogens whenever an animal food is exposed to the environment prior 
to packaging and the packaged animal food does not receive a treatment 
that would significantly minimize the pathogen (proposed Sec.  
507.33(c)(2)). We also proposed that the hazard evaluation must 
consider the effect of the following on the safety of the finished 
animal food for the intended consumer: (1) The formulation of the 
animal food; (2) the condition, function, and design of the facility 
and equipment; (3) raw materials and ingredients; (4) transportation 
practices; (5) manufacturing/processing procedures; (6) packaging 
activities and labeling activities; (7) storage and distribution; (8) 
intended or reasonably foreseeable use; (9) sanitation, including 
employee hygiene; and (10) any other relevant factors (proposed Sec.  
507.33(d)(1) through (10)).
    (Comment 268) Some comments ask us to revise the requirement to 
include an evaluation of environmental pathogens to avoid the 
implication that an intervention is needed when there may be other 
controls (such as pH or formulation) that would significantly minimize 
or prevent the pathogen. These comments suggest that we revise the 
provision to require that a hazard evaluation include an evaluation of 
environmental pathogens whenever a food is exposed to the environment 
prior to packaging and the packaged food does not receive a treatment 
``or otherwise include a control measure'' that would significantly 
minimize the pathogen.
    (Response 268) We have revised the provision on the hazard 
evaluation for environmental pathogens to specify that the packaged 
animal food does not receive a treatment or otherwise include a control 
measure (such as a formulation lethal to the pathogen) that would 
significantly minimize the pathogen. We agree that controls such as 
formulation can function as a ``kill step'' and that the provision 
should make clear that such controls can be used in lieu of 
``treatment.''
    (Comment 269) Some comments ask us to clarify what we meant by 
``other relevant factors'' and note that natural disasters (which we 
previously discussed) (78 FR 64736 at 64785) are ``usually exceptional 
events'' that are best managed in a facility crisis management plan. 
Other comments ask us to specify that the hazard evaluation must 
consider any relevant geographic, temporal, agricultural, or other 
factors that may affect the severity or probability of the hazard.
    (Response 269) We included ``other relevant factors'' to emphasize 
that the list of factors in the provision is not an exhaustive list and 
that a facility is responsible for considering those factors that play 
a role in its determination of whether a potential hazard is a hazard 
requiring a preventive control, regardless of whether those factors are 
listed in the provision. A facility that already addresses 
circumstances such as natural disasters in other plans may consider the 
applicable part of those plans to be part of its food safety plan (see 
Sec.  507.212).
    We agree that geographic, temporal, and agricultural factors are 
examples of ``other relevant factors.'' For example, hazards such as 
aflatoxin are subject to a weather-dependent effect in that aflatoxin 
levels in some RACs are more of a problem in some years than in others. 
We have added the temporal nature of some hazards associated with some 
RACs as an example of ``other relevant factors'' to consider (see Sec.  
507.33(d)(10)).
    (Comment 270) Some comments ask us to specify that the hazard 
evaluation be more specific about issues relevant to raw materials and 
ingredients, including how raw materials are selected and shipped, how 
suppliers are evaluated, and how shipments are inspected on receipt.
    (Response 270) We decline this request. When a hazard requiring a 
preventive control in a raw material or other ingredient is controlled 
before receipt, the receiving facility would address such specifics in 
the supply-chain program that would be required as a preventive control 
(see subpart E).
    (Comment 271) Some comments assert that the proposed requirements 
for hazard evaluation could be interpreted in many ways. For example, a 
facility could conclude that the presence of a hand sink or boot dip 
prior to entering the processing area will reduce the likelihood of 
environmental pathogens and that environmental pathogens are not a 
significant hazard, whereas a regulator could interpret this provision 
to mean that a facility must always consider an environmental pathogen 
to be a significant hazard when the criteria in the provision are met, 
unless the facility can provide evidence to the contrary.
    (Response 271) We agree that the requirements for hazard evaluation 
are subject to alternative interpretations. This is often the case, 
particularly when a regulation is new. The provision specifies that a 
facility must evaluate whether an environmental pathogens is a hazard 
requiring a preventive control in particular circumstances, i.e., 
whenever a finished animal food (for which an environmental pathogen is 
identified as a hazard) is exposed to the environment prior to 
packaging and the packaged animal food does not receive a treatment or 
otherwise include a control measure (such as a formulation lethal to 
the pathogen) that would significantly minimize the pathogen. The 
written hazard analysis must be prepared (or its preparation overseen 
by) a preventive controls qualified individual (see Sec.  507.31(b) and 
(c)(1)). The preventive controls qualified individual for a facility 
that determines that an environmental pathogen is not a hazard 
requiring a preventive control in

[[Page 56247]]

such circumstances must document that determination, and a regulator 
would consider the adequacy of the documented determination before 
reaching a conclusion as to whether the facility had failed to satisfy 
the requirements. However, the use of a hand sink or boot dip prior to 
entering the processing areas to reduce the likelihood of environmental 
pathogens may also be considered to be part of the sanitation controls 
for the environmental pathogen.
    (Comment 272) Some comments ask us to focus on language that will 
clearly differentiate between functions, processes, and controls for 
facilities with food safety plans that identify microbial hazards and 
those that do not identify microbial hazards, and other known or 
reasonably foreseeable hazards. These comments assert that sanitation 
of objects and surfaces may be appropriate for the former, but not 
necessarily for the latter.
    (Response 272) The facility is responsible for conducting a hazard 
analysis, and if hazards are identified that require a preventive 
control, the facility must consider the effect of sanitation on the 
safety of the finished animal food for the intended animal (see Sec.  
507.33(d)). Based on the outcome of its hazard evaluation, the facility 
may determine that sanitation is not an appropriate preventive control 
for the hazards it identified.
    (Comment 273) Some comments assert that a food safety plan and 
hazard analysis should not include numerous hazards and hazard analysis 
steps. Some comments assert that hazard analysis should not be as 
detailed (stringent) for animal food as it is for human food. These 
comments maintain that prerequisite programs, which reduce the 
likelihood of a potential hazard to the point where the hazard is not 
reasonably likely to occur, would satisfy the requirement that the 
hazard be adequately controlled, making it unnecessary for a facility 
to include the identified hazards in its hazard analysis and preventive 
controls. Other comments assert that many hazards can be exclusively 
controlled through prerequisite programs without a need for CCPs.
    (Response 273) While known and reasonably foreseeable hazards and 
the outcome of a hazard analysis for human food and animal food may not 
be identical, in each case the purpose of a hazard analysis is to 
identify and evaluate known or reasonably foreseeable hazards for the 
type of food manufactured, processed, packed, or held to determine 
whether there are any hazards requiring a preventive control. As 
previously discussed in the 2013 animal food preventive control 
proposed rule (78 FR 64736 at 64781), the process of identifying and 
evaluating the hazards that may occur for specific types of animal food 
handled in a facility provides an efficient means for keeping track of 
multiple hazards that may occur in a facility that handles several 
types of animal food. Such a process also provides an efficient means 
for ensuring that preventive controls are applied to specific animal 
food products when required. If a facility identifies a hazard 
requiring a preventive control, the facility must determine an 
appropriate preventive control and include that preventive control in 
its food safety plan. A facility that establishes other controls (such 
as those that the comments describe as ``prerequisite programs'') for 
hazards that are not, based on the outcome of the facility's hazard 
analysis, ``hazards requiring a preventive control'' would not need to 
establish preventive control management components for such controls. 
However, some controls previously established in ``prerequisite 
programs'' would be considered ``preventive controls.'' We provide some 
flexibility for facilities with respect to how they manage preventive 
controls, and the preventive control management components may be 
different for hazards that have been managed as ``prerequisite 
programs'' compared to those managed with CCPs. The same principles 
would apply for the hazards a facility identifies as needing a 
preventive control.
    (Comment 274) Some comments assert that the statutory language 
within FSMA does not mandate that covered animal food and pet food 
facilities implement regulatory HACCP plans. These comments further 
urge us to remove reference to HACCP.
    (Response 274) We agree that section 103 of FSMA does not mandate 
HACCP regulations; however, we have concluded that HACCP is the 
appropriate framework to reference in interpreting and implementing 
section 103 of FSMA. For discussion, see section II.C.2. of the 2013 
proposed preventive controls rule for human food (78 FR 3646 at 3660).
    (Comment 275) Some comments ask us to allow consideration of both 
severity and probability in the scientific hazard analysis as this 
would be consistent with international standards.
    (Response 275) Section 507.33(c)(1) requires that a hazard 
evaluation must include an assessment of the severity of the injury or 
illness if a hazard were to occur and the probability that the hazard 
will occur in the absence of preventive controls.
    For additional discussion of comments on hazard analysis, see 
section XXV in the final rule for preventive controls for human food 
published elsewhere in this issue of the Federal Register.

XXVI. Subpart C: Comments on Proposed Sec.  507.36--Preventive Controls 
(Final Sec.  507.34)

    We proposed requirements to identify and implement preventive 
controls to provide assurances that significant hazards will be 
significantly minimized or prevented and the animal food manufactured, 
processed, packed, or held by the facility will not be adulterated 
under section 402 of the FD&C Act. Some comments support the proposed 
requirements without change. For example, some comments agree that 
preventive controls must be written and include process controls, 
sanitation controls, a recall plan, and other controls as appropriate 
and necessary. Some comments that support the proposed provisions 
suggest alternative or additional regulatory text or ask us to clarify 
how we will interpret the provision.
    In the following sections, we discuss comments that ask us to 
clarify the proposed requirements or that disagree with, or suggest one 
or more changes to, the proposed requirements. After considering these 
comments, we have revised the proposed requirements as shown in table 
11, with editorial and conforming changes as shown in table 31.

Table 11--Revisions to the Proposed Requirements for Preventive Controls
------------------------------------------------------------------------
            Section                Description            Revision
------------------------------------------------------------------------
507.34(c)(1)..................  Process controls.  Clarify that the
                                                    requirements for
                                                    process controls
                                                    depend on the role
                                                    of the process
                                                    control in the food
                                                    safety system.
------------------------------------------------------------------------


[[Page 56248]]

A. Proposed Sec.  507.36(a)--Requirement To Identify and Implement 
Preventive Controls (Final Sec.  507.34(a))

    We proposed that you must identify and implement preventive 
controls, including at critical control points, if any, to provide 
assurances that significant hazards will be significantly minimized or 
prevented and the animal food manufactured, processed, packed, or held 
by your facility will not be adulterated under section 402 of the FD&C 
Act. We also proposed that these preventive controls include controls 
at CCPs, if there are any CCPs, and controls, other than those at CCPs, 
that are also appropriate for animal food safety.
    Some comments support the flexibility provided to facilities to 
implement preventive controls that are appropriate to the facility and 
the animal food. Other comments support the clarification, in the 2014 
supplemental notice, that not all preventive controls are established 
at CCPs and that some food safety plans will not have CCPs. We are 
finalizing the provision as proposed with the editorial and conforming 
changes in table 31.

B. Proposed Sec.  507.36(b)--Requirement for Written Preventive 
Controls (Final Sec.  507.34(b))

    We proposed that preventive controls must be written.
    (Comment 276) Some comments ask us to clarify whether documentation 
of treatment by a ``custom processor'' would be accepted as a ``written 
preventive control'' when the ``custom processor'' controls the hazard.
    (Response 276) The question posed by these comments highlights the 
difference between the records required in the food safety plan and the 
records documenting the implementation of the food safety plan. The 
``written preventive controls'' are part of the food safety plan, 
whereas the records documenting treatment are implementation records. 
Implementation records documenting treatment, whether by a facility or 
its ``custom processor,'' would not satisfy the requirements for 
written preventive controls. However, specifying that the preventive 
control for a specific hazard is a particular treatment by a ``custom 
processor,'' along with information that describes the treatment, would 
satisfy the requirement for written preventive controls.

C. Proposed Sec.  507.36(c)(1)--Process Controls (Final Sec.  
507.34(c)(1))

    We proposed that preventive controls include process controls as 
appropriate to the facility and the animal food. Process controls 
include procedures, practices, and processes to ensure the control of 
parameters during operations such as heat processing, irradiating, and 
refrigerating animal foods. Process controls must include, as 
appropriate to the applicable control, parameters associated with the 
control of the hazard, and the maximum or minimum value, or combination 
of values, to which any biological, chemical, or physical parameter 
must be controlled to significantly minimize or prevent a significant 
hazard.
    (Comment 277) Some comments state that assigning a parameter and 
associated minimum and maximum values for some process controls (such 
as refrigeration (including freezing), or water activity) may be 
possible, but not be necessary for food safety. These comments ask us 
to require minimum and maximum values to be assessed against the 
applicable food safety need, or otherwise make clear that the 
implications of not controlling minimum and maximum values must be 
assessed in light of the circumstances. Other comments express concern 
that ``as appropriate to the applicable control'' could be interpreted 
as suggesting that if it is merely feasible to establish parameters for 
a process control, they must be established. Other comments express 
concern that the proposed requirement suggests that if a parameter is 
not ``controlled,'' a regulator could conclude that the facility is not 
in compliance with the rule because it necessarily has not 
significantly minimized or prevented a significant hazard.
    Some comments recommend incorporating recognition that the degree 
of rigor in application of subpart C parameters should be applied on a 
sliding scale, commensurate with the nature of the risk and the 
preventive control used. The comments request that the language in this 
section is altered to indicate that the parameters will not always be 
applicable.
    (Response 277) See Response 293. We have revised the regulatory 
text to specify that process controls must include parameters and 
minimum or maximum values as appropriate to both the nature of the 
applicable control and its role in the facility's food safety system. 
We decline the request to indicate that parameters of subpart C will 
not always be applicable, as the revised regulatory text provides 
adequate flexibility for a facility to determine what preventive 
controls, including process controls, are appropriate to the facility 
and its animal food, if a hazard requiring a preventive control is 
identified.
    (Comment 278) Some comments ask us to delete the phrase ``to 
significantly minimize or prevent a significant hazard.''
    (Response 278) We decline this request. ``Significantly minimize or 
prevent a significant hazard'' (which we have revised to 
``significantly minimize or prevent a hazard requiring a process 
control'') is the standard for controlling the hazards. Although the 
phrase could be viewed as redundant with the standard in the 
requirement to identify and implement preventive controls (Sec.  
507.34(a)(1)), repeating that standard in the requirements for 
parameters and the minimum or maximum values associated with control of 
the hazard emphasizes the standard, which is appropriate for process 
controls.

D. Proposed Sec.  507.36(c)(2)--Sanitation Controls (Final Sec.  
507.34(c)(2))

    We proposed that preventive controls include, as appropriate to the 
facility and the animal food, sanitation controls that include 
procedures, practices, and processes to ensure that the facility is 
maintained in a sanitary condition adequate to significantly minimize 
or prevent hazards such as environmental pathogens and biological 
hazards due to employee handling. We also proposed that sanitation 
controls must include procedures, practices, and processes for the 
cleanliness of animal food-contact surfaces, including animal food-
contact surfaces of utensils and equipment, and procedures for the 
prevention of cross-contamination from insanitary objects and from 
personnel to animal food, animal food packaging material, and other 
animal food-contact surfaces and from raw product to processed product.
    (Comment 279) One comment states that sanitation is not always a 
feasible step for facilities handling animal food, especially in dry 
blending facilities and dry storage operations. The comment asks us to 
remove the reference to ``sanitary condition'' and replace it with 
language consistent with the GMP section such as ``to ensure the 
facility is adequately cleaned and properly maintained to significantly 
minimize or prevent hazards.''
    (Response 279) We decline this request. The sanitation controls are 
flexible so that a facility can determine what sanitation controls are 
necessary for their facility and animal food if they identify a hazard 
requiring sanitation controls as a preventive control. Replacing the 
term ``sanitary condition'' with the suggested language would not 
improve the flexibility of the sanitation control requirements.

[[Page 56249]]

    (Comment 280) Some comments assert that sanitation controls are not 
necessary to prevent any hazards in distribution facilities where 
animal food-contact surfaces are not present. Other comments assert 
that sanitation controls should be required in all cases (rather than 
``as appropriate'') given their central importance.
    (Response 280) Under the framework established by FSMA, and 
implemented in this rule, each facility determines through its hazard 
analysis when sanitation controls are necessary to control a hazard 
requiring a preventive control. The rule neither establishes 
circumstances (such as in distribution centers) where sanitation 
controls are not necessary nor prejudges whether sanitation controls 
are necessary in specific circumstances. Although we do not expect that 
facilities such as distribution centers would determine through their 
hazard analysis that sanitation controls are required, we do expect all 
animal food establishments that are subject to the CGMP requirements 
established in subpart B to fully comply with the applicable 
requirements for sanitation.
    (Comment 281) One comment states that sanitation is discussed in 
two sections, as a CGMP and as a preventive control, and asks that all 
of the discussion related to sanitation is moved to one section.
    (Response 281) The two sections discuss sanitation for different 
purposes. The requirements for general sanitation are located in the 
CGMP regulations, which may be considered prerequisites to the 
preventive controls. The requirements for sanitation as a preventive 
control are specific for controlling an identified hazard. Sanitation 
activities conducted at a facility may be different depending on 
whether the sanitation activity is used as general facility sanitation 
or specifically to control a hazard. Also, sanitation as a preventive 
control is subject to the management components of Sec.  507.39.

E. Proposed Sec.  507.36(c)(3)--Supplier Controls (Final Sec.  
507.34(c)(3))

    We proposed that supplier controls include the supplier program. 
See the discussion of comments on the supply-chain program, now in 
subpart E, in sections XL through XLVII.

F. Proposed Sec.  507.36(c)(4)--Recall Plan (Final Sec.  507.34(c)(4))

    We proposed that preventive controls include, as appropriate, a 
recall plan as would be required by proposed Sec.  507.38. See the 
discussion of comments on the recall plan in section XXVIII.

G. Proposed Sec.  507.36(c)(5)--Other Controls (Final Sec.  
507.34(c)(5))

    We proposed that preventive controls include any other procedures, 
practices, and processes necessary to satisfy the requirements of 
paragraph (a) of this section. Examples of other controls include 
hygiene training and other current good manufacturing practices.
    (Comment 282) Some comments ask us to specify that preventive 
controls include controls on raw materials and other ingredients.
    (Response 282) The final rule specifies that preventive controls 
include supply-chain controls as appropriate to the facility and the 
animal food. The request of these comments is addressed by the 
requirements for the supply-chain program (see Sec.  507.34(c)(3) and 
subpart E).
    (Comment 283) One comment asks us to require compliance with the 
good manufacturing and feeding practices that apply to GRAS substances, 
found in Sec.  582.1(b), as a preventive control.
    (Response 283) Facilities required to register that manufacture, 
process, pack, or hold GRAS substances are subject to this final rule, 
including applicable preventive controls requirements. Preventive 
controls are intended to address certain known or reasonably 
foreseeable hazards, not an animal food facility's compliance with the 
good manufacturing and feeding practices of Sec.  582.1(b), although a 
facility may determine that a good manufacturing practice is a 
preventive control for a particular hazard.

XXVII. Subpart C: Circumstances in Which the Owner, Operator or Agent 
in Charge of a Manufacturing/Processing Facility Is Not Required To 
Implement a Preventive Control (Final Sec. Sec.  507.36 and 507.37)

    In the 2014 supplemental notice, we provided an opportunity for 
public comment on potential requirements for a supplier program as a 
preventive control, including comments on when a supplier program would 
not be required. As discussed in more detail in section XL, we have 
revised the phrase ``supplier program'' to ``supply-chain program'' 
throughout the regulatory text. As summarized in table 12 and discussed 
more fully in the following paragraphs, after considering comments on 
when a supplier program would not be required, we are establishing two 
new provisions. Although both sets of provisions have an effect on the 
required supply-chain program, they will be implemented outside the 
framework of a supply-chain program.

     Table 12--Summary of Applicable Provisions Regarding When the Owner, Operator, or Agent in Charge of a
               Manufacturing/Processing Facility Is Not Required To Implement a Preventive Control
----------------------------------------------------------------------------------------------------------------
  Final section designation        Proposed section designation            Description             Revision
----------------------------------------------------------------------------------------------------------------
507.36(a)(1)................  N/A..................................  A manufacturer/          N/A.
                                                                      processor is not
                                                                      required to implement
                                                                      a preventive control
                                                                      if it determines and
                                                                      documents that the
                                                                      type of animal food
                                                                      could not be consumed
                                                                      without application of
                                                                      an appropriate control.
507.36(a)(2)................  507.37(a)(1)(ii)(C)..................  A manufacturer/          Includes a
                                                                      processor is not         requirement for
                                                                      required to implement    documentation
                                                                      a preventive control     that the animal
                                                                      if it relies on its      food is ``not
                                                                      customer, who is         processed to
                                                                      subject to the           control
                                                                      requirements for         [identified
                                                                      hazard analysis and      hazard].''
                                                                      risk-based preventive
                                                                      controls in subpart C,
                                                                      to ensure that the
                                                                      identified hazard will
                                                                      be significantly
                                                                      minimized or prevented
                                                                      and both: (1)
                                                                      Discloses in documents
                                                                      accompanying the
                                                                      animal food that the
                                                                      animal food is ``not
                                                                      processed to control
                                                                      [identified hazard]''
                                                                      and (2) annually
                                                                      obtains from its
                                                                      customer written
                                                                      assurance that the
                                                                      customer has
                                                                      established and is
                                                                      following procedures
                                                                      that will
                                                                      significantly minimize
                                                                      or prevent the
                                                                      identified hazard.

[[Page 56250]]

 
507.36(a)(3)................  .....................................  A manufacturer/          N/A.
                                                                      processor is not
                                                                      required to implement
                                                                      a preventive control
                                                                      if it relies on its
                                                                      customer who is not
                                                                      subject to the
                                                                      requirements for
                                                                      hazard analysis and
                                                                      risk-based preventive
                                                                      controls in subpart C
                                                                      to provide assurance
                                                                      it is manufacturing,
                                                                      processing, or
                                                                      preparing the animal
                                                                      food in accordance
                                                                      with applicable animal
                                                                      food safety
                                                                      requirements and it:
                                                                      (1) Discloses in
                                                                      documents accompanying
                                                                      the animal food, in
                                                                      accordance with the
                                                                      practice of the trade,
                                                                      that the animal food
                                                                      is ``not processed to
                                                                      control [identified
                                                                      hazard]'' and (2)
                                                                      annually obtains from
                                                                      its customer written
                                                                      assurance that it is
                                                                      manufacturing,
                                                                      processing, or
                                                                      preparing the animal
                                                                      food in accordance
                                                                      with applicable animal
                                                                      food safety
                                                                      requirements.
507.36(a)(4)................  507.37(a)(1)(ii)(C)..................  A manufacturer/           Addresses
                                                                      processor is not         the circumstance
                                                                      required to implement    where an entity
                                                                      a preventive control     (other than the
                                                                      if it relies on its      facility's
                                                                      customer to ensure       customer) in the
                                                                      that the animal food     distribution
                                                                      will be processed to     chain controls
                                                                      control the identified   the hazard
                                                                      hazard by an entity in   Includes
                                                                      the distribution chain   a requirement for
                                                                      subsequent to the        documentation
                                                                      customer and both: (1)   that the animal
                                                                      Discloses in documents   food is ``not
                                                                      accompanying the         processed to
                                                                      animal food that the     control
                                                                      animal food is ``not     [identified
                                                                      processed to control     hazard].''
                                                                      [identified hazard]''
                                                                      and (2) annually
                                                                      obtains from its
                                                                      customer written
                                                                      assurance that the
                                                                      customer will both
                                                                      disclose the
                                                                      information that the
                                                                      animal food is ``not
                                                                      processed to control
                                                                      [identified hazard]''
                                                                      and will only sell to
                                                                      another entity that
                                                                      agrees, in writing, it
                                                                      will either follow
                                                                      procedures that will
                                                                      significantly minimize
                                                                      or prevent the
                                                                      identified hazard (if
                                                                      the entity is subject
                                                                      to subject to the
                                                                      requirements for
                                                                      hazard analysis and
                                                                      risk-based preventive
                                                                      controls in subpart C)
                                                                      or manufacture,
                                                                      process, or prepare
                                                                      the animal food in
                                                                      accordance with
                                                                      applicable animal food
                                                                      safety requirements
                                                                      (if the entity is not
                                                                      subject to the
                                                                      requirements for
                                                                      hazard analysis and
                                                                      risk-based preventive
                                                                      controls in subpart C)
                                                                      or obtain a similar
                                                                      written assurance from
                                                                      the entity's customer.
507.36(a)(5)................  N/A..................................  A manufacturer/          N/A.
                                                                      processor is not
                                                                      required to implement
                                                                      a preventive control
                                                                      if it has established,
                                                                      documented, and
                                                                      implemented a system
                                                                      that ensures control,
                                                                      at a subsequent
                                                                      distribution step, of
                                                                      the hazards in the
                                                                      animal food product it
                                                                      distributes and
                                                                      documents the
                                                                      implementation of that
                                                                      system.
507.36(b)...................  507.37(g)(3).........................  Records documenting the  Includes a
                                                                      applicable               requirement for
                                                                      circumstances in Sec.    documentation of
                                                                       507.36(a).              the additional
                                                                                               circumstances in
                                                                                               which a
                                                                                               manufacturer/
                                                                                               processor is not
                                                                                               required to
                                                                                               implement a
                                                                                               preventive
                                                                                               control.
507.36(c)...................  N/A..................................  If a customer of the     N/A.
                                                                      manufacturer/processer
                                                                      has determined that
                                                                      the identified hazard
                                                                      is not a hazard in the
                                                                      animal food intended
                                                                      for use for a specific
                                                                      animal species, the
                                                                      customer may provide
                                                                      this determination
                                                                      (including animal
                                                                      species and why the
                                                                      identified hazard is
                                                                      not a hazard) in its
                                                                      written assurance
                                                                      under Sec.
                                                                      507.36(a)(2)(ii)
                                                                      instead of providing
                                                                      assurance of
                                                                      procedures established
                                                                      and followed that will
                                                                      significantly minimize
                                                                      or prevent the
                                                                      identified hazard.
507.36(d)...................  N/A..................................  If a customer of the     N/A.
                                                                      customer of the
                                                                      manufacturer/processer
                                                                      (i.e., another entity
                                                                      in the distribution
                                                                      chain) has determined
                                                                      that the identified
                                                                      hazard is not a hazard
                                                                      in the animal food
                                                                      intended for use for a
                                                                      specific animal
                                                                      species, the entity
                                                                      may provide this
                                                                      determination
                                                                      (including animal
                                                                      species and why the
                                                                      identified hazard is
                                                                      not a hazard) in its
                                                                      written assurance
                                                                      under Sec.
                                                                      507.36(a)(4)(ii)(B
                                                                      instead of providing
                                                                      assurance of
                                                                      procedures established
                                                                      and followed that will
                                                                      significantly minimize
                                                                      or prevent the
                                                                      identified hazard.

[[Page 56251]]

 
507.37......................  N/A..................................  A facility that          N/A.
                                                                      provides a written
                                                                      assurance under Sec.
                                                                      507.36(a)(2), (3), or
                                                                      (4) must act
                                                                      consistently with the
                                                                      assurance and document
                                                                      its actions taken to
                                                                      satisfy the written
                                                                      assurance.
----------------------------------------------------------------------------------------------------------------

    The first provision allows a manufacturer/processor to not 
implement a preventive control if the manufacturer/processor determines 
and documents that the type of animal food could not be consumed 
without application of the appropriate control by an entity in the 
supply or distribution chain other than that manufacturer/processor 
(see Sec.  507.36(a)(1)). We describe comments leading to this 
provision, and our response to those comments, in Comment 284 and 
Response 284 respectively. Although we are establishing these 
provisions outside the framework of the supply-chain program, these 
provisions continue to play a role in the requirements for a supply-
chain program, because they also provide an exception to the 
requirements for a manufacturer/processor to establish and implement a 
supply-chain program.
    The second provision relates to comments we received on a proposed 
exception to the requirement for a manufacturer/processor to establish 
and implement a supplier program (proposed Sec.  507.37(a)(1)(ii)(C)). 
(See Comment 285). Under proposed Sec.  507.37(a)(1)(ii)(C), a 
receiving facility would not have been required to have a supplier 
program if it relied on its customer to control the hazard and annually 
obtained from its customer written assurance that the customer has 
established and is following procedures (identified in the written 
assurance) that will significantly minimize or prevent the hazard. As 
discussed in Response 285, we are replacing this provision with several 
provisions that apply when a manufacturer/processor identifies a hazard 
requiring a preventive control (``identified hazard''), does not 
control the identified hazard, but can demonstrate and document that 
the identified hazard will be controlled by an entity in its 
distribution chain. A manufacturer/processor that satisfies the 
criteria in these provisions will not be required to implement a 
preventive control for the identified hazard. Under these provisions, 
the combination of three requirements will provide adequate assurance 
that the animal food will be processed to control the identified hazard 
before it reaches consumers. These requirements are: (1) Documentation 
provided by the manufacturer/processor to its direct customer that the 
animal food is ``not processed to control [identified hazard]''; (2) 
written assurances from customers regarding appropriate procedures to 
ensure that the animal food will receive further processing to control 
the identified hazards; and (3) provisions relating to accountability 
for written assurances. (In these provisions, ``customer'' means a 
commercial customer, not a consumer.)
    (Comment 284) Some comments express concern about the ability for 
distributors/cooperatives identify the individual raw material or other 
ingredient supplier when the supplier that applied the control is more 
than one step back in the food chain. Some comments assert that 
receiving facilities should not be required to verify suppliers with 
which they do not have a direct commercial relationship. For example, 
in the case of the soybean supply chain, the U.S. processing facility 
likely has no direct relationship with the many farms involved in the 
growing and harvesting of the soybeans. Some comments ask for an 
exemption from supplier verification activities for animal foods such 
as soybeans because it is problematic to have a requirement that 
potentially could necessitate trace back to farms.
    (Response 284) We are establishing a provision, applicable to both 
the supply chain and the distribution chain of a manufacturer/
processor, for a circumstance when a manufacturer/processor does not 
need to implement a preventive control. We are providing that a 
manufacturer/processor does not need to implement a preventive control 
if it determines and documents that the type of animal food could not 
be consumed without application of the appropriate control (see Sec.  
507.36(a)(1)). However, depending on the facility, the raw material or 
other ingredient, and the type of animal food produced by the 
manufacturer/processor, there may be some circumstances where a 
manufacturer/processor could determine that a particular animal food 
that passes through its facility satisfies the criterion ``could not be 
consumed without application of the appropriate control.'' In other 
cases, a facility may have determined through its hazard analysis that 
there are no hazards requiring a preventive control, and will not 
consider whether one of the circumstances in new Sec.  507.36 apply.
    As a consequential addition, new Sec.  507.36(b) specifies the 
records that a manufacturer/processor would need to satisfy the 
documentation requirements established in new Sec.  507.36(a)(1), and 
we have added new Sec.  507.36(b) to the list of implementation records 
(Sec.  507.55) that are subject to the recordkeeping requirements of 
subpart F.
    See also Comment 429, in which we discuss comments asking us to add 
flexibility to the requirements for a supply-chain program such that 
any entity other than the receiving facility can perform supplier 
verification activities. As discussed in Response 429, the rule 
provides additional flexibility in the supply-chain program with regard 
to who can perform certain activities (see Sec.  507.115).
    (Comment 285) Some comments ask us to delete the criterion for 
control of the hazard by the receiving facility's customer, with annual 
written assurance that the customer had established and was following 
procedures (identified in the written assurance) that would 
significantly minimize or prevent the hazard. The stated reasons 
varied. For example, some comments state that a receiving facility may 
have so many customers that it is not possible to obtain written 
assurance annually from all customers. Other comments express concern 
that a customer may be unwilling to describe confidential trade secrets 
in order to identify in writing the procedures the customer has 
established and is following to control the hazard. Other comments 
express concern about ``legal issues'' when a receiving facility needs 
to assess the adequacy of the customers' procedures for controlling a 
hazard because under current business practices a vendor can provide 
assurance to a buyer (its customer), but buyers do not typically 
provide such

[[Page 56252]]

assurance to vendors. Some comments express concern that written 
assurance does not guarantee that the customer is actually doing 
anything to significantly minimize or prevent the hazard.
    Some comments ask us to provide an alternative that would allow the 
receiving facility to provide documentation to its customer about a 
hazard that needs a preventive control at a processing facility later 
in the distribution chain rather than obtain written assurance that its 
customer will control a hazard. If written assurance must be required, 
these comments ask us to allow the written assurance provided by the 
customer to state that the customer would evaluate the hazard and if 
necessary establish and follow procedures to significantly minimize or 
prevent the hazard.
    Some comments state the receiving facility may not know the 
identity of all its ultimate customers, particularly if the receiving 
facility sells its products to a distributor who then sells to other 
entities. Some comments ask us to provide flexibility for facilities to 
determine whether annual updates of written assurance are necessary. 
Other comments ask us to specify that a receiving facility need not 
establish and implement a supplier program for raw materials and 
ingredients intended for further processing.
    Some comments assert that the presence of low levels of pathogens 
on a raw product that will be subject to a lethal process further 
downstream does not pose a risk to the consumer, and should not be 
considered a significant hazard (i.e., a hazard requiring a preventive 
control). These comments also assert that if we maintain that 
Salmonella contamination is a significant hazard for each member of the 
supply chain, then we should allow the preventive control to be applied 
in a subsequent step at another facility. Other comments ask us to 
clarify that a facility would not need to develop preventive controls 
where it produces raw materials or ingredients that are subject to 
subsequent processing that will address known or reasonably foreseeable 
hazards.
    (Response 285) We are establishing several provisions, specifically 
applicable to the distribution chain of a manufacturer/processor, for 
circumstances when a manufacturer/processor does not need to implement 
a preventive control (Sec. Sec.  507.36(a)(2), (3), (4), and (5); 
507.36(b)(2), (3), (4) and (5); 507.36(c); 507.36(c) and (d), 507.37; 
and 507.215). See Response 284 for another new provision that applies 
to the supply chain in addition to the distribution chain (Sec.  
507.36(a)(1)).
    Under the first of these provisions (Sec.  507.36(a)(2)), a 
manufacturer/processor is not required to implement a preventive 
control if it relies on its customer (who is subject to the 
requirements for hazard analysis and risk-based preventive controls in 
subpart C) to ensure that the identified hazard will be significantly 
minimized or prevented and: (1) Discloses in documents accompanying the 
animal food, in accordance with the practice of the trade, that the 
animal food is ``not processed to control [identified hazard]''; and 
(2) annually obtains from its customer written assurance, subject to 
the requirements of Sec.  507.37, that the customer has established and 
is following procedures (identified in the written assurance) that will 
significantly minimize or prevent the hazard. The manufacturer/
processor would include the specific hazard requiring a preventive 
control (e.g., Salmonella) where the statement says ``[identified 
hazard].'' A facility that provides the written assurance must act 
consistently with the assurance and document its actions taken to 
satisfy the written assurance (see new Sec.  507.37). The documents 
could be bills of lading or other papers that accompany the animal food 
or labels on the containers of the animal food.
    Under the second of these provisions, (Sec.  507.36(a)(3)), a 
manufacturer/processor is not required to implement a preventive 
control if it relies on its customer (who is not subject to the 
requirements for hazard analysis and risk-based preventive controls in 
subpart C), to provide assurance it is manufacturing, processing, or 
preparing the animal food in accordance with applicable animal food 
safety requirements and it: (1) Discloses in documents accompanying the 
animal food, in accordance with the practice of the trade, that the 
animal food is ``not processed to control [identified hazard]''; and 
(2) annually obtains from its customer written assurance that it is 
manufacturing, processing, or preparing the animal food in accordance 
with applicable animal food safety requirements. By ``customer who is 
not required to implement preventive controls under this part'' we mean 
entities such as qualified facilities and retail food establishments.
    Under the third of these provisions (Sec.  507.36(a)(4)), a 
manufacturer/processor is not required to implement a preventive 
control if it relies on its customer to provide assurance that the 
animal food will be processed to control the identified hazard by an 
entity in the distribution chain subsequent to the customer and: (1) 
Discloses in documents accompanying the animal food, in accordance with 
the practice of the trade, that the animal food is ``not processed to 
control [identified hazard]''; and (2) annually obtains from its 
customer written assurance, subject to the requirements of Sec.  
507.37, that the customer will disclose in documents accompanying the 
animal food, in accordance with the practice of the trade, that the 
animal food is ``not processed to control [identified hazard]''. The 
manufacturer/processor also must obtain written assurance that its 
customer will only sell to another entity that agrees, in writing, it 
will either: (1) Follow procedures (identified in a written assurance) 
that will significantly minimize or prevent the hazard (if the entity 
is subject to the requirements for hazard analysis and risk-based 
preventive controls in subpart C), or manufacture, process, or prepare 
the animal food in accordance with applicable animal food safety 
requirements (if the entity is not subject to the requirements for 
hazard analysis and risk-based preventive controls in subpart C) or (2) 
obtain a similar written assurance from the entity's customer.
    Under the fourth of these provisions (Sec.  507.36(a)(5)), a 
manufacturer/processor is not required to implement a preventive 
control if it has established, documented, and implemented a system 
that ensures control, at a subsequent distribution step, of the hazards 
in the animal food product it distributes and documents the 
implementation of that system. Comments did not provide examples of 
such a system, but we do not want to preclude the development of such 
systems.
    We have added several other requirements related to the four new 
provisions that we are specifically establishing as circumstances in 
which a manufacturer/processor need not implement a preventive control. 
As already noted in this response, new Sec.  507.37 requires that a 
facility that provides a written assurance must act consistently with 
the assurance and document its actions taken to satisfy the written 
assurance. In addition, new Sec.  507.36(b)(2), (3), (4), and (5) 
specify the records that a manufacturer/processor would need to satisfy 
the documentation requirements established in new Sec.  507.36(a)(2), 
(3), (4) and (5), and new Sec.  507.215 establishes requirements 
applicable to the written assurance between a manufacturer/processor 
and its customer. Taken together, the provisions of Sec. Sec.  507.37 
and 507.215 establish legal responsibilities for a facility that 
provides a written assurance under Sec.  507.36(a)(2), (3) or

[[Page 56253]]

(4), even if that facility is not a manufacturer/processor.
    The point of these provisions is to ensure that hazards that a 
manufacturer/processor has determined, through its hazard analysis, 
require a preventive control, but are not controlled in the supply 
chain before the manufacturer/processor or by the manufacturer/
processor itself, are in fact controlled by a subsequent entity in the 
distribution chain. With the assurance from the manufacturer/
processor's customer that the hazards will be controlled after the 
animal food product leaves the manufacturer/processor it is not 
necessary for the first manufacturer/processor to implement the 
applicable preventive control. We continue to believe that annual 
written assurance from a manufacturer/processor's direct customer is an 
appropriate mechanism to ensure that its customer is aware of the 
identified hazard and is taking steps to ensure that the animal food is 
processed to control the identified hazard. We do not believe that a 
manufacturers/processor will need all of the details of its customer's 
process to satisfy the requirement to state in writing the procedures 
the customer has established and is following to control the hazard. 
For example, the customer could merely state that its manufacturing 
processes include a lethality step for microbial pathogens of concern.
    We agree that it is appropriate to require that the manufacturer/
processor provide documentation to its customer indicating that the 
animal food must be processed to control an identified hazard. Such 
documentation will be a means of clear communication from the 
manufacturer/processor to its customer. When the hazard will not be 
controlled by the customer, the customer will still have documentation 
that can be passed on to the entity that is expected to process the 
animal food to control the identified hazard, so that it will be very 
clear to that entity that the identified hazard still needs to be 
controlled.
    We understand that not all identified hazards in an animal food 
will be a hazard to all species of animals. For example, we consider 
all serotypes of Salmonella to be a hazard for dog and cat food. 
However, we would not consider Salmonella Heidelberg a hazard in food 
for cattle. Therefore, we have added provisions to allow this 
determination to be included in the customer's written assurance 
regarding an identified hazard so that the customer will not be 
required to assure it is controlling a hazard that it has determined 
does not need to be controlled for a specific animal species.
    For the written assurance required by Sec.  507.36(a)(2)(ii), new 
paragraph (c) of this section provides that if the customer has 
determined that the identified hazard is not a hazard in the animal 
food intended for use for a specific animal species, the customer's 
written assurance may provide this determination (including animal 
species and why the identified hazard is not a hazard) instead of 
providing assurance of procedures established and followed that will 
significantly minimize or prevent the identified hazard.
    For the written assurance required by Sec.  507.36(a)(4)(ii)(B), 
new paragraph (d) of this section provides that if the entity in the 
distribution chain subsequent to the customer is subject to subpart C 
and has determined that the identified hazard is not a hazard in the 
animal food intended for use for a specific animal species, that 
entity's written assurance may provide this determination (including 
animal species and why the identified hazard is not a hazard) in its 
written assurance instead of providing assurance that the identified 
hazard will be significantly minimized or prevented.
    (Comment 286) Some comments that ask us to delete the proposed 
requirement to maintain the written assurance as a record. Other 
comments ask us to revise the regulatory text of the documentation 
requirement to focus on documentation that (1) the receiving facility 
has notified its customers of the existence of actual or potential 
hazards in animal food provided to them by the receiving facility; or 
(2) the receiving facility has notified its customers of the existence 
of actual or potential hazards in animal food provided to them by the 
receiving facility and has received a written assurance that the 
customer will evaluate the hazard and, if necessary, will follow 
procedures to significantly minimize or prevent the hazard.
    (Response 286) We decline this request. As already discussed in 
this section, it is the combination of requirements (i.e., for 
documentation that the animal food is ``not processed to control 
[identified hazard]''; assurance from customers regarding appropriate 
procedures to ensure that the animal food will receive further 
processing to control the identified hazards; and provisions relating 
to accountability for written assurances) that will provide adequate 
assurance that the animal food will be processed to control the 
identified hazard before it reaches consumers. Records documenting the 
written assurances are a key component of the provisions.

XXVIII. Subpart C: Comments on Proposed Sec.  507.38--Recall Plan

    We proposed that you must establish a written recall plan for 
animal food with a significant hazard and that the recall plan must 
include certain procedures. Some comments support the proposed 
requirements without change. For example, some comments express the 
view that a written recall plan is critical in the event of a system 
breakdown where adulterated animal foods have been distributed. Some 
comments that support the proposed requirements suggest alternative or 
additional regulatory text or other changes.
    In the following paragraphs, we discuss comments that ask us to 
clarify the proposed requirements or that disagree with, or suggest one 
or more changes to, the proposed requirements. After considering these 
comments, we are finalizing the requirements as proposed with the 
conforming revision to use the term ``hazard requiring a preventive 
control'' rather than ``significant hazard.'' See Response 62 and table 
31. As discussed in section XXVII, we are establishing a provision 
applying to certain assurances in Sec.  507.37.

A. Proposed Sec.  507.38(a)--Requirement for a Written Recall Plan

    We proposed that you must establish a written recall plan for 
animal food with a significant hazard.
    (Comment 287) Some comments ask us to require a written recall plan 
for all animal food (rather than just for animal food with a 
significant hazard) and to establish the requirements for a written 
recall plan as CGMP requirements in subpart B rather than as part of 
the requirements for hazard analysis and risk-based preventive controls 
in subpart C. These comments assert that all products can be subject to 
a recall. These comments contrast recall plans with other preventive 
controls in that recall plans are often specific to a firm or facility, 
but rarely are specific to particular animal foods. In addition, these 
comments note that a recall may be administered and managed at the 
corporate office rather than at the specific manufacturing facility 
that produced the animal food.
    Some comments note the requirements for a written recall plan are 
sufficiently different from other provisions in subpart C that we 
proposed to specify that the recall plan would not be subject to the 
preventive control management requirements for monitoring, corrective 
actions, and verification (see Sec.  507.39(c)). Other

[[Page 56254]]

comments assert that a recall plan is not a preventive control because 
it deals with products after they have been produced. Some comments 
note that facilities that are exempt from the requirements of subpart 
C, but remain subject to the CGMP requirements, would not be required 
to have a recall plan unless we establish the requirements in subpart 
B. Other comments note that the requirement for a recall plan is only 
if there is a hazard that requires a preventive control, but assert 
that a recall should only be initiated if a hazard has actually been 
identified to be present in the product.
    Some comments note that our authority to require recall plans is 
not limited to section 418 of the FD&C Act and that we can use other 
legal authority to impose a requirement for recall plans in subpart B. 
Some comments note that FSMA specifically amended the FD&C Act to 
provide us with the authority to mandate a food recall (section 423 of 
the FD&C Act). These comments assert that it would be reasonable for us 
to conclude that in order to efficiently carry out section 423 of the 
FD&C Act we should issue requirements governing the conduct of recalls, 
because section 423 of the FD&C Act requires that we provide a firm 
with an opportunity to voluntarily recall a product before issuing an 
order to the firm to cease distribution and recall a product.
    (Response 287) We decline the request to establish requirements for 
a written recall plan as a CGMP requirement in subpart B and are 
establishing the requirements as a preventive control in subpart C as 
proposed. We acknowledge that a recall plan would be useful to all 
animal food establishments, and we encourage all animal food 
establishments to have a recall plan. However, the report issued by the 
human food CGMP Modernization Working Group did not identify the lack 
of a written recall plan as something that needed to be changed (Ref. 
41). (See 78 FR 3646 at 3651, the proposed rule for preventive controls 
for human food, for a discussion of the CGMP Modernization Working 
Group and the process leading to its report.) However, going forward we 
intend to monitor whether the lack of a broader requirement for a 
recall plan leads to problems when animal food establishments that are 
not subject to the requirements of subpart C are faced with recall 
situations. As we gain experience with the impact of the new 
requirement for a recall plan on those facilities subject to subpart C, 
we can reassess at a later date whether to conduct rulemaking to 
broaden the requirement to apply to all animal food establishments 
subject to the CGMP requirements in subpart B. For now, animal food 
establishments that are not subject to subpart C can continue to follow 
our longstanding recall policy in part 7 (21 CFR part 7).
    Consistent with the overall framework of FSMA, a recall plan (like 
other preventive controls) is only required when the facility has 
identified a hazard requiring a preventive control. A facility could 
establish a recall plan that applies to other animal foods it 
manufactures. We recognize that recalls may be managed by the corporate 
office of a firm rather than at the specific manufacturing facility 
that produced the animal food. Nothing in the rule precludes this 
approach. In such cases the corporate recall policy would be reflected 
in a facility's recall plan. (See also Response 239.) In addition, a 
facility that identifies one or more hazards requiring a preventive 
control in multiple animal food products could use the same recall plan 
for all applicable animal food products.
    The rule specifies that the requirements for preventive control 
management components (i.e., monitoring, corrective actions and 
corrections, and verification) apply as appropriate to ensure the 
effectiveness of the preventive control, taking into account the nature 
of the preventive control (Sec.  507.39(a)). As previously discussed, 
the preventive control management components are directed at animal 
food that remains at the facility, whereas the recall plan addresses 
animal food that has left the facility (78 FR 64736 at 64788). Our 
determination that the nature of the recall plan does not require these 
preventive control management components demonstrates the flexibility 
provided by FSMA and this rule, not that the recall plan must be 
considered a CGMP rather than a preventive control.
    We have not yet made a determination of whether we should issue 
requirements governing the conduct of recalls, rather than rely on the 
guidelines in part 7, in order to fully implement section 423 of the 
FD&C Act. However, we have issued a draft guidance entitled ``Draft 
Guidance for Industry: Questions and Answers Regarding Mandatory Food 
Recalls'' which, when finalized, would address topics such as the 
criteria for a mandatory recall and the process that FDA must follow 
for a mandatory recall (Ref. 42).
    (Comment 288) Some comments ask us to cross-reference the 
provisions of part 7 (21 CFR part 7) rather than establish requirements 
that these comments assert would be duplicative with the provisions of 
part 7. These comments ask us to address any more substantive 
requirements than are already in part 7 as part of a review of part 7. 
These comments assert that part 507 should require a written recall 
plan, but not require a written recall plan for the animal food, to be 
consistent with the approach of part 7.
    (Response 288) We decline these requests. Part 7 addresses 
enforcement policy and the provisions for recalls in subpart C of part 
7 are ``Guidance on Policy, Procedures, and Industry 
Responsibilities.'' These recall provisions do not establish 
requirements and are not binding on industry. They also are broadly 
directed to recalls for all FDA-regulated products, not just food. As 
already discussed in Response 284, nothing in this rule would prevent a 
facility that establishes a recall plan for a particular animal food 
from using that recall plan for any animal food product that the 
facility decides to recall.
    (Comment 289) Some comments request that we have separate recall 
program requirements for human food by-products so that by-products 
produced during the manufacture of food and sold, or otherwise 
provided, for use in animal food would not be recalled if the product 
for people is recalled. Other comments assert we will need to define 
the criteria for an animal food recall in guidance.
    (Response 289) We decline the request to have separate recall 
program requirements for human food by-products for use as animal food. 
Whether or not the by-product of a human food that is recalled should 
itself be recalled may depend on assessment of several factors such as 
what the hazard is, whether the hazard for which the human food is 
recalled is also a hazard for the animal(s) that consume the by-
product, and where the hazard occurred in the manufacturing process. We 
have previously addressed the request for guidance. (See Response 1.)

B. Proposed Sec.  507.38(b)--Procedures That Describe the Steps To Be 
Taken, and Assign Responsibility for Taking Those Steps

    We proposed that the recall plan must include procedures that 
describe the steps to be taken, and assign responsibility for taking 
those steps, to perform the following actions as appropriate to the 
facility: (1) Directly notify the direct consignees of the animal food 
being recalled, including how to return or dispose of the affected 
animal food; (2) notify the public about any hazard presented by the 
animal

[[Page 56255]]

food when appropriate to protect human or animal health; (3) conduct 
effectiveness checks to verify that the recall is carried out; and (4) 
appropriately dispose of recalled animal food (e.g., through 
reprocessing, reworking, diverting to another use that would not 
present a safety concern, or destroying). We requested comment on 
whether: (1) The proposed procedures are appropriate for all types of 
facilities; (2) we should require a recall plan to include procedures 
and assignment of responsibility for notifying FDA of recalls subject 
to the plan; and (3) we should include a requirement for a mock recall 
as a verification activity.
    (Comment 290) Some comments ask us to delete the proposed 
requirement that the recall plan include procedures for a facility to 
notify the public about any hazard presented by the animal food when 
appropriate to protect public health. These comments assert that such a 
requirement would be highly subjective and create a nebulous regulatory 
burden that could subject facilities to unnecessary regulatory 
oversight and enforcement actions. Other comments indicate that the 
requirement for notifying the public should specifically prevent silent 
recalls when manufacturers pull products from store shelves without 
consumer notification.
    (Response 290) We decline this request. Our guidance for a recall 
strategy has long recommended issuing a public warning to alert the 
public that a product being recalled presents a serious hazard to 
health in urgent situations where other means for preventing use of the 
recalled product appear inadequate (Sec.  7.42(b)(2)). Operationally, 
such notification to the public is so common that our current home page 
on our Internet site (Ref. 43) gives prominence to recall information 
and we have established a free email subscription service for updates 
on recalls (Ref. 44). Consistent with the longstanding recall policy in 
part 7, subpart C, the proposed requirement qualifies that the 
notification to the public is ``when appropriate to protect public 
health.'' A market withdrawal of a product (see Sec.  7.3(j)) is not a 
recall that would be subject to public notification.
    (Comment 291) Some comments ask us to specify that the procedures 
require facilities to notify us about a recall to ensure that all 
suppliers, retailers, and consumers will have adequate notification of 
the recall action. Other comments agree that it is important for 
facilities to involve us in a recall situation as soon as possible, but 
assert that the best way to address such a notification is through the 
existing RFR system. These comments assert that additional procedures 
or means to notify us would involve unnecessary additional steps and be 
duplicative, with no improvement to the public health. Some comments 
assert that if the recall is issued by a foreign facility, the 
responsibility should be with the importer of the product for notifying 
FDA. Some comments ask us to specify that the appropriate State 
regulatory Agency with inspection jurisdiction be notified in the event 
of a recall.
    (Response 291) We agree with comments that it is important to 
notify us about a recall and that doing so can help to ensure that 
suppliers, retailers, and consumers will have adequate notification of 
the recall action. We also agree that the existing procedures to notify 
us through the RFR system can accomplish this goal when an animal food 
presents a risk of serious adverse health consequences or death and 
that it therefore is not necessary to duplicate the notification 
procedures already established in the RFR system in part 507. However, 
we encourage facilities to include in their recall plan any procedures 
they have to comply with the RFR or to include a cross-reference to 
those procedures. Doing so may save time, which is critical during a 
recall. When the recalled animal food does not present a risk of 
serious adverse health consequences or death (and, thus, there is not a 
report to the RFR), our guidance entitled ``Guidance for Industry: 
Product Recalls, Including Removals and Corrections'' recommends that 
recalling firms notify the local FDA District Recall Coordinator as 
soon as a decision is made that a recall is appropriate and prior to 
the issuance of press or written notification to customers (Ref. 45). 
Including this guidance with the facility's recall procedures may also 
save time.
    We decline the request to designate that it is solely the importer 
of a food manufactured by a foreign facility who must notify FDA if the 
food is recalled by the foreign facility. We are not requiring that a 
recall plan include procedures and assignments of responsibility for 
notifying FDA of recalls subject to the recall plan. Facilities should 
refer to our guidance in part 7 entitled ``Guidance for Industry: 
Product Recalls, Including Removals and Corrections'' for 
recommendations on conducting recalls of food that does not present a 
risk of serious adverse health consequences or death, including 
notification to FDA (Ref. 45). If the recalled food is a reportable 
food (i.e., it does present a reasonable probability that use will 
cause serious adverse health consequences or death to humans or 
animals), then section 417 of the FD&C Act requires that the 
responsible party, as defined in section 417, submit a report to FDA.
    We agree with comments that it is important to notify appropriate 
State regulatory Agencies about a recall. We generally request that FDA 
District Offices notify State control officials of recalls issued by 
animal food manufacturers. Also, State officials with responsibilities 
for regulating animal food can access our Web site for ``Animal and 
Veterinary Recalls and Withdrawals'' where we post the current and most 
recent recalls of animal products, including animal food (Ref. 46). We 
note that whatever methods are used to dispose of adulterated animal 
food, the methods should comply with State and local requirements.
    (Comment 292) Some comments ask us to add a requirement for mock 
recalls on a regular basis, such as biannually. Some of these comments 
state that mock recalls would familiarize the staff and communications 
network(s) with the recall process and would improve the facility's 
capacity to conduct effective and efficient recalls in the event of a 
contamination event. Other comments assert that mock recalls would be 
the only way to determine the effectiveness of a recall program. Some 
comments note that mock recalls would be particularly critical for 
manufacturers that have limited experience in actual recalls.
    Some comments acknowledge that a mock recall could be an important 
element of a recall plan but recommend that mock recalls remain 
voluntary, such as by including mock recalls as an example of how 
verification may be accomplished. Other comments note that the current 
recall procedures in part 7 do not recommend mock recalls. Some 
comments assert that a requirement to include a mock recall as a 
verification activity would be an excessive and inappropriate burden; 
that any gain in the protection of public health will not offset the 
resource requirements to accomplish a mock recall; that resources are 
better dedicated to developing a robust plan; and, use of a mock recall 
should be addressed in FDA guidance.
    Some comments ask us to clarify the ``metrics'' for a mock recall, 
particularly with respect to the consequences of failing to meet an 
appropriate metric if a mock recall is conducted as a verification 
activity.
    (Response 292) We agree that a mock recall would familiarize the 
facility with the recall process, could improve the facility's capacity 
to conduct effective

[[Page 56256]]

and efficient recalls during a contamination event, may be particularly 
helpful for manufacturers that have limited experience in actual 
recalls, and could support the development of guidance on best 
practices for recalls, and we encourage facilities to conduct one or 
more mock recalls to accomplish these goals. However, as previously 
discussed, a recall plan would address food that had left the facility, 
whereas the proposed requirements for monitoring, corrective actions, 
and verification would all be directed at food while it remains at the 
facility. Comments are mixed regarding whether the rule should require 
a mock recall as a verification activity for the recall plan, and we 
have decided to not require a facility to conduct a mock recall as a 
verification activity for its recall plan so that the focus of the 
monitoring, corrective actions, and verification in the rule remains 
focused on food being produced rather than on food that is distributed 
in commerce. We acknowledge that requiring mock recalls would go beyond 
our longstanding policies established in part 7. A facility that 
voluntarily conducts a mock recall would establish metrics appropriate 
to its plan and take action (such as modifications to its procedures, 
or additional training for its employees) if it is not satisfied with 
the results of the mock recall.
    We note that retail companies are not subject to this rule and, 
thus, are not subject to the requirement to have a written recall plan.

XXIX. Comments on Proposed Sec.  507.39--Preventive Control Management 
Components

    We proposed preventive control management components as appropriate 
to ensure the effectiveness of the preventive controls, taking into 
account the nature of the preventive control. Most of the comments that 
support the proposed provisions suggest alternative or additional 
regulatory text.
    In the following sections, we discuss comments that disagree with, 
or suggest one or more changes to, the proposed requirements. After 
considering these comments, we have revised the proposed requirements 
as shown in table 13 with editorial and conforming changes as shown in 
table 31.

          Table 13--Revisions to the Proposed Requirements for Preventive Control Management Components
----------------------------------------------------------------------------------------------------------------
               Section                       Description                            Revision
----------------------------------------------------------------------------------------------------------------
507.39...............................  Flexible requirements    Provide that preventive control management
                                        for preventive control   components take into account both the nature of
                                        management components.   the preventive control and its role in the
                                                                 facility's food safety system.
----------------------------------------------------------------------------------------------------------------

A. Proposed Sec.  507.39(a)--Flexible Requirements for Monitoring, 
Corrective Actions and Corrections, and Verification

    We proposed that, with some exceptions, the preventive controls 
would be subject to three preventive control management components as 
appropriate to ensure the effectiveness of the preventive controls, 
taking into account the nature of the preventive control: Monitoring, 
corrective actions and corrections, and verification.
    (Comment 293) Some comments support our proposal to provide 
flexibility in the oversight and management of preventive controls, 
including the explicit provision that preventive control management 
components take into account the nature of the preventive control. Some 
of these comments state that the provisions for the preventive control 
management components will allow facilities to tailor their food safety 
plans to their specific facility, product, and process and ensure that 
the regulatory requirements are risk-based. Other comments state that 
the proposed approach acknowledges the safety benefits derived from the 
use of prerequisite programs, such as CGMPs, and provides for a 
framework whereby appropriate decisions may be reached regarding 
hazards that require management controls that may include monitoring, 
corrections or corrective actions, verification, and records. Other 
comments state that the provisions will allow businesses to allocate 
resources to spend the most time and resources controlling and 
monitoring those hazards that pose the greatest risk to public health.
    However, many of these comments also ask us to convey not only that 
the application of a particular management component be appropriate 
(i.e., capable of being applied), but also that it be necessary for 
food safety (i.e., to meet the overall FSMA food safety goals or to 
ensure a particular control is effective) by specifying that the 
preventive control management components take into account both the 
nature of the preventive control and its role within the facility's 
overall food safety system. Some of these comments ask us to make 
companion changes reflecting that the preventive control management 
components take into account both the nature of the preventive control 
and its role within the facility's overall food safety system 
throughout applicable provisions of the rule, such as the definition of 
``significant hazard'' (which we now refer to as ``hazard requiring a 
preventive control'') and in the requirements for preventive controls, 
monitoring, corrective actions and corrections, and verification. Some 
comments ask us to consistently refer to ``the nature of the preventive 
control'' (rather than simply to ``the preventive control'') when 
communicating the flexibility that a facility has in identifying 
preventive controls and associated preventive control management 
components.
    (Response 293) We agree that preventive control management 
components should take into account both the nature of the preventive 
control and its role in the facility's food safety system and have 
modified the regulatory text of Sec.  507.39 to incorporate this 
suggestion. We reviewed the full regulatory text of proposed subpart C 
and made similar modifications to the regulatory text for the 
definition of ``hazard requiring a preventive control'' (Sec.  507.3); 
process controls (Sec.  507.34(c)(1)); monitoring (Sec.  507.40); 
verification (Sec.  507.45); validation (Sec.  507.47); and 
verification of implementation and effectiveness (Sec.  507.49).
    (Comment 294) Some comments assert that the flexibility explicitly 
provided in the regulatory text could result in some facilities taking 
a broad approach to significant hazards and other facilities taking a 
more detailed approach. These comments express concern that inspectors 
will view the detailed approach (e.g., with more preventive controls), 
as the standard to judge compliance with the rule. Other comments 
express concern that identifying a large number of preventive controls 
could also undermine the value of HACCP programs because treating too 
many controls as CCPs will pull

[[Page 56257]]

resources from those controls that are truly critical.
    (Response 294) We agree that facilities are likely to take 
different approaches to complying with the rule. A facility-specific 
approach is consistent with FSMA, which places responsibility for 
hazard analysis and risk-based preventive controls on the owner, 
operator, or agent in charge of the facility (section 418(a) of the 
FD&C Act). We agree that having too many CCPs could dilute their 
significance, but not every hazard will require a CCP to be controlled. 
See table 6 in the 2014 supplemental notice for examples of preventive 
controls that would not be CCPs (79 FR 58476 at 58493).
    During the initial stages of implementation, we expect that our 
investigators will ask subject matter experts in CVM to review the 
outcome of the facility's hazard analysis, the preventive controls 
established by the facility, and the associated preventive control 
management components that the facility has established and 
implemented. Over time, as our investigators gain experience, we expect 
that there will be fewer circumstances in which our investigators would 
consult CVM about such an outcome. (See also Response 2 and section LIV 
regarding our approach to compliance.)
    (Comment 295) Some comments state that USDA's regulations (in 7 CFR 
205.201(a)(3)) for the National Organic Program include regulatory text 
to ``ensure the effectiveness'' of measures in that program and that 
this regulatory text is similar to regulatory text in the requirements 
for preventive control management components. These comments assert 
that this type of regulatory text has created compliance challenges and 
ask us to consult with USDA about its experience with implementing 
effectiveness language associated with monitoring practices and 
procedures and ensure that the final rule uses regulatory text that 
will be clearly understood and readily implementable by those subject 
to its provisions.
    (Response 295) Under the USDA regulation cited by these comments, 
an organic production or handling system plan must include a 
description of the monitoring practices and procedures to be performed 
and maintained, including the frequency with which they will be 
performed, to ``verify that the plan is effectively implemented.'' We 
have not consulted with USDA regarding its experience in evaluating 
compliance with this requirement because we addressed the issue likely 
to cause these compliance challenges for monitoring practices and 
procedures in an organic production or handling system plan when we 
established our requirements for monitoring preventive controls. 
Specifically, we require that a facility monitor the preventive 
controls with adequate frequency to ``provide assurance that they are 
consistently performed,'' not to ``verify that the plan is effectively 
implemented.'' Our requirements more clearly distinguish the purpose of 
monitoring and verification activities. See our previous discussion of 
the relationship between monitoring and verification, and our tentative 
conclusion to require monitoring of the performance of the preventive 
controls (78 FR 64736 at 64790). We are affirming that conclusion in 
this rule. (See Response 297.)

B. Proposed Sec.  507.39(b)--Applicability of Preventive Control 
Management Components to the Supply-Chain Program

    We proposed that the supplier program (which we now refer to as 
``supply-chain program'') would be subject to the following preventive 
control management components as appropriate to ensure the 
effectiveness of the supplier program, taking into account the nature 
of the hazard controlled before receipt of the raw material or 
ingredient: (1) Corrective actions and corrections, taking into account 
the nature of any supplier non-conformance; (2) review of records; and 
(3) reanalysis. We address comments on the supply-chain program in 
sections XL through XLVII. We are finalizing the applicability of 
preventive control management components to the supply-chain program as 
proposed.

C. Proposed Sec.  507.39(c)--Recall Plan Is Not Subject to Preventive 
Control Management Components

    We proposed that the recall plan that would be established in Sec.  
507.38 would not be subject to the preventive control management 
components.
    (Comment 296) As discussed in Comment 287, some comments ask us to 
establish requirements for a written recall plan as a CGMP requirement 
in subpart B rather than as a preventive control in subpart C. As a 
companion change, some of these comments ask us to delete our proposed 
provision that the recall plan would not be subject to the preventive 
control management components.
    (Response 296) As discussed in Response 287, we are establishing 
the requirements as a preventive control in subpart C as proposed. 
Therefore, we are finalizing the provision that the recall plan not be 
subject to the preventive control management components.
    For further discussion on comments on preventive control management 
components, see section XXIX in the final rule for preventive controls 
for human food, published elsewhere in this issue of the Federal 
Register.

XXX. Subpart C: Comments on Proposed Sec.  507.40--Monitoring

    We proposed to establish requirements for monitoring the preventive 
controls. We also discussed our tentative conclusion that the language 
of section 418 of the FD&C Act regarding monitoring is ambiguous and 
that it would be appropriate to require monitoring of the 
``performance'' of preventive controls.
    Some comments agree with our tentative conclusion regarding the 
ambiguous nature of section 418. For example, some comments state that 
our interpretation seems appropriate because requiring monitoring of 
the ``effectiveness'' of the preventive controls would be redundant 
with required verification activities. In addition, requiring 
monitoring of the performance of preventive controls is consistent with 
applicable domestic and internationally recognized standards.
    Some comments agree that facilities must be required to maintain 
records; but disagree regarding the scope of monitoring. One comment 
agrees that monitoring the performance of preventive controls would 
provide evidence that the preventive controls established to control 
the identified hazards are implemented appropriately. Some comments 
support the proposed provisions without change. Some comments ask us to 
clarify how we will interpret the provision.
    In the following paragraphs, we discuss comments that disagree with 
our tentative conclusion or with the proposed requirements, or ask us 
to clarify the proposed requirements or suggest one or more changes to 
the proposed requirements. After considering these comments, we are 
affirming our tentative conclusion that the language of section 418 of 
the FD&C Act regarding monitoring is ambiguous and that it would be 
appropriate to require monitoring of the ``performance'' of preventive 
controls. We also have revised the proposed requirements as shown in 
table 14, with editorial and conforming changes as shown in table 31.

[[Page 56258]]



     Table 14--Revisions to the Proposed Requirements for Monitoring
------------------------------------------------------------------------
            Section                Description            Revision
------------------------------------------------------------------------
507.40........................  Flexibility in     Provide that
                                 requirements for   monitoring take into
                                 monitoring.        account both the
                                                    nature of the
                                                    preventive control
                                                    and its role in the
                                                    facility's food
                                                    safety system.
507.40(c)(2)(i)...............  Records of         Provide that records
                                 monitoring.        of refrigeration
                                                    temperature during
                                                    storage of animal
                                                    food that requires
                                                    time/temperature
                                                    control to
                                                    significantly
                                                    minimize or prevent
                                                    the growth of, or
                                                    toxin production by,
                                                    pathogens may be
                                                    affirmative records
                                                    demonstrating
                                                    temperature is
                                                    controlled or
                                                    exception records
                                                    demonstrating loss
                                                    of temperature
                                                    control.
507.40(c)(2)(ii)..............  Records of         Provide for exception
                                 monitoring.        records for
                                                    monitoring of
                                                    preventive controls
                                                    other than
                                                    refrigeration.
------------------------------------------------------------------------

A. Our Tentative Conclusion To Require Monitoring of the Performance of 
Preventive Controls

    (Comment 297) Some comments disagree with our tentative conclusion 
that it would be appropriate to require monitoring of the 
``performance'' of preventive controls and assert that the concept of 
``performance evaluation'' is too complex to be included in the rule.
    (Response 297) These comments may have misinterpreted what we meant 
by ``monitoring performance of preventive controls.'' We used the term 
``performance'' to mean ``the execution or accomplishment of an action, 
operation, or process undertaken or ordered'' (78 FR 64736 at 64790). 
We acknowledge that the definition of ``monitoring'' that we are 
establishing in this rule includes that the purpose of observations or 
measurements conducted as part of monitoring is to ``assess'' whether 
control measures are operating as intended. However, we provided 
examples showing that this assessment is a straightforward 
determination of whether a process is operating as intended and is not 
a complex evaluation as asserted by the comments. (See, e.g., the 
discussion of monitoring oven temperature to ensure pathogen 
elimination during baking of a pet treat 78 FR 64736 at 64789 through 
64790.)
    (Comment 298) Some comments that support monitoring the performance 
of preventive controls assert that our proposed definition of 
``monitoring'' (proposed Sec.  507.3), and our preamble discussions of 
``monitoring,'' have the potential to confuse ``monitoring the 
performance of preventive controls'' with verification activities that 
address ongoing implementation of control measures.
    (Response 298) See Response 47 in which we discuss comments on the 
definition of monitoring and describe the changes we have made to that 
definition to address concerns about the potential to confuse 
``monitoring the performance of preventive controls'' with verification 
activities that address ongoing implementation of control measures.
    (Comment 299) Some comments assert that authority should be 
explicitly granted to the States to conduct food safety monitoring and 
that we should maintain our responsibilities for product tracing.
    (Response 299) These comments misinterpret the provisions of 
section 418 of the FD&C Act and this rule. Section 418 places the 
responsibility for establishing and implementing a food safety system 
(including hazard analysis, risk-based preventive controls, preventive 
control management components (including monitoring, corrective action 
procedures, and verification), and recordkeeping) on the owner, 
operator, or agent in charge of a facility, not on FDA or any other 
regulatory authority. This requirement for monitoring within the 
framework of hazard analysis and risk-based preventive controls is 
distinct from regulatory oversight of animal food safety, such as 
during inspections and investigations of outbreaks of foodborne 
illness, which generally involve product tracing. We agree that it is 
important to coordinate regulatory oversight of animal food safety with 
the States and other food safety partners. As discussed in Response 2, 
we are working through the PFP to develop and implement a national 
Integrated Food Safety System consistent with FSMA's emphasis on 
establishing partnerships for achieving compliance (see section 209(b) 
of FSMA).
    (Comment 300) One comment requests that routine monitoring not be 
required for feed mills unless they manufacture pet food.
    (Response 300) We decline this request. We assume this comment is 
based on a presumption that pet food is a higher risk product than 
livestock or poultry food. The exemptions from preventive control 
requirements that we are establishing are specifically provided by 
section 103 of FSMA and we decline to apply the rule only to animal 
foods deemed to be of higher risk. Instead, several provisions of the 
rule expressly qualify that the requirements apply as appropriate to 
the facility, the animal food, the nature of the preventive control, 
and its role in the facility's food safety system, the nature of the 
hazard, or a combination of these factors (e.g., monitoring procedures 
must be established as appropriate to the nature of the preventive 
control and its role in the facility's food safety system). For 
example, the hazards in a facility and historical information on the 
consistency of the control measure can be factors in determining the 
frequency of monitoring.

B. Proposed Sec.  507.40(a) and (b)--Flexibility in Requirements for 
Monitoring

    We proposed that, as appropriate to the preventive control, you 
must establish and implement written procedures, including the 
frequency with which they are to be performed, for monitoring the 
preventive controls, and monitor the preventive controls with adequate 
frequency to provide assurance that they are consistently performed.
    (Comment 301) Some comments agree that frequency and areas to be 
tested and monitored need to be determined based on each product and 
facility and ask us to allow each individual facility to determine the 
frequency and areas to be monitored based on a completed risk 
assessment. Some comments ask us to specify that the frequency of 
monitoring preventive controls must have a scientific basis.
    (Response 301) It is unclear whether the comment agreeing that 
monitoring frequency and areas to be tested need to be determined based 
on each product and facility was directed to the monitoring provision 
or to environmental monitoring. Regardless, by requiring written 
procedures for monitoring, and specifying that the

[[Page 56259]]

procedures include the frequency with which the procedures are to be 
performed, the rule provides that each facility must determine the 
frequency of monitoring, as well as details such as the areas to be 
monitored. However, we decline the request to specify that these 
procedures be based on a completed ``risk assessment.'' The rule 
requires the facility to conduct a hazard analysis, which determines 
whether there are any hazards requiring a preventive control, and the 
facility would establish preventive controls for such hazards as 
appropriate to the facility and the animal food. The facility must 
consider factors associated with risk (i.e., the severity of the 
illness or injury if the hazard were to occur and the probability that 
the hazard will occur in the absence of preventive controls) in 
evaluating whether any potential hazard is a hazard requiring a 
preventive control (Sec.  507.33(c)). Risk could be relevant to a 
facility's identification of appropriate preventive controls for a 
particular hazard requiring a preventive control. However, it is the 
nature of the preventive control, rather than the risk associated with 
the hazard, that is more relevant to the frequency of monitoring and 
the areas to be monitored. Accordingly, the rule specifies that the 
facility establish written procedures, and conduct monitoring, as 
appropriate to the preventive control rather than based on risk 
associated with the hazard. (See, e.g., the discussion of monitoring 
oven temperature to ensure pathogen elimination during baking of a pet 
treat 78 FR 64736 at 64789 through 64790.)
    We decline the request to specify that the frequency of monitoring 
preventive controls must have a scientific basis. Monitoring should 
take place with sufficient frequency to detect a problem in the 
performance of a preventive control. The importance of the preventive 
control to the safety of the animal food can be one factor in setting a 
frequency. We acknowledge that scientific information may be 
appropriate in determining the frequency of monitoring in some cases. 
For example, the frequency may be statistically based, such as with 
statistical process control. However, in some cases, factors other than 
scientific information may be appropriate in determining the frequency 
of monitoring. For example, historical information on the consistency 
of the control measure can be a factor in determining frequency. When 
variability of the process is low, the frequency may be less than with 
a process that has more variability. As another example, a process that 
is operated at a point close to a food safety parameter limit may be 
monitored more frequently than one where there is a large safety margin 
built into the process.

C. Proposed Sec.  507.40(c)--Records

    We proposed that all monitoring of preventive controls must be 
documented in records that are subject to verification and records 
review.
    (Comment 302) Some comments point out that table 6 in the 2014 
supplemental notice includes an example of a monitoring activity that 
generally would not require monitoring records (i.e., monitoring for 
pieces of ferrous material with magnets) (see 79 FR 585476 at 58493). 
These comments assert that this example is in conflict with the 
proposed regulatory text and ask us to modify the regulatory text to 
provide the flexibility we acknowledged in the 2014 supplemental 
notice. One comment states the examples provided by FDA for monitoring 
performance of preventive controls pertain to preventive controls that 
have specific parameters. The comment states in the absence of specific 
parameters for a preventive control, monitoring is neither necessary 
nor appropriate. Other comments ask us to specify that monitoring must 
be documented as appropriate to the nature of the preventive control.
    Some comments ask us to recognize the acceptability of monitoring 
systems that exclusively provide exception reports. These comments 
describe exception reporting as a structure where automated systems are 
designed to alert operators and management on an exception basis, i.e., 
only when a deviation from food safety parameter limits are observed by 
the system. These comments assert that, in many cases, monitoring of 
preventive controls can be done by automated systems that provide 
exception reporting in a much more efficient manner than if performed 
by operators and that automated monitoring allows for increased 
sampling frequency (often continuous) and reduction of human error. The 
comments provide an example of a refrigeration temperature control that 
notifies on exception (e.g., high temperature alarm) and may only 
record temperatures that exceed the specified temperature (without 
recording temperatures that meet control requirements). These comments 
acknowledge that such systems must be validated and periodically 
verified to ensure they are working properly. These comments ask us to 
clarify in the preamble to the final rule that monitoring systems can 
work affirmatively or by exception and that both types of systems and 
their related documentation are acceptable.
    (Response 302) We have made several revisions to the regulatory 
text, with associated editorial changes, to clarify that monitoring 
records may not always be necessary. We agree that the exception 
reporting described in these comments, including validation and 
periodic verification to ensure that the system is working properly, 
would be an acceptable monitoring system in the circumstances provided 
in the comments, i.e., for monitoring refrigeration temperature. 
Therefore, we have revised the regulatory text to provide that records 
of refrigeration temperature during storage of food that requires time/
temperature control to significantly minimize or prevent the growth of, 
or toxin production by, pathogens may be affirmative records 
demonstrating temperature is controlled or exception records 
demonstrating loss of temperature control. Although the comments 
specifically requested that we clarify our view on exception records in 
the preamble, we believe that clarifying the regulatory text will be 
more useful, both to facilities and to regulatory agencies that conduct 
inspections for compliance with the rule. If a facility uses 
``exception records,'' the facility must have evidence that the system 
is working as intended, such as a record that the system has been 
challenged by increasing the temperature to a point at which an 
``exception record'' is generated.
    We also have revised the regulatory text to provide that exception 
records may be adequate in circumstances other than monitoring of 
refrigeration temperature. For example, in table 6 of the 2014 
supplemental notice the example we provided of a monitoring activity 
that generally would not require monitoring records is monitoring for 
pieces of ferrous material with magnets. We believe that a magnet 
system that monitors for ferrous material would result in a record only 
when the system detects ferrous material.

XXXI. Subpart C: Comments on Proposed Sec.  507.42--Corrective Actions 
and Corrections

    We proposed to establish requirements for corrective actions and 
corrections. Some comments support the proposed requirements without 
change. For example, some comments assert that there is virtually no 
reason to have a food safety plan unless there are proper corrective 
actions in place so the product can be properly disposed of. Some 
comments agree that there should

[[Page 56260]]

be written procedures for corrective actions and note the importance of 
identifying and evaluating the problem, correcting it, and documenting 
the corrective action. Some comments express the view that the proposed 
requirement for clear corrective action in the event of an 
unanticipated problem, and documenting all corrective actions, 
contributes to a comprehensive safety plan. Some comments that support 
the proposed provisions suggest alternative or additional regulatory 
text.
    In the following paragraphs, we discuss comments that disagree 
with, or suggest one or more changes to, the proposed requirements. 
After considering these comments, we have revised the proposed 
requirements as shown in table 15 with editorial and conforming changes 
as shown in table 31.

 Table 15--Revisions to the Proposed Requirements for Corrective Actions
                             and Corrections
------------------------------------------------------------------------
            Section                Description            Revision
------------------------------------------------------------------------
507.42(a).....................  Corrective action  Clarify that
                                 procedures.        corrective action
                                                    procedures depend on
                                                    the nature of the
                                                    hazard, as well as
                                                    the nature of the
                                                    preventive control.
507.42(a)(1)..................  Corrective action  Clarify that the
                                 procedures.        specified list of
                                                    corrective action
                                                    procedures is not
                                                    intended to be
                                                    finite.
507.42(b).....................  Corrective action  Specify that the
                                 in the event of    requirement applies
                                 an unanticipated   when ``a corrective
                                 food safety        action procedure''
                                 problem.           (rather than ``a
                                                    specific corrective
                                                    action procedure'')
                                                    has not been
                                                    established.
507.42(b)(1)(ii)..............  Corrective action  Specify that the
                                 in the event of    requirement applies
                                 an unanticipated   when a preventive
                                 food safety        control, combination
                                 problem.           of preventive
                                                    controls, or the
                                                    food safety plan as
                                                    a whole is found to
                                                    be ineffective
                                                    (rather than just
                                                    when a single
                                                    preventive control
                                                    has been found to be
                                                    ineffective).
507.42(c)(2)..................  Corrections......  Provide for
                                                    additional
                                                    circumstances when
                                                    corrections, rather
                                                    than corrective
                                                    actions, are
                                                    warranted.
------------------------------------------------------------------------

A. Proposed Sec.  507.42(a)(1)--Requirement To Establish and Implement 
Corrective Action Procedures

    We proposed that, with some exceptions, as appropriate to the 
preventive control you must establish and implement written corrective 
action procedures that must be taken if preventive controls are not 
properly implemented. The corrective action procedures must include 
procedures to address, as appropriate, the presence of a pathogen or 
appropriate indicator organism in animal food detected as a result of 
product testing, as well as the presence of an environmental pathogen 
or appropriate indicator organism detected through environmental 
monitoring.
    (Comment 303) Some comments note that we proposed to list two 
circumstances that require written corrective active procedures (i.e., 
product testing and environmental monitoring) and that it is not clear 
whether this list is intended to be exhaustive or not (i.e., whether 
written corrective action procedures are required in only these two 
circumstances, or whether there may be other circumstances that require 
written corrective action procedures). These comments ask us to insert 
``but are not limited to'' after ``must include,'' if we intend that 
the list is not exhaustive. Likewise, other comments state our proposal 
to specifically require corrective action procedures may result in a 
misunderstanding by some facilities about the need to take corrective 
actions in circumstances other than in response to testing results, 
other non-conformances, or other types of verification activities. 
These comments assert that it would be better for food safety if the 
regulatory requirements took a more principled approach and generally 
required corrective action procedures, with the importance of 
corrective action procedures for testing programs addressed through 
guidance. If, however, we conclude that specific requirements for 
corrective action procedures for testing programs are necessary, these 
comments ask us to clarify that the nature and extent of any corrective 
actions should be proportional to the nature of the test findings.
    (Response 303) We have revised the regulatory text, with associated 
editorial revisions and redesignations, to clarify that the specified 
list of corrective action procedures is not intended to be exhaustive 
(i.e., not limited to the two corrective action procedures that we 
specified in the 2014 supplemental notice). The approach we used in the 
modified regulatory text (i.e., ``You must establish and implement 
written corrective action procedures . . ., including procedures to 
address, as appropriate . . .'') is similar to the approach used in 
several other provisions of the rule. (See, e.g., sanitation controls 
(Sec.  507.34(c)(2)); and monitoring (Sec.  507.40(a)). We decline the 
suggestion to modify the regulatory text by adding ``but is not limited 
to'' after ``includes''. The word ``includes'' means to have (someone 
or something) as part of a group or total; to contain (someone or 
something) in a group or as a part of something (Ref. 47). The word 
``includes'' does not need to be followed by ``but is not limited to'' 
to clearly communicate that a following list is not complete. We agree 
that the nature and extent of any corrective actions in response to the 
findings of testing programs should be proportional to the nature of 
the test findings. (See Response 304.)
    (Comment 304) Some comments state that the nature and extent of the 
corrective actions should be proportional to the nature of the testing 
results. These comments ask us to require that a facility establish and 
implement corrective action procedures that must be taken if preventive 
controls are not properly implemented as appropriate to the nature of 
the hazard, the nature of the control measure, and the extent of the 
deviation.
    (Response 304) We have revised the regulatory text to specify that 
the corrective action procedures are established and implemented based 
on the nature of the hazard in addition to the nature of the preventive 
control. We agree that the nature of the hazard plays a key role in the 
corrective actions that a facility would take. Although a facility's 
corrective action procedures likely would specify actions to take based 
on the extent of the deviation, we consider this a detail that does not 
need to be specified in the rule.
    (Comment 305) Some comments ask us to revise the provisions to 
clarify that corrective action procedures are not always necessary when 
testing detects the presence of a pathogen or indicator organism. These 
comments assert that

[[Page 56261]]

the extent of the corrective actions should be proportional to the 
nature of the testing results themselves because the level of 
contamination matters for those microorganisms with thresholds that 
need to be taken into account and because the location of contamination 
in the food processing environment matters (e.g., the zone in the 
facility where the contamination is detected). (For information about 
zones associated with environmental monitoring, see 78 FR 3646 at 
3816.)
    (Response 305) We decline this request. These comments appear to be 
confusing the requirement to establish and implement corrective action 
procedures with the content of the corrective action procedures. These 
comments also appear to assume that a requirement to have corrective 
action procedures (which describe the steps to be taken to ensure that 
appropriate action is taken to identify and correct a problem and, when 
necessary, to reduce the likelihood that the problem will recur; that 
all affected animal food is evaluated for safety; and that all affected 
animal food is prevented from entering into commerce when appropriate) 
pre-determines the outcome of following the corrective action 
procedures. This is not the case. If, as the comments assert, a 
facility concludes, for example, that the nature of some test results 
do not warrant steps to reduce the likelihood that a problem will recur 
and that affected animal food is safe and lawful (or, in the case of 
finding a pathogen in some zones in the facility, that no animal food 
is affected), then that is what its corrective action procedures would 
say. The reason to have corrective action procedures is to consider the 
likely scenarios in advance, with appropriate input from the facility's 
food safety team and preventive controls qualified individual, rather 
than react to these scenarios on an ad hoc basis.
    (Comment 306) Some comments ask us to require that corrective 
actions include an analysis to determine the root cause of a problem, 
not only identify it. These comments also ask us to require follow-up 
actions to ensure the corrective action was effective and assert that 
although the requirements address the need to reanalyze the food safety 
plan they do not appear to specifically address a review of the 
corrective action.
    (Response 306) The requests of these comments do not require any 
revisions to the regulatory text. The rule does not use the term ``root 
cause'' but it does require the facility to take appropriate action, 
when necessary, to reduce the likelihood that the problem will recur 
(see Sec.  507.42(a)(2)(ii)). Root cause analysis is simply part of a 
common approach to complying with this requirement. (Knowing the root 
cause is key to reducing the likelihood that a problem will happen 
again.) The rule also requires a review of records of corrective 
actions, but does so as a verification activity rather than as part of 
the corrective action procedures (see Sec.  507.49(a)(4)).
    (Comment 307) Some comments ask us to revise the proposed rule to 
address corrective actions in a more general way and then outline areas 
where specific corrective action procedures would be helpful, such as 
for testing programs, in guidance.
    (Response 307) The proposed provisions do not prescribe the outcome 
of the corrective action procedures, but merely direct the facility to 
the types of actions that the procedures must address. In essence, the 
proposed provisions already do, as the comments request, address 
corrective actions in a general way.
    (Comment 308) Some comments ask us to specify that the requirements 
to establish and implement written corrective action procedures also 
apply when a preventive control is found to be ineffective.
    (Response 308) We have not revised the regulatory text as requested 
by these comments. The appropriate action when a preventive control is 
found to be ineffective is to reanalyze the food safety plan and to 
establish and implement a preventive control that is effective, not 
follow a corrective action procedure. A corrective action procedure is 
intended to address a problem that happens when following the 
procedures in a food safety plan that previously was verified to be 
valid, not to fix problems on an ongoing basis when a preventive 
control is ineffective (and, thus, the food safety plan is not valid). 
We agree that some of the steps that apply to corrective actions may 
need to be taken, such as evaluating affected animal food for safety 
and ensuring that adulterated animal food does not enter commerce. This 
is addressed by the provisions for corrective actions in the event of 
an unanticipated problem (Sec.  507.42(b)(1)), which require specific 
corrective actions to be taken (Sec.  507.42(b)(2)).
    (Comment 309) Some comments requests flexibility as every facility 
is different from the next so prescriptive corrective actions required 
by rules may not be applicable or possible in all cases. Some 
commenters requested that documentation be maintained for corrective 
actions only if the corrective action was made to address an animal 
food safety issue. Other comments say that the animal food safety plan 
should outline when a corrective action is required, as well as the 
procedure to be followed and the requirement should only focus on 
animal food safety issues and not quality issues.
    (Response 309) As stated in Response 304, we have revised the 
regulatory text to specify that the corrective action procedures are 
established and implemented based on the nature of the hazard in 
addition to the nature of the preventive control. We agree that the 
nature of the hazard plays a key role in the corrective actions that a 
facility would take. The requirement is intended to address hazards and 
therefore would not address animal food quality issues unless they 
would present a hazard (e.g., if insufficient mixing would present the 
potential for nutrient deficiencies or toxicities). All corrective 
actions must be documented in records (see Sec.  507.42(d)).

B. Proposed Sec.  507.42(a)(2)--Content of Corrective Action Procedures

    We proposed that corrective action procedures must describe the 
steps to be taken to ensure that: (1) Appropriate action is taken to 
identify and correct a problem that has occurred with implementation of 
a preventive control; (2) appropriate action is taken to reduce the 
likelihood that the problem will recur; (3) all affected animal food is 
evaluated for safety; and (4) all affected animal food is prevented 
from entering into commerce, if you cannot ensure that the affected 
animal food is not adulterated under section 402 of the FD&C Act.
    (Comment 310) Some comments assert that the corrective action 
procedures should not consider food to be ``affected'' if it is 
immediately subjected to an additional (or repeat) preventive control 
after determining that the initial preventive control was not properly 
implemented. These comments discuss an example in which there is a 
temperature deviation below accepted parameter limits for a given 
process, and the incorrectly processed product is re-processed 
correctly, and assert that it would be illogical to consider the food 
to be ``affected'' in the circumstance. Other comments ask us to modify 
the requirements to specify that they apply to all affected food ``if 
any.'' One comment states the use of the term ``all'' with ``affected'' 
is redundant and may contribute to unwarranted and unnecessary 
regulatory emphasis and requests that the word ``all'' be removed.
    (Response 310) We decline the requests to modify the regulatory 
text to remove the word ``all'' or specify that

[[Page 56262]]

the requirements apply to all affected animal food ``if any.'' Animal 
food is ``affected'' if a preventive control is not properly 
implemented during its production. However, the rule does not pre-
determine the consequences when animal food is ``affected.'' Instead, 
the rule provides for the facility to evaluate the affected animal food 
for safety. If, as in the example described by the comments, the 
facility reapplies the preventive control such that the animal food is 
safe and is not adulterated under section 402 of the FD&C Act, there 
would be no need to take steps to prevent that animal food from 
entering commerce.
    (Comment 311) Some comments ask us to provide that requirements for 
corrective actions be principle-based (e.g., affected product 
containment, control restored to operation before commencing 
production) rather than prescriptive.
    (Response 311) The requirements for corrective actions established 
by this rule are principle-based in that they require the facility to 
describe the steps it will take rather than prescribe the steps it will 
take.
    (Comment 312) Some comments ask us to revise the provision to make 
resampling and/or retesting one of the first steps in a corrective 
action procedure to take into account human error. These comments 
assert that mishandling during sampling, transport, and testing can 
contribute to a false positive result and that if the results of a 
followup test are negative, then the previous test could be considered 
an anomaly that could be ignored.
    (Response 312) We decline this request. We disagree that an 
appropriate approach to positive findings of a test for contamination 
is to resample and retest and to consider positive findings to be an 
anomaly if subsequent test results are negative. Many animal food 
products are not homogeneous and contamination is localized. Even for 
homogeneous animal food products (such as liquids), the problem could 
be the sensitivity of the method if the level of contamination is low. 
For further discussion on our current thinking on presumptive positive 
results and additional testing, see our guidance entitled ``Guidance 
for Industry: Testing for Salmonella Species in Human Foods and Direct-
Human-Contact Animal Foods'' (Ref. 48).

C. Proposed Sec.  507.42(b)--Corrective Action in the Event of an 
Unanticipated Problem

    With some exceptions, we proposed that you must take corrective 
action to identify and correct a problem, reduce the likelihood that 
the problem will recur, evaluate all affected animal food for safety, 
and, as necessary, prevent affected animal food from entering commerce 
as would be done following a corrective action procedure if any of the 
following circumstances apply: (1) A preventive control is not properly 
implemented and a specific corrective action has not been established; 
(2) a preventive control is found to be ineffective; or (3) a review of 
records finds that the records are not complete, the activities 
conducted did not occur in accordance with the food safety plan, or 
appropriate decisions were not made about corrective actions. We also 
proposed that if any of these circumstances apply, when appropriate you 
must reanalyze the food safety plan to determine whether modification 
of the food safety plan is required.
    (Comment 313) Some comments ask us to delete the proposed 
requirement that a facility must reanalyze the food safety plan in the 
event of an unanticipated problem. These comments argue that FSMA does 
not specify reanalysis in the event of an unanticipated problem. In 
addition, these comments assert that the proposed requirement for 
reanalysis in the event of an unanticipated problem would be redundant 
with the proposed requirements for reanalysis as a verification 
activity (proposed Sec.  507.50) and would not add value for food 
safety. These comments also assert that the term ``problem'' is 
ambiguous and ask us to replace ``problem'' with ``food safety issue'' 
if we retain the provision in the final rule.
    (Response 313) We acknowledge that section 418 of the FD&C Act does 
not explicitly specify that a facility must reanalyze its food safety 
plan in the event of an unanticipated problem. In the 2014 supplemental 
notice, we clarified that reanalysis would be conducted ``when 
appropriate.'' For example, if a problem occurs because personnel did 
not understand the procedures or carry out the procedures correctly, 
additional training for applicable personnel may be warranted, but 
there likely would be no need to reanalyze the food safety plan.
    We disagree that the term ``problem'' is ambiguous. The term 
``problem'' signifies that something is wrong, whereas the term 
suggested by the comments (i.e., ``issue'') may or may not signify that 
something is wrong. We agree that the requirements are directed to 
problems related to animal food safety.
    We agree that there is a relationship between the requirements for 
corrective actions in the event of an unanticipated food safety problem 
and the requirements for reanalysis. To reduce redundant regulatory 
text, in the 2014 supplemental notice we proposed to modify the 
regulatory text of the requirements for reanalysis to specify that 
reanalysis is required when appropriate after an unanticipated food 
safety problem, and we are establishing that modified provision in this 
final rule. Importantly, the provisions for reanalysis continue to 
require reanalysis when a preventive control is found to be 
ineffective. We are not aware of any circumstances in which it would 
not be appropriate to reanalyze the food safety plan if a preventive 
control is found to be ineffective.
    (Comment 314) Some comments assert that the word ``specific'' is 
not appropriate as a modifier for ``corrective action procedure'' 
because many preventive controls will have corrective action procedures 
that allow flexibility based upon the nature of the hazard and control. 
These comments also state that the term ``specific'' in this context is 
more appropriate for a CCP control in a HACCP system.
    (Response 314) We have revised the regulatory text to delete the 
word ``specific.''
    (Comment 315) Some comments ask us to emphasize that reanalysis is 
required only when a combination of two events occurs (i.e., a 
preventive control is not properly implemented and the facility has not 
established a corrective action procedure).
    (Response 315) In the 2014 supplemental notice, we proposed 
revisions to the regulatory text to clearly specify the circumstances 
requiring reanalysis. One such circumstance is when a preventive 
control is not properly implemented and a corrective action procedure 
has not been established, as stated in Sec.  507.42(b)(1)(i)). The 
final provision includes the revisions included in the 2014 
supplemental notice and is consistent with the request of these 
comments.
    (Comment 316) Some comments ask us to add that corrective actions 
in the event of an unanticipated problem also apply when a preventive 
control is ``missing.''
    (Response 316) We have revised the regulatory text to require 
corrective actions whenever a preventive control, combination of 
preventive controls, or the food safety plan as a whole, is 
ineffective. (See Sec.  507.42(b)(1)(ii).) In assessing what the 
comment might mean by a preventive control that is ``missing,'' we 
concluded that an unanticipated problem could, in some cases, mean that 
a combination of

[[Page 56263]]

preventive controls, or the facility's food safety plan as a whole 
(rather than a single preventive control), simply was not effective. If 
this is the case, reanalysis would be appropriate, and we also have 
modified the requirements for reanalysis to specify that a facility 
must reanalyze its food safety plan whenever it finds that a preventive 
control, combination of preventive controls, or the food safety plan as 
a whole is ineffective.
    (Comment 317) Some comments ask us to replace the term 
``reanalyze'' with the term ``reassess.''
    (Response 317) We decline this request. Reanalysis goes beyond 
assessing the validity of a preventive control or food safety plan to 
control a hazard. Reanalysis can also include assessing whether all 
hazards have been identified, whether established procedures are 
practical and effective, and other factors.

D. Proposed Sec.  507.42(c)--Corrections

    We proposed that you do not need to comply with the requirements 
for corrective actions and corrections for conditions and practices 
that are not consistent with specified sanitation if you take action, 
in a timely manner, to correct such conditions and practices.
    (Comment 318) Some comments support our proposal to provide for 
corrections, rather than corrective actions, for sanitation controls in 
some circumstances. Other comments assert that situations in which 
``corrections'' can be applied are not limited to sanitation controls 
and could include actions to address other preventive controls such as 
preventive maintenance controls or CGMPs. As discussed in Comment 82, 
some comments emphasize the importance of distinguishing between the 
terms ``correction'' and ``corrective action.''
    (Response 318) We have revised the regulatory text, with associated 
editorial revisions and redesignations, to provide for corrections, 
rather than corrective actions and corrective action procedures, for 
minor and isolated problems that do not directly impact product safety. 
As discussed in Response 82, we also have defined the term 
``correction'' to mean an action to identify and correct a problem that 
occurred during the production of animal food, without other actions 
associated with a corrective action procedure (such as actions to 
reduce the likelihood that the problem will recur, evaluate all 
affected animal food for safety, and prevent affected animal food from 
entering commerce).

E. Proposed Sec.  507.42(d)--Records

    We proposed that all corrective actions (and, when appropriate, 
corrections) must be documented in records and that these records are 
subject to the verification requirements in Sec. Sec.  507.45(a)(3) and 
507.49(a)(4)(i). We received no comments that disagreed with this 
proposed requirement and are finalizing it as proposed.

XXXII. Subpart C: Comments on Proposed Sec.  507.45--Verification

    In the 2013 proposed preventive controls rule for animal food, we 
proposed verification activities that would include validation, 
verification of monitoring, verification of corrective actions, 
verification of implementation and effectiveness, written procedures, 
reanalysis, and documentation of all verification activities. We also 
requested comment on whether we should specify the verification 
activities that must be conducted for verification of monitoring (78 FR 
64736 at 64796) and for verification of corrective actions (78 FR 64736 
at 64796), and if so, what verification activities should be required.
    To improve clarity and readability, in the 2014 supplemental notice 
we proposed to move the more extensive verification requirements for 
validation, implementation and effectiveness, and reanalysis from the 
single proposed section (proposed Sec.  507.45) to separate sections 
(proposed Sec. Sec.  507.47, 507.49, and 507.50, respectively). In 
addition, to address comments that asked us to provide more flexibility 
to facilities, including flexibility in determining whether and how to 
conduct verification activities, in the 2014 supplemental notice we 
proposed that the verification activities be performed ``as appropriate 
to the preventive control.''
    In this section, we discuss the proposed requirements for 
verification of monitoring, verification of corrective actions, and 
documentation of verification activities. See sections XXXIII through 
XXXV for comments on the proposed requirements for validation, 
verification of implementation and effectiveness, written procedures, 
and reanalysis. See tables 17, 18, and 19 for a summary of the 
revisions to those proposed requirements.
    Some comments support the proposed requirements for verification of 
monitoring, verification of corrective actions, and documentation of 
verification activities without change. For example, comments support 
the documentation of verification activities (see section XXXI.C). In 
the following paragraphs, we discuss comments on the flexibility 
provided for a facility to conduct verification activities as 
appropriate to the nature of the preventive control. We also discuss 
comments that address our request for comment on whether we should 
revise the regulatory text to specify the verification activities that 
must be conducted for verification of monitoring and for verification 
of corrective actions, or express concern that the requirements as 
proposed are too prescriptive. After considering these comments, we 
have revised the verification requirements described in Sec.  507.45 as 
shown in table 16.

    Table 16--Revisions to the Proposed Requirements for Verification
------------------------------------------------------------------------
            Section                Description            Revision
------------------------------------------------------------------------
507.45(a).....................  Flexibility to     Provide that
                                 conduct            verification
                                 verification       activities take into
                                 activities.        account both the
                                                    nature of the
                                                    preventive control
                                                    and its role in the
                                                    facility's food
                                                    safety system.
------------------------------------------------------------------------

A. Flexibility in Requirements for Verification

    (Comment 319) Some comments support the flexibility provided by use 
of the phrase ``as appropriate to the preventive control'' in the 
requirement that verification activities must include, as appropriate 
to the preventive control, specified verification activities (i.e., 
validation, verification that monitoring is being conducted, 
verification that appropriate decisions about corrective actions are 
being made, verification of implementation and effectiveness, and 
reanalysis). These comments emphasize that verification activities must 
be tailored to the preventive control and assert that the use of the 
word ``must'' is potentially confusing in light of this flexibility, 
e.g., because not all preventive controls must be validated

[[Page 56264]]

for food safety, and those preventive controls that do not need 
monitoring would not need verification of monitoring. Other comments 
ask us to allow facilities flexibility to verify that preventive 
controls are effective in the manner prescribed by FSMA, i.e., such 
controls should be deemed to be effective by an appropriate means as 
determined and supported by the facility within its food safety plan.
    (Response 319) The provisions for preventive control management 
components make clear that all preventive control management 
components, including verification, are required as appropriate to 
ensure the effectiveness of the preventive control, taking into account 
the nature of the preventive control and its role in the facility's 
food safety system (see Sec.  507.39). Likewise, the provisions for 
each of the preventive control management components (i.e., monitoring, 
corrective actions and corrections, and verification) individually 
provide flexibility, either by specifying that the provisions apply as 
appropriate to the nature of the preventive control and its role in the 
facility's food safety system (i.e., for monitoring and verification) 
or both the nature of the preventive control and the nature of the 
hazard (i.e., for corrective actions and corrections). The word 
``must'' specifies the type of activities that a facility can use to 
satisfy the requirements for a particular preventive control management 
component.
    We are retaining the term ``must.'' However, we agree that the rule 
should provide flexibility for additional verification of 
implementation and effectiveness. To provide that additional 
flexibility, we have revised the specific requirements for verification 
of implementation and effectiveness to provide for other activities 
appropriate for verification of implementation and effectiveness (see 
Sec.  507.49(a)(5)). As a conforming revision, we have revised the 
requirement for review of records to include a review of records of 
other verification activities within a reasonable time after the 
records are created (see Sec.  507.49(a)(4)(ii)).

B. Proposed Sec.  507.45(a)--Verification Activities

1. Proposed Sec.  507.45(a)(1)--Validation
    We proposed that verification activities must include, as 
appropriate to the preventive control, validation in accordance with 
Sec.  507.47. See section XXXIII for comments on validation as a 
verification activity.
2. Proposed Sec.  507.45(a)(2)--Verification of Monitoring
    We proposed that verification activities must include, as 
appropriate to the preventive control, verification that monitoring is 
being conducted in accordance with Sec.  507.40. We requested comment 
on whether we should specify the verification activities that must be 
conducted for monitoring, and if so, what verification activities 
should be required.
    (Comment 320) Comments that address our request for comment on 
whether we should specify the verification activities that must be 
conducted for monitoring ask us to not do so because this prescriptive 
approach would be too limiting. These comments ask us to instead 
provide flexibility for the facility to determine the appropriate 
verification activities.
    (Response 320) We agree that we should provide flexibility for the 
facility to determine these verification activities, and are not 
specifying the verification activities that must be conducted for 
monitoring.
3. Proposed Sec.  507.45(a)(3)--Verification of Corrective Actions
    We proposed that verification activities must include, as 
appropriate to the preventive control, verification that appropriate 
decisions about corrective actions are being made in accordance with 
Sec.  507.42. We requested comment on whether this section should 
specify the verification activities that must be conducted for 
corrective actions, and if so, what verification activities should be 
required.
    (Comment 321) Some comments ask us not to specify the verification 
activities that must be conducted for corrective actions because this 
approach would be too limiting. These comments ask us to instead 
provide flexibility for the facility to determine the appropriate 
verification activities.
    (Response 321) We agree that we should provide flexibility for the 
facility to determine the appropriate verification activities for 
corrective actions, and are not specifying the verification activities 
that must be conducted for corrective actions.
4. Proposed Sec.  507.45(a)(4)--Verification of Implementation and 
Effectiveness
    We proposed that verification activities must include, as 
appropriate to the preventive control, verification of implementation 
and effectiveness in accordance with Sec.  507.49. See section XXXIV 
for comments on verification of implementation and effectiveness.
    (Comment 322) One comment contends that animal food facilities 
should not be required to conduct product testing or environmental 
monitoring to verify implementation and effectiveness of preventive 
controls. The comment states that product testing and environmental 
monitoring at a facility that is not using appropriate controls will 
not normally discover potential hazards. The comment also states that 
all of the safety requirements necessary to protect the health of 
animals are already being met because this is necessary as a good 
business practice and is required by customers.
    (Response 322) When a food safety plan is completed by a preventive 
controls qualified individual, they must ensure that the preventive 
controls in place are adequate to provide assurance that any hazards 
requiring a preventive control will be significantly minimized or 
prevented. We have provided adequate flexibility for a preventive 
controls qualified individual in an animal food facility to determine 
if product testing or environmental monitoring is necessary considering 
the facility, the animal food, the nature of the preventive control, 
and its role in the facility's food safety system (for further 
discussion see section XXXIV.C and XXXIV.E).
    We disagree that all food safety measures necessary to protect the 
health of animals are always being followed. Each year, animal food is 
recalled, often due to a hazard that could cause serious health 
consequences or death. Animal food from a facility that is required to 
register and for which there is a reasonable probability that use of or 
exposure to the food would cause serious adverse health consequences or 
death to humans or animals is subject to reporting to FDA under section 
417 of the FD&C Act (Reportable Food Registry).
5. Proposed Sec.  507.45(a)(5)--Reanalysis
    We proposed that verification activities must include, as 
appropriate to the preventive control, reanalysis in accordance with 
Sec.  507.50. See section XXXV for comments on reanalysis as a 
verification activity.

C. Proposed Sec.  507.45(b)--Documentation of Verification Activities

    We proposed that all verification activities must be documented in 
records. We received no comments that disagreed with this proposed 
requirement and are finalizing it as proposed.

D. Comments on Potential Requirements Regarding Complaints

    We requested comment on whether and how a facility's review of

[[Page 56265]]

complaints, including complaints from consumers, customers, or other 
parties, should be required as a component of its activities to verify 
that its preventive controls are effectively minimizing the occurrence 
of hazards (78 FR 64736 at 64809).
    (Comment 323) Some comments ask us to require review of consumer 
complaints as a verification activity and note that our HACCP 
regulations for seafood and juice require that verification activities 
include a review of consumer complaints to determine whether they 
relate to the performance of the HACCP plan or reveal the existence of 
unidentified CCPs. Some comments note circumstances in which consumer 
complaints have identified food safety problems that resulted in a 
company report to the RFR. Other comments assert that review of 
customer complaint data should not be required in the rule to verify 
that a facility's preventive controls are effectively minimizing the 
occurrence of hazards.
    Some comments state that the frequency and type of complaints a 
facility receives is a very good indicator of the underlying issues 
associated with food production, reviewing these records would provide 
valuable insight into the type of issues that should be investigated, 
and this type of verification activity could therefore be extremely 
effective with little to no cost because the facility would already be 
performing this type of activity. Some comments state that many 
foodborne outbreaks have been identified through complaints and a 
review of complaints is a critical component of a food safety system. 
One comment says that many times customer complaints may be the first 
and only clue that problems exist in animal food because animal 
illnesses are not subject to the same reporting requirements as human 
illnesses, resulting in a much weaker basis for identifying, tracing, 
and correcting foodborne problems.
    Other comments state that a food safety review of complaints is a 
prudent part of a food safety program but that the value of such a 
review is in providing information and feedback for continuous 
improvement of the food safety management system rather than as a 
verification of preventive controls. These comments caution against use 
of consumer complaints as a regulatory requirement for verification of 
the food safety plan because most complaints relate to product quality. 
If such a requirement is nonetheless established in the final rule, 
these comments recommend that the rule only require followup and 
documentation for the rare occurrences where consumer complaints relate 
to food safety issues.
    Other comments ask us not to require review of complaints as a 
verification activity. Some of these comments assert that complaints 
rarely relate to food safety or yield information that leads to 
discovery of a food safety issue. Some comments assert that requiring 
review of consumer complaints could result in unnecessary time and 
effort being spent on an activity with a limited correlation to food 
safety. Some comments assert that the provision would provide FDA 
access unnecessarily to all complaint files and lead to unproductive 
and subjective evaluations as to whether a given complaint pertains to 
the performance of the food safety plan. Other comments assert that 
complaints would be acted upon immediately for business reasons, and 
that waiting to react to complaints until conducting a review of 
records as a verification activity would be too late. Other comments 
assert that complaints are sensitive business information. Other 
comments assert that some consumer complaints are false or emotional 
(rather than factual) and have no place in development of preventive 
controls. Some comments assert that FSMA does not expressly direct us 
to require review of complaints. Some comments assert that review of 
complaints is not a precise scientific process, and that consumer 
comments are often open to different interpretations.
    Some comments discuss the feasibility of consumer complaint review. 
Comments state that consumer complaint records are often kept at a 
corporate level rather than at the individual facility. One comment 
requests mandatory complaint monitoring for animal food manufacturers. 
One comment points out FDA already has access to records, including 
complaint files, associated with animal food, which the Agency 
reasonably believes to be adulterated and presenting a threat of 
serious adverse health consequences.
    (Response 323) We are not establishing a requirement for a review 
of complaints as a verification activity. We agree that review of 
complaints is more likely to be useful in providing information and 
feedback for continuous improvement of the food safety system rather 
than as a verification of preventive controls. However, we encourage 
facilities to do such a review, as they occasionally do uncover animal 
food safety issues.

XXXIII. Subpart C: Comments on Proposed Sec.  507.47--Validation

    We proposed to establish requirements for validation of preventive 
controls. Some comments support the proposed requirements without 
change. For example, some comments agree that validation must be 
performed by (or overseen by) a preventive controls qualified 
individual and that some preventive controls (e.g., sanitation controls 
and recall plans) do not require validation. Some comments that support 
the proposed provisions suggest alternative or additional regulatory 
text or ask us to clarify how we will interpret the provision.
    In the following paragraphs, we discuss comments that ask us to 
clarify the proposed requirements or that disagree with, or suggest one 
or more changes to, the proposed requirements. After considering these 
comments, we have revised the proposed requirements as shown in table 
17, with editorial and conforming changes as shown in table 31.

     Table 17--Revisions to the Proposed Requirements for Validation
------------------------------------------------------------------------
            Section                Description            Revision
------------------------------------------------------------------------
507.47(a).....................  Flexibility for    Provide that
                                 validating         validation be
                                 preventive         conducted as
                                 controls.          appropriate to both
                                                    the nature of the
                                                    preventive control
                                                    and its role in the
                                                    facility's food
                                                    safety system.
507.47(b)(1)..................  Circumstances      Provide that, when
                                 requiring          necessary to
                                 validation.        demonstrate the
                                                    control measures can
                                                    be implemented as
                                                    designed, validation
                                                    may be performed (1)
                                                    Within 90 calendar
                                                    days after
                                                    production of the
                                                    applicable animal
                                                    food first begins or
                                                    (2) within a
                                                    reasonable
                                                    timeframe, provided
                                                    that the preventive
                                                    controls qualified
                                                    individual prepares
                                                    (or oversees the
                                                    preparation of) a
                                                    written
                                                    justification.

[[Page 56266]]

 
507.47(b)(1)..................  Circumstances      Add an additional
                                 requiring          circumstance
                                 validation.        requiring
                                                    validation, i.e.,
                                                    whenever a change to
                                                    a control measure or
                                                    combination of
                                                    control measures
                                                    could impact whether
                                                    the control measure
                                                    or combination of
                                                    control measures,
                                                    when properly
                                                    implemented, will
                                                    effectively control
                                                    the hazards
                                                    requiring a
                                                    preventive control.
507.47(c).....................  Preventive         Clarify that a list
                                 controls that do   of preventive
                                 not require        controls that do not
                                 validation.        require validation
                                                    is not an exhaustive
                                                    list.
------------------------------------------------------------------------

A. Flexibility in the Requirements To Validate Preventive Controls

    With some exceptions (see discussion of proposed Sec.  507.47(b)(3) 
in section XXXIII.D), we proposed that you must validate that the 
preventive controls identified and implemented in accordance with 
proposed Sec.  507.36 to control the significant hazards are adequate 
to do (proposed Sec.  507.47(a)).
    (Comment 324) Some comments assert that the regulatory text is in 
conflict with the preamble discussion in the 2014 supplemental notice 
because the regulatory text (i.e., ``(e)xcept as provided by . . .'') 
narrowly provides exceptions only for validation of sanitation 
controls, supplier controls, and the recall plan, whereas the preamble 
discussion provides other examples of preventive controls that would 
not require validation (i.e., zoning, training, preventive maintenance, 
and refrigerated storage). These comments also assert that although the 
regulatory text specifies that validation requirements apply ``as 
appropriate to the nature of the preventive control,'' that phrase 
could be interpreted to mean that only the validation act itself can be 
tailored and that the facility does not have the flexibility to 
conclude that validation isn't necessary.
    Some comments assert that the proposed regulatory text would 
prevent us from requiring validation of specific sanitation controls 
where it may be prudent to do so, either now or in the future as a 
result of a newly identified hazard, or the development of a tool, such 
as a test method, that would enable validation of the control for the 
specific hazard.
    (Response 324) We have deleted ``except as provided by paragraph 
(b)(3) of this section'' from proposed Sec.  507.47(a) to remove the 
limitation seen by the comments on the exceptions to the requirement 
for validation of preventive controls. We also have revised the 
regulatory text of Sec.  507.47(c) to provide that a facility does not 
need to validate other preventive controls, if the preventive controls 
qualified individual prepares (or oversees the preparation of) a 
written justification that validation is not applicable based on 
factors such as the nature of the hazard, and the nature of the 
preventive control and its role in the facility's food safety system. 
We specified that the determination that validation is not required 
must be made by the preventive controls qualified individual to 
emphasize that specialized experience is necessary to evaluate whether 
validation is required. We made a conforming revision to the list of 
responsibilities of the preventive controls qualified individual (see 
Sec.  507.53(a)).
    (Comment 325) Some comments ask us to separate requirements for 
validation from requirements for verification because verification and 
validation are two different concepts and combining them is confusing. 
One comment said that we reversed the definitions of validation and 
verification, compared to the common use of the terms in HACCP 
activities. Some comments point out that while section 418(f)(1) of the 
FD&C Act explicitly requires verification, it does not require 
validation. Some of these comments assert that our proposed 
requirements for validation exceed the mandate of FSMA while others 
argue that the lack of explicit language in section 418 of the FD&C Act 
gives us legal flexibility in determining whether and how to require 
validation.
    (Response 325) Our approach is consistent with section 418 of the 
FD&C Act. Section 418(f)(1) of the FD&C Act requires verification of 
the preventive controls, and validation is an element of verification 
(see both the NACMCF HACCP guidelines (Ref. 49) and our HACCP 
regulation for juice (Sec.  120.3(p)). We agree that the purpose of 
validation is different from the purpose of other verification 
activities, and we have revised the definitions of both terms to make 
this clearer. Although we are establishing a separate regulatory 
section for the validation requirements, we did so to improve clarity 
and readability rather than as a substantive change relevant to the 
issues discussed in these comments. (See Response 75.)
    (Comment 326) Some comments assert that validation is more 
appropriate for a HACCP regulation and that requiring the validation of 
all preventive controls does not reflect the flexibility mandated by 
section 418(n)(3)(A) of FSMA. Other comments assert that effective 
preventive measures may be identified in the future that are not 
amenable to validation and it would be counterproductive for them not 
to be employed in food safety plans because they cannot meet the 
validation requirements. These comments explain that certain control 
measures are not suitable for validation activities due to the nature 
of the activity or previous validation by another entity (e.g., a 
supplier).
    (Response 326) The 2013 proposed preventive controls rule for 
animal food would not have required the validation of all preventive 
controls. For example, we specifically proposed that the validation of 
preventive controls need not address sanitation controls and the recall 
plan. To emphasize that a facility has flexibility in determining which 
other preventive controls require validation, in the 2014 supplemental 
notice we revised the proposed regulatory text to require validation 
``as appropriate to the nature of the preventive control.'' See 
Response 324 for additional revisions we have made to the regulatory 
text to provide flexibility for a facility to determine that validation 
is not necessary.
    (Comment 327) Some comments ask us to allow validation of the whole 
system instead of individual controls.
    (Response 327) See the discussion of the definition of validation 
in Response 75. Under the definition, validation can be directed to a 
control measure, combination of control measures, or the food safety 
plan as a whole.
    (Comment 328) Some comments ask us to align validation requirements 
with the relative risk of operations.
    (Response 328) Validation requirements apply only to preventive 
controls that are established and implemented based on the outcome of a 
hazard analysis, which requires consideration of risk. We also require

[[Page 56267]]

validation as appropriate to the nature of the preventive control and 
its role in the facility's food safety system. This provides 
flexibility with respect to validation and allows consideration of 
risk.
    (Comment 329) Some comments ask us to provide guidance and 
clarification on topics relevant to validation, especially for small 
facilities that may lack the resources needed to generate studies and 
scientific data to validate processes. Some comments ask us to clarify 
our expectations for a validated process and on conducting studies for 
validation purposes. Some comments ask us to provide resources for 
validation, noting that some preventive controls will be difficult to 
validate and that no scientific research or data are available for 
certain controls. Some comments indicate that validation information 
provided by FDA should be in the form of non-binding guidance 
documents. Some comments ask us to delay enforcement for the validation 
requirements until a readily accessible repository of validated 
processes, and scientific and technical information, can be created to 
assist stakeholders in complying with the validation requirements.
    (Response 329) We intend that the guidance we are developing will 
address topics such as those recommended in the comments. (See Response 
1). In addition, the FSPCA is developing information for training, 
which may be useful to animal food facilities. We are not requiring 
facilities to comply with the requirements of subparts C and E of this 
rule, including the validation requirements, for 2, 3, or 4 years 
depending on the size of the facility. We expect that segments of the 
animal food industry will work together and with the FSPCA to develop 
scientific and technical information that can be used as evidence to 
validate a variety of preventive controls, and will be helpful to 
facilities.
    (Comment 330) Some comments indicate that the rule lacked 
specifications for, and was unclear on, the process that FDA would 
utilize to approve or accept validation data and/or studies. Some 
comments ask us to develop a mechanism for industry to make sure their 
approach and studies meet the requirements of the rule, such as 
certification of process authorities or the establishment of a liaison 
between FDA and industry to ensure validation protocols are in 
compliance.
    (Response 330) As discussed in Response 1, we are developing 
several guidance documents within FDA, including guidance on 
validation. In addition, as part of a collaborative effort with the 
FSPCA we are obtaining technical information useful for developing 
guidelines for preventive controls and outreach to industry, and we 
intend that effort to include guidance on approaches to satisfy the 
validation requirements of the rule. We do not intend to develop a 
mechanism for certification of process authorities or establish a 
liaison between FDA and industry to ensure validation protocols are in 
compliance. The guidance we are developing on validation should help 
industry determine whether their validation approaches are likely to be 
acceptable to us.

B. Proposed Sec.  507.47(b)(1)--When Validation Must Be Performed and 
Role of Preventive Controls Qualified Individual in Validation

    We proposed that validation of the preventive controls must be 
performed by (or overseen by) a preventive controls qualified 
individual prior to implementation of the food safety plan (or, when 
necessary, during the first 6 weeks of production) and whenever a 
reanalysis of the food safety plan reveals the need to do so.
    (Comment 331) Some comments ask us to clarify whether an individual 
attending food safety training by an entity such as a cooperative 
extension or a State department of agriculture could be a ``preventive 
controls qualified individual'' for the purpose of performing or 
overseeing the validation of preventive controls.
    (Response 331) See the discussion in section XXXVII.B for 
additional information about training applicable to a preventive 
controls qualified individual. We have not specified additional 
requirements for a preventive controls qualified individual with 
respect to validation. A person may be a preventive controls qualified 
individual through job experience, as well as training. Food safety 
training provided by an entity such as a cooperative extension 
specialist or a State department of agriculture could be appropriate 
training for many of the functions of the preventive controls qualified 
individual if the training is consistent with the standardized 
curriculum being developed by the FSPCA.
    (Comment 332) Some comments question whether 6 weeks is enough time 
to perform all applicable validation studies that would address the 
execution element of validation. Some comments ask us to explain the 
basis for the proposed 6-week timeframe. Some comments ask us to align 
with the 90-day timeframe in the FSIS Validation Guidelines (Ref. 50). 
Some comments note that the seasonal nature of production of some food 
products may make it impractical to perform all required validations 
within 6 weeks. Some comments suggest that validation be performed 
within a specified number of production batches, such as 10 production 
batches. Some comments emphasize the need for flexibility and ask us to 
both adopt a 90-day timeframe and provide for a longer timeframe with a 
written justification, or provide for ongoing evidence of process 
validation. One comment recommends removing a required timeframe for 
validation or providing a compliance extension until such time as we 
could better support the requirements, such as in guidance. One comment 
asserts that the timeframe should be prior to implementation of the 
food safety plan. Some comments ask as us to specify that validation be 
performed within a reasonable time as justified by the preventive 
controls qualified individual. Some comments ask for more time for 
small businesses to perform validation studies.
    (Response 332) We note that the 90-day timeframe for validation is 
established in FSIS' regulations at 9 CFR 304.3(b) and (c) and 9 CFR 
381.22(b) and (c) (Conditions for receiving inspection for meat and 
meat products and poultry and poultry products, respectively). The FSIS 
Validation Guidelines are a companion to those regulations. We have 
revised the regulatory text, with associated editorial changes, to make 
two changes to the proposed 6-week timeframe for validation of 
preventive controls. First, we have adopted the 90-day timeframe 
already established in the FSIS' regulations by specifying that when 
necessary to demonstrate the control measures can be implemented as 
designed, validation may be performed within 90 days after production 
of the applicable animal food first begins. Although we had proposed a 
6-week timeframe based on the 3 to 6 week timeframe suggested in the 
Codex Guidelines for the Validation of Food Safety Control Measures 
(Ref. 22), we agree that practical limitations associated with the 
production of some animal food products may make it difficult to 
perform validation within 6 weeks. The 90-day timeframe in FSIS' 
regulations, and incorporated into the FSIS Validation Guidelines, 
reflects more than 15 years of experience with validating HACCP systems 
for meat and poultry. Although we have provided for validation to be 
performed within 90 days after production of the applicable food first 
begins, we do not believe it would take a full 90-days of production

[[Page 56268]]

to determine whether the facility can provide assurances that a control 
measure is working as intended to control the hazard.
    Second, we have provided for validation within a reasonable 
timeframe, provided that the preventive controls qualified individual 
prepares (or oversees the preparation of) a written justification for a 
timeframe that exceeds 90 days after production of the applicable 
animal food first begins. We acknowledge that practical limitations 
such as those described in the comments could prevent a facility from 
performing the validation within 90 days after production of the 
applicable animal food first begins. A timeframe that exceeds 90 days 
after production of the applicable animal food first begins will be the 
exception rather than the norm and we are requiring that the preventive 
controls qualified individual provide (or oversee the preparation of) a 
written justification for such a timeframe. We made a conforming 
revision to the list of responsibilities of the preventive controls 
qualified individual (see Sec.  507.53(a)).
    (Comment 333) Some comments ask us to add another circumstance when 
validation would be required, i.e., whenever a change is made to the 
control being applied.
    (Response 333) We have revised the regulatory text to require 
validation whenever a change to a control measure or combination of 
control measures could impact whether the control measure or 
combination of control measures, when properly implemented, will 
effectively control the hazards requiring a preventive control. Under 
this provision, a facility would revalidate a preventive control if, 
for example, a different type of equipment is used to deliver a heat 
process, because it would be necessary to determine that the new 
equipment can consistently achieve the required temperature and time of 
the process. However, a facility would not need to revalidate a 
preventive control if, for example, a thermal process is changed by 
increasing the time or temperature, because a less stringent thermal 
process would already have been validated.
    (Comment 334) Some comments ask us to require validation both 
before production and 6 weeks after production begins.
    (Response 334) We decline this request. A facility has flexibility 
to perform validation as appropriate to the nature of the preventive 
controls, whether before production (e.g., by obtaining and evaluating 
generally available scientific and technical information or by 
conducting studies), after production begins (to demonstrate the 
control measures can be implemented as designed during full-scale 
production), or both.

C. Proposed Sec.  507.47(b)(2)--What Validation Must Include

    We proposed that the validation of preventive controls must include 
collecting and evaluating scientific and technical information (or, 
when such information is not available or is inadequate, conducting 
studies) to determine whether the preventive controls, when properly 
implemented, will effectively control the significant hazards.
    (Comment 335) Some comments assert that our discussion of 
validation refers to ``scientific proof'' for the validation of a 
processing step and ask us to define what is and is not considered 
scientific proof for validation.
    (Response 335) We used terms such as ``scientific and technical 
information'' and ``scientific and technical basis'' rather than 
``scientific proof'' when discussing validation. For information about 
what we mean by ``scientific and technical information,'' (see 78 FR 
64736 at 64794 through 64795).
    (Comment 336) Some comments ask us to clarify expectations of 
validations for basic sanitary processes. Another comment asks us to 
exempt the validation of CGMPs.
    (Response 336) The requirements for validation only apply to 
preventive controls. Any practice governed by CGMPs only requires 
validation if a facility identifies that practice as a preventive 
control for a hazard. To the extent that the comment is referring to 
sanitary practices governed by CGMPs (such as in Sec.  507.19), the 
validation requirements would not apply. To the extent that the comment 
is referring to sanitation controls established as a preventive 
control, those sanitation controls are excluded from the validation 
requirements (see Sec.  507.47(c)).
    (Comment 337) Some comments ask that we not require further 
validation of well-accepted preventive controls, such as refrigeration 
temperature.
    (Response 337) A facility may rely on generally available 
scientific and technical information to demonstrate the adequacy of 
controls such as refrigeration but must obtain that information and 
establish it as a record (see Sec.  507.45(b)).
    (Comment 338) Some comments express concern that specific methods 
are not available to enable validation. Some comments express concern 
that the requirement to ``conduct studies'' might be intended, or could 
be interpreted, to mean that firms are required to develop or validate 
analytical methods (either in general or for specific food matrices). 
These comments assert that any such requirement would incur extreme 
costs and burdens without delivering commensurate public health 
benefits.
    (Response 338) We do not intend the requirement to ``conduct 
studies'' to mean that firms are required to develop or validate 
analytical methods.
    (Comment 339) Some comments recommend validation via indirect 
methods such as scientific publications, government documents, 
predictive modeling and other technical information from equipment 
manufacturers and other sources. Other comments assert that there are a 
variety of circumstances in which the collection and evaluation of 
scientific and technical information is not necessary (e.g., the use of 
sieving or metal detectors to control physical hazards).
    (Response 339) See Responses 324 and 326. We agree that not all 
preventive controls require validation, and the facility has 
flexibility to take into account the nature of the preventive control 
when determining whether to perform validation. The regulatory text, 
which provides for scientific and technical evidence that a control 
measure is capable of effectively controlling the identified hazards, 
provides for the use of ``indirect methods'' as recommended by the 
comments. However, even when sources such as scientific publications 
are the basis for validation, studies may be needed to demonstrate that 
the process used can be implemented in the facility to control the 
hazard.

D. Proposed Sec.  507.47(c)(3)--Preventive Controls for Which 
Validation Is Not Required

    We proposed that validation need not address sanitation controls, 
the recall plan, and the supplier program (which we now refer to as the 
``supply-chain'' program).
    (Comment 340) Some comments ask us to eliminate the specific list 
of controls that are excluded from the validation requirement and 
instead revise the regulatory text to provide the facility with 
flexibility to determine when validation is appropriate.
    (Response 340) As discussed in Response 324, we have deleted 
``except as provided by paragraph (b)(3) of this section'' from 
proposed Sec.  507.47(a) to remove the limitation seen by the comments 
on the exceptions to the requirement for validation of preventive 
controls. We also have revised the

[[Page 56269]]

regulatory text of Sec.  507.47(c) to provide that a facility does not 
need to validate other preventive controls, if the preventive controls 
qualified individual prepares (or oversees the preparation of) a 
written justification that validation is not applicable based on 
factors such as the nature of the hazard, and the nature of the 
preventive control and its role in the facility's food safety system. 
We see no reason to also eliminate the list of those controls for which 
we have already determined that validation is not necessary, and 
require each facility to develop its own rationale for concluding that 
validation is not necessary based on the nature of these preventive 
controls. The rule would not prevent a facility from validating one of 
these preventive controls, such as a sanitation control, if it chooses 
to do so.

XXXIV. Subpart C: Comments on Proposed Sec.  507.49--Verification of 
Implementation and Effectiveness

    We proposed that you must verify that the preventive controls are 
consistently implemented and are effectively and significantly 
minimizing or preventing the significant hazards. We proposed that to 
do so you must conduct specified activities (i.e., calibration, product 
testing, environmental monitoring, and review of records) as 
appropriate to the facility, the animal food, and the nature of the 
preventive control. We also proposed that you must establish and 
implement written procedures for the frequency of calibrating process 
monitoring instruments and verification instruments, product testing, 
and environmental monitoring.
    Some comments that support the proposed provisions suggest 
alternative or additional regulatory text or ask us to clarify how we 
will interpret the provision. In the following paragraphs, we discuss 
comments that ask us to clarify the proposed requirements or that 
disagree with, or suggest one or more changes to, the proposed 
requirements. After considering these comments, we have revised the 
proposed requirements as shown in table 18.

  Table 18--Revisions to the Proposed Requirements for Verification of
                    Implementation and Effectiveness
------------------------------------------------------------------------
            Section                Description            Revision
------------------------------------------------------------------------
507.49(a).....................  Flexibility in     Provide that
                                 the requirement    activities for
                                 to conduct         verification of
                                 activities to      implementation and
                                 verify             effectiveness take
                                 implementation     into account both
                                 and                the nature of the
                                 effectiveness.     preventive control
                                                    and its role in the
                                                    facility's food
                                                    safety system.
507.49(a)(1)..................  Verification of    Provide for accuracy
                                 implementation     checks in addition
                                 and                to calibration.
                                 effectiveness
                                 for process
                                 monitoring
                                 instruments and
                                 verification
                                 instruments.
507.49(a)(4)(i)...............  Timeframe for      Provide for records
                                 review of          review within 7
                                 records of         working days after
                                 monitoring and     the records are
                                 corrective         created, or within
                                 action records.    or within a
                                                    reasonable
                                                    timeframe, provided
                                                    that the preventive
                                                    controls qualified
                                                    individual prepares
                                                    (or oversees the
                                                    preparation of) a
                                                    written
                                                    justification.
507.49(a)(5)..................  Other activities   Clarify that there
                                 appropriate for    could be alternative
                                 verification of    verification
                                 implementation     activities of
                                 and                implementation and
                                 effectiveness.     effectiveness other
                                                    than those that we
                                                    specify in the rule.
507.49(b).....................  Written            Clarify that written
                                 procedures for     procedures for
                                 verification of    verification of
                                 implementation     implementation and
                                 and                effectiveness are
                                 effectiveness.     established and
                                                    implemented as
                                                    appropriate to the
                                                    role of the
                                                    preventive control
                                                    in the facility's
                                                    food safety system,
                                                    as well as
                                                    appropriate to the
                                                    facility, the animal
                                                    food, and the nature
                                                    of the preventive
                                                    control.
507.49(b)(1)..................  Written            Require written
                                 procedures for     procedures for
                                 verification of    accuracy checks in
                                 implementation     addition to
                                 and                calibration.
                                 effectiveness
                                 for process
                                 monitoring
                                 instruments and
                                 verification
                                 instruments.
------------------------------------------------------------------------

A. Flexibility in the Requirement To Conduct Activities To Verify 
Implementation and Effectiveness

    We proposed that you must verify that the preventive controls are 
consistently implemented and are effectively and significantly 
minimizing or preventing the significant hazards by conducting 
specified activities as appropriate to the facility, the animal food, 
and the nature of the preventive control. We proposed to specify the 
following verification activities: (1) Calibration; (2) product 
testing; (3) environmental monitoring; and (4) review of records.
    In the following paragraphs, we discuss comments generally directed 
to the need for a facility to have flexibility to apply these 
requirements (particularly the requirements for product testing and 
environmental monitoring) in a manner that works best for the facility 
in light of its animal food products and the nature of the preventive 
controls that would be verified. In sections XXXIV.B through XXXIV.F, 
we discuss the requirements for calibration, product testing, 
environmental monitoring, and review of records more specifically.
    (Comment 341) Some comments express support for the flexibility 
provided by specifying that verification activities must be conducted 
``as appropriate to the facility, the animal food, and the nature of 
the preventive control.'' Some comments state that the proposed 
provision means that, based on risk, an animal food manufacturer could 
decide whether or not to do product testing and, when applicable, the 
type of test and the testing frequency. One comment says the provision 
will have limited value where the presence of some levels of pathogens 
is expected and is not necessarily an animal food safety problem. Some 
comments agree with the proposed provisions because they address 
product testing through flexible written procedures that consider both 
testing and corrective action plans rather than through mandatory or 
prescribed requirements. Other comments agree with the proposed 
provisions because they require facilities to develop and use testing 
programs that are tailored to their facility, equipment, processes, 
products, and other specific circumstances, and do not prescribe 
specific requirements for testing, such as finished product testing. 
Some comments state that product testing may

[[Page 56270]]

not be effective in identifying the acceptability of a specific 
ingredient or finished product lot on any given day, but it can help 
assess and verify the effectiveness of a food safety plan as a whole 
and the facility's capability to consistently deliver against it.
    Some comments assert that the preamble discussion in the 2014 
supplemental notice is in conflict with the proposed regulatory text 
and ask us to modify the regulatory text to provide the flexibility we 
signaled in that supplemental notice. These comments express concern 
that the term ``must'' (i.e., ``you must conduct activities that 
include the following'') could be interpreted to mean that activities 
listed in the regulatory text (in particular, product testing and 
environmental monitoring) are always required in some form. Some 
comments ask us to clarify whether product testing and environmental 
monitoring are required or optional. Other comments assert that 
facilities should have the flexibility to determine whether to conduct 
product testing and environmental monitoring based on a risk 
assessment. Some comments assert that there are circumstances (such as 
unpackaged animal food; ingredients for animal food stored in vented or 
open areas, in oilseed production; and rendering) where these tests 
would not be necessary. Some comments assert that a determination to 
conduct environmental monitoring should be on a case-by-case basis and 
that other verification activities may be used (such as process 
verifications or testing of intermediates) to verify implementation and 
effectiveness. Other comments ask us to exempt operations when their 
hazard analysis appropriately concludes that there is no foreseeable 
risk. One comment says FDA should not require routine monitoring for 
feed mills unless they manufacture pet food.
    One comment says environmental monitoring should not be required as 
a verification activity for significant hazards as other controls can 
be used and environmental monitoring will impose undue burdens and 
costs to industry. Many comments state that environmental monitoring 
requirements should only be applied to ``significant hazards,'' if any, 
that are present within the firm's operation, and as with product 
testing, animal food facilities must be provided the flexibility to 
tailor their environmental monitoring programs based on risk. Comments 
note that in cases where the animal food is likely to undergo further 
processing that would minimize or eliminate any microbiological 
hazards, environmental pathogens would not be a significant hazard and 
such facilities could focus their resources on other controls. One 
comment says it does not agree that the potential for later processing 
mitigates the need for environmental monitoring because processes such 
as pelleting reduce but do not entirely eliminate pathogens.
    (Response 341) The provisions for verification provide flexibility 
by specifying that they apply as appropriate to the nature of the 
preventive control and its role in the facility's food safety system. 
As noted by some comments, the provisions address testing through 
flexible written procedures that allow facilities to develop and use 
testing programs that are tailored to their facility, equipment, 
processes, products, and other specific circumstances. We agree that an 
appropriate outcome of the hazard analysis for some facilities will be 
that product testing and environmental monitoring are not required; it 
is not necessary to grant an ``exemption'' to allow a facility to 
achieve this outcome. For example, environmental monitoring would be 
required to verify effectiveness of sanitation controls when an animal 
food is exposed to the environment prior to packaging and the packaged 
food does not receive a treatment or otherwise include a control 
measure (such as a formulation lethal to the pathogen) that would 
significantly minimize the pathogen because such environmental 
monitoring is appropriate to the facility (one manufacturing animal 
food), the food (such as a dry (extruded) pet food exposed to the 
environment), and the nature of the preventive control (sanitation 
controls). Animal food such as dry and raw pet food and pet treats are 
among the products for which manufacturing operations might need to 
have an environmental monitoring program when such animal food is 
exposed to the environment.
    We discuss product testing for microbial pathogens in another FDA 
memorandum, including the use of pathogens and indicator organisms and 
microbial testing of foods for process control and for problem solving 
(Ref. 52). The circumstances in which product testing would be required 
are dependent on a variety of factors as described in the Appendix to 
the 2013 proposed preventive controls rule for animal food (78 FR 64736 
at 64836). As with environmental monitoring, product testing must be 
conducted as appropriate to the facility, the animal food, and the 
nature of the preventive control and its role in the facility's food 
safety system. For example, a raw material or other ingredient added to 
an animal food after a pathogen ``kill step'' must be tested before use 
when the raw material or other ingredient has been associated with a 
pathogen and has not been treated to significantly minimize or prevent 
that pathogen (e.g., poultry based flavoring spray applied on dry pet 
food). Product testing would be required because it is appropriate to 
the facility (one making an animal food), the food (pet food), and the 
nature of the preventive control (there is no control applied to the 
poultry based flavoring spray).
    When process control testing for an indicator organism, or 
environmental monitoring for an indicator organism, indicates an animal 
food (e.g., dry pet food) is reasonably likely to be contaminated with 
a pathogen, that animal food must be tested for the pathogen. For 
example, if environmental monitoring reveals animal food-contact 
surfaces contaminated with Salmonella and additional environmental 
monitoring following corrective actions indicates animal food-contact 
surfaces are still contaminated with Salmonella, product testing would 
be required because it is appropriate to the facility (one making that 
animal food), the animal food (pet food, which supports the growth of 
Salmonella), test results from environmental monitoring (which show the 
presence of an indicator organism for Salmonella on animal food-contact 
surfaces in the animal food processing environment), and the nature of 
the preventive control (sanitation controls to prevent contamination by 
environmental pathogens, which appear to be inadequate).
    The word ``must'' specifies the type of activities that a facility 
can use to satisfy the requirements for a particular preventive control 
management component, and we are retaining the term ``must.'' However, 
we agree that the rule should provide flexibility for additional 
verification of implementation and effectiveness. To provide that 
additional flexibility, we have revised the specific requirements for 
verification of implementation and effectiveness to provide for other 
activities appropriate for verification of implementation and 
effectiveness (see Sec.  507.49(a)(5)).
    We believe that the performance of environmental monitoring, for an 
appropriate microorganism of public (human and animal) health 
significance or for an appropriate indicator organism, is particularly 
useful as a verification measure for preventive controls (i.e., 
sanitation controls) when contamination of animal food with an 
environmental pathogen is a hazard

[[Page 56271]]

requiring a preventive control. We anticipate that facilities producing 
animal food that enters into the home and is frequently handled in the 
home will include biologic hazards of human health concerns associated 
with that animal food, as well as those of animal health concerns in 
their hazards requiring a preventive control. (See, for example, our 
discussion of Salmonella in pet food in the 2013 proposed preventive 
controls rule for animal food (78 FR 64736 at 64747).)
    (Comment 342) Many comments ask us to issue guidance, rather than 
requirements, for product testing and environmental monitoring based on 
concerns such as the following: The value of environmental monitoring 
will be reduced if it becomes a minimum regulatory requirement; there 
are well-known limitations to product testing and negative results from 
product testing can create a false sense of security; negative results 
are likely to occur unless intensive sampling is conducted dependent 
upon quality sampling criteria; product testing is not preventive, 
would put industry into a reactive mode, and would pull valuable 
resources from activities focused on preventing contamination; there is 
limited technology available to test contaminants in some animal food 
matrices and limited time available for perishable commodities; any 
regulatory requirement will soon be outdated as products change and 
science improves; and product testing would vastly increase the cost of 
the rule and will drive many businesses out of business without 
necessarily improving animal food safety; and requirements for product 
testing would require the States to direct resources to respond to non-
compliant product testing results, and such resources would be better 
directed to environmental monitoring.
    Some of these comments emphasize the need for flexibility so that 
product testing and environmental monitoring are options that are 
available to the facility rather than requirements for all facilities. 
Other comments assert that guidance provides greater opportunity for 
industry innovation and stakeholder participation to determine the 
appropriate use of verification measures, and avoids a ``one-size-fits-
all'' approach to regulations. Some of these comments state that we 
should encourage environmental monitoring to be conducted ``through 
facility specific food safety plans,'' which would provide the 
flexibility necessary to monitor risks associated with exposures of 
animal foods. Other comments state that operators should be given the 
necessary flexibility to implement any requirements in the most 
effective and efficient manner using a risk-based approach and taking 
into account the specific conditions of their facilities and 
operations. Some comments express concern that including a requirement 
makes it difficult for businesses to justify a conclusion that testing 
is not necessary.
    Some comments ask us to solicit drafts of proposed guidance 
documents from the sustainable agriculture and local/regional food 
system community; publish a list of possible topics for future guidance 
each year; seek input in advance from the sustainable agriculture and 
local/regional food system community before preparing draft guidance 
(including public meetings, workshops, and formation of an advisory 
committee); hold public meetings on draft guidance after publication; 
and present draft guidance to an advisory committee including 
representatives from the sustainable agriculture and local/regional 
food system community.
    Some comments suggest that an ingredient manufacturer may identify 
an environmental pathogen but the facility would not implement a 
preventive control to significantly minimize or prevent the 
environmental pathogen because the ingredient would be subsequently 
processed to control the hazard by another facility.
    (Response 342) We are retaining the requirements for product 
testing and environmental monitoring in the rule, with the revisions, 
already discussed, to provide that verification activities depend on 
the role of the preventive control in the facility's food safety system 
(see Response 293); corrective action procedures depend on the nature 
of the hazard (see Response 304); and written procedures for product 
testing and environmental monitoring are established and implemented as 
appropriate to the role of the preventive control in the facility's 
food safety system. These revisions clarify in the regulatory text the 
flexibility that we discussed in the 2014 supplemental notice (79 FR 
58476 at 58493 through 58495). Some of the comments that ask us to 
issue guidance rather than requirements appear to believe that only 
guidance can provide sufficient flexibility for product testing and 
environmental monitoring. This is not the case. (See Response 341.)
    We disagree that environmental monitoring will become a minimum 
regulatory requirement in all cases; the decision to conduct 
environmental monitoring is made by the facility and some comments 
discuss specific examples of when environmental monitoring or product 
testing would not be warranted. If a facility relies on its customer to 
control an environmental pathogen then the facility must follow the 
requirements in subpart E for supply-chain program. Moreover, the fact 
that further manufacturing might be capable of eliminating an 
environmental pathogen that has contaminated an animal food is not a 
reason to not take reasonable measures to prevent contamination from 
the environment and to verify that such measures are effective through 
environmental monitoring.
    We have acknowledged limitations of product testing (79 FR 58476 at 
58493 through 58494) and agree that a facility should consider such 
limitations when determining whether to conduct product testing and 
keep such limitations in mind when obtaining negative results from 
product testing. We also agree that product testing is not preventive. 
However, the mere facts that there are limitations, and that product 
testing is itself not a preventive measure, do not eliminate all 
benefits of product testing; we agree with comments that although 
product testing may not be effective in identifying the acceptability 
of a specific ingredient or finished product lot on any given day, it 
can help assess and verify the effectiveness of a food safety plan as a 
whole and the facility's capability to consistently deliver against it. 
We agree that there is limited technology available to test for some 
hazards in animal food but expect that testing of animal food by a 
facility as the sole verification of the effectiveness its food safety 
plan as a whole would be the exception rather than the norm.
    We disagree that regulatory requirements for product testing and 
environmental monitoring will soon be outdated as products change and 
science improves; the rule requires reanalysis of the food safety plan 
as a whole at least every 3 years, and requires reanalysis of the food 
safety plan as a whole, or the applicable preventive control, in light 
of new information (see Sec.  507.50(a) and (b)). We agree that there 
are some costs to product testing, but the rule provides flexibility 
for the facility to determine when product testing is appropriate. We 
acknowledge that the States will be required, in many cases, to follow 
up on positive findings obtained during product testing but disagree 
that this is a reason to eliminate the proposed requirements. The 
States would only be directing resources when the findings indicate 
contamination of animal food, and doing so will protect public (human 
and animal) health.

[[Page 56272]]

    We will follow the procedures in Sec.  10.115 for issuing guidance 
documents. Under Sec.  10.115(f), members of the public can suggest 
areas for guidance document development and submit drafts of proposed 
guidance documents for FDA to consider. Under Sec.  10.115(g), after we 
prepare a draft guidance we may hold public meetings or workshops, or 
present the draft guidance document to an advisory committee for 
review; doing so is not common and is determined on a case-by-case 
basis.
    (Comment 343) One comment requests that we add the additional 
factor of the ``intended use of the animal food'' to help further 
clarify that these activities should be conducted based upon the 
appropriate end use of the animal food as it was intended by the 
manufacturer, and not upon any potential use of the product not 
originally intended.
    (Response 343) We believe the requirement as written allows the 
manufacturer's intended use to be taken into consideration when 
conducting the hazard analysis. However, to the extent that these 
comments are asserting that a facility can ignore consumer behavior 
that the facility considers contrary to principles of food safety, we 
disagree. For example, a facility could not conclude that it need not 
identify and evaluate a known or reasonably foreseeably hazard because 
the facility intends to provide safe handling instructions on the label 
of a packaged pet food. We do recognize that if a manufacturer/
processor has adequately controlled a hazard and has properly packaged, 
held, and labeled their product, they are not responsible for 
unforeseeable misuse by a consumer, such as a person who intentionally 
feeds swine food to sheep even though the product is accurately labeled 
as containing copper which can be toxic for sheep. For manufacturers/
processors that rely on their customer or another entity in the 
distribution chain to the control a hazard, they must follow the 
requirements in Sec.  507.36(a)(2), (3), (4) or (5). (See Response 285 
for additional information.)

B. Proposed Sec.  507.49(a)(1)--Calibration

    We proposed to require calibration of process monitoring 
instruments and verification instruments.
    (Comment 344) Some comments distinguish ``calibration'' from an 
accuracy check, which the comments describe as a test to confirm that a 
particular equipment or measurement device is accurate. These comments 
assert that calibration may not be possible for certain equipment or 
measurement devices, and the appropriate corrective action may be 
replacement or application of corrective values. These comments ask us 
to specify that an accuracy check may be used as a verification 
activity in lieu of calibration.
    (Response 344) We have revised the proposed requirements to require 
calibration of process monitoring instruments and verification 
instruments, or checking them for accuracy. However, if the outcome of 
an accuracy check is that a process monitoring instrument or 
verification instrument is not accurate, the facility must follow up by 
calibrating the device, rather than by applying corrective values, when 
it is practical to do so and replace the device when it is not 
practical to calibrate it.

C. Comments Directed to Proposed Requirements for Both Product Testing 
(Proposed Sec.  507.49(a)(2) and (b)(2)) and Environmental Monitoring 
(Proposed Sec.  507.49(a)(3) and (b)(3))

    We proposed that to verify that the preventive controls are 
consistently implemented and are effectively and significantly 
minimizing or preventing the significant hazards you must conduct 
activities that include product testing and environmental monitoring, 
as appropriate to the facility, the animal food, and the nature of the 
preventive control (Sec.  507.49(a)(2) and (a)(3)). We also proposed 
that you must establish and implement written procedures for product 
testing and for environmental monitoring (Sec.  507.49(b)(2) and 
(b)(3)).
    (Comment 345) Some comments ask us to revise the regulatory text to 
be explicit that there are circumstances when product testing and 
environmental monitoring would not be necessary. One comment supports a 
requirement that incoming raw materials and feed ingredients must be 
tested for harmful pathogens. Another comment opposes mandatory product 
testing for every lot of raw material received. Some comments discuss 
topics for us to include in guidance on procedures for product testing 
and environmental monitoring, such as which pathogens to test for; the 
range of products that should be tested; circumstances that warrant 
testing; what a facility would document and what factors the facility 
would consider before determining that product testing is not 
appropriate for its animal food product; frequency of sampling and 
number of samples to be collected; actions to take after a positive 
result; available test methods; reporting requirements for results; 
compliance strategies; and criteria for laboratories conducting the 
testing.
    (Response 345) We decline to revise the regulatory text. The 
decision as to whether product testing and environmental monitoring are 
warranted depends on the facility and its animal food product, as well 
as the nature of the preventive control and its role in the facility's 
food safety system, and a slight variation on circumstances that would 
lead one facility to conclude that such testing programs were not 
required could lead a different facility to the opposite conclusion. 
Memoranda placed in the docket for the 2014 preventive controls 
supplemental notice for human food provide additional information on 
these topics requested in the comment (Refs. 51 and 52). Although 
directed to product testing and environmental monitoring for human food 
production, some of the information is relevant to animal food, as 
well.
    (Comment 346) Some comments ask us to clarify that tests can be 
performed by third-party facilities or laboratories, as well as by the 
facility itself. Some comments ask us to clarify that we will accept 
test results in the same format as the format used for other purposes, 
such as third-party certification services.
    (Response 346) The rule places no restrictions on who conducts 
testing. However, facilities have a responsibility to choose testing 
labs that will produce reliable and accurate test results. (See 
Response 348.) The rule does not specify the format of test results, 
provided that the record documenting testing satisfies the 
recordkeeping requirements of subpart F.
    (Comment 347) Some comments express concern about requirements for 
product testing and environmental monitoring in light of section 202 of 
FSMA (section 422 of the FD&C Act (21 U.S.C. 350k)). (Section 422 of 
the FD&C Act addresses laboratory accreditation for the analyses of 
foods, including use of accredited laboratories in certain 
circumstances and including requirements for accredited laboratories to 
report the results of laboratory testing to FDA in certain 
circumstances.) These comments express concern that requirements for 
facilities to submit results of environmental monitoring to us will 
create an additional disincentive to looking for pathogens established 
in the facility. These comments assert that the results of 
environmental monitoring tests should be available to us for inspection 
but not submitted to us if product has not been distributed and that 
submitting the results of routine tests would be burdensome without 
benefit. These comments ask us to

[[Page 56273]]

clarify whether facilities or laboratories would be required to submit 
the results of environmental monitoring tests to us. Likewise, some 
comments ask us to clarify whether product testing (including testing 
of raw materials or other ingredients as part of supplier controls) is 
subject to the requirements of section 422 of the FD&C Act for using 
accredited laboratories and for reporting test results to us. Other 
comments ask us to establish standards and procedures for certifying 
laboratories that would perform the tests. These comments assert that 
these standards and procedures are needed to ensure the credibility of 
the testing and to provide direction for facilities that establish in-
house testing facilities. Other comments urge us to establish 
regulations implementing section 422 of the FD&C Act because they would 
complement the requirements of the animal food preventive controls rule 
and because model laboratory standards that address quality controls, 
proficiency testing, training and education of laboratory personnel 
offer the protections necessary for ensuring reliable, accurate test 
results. Other comments assert that if laboratories are not accredited 
or samples are not collected in a sanitary manner, there is no 
guarantee the results will be scientifically valid.
    (Response 347) Section 422 of the FD&C Act would require, in 
relevant part, that food testing be conducted by an accredited 
laboratory (and the results of such testing be sent directly to FDA) 
whenever such testing is conducted in response to a specific testing 
requirement under the FD&C Act or its implementing regulations when 
applied to address an identified or suspected animal food safety 
problem or to support admission of an animal food under an Import Alert 
that requires food testing. Although another rulemaking will address 
the requirements of section 422 of the FD&C Act, our current thinking 
is that routine product testing and environmental monitoring conducted 
as a verification activity is not being applied to address an 
identified or suspected animal food safety problem that requires food 
testing and would not be subject to requirements to use an accredited 
laboratory that would submit the results to FDA. We will review the 
results of environmental monitoring and product testing, if any, during 
inspections.
    The primary concern expressed in these comments was with respect to 
laboratories reporting results to FDA and not with use of accredited 
laboratories. The rule requires a facility to establish and implement 
written procedures for product testing and environmental monitoring and 
that the procedures for such testing be scientifically valid. One way 
to comply with the requirement that testing procedures be 
scientifically valid is to use an accredited laboratory.
    (Comment 348) Some comments ask us to expand the proposed 
requirement to identify the laboratory conducting the testing to also 
specify whether that laboratory is accredited and uses the appropriate 
standards (such as quality control, proficiency testing, and trained 
laboratory staff). These comments assert that such information would be 
useful to facilities.
    (Response 348) We decline this request. These comments appear to be 
asking us to establish in the preventive controls for animal food rule 
requirements related to section 422 of the FD&C Act. Doing so in 
advance of regulations implementing section 422 of the FD&C Act is 
premature. However, facilities have a responsibility to choose testing 
labs that will produce reliable and accurate test results even if the 
rule does not require the facility to specify whether the laboratory is 
accredited.
    (Comment 349) One comment requested the FSMA regulations regarding 
ISO methods for Listeria and Salmonella be changed to using BAM 
(Bacteriological Analytical Manual) methodology.
    (Response 349) While we require scientifically valid procedures for 
testing, the rule does not specify a particular method be used. A 
laboratory could use an FDA BAM method, an ISO method, or another 
method that is validated in the relevant animal food matrix.
    (Comment 350) Some comments say that there is little scientific 
data to show environmentally exposed animal food, such as raw liquid 
ingredients and finished liquid animal food products, as well as food 
for livestock creates a potential for harmful biological hazards and an 
evaluation of environmental pathogens should not be required as part of 
the hazard analysis. Other comments point out it is common practice to 
store ingredients with some exposure to the environment during a 
portion of their storage, complete outdoor storage is standard practice 
both at the production facility, as well as where it will be consumed 
without resulting in harm. Some comments say that mere exposure to the 
environment does not inherently increase the risk of contamination of 
animal food.
    Some comments say environmental testing should only be required for 
packaged animal foods and recommend that environmental testing be 
required whenever animal food ingredients or finished animal foods are 
exposed to the environment after undergoing a process aimed at reducing 
pathogens (e.g., a heat kill step such as rendering or the extrusion 
process) or other hazards that could be transmitted through the 
environment. These comments say processing aimed at reducing hazards 
will be ineffective if pathogen loads or hazard levels going into the 
processing are too high and are concerned that the proposed rule would 
not require renderers, who often handle sick and dead animals, to make 
sure that the plant environment is not a pathway for the recycling of 
pathogens into the animal food system through contaminated animal 
products. Many comments state that all finished animal food is ready to 
eat whether or not it is packaged, so it is not reasonable to limit 
environmental monitoring only to animal foods that may be packaged.
    (Response 350) We do not expect either product testing or 
environmental monitoring to be common in facilities that process, pack, 
or hold RACs for animal consumption. We agree that there would be 
little or no benefit to product testing or environmental monitoring in 
facilities that pack or hold RACs that are rarely consumed unprocessed, 
such as soybeans, or for a manufacturer/processor that will rely on its 
customer or another entity in the distribution chain to control a 
hazard as specified in Sec.  507.36(a)(2), (3), and (4). We expect that 
many facilities that conduct operations such as drying grain are likely 
to conclude, as a result of their hazard analysis, that neither product 
testing nor environmental monitoring are warranted and would direct 
their resources to food safety practices and verification measures 
other than environmental monitoring or product testing. While a hazard 
analysis must include an evaluation of environmental pathogens when 
animal food is exposed to the environment prior to packaging and the 
animal food does not include a control measure that would significantly 
minimize the pathogens (see Sec.  507.33(c)(2)), we agree that holding 
animal food in areas exposed to the environment in some instances will 
present a low risk of contamination from environmental pathogens. 
Facilities in these instances will likely conclude there is not a 
hazard requiring a preventive control. However, facilities that 
identify an environmental pathogen requiring a preventive control would 
conduct environmental monitoring as appropriate to the facility, the 
animal food, and the nature of the preventive control.

[[Page 56274]]

    (Comment 351) Some comments express concern about the cost of 
testing and suggest creation of a one-time grant program for very small 
businesses that would assist them in developing their initial food 
safety plans and testing programs. One comment says that segments of 
the animal food production industry currently not performing these 
types of activities will be challenged to interpret the requirements 
and develop effective programs. The comment states that inconsistent 
interpretations of these requirements by an industry fearful of being 
found in violation of the rule may lead to unnecessary testing and 
supplier activities and needlessly drive up the cost of compliance.
    (Response 351) Very small businesses are qualified facilities that 
are subject to modified requirements, which do not require testing or 
development of a food safety plan. We intend that the guidance we are 
developing will be helpful to all sizes of businesses, and particularly 
those not currently conducting these activities, that are subject to 
the requirements for product testing and environmental monitoring. (See 
Response 1.)

D. Proposed Sec.  507.49(a)(2)--Product Testing

    (Comment 352) Some comments ask us to require finished product 
testing for food products designated as high-risk, particularly when 
the product supports pathogen growth during its shelf life. Other 
comments suggest that finished product or ingredient testing should be 
implemented as appropriate in situations where a risk has been 
identified and an effective preventive control cannot be implemented. 
Other comments ask us to require product testing if an environmental 
pathogen is identified as a significant hazard.
    (Response 352) We decline these requests. A facility's decision to 
conduct product testing, and to establish the frequency of such 
testing, will reflect a risk-based approach consistent with its hazard 
analysis. Consequently, we expect that facilities that produce animal 
foods that have frequently been associated with outbreaks of foodborne 
illness (in humans or animals), or produce animal food for which an 
effective preventive control cannot be implemented, would establish 
product testing programs more often than facilities that do not produce 
such animal foods.
    A facility that identifies an environmental pathogen as a hazard 
requiring a preventive control such as sanitation controls would 
conduct environmental monitoring. Such a facility would decide what, if 
any, role product testing would play as a verification activity, or as 
part of a corrective action as a result of positive findings from 
environmental monitoring, based on the facility, the animal food, the 
nature of the preventive control, and the role of the preventive 
control in the facility's food safety system.
    (Comment 353) Some comments ask us to clarify (or specify) when 
product testing would be directed at raw materials and other 
ingredients and when product testing would be directed at finished 
product. Some comments favor testing raw materials and other 
ingredients as part of ``product testing,'' whereas other comments 
state that testing raw materials and other ingredients should be 
considered part of a supplier program rather than verification of 
implementation and effectiveness. Other comments state that it is 
unclear what preventive control step would be verified by product 
testing and what types of facilities would be required to perform 
product testing. One comment states product testing for animal food 
should solely focus on finished products that are consumed by animals 
in accordance with their intended use as described in the facility's 
animal food safety plan.
    (Response 353) We use the term ``product testing'' to mean testing 
any animal food product, whether raw materials or other ingredients, 
in-process animal foods, or finished products and, thus, product 
testing can be directed to any of these animal food products. For 
example, testing raw materials and other ingredients could be 
verification of a supplier; testing in-process material after a kill 
step could be verification of process control; testing finished product 
could be verification of the food safety plan as a whole, and capture a 
problem introduced during manufacture, including from contaminated raw 
materials and other ingredients, if raw materials and other ingredients 
had been tested before use. Product testing generally is not the most 
effective means of measuring the adequacy of cleaning and sanitation 
programs, but such testing is common to track a facility's overall 
hygienic production measures.
    (Comment 354) Some comments assert that a facility that implements 
supplier verification and environmental monitoring (or other measures) 
should not be required to perform product testing in addition to the 
other controls and verification measures.
    (Response 354) The facility determines whether product testing is 
necessary as appropriate to the facility, the animal food, and the 
nature of the preventive control and its role in the facility's food 
safety system. The factors mentioned by the comment are examples of 
factors that a facility would consider in making its determination.
    (Comment 355) Some comments ask us to revise the requirement for 
product testing to clarify that product testing applies to significant 
hazards.
    (Response 355) We decline this request. Product testing is a 
verification activity for a preventive control, and a preventive 
control is established for a ``significant hazard'' (which we now refer 
to as ``hazard requiring a preventive control''). It is not necessary 
to repeat, for each type of verification activity, that the activity 
applies to hazards requiring a preventive control.
    (Comment 356) Some comments assert that the real point of product 
testing is to test all lots or batches. These comments explain that 
they would be required to retest every lot of product in order to pass 
an analysis of the product on to its customers, even if testing had 
already been performed by their vendors (i.e., suppliers), because each 
of their customers receives a proprietary blend. These comments further 
explain that it is not economically or physically possible to retest 
small lots of product already tested by their vendors, and that the 
risk has already been mitigated by its vendors.
    (Response 356) The situation described by these comments appears to 
be a supplier-customer relationship in that the customer. not this 
rule, has established a requirement for a certificate of analysis for 
every lot of received product. The product testing that this rule 
requires as a verification activity is to help assess and verify the 
effectiveness of a food safety plan and the facility's capability to 
consistently deliver against it, not to establish the acceptability of 
every lot or batch.
    (Comment 357) Some comments assert product testing should primarily 
be used as a measure of process control, not for acceptance testing; 
that product testing should normally be viewed as a monitoring and 
review tool, not as a product conformance verification tool. The 
comment states testing programs for product conformance verification 
should be the exception rather than the rule.
    (Response 357) These comments appear to have misunderstood the 
proposed requirements for product testing. Consistent with the views 
expressed by these comments, we proposed requirements for product 
testing as a verification measure of the food safety plan as a whole, 
not for product conformance.

[[Page 56275]]

    (Comment 358) One comment says test results, whether via voluntary 
company programs to verify process controls or mandated by regulation, 
should not be required to be submitted to FDA unless they indicate 
serious human or animal health consequences (i.e., necessitate a Class 
I recall) as is required under the existing requirements for the RFR. 
Comments state that FDA inspectors should not penalize facilities for 
finding potential problems through verification if appropriate 
corrective actions are taken.
    (Response 358) This comment appears to have misunderstood the 
requirements for product testing, which do not include reporting 
product testing results to FDA. However, during an inspection, if 
product testing was used as a verification measure, the inspector may 
review the documentation for that testing and the records documenting 
any corrective action procedures taken as a result of that testing.

E. Proposed Sec.  507.49(a)(3)--Environmental Monitoring

    We proposed to require environmental monitoring, for an 
environmental pathogen or for an appropriate indicator organism, if 
contamination of an animal food with an environmental pathogen is a 
significant hazard, by collecting and testing environmental samples.
    (Comment 359) Some comments ask us to specify that environmental 
monitoring of pathogens be executed according to a risk analysis. Many 
comments say environmental monitoring should be a verification tool 
based on a risk assessment as different animals show different 
susceptibility to pathogens, pathogen growth is dependent upon the 
animal food, and pathogens grow differently in different environments 
and seasons. Some comments state that the corrective actions for 
environmental monitoring should be risk based and take into account 
information such as organism threshold, sampling, and analytical 
methodology. One comment says the requirement should be applied only to 
``significant hazards'' if any, that are present within the operation. 
One comment states that it is not clear who would be responsible for 
environmental monitoring at various points in the supply chain. The 
comment requests more clarification on the ``boundaries'' of 
responsibility for proposed measures like environmental monitoring. One 
comment says prior to including environmental monitoring in the 
regulation, methodologies and minimum standards that establish the 
threshold industry must meet should be developed and vetted.
    (Response 359) We decline these requests. See the discussion in 
Response 301, which explains how risk applies to the facility's hazard 
analysis and the determination by the facility to establish preventive 
controls for hazards requiring a preventive control as appropriate to 
the facility and the animal food. In contrast, the requirements for 
environmental monitoring are a verification activity that a facility 
would conduct to verify that one or more preventive controls are 
consistently implemented and are effectively and significantly 
minimizing or preventing the hazards requiring a preventive control and 
would be established as appropriate to the facility, the animal food, 
and the nature of the preventive control rather than according to a 
risk analysis. The rule provides flexibility for the facility to 
determine appropriate test methodologies and the threshold appropriate 
for the environmental pathogen being monitored to verify the 
effectiveness of the facility's preventive control. For requirements 
that apply to hazards that a customer of the facility, ``or another 
entity in the distribution chain,'' will control. See the requirements 
in Sec.  507.36 and the discussion in section XXVII.
    (Comment 360) Numerous comments request that we distinguish between 
production of pet food and other animal food. Many comments state that 
FDA has publically stated that it intends environmental monitoring to 
apply mainly to facilities that manufacture pet food and pet treats; 
however, the language extends the requirement to any facility that 
packages animal food that does not receive a treatment to minimize 
pathogens. Comments say it must be made clear, through outreach, 
education, and compliance policy guides, that the requirement to 
conduct environmental monitoring is intended for a limited range of 
facilities, products and processes, and does not apply to livestock 
feed or animal food for which environmental pathogens do not pose a 
significant hazard in the finished animal food. Another comment 
expressed concern because Salmonella has been found in finished poultry 
feed. One comment says we should require Salmonella testing as part of 
an environmental program. One comment asks us to explicitly recognize 
in the preamble to the final rule that contamination of animal food 
with an environmental pathogen may be a significant hazard in many dry 
pet food manufacturing facilities.
    (Response 360) We agree that environmental monitoring may be 
particularly relevant to pet food manufacturing and the majority of 
environmental monitoring may occur in dry or raw pet food manufacturing 
facilities. However, its usefulness is not limited exclusively to pet 
food production. Therefore, the requirement for environmental 
monitoring is flexible to allow a facility to determine whether 
environmental monitoring is needed based on the facility, the type of 
animal food produced, the nature of the preventive control for the 
environmental hazard and its role in a facility's food safety system.
    We decline the request to require Salmonella testing as part of 
environmental monitoring. We believe that most facilities producing pet 
foods (other than those subject to part 113 that are exempt from 
subpart C with respect to microbiological hazards regulated under part 
113) will identify Salmonella spp. as a known or reasonably foreseeable 
hazard that requires a preventive control verified by environmental 
monitoring. We decline the request to exempt livestock food or animal 
food other than pet food from the provisions for environmental 
monitoring. However, we believe use of environmental monitoring by a 
livestock or poultry food facility as a verification of a preventive 
control would be the exception rather than the norm.

F. Proposed Sec.  507.49(a)(4)--Review of Records

    We proposed to require review of specified records by (or under the 
oversight of) a preventive controls qualified individual, to ensure 
that the records are complete, the activities reflected in the records 
occurred in accordance with the food safety plan, the preventive 
controls are effective, and appropriate decisions were made about 
corrective actions. We proposed to require review of records of 
monitoring and corrective action records within a week after the 
records are made, and review of records of calibration, product 
testing, environmental monitoring, and supplier verification activities 
within a reasonable time after the records are made.
    (Comment 361) Some comments assert that it is not necessary for a 
preventive controls qualified individual to conduct or oversee review 
of records as a verification activity, noting that review of records in 
another food safety regulation (i.e., the LACF requirements in part 
113) can be done by persons adequately trained in recordkeeping and 
review of records.

[[Page 56276]]

    (Response 361) The rule does not preclude review of records by 
persons other than the preventive controls qualified individual, 
provided that the preventive controls qualified individual provides 
oversight for that review. Oversight by a preventive controls qualified 
individual is necessary because the review of records is critical to 
assessing the facility's application of the preventive controls system 
and, thus, is fundamental to ensuring its successful operation (78 FR 
64736 at 64796 through 64797). Oversight by a preventive controls 
qualified individual is consistent with requirements of Federal HACCP 
regulations for seafood, juice, and meat and poultry (Ref. 49) (78 FR 
64736 at 64796 through 64797).
    (Comment 362) Some comments ask us to provide for a timeframe 
longer than 1 week (such as 7 working days) for review of records of 
monitoring and corrective actions. Some comments ask us to provide the 
same flexibility for review of records of monitoring and corrective 
actions as we proposed for review of records of calibration, product 
testing, environmental monitoring, and supplier verification activities 
(``within a reasonable time'' after the records are made), e.g., 
because some preventive controls may be monitored less frequently than 
is typical in a traditional HACCP plan dominated with CCPs. Some 
comments note that corrective actions may not be fully implemented 
within 7 days and ask us to provide for review of these records within 
a week or other timeframe determined to be appropriate to ensure that 
potentially hazardous goods do not enter commerce. Some comments ask us 
to retain the 1 week timeframe for review of records associated with 
perishable foods, but to extend the timeframe to 1 month for 
nonperishable foods.
    Some comments state that some food processors that operate on a 
batch production basis (rather than a continuous production basis) 
review all records related to a particular batch all at once just 
before release of the batch for distribution. These comments assert 
that it would be inefficient, unnecessary, and needlessly complicated 
to require management to review a few production records in advance of 
the normal complete records review, particularly when laboratory 
testing conducted on the batch by an outside laboratory takes several 
weeks to complete.
    (Response 362) We have revised the proposed requirement to require 
review of records of monitoring and corrective actions within 7 working 
days after the records are made or within a reasonable timeframe, 
provided that the preventive controls qualified individual prepares (or 
oversees the preparation of) a written justification for a timeframe 
that exceeds 7 working days. A timeframe that exceeds 7 working days 
will be the exception rather than the norm. For example, reviewing 
records before release of product may be considered adequate by a 
facility, although this may be later than one week after the records 
were created. A facility may determine that all records for a lot of 
product will be reviewed after product testing or environmental 
monitoring records relevant to that lot of product are available, which 
may be more than a week after monitoring records were created. We made 
a conforming change to the list of responsibilities of the preventive 
controls qualified individual to address the requirement for the 
preventive controls qualified individual to provide (or oversee the 
preparation of) a written justification for such a timeframe (see Sec.  
507.53(a)).
    We are not requiring that a facility review records of monitoring 
and corrective actions before release of product or that the timeframe 
for the review depends on the shelf life of the animal food. The 
purpose of reviewing records is not to determine whether to release 
product. Instead, the purpose of reviewing records is to ensure that 
the records are complete, the activities reflected in the records 
occurred in accordance with the food safety plan, the preventive 
controls are effective, and appropriate decisions were made about 
corrective actions. However, a facility will have flexibility to review 
records of monitoring and corrective actions within a timeframe that 
exceeds 7 working days, such as before product release, provided that 
the facility provides a written justification for doing so. Depending 
on the nature of the record, a facility that reviews these types of 
records in a timeframe that exceeds 7 working days, and finds a 
problem, may be faced with recall decisions for a relatively large 
number of affected lots of product.
    (Comment 363) Some comments ask us to revise the provisions for 
review of records by more generally referring to records of 
``verification testing (e.g., product testing and/or environmental 
monitoring as applicable).''
    (Response 363) We have revised the regulatory text to refer to 
records of ``testing (e.g., product testing, environmental 
monitoring).''
    (Comment 364) Some comments refer to our request for comment on 
whether the regulatory text should specify the verification activities 
that must be conducted for corrective actions. These comments assert 
that if we do not further specify verification activities for 
corrective actions then we should eliminate the proposed requirement to 
review records of corrective actions.
    (Response 364) Records are necessary to document all verification 
activities (see Sec.  507.45(b)). The fact that the rule provides 
flexibility for the facility to determine the verification activities 
for corrective actions, rather than prescribes these verification 
activities, has no bearing on the requirement to document the 
verification activities.
    (Comment 365) Some comments emphasize the importance of calibrating 
those instruments and monitoring devices that are critical to the 
preventive control, and reviewing the associated records, before 
validation of a lethality step and as frequently as necessary 
thereafter. These comments question whether requiring review of 
calibration records ``within a reasonable time'' will be adequate.
    (Response 365) We agree that instruments and monitoring devices 
that are critical to a preventive control should be calibrated, and 
calibration records should be reviewed, before conducting studies to 
validate a lethality step. However, the provision is directed at 
verification of implementation and effectiveness of preventive controls 
on an ongoing basis. This rule does not prescribe specific steps that a 
facility must take before conducting validation studies.
    A facility has flexibility to appropriately determine the frequency 
of reviewing calibration records based on the facility, the animal 
food, and the nature of the preventive control. We agree that it would 
be prudent to review calibration records of those instruments and 
monitoring devices that are critical to the preventive control more 
frequently than of those instruments and monitoring devices that are 
not critical to the preventive control. Depending on the nature of the 
control being calibrated, a facility that reviews calibration records 
infrequently, and finds a problem with calibration of process 
monitoring instruments and verification instruments, may be faced with 
recall decisions for a relatively large number of affected lots of 
product.

G. Proposed Sec.  507.49(b)--Written Procedures

1. Proposed Sec.  507.49(b)(1)--Frequency of Calibration
    We proposed that you must establish and implement written 
procedures for the frequency of calibrating process monitoring 
instruments and verification instruments.

[[Page 56277]]

    (Comment 366) Some comments ask us to specify that an accuracy 
check may be used as a verification activity in lieu of calibration. 
These comments also ask us to specify that written procedures address 
the frequency of accuracy checks, as well as calibration.
    (Response 366) We have revised the proposed requirement to specify 
that written procedures address the frequency of accuracy checks, as 
well as calibration.
2. Proposed Sec.  507.49(b)(2) and (b)(3)--Product Testing and 
Environmental Monitoring
    We proposed that you must establish and implement written 
procedures for product testing. We proposed that procedures for product 
testing must: (1) Be scientifically valid; (2) identify the test 
microorganism(s); (3) specify the procedures for identifying samples, 
including their relationship to specific lots of product; (4) include 
the procedures for sampling, including the number of samples and the 
sampling frequency; (5) identify the test(s) conducted, including the 
analytical method(s) used; (6) identify the laboratory conducting the 
testing; and (7) include the corrective action procedures required by 
Sec.  507.42(a)(1).
    Likewise, we proposed that you must establish and implement written 
procedures for environmental monitoring. Procedures for environmental 
monitoring must: (1) Be scientifically valid; (2) identify the test 
microorganism(s); (3) identify the locations from which the samples 
will be collected and the number of sites to be tested during routine 
environmental monitoring; (4) identify the timing and frequency for 
collecting and testing samples; (5) identify the test(s) conducted, 
including the analytical method(s) used; (6) identify the laboratory 
conducting the testing; and (7) include the corrective action 
procedures required by Sec.  507.42(a)(1)(ii).
    (Comment 367) Some comments express concern that the word ``valid'' 
in the phrase ``scientifically valid'' could be construed to mean 
``validated'' because not all testing protocols can be validated within 
the traditional meaning of the term. These comments state their belief 
that what we intend is for these testing programs to be ``technically 
sound.'' Other comments express concern that ``scientifically valid'' 
may be interpreted to mean that firms are required to develop or 
validate analytical methods (either in general or for specific food 
matrices).
    (Response 367) We are retaining the term ``scientifically valid'' 
in these provisions. We disagree that we would interpret 
``scientifically valid'' to mean that facilities are required to 
develop or validate analytical methods. We discussed our interpretation 
of the term ``scientifically valid'' in the Appendix to the 2013 
proposed preventive controls rule (78 FR 64736 at 64834 through 64835), 
and noted that this interpretation was consistent with our previous 
discussion of the term ``scientifically valid'' (in place of 
``validated'') in the rulemaking to establish CGMP requirements for 
dietary supplements (68 FR 12158 at 12198, March 13, 2003). While 
validated methods are considered ``scientifically valid,'' methods that 
have not gone through formal validation processes but have been 
published in scientific journals, for example, may also be 
``scientifically valid.'' We do expect methods used for testing to be 
adequate for their intended use.
    Although we agree that methods that are ``scientifically valid'' 
would also be ``technically sound,'' we disagree that the hypothetical 
concern that we would construe ``scientifically valid'' to mean 
``validated'' warrants changing ``scientifically valid'' to a new term 
(such as ``technically sound'') in light of our previous statements 
regarding this term and experience in the context of CGMP requirements. 
See the final rule establishing the dietary supplement CGMPs for 
additional discussion on the terms ``validated'' and ``scientifically 
valid'' (72 FR 34752 at 34853).
    (Comment 368) Some comments support the proposed requirements for 
written procedures for environmental monitoring, including providing 
flexibility to use indicator organisms and to design the timing, 
location, and frequency of environmental monitoring programs in a risk-
based manner, and in not prescribing specific locations (e.g., food-
contact surfaces or ``zone 1'') or sample quantities for testing. Other 
comments ask us to add details to the written procedures for product 
testing and environmental monitoring regarding when and where sampling 
is required and the number of samples to take. Some comments ask us to 
make sure the most current ``sampling planning science'' is used for 
environmental monitoring by specifying that procedures for 
environmental monitoring must employ sample quality criteria 
objectives. Other comments assert that the product testing procedure 
requirements are inadequate and ask us to require that procedures for 
product testing specify the procedures for identifying samples 
(including their relationship to specific lots of product); describe 
how sampling was conducted (to establish that the sample obtained 
adequately represents the lot of product the sample is intended to 
represent); and include the procedures for sample quality control from 
field to lab.
    (Response 368) We decline the request to prescribe additional 
details, such as those described in these comments, in the requirements 
for written procedures for product testing and environmental 
monitoring. As with other procedures required by the rule, those 
relating to environmental monitoring and product testing must be 
adequate for their intended purpose. Further, procedures will not be 
identical in all circumstances. For example, a facility that produces 
products with a short shelf life may choose a different frequency of 
swabbing and testing than a facility that produces products with a long 
shelf life.
    (Comment 369) Some comments ask us to provide more flexibility in 
product testing by not requiring establishments to provide written 
procedures for product testing and corrective action procedures.
    (Response 369) These comments are unclear. By requiring that a 
facility establish its own procedures, the rule provides facilities 
with flexibility to develop a product testing program that works best 
for its facility and its products. We are retaining the requirements 
for written procedures for product testing, as well as for corrective 
action procedures.
    (Comment 370) Some comments ask us to add a provision requiring 
that all positive results must result in corrective action being taken.
    (Response 370) We decline this request. The rule requires that a 
facility must establish and implement written corrective action 
procedures that must be taken if preventive controls are not properly 
implemented, including procedures to address, as appropriate, the 
presence of a pathogen or appropriate indicator organism in an animal 
food product detected as a result of product testing and the presence 
of an environmental pathogen or appropriate indicator organism detected 
through environmental monitoring (see Sec.  507.42(a)(1)). However, the 
rule does not predetermine what corrective actions a facility must take 
when presented with positive results from product testing or 
environmental monitoring. The corrective action procedures that a 
facility would develop, and the actual corrective actions that the 
facility would take, will depend on the nature of the hazard and the 
nature of the preventive control, as well as information relevant to 
the positive result (e.g., pathogen or

[[Page 56278]]

indicator organism, product or environment, animal food-contact surface 
or non-animal food-contact surface).
    For additional discussion of comments on verification of 
implementation and effectiveness, see section XXXIV of the final rule 
for preventive controls for human food published elsewhere in this 
issue of the Federal Register.

XXXV. Subpart C: Comments on Proposed Sec.  507.50--Reanalysis

    We proposed to establish requirements for reanalysis of the food 
safety plan. Some comments support the proposed requirements without 
change. For example, comments agree that a preventive controls 
qualified individual must perform (or oversee) the reanalysis (see 
section XXXV.D). Some comments that support the proposed provisions 
suggest alternative or additional regulatory text.
    In the following paragraphs, we discuss comments that disagree 
with, or suggest one or more changes to, the proposed requirements. 
After considering these comments, we have revised the proposed 
requirements as shown in table 19, with editorial and conforming 
changes as shown in table 31.

     Table 19--Revisions to the Proposed Requirements for Reanalysis
------------------------------------------------------------------------
            Section                Description            Revision
------------------------------------------------------------------------
507.50(b).....................  Circumstances      Provide for
                                 that require       reanalysis of an
                                 reanalysis.        applicable portion
                                                    of the food safety
                                                    plan (rather than
                                                    the complete food
                                                    safety plan) in
                                                    specified
                                                    circumstances.
507.50(b)(4)..................  Circumstances      Require reanalysis of
                                 that require       the food safety plan
                                 reanalysis.        as a whole, or the
                                                    applicable portion
                                                    of the food safety
                                                    plan, whenever a
                                                    preventive control,
                                                    combination of
                                                    preventive controls,
                                                    or the food safety
                                                    plan as a whole is
                                                    found to be
                                                    ineffective.
507.507(c)....................  Timeframe to       Clarify that the
                                 complete the       requirement applies
                                 reanalysis.        to completing the
                                                    reanalysis and
                                                    validating any
                                                    additional
                                                    preventive controls
                                                    (as appropriate to
                                                    the nature of the
                                                    preventive control
                                                    and its role in the
                                                    facility's food
                                                    safety system),
                                                    rather than to
                                                    completing the
                                                    reanalysis and
                                                    implementing any
                                                    additional
                                                    preventive controls
                                                    (emphasis added).
------------------------------------------------------------------------

A. Proposed Sec.  507.50(a)--Circumstances Requiring Reanalysis

    We proposed that you must conduct a reanalysis of the food safety 
plan: (1) At least once every 3 years; (2) whenever a significant 
change in the activities conducted at your facility creates a 
reasonable potential for a new hazard or creates a significant increase 
in a previously identified hazard; (3) whenever you become aware of new 
information about potential hazards associated with the animal food; 
(4) whenever appropriate after an unanticipated animal food safety 
problem; and (5) whenever you find that a preventive control is 
ineffective.
    (Comment 371) Some comments assert that the need to reanalyze the 
food safety plan will depend on the nature of the preventive control 
and its role in the food safety system. These comments also assert that 
if a specific preventive control is found to be ineffective, only the 
applicable portion of the food safety plan would need to be reanalyzed.
    (Response 371) We agree and have revised the regulatory text, with 
associated editorial changes and redesignation, to separate the 
requirement to reanalyze the food safety plan as a whole every 3 years 
from all other circumstances when reanalysis is required ``for cause.'' 
When reanalysis is ``for cause,'' the regulatory text provides that 
reanalysis is of the food safety plan as a whole, or the applicable 
portion of the food safety plan.
    (Comment 372) Some comments ask us to define ``reanalysis'' to mean 
``a reassessment of the validity of a preventive control or food safety 
plan to control a hazard. Reanalysis may include a system review and, 
where necessary, activities to revalidate a control measure or 
combination of control measures.''
    (Response 372) We decline this request. Reanalysis goes beyond 
assessing the validity of a preventive control or food safety plan to 
control a hazard. Reanalysis can also include assessing whether all 
hazards have been identified, whether established procedures are 
practical and effective, and other factors.
    (Comment 373) Some comments ask us to require reanalysis on an 
annual basis, noting that annual reanalysis is required by Federal 
HACCP regulations for seafood, juice, and meat and poultry.
    (Response 373) We decline this request. We proposed to require 
reanalysis at least once every 3 years as a minimum requirement in the 
event that there is no other circumstance warranting reanalysis (see 
Sec.  507.50(b)(2) through (4)). That 3-year minimum is consistent with 
the statute (see section 418(i) of the FD&C Act). As a practical 
matter, we expect that reanalysis will occur more frequently as a 
result of changes in the activities conducted at a facility (Sec.  
507.50(b)(1) through (4)).
    (Comment 374) Some comments suggest editorial changes to improve 
the readability of the requirement to conduct reanalysis when there is 
a change in a preventive control.
    (Response 374) We are including these editorial changes in the 
regulatory text, which now reads whenever ``a significant change in the 
activities conducted at your facility creates a reasonable potential . 
. .''
    (Comment 375) Some comments assert that the proposed requirement to 
conduct reanalysis whenever you become aware of new information about 
potential hazards associated with the food does not align with FSMA 
statutory language, is ambiguous, and would establish vague compliance 
obligations.
    (Response 375) We disagree that the proposed requirement is 
ambiguous and would establish vague compliance obligations. See our 
previous discussion regarding the emergence of the first outbreak of 
foodborne illness in the United States, in 2006-2007, caused by 
consumption of peanut butter contaminated with Salmonella (78 FR 64736 
at 64798). Although we acknowledge that the proposed requirement is not 
explicit in section 418(i) of the FD&C Act, we disagree it is not in 
alignment with FSMA as a whole. FSMA directs the owner, operator, or 
agent in charge of a facility to evaluate the hazards that could affect 
food manufactured, processed, packed, or held by such facility and 
identify and implement preventive controls to significantly minimize or 
prevent the occurrence of those hazards (see section

[[Page 56279]]

418(a) of the FD&C Act). In other words, FSMA focuses on a system to 
prevent food safety problems rather than a system to react to problems 
after they occur. Requiring that a facility reanalyze its food safety 
plan, or the applicable portion of the food safety plan, in response to 
information such as the emergence of a new foodborne pathogen, or an 
outbreak of foodborne illness from consumption of an animal food 
product (or handling by consumers of a pet food product) not previously 
associated with foodborne illness from a well-known pathogen, aligns 
very well with the statutory direction in FSMA.
    (Comment 376) Some comments ask us to add a requirement to conduct 
reanalysis whenever a preventive control is found to be ``missing'' in 
addition to whenever a preventive control is found to be 
``ineffective.''
    (Response 376) We have revised the regulatory text to require 
reanalysis whenever a preventive control, a combination of preventive 
controls, or the food safety plan as a whole, is ineffective. (See 
Sec.  507.50(b)(4).) A ``missing'' preventive control could be 
discovered during verification to establish the validity of the food 
safety plan as a whole or as a result of an unanticipated problem. If 
circumstances lead a facility to conclude that an additional (or 
different) preventive control is necessary, the facility would include 
that preventive control in its food safety plan along with associated 
preventive control management components, including verification to 
establish the validity of the food safety plan.

B. Proposed Sec.  507.50(b)--Timeframe To Complete Reanalysis

    We proposed that you must complete the reanalysis and implement any 
additional preventive controls needed to address the hazard identified, 
if any, before the change in activities at the facility is operative 
or, when necessary, during the first 6 weeks of production. We have 
clarified that the requirement is to complete the reanalysis and 
validate (rather than implement) any additional preventive controls as 
appropriate to the nature of the preventive control and its role in the 
facility's food safety system.
    (Comment 377) As discussed in Comment 332, some comments question 
whether 6 weeks is enough time to perform all applicable validation 
studies that would address the execution element of validation. 
Likewise, some comments question whether 6 weeks is enough time to 
complete reanalysis.
    (Response 377) Consistent with revisions we have made to the 
timeframe to complete validation (see Response 332), we have revised 
the timeframe to complete the reanalysis and validate, as appropriate 
to the nature of the preventive control and its role in the facility's 
food safety system, any additional preventive controls to be within 90 
days after production of the applicable animal food first begins or 
within a reasonable timeframe, provided that the preventive controls 
qualified individual provides (or oversees the preparation of) a 
written justification for a timeframe that exceeds 90 days after 
production of the applicable animal food first begins. We made a 
conforming change to the list of responsibilities of the preventive 
controls qualified individual (see Sec.  507.53(a)).
    (Comment 378) Some comments state that the phrase ``before the 
change in activities at the facility is operative'' is ambiguous in 
that it is unclear if the phrase is referencing the initial change in 
activities that triggered the reanalysis or a change in activities 
subsequent to the reanalysis. These comments ask us to clarify the 
requirement by substituting the phrase ``before the relevant process is 
operative.''
    (Response 378) We agree that there was ambiguity in this phrase, 
because changes in activities could result in the need for reanalysis 
and reanalysis could result in the need for changes in activities, both 
of which can result in a new preventive control. We have made several 
revisions to the regulatory text, with associated editorial changes, to 
clarify the requirements for reanalysis. First, we have clarified that 
reanalysis can be routine (at least every 3 years) or ``for cause'' 
(i.e., a significant change that creates the potential for a new hazard 
or an increase in a previously identified hazard; when you become aware 
of new information about potential hazards associated with the animal 
food; when there is an unanticipated animal food safety problem; or 
whenever a preventive control, combination of preventive controls or 
the food safety plan as a whole is ineffective). Second, we have 
specified that the reanalysis ``for cause'' may be for the entire food 
safety plan or only for an applicable portion.
    In addition, we have clarified that the reanalysis and the 
validation, as appropriate to the nature of the preventive control and 
its role in the facility's food safety system, of any additional 
preventive controls needed to address an identified hazard, would need 
to be completed before any change in activities (including any change 
in preventive controls) is operative. When additional time is 
necessary, we have provided for a timeframe within 90 days after 
production of the applicable animal food first begins or within a 
reasonable timeframe, provided that the preventive controls qualified 
individual provides (or oversees the preparation of) a written 
justification for a timeframe that exceeds 90 days after production of 
the applicable animal food first begins. In other words, if you decide 
to make a change, you should conduct a reanalysis before you make that 
change if there is potential for that change to create or increase a 
hazard; a reanalysis that results in changes to preventive controls 
should be completed and the preventive controls validated, as 
appropriate to the nature of the preventive control and its role in the 
facility's food safety system, before changes in activities to produce 
animal food using a new preventive control are put into operation. 
However, we acknowledge that it may be necessary to produce product to 
demonstrate a revised preventive control can be implemented 
appropriately, and provide for an extended timeframe to make this 
assessment.

C. Proposed Sec.  507.50(c)--Requirement To Revise the Written Food 
Safety Plan or Document Why Revisions Are Not Needed

    We proposed that you must revise the written food safety plan if a 
significant change is made or document the basis for the conclusion 
that no revisions are needed. We received no comments that disagreed 
with this proposed requirement and are finalizing it as proposed.

D. Proposed Sec.  507.50(d)--Requirement for Oversight of Reanalysis by 
a Preventive Controls Qualified Individual

    We proposed that a preventive controls qualified individual must 
perform (or oversee) the reanalysis. We received no comments that 
disagreed with this proposed requirement and are finalizing it as 
proposed. See section XXXVII.B for comments on the qualifications for a 
preventive controls qualified individual who would perform or oversee 
the reanalysis.

E. Proposed Sec.  507.50(e)--Reanalysis on the Initiative of FDA

    We proposed that you must conduct a reanalysis of the food safety 
plan when FDA determines it is necessary to respond to new hazards and 
developments in scientific understanding.
    (Comment 379) Some comments ask us to issue formal, written 
communications about new hazards and developments in scientific 
understanding. These comments express

[[Page 56280]]

concern that communications of this type could be inconsistent if they 
are communicated by individual investigators. Other comments ask us to 
specify in the regulatory text that it is the Commissioner of Food and 
Drugs who makes the determination that it is necessary to conduct a 
reanalysis of the food safety plan.
    (Response 379) We agree that a communication from FDA about the 
need to reanalyze the food safety plan should be issued in a formal 
written manner but disagree that it is necessary to specify that it is 
the Commissioner of Food and Drugs who makes the determination that it 
is necessary to conduct a reanalysis of the food safety plan. The 
comment provides no basis for precluding such a determination by an 
organizational component (such as CVM or a component of FDA's Office of 
Regulatory Affairs) that has operational responsibility for animal food 
safety and subject matter experts to advise the managers in those 
organizational components.

XXXVI. Subpart C: Comments on Proposed Sec.  507.51--Modified 
Requirements That Apply to a Facility Solely Engaged in the Storage of 
Unexposed Packaged Animal Food

    We proposed that if your facility is solely engaged in the storage 
of packaged animal food that is not exposed to the environment, you 
must conduct certain activities for any such refrigerated packaged 
animal food that requires time/temperature controls for safety (TCS 
animal food) to significantly minimize or prevent the growth of, or 
toxin production by, microorganisms of animal or human health 
significance. We requested comment on the proposed list of modified 
requirements. Some comments that support the proposed provisions 
suggest alternative or additional regulatory text or ask us to clarify 
how we will interpret the provision.
    In this section, we discuss comments that ask us to clarify the 
proposed requirements or that disagree with, or suggest one or more 
changes to, the proposed requirements. After considering these 
comments, we have revised the proposed requirements as shown in table 
20.

Table 20--Revisions to the Proposed Modified Requirements for Unexposed,
                   Refrigerated, Packaged Animal Food
------------------------------------------------------------------------
            Section                Description            Revision
------------------------------------------------------------------------
507.51(a).....................  Circumstances      Clarify that the
                                 that make a        requirements apply
                                 facility subject   to a temperature
                                 to the modified    control area in a
                                 requirements for   facility that holds
                                 unexposed,         TCS animal food
                                 refrigerated       rather than to each
                                 packaged animal    product in the
                                 food.              holding facility.
507.51(a)(2)..................  Modified           Specify that it is
                                 requirements for   the temperature
                                 monitoring the     controls that are
                                 temperature        consistently
                                 controls.          performed.
507.51(a)(3)..................  Modified           Clarify that
                                 requirements for   corrective actions
                                 corrective         need only be taken
                                 actions.           when a loss of
                                                    temperature control
                                                    may impact the
                                                    safety of the TCS
                                                    animal food.
507.51(a)(4)(i)...............  Modified           Provide additional
                                 requirements for   flexibility for
                                 verification of    accuracy checks, in
                                 temperature        addition to
                                 controls.          calibration, to
                                                    verify that
                                                    temperature controls
                                                    are consistently
                                                    implemented.
507.51(a)(4)(iii).............  Modified           Provide additional
                                 requirements for   flexibility for
                                 verification of    reviewing records of
                                 temperature        monitoring and
                                 controls.          corrective actions
                                                    either within 7-
                                                    working days after
                                                    the records are made
                                                    or within a
                                                    reasonable
                                                    timeframe.
507.51(a)(5)(i)...............  Records            Provide additional
                                 documenting the    flexibility for
                                 monitoring of      records documenting
                                 temperature        the monitoring of
                                 controls.          temperature controls
                                                    to be kept either as
                                                    affirmative records
                                                    demonstrating
                                                    temperature is
                                                    controlled or as
                                                    exception records
                                                    demonstrating loss
                                                    of temperature
                                                    control.
507.51(a)(5)(ii)..............  Records            Conforming change
                                 documenting        associated with the
                                 corrective         modified
                                 actions.           requirements for
                                                    corrective actions
                                                    to clarify that
                                                    records of
                                                    corrective actions
                                                    are required when
                                                    there is a loss of
                                                    temperature control
                                                    that may impact the
                                                    safety of the TCS
                                                    animal food.
------------------------------------------------------------------------

A. Proposed Sec.  507.51(a)--Modified Requirements for Unexposed 
Refrigerated Packaged Animal Food That Requires Time/Temperature 
Controls

1. Proposed Sec.  507.51(a)(1)--Establish and Implement Temperature 
Controls
    We proposed that if your facility is subject to the modified 
requirements, you must establish and implement temperature controls 
adequate to significantly minimize or prevent the growth of, or toxin 
production by, microorganisms of animal or human health significance.
    We also tentatively concluded that it would be rare for a facility 
solely engaged in the storage of unexposed packaged animal food to not 
have information regarding whether a refrigerated packaged animal food 
is a TCS animal food and, if so, what specific temperature controls are 
necessary for safe storage of the food. We requested comment on this 
tentative conclusion.
    (Comment 380) Some comments ask us to clarify that the requirement 
to establish and implement temperature controls applies to temperature 
control areas in a facility rather than to each product in a facility.
    (Response 380) We agree that the requirement to establish and 
implement temperature controls applies to temperature control areas in 
a facility rather than to each product in a facility. To make this 
clearer, we have revised the proposed requirement to clarify that the 
facility must conduct activities as appropriate to ensure the 
effectiveness of the temperature controls rather than conduct 
activities ``for any such refrigerated packaged animal food.''
    (Comment 381) Some comments disagree with our tentative conclusion 
that it would be rare for a facility solely engaged in the storage of 
unexposed packaged animal food to not have information regarding 
whether a refrigerated packaged food is a TCS animal food and, if so, 
what specific temperature controls are necessary for safe storage of 
the animal food. These comments ask us to specify that the 
responsibility for determining whether an animal food is a TCS animal 
food falls to the manufacturer of the animal food rather than the 
warehouse storing the animal food, because the warehouse merely 
provides a service. Other

[[Page 56281]]

comments note that the animal food product owners determine the optimal 
conditions for storage of their products based on their own hazard 
analysis and preventive controls, and that the animal food product 
owners can simply communicate those requirements to the warehouses that 
will store the products.
    (Response 381) In this type of circumstance, it is appropriate for 
the manufacturer of the animal food to share the responsibility with 
the warehouse for proper storage of the animal food. The various 
provisions of section 418 of the FD&C Act explicitly place the 
responsibility for complying with the requirements for hazard analysis 
and risk-based preventive controls, including modified requirements, on 
the owner, operator, or agent in charge of a facility and, thus, a 
facility that is a warehouse is responsible for its own food safety 
plan. Regardless, the manufacturer also has responsibilities under 
section 418 of the FD&C Act to determine the storage conditions 
necessary for animal food safety and to take steps to ensure that the 
animal food is stored under conditions that will ensure its safety.
    It is not necessary to specify this joint responsibility for 
determining storage conditions in the rule, because the rule already 
clearly specifies that its provisions apply to persons who manufacture/
process animal food, as well as to persons who hold animal food. Both 
the warehouse and the manufacturer have flexibility in determining how 
to comply with the rule, including the specific mechanism whereby the 
warehouse would receive information about storage of an animal food 
product from the manufacturer or owner of the product. Moreover, a 
citizen petition submitted to FDA (Docket No. FDA-2011-P-056), in 
requesting an exemption or modified requirements for facilities solely 
engaged in the storage of packaged foods not exposed to the 
environment, asserts that such facilities work closely with food 
manufacturers to understand the conditions and controls needed to 
ensure the quality of the foods they store and distribute and that 
manufacturers appropriately instruct the warehouses to ensure packaged 
products are being properly stored (78 FR 64736 at 64768).
    (Comment 382) Some comments ask us to clarify which facility, the 
shipping facility or the receiving facility, will be responsible for 
ensuring that temperature control is maintained during transportation 
of TCS animal foods.
    (Response 382) We address specifics about the responsibilities of 
shipping facilities and receiving facilities in the 2014 proposed 
sanitary transportation rule (79 FR 7006). We will address comments 
regarding the responsibilities of shippers and receivers in the final 
sanitary transportation rule.
2. Proposed Sec.  507.51(a)(2)--Monitor the Temperature Controls
    We proposed that if your facility is subject to the modified 
requirements, you must monitor the temperature controls with sufficient 
frequency to provide assurance they are consistently performed. We 
requested comment on whether there would be a benefit to requiring a 
facility to develop written procedures for monitoring temperature.
    (Comment 383) Some comments ask us to explain in the preamble of 
the final rule that we will accept monitoring systems that provide 
exception reports to satisfy the modified requirements. The comments 
describe exception reporting as a structure where automated systems are 
designed to alert operators and management when the monitoring system 
observes a deviation from an established limit. These comments assert 
that monitoring of preventive controls by automated systems can be more 
efficient than monitoring by personnel, and can eliminate human error.
    (Response 383) We have revised the recordkeeping provisions of 
these modified requirements to provide that the temperature monitoring 
records for the modified requirements may be kept either as affirmative 
records demonstrating temperature is controlled or as exception records 
demonstrating loss of temperature control. Although the comments 
explicitly asked us to provide a clarification in the preamble of this 
rule, we decided the clarification within the regulatory text would be 
clearer to facilities that are subject to the requirements, as well as 
to investigators who will be inspecting facilities for compliance with 
the rule.
    (Comment 384) Some comments state that written procedures for 
monitoring temperature are not necessary. One reason provided by the 
comments is that the required records (specified in proposed Sec.  
507.51(a)(5)) would provide sufficient information on the type and 
frequency of monitoring. Another reason is that the specific activities 
we proposed to ensure the effectiveness of the temperature controls 
already address activities that a facility would include in a written 
procedure.
    (Response 384) We agree with the comments that we need not require 
that a facility develop written procedures for monitoring temperature.
3. Proposed Sec.  507.51(a)(3)--Requirement To Take Corrective Actions
    We proposed that if your facility is subject to the modified 
requirements, you must take appropriate corrective actions if there is 
a problem with the temperature controls for a TCS animal food.
    (Comment 385) Some comments ask us to narrow the term ``temperature 
control'' to more specifically focus it on temperature controls that 
are relevant to food safety because some problems with the controls may 
not impact the product temperature (and, thus, would not impact food 
safety).
    (Response 385) We have revised the proposed requirement (and the 
applicable recordkeeping requirement) to specify that corrective 
actions are necessary only when there is a loss of temperature control 
that may impact the safety of a TCS animal food.
    (Comment 386) Some comments assert that the responsibility for 
determining any corrective actions for a TCS animal food when there is 
a loss of temperature control falls to the manufacturer of the food 
rather than to the warehouse. These comments also assert that a 
warehouse is a third party who is not legally empowered to make 
independent decisions about when and where to ship the product, or not 
to ship it at all. These comments ask us to clarify that the 
responsibility of a warehouse for ``preventing'' affected food entering 
commerce ends when the product is returned to the manufacturer or 
processor.
    (Response 386) Returning affected animal food to the manufacturer/
processor or owner of the animal food is one way to satisfy the 
requirement to prevent animal food from entering commerce if the owner, 
operator, or agent in charge of a warehouse cannot ensure the affected 
animal food is not adulterated under section 402 of the FD&C Act, 
either on its own or after consultation with the manufacturer or 
processor of the animal food. It is not necessary to specify this 
specific action on the part of a warehouse in the regulatory text.
4. Proposed Sec.  507.51(a)(4)--Requirement To Verify Consistent 
Implementation of Temperature Controls
    We proposed that if your facility is subject to the modified 
requirements, you must verify that temperature controls are 
consistently implemented by: (1) Calibrating temperature monitoring and 
recording devices; (2) reviewing records of calibration within

[[Page 56282]]

a reasonable time after the records are made; and (3) reviewing records 
of monitoring and corrective actions taken to correct a problem with 
the control of temperature within a week after the records are made.
    (Comment 387) Some comments assert that the proposed requirement to 
``calibrate'' devices that monitor and record temperature is 
inconsistent with the requirement to test such devices for accuracy in 
the LACF regulations in part 113. These comments assert that ``accuracy 
check'' is a more appropriate term to use in the modified requirements 
because many instruments that monitor or record temperature have very 
low drift values and may seldom require calibration.
    (Response 387) We have revised the proposed requirements to require 
verification that temperature controls are consistently implemented by 
calibrating temperature monitoring and recording devices or checking 
them for accuracy. However, if the outcome of an accuracy check is that 
a temperature monitoring or recording device is not accurate, the 
facility must follow up by calibrating or replacing the device. See 
also Comment 344 and Response 344.
    (Comment 4388) Some comments assert that reviewing records of 
calibration or accuracy checks is only needed if a designated tolerance 
is exceeded.
    (Response 4388) Although we recognize that in most instances an 
out-of-calibration device will be identified and corrected at the time 
a calibration or accuracy check is performed, this is not always the 
case. The purpose of reviewing records of calibration or accuracy 
checks is to identify a problem that may have been missed or may not 
have been corrected rather than to react to a problem after the problem 
is identified. The records review is also a verification that the 
temperature controls were consistently implemented and that corrective 
actions were taken if needed.
    (Comment 389) Some comments ask us to modify the frequency of 
checking monitoring records to specify that it be done with a frequency 
to demonstrate control rather than within a week after the records are 
made.
    (Response 389) We have revised the proposed requirement to require 
review of records of monitoring (as well as records of corrective 
actions taken to correct a problem with the control of temperature) 
within 7-working days after the records are created or within a 
reasonable timeframe, provided that the preventive controls qualified 
individual prepares (or oversees the preparation of) a written 
justification for a timeframe that exceeds 7 working days.
    (Comment 390) Some comments assert that the proposed verification 
and review activities are too prescriptive because they require reviews 
that are not necessary. However, these comments also assert that the 
proposed verification activities are too vague because they do not 
specify the reasons for reviewing the records. These comments ask us to 
focus the regulatory text on achieving the overall objective of the 
review (i.e., ensuring the adequacy of the control) and to provide 
examples of meaningful review activities in guidance.
    (Response 390) We disagree that the proposed verification 
activities would require reviews that are not necessary. The purpose of 
the records review is both to identify a problem with a temperature 
monitoring device that may not have been detected or corrected, and to 
verify that the temperature controls were consistently implemented and 
that corrective actions were taken if needed. The requirement is 
consistent with requirement for records review in subpart C (Sec.  
507.49(a)(4)), which specifies records review as a verification 
activity to ensure that the records are complete, the activities 
reflected in the records occurred in accordance with the food safety 
plan, the preventive controls are effective, and appropriate decisions 
were made about corrective actions.
5. Proposed Sec.  507.51(a)(5)--Establish and Maintain Records
    We proposed that if your facility is subject to the modified 
requirements, you must establish and maintain records that document 
monitoring, corrective actions, and verification activities.
    (Comment 391) Some comments state that temperature controls in 
refrigerated warehouses are extremely reliable and therefore extensive 
record keeping and record review are not value-added. These comments 
ask us to revise the proposed provision to require a record only if a 
deviation in the environmental temperature from the prescribed limits 
was noted.
    (Response 391) We have revised the regulatory text to provide that 
temperature monitoring records may be kept either as affirmative 
records demonstrating temperature is controlled or as exception records 
demonstrating loss of temperature control. The revised provision is 
consistent with the more general requirement for monitoring records of 
refrigeration temperature during storage of TCS animal food (see Sec.  
507.40(c)(2)).

B. Proposed Sec.  507.51(b)--Records

    We proposed that the records that a facility must establish and 
maintain for the proposed modified requirements are subject to the 
requirements that would be established in proposed subpart F. We 
received no comments that disagreed with our proposal, and are 
finalizing proposed Sec.  507.51(b) without change.

XXXVII. Subpart C: Comments on Proposed Sec.  507.53--Requirements 
Applicable to a Preventive Controls Qualified Individual and a 
Qualified Auditor

    We proposed to establish requirements for the qualifications of a 
preventive controls qualified individual and a qualified auditor. Some 
comments support the proposed requirements without change. Some 
comments that support the proposed provisions suggest alternative or 
additional regulatory text.
    In the following paragraphs, we discuss comments that ask us to 
clarify the proposed requirements or that disagree with, or suggest one 
or more changes to, the proposed requirements. After considering these 
comments, we are finalizing the provisions as proposed with conforming 
changes as shown in table 31.

A. Proposed Sec.  507.53(a) and (b)--What a Preventive Controls 
Qualified Individual or Qualified Auditor Must Do or Oversee

    We proposed to list the functions that must be performed by one or 
more preventive controls qualified individuals (i.e., preparation of 
the food safety plan; validation of the preventive controls; review of 
records for implementation and effectiveness of preventive controls and 
appropriateness of corrective actions; and reanalysis of the food 
safety plan) or by a qualified auditor (i.e., conduct an onsite audit). 
We proposed to list these functions for simplicity (i.e., to make it 
easy to see all of the requirements in a single place). We specified 
that this list of functions already proposed to be established in 
applicable sections of the rule did not in itself impose any additional 
requirements.
    (Comment 392) Some comments ask us to clarify whether the 
preventive controls qualified individual must be on the premises during 
operating hours. Other comments ask us to clarify that the preventive 
controls qualified individual is not responsible for performing 
laboratory testing, because the preventive controls qualified 
individual may not be appropriately educated and trained for laboratory 
testing.

[[Page 56283]]

    (Response 392) The rule does not require that the preventive 
controls qualified individual be onsite during operating hours. The 
rule also does not require that the preventive controls qualified 
individual be responsible for performing laboratory testing, although 
review of testing records (e.g., records of product testing or 
environmental testing) must be conducted or overseen by a preventive 
controls qualified individual.
    (Comment 393) Some comments ask us to consider the implication of 
having the preventive controls qualified individual serve as the 
process authority, serve as the auditor, and offer final sign off on a 
validation and corrective actions, and suggest that a third party may 
be necessary to ensure that uniform standards are applied.
    (Response 393) To the extent that the comment suggests that the 
functions of the preventive controls qualified individual create a 
conflict of interest, we disagree. The rule focuses on the need for 
applicable training and experience to perform certain functions. The 
preventive controls qualified individual must develop (or oversee the 
development of) the food safety plan that controls the identified 
hazards and then ensures through review of records that the plan is 
being implemented as designed. The rule does not require that a 
facility engage a third party to provide oversight of any individual, 
including a preventive controls qualified individual, but does not 
preclude a facility from doing so if it chooses.

B. Proposed Sec.  507.53(c)--Qualification Requirements

1. Proposed Sec.  507.53(c)(1)--Preventive Controls Qualified 
Individual
    We proposed that to be a preventive controls qualified individual, 
the individual must have successfully completed training in the 
development and application of risk-based preventive controls at least 
equivalent to that received under a standardized curriculum recognized 
as adequate by FDA or be otherwise qualified through job experience to 
develop and apply a food safety system. We also proposed that this 
individual may be, but is not required to be, an employee of the 
facility.
    (Comment 394) Some comments express concern that there is lack of 
specificity on what constitutes appropriate training and experience for 
a preventive controls qualified individual and ask us to clarify what 
FDA's standardized curriculum for preventive controls qualified 
individuals will consist of, what experience will be recognized as 
meeting the requirement, how FDA will recognize the experience and 
whether and how FDA will recognize industry providers of training 
programs. Some comments state that currently industry members may 
choose from many private organizations and academia to obtain training 
under established HACCP based training programs and audit training 
programs. Some comments ask us to allow flexibility for industry to 
continue current training programs without receiving express approval 
from the FSPCA.
    (Response 394) As discussed in Response 1, the FSPCA is 
establishing a standardized curriculum. The curriculum will focus on 
the specific requirements of the preventive controls rule. Training 
providers do not need approval from the FSPCA to use the curriculum.
    (Comment 395) Some comments ask who will assess the qualifications 
of a particular preventive controls qualified individual or determine 
whether particular individuals are in fact ``qualified.'' Some comments 
ask us to use an outcome-based demonstration of competency. Some 
comments ask us to specify that all work experience must be comparable 
or that a preventive controls qualified individual must pass a 
proficiency test. Some comments ask us to establish minimum standards 
for competency. Some comments ask us to clarify what job experiences 
would be sufficient. Some comments ask how we will verify that reported 
training and experience are true.
    (Response 395) We are not establishing minimum standards for 
competency and do not intend routinely to directly assess the 
qualifications of persons who function as the preventive controls 
qualified individual, whether by their training or by their job 
experience. Instead, we intend to focus our inspections on the adequacy 
of the food safety plan. As necessary and appropriate, we will consider 
whether deficiencies we identify in the food safety plan suggest that 
the preventive controls qualified individual may not have adequate 
training or experience to carry out the assigned functions, including 
whether reported training and experience is accurately represented.
    (Comment 396) Some comments ask us to provide for competency 
requirements to be met through on-the-job experience in lieu of 
traditional classroom training. Some comments ask us to clarify what we 
mean by training that is ``at least equivalent'' to that received under 
a standardized curriculum recognized as adequate by FDA. Some comments 
ask us to clarify whether individuals who have successfully completed 
training in the development and application of risk-based preventive 
controls through programs delivered and recognized under the 
International HACCP Alliance would be considered to have completed 
training ``equivalent'' to that recognized by FDA for the development 
and application of risk-based preventive controls.
    (Response 396) The requirements do provide for qualification 
through appropriate job experience, such as experience with 
successfully implementing HACCP systems or other preventive-based food 
safety systems. It is the responsibility of the owner, operator, or 
agent in charge of the facility to determine whether any individual who 
prepares (or oversees the preparation of) the food safety plan has 
appropriate qualifications to do so, whether by on-the-job experience 
or by training.
    There are some differences in the requirements of the animal food 
preventive controls rule compared to the requirements of HACCP 
regulations for seafood, juice, and meat and poultry such that training 
provided by the International HACCP Alliance may not be equivalent. To 
avoid unnecessary duplication of training, such an individual may only 
need to attend partial, supplemental courses in order to meet the 
training requirements. Alternatively, a person who has received the 
International HACCP Alliance training and has implemented a HACCP plan 
may be qualified through job experience.
    (Comment 397) Some comments ask us to emphasize that a standardized 
curriculum in the development and application of risk-based preventive 
controls may not provide a preventive controls qualified individual 
with sufficient expertise to design and conduct robust, scientific 
validation studies to support the adequacy of control measures.
    (Response 397) We acknowledge that a single training course may not 
provide adequate training for every function of the preventive controls 
qualified individual for the animal foods produced by a facility. In 
some cases an individual may gain the full complement of knowledge and 
experience through multiple, specific training courses; in other cases 
an individual may gain the full complement of knowledge and experience 
through job experience or through a combination of training and job 
experience.
    (Comment 398) Some comments ask us not to establish requirements 
that are

[[Page 56284]]

overly strict because there is a finite supply of food safety experts 
in the country and many facilities will need multiple preventive 
controls qualified individuals.
    (Response 398) We disagree that the requirements applicable to the 
preventive controls qualified individual should be designed to match 
any current limitations in the number of individuals who have the 
knowledge and skill to prepare (or oversee the preparation of) a food 
safety plan. We expect that market forces will act to increase the 
number of preventive controls qualified individuals to match the demand 
generated by this rule. In addition, as discussed in section LIII.A, we 
are further staggering the compliance dates for subparts C and E of the 
rule, so that those businesses that are not small will need to comply 
with subparts C and E of the rule within 2 years, and small businesses 
will need to comply with subparts C and E of the rule within 3 years. 
Very small businesses are not required to develop a food safety plan or 
conduct other activities that require oversight by a preventive 
controls qualified individual.
2. Proposed Sec.  507.53(c)(2)--Qualified Auditor
    We proposed that to be a qualified auditor, a preventive controls 
qualified individual must have technical expertise obtained by a 
combination of training and experience appropriate to perform the 
auditing function.
    (Comment 399) Some comments object to the proposed requirement that 
a qualified auditor must be a preventive controls qualified individual 
with certain technical auditing expertise. One comment asserts that a 
qualified auditor should not be required to have the broader skills of 
a preventive controls qualified individual.
    (Response 399) We have revised the definition of ``qualified 
auditor,'' and the requirements applicable to a ``qualified auditor,'' 
such that a ``qualified auditor'' means a person who is a ``qualified 
individual'' as that term is defined in this final rule, rather than a 
``preventive controls qualified individual,'' because some auditors may 
be auditing businesses (such as produce farms) that are not subject to 
the requirements for hazard analysis and risk-based preventive 
controls, and it would not be necessary for such an auditor to be a 
``preventive controls qualified individual.''
    (Comment 400) Some comments ask us to consider specifying training 
for qualified auditors. These comments also ask us to consider certain 
industry documents in any guidance we may issue regarding qualified 
auditors.
    (Response 400) At this time, we are not planning to specify a 
training curriculum for qualified auditors. If we develop guidance 
related to qualified auditors, we will consider industry documents that 
are already available.

C. Proposed Sec.  507.53(d)--Records

    We proposed that all applicable training must be documented in 
records, including the date of the training, the type of training, and 
the person(s) trained. For clarity, we have revised the requirement to 
specify the type of training that must be documented, i.e., applicable 
training in the development and application of risk-based preventive 
controls (see 78 FR 64736 at 64804).
    (Comment 401) Some comments ask us to explain how job experience 
should be documented in records to prove qualifications.
    (Response 401) The rule does not require documentation of job 
experience. A facility has flexibility to determine whether and how to 
document a preventive controls qualified individual's job experience. 
For example, a facility could ask a preventive controls qualified 
individual to provide a resume documenting applicable experience. As 
discussed in Response 395, we intend to focus our inspections on the 
adequacy of the food safety plan. As necessary and appropriate, we will 
consider whether deficiencies we identify in the food safety plan 
suggest that the preventive controls qualified individual may not have 
adequate experience to carry out the assigned functions.
    For further discussion on comments received to the proposed rule 
for preventive controls rule for human food, see the final rule of the 
human food preventive controls rule published elsewhere in this issue 
of the Federal Register.

XXXVIII. Subpart C: Comments on Proposed Sec.  507.55--Implementation 
Records

    We proposed to list all records documenting implementation of the 
food safety plan in Sec.  507.55(a). We noted that proposed Sec.  
507.55(a) would not establish any new requirements but merely make it 
obvious at a glance what implementation records are required under 
proposed part 507, subpart C. We received no comments that disagreed 
with this proposed provision and are finalizing it as proposed.
    We proposed that the records that you must establish and maintain 
are subject to the requirements of proposed subpart F (``Requirements 
Applying to Records that Must be Established and Maintained''). 
(Proposed subpart F would establish requirements that would apply to 
all records that would be required by the various proposed provisions 
of proposed part 507.) We received no comments that disagreed with this 
proposed provision and are finalizing it as proposed.

XXXIX. Subpart D: Comments on Proposed New Provisions for Withdrawal of 
a Qualified Facility Exemption

    In the 2013 proposed animal food preventive controls rule, we 
proposed to establish procedural requirements that would govern our 
withdrawal of an exemption for a qualified facility (proposed subpart 
D; the withdrawal provisions). In the 2014 supplemental notice, we 
discussed several comments we received on these withdrawal provisions 
and proposed modifications and additions to them. Some of the 
reproposed provisions would modify the provisions that we included in 
the 2013 proposed preventive controls rule (such as the timeframe for 
compliance with an order withdrawing an exemption), whereas others 
would be new provisions (such as a procedure to reinstate an exemption 
that had been withdrawn). In this section of this document we discuss 
comments that we received on the withdrawal provisions in the 2013 
proposed preventive controls rule, but did not address in the 2014 
supplemental notice. We also discuss comments that we received on the 
re-proposed withdrawal provisions in the 2014 supplemental notice.
    Most of the comments support the proposed provisions, suggest 
alternative or additional regulatory text, or ask us to clarify how we 
will interpret the provision.
    For several provisions, we received no comments that disagreed with 
our proposal, and are finalizing the provisions without change. These 
provisions are Sec.  507.75 (Presiding officer for an appeal and for an 
informal hearing); Sec.  507.77 (Timeframe for issuing a decision on an 
appeal); Sec.  507.80 (Revocation of an order to withdraw a qualified 
facility exemption); and Sec.  507.83 (Final agency action).
    In the following paragraphs, we discuss comments that ask us to 
clarify the proposed requirements or that disagree with or suggest one 
or more changes to the proposed requirements. After considering these 
comments, we have revised the proposed requirements as shown in table 
21 with editorial and conforming changes as shown in table 31.

[[Page 56285]]



   Table 21--Revisions to the Proposed Provisions for Withdrawal of a
                      Qualified Facility Exemption
------------------------------------------------------------------------
            Section                Description            Revision
------------------------------------------------------------------------
507.60(b)(2)..................  Timeframe for a    Allow 15 calendar
                                 qualified          days, rather than 10
                                 facility to        calendar days, for
                                 respond to a       the facility to
                                 notification       respond.
                                 from FDA about
                                 circumstances
                                 that may lead
                                 FDA to withdraw
                                 the facility's
                                 exemption.
507.65(c).....................  Contents of an     Editorial changes to
                                 order to           clarify that the
                                 withdraw a         order will specify
                                 qualified          which of two
                                 facility           circumstances that
                                 exemption.         may lead FDA to
                                                    withdraw a qualified
                                                    facility exemption
                                                    apply, or whether
                                                    both of these two
                                                    circumstances apply.
507.65(d)(1)..................  Contents of an     Specify that the
                                 order to           timeframe for the
                                 withdraw a         qualified facility
                                 qualified          to comply with the
                                 facility           order is 120
                                 exemption.         calendar days after
                                                    the date of receipt
                                                    of the order, or
                                                    within a reasonable
                                                    timeframe, agreed to
                                                    by FDA, based on a
                                                    written
                                                    justification,
                                                    submitted to FDA,
                                                    for a timeframe that
                                                    exceeds 120 calendar
                                                    days from the date
                                                    of receipt of the
                                                    order.
507.65(d)(2)..................  Timeframe for a    Allow 15 calendar
                                 qualified          days, rather than 10
                                 facility to        calendar days, for
                                 appeal an order    the facility to
                                 withdrawing the    appeal the order.
                                 facility's
                                 exemption.
507.65(e).....................  Contents of an     Include a statement
                                 order to           informing the
                                 withdraw a         facility that it may
                                 qualified          ask us to reinstate
                                 facility           an exemption that
                                 exemption.         was withdrawn by
                                                    following the
                                                    procedures in Sec.
                                                    507.85.
507.67........................  Compliance with,   Specifies that a
                                 or appeal of, an   qualified facility
                                 order to           that loses its
                                 withdraw a         exemption would no
                                 qualified          longer need to
                                 facility           comply with the
                                 exemption.         modified
                                                    requirements that
                                                    apply to qualified
                                                    facilities that have
                                                    an active exemption.
507.67(a)(1) and (c)(1).......  Compliance with,   Specify that the
                                 or appeal of, an   timeframe for the
                                 order to           qualified facility
                                 withdraw a         to comply with the
                                 qualified          order is 120
                                 facility           calendar days after
                                 exemption.         the date of receipt
                                                    of the order, or
                                                    within a reasonable
                                                    timeframe, agreed to
                                                    by FDA, based on a
                                                    written
                                                    justification,
                                                    submitted to FDA,
                                                    for a timeframe that
                                                    exceeds 120 calendar
                                                    days from the date
                                                    of receipt of the
                                                    order.
------------------------------------------------------------------------

A. Proposed Sec.  507.60--Circumstances That May Lead FDA To Withdraw a 
Qualified Facility Exemption

    We proposed that we may withdraw the exemption that would apply to 
a qualified facility in the event of an active investigation of a 
foodborne illness outbreak that is directly linked to the qualified 
facility, or if we determine that it is necessary to protect the public 
(human or animal) health and prevent or mitigate a foodborne illness 
outbreak based on conditions or conduct associated with a qualified 
facility that are material to the safety of the animal food 
manufactured, processed, packed, or held at such facility. We also 
proposed that before we issue an order to withdraw an exemption, we: 
(1) May consider one or more other actions to protect the public health 
or mitigate a foodborne illness outbreak; (2) must notify you, in 
writing, of circumstances that may lead us to withdraw the exemption, 
and provide an opportunity for you to respond in writing, within 10 
calendar days of the date of receipt of the notification, to our 
notification; and (3) must consider your actions to address the 
circumstances that may lead us to withdraw the exemption.
    (Comment 402) Some comments agree with the proposed provisions 
regarding certain actions we may take, and other actions we must take, 
before issuing an order to withdraw a qualified facility exemption. For 
example, some comments agree that other regulatory actions should be 
considered before withdrawing a qualified facility exemption, and some 
comments agree that it is appropriate to assess corrective actions 
taken by a qualified facility in response to an animal food safety 
problem when considering whether to withdraw its exemption. Other 
comments agree that these provisions are reasonable and will provide 
qualified facilities due process and greater clarity on the withdrawal 
process, but suggest that we could issue guidance rather than include 
these provisions in the rule to allow us greater flexibility should we 
have to act quickly to protect the public (human or animal) health.
    Other comments disagree with these proposed provisions and ask us 
to delete them from the final rule. These comments assert that FSMA 
does not require us to describe the actions that we may take prior to 
withdrawing a qualified facility exemption and that it is not necessary 
to do so because it is customary for us to work with an animal food 
facility to address problems before taking enforcement actions. These 
comments also express concern that listing possible regulatory actions 
before we would issue an order to withdraw a qualified facility 
exemption could create an expectation that we will always exercise such 
regulatory actions before issuing the order. These comments also 
express concern that being bound by these provisions could prevent us 
from acting quickly to protect public health.
    (Response 402) We are retaining the provisions regarding certain 
actions we may take, and other actions we must take, before issuing an 
order to withdraw a qualified facility exemption. We agree that it is 
customary for us to work with an animal food facility to address 
problems before taking enforcement actions, but disagree that 
specifying this customary practice in the rule would prevent us from 
acting quickly to protect public (human or animal) health. As 
previously discussed, we consider that issuing an order to withdraw an 
exemption would be a rare event, in part because alternative actions 
such as those described in these provisions may provide a more 
expeditious approach to correcting a problem than withdrawing an 
exemption (79 FR 58524 at 58553). We also disagree that the rule binds 
us to take alternative regulatory action before issuing an order to 
withdraw a qualified facility exemption, other than to notify the 
facility in writing of circumstances that may lead us to withdraw the 
exemption, provide an opportunity for the facility to respond in 
writing, and consider the actions taken by the facility to address the 
circumstances we describe. The rule clearly specifies that regulatory 
actions such as a warning letter, recall, administrative detention, 
suspension of registration, refusal of animal food offered for import, 
seizure, and injunction are actions that we ``may'' (not ``must'') take 
before issuing an order to withdraw a qualified facility

[[Page 56286]]

exemption. Providing the facility with an opportunity to correct the 
problems before we take steps to withdraw an exemption has the 
potential to save Agency resources associated with preparing an order, 
responding to an appeal of the order and request for a hearing, and 
administering a hearing. Directing resources to help a facility correct 
problems, rather than to administer a withdrawal process that could be 
resolved by the time of a hearing, is appropriate public health policy.
    (Comment 403) Some comments ask us to specify that the notification 
of circumstances that may lead FDA to withdraw the exemption must 
include facts specific to the situation and information about how the 
facility can remedy the situation.
    (Response 403) By specifying that we must notify the facility of 
circumstances that may lead us to withdraw an exemption, we mean that 
we would include facts specific to the situation. It is the 
responsibility of the facility, not FDA, to remedy the situation.
    (Comment 404) Some comments ask us to state affirmatively that we 
must not withdraw the exemption if the facility has satisfactorily 
addressed the problematic conditions or conduct at the facility. These 
comments assert that, without this affirmative statement, the 
requirement that we ``consider the actions taken by the facility'' 
remains unclear.
    (Response 404) We decline this request. If the facility has 
satisfactorily addressed the problematic conditions or conduct, there 
would be no problematic circumstances for us to describe in the order 
withdrawing the qualified facility exemption.
    (Comment 405) Some comments ask us to provide additional time for a 
qualified facility to respond, in writing, to a notification of 
circumstances that may lead us to withdraw its exemption. Comments 
suggest timeframes of 60, 90, and 120 days as a reasonable or 
appropriate period of time for a qualified facility to compile 
information and documentation of facts and to respond to a notification 
of circumstances that may cause us to withdraw its exemption. Some of 
these comments express concern that the proposed deadline is too short, 
and that the short timeframe violates the intent of the exemption. Some 
comments ask us to establish graduated response times, with less 
response time allowed for more serious animal food safety concerns.
    (Response 405) We have revised the provision to provide for 15 
calendar days, rather than 10 calendar days, for a facility to respond 
in writing to our notification. The 15-day timeframe is the same as the 
timeframe for responding to a warning letter. Circumstances that could 
lead us to withdraw a qualified facility exemption require prompt 
action on the part of a facility, just as circumstances that lead us to 
issue a warning letter require prompt action.
    (Comment 406) Some comments ask us to clarify how an exemption can 
be revoked (and restored) on diversified farms that produce both exempt 
and non-exempt products.
    (Response 406) We assume that this comment is referring to a farm 
mixed-type facility that produces some products (such as forage 
products or plant protein meals) that are exempt from the requirements 
for hazard analysis and risk-based preventive controls, as well as some 
products that are not exempt from these requirements. Neither 
withdrawing nor reinstating a qualified facility exemption would have 
any impact on products that are not subject to the requirements for 
hazard analysis and risk-based preventive controls. In contrast, 
administrative procedures such as injunction and suspension of 
registration likely would apply to all animal food production by the 
facility.
    (Comment 407) Some comments ask us to consistently use either 
``calendar days'' or ``working days'' throughout the provisions 
directed to withdrawal of an exemption. Some comments ask us to use 
``business days'' rather than ``calendar days'' or ``working days.''
    (Response 407) We have expressed the timeframes for all of the 
withdrawal provisions in calendar days.
    (Comment 408) Some comments ask us to clarify that the decision to 
withdraw a qualified facility exemption is an individualized 
determination and will not be applied to a class of farmers by stating 
this clearly in the preamble.
    (Response 408) The decision to withdraw a qualified facility 
exemption is an individualized determination and will not be applied to 
a class of facilities or farmers.
    (Comment 409) Some comments assert that the timeframes for 
responding to a notification that an exemption may be withdrawn should 
be the same regardless of whether the notification is sent to a 
qualified facility subject to the human or animal food preventive 
controls rule or a farm subject to the produce safety rule. These 
comments state that many small farms do value-added processing and will 
be subject to both rules.
    (Response 409) Although the produce safety rule is not yet final, 
we intend to make the administrative procedures associated with 
withdrawal of an exemption consistent to the extent practicable, 
including the timeframe for responding to a notification.
    (Comment 410) Some comments ask us to expand the scope of the 
withdrawal provisions to include facilities that would satisfy criteria 
for an exemption from the requirements for hazard analysis and risk-
based preventive controls for low-risk activity/food combinations 
(i.e., the exemptions in proposed Sec. Sec.  507.5(e) and (f)).
    (Response 410) We decline this request. Section 418 of the FD&C Act 
does not provide for withdrawal of the exemptions established in Sec.  
507.5(e) and (f). The withdrawal provision in section 418(l)(3) of the 
FD&C Act is limited to qualified facilities.

B. Proposed Sec.  507.62--Issuance of an Order To Withdraw a Qualified 
Facility Exemption

    We proposed procedures for the steps we would take to issue an 
order to withdraw an exemption applicable to a qualified facility, 
including procedures that would: (1) Emphasize that a senior FDA 
official (such as an FDA District Director, the Director of the 
Division of Compliance in CVM, or a more senior FDA official) must 
approve an order to withdraw the exemption before the order is issued; 
(2) provide that any officer or qualified employee of FDA may issue the 
order after it has been approved; (3) specify that we would issue the 
order to the owner, operator, or agent in charge of the facility; and 
(4) require that the order be in writing and be signed and dated by the 
officer or qualified employee of FDA who is issuing the order.
    (Comment 411) Some comments ask us to include in the procedures 
timeframes for: (1) Submitting an order after an initial determination 
that criteria for withdrawing an exemption are met; (2) approval or 
denial by the FDA District Director; (3) issuing the withdrawal (with 
automatic revocation of order if FDA does not issue the order within 
the specified timeframe); and (4) delivery of the order to the owner, 
operator, or agent in charge of the facility. Other comments recommend 
that the procedures for issuing an order specify that we send the order 
in a way that ensures its receipt, such as through certified mail with 
confirmation of delivery to ensure the facility operator receives the 
order.
    (Response 411) We are not establishing timeframes for the steps we 
take before a facility receives an order for withdrawal of an 
exemption. The timeframes surrounding our internal

[[Page 56287]]

process for developing an order have no bearing on the time that a 
facility will need to respond to the order or on the information it 
will need to do so. We agree that it is appropriate to specify 
timeframes for the procedural steps that follow a facility's receipt of 
an order, and the withdrawal procedures include such timeframes.
    We are not specifying that we send an order in a way that ensures 
its receipt. Although certified mail with confirmation of delivery is 
one way to ensure receipt, other methods are available, including 
delivery through private carriers that provide mechanisms to document 
receipt. In light of the provision (which we included in the 2014 
supplemental notice) linking the timeframes for a facility to comply 
with, or appeal, an order to the date of receipt of the order (rather 
than to the date of the order), it will be up to us to deliver the 
order in a way that provides us with evidence of receipt.

C. Proposed Sec.  507.65--Contents of an Order To Withdraw a Qualified 
Facility Exemption

    We proposed specific information that would be included in an order 
to withdraw an exemption, including (1) The date of the order and the 
name, address, and location of the qualified facility; (2) a brief, 
general statement of the reasons for the order, including information 
relevant to the circumstances that led us to issue the order; (3) a 
statement that the facility must either comply with subpart C within 
120 calendar days of receipt, or appeal the order within 10 calendar 
days of receipt; (4) the text of section 418(l) of the FD&C Act and of 
the withdrawal provisions in part 507, subpart D; (5) information about 
an informal hearing on an appeal of the order; and (6) contact 
information for appropriate senior FDA officials, as well as the name 
and the title of the FDA representative who approved the order.
    (Comment 412) Some comments recommend that the order specify which 
of the two circumstances that could lead us to issue the order apply.
    (Response 412) We have made editorial changes to the regulatory 
text to make it more clear that the provision requires us to specify 
which circumstance applies. (i.e., an active investigation of foodborne 
illness, or conduct or conditions associated with the qualified 
facility), or whether both of these two circumstances apply. See the 
revised regulatory text for Sec.  507.65(c).
    (Comment 413) Some comments ask us to add more specific 
requirements for the content of an order to withdraw an exemption, 
including specific evidence about the circumstances leading to the 
order. The comments maintain that doing so would help the facility 
respond with particularity to the facts and issues contained in the 
order if the facility appeals the order. The comments also recommend 
that the order include the evidence on which the order is based 
including, as applicable, evidence linking the active investigation of 
a foodborne illness outbreak directly to the facility or measurable 
evidence (collected using generally accepted scientific standards) 
indicating the presence in the facility of pathogens that pose an 
imminent threat to public (human or animal) health, or conduct or 
conditions that are material to the safety of animal food. The comments 
also recommend that the order include, when applicable, a statement 
explaining how altering the conduct or conditions would prevent or 
mitigate a foodborne illness outbreak.
    (Response 413) We agree that the order must provide sufficient 
information to enable a facility to respond with particularity to 
specific evidence about the circumstances leading to the order. 
However, we disagree that the order must do so by including the 
specific information recommended by the comments, and we have not 
revised the proposed withdrawal provisions to incorporate the 
suggestions of these comments. The comments appear to be more focused 
on whether the circumstances that lead us to issue an order meet an 
evidentiary standard than on explaining the problem so that a facility 
can both understand the problem and respond with particularity to the 
facts and issues contained in the order. The withdrawal provisions that 
we are establishing in this provision require the order to include a 
brief, general statement of the reasons for the order, including 
information relevant to: (1) An active investigation of a foodborne 
illness outbreak that is directly linked to the facility; or (2) 
conditions or conduct associated with a qualified facility that are 
material to the safety of the animal food manufactured, processed, 
packed, or held at the facility. The requirements that we are 
establishing in this provision would enable a qualified facility to 
both understand the problem and respond to it. In addition, because 
other requirements in these withdrawal provisions specify that we must 
notify a qualified facility of circumstances that may lead us to 
withdraw its exemption before we issue the actual order, the order 
withdrawing the exemption would be the second time that the facility 
hears about the problems (see Sec.  507.60(b)(2)). We intend that the 
process of responding to the notification that we must send before 
issuing an order to withdraw an exemption, including discussing the 
problems with FDA as warranted, would provide additional information to 
the facility to enable the facility to both understand the problem and 
respond to it.
    (Comment 414) Some comments ask us to provide 15 ``business days'' 
from date of receipt of the order, rather than the proposed 10 calendar 
days from date of receipt of the order, for the facility to appeal the 
order.
    (Response 414) We have revised the provision to provide for 15 
calendar days, rather than 15 business days, for a facility to appeal 
the order. We also have made conforming changes to establish the same 
15 calendar day timeframe in all provisions that specify the timeframe 
to appeal the order (i.e., Sec. Sec.  507.67(a)(2), 507.69(a)(1), and 
507.71(a)(2)). We also extended the timeframe for the hearing to be 
held to be within 15 calendar days, rather than the proposed 10 
calendar days, after the date the appeal is filed to provide more time 
for the facility to prepare for the hearing (see Sec.  507.73(a)). The 
timeframe for the hearing to be held continues to provide for an 
alternative timeframe agreed upon in writing by both the facility and 
FDA; a facility that would have preferred the proposed timeframe of 10 
calendar days could request that the hearing be held more quickly than 
15 calendar days.
    The 15-day timeframe is the same as the timeframe for responding to 
a warning letter. Circumstances that could lead us to withdraw a 
qualified facility exemption require prompt action on the part of a 
facility, just as circumstances that lead us to issue a warning letter 
require prompt action.
    (Comment 415) Some comments support the proposed timeframe of 120 
calendar days for a qualified facility whose exemption has been 
withdrawn to comply with the animal food preventive controls rule, but 
ask us to make the timeframe for complying with a FSMA rule the same 
regardless of whether the exemption is withdrawn from a qualified 
facility subject to the animal food preventive controls rule or from a 
farm subject to the produce safety rule. Other comments ask us to 
extend the timeframe to come into compliance, e.g., to 1 or 2 years. 
Some of these comments suggest that qualified facilities should have 
120 days to develop a plan of action, but 2 years to fully comply. Some 
of the comments argue that large farms and

[[Page 56288]]

manufacturers are given a year to come into compliance, and that 
requiring small and very small businesses to comply in a shorter time 
period would effectively drive them out of business. Other comments ask 
us to consider provisions that would require compliance with only those 
portions of the rule that formed the basis for the revocation.
    (Response 415) We continue to believe that the 120-day timeframe is 
adequate, but we have added flexibility such that a facility may 
request, with a justification in writing to FDA, a reasonable timeframe 
for compliance that exceeds 120 calendar days from the receipt of the 
order. FDA must grant the request for the facility to receive the 
extended timeframe. We are not generally extending the timeframe 
because circumstances that could lead us to withdraw a qualified 
facility exemption require prompt action on the part of a facility. A 
qualified facility that receives an order to withdraw its exemption 
would have received advance notification of the circumstances leading 
to the order and would have had an opportunity to correct the problems 
rather than have us proceed to issue the order (see Sec.  570.60(b)). 
If the facility requests a hearing, more than 40 days could elapse 
between the date that the facility receives the order and the date that 
the presiding officer for the hearing confirms the order to withdraw 
the exemption. Given that the circumstances that would lead us to issue 
the order involve either: (1) An active investigation of a foodborne 
illness outbreak that is directly linked to the qualified facility or 
(2) a determination that withdrawal of the exemption is necessary to 
protect the public (human or animal) health and prevent or mitigate a 
foodborne illness outbreak based on conditions or conduct associated 
with the qualified facility that are material to the safety of the 
animal food manufactured, processed, packed, or held at the facility, a 
delay of 1 to 2 years to comply with the rule is not warranted. We also 
do not believe that it would be appropriate to require a facility to 
come into compliance with only those provisions that formed the basis 
of the revocation. The provisions of subparts C and E are interrelated 
and operate as a system and therefore are not optimized through 
piecemeal implementation. However, FDA may consider staggered 
implementation as an option in granting a request for an extension of 
the timeframe to comply with an order to withdraw the exemption for a 
qualified facility.
    As already discussed, the new requirements for hazard analysis and 
risk-based preventive controls are not ``one-size-fits-all.'' Although 
each facility subject to the rule must prepare and implement a food 
safety plan, the preventive controls that the facility would establish 
and implement would depend on the facility, the animal food, and the 
outcome of the facility's hazard analysis. In addition, the preventive 
control management components that a facility would establish and 
implement for its preventive controls would be established as 
appropriate to ensure the effectiveness of the preventive controls, 
taking into account the nature of the preventive control and its role 
in the facility's animal food safety system.
    Although the produce safety rule is not yet final, we intend to 
make the administrative procedures associated with withdrawal of an 
exemption consistent to the extent practicable, including the timeframe 
to comply with the applicable rule if an exemption is withdrawn.
    (Comment 416) Some comments ask us to include in the order a 
statement that a facility may request that FDA reinstate an exemption 
that was withdrawn by following the procedures in Sec.  507.85.
    (Response 416) We have revised the requirements for the contents of 
an order as requested by these comments.

D. Proposed Sec.  507.67--Compliance With, or Appeal of, an Order To 
Withdraw a Qualified Facility Exemption

    We proposed that: (1) You must either comply with applicable 
requirements of part 507 within 120 calendar days of receipt, or appeal 
the order within 10 calendar days of receipt; (2) submission of an 
appeal, including submission of a request for an informal hearing, will 
not operate to delay or stay any administrative action unless the 
Commissioner of FDA, as a matter of discretion, determines that delay 
or a stay is in the public interest; and (3) if you appeal the order, 
and we confirm the order, you must comply with applicable requirements 
of part 507 within 120 calendar days of confirmation of receipt of the 
order.
    (Comment 417) Some comments ask us to specify that a qualified 
facility that loses its exemption from the requirements for hazard 
analysis and risk-based preventive controls would no longer need to 
comply with the modified requirements that apply to qualified 
facilities that have an active exemption.
    (Response 417) A qualified facility that loses its exemption from 
the requirements for hazard analysis and risk-based preventive controls 
would no longer need to comply with the modified requirements that 
apply to qualified facilities that have an active exemption. To make 
this clearer, the final withdrawal procedures now include this 
information (see the regulatory text for Sec.  507.67(c)).

E. Proposed Sec.  507.69--Procedure for Submitting an Appeal

    We proposed that (1) To appeal an order, you must submit a written 
appeal to FDA within 15 calendar days of receipt and respond with 
particularity to the facts and issues contained in the order, including 
any supporting documentation upon which you rely; and (2) In your 
written appeal, you may include a written request for an informal 
hearing.
    (Comment 418) Some comments ask us to rely on records kept in the 
normal course of business for documentation that will be sufficient to 
respond to an order to withdraw a qualified facility's exemption, 
rather than requiring a facility to ``respond with particularity to the 
facts and issues contained in the order, including any supporting 
documentation upon which the owner, operator or agent in charge of the 
facility relies.'' These comments assert that we should not require a 
facility that submits a written appeal to provide documents and records 
that they are not required to keep.
    (Response 418) We decline this request. In a withdrawal action, FDA 
is providing a qualified facility multiple opportunities to persuade 
FDA that withdrawal is not appropriate. If the facility relies on 
documentation as part of its response, it is reasonable to require that 
this documentation be provided to FDA.

F. Proposed Sec.  507.71--Procedure for Requesting an Informal Hearing

    We proposed that if you appeal the order: (1) You may request an 
informal hearing, and must do so together with your written appeal 
(within 15 calendar days of the date of receipt of the order and (2) a 
request for an informal hearing may be denied, in whole or in part, if 
the presiding officer determines that no genuine and substantial issue 
of material fact has been raised by the material submitted; you would 
receive written notice of the presiding officer's determination, 
explaining the reason for the denial.
    (Comment 419) Some comments ask us to guarantee a hearing so that a 
qualified facility can present its case in

[[Page 56289]]

person before having its exemption revoked.
    (Response 419) We decline this request. We agree that a qualified 
facility has a right to appeal an order to withdraw an exemption, and 
we have provided for a right to appeal.

G. Proposed Sec.  507.73--Requirements Applicable to an Informal 
Hearing

    We proposed that if you request an informal hearing, and we grant 
the request: (1) The hearing will be held within 10 calendar days after 
the date the appeal is filed or, if applicable, within a timeframe 
agreed upon in writing by you and by us; (2) the presiding officer may 
require that the hearing be completed within 1 calendar day; and (3) we 
must conduct the hearing in accordance with part 16 (21 CFR part 16), 
with some specified modifications, including that no party shall have 
the right, under Sec.  16.119, to petition FDA for reconsideration or a 
stay of the presiding officer's final decision.
    (Comment 420) Some comments object to our proposal that no party 
shall have the right, under Sec.  16.119 to petition FDA for 
reconsideration or a stay of the presiding officer's final decision. 
These comments assert that our justification (i.e., that the 
circumstances that would lead to a withdrawal merit prompt action and 
that a facility has the opportunity for judicial review in accordance 
with 21 CFR 10.45) is not a sufficient argument for justifying the 
removal of the option to file a motion for reconsideration or stay. 
These comments ask us to revise proposed Sec.  507.73(c)(6) to specify 
that the qualified facility shall have the right to file a motion for 
reconsideration or stay.
    (Response 420) We decline this request. In the 2014 supplemental 
controls notice, we proposed an additional mechanism for a qualified 
facility to present its view that its exemption should not be 
withdrawn, i.e., by providing advance written notification to a 
qualified facility if we are considering withdrawing an exemption and 
providing an opportunity for the facility to respond before we issue an 
order to withdraw an exemption. We also proposed to provide an 
opportunity for reinstatement of an exemption that had been withdrawn. 
We believe the multiple opportunities now available to a facility 
provide adequate opportunities for a facility's views to be considered, 
and further mechanisms are not warranted.

H. Proposed Sec.  507.85--Reinstatement of a Qualified Facility 
Exemption That Was Withdrawn

    We proposed four provisions for reinstating a withdrawn qualified 
facility exemption. First, we proposed that if the FDA District 
Director in whose district your facility is located (or, in the case of 
a foreign facility, the Director of the Division of Compliance in CVM) 
determines that a facility has adequately resolved problems with the 
conditions and conduct that are material to the safety of the animal 
food manufactured, processed, packed, or held at the facility and that 
continued withdrawal of the exemption is not necessary to protect 
public health and prevent or mitigate a foodborne illness outbreak, the 
FDA District Director in whose district your facility is located (or in 
the case of a foreign facility, the Director of the Division of 
Compliance in CVM) will, on his own initiative or on the request of a 
facility, reinstate the exemption (proposed Sec.  507.85(a)).
    Second, we proposed that you may ask FDA to reinstate an exemption 
that has been withdrawn by following specific steps (Sec.  507.85(b)(1) 
and (2)). Third, we proposed that if your exemption was withdrawn in 
the event of an active investigation of a foodborne illness outbreak 
that is directly linked to your facility and FDA later determines, 
after finishing the active investigation of a foodborne illness 
outbreak, that the outbreak is not directly linked to your facility, 
FDA will reinstate your qualified facility exemption and will notify 
you in writing that your exempt status has been reinstated.
    We proposed that if your exemption was withdrawn both in the event 
of an active investigation of a foodborne illness outbreak that is 
directly linked to your facility and because FDA had determined that it 
is necessary to protect the public (human or animal) health and prevent 
or mitigate a foodborne illness outbreak based on conditions or conduct 
associated with your facility that are material to the safety of the 
animal food manufactured, processed, packed, or held at such facility, 
and FDA later determines, after finishing the active investigation of a 
foodborne illness outbreak, that the outbreak is not directly linked to 
your facility, FDA will inform you of this finding, and you may ask FDA 
to reinstate your qualified facility exemption.
    (Comment 421) Some comments agree with our tentative conclusion 
that the absence of a specific provision in section 418 of the FD&C Act 
for the reinstatement of an exemption that is withdrawn does not 
preclude us from providing for such a process (79 FR 58524 at 58553). 
Other comments disagree with that tentative conclusion and assert that 
Congress crafted the withdrawal provision as a ``one strike, you're 
out'' provision. These comments also assert that including the 
withdrawal provision as a ``one strike, you're out'' provision was an 
essential part of the legislative agreement that allowed for adoption 
of the qualified facility exemption. These comments also assert that 
reinstatement would undermine the intent of the withdrawal provision 
because it would reduce the incentive for small animal food processors 
to ensure that the products they sell are as safe as possible. These 
comments also assert that a recognized principle of statutory 
interpretation provides that exemptions to statutes should be strictly 
construed, particularly when the statute addresses public health and 
safety, and that we are giving the exemption an impermissibly broad 
construction.
    Some comments ask why we believe that a business deserves a 
``second bite of the apple'' in light of the understanding (under 
proposed Sec.  507.60(b) and (c)) that we will first seek to correct 
problems before considering withdrawal. These comments also question at 
what point a facility would apply for reinstatement, and ask why we 
would allow a facility that has already come into compliance with 
FSMA's requirement to implement preventive controls to abandon those 
controls in favor of reinstating its exempt status. These comments ask 
us to eliminate the proposed provisions allowing for reinstatement.
    Some comments do not support the proposed reinstatement provisions 
when an animal food facility has been directly linked to a foodborne 
illness outbreak. Some comments support the proposed reinstatement 
provisions only when we determine, after finishing an active 
investigation of a foodborne illness outbreak, that the outbreak is not 
directly linked to the facility that had its exemption withdrawn.
    (Response 421) We disagree that the proposed reinstatement 
provisions would give the exemption an impermissibly broad 
construction. The express statutory language of section 418(l) of the 
FD&C Act does not support the comments' assertion that the withdrawal 
provision is a ``one strike, you're out'' provision. We also disagree 
that reinstatement would undermine the intent of the withdrawal 
provision because it would reduce the incentive for small animal food 
processors to ensure that the products they sell are as

[[Page 56290]]

safe as possible. We expect that the withdrawal provision itself 
provides a big incentive for small animal food processors to ensure 
that the products they sell are as safe as possible because of the 
business disruption that would occur if they are subject to withdrawal 
of the exemption. We proposed that a facility would need to present 
data and information to demonstrate that it has adequately resolved the 
problems with the conditions or conduct that are material to the safety 
of the animal food manufactured, processed, packed, or held at the 
facility, such that continued withdrawal of the exemption is not 
necessary to protect public (human or animal) health and prevent or 
mitigate a foodborne illness outbreak.
    We disagree that we should categorically refuse to consider 
reinstating a qualified facility exemption if we had withdrawn the 
exemption because an animal food facility had been directly linked to a 
foodborne illness outbreak. First, if information later comes to light 
to raise considerable doubt that a qualified facility had, indeed, been 
directly linked to a foodborne illness outbreak, and conditions and 
conduct at the facility do not otherwise warrant withdrawing the 
facility's exemption, it would be appropriate for us to reinstate the 
facility's exemption. Second, we would only reinstate the exemption if 
we determined that a facility has adequately resolved any problems with 
the conditions and conduct that are material to the safety of the 
animal food manufactured, processed, packed, or held at the facility 
and that continued withdrawal of the exemption is not necessary to 
protect public (human or animal) health and prevent or mitigate a 
foodborne illness outbreak.
    (Comment 422) Some comments that support the reinstatement of a 
withdrawn exemption ask us to establish a timeframe within which FDA 
will reinstate an exemption. Some comments ask us to specify in the 
regulatory text that the reinstatement would occur in a reasonable 
period of time, both in circumstances where FDA has decided on its own 
initiative to reinstate the exemption and in circumstances where a 
facility submits a request for reinstatement. Some comments suggest 10 
days is a reasonable period of time within which FDA should reinstate 
an exemption.
    (Response 422) We decline the requests to establish a timeframe for 
reinstatement in the regulatory text. If we determine on our own 
initiative to reinstate an exemption (e.g., because we later determine, 
after finishing the active investigation of a foodborne illness 
outbreak, that the outbreak is not directly linked to the facility), 
our determination would be effective immediately. If we receive a 
request to reinstate a withdrawn exemption, we intend to respond in a 
reasonable timeframe consistent with available resources. In some 
cases, we may respond that we need more information in order to 
evaluate your request.
    (Comment 423) Some comments ask that the process for reinstatement 
include at least one level of administrative appeal if we deny a 
facility's request for reinstatement.
    (Response 423) We have not revised the regulatory text to provide 
for an administrative appeal if we deny a facility's request for 
reinstatement. Existing procedures allow a facility to ask for a 
meeting with applicable FDA officials (see Sec.  10.65(c)) and appeal 
our decision if we deny the request (see Sec.  10.75).
    (Comment 424) Some comments ask us to establish a 1-year 
probationary period before the withdrawn qualified facility exemption 
could be fully reinstated.
    (Response 424) We decline this request. We intend to act on a 
request for reinstatement based on the merits of the data and 
information presented in the request, not after a pre-determined 
timeframe.

I. Conforming Amendment to 21 CFR Part 16

    We proposed to amend Sec.  16.1(b)(2) to include part 507, subpart 
D, relating to the withdrawal of an exemption applicable to a qualified 
facility, to the list of regulatory provisions under which regulatory 
hearings are available. We received no comments that disagreed with 
this proposed provision, and are finalizing it as proposed.

J. Other Comments on the Withdrawal Provisions

    (Comment 425) Several comments ask us to provide clarification 
through guidance, issued for public comment, on a variety of topics 
associated with the withdrawal provisions.
    (Response 425) We will consider the need for guidance in the 
future. At this time, we consider that withdrawing an exemption would 
be both rare and dependent upon the circumstances. We need to direct 
our resources to developing guidance on issues that would apply more 
broadly, and more generally, than the withdrawal provisions.
    (Comment 426) Some comments ask detailed questions about how we 
would coordinate the withdrawal process with the States.
    (Response 426) In general, we work with our State partners and 
other government counterparts in dealing with enforcement actions, 
including coordinating actions or deferring to each other when one 
department has authority to swiftly act to protect the consumer. In the 
specific case of this rule, we are working through the PFP to develop 
and implement a national Integrated Food Safety System consistent with 
FSMA's emphasis on establishing partnerships for achieving compliance 
(see Response 2 and section 209(b) of FSMA).
    (Comment 427) Some comments ask us to add provisions regarding 
notification of the appropriate State regulatory agency when a 
qualified facility exemption is withdrawn and reinstated.
    (Response 427) We decline this request. As previously noted, we are 
sensitive to the time required for various inspection activities and 
intend to communicate with States regarding our expectations for how to 
verify whether a facility is a qualified facility. The status of a 
facility as a qualified facility principally affects the requirements 
that it is subject to, and will be most useful to FDA and our food 
safety partners when preparing for inspection. At this time we do not 
intend to establish a system notifying the applicable State authorities 
at a point in time when the status of a facility as a qualified 
facility changes, whether as a result of withdrawal or reinstatement of 
a qualified facility exemption or because the facility's business has 
grown to the point where it exceeds the financial for very small 
business.

XL. Subpart E: General Comments on Proposed Requirements for a Supply-
Chain Program

    In the 2014 supplemental notice, we provided an opportunity for 
public comment on potential requirements for a supplier program as a 
preventive control. The supplier program for a receiving facility would 
be limited to those raw materials and other ingredients for which the 
receiving facility has identified a significant hazard (which we now 
refer to as a ``hazard requiring a preventive control''). Under the 
definitions established in this rule, ``supplier'' means the 
establishment that manufactures/processes the food, raises the animal, 
or grows the food that is provided to a receiving facility without 
further manufacturing/processing by another establishment, except for 
further manufacturing/processing that consists solely of the addition 
of labeling or similar activity of a de

[[Page 56291]]

minimis nature; ``receiving facility'' means a facility that is subject 
to subparts C and E and that manufactures/processes a raw material or 
other ingredient that it receives from a supplier (see Sec.  507.3).
    We previously explained our understanding that, particularly for 
RACs, there may be multiple establishments, including cooperatives, 
packing houses, and distributors, between a receiving facility and the 
establishment that would be considered the supplier, which would make 
supplier verification very challenging under certain circumstances (79 
FR 58476 at 58497). We requested comment on what verification 
activities would be appropriate for receiving facilities to conduct 
when a raw material or ingredient passes through more than one facility 
that would not be required to verify control of hazards if supplier 
programs are limited to manufacturers/processors. We discussed an 
example in which a receiving facility is a feed mill that receives oats 
from a distributor, who receives grains from a cooperative, and neither 
the distributor nor the cooperative is required to establish supplier 
controls for the farms, where the hazards are being controlled, and 
asked what supplier controls should be applied for the grains coming 
from the farms. We requested comment on whether and how the 
requirements for supplier verification should address such situations. 
We also requested comment regarding whether (and, if so, how) the final 
preventive controls rule for animal food should address the potential 
for gaps in supplier controls when a hazard is controlled at Point A in 
the supply chain, and Point B in the supply chain is a facility that 
only packs or holds animal food, but does not manufacture/process 
animal food (and therefore would not be required to have a supplier 
program) before passing it on to Point C in the supply chain.
    In the remainder of this section, we discuss comments that address 
our request for comment on complex supply-chain scenarios such as those 
described in the 2014 supplemental notice. We also describe our reasons 
for revising the proposed requirements for a supplier program to 
provide additional flexibility for an entity other than the receiving 
facility to determine, conduct, and document the appropriate supplier 
verification activities. When an entity other than the receiving 
facility determines, conducts, or both determines and conducts the 
appropriate supplier verification activities, the receiving facility 
must review and assess that entity's applicable documentation, and 
document the receiving facility's review and assessment. Providing this 
additional flexibility required a series of changes to multiple 
proposed provisions. To improve clarity and readability, we 
redesignated proposed Sec.  507.36 into eight distinct sections of 
regulatory text in a newly established subpart E (Supply-Chain 
Program), with editorial changes associated with the new structure of 
the redesignated regulations. See table 22 for the section numbers and 
titles in subpart E. See table 23 for an overview of the major 
revisions to the proposed requirements for a supply-chain program. See 
sections XLI through XLVII for a discussion of the specific provisions 
of the final requirements for a supply-chain program, and tables 24 to 
29 for more detailed summaries of revisions to these specific 
provisions. Because table 23 is an overview, the changes identified in 
table 23 appear again in, tables 24 to 29. Because the editorial 
changes associated with the redesignation are extensive, we do not list 
them in table 31.
    The title of subpart E is ``Supply-Chain Program'' rather than 
``Supplier Program.'' As shown in table 23 and discussed in more detail 
in section XLI.D, we have added one requirement applicable to non-
suppliers. ``Supply-chain program'' is a more appropriate term to 
reflect a subpart that includes a requirement applicable to 
nonsuppliers in addition to the requirements applicable to suppliers. 
In the remainder of this document, we use the phrase ``supply-chain 
program'' in section headings and when referring to the provisions of 
the final rule. We continue to use the term ``supplier program'' when 
describing the proposed provisions and the comments regarding the 
proposed provisions.

Table 22.4--Redesignation of the Requirements for a Supply-Chain Program
                              in Subpart E
                         [Supply-chain program]
------------------------------------------------------------------------
               Section                            Description
------------------------------------------------------------------------
507.105..............................  Requirement to establish and
                                        implement a supply-chain
                                        program.
507.110..............................  General requirements applicable
                                        to a supply-chain program.
507.115..............................  Responsibilities of the receiving
                                        facility.
507.120..............................  Using approved suppliers.
507.125..............................  Determining appropriate supplier
                                        verification activities
                                        (including determining the
                                        frequency of conducting the
                                        activity).
507.130..............................  Conducting supplier verification
                                        activities for raw materials and
                                        other ingredients.
507.135..............................  Onsite audit.
507.175..............................  Records documenting the supply-
                                        chain program.
------------------------------------------------------------------------


            Table 23.5--Overview of Revisions to the Proposed Requirements for a Supply-Chain Program
----------------------------------------------------------------------------------------------------------------
                                       Proposed section
     Final section designation           designation               Description                  Revision
----------------------------------------------------------------------------------------------------------------
Throughout........................  Throughout...........  The type of preventive      Refer to ``supply-chain-
                                                            control applicable to the   applied control'' rather
                                                            supply-chain program.       than ``preventive
                                                                                        control'' or variations
                                                                                        such as ``hazard
                                                                                        requiring a preventive
                                                                                        control when the hazard
                                                                                        is controlled before
                                                                                        receipt of the raw
                                                                                        material or other
                                                                                        ingredient.''
507.36(a)(2) (in subpart C).......  507.37(a)(1)(ii).....  A supply-chain program is   Shifted to be in
                                                            not required when the       provisions outside the
                                                            hazard will be controlled   framework of the supply-
                                                            by the receiving            chain program in subpart
                                                            facility's customer in      E.
                                                            the distribution chain.

[[Page 56292]]

 
507.105(a)(2).....................  N/A..................  Circumstances that do not   The receiving facility
                                                            require a supply-chain      does not need a supply-
                                                            program.                    chain program when the
                                                                                        receiving facility is an
                                                                                        importer, is in
                                                                                        compliance with the
                                                                                        forthcoming FSVP
                                                                                        requirements, and has
                                                                                        documentation of
                                                                                        verification activities
                                                                                        conducted under the
                                                                                        forthcoming FSVP
                                                                                        program.
507.105(a)(3).....................  N/A..................  Exemption from the          Exemption for animal food
                                                            requirements for a supply-  supplied for research or
                                                            chain program.              evaluation.
507.105(c)........................  N/A..................  Requirements applicable to  When a supply-chain-
                                                            non-suppliers.              applied control is
                                                                                        applied by an entity
                                                                                        other than the receiving
                                                                                        facility's supplier
                                                                                        (e.g., when a
                                                                                        nonsupplier applies
                                                                                        controls to certain
                                                                                        produce (i.e., produce
                                                                                        that will be subject to
                                                                                        the forthcoming produce
                                                                                        safety rule), because
                                                                                        growing, harvesting, and
                                                                                        packing activities are
                                                                                        under different
                                                                                        management), the
                                                                                        receiving facility must
                                                                                        (1) verify the supply-
                                                                                        chain-applied control;
                                                                                        or (2) obtain
                                                                                        documentation of an
                                                                                        appropriate verification
                                                                                        activity from another
                                                                                        entity in the supply
                                                                                        chain, review and assess
                                                                                        the entity's applicable
                                                                                        documentation, and
                                                                                        document that review and
                                                                                        assessment.
507.110(c)........................  507.37(a)(3)(ii).....  Purpose of the supply-      Specify only that the
                                                            chain program.              supply-chain program
                                                                                        must provide assurance
                                                                                        that a hazard requiring
                                                                                        a supply-chain-applied
                                                                                        control has been
                                                                                        significantly minimized
                                                                                        or prevented.
507.110(d)........................  507.37(b)............  Factors that must be         Clarification
                                                            considered in determining   that these factors must
                                                            appropriate supplier        be considered in
                                                            verification activities.    approving suppliers, as
                                                                                        well as in determining
                                                                                        appropriate supplier
                                                                                        verification activities.
                                                                                        Flexibility in
                                                                                        the factors that must be
                                                                                        considered if a supplier
                                                                                        is a qualified facility,
                                                                                        a produce farm that will
                                                                                        not be subject to the
                                                                                        forthcoming produce
                                                                                        safety rule on the basis
                                                                                        of size and/or direct
                                                                                        farm marketing, or a
                                                                                        shell egg producer that
                                                                                        is not subject to the
                                                                                        requirements of 21 CFR
                                                                                        part 118 (production,
                                                                                        storage, and
                                                                                        transportation of shell
                                                                                        eggs) because it has
                                                                                        less than 3,000 laying
                                                                                        hens.
507.115(a)........................  N/A..................  Responsibilities of the     Provide flexibility for
                                                            receiving facility.         an entity other than the
                                                                                        receiving facility to
                                                                                        determine, conduct, and
                                                                                        document supplier
                                                                                        verification activities,
                                                                                        provided that the
                                                                                        receiving facility
                                                                                        reviews and assesses
                                                                                        applicable documentation
                                                                                        from that entity and
                                                                                        documents the receiving
                                                                                        facility's review and
                                                                                        assessment.
507.115(b)........................  N/A..................  Responsibilities of the     Specify documentation
                                                            receiving facility.         that a receiving
                                                                                        facility may not accept
                                                                                        from a supplier to
                                                                                        satisfy the receiving
                                                                                        facility's
                                                                                        responsibilities for its
                                                                                        supply-chain program.
507.120(a)........................  507.37(a)(3)(i)......  Approval of suppliers.....  Explicit requirement for
                                                                                        a receiving facility to
                                                                                        approve its suppliers.
507.120(b)........................  507.37(a)(3)(i)......  Approval of suppliers.....  Explicit requirement for
                                                                                        a receiving facility to
                                                                                        establish and follow
                                                                                        written procedures for
                                                                                        receiving raw materials
                                                                                        and other ingredients.
507.130(e)........................  N/A..................  Alternative supplier        Provide for an
                                                            verification activity.      alternative supplier
                                                                                        verification activity
                                                                                        when the supplier is a
                                                                                        shell egg producer with
                                                                                        less than 3,000 laying
                                                                                        hens.
507.130(f)........................  N/A..................  Independence of the         Specify that there must
                                                            supplier.                   not be any financial
                                                                                        conflicts of interests
                                                                                        that influence the
                                                                                        results of the
                                                                                        verification activities
                                                                                        listed in Sec.
                                                                                        507.110(b) and payment
                                                                                        must not be related to
                                                                                        the results of the
                                                                                        activity.

[[Page 56293]]

 
507.135(c)(1).....................  507.37(e)............  Substitution of an          Provide additional
                                                            inspection for an audit.    flexibility for domestic
                                                                                        inspection by
                                                                                        representatives of other
                                                                                        Federal Agencies (such
                                                                                        as USDA), or by
                                                                                        representatives of
                                                                                        State, local, tribal, or
                                                                                        territorial agencies.
507.175...........................  507.37(g)............  Records documenting the     List additional records
                                                            supply-chain program.       associated with the
                                                                                        revised provisions.
----------------------------------------------------------------------------------------------------------------

    (Comment 428) Several comments ask us to issue guidance rather than 
establish requirements for a supplier program in the rule. Some 
comments assert that the benefits of a supplier verification program do 
not outweigh the costs; that we did not consider the effects of such a 
requirement on farms and small businesses; and that FSMA does not 
actually contain a requirement for a supplier verification program. 
Conversely, other comments support including a mandatory supplier 
program in the rule for hazards that are controlled in raw materials 
and other ingredients before receipt by the receiving facility, 
although many comments assert that a supplier verification program 
should be viewed as a verification activity rather than a preventive 
control. Some comments assert that a mandatory domestic supplier 
program is necessary to provide parity with the requirements of the 
FSVP rule authorized by FSMA, while other comments assert that FSMA's 
authorization of foreign supplier verification should not be used to 
justify a domestic supplier program. Some of these comments single out 
our request for comment, in the proposed FSVP rule, on whether to allow 
an entity that would be both an importer (under the FSVP rule) and a 
receiving facility (under the animal food preventive controls rule) to 
be deemed in compliance with the FSVP rule if it was in compliance with 
the supplier verification provisions of the animal food preventive 
controls rule, and agree with such an approach (78 FR 45730 at 45748).
    (Response 428) We agree that it is necessary to include a mandatory 
supply-chain program in the rule to ensure the safety of animal food 
where hazards are controlled in raw materials and other ingredients 
before receipt by a receiving facility, and we are finalizing such a 
requirement in this rule. The statute specifically identifies supplier 
verification activities as a preventive control (see section 418(o)(3) 
of the FD&C Act). Further, we believe a supply-chain program is a 
measure that a person knowledgeable about food safety would establish 
and implement in order to significantly minimize or prevent hazards 
requiring a preventive control in an incoming raw material or other 
ingredient.
    Supplier verification is sufficiently important for the control of 
hazards in both domestic and imported animal foods that FSMA contains 
provisions for both domestic and foreign supplier verification 
(sections 418(o)(3) and 805 of the FD&C Act). Because we have aligned 
the provisions for supplier verification in the FSVP rule with the 
provisions for a supply-chain program in this rule, we are allowing 
importers and receiving facilities to take advantage of that fact in 
considering compliance with both part 507 and our forthcoming FSVP 
regulations that we proposed to establish in part 1, subpart L, so that 
they do not have to duplicate verification activities (see Sec.  
507.105(a)(2)).
    (Comment 429) Some comments that addressed questions we asked in 
the 2013 proposed preventive controls rule for animal food and the 2014 
supplemental notice recommend that we add flexibility to the 
requirements for a supplier program such that any entity in the supply 
chain between the supplier and the receiving facility can perform 
supplier verification activities. Some comments ask us to allow a 
receiving facility to have a supplier program established for it by 
another entity. Other comments assert that it would be too burdensome 
for a receiving facility to consider any information related to the 
supplier's supplier or to go further back in the supply chain beyond 
the entity that is one back from the receiving facility. Other comments 
assert that we should eliminate any requirements for a supplier program 
from the rule because a supplier program involving more entities than 
just the receiving facility and the supplier would become too complex. 
Some comments express concern that we would be creating ``an 
environment where our supply chain is required to be disclosed to our 
customers via product testing, audits and supplier verification,'' 
asserting that this would discourage customers from buying from 
entities such as repackers when they could go to the source. Some 
comments state that we have not taken into account the low-risk nature 
of some industries. Other comments ask us to confirm that distributors 
and warehouses are not included in the requirements for a supplier 
program because they would not likely meet the definition of a 
receiving facility or a supplier.
    (Response 429) We agree with comments recommending additional 
flexibility in the supply-chain program with regard to who can perform 
certain activities and have added this flexibility to the final rule 
(see Sec.  507.115). Because the receiving facility and the supplier 
may be separated by several entities in a supply chain, we are allowing 
such entities (e.g., distributors, brokers, aggregators) to determine, 
conduct, and document supplier verification activities as a service to 
the receiving facility, provided that the receiving facility reviews 
and assesses applicable documentation provided by the other entity and 
documents that review and assessment. However, because the approval of 
suppliers is ultimately the responsibility of the receiving facility, 
the rule specifies that only a receiving facility can approve suppliers 
(see Sec. Sec.  507.115(a)(1) and 507.120(a) and Response 430).
    We disagree that complex supply chains make a supply-chain program 
too difficult and that a receiving facility cannot be expected to reach 
further back in a supply chain than the entity immediately before it in 
the supply chain. Supply-chain programs are currently used by 
facilities as a standard business practice and we understand that some 
of those supply chains are complex, with entities between the receiving 
facility and the supplier. We acknowledge that complex supply chains 
present a challenge because information will need to flow through 
several entities to allow the link between the receiving facility and 
the

[[Page 56294]]

supplier. However, we believe a supply-chain program is a critical 
preventive control for receiving facilities that will rely on suppliers 
to control hazards in raw materials and other ingredients. Although 
distributors, brokers, and other entities in the supply chain between a 
receiving facility and its supplier are not required to have a role in 
supplier verification, they have the option to determine, conduct, and 
document supplier verification activities as a service to the receiving 
facility if they so choose. If these entities choose not to participate 
in supplier verification, the receiving facility will need to reach 
back in the supply chain past them. In such situations, it may be 
necessary for the entities between the receiving facility and the 
supplier to provide the identity of the supplier to the receiving 
facility, if that identity is not available on the raw material or 
other ingredient or otherwise apparent. In such cases, the role that 
distributors, brokers, aggregators and similar entities would play in 
supplier verification would be minimal. We cannot determine whether 
having to provide the identity of the supplier to the receiving 
facility would change buying practices. However, we believe that 
manufacturers consider a number of factors in determining who they will 
purchase from, including the services provided, and that there will 
continue to be a role for aggregators, repackers, brokers and others. 
We have provided flexibility for these entities to play a role in 
supplier verification if the receiving facility and the business entity 
determine there is a benefit to do so.
    See also the discussion in section XLIII regarding the specific 
provisions of Sec.  507.115. Although comments focus on flexibility for 
an entity in the supply chain between the supplier and the receiving 
facility to perform supplier verification activities, and such entities 
are the most likely to be determining, conducting, and documenting 
supplier verification activities, the flexibility provided by the rule 
is not limited to such entities.
    (Comment 430) Some comments ask us to establish a general 
requirement for a supplier program without specifying roles and 
responsibilities for the various entities involved. Other comments ask 
us to define ``supplier'' as the entity with which the receiving 
facility has a commercial relationship.
    (Response 430) We disagree that we should establish a general 
requirement for a supply-chain program without specifying roles and 
responsibilities for the various entities involved. Although we have 
added flexibility to provide that an entity other than the receiving 
facility may determine, conduct, and document supplier verification 
activities (see Sec.  507.115), we continue to believe it is important 
to clearly define two roles in the supply chain that share the primary 
responsibility in the supplier verification process--i.e., the 
receiving facility and the supplier. In all cases where we have added 
flexibility for participation by an entity other than the receiving 
facility, the responsibility for the supply-chain program is clearly 
lodged with the receiving facility, and linked to the supplier (see 
Sec.  507.115). To emphasize the responsibility of the receiving 
facility and its link to the supplier, the final rule clearly states 
that the receiving facility must approve its suppliers before receiving 
raw materials and other ingredients (see Sec.  507.120(a)).
    For the supply-chain program to be meaningful and robust, there 
must be an exchange of information between these two entities--the 
entity receiving the animal food and the entity that controlled the 
hazard--even when an entity other than the receiving facility 
participates by determining, conducting, and documenting some supplier 
verification activities. The ultimate responsibility for supplier 
verification rests with the receiving facility through its 
determination in approving suppliers and in reviewing and assessing 
applicable documentation provided by another entity. Therefore, we also 
disagree that the definition of ``supplier'' should be revised to be 
the next entity back in a supply chain (e.g., the entity with which a 
receiving facility has a commercial relationship). The entity with 
which a receiving facility has a commercial relationship might be a 
distributor, broker or aggregator. A distributor, broker or aggregator 
does not control an identified hazard and, therefore, cannot assume the 
same role as an establishment that manufactures/processes the animal 
food, raises the animal, or grows the food.
    (Comment 431) Some comments ask us to provide flexibility in the 
content of the supplier program. Some comments assert that specifying 
the content of the supplier program would result in duplicative 
requirements on suppliers, who must first comply with certain 
regulations and then demonstrate that compliance in order to comply 
with a different regulation.
    (Response 431) We disagree that a requirement for a supply-chain 
program in which compliance with an underlying regulation is 
demonstrated is duplicative with the need to comply with the underlying 
regulation. The requirement for a supply-chain program is not mandating 
that the facility or farm comply twice with the animal food preventive 
controls rule or the produce safety rule; it is merely requiring that 
the compliance by the facility or the farm with the applicable 
regulation be verified to ensure that hazards requiring a preventive 
control are being controlled.
    We are continuing to specify the basic content of a supply-chain 
program, i.e., using approved suppliers; determining appropriate 
supplier verification activities; conducting supplier verification 
activities; and establishing records documenting these activities (see 
Sec.  507.110(a)). However, the rule provides flexibility in the choice 
of supplier verification activities and how often such activities must 
be performed. (See Sec. Sec.  507.110(b)(4) and 507.130(b)(2), (c), 
(d), and (e)). In addition, the rule provides for an alternative 
supplier verification activity for certain entities (see Sec.  
507.130(c), (d), and (e) regarding alternative supplier verification 
activities for qualified facilities, certain produce farms, and certain 
shell egg producers, respectively).

XLI. Subpart E: Comments on Requirement To Establish and Implement a 
Supply-Chain Program

    We proposed that the receiving facility must establish and 
implement a risk-based supplier program for those raw materials and 
ingredients for which the receiving facility has identified a 
significant hazard when the hazard is controlled before receipt of the 
raw material or ingredient (proposed Sec.  507.37(a)). We also proposed 
circumstances when a receiving facility would not be required to have a 
supplier program.
    In the following sections, we discuss comments that ask us to 
clarify the proposed requirement to establish and implement a written 
supplier program or that disagree with, or suggest one or more changes 
to, the proposed requirements. After considering these comments, we 
have revised the regulatory text as shown in table 24.

[[Page 56295]]



       Table 24--Revisions to the Proposed Requirements To Establish and Implement a Supply-Chain Program
----------------------------------------------------------------------------------------------------------------
                                       Proposed section
    Final section  designation           designation               Description                  Revision
----------------------------------------------------------------------------------------------------------------
N/A...............................  507.37(a)(1)(ii).....  A supplier program is not   Deleted as unnecessary.
                                                            required when there are
                                                            no hazards requiring a
                                                            preventive control.
N/A...............................  507.37(a)(1)(ii).....  A supplier program is not   Deleted as unnecessary.
                                                            required when the
                                                            preventive controls at
                                                            the receiving facility
                                                            are adequate to
                                                            significantly minimize or
                                                            prevent each of the
                                                            hazards requiring a
                                                            preventive control.
507.36(a)(2)......................  507.37(a)(1)(ii).....  A supplier program is not   Shifted to be in
                                                            required when the hazard    provisions outside the
                                                            will be controlled by the   framework of the supply-
                                                            receiving facility's        chain program in subpart
                                                            customer in the             E.
                                                            distribution chain.
507.105(a)(2).....................  N/A..................  Circumstances that do not   A receiving facility is
                                                            require a supply-chain      an importer, is in
                                                            program even though the     compliance with the FSVP
                                                            receiving facility's        requirements, and has
                                                            hazard analysis             documentation of
                                                            determines that a hazard    verification activities
                                                            requires a supply-chain-    conducted under the FSVP
                                                            applied control.            program.
507.105(a)(3).....................  N/A..................  Exemption from the          Exemption for animal food
                                                            requirements for a supply-  supplied for research or
                                                            chain program.              evaluation.
507.105(c)........................  N/A..................  Requirements applicable to  When a supply-chain-
                                                            non-suppliers.              applied control is
                                                                                        applied by an entity
                                                                                        other than the receiving
                                                                                        facility's supplier, the
                                                                                        receiving facility must
                                                                                        (1) verify the supply-
                                                                                        chain-applied control;
                                                                                        or (2) obtain
                                                                                        documentation of an
                                                                                        appropriate verification
                                                                                        activity from another
                                                                                        entity in the supply
                                                                                        chain, review and assess
                                                                                        the entity's applicable
                                                                                        documentation, and
                                                                                        document that review and
                                                                                        assessment.
----------------------------------------------------------------------------------------------------------------

A. Requirement for a Written Supply-Chain Program (Final Sec.  
507.105(a)(1) and (b))

    We proposed that the receiving facility must establish and 
implement a risk-based supplier program for those raw materials and 
ingredients for which the receiving facility has identified a 
significant hazard when the hazard is controlled before receipt of the 
raw material or ingredient. We also proposed that the supplier program 
must be written. (See proposed Sec.  507.37(a)(1)(i) and (2).) To 
improve clarity, we have revised the provision to substitute the phrase 
``hazard requiring a supply-chain-applied control'' for the phrase 
``significant hazard when the hazard is controlled before receipt of 
the raw material or ingredient.'' We have added a definition for the 
term ``supply-chain-applied control'' to mean a preventive control for 
a hazard in a raw material or other ingredient when the hazard in the 
raw material or other ingredient is controlled before its receipt (see 
Sec.  507.3) and use the more specific term '' supply-chain-applied 
control,'' rather than the broader term ``preventive control,'' 
throughout the provisions for a supply-chain program.
    (Comment 432) As discussed in Comment 428, several comments ask us 
to issue guidance rather than establish requirements for a supplier 
program in the rule.
    (Response 432) See Response 428 for a discussion of our reasons for 
declining this request and establishing requirements for a supply-chain 
program in the rule.
    (Comment 433) Some comments ask us to revise the regulatory text to 
remove the condition that all hazards be foreseeable so that the 
supplier program can address economically motivated adulteration.
    (Response 433) This comment is unclear. The requirement for a 
supply-chain program applies when the outcome of a hazard analysis is 
that a known or reasonably foreseeable hazard requires a preventive 
control, and the hazard would be controlled by the receiving facility's 
supplier. The requirement applies regardless of whether the hazard 
requiring a preventive control is, or is not, a hazard that would be 
introduced into a food for the purposes of economic gain.
    (Comment 434) Some comments ask us to specify that a Certificate of 
Analysis or other documentation of the existence and/or level of a 
hazard could be provided to the receiving facility to indicate the 
potential for an actual existence of a hazard so that the receiving 
facility could evaluate whether the hazard requires a preventive 
control. Some comments state that chemical hazards such as nutrient 
imbalances are not controlled through easily described ``procedures'' 
but are instead controlled through factors such as product formulation 
(e.g., controlling the levels of required or contaminating chemicals in 
each ingredient depending on the proportion of the ingredient in the 
finished animal food) and the amount fed. For example, some comments 
explain that mineral content of certain raw materials or ingredients 
may require control in some situations (e.g., copper content in food 
for sheep) but not in other situations (e.g., copper content in swine 
food). One comment expresses concern about whether customers would be 
willing to provide the receiving facility with confidential information 
about the customer's own hazard analysis with respect to sensitive 
topics. Furthermore, in such cases the receiving facility will not even 
know whether the chemical contaminant constitutes an actual ``hazard'' 
for the purposes of the customer's finished food. This comment also 
asserts that a Certificate of Analysis provided to a receiving facility 
constitutes ``control before receipt of the raw material or 
ingredient.''
    (Response 434) We do not understand the concern of this comment. A 
receiving facility and a supplier do not need to share all of the 
details of product formulation for a receiving facility to communicate 
its requirements to a supplier. In the example provided by the comment, 
the receiving facility could provide the supplier with a

[[Page 56296]]

written specification for a contaminant such as lead, and the supplier 
could demonstrate that it satisfied the receiving facility's 
specification by providing a Certificate of Analysis showing the 
results of laboratory testing for lead. Neither the written 
specification provided by the receiving facility, nor the Certificate 
of Analysis provided by the supplier, would disclose confidential 
information about the formulations or procedures of either entity.
    This comment also appears to misunderstand the applicability of the 
supply-chain program. The rule requires a supply-chain program when the 
receiving facility has identified, through its hazard analysis, that 
there is a hazard requiring a supplier-applied control. In the 
circumstances described by the comment, a Certificate of Analysis or 
other documentation of test results from the supplier to the receiving 
facility could demonstrate that the supplier has controlled the hazard 
to the receiving facility's specifications, but would not overturn the 
outcome of the receiving facility's hazard analysis that there is a 
hazard requiring a preventive control, and that the appropriate control 
is applied by the supplier. On the contrary, the Certificate of 
Analysis simply demonstrates that the supply-chain-applied control 
functioned as intended.
    (Comment 435) One comment asks us to specify in the regulatory text 
that the supplier program must be written ``if required'' because there 
are specified circumstances when a supplier program is not required.
    (Response 435) We decline this request. Although the rule provides 
circumstances when a supply-chain program is not required (see Sec.  
507.105(a)(2)), it is not necessary to specify, for all other 
provisions of the supply-chain program, that the provision only applies 
``if required.''

B. Circumstances That Do Not Require a Written Supply-Chain Program 
(Final Sec.  507.105(a)(2))

    We proposed that the receiving facility is not required to 
establish and implement a supplier program for raw materials and 
ingredients for which there are no significant hazards; the preventive 
controls at the receiving facility are adequate to significantly 
minimize or prevent each of the significant hazards; or the receiving 
facility relies on its customer to control the hazard and annually 
obtains from its customer written assurance that the customer has 
established and is following procedures (identified in the written 
assurance) that will significantly minimize or prevent the hazard. (See 
proposed Sec.  507.37(a)(1)(ii)(A), (B), and (C).)
    We are deleting the proposed provision that a supplier program is 
not required for raw materials and ingredients for which there are no 
``significant hazards'' (which we now refer to as ``hazards requiring a 
preventive control'') because it is unnecessary. The supply-chain 
program is required when a hazard identified in the receiving 
facility's hazard analysis identifies a hazard requiring a supply-
chain-applied control; it is not necessary to also state the converse. 
Likewise, we are deleting the proposed provision that a supplier 
program is not required if the preventive controls at the receiving 
facility are adequate to significantly minimize or prevent each of the 
significant hazards. In such a case, the outcome of the hazard analysis 
would not be that the hazard requires a supply-chain-applied control.
    As discussed in section XXVII, after considering comments, we are 
shifting the provision in which the receiving facility relies on its 
customer to control the hazard from the requirements for a supply-chain 
program to a series of provisions that apply when a manufacturer/
processor identifies a hazard requiring a preventive control, but can 
demonstrate and document that the hazard will be controlled by an 
entity in its distribution chain (see Sec. Sec.  507.36 and 507.37). 
However, as discussed in Response 428 and section XLI.C, we also are 
establishing two additional circumstances when a supply-chain program 
is not required (see Sec.  507.105(a)(2) and (3)).
    (Comment 436) As noted in Comment 428, some comments single out our 
request for comment, in the proposed FSVP rule, on whether to allow an 
entity that would be both an importer (under the FSVP rule) and a 
receiving facility (under animal food the preventive controls rule) to 
be deemed in compliance with the FSVP rule if it was in compliance with 
the supplier verification provisions of the animal food preventive 
controls rule, and agree with such an approach (78 FR 45730 at 45748).
    (Response 436) As noted in Response 428, we have aligned the 
provisions for supplier verification in the FSVP rule with the 
provisions for a supply-chain program in this rule, and we are allowing 
importers and receiving facilities to take advantage of that fact in 
considering compliance with our forthcoming FSVP regulations that we 
proposed to establish in in part 1, subpart L, so that they do not have 
to duplicate verification activities (see Sec.  507.105(a)(2)).
    (Comment 437) Some comments support the specified criteria for when 
a receiving facility would not be required to establish and implement a 
supplier program. Other comments express concern that these criteria 
suggest no supplier verification is needed at all in some circumstances 
despite supplier verification activities being potentially informative 
about a particular supplier. These comments ask us to establish some 
general requirement to perform verification activities for all 
suppliers.
    (Response 437) We decline this request because it is neither risk-
based nor consistent with the nature and purpose of the supply-chain 
program, which is to provide assurance that a hazard requiring a 
supply-chain-applied control has been significantly minimized or 
prevented (see the regulatory text of Sec.  507.110(c)). We agree that 
some degree of verification of all suppliers may prove useful to a 
receiving facility for various purposes, and the rule would not prevent 
a receiving facility from establishing a supply-chain program for all 
of its suppliers regardless of risk and regardless of whether the 
applicable hazard in a raw material or other ingredient is controlled 
before its receipt.
    (Comment 438) Some comments ask us to specify that a ``kill step'' 
would be an adequate indicator to significantly minimize or prevent 
significant hazards identified by the receiving facility when the 
receiving facility controls the hazard.
    (Response 438) These comments appear to misunderstand the 
applicability of the supply-chain program. The rule requires a supply-
chain program when the receiving facility has identified, through its 
hazard analysis, that there is a hazard requiring a preventive control 
and the receiving facility's manufacturing/processing will not control 
the hazard. In the circumstances described by the comment, the 
receiving facility is controlling the hazard and a supply-chain program 
for the raw material or other ingredient is not required. It is not 
necessary to specify the types of controls that the receiving facility 
may use to control the hazard.
    (Comment 439) Some comments ask us to specify that a receiving 
facility need not establish and implement a supplier program for raw 
materials and ingredients if those raw materials or ingredients were 
received from an affiliated party within the same corporate or 
controlling entity.

[[Page 56297]]

    (Response 439) We decline this request. With the revisions we have 
made to the proposed requirements for a supplier program, the supply-
chain program that we are establishing in this rule provides ample 
opportunities for an affiliated party within the same corporate or 
controlling entity to establish and implement a supply-chain program 
that is suited to its relationship to these entities. For example, as 
discussed in Response 458, a receiving facility might be able to 
determine and document a justification for a supplier verification 
activity other than an annual audit when a supplier is an affiliated 
party based on the receiving facility's knowledge of the corporate 
policies regarding animal food safety practices (see Sec.  
507.130(b)(2)). In addition, as discussed in Response 461, we have 
agreed that the corporate parent of a facility can be active in 
developing and implementing the facility's food safety plan (see 
section XXIV.A). If, for example, a corporate headquarters establishes 
and implements a supply-chain program for use company-wide, a receiving 
facility could rely on supplier verification activities conducted by 
its corporate headquarters, with applicable documentation available 
during inspection.

C. Exemption for Animal Food Supplied for Research or Evaluation (Final 
Sec.  507.105(a)(3))

    We are establishing an exemption from the requirement for a 
receiving facility to establish and implement a supply-chain program 
when it receives animal food for the purposes of research or 
evaluation, provided that certain conditions are met (see Sec.  
507.105(a)(3)). Those conditions are that the animal food: (1) Is not 
intended for retail sale and is not sold or distributed to the public; 
(2) is labeled with the statement ``Animal food for research or 
evaluation use''; (3) is supplied in a small quantity that is 
consistent with a research, analysis, or quality assurance purpose, the 
animal food is used only for this purpose, and any unused quantity is 
properly disposed of; and (4) is accompanied with documents, in 
accordance with the practice of the trade, stating that the animal food 
will be used for research or evaluation purposes and cannot be sold or 
distributed to the public. The exemption is analogous to an exemption 
we proposed for the FSVP rule under section 805(f) of the FD&C Act. 
(See proposed Sec.  1.501(c), 78 FR 45730 at 45745.) We believe it is 
not necessary to conduct supplier verification activities when animal 
food is obtained in this limited circumstance.

D. Additional Requirements for Non-Suppliers (Final Sec.  507.105(c))

    As discussed in section IV.B of this rule and in section IV.B of 
the final rule for preventive controls for human food as published 
elsewhere in this addition of the Federal Register, the final rule for 
preventive controls for human food includes several revisions to the 
``farm'' definition in response to comments. One change includes adding 
a new definition for a ``secondary activities farm,'' which provides 
for practices such as packing by cooperatives and packing houses under 
the ownership of multiple growers to remain within the ``farm'' 
definition (see Response 25 in the final rule for preventive controls 
for human food). Another change to the ``farm'' definition accommodates 
business models in which one operation grows crops but does not harvest 
them, and another operation, not under the same management, harvests 
crops but does not grow them (see Response 32 in the final rule for 
preventive controls for human food). This revision is a change from the 
``farm'' definition established in the section 415 registration 
regulations in 2003, and the proposed revisions to the ``farm'' 
definition in the 2013 proposed human food preventive controls rule and 
the 2014 supplemental human food preventive controls notice, which all 
describe a ``farm'' as an entity ``devoted to the growing and 
harvesting of crops'' (emphasis added).
    We proposed the requirements for a supplier program in the context 
of a single business entity ``devoted to the growing and harvesting of 
crops'' (emphasis added) in which packing operations were often done by 
that same business entity. The final ``farm'' definition accommodates 
business models where growing, harvesting, and packing operations will 
be done by different business entities. Harvesting and packing 
operations include some supply-chain-applied controls, such as controls 
on worker hygiene, quality of water used during harvesting and packing 
operations, and establishing and following water-change schedules for 
recirculated water, even though the harvesting and packing operations 
do not fall within the definition of ``supplier.''
    A receiving facility has an obligation to identify and implement 
preventive controls to provide assurances that any hazards requiring a 
preventive control will be significantly minimized or prevented and the 
animal food manufactured, processed, packed, or held by the facility 
will not be adulterated under section 402 of the FD&C Act (see section 
418(c) of the FD&C Act and Sec.  507.34(a)). That obligation includes 
responsibilities for raw materials and other ingredients when a supply-
chain-applied control is applied by an entity other than the receiving 
facility's supplier. To clarify the receiving facility's 
responsibilities when a supply-chain-applied control is applied by a 
non-supplier, we are establishing a requirement specifying that when a 
supply-chain-applied control is applied by an entity other than the 
receiving facility's supplier, the receiving facility must: (1) Verify 
the supply-chain-applied control or (2) obtain documentation of an 
appropriate verification activity from another entity in the supply 
chain, review and assess the entity's applicable documentation, and 
document that review and assessment. See Sec.  507.105(c). Because 
Sec.  507.105(c) refers to provisions in a future produce safety rule, 
we will publish a document in the Federal Register announcing the 
effective date of that provision when we finalize the produce safety 
rule.
    We do not expect the receiving facility to follow all of the 
requirements of subpart E applicable to ``suppliers'' when verifying a 
control by a ``non-supplier,'' as required by Sec.  507.105(c). 
Instead, we expect the receiving facility to take steps such as a 
review of the non-supplier's applicable food safety records. For 
example, if a receiving facility receives produce from a supply chain 
that includes a separate grower, harvester, and packer, the grower is 
the supplier and the requirements of subpart E applicable to 
``suppliers'' apply to the grower. To verify controls applied by the 
harvester, the receiving facility could review the harvester's records, 
such as records of training for harvest workers and records of 
agricultural water quality used in harvest operations. To verify 
controls applied by the packer, the receiving facility could review the 
packer's records, such as records of agricultural water quality used in 
packing operations. As discussed in Response 429, we are allowing 
entities such as distributors, brokers, and aggregators to determine, 
conduct, and document verification activities that apply to suppliers 
as a service to the receiving facility, provided that the receiving 
facility reviews and assesses applicable documentation provided by the 
other entity and documents that review and assessment. Likewise, under 
Sec.  507.105(c)(2) a receiving facility could obtain documentation of 
review of applicable records maintained by the harvester or packer from 
another entity, review and assess the entity's applicable

[[Page 56298]]

documentation, and document that review and assessment.
    We recognize that 507.105(c) may have limited applicability to raw 
material and other ingredients used in animal food. At this time, we do 
not have an example of when we would expect an animal food manufacturer 
to verify non-supplier controls for its raw materials or other 
ingredients. Although we do not have examples and expect limited 
applicability of Sec.  507.105(c)(2), we have included these provisions 
to provide for instances when an animal food facility identifies 
situations in which controls applied by a ``non-supplier'' need to be 
verified as part of the facility's supply-chain program.

E. Proposed General Requirements for the Supply-Chain Program That We 
Are Not Including in the Final Rule (Proposed Sec.  507.37(a)(4) and 
(5))

    We proposed that when supplier verification activities are required 
for more than one type of hazard in a food, the receiving facility must 
conduct the verification activity or activities appropriate for each of 
those hazards. We also proposed that for some hazards, in some 
situations it will be necessary to conduct more than one verification 
activity and/or to increase the frequency of one or more verification 
activities to provide adequate assurances that the hazard is 
significantly minimized or prevented. We have concluded that these 
provisions are largely self-evident and need not be included in the 
regulatory text. Therefore, we are not finalizing these proposed 
provisions. We will consider whether it will add value to discuss the 
principles in these proposed provisions in guidance that we intend to 
develop for the supply-chain program.

XLII. Subpart E: Comments on General Requirements for the Supply-Chain 
Program

    We proposed several requirements generally applicable to the 
supplier program (such as factors to consider in determining 
appropriate supplier verification activities (proposed Sec.  
507.37(b)), as well as several requirements more narrowly targeted to 
specific aspects of the supplier program (such as requirements 
applicable to onsite audits). As part of the redesignation of proposed 
Sec.  507.37 into subpart E, with eight distinct sections, we are 
establishing the more general requirements in Sec.  507.110 (see table 
25).
    Most comments that support the proposed provisions suggest 
alternative or additional regulatory text. In the following sections, 
we discuss comments that ask us to clarify the proposed requirements or 
that disagree with, or suggest one or more changes to, the proposed 
requirements. After considering these comments, we have revised the 
regulatory text as shown in table 25.

          Table 25--Revisions to the Proposed General Requirements Applicable to a Supply-Chain Program
----------------------------------------------------------------------------------------------------------------
                                        Proposed section
     Final section designation             designation             Description                 Revision
----------------------------------------------------------------------------------------------------------------
507.110(a).........................  507.37(a)(3)..........  What the supply-chain   Add that the supply-chain
                                                              program must include.   program includes, when
                                                                                      applicable, verifying a
                                                                                      supply-chain-applied
                                                                                      control applied by an
                                                                                      entity other than the
                                                                                      receiving facility's
                                                                                      supplier and documenting
                                                                                      that verification, or
                                                                                      obtaining documentation of
                                                                                      an appropriate
                                                                                      verification activity from
                                                                                      another entity, reviewing
                                                                                      and assessing that
                                                                                      documentation, and
                                                                                      documenting the review and
                                                                                      assessment.
507.110(b).........................  507.37(c)(1)..........  Appropriate supplier    N/A.
                                                              verification
                                                              activities.
507.110(c).........................  507.37(a)(3)(ii)......  Purpose of supplier     Specify only that the
                                                              verification            supply-chain program must
                                                              activities for raw      provide assurance that a
                                                              materials and other     hazard requiring a supply-
                                                              ingredients.            chain-applied control has
                                                                                      been significantly
                                                                                      minimized or prevented.
507.110(d).........................  507.37(b).............  Factors that must be    Clarify that the factors
                                                              considered when         apply in approving
                                                              approving suppliers     suppliers, as well as in
                                                              and determining         determining appropriate
                                                              appropriate supplier    supplier verification
                                                              verification            activities.
                                                              activities for raw
                                                              materials and other
                                                              ingredients.
507.110(d).........................  507.37(b).............  Factors that must be     Specify that three
                                                              considered when         of the factors relate to
                                                              approving suppliers     ``supplier performance''
                                                              and determining         Specify ``The
                                                              appropriate supplier    entity or entities that
                                                              verification            will be applying controls
                                                              activities for raw      for the hazards requiring
                                                              materials and other     a supply-chain-applied
                                                              ingredients; Supplier   control'' rather than
                                                              performance..           ``Where the preventive
                                                                                      controls for those hazards
                                                                                      are applied for the raw
                                                                                      material and ingredients--
                                                                                      such as at the supplier or
                                                                                      the supplier's supplier''.
                                                                                      Add ``other FDA
                                                                                      compliance actions related
                                                                                      to food safety'' as an
                                                                                      example of information
                                                                                      relevant to the supplier's
                                                                                      compliance with applicable
                                                                                      FDA food safety
                                                                                      regulations.
                                                                                      Clarify that
                                                                                      consideration of supplier
                                                                                      performance includes, when
                                                                                      applicable, relevant laws
                                                                                      and regulations of a
                                                                                      country whose food safety
                                                                                      system FDA has officially
                                                                                      recognized as comparable
                                                                                      or has determined to be
                                                                                      equivalent to that of the
                                                                                      United States and
                                                                                      information relevant to
                                                                                      the supplier's compliance
                                                                                      with those laws and
                                                                                      regulations.

[[Page 56299]]

 
                                                                                      Provide
                                                                                      flexibility in the factors
                                                                                      that must be considered if
                                                                                      a supplier is a qualified
                                                                                      facility, a produce farm
                                                                                      that will not be subject
                                                                                      to the forthcoming produce
                                                                                      safety rule on the basis
                                                                                      of size and/or direct farm
                                                                                      marketing, or a shell egg
                                                                                      producer that is not
                                                                                      subject to the
                                                                                      requirements of 21 CFR
                                                                                      part 118 (production,
                                                                                      storage, and
                                                                                      transportation of shell
                                                                                      eggs) because it has less
                                                                                      than 3,000 laying hens.
507.110(e).........................  507.37(f).............  Supplier non-           N/A.
                                                              conformance.
----------------------------------------------------------------------------------------------------------------

A. Description of What the Supply-Chain Program Must Include (Final 
Sec.  507.110(a))

    We proposed to require that a supplier program include verification 
activities, as appropriate to the hazard, and documentation of these 
activities, to ensure raw materials and ingredients are received only 
from suppliers approved for control of the hazard(s) in that raw 
material or ingredient (or, when necessary and appropriate, on a 
temporary basis from unapproved suppliers) (proposed Sec.  
507.37(a)(3)(i)). We also proposed to require that a supplier program 
include verification activities, as appropriate to the hazard, and 
documentation of these activities. We also proposed requirements 
applicable to the determination and documentation of appropriate 
supplier verification activities (proposed Sec.  507.37(b)). We also 
proposed specific documentation requirements for records associated 
with the supplier program (proposed Sec.  507.37(g)).
    The final rule specifies that the supply-chain program must 
include: (1) Using approved suppliers; (2) determining appropriate 
supplier verification activities (including determining the frequency 
of conducting the activity); (3) conducting supplier verification 
activities; and (4) documenting supplier verification activities. For 
clarity, Sec.  507.110(a) states this general requirement for the 
supply-chain program and Sec. Sec.  507.120, 507.125, 507.130, 507.135, 
and 507.175 provide the specific requirements for using approved 
suppliers, determining appropriate supplier verification activities, 
conducting verification activities, specific requirements for onsite 
audits, and records, respectively. See the discussion of the specific 
requirements of Sec. Sec.  507.120, 507.125, 507.130, 507.135, and 
507.175 in sections XLIV, XLV, XLVI, and XLVII, respectively.
    As discussed in section XLI.D, the final rule establishes a 
verification requirement when a supply-chain-applied control is applied 
by an entity other than the receiving facility's supplier (see Sec.  
507.105(c)). For clarity, Sec.  507.110(a) states this general 
requirement for the supply-chain program in Sec.  507.105(a)(5), and 
Sec.  507.105(c) provides the specific requirements that apply when a 
supply-chain-applied control is applied by an entity other than the 
receiving facility's supplier.

B. Appropriate Supplier Verification Activities ((Final Sec.  
507.110(b))

    We proposed to require that appropriate supplier verification 
activities include: (1) Onsite audits; (2) sampling and testing of the 
raw material or ingredient, which may be conducted by either the 
supplier or receiving facility; (3) review by the receiving facility of 
the supplier's relevant food safety records; or (4) other appropriate 
supplier verification activities based on the risk associated with the 
ingredient and the supplier (proposed Sec.  507.37(c)(1)).
    (Comment 440) Some comments support the inclusion of onsite audits 
as an appropriate supplier verification activity. However, other 
comments oppose it, and ask us to remove the onsite audit requirement 
from the supplier verification program, stating that Congress 
prohibited FDA from requiring third parties to verify or audit 
compliance with the rules. These comments express concern that the 
supplier verification program effectively imposes an ``entire second 
layer of regulation'' on farms that are supplying ingredients to 
processors, and claim this is an unnecessary burden that is not 
authorized by FSMA.
    (Response 440) We are retaining onsite audits as an appropriate 
supplier verification activity. Onsite audits may be less commonly used 
by the animal food industry than the human food industry. However, 
onsite audits provide the opportunity to review the food safety plan 
and written procedures and to observe the implementation of animal food 
safety procedures, as well as to review the records related to the past 
application of control measures, including laboratory test results. 
Audits also provide the opportunity to interview employees to assess 
their understanding of the animal food safety measures for which they 
are responsible. Thus, an audit can provide for a more comprehensive 
assessment of animal food safety implementation by a facility. Comments 
that oppose including onsite audits as a verification activity are 
concerned that farms will be required to have audits to verify that 
they are in compliance with produce safety standards or facilities will 
be required to have audits to verify preventive controls. These 
comments apparently refer to the provision in section 419(c)(1)(E) of 
the FD&C Act that the regulation issuing standards for the safety of 
produce ``not require a business to hire a consultant or other third 
party to identify, implement, certify compliance with these procedures, 
processes and practices,'' or the provision in section 418(n)(3)(D) of 
the FD&C Act that the preventive controls regulation ``not require a 
facility to hire a consultant or other third party to identify, 
implement, certify or audit preventative controls.'' The regulations 
proposed under section 419 of the FD&C Act would not impose such 
requirements. The requirements for supplier verification in this rule 
(under section 418 of the FD&C Act) provide for audits as one supplier 
verification activity. Although the rule does specify an annual onsite 
audit as the appropriate supplier verification activity when a hazard 
in a raw material or other ingredient will be controlled by the 
supplier and is one for which there is a reasonable probability that 
exposure to the hazard will result in serious adverse health 
consequences or death to humans or animals, the receiving facility is 
not required to hire a third

[[Page 56300]]

party to conduct the audit. Any qualified auditor, other than the 
supplier, may conduct the audit, including an employee of the receiving 
facility or another entity, such as an entity in the supply chain 
between the supplier and the receiving facility. The rule also provides 
that a receiving facility may determine and document that other 
verification activities and/or less frequent onsite auditing of the 
supplier provide adequate assurance that the hazards are controlled 
(see Sec.  507.130(b)(1) and (2)). Audits already conducted on a 
supplier's facility or operation for other business purposes may meet 
the requirement for supplier verification. In addition, the rule 
provides alternative requirements for verification of suppliers that 
are farms that grow produce and are not a covered farm under part 112 
in accordance with Sec.  112.4(a), or in accordance with Sec. Sec.  
112.4(b) and 112.5 (see Sec.  507.130(d)). Finally, we have also 
provided that inspections may substitute for an audit under specified 
circumstances (see Sec.  507.135(c)).
    While we realize that some farms may receive audits under the 
supplier verification provisions of part 507, we anticipate that onsite 
audits will be used as a verification activity more frequently for non-
farm facilities because hazards associated with commercial animal food 
production are not typically controlled by the farm, but rather during 
manufacture or processing of the animal food.
    (Comment 441) Some comments support the inclusion of sampling and 
testing of the raw material or other ingredient as an appropriate 
supplier verification activity, and note that verification testing is 
more effective when conducted by the supplier than the receiving 
facility because the supplier can control the lot of product tested. 
However, other comments oppose it, stating that sampling and testing is 
not useful for products for various reasons such as the non-homogeneous 
distribution of some hazards, or statistical limitations because of 
practical limits on number of samples or limited shelf life of some 
products.
    (Response 441) We are retaining sampling and testing as an 
appropriate supplier verification activity. As noted in the FDA 
memorandum on supplier programs, sampling and testing are commonly used 
by industry in the verification of supplier performance (Ref. 53). We 
have previously discussed factors that impact the utility and frequency 
of raw material/ingredient testing (see the Appendix published in the 
2013 proposed preventive controls rule for animal food (78 FR 64736 at 
64836)). We agree that there are benefits in having sampling and 
testing conducted by the supplier, because the supplier can then take 
appropriate action with respect to the findings, including not shipping 
contaminated product. However, because contamination with some hazards 
is likely to be non-homogeneous and for microbial pathogens or 
microbial toxins the numbers are likely to be low, a negative test 
result does not guarantee the absence of contamination. This should be 
taken into account when deciding which verification activity (or 
activities) is appropriate. Because of the limitations of sampling and 
testing, the controls the supplier has in place to minimize 
contamination, and the management of those controls, are key in 
determining when sampling and testing is appropriate as a verification 
activity. For short shelf life products, where holding product pending 
test results can negatively impact product quality and usefulness, an 
onsite audit to verify control of hazards may be more appropriate than 
sampling and testing.
    (Comment 442) Some comments ask us to specify in the regulatory 
text that sampling and testing can be conducted by or on behalf of the 
supplier or the receiving facility.
    (Response 442) The provisions of Sec.  507.115 specify the 
responsibilities of the receiving facility, and allow a receiving 
facility to conduct all supplier verification activities, including 
sampling and testing. These provisions also provide that a supplier, or 
an entity other than the receiving facility (such as an entity in the 
supply chain between the supplier and the receiving facility), can 
conduct sampling and testing, provided that the receiving facility 
reviews and assesses the documentation provided by the supplier. The 
rule places no restrictions on when a receiving facility, a supplier, 
or an entity other than the receiving facility could have a business 
relationship with a third party (such as a contract laboratory) to 
conduct sampling and testing.
    (Comment 443) Some comments suggest that, for a facility regularly 
undergoing audits, reviewing a ``supplier's relevant food safety 
records'' should allow for the receiving facility to review 
documentation related to pre-existing audits. These comments ask us to 
revise the provision to add ``including, but not limited to, records 
related to audits previously performed on the supplier's facility.''
    (Response 443) We decline this request. The comment misinterprets 
what we mean by a ``supplier's relevant food safety records.'' The rule 
provides for onsite audits as a verification activity, as well as 
reviewing a ``supplier's relevant food safety records.'' When an annual 
audit is determined to be an appropriate verification activity (see 
Sec.  507.130(b)(1)), the audit would be reviewed by the receiving 
facility, but a review of this audit is not what we meant by a 
``supplier's relevant food safety records.'' As described in an FDA 
memorandum on supplier programs, food safety records are records 
documenting that the food safety procedures that have been established 
to control hazards are being followed and are adequately controlling 
such hazards (Ref. 53). Thus, a receiving facility may obtain 
documentation of a supplier's control measures for a particular lot of 
a raw material or other ingredient provided to the receiving facility, 
such as the records created when a process control measure was applied. 
The food safety records may also include supplier records that show 
that the supplier's supplier has controlled a hazard. Such records may 
include audits, for example, when the supplier's supplier controls the 
hazard and the supplier's records include records of an audit conducted 
with respect to the hazard control activities of the supplier's 
supplier. To emphasize that the review of a supplier's relevant food 
safety records can include records other than records of audits, we 
have revised the documentation requirements applicable to review of a 
supplier's food safety records to specify that the documentation must 
include the general nature of the records reviewed (see Sec.  
507.175(c)(9)). By ``general nature of the records reviewed'', we mean 
information such as ``records of process controls.''
    (Comment 444) Some comments support the inclusion of other 
appropriate supplier verification activities based on the risks 
associated with the ingredient and the supplier, because it provides 
flexibility for facilities to design risk-based programs that are 
appropriate for their operations. Comments suggest other verification 
activities may include receiving raw materials and other ingredients 
from a supplier without a full audit report if the supplier maintains 
certification to a standard recognized by the Global Food Safety 
Initiative (GFSI); providing for documentary verification (such as 
fact-specific questionnaires and representations exchanged between the 
supplier and the receiving facility); and confirming that a facility, 
especially a small manufacturing facility, is licensed

[[Page 56301]]

by the appropriate State or local regulatory authority.
    (Response 444) We are retaining this provision to allow other 
appropriate supplier verification activities based on supplier 
performance and the risk associated with the raw material or other 
ingredient (Sec.  507.110(b)(4)). We have revised the regulatory text 
to refer to ``supplier performance and the risk associated with the raw 
material or other ingredient'' because ``supplier performance'' is more 
appropriate than ``risk associated with the supplier.'' We use the term 
``risk'' as defined by the Codex Alimentarius Commission to be ``a 
function of the probability of an adverse health effect and the 
severity of that effect, consequential to a hazard(s) in food'' (Ref. 
54). As discussed in section XLII.D, the considerations for supplier 
performance, which can be related to the probability of a hazard in the 
raw material or ingredient and the severity of adverse health effects 
that can result, are broader than this.
    We do not believe that a supplier maintaining certification to an 
industry standard would, by itself, serve as verification that a 
supplier is controlling the hazard; however we agree that this can be a 
consideration in the determination of the type and frequency of the 
verification activity conducted. Similarly, fact-specific 
questionnaires and representations exchanged between the supplier and 
the receiving facility can be a consideration in the determination of 
the type and frequency of the verification activity conducted. 
Confirming that a facility is licensed by the appropriate State or 
local regulatory authority should not serve as the only verification 
that a supplier is controlling the hazard, because the requirements for 
a license and the degree of inspectional oversight could vary greatly. 
We do provide for modified supplier verification activities for 
qualified facilities, which are very small businesses (Sec.  
507.130(c)).

C. Purpose of Supplier Verification Activities for Raw Materials and 
Other Ingredients (Final Sec.  507.110(c))

    We proposed to require that a supplier program include verification 
activities, as appropriate to the hazard, and documentation of these 
activities, to verify that: (1) The hazard is significantly minimized 
or prevented; (2) the incoming raw material or ingredient is not 
adulterated under section 402 of the FD&C Act of the FD&C Act; and (3) 
the incoming raw material or ingredient is produced in compliance with 
the requirements of applicable FDA food safety regulations (proposed 
Sec.  507.37(a)(3)(ii)). We have revised the provision to specify that 
the supply-chain program must provide assurance that a hazard requiring 
a supply-chain-applied control has been significantly minimized or 
prevented. If the supply-chain program provides assurance that a hazard 
requiring a supply-chain-applied control has been significantly 
minimized or prevented, it is not necessary to also specify that the 
incoming raw material or ingredient is not adulterated under section 
402 of the FD&C Act. We also have deleted the requirement that the 
verification activities must verify that the incoming raw material or 
ingredient is produced in compliance with the requirements of 
applicable FDA food safety regulations and instead focused that 
requirement as a factor that must be considered in approving suppliers 
and determining the appropriate supplier verification activities and 
the frequency with which they are conducted rather than as one of the 
stated purposes of the supply-chain program. See the regulatory text of 
Sec.  507.110(d)(i)(iii)(B).
    (Comment 445) Some comments ask us to revise this provision to 
state that the receiving facility's use of the incoming raw material or 
ingredient will not cause the finished food to be adulterated under 
section 402 of the FD&C Act. These comments assert that FSMA does not 
mandate, nor is it reasonable to expect, that incoming raw materials 
and ingredients will not be adulterated under section 402, and that it 
is acceptable for a receiving facility to control the ``adulterating 
hazard,'' even if it relies on the supplier to control other hazards.
    (Response 445) We decline this request. We acknowledge that in some 
circumstances a receiving facility may rely on the supplier to control 
certain hazards, while controlling other hazards itself. For example, a 
receiving facility that produces dry dog food that contains corn could 
rely on its supplier for the control of the chemical hazard aflatoxin, 
but control the biological hazard Salmonella through its own heat-
treatment process. However, the supply-chain program applies to hazards 
requiring a supply-chain-applied control, and the purpose relates to 
those hazards. In the example where the receiving facility is relying 
on the supplier to control aflatoxin, the provision would require the 
receiving facility to verify that the hazard (aflatoxin) has been 
significantly minimized or prevented by the supplier and that the level 
of aflatoxin in the corn does not render it adulterated under the FD&C 
Act.

D. Factors That Must Be Considered When Approving Suppliers and 
Determining Appropriate Supplier Verification Activities for Raw 
Materials and Other Ingredients (Final Sec.  507.110(d))

    We proposed that in determining and documenting the appropriate 
verification activities, the receiving facility must consider the 
following: (1) The hazard analysis, including the nature of the hazard, 
applicable to the raw material and ingredients; (2) where the 
preventive controls for those hazards are applied for the raw material 
and ingredients, such as at the supplier or the supplier's supplier; 
(3) the supplier's procedures, processes, and practices related to the 
safety of the raw material and ingredients; (4) applicable FDA food 
safety regulations and information relevant to the supplier's 
compliance with those regulations, including an FDA warning letter or 
import alert relating to the safety of the animal food; (5) the 
supplier's food safety performance history relevant to the raw 
materials or ingredients that the receiving facility receives from the 
supplier, including available information about results from testing 
raw materials or ingredients for hazards, audit results relating to the 
safety of the food, and responsiveness of the supplier in correcting 
problems; and (6) any other factors as appropriate and necessary, such 
as storage and transportation practices (proposed Sec.  507.37(b)).
    As discussed in Responses 429 and 430 and section XLIV.A, we have 
revised the regulatory text regarding use of approved suppliers to more 
explicitly state that the receiving facility must approve suppliers. 
The factors that must be considered in determining the appropriate 
supplier verification activities are equally relevant to approving 
suppliers, and the final rule requires that these factors must be 
considered in approving suppliers, as well as in determining 
appropriate supplier verification activities. For clarity and 
consistency with terms used throughout the final provisions for a 
supply-chain program, the final rule specifies ``the entity or entities 
that will be applying controls for the hazards requiring a supply-
chain-applied control'' rather than ``Where the preventive controls for 
those hazards are applied for the raw material and ingredients--such as 
at the supplier or the supplier's supplier.''
    As discussed in Response 444, we are using the term ``supplier 
performance,'' rather than ``risk of supplier,'' when discussing 
factors associated with

[[Page 56302]]

suppliers. The final rule groups three of the proposed factors as 
``supplier performance.'' As a companion change to emphasize that 
``supplier performance'' applies to all three of these factors, we 
refer to the supplier's ``food safety history'' rather than ``food 
safety performance history.''
    We also have revised the regulatory text to clarify that 
consideration of supplier performance includes, when applicable, 
relevant laws and regulations of a country whose food safety system FDA 
has officially recognized as comparable or has determined to be 
equivalent to that of the United States and information relevant to the 
supplier's compliance with those laws and regulations. We made this 
change because the final rule includes several provisions that 
acknowledge that some animal food establishments, including animal food 
establishments that are ``suppliers'' as that term is defined in this 
rule, operate in a foreign country. (See, e.g., the definition of 
``qualified auditor'' in Sec.  507.3 and Sec. Sec.  507.7(a)(2)(ii), 
507.7(e), 507.105(a)(2), 507.130(c), 507.135(c)(1)(ii), 507.135(c)(2), 
and 507.175(c)(15)). Some of these provisions (e.g., Sec. Sec.  
507.105(a)(2), 507.130(c), 507.135(c)(1)(ii), 507.135(c)(2), and 
507.175(c)(15)) are in the requirements for a supply-chain program. 
When the supplier is in a foreign country whose food safety system FDA 
has officially recognized as comparable or determined to be equivalent 
to that of the United States, a receiving facility may substitute the 
written results of an inspection by the applicable food safety 
authority for an audit, provided that certain conditions are met (see 
Sec.  507.135(c)(1)(ii) and (2)). However, as of August 30, 2015, FDA 
has not developed a systems recognition program for animal food; 
therefore, we have no signed systems recognition agreements with any 
foreign food safety authority relating to animal food. The currently 
existing systems recognition agreement relates solely to human food and 
does not apply to animal food. The final rule provides flexibility for 
alternative verification requirements for certain entities (see Sec.  
507.130(c), (d), and (e)). We have revised the factors that must be 
considered regarding supplier performance to reflect the flexibility 
the rule provides for conducting supplier verification activities for 
these entities (see Sec.  507.110(d)(2)).
    (Comment 446) Some comments support the flexibility for receiving 
facilities to determine the appropriate supplier verification 
activities and frequency with which to conduct these activities. Some 
comments state that not all of the factors that we proposed a receiving 
facility consider are relevant for the process of selecting the 
verification activity. These comments suggest changing the regulatory 
text to require a receiving facility to consider ``both food and 
supplier related risks, including the following, as appropriate'' and 
then listing the factors as proposed. Other comments suggested similar 
changes to the regulatory text.
    (Response 446) We disagree that not all of the factors that we 
proposed a receiving facility to consider are relevant to determining 
the appropriate verification activity. Every factor might not be 
determinative in all cases, and our requirement merely to consider each 
factor does not assume so. However, any one of these factors could be 
crucial depending on the animal food, the hazard, and the nature of the 
preventive control. We continue to consider it appropriate to require 
receiving facilities to consider each of these factors in making their 
determinations about the appropriate verification activities.
    (Comment 447) Some comments ask us to clarify that the phrase ``the 
nature of the hazard'' means the nature of the hazard requiring 
control.
    (Response 447) We have revised the regulatory text to specify ``the 
nature of the hazard controlled before receipt of the raw material or 
other ingredient.'' The revised regulatory text is consistent with 
regulatory text in the provisions for the preventive control management 
components (see Sec.  507.39(b), which specifies ``taking into account 
the nature of the hazard controlled before receipt of the raw material 
or other ingredient'').
    (Comment 448) Some comments agree that a receiving facility must 
consider where the preventive controls for hazards are applied for the 
raw materials and ingredients, such as at the supplier or the 
supplier's supplier. Other comments assert that this consideration 
should not be used to determine if supplier oversight is needed. Other 
comments state that it may be hard to review the procedures used by a 
supplier's supplier and beyond and ask us to provide clear flexibility 
regarding requirements for the content and performance of a receiving 
facility's supplier program.
    (Response 448) The purpose of the requirement to consider where the 
hazard is controlled is to assist a receiving facility in determining 
what supplier verification activities are appropriate, not to determine 
whether supplier oversight is needed. Once a receiving facility has 
determined that a hazard requiring a preventive control is controlled 
before receipt of a raw material or other ingredient, supplier 
oversight is needed.
    We recognize that there is need for additional flexibility 
regarding conducting supplier verification activities. As discussed in 
Response 429, we are providing significant additional flexibility to 
address this situation in the final rule.
    (Comment 449) Some comments object to the proposed requirement to 
consider applicable FDA food safety regulations and information 
relevant to the supplier's compliance with those regulations, including 
an FDA warning letter or import alert relating to the safety of the 
food. These comments assert that it is difficult for a receiving 
facility to know a supplier's compliance status, because it is not easy 
to obtain this kind of information in a timely fashion. Some comments 
ask us to develop an online database to house this information to help 
make it easier to find. Some comments ask us to replace the broad 
requirement to consider applicable FDA food safety regulations and 
information relevant to the supplier's compliance with those 
regulations with a narrower requirement to only consider any FDA 
warning letter or import alert relating to the safety of the food.
    (Response 449) We are retaining the broad requirement to consider 
applicable FDA food safety regulations and information relevant to the 
supplier's compliance with those regulations. Such information is 
relevant to supplier performance regardless of whether there is an 
applicable warning letter or import alert.
    We currently have a searchable online database for warning letters 
(Ref. 55) and another searchable online database for import alerts 
(Ref. 56). Both of these databases are available to the public from our 
homepage at http://www.fda.gov. We also publicize actions to suspend a 
facility's registration, such as in our 2012 suspension of registration 
due to Salmonella contamination of nut butter and nut products 
(including ingredients used in animal foods) manufactured, processed, 
packed, and held by the facility (Ref. 57). Under the requirement to 
consider supplier performance with respect to applicable food safety 
regulations, a receiving facility cannot ignore published information 
relating to a supplier's compliance with applicable FDA food safety 
regulations in determining the appropriate verification activities, 
such as publicized information regarding suspension of registration. To

[[Page 56303]]

emphasize this point, we have revised the regulatory text to specify 
that the applicable information includes ``other FDA compliance actions 
related to animal food safety.'' We also have revised the regulatory 
text to specify that the compliance relates to an FDA warning letter or 
import alert relating to the ``safety of animal food,'' rather than the 
``safety of the animal food,'' to provide flexibility for a receiving 
facility to identify information that may raise a question about a 
supplier's compliance history in a more general way, rather than only 
with respect to a particular animal food.
    (Comment 450) Some comments state we should only require 
consideration of the supplier's food safety performance history 
relevant to the hazards requiring control in the raw materials or 
ingredients that the receiving facility receives from the supplier.
    (Response 450) Consideration of the supplier's animal food safety 
history relevant to the raw materials or other ingredients that the 
receiving facility receives from the supplier will be focused on the 
hazard that the supplier is controlling because that is the food safety 
information the receiving facility will consider to be relevant and for 
which the receiving facility would develop a history. The information 
could indicate that certain verification activities may be more 
appropriate than others for verifying the control of the hazard at that 
particular supplier or provide information useful in determining a 
frequency for the verification activity. However, we decline to revise 
the provision to specify that consideration should be limited to the 
hazards requiring control. Even though this is the most relevant 
information, a facility may become aware of information with respect to 
a raw material or other ingredient provided to another customer of the 
supplier that may suggest the need to conduct a different verification 
activity. For example, if the receiving facility is obtaining mineral 
premix from a supplier that is controlling for a nutrient imbalance of 
copper and molybdenum and becomes aware that mineral premixes from this 
supplier have been associated with a recall due to contamination with a 
physical hazard, the receiving facility would determine that it should 
implement verification activities related to controlling for physical 
hazards.
    (Comment 451) Some comments ask us to replace the phrase ``examples 
of factors that a receiving facility may determine are appropriate and 
necessary are storage and transportation'' with ``such as storage and 
transportation.''
    (Response 451) We have made this editorial change.

E. Supplier Non-Conformance (Final Sec.  507.110(e))

    We proposed that if the owner, operator, or agent in charge of a 
receiving facility determines through auditing, verification testing, 
relevant consumer, customer or other complaints, or otherwise that the 
supplier is not controlling hazards that the receiving facility has 
identified as significant, the receiving facility must take and 
document prompt action in accordance with Sec.  507.42 to ensure that 
raw materials or ingredients from the supplier do not cause food that 
is manufactured or processed by the receiving facility to be 
adulterated under section 402 of the FD&C Act (proposed Sec.  
507.37(f)).
    (Comment 452) Some comments object to the use of the word 
``significant'' in this proposed provision, recommending that we 
replace it with ``requiring control by the supplier.'' These comments 
reason that these activities are only necessary if the receiving 
facility is relying on the supplier to control the specific hazards.
    (Response 452) We have revised the regulatory text to state ``a 
hazard requiring a supply-chain-applied control'' rather than 
``significant.''

XLIII. Subpart E: New Requirement Specifying the Responsibilities of 
the Receiving Facility (Final Sec.  507.115)

    As discussed in Response 429, after considering comments we are 
providing flexibility for an entity other than the receiving facility 
to determine, conduct, and document the appropriate supplier 
verification activities, provided that the receiving facility reviews 
and assesses the entity's applicable documentation, and documents the 
receiving facility's review and assessment. We are specifying that 
flexibility in Sec.  507.115. We have titled this section 
``Responsibilities of the receiving facility'' to emphasize the 
responsibility of the receiving facility for its supply-chain program. 
(See Responses 429 and 430.) Although comments focus on flexibility for 
an entity in the supply chain between the supplier and the receiving 
facility to perform supplier verification activities, and such entities 
are the most likely entities to be the entities determining, 
conducting, and documenting supplier verification activities, the 
flexibility provided by the rule is not limited to such entities.
    The rule does, however, set some bounds on the flexibility for 
determining, conducting, and documenting appropriate supplier 
verification activities. For example, as discussed in Responses 429 and 
430, only the receiving facility can approve its suppliers. As another 
example, although it would not be appropriate for a supplier to 
determine the appropriate supplier verification activities for itself, 
we had proposed that it would be appropriate for a supplier to conduct 
sampling and testing of raw materials and ingredients as a supplier 
verification activity (proposed Sec.  507.37(c)(1)(ii)), and we are 
retaining that provision in the final rule (see Sec.  507.115(a)(4)). 
Likewise, it is common industry practice for a supplier to arrange for 
an audit by a third party (Ref. 53), and the new flexibility provision 
does not prohibit a receiving facility from relying on an audit 
provided by its supplier when the audit of the supplier was conducted 
by a third-party qualified auditor in accordance with the requirements 
of the rule applicable to audits (Sec.  507.135). See Sec.  507.115 for 
the full text of this new flexibility provision.

XLIV. Subpart E: Comments on Using Approved Suppliers and Determining 
Appropriate Supplier Verification Activities

    We proposed requirements for the use of approved suppliers 
(proposed Sec.  507.37(a)(3)(i)) and for determining and documenting 
appropriate supplier verification activities (proposed Sec.  
507.37(b)). See table 26 for a description of the final provisions and 
the changes we have made to clarify the requirements.

  Table 26--Revisions to the Proposed Requirements for Approving Suppliers and for Determining and Documenting
                                  Appropriate Supplier Verification Activities
----------------------------------------------------------------------------------------------------------------
                                       Proposed section
     Final section designation           designation               Description                  Revision
----------------------------------------------------------------------------------------------------------------
507.120(a)........................  507.37(a)(3)(i)......  The receiving facility      Explicit statement of
                                                            must approve suppliers      this requirement.
                                                            and document that
                                                            approval.

[[Page 56304]]

 
507.120(b)(1).....................  507.37(a)(3)(i)......  Written procedures for      Explicit requirement for
                                                            receiving raw materials     written procedures.
                                                            and other ingredients
                                                            must be established and
                                                            followed.
507.120(b)(2).....................  .....................  The purpose of the written  N/A.
                                                            procedures is to ensure
                                                            that raw materials and
                                                            other ingredients are
                                                            received only from
                                                            approved suppliers (or,
                                                            when necessary and
                                                            appropriate, on a
                                                            temporary basis from
                                                            unapproved suppliers
                                                            whose raw materials or
                                                            other ingredients the
                                                            receiving facility
                                                            subjects to adequate
                                                            verification activities
                                                            before acceptance for
                                                            use).
507.120(b)(3).....................  507.37(a)(3)(i)......  Use of the written          Conforming change
                                                            procedures for receiving    associated with the
                                                            raw materials and other     explicit requirement to
                                                            ingredients must be         establish and follow
                                                            documented.                 written procedures.
507.125...........................  507.37(b)............  Requirement to determine    N/A.
                                                            and document appropriate
                                                            supplier verification
                                                            activities.
----------------------------------------------------------------------------------------------------------------

A. Using Approved Suppliers (Final Sec. Sec.  507.120)

    We proposed to require that a supplier program include verification 
activities, as appropriate to the hazard, and documentation of these 
activities, to ensure raw materials and ingredients are received only 
from suppliers approved for control of the hazard(s) in that raw 
material or ingredient (or, when necessary and appropriate, on a 
temporary basis from unapproved suppliers whose raw materials or 
ingredients the receiving facility subjects to adequate verification 
activities before acceptance for use) (proposed Sec.  507.37(a)(i)).
    This proposed requirement included an implicit requirement that a 
facility must approve suppliers. For clarity, we make that requirement, 
and documentation of that approval, explicit in the final rule. (See 
Sec.  507.120(a)).
    The rule continues to require that a receiving facility ensure raw 
materials and other ingredients are received only from suppliers 
approved for control of the hazard(s) in that raw material or other 
ingredient (or, when necessary and appropriate, on a temporary basis 
from unapproved suppliers whose raw materials or other ingredients are 
subject to adequate verification activities before acceptance for use), 
but we revised the provision to specify that the receiving facility 
must do so by establishing and following written procedures, and 
require documentation that these procedures were followed. To simplify 
the provisions, we also established a definition for the term ``written 
procedures for receiving raw materials and other ingredients'' to mean 
written procedures to ensure that raw materials and other ingredients 
are received only from suppliers approved by the receiving facility 
(or, when necessary and appropriate, on a temporary basis from 
unapproved suppliers whose raw materials or other ingredients are 
subjected to adequate verification activities before acceptance for 
use), and use that term throughout subpart E. For example, a facility 
could design a checklist for employees to use when raw materials and 
other ingredients are delivered to the facility. We decided to specify 
use of written procedures for receiving raw materials and other 
ingredients in light of the flexibility the final rule provides for an 
entity other than the receiving facility (such as an entity in the 
supply chain between the supplier) to conduct this activity (see Sec.  
507.115(a)(2)). Although we agree that such an entity can do this as a 
service to the receiving facility, a written procedure is appropriate 
to ensure a robust and meaningful verification. As a companion change, 
we revised the associated documentation requirement to specify 
documentation of use of the written procedures.
    (Comment 453) Some comments support the requirement to approve 
suppliers. Other comments ask us to provide guidance for use of 
unapproved suppliers on a temporary basis, because the use of 
unapproved suppliers could be a high risk situation. Other comments 
emphasize that if the final supplier approval process is significantly 
changed compared to the proposed supplier approval process, industry 
must have enough time to plan and develop supplier verification plans 
and a process for unapproved sources.
    (Response 453) We will consider including guidance for use of 
unapproved suppliers on a temporary basis in guidance that we intend to 
issue regarding the supply-chain program. We do not believe that the 
final requirements regarding the use of approved suppliers will require 
increased implementation time. The principal change is to allow 
flexibility for entities in the supply chain other than the receiving 
facility to establish written procedures for receiving raw materials 
and other ingredients and document that written procedures for 
receiving raw materials and other ingredients are being followed.

B. Determining Appropriate Verification Activities (Final Sec.  
507.125)

    The rule requires that a supply-chain program include determining 
appropriate supplier verification activities (including determining the 
frequency of conducting the activity) (see Sec.  507.110(a)(2)). 
Comments that addressed the proposed provision for determining 
appropriate verification activities (which provides flexibility to the 
facility to determine the appropriate verification activities) did not 
disagree with it. The rule also requires that certain factors must be 
considered in determining appropriate verification activities (Sec.  
507.110(d)). We discuss those factors, and comments that addressed 
those factors, in section XLII.D. Both of these provisions (i.e., Sec.  
507.110(a)(2) and Sec.  507.110(d)) derive from the proposed 
requirement regarding factors that must be considered in determining 
appropriate supplier verification activities (proposed Sec.  
507.37(b)). To give prominence to both the responsibility and the 
flexibility to determine appropriate supplier verification activities, 
and emphasize the factors

[[Page 56305]]

that must be considered in addressing this responsibility, new Sec.  
507.125 specifies that appropriate supplier verification activities 
(including the frequency of conducting the activity) must be determined 
in accordance with the requirements of Sec.  507.110(d).

XLV. Subpart E: Comments on Conducting Supplier Verification Activities 
for Raw Materials and Other Ingredients

    We proposed requirements applicable to conducting supplier 
verification activities (proposed Sec.  507.37(c)). Most comments that 
support the proposed provisions suggest alternative or additional 
regulatory text or ask us to clarify how we will interpret the 
provision. In the following sections, we discuss comments that ask us 
to clarify the proposed requirements or that disagree with, or suggest 
one or more changes to, the proposed requirements. After considering 
these comments, we have revised the proposed requirements as shown in 
table 27.

    Table 27--Revisions to the Proposed Requirements for Conducting Supplier Verification Activities for Raw
                                         Materials and Other Ingredients
----------------------------------------------------------------------------------------------------------------
                                       Proposed section
     Final section designation           designation               Description                  Revision
----------------------------------------------------------------------------------------------------------------
507.130(a)........................  507.37(c)(1).........  Requirement to conduct one  Add reference to an
                                                            or more appropriate         additional provision
                                                            supplier verification       that provides for
                                                            activities.                 alternative supplier
                                                                                        verification activities
                                                                                        for shell egg producers
                                                                                        that have less than
                                                                                        3,000 laying hens.
507.130(b)(1).....................  507.37(c)(2)(i)......  Requirement to conduct an   N/A.
                                                            onsite audit as the
                                                            supplier verification
                                                            activity when the hazard
                                                            being controlled by the
                                                            supplier is one for which
                                                            there is a reasonable
                                                            probability that exposure
                                                            to the hazard will result
                                                            in serious adverse health
                                                            consequences or death to
                                                            humans or animals.
507.130(b)(2).....................  507.37(c)(2)(ii).....  Exception to the            N/A.
                                                            requirement to conduct an
                                                            annual onsite audit with
                                                            a written determination.
507.130(c)........................  507.37(c)(3).........  Alternative supplier         Modify the
                                                            verification activity       regulatory text to
                                                            when the supplier is a      better align with the
                                                            qualified facility.         responsibilities of a
                                                                                        qualified facility to
                                                                                        submit an attestation to
                                                                                        FDA about its food
                                                                                        safety practices or its
                                                                                        compliance with State,
                                                                                        local, county, tribal,
                                                                                        or other applicable non-
                                                                                        Federal food safety law,
                                                                                        including relevant laws
                                                                                        and regulations of
                                                                                        foreign countries.
                                                                                        Clarify that the
                                                                                        date for a receiving
                                                                                        facility to obtain
                                                                                        written assurance that a
                                                                                        supplier is a qualified
                                                                                        facility is before first
                                                                                        approving the supplier
                                                                                        for an applicable
                                                                                        calendar year, and on an
                                                                                        annual basis thereafter,
                                                                                        by December 31 of each
                                                                                        calendar year for the
                                                                                        following calendar year.
                                                                                        Provide for
                                                                                        written assurance that,
                                                                                        when applicable, the
                                                                                        supplier is producing
                                                                                        the raw material or
                                                                                        other ingredient in
                                                                                        compliance with relevant
                                                                                        laws and regulations of
                                                                                        a country whose food
                                                                                        safety system FDA has
                                                                                        officially recognized as
                                                                                        comparable or has
                                                                                        determined to be
                                                                                        equivalent to that of
                                                                                        the United States.
507.130(d)........................  507.37(c)(4).........  Alternative supplier         Clarify that the
                                                            verification activity       applicable farms are
                                                            when the supplier is a      ``not covered farms''
                                                            farm that is not a          rather than ``not
                                                            ``covered farm'' under      subject to part 112''
                                                            part 112 in accordance      because some of these
                                                            with Sec.   112.4(a) or     farms are subject to
                                                            in accordance with Sec.     modified requirements in
                                                            Sec.   112.4(b) and 112.5.  Sec.   112.6.
                                                                                        Clarify that the
                                                                                        date for a receiving
                                                                                        facility to obtain
                                                                                        written assurance from
                                                                                        the farm about its
                                                                                        status is before first
                                                                                        approving the supplier
                                                                                        for an applicable
                                                                                        calendar year, and on an
                                                                                        annual basis thereafter,
                                                                                        by December 31 of each
                                                                                        calendar year for the
                                                                                        following calendar year.

[[Page 56306]]

 
                                                                                        Clarify that the
                                                                                        written assurance from
                                                                                        the farm is an
                                                                                        acknowledgement that its
                                                                                        food is subject to
                                                                                        section 402 of the
                                                                                        Federal Food, Drug, and
                                                                                        Cosmetic Act (or, when
                                                                                        applicable, that its
                                                                                        food is subject to
                                                                                        relevant laws and
                                                                                        regulations of a country
                                                                                        whose food safety system
                                                                                        FDA has officially
                                                                                        recognized as comparable
                                                                                        or has determined to be
                                                                                        equivalent to that of
                                                                                        the United States).
507.130(e)........................  N/A..................  Alternative supplier        Specify an additional
                                                            verification activity       situation where the
                                                            when the supplier is a      receiving facility can
                                                            shell egg producer that     consider an alternative
                                                            has fewer than 3,000        supplier verification
                                                            laying hens.                activity.
----------------------------------------------------------------------------------------------------------------

A. Requirement To Conduct One or More Supplier Verification Activities 
(Final Sec.  507.130(a))

    With two exceptions, we proposed that the receiving facility must 
conduct and document one or more specified supplier verification 
activities for each supplier before using the raw material or 
ingredient and periodically thereafter (proposed Sec.  507.37(c)(1)). 
See section XLII.B for a discussion of comments regarding the 
appropriate verification activities (i.e., onsite audits, sampling and 
testing, records review, and other appropriate supplier verification 
activities based on supplier performance and the risk associated with 
the raw material or other ingredient). See sections XLV.C and XLV.D for 
a discussion of the proposed exceptions to this requirement to conduct 
and document verification activities. As discussed in section XLV.E, 
the final rule provides for an additional circumstance in which an 
alternative supplier verification activity may be conducted, i.e., when 
the supplier is a shell egg producer that has fewer than 3,000 laying 
hens.

B. Requirement for an Onsite Audit as a Verification Activity When a 
Hazard Has a Reasonable Probability of Resulting in Serious Adverse 
Health Consequences or Death to Humans or Animals (Final Sec.  
507.130(b))

    We proposed that when a hazard in a raw material or ingredient will 
be controlled by the supplier and is one for which there is a 
reasonable probability that exposure to the hazard will result in 
serious adverse health consequences or death to humans or animals, the 
receiving facility must have documentation of an onsite audit of the 
supplier before using the raw material or ingredient from the supplier 
and at least annually thereafter. We also proposed that this 
requirement does not apply if the receiving facility documents its 
determination that other verification activities and/or less frequent 
onsite auditing of the supplier provide adequate assurance that the 
hazards are controlled. (Proposed Sec.  507.37(c)(2)).
    (Comment 454) Some comments support the provision for audits when 
there is a reasonable probability that exposure to the hazard will 
result in serious adverse health consequences or death to humans or 
animals. Some of these comments state that audits should be the default 
verification activity in order to eliminate facilities choosing the 
lowest cost option regardless of whether it was best for food safety. 
Other comments state that audits would be the best option for 
facilities that cannot visit each supplier annually and that onsite 
inspection can identify problems in ways that paperwork reviews cannot.
    However, other comments oppose this requirement. Some of these 
comments state that facilities should have flexibility in choosing 
verification activities, regardless of whether or not the hazards could 
result in serious adverse health consequences or death to humans or 
animals and express concern that this requirement does not allow the 
necessary flexibility for a facility to tailor an effective supplier 
program based upon risk. Other comments express concern that the 
provision sets a precedent that annual audits are the preferred or most 
effective verification measure and that other verification activities 
often can help paint a more accurate picture of a supplier over time. 
Other comments express concern that audits only give a ``snapshot'' of 
a supplier's performance at a given time and ask that we not 
overemphasize audits.
    (Response 454) We are retaining this provision as proposed. As we 
indicated in the Appendix of our 2013 proposed preventive controls 
rule, an increasing number of establishments are requiring, as a 
condition of doing business, that their suppliers become certified to 
food safety management schemes that involve third-party audits (78 FR 
64736 at 64836 through 64837). We agree that onsite audits can identify 
problems in ways that paperwork reviews cannot. Because an audit 
involves more than simply observing the facility producing an animal 
food product, we believe it is more than just a ``snapshot'' of the 
supplier's programs. As discussed in Response 440, onsite audits can 
include observations, records review and employee interviews.
    The requirement to conduct an annual audit in specified 
circumstances is risk-based because the specified circumstances are 
limited to situations where there is a reasonable probability that 
exposure to the hazard in the raw material or other ingredient will 
result in serious adverse health consequences or death to humans or 
animals. The food safety controls applied by suppliers of such raw 
materials or other ingredients are more important than for other types 
of hazards because of the serious adverse health consequences that can 
occur if the hazards are not controlled. Annual audits are required of 
certification schemes that are benchmarked to the Global Food Safety 
Initiative Guidance Document for GFSI recognition (Ref. 58). We 
disagree that this requirement does not provide flexibility in choosing 
verification activities; in recognition that other verification 
activities can help paint a more accurate picture of a supplier over 
time, we have provided for alternative verification activities or audit 
frequencies if the receiving facility documents its determination that 
other verification activities and/or less frequent onsite auditing of 
the supplier provide adequate assurance that the hazards are controlled 
(see Sec.  507.130(b)(2)).

[[Page 56307]]

    (Comment 455) Some comments ask us to define those products that 
may trigger the requirement for an audit, especially with respect to 
farms. These comments question how to assess whether a hazard could 
result in serious adverse health consequences or death to humans or 
animals.
    (Response 455) We decline this request. Any list of such products 
would be extensive and it is unlikely we could capture all the 
circumstances in which this could apply. Hazards for which there is a 
reasonable probability that exposure to the hazard will result in 
serious adverse health consequences or death are those for which a 
recall of a violative product posing such a hazard is designated as 
``Class 1'' under 21 CFR 7.3(m)(1). Examples of such hazards that, in 
some circumstances, have resulted in serious adverse health 
consequences or death to humans or animals include pathogens or their 
toxins in animal food. Animal food containing a hazard for which there 
is a reasonable probability that exposure to the hazard will result in 
serious adverse health consequences or death to humans or animals are 
considered reportable foods; examples of foods FDA has considered to 
present a reasonable probability of serious adverse health consequences 
or death can be found in our Guidance for Industry: Questions and 
Answers Regarding the Reportable Food Registry as Established by the 
Food and Drug Administration Amendments Act of 2007 (Refs. 19 and 20).
    (Comment 456) Some comments ask us to clarify the role of third-
party audits and the Good Agricultural Practice (GAP) program and ask 
us to allow GAPs to be a voluntary mechanism to satisfy buyer demands 
for food safety certification.
    (Response 456) Although the rule would not require a receiving 
facility to hire a third party to conduct an audit, onsite audits can 
include third-party audits. There are likely to be benefits for 
suppliers having a third-party audit, because the same audit may be 
acceptable to multiple receiving facilities as an appropriate supplier 
verification activity. For farms, GAPs audits may be viewed as an 
appropriate supplier verification activity. GAPs audits and other 
third-party audits would need to comply with the requirements of this 
rule applicable to onsite audits (see Sec.  507.135).
    (Comment 457) Some comments assert that we should delete this 
provision entirely, stating that this requirement for an audit is 
``outside the scope of FSMA.''
    (Response 457) We disagree that a requirement for an audit is 
``outside the scope of FSMA.'' See the discussion in Response 440 
regarding the provision in section 419(c)(1)(E) of the FD&C Act that 
the regulation issuing standards for the safety of produce ``not 
require a business to hire a consultant or other third party to 
identify, implement, certify compliance with the procedures, processes 
and practices'' and the provision in section 418(n)(3)(D) of the FD&C 
Act that the preventive controls regulation ``not require a facility to 
hire a consultant or other third party to identify, implement, certify 
or audit preventive controls.'' As noted in that response, a facility 
is not required to hire a third party to conduct an audit.
    (Comment 458) Some comments support the flexibility to not conduct 
an annual onsite audit if the receiving facility documents its 
determination that other verification activities and/or less frequent 
onsite auditing of the supplier provide adequate assurance that the 
hazards are controlled. Other comments question how a facility would 
prove that alternative measures are equally effective as an annual 
audit, when it is not known how effective an annual audit is. Other 
comments assert that the provision is meaningless because a farm or 
facility would not take the legal risk of verifying it has received 
``adequate assurance,'' because this would be subject to an FDA 
inspector's interpretation.
    (Response 458) This provision requires a facility to use a 
verification activity that provides adequate assurance that a hazard is 
controlled, not to determine how effective an audit is and assess 
whether alternative measures are equally effective.
    As an example of using an alternative approach to an annual onsite 
audit, consider the situation in which a receiving facility is part of 
a large corporation, is making a pet food, and obtains meat and bone 
meal from a supplier that is a subsidiary of the corporation and is 
operating under the same food safety system as the receiving facility. 
The receiving facility could determine that the food safety 
requirements established by the parent company and applied at the 
subsidiary provide the needed assurance that Salmonella in meat and 
bone meal is adequately controlled. The facility could support its 
decision by documenting this determination, including the procedures in 
effect at the supplier and the activities used by the corporation to 
verify that the subsidiary operates in accordance with corporate food 
safety policies and practices to ensure that hazards are adequately 
controlled.
    We disagree that the provision is meaningless because a farm or 
facility would see a legal risk in using an alternative to annual 
onsite audits as a supplier verification activity. First, a farm would 
be a supplier and would not be the entity that would determine whether 
an onsite audit or some other supplier verification activity is 
appropriate. As established in Sec.  507.115, determining the 
appropriate supplier verification activity would be the responsibility 
of a receiving facility, and although appropriate supplier verification 
activities could be determined by another entity in the receiving 
facility's supply chain as a service, the supplier verification 
activities could not be determined by the supplier itself. Second, 
although there is always a potential for differences in interpretation 
between an FDA inspector and an inspected firm, we are establishing a 
new inspection paradigm focused on whether firms are implementing 
systems that effectively prevent food contamination, requiring 
fundamentally different approaches to food safety inspection and 
compliance. For example, FDA intends to deploy specialized 
investigators, backed up by technical experts, to assess the soundness 
and performance of a facility's food safety system (Ref. 10). In 
addition, a central element of FDA's strategy to gain industry 
compliance is to help make available to farmers, food processors, and 
importers, especially small businesses, the education and technical 
assistance they need to understand and implement FSMA's new prevention-
oriented standards (Ref. 5). The new inspection paradigm and the 
assistance and training for industry should help minimize different 
interpretations between industry and regulators.
    (Comment 459) Some comments ask us to require facilities to notify 
us when they determine that an alternative to an audit is an 
appropriate supplier verification activity and be able to justify and 
document how an alternative verification activity provides the same 
level of assurance as an onsite audit.
    (Response 459) We decline this request. We will assess a facility's 
supplier verification activities during a facility inspection, 
including the documentation that an alternative verification activity 
provides the same level of assurance as an onsite audit.
    (Comment 460) Some comments ask us to specify the type of 
documentation required for our investigators to determine when the 
activities are ``in

[[Page 56308]]

compliance with the law and sufficient to protect public health.''
    (Response 460) We decline this request. The facility's approach to 
the determination, and the applicable documentation required to support 
that determination, would depend on the circumstances. For example, in 
Response 458, we discuss a possible approach in a situation in which a 
receiving facility is part of a corporation and obtains an ingredient 
from a supplier that is a subsidiary of the corporation and is 
operating under the same food safety system as the receiving facility. 
Another situation could be when a receiving facility has many years of 
experience with the same supplier, but the approach and documentation 
in that situation likely would be different from an approach and 
documentation used when the supplier and the receiving facility are 
part of the same corporation.
    (Comment 461) Some comments ask that we not limit the determination 
for a supplier verification activity other than an onsite audit to a 
determination by the receiving facility. These comments explain that 
the corporate parent of a facility can be the entity that makes this 
determination. These comments suggest that we can account for the role 
of the corporation by specifying that a facility documents ``the 
determination'' (rather than ``its'' determination).
    (Response 461) We have agreed that the corporate parent of a 
facility can be active in developing and implementing the facility's 
food safety plan (see section XXIV.A). However, the specific suggestion 
of these comments is not necessary to achieve the outcome requested by 
the comments because of editorial changes we made to provide for 
entities other than the receiving facility to determine and conduct the 
appropriate supplier verification activities.

C. Alternative Verification Activity When the Supplier Is a Qualified 
Facility (Final Sec.  507.130(c))

    We proposed that if a supplier is a qualified facility the 
receiving facility need not comply with the specified verification 
requirements if the receiving facility: (1) Documents, at the end of 
each calendar year, that the supplier is a qualified facility and (2) 
obtains written assurance, at least every 2 years, that the supplier is 
producing the raw material or ingredient in compliance with applicable 
FDA food safety regulations and that the raw material or ingredient is 
not adulterated under section 402 of the FD&C Act. The written 
assurance must include a brief description of the processes and 
procedures that the supplier is following to ensure the safety of the 
animal food.
    This rule has several provisions that require written assurances. 
We have established specific elements that each of these written 
assurances must include, i.e., the effective date; printed names and 
signatures of authorized officials; and the applicable assurance (see 
Sec.  507.215).
    We have revised the provision to clarify that the receiving 
facility must have written assurance that a facility is a qualified 
facility: (1) Before first approving the supplier for an applicable 
calendar year and (2) by December 31 of each calendar year (rather than 
``at the end of the calendar year'') and that the written assurance is 
regarding the status of the qualified facility for the following 
calendar year. By specifying ``by December 31,'' a receiving facility 
can work with each applicable supplier to determine the specific date 
within a calendar year for that supplier to annually notify the 
receiving facility about its status. See also Responses 76, 139, 140, 
the requirements in Sec.  507.7(a) for an annual determination of the 
status of a facility as a qualified facility, and the requirements in 
Sec.  507.7(d) that apply when the status of a facility changes from 
``qualified facility'' to ``not a qualified facility.'' A receiving 
facility and its suppliers have flexibility to approach the potential 
for the status of a facility to shift between ``qualified facility'' 
and ``not a qualified facility'' (or vice versa) in a way that works 
best for their specific business relationship.
    As discussed in section XLII.D, we have revised the requirements 
for considering supplier performance to provide that the receiving 
facility may, when applicable, consider relevant laws and regulations 
of a country whose food safety system FDA has officially recognized as 
comparable or has determined to be equivalent to that of the United 
States, and information relevant to the supplier's compliance with 
those laws and regulations, rather than consider applicable FDA food 
safety regulations and information relevant to the supplier's 
compliance with applicable FDA food safety regulations. We have made a 
conforming change to the alternative verification activities for a 
qualified facility (see the regulatory text of Sec.  507.130(c)(2)).
    (Comment 462) Some comments support this alternative supplier 
verification activity because it provides flexibility. Other comments 
ask us to revise the provision so that it only requires that the 
supplier document its status as a qualified facility. Still other 
comments ask us to remove all provisions on qualified facilities 
because they view these provisions as effectively adding a second layer 
of regulations on produce farms, and claim this is not authorized by 
FSMA. Other comments ask us to delete the requirement that the written 
assurance include a brief description of the processes and procedures 
that the supplier is following to ensure the safety of the food.
    (Response 462) We have revised the provisions for an alternative 
verification activity for a qualified facility to better align with the 
responsibilities of a qualified facility to submit an attestation to 
FDA about its food safety practices (Sec.  507.7(a)(2)(i)) or its 
compliance with State, local, county, tribal, or other applicable non-
Federal food safety law, including relevant laws and regulations of 
foreign countries (Sec.  507.7(a)(2)(ii)) (see the regulatory text of 
Sec.  507.130(c)). Importantly, a qualified facility is still subject 
to CGMPs and the FD&C Act, and, if the qualified facility is a supplier 
controlling a hazard, it is reasonable for a receiving facility to 
expect the qualified facility to provide to the receiving facility, an 
assurance that reflects an attestation the facility has made to FDA. As 
modified, one possibility is for a qualified facility to provide a 
receiving facility with a brief description of the preventive controls 
it is implementing to control the applicable hazard, consistent with an 
attestation of its food safety practices in accordance with Sec.  
507.7(a)(2)(i). For example, the qualified facility could state that 
its manufacturing processes include a lethality step for microbial 
pathogens of concern. As required by Sec.  507.7(f), a qualified 
facility that submits an attestation to FDA about its animal food 
safety practices would have documentation of those practices to support 
its attestation to FDA and, thus, would have documentation to support 
its written assurance to the receiving facility. Although a qualified 
facility that submits an attestation to FDA about its food safety 
practices also would have documentation of monitoring the performance 
of the preventive controls to ensure that such controls are effective 
as required by Sec.  507.7(a)(2)(i), we are not requiring the qualified 
facility to describe its monitoring of the performance of preventive 
controls to ensure that they are effective. Alternatively, a qualified 
facility could provide a receiving facility with a statement that the 
facility is in compliance with State, local, county, tribal, or other 
applicable non-Federal

[[Page 56309]]

food safety law, including relevant laws and regulations of foreign 
countries.
    We disagree that the alternative verification activity for produce 
farms would add a second layer of regulations on produce farms and are 
retaining this provision.
    (Comment 463) Some comments ask us to remove the requirement that 
the written assurance be obtained at least every 2 years. Other 
comments ask us to revise the purpose of the written assurance from 
``the raw material or ingredient is not adulterated'' to ``the 
receiving facility's use of the raw material or ingredient will not 
cause the finished food to be adulterated.''
    (Response 463) We decline these requests. A supplier verification 
activity needs to consider supplier performance on an ongoing basis. 
Procedures and practices evolve over time, and it is appropriate for a 
receiving facility that is obtaining written assurance from a supplier 
as an alternative verification activity to be aware of both procedures 
and practices that have changed, as well as procedures and practices 
that have stayed the same. The specified timeframe for updating the 
written assurance, i.e., at least every two years, is reasonable.
    A supplier can only provide assurance about raw materials and other 
ingredients that it supplies to the receiving facility, not about the 
animal food product that the receiving facility will produce using the 
supplier's raw material or other ingredients.

D. Alternative Verification Activity When the Supplier Is a Produce 
Farm That Is Not a ``Covered Farm'' for the Purposes of the Future 
Produce Safety Rule (Final Sec.  507.130(d))

    We proposed that if a supplier is a farm that is not subject to the 
requirements that we have proposed to be established in the produce 
safety rule in accordance with proposed Sec.  112.4 regarding the raw 
material or ingredient that the receiving facility receives from the 
farm, the receiving facility does not need to comply with the 
verification requirements if the receiving facility: (1) Documents, at 
the end of each calendar year, that the raw material or ingredient 
provided by the supplier is not subject to the produce safety rule and 
(2) obtains written assurance, at least every 2 years, that the 
supplier is producing the raw material or ingredient in compliance with 
applicable FDA food safety regulations and that the raw material or 
ingredient is not adulterated under section 402 of the FD&C Act. See 
also Sec.  507.215, which establishes specific elements that this 
written assurance must include, i.e., the effective date; printed names 
and signatures of authorized officials; and the applicable assurance.
    Produce farms that are not ``covered farms'' under Sec.  112.4 of 
the forthcoming produce safety rule have less than $25,000 in annual 
sales averaged over the previous 3-year period, or satisfy the 
requirements for a qualified exemption in Sec.  112.5 and associated 
modified requirements in Sec.  112.6 based on average monetary value of 
all food sold (less than $500,000) and direct farm marketing (during 
the previous 3-year period, the average annual monetary value of food 
sold directly to qualified end users exceeded the average annual 
monetary value of the food sold to all other buyers). In the 2014 
supplemental notice, we erroneously referred to these farms as farms 
``not subject to the requirements established in part 112.'' While 
produce farms that make less than $25,000 are not subject to the 
requirements in part 112, produce farms that satisfy the requirements 
for a qualified exemption are not subject to the full requirements of 
part 112, but they do have certain modified requirements that they must 
meet, as described in Sec.  112.6. We have corrected the description of 
these farms in Sec.  507.130(d).
    We have revised the provision to clarify that the receiving 
facility must have documentation that the raw material or other 
ingredient provided by the supplier is not subject to part 112 in 
accordance with Sec.  112.4(a), or in accordance with Sec. Sec.  
112.4(b) and 112.5: (1) Before first approving the supplier for an 
applicable calendar year and (2) by December 31 of each calendar year 
(rather than ``at the end of the calendar year'') and that the 
documentation is regarding the status of supplier for the following 
calendar year. By specifying ``by December 31,'' a receiving facility 
can work with each applicable supplier to determine the specific date 
within a calendar year for that supplier to annually notify the 
receiving facility about its status. See also the discussion in section 
XLV.C regarding a similar revision we made when the supplier is a 
qualified facility.
    (Comment 464) Some comments support the proposed alternative 
supplier verification activity. Other comments support applying the 
proposed alternative supplier verification activity more broadly, i.e., 
to any farm that will not be subject to part 112 (e.g., a farm that 
grows wheat), stating that both small and large non-produce farms 
should have the same option as farms that are exempted under Sec.  
112.4. Some comments ask us to revise the alternative verification 
requirements to apply to raw materials from farms that do not grow and 
harvest ``produce'' as we proposed to define it in Sec.  112.3(c) so 
that the alternative verification requirements would apply to grain. 
Some comments assert that it is not possible to receive ``written 
assurances'' of compliance from growers of grain because there is no 
safety standard for grain growers, and that any such documents would be 
essentially meaningless.
    Some comments ask us to revise the requirement to obtain written 
assurance so that it does not apply to ``food not subject to the 
requirements of part 112 of this chapter pursuant to part 112.2.'' 
Other comments assert that a documentation requirement for commodities 
that will be exempt from the produce safety rule would increase 
recordkeeping burdens without added benefit because produce that will 
be exempt from the produce safety rule is low risk.
    Some comments assert that farms should not have to provide written 
assurances because the requirement is ambiguous. These comments assert 
that exempt farmers are small-scale producers who are subject primarily 
to state and local laws and this provision would require them to 
provide written assurances that they are complying with unspecified 
Federal regulations. The comments claim that, without seeking legal 
counsel, many exempt farmers would be unable to provide such 
assurances, limiting the ability of these farmers to market their 
products to non-exempt facilities (the overwhelming majority of the 
food market).
    (Response 464) We have revised the to specify that the written 
assurance from the farm must state that the farm acknowledges that its 
food is subject to section 402 of the FD&C Act (or, when applicable, 
that its food is subject to relevant laws and regulations of a country 
whose food safety system FDA has officially recognized as comparable or 
has determined to be equivalent to that of the United States). Any 
business that introduces food into interstate commerce is subject the 
prohibited acts provisions in section 301 of the FD&C Act, and is 
accountable if it produces food that is adulterated.
    As discussed in Response 284, new Sec.  507.36(a) allows a 
manufacturer/processor to not implement a preventive control if it 
determines and documents that the type of animal food (e.g., soybeans) 
could not be consumed without application of the appropriate control. 
We believe most receiving facilities will take advantage of this 
provision, and not establish supply-chain controls under the supply-
chain

[[Page 56310]]

program in subpart E for some specific RACs.
    This alternative supplier verification activity is intended to 
minimize the burden on suppliers that are small farms. The amount of 
food produced by such farms is small, and the exposure to food from 
such farms therefore is low. We disagree that a written assurance from 
such a farm would be meaningless. Any business that distributes food in 
interstate commerce is subject to the FD&C Act, and must produce food 
that is in compliance with the FD&C Act, regardless of whether FDA has 
established a specific regulation governing the production of the food.
    (Comment 465) Some comments ask us to delete this alternative 
supplier verification activity because they see it as a contradiction 
to the traceability provisions of the Bioterrorism Act and FSMA, 
because ``trace back'' is only required for ``one step back'' or for a 
single supplier for a particular shipment of food.
    (Response 465) The supply-chain program that is being established 
in this rule is a preventive control for the ongoing production of safe 
animal food, not a ``trace back'' provision, established under the 
Bioterrorism Act, to help address credible threats relating to food 
that is reasonably believed to be adulterated and to present a threat 
of serious adverse health consequences or death to humans or animals.
    (Comment 466) Some comments ask us to specify 3 options for 
verification if a supplier is a farm subject to the requirements of 
part 112: (1) Documentation at the end of each calendar year that the 
raw material or ingredient provided by the supplier is subject to part 
112; (2) written assurance, at least every 2 years, that the supplier 
is producing the raw material or ingredient in compliance with 
applicable FDA food safety regulations and that the raw material or 
ingredient is not adulterated under the FD&C Act; or (3) evidence that 
the supplier is certified to a recognized third-party GAP/GHP/GMP/HACCP 
audit scheme. (We note that we are assuming that ``GHP'' is an 
abbreviation for ``Good Hygienic Practice.'')
    (Response 466) We decline this request. Documenting that a raw 
material or other ingredient is subject to the produce safety rule has 
no bearing on whether the farm is complying with that rule to control 
the hazards. With respect to all farms subject to the requirements of 
part 112 providing a written assurance, as discussed in Response 464, 
the amount of food produced by the small farms that could provide 
written assurance to a receiving facility is small, and the exposure to 
food from such farms therefore is low. We disagree that it is 
appropriate to extend this alternative supplier verification activity 
to larger farms because such farms provide a larger volume of produce.
    A farm that has been subject to an audit that complies with the 
requirements of this rule can provide the results of the audit; a mere 
statement that the farm has been certified based on an audit is 
insufficient.

E. Alternative Verification Activity When the Supplier Is a Shell Egg 
Producer That Has Less Than 3,000 Laying Hens (Final Sec.  507.130(e))

    We are establishing an additional alternative supplier verification 
activity when a supplier is a shell egg producer that is not subject to 
the requirements of 21 CFR part 118 because it has less than 3,000 
laying hens. See the regulatory text of Sec.  507.130(e). The provision 
is analogous to the alternative supplier verification activity when a 
supplier is a farm that meets the criteria in Sec.  507.130(d) and 
would account for a very small amount of eggs in the food supply. See 
also Sec.  507.215, which establishes specific elements that the 
required written assurance must include, i.e., the effective date; 
printed names and signatures of authorized officials; and the 
applicable assurance.

F. Independence of Persons Who Conduct Supplier Verification Activities 
(Final Sec.  507.130(f))

    In the 2014 supplemental notice, we requested comment on whether we 
should include in the final preventive controls rule requirements to 
address conflicts of interest for individuals conducting verification 
activities and, if so, the scope of such requirements.
    (Comment 467) Some comments request that requirements to address 
conflicts of interest should not be implemented or ask that conflict of 
interest provisions not be written too broadly, and be limited to 
circumstances where the individual employee carrying out the 
verification activities has a direct personal financial interest in or 
financial ties to the supplier (e.g., owns a substantial amount of 
stock in the supplier or is personally paid directly by the supplier). 
Comments state that it would not be uncommon for a receiving facility 
to have a shared financial interest in the supplier (e.g., partial 
ownership of one by the other or both being owned by the same parent 
company). Thus, employees that have an indirect financial interest 
(e.g., owning stock in a supplier because they own stock in their own 
company, which in turn owns an interest in the supplier) should not be 
disqualified from performing verification activities. Comments also 
indicate that a laboratory analyst performing ingredient testing should 
not be precluded from testing ingredients from a supplier in which the 
analyst has a potential conflict of interest, as long as the analyst is 
not aware of the identity of the supplier at the time the test is 
performed.
    (Response 467) We are establishing a requirement that there must 
not be any financial conflicts of interests that influence the results 
of the verification activities listed in Sec.  507.110(b) and payment 
must not be related to the results of the activity. This does not 
prohibit employees of a supplier from performing the functions 
specified in Sec.  507.115 in accordance with Sec.  507.115. For 
example, this provision would not prohibit an employee of a supplier 
from conducting sampling and testing so that the supplier could provide 
the results in documentation provided to the receiving facility. The 
provisions would not prevent a person who is employed by a receiving 
facility from having an indirect financial interest in a supplier 
(e.g., if a company in which the employee owns stock owns an interest 
in the supplier).
    (Comment 468) Comments ask that we not preclude a supplier from 
hiring an outside party to perform onsite audits, food certifications, 
or sampling and testing.
    (Response 468) We have specified that the requirements do not 
prohibit a receiving facility from relying on an audit provided by its 
supplier when the audit of the supplier was conducted by a third-party 
qualified auditor (see Sec.  507.115(c)). We also have specified that a 
supplier may conduct and document sampling and testing of raw materials 
and other ingredients, for the hazard controlled by the supplier, as a 
supplier verification activity for a particular lot of product and 
provide the documentation to the receiving facility (see Sec.  
507.115(a)(4)). This acknowledges that it is common for suppliers to 
include Certificates of Analysis for tests conducted on specific lots 
of product along with the shipment to the receiving facility.

XLVI. Subpart E: Comments on Onsite Audit

    We proposed requirements that would apply to an onsite audit. Most 
comments that support the proposed provisions suggest alternative or 
additional regulatory text or ask us to clarify how we will interpret 
the provision. In the following sections, we

[[Page 56311]]

discuss comments that ask us to clarify the proposed requirements or 
that disagree with, or suggest one or more changes to, the proposed 
requirements. After considering these comments, we have revised the 
proposed requirements as shown in table 28.

                       Table 28--Revisions to the Proposed Requirements for Onsite Audits
----------------------------------------------------------------------------------------------------------------
   Final section designation         Proposed section designation         Description            Revision
----------------------------------------------------------------------------------------------------------------
507.135(a).....................  507.37(d)(1)........................  An onsite audit    N/A.
                                                                        of a supplier
                                                                        must be
                                                                        performed by a
                                                                        qualified
                                                                        auditor.
507.135(b).....................  507.37(d)(2)........................  An onsite audit    Clarify that, when
                                                                        must consider      applicable, an onsite
                                                                        applicable FDA     audit may consider
                                                                        regulations.       relevant laws and
                                                                                           regulations of a
                                                                                           country whose food
                                                                                           safety system FDA has
                                                                                           officially recognized
                                                                                           as comparable or has
                                                                                           determined to be
                                                                                           equivalent to that of
                                                                                           the United States.
507.135(c)(1)(i)...............  507.37(e)(1)........................  Substitution of    Broaden the list of
                                                                        inspection for     applicable
                                                                        domestic           inspections to
                                                                        suppliers.         include inspections
                                                                                           by representatives of
                                                                                           other Federal
                                                                                           Agencies (such as the
                                                                                           United States
                                                                                           Department of
                                                                                           Agriculture), or by
                                                                                           representatives of
                                                                                           State, local, tribal,
                                                                                           or territorial
                                                                                           agencies.
507.135(c)(1)(ii) and            507.37(e)(2)........................  Substitution of    N/A.
 507.135(c)(2).                                                         inspection for
                                                                        foreign
                                                                        suppliers.
507.135(d).....................  N/A.................................  Use of a third-    If the onsite audit is
                                                                        party auditor      solely conducted to
                                                                        that has been      meet the requirements
                                                                        accredited in      of the animal food
                                                                        accordance with    preventive controls
                                                                        regulations that   rule by an audit
                                                                        will be            agent of a
                                                                        established in     certification body
                                                                        the forthcoming    that is accredited in
                                                                        third-party        accordance with
                                                                        certification      regulations that will
                                                                        rule.              be established in
                                                                                           part 1, subpart M,
                                                                                           the audit is not
                                                                                           subject to the
                                                                                           requirements in those
                                                                                           regulations.
----------------------------------------------------------------------------------------------------------------

A. Requirements Applicable to an Onsite Audit (Final Sec.  507.135(a) 
and (b))

    We proposed that an onsite audit of a supplier must be performed by 
a qualified auditor. If the raw material or ingredient at the supplier 
is subject to one or more FDA food safety regulations, an onsite audit 
would need to consider such regulations and include a review of the 
supplier's written plan (e.g., HACCP plan or other food safety plan), 
if any, including its implementation, for the hazard being audited 
(proposed Sec.  507.37(d)). We have revised ``including its 
implementation'' to ``and its implementation'' to emphasize that 
implementation of the plan is distinct from the plan itself (e.g., 
Sec.  507.31(c) establishes the recordkeeping requirement for the food 
safety ``plan,'' and Sec.  507.55 lists implementation records.)
    As discussed in section XLII.D, we have revised the requirements 
for considering supplier performance to provide that the receiving 
facility may, when applicable, consider relevant laws and regulations 
of a country whose food safety system FDA has officially recognized as 
comparable or has determined to be equivalent to that of the United 
States, and information relevant to the supplier's compliance with 
those laws and regulations, rather than consider applicable FDA food 
safety regulations and information relevant to the supplier's 
compliance with applicable FDA food safety regulations. We have made a 
conforming change to the requirements for an onsite audit to clarify 
that an onsite audit may consider relevant laws and regulations of a 
country whose food safety system FDA has officially recognized as 
comparable or has determined to be equivalent to that of the United 
States. However, as of August 30, 2015, FDA has not developed a systems 
recognition program for animal food; therefore, we have no signed 
systems recognition agreements with any foreign food safety authority 
relating to animal food. The currently existing systems recognition 
agreement relates solely to human food and does not apply to animal 
food.
    (Comment 469) Comments support a requirement that an onsite audit 
be performed by a qualified auditor, provided that we finalize 
provisions (in proposed Sec.  507.37(e)) whereby an inspection by 
certain authorities could substitute for an audit. Some comments ask us 
to specify that the rule permits the use of audits conducted by private 
third-party food safety auditing firms. Other comments ask us to 
provide a list of recognized private third-party food safety schemes 
and consider making third-party food safety certification to a 
recognized audit scheme mandatory for all food operations that grow, 
pack, hold and manufacture/process food for wholesale markets. Other 
comments ask us to further specify that FDA will audit all food 
facilities no less than once every 5 years to verify that private 
third-party audits are consistent with FDA audits and findings.
    (Response 469) See our discussion in section XLVI.B of the final 
provisions governing substitution of inspection for an audit. We agree 
that onsite audits may be conducted by third parties, but disagree that 
it is necessary to specify this in the rule. Nothing in this rule 
prevents a facility from hiring a third party to conduct audits.
    We decline the requests to provide a list of recognized private 
third-party food safety schemes or to make third-party food safety 
certification to a recognized audit scheme mandatory for all food 
operations that grow, pack, hold and manufacture/process animal food 
for wholesale markets. The rule provides flexibility regarding use of 
third-party auditors and the information is easily obtained from other 
sources.

[[Page 56312]]

Private third-party food safety audit schemes are a function of the 
private sector, not a function of the Federal government. Likewise, we 
decline the request to specify that FDA will ``audit'' all food 
facilities no less than once every 5 years to verify that private 
third-party audits are consistent with FDA audits and findings. We will 
inspect food facilities for compliance with this rule, not to verify 
the findings of a third-party audit, with a frequency consistent with 
our responsibilities under the FD&C Act.
    (Comment 470) Some comments express concern about the multiple 
audits that facilities are subject to each year and ask us to encourage 
those subject to the rule to accept an audit performed by any of the 
``bona fide authorities'' where it is warranted. Other comments note 
that food manufacturers conduct their own audits and have developed 
extensive expertise in doing so, and oppose any supplier verification 
requirement that would affect those audits. Other comments ask us to 
allow audits to industry standards (such as GFSI or ISO) to satisfy 
supplier verification requirements to avoid adding a new audit to 
audits currently being conducted. Some comments assert that audits to 
industry standards (such as GFSI or ISO) and other similarly accredited 
audits should be considered equivalent to onsite audits. Some comments 
express concern that requiring a new audit in addition to audits 
already being conducted could lead to auditor shortages and unnecessary 
additional costs.
    (Response 470) We expect that a facility will adopt an approach to 
audits that works best for the facility and minimizes the number of 
audits conducted for the same facility. An employee of a receiving 
facility may perform an audit, provided that the employee satisfies the 
criteria established in the rule for qualified auditors. Under Sec.  
507.3 and Sec.  507.53, a qualified auditor is a qualified individual 
(as defined in Sec.  507.3) and has technical expertise obtained 
through education, training, or experience (or a combination thereof) 
necessary to perform the auditing function. For additional information, 
see Response 700 in the final rule for preventive controls for human 
food published elsewhere in this issue of the Federal Register, in 
which we discuss auditor qualifications with respect to the GFSI's 
auditor competency model.
    (Comment 471) Some comments ask us to delete the proposed 
requirement for a review of the supplier's written plan as part of an 
audit because review of the supplier's food safety plan should be part 
of an overall supplier verification program when the supplier is 
controlling a hazard that could cause serious adverse health 
consequences or death, but should not be tied to an audit. These 
comments state that receiving facilities may choose to use an 
unannounced audit program where the auditor spends time focusing on the 
actual conditions on the production floor, with a review of the 
supplier's food safety plan being done as a separate verification 
activity.
    (Response 471) We decline this request. We agree that review of an 
applicable food safety plan should be part of an overall supplier 
verification program and that the review of the food safety plan may be 
conducted separately from the observation of actual conditions on the 
production floor, provided that both are conducted within the annual 
timeframe. However, we believe it important that the audit address 
whether the food safety plan is being implemented as designed and other 
comments to this rule support that view. For example, as discussed in 
Comment 493 regarding our inspection of a food facility, some comments 
assert that our access to company records must be conducted onsite in 
the course of an authorized inspection so that we may understand the 
full context of what the records show. Thus, the onsite observations 
and the food safety plan review cannot be entirely separated, as the 
comment seems to suggest.
    We note that the requirement to include a review of the supplier's 
food safety plan only applies when the supplier has a food safety plan. 
For example, we did not propose a requirement for a farm that would be 
subject to the forthcoming produce safety rule to have a food safety 
plan.

B. Substitution of Inspection by FDA or an Officially Recognized or 
Equivalent Food Safety Authority

    We proposed that instead of an onsite audit, a receiving facility 
may rely on the results of an inspection of the supplier by FDA or, for 
a foreign supplier, by FDA or the food safety authority of a country 
whose food safety system FDA has officially recognized as comparable or 
has determined to be equivalent to that of the United States, provided 
that the inspection was conducted within 1 year of the date that the 
onsite audit would have been required to be conducted. For inspections 
conducted by the food safety authority of a country whose food safety 
system FDA has officially recognized as comparable or determined to be 
equivalent to that of the United States, the food that is the subject 
of the onsite audit would need to be within the scope of the official 
recognition or equivalence determination, and the foreign supplier 
would need to be in, and under the regulatory oversight of, such 
country (proposed Sec.  507.37(e)).
    As of August 30 2015, FDA has not developed a systems recognition 
program for animal food; therefore, we have no signed systems 
recognition agreements with any foreign food safety authority for 
animal food. A signed systems recognition agreement for human food does 
not apply to animal food.
    (Comment 472) Some comments ask us to allow State or local 
inspection reports, as well as FDA inspection reports, to substitute 
for an onsite audit for small and very small facilities. Other comments 
ask us to create a ``safe harbor'' provision in which a supplier 
providing a copy of permits obtained from the most recent inspection 
done by Federal, State, or local health authorities satisfies the 
supplier verification requirement; if there are no permits, review of 
relevant records and/or sampling of raw material based on scale of 
production should be adequate.
    (Response 472) We have revised the regulatory text to provide for 
an appropriate inspection of the supplier for compliance with 
applicable FDA food safety regulations by FDA, by representatives of 
other Federal Agencies (such as USDA), or by representatives of State, 
local, tribal, or territorial agencies. We are specifying that the 
inspection must be ``appropriate'' and be conducted for compliance 
``with applicable FDA food safety regulations'' to make clear that the 
inspection must be sufficiently relevant to an onsite audit to credibly 
substitute for an onsite audit. For example, inspection by USDA to 
determine whether a farm satisfies the requirements of the produce 
safety rule could constitute an appropriate inspection that could 
substitute for an audit, but an inspection by USDA to determine whether 
a farm satisfies the requirements of the National Organic Program could 
not.
    We have not provided for substitution of a ``permit obtained from 
the most recent inspection'' for an onsite audit. We do not see how a 
``permit'' could shed light on whether a business is complying with 
specific applicable FDA regulations. We have provided for an 
alternative verification activity to the annual onsite audit (such as a 
review of relevant records and/or sampling of raw material) with a 
written justification (see Sec.  507.130(b)). The rule would not 
preclude an appropriate review of records, or sampling and testing of 
raw

[[Page 56313]]

materials, by other Federal Agencies, or by representatives of State, 
local, tribal, or territorial agencies, provided that the receiving 
facility satisfies the requirements for an adequate written 
justification.
    (Comment 473) Some comments ask us to clarify what we mean by 
``food safety authority of a country whose food safety system FDA has 
officially recognized as comparable or has determined to be equivalent 
to that of the United States.'' These comments also ask whether a 
specific country qualifies and whether HACCP certificates issued by a 
specific foreign government agency would replace an onsite audit.
    (Response 473) A country whose food safety system FDA has 
officially recognized as ``comparable'' to that of the United States 
would be one for which there is a signed systems recognition 
arrangement or other agreement between FDA and the country establishing 
official recognition of the foreign food safety system. Information on 
FDA systems recognition can be found on the FDA Web site (Ref. 59). As 
of August 30 2015, FDA has not developed a systems recognition program 
for animal food; therefore, we have no signed systems recognition 
agreements with any foreign food safety authority relating to animal 
food. The currently existing systems recognition agreement relates 
solely to human food and does not apply to animal food. We would not 
accept a HACCP certificate issued by a foreign government as a 
substitute for an onsite audit, but a receiving facility could consider 
whether such a certificate could be part of its justification for 
conducting another supplier verification activity in lieu of an annual 
onsite audit, or for conducting an audit on a less frequent basis than 
annually.
    (Comment 474) Some comments ask us to clarify that the applicable 
standards will be those applied by the food safety authority of a 
country with a food safety system recognized as comparable or 
equivalent rather than having to achieve compliance with the applicable 
U.S. FDA food safety regulations.
    (Response 474) The applicable standards will be those applied by 
the food safety authority of a country with a food safety system 
recognized as comparable or equivalent to that of the United States. As 
of August 30, 2015, FDA has not developed a systems recognition program 
for animal food; therefore, we have no signed systems recognition 
agreements with any foreign food safety authority relating to animal 
food. The currently existing systems recognition agreement relates 
solely to human food and does not apply to animal food.

C. Onsite Audit by a Third-Party Auditor Accredited for the Purposes of 
Section 808 of the FD&C Act

    We have proposed to establish regulations (in part 1, subpart M) to 
provide for accreditation of third-party auditors/certification bodies 
to conduct food safety audits of foreign food entities, including 
registered foreign food facilities, and to issue food and facility 
certifications (78 FR 45782, July 29, 2013). The purpose of the 
proposed third-party certification rule is to help us ensure the 
competence and independence of third-party auditors/certification 
bodies who conduct foreign food safety audits and to help ensure the 
reliability of food and facility certifications issued by third-party 
auditors/certification bodies that we will use in making certain 
decisions relating to imported animal food, such as animal food 
certifications required by FDA as a condition of granting admission to 
an animal food determined to pose a safety risk.
    (Comment 475) Comments support use of third-party auditors, but 
emphasize that such auditors need not be accredited under the 
requirements to be established under our forthcoming third-party 
certification rule.
    (Response 475) We agree that a third-party auditor who conducts an 
audit as a supplier verification activity to satisfy the requirements 
of this rule need not be accredited under our forthcoming third-party 
certification rule. In addition, we see no reason that any requirements 
of our forthcoming third-party certification rule should apply to an 
audit merely because it was conducted by a person who had been 
accredited under that rule. To make this clear, we have added a 
provision to specify that if an onsite audit is solely conducted to 
meet the requirements of this rule by an audit agent of a certification 
body that is accredited in accordance with regulations in part 1, 
subpart M, the audit is not subject to the requirements in those 
regulations. See Sec.  507.135(d). Because Sec.  507.135(d) refers to 
provisions in a future third-party certification rule, we will publish 
a document in the Federal Register announcing the effective date of 
Sec.  507.135(d) when we finalize the third-party certification rule.

XLVII. Subpart E: Comments on Records Documenting the Supply-Chain 
Program (Final Sec.  507.175)

    We proposed to require documentation of verification activities in 
records, including minimum requirements for records documenting an 
audit, records of sampling and testing, and records documenting a 
review by the receiving facility of the supplier's relevant food safety 
records. We also proposed that the receiving facility must review such 
records in accordance with the requirements applicable to review of 
records as a verification activity (i.e., in accordance with Sec.  
507.49(a)(4)).
    We did not receive comments on the documentation requirements 
associated with a written supplier program, determination of 
appropriate supplier verification activities, review of records, 
supplier verification activities other than an annual onsite audit when 
the hazard being controlled by the supplier is one for which there is a 
reasonable probability that exposure to the hazard will result in 
serious adverse health consequences or death to humans or animals, 
alternative supplier verification activity when the supplier is a 
qualified facility, substitution of inspection for an audit, or 
supplier nonconformance (proposed Sec.  507.37(g)(1), (2), (7), (9), 
(10), (12), and (13), respectively). We are finalizing these 
documentation requirements with editorial and conforming changes 
associated with the final requirements of the supply-chain program.
    The supply-chain program includes two provisions that are explicit 
requirements of the final animal food preventive controls rule, but had 
been implicit requirements of the 2014 supplemental notice. The first 
of these provisions is the explicit requirement that the receiving 
facility must approve suppliers in accordance with the requirements of 
Sec.  507.110(d), and document that approval, before receiving raw 
materials and other ingredients from those suppliers (see Sec.  
507.120(a)). The second of these requirements is that written 
procedures for receiving raw materials and other ingredients must be 
established and followed (see Sec.  507.120(b)(1)). We are including in 
Sec.  507.175 the documentation associated with these requirements (see 
Sec.  507.175(c)(3) and (4)).
    The supply-chain program includes four provisions that were not in 
the 2014 supplemental notice: (1) A receiving facility that is an 
importer can comply with the foreign supplier verification requirements 
in the FSVP rule rather than conduct supplier verification activities 
for that raw material or other ingredient under this rule (Sec.  
507.105(a)(2)); (2) a receiving facility may use an alternative 
verification activity for a supplier that is

[[Page 56314]]

a shell egg producer that is not subject to the requirements 
established in part 118 because it has less than 3,000 laying hens 
(Sec.  507.130(e)); (3) when applicable, a receiving facility must 
verify a supply-chain-applied control applied by an entity other than 
the receiving facility's supplier (Sec.  507.105(c)); and (4) entities 
other than the receiving facility may determine, conduct, and document 
certain specified supplier verification activities, provided that the 
receiving facility reviews and assesses the other entity's applicable 
documentation, and documents its review and assessment (Sec.  507.115). 
We are establishing the associated documentation requirements in Sec.  
507.175(c)(2), (14), (17), and (18), respectively.
    In the following sections, we discuss comments on the proposed 
records for the supplier program. After considering these comments, we 
have revised the proposed requirements as shown in table 29.

            Table 29--Revisions to the Proposed Requirements for Records for the Supply-Chain Program
----------------------------------------------------------------------------------------------------------------
                                                                                                  Did we revise
                                                                                                       the
                                                                                                  documentation
                                                                                                   requirement
                                                                                                   other than
                                                                             Did we receive       editorial and
      Final section             Proposed section         Description      comments  regarding      conforming
       designation                designation                                 the proposed           changes
                                                                              requirement?       associated with
                                                                                                    the final
                                                                                                requirements for
                                                                                                  the  supply-
                                                                                                 chain program?
----------------------------------------------------------------------------------------------------------------
507.175(a)...............  N/A......................  The records        N/A..................  Consequential
                                                       documenting the                           change
                                                       supply-chain                              associated with
                                                       program are                               establishing
                                                       subject to the                            the
                                                       requirements of                           requirements
                                                       subpart F.                                for a supplier
                                                                                                 in subpart E
                                                                                                 rather than
                                                                                                 subpart C.
507.175(b)...............  507.37(g)................  The receiving      Yes..................  No.
                                                       facility must
                                                       review the
                                                       records in
                                                       accordance with
                                                       Sec.
                                                       507.49(a)(4).
507.175(c)(1)............  507.37(g)(1).............  The written        No...................  N/A.
                                                       supply-chain
                                                       program.
507.36(b)(2).............  507.37(g)(3).............  Annual written     Yes..................  Shifted to be in
                                                       assurance from a                          provisions
                                                       receiving                                 outside the
                                                       facility's                                framework of
                                                       customer.                                 the supply-
                                                                                                 chain program
                                                                                                 in subpart E.
507.175(c)(2)............  N/A......................  Documentation      N/A..................  N/A.
                                                       obtained from an
                                                       importer.
507.175(c)(3)............  507.37(g)(1).............  Documentation of   No...................  No.
                                                       the approval of
                                                       a supplier.
507.175(c)(4)............  507.37(g)(1).............  Written            No...................  No.
                                                       procedures for
                                                       receiving raw
                                                       materials and
                                                       other
                                                       ingredients.
507.175(c)(5)............  507.37(g)(4).............  Documentation      Yes..................  Yes.
                                                       demonstrating
                                                       use of the
                                                       written
                                                       procedures for
                                                       receiving raw
                                                       materials and
                                                       other
                                                       ingredients.
507.175(c)(6)............  507.37(g)(2).............  Documentation of   No...................  No.
                                                       the
                                                       determination of
                                                       the appropriate
                                                       supplier
                                                       verification
                                                       activities for
                                                       raw materials
                                                       and other
                                                       ingredients.
507.175(c)(7)............  507.37(g)(5).............  Documentation of   Yes..................  Added a
                                                       the conduct of                            requirement for
                                                       an onsite audit.                          the
                                                                                                 documentation
                                                                                                 to include the
                                                                                                 name of the
                                                                                                 supplier
                                                                                                 subject to the
                                                                                                 onsite audit.
507.175(c)(8)............  507.37(g)(6).............  Documentation of   Yes..................  Specify that the
                                                       sampling and                              documentation
                                                       testing                                   include the
                                                       conducted as a                            date(s) on
                                                       supplier                                  which the
                                                       verification                              test(s) were
                                                       activity.                                 conducted and
                                                                                                 the date of the
                                                                                                 report.
507.175(c)(9)............  507.37(g)(7).............  Documentation of   No...................  Specify that the
                                                       the review of                             documentation
                                                       the supplier's                            must include
                                                       relevant food                             the general
                                                       safety records.                           nature of the
                                                                                                 records
                                                                                                 reviewed and
                                                                                                 conclusions of
                                                                                                 the review.
507.175(c)(10)...........  507.37(g)(8).............  Documentation of   Yes..................  Specify that the
                                                       other                                     other
                                                       appropriate                               appropriate
                                                       supplier                                  supplier
                                                       verification                              verification
                                                       activities.                               activities are
                                                                                                 based on
                                                                                                 supplier
                                                                                                 performance and
                                                                                                 the risk
                                                                                                 associated with
                                                                                                 the raw
                                                                                                 material or
                                                                                                 other
                                                                                                 ingredient.
507.175(c)(11)...........  507.37(g)(9).............  Documentation of   No...................  No.
                                                       any
                                                       determination
                                                       that
                                                       verification
                                                       activities other
                                                       than an onsite
                                                       audit, and/or
                                                       less frequent
                                                       onsite auditing
                                                       of a supplier,
                                                       provide adequate
                                                       assurance that
                                                       the hazards are
                                                       controlled when
                                                       a hazard in a
                                                       raw material or
                                                       other ingredient
                                                       will be
                                                       controlled by
                                                       the supplier and
                                                       is one for which
                                                       there is a
                                                       reasonable
                                                       probability that
                                                       exposure to the
                                                       hazard will
                                                       result in
                                                       serious adverse
                                                       health
                                                       consequences or
                                                       death to humans
                                                       or animals.

[[Page 56315]]

 
507.175(c)(12)...........  507.37(g)(10)............  Documentation of   No...................  Provide for
                                                       an alternative                            documentation,
                                                       verification                              when
                                                       activity for a                            applicable, of
                                                       supplier that is                          a written
                                                       a qualified                               assurance that
                                                       facility.                                 the supplier is
                                                                                                 producing the
                                                                                                 raw material or
                                                                                                 other
                                                                                                 ingredient in
                                                                                                 compliance with
                                                                                                 relevant laws
                                                                                                 and regulations
                                                                                                 of a country
                                                                                                 whose food
                                                                                                 safety system
                                                                                                 FDA has
                                                                                                 officially
                                                                                                 recognized as
                                                                                                 comparable or
                                                                                                 has determined
                                                                                                 to be
                                                                                                 equivalent to
                                                                                                 that of the
                                                                                                 United States.
507.175(c)(13)...........  507.37(g)(11)............  Documentation of   Yes..................  No.
                                                       an alternative
                                                       verification
                                                       activity for a
                                                       supplier that is
                                                       a farm that
                                                       supplies a raw
                                                       material or
                                                       other ingredient
                                                       that would not
                                                       be a covered
                                                       farm subject to
                                                       the forthcoming
                                                       produce safety
                                                       rule.
507.175(c)(14)...........  N/A......................  Documentation of   N/A..................  N/A.
                                                       an alternative
                                                       verification
                                                       activity for a
                                                       supplier that is
                                                       a shell egg
                                                       producer that is
                                                       not subject to
                                                       the requirements
                                                       established in
                                                       part 118 because
                                                       it has less than
                                                       3,000 laying
                                                       hens.
507.175(c)(15)...........  507.37(g)(12)............  The written        No...................  No.
                                                       results of an
                                                       appropriate
                                                       inspection of
                                                       the supplier by
                                                       FDA, by
                                                       representatives
                                                       of other Federal
                                                       Agencies (such
                                                       as USDA), or by
                                                       representatives
                                                       from State,
                                                       local, tribal,
                                                       or territorial
                                                       Agencies, or the
                                                       food safety
                                                       authority of
                                                       another country
                                                       when the results
                                                       of such an
                                                       inspection is
                                                       substituted for
                                                       an onsite audit.
507.175(c)(16)...........  507.37(g)(13)............  Documentation of   No...................  No.
                                                       actions taken
                                                       with respect to
                                                       supplier non-
                                                       conformance.
507.175(c)(17)...........  N/A......................  Documentation of   N/A..................  N/A.
                                                       verification of
                                                       a supply-chain-
                                                       applied control
                                                       applied by an
                                                       entity other
                                                       than the
                                                       receiving
                                                       facility's
                                                       supplier.
507.175(c)(18)...........  N/A......................  When applicable,   N/A..................  N/A.
                                                       documentation of
                                                       the receiving
                                                       facility's
                                                       review and
                                                       assessment of
                                                       documentation of
                                                       a supplier
                                                       verification
                                                       activity
                                                       provided by a
                                                       supplier or by
                                                       an entity other
                                                       than the
                                                       receiving
                                                       facility.
----------------------------------------------------------------------------------------------------------------

A. Applicability of the Recordkeeping Requirements of Subpart F

    We have added new Sec.  507.175(a) to specify that the records 
documenting the supply-chain program in subpart E are subject to the 
requirements of subpart F. Under the 2014 supplemental notice, the 
documentation requirements would have been in subpart C, and the 
applicability of subpart F was specified in Sec.  507.55 in subpart C. 
The new provision specifying the applicability of subpart F to the 
records associated with the supply-chain program is a consequential 
change associated with establishing the requirements for a supply-chain 
program in subpart E, rather than in subpart C.

B. Requirement To Review Records of the Supply-Chain Program (Final 
Sec.  507.175(b))

    We proposed that a receiving facility must review records 
documenting the supplier program in accordance with the requirements 
applicable to review of records as a verification activity (i.e., in 
accordance with Sec.  507.49(a)(4)). (Proposed Sec.  507.37(g).)
    (Comment 476) Some comments ask us to provide consideration for 
records associated with the supplier program to be administered and 
maintained at corporate headquarters rather than at individual 
facilities, because this is common industry practice.
    (Response 476) We are aware that certain programs are administered, 
and records are maintained, at corporate headquarters rather than at 
individual facilities. The rule provides that offsite storage of 
records is permitted if such records can be retrieved and provided 
onsite within 24 hours of request for official review and electronic 
records are considered to be onsite if they are accessible from an 
onsite location (see Sec.  507.208(c)). We expect that the facility 
would be able to access information and records relevant to the supply-
chain program within 24 hours (e.g., electronically) when the records 
are maintained at corporate headquarters. As necessary and appropriate, 
we intend to work with facilities on a case-by-case basis to determine 
the best way to review records associated with the supply-chain program 
when the supply-chain program is administered at the corporate level.

[[Page 56316]]

    (Comment 477) Some comments ask us to clarify in the regulatory 
text that the required records are ``as appropriate to the supplier 
program.''
    (Response 477) We have revised the regulatory text to specify that 
the required records are ``as applicable to its supply-chain program'' 
(see Sec.  507.175(c)).

C. Documentation Demonstrating Use of the Written Procedures for 
Receiving Raw Materials and Other Ingredients (Final Sec.  
507.175(c)(5))

    We proposed to require documentation demonstrating that products 
are received only from approved suppliers (proposed Sec.  
507.37(g)(4)).
    (Comment 478) Some comments support the proposed requirement with 
no changes. Other comments ask us to specify ``raw materials and 
ingredients'' rather than ``products'' in the regulatory text.
    (Response 478) We have revised the regulatory text to specify ``raw 
materials and other ingredients'' with associated conforming changes.

D. Documentation of the Conduct of an Onsite Audit (Final Sec.  
507.175(c)(7))

    We proposed to require documentation of an onsite audit. This 
documentation must include: (1) Documentation of audit procedures; (2) 
the dates the audit was conducted; (3) the conclusions of the audit; 
(4) corrective actions taken in response to significant deficiencies 
identified during the audit; and (5) documentation that the audit was 
conducted by a qualified auditor. For clarity, we have revised the 
regulatory text to specify documentation of the ``conduct'' of an audit 
and added a requirement for the documentation to include the name of 
the supplier subject to the onsite audit.
    (Comment 479) Some comments ask that we add ``if applicable'' to 
the requirement to maintain documentation of an audit because an audit 
may not be necessary if a receiving facility has documented that other 
verification activities are appropriate.
    (Response 479) We decline this request. The documentation is always 
necessary if an audit is used as a verification activity. The provision 
is about maintaining documentation when an audit is conducted, not 
about when an audit needs to be conducted.
    (Comment 480) Some comments ask us to maintain the confidentiality 
of audit reports and exempt such audit reports from disclosure under 
the Freedom of Information Act (FOIA).
    (Response 480) These comments are similar to comments we received 
related to disclosure of other records required by this part (see 
Comments 490 and 491). We would establish the status of supply-chain 
program records, such as audit reports, as available for, or protected 
from, public disclosure on a case-by-case basis. As discussed in 
Response 491, we primarily intend to copy such records when we conduct 
an inspection for cause or if the preliminary assessment by our 
investigator during a routine inspection is that regulatory followup 
may be appropriate (e.g., if the report indicates that a significant 
food safety problem was noted). See Response 491 for a discussion of 
situations in which records would, or would not, be protected from 
disclosure.
    (Comment 481) Some comments express concern about maintaining 
documentation of the conclusions of an audit and documentation of 
corrective actions taken in response to significant deficiencies 
identified during the audit. These comments explain that FDA's access 
to such documentation during inspection might discourage suppliers from 
allowing unannounced audits. These comments ask us to delete these 
proposed requirements. If the requirement regarding documentation of 
corrective actions remains in the final rule, these comments ask us to 
limit such documentation to situations in which the identified 
deficiencies posed a risk to public health.
    (Response 481) We are retaining these documentation requirements as 
proposed. These comments appear to be suggesting that documentation 
requirements be established based on whether a business entity would 
want us to see information during inspection rather than on the utility 
and value of the documentation. We expect that receiving facilities, in 
general, maintain documentation of the conclusions of audits that they 
have conducted or arranged to have conducted. A receiving facility must 
approve all of its suppliers, and documentation of corrective actions 
taken in response to significant deficiencies identified during an 
audit has value to a receiving facility in determining whether to 
approve a supplier before first receiving any raw materials or other 
ingredients and then on an ongoing basis.
    The rule does not require that onsite audits be unannounced, 
although we acknowledge that some receiving facilities may see value in 
unannounced audits. We decline the request to require a receiving 
facility to maintain documentation of corrective actions only if the 
identified deficiencies posed a risk to public (human and animal) 
health. The purpose of an audit, like the purpose of all the supplier 
verification activities, is broader than identifying deficiencies that 
pose a risk to public (human and animal) health and includes verifying 
whether a raw material or other ingredient is adulterated under section 
402 of the FD&C Act and is produced in compliance with applicable FDA 
food safety regulations (see Sec.  507.110(c)). If, for example, a 
supplier's facility has filthy conditions or the raw materials and 
other ingredients it supplies are contaminated with filth, a receiving 
facility may find it inappropriate to approve that supplier. Even 
though filth often does not pose a risk to public (human and animal) 
health, a food may be deemed to be adulterated under section 402(a)(4) 
of the FD&C Act if it has been prepared, packed, or held under 
insanitary conditions whereby it may have become contaminated with 
filth.

E. Documentation of Sampling and Testing (Final Sec.  507.175(c)(8))

    We proposed to require records of sampling and testing. These 
records must include: (1) Identification of the raw material or 
ingredient tested (including lot number, as appropriate) and the number 
of samples tested; (2) identification of the test(s) conducted, 
including the analytical method(s) used; (3) the date(s) on which the 
test(s) were conducted and the date of the report; (4) the results of 
the testing; (5) corrective actions taken in response to detection of 
hazards; and (6) information identifying the laboratory conducting the 
testing.
    (Comment 482) Some comments ask us to not apply the requirement to 
maintain records related to sampling and testing to the receipt of RACs 
because sampling and testing of RACs is neither common nor effective 
for detecting biological or chemical hazards, especially in raw, intact 
produce.
    (Response 482) We decline this request. These comments appear to 
suggest that documentation requirements be established based on the 
frequency and utility of sampling and testing a particular commodity 
rather than on a determination by a receiving facility that sampling 
and testing is an appropriate supplier verification activity for a 
particular supplier. We disagree with such a suggestion. A receiving 
facility that has determined that sampling and testing is an 
appropriate supplier verification activity needs to maintain records of 
those results as it would for any other supplier verification activity. 
To the extent that these comments are concerned that the supply-chain

[[Page 56317]]

program requires sampling and testing of RACs, we emphasize that this 
is not the case. See also Response 350 for a discussion of the 
usefulness of sampling and testing as a verification measure for RACs.
    (Comment 483) Some comments ask us to allow documentation of 
testing to include the date the test results were reported as an 
alternative to the date(s) on which the test(s) were conducted.
    (Response 483) We have revised the provision to require ``The 
date(s) on which the test(s) were conducted and the date of the 
report.'' We agree that the date on which the test results are reported 
can be important, but it should not be a replacement for the date of 
the test.
    (Comment 484) Some comments ask us to add ``if necessary'' to the 
end of the proposed requirement for documentation of corrective actions 
taken in response to detection of hazards.
    (Response 484) We decline this request. The documentation is always 
necessary if corrective actions are taken. The provision is about 
maintaining documentation when corrective actions are taken, not about 
the fact that corrective actions may not always be needed.

F. Documentation of Other Appropriate Supplier Verification Activity 
(Final Sec.  507.175(c)(10))

    We proposed to require records of other appropriate verification 
activities based on the risk associated with the ingredient. For 
clarity and consistency, we have revised the proposed requirement to 
specify ``documentation'' of the other appropriate supplier 
verification activity rather than ``records'' of the activity. As a 
conforming change associated with using the term ``supplier 
performance,'' rather than ``risk of supplier,'' when discussing 
factors associated with suppliers, the final requirement specifies that 
the other appropriate supplier verification activities are based on the 
supplier performance and the risk associated with the raw material or 
other ingredient.
    (Comment 485) Some comments ask us to also specify that an 
``other'' appropriate supplier verification activity be based on the 
risk associated with raw materials and suppliers.
    (Response 485) We have revised the regulatory text to specify 
``Documentation of other appropriate supplier verification activities 
based on the supplier performance and the risk associated with the raw 
material or other ingredient.'' The revised regulatory text of the 
documentation tracks the regulatory text of this ``other'' appropriate 
supplier verification activity (see Sec.  507.110(b)(4)). As discussed 
in Response 444, ``supplier performance'' is more appropriate than 
``risk associated with the supplier.''

G. Documentation of an Alternative Verification Activity for a Supplier 
That Is a Farm That Is Not a ``Covered Farm'' for the Purposes of the 
Future Produce Safety Rule (Final Sec.  507.175(c)(13))

    We proposed to require documentation of an alternative verification 
activity for a supplier that is a farm that is not a ``covered farm'' 
for the purposes of the future produce safety rule, including: (1) The 
documentation that the raw material or ingredient provided by the 
supplier is not subject to the produce safety rule and (2) the written 
assurance that the supplier is producing the raw material or ingredient 
in compliance with applicable FDA food safety regulations and that the 
raw material or ingredient is not adulterated under section 402 of the 
FD&C Act. We have revised the documentation to reflect the final 
requirements of Sec.  507.130(d)--i.e., to require: (1) Written 
assurance that the supplier is not a covered farm under part 112 in 
accordance with Sec.  112.4(a), or in accordance with Sec. Sec.  
112.4(b) and 112.5, before approving the supplier and on an annual 
basis thereafter and (2) the written assurance that the farm 
acknowledges that its food is subject to section 402 of the FD&C Act 
(or, when applicable, that its food is subject to relevant laws and 
regulations of a country whose food safety system FDA has officially 
recognized as comparable or has determined to be equivalent to that of 
the United States). However as of August 30, 2015, FDA has not 
developed a systems recognition program for animal food; therefore, we 
have no signed systems recognition agreements with any foreign food 
safety authority relating to animal food. The currently existing 
systems recognition agreement relates solely to human food and does not 
apply to animal food.
    (Comment 486) Some comments ask us to delete this documentation 
requirement because RACs except fruits and vegetables should be exempt 
from supplier verification.
    (Response 486) See Response 464. This alternative supplier 
verification activity is intended to minimize the burden on suppliers 
that are small farms.
    (Comment 487) Some comments ask us to include a cross-reference to 
the applicable requirement.
    (Response 487) We have not added this cross-reference. We agree 
that adding the cross-reference has the potential to be helpful, but it 
also has the potential to clutter the regulatory text. We considered it 
would be more useful to specify what the documentation needs to be 
rather than to specify the cross-reference to the applicable 
alternative supplier verification activity.

XLVIII. Subpart F: Comments on Proposed New Recordkeeping Requirements

    We proposed to establish in subpart F requirements that would apply 
to all records that would be required by the various provisions of 
proposed part 507, including general requirements related to the 
content and form of records; additional requirements specific to the 
food safety plan; requirements for record retention; requirements for 
official review of records by FDA; and public disclosure.
    Some comments support the proposed requirements without change. 
Some comments that support the proposed provisions suggest alternative 
or additional regulatory text or ask us to clarify how we will 
interpret the provision.
    In the following paragraphs, we discuss comments that disagree with 
or suggest one or more changes to the proposed requirements. After 
considering these comments, we have revised the proposed requirements 
as shown in table 30 with editorial and conforming changes as shown in 
table 31.

     Table 30--Revisions to the Proposed Recordkeeping Requirements
------------------------------------------------------------------------
            Section                Description            Revision
------------------------------------------------------------------------
507.200(b)....................  Requirements for   Specify that the
                                 public             requirement applies
                                 disclosure.        to records
                                                    ``obtained by FDA.''
507.200(c)....................  Requirements for   Clarify that FDA may
                                 official review.   copy records upon
                                                    oral or written
                                                    request by a duly
                                                    authorized
                                                    representative of
                                                    the Secretary of
                                                    Health and Human
                                                    Services.

[[Page 56318]]

 
507.202(b)....................  General            Provide that the time
                                 requirements       of an activity being
                                 applying to        documented only
                                 records.           include the time of
                                                    the activity when
                                                    appropriate.
507.202(c)....................  General            Specify that
                                 requirements       electronic records
                                 applying to        are exempt from the
                                 records.           requirements of 21
                                                    CFR part 11.
507.208(a)(2).................  Requirements for   Specify that records
                                 record retention.  that a facility
                                                    relies on during the
                                                    3-year period
                                                    preceding the
                                                    applicable calendar
                                                    year to support its
                                                    status as a
                                                    qualified facility
                                                    must be retained at
                                                    the facility for as
                                                    long as necessary to
                                                    support the status
                                                    of a facility as a
                                                    qualified facility
                                                    during the
                                                    applicable calendar
                                                    year.
507.208(c)....................  Requirements for   Provide for offsite
                                 record retention.  storage of all
                                                    records other than
                                                    the food safety
                                                    plan, provided that
                                                    the offsite records
                                                    can be retrieved and
                                                    provided onsite
                                                    within 24 hours of
                                                    request for official
                                                    review.
507.208(d)....................  Requirements for   Provide that the food
                                 record retention.  safety plan may be
                                                    transferred to some
                                                    other reasonably
                                                    accessible location
                                                    if the plant or
                                                    facility is closed
                                                    for a prolonged
                                                    period, provided
                                                    that it is returned
                                                    to the plant or
                                                    facility within 24
                                                    hours of request for
                                                    official review.
507.215.......................  Special             Establish
                                 requirements       requirements
                                 applicable to a    applicable to all
                                 written            written assurances
                                 assurance.         required by the
                                                    rule.
                                                    Establish
                                                    additional
                                                    requirements
                                                    applicable to
                                                    written assurances
                                                    that are required
                                                    when a food product
                                                    distributed by
                                                    manufacturer/
                                                    processor requires
                                                    further processing
                                                    for food safety by a
                                                    subsequent
                                                    manufacturer.
------------------------------------------------------------------------

A. Proposed Sec.  507.200--Records Subject to the Requirements of 
Subpart F and Requirements for Official Review

    We proposed that all records required by part 507 would be subject 
to all requirements of subpart F, except that certain specific 
requirements (proposed Sec.  507.206) would apply only to the written 
food safety plan. We also proposed that certain proposed requirements 
(e.g., for records to contain the actual values and observations 
obtained during monitoring and, as appropriate, during verification 
activities) would not apply to the records that would be kept by 
qualified facilities. We proposed that records required by proposed 
part 507 are subject to the disclosure requirements under part 20 (21 
CFR part 20). We proposed that all records required by proposed part 
507 be made promptly available to a duly authorized representative of 
the Secretary of HHS upon oral or written request. We also asked for 
comment on whether we should require a facility to send records to us 
rather than make the records available for review at a facility's place 
of business and, if so, whether we should require that the records be 
submitted electronically.
    (Comment 488) Some comments disagree with the proposal to exempt 
the records that would be kept by qualified facilities from 
requirements to keep accurate, detailed records. The comments note that 
the proposed exemption would apply to qualified facilities regardless 
of whether they operate under the first option for documentation (i.e., 
food safety practices) plans or under the second option for 
documentation (i.e. compliance with non-Federal food safety laws). 
These comments assert that the proposed detailed record keeping 
requirements should apply to records relating to monitoring food safety 
practices and ask us to revise the proposed requirements so that this 
exemption would apply only to those qualified facilities that operate 
under non-Federal food safety laws.
    (Response 488) We decline this request. We based the proposed 
exemption on a statutory provision that a qualified facility is not 
subject to certain requirements, including the statutory recordkeeping 
requirements (see section 418(l)(2) of the FD&C Act). Although the 
requirements that apply to a qualified facility require submission of 
certain attestations to FDA (see Sec.  507.7(a) and (b)), and these 
attestations must be supported by documentation (see Sec.  507.7(f)), 
the rule does not require that records kept by a qualified facility to 
support its attestations be the same type of records that would be kept 
by a facility subject to subparts C and E. For example, if the facility 
attests that it has identified the potential hazards associated with 
the animal food being produced, implemented preventive controls to 
address the hazards, and is monitoring the performance of the 
preventive controls, the qualified facility might support its 
attestation by having a standard operating procedure for monitoring 
preventive controls rather than detailed records of actual monitoring.
    (Comment 489) Some comments assert that the proposed requirements 
governing public disclosure are not aligned with other risk-based 
preventive controls programs, such as HACCP programs. These comments 
argue that these proposed requirements should be realigned with other 
risk-based preventive controls programs to preserve the privacy of 
information maintained in required records unless that information has 
been otherwise made publicly available. Some comments suggest that we 
revise the proposed requirements to be analogous to the public 
disclosure requirements in our HACCP regulations for seafood and juice 
(see Sec. Sec.  123.9(d) and 120.12(f), respectively).
    (Response 489) We disagree that the proposed provisions governing 
public disclosure are not aligned with the public disclosure provisions 
of our HACCP regulations for seafood and juice. Our regulations in part 
20 regarding public information apply to all Agency records, regardless 
of whether a particular recordkeeping requirement says so. In the case 
of the recordkeeping requirements for our HACCP regulations for seafood 
and juice, we framed the provisions regarding public disclosure by 
providing specific details about how particular provisions in part 20 
(i.e., Sec.  20.61 (Trade secrets and commercial or financial 
information which is privileged or confidential) and Sec.  20.81 (Data 
and information previously disclosed to the public)) would apply to the 
applicable records. In the case of the recordkeeping requirements for 
this

[[Page 56319]]

rule, we framed the provisions regarding public disclosure by more 
broadly referring to all the requirements of part 20, consistent with 
our more recent approach for framing the provisions regarding public 
disclosure in the rule ``Prevention of Salmonella Enteritidis in Shell 
Eggs During Production, Storage, and Transportation'' (part 118; see 
Sec.  118.10(f)). Provisions such as Sec.  20.20 (Policy on disclosure 
of Food and Drug Administration records) apply to all records that we 
have in our system, including HACCP records, even though the HACCP 
regulations do not specify that this is the case.
    (Comment 490) Some comments ask us to clarify that the disclosure 
requirements of part 20 include protections for trade secrets and 
privileged or confidential commercial information and financial 
information. Other comments ask us to clarify that written food safety 
plans and associated records are not subject to public disclosure 
because they represent trade secret or confidential commercial 
information. Other comments ask us to clarify how the disclosure 
requirements of part 20 would apply to verification records (such as 
testing records).
    (Response 490) The questions raised in these comments are similar 
to some of the questions raised during the rulemaking to establish 
FDA's HACCP regulation for seafood (see the discussion at 60 FR 65096 
at 65137 through 65140, December 18, 1995). FDA's experience in 
conducting CGMP inspections in processing plants, our experience with 
enforcing the HACCP regulations for seafood and juice, and our 
understanding from the Final Regulatory Impact Analysis (FRIA) for this 
rule (Ref. 60) make it clear that food safety plans will take each 
facility some time and money to develop. Thus, we conclude that food 
safety plans generally will meet the definition of trade secret, 
including the court's definition in Public Citizen Health Research 
Group v. FDA, 704 F.2d 1280 (D.C. Cir. 1983). Plans that incorporate 
unique regimens or parameters to achieve product safety, which are the 
result of considerable research and effort, will surely meet this 
definition.
    We would establish the status of verification records, such as the 
results of product testing and environmental monitoring, as available 
for, or protected from, public disclosure on a case by case basis. As 
discussed in Response 491, we primarily intend to copy such records 
when we conduct an inspection for cause. We also intend to copy such 
records if the preliminary assessment by our investigator during a 
routine inspection is that regulatory followup may be appropriate 
(e.g., if these records demonstrate that an environmental pathogen has 
become established in a niche environment in an animal food processing 
plant).
    (Comment 491) Some comments assert that we should not copy 
documents as part of routine investigations so as to prevent critical 
documents from release under the FOIA. These comments are particularly 
concerned that our ability to copy verification records (such as 
testing records) and potentially release these records under the FOIA 
would discourage facilities from testing as a verification activity. 
These comments also express concern that some facilities would include 
in their food safety plans elements, not required by the proposed rule, 
that address food defense, as well as food safety, and that disclosure 
of such a food safety plan without proper redaction could provide 
useful information to persons seeking to defeat the facility's food 
defense strategies. In addition, these comments express concern that 
the task of reviewing all of these records and redacting trade secrets 
and confidential information would further set back FDA's already 
overburdened FOIA offices and create even longer delays in responding 
to FOIA requests.
    (Response 491) We have revised the proposed requirement to specify 
that all required records must be made promptly available ``for 
official review and copying'' to increase the alignment of the 
recordkeeping requirements of this rule with those of our HACCP 
regulations for seafood and juice. The issues raised by these comments 
are similar to some of the issues raised by comments during the 
rulemaking to establish our HACCP regulations for seafood (see the 
discussion at 60 FR 65096 at 65137 through 65140) and our regulations 
in part 118 for the prevention of Salmonella Enteritidis in shell eggs. 
We intend to copy records on a case-by-case basis as necessary and 
appropriate. We may consider it necessary to copy records when, for 
example, our investigators may need assistance in reviewing a certain 
record from relevant experts in headquarters. If we are unable to copy 
the records, we would have to rely solely on our investigators' notes 
and reports when drawing conclusions. In addition, copying records will 
facilitate followup regulatory actions.
    We primarily intend to copy records such as the results of product 
testing or environmental monitoring when we conduct an inspection for 
cause, e.g., as a result of an outbreak investigation, violative sample 
results, or followup to a consumer complaint. See Response 490 for a 
discussion of how the FOIA would apply to records, such as records of 
testing as a verification activity, that we copy during an inspection 
and maintain in our system.
    (Comment 492) Some comments ask us to modify the proposed 
requirement to clarify that it is ``records required by this part and 
provided to the Agency,'' rather than ``records obtained by the 
Agency'' that are subject to public disclosure.
    (Response 492) We agree that it is appropriate to specify that the 
disclosure requirements of this rule apply to information that we 
maintain as a record (see the description of ``record'' in Sec.  
20.20(e)). (See also the discussion (in the proposed rule to establish 
our seafood HACCP regulation, 59 FR 4142 at 4160, January 28, 1994) 
that there are significant legal and practical questions as to whether 
FDA has the authority to require disclosure of industry records that 
are not in FDA's possession.) However, we see no meaningful distinction 
between records ``provided to FDA'' and records ``obtained by FDA,'' 
and have revised the provision to specify that records obtained by FDA 
in accordance with this part are subject to the disclosure requirements 
under part 20. The revised regulatory text makes clear that the 
requirements of part 20 attach to those documents obtained by FDA. To 
the extent that these comments are addressing the difference between 
records provided during inspection and records submitted to us, as 
already discussed we have decided not to require submission of certain 
records to us (see Response 493).
    (Comment 493) Some comments strongly oppose any requirement for 
submission of records to FDA remotely and assert that there is no basis 
in FSMA for such a requirement. Some comments express concern about our 
ability to protect confidential information (such as supplier and 
customer records received by a facility under the protection of 
confidentiality agreements) that is transmitted electronically (e.g., 
the information that might be released through computer hacking or 
leaks). Some comments note that inadvertent disclosure of information 
related to specific products, hazards, and preventive controls 
implemented at food facilities could both prove harmful from a 
commercial or competitive standpoint and expose existing 
vulnerabilities in the U.S. food supply, thus potentially rendering 
food facilities susceptible to malicious attack.
    Some comments express concern over any potential requirements to 
submit

[[Page 56320]]

reports from third-party audits to FDA. The comments state that a 
requirement to submit audit reports, which may be included as voluntary 
or required components of a facility's food safety plan, would not be 
of public health benefit and could potentially impact a facility's 
willingness to use audits in their food safety program.
    Some comments offered that instead of submission of the food safety 
plan, a facility should submit a ``certification'' that the facility 
has a food safety plan during the course of the facility registration 
process.
    Some comments oppose the concept of a ``desk audit'' whereby our 
investigators conduct their inspections from a remote office without 
actually visiting the facility and assert that our access to company 
records must be conducted on-site in the course of an authorized 
inspection so that we may understand the full context of what the 
records show. Some comments point out that there would be challenges 
associated with credential validation when we asked for records to be 
sent remotely, such as in an email request. Some comments ask that we 
modify the proposed requirement to specify that records would only be 
made available to us during a facility inspection.
    (Response 493) We have decided not to establish any requirements 
for a facility to send records to us. We will review records when we 
are onsite in the course of an authorized inspection, and copy records 
as necessary and appropriate.
    We are not modifying the proposed requirement to specify that 
records would only be made available to us during a facility inspection 
because it is not necessary to do so. The regulatory text specifying 
that the records be made available to a duly authorized representative 
of the Secretary of HHS provides the context that the records would be 
made available during inspection.

B. Proposed Sec.  507.202--General Requirements Applying to Records

    We proposed that the records must: (1) Be kept as original records, 
true copies, or electronic records (and that electronic records must be 
kept in accordance with part 11 (21 CFR part 11)); (2) contain the 
actual values and observations obtained during monitoring and, as 
appropriate, during verification activities; (3) be accurate, 
indelible, and legible; (4) be created concurrently with performance of 
the activity documented; (5) be as detailed as necessary to provide 
history of work performed; and (6) include the name and location of the 
plant or facility, the date and time of the activity documented, the 
signature or initials of the person performing the activity, and, where 
appropriate, the identity of the product and the production code, if 
any.
    We have revised the provision to require information adequate to 
identify the plant or facility (e.g., the name, and when necessary, the 
location of the plant or facility) rather than to always require both 
the name and location of the plant or facility (see Sec.  
507.202(b)(1)). In some cases, the name of the plant or facility will 
be adequate to identify it, e.g., when a plant or facility is not part 
of a larger corporation that has facilities at more than one location. 
In other cases, the name of the plant or facility may not, by itself, 
be adequate to identify the plant or facility, e.g., when a plant or 
facility is part of a larger corporation with more than one location 
and the ``name'' of each plant or facility is the same.
    (Comment 494) Some comments express concern about ``apparent 
mandates'' that we will require records to be kept as paper copies, 
even if the records were generated electronically, for 2 years.
    (Response 494) We did not propose to require that all records must 
be kept as paper copies. A facility has the choice to keep records as 
original records, true copies, or electronic records.
    (Comment 495) Some comments assert that compliance with part 11 for 
the secure operation of many systems currently in use is unnecessary 
and would create the need to redesign and recreate existing systems, 
thus leading to considerable cost and complexity. These comments 
identify the requirement for hardware and software to be validated as a 
key cost concern and assert that validation activities would be 
difficult to maintain and would not deliver added value. As an example, 
these comments explain that an expectation for validation of electronic 
recordkeeping software and hardware would be particularly problematic 
because software patches and security updates are distributed on a 
nearly weekly basis, and express the view that validation procedures 
are most appropriately applied before use of a new system and after 
major software changes or updates. These comments also assert that it 
would be costly, burdensome, and require specialized resources to 
modify or replace existing electronic systems to comply with part 11. 
These comments provide an example in which a facility needed more than 
9 months to upgrade one system alone to comply with part 11, and note 
that it would not be unusual for companies to employ multiple systems, 
so the burden and cost would exponentially increase. These comments ask 
us to instead require facilities that use electronic records to a use 
secure system that ensures records are trustworthy, reliable, and 
generally equivalent to paper records and handwritten signatures 
executed on paper.
    Other comments express concern about the financial burden for small 
facilities such as farm mixed-type facilities and ask us to either 
modify requirements for farm mixed-type facilities, very small 
businesses, and small businesses or provide that such facilities be 
fully exempt from part 11 requirements for electronic records. Other 
comments state that, as with the recordkeeping requirements under the 
Bioterrorism Act, such requirements are disproportionate to the 
regulatory need.
    Some comments state that major advances in software technology have 
been made since part 11 published in 1997, and such advances must be 
carefully considered in evaluating any potential expansion or new 
applications of part 11. These comments also state that we already are 
in the process of reevaluating part 11 for the regulations for which it 
currently applies, citing industry guidance issued more than 10 years 
ago in which we acknowledged that part 11 is unworkable in many 
respects and decided to exercise enforcement discretion for part of the 
regulations and announced plans to reexamine part 11 as a whole.
    Some comments recommend that we develop guidance, with input from 
key stakeholders, to describe the kinds of systems and steps that can 
be used to assure records meet the required standard. This guidance 
should clearly establish that specific security needs will depend on 
the circumstances, including the system at issue, its intended use, the 
criticality of the preventive control or other food safety measure it 
is used to manage, and other relevant factors. For example, these 
comments explain that a quality system used to manage CCP documentation 
would have greater security needs than a review of a Certificate of 
Analysis for a non-sensitive ingredient.
    (Response 495) In light of the substantial burden that could be 
created by the need to redesign large numbers of already existing 
electronic records and recordkeeping, we are providing in new Sec.  
507.202(c) that records that are established or maintained to satisfy 
the requirements of part 507 and that meet the definition of electronic 
records in Sec.  11.3(b)(6) are exempt from the requirements of part 
11. As we did in the section 414 recordkeeping

[[Page 56321]]

regulations, we also are specifying that records that satisfy the 
requirements of part 507, but that also are required under other 
applicable statutory provisions or regulations, remain subject to part 
11. The rule provides that a facility may rely on existing records to 
satisfy the requirements of this rule, and this rule does not change 
the status under part 11 of any such records if those records are 
currently subject to part 11. As we did in the rulemaking to establish 
the section 414 recordkeeping regulations, we are establishing a 
conforming change in part 11 to specify in new Sec.  11.1(j) that part 
11 does not apply to records required to be established or maintained 
under part 507, and that records that satisfy the requirements of part 
507, but that also are required under other applicable statutory 
provisions or regulations, remain subject to part 11.
    Although we are not specifying that part 11 applies, facilities 
should take appropriate measures to ensure that records are 
trustworthy, reliable, and generally equivalent to paper records and 
handwritten signatures executed on paper.
    (Comment 496) Some comments assert that certain production and 
associated activities are not time-sensitive and would not require 
documentation of the time the activity is performed. These comments ask 
us to modify the proposed requirements so that the records would only 
require the time of the activity documented where appropriate for food 
safety.
    (Response 496) We agree that certain activities (e.g., record 
review and verification activities) are not time-sensitive and, thus, 
would not need to include the time that the activity was performed. The 
final rule provides flexibility for the facility to determine when to 
document the time by specifying that the time be documented ``when 
appropriate'' (see Sec.  507.202(b)(2)).
    (Comment 497) Some comments assert that concurrent record creation 
will prove difficult in many animal food-processing environments. These 
comments ask us to modify the proposed requirement that records be 
created concurrently with the performance of the activity documented to 
qualify that the requirement only applies where feasible, and that the 
records could be created as soon as possible thereafter under 
circumstances where concurrent record creation is not feasible.
    (Response 497) We decline this request. The comments did not 
provide any examples of activities where concurrent record creation in 
animal food manufacturing/processing, packing, or holding environments 
would prove difficult, and we are not aware of any such example. For 
example, we are not aware of any difficulty complying with longstanding 
similar requirements associated with our HACCP regulations for seafood 
and juice (see Sec. Sec.  123.9(a)(4) and 120.12(b)(4), respectively).

C. Proposed Sec.  507.206--Additional Requirements Applying to the Food 
Safety Plan

    We proposed that the food safety plan must be signed and dated by 
the owner, operator, or agent in charge of the facility upon initial 
completion and upon any modification.
    (Comment 498) Some comments ask for clarification on who can sign 
and date the food safety plan. Some comments state that the proposed 
rule would exclude the preventive controls qualified individual from 
signing and dating the food safety plan unless the preventive controls 
qualified individual is the owner, operator, or agent in charge of the 
facility. These comments ask us to revise the rule to allow the 
preventive controls qualified individual to sign and date the food 
safety plan (e.g., because it is the preventive controls qualified 
individual who prepares (or oversees the preparation of) the food 
safety plan). One comment suggests that ``agent in charge'' be defined 
to include all preventive controls qualified individuals. Some comments 
ask us to require that any preventive controls qualified individuals 
who prepare (or oversee the preparation of) specific sections of the 
food safety plan sign and date applicable sections.
    (Response 498) We decline these requests. The statute expressly 
directs the owner, operator, or agent in charge of a facility to 
prepare the food safety plan (see section 418(h) of the FD&C Act). As 
previously discussed, such a signature would provide direct evidence of 
the owner, operator or agent's acceptance of the plan and commitment to 
implementation of the plan (78 FR 64736 at 64816). A facility has 
flexibility to require the signature of one or more preventive controls 
qualified individuals who prepared, or oversaw the preparation of, its 
food safety plan in addition to the minimum signature requirement 
specified in the rule. Likewise, a facility also has flexibility to 
require the signature of one or more members of its food safety team 
who contributed to the preparation of the food safety plan, even if 
those individuals are not serving as the preventive controls qualified 
individual for the facility.

D. Proposed Sec.  507.208--Requirements for Record Retention

    We proposed that: (1) All required records must be retained at the 
plant or facility for at least 2 years after the date they were 
prepared; (2) records relating to the general adequacy of equipment or 
processes being used by a facility, including the results of scientific 
studies and evaluations, must be retained at the facility for at least 
2 years after their use is discontinued; (3) except for the food safety 
plan, offsite storage of records is permitted after 6 months following 
the date that the records were made if such records can be retrieved 
and provided onsite within 24 hours of request for official review; and 
(4) if the plant or facility is closed for a prolonged period, the 
records may be transferred to some other reasonably accessible location 
but must be returned to the plant or facility within 24 hours for 
official review upon request.
    (Comment 499) Some comments ask us to clarify that the 2-year 
record retention requirement only applies to records created after the 
compliance date for the final rule.
    (Response 499) The retention requirements only apply to records 
created after the applicable compliance date for the final rule. See 
Response 76 and section LIII.A, which explain that the compliance date 
for a facility to retain records to support its status as a qualified 
facility is January 1, 2017. See also Response 502, which explains that 
we have revised the record retention provisions to specify that records 
that a facility relies on during the 3-year period preceding the 
applicable calendar year to support its status as a qualified facility 
must be retained at the facility for as long as necessary to support 
the status of facility as a qualified facility during the applicable 
calendar year.
    (Comment 500) Some comments ask us to delete the proposed 
requirement to keep records on site for 6 months or 2 years (depending 
on the record) and assert that it should suffice to require that 
records be available within 24 hours of request or within a reasonable 
period of time. Some comments assert that records should be able to be 
kept in the location where they are created, which may be at corporate 
headquarters. Other comments state that it may be difficult to obtain 
records within 24 hours and requested additional time. Comments also 
assert that specifying the location for record storage will increase 
costs but will not contribute to improvements in public health. Some

[[Page 56322]]

comments ask us to permit offsite storage for all records over 6 months 
old, in contrast to the 2-year retention period we proposed for records 
relating to the general adequacy of equipment or processes being used 
by a facility, including the results of scientific studies and 
evaluations.
    (Response 500) We have revised the provisions to provide for 
offsite storage of all records (except the food safety plan), provided 
that the records can be retrieved and made available to us within 24 
hours of request for official review. We have determined that in order 
to maintain inspectional efficiency, 24 hours is a reasonable period to 
allow for retrieval of any offsite records. We expect that many records 
will be electronic records that are accessible from an onsite location 
and, thus, would be classified as being onsite (see Sec.  507.208(c)). 
As a companion change, we have revised the proposed provision directed 
to the special circumstance of storing records when a facility is 
closed for prolonged periods of time so that it only relates to the 
offsite storage of the food safety plan in such circumstances (see 
Sec.  507.208(d)).
    (Comment 501) Some comments assert that a 2-year retention period 
for records is much longer than needed for animal food products, as 
animal food is often consumed within a short time after manufacture. 
These comments ask us to establish a 1-year period for record 
retention, which would be similar to record retention periods required 
in other FDA regulations. Some comments assert that records should be 
required to be kept for the shelf life of the product plus an 
additional 6 months, for certain animal foods such as pet foods.
    (Response 501) We decline these requests. The proposed 2-year 
retention period is authorized by the statute (see section 418(g) of 
the FD&C Act). Moreover, the reasons discussed by the comments for 
linking the retention period to shelf life are more relevant to the 
record retention requirements for the purpose of tracking potentially 
contaminated food (part 1, subpart J; see Sec.  1.360) than to the 
record retention requirements for the purpose of evaluating compliance 
with this rule.
    (Comment 502) Some comments ask us to require that qualified 
facilities keep financial and sales records for 3 or 4 years, because a 
qualified facility must document that the average value of food it sold 
over the prior 3 years did not exceed $500,000 annually.
    (Response 502) We have revised the record retention provisions to 
specify that records that a facility relies on during the 3-year period 
preceding the applicable calendar year to support its status as a 
qualified facility must be retained at the facility as long as 
necessary to support the status of a facility as a qualified facility 
during the applicable calendar year. As discussed in section VIII.A, 
the definition of very small business established in this rule is based 
on an average (of sales plus market value of animal food held without 
sale) during the 3-year period preceding the applicable calendar year. 
Thus, both of the criteria for the qualified facility exemption are 
based on financial records associated with the preceding 3-year period. 
The actual retention time necessary to support the status of a 
qualified facility during the applicable calendar year could be as long 
as 4 years. For example, if we inspect a facility on May 1, 2024, the 
facility would have retained the records from 2021 to 2023 for 3 years 
and 4 months. If we inspect the facility on December 28, 2024, the 
facility would have retained the records from 2021 to 2023 for nearly 4 
years.

E. Proposed Sec.  507.212--Use of Existing Records

    We proposed that existing records (e.g., records that are kept to 
comply with other Federal, State, or local regulations, or for any 
other reason) do not need to be duplicated if they contain all of the 
required information and satisfy the requirements of subpart F. 
Existing records may be supplemented as necessary to include all of the 
required information and satisfy the requirements of subpart F. We also 
proposed that the information required by part 507 does not need to be 
kept in one set of records. If existing records contain some of the 
required information, any new information required by part 507 may be 
kept either separately or combined with the existing records.
    Comments that address this proposed requirement support it. For 
example, some comments state that this provision would provide 
flexibility to facilities to comply with the record requirements in an 
efficient manner. Other comments state that this provision would 
prevent companies from having to duplicate records or create new 
records solely to satisfy recordkeeping requirements.
    (Comment 503) Some comments state that food safety plan records are 
a ``web of related documents'' that may be used in other programs and 
cannot be collected or reduced to a ``binder.''
    (Response 503) We agree that food safety plan records could be 
considered a ``web of related documents,'' i.e., a set of records that 
could include documents used in other programs. We also agree that the 
food safety plan records need not be collected in a single location or 
``reduced to a binder.'' Likewise, the records documenting 
implementation of the plan could be a ``web of related documents.'' For 
example, a facility that collects samples of product and sends them to 
a laboratory for testing would have records documenting its collection 
of samples, as well as records documenting the laboratory's test 
results. Consistent with the requirements of the rule for written 
procedures for product testing (Sec.  507.49(b)(2)) and the general 
recordkeeping requirements of subpart F (Sec.  507.202), the sampling 
records would contain information such as the name and location of the 
facility, the date when the samples were collected, the signature or 
initials of the person collecting the samples, and the identity and lot 
code of the sampled product.
    Likewise, the laboratory report would contain information 
identifying the laboratory, the product tested (and associated lot 
code), the test analyte, the test(s) conducted (including the 
analytical method(s) used), the date of the test(s), the test results, 
and the signature or initials of the person who conducted the test. 
Alternatively, it would be acceptable to have the signature or initials 
of the person who approved the release of the test results from the 
laboratory. Together, these records contain all the required 
information to associate them with a facility, a specific lot of 
product, and the results of laboratory testing on that product.
    Although the provisions for use of existing records provide 
flexibility, there are some limitations. For example, monitoring 
records must be created concurrently with the monitoring activity and 
contain the signature or initials of the person conducting the 
monitoring. If the facility has an existing form that it uses to 
document the monitoring activity, and that form does not provide (or 
have space to add) information adequate to identify the plant or 
facility (e.g., the name and, when necessary, the location of the 
facility), and does have (or have space to add) a place for the 
signature of the person performing the activity, we expect the facility 
to modify the form rather than use the existing form. The provisions 
for ``supplementing'' existing records do not extend to providing 
information identifying the facility, or signatures, on separate pages.
    (Comment 504) Some comments state that our review of records should 
be limited to issues under our jurisdiction, regardless of the other 
information that may be contained in the record. Other

[[Page 56323]]

comments ask us to ensure that inspectors are adequately trained on how 
to review facility records for the requisite information across 
multiple sets of documents, as needed.
    (Response 504) Section 418(h) of the FD&C Act requires that the 
written plan that documents and describes the procedures used by the 
facility to comply with the requirements of section 418, together with 
the documentation of monitoring of preventive controls, instances of 
nonconformance material to food safety, the results of testing and 
other means of verification, instances when corrective actions were 
implemented and the efficacy of preventive controls and corrective 
actions, be made available to FDA. Our inspectors will be trained to 
focus on the written food safety plan and the records documenting 
implementation of the plan during inspections. Our inspectors have 
experience in the review of records that an animal food business 
establishes and maintains for more than one purpose--e.g., during the 
review of records kept under the section 414 recordkeeping regulations 
during the investigation of an outbreak of foodborne illness.
    For further discussion of comments received on recordkeeping 
requirements, see section XLI in the final rulemaking for preventive 
controls for human food published elsewhere in this issue of the 
Federal Register.

F. Final Sec.  507.215--Special Requirements Applicable to a Written 
Assurance

    As discussed in section XXVII, new Sec.  507.215 establishes 
requirements applicable to the written assurance a manufacturer/
processor obtains from its customer. New Sec.  507.215(a) applies to 
all written assurances required by the rule, i.e., the assurance must 
contain the effective date; printed names and signatures of authorized 
officials; and the applicable assurance.
    The provisions of Sec.  507.215(b), together with another new 
provision (Sec.  507.37), establish legal responsibilities under the 
rule for a facility that provides a written assurance regarding a food 
product that a manufacturer/processor distributes without application 
of a preventive control that is needed to control a hazard. This 
responsibility exists even for a facility that is not itself a 
manufacturer/processor, such as for a facility that is a distributor. 
We are establishing legal responsibilities for the facilities that 
provide these written assurances because following these assurances is 
critical to ensuring that required preventive controls are applied to 
the food by an entity in the distribution chain before the food reaches 
consumers.

XLIX. Comments by Foreign Governments and Foreign Businesses

    We received several comments from foreign governments and foreign 
businesses covering a wide range of issues. Many of those comments were 
similar to comments made on certain topics by domestic stakeholders, so 
we are addressing those comments in other sections throughout this 
preamble. In this section, we are responding to comments that are 
primarily focused on international issues, such as the obligations of 
the United States under the World Trade Organization Agreement (WTO).
    (Comment 505) Some comments by foreign government representatives 
ask us to provide extended periods of time for the implementation of 
the rule for facilities in foreign countries.
    (Response 505) The concept of special and differential treatment is 
incorporated in the WTO Agreements. Article 10.2 of the WTO Sanitary 
and Phytosanitary (SPS) Agreement states: ``Where the appropriate level 
of sanitary or phytosanitary protection allows scope for the phased 
introduction . . . longer timeframes for compliance should be accorded 
on products of interest to developing country Members so as to maintain 
opportunities for their exports.''
    In 2001, at the WTO Ministerial Conference in Doha, WTO Members 
issued a Ministerial Decision that interpreted the special and 
differential obligations of the SPS Agreement (Ref. 61). The 
Ministerial Decision defined ``longer timeframe for compliance'' to 
normally mean a period of not less than 6 months.
    We recognize that businesses of all sizes may need more time to 
comply with the new requirements established under this rule. As 
discussed in section LIII, the compliance date for implementation of 
subpart C, Hazard Analysis and Preventive Controls is extended one year 
beyond the compliance date for the implementation of subpart B, Current 
Good Manufacturing Practice. Businesses other than small and very small 
businesses will have 1 year after the date of publication to comply 
with the CGMP requirements and 2 years after publication to comply with 
preventive controls requirements. Small businesses will have 2 years 
after publication to comply with the CGMP requirements and 3 years 
after publication to comply with preventive controls requirements. Very 
small businesses will have 3 years after publication to comply with the 
CGMP requirements and 4 years after publication to comply with 
preventive controls requirements. We anticipate that these extended 
implementation periods for small businesses and very small businesses 
will apply to a number of businesses in developing countries. Because 
all of these time periods are longer than the 6 month minimum defined 
in the WTO Ministerial Decision, we believe these implementation 
periods are sufficient to address the needs of businesses in developing 
countries, particularly for small and very small businesses in such 
countries.
    In addition to the extended time periods for compliance for small 
and very small businesses, we have also established modified 
requirements for very small businesses, which we define as a business 
(including any subsidiaries; and affiliates) averaging less than 
$2,500,000, adjusted for inflation, per year, during the 3-year period 
preceding the applicable calendar year, in sales of animal food plus 
the market value of animal food manufactured, processed, packed, or 
held without sale (e.g., held for a fee or supplied to a farm without 
sale). These modified requirements for very small businesses are less 
burdensome and are described in Sec.  507.7 of this regulation.
    In addition to the extended and staggered time periods for 
compliance for all firms, and modified requirements for very small 
businesses, we intend to work with the animal food industry, education 
organizations, USDA, the United States Agency for International 
Development, and foreign governments to develop tools and training 
programs to facilitate implementation of this rule.
    (Comment 506) Some comments assert that the food safety systems of 
the European Union and other countries afford a similar level of food 
safety protection and must therefore be recognized by FDA as equivalent 
under the WTO SPS Agreement. These comments urge FDA to accept the 
HACCP plans and other steps taken to comply with European food safety 
laws as being sufficient to comply with this rule.
    (Response 506) The concept of ``equivalence'' for food safety 
regulatory measures is contained in Article 4 of the World Trade 
Organization Agreement on the Application of Sanitary and Phytosanitary 
Measures (the ``SPS Agreement'') (Ref. 62). That article provides that 
WTO Member countries ``shall accept the sanitary or phytosanitary 
measures of other Members as equivalent, even if these measures differ 
from their own or from

[[Page 56324]]

those used by other Members trading in the same product, if the 
exporting Member objectively demonstrates to the importing Member that 
its measures achieve the importing Member's appropriate level of 
sanitary or phytosanitary protection.'' This provision of the SPS 
Agreement envisions a process in which the exporting country provides 
evidence to the food safety regulator in the importing country in order 
to ``objectively demonstrate'' that the food safety system in the 
exporting member meets the level of food safety protection established 
by the importing country. To date, FDA has considered equivalence as 
most appropriately applied to the assessment of a foreign government's 
specific programs for specific types of foods, such as shellfish and 
dairy products. In that context, the equivalence assessment provides a 
very detailed comparison of each measure that a country applies in 
controlling risks associated with the particular commodity under 
review. FDA continues to have latitude to engage in equivalence 
determinations for market access and as required by our regulations for 
certain commodities.
    In contrast to the assessment of equivalence for the regulation of 
specific foods based upon a detailed review of an individual food 
safety measure or group of measures applied to a specific food, FDA has 
established a process of assessing foreign food safety systems to 
identify systems that offer a comparable level of public health 
protection as the U.S. food safety system for FDA regulated foods. We 
refer to that process as ``systems recognition,'' which we discuss in 
Response 507.
    (Comment 507) Some comments urge FDA to include a provision in this 
rule that would reflect a determination made by FDA in the ``systems 
recognition'' process so that FDA's compliance framework, including 
audit and inspection activities, takes into account the effectiveness 
of the regulatory or administrative control of food safety systems. 
These comments ask us to include a provision in this rule establishing 
that an affirmative systems recognition determination by FDA for an 
exporting country would be a sufficient basis to exempt exporting 
businesses from that country from their obligation to comply with the 
requirements of this rule. Another comment urges FDA to utilize the 
systems recognition process to recognize the effectiveness of the 
European Union (EU) system in order to avoid unnecessary or duplicative 
requirements and controls on food imports from the EU. Another comment 
requests that FDA coordinate inspection and audits with the relevant 
competent authority.
    (Response 507) We agree, in part, with this comment. We agree that 
the systems recognition program can allow FDA to take into account the 
effectiveness of a foreign food safety regulatory system as we develop 
a compliance framework for imported foods from a country for which we 
have made an affirmative determination of comparability via the systems 
recognition program. While we decline to add an exemption for food 
imported from a country with affirmative systems recognition 
determination by FDA, we note that the systems recognition program is 
based upon the concept that foreign food businesses can meet U.S. food 
safety requirements by providing assurances that these foods are 
produced according to the food safety standards of a country that FDA 
has found to be comparable or equivalent to that of the United States. 
Several provisions of the supply-chain program specifically provide for 
consideration of relevant laws and regulations of a country whose food 
safety system FDA has officially recognized as comparable or has 
determined to be equivalent to that of the United States (see 
Sec. Sec.  507.110(d)(1)(iii)(B); 507.130(c)(2), (d)(2), and (e)(2); 
and 507.135(b) and (c)(1)(ii)). However, as of August 30, 2015, FDA has 
not developed a systems recognition program for animal food; therefore, 
we have no signed systems recognition agreements with any foreign food 
safety authority relating to animal food. The currently existing 
systems recognition agreement relates solely to human food and does not 
apply to animal food. For further discussion of the systems recognition 
program, see Response 718 of the final rule for preventive controls for 
human food, published elsewhere in this issue of the Federal Register.
    We also note that we intend to publish a final FSVP rule in the 
near future. There, we intend to establish modified requirements for 
food imported from a foreign supplier in, and under the regulatory 
oversight of, a country whose food safety system FDA has officially 
recognized as ``comparable'' to that of the United States.
    Section 507.105(a)(2) of this rule provides the option for a 
receiving facility that is an importer to comply with the supplier 
verification requirements in this rule or with the foreign supplier 
verification program requirements that we will establish in part 1, 
subpart L for a raw material or other ingredient. We intend that the 
final FSVP rule will contain a similar provision (derived from proposed 
Sec.  1.502), so that only one supplier verification procedure needs to 
be undertaken in order to comply with both rules when the specified 
conditions are met.
    (Comment 508) Some comments assert that a proper harmonization is 
needed with international standards and ask us to harmonize the FSMA 
requirements for the food safety plan with international and domestic 
HACCP programs. These comments also ask us to explain any differences 
between the FSMA food safety plan and the existing HACCP programs and 
ask us to provide exporters with background information and specific 
examples of differences, including how firms are directed to set their 
CCPs and critical limits.
    (Response 508) We currently have no HACCP requirements applicable 
to animal food. For discussion of this comment, see Response 725 in the 
final rule for preventive controls for human food, published elsewhere 
in this issue of the Federal Register.

L. Editorial and Conforming Changes

    The revised regulatory text includes several changes that we have 
made to make the requirements more clear and improve readability. The 
revised regulatory text also includes several conforming changes that 
we have made when a change to one provision affects other provisions. 
We summarize the principal editorial and conforming changes in table 
31.

[[Page 56325]]



          Table 31--Principal Editorial and Conforming Changes
------------------------------------------------------------------------
  Designation in the revised
   regulatory text (Sec.   )         Revision           Explanation
------------------------------------------------------------------------
 11.1(j)..............  Specify that part  Conforming change
                                 11 does not        associated with the
                                 apply to records   recordkeeping
                                 required to be     requirements in Sec.
                                 established or       507.202, which
                                 maintained under   provide that part 11
                                 part 507, and      does not apply to
                                 that records       records required to
                                 that satisfy the   be established or
                                 requirements of    maintained under
                                 part 507, but      part 507.
                                 that also are
                                 required under
                                 other applicable
                                 statutory
                                 provisions or
                                 regulations,
                                 remain subject
                                 to part 11.
Throughout part 507...........             Conforming change
                                 Substitute the     associated with our
                                 term               proposal, in the
                                 ``adequate'' for   2014 supplemental
                                 the term           animal preventive
                                 ``sufficient''.    controls notice, to
                                            make this
                                 Substitute the     substitution so that
                                 term               the rule
                                 ``inadequate''     consistently uses
                                 for the term       the term
                                 ``insufficient''.  ``adequate.''
Throughout part 507...........  Substitute the     Conforming change
                                 term               associated with the
                                 ``pathogen'' for   definition of
                                 the term           ``pathogen.''
                                 ``microorganism
                                 of public health
                                 significance''.
Throughout part 507...........  Substitute the     Conforming change
                                 term               associated with
                                 ``preventive       adding the term
                                 controls           ``preventive
                                 qualified          controls qualified
                                 individual'' for   individual''.
                                 the term
                                 ``qualified
                                 individual''.
Throughout part 507...........  Substitute the     Conforming change
                                 term ``unexposed   associated with the
                                 packaged animal    definition of
                                 food'' for the     ``unexposed packaged
                                 phrase             animal food''.
                                 ``packaged
                                 animal food that
                                 is not exposed
                                 to the
                                 environment''.
Throughout part 507...........  Substitute the     Conforming change
                                 phrase             associated with the
                                 ``chemical         definition of
                                 (including         ``hazard''.
                                 radiological)
                                 hazards'' for
                                 phrases such as
                                 ``chemical and
                                 radiological
                                 hazards''.
Throughout part 507...........  Substitute the     Conforming change
                                 term ``hazard      associated with the
                                 requiring a        proposed definition
                                 preventive         of ``significant
                                 control'' for      hazard'' (which we
                                 the term           now refer to as
                                 ``significant      ``hazard requiring a
                                 hazard''.          preventive
                                                    control'').
Throughout part 507...........  Shorten ``raw      Conforming change
                                 agricultural       associated with the
                                 commodity as       new definition of
                                 defined in         ``raw agricultural
                                 section 201(r)     commodity''.
                                 of the Federal
                                 Food, Drug, and
                                 Cosmetic Act''
                                 to ``raw
                                 agricultural
                                 commodity''.
507.1(a)......................  Redesignate        Improve clarity.
                                 subparagraphs to
                                 distinguish
                                 between applying
                                 the provisions
                                 in determining
                                 whether animal
                                 food is
                                 adulterated and
                                 applying the
                                 provisions in
                                 determining
                                 whether there is
                                 a violation of
                                 the PHS Act.
507.3.........................  Substitute         Improve clarity.
                                 ``apply'' for
                                 ``are
                                 applicable'' in
                                 the introductory
                                 paragraph.
507.3.........................  Alphabetize the    Improve clarity.
                                 examples of
                                 harvesting
                                 activities in
                                 the definition
                                 of
                                 ``harvesting''.
507.3.........................  Alphabetize the    Improve clarity.
                                 examples of
                                 manufacturing/
                                 processing
                                 activities in
                                 the definition
                                 of
                                 ``manufacturing/
                                 processing''.
507.3.........................  Specify that the   Give prominence to
                                 definition of      this aspect of the
                                 ``very small       definition of ``very
                                 business''         small business.''
                                 includes any       The relevance of
                                 subsidiaries and   subsidiaries and
                                 affiliates.        affiliates to the
                                                    definition of ``very
                                                    small business'' is
                                                    established in the
                                                    definition of
                                                    ``qualified
                                                    facility,'' but
                                                    including it again
                                                    in the definition of
                                                    ``very small
                                                    business'' will help
                                                    to ensure that it is
                                                    considered when
                                                    determining whether
                                                    the business is
                                                    within the dollar
                                                    threshold
                                                    established in the
                                                    definition of ``very
                                                    small business''.
 507.3................  Substitute         Conforming change
 507.5................   ``subparts C and   associated with the
 507.7(d).............   E'' for            redesignation of the
 507.10(a)............   ``subpart C''.     requirements for a
 507.65(d)(1).........                      supply-chain program
                                                    in new subpart E.

[[Page 56326]]

 
507.7(a)(2)(ii)...............  Editorial change   Improve clarity.
                                 to place the
                                 clause
                                 ``including an
                                 attestation
                                 based on
                                 licenses,
                                 inspection
                                 reports,
                                 certificates,
                                 permits,
                                 credentials,
                                 certification by
                                 an appropriate
                                 agency (such as
                                 a State
                                 department of
                                 agriculture), or
                                 other evidence
                                 of oversight''
                                 at the end of
                                 the provision,
                                 rather than in a
                                 parenthetical at
                                 the beginning of
                                 the provision.
 507.14...............  Conforming         The definition of
 507.17(a)............   changes            ``plant'' focuses on
 507.20(d)............   associated with    the building,
 507.202(b)...........   the definition     structure, or parts
                                 of ``plant''.      thereof, used for or
                                                    in connection with
                                                    the manufacturing,
                                                    processing, packing,
                                                    or holding of animal
                                                    food. The term
                                                    ``establishment''
                                                    focuses on a
                                                    business entity
                                                    rather than on
                                                    buildings or other
                                                    structures.
507.20(d).....................  Refer to           Editorial change.
                                 ``employees''
                                 rather than
                                 ``its
                                 employees''.
 507.25(a)(2)           Changes to         Conforming change
 through(b)(1).                  consistently       with preventive
 507.33(d)(3).........   refer to raw       controls rule for
 507.105(a)(1)........   materials and      human food.
 507.110(b) through      ``other
 (e).                            ingredients''.
 507.115(a)...........
 507.120(a) and (b)...
 507.130..............
 507.175(c)...........
507.31(b)(3), 507.34(c)(3),     Refer to ``supply- Conforming change
 507.39(b), 507.47(c)(3),        chain program''    associated with the
 507.55(a)(5).                   rather than        title of final
                                 ``supplier         subpart E (proposed
                                 program''.         Sec.   507.37).
 507.47(b)(2).........  Conforming         Improve clarity;
 507.50(b)(4).........   changes            consistency with the
                                 associated with    requirements for
                                 the definition     validation.
                                 of
                                 ``validation''.
507.49(a)(4)(ii)..............  Refer to ``supply- Consequential change
                                 chain              as a result of the
                                 verification       requirement in Sec.
                                 activities,'' as    507.105(c) for
                                 well as            verification of an
                                 ``supplier         entity that is in
                                 verification       the supply-chain but
                                 activities''.      is not a supplier.
507.49(b)(1)..................  Changes to         Conforming change
                                 require written    associated with the
                                 procedures for     requirements to
                                 method and         calibrate process
                                 frequency of       monitoring
                                 accuracy checks    instruments and
                                 for process        verification
                                 monitoring         instruments (or
                                 instruments and    check them for
                                 verification       accuracy).
                                 instruments.
507.50(c)(2)..................  Conforming         Consistency with the
                                 changes            requirements for
                                 associated with    validating
                                 the timeframe      preventive controls.
                                 for validating
                                 preventive
                                 controls.
507.50(d).....................  Editorial changes  Improve clarity.
                                 to the
                                 requirement to
                                 revise the
                                 written food
                                 safety plan or
                                 document why
                                 revisions are
                                 not needed.
507.51(a)(2)..................  Editorial change   Improve clarity.
                                 to specify
                                 ``provide
                                 assurance that
                                 the temperature
                                 controls are
                                 consistently
                                 performed''
                                 rather than
                                 ``provide
                                 assurance that
                                 they are
                                 consistently
                                 performed''.
 507.51(a)(4)(ii).....  Substitute the     Consistency with
 507.51(a)(4)(iii)....   phrase ``records   other recordkeeping
                                 are created''      requirements of the
                                 for the phrase     rule.
                                 ``records are
                                 made''.
507.51(a)(4)(iii).............  Change ``within a  Conforming change
                                 week'' to          associated with
                                 ``within 7         review of records of
                                 working days''.    monitoring and
                                                    corrective action
                                                    records.
507.53(a)(3)..................  Change to specify  Conforming change
                                 the role of the    associated with
                                 preventive         flexibility to
                                 controls           determine the
                                 qualified          timeframe for
                                 individual in      validation of a
                                 determining an     preventive control.
                                 alternative
                                 timeframe for
                                 validation.
507.53(a)(4)..................  Change to specify  Conforming change
                                 the role of the    associated with
                                 preventive         flexibility to
                                 controls           determine that
                                 qualified          validation of a
                                 individual in      preventive control
                                 determining that   is not required.
                                 validation is
                                 not required.
507.53(a)(6)..................  Change to specify  Conforming change
                                 the role of the    associated with
                                 preventive         flexibility to
                                 controls           determine the
                                 qualified          timeframe for review
                                 individual in      of records of
                                 determining an     monitoring and
                                 alternative        corrective actions.
                                 timeframe for
                                 review of
                                 records of
                                 monitoring and
                                 corrective
                                 actions.

[[Page 56327]]

 
507.53(a)(8)..................  Change to specify  Conforming change
                                 the role of the    associated with
                                 preventive         flexibility to
                                 controls           determine the
                                 qualified          timeframe for
                                 individual in      completing
                                 determining an     reanalysis.
                                 alternative
                                 timeframe for
                                 completing
                                 reanalysis.
Subpart D (title).............  Substitute the     Conforming change
507.60........................   term ``qualified   associated with the
507.62........................   facility           definition of
507.65........................   exemption'' for    ``qualified facility
507.67........................   the phrase         exemption''.
507.80........................   ``exemption
507.85........................   applicable to a
                                 qualified
                                 facility'' or
                                 the phrase
                                 ``exemption
                                 applicable to a
                                 qualified
                                 facility under
                                 Sec.
                                 507.5(d)''.
507.60(b)(1)..................  Change ``import    Align with statutory
                                 alert'' to         language regarding
                                 ``refusal of       imports rather than
                                 animal food        with specific
                                 offered for        procedures that FDA
                                 import''.          uses for refusing
                                                    admission to animal
                                                    foods offered for
                                                    import.
507.62(a).....................  Change ``FDA       The provision refers
                                 official senior    to two ``Directors''
                                 to such            and the clause
                                 Director'' to      applies to either
                                 ``FDA official     Director.
                                 senior to either
                                 such Director''.
507.65(c)(2)..................  Refer to           Consistency with
                                 ``conditions or    regulatory text in
                                 conduct'' rather   Sec.   507.60(a)(2).
                                 than ``conduct
                                 or conditions''.
 507.67(a)(2).........  Change ``within    Conforming change to
 507.69(a)(1).........   10 calendar        reflect a timeframe
 507.71(a)(2),........   days'' to          of 15 calendar days,
 507.73(a)............   ``within 15        rather than 10
                                 calendar days''.   calendar days, in
                                                    the order
                                                    withdrawing a
                                                    qualified facility
                                                    exemption.
 507.85(a)............  Specify ``any      Clarify that
 507.85(b)(2).........   problems with      reinstatement of a
                                 the conditions     qualified exemption
                                 and conduct''      that was withdrawn
                                 rather than        requires resolution
                                 ``problems with    of any problems,
                                 the conditions     regardless of
                                 and conduct'' or   whether the problems
                                 ``problems with    related to
                                 the conditions     conditions, conduct,
                                 or conduct''.      or both conditions
                                                    and conduct.
507.202.......................  Refer to ``lot     Consistency with the
                                 code'' rather      definition of
                                 than               ``lot''.
                                 ``production
                                 code''.
507.206.......................  Editorial changes  Improve clarity.
                                 to present the
                                 requirement in
                                 active voice.
------------------------------------------------------------------------

LI. Comments on FSMA's Rulemaking Provisions

A. Comments on Section 418(m) of the FDA&C Act Regarding Modified 
Requirements for Facilities Solely Engaged in the Production of Food 
for Animals Other Than Man

    Section 418(m) of the FD&C Act authorizes the Secretary, by 
regulation, to modify the requirements for compliance under the section 
with respect to facilities that are solely engaged in the production of 
food for animals other than man. We tentatively concluded that the 
requirements of section 418 of the FD&C Act are needed to ensure the 
safety of animal food and in turn the health of animals, the health of 
humans who are exposed to animal food, and the safety of animal derived 
products for human consumption. We proposed certain limited exemptions, 
described elsewhere in this rule, as provided by section 103 of FSMA. 
We sought comment on whether the requirements in section 418 of the 
FD&C Act should be modified further for facilities that are solely 
engaged in the production of food for animals other than man, based on 
scientific and public health principles (78 FR 64736 at 64745).
    (Comment 509) Some comments agree with our proposal to establish 
only minor modifications to the requirements of section 418 of the FD&C 
Act for facilities solely engaged in the production of food for animals 
other than man. Other comments ask that we consider proposing more 
extensive modified requirements for animal food, or exempting feed 
mills, using the authority under section 418(m).
    (Response 509) We did not receive comments that provided sufficient 
data and rationale to support changing our proposed modifications to 
the requirements in section 418 of the FD&C Act. However, the final 
rule provides risk-based flexibility in the preventive controls 
requirements and their management components by recognizing the 
importance of the facility, the food, the nature of the preventive 
control, and its role in the facility's food safety system. For our 
approach to feed mills, see our discussion in section IV.

B. Comments on Requirements in Section 418(n)(3) of the FD&C Act 
Regarding Content

    FSMA specifies that this rule acknowledge differences in risk and 
minimize, as appropriate, the number of separate standards that apply 
to separate foods (section 418(n)(3)(C) of the FD&C Act).
    (Comment 510) Some comments agree that the proposed preventive 
controls requirements reflect a risk-based approach and recognition 
that a ``one-size-fits-all'' approach is not appropriate in the 
application of hazard analysis and risk-based preventive controls 
across the entire domestic and international food industry. These 
comments ask us to retain this flexibility in the final rule by 
describing the required and expected results of the program, but not 
going as far as prescribing the process and methodology taken to get 
there. Other comments emphasize that the final rule must provide 
sufficient flexibility to allow facilities to adopt practices that are 
practical and effective for their specific, individual operations. One 
comment expressed the opinion that

[[Page 56328]]

different manufacturing and distribution practices are necessary to 
ensure the safety of human food, pet food, and livestock food.
    (Response 510) The final rule directs the owner, operator, or agent 
in charge of a facility to establish and implement a food safety plan 
that includes a written hazard analysis, preventive controls that the 
facility identifies to control hazards requiring a preventive control, 
and establish and implement appropriate preventive control management 
components to ensure the effectiveness of the preventive controls, 
taking into account the facility, the food, the nature of the hazard, 
the nature of the preventive control and its role in the facility's 
food safety system. As requested by the comments, the rule does not 
prescribe the process and methodology to ``get there.''
    (Comment 511) Some comments interpret the statutory direction in 
section 418(n)(3)(C) of the FD&C Act to mean that Congress granted us 
authority to provide flexibility for businesses of all sizes and types 
(i.e., not just small businesses), as well as to acknowledge 
differences in risk. These comments assert that section 418(n)(3)(C) 
grants us authority to exempt distribution centers from the 
requirements for hazard analysis and risk-based preventive controls 
because: (1) Distribution centers are very low-risk facilities and (2) 
requiring distribution centers to comply with those requirements would 
not be practicable.
    (Response 511) We disagree with these comments. A pet food 
distribution center must register as a food facility because it holds 
food for animal consumption and does not satisfy any of the criteria 
for entities that are not required to register (see Sec.  1.226). The 
preventive controls that such a facility would establish and implement 
would depend on the facility, the animal food, and the outcome of the 
facility's hazard analysis, and any preventive control management 
components associated with a facility's preventive controls would be 
established as appropriate to ensure the effectiveness of the 
preventive controls, taking into account the nature of the preventive 
control and its role in the facility's food safety system. In the case 
of a facility that is a pet food distribution center, the facility 
would, as part of its evaluation, determine whether any preventive 
controls are necessary for unexposed, non-refrigerated packaged animal 
foods. The facility might determine that the modified requirements in 
Sec.  507.51 for unexposed, refrigerated, packaged TCS animal foods are 
appropriate to apply to such foods that it holds. If so, the facility 
could establish its food safety plan by building on the provisions 
established in Sec.  507.51.

LII. Comments on Proposed Conforming Amendments

    We proposed a series of conforming amendments to current 
regulations to add a reference to part 507. The affected sections in 
Title 21 CFR Chapter 1 are:
     Sec.  11.1 Scope;
     Sec.  16.1 Scope;
     Sec.  117.95 Holding and distribution of human food by-
products for use as animal food;
     Sec.  225.1 Current good manufacturing practice;
     Sec.  500.23 Thermally processed low-acid foods packaged 
in hermetically sealed containers; and
     Sec.  579.12 Incorporation of regulations in part 179.
    We received no comments that disagree with the proposed conforming 
changes. Therefore, at this time we are amending each of these current 
regulations so that they refer to part 507 except for the amendment to 
part 225. We proposed to add a new paragraph (d) in Sec.  225.1 stating 
that ``In addition, nonmedicated feed is subject to part 507 of this 
chapter.'' All animal food facilities that are required to register as 
a food facility under section 415 of the FD&C Act are subject to the 
requirements of part 507. This would include those facilities that 
manufacture medicated animal feed, nonmedicated animal feed, or both. 
Because of this, we do not think the conforming change to part 225 is 
necessary and we are not finalizing this conforming change.

LIII. Effective and Compliance Dates

A. Effective and Compliance Dates for Part 507

    We proposed that the final rule based on proposed part 507 would 
become effective 60 days after its date of publication in the Federal 
Register, with staggered compliance dates (78 FR 64736 at 64751). We 
tentatively concluded that it was reasonable to allow for 1 year after 
the date of publication of the final rule for businesses other than 
small and very small businesses to comply with the rule. We also 
tentatively concluded that it was reasonable to allow for 2 years after 
the date of publication of the final rule for small businesses to 
comply with the rule, and 3 years after the date of publication of the 
final rule for very small businesses to comply with the rule.
    We received one comment agreeing with our proposed compliance 
dates. In the following paragraphs, we discuss comments that disagree 
with, or suggest one or more changes to, these proposed compliance 
dates. After considering these comments, we have concluded that 
additional time is needed for the animal food industry to comply with 
this final rule. Therefore, the compliance date for implementation of 
subpart C, Hazard Analysis and Preventive Controls and subpart E, 
Supply-Chain Program, is extended one year beyond the compliance date 
for the implementation of subpart B, Current Good Manufacturing 
Practice. Businesses other than small and very small businesses will 
have 1 year after the date of publication to comply with the CGMP 
requirements and 2 years after publication to comply with preventive 
controls and supply-chain requirements. Small businesses will have 2 
years after publication to comply with the CGMP requirements and 3 
years after publication to comply with preventive controls and supply-
chain requirements. Very small businesses will have 3 years after 
publication to comply with the CGMP requirements and 4 years after 
publication to comply with preventive controls requirements.
    In addition, we are establishing an earlier compliance date for the 
financial records that a facility maintains to support its status as a 
very small business that is eligible for the qualified facility 
exemption in Sec.  507.5(d). Specifically, the compliance date for a 
facility to retain records to support its status as a qualified 
facility is January 1, 2017. (See Response 76.)
    We are also establishing separate compliance dates for the supply-
chain program provisions. As discussed in Response 515, a receiving 
facility's compliance date for the supply-chain program provisions of 
this rule is the later of: (1) The receiving facility's compliance date 
for the other preventive controls requirements under this rulemaking; 
(2) for a raw material or other ingredient from a supplier subject to 
the preventive controls requirements of this rule, six months after the 
receiving facility's supplier of that raw material or ingredient is 
required to comply with the preventive controls requirements of this 
rule; or (3) for a raw material or other ingredient that from a 
supplier subject to CGMPs, but not the preventive controls requirements 
of this rule, 6 months after the receiving facility's supplier of that 
animal food is required to comply with the CGMP requirements of this 
rule. See tables 32 and 33 for a summary of these compliance dates.

[[Page 56329]]



 Table 32--Compliance Dates for the Requirements of Part 507 Other Than
         the Requirements for a Supply-Chain Program (Subpart E)
------------------------------------------------------------------------
                                  Compliance date
                                   for subpart B     Compliance date for
        Size of business            and related      subpart C and Sec.
                                    requirements            507.7
------------------------------------------------------------------------
Qualified facility (including    September 17,      September 17, 2019,
 very small business) as          2018.              except that the
 defined in Sec.   507.3.                            compliance date for
                                                     a facility to
                                                     retain records to
                                                     support its status
                                                     as a qualified
                                                     facility is January
                                                     1, 2017.
Small business as defined in     September 18,      September 17, 2018.
 Sec.   507.3.                    2017.
All other businesses...........  September 19,      September 18, 2017.
                                  2016.
------------------------------------------------------------------------


   Table 33--Compliance Dates for the Requirements of the Supply-Chain
                           Program (Subpart E)
------------------------------------------------------------------------
               Situation                         Compliance date:
------------------------------------------------------------------------
A receiving facility is a small          6 months after the receiving
 business and its supplier will be        facility's supplier of that
 subject to the CGMPs, but not the        raw material or other
 preventive control requirements, of      ingredient is required to
 the animal food preventive controls      comply with the CGMP
 rule.                                    requirements of this rule.
A receiving facility is a small          The later of: September 17,
 business and its supplier is subject     2018 or 6 months after the
 to the animal food preventive controls   receiving facility's supplier
 rule.                                    of that raw material or other
                                          ingredient is required to
                                          comply with this rule.
A receiving facility is not a small      6 months after the receiving
 business or a very small business and    facility's supplier of that
 its supplier will be subject to CGMPs,   raw material or other
 but not the preventive control           ingredient is required to
 requirements, of the animal food         comply with the CGMP
 preventive controls rule.                requirements of this rule.
A receiving facility is not a small      The later of: September 18,
 business or a very small business and    2017 or 6 months after the
 its supplier will be subject to the      receiving facility's supplier
 animal food preventive controls rule.    of that raw material or other
                                          ingredient is required to
                                          comply with the applicable
                                          rule.
------------------------------------------------------------------------

    We also are establishing two additional compliance dates applicable 
to qualified facilities. We are establishing December 16, 2019 first as 
the compliance date for the initial submission of the attestation by a 
facility that it is a qualified facility (see Sec.  507.7(a)(1)) and 
the attestation by a qualified facility about its food safety practices 
(see Sec.  507.7(a)(2)(i)), or that it is in compliance with non-
Federal food safety law (see Sec.  507.7(a)(2)(ii)), and second as the 
compliance date for the notification requirement of Sec.  507.7(e)(1). 
A qualified facility that submits an attestation that it is in 
compliance with applicable non-Federal food safety law must notify 
consumers as to the name and complete business address of the facility 
where the animal food was manufactured or processed (see Sec.  
507.7(e)). If an animal food packaging label is required, the required 
notification must appear prominently and conspicuously on the label of 
the animal food (see Sec.  507.7(e)(1)). This notification requirement 
may require some qualified facilities to update the labels of their 
packaged animal food products.
    (Comment 512) Some comments disagree with the proposed compliance 
dates and our tentative conclusion that concepts in the CGMP 
regulations would not be new to the animal food industry. Comments 
state that both large and small facilities would need to expend 
considerable resources to implement the practices and procedures to 
comply with the new requirements. A few comments note that the 
complexity of the proposed regulation presents a challenge for 
compliance within the proposed timeframes. Because both CGMPs and 
preventive controls are new for the animal food industry, comments 
request additional time to comply with the regulations. Some comments 
also note that manufacturers of human food have had many years to 
comply with CGMPs, and the expectation that the animal food industry 
will comply with both CGMP and preventive controls requirements in a 
narrow timeframe is not reasonable. The majority of comments agree that 
the implementation dates for the CGMP regulations should come before 
the implementation date of the preventive controls regulations.
    (Response 512) We agree with the comments and are extending the 
compliance date for implementation of the preventive controls 
regulations 1 year beyond the compliance date for the implementation of 
CGMP requirements. Because both the CGMP and preventive controls 
regulations are new to the animal food industry, we understand that 
these facilities would have been learning and implementing many new 
requirements during the proposed timeframe. With an extra year before 
they must implement preventive controls requirements, animal food 
facilities will be able to focus on developing and implementing the 
applicable CGMPs for their facilities. Many of these CGMPs are 
considered prerequisites for a preventive controls program. Having 
CGMPs well in place before having to implement the preventive controls 
requirements will provide the facility with a better understanding of 
the additional controls that might be needed to significantly minimize 
or prevent any significant hazards associated with the animal food that 
the facility has identified. In addition, facilities will have more 
time to educate and train their employees on the preventive controls 
requirements the facility will need to implement. FDA intends to work 
closely with the animal food industry, extension and education 
organizations, and state partners to develop the tools and training 
programs needed to facilitate implementation of the final rule.
    (Comment 513) Some comments recommend that compliance dates for the 
preventive controls rule for animal food be set for 3 years after the 
60-day effective date of the rule, regardless of firm size.
    (Response 513) We disagree with this comment. Although the 
requirements in this final regulation are new for the animal food 
industry, some individual animal food facilities, either individually 
or through feed industry associations, have implemented some procedures 
that are consistent with the proposed requirements. Not all concepts

[[Page 56330]]

and processes are new to the entire animal food industry, especially 
the larger facilities. Therefore, we conclude that these larger 
facilities should not need 3 years to comply with the requirements of 
this final regulation, in contrast to some of the very small 
businesses.
    (Comment 514) Some comments ask us to clarify when a very small 
business would need to comply with the rule if the business starts up 
after the rule goes into effect.
    (Response 514) A very small business that is operating as of the 
date of publication of the final rule, or begins operating any time 
before the compliance date for very small businesses, must comply with 
the rule by the compliance date for very small businesses. A very small 
business that begins operation any time after the compliance date for 
very small businesses must comply with the rule when it begins 
operation, and should plan accordingly.
    (Comment 515) Some comments request that compliance dates for the 
proposed preventive controls rule coincide with the requirements of the 
proposed foreign supplier verification program rule.
    (Response 515) We are finalizing separate compliance dates for the 
supply-chain program provisions of this rule. While this adds 
complexity, we are doing this for two main reasons. First, we are 
aligning, to the extent feasible, the compliance dates of the supply-
chain program provisions of this rule with the compliance dates of the 
forthcoming FSVP rule, which we intend to publish in the coming months. 
This will provide greater coordination across the programs, 
particularly with respect to the verification of domestic and imported 
raw materials and other ingredients. Second, we want to minimize the 
likelihood that a receiving facility will be required to comply with 
the supply-chain program provisions of this rulemaking before its 
supplier is required to comply with applicable new food safety 
regulations implementing FSMA. Our goal is to avoid a situation in 
which a receiving facility would be required to develop a supply-chain 
program for an animal food from a particular supplier and then be 
required to revise this supply-chain program shortly thereafter once 
the supplier is subject to an applicable new food safety regulation--
specifically, the preventive controls rule for animal food. Therefore, 
the compliance dates for the supply-chain program have been revised. A 
receiving facility's compliance date for the supply-chain program 
provisions of this rule is the later of: (1) The receiving facility's 
compliance date for the other preventive controls requirements under 
this rulemaking; (2) for a raw material or other ingredient from a 
supplier subject to the preventive controls requirements of this rule, 
6 months after the receiving facility's supplier of that raw material 
or ingredient is required to comply with the preventive controls 
requirements of this rule; or (3) for a raw material or other 
ingredient that from a supplier subject to CGMPs, but not the 
preventive controls requirements of this rule, 6 months after the 
receiving facility's supplier of that animal food is required to comply 
with the CGMP requirements of this rule.

B. Effective Dates for Conforming Amendments

    The conforming amendments to regulations in parts 500 and 579 are 
technical amendments that add a cross-reference to part 507. The 
conforming amendment to part 11 adds a reference to the scope of part 
11 that the records required under part 507 are not subject to part 11. 
The conforming amendment to part 16 adds a reference to the scope of 
part 16 for new procedures in part 507, subpart D that provide a person 
with an opportunity for a hearing under part 16. These conforming 
amendments are effective on November 16, 2015, the same date as the 
effective date of part 507. We are not establishing compliance dates 
for these conforming amendments. As a practical matter, compliance 
dates will be determined by the dates for compliance with part 507.

C. Delayed Effective Dates for Provisions That Refer to the Forthcoming 
Rules for Produce Safety and Third-Party Certification

    The following provisions refer to provisions we intend to establish 
in the near future in part 112 (Standards for the Growing, Harvesting, 
Packing, and Holding of Produce for Human Consumption): Sec. Sec.  
507.12(a)(1)(ii), 507.105(c), 507.110(d)(2)(ii), 507.130(d), and 
507.175(c)(13). In addition, paragraph (2) of the definition of 
``qualified auditor'' in Sec.  507.3 and Sec.  507.135(d) refers to 
provisions we intend to establish in the near future in part 1, subpart 
M (Accredited Third-Party Food Safety Audits and Food or Facility 
Certification). In addition, Sec. Sec.  507.105(a)(2) and 507.175(c)(2) 
refer to provisions we intend to establish in the near future in part 
1, subpart L (Foreign Supplier Verification Programs for Food 
Importers). We will publish a document in the Federal Register 
announcing the effective dates of paragraph (2) of the definition of 
``qualified auditor'' in Sec.  507.3, and Sec. Sec.  507.12(a)(1)(ii), 
507.105(a)(2), 507.105(c), 507.110(d)(2)(ii), 507.130(d), 507.135(d), 
507.175(c)(2) and 507.175(c)(13).

LIV. Compliance and Enforcement

    Gaining industry compliance with the provisions of this rule is as 
important as establishing the provisions. A central element of our 
strategy to gain industry compliance is to help make available to 
facilities subject to this rule the education and technical assistance 
they need to understand and implement the requirements (Ref. 5). Within 
the Agency we are establishing a Food Safety Technical Assistance 
Network and seeking funding to increase FDA staffing to provide a 
central source of information to support industry understanding and 
implementation of FSMA standards (Ref. 5). This will allow us to 
respond in a timely and consistent way to industry questions on 
preventive controls technical and compliance issues (Ref. 5).
    We also are working in collaboration with the FSPCA to develop 
training materials and establish training and technical assistance 
programs (Ref. 4) and (Ref. 6). The FSPCA includes members from FDA, 
State food protection agencies, the animal food industry, and academia. 
It is funded by a grant to the Illinois Institute of Technology's 
Institute for Food Safety and Health, a nationally-recognized leader in 
food safety. In addition to developing a standardized preventive 
controls training curriculum, the FSPCA is developing selected sections 
of model food safety plans for several animal food types that will 
provide needed instructional examples. Although we have provided 
funding to the FSPCA to develop a standardized preventive controls 
training curriculum, we are unable to fund training for individual 
groups who might need particular training materials.
    We also are partnering with the NIFA of USDA to administer the 
FSMA-mandated National Food Safety Training, Education, Extension, 
Outreach, and Technical Assistance Program, a grant program to provide 
technical assistance for FSMA compliance to owners and operators of 
small and medium-size farms and small food processors (Ref. 7). Such 
efforts will help ensure widespread voluntary compliance by encouraging 
greater understanding and adoption of established food safety 
standards, guidance, and protocols.
    With regard to inspections, we will conduct regular inspections of 
domestic facilities to ensure that facilities subject to this rule are 
adequately implementing

[[Page 56331]]

the required preventive controls and supply-chain program, pursuant to 
our inspection authority under section 704 of the FD&C Act. Our 
inspections will verify that such facilities are implementing systems 
that effectively protect against animal food contamination, and in 
particular, that they comply with the rule by implementing preventive 
controls, including supply-chain programs, to provide assurances that 
any hazard requiring a preventive control or supply-chain applied 
control has been significantly minimized or prevented.
    In order to effectively carry out this new paradigm of animal food 
safety, we will need to reorient and retrain our staff. To this end, we 
are seeking additional funding, including for the training of more than 
2,000 FDA inspectors, compliance officers, and other staff involved in 
food safety activities (Ref. 10).
    We also plan to leverage the resources of State, local, tribal, and 
territorial governments to conduct domestic verification activities. We 
are working with officials from these governments through the PFP to 
develop and implement a national Integrated Food Safety System, which 
will focus on establishing partnerships for achieving compliance (see 
section 209(b) of FSMA), and which will allow us to utilize the 
thousands of State, local, and tribal inspectors available to help with 
the domestic verification process.
    Section 201 of FSMA mandates that FDA inspect domestic high-risk 
facilities no less than once every 3 years. Consistent with FSMA, FDA 
will use its current resources, new resources that it obtains, and its 
partnerships to conduct regular inspections of covered facilities, 
focusing on those facilities that pose the highest risk to animal food 
safety.

LV. Executive Order 13175

    In accordance with Executive Order 13175, FDA has consulted with 
tribal government officials. A tribal summary impact statement has been 
prepared that includes a summary of tribal officials' concerns and how 
FDA has addressed them (Ref. 63). Persons with access to the Internet 
may obtain the tribal consultation report at http://www.fda.gov/pcafrule or at http://www.regulations.gov. Copies of the tribal summary 
impact statement also may be obtained by contacting the person listed 
under FOR FURTHER INFORMATION CONTACT.

LVI. Economic Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all 
costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety, and other advantages; distributive impacts; and 
equity). Executive Order 13563 emphasizes the importance of quantifying 
both costs and benefits, of reducing costs, of harmonizing rules, and 
of promoting flexibility. FDA has developed an FRIA that presents the 
benefits and costs of this final rule (Ref. 60). The Office of 
Management and Budget (OMB) has determined that this final rule is an 
economically significant regulatory action as defined by Executive 
Order 12866.
    The summary analysis of benefits and costs included in this 
document is drawn from the detailed FRIA (Ref. 60) which is available 
at http://www.regulations.gov (enter Docket No. FDA-2011-N-0922), and 
is also available on FDA's Web site at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.
    The Regulatory Flexibility Act requires Agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on a substantial number of small entities. Because the final rule would 
impose annualized costs that range from $25,000 to $34,000 on many 
small entities, the Agency determined that the final rule will have a 
significant economic impact on a substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that Agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before finalizing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $144 million, using the most current (2014) Implicit 
Price Deflator for the Gross Domestic Product. FDA expects this final 
rule will likely result in a 1-year expenditure that will meet or 
exceed this amount.

LVII. Analysis of Environmental Impact

    FDA has determined under 21 CFR 25.30(j) that this action is of a 
type that does not individually or cumulatively have a significant 
effect on the human environment (Ref. 64). Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.

LVIII. Paperwork Reduction Act of 1995

    This final rule contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The title, 
description, and respondent description of the information collection 
provisions are shown in this section with an estimate of the annual 
reporting, recordkeeping, and third-party disclosure burden. Included 
in the estimate is the time for reviewing instructions, searching 
existing data sources, gathering and maintaining the data needed, and 
completing and reviewing each collection of information.
    Title: Current Good Manufacturing Practice, Hazard Analysis and 
Risk-Based Preventive Controls for Food for Animals.
    Description: Regulations issued in the final rule entitled, 
``Current Good Manufacturing Practice, Hazard Analysis and Risk-Based 
Preventive Controls for Food for Animals,'' implement section 418 of 
the FD&C Act, as amended by the FDA Food Safety Modernization Act 
(FSMA). The regulations establish science-based minimum standards for 
conducting a hazard analysis, documenting hazards requiring preventive 
controls, implementing preventive controls, and documenting the 
implementation of the preventive controls by domestic and foreign 
animal food facilities registered with FDA under section 415 of the 
FD&C Act. The regulations also establish current good manufacturing 
practice for the manufacturing, processing, packing, and holding of 
animal food.
    The preventive controls regulations require animal food facilities 
to have a written food safety plan that includes a hazard analysis; a 
description of preventive controls (including recall procedures); a 
supply-chain program, a description of procedures for monitoring the 
preventive controls; corrective action if preventive controls are not 
properly implemented; and a description of procedures for verifying 
implementation and effectiveness of the preventive controls.

[[Page 56332]]

    The regulations further require facilities to establish and 
implement verification procedures for product testing and environmental 
monitoring, and require that the hazard analysis and risk-based 
preventive controls for animal food take into account the possibility 
of economically motivated adulteration of animal food. Facilities that 
manufacture, process, pack, or hold food for animals and foods for 
human consumption and are subject to part 117 (as finalized elsewhere 
in this issue of the Federal Register) may choose to comply with part 
117 with respect to the animal food, provided the food safety plan 
addresses the hazards specific to animal food where applicable.
    The final rule also establishes certain exemptions, under 
applicable regulations. The rule imposes specific reporting 
requirements on facilities claiming the very small business qualified 
facility exemption.
    Description of Respondents: Facilities that manufacture, process, 
pack, or hold food for animals. Generally, a facility is required to 
register if it manufactures, processes, packs, or holds animal food for 
consumption in the United States. At the time of this analysis, the 
number of animal food facilities registered with the Agency was 7,469.
    In the Federal Register of October 29, 2013 (78 FR 64736), FDA 
published a proposed rule including a Paperwork Reduction Act (PRA) 
analysis of the information collection provisions found in the 
regulations. In the Federal Register of September 29, 2014 (79 FR 
58476), FDA published a supplemental notice of proposed rulemaking also 
including a PRA analysis. Although FDA did not receive comments 
specifically addressing the four information collection topics 
solicited in both the 2013 proposed preventive controls rule for animal 
food and the 2014 supplemental notice, we have revised our burden 
estimate consistent with finalization of the rule's requirements.
    FDA estimates the burden for this information collection as 
follows:
Reporting Burden
    Table 34 shows the total estimated annual reporting burden 
associated with this final rule. This estimate is a revision from 
reporting estimates found in our proposed rulemaking, reflecting an 
updated count of the number of facilities registered with the Agency as 
animal food facilities, and resulting in an overall decrease from our 
previous estimate.

                                 Table 34--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                     Number of       Number of     Total annual     burden per
    21 CFR Section; activity        respondents    responses per     responses     response  (in    Total hours
                                                    respondent                        hours)
----------------------------------------------------------------------------------------------------------------
507.7 exemption: submit                    1,120              .5             560             *.5             280
 attestation that facility is a
 qualified facility and
 attestation of preventive
 controls or compliance with non-
 Federal food safety laws.......
507.67, 507.69, and 507.71;                    1               1               1               4               4
 submission of an appeal,
 including submission of a
 request for an informal hearing
507.85(b); requests for                        1               1               1               2               2
 reinstatement of exemption.....
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............             286
----------------------------------------------------------------------------------------------------------------
\1\ Capital and other costs of implementation and compliance for this final rule are discussed in the FRIA (Ref.
  60).
* (30 minutes).

    Out of 7,469 animal food facilities registered with FDA, we 
estimate approximately 15% (1,120) could be ``qualified'' facilities 
under the ``very small business'' definition as discussed in the FRIA 
(Ref. 60), and thus eligible for certain limited exemptions under the 
applicable regulations. Section 507.5 exempts qualified facilities from 
subpart C and E of the regulations, which includes all of the hazard 
analysis and preventive controls requirements, including supply-chain 
program requirements. The number of respondents in table 34, row 1 is 
derived from Agency estimates of the number of qualified animal food 
facilities that must report their status as such a facility every 2 
years. The number of total annual responses is calculated by 
multiplying the number of respondents by the number of responses 
submitted annually. The average hourly time burden per response found 
in table 34, column 5 is based on FDA's assumption that a facility will 
report its status electronically through a Web portal maintained by 
FDA, and that this will take approximately 0.5 hours (30 minutes).
    The estimated burden associated with the requirements under 
Sec. Sec.  507.67, 507.69, and 507.71 of the regulations is reflected 
in table 34, row 2. Based on the limited data on foodborne illness 
outbreaks originating at very small animal food facilities, FDA does 
not expect to withdraw many qualified facility exemptions and expects 
the number of appeals to be even fewer. The estimated number of 
respondents is based on the Agency's expectation that the number of 
appeals will be very few. The number of responses per respondent 
reflects that the rule only requires one submission per appeal. Given 
that facilities must respond with particularity to the facts and issues 
contained in the withdrawal order, the Agency estimates an average 
burden of 4 hours per response.
    The estimated burden associated with the requirements under Sec.  
507.85(b) is reflected in table 34, row 3. The Agency expects few, if 
any, requests for reinstatement of an exemption that has been withdrawn 
under the regulations and thus is providing an estimate of only 1 per 
year at this time. We estimate the time necessary for making such a 
request to be no more than 2 hours, which includes submitting the 
written request and presenting information that the animal food safety 
problems were adequately resolved and continued withdrawal of the 
exemption is not necessary to protect public (human and animal) health.
Recordkeeping Burden
    Table 35 shows the total estimated annual recordkeeping burden 
associated with this final rule. This estimate is a revision from the 
recordkeeping estimates found in our proposed rulemaking, reflecting an 
updated count of the number of registered animal food facilities, as 
well as additional recordkeeping requirements associated with the 
various preventive control provisions and recordkeeping

[[Page 56333]]

requirements associated with the supply-chain program implemented at 
Subpart E.

                                                     Table 35--Estimated Annual Recordkeeping Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                   Number of
          21 CFR part 507; activity               Number of       records per      Total annual     Average  burden per  recordkeeping      Total hours
                                                recordkeepers     recordkeeper       records                    (in hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              Subpart A--General Provisions
--------------------------------------------------------------------------------------------------------------------------------------------------------
507.7(e); records attesting that the facility            1,120               .5              560  .1 (6 minutes)........................              56
 is a ``qualified'' facility.
507.4(d); documentation of animal food safety            7,469             0.75            5,579  0.04 (2 minutes)......................             279
 and hygiene training.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                              Subpart C--Hazard Analysis and Risk-Based Preventive Controls
--------------------------------------------------------------------------------------------------------------------------------------------------------
507.31-507.55; food safety plan, including               7,469              519        3,876,411  .10 (6 minutes).......................         387,641
 hazard analysis, preventive controls, and
 procedures for monitoring, corrective
 actions, and verification; recall plan;
 validation; reanalysis; modifications; and
 implementation records.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                             Subpart E--Supply-Chain Program
--------------------------------------------------------------------------------------------------------------------------------------------------------
507.105-507.175; written supply-chain                    7,469              519        3,876,411  .10 (6 minutes).......................         387,641
 program, including records documenting
 program.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                       Subpart F--Requirements Applying to Records
--------------------------------------------------------------------------------------------------------------------------------------------------------
507.200-507.215; general requirements,                   7,469              519        3,876,411  .10 (6 minutes).......................         387,641
 additional requirements applying to food
 safety plan, requirements for record
 retention, use of existing records, and
 special requirements applicable to written
 assurance.
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................  ...............  ...............       11,629,793  ......................................       1,163,258
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Capital and other costs of implementation and compliance with this final rule are discussed in the FRIA (Ref. 60).

    Under the final rule, we estimate a total of 7,469 respondents (the 
number of registered animal food facilities) are subject to 
recordkeeping requirements found in the applicable regulations. 
Although FDA believes that, in some cases, all respondents will incur 
new recordkeeping activities as a result of the final rule (e.g., 
documentation of training in the principles of animal food hygiene and 
safety), we believe other provisions may apply only to certain 
respondents (e.g., documentation of a supply-chain program), depending 
upon the applicable regulation. With regard to the hazard-analysis and 
risk-based preventive controls, the supply-chain program, and the 
requirements applying to records under part 507 subparts C, E, and F, 
respectively, we have provided a cumulative burden and averaged burden 
per recordkeeping that we believe will be incurred by the respondents 
under this final rule based on information available to us at this 
time. After allowing for implementation of the final rule and upon 
seeking reauthorization for its information collection provisions, FDA 
will reassess its burden estimate accordingly.
Third-Party Disclosure Burden
    Table 36 shows the total estimated third-party disclosure burden 
associated with the final rule. This figure has been revised from the 
third-party disclosure estimates found in our proposed rulemaking. This 
revision reflects fewer than anticipated third-party disclosure 
requirements under the final rule and results in an overall decrease to 
our total estimated annual third-party disclosure burden by 36,315 
hours.

                                              Table 36--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                     Number of
            21 CFR Section; activity                Number of     disclosures per    Total annual   Average  burden per  disclosure  (in    Total hours
                                                   respondents       respondent      disclosures                   hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
507.27(b); labeling for the animal food product              330               10            3,300  0.25 (15 minutes)...................             825
 contains the specific information and
 instructions needed so the food can be safely
 used for the intended animal species.
507.7(e)(1); change labels on products with                1,526                4            6,104  1...................................           6,104
 labels.
507.7(e)(2); change address on labeling (sales             1,329                1            1,329  1...................................           1,329
 documents) for qualified facilities.
507.25(a)(2); animal food, including raw                     330              312          102,960  .01 (1 minute)......................           1,030
 materials, other ingredients, and rework, is
 accurately identified.

[[Page 56334]]

 
507.28(b); holding and distribution of human              40,798                2           81,596  0.25 (15 minutes)...................          20,399
 food byproducts for use as animal food.
                                                --------------------------------------------------------------------------------------------------------
    Total......................................  ...............  ...............  ...............  ....................................          29,687
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Capital and other costs of implementation and compliance for this final rule are discussed in the FRIAs (Ref. 60).

    Under the final rule, we estimate all (7,469) respondents are 
subject to third-party disclosure requirements found in the applicable 
regulations. The number in column 2 represents an estimated annual 
number of those respondents we believe will incur third-party 
disclosure burdens under the respective regulation shown in column 1. 
This figure is derived from our familiarity with third-party burden 
associated with similar FDA regulations. Upon implementation of the 
final rule, the Agency will reevaluate its estimate accordingly.
    To calculate the number of annual disclosures, we multiplied the 
number of respondents in column 2 by an estimated number of disclosures 
in column 3. This figure represents the estimated annual number of 
disclosures per respondent we attribute for the respective requirement. 
To calculate the annual hourly burden, we multiplied the number of 
annual disclosures by an estimated hourly burden in column 5. This 
figure represents the amount of time we attribute to conducting the 
respective disclosure activities identified in column 1.
    Section 507.7(a)(2) provides that qualified facilities must either 
submit to FDA attestation of hazard identification, preventive controls 
implementation, and monitoring, or attestation that the facility is in 
compliance with applicable non-Federal food safety law.
    Section 507.7(e) requires a qualified facility that chose the 
latter to notify consumers of the name and business address of the 
facility where the animal food was manufactured or processed: (1) On 
the label if a package label is required by other provisions of the 
FD&C Act or (2) on labeling at the point of purchase if no label is 
required.
    Section 507.25(a)(2) provides that the management of the plant must 
ensure that animal food, including raw materials, other ingredients, or 
rework, is accurately identified as part of plant operations. (See 
Sec. Sec.  7.49 and 7.42(b)(1) and (2) (21 CFR 7.49 and 7.42(b)(1) and 
(2)).)
    Section 507.38(b)(1) and (2) does not add to the estimated hourly 
burden because facilities initiating recalls may notify consignees and 
the public. (See Sec. Sec.  7.49 and 7.42(b)(1) and (2)).)
    Under section 507.28(b), labeling that identifies the product by 
the common or usual name must be affixed to or accompany the human food 
by-product for use as animal food when distributed. The estimated 
number of disclosures per respondent and average burden per disclosure 
assumes that 60 percent of the 67,996 domestic human food manufacturing 
facilities (Ref. 65) or 40,798 facilities are affected, and that two 
sets of labeling per facility per year will be required. We estimate 
0.25 hours per disclosure to prepare labeling, and affix to the 
containers, for a total of 20,399 burden hours.
    The information collection provisions of this final rule have been 
submitted to OMB for review. Prior to the effective date of this final 
rule, FDA will publish a notice in the Federal Register announcing 
OMB's decision to approve, modify, or disapprove the information 
collection provisions in this final rule. An Agency may not conduct or 
sponsor, and a person is not required to respond to, a collection of 
information unless it displays a currently valid OMB control number.

LIX. Federalism

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the rule 
does not contain policies that have substantial direct effects on the 
States, on the relationship between the National Government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government. Accordingly, the Agency has concluded 
that the rule does not contain policies that have federalism 
implications as defined in the Executive order and, consequently, a 
federalism summary impact statement is not required.

LX. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES) and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday, 
and are available electronically at http://www.regulations.gov. (FDA 
has verified the Web site addresses in this section, but FDA is not 
responsible for any subsequent changes to the Web sites after this 
document publishes in the Federal Register.)

1. FDA, ``Record of Outreach for Proposed Rule for PC Animal Food,'' 
2014.
2. FDA, `` Record of Outreach for Supplemental Rule for PC Animal 
Food,'' 2015.
3. FDA, `` Qualitative Risk Assessment: Risk of Activity/Animal Food 
Combinations for Activities (Outside the Farm Definition) Conducted 
in a Facility Co-Located on a Farm,'' 2015.
4. FDA, ``Technical Staffing and Guidance Development at FDA,'' 
(http://www.fda.gov/Food/GuidanceRegulation/FSMA/UCM436592.pdf), 
2015 Accessed on June 19, 2015.
5. FDA, ``Education and Technical Assistance for Industry,'' (http://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM436593.pdf), 
March 5, 2015. Accessed on June 19, 2015.
6. FDA, ``Food Safety Preventive Controls Alliance,'' (http://www.fda.gov/food/guidanceregulation/fsma/ucm284406.htm), November 
12, 2013. Accessed on June 19, 2015.
7. FDA, ``FDA Announces Competitive Grant Program with NIFA to Fund 
Food Safety Training, Education and Technical Assistance,'' (http://www.fda.gov/food/newsevents/constituentupdates/ucm430492.htm), 
January 15, 2015. Accessed on June 19, 2015.
8. Partnership for Food Protection National Workplan Workgroup, 
``Model for Local Federal/State Planning and Coordination of Field 
Operations and Training: A Partnership for Food Protection ``Best 
Practice'','' (http://www.fda.gov/downloads/ForFederalStateandLocalOfficials/FoodSafetySystem/UCM373333.pdf) 
October, 2013. Accessed on August 10, 2015.
9. FDA, ``Operational Strategy for Implementing the FDA Food Safety 
Modernization Act (FSMA),'' (http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm395105.htm), May 2, 2014. Accessed on 
June 25, 2015.
10. FDA, ``Inspection Modernization and Training: Key Investments 
for

[[Page 56335]]

Implementing the FDA Food Safety Modernization Act (FSMA),'' (http://www.fda.gov/food/guidanceregulation/fsma/ucm432576.htm), 2015. 
Accessed on June 25, 2015.
11. FDA, ``Draft Qualitative Risk Assessment Risk of Activity/Animal 
Food Combinations for Activities (Outside the Farm Definition) 
Conducted in a Facility Co-Located on a Farm,'' 2012. See Reference 
33 to the 2013 proposed rule for preventive controls for animal 
food.
12. Muth, M. K., C. Zhen, M. Coglaiti, S. Karns, and C. Viator, 
``Food Processing Sector Study,'' 2011. See Reference 21 to the 2014 
supplemental notice.
13. FDA, ``The Reportable Food Registry: A New Approach to Targeting 
Inspection Resources and Identifying Patterns of Adulteration--First 
Annual Report: September 8, 2009-September 7, 2010,'' (http://www.fda.gov/downloads/Food/ComplianceEnforcement/UCM291297.pdf), 
January, 2011. Accessed on June 29, 2015. See Reference 48 to the 
2013 proposed rule for preventive controls for animal food.
14. FDA, ``The Reportable Food Registry: Targeting Inspection 
Resources and Identifying Patterns of Adulteration--Second Annual 
Report: September 8, 2010-September 7, 2011,'' (http://www.fda.gov/downloads/Food/ComplianceEnforcement/UCM301013.pdf), April 19, 2012. 
Accessed on June 29, 2015.
15. FDA, ``The Reportable Food Registry: Targeting Inspection 
Resources and Identifying Patterns of Adulteration--Third Annual 
Report: September 8, 2011-September 7, 2012,'' (http://www.fda.gov/downloads/Food/ComplianceEnforcement/RFR/UCM349856.pdf), May 1, 
2013. Accessed on June 29, 2015.
16. FDA, ``The Reportable Food Registry: Targeting Inspection 
Resources and Identifying Patterns of Adulteration--Fourth Annual 
Report: September 8, 2012-September 7, 2013,'' (http://www.fda.gov/downloads/Food/ComplianceEnforcement/RFR/UCM395684.pdf), May 5, 
2014. Accessed on June 29, 2015.
17. FDA, ``Bravo Issues Nationwide Recall of Pet Food for Dogs and 
Cats,'' (http://www.fda.gov/Safety/Recalls/ucm397362.htm), May 14, 
2014. Accessed on June 26, 2015.
18. FDA, ``J.J. Fuds, Inc. Issues Recall of Pet Food,'' (http://www.fda.gov/Safety/Recalls/ucm431432.htm), January 20, 2015. 
Accessed on July 1, 2015.
19. FDA, ``Draft Guidance for Industry: Questions and Answers 
Regarding the Reportable Food Registry as Established by the Food 
and Drug Administration Amendments Act of 2007 (Edition 2),'' 
(http://www.fda.gov/downloads/Food/GuidanceRegulation/UCM213214.pdf), May, 2010. Accessed on June 29, 2015.
20. FDA, ``Guidance for Industry: Questions and Answers Regarding 
the Reportable Food Registry as Established by the Food and Drug 
Administration Amendments Act of 2007,'' (http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/RFR/ucm180761.htm), September, 2009. Accessed on June 29, 2015.
21. Capogrossi, K., L. Calvin, M. Coglaiti, D. Hinman, S. Karns, A. 
Lasher, T. Minor, M.K. Muth, V. Nigh, P. Vardon, C. Viator and C. 
Zhen, ``Food Processing Sector Study, (Contract HHSF-223-2011-
10005B, Task Order 20), Final Report,'' 2015.
22. Codex Alimentarius Commission, ``Guidelines for the Validation 
of Food Safety Control Measures, CAC/GL 69-2008,'' (http://www.codexalimentarius.org/input/download/standards/11022/CXG_069e.pdf), 2008. Accessed on June 29, 2015. See Reference 79 to 
the 2013 proposed rule for preventive controls for animal food.
23. FDA, ``Guidance for Industry: Questions and Answers Regarding 
Food Facility Registration (Sixth Edition),'' (http://www.fda.gov/downloads/Food/GuidanceRegulation/UCM332460.pdf), 2014. Accessed and 
printed on June 29, 2015.
24. Dictionary.com, ``Definition of ``Solely'','' (http://dictionary.reference.com/browse/solely), 2015. Accessed on June 11, 
2015.
25. FDA, ``Compliance Policy Guide Sec.675.100 Diversion of 
Contaminated Food for Animal Use,'' (http://www.fda.gov/iceci/compliancemanuals/compliancepolicyguidancemanual/ucm074693.htm) 
Revised: March 1995, Page Last Updated: December 15, 2009. Accessed 
on September 5, 2014. See Reference 11 to the 2014 supplemental 
notice.
26. FDA, ``Compliance Policy Guide Sec.675.200 Diversion of 
Adulterated Food to Acceptable Animal Feed Use.'' (http://www.fda.gov/iceci/compliancemanuals/compliancepolicyguidancemanual/ucm074694.htm) Revised: March 1995. Page Last Updated: December 15, 
2009. Accessed on September 5, 2014). See Reference 12 to the 2014 
supplemental notice.
27. British Standards Institute (BSI), ``Publicly Available 
Specification (PAS)222:2011 Prerequisite Programmes for Food Safety 
in the Manufacture of Food and Feed for Animals,'' 2011. See 
Reference 44 to the 2013 proposed rule for preventive controls for 
animal food.
28. Association of American Feed Control Officials (AAFCO), ``Model 
Good Manufacturing Practice Regulations for Feed and Feed 
Ingredients'', In: AAFCO Official Publication, 210-215, 2010. See 
Reference 42 to the 2013 proposed rule for preventive controls for 
animal food.
29. Food and Agriculture Organization of the United Nations (FAO) 
and World Health Organization (WHO), ``Good Practices for the Feed 
Industry--Implementing the Codex Alimentarius Code of Practice on 
Good Animal Feeding--Section 3 Good Production Practices,'' (http://www.fao.org/docrep/012/i1379e/i1379e00.htm), 2010. Accessed on June 
29, 2015. See Reference 14 in the 2014 supplemental notice.
30. USDA National Nutrient Database for Standard Reference, (http://ndb.nal.usda.gov/), 2011. Accessed on June 29, 2015.
31. FDA, ``P&G Recalls Specific Canned Cat Foods Due to Low Levels 
of Thiamine (Vitamin B1),'' (http://www.fda.gov/Safety/Recalls/ArchiveRecalls/2010/ucm214996.htm), June 9, 2010. Accessed on June 
30, 2015.
32. FDA, ``Ridley Block Operations Announces Voluntary Recall in 
Oklahoma and Texas,'' (http://www.fda.gov/Safety/Recalls/ucm266082.htm), July 29, 2011. Accessed on June 30, 2015.
33. FDA, ``Expanded Voluntary Recall of Mazuri and LabDiet Feed 
Products Due to Potential Elevated Vitamin D Level,'' (http://www.fda.gov/safety/recalls/ucm312988.htm), July 20, 2012. Accessed 
on June 30, 2015.
34. FDA, ``ADM Alliance Nutrition Recalling MoorMan's ShowTec 18 
Elite Lamb Feed,'' (http://www.fda.gov/Safety/Recalls/ucm333676.htm), December 28, 2012. Accessed on June 30, 2015.
35. FDA, ``PGG/HSC Feed Company LLC Issues Voluntary Recall of 
Champion Lamb Texturized Feed B30, Lot-88022114M908840,'' (http://www.fda.gov/Safety/Recalls/ucm399978.htm), June 4, 2014. Accessed on 
June 30, 2015.
36. FDA, ``Cargill Conducts Voluntary Recall of Select 
Nutrena[supreg] NatureWise Meatbird Feed Due to Possible Animal 
Health Risk,'' (http://www.fda.gov/Safety/Recalls/ucm403829.htm), 
July 1, 2014. Accessed on June 30, 2015.
37. FDA, ``Natura Pet Recalls 5 Lots of Dry Cat and Dry Ferret Food 
due to Vitamin Insufficiency,'' (http://www.fda.gov/Safety/Recalls/ucm424607.htm), November 24, 2014. Accessed on June 30, 2015.
38. FDA, ``Primal Pet Foods Voluntarily Recalls A Single Lot of Raw 
Frozen Cat Food,'' (http://www.fda.gov/Safety/Recalls/ucm438183.htm), March 13, 2015. Accessed on June 30, 2015.
39. FDA, ``Ainsworth Pet Nutrition Voluntarily Recalls Five Nutrish 
Wet Cat Food Varieties for Potentially Elevated Vitamin D Levels,'' 
(http://www.fda.gov/Safety/Recalls/ucm449841.htm), June 4, 2015. 
Accessed on June 30, 2015.
40. Markovich, J.E., Freeman, L.M., and Heinze, C.R., ``Analysis of 
thiamine concentrations in commercial canned foods formulated for 
cats,'' Journal of the American Veterinary Medical Association, Vol. 
244, No. 2, January 15, 2014.
41. FDA, ``Food CGMP Modernization--A Focus on Food Safety,'' 
(http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/CurrentGoodManufacturingPracticesCGMPs/ucm207458.htm), November 2, 
2005. Accessed on June 29, 2015. See Reference 49 to the 2013 
proposed rule for preventive controls for animal food.
42. FDA, ``Draft Guidance for Industry: Questions and Answers 
Regarding Mandatory Food Recalls,'' (http://www.fda.gov/Food/
GuidanceRegulation/

[[Page 56336]]

GuidanceDocumentsRegulatoryInformation/ucm445428.htm), May, 2015. 
Accessed on June 30, 2015.
43. FDA, ``FDA Homepage,'' (http://www.fda.gov/), March 25, 2015. 
Accessed and printed on June 30, 2015.
44. FDA, ``Recalls, Market Withdrawals, & Safety Alerts (FDA Email 
Sign-up Web page),'' (https://service.govdelivery.com/accounts/USFDA/subscriber/new?topic_id=USFDA_48), 2015. Accessed on June 30, 
2015.
45. FDA, ``Guidance for Industry: Product Recalls, Including 
Removals and Corrections,'' (http://www.fda.gov/Safety/Recalls/IndustryGuidance/ucm129259.htm), November 3, 2003. Accessed on June 
30, 2015.
46. FDA, ``Animal and Veterinary Recalls and Withdrawals Web page,'' 
(http://www.fda.gov/AnimalVeterinary/SafetyHealth/RecallsWithdrawals/default.htm2015), 2015. Accessed on June 30, 
2015.
47. Merriam-Webster.com, ``Definition of ``Include'','' (http://www.merriam-webster.com/dictionary/include), 2015. Accessed on June 
30, 2015.
48. FDA, ``Guidance for Industry: Testing for Salmonella in Human 
Foods and Direct-Human-Contact Animal Foods,'' (http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/salmonella/ucm295271.htm), March, 2012. Accessed on June 30, 2015.
49. National Advisory Committee on Microbiological Criteria for 
Foods, ``Hazard Analysis and Critical Control Point Principles and 
Application Guidelines,'' Journal of Food Protection, 61:1246-1259, 
1998. See Reference 29 to the 2013 proposed preventive controls rule 
for animal food.
50. USDA Food Safety and Inspection Service, ``Compliance Guideline 
HACCP Systems Validation,'' (http://www.fsis.usda.gov/shared/PDF/HACCP_Systems_Validation.pdf), May 2013. Accessed on June 30, 2015.
51. FDA, ``Memorandum on Environmental Monitoring,'' 2014. See 
Reference 23 to the 2014 supplemental human preventive controls 
notice, Docket No. FDA-2011-N-0920.
52. FDA, ``Memorandum on Product Testing,'' 2014. See Reference 18 
to the 2014 supplemental human preventive controls notice, Docket 
No. FDA-2011-N-0920.
53. FDA, ``Memorandum on Supplier Programs,'' 2014. See Reference 24 
to the 2014 supplemental human preventive controls notice, Docket 
No. FDA-2011-N-0920.
54. Codex Alimentarius Commission, ``Codex Alimentarius Commission 
Procedural Manual, 23rd Edition,'' (ftp://ftp.fao.org/codex/Publications/ProcManuals/Manual_23e.pdf), 2015. Accessed on June 30, 
2015.
55. FDA, ``Inspections, Compliance, Enforcement, and Criminal 
Investigations: Warning Letters,'' (http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm), March 26, 2015. 
Accessed on June 30, 2015.
56. FDA, ``Import Alerts,'' (http://www.fda.gov/ForIndustry/ImportProgram/ImportAlerts/default.htm), 2015. Accessed on June 30, 
2015.
57. FDA, ``Letter to Sunland Inc. Concerning Suspension of Food 
Facility Registration; Notice of Opportunity for Hearing,'' (http://www.fda.gov/aboutfda/centersoffices/officeoffoods/cfsan/cfsanfoiaelectronicreadingroom/ucm329370.htm), November 26, 2012. 
Accessed June 30, 2015.
58. Global Food Safety Initiative, ``GFSI Guidance Document, Version 
6.3,'' (http://www.mygfsi.com/images/mygfsi/gfsifiles/gfsi_guidance/GFSI_Guidance_Document_Over.pdf), 2013. Accessed on June 30, 2015.
59. FDA, ``Information for Foreign Governments: Frequently Asked 
Questions on Systems Recognition,'' (http://www.fda.gov/Food/InternationalInteragencyCoordination/ucm367400.htm), September 5, 
2013. Accessed on July 1, 2015.
60. FDA, ``FSMA Final Rulemaking for Current Good Manufacturing 
Practice, Hazard Analysis, and Risk-Based Preventive Controls for 
Food for Animals Final Regulatory Impact Analysis,'' 2015.
61. World Trade Organization, ``WTO Ministerial Conference: 
Implementation-Related Issues and Concerns,'' (https://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_implementation_e.pdf), 
November 20, 2001. Accessed on July 1, 2015.
62. World Trade Organization, ``The WTO Agreement on the Application 
of Sanitary and Phytosanitary Measures (SPS Agreement),'' (https://www.wto.org/english/tratop_e/sps_e/spsagr_e.htm), April 15, 1994. 
Accessed on July 1, 2015.
63. FDA, ``Tribal Summary Impact Statement,'' 2015.
64. Environmental Review of Final Rule: Current Good Manufacturing 
Practice, Hazard Analysis, and Risk-Based Preventive Controls for 
Food for Animals, August 28, 2015.
65. FDA, ``Current Good Manufacturing Practice and Hazard Analysis 
and Risk-based Preventive Controls for Human Food--Preliminary 
Regulatory Impact Analysis,'' 2013. See Reference 23 in the 2014 
supplemental notice.

List of Subjects

21 CFR Part 11

    Administrative practice and procedure, Computer technology, 
Reporting and recordkeeping requirements.

21 CFR Part 16

    Administrative practice and procedure.

21 CFR Part 117

    Food packaging, Foods.

21 CFR Part 500

    Animal drugs, Animal feeds, Cancer, Labeling, Packaging and 
containers, Polychlorinated biphenyls (PCB's).

21 CFR Part 507

    Animal foods, Labeling, Packaging and containers, Reporting and 
recordkeeping requirements.

21 CFR Part 579

    Animal feeds, Animal foods, Radiation protection.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR 
chapter I is amended as follows:

PART 11--ELECTRONIC RECORDS; ELECTRONIC SIGNATURES

0
1. The authority citation for 21 CFR part 11 continues to read as 
follows:

    Authority:  21 U.S.C. 321-393; 42 U.S.C. 262.


0
2. In Sec.  11.1, add paragraph (j) to read as follows:


Sec.  11.1  Scope.

* * * * *
    (j) This part does not apply to records required to be established 
or maintained by part 507 of this chapter. Records that satisfy the 
requirements of part 507 of this chapter, but that also are required 
under other applicable statutory provisions or regulations, remain 
subject to this part.

PART 16--REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION

0
3. The authority citation for 21 CFR part 16 continues to read as 
follows:

    Authority:  15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-394, 
467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201-262, 263b, 364.


0
4. In Sec.  16.1(b)(2), add the following entry in numerical order to 
read as follows:


Sec.  16.1  Scope.

* * * * *
    (b) * * *
    (2) * * *
    Sec. Sec.  507.60 through 507.85 (part 507, subpart D of this 
chapter) relating to withdrawal of a qualified facility exemption.
* * * * *

[[Page 56337]]

PART 117--CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND 
RISK-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD

0
5. The authority citation for 21 CFR part 117 continues to read as 
follows:

    Authority: 21 U.S.C. 331, 342, 343, 350d note, 350g, 350g note, 
371, 374; 42 U.S.C. 243, 264, 271.


0
6. Add Sec.  117.95 to subpart B to read as follows:


Sec.  117.95  Holding and distribution of human food by-products for 
use as animal food.

    (a) Human food by-products held for distribution as animal food 
without additional manufacturing or processing by the human food 
processor, as identified in Sec.  507.12 of this chapter, must be held 
under conditions that will protect against contamination, including the 
following:
    (1) Containers and equipment used to convey or hold human food by-
products for use as animal food before distribution must be designed, 
constructed of appropriate material, cleaned as necessary, and 
maintained to protect against the contamination of human food by-
products for use as animal food;
    (2) Human food by-products for use as animal food held for 
distribution must be held in a way to protect against contamination 
from sources such as trash; and
    (3) During holding, human food by-products for use as animal food 
must be accurately identified.
    (b) Labeling that identifies the by-product by the common or usual 
name must be affixed to or accompany human food by-products for use as 
animal food when distributed.
    (c) Shipping containers (e.g., totes, drums, and tubs) and bulk 
vehicles used to distribute human food by-products for use as animal 
food must be examined prior to use to protect against contamination of 
the human food by-products for use as animal food from the container or 
vehicle when the facility is responsible for transporting the human 
food by-products for use as animal food itself or arranges with a third 
party to transport the human food by-products for use as animal food.

PART 500--GENERAL

0
7. The authority citation for 21 CFR part 500 continues to read as 
follows:


    Authority: 21 U.S.C. 321, 331, 342, 343, 348, 351, 352, 353, 
360b, 371, 379e.

0
8. Revise Sec.  500.23 to read as follows:


Sec.  500.23  Thermally processed low-acid foods packaged in 
hermetically sealed containers.

    Except as provided in Sec.  507.5(b) of this chapter, the 
provisions of parts 507 and 113 of this chapter apply to the 
manufacturing, processing, or packing of low-acid foods in hermetically 
sealed containers, and intended for use as food for animals.

0
9. Add part 507 to read as follows:

PART 507--CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND 
RISK-BASED PREVENTIVE CONTROLS FOR FOOD FOR ANIMALS

Subpart A--General Provisions
Sec.
507.1 Applicability and status.
507.3 Definitions.
507.4 Qualifications of individuals who manufacture, process, pack, 
or hold animal food.
507.5 Exemptions.
507.7 Requirements that apply to a qualified facility.
507.10 Applicability of subparts C and E of this part to a facility 
solely engaged in the storage of unexposed packaged animal food.
507.12 Applicability of this part to the holding and distribution of 
human food by-products for use as animal food.
Subpart B--Current Good Manufacturing Practice
507.14 Personnel.
507.17 Plant and grounds.
507.19 Sanitation.
507.20 Water supply and plumbing.
507.22 Equipment and utensils.
507.25 Plant operations.
507.27 Holding and distribution.
507.28 Holding and distribution of human food by-products for use as 
animal food.
Subpart C--Hazard Analysis and Risk-Based Preventive Controls
507.31 Food safety plan.
507.33 Hazard analysis.
507.34 Preventive controls.
507.36 Circumstances in which the owner, operator, or agent in 
charge of a manufacturing/processing facility is not required to 
implement a preventive control.
507.37 Provision of assurances required under Sec.  507.36(a)(2), 
(3), and (4).
507.38 Recall plan.
507.39 Preventive control management components.
507.40 Monitoring.
507.42 Corrective actions and corrections.
507.45 Verification.
507.47 Validation.
507.49 Verification of implementation and effectiveness.
507.50 Reanalysis.
507.51 Modified requirements that apply to a facility solely engaged 
in the storage of unexposed packaged animal food.
507.53 Requirements applicable to a preventive controls qualified 
individual and a qualified auditor.
507.55 Implementation records required for this subpart.
Subpart D--Withdrawal of a Qualified Facility Exemption
507.60 Circumstances that may lead FDA to withdraw a qualified 
facility exemption.
507.62 Issuance of an order to withdraw a qualified facility 
exemption.
507.65 Contents of an order to withdraw a qualified facility 
exemption.
507.67 Compliance with, or appeal of, an order to withdraw a 
qualified facility exemption.
507.69 Procedure for submitting an appeal.
507.71 Procedure for requesting an informal hearing.
507.73 Requirements applicable to an informal hearing.
507.75 Presiding officer for an appeal and for an informal hearing.
507.77 Timeframe for issuing a decision on an appeal.
507.80 Revocation of an order to withdraw a qualified facility 
exemption.
507.83 Final agency action.
507.85 Reinstatement of a qualified facility exemption that was 
withdrawn.
Subpart E--Supply-Chain Program
507.105 Requirement to establish and implement a supply-chain 
program.
507.110 General requirements applicable to a supply-chain program.
507.115 Responsibilities of the receiving facility.
507.120 Using approved suppliers.
507.125 Determining appropriate supplier verification activities 
(including determining the frequency of conducting the activity).
507.130 Conducting supplier verification activities for raw 
materials and other ingredients.
507.135 Onsite audit.
507.175 Records documenting the supply-chain program.
Subpart F--Requirements Applying to Records That Must Be Established 
and Maintained
507.200 Records subject to the requirements of this subpart.
507.202 General requirements applying to records.
507.206 Additional requirements applying to the food safety plan.
507.208 Requirements for record retention.
507.212 Use of existing records.
507.215 Special requirements applicable to a written assurance.

    Authority:  21 U.S.C. 331, 342, 343, 350d note, 350g, 350g note, 
371, 374; 42 U.S.C. 243, 264, 271.

Subpart A--General Provisions


Sec.  507.1  Applicability and status.

    (a) The criteria and definitions in this part apply in determining 
whether an animal food is:

[[Page 56338]]

    (1) Adulterated within the meaning of:
    (i) Section 402(a)(3) of the Federal Food, Drug, and Cosmetic Act 
in that the food has been manufactured under such conditions that it is 
unfit for food; or
    (ii) Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act 
in that the food has been prepared, packed, or held under insanitary 
conditions whereby it may have become contaminated with filth, or 
whereby it may have been rendered injurious to health; and
    (2) In violation of section 361 of the Public Health Service Act 
(42 U.S.C. 264).
    (b) The operation of a facility that manufactures, processes, 
packs, or holds animal food for sale in the United States if the owner, 
operator, or agent in charge of such facility is required to comply 
with, and is not in compliance with, section 418 of the Federal Food, 
Drug, and Cosmetic Act or subparts C, D, E, or F of this part and Sec.  
507.7 is a prohibited act under section 301(uu) of the Federal Food, 
Drug, and Cosmetic Act.
    (c) Animal food covered by specific current good manufacturing 
practice regulations also is subject to the requirements of those 
regulations.
    (d) Except as provided by Sec.  507.12, if a facility is required 
to comply with subpart B of part 507 and is also required to comply 
with subpart B of part 117 of this chapter because the facility 
manufactures, processes, packs, or holds human food and animal food, 
then the facility may choose to comply with the requirements in subpart 
B of part 117, instead of subpart B of part 507, as to the 
manufacturing, processing, packing, and holding of animal food at that 
facility. If a facility is required to comply with subpart C of part 
507 and is also required to comply with subpart C of part 117 of this 
chapter, then the facility may choose to comply with the requirements 
in subpart C of part 117 as to the manufacturing, processing, packing, 
and holding of animal food at the facility, instead of subpart C of 
part 507, provided the food safety plan also addresses hazards for the 
animal food, if applicable, that require a preventive control. When 
applying the requirements of part 117 of this chapter to animal food, 
the term ``food'' in part 117 includes animal food.


Sec.  507.3  Definitions.

    The definitions and interpretations contained in section 201 of the 
Federal Food, Drug, and Cosmetic Act apply to such terms when used in 
this part. The following definitions also apply:
    Adequate means that which is needed to accomplish the intended 
purpose in keeping with good public (human and animal) health practice.
    Affiliate means any facility that controls, is controlled by, or is 
under common control with another facility.
    Animal food means food for animals other than man and includes pet 
food, animal feed, and raw materials and ingredients.
    Audit means the systematic, independent, and documented examination 
(through observation, investigation, records review, discussions with 
employees of the audited entity, and, as appropriate, sampling and 
laboratory analysis) to assess a supplier's food safety processes and 
procedures.
    Calendar day means every day shown on the calendar.
    Correction means an action to identify and correct a problem that 
occurred during the production of animal food, without other actions 
associated with a corrective action procedure (such as actions to 
reduce the likelihood that the problem will recur, evaluate all 
affected animal food for safety, and prevent affected animal food from 
entering commerce).
    Critical control point means a point, step, or procedure in a food 
process at which control can be applied and is essential to prevent or 
eliminate a food safety hazard or reduce such hazard to an acceptable 
level.
    Environmental pathogen means a pathogen capable of surviving and 
persisting within the manufacturing, processing, packing, or holding 
environment such that food for animals may be contaminated and may 
result in foodborne illness if that animal food is not treated to 
significantly minimize or prevent the environmental pathogen. Examples 
of environmental pathogens for the purposes of this part include 
Listeria monocytogenes and Salmonella spp. but do not include the 
spores of pathogenic sporeforming bacteria.
    Facility means a domestic facility or a foreign facility that is 
required to register under section 415 of the Federal Food, Drug, and 
Cosmetic Act, in accordance with the requirements of part 1, subpart H 
of this chapter.
    Farm means farm as defined in Sec.  1.227 of this chapter.
    FDA means the Food and Drug Administration.
    Food means food as defined in section 201(f) of the Federal Food, 
Drug, and Cosmetic Act and includes raw materials and ingredients.
    Food-contact surfaces are those surfaces that contact animal food 
and those surfaces from which drainage, or other transfer, onto the 
animal food or onto surfaces that contact the animal food ordinarily 
occurs during the normal course of operations. ``Food-contact 
surfaces'' includes utensils and animal food-contact surfaces of 
equipment.
    Full-time equivalent employee is a term used to represent the 
number of employees of a business entity for the purpose of determining 
whether the business qualifies for the small business exemption. The 
number of full-time equivalent employees is determined by dividing the 
total number of hours of salary or wages paid directly to employees of 
the business entity and of all of its affiliates and subsidiaries by 
the number of hours of work in 1 year, 2,080 hours (i.e., 40 hours x 52 
weeks). If the result is not a whole number, round down to the next 
lowest whole number.
    Harvesting applies to farms and farm mixed-type facilities and 
means activities that are traditionally performed on farms for the 
purpose of removing raw agricultural commodities from the place they 
were grown or raised and preparing them for use as animal food. 
Harvesting is limited to activities performed on raw agricultural 
commodities, or on processed foods created by drying/dehydrating a raw 
agricultural commodity without additional manufacturing/processing, on 
a farm. Harvesting does not include activities that transform a raw 
agricultural commodity into a processed food as defined in section 
201(gg) of the Federal Food, Drug, and Cosmetic Act. Examples of 
harvesting include cutting (or otherwise separating) the edible portion 
of the raw agricultural commodity from the crop plant and removing or 
trimming part of the raw agricultural commodity (e.g., foliage, husks, 
roots or stems). Examples of harvesting also include cooling, field 
coring, filtering, gathering, hulling, removing stems and husks from, 
shelling, sifting, threshing, trimming of outer leaves of, and washing 
raw agricultural commodities grown on a farm.
    Hazard means any biological, chemical (including radiological), or 
physical agent that has the potential to cause illness or injury in 
humans or animals.
    Hazard requiring a preventive control means a known or reasonably 
foreseeable hazard for which a person knowledgeable about the safe 
manufacturing, processing, packing, or holding of animal food would, 
based on

[[Page 56339]]

the outcome of a hazard analysis (which includes an assessment of the 
severity of the illness or injury if the hazard were to occur and the 
probability that the hazard will occur in the absence of preventive 
controls), establish one or more preventive controls to significantly 
minimize or prevent the hazard in an animal food and components to 
manage those controls (such as monitoring, corrections or corrective 
actions, verification, and records) as appropriate to the animal food, 
the facility, and the nature of the preventive control and its role in 
the facility's food safety system.
    Holding means storage of animal food and also includes activities 
performed incidental to storage of an animal food (e.g., activities 
performed for the safe or effective storage of that animal food, such 
as fumigating animal food during storage, and drying/dehydrating raw 
agricultural commodities when the drying/dehydrating does not create a 
distinct commodity (such as drying/dehydrating hay or alfalfa)). 
Holding also includes activities performed as a practical necessity for 
the distribution of that animal food (such as blending of the same raw 
agricultural commodity and breaking down pallets), but does not include 
activities that transform a raw agricultural commodity into a processed 
food as defined in section 201(gg) of the Federal Food, Drug, and 
Cosmetic Act. Holding facilities could include warehouses, cold storage 
facilities, storage silos, grain elevators, and liquid-storage tanks.
    Known or reasonably foreseeable hazard means a biological, chemical 
(including radiological), or physical hazard that is known to be, or 
has the potential to be, associated with the facility or the animal 
food.
    Lot means the animal food produced during a period of time and 
identified by an establishment's specific code.
    Manufacturing/processing means making animal food from one or more 
ingredients, or synthesizing, preparing, treating, modifying, or 
manipulating animal food, including food crops or ingredients. Examples 
of manufacturing/processing activities include: Baking, boiling, 
bottling, canning, cooking, cooling, cutting, distilling, drying/
dehydrating raw agricultural commodities to create a distinct commodity 
(such as drying/dehydrating grapes to produce raisins), evaporating, 
eviscerating, extracting juice, extruding, formulating, freezing, 
grinding, homogenizing, irradiating, labeling, milling, mixing, 
packaging (including modified atmosphere packaging), pasteurizing, 
peeling, pelleting, rendering, treating to manipulate ripening, 
trimming, washing, or waxing. For farms and farm mixed-type facilities, 
manufacturing/processing does not include activities that are part of 
harvesting, packing, or holding.
    Microorganisms means yeasts, molds, bacteria, viruses, protozoa, 
and microscopic parasites and includes species that are pathogens. The 
term ``undesirable microorganisms'' includes those microorganisms that 
are pathogens, that subject animal food to decomposition, that indicate 
that animal food is contaminated with filth, or that otherwise may 
cause animal food to be adulterated.
    Mixed-type facility means an establishment that engages in both 
activities that are exempt from registration under section 415 of the 
Federal Food, Drug, and Cosmetic Act and activities that require the 
establishment to be registered. An example of such a facility is a 
``farm mixed-type facility,'' which is an establishment that is a farm, 
but also conducts activities outside the farm definition that require 
the establishment to be registered.
    Monitor means to conduct a planned sequence of observations or 
measurements to assess whether control measures are operating as 
intended.
    Packing means placing animal food into a container other than 
packaging the animal food and also includes repacking and activities 
performed incidental to packing or repacking an animal food (e.g., 
activities performed for the safe or effective packing or repacking of 
that animal food (such as sorting, culling, grading, and weighing or 
conveying incidental to packing or repacking)), but does not include 
activities that transform a raw agricultural commodity into a processed 
food as defined in section 201(gg) of the Federal Food, Drug, and 
Cosmetic Act.
    Pathogen means a microorganism of public (human or animal) health 
significance.
    Pest refers to any objectionable animals or insects including 
birds, rodents, flies, and larvae.
    Plant means the building or structure, or parts thereof, used for 
or in connection with the manufacturing, processing, packing, or 
holding of animal food.
    Preventive controls means those risk-based, reasonably appropriate 
procedures, practices, and processes that a person knowledgeable about 
the safe manufacturing, processing, packing, or holding of animal food 
would employ to significantly minimize or prevent the hazards 
identified under the hazard analysis that are consistent with the 
current scientific understanding of safe food manufacturing, 
processing, packing, or holding at the time of the analysis.
    Preventive controls qualified individual means a qualified 
individual who has successfully completed training in the development 
and application of risk-based preventive controls at least equivalent 
to that received under a standardized curriculum recognized as adequate 
by FDA, or is otherwise qualified through job experience to develop and 
apply a food safety system.
    Qualified auditor means a person who is a qualified individual as 
defined in this part and has technical expertise obtained through 
education, training, or experience (or the combination thereof) 
necessary to perform the auditing function. Examples of potential 
qualified auditors include:
    (1) A government employee, including a foreign government employee; 
and
    (2) An audit agent of a certification body that is accredited in 
accordance with regulations in part 1, subpart M of this chapter.
    Qualified end-user, with respect to food, means the consumer of the 
food (where the term consumer does not include a business); or a 
restaurant or retail food establishment (as those terms are defined in 
Sec.  1.227 of this chapter) that:
    (1) Is located:
    (i) In the same State or the same Indian reservation as the 
qualified facility that sold the food to such restaurant or retail food 
establishment; or
    (ii) Not more than 275 miles from such facility; and
    (2) Is purchasing the food for sale directly to consumers at such 
restaurant or retail food establishment.
    Qualified facility means (when including the sales by any 
subsidiary; affiliate; or subsidiaries or affiliates, collectively, of 
any entity of which the facility is a subsidiary or affiliate) a 
facility that is a very small business as defined in this part, or a 
facility to which both of the following apply:
    (1) During the 3-year period preceding the applicable calendar 
year, the average annual monetary value of the food manufactured, 
processed, packed, or held at such facility that is sold directly to 
qualified end-users (as defined in this part) during such period 
exceeded the average annual monetary value of the food sold by such 
facility to all other purchasers; and
    (2) The average annual monetary value of all food sold during the 
3-year period preceding the applicable

[[Page 56340]]

calendar year was less than $500,000, adjusted for inflation.
    Qualified facility exemption means an exemption applicable to a 
qualified facility under Sec.  507.5(d).
    Qualified individual means a person who has the education, 
training, or experience (or a combination thereof) necessary to 
manufacture, process, pack, or hold safe animal food as appropriate to 
the individual's assigned duties. A qualified individual may be, but is 
not required to be, an employee of the establishment.
    Raw agricultural commodity has the meaning given in section 201(r) 
of the Federal Food, Drug, and Cosmetic Act.
    Receiving facility means a facility that is subject to subparts C 
and E of this part and that manufactures/processes a raw material or 
other ingredient that it receives from a supplier.
    Rework means clean, unadulterated animal food that has been removed 
from processing for reasons other than insanitary conditions or that 
has been successfully reconditioned by reprocessing and that is 
suitable for use as animal food.
    Sanitize means to adequately treat cleaned surfaces by a process 
that is effective in destroying vegetative cells of pathogens, and in 
substantially reducing numbers of other undesirable microorganisms, but 
without adversely affecting the product or its safety for animals or 
humans.
    Significantly minimize means to reduce to an acceptable level, 
including to eliminate.
    Small business means, for purposes of this part, a business 
employing fewer than 500 full-time equivalent employees.
    Subsidiary means any company which is owned or controlled directly 
or indirectly by another company.
    Supplier means the establishment that manufactures/processes the 
animal food, raises the animal, or grows the food that is provided to a 
receiving facility without further manufacturing/processing by another 
establishment, except for further manufacturing/processing that 
consists solely of the addition of labeling or similar activity of a de 
minimis nature.
    Supply-chain-applied control means a preventive control for a 
hazard in a raw material or other ingredient when the hazard in the raw 
material or other ingredient is controlled before its receipt.
    Unexposed packaged animal food means packaged animal food that is 
not exposed to the environment.
    Validation means obtaining and evaluating scientific and technical 
evidence that a control measure, combination of control measures, or 
the food safety plan as a whole, when properly implemented, is capable 
of effectively controlling the identified hazards.
    Verification means the application of methods, procedures, tests 
and other evaluations, in addition to monitoring, to determine whether 
a control measure or combination of control measures is or has been 
operating as intended and to establish the validity of the food safety 
plan.
    Very small business means, for purposes of this part, a business 
(including any subsidiaries and affiliates) averaging less than 
$2,500,000, adjusted for inflation, per year, during the 3-year period 
preceding the applicable calendar year in sales of animal food plus the 
market value of animal food manufactured, processed, packed, or held 
without sale (e.g., held for a fee or supplied to a farm without sale).
    Water activity (aw) means a measure of the free moisture 
in an animal food and is the quotient of the water vapor pressure of 
the substance divided by the vapor pressure of pure water at the same 
temperature.
    Written procedures for receiving raw materials and other 
ingredients means written procedures to ensure that raw materials and 
other ingredients are received only from suppliers approved by the 
receiving facility (or, when necessary and appropriate, on a temporary 
basis from unapproved suppliers whose raw materials or other 
ingredients are subjected to adequate verification activities before 
acceptance for use).
    You means, for purposes of this part, the owner, operator, or agent 
in charge of a facility.


Sec.  507.4  Qualifications of individuals who manufacture, process, 
pack, or hold animal food.

    (a)(1) The management of an establishment must ensure that all 
individuals who manufacture, process, pack, or hold animal food subject 
to subparts B and F of this part are qualified to perform their 
assigned duties; and
    (2) The owner, operator, or agent in charge of a facility must 
ensure that all individuals who manufacture, process, pack, or hold 
animal food subject to subparts C, D, E, or F of this part are 
qualified to perform their assigned duties.
    (b) Each individual engaged in manufacturing, processing, packing, 
or holding animal food (including temporary and seasonal personnel) or 
in the supervision thereof must:
    (1) Be a qualified individual as that term is defined in Sec.  
507.3, i.e., have the education, training, or experience (or a 
combination thereof) necessary to manufacture, process, pack, or hold 
safe animal food as appropriate to the individual's assigned duties; 
and
    (2) Receive training in the principles of animal food hygiene and 
animal food safety, including the importance of employee health and 
personal hygiene, as appropriate to the animal food, the facility and 
the individual's assigned duties.
    (c) Responsibility for ensuring compliance by individuals with the 
requirements of this part must be clearly assigned to supervisory 
personnel who have the education, training, or experience (or a 
combination thereof) necessary to supervise the production of safe 
animal food.
    (d) Records that document training required by paragraph (b)(2) of 
this section must be established and maintained and are subject to the 
recordkeeping requirements in subpart F of this part.


Sec.  507.5  Exemptions.

    (a) This part does not apply to establishments, including ``farms'' 
(as defined in Sec.  1.227 of this chapter), that are not required to 
register under section 415 of the Federal Food, Drug, and Cosmetic Act.
    (b)(1) Subparts C and E of this part do not apply with respect to 
activities that are subject to Sec.  500.23 and part 113 of this 
chapter (Thermally Processed Low-Acid Foods Packaged in Hermetically 
Sealed Containers) at an animal food facility if you are required to 
comply with, and are in compliance with, part 113 of this chapter with 
respect to those activities.
    (2) The exemption in paragraph (b)(1) of this section is applicable 
only with respect to those microbiological hazards regulated under part 
113 of this chapter.
    (c) Subparts C and E of this part do not apply to activities of a 
facility that are subject to section 419 of the Federal Food, Drug, and 
Cosmetic Act (Standards for Produce Safety).
    (d) Except as provided in subpart D of this part, subparts C and E 
of this part do not apply to a qualified facility. Qualified facilities 
are subject to the requirements in Sec.  507.7.
    (e) For a farm mixed-type facility that is a small or very small 
business, subparts C and E of this part do not apply to on-farm packing 
or holding of processed animal food, and Sec.  507.7 does not apply to 
on-farm packing or holding of processed animal food by a very small 
business, if the only packing or holding activities subject to section 
418

[[Page 56341]]

of the Federal Food, Drug, and Cosmetic Act that the business conducts 
are the following low-risk packing or holding activity/animal food 
combinations--i.e., packing (or repacking) (including weighing or 
conveying incidental to packing or repacking); sorting, culling, or 
grading incidental to packing or storing; and storing (ambient, cold 
and controlled atmosphere) of:
    (1) Roughage products (e.g., alfalfa meal, entire plant meal, stem 
meal, pomace, and pulp);
    (2) Plant protein meals (e.g., algae, coconut (copra), guar, and 
peanut);
    (3) Grain by-products and processed grain products (e.g., bran, 
flour, germ meal, grits, groats, hominy feed, malt sprouts, middlings, 
pearled grain, polished grain, brewers grain, distillers grain, and 
gluten meal);
    (4) Oilseed products (e.g., oil and meal of safflower, soybean, or 
sunflower);
    (5) Molasses (e.g., processed sugar cane, sugar beets, and 
citrus).;
    (6) Animal protein meals (e.g., blood, feather, meat, meat and 
bone, and marine (e.g., crab, fish, shrimp));
    (7) Milk products (e.g., casein, cheese rind, and lactalbumin);
    (8) Animal tissue-derived products (e.g., fat);
    (9) Vitamins, minerals, and concentrates;
    (10) Processing aids (e.g., enzymes, preservatives, and 
stabilizers); and
    (11) Any other processed animal food that does not require time/
temperature control for safety.
    (f) For a farm mixed-type facility that is a small or very small 
business, subparts C and E of this part do not apply to on-farm 
manufacturing/processing activities conducted by a small or very small 
business for distribution into commerce, and Sec.  507.7 does not apply 
to on-farm manufacturing/processing activities conducted by a very 
small business for distribution into commerce, if the only 
manufacturing/processing activities subject to section 418 of the 
Federal Food, Drug, and Cosmetic Act that the business conducts 
consists of the following low-risk manufacturing/processing activity/
animal food combinations:
    (1) Chopping or shredding hay;
    (2) Cracking, crimping, flaking, pearling, peeling, shelling, or 
wafering--grain (e.g., barley, sorghum, corn, oats, rice, rye, and 
wheat) or oilseed (e.g., beans, canola, cottonseed, linseed, soybeans, 
and sunflowers);
    (3) Crushing, dry rolling, grinding, milling, pulverizing--grain, 
oilseed, grain by-products and processed grain products, oilseed 
products, hay, ensiled material, culled fruits and vegetables, roughage 
(e.g., cobs, hulls, husks, and straws), or roughage products;
    (4) Ensiling (including chopping, shredding, mixing, storing, or 
fermenting), that is, making silage or haylage from forage (e.g., 
sorghum (milo), corn (maize), alfalfa, and grass), grain, culled fruits 
and vegetables, or roughage;
    (5) Extracting (mechanical) or wet rolling grain, oilseed, brewers 
grain by-products, or distillers grain by-products;
    (6) Labeling roughage products, plant protein meals, grain by-
products and processed grain products, oilseed products, molasses, 
animal protein meals, milk products, animal tissue-derived products, 
vitamins, minerals, concentrates, processing aids, finished animal 
food, including animal food ready for consumption, or any other 
processed animal food that does not require time/temperature control 
for safety; and
    (7) Packaging roughage products, plant protein meals, grain by-
products and processed grain products, oilseed products, molasses, 
animal protein meals, milk products, animal tissue-derived products, 
vitamins, minerals, concentrates, processing aids, finished animal 
food, including animal food ready for consumption, or any other 
processed animal food that does not require time/temperature control 
for safety.
    (g) Subparts C and E of this part do not apply to facilities that 
are solely engaged in the storage of raw agricultural commodities 
(other than fruits and vegetables) intended for further distribution or 
processing.
    (h) Subpart B of this part does not apply to any of the following:
    (1) Establishments solely engaged in the holding and/or 
transportation of one or more raw agricultural commodities;
    (2) Establishments solely engaged in hulling, shelling, drying, 
packing, and/or holding nuts and hulls (without manufacturing/
processing, such as grinding shells or roasting nuts); and
    (3) Establishments solely engaged in ginning of cotton (without 
manufacturing/processing, such as extracting oil from cottonseed).


Sec.  507.7  Requirements that apply to a qualified facility.

    (a) A qualified facility must submit the following attestations to 
FDA:
    (1) An attestation that the facility is a qualified facility as 
defined in Sec.  507.3. For the purpose of determining whether a 
facility satisfies the definition of qualified facility, the baseline 
year for calculating the adjustment for inflation is 2011; and
    (2)(i) An attestation that you have identified the potential 
hazards associated with the animal food being produced, are 
implementing preventive controls to address the hazards, and are 
monitoring the performance of the preventive controls to ensure that 
such controls are effective; or
    (ii) An attestation that the facility is in compliance with State, 
local, county, tribal, or other applicable non-Federal food safety law, 
including relevant laws and regulations of foreign countries, including 
an attestation based on licenses, inspection reports, certificates, 
permits, credentials, certification by an appropriate agency (such as a 
State department of agriculture), or other evidence of oversight.
    (b) The attestations required by paragraph (a) of this section must 
be submitted to FDA by any one of the following means:
    (1) Electronic submission. To submit electronically, go to http://www.fda.gov/furls and follow the instructions. This Web site is 
available from wherever the Internet is accessible, including 
libraries, copy centers, schools, and Internet cafes. FDA encourages 
electronic submission.
    (2) Submission by mail. (i) You must use Form FDA 3942b. You may 
obtain a copy of this form by any of the following mechanisms:
    (A) Download it from http://www.fda.gov/pcafrule;
    (B) Write to the U.S. Food and Drug Administration (HFS-681), 5100 
Paint Branch Parkway, College Park, MD 20550; or
    (C) Request a copy of this form by phone at 1-800-216-7331 or 301-
575-0156.
    (ii) Send a paper Form FDA 3942b to the U.S. Food and Drug 
Administration (HFS-681), 5100 Paint Branch Parkway, College Park, MD 
20550. We recommend that you submit a paper copy only if your facility 
does not have reasonable access to the Internet.
    (c)(1) A facility must determine and document its status as a 
qualified facility on an annual basis no later than July 1 of each 
calendar year.
    (2) The attestations required by paragraph (a) of this section must 
be:
    (i) Submitted to FDA initially:
    (A) By December 16, 2019 for a facility that begins manufacturing, 
processing, packing, or holding animal food before September 17, 2019;
    (B) Before beginning operations, for a facility that begins 
manufacturing, processing, packing, or holding animal food after 
September 17, 2019; or
    (C) By July 31 of the applicable calendar year, when the status of 
a facility changes from ``not a qualified

[[Page 56342]]

facility'' to ``qualified facility'' based on the annual determination 
required by paragraph (c)(1) of this section; and
    (ii) Beginning in 2020, submitted to FDA every 2 years during the 
period beginning on October 1 and ending on December 31.
    (3) When the status of a facility changes from ``qualified 
facility'' to ``not a qualified facility'' based on the annual 
determination required by paragraph (c)(1) of this section, the 
facility must notify FDA of that change in status using Form FDA 3942b 
by July 31 of the applicable calendar year.
    (d) When the status of a facility changes from ``qualified 
facility'' to ``not a qualified facility,'' the facility must comply 
with subparts C and E of this part no later than December 31 of the 
applicable calendar year unless otherwise agreed to by FDA and the 
facility.
    (e) A qualified facility that does not submit attestations under 
paragraph (a)(2)(i) of this section must provide notification to 
consumers as to the name and complete business address of the facility 
where the animal food was manufactured or processed (including the 
street address or P.O. Box, city, state, and zip code for domestic 
facilities, and comparable full address information for foreign 
facilities) as follows:
    (1) If an animal food packaging label is required, the notification 
required by paragraph (e) of this section must appear prominently and 
conspicuously on the label of the animal food.
    (2) If an animal food packaging label is not required, the 
notification required by paragraph (e) of this section must appear 
prominently and conspicuously, at the point of purchase, on a label, 
poster, sign, placard, or documents delivered contemporaneously with 
the animal food in the normal course of business, or in an electronic 
notice, in the case of Internet sales.
    (f)(1) A qualified facility must maintain those records relied upon 
to support the attestations that are required by paragraph (a) of this 
section.
    (2) The records that a qualified facility must maintain are subject 
to the requirements of subpart F of this part.


Sec.  507.10  Applicability of subparts C and E of this part to a 
facility solely engaged in the storage of unexposed packaged animal 
food.

    (a) Subparts C and E of this part do not apply to a facility solely 
engaged in the storage of unexposed packaged animal food that does not 
require time/temperature control to significantly minimize or prevent 
the growth of, or toxin production by, pathogens.
    (b) A facility solely engaged in the storage of unexposed packaged 
animal food, including unexposed packaged animal food that requires 
time/temperature control to significantly minimize or prevent the 
growth of, or toxin production by, pathogens is subject to the modified 
requirements in Sec.  507.51 for any unexposed packaged animal food 
that requires time/temperature control to significantly minimize or 
prevent the growth of, or toxin production by, pathogens.


Sec.  507.12  Applicability of this part to the holding and 
distribution of human food by-products for use as animal food.

    (a) Except as provided by paragraph (b) of this section, the 
requirements of this part do not apply to by-products of human food 
production, or the off-farm packing and holding of raw agricultural 
commodities, that are packed or held by that human food facility for 
distribution as animal food if:
    (1)(i) The human food facility is subject to and in compliance with 
subpart B of part 117 of this chapter and in compliance with all 
applicable human food safety requirements of the Federal Food, Drug, 
and Cosmetic Act and implementing regulations; or
    (ii) For the off-farm packing and holding of produce (as defined in 
part 112 of this chapter), the human food facility is subject to and in 
compliance with Sec.  117.8 of this chapter and in compliance with all 
applicable human food safety requirements of the Federal Food, Drug, 
and Cosmetic Act and implementing regulations; and
    (2) The human food facility does not further manufacture or process 
the by-products intended for use as animal food.
    (b) The human food by-products for use as animal food identified in 
paragraph (a) of this section must be held and distributed by that 
facility in accordance with Sec.  507.28 and Sec.  117.95 of this 
chapter.

Subpart B--Current Good Manufacturing Practice


Sec.  507.14  Personnel.

    (a) The management of the establishment must take reasonable 
measures and precautions to ensure that all persons working in direct 
contact with animal food, animal food-contact surfaces, and animal 
food-packaging materials conform to hygienic practices to the extent 
necessary to protect against the contamination of animal food.
    (b) The methods for conforming to hygienic practices and 
maintaining cleanliness include:
    (1) Maintaining adequate personal cleanliness;
    (2) Washing hands thoroughly in an adequate hand-washing facility 
as necessary and appropriate to protect against contamination;
    (3) Removing or securing jewelry and other objects that might fall 
into animal food, equipment, or containers;
    (4) Storing clothing or other personal belongings in areas other 
than where animal food is exposed or where equipment or utensils are 
cleaned; and
    (5) Taking any other necessary precautions to protect against the 
contamination of animal food, animal food-contact surfaces, or animal 
food-packaging materials.


Sec.  507.17  Plant and grounds.

    (a) The grounds around an animal food plant under the control of 
the management of the establishment must be kept in a condition that 
will protect against the contamination of animal food. Maintenance of 
grounds must include:
    (1) Properly storing equipment, removing litter and waste, and 
cutting weeds or grass within the immediate vicinity of the plant that 
may constitute an attractant, breeding place, or harborage for pests;
    (2) Maintaining driveways, yards, and parking areas so that they do 
not constitute a source of contamination in areas where animal food is 
exposed;
    (3) Adequately draining areas that may contribute to contamination 
of animal food; and
    (4) Treating and disposing of waste so that it does not constitute 
a source of contamination in areas where animal food is exposed.
    (b) The plant must be suitable in size, construction, and design to 
facilitate cleaning, maintenance, and pest control to reduce the 
potential for contamination of animal food, animal food-contact 
surfaces, and animal food-packaging materials, including that the plant 
must:
    (1) Provide adequate space between equipment, walls, and stored 
materials to permit employees to perform their duties and to allow 
cleaning and maintenance of equipment;
    (2) Be constructed in a manner such that drip or condensate from 
fixtures, ducts, and pipes does not serve as a source of contamination;
    (3) Provide adequate ventilation (mechanical or natural) where 
necessary and appropriate to minimize vapors (e.g., steam) and fumes in 
areas where they may contaminate animal food and in a manner that 
minimizes the potential for contaminating animal food;
    (4) Provide adequate lighting in hand-washing areas, toilet rooms, 
areas where animal food is received, manufactured,

[[Page 56343]]

processed, packed, or held, and areas where equipment or utensils are 
cleaned; and
    (5) Provide shatter-resistant light bulbs, fixtures, and skylights, 
or other glass items suspended over exposed animal food in any step of 
preparation, to protect against the contamination of animal food in 
case of glass breakage.
    (c) The plant must protect animal food stored outdoors in bulk from 
contamination by any effective means, including:
    (1) Using protective coverings where necessary and appropriate;
    (2) Controlling areas over and around the bulk animal food to 
eliminate harborages for pests; and
    (3) Checking on a regular basis for pests, pest infestation, and 
product condition related to safety of the animal food.


Sec.  507.19  Sanitation.

    (a) Buildings, structures, fixtures, and other physical facilities 
of the plant must be kept clean and in good repair to prevent animal 
food from becoming adulterated.
    (b) Animal food-contact and non-contact surfaces of utensils and 
equipment must be cleaned and maintained and utensils and equipment 
stored as necessary to protect against the contamination of animal 
food, animal food-contact surfaces, or animal food-packaging materials. 
When necessary, equipment must be disassembled for thorough cleaning. 
In addition:
    (1) When animal food-contact surfaces used for manufacturing, 
processing, packing, or holding animal food are wet-cleaned, the 
surfaces must, when necessary, be thoroughly dried before subsequent 
use; and
    (2) In wet processing of animal food, when cleaning and sanitizing 
is necessary to protect against the introduction of undesirable 
microorganisms into animal food, all animal food-contact surfaces must 
be cleaned and sanitized before use and after any interruption during 
which the animal food-contact surfaces may have become contaminated.
    (c) Cleaning compounds and sanitizing agents must be safe and 
adequate under the conditions of use.
    (d) The following applies to toxic materials:
    (1) Only the following toxic materials may be used or stored in the 
plant area where animal food is manufactured, processed, or exposed:
    (i) Those required to maintain clean and sanitary conditions;
    (ii) Those necessary for use in laboratory testing procedures;
    (iii) Those necessary for plant and equipment maintenance and 
operation; and
    (iv) Those necessary for use in the plant's operations.
    (2) Toxic materials described in paragraph (d)(1) of this section 
(e.g., cleaning compounds, sanitizing agents, and pesticide chemicals) 
must be identified, used, and stored in a manner that protects against 
the contamination of animal food, animal food-contact surfaces, or 
animal food-packaging materials; and
    (3) Other toxic materials (such as fertilizers and pesticides not 
included in paragraph (d)(1) of this section) must be stored in an area 
of the plant where animal food is not manufactured, processed, or 
exposed.
    (e) Effective measures must be taken to exclude pests from the 
manufacturing, processing, packing, and holding areas and to protect 
against the contamination of animal food by pests. The use of 
pesticides in the plant is permitted only under precautions and 
restrictions that will protect against the contamination of animal 
food, animal food-contact surfaces, and animal food-packaging 
materials.
    (f) Trash must be conveyed, stored, and disposed of in a way that 
protects against the contamination of animal food, animal food-contact 
surfaces, animal food-packaging materials, water supplies, and ground 
surfaces, and minimizes the potential for the trash to become an 
attractant and harborage or breeding place for pests.


Sec.  507.20  Water supply and plumbing.

    (a) The following apply to the water supply:
    (1) Water must be adequate for the operations and must be derived 
from an adequate source;
    (2) Running water at a suitable temperature, and under suitable 
pressure as needed, must be provided in all areas where required for 
the manufacturing, processing, packing, or holding of animal food, for 
the cleaning of equipment, utensils, and animal food-packaging 
materials, or for employee hand-washing facilities;
    (3) Water that contacts animal food, animal food-contact surfaces, 
or animal food-packaging materials must be safe for its intended use; 
and
    (4) Water may be reused for washing, rinsing, or conveying animal 
food if it does not increase the level of contamination of the animal 
food.
    (b) Plumbing must be designed, installed, and maintained to:
    (1) Carry adequate quantities of water to required locations 
throughout the plant;
    (2) Properly convey sewage and liquid disposable waste from the 
plant;
    (3) Avoid being a source of contamination to animal food, water 
supplies, equipment, or utensils, or creating an unsanitary condition;
    (4) Provide adequate floor drainage in all areas where floors are 
subject to flooding-type cleaning or where normal operations release or 
discharge water or other liquid waste on the floor; and
    (5) Ensure that there is no backflow from, or cross-connection 
between, piping systems that discharge waste water or sewage and piping 
systems that carry water for animal food or animal food manufacturing.
    (c) Sewage and liquid disposal waste must be disposed of through an 
adequate sewerage system or through other adequate means.
    (d) Each plant must provide employees with adequate, readily 
accessible toilet facilities. Toilet facilities must be kept clean and 
must not be a potential source of contamination of animal food, animal 
food-contact surfaces, or animal food-packaging materials.
    (e) Each plant must provide hand-washing facilities designed to 
ensure that an employee's hands are not a potential source of 
contamination of animal food, animal food-contact surfaces, or animal 
food-packaging materials.


Sec.  507.22  Equipment and utensils.

    (a) The following apply to plant equipment and utensils used in 
manufacturing, processing, packing, and holding animal food:
    (1) All plant equipment and utensils, including equipment and 
utensils that do not come in contact with animal food, must be designed 
and constructed of such material and workmanship to be adequately 
cleanable, and must be properly maintained;
    (2) Equipment and utensils must be designed, constructed, and used 
appropriately to avoid the adulteration of animal food with non-food 
grade lubricants, fuel, metal fragments, contaminated water, or any 
other contaminants;
    (3) Equipment must be installed so as to facilitate the cleaning 
and maintenance of the equipment and adjacent spaces;
    (4) Animal food-contact surfaces must be:
    (i) Made of materials that withstand the environment of their use 
and the action of animal food, and, if applicable, the action of 
cleaning compounds, cleaning procedures, and sanitizing agents;
    (ii) Made of nontoxic materials; and

[[Page 56344]]

    (iii) Maintained to protect animal food from being contaminated.
    (b) Holding, conveying, manufacturing, and processing systems, 
including gravimetric, pneumatic, closed, and automated systems, must 
be designed, constructed, and maintained in a way to protect against 
the contamination of animal food.
    (c) Each freezer and cold storage compartment used to hold animal 
food must be fitted with an accurate temperature-measuring device.
    (d) Instruments and controls used for measuring, regulating, or 
recording temperatures, pH, aw, or other conditions that 
control or prevent the growth of undesirable microorganisms in animal 
food must be accurate, precise, adequately maintained, and adequate in 
number for their designated uses.
    (e) Compressed air or other gases mechanically introduced into 
animal food or used to clean animal food-contact surfaces or equipment 
must be used in such a way to protect against the contamination of 
animal food.


Sec.  507.25  Plant operations.

    (a) Management of the establishment must ensure that:
    (1) All operations in the manufacturing, processing, packing, and 
holding of animal food (including operations directed to receiving, 
inspecting, transporting, and segregating) are conducted in accordance 
with the current good manufacturing practice requirements of this 
subpart;
    (2) Animal food, including raw materials, other ingredients, or 
rework is accurately identified;
    (3) Animal food-packaging materials are safe and suitable;
    (4) The overall cleanliness of the plant is under the supervision 
of one or more competent individuals assigned responsibility for this 
function;
    (5) Adequate precautions are taken so that plant operations do not 
contribute to contamination of animal food, animal food-contact 
surfaces, and animal food-packaging materials;
    (6) Chemical, microbial, or extraneous-material testing procedures 
are used where necessary to identify sanitation failures or possible 
animal food contamination;
    (7) Animal food that has become adulterated is rejected, disposed 
of, or if appropriate, treated or processed to eliminate the 
adulteration. If disposed of, it must be done in a manner that protects 
against the contamination of other animal food; and
    (8) All animal food manufacturing, processing, packing, and holding 
is conducted under such conditions and controls as are necessary to 
minimize the potential for the growth of undesirable microorganisms to 
protect against the contamination of animal food.
    (b) Raw materials and other ingredients:
    (1) Must be examined to ensure that they are suitable for 
manufacturing and processing into animal food and must be handled under 
conditions that will protect against contamination and minimize 
deterioration. In addition:
    (i) Shipping containers (e.g., totes, drums, and tubs) and bulk 
vehicles holding raw materials and other ingredients must be examined 
upon receipt to determine whether contamination or deterioration of 
animal food has occurred;
    (ii) Raw materials must be cleaned as necessary to minimize 
contamination; and
    (iii) Raw materials and other ingredients, including rework, must 
be stored in containers designed and constructed in a way that protects 
against contamination and deterioration, and held under conditions, 
e.g., appropriate temperature and relative humidity, that will minimize 
the potential for growth of undesirable microorganisms and prevent the 
animal food from becoming adulterated;
    (2) Susceptible to contamination with mycotoxins or other natural 
toxins must be evaluated and used in a manner that does not result in 
animal food that can cause injury or illness to animals or humans; and
    (3) If frozen, must be kept frozen. If thawing is required prior to 
use, it must be done in a manner that minimizes the potential for the 
growth of undesirable microorganisms.
    (c) For the purposes of manufacturing, processing, packing, and 
holding operations, the following apply:
    (1) Animal food must be maintained under conditions, e.g., 
appropriate temperature and relative humidity, that will minimize the 
potential for growth of undesirable microorganisms and prevent the 
animal food from becoming adulterated during manufacturing, processing, 
packing, and holding;
    (2) Measures taken during manufacturing, processing, packing, and 
holding of animal food to significantly minimize or prevent the growth 
of undesirable microorganisms (e.g., heat treating, freezing, 
refrigerating, irradiating, controlling pH, or controlling 
aw) must be adequate to prevent adulteration of animal food;
    (3) Work-in-process and rework must be handled in such a way that 
it is protected against contamination and the growth of undesirable 
microorganisms;
    (4) Steps such as cutting, drying, defatting, grinding, mixing, 
extruding, pelleting, and cooling, must be performed in a way that 
protects against the contamination of animal food;
    (5) Filling, assembling, packaging, and other operations must be 
performed in such a way that protects against the contamination of 
animal food and the growth of undesirable microorganisms;
    (6) Animal food that relies principally on the control of water 
activity (aw) for preventing the growth of undesirable 
microorganisms must be processed to and maintained at a safe 
aw level;
    (7) Animal food that relies principally on the control of pH for 
preventing the growth of undesirable microorganisms must be monitored 
and maintained at the appropriate pH; and
    (8) When ice is used in contact with animal food, it must be made 
from water that is safe and must be used only if it has been 
manufactured in accordance with current good manufacturing practice as 
outlined in this subpart.


Sec.  507.27  Holding and distribution.

    (a) Animal food held for distribution must be held under conditions 
that will protect against contamination and minimize deterioration, 
including the following:
    (1) Containers used to hold animal food before distribution must be 
designed, constructed of appropriate material, cleaned as necessary, 
and maintained to protect against the contamination of animal food; and
    (2) Animal food held for distribution must be held in a way that 
protects against contamination from sources such as trash.
    (b) The labeling for the animal food product ready for distribution 
must contain, when applicable, information and instructions for safely 
using the animal food product for the intended animal species.
    (c) Shipping containers (e.g., totes, drums, and tubs) and bulk 
vehicles used to distribute animal food must be examined prior to use 
to protect against the contamination of animal food from the container 
or vehicle when the facility is responsible for transporting the animal 
food itself or arranges with a third party to transport the animal 
food.
    (d) Animal food returned from distribution must be assessed for 
animal food safety to determine the appropriate disposition. Returned 
animal food must be identified as such and segregated until assessed.
    (e) Unpackaged or bulk animal food must be held in a manner that 
does not

[[Page 56345]]

result in unsafe cross contamination with other animal food.


Sec.  507.28  Holding and distribution of human food by-products for 
use as animal food.

    (a) Human food by-products held for distribution as animal food 
must be held under conditions that will protect against contamination, 
including the following:
    (1) Containers and equipment used to convey or hold human food by-
products for use as animal food before distribution must be designed, 
constructed of appropriate material, cleaned as necessary, and 
maintained to protect against the contamination of human food by-
products for use as animal food;
    (2) Human food by-products for use as animal food held for 
distribution must be held in a way to protect against contamination 
from sources such as trash; and
    (3) During holding, human food by-products for use as animal food 
must be accurately identified.
    (b) Labeling that identifies the product by the common or usual 
name must be affixed to or accompany the human food by-products for use 
as animal food when distributed.
    (c) Shipping containers (e.g., totes, drums, and tubs) and bulk 
vehicles used to distribute human food by-products for use as animal 
food must be examined prior to use to protect against the contamination 
of animal food from the container or vehicle when the facility is 
responsible for transporting the human food by-products for use as 
animal food itself or arranges with a third party to transport the 
human food by-products for use as animal food.

Subpart C--Hazard Analysis and Risk-Based Preventive Controls


Sec.  507.31  Food safety plan.

    (a) You must prepare, or have prepared, and implement a written 
food safety plan.
    (b) One or more preventive controls qualified individuals must 
prepare, or oversee the preparation of, the food safety plan.
    (c) The written food safety plan must include:
    (1) The written hazard analysis as required by Sec.  507.33(a)(2);
    (2) The written preventive controls as required by Sec.  507.34(b);
    (3) The written supply-chain program as required by subpart E of 
this part;
    (4) The written recall plan as required by Sec.  507.38(a)(1);
    (5) The written procedures for monitoring the implementation of the 
preventive controls as required by Sec.  507.40(a)(1);
    (6) The written corrective action procedures as required by Sec.  
507.42(a)(1); and
    (7) The written verification procedures as required by Sec.  
507.49(b).
    (d) The food safety plan required by this section is a record that 
is subject to the requirements of subpart F of this part.


Sec.  507.33  Hazard analysis.

    (a)(1) You must conduct a hazard analysis to identify and evaluate, 
based on experience, illness data, scientific reports, and other 
information, known or reasonably foreseeable hazards for each type of 
animal food manufactured, processed, packed, or held at your facility 
to determine whether there are any hazards requiring a preventive 
control; and
    (2) The hazard analysis must be written regardless of its outcome.
    (b) The hazard identification must consider:
    (1) Known or reasonably foreseeable hazards that include:
    (i) Biological hazards, including microbiological hazards such as 
parasites, environmental pathogens, and other pathogens;
    (ii) Chemical hazards, including radiological hazards, substances 
such as pesticide and drug residues, natural toxins, decomposition, 
unapproved food or color additives, and nutrient deficiencies or 
toxicities (such as inadequate thiamine in cat food, excessive vitamin 
D in dog food, and excessive copper in food for sheep); and
    (iii) Physical hazards (such as stones, glass, and metal 
fragments); and
    (2) Known or reasonably foreseeable hazards that may be present in 
the animal food for any of the following reasons:
    (i) The hazard occurs naturally;
    (ii) The hazard may be unintentionally introduced; or
    (iii) The hazard may be intentionally introduced for purposes of 
economic gain.
    (c)(1) The hazard analysis must include an evaluation of the 
hazards identified in paragraph (b) of this section to assess the 
severity of the illness or injury if the hazard were to occur and the 
probability that the hazard will occur in the absence of preventive 
controls.
    (2) The hazard evaluation required by paragraph (c)(1) of this 
section must include an evaluation of environmental pathogens whenever 
an animal food is exposed to the environment prior to packaging and the 
packaged animal food does not receive a treatment or otherwise include 
a control measure (such as a formulation lethal to the pathogen) that 
would significantly minimize the pathogen.
    (d) The hazard evaluation must consider the effect of the following 
on the safety of the finished animal food for the intended animal:
    (1) The formulation of the animal food;
    (2) The condition, function, and design of the facility and 
equipment;
    (3) Raw materials and other ingredients;
    (4) Transportation practices;
    (5) Manufacturing/processing procedures;
    (6) Packaging activities and labeling activities;
    (7) Storage and distribution;
    (8) Intended or reasonably foreseeable use;
    (9) Sanitation, including employee hygiene; and
    (10) Any other relevant factors such as the temporal (e.g., 
weather-related) nature of some hazards (e.g., levels of some natural 
toxins).


Sec.  507.34  Preventive controls.

    (a)(1) You must identify and implement preventive controls to 
provide assurances that any hazards requiring a preventive control will 
be significantly minimized or prevented and the animal food 
manufactured, processed, packed, or held by your facility will not be 
adulterated under section 402 of the Federal Food, Drug, and Cosmetic 
Act; and
    (2) Preventive controls required by paragraph (a)(1) of this 
section include:
    (i) Controls at critical control points (CCPs), if there are any 
CCPs; and
    (ii) Controls, other than those at CCPs, that are also appropriate 
for animal food safety.
    (b) Preventive controls must be written.
    (c) Preventive controls include, as appropriate to the facility and 
animal food:
    (1) Process controls. Process controls include procedures, 
practices, and processes to ensure the control of parameters during 
operations such as heat processing, irradiating, and refrigerating 
animal food. Process controls must include, as appropriate to the 
nature of the applicable control and its role in the facility's food 
safety system:
    (i) Parameters associated with the control of the hazard; and
    (ii) The maximum or minimum value, or combination of values, to 
which any biological, chemical, or physical parameter must be 
controlled to significantly minimize or prevent a hazard requiring a 
process control.

[[Page 56346]]

    (2) Sanitation controls. Sanitation controls include procedures, 
practices, and processes to ensure that the facility is maintained in a 
sanitary condition adequate to significantly minimize or prevent 
hazards such as environmental pathogens and biological hazards due to 
employee handling. Sanitation controls must include, as appropriate to 
the facility and the animal food, procedures, practices, and processes 
for the:
    (i) Cleanliness of animal food-contact surfaces, including animal 
food-contact surfaces of utensils and equipment; and
    (ii) Prevention of cross-contamination from insanitary objects and 
from personnel to animal food, animal food-packaging material, and 
other animal food-contact surfaces and from raw product to processed 
product.
    (3) Supply-chain controls. Supply-chain controls include the 
supply-chain program as required by subpart E of this part;
    (4) A recall plan as required by Sec.  507.38; and
    (5) Other preventive controls. These include any other procedures, 
practices, and processes necessary to satisfy the requirements of 
paragraph (a) of this section. Examples of other controls include 
hygiene training and other current good manufacturing practices.


Sec.  507.36  Circumstances in which the owner, operator, or agent in 
charge of a manufacturing/processing facility is not required to 
implement a preventive control.

    (a) If you are a manufacturer/processor, you are not required to 
implement a preventive control when you identify a hazard requiring a 
preventive control (identified hazard) and any of the following 
circumstances apply:
    (1) You determine and document that the type of animal food could 
not be consumed without application of an appropriate control;
    (2) You rely on your customer who is subject to the requirements 
for hazard analysis and risk-based preventive controls in subpart C of 
this part to ensure that the identified hazard will be significantly 
minimized or prevented; and you:
    (i) Disclose in documents accompanying the animal food, in 
accordance with the practice of the trade, that the animal food is 
``not processed to control [identified hazard]''; and
    (ii) Annually obtain from your customer written assurance, subject 
to the requirements of Sec.  507.37, that the customer has established 
and is following procedures (identified in the written assurance) that 
will significantly minimize or prevent the identified hazard (except as 
provided in paragraph (c) of this section);
    (3) You rely on your customer who is not subject to the 
requirements for hazard analysis and risk-based preventive controls in 
subpart C of this part to provide assurance it is manufacturing, 
processing, or preparing the animal food in accordance with applicable 
animal food safety requirements and you:
    (i) Disclose in documents accompanying the animal food, in 
accordance with the practice of the trade, that the animal food is 
``not processed to control [identified hazard]''; and
    (ii) Annually obtain from your customer written assurance that it 
is manufacturing, processing, or preparing the animal food in 
accordance with applicable animal food safety requirements;
    (4) You rely on your customer to provide assurance that the animal 
food will be processed to control the identified hazard by an entity in 
the distribution chain subsequent to the customer and you:
    (i) Disclose in documents accompanying the animal food, in 
accordance with the practice of the trade, that the animal food is 
``not processed to control [identified hazard]''; and
    (ii) Annually obtain from your customer written assurance, subject 
to the requirements of Sec.  507.37, that your customer:
    (A) Will disclose in documents accompanying the animal food, in 
accordance with the practice of the trade, that the animal food is 
``not processed to control [identified hazard]''; and
    (B) Will only sell to another entity that agrees, in writing, it 
will:
    (1) Follow procedures (identified in a written assurance) that will 
significantly minimize or prevent the identified hazard (if the entity 
is subject to the requirements for hazard analysis and risk-based 
preventive controls in subpart C of this part), except as provided in 
paragraph (d) of this section, or manufacture, process, or prepare the 
animal food in accordance with applicable animal food safety 
requirements (if the entity is not subject to the requirements for 
hazard analysis and risk-based preventive controls in subpart C of this 
part); or
    (2) Obtain a similar written assurance from the entity's customer, 
subject to the requirements of Sec.  507.37, as in paragraphs 
(a)(4)(ii)(A) and (B) of this section, as appropriate; or
    (5)You have established, documented, and implemented a system that 
ensures control, at a subsequent distribution step, of the hazards in 
the animal food product you distribute and you document the 
implementation of that system.
    (b) You must document any circumstance specified in paragraph (a) 
of this section that applies to you, including:
    (1) A determination in accordance with paragraph (a) of this 
section that the type of animal food could not be consumed without 
application of an appropriate control;
    (2) The annual written assurance from your customer in accordance 
with paragraph (a)(2) of this section;
    (3) The annual written assurance from your customer in accordance 
with paragraph (a)(3) of this section;
    (4) The annual written assurance from your customer in accordance 
with paragraph (a)(4) of this section; and
    (5) Your system, in accordance with paragraph (a)(5) of this 
section, that ensures control, at a subsequent distribution step, of 
the hazards in the animal food product you distribute.
    (c) For the written assurance required by paragraph (a)(2)(ii) of 
this section, if your customer has determined that the identified 
hazard in paragraph (a) of this section is not a hazard in the animal 
food intended for use for a specific animal species, your customer's 
written assurance may provide this determination (including animal 
species and why the identified hazard is not a hazard) instead of 
providing assurance of procedures established and followed that will 
significantly minimize or prevent the identified hazard.
    (d) For the written assurance required by paragraph (a)(4)(ii)(B) 
of this section, if the entity in the distribution chain subsequent to 
your customer is subject to subpart C of this part and has determined 
that the identified hazard in paragraph (a) of this section is not a 
hazard in the animal food intended for use for a specific animal 
species, that entity's written assurance may provide this determination 
(including animal species and why the identified hazard is not a 
hazard) instead of providing assurance that the identified hazard will 
be significantly minimized or prevented.


Sec.  507.37  Provision of assurances required under Sec.  
507.36(a)(2), (3), and (4).

    A facility that provides a written assurance under Sec.  
507.36(a)(2), (3), or (4) must act consistently with the assurance and 
document its actions taken to satisfy the written assurance.


Sec.  507.38  Recall plan.

    (a) For animal food with a hazard requiring a preventive control 
you must:

[[Page 56347]]

    (1) Establish a written recall plan for the animal food; and
    (2) Assign responsibility for performing all procedures in the 
recall plan.
    (b) The written recall plan must include procedures that describe 
the steps to perform the following actions as appropriate to the 
facility:
    (1) Directly notify direct consignees about the animal food being 
recalled, including how to return or dispose of the affected animal 
food;
    (2) Notify the public about any hazard presented by the animal food 
when appropriate to protect human and animal health;
    (3) Conduct effectiveness checks to verify the recall has been 
carried out; and
    (4) Appropriately dispose of recalled animal food, e.g., through 
reprocessing, reworking, diverting to another use that would not 
present a safety concern, or destroying the animal food.


Sec.  507.39  Preventive control management components.

    (a) Except as provided by paragraphs (b) and (c) of this section, 
the preventive controls required under Sec.  507.34 are subject to the 
following preventive control management components as appropriate to 
ensure the effectiveness of the preventive controls, taking into 
account the nature of the preventive control and its role in the 
facility's food safety system:
    (1) Monitoring in accordance with Sec.  507.40;
    (2) Corrective actions and corrections in accordance with Sec.  
507.42; and
    (3) Verification in accordance with Sec.  507.45.
    (b) The supply-chain program established in subpart E of this part 
is subject to the following preventive control management components as 
appropriate to ensure the effectiveness of the supply-chain program, 
taking into account the nature of the hazard controlled before receipt 
of the raw material or other ingredient:
    (1) Corrective actions and corrections in accordance with Sec.  
507.42, taking into account the nature of any supplier non-conformance;
    (2) Review of records in accordance with Sec.  507.49(a)(4)(ii); 
and
    (3) Reanalysis in accordance with Sec.  507.50.
    (c) The recall plan established in Sec.  507.38 is not subject to 
the requirements of paragraph (a) of this section.


Sec.  507.40  Monitoring.

    As appropriate to the nature of the preventive control and its role 
in the facility's food safety system you must:
    (a) Establish and implement written procedures, including the 
frequency with which they are to be performed, for monitoring the 
preventive controls; and
    (b) Monitor the preventive controls with adequate frequency to 
provide assurance that they are consistently performed.
    (c)(1) You must document the monitoring of preventive controls in 
accordance with this section in records that are subject to 
verification in accordance with Sec.  507.45(a)(2) and records review 
in accordance with Sec.  507.49(a)(4)(i);
    (2)(i) Records of refrigeration temperature during storage of 
animal food that requires time/temperature control to significantly 
minimize or prevent the growth of, or toxin production by, pathogens 
may be affirmative records demonstrating temperature is controlled or 
exception records demonstrating loss of temperature control; and
    (ii) Exception records may be adequate in circumstances other than 
monitoring of refrigeration temperature.


Sec.  507.42  Corrective actions and corrections.

    (a) As appropriate to the nature of the hazard and the nature of 
the preventive control, except as provided by paragraph (c) of this 
section:
    (1) You must establish and implement written corrective action 
procedures that must be taken if preventive controls are not properly 
implemented, including procedures to address, as appropriate:
    (i) The presence of a pathogen or appropriate indicator organism in 
animal food detected as a result of product testing conducted in 
accordance with Sec.  507.49(a)(2); and
    (ii) The presence of an environmental pathogen or appropriate 
indicator organism detected through the environmental monitoring 
conducted in accordance with Sec.  507.49(a)(3).
    (2) The corrective action procedures must describe the steps to be 
taken to ensure that:
    (i) Appropriate action is taken to identify and correct a problem 
that has occurred with implementation of a preventive control;
    (ii) Appropriate action is taken when necessary, to reduce the 
likelihood that the problem will recur;
    (iii) All affected animal food is evaluated for safety; and
    (iv) All affected animal food is prevented from entering into 
commerce if you cannot ensure the affected animal food is not 
adulterated under section 402 of the Federal Food, Drug, and Cosmetic 
Act.
    (b)(1) Except as provided by paragraph (c) of this section, you are 
subject to the requirements of paragraph (b)(2) of this section if any 
of the following circumstances apply:
    (i) A preventive control is not properly implemented and a 
corrective action procedure has not been established;
    (ii) A preventive control, combination of preventive controls, or 
the food safety plan as a whole is found to be ineffective; or
    (iii) A review of records in accordance with Sec.  507.49(a)(4) 
finds that the records are not complete, the activities conducted did 
not occur in accordance with the food safety plan, or appropriate 
decisions were not made about corrective actions.
    (2) If any of the circumstances listed in paragraph (b)(1) of this 
section apply, you must:
    (i) Take corrective action to identify and correct the problem;
    (ii) Reduce the likelihood that the problem will recur;
    (iii) Evaluate all affected animal food for safety;
    (iv) As necessary, prevent affected animal food from entering 
commerce as would be done following the corrective action procedure 
under paragraph (a)(2) of this section; and
    (v) When appropriate, reanalyze the food safety plan in accordance 
with Sec.  507.50 to determine whether modification of the food safety 
plan is required.
    (c) You do not need to comply with the requirements of paragraphs 
(a) and (b) of this section if:
    (1) You take action, in a timely manner, to identify and correct 
conditions and practices that are not consistent with the sanitation 
controls in Sec.  507.34(c)(2)(i) or (ii); or
    (2) You take action, in a timely manner, to identify and correct a 
minor and isolated problem that does not directly impact product 
safety.
    (d) All corrective actions (and, when appropriate, corrections) 
taken in accordance with this section must be documented in records. 
These records are subject to verification in accordance with Sec.  
507.45(a)(3) and records review in accordance with Sec.  
507.49(a)(4)(i).


Sec.  507.45  Verification.

    (a) Verification activities must include, as appropriate to the 
nature of the preventive control and its role in the facility's food 
safety system:
    (1) Validation in accordance with Sec.  507.47;
    (2) Verification that monitoring is being conducted as required by 
Sec.  507.39 (and in accordance with Sec.  507.40);

[[Page 56348]]

    (3) Verification that appropriate decisions about corrective 
actions are being made as required by Sec.  507.39 (and in accordance 
with Sec.  507.42);
    (4) Verification of implementation and effectiveness in accordance 
with Sec.  507.49; and
    (5) Reanalysis in accordance with Sec.  507.50.
    (b) All verification activities conducted in accordance with this 
section must be documented in records.


Sec.  507.47  Validation.

    (a) You must validate that the preventive controls identified and 
implemented in accordance with Sec.  507.34 are adequate to control the 
hazard as appropriate to the nature of the preventive control and its 
role in the facility's food safety system.
    (b) The validation of the preventive controls:
    (1) Must be performed (or overseen) by a preventive controls 
qualified individual:
    (i)(A) Prior to implementation of the food safety plan or;
    (B) When necessary to demonstrate the control measures can be 
implemented as designed:
    (1) Within 90 calendar days after production of the applicable 
animal food first begins;
    (2) Within a reasonable timeframe, provided that the preventive 
controls qualified individual prepares (or oversees the preparation of) 
a written justification for a timeframe that exceeds 90 calendar days 
after production of the applicable animal food first begins;
    (ii) Whenever a change to a control measure or combination of 
control measures could impact whether the control measure or 
combination of control measures, when properly implemented, will 
effectively control the hazards; and
    (iii) Whenever a reanalysis of the food safety plan reveals the 
need to do so.
    (2) Must include obtaining and evaluating scientific and technical 
evidence (or, when such evidence is not available or is inadequate, 
conducting studies) to determine whether the preventive controls, when 
properly implemented, will effectively control the hazards.
    (c) You do not need to validate:
    (1) The sanitation controls in Sec.  507.34(c)(2);
    (2) The recall plan in Sec.  507.38;
    (3) The supply-chain program in subpart E of this part; and
    (4) Other preventive controls, if the preventive controls qualified 
individual prepares (or oversees the preparation of) a written 
justification that validation is not applicable based on factors such 
as the nature of the hazard, and the nature of the preventive control 
and its role in the facility's food safety system.


Sec.  507.49  Verification of implementation and effectiveness.

    (a) You must verify that the preventive controls are consistently 
implemented and are effectively and significantly minimizing or 
preventing the hazards. To do so, you must conduct activities that 
include the following, as appropriate to the facility, the animal food, 
and the nature of the preventive control and its role in the facility's 
food safety system:
    (1) Calibration of process monitoring and verification instruments 
(or checking them for accuracy);
    (2) Product testing for a pathogen (or appropriate indicator 
organism) or other hazard;
    (3) Environmental monitoring, for an environmental pathogen or for 
an appropriate indicator organism, if contamination of an animal food 
with an environmental pathogen is a hazard requiring a preventive 
control, by collecting and testing environmental samples; and
    (4) Review of the following records within the specified 
timeframes, by (or under the oversight of) a preventive controls 
qualified individual, to ensure the records are complete, the 
activities reflected in the records occurred in accordance with the 
food safety plan, the preventive controls are effective, and 
appropriate decisions were made about corrective actions:
    (i) Monitoring and corrective action records within 7-working days 
after the records are created or within a reasonable timeframe, 
provided that the preventive controls qualified individual prepares (or 
oversees the preparation of) a written justification for a timeframe 
that exceeds 7-working days; and
    (ii) Records of calibration, testing (e.g., product testing, 
environmental monitoring), and supplier and supply-chain verification 
activities, and other verification activities within a reasonable time 
after the records are created; and
    (5) Other activities appropriate for verification of implementation 
and effectiveness.
    (b) As appropriate to the facility, the food, the nature of the 
preventive control, and the role of the preventive control in the 
facility's food safety system, you must establish and implement written 
procedures for the following activities:
    (1) The method and frequency of calibrating process monitoring 
instruments and verification instruments (or checking them for 
accuracy) as required by paragraph (a)(1) of this section;
    (2) Product testing as required by paragraph (a)(2) of this 
section. Procedures for product testing must:
    (i) Be scientifically valid;
    (ii) Identify the test microorganism(s) or other analyte(s);
    (iii) Specify the procedures for identifying samples, including 
their relationship to specific lots of product;
    (iv) Include the procedures for sampling, including the number of 
samples and the sampling frequency;
    (v) Identify the test(s) conducted, including the analytical 
method(s) used;
    (vi) Identify the laboratory conducting the testing; and
    (vii) Include the corrective action procedures required by Sec.  
507.42(a)(1).
    (3) Environmental monitoring as required by paragraph (a)(3) of 
this section. Procedures for environmental monitoring must:
    (i) Be scientifically valid;
    (ii) Identify the test microorganism(s);
    (iii) Identify the locations from which samples will be collected 
and the number of sites to be tested during routine environmental 
monitoring. The number and location of sampling sites must be adequate 
to determine whether preventive controls are effective;
    (iv) Identify the timing and frequency for collecting and testing 
samples. The timing and frequency for collecting and testing samples 
must be adequate to determine whether preventive controls are 
effective;
    (v) Identify the test(s) conducted, including the analytical 
method(s) used;
    (vi) Identify the laboratory conducting the testing; and
    (vii) Include the corrective action procedures required by Sec.  
507.42(a)(1)(ii).


Sec.  507.50  Reanalysis.

    (a) You must conduct a reanalysis of the food safety plan as a 
whole at least once every 3 years.
    (b) You must conduct a reanalysis of the food safety plan as a 
whole, or the applicable portion of the food safety plan:
    (1) Whenever a significant change in the activities conducted at 
your facility creates a reasonable potential for a new hazard or 
creates a significant increase in a previously identified hazard;
    (2) Whenever you become aware of new information about potential 
hazards associated with the animal food;
    (3) Whenever appropriate after an unanticipated animal food safety 
problem in accordance with Sec.  507.42(b); and

[[Page 56349]]

    (4) Whenever you find that a preventive control, combination of 
preventive controls, or the food safety plan as a whole is ineffective.
    (c) You must complete the reanalysis required by paragraphs (a) and 
(b) of this section and validate, as appropriate to the nature of the 
preventive control and its role in the facility's food safety system, 
any additional preventive controls needed to address the hazard 
identified:
    (1) Before any change in activities (including any change in 
preventive control) at the facility is operative; or,
    (2) When necessary to demonstrate the control measures can be 
implemented as designed:
    (i) Within 90 calendar days after production of the applicable 
animal food first begins; or
    (ii) Within a reasonable timeframe, provided that the preventive 
controls qualified individual prepares (or oversees the preparation of) 
a written justification for a timeframe that exceeds 90 calendar days 
after production of the applicable animal food first begins.
    (d) You must revise the written food safety plan if a significant 
change in the activities conducted at your facility creates a 
reasonable potential for a new hazard or a significant increase in a 
previously identified hazard, or document the basis for the conclusion 
that no revisions are needed.
    (e) A preventive controls qualified individual must perform (or 
oversee) the reanalysis.
    (f) You must conduct a reanalysis of the food safety plan when FDA 
determines it is necessary to respond to new hazards and developments 
in scientific understanding.


Sec.  507.51  Modified requirements that apply to a facility solely 
engaged in the storage of unexposed packaged animal food.

    (a) If a facility that is solely engaged in the storage of 
unexposed packaged animal food stores any such refrigerated packaged 
animal food that requires time/temperature control to significantly 
minimize or prevent the growth of, or toxin formation by pathogens, the 
facility must conduct the following activities as appropriate to ensure 
the effectiveness of the temperature controls:
    (1) Establish and implement temperature controls adequate to 
significantly minimize or prevent the growth of, or toxin formation by, 
pathogens;
    (2) Monitor the temperature controls with adequate frequency to 
provide assurance that the temperature controls are consistently 
performed;
    (3) If there is a loss of temperature control that may impact the 
safety of such refrigerated packaged animal food, take appropriate 
corrective actions to:
    (i) Correct the problem and reduce the likelihood that the problem 
will recur;
    (ii) Evaluate all affected animal food for safety; and
    (iii) Prevent the animal food from entering commerce, if you cannot 
ensure the affected animal food is not adulterated under section 402 of 
the Federal Food, Drug, and Cosmetic Act;
    (4) Verify that temperature controls are consistently implemented 
by:
    (i) Calibrating temperature monitoring and recording devices (or 
checking them for accuracy);
    (ii) Reviewing records of calibration within a reasonable time 
after the records are created; and
    (iii) Reviewing records of monitoring and corrective actions taken 
to correct a problem with the control of temperature within 7-working 
days after the records are created or within a reasonable timeframe, 
provided that the preventive controls qualified individual prepares (or 
oversees the preparation of) a written justification for a timeframe 
that exceeds 7-working days;
    (5) Establish and maintain the following records:
    (i) Records (whether affirmative records demonstrating temperature 
is controlled or exception records demonstrating loss of temperature 
control) documenting the monitoring of temperature controls for any 
such refrigerated packaged animal food;
    (ii) Records of corrective actions taken when there is a loss of 
temperature control that may impact the safety of any such refrigerated 
packaged animal food; and
    (iii) Records documenting the verification activities.
    (b) The records that a facility must establish and maintain under 
paragraph (a)(5) of this section are subject to the requirements of 
subpart F of this part.


Sec.  507.53  Requirements applicable to a preventive controls 
qualified individual and a qualified auditor.

    (a) One or more preventive controls qualified individuals must do 
or oversee the following:
    (1) Preparation of the food safety plan (Sec.  507.31(b));
    (2) Validation of the preventive controls (Sec.  507.47(b)(1));
    (3) Written justification for validation to be performed in a 
timeframe that exceeds the first 90 calendar days of production of the 
applicable animal food;
    (4) Determination that validation is not required (Sec.  
507.47(c)(4));
    (5) Review of records (Sec.  507.49(a)(4));
    (6) Written justification for review of records of monitoring and 
corrective actions within a timeframe that exceeds 7-working days;
    (7) Reanalysis of the food safety plan (Sec.  507.50(d)); and
    (8) Determination that reanalysis can be completed, and additional 
preventive controls validated, as appropriate to the nature of the 
preventive control and its role in the facility's food safety system, 
in a timeframe that exceeds the first 90 calendar days of production of 
the applicable animal food.
    (b) A qualified auditor must conduct an onsite audit (Sec.  
507.135(a)).
    (c)(1) To be a preventive controls qualified individual, the 
individual must have successfully completed training in the development 
and application of risk-based preventive controls at least equivalent 
to that received under a standardized curriculum recognized as adequate 
by FDA or be otherwise qualified through job experience to develop and 
apply a food safety system. Job experience may qualify an individual to 
perform these functions if such experience has provided an individual 
with knowledge at least equivalent to that provided through the 
standardized curriculum. This individual may be, but is not required to 
be, an employee of the facility; and
    (2) To be a qualified auditor, a qualified individual must have 
technical expertise obtained through education, training, or experience 
(or a combination thereof) necessary to perform the auditing function.
    (d) All applicable training in the development and application of 
risk-based preventive controls must be documented in records, including 
the date of the training, the type of training, and the person(s) 
trained.


Sec.  507.55  Implementation records required for this subpart.

    (a) You must establish and maintain the following records 
documenting implementation of the food safety plan:
    (1) Documentation, as required by Sec.  507.36(b), of the basis for 
not establishing a preventive control in accordance with Sec.  
507.36(a);
    (2) Records that document the monitoring of preventive controls;
    (3) Records that document corrective actions;
    (4) Records that document verification, including, as applicable, 
those related to:
    (i) Validation;
    (ii) Verification of monitoring;
    (iii) Verification of corrective actions;
    (iv) Calibration of process monitoring and verification 
instruments;

[[Page 56350]]

    (v) Product testing;
    (vi) Environmental monitoring;
    (vii) Records review; and
    (viii) Reanalysis;
    (5) Records that document the supply-chain program; and
    (6) Records that document applicable training for the preventive 
controls qualified individual and the qualified auditor.
    (b) The records that you must establish and maintain are subject to 
the requirements of subpart F of this part.

Subpart D--Withdrawal of a Qualified Facility Exemption


Sec.  507.60  Circumstances that may lead FDA to withdraw a qualified 
facility exemption.

    (a) FDA may withdraw a qualified facility exemption under Sec.  
507.5(d):
    (1) In the event of an active investigation of a foodborne illness 
outbreak that is directly linked to the qualified facility; or
    (2) If FDA determines that it is necessary to protect the public 
(human or animal) health and prevent or mitigate a foodborne illness 
outbreak based on conditions or conduct associated with the qualified 
facility that are material to the safety of the animal food 
manufactured, processed, packed, or held at such facility.
    (b) Before FDA issues an order to withdraw a qualified facility 
exemption, FDA:
    (1) May consider one or more other actions to protect the public 
(human or animal) health or mitigate a foodborne illness outbreak, 
including, a warning letter, recall, administrative detention, 
suspension of registration, refusal of animal food offered for import, 
seizure, and injunction;
    (2) Must notify the owner, operator, or agent in charge of the 
facility, in writing of circumstances that may lead FDA to withdraw the 
exemption, and provide an opportunity for the owner, operator, or agent 
in charge of the facility to respond in writing, within 15 calendar 
days of the date of receipt of the notification, to FDA's notification; 
and
    (3) Must consider the actions taken by the facility to address the 
circumstances that may lead FDA to withdraw the exemption.


Sec.  507.62  Issuance of an order to withdraw a qualified facility 
exemption.

    (a) An FDA District Director in whose district the qualified 
facility is located (or, in the case of a foreign facility, the 
Director of the Division of Compliance in the Center for Veterinary 
Medicine), or an FDA official senior to either such Director, must 
approve an order to withdraw the exemption before the order is issued.
    (b) Any officer or qualified employee of FDA may issue an order to 
withdraw the exemption after it has been approved in accordance with 
paragraph (a) of this section.
    (c) FDA must issue an order to withdraw the exemption to the owner, 
operator, or agent in charge of the facility.
    (d) FDA must issue an order to withdraw the exemption in writing, 
signed and dated by the officer or qualified employee of FDA who is 
issuing the order.


Sec.  507.65  Contents of an order to withdraw a qualified facility 
exemption.

    An order to withdraw a qualified facility exemption under Sec.  
507.5(d) must include the following information:
    (a) The date of the order;
    (b) The name, address, and location of the qualified facility;
    (c) A brief, general statement of the reasons for the order, 
including information relevant to one or both of the following 
circumstances that leads FDA to issue the order:
    (1) An active investigation of a foodborne illness outbreak that is 
directly linked to the facility; or
    (2) Conditions or conduct associated with a qualified facility that 
are material to the safety of the animal food manufactured, processed, 
packed, or held at such facility.
    (d) A statement that the facility must either:
    (1) Comply with subparts C and E of this part on the date that is 
120 calendar days after the date of receipt of the order or within a 
reasonable timeframe, agreed to by FDA, based on a written 
justification, submitted to FDA, for a timeframe that exceeds 120 
calendar days from the date of receipt of the order; or
    (2) Appeal the order within 15 calendar days of the date of receipt 
of the order in accordance with the requirements of Sec.  507.69.
    (e) A statement that a facility may request that FDA reinstate an 
exemption that was withdrawn by following the procedures in Sec.  
507.85.
    (f) The text of section 418(l) of the Federal Food, Drug, and 
Cosmetic Act and of this subpart;
    (g) A statement that any informal hearing on an appeal of the order 
must be conducted as a regulatory hearing under part 16 of this 
chapter, with certain exceptions described in Sec.  507.73;
    (h) The mailing address, telephone number, email address, and 
facsimile number of the FDA district office and the name of the FDA 
District Director in whose district the facility is located (or, in the 
case of a foreign facility, the same information for the Director of 
the Division of Compliance in the Center for Veterinary Medicine); and
    (i) The name and the title of the FDA representative who approved 
the order.


Sec.  507.67  Compliance with, or appeal of, an order to withdraw a 
qualified facility exemption.

    (a) If you receive an order under Sec.  507.65 to withdraw a 
qualified facility exemption, you must either:
    (1) Comply with applicable requirements of this part within 120 
calendar days of the date of receipt of the order, or within a 
reasonable timeframe, agreed to by FDA, based on a written 
justification, submitted to FDA, for a timeframe that exceeds 120 
calendar days from the date of receipt of the order; or
    (2) Appeal the order within 15 calendar days of the date of receipt 
of the order in accordance with the requirements of Sec.  507.69.
    (b) Submission of an appeal, including submission of a request for 
an informal hearing, will not operate to delay or stay any 
administrative action, including enforcement action by FDA, unless the 
Commissioner of Food and Drugs, as a matter of discretion, determines 
that delay or a stay is in the public interest.
    (c) If you appeal the order, and FDA confirms the order:
    (1) You must comply with applicable requirements of this part 
within 120 calendar days of the date of receipt of the order, or within 
a reasonable timeframe, agreed to by FDA, based on a written 
justification, submitted to FDA, for a timeframe that exceeds 120 
calendar days from the date of receipt of the order; and
    (2) You are no longer subject to the requirements in Sec.  507.7.


Sec.  507.69  Procedure for submitting an appeal.

    (a) To appeal an order to withdraw a qualified facility exemption, 
you must:
    (1) Submit the appeal in writing to the FDA District Director in 
whose district the facility is located (or, in the case of a foreign 
facility, the Director of the Division of Compliance in the Center for 
Veterinary Medicine), at the mailing address, email address, or 
facsimile number identified in the order within 15 calendar days of the 
date of receipt of confirmation of the order;
    (2) Respond with particularity to the facts and issues contained in 
the order, including any supporting documentation upon which you rely.
    (b) In a written appeal of the order withdrawing an exemption 
provided under Sec.  507.5(d), you may include a

[[Page 56351]]

written request for an informal hearing as provided in Sec.  507.71.


Sec.  507.71  Procedure for requesting an informal hearing.

    (a) If you appeal the order, you:
    (1) May request an informal hearing; and
    (2) Must submit any request for an informal hearing together with 
your written appeal submitted in accordance with Sec.  507.69 within 15 
calendar days of the date of receipt of the order.
    (b) A request for an informal hearing may be denied, in whole or in 
part, if the presiding officer determines that no genuine and 
substantial issue of material fact has been raised by the material 
submitted. If the presiding officer determines that a hearing is not 
justified, written notice of the determination will be given to you 
explaining the reason for the denial.


Sec.  507.73  Requirements applicable to an informal hearing.

    If you request an informal hearing, and FDA grants the request:
    (a) The hearing will be held within 15 calendar days after the date 
the appeal is filed or, if applicable, within a timeframe agreed upon 
in writing by you and FDA.
    (b) The presiding officer may require that a hearing conducted 
under this subpart be completed within 1 calendar day, as appropriate.
    (c) FDA must conduct the hearing in accordance with part 16 of this 
chapter, except that:
    (1) The order withdrawing an exemption under Sec. Sec.  507.62 and 
507.65, rather than the notice under Sec.  16.22(a) of this chapter, 
provides notice of opportunity for a hearing under this section and is 
part of the administrative record of the regulatory hearing under Sec.  
16.80(a) of this chapter.
    (2) A request for a hearing under this subpart must be addressed to 
the FDA District Director (or, in the case of a foreign facility, the 
Director of the Division of Compliance in the Center for Veterinary 
Medicine) as provided in the order withdrawing an exemption.
    (3) Section 507.75, rather than Sec.  16.42(a) of this chapter, 
describes the FDA employees who preside at hearings under this subpart.
    (4) Section 16.60(e) and (f) of this chapter does not apply to a 
hearing under this subpart. The presiding officer must prepare a 
written report of the hearing. All written material presented at the 
hearing will be attached to the report. The presiding officer must 
include as part of the report of the hearing a finding on the 
credibility of witnesses (other than expert witnesses) whenever 
credibility is a material issue, and must include a proposed decision, 
with a statement of reasons. The hearing participant may review and 
comment on the presiding officer's report within 2 calendar days of 
issuance of the report. The presiding officer will then issue the final 
decision.
    (5) Section 16.80(a)(4) of this chapter does not apply to a 
regulatory hearing under this subpart. The presiding officer's report 
of the hearing and any comments on the report by the hearing 
participant under paragraph (c)(4) of this section are part of the 
administrative record.
    (6) No party shall have the right, under Sec.  16.119 of this 
chapter to petition the Commissioner of Food and Drugs for 
reconsideration or a stay of the presiding officer's final decision.
    (7) If FDA grants a request for an informal hearing on an appeal of 
an order withdrawing an exemption, the hearing must be conducted as a 
regulatory hearing under a regulation in accordance with part 16 of 
this chapter, except that Sec.  16.95(b) does not apply to a hearing 
under this subpart. With respect to a regulatory hearing under this 
subpart, the administrative record of the hearing specified in 
Sec. Sec.  16.80(a)(1) through (3), and (a)(5), of this chapter, and 
507.73(c)(5) constitutes the exclusive record for the presiding 
officer's final decision. For purposes of judicial review under Sec.  
10.45 of this chapter, the record of the administrative proceeding 
consists of the record of the hearing and the presiding officer's final 
decision.


Sec.  507.75  Presiding officer for an appeal and for an informal 
hearing.

    The presiding officer for an appeal, and for an informal hearing, 
must be an FDA Regional Food and Drug Director or another FDA official 
senior to an FDA District Director.


Sec.  507.77  Timeframe for issuing a decision on an appeal.

    (a) If you appeal the order without requesting a hearing, the 
presiding officer must issue a written report that includes a final 
decision confirming or revoking the withdrawal by the 10th calendar day 
after the appeal is filed.
    (b) If you appeal the order and request an informal hearing:
    (1) If FDA grants the request for a hearing and the hearing is 
held, the presiding officer must provide a 2 calendar day opportunity 
for the hearing participants to review and submit comments on the 
report of the hearing under Sec.  507.73(c)(4), and must issue a final 
decision within 10 calendar days after the hearing is held; or
    (2) If FDA denies the request for a hearing, the presiding officer 
must issue a final decision on the appeal confirming or revoking the 
withdrawal within 10 calendar days after the date the appeal is filed.


Sec.  507.80  Revocation of an order to withdraw a qualified facility 
exemption.

    An order to withdraw a qualified facility exemption is revoked if:
    (a) You appeal the order and request an informal hearing, FDA 
grants the request for an informal hearing, and the presiding officer 
does not confirm the order within the 10 calendar days after the 
hearing, or issues a decision revoking the order within that time; or
    (b) You appeal the order and request an informal hearing, FDA 
denies the request for an informal hearing, and FDA does not confirm 
the order within the 10 calendar days after the appeal is filed, or 
issues a decision revoking the order within that time; or
    (c) You appeal the order without requesting an informal hearing, 
and FDA does not confirm the order within the 10 calendar days after 
the appeal is filed, or issues a decision revoking the order within 
that time.


Sec.  507.83  Final agency action.

    Confirmation of a withdrawal order by the presiding officer is 
considered a final agency action for purposes of 5 U.S.C. 702.


Sec.  507.85  Reinstatement of a qualified facility exemption that was 
withdrawn.

    (a) If the FDA District Director in whose district your facility is 
located (or, in the case of a foreign facility, the Director of the 
Division of Compliance in the Center for Veterinary Medicine) 
determines that a facility has adequately resolved any problems with 
the conditions and conduct that are material to the safety of the 
animal food manufactured, processed, packed, or held at the facility 
and that continued withdrawal of the exemption is not necessary to 
protect public (human and animal) health and prevent or mitigate a 
foodborne illness outbreak, the FDA District Director in whose district 
your facility is located (or, in the case of a foreign facility, the 
Director of the Division of Compliance in the Center for Veterinary 
Medicine) will, on his own initiative or on the request of a facility, 
reinstate the exemption.
    (b) You may ask FDA to reinstate an exemption that has been 
withdrawn under the procedures of this subpart as follows:
    (1) Submit a request, in writing, to the FDA District Director in 
whose district your facility is located (or, in the case

[[Page 56352]]

of a foreign facility, the Director of the Division of Compliance in 
the Center for Veterinary Medicine); and
    (2) Present data and information to demonstrate that you have 
adequately resolved any problems with the conditions and conduct that 
are material to the safety of the animal food manufactured, processed, 
packed, or held at your facility, such that continued withdrawal of the 
exemption is not necessary to protect public (human and animal) health 
and prevent or mitigate a foodborne illness outbreak.
    (c) If your exemption was withdrawn under Sec.  507.60(a)(1) and 
FDA later determines, after finishing the active investigation of a 
foodborne illness outbreak, that the outbreak is not directly linked to 
your facility, FDA will reinstate your exemption under Sec.  507.5(d), 
and FDA will notify you in writing that your exempt status has been 
reinstated.
    (d) If your exemption was withdrawn under both Sec.  507.60(a)(1) 
and (2) and FDA later determines, after finishing the active 
investigation of a foodborne illness outbreak, that the outbreak is not 
directly linked to your facility, FDA will inform you of this finding 
and you may ask FDA to reinstate your exemption under Sec.  507.5(d) in 
accordance with the requirements of paragraph (b) of this section.

Subpart E--Supply-Chain Program


Sec.  507.105  Requirement to establish and implement a supply-chain 
program.

    (a)(1) Except as provided by paragraphs (a)(2) and (3) of this 
section, the receiving facility must establish and implement a risk-
based supply-chain program for those raw materials and other 
ingredients for which the receiving facility has identified a hazard 
requiring a supply-chain-applied control.
    (2) A receiving facility that is an importer, is in compliance with 
the foreign supplier verification requirements under part 1, subpart L 
of this chapter, and has documentation of verification activities 
conducted under Sec.  1.506(e) of this chapter (which provides 
assurance that the hazards requiring a supply-chain-applied control for 
the raw material or other ingredient have been significantly minimized 
or prevented) need not conduct supplier verification activities for 
that raw material or other ingredient.
    (3) The requirements in this subpart do not apply to animal food 
that is supplied for research or evaluation use, provided that such 
animal food:
    (i) Is not intended for retail sale and is not sold or distributed 
to the public;
    (ii) Is labeled with the statement ``Animal food for research or 
evaluation use'';
    (iii) Is supplied in a small quantity that is consistent with a 
research, analysis, or quality assurance purpose, the animal food is 
used only for this purpose, and any unused quantity is properly 
disposed of; and
    (iv) Is accompanied with documents, in accordance with the practice 
of the trade, stating that the animal food will be used for research or 
evaluation purposes and cannot be sold or distributed to the public.
    (b) The supply-chain program must be written.
    (c) When a supply-chain-applied control is applied by an entity 
other than the receiving facility's supplier (e.g., when a non-supplier 
applies controls to certain produce (i.e., produce covered by part 112 
of this chapter), because growing, harvesting, and packing activities 
are under different management), the receiving facility must:
    (1) Verify the supply-chain-applied control; or
    (2) Obtain documentation of an appropriate verification activity 
from another entity, review and assess the entity's applicable 
documentation, and document that review and assessment.


Sec.  507.110  General requirements applicable to a supply-chain 
program.

    (a) The supply-chain program must include:
    (1) Using approved suppliers as required by Sec.  507.120;
    (2) Determining appropriate supplier verification activities 
(including determining the frequency of conducting the activity) as 
required by Sec.  507.125;
    (3) Conducting supplier verification activities as required by 
Sec. Sec.  507.130 and 507.135;
    (4) Documenting supplier verification activities as required by 
Sec.  507.175; and
    (5) When applicable, verifying a supply-chain-applied control 
applied by an entity other than the receiving facility's supplier and 
documenting that verification as required by Sec.  507.175, or 
obtaining documentation of an appropriate verification activity from 
another entity, reviewing and assessing that documentation, and 
documenting the review and assessment as required by Sec.  507.175.
    (b) The following are appropriate supplier verification activities 
for raw materials and other ingredients:
    (1) Onsite audits;
    (2) Sampling and testing of the raw material or other ingredient;
    (3) Review of the supplier's relevant food safety records; and
    (4) Other appropriate supplier verification activities based on 
supplier performance and the risk associated with the raw material or 
other ingredient.
    (c) The supply-chain program must provide assurance that a hazard 
requiring a supply-chain-applied control has been significantly 
minimized or prevented.
    (d)(1) Except as provided by paragraph (d)(2) of this section, in 
approving suppliers and determining the appropriate supplier 
verification activities and the frequency with which they are 
conducted, the following must be considered:
    (i) The hazard analysis of the animal food, including the nature of 
the hazard controlled before receipt of the raw material or other 
ingredient, applicable to the raw material and other ingredients;
    (ii) The entity or entities that will be applying controls for the 
hazards requiring a supply-chain-applied control;
    (iii) Supplier performance, including:
    (A) The supplier's procedures, processes, and practices related to 
the safety of the raw material and other ingredients;
    (B) Applicable FDA food safety regulations and information relevant 
to the supplier's compliance with those regulations, including an FDA 
warning letter or import alert relating to the safety of animal food 
and other FDA compliance actions related to animal food safety (or, 
when applicable, relevant laws and regulations of a country whose food 
safety system FDA has officially recognized as comparable or has 
determined to be equivalent to that of the United States, and 
information relevant to the supplier's compliance with those laws and 
regulations); and
    (C) The supplier's food safety history relevant to the raw 
materials or other ingredients that the receiving facility receives 
from the supplier, including available information about results from 
testing raw materials or other ingredients for hazards, audit results 
relating to the safety of the animal food, and responsiveness of the 
supplier in correcting problems; and
    (iv) Any other factors as appropriate and necessary, such as 
storage and transportation practices.
    (2) Considering supplier performance can be limited to the 
supplier's compliance history as required by paragraph (d)(1)(iii)(B) 
of this section, if the supplier is:
    (i) A qualified facility as defined by Sec.  507.3;

[[Page 56353]]

    (ii) A farm that grows produce and is not a covered farm under part 
112 of this chapter in accordance with Sec.  112.4(a), or in accordance 
with Sec. Sec.  112.4(b) and 112.5; or
    (iii) A shell egg producer that is not subject to the requirements 
of part 118 of this chapter because it has less than 3,000 laying hens.
    (e) If the owner, operator, or agent in charge of a receiving 
facility determines through auditing, verification testing, document 
review, relevant consumer, customer, or other complaints, or otherwise 
that the supplier is not controlling hazards that the receiving 
facility has identified as requiring a supply-chain-applied control, 
the receiving facility must take and document prompt action in 
accordance with Sec.  507.42 to ensure that raw materials or other 
ingredients from the supplier do not cause animal food that is 
manufactured or processed by the receiving facility to be adulterated 
under section 402 of the Federal Food, Drug, and Cosmetic Act.


Sec.  507.115  Responsibilities of the receiving facility.

    (a)(1) The receiving facility must approve suppliers.
    (2) Except as provided by paragraphs (a)(3) and (4) of this 
section, the receiving facility must determine and conduct appropriate 
supplier verification activities, and satisfy all documentation 
requirements of this subpart.
    (3) An entity other than the receiving facility may do any of the 
following, provided that the receiving facility reviews and assesses 
the entity's applicable documentation, and documents that review and 
assessment:
    (i) Establish written procedures for receiving raw materials and 
other ingredients by the entity;
    (ii) Document that written procedures for receiving raw materials 
and other ingredients are being followed by the entity; and
    (iii) Determine, conduct, or both determine and conduct, the 
appropriate supplier verification activities, with appropriate 
documentation.
    (4) The supplier may conduct and document sampling and testing of 
raw materials and other ingredients, for the hazard controlled by the 
supplier, as a supplier verification activity for a particular lot of 
product and provide such documentation to the receiving facility, 
provided that the receiving facility reviews and assesses that 
documentation, and documents that review and assessment.
    (b) For the purposes of this subpart, a receiving facility may not 
accept any of the following as a supplier verification activity:
    (1) A determination by its supplier of the appropriate supplier 
verification activities for that supplier;
    (2) An audit conducted by its supplier;
    (3) A review by its supplier of that supplier's own relevant food 
safety records; or
    (4) The conduct by its supplier of other appropriate supplier 
verification activities for that supplier within the meaning of Sec.  
507.110(b)(4).
    (c) The requirements of this section do not prohibit a receiving 
facility from relying on an audit provided by its supplier when the 
audit of the supplier was conducted by a third-party qualified auditor 
in accordance with Sec. Sec.  507.130(f) and 507.135.


Sec.  507.120  Using approved suppliers.

    (a) The receiving facility must approve suppliers in accordance 
with the requirements of Sec.  507.110(d), and document that approval, 
before receiving raw materials and other ingredients received from 
those suppliers;
    (b)(1) Written procedures for receiving raw materials and other 
ingredients must be established and followed;
    (2) The written procedures for receiving raw materials and other 
ingredients must ensure that raw materials and other ingredients are 
received only from approved suppliers (or, when necessary and 
appropriate, on a temporary basis from unapproved suppliers whose raw 
materials or other ingredients are subjected to adequate verification 
activities before acceptance for use); and
    (3) Use of the written procedures for receiving raw materials and 
other ingredients must be documented.


Sec.  507.125  Determining appropriate supplier verification activities 
(including determining the frequency of conducting the activity).

    Appropriate supplier verification activities (including the 
frequency of conducting the activity) must be determined in accordance 
with the requirements of Sec.  507.110(d).


Sec.  507.130  Conducting supplier verification activities for raw 
materials and other ingredients.

    (a) Except as provided by paragraphs (c), (d), or (e) of this 
section, one or more of the supplier verification activities specified 
in Sec.  507.110(b), as determined under Sec.  507.110(d), must be 
conducted for each supplier before using the raw material or other 
ingredient from that supplier and periodically thereafter.
    (b)(1) Except as provided by paragraph (b)(2) of this section, when 
a hazard in a raw material or other ingredient will be controlled by 
the supplier and is one for which there is a reasonable probability 
that exposure to the hazard will result in serious adverse health 
consequences or death to humans or animals:
    (i) The appropriate supplier verification activity is an onsite 
audit of the supplier; and
    (ii) The audit must be conducted before using the raw material or 
other ingredient from the supplier and at least annually thereafter.
    (2) The requirements of paragraph (b)(1) of this section do not 
apply if there is a written determination that other verification 
activities and/or less frequent onsite auditing of the supplier provide 
adequate assurance that the hazards are controlled.
    (c) If a supplier is a qualified facility as defined by Sec.  
507.3, the receiving facility does not need to comply with paragraphs 
(a) and (b) of this section if the receiving facility:
    (1) Obtains written assurance that the supplier is a qualified 
facility as defined by Sec.  507.3:
    (i) Before first approving the supplier for an applicable calendar 
year; and
    (ii) On an annual basis thereafter, by December 31 of each calendar 
year, for the following calendar year; and
    (2) Obtains written assurance, at least every 2 years, that the 
supplier is producing the raw material or other ingredient in 
compliance with applicable FDA food safety regulations (or, when 
applicable, relevant laws and regulations of a country whose food 
safety system FDA has officially recognized as comparable or has 
determined to be equivalent to that of the United States). The written 
assurance must include either:
    (i) A brief description of the preventive controls that the 
supplier is implementing to control the applicable hazard in the animal 
food; or
    (ii) A statement that the facility is in compliance with State, 
local, county, tribal or other applicable non-Federal food safety laws, 
including relevant laws and regulations of foreign counties.
    (d) If a supplier is a farm that grows produce and is not a covered 
farm under part 112 of this chapter in accordance with Sec.  112.4(a), 
or in accordance with Sec. Sec.  112.4(b) and 112.5, the receiving 
facility does not need to comply with paragraphs (a) and (b) of this 
section for produce that the receiving facility receives from the farm 
as a raw material or other ingredient if the receiving facility:

[[Page 56354]]

    (1) Obtains written assurance that the raw material or other 
ingredient provided by the supplier is not subject to part 112 of this 
chapter in accordance with Sec.  112.4(a), or in accordance with 
Sec. Sec.  112.4(b) and 112.5:
    (i) Before first approving the supplier for an applicable calendar 
year; and
    (ii) On an annual basis thereafter, by December 31 of each calendar 
year, for the following calendar year; and
    (2) Obtains written assurance, at least every 2 years, that the 
farm acknowledges that its food is subject to section 402 of the 
Federal Food, Drug, and Cosmetic Act (or, when applicable, that its 
food is subject to relevant laws and regulations of a country whose 
food safety system FDA has officially recognized as comparable or has 
determined to be equivalent to that of the United States).
    (e) If a supplier is a shell egg producer that is not subject to 
the requirements of part 118 of this chapter because it has less than 
3,000 laying hens, the receiving facility does not need to comply with 
paragraphs (a) and (b) of this section if the receiving facility:
    (1) Obtains written assurance that the shell eggs produced by the 
supplier are not subject to part 118 because the shell egg producer has 
less than 3,000 laying hens:
    (i) Before first approving the supplier for an applicable calendar 
year; and
    (ii) On an annual basis thereafter, by December 31 of each calendar 
year, for the following calendar year; and
    (2) Obtains written assurance, at least every 2 years, that the 
shell egg producer acknowledges that its food is subject to section 402 
of the Federal Food, Drug, and Cosmetic Act (or, when applicable, that 
its food is subject to relevant laws and regulations of a country whose 
food safety system FDA has officially recognized as comparable or has 
determined to be equivalent to that of the United States).
    (f) There must not be any financial conflicts of interest that 
influence the results of the verification activities listed in Sec.  
507.110(b) and payment must not be related to the results of the 
activity.


Sec.  507.135  Onsite audit.

    (a) An onsite audit of a supplier must be performed by a qualified 
auditor.
    (b) If the raw material or other ingredient at the supplier is 
subject to one or more FDA food safety regulations, an onsite audit 
must consider such regulations and include a review of the supplier's 
written plan (e.g., Hazard Analysis and Critical Control Point (HACCP) 
plan or other food safety plan), if any, and its implementation, for 
the hazard being controlled (or, when applicable, an onsite audit may 
consider relevant laws and regulations of a country whose food safety 
system FDA has officially recognized as comparable or has determined to 
be equivalent to that of the United States).
    (c)(1) The following may be substituted for an onsite audit, 
provided that the inspection was conducted within 1 year of the date 
that the onsite audit would have been required to be conducted:
    (i) The written results of an appropriate inspection of the 
supplier for compliance with applicable FDA food safety regulations by 
FDA, by representatives of other Federal Agencies (such as the United 
States Department of Agriculture), or by representatives of State, 
local, tribal, or territorial agencies; or
    (ii) For a foreign supplier, the written results of an inspection 
by FDA or the food safety authority of a country whose food safety 
system FDA has officially recognized as comparable or has determined to 
be equivalent to that of the United States.
    (2) For inspections conducted by the food safety authority of a 
country whose food safety system FDA has officially recognized as 
comparable or determined to be equivalent, the animal food that is the 
subject of the onsite audit must be within the scope of the official 
recognition or equivalence determination, and the foreign supplier must 
be in, and under the regulatory oversight of, such country.
    (d) If the onsite audit is solely conducted to meet the 
requirements of this subpart by an audit agent of a certification body 
that is accredited in accordance with regulations in part 1, subpart M 
of this chapter, the audit is not subject to the requirements in those 
regulations.


Sec.  507.175  Records documenting the supply-chain program.

    (a) The records documenting the supply-chain program are subject to 
the requirements of subpart F of this part.
    (b) The receiving facility must review the records listed in 
paragraph (c) of this section in accordance with Sec.  507.49(a)(4).
    (c) The receiving facility must document the following in records 
as applicable to its supply-chain program:
    (1) The written supply-chain program;
    (2) Documentation that a receiving facility that is an importer is 
in compliance with the foreign supplier verification program 
requirements under part 1, subpart L of this chapter, including 
documentation of verification activities conducted under Sec.  1.506(e) 
of this chapter;
    (3) Documentation of the approval of a supplier;
    (4) Written procedures for receiving raw materials and other 
ingredients;
    (5) Documentation demonstrating use of the written procedures for 
receiving raw materials and other ingredients;
    (6) Documentation of the determination of the appropriate supplier 
verification activities for raw materials and other ingredients;
    (7) Documentation of the conduct of an onsite audit. This 
documentation must include:
    (i) The name of the supplier subject to the onsite audit;
    (ii) Documentation of audit procedures;
    (iii) The dates the audit was conducted;
    (iv) The conclusions of the audit;
    (v) Corrective actions taken in response to significant 
deficiencies identified during the audit; and
    (vi) Documentation that the audit was conducted by a qualified 
auditor;
    (8) Documentation of sampling and testing conducted as a supplier 
verification activity. This documentation must include:
    (i) Identification of the raw material or other ingredient tested 
(including lot number, as appropriate) and the number of samples 
tested;
    (ii) Identification of the test(s) conducted, including the 
analytical method(s) used;
    (iii) The date(s) on which the test(s) were conducted and the date 
of the report;
    (iv) The results of the testing;
    (v) Corrective actions taken in response to detection of hazards; 
and
    (vi) Information identifying the laboratory conducting the testing;
    (9) Documentation of the review of the supplier's relevant food 
safety records. This documentation must include:
    (i) The name of the supplier whose records were reviewed;
    (ii) The date(s) of review;
    (iii) The general nature of the records reviewed;
    (iv) The conclusions of the review; and
    (v) Corrective actions taken in response to significant 
deficiencies identified during the review;
    (10) Documentation of other appropriate supplier verification 
activities based on the supplier performance and the risk associated 
with the raw material or other ingredient;
    (11) Documentation of any determination that verification 
activities

[[Page 56355]]

other than an onsite audit, and/or less frequent onsite auditing of a 
supplier, provide adequate assurance that the hazards are controlled 
when a hazard in a raw material or other ingredient will be controlled 
by the supplier and is one for which there is a reasonable probability 
that exposure to the hazard will result in serious adverse health 
consequences or death to humans or animals;
    (12) The following documentation of an alternative verification 
activity for a supplier that is a qualified facility:
    (i) The written assurance that the supplier is a qualified facility 
as defined by Sec.  507.3; and
    (ii) The written assurance that the supplier is producing the raw 
material or other ingredient in compliance with applicable FDA food 
safety regulations (or, when applicable, relevant laws and regulations 
of a country whose food safety system FDA has officially recognized as 
comparable or has determined to be equivalent to that of the United 
States);
    (13) The following documentation of an alternative verification 
activity for a supplier that is a farm that supplies a raw material or 
other ingredient and is not a covered farm under part 112 of this 
chapter:
    (i) The written assurance that supplier is not a covered farm under 
part 112 of this chapter in accordance with Sec.  112.4(a), or in 
accordance with Sec. Sec.  112.4(b) and 112.5; and
    (ii) The written assurance that the farm acknowledges that its food 
is subject to section 402 of the Federal Food, Drug, and Cosmetic Act 
(or, when applicable, that its food is subject to relevant laws and 
regulations of a country whose food safety system FDA has officially 
recognized as comparable or has determined to be equivalent to that of 
the United States);
    (14) The following documentation of an alternative verification 
activity for a supplier that is a shell egg producer that is not 
subject to the requirements established in part 118 of this chapter 
because it has less than 3,000 laying hens:
    (i) The written assurance that the shell eggs provided by the 
supplier are not subject to part 118 of this chapter because the 
supplier has less than 3,000 laying hens; and
    (ii) The written assurance that the shell egg producer acknowledges 
that its food is subject to section 402 of the Federal Food, Drug, and 
Cosmetic Act (or, when applicable, that its food is subject to relevant 
laws and regulations of a country whose safety system FDA has 
officially recognized as comparable or has determined to be equivalent 
to that of the United States);
    (15) The written results of an appropriate inspection of the 
supplier for compliance with applicable FDA food safety regulations by 
FDA, by representatives of other Federal Agencies (such as the United 
States Department of Agriculture), or by representatives from State, 
local, tribal, or territorial agencies, or the food safety authority of 
another country when the results of such an inspection is substituted 
for an onsite audit;
    (16) Documentation of actions taken with respect to supplier non-
conformance;
    (17) Documentation of verification of a supply-chain-applied 
control applied by an entity other than the receiving facility's 
supplier; and
    (18) When applicable, documentation of the receiving facility's 
review and assessment of:
    (i) Applicable documentation from an entity other than the 
receiving facility that written procedures for receiving raw materials 
and other ingredients are being followed;
    (ii) Applicable documentation, from an entity other than the 
receiving facility, of the determination of the appropriate supplier 
verification activities for raw materials and other ingredients;
    (iii) Applicable documentation, from an entity other than the 
receiving facility, of conducting the appropriate supplier verification 
activities for raw materials and other ingredients;
    (iv) Applicable documentation, from its supplier, of:
    (A) The results of sampling and testing conducted by the supplier; 
or
    (B) The results of an audit conducted by a third-party qualified 
auditor in accordance with Sec. Sec.  507.130(f) and 507.135; and
    (v) Applicable documentation, from an entity other than the 
receiving facility, of verification activities when a supply-chain-
applied control is applied by an entity other than the receiving 
facility's supplier.

Subpart F--Requirements Applying to Records That Must Be 
Established and Maintained


Sec.  507.200  Records subject to the requirements of this subpart.

    (a) Except as provided by paragraphs (d) and (e) of this section, 
all records required by this part are subject to all requirements of 
this subpart.
    (b) Records obtained by FDA in accordance with this part are 
subject to the disclosure requirements under part 20 of this chapter.
    (c) All records required by this part must be made promptly 
available to a duly authorized representative of the Secretary of 
Health and Human Services for official review and copying upon oral or 
written request.
    (d) The requirements of Sec.  507.206 apply only to the written 
food safety plan.
    (e) The requirements of Sec.  507.202(a)(2), (4), and (5) and (b) 
do not apply to the records required by Sec.  507.7.


Sec.  507.202  General requirements applying to records.

    (a) Records must:
    (1) Be kept as original records, true copies (such as photocopies, 
pictures, scanned copies, microfilm, microfiche, or other accurate 
reproductions of the original records), or electronic records;
    (2) Contain the actual values and observations obtained during 
monitoring and as appropriate, during verification activities;
    (3) Be accurate, indelible, and legible;
    (4) Be created concurrently with performance of the activity 
documented; and
    (5) Be as detailed as necessary to provide history of work 
performed.
    (b) All records must include:
    (1) Information adequate to identify the plant or facility (e.g., 
the name, and when necessary, the location of the plant or facility);
    (2) The date and, when appropriate, the time of the activity 
documented;
    (3) The signature or initials of the person performing the 
activity; and
    (4) Where appropriate, the identity of the product and the lot 
code, if any.
    (c) Records that are established or maintained to satisfy the 
requirements of this part and that meet the definition of electronic 
records in Sec.  11.3(b)(6) of this chapter are exempt from the 
requirements of part 11 of this chapter. Records that satisfy the 
requirements of this part, but that also are required under other 
applicable statutory provisions or regulations, remain subject to part 
11 of this chapter.


Sec.  507.206  Additional requirements applying to the food safety 
plan.

    The owner, operator, or agent in charge of the facility must sign 
and date the food safety plan upon initial completion and upon any 
modification.


Sec.  507.208  Requirements for record retention.

    (a)(1) All records required by this part must be retained at the 
plant or facility for at least 2 years after the date they were 
prepared.
    (2) Records that a facility relies on during the 3-year period 
preceding the

[[Page 56356]]

applicable calendar year to support its status as a qualified facility 
must be retained at the facility as long as necessary to support the 
status of a facility as a qualified facility during the applicable 
calendar year.
    (b) Records that relate to the general adequacy of the equipment or 
processes being used by a facility, including the results of scientific 
studies and evaluations, must be retained by the facility for at least 
2 years after their use is discontinued (e.g., because the facility has 
updated the written food safety plan (Sec.  507.31) or records that 
document validation of the written food safety plan (Sec.  507.45(b))).
    (c) Except for the food safety plan, offsite storage of records is 
permitted if such records can be retrieved and provided onsite within 
24 hours of request for official review. The food safety plan must 
remain onsite. Electronic records are considered to be onsite if they 
are accessible from an onsite location.
    (d) If the plant or facility is closed for a prolonged period, the 
food safety plan may be transferred to some other reasonably accessible 
location but must be returned to the plant or facility within 24 hours 
for official review upon request.


Sec.  507.212  Use of existing records.

    (a) Existing records (e.g., records that are kept to comply with 
other Federal, State, or local regulations, or for any other reason) do 
not need to be duplicated if they contain all of the required 
information and satisfy the requirements of this subpart. Existing 
records may be supplemented as necessary to include all of the required 
information and satisfy the requirements of this subpart.
    (b) The information required by this part does not need to be kept 
in one set of records. If existing records contain some of the required 
information, any new information required by this part may be kept 
either separately or combined with the existing records.


Sec.  507.215  Special requirements applicable to a written assurance.

    (a) Any written assurance required by this part must contain the 
following elements:
    (1) Effective date;
    (2) Printed names and signatures of authorized officials;
    (3) The applicable assurance under:
    (i) Sec.  507.36(a)(2);
    (ii) Sec.  507.36(a)(3);
    (iii) Sec.  507.36(a)(4);
    (iv) Sec.  507.130(c)(2);
    (v) Sec.  507.130(d)(2); or
    (vi) Sec.  507.130(e)(2).
    (b) A written assurance required under Sec.  507.36(a)(2), (3) or 
(4) must include:
    (1) Acknowledgement that the facility that provides the written 
assurance assumes legal responsibility to act consistently with the 
assurance and document its actions taken to satisfy the written 
assurance; and
    (2) Provision that if the assurance is terminated in writing by 
either entity, responsibility for compliance with the applicable 
provisions of this part reverts to the manufacturer/processor as of the 
date of termination.

PART 579--IRRADIATION IN THE PRODUCTION, PROCESSING, AND HANDLING 
OF ANIMAL FEED AND PET FOOD

0
10. The authority citation for 21 CFR part 579 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 342, 343, 348, 371.

0
11. In Sec.  579.12, add the following sentence to the end of the 
paragraph to read as follows:


Sec.  579.12  Incorporation of regulations in part 179.

    * * * Any facility that treats animal feed and pet food with 
ionizing radiation must comply with the requirements of part 507 of 
this chapter and other applicable regulations.

    Dated:August 31, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-21921 Filed 9-10-15; 8:45 am]
 BILLING CODE 4164-01-P


