
[Federal Register Volume 79, Number 188 (Monday, September 29, 2014)]
[Proposed Rules]
[Pages 58523-58572]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-22446]



[[Page 58523]]

Vol. 79

Monday,

No. 188

September 29, 2014

Part IV





 Department of Health and Human Services





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 Food and Drug Administration





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21 CFR Parts 16, 117, and 507





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

  Federal Register / Vol. 79 , No. 188 / Monday, September 29, 2014 / 
Proposed Rules  

[[Page 58524]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1, 16, and 117

[Docket No. FDA-2011-N-0920]
RIN 0910-AG36


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; supplemental notice of proposed rulemaking.

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SUMMARY: The Food and Drug Administration (FDA or we) is proposing to 
amend our 2013 proposed rule for Current Good Manufacturing Practice 
(CGMP) and Hazard Analysis and Risk-Based Preventive Controls for Human 
Food. In that 2013 proposed rule, we proposed to amend the CGMP 
requirements to modernize them and to add requirements for certain 
domestic and foreign facilities to establish and implement hazard 
analysis and risk-based preventive controls for human food. We also 
proposed to revise certain definitions in our current regulation for 
Registration of Food Facilities to clarify the scope of an exemption 
from registration requirements for ``farms'' and, in so doing, to 
clarify which domestic and foreign facilities would be subject to the 
proposed requirements for hazard analysis and risk-based preventive 
controls for human food. We are taking this action because the 
extensive input we have received from public comments has led to 
significant changes in our current thinking on certain key provisions 
of these proposed rules. We are reopening the comment period only with 
respect to specific issues identified in this proposed rule.

DATES: Submit either electronic or written comments on the proposed 
rule by December 15, 2014 Submit comments on information collection 
issues under the Paperwork Reduction Act of 1995 by December 15, 2014 
(see the ``Paperwork Reduction Act of 1995'' section of this document).

ADDRESSES: You may submit comments by any of the following methods, 
except that comments on information collection issues under the 
Paperwork Reduction Act of 1995 must be submitted to the Office of 
Information and Regulatory Affairs, Office of Management and Budget 
(OMB) (see the ``Paperwork Reduction Act of 1995'' section of this 
document).

Electronic Submissions

    Submit electronic comments in the following way:
    Federal eRulemaking Portal: http://www.regulations.gov. Follow the 
instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
    Mail/Hand delivery/Courier (for paper submissions): Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Docket No. 
FDA-2011-N-0920 for this rulemaking. All comments received may be 
posted without change to http://www.regulations.gov, including any 
personal information provided. For additional information on submitting 
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION 
section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov and insert the 
docket number, found in brackets in the heading of this document, into 
the ``Search'' box and follow the prompts and/or go to the Division of 
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Jenny Scott, Center for Food Safety 
and Applied Nutrition (HFS-300), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 240-402-2166.

SUPPLEMENTARY INFORMATION:

Table of Contents

Executive Summary
    Purpose and Coverage of the Supplemental Notice of Proposed 
Rulemaking
    Summary of the Major Provisions of the Supplemental Notice of 
Proposed Rulemaking
    Costs and Benefits
I. Background
    A. Introduction
    B. 2013 Proposed Preventive Controls Rule
    C. Definition of ``Retail Food Establishment''
II. Public Comments
    A. Opportunities for Public Comment
    B. Overview of Public Comments on the 2013 Proposed Preventive 
Controls Rule
    C. Our Decision To Issue a Supplemental Notice of Proposed 
Rulemaking for Public Comment
III. Scope of the Supplemental Notice of Proposed Rulemaking and Our 
Request for Public Comment
IV. Legal and Regulatory Framework Under Sections 415 and 418 of the 
FD&C Act and Regulations Implementing Section 415 of the FD&C Act
V. The ``Farm'' Definition
    A. 2013 Proposed Definitions of ``Farm,'' ``Harvesting,'' 
``Holding,'' and ``Packing''
    B. Conducting Packing and Holding Activities on Others' RACs
    C. Field Coring as a Harvesting Activity
    D. Drying/Dehydrating Raw Agricultural Commodities To Create a 
Distinct Commodity
    E. One General Physical Location
    F. Proposed Revisions to the Exemption From CGMP Requirements 
for ``Farms'' and Activities of ``Farm Mixed-Type Facilities'' That 
Fall Within the ``Farm'' Definition
    G. Comparing Proposed Requirements for Packing Produce Under the 
2013 Proposed Preventive Controls Rule to Proposed Requirements for 
Packing Produce Under the 2013 Proposed Produce Safety Rule
VI. Definitions of ``Holding'' and ``Packing''
    A. 2013 Proposed Definition of ``Holding''
    B. 2013 Proposed Exemptions Relevant to the Definition of 
``Holding''
    C. Comments on the 2013 Proposed Exemption for a Facility Solely 
Engaged in the Storage of RACs (Other Than Fruits and Vegetables) 
Intended for Further Distribution or Processing
    D. Comments on the 2013 Proposed Exemption for a Facility Solely 
Engaged in the Storage of Packaged Food That Is Not Exposed to the 
Environment
    E. Proposed Revisions to the Definition of ``Holding''
    F. Proposed Revisions to the Definition of ``Packing''
VII. Impact of the Proposed Revisions to the Farm-Related 
Definitions on the Classification of On-Farm Activities
    A. Comments on the 2013 Organizing Principles for Classifying 
Activities Conducted on Farms and on Farm Mixed-Type Facilities
    B. Updated Organizing Principles That Would Apply to the 
``Farm'' Definition
    C. Changes to Classification of On-Farm Activities
VIII. Proposed Exemptions for On-Farm Low-Risk Activity/Food 
Combinations
    A. The 2013 Proposed Exemptions
    B. Comments on the 2013 Proposed Exemptions for On-Farm Low-Risk 
Activity/Food Combinations
    C. Impact of the Proposed Revisions to the Definitions for 
``Farm,'' ``Harvesting,'' Holding,'' and ``Packing'' on the 2013 
Proposed Exemptions for On-Farm Low-Risk Activity/Food Combinations
IX. Overall Framework for Hazard Analysis and Risk-Based Preventive 
Controls
    A. 2013 Proposed Overall Framework for Hazard Analysis and Risk-
Based Preventive Controls
    B. Comments on the ``Reasonably Likely to Occur'' Construct 
Within the 2013 Overall Framework for Hazard Analysis and Risk-Based 
Preventive Controls
    C. Proposed Revisions to the Overall Framework for Hazard 
Analysis and Risk-Based Preventive Controls
X. Potential Requirements for Product Testing and Environmental 
Monitoring
    A. Our Request for Comment on Including Requirements for Product 
Testing and

[[Page 58525]]

Environmental Monitoring in a Final Rule
    B. Product Testing
    C. Environmental Monitoring
XI. Potential Requirements for a Supplier Program
    A. Our Request for Comment on When and How Supplier Verification 
Activities Are an Appropriate Means of Implementing the Statutory 
Framework of Section 418 of the FD&C Act
    B. Comments on When and How Supplier Verification Activities Are 
an Appropriate Means of Implementing the Statutory Framework of 
Section 418 of the FD&C Act
    C. Potential Requirements for a Supplier Program
    D. Request for Additional Comment on Requirements To Address 
Conflicts of Interest for Persons Conducting Verification Activities
XII. Potential Requirements for the Hazard Analysis To Address 
Economically Motivated Adulteration
    A. Our Request for Comment on Whether the Final Rule Should 
Address Economically Motivated Adulteration
    B. Comments on Economically Motivated Adulteration
    C. Potential Requirements To Address Economically Motivated 
Adulteration
XIII. Provisions for Withdrawal of an Exemption for a Qualified 
Facility
    A. 2013 Proposed Provisions for Withdrawal of an Exemption for a 
Qualified Facility
    B. Proposed Clarification of What FDA Will Do Before Issuing an 
Order and Proposed Mechanism for Re-Instating an Exemption
    C. Proposed Revisions to the Content of an Order To Withdraw an 
Exemption
    D. Proposed Revisions to the Timeframes for a Facility To Comply 
With, or Appeal, an Order
XIV. Definition of Very Small Business
    A. The 2013 Proposed Options for Definition of Very Small 
Business
    B. Comments on the 2013 Proposed Options for Definition of Very 
Small Business
    C. Proposed Revisions to the Definition of Very Small Business
XV. Other New and Revised Proposed Provisions
    A. Proposed New Definitions
    B. Proposed Revisions to Definitions
    C. Proposed Editorial Changes
XVI. Holding Human Food By-Products Intended for Use in Animal Food
XVII. Preliminary Regulatory Impact Analysis
    A. Overview
    B. Regulatory Flexibility Act
    C. Small Business Regulatory Enforcement Fairness Act of 1996
    D. Unfunded Mandates Reform Act of 1995
XVIII. Paperwork Reduction Act of 1995
XIX. Analysis of Environmental Impact
XX. Comments
XXI. References

Executive Summary

Purpose and Coverage of the Supplemental Notice of Proposed Rulemaking

    We previously proposed to add requirements for certain domestic and 
foreign facilities to establish and implement hazard analysis and risk-
based preventive controls for human food, as required by the FDA Food 
Safety Modernization Act (FSMA). The proposed requirements would apply 
to establishments that are required to register with us as a food 
``facility.'' In this document we are proposing to revise several 
previously proposed requirements, taking into account the comments we 
have reviewed so far, because the extensive input we have received from 
public comments has led to significant changes in our current thinking 
on certain key provisions.
    ``Farms'' are exempt from the registration requirements and, thus, 
would be exempt from the proposed requirements for hazard analysis and 
risk-based preventive controls for human food. We are proposing to 
revise the definition of ``farm,'' as well as definitions for three 
activities (``harvesting'', ``holding'', and ``packing'') that play a 
key role in determining whether an establishment is within the ``farm'' 
definition. The effect of the revised definitions would be that a farm 
would no longer be required to register as a food facility merely 
because it packs or holds raw agricultural commodities (RACs) grown on 
another farm not under the same ownership. The revised definitions 
would not create any new circumstances where a farm that would not have 
been required to register under the previous proposal would now be 
required to register.
    In the previous proposal, we asked for comment on when and how 
three provisions (i.e., product testing programs, environmental 
monitoring programs, and supplier programs) are an appropriate means of 
implementing the statutory directives of FSMA. We also requested 
comment on whether a facility should be required to address potential 
hazards that may be intentionally introduced for economic reasons. Some 
comments to the previous proposal assert that additional public comment 
is warranted before consideration is given to whether a final rule 
includes or does not include provisions that were discussed in the 
previous proposal but for which we had not included regulatory text in 
the previous proposal. In this document we are providing an opportunity 
for such public comment on potential requirements for product testing 
programs, environmental monitoring programs, supplier programs, and 
hazards that may be intentionally introduced for purposes of economic 
gain, taking into account the comments we have reviewed so far. We are 
seeking comment on whether such requirements should be included in a 
final rule and, if so, what (if any) modifications to the proposed 
regulatory text would be appropriate.
    In the previous proposal, we requested comment on three options for 
classifying a facility as a ``very small business,'' with consequences 
for facilities in terms of eligibility for exemptions and the timeframe 
to comply with this rule. In this document we are proposing a 
definition for ``very small business'' (i.e., a business that has less 
than $1,000,000 in total annual sales of human food adjusted for 
inflation).

Summary of the Major Provisions of the Supplemental Notice of Proposed 
Rulemaking

    The revised ``farm'' definition would continue to describe a farm 
as an establishment devoted to the growing of crops, the raising of 
animals, or both. However, the revised ``farm'' definition would no 
longer limit packing and holding of RACs to the farm's own RACs; 
instead, a ``farm'' could now pack and hold RACs grown on another farm 
not under the same ownership. In addition, a farm could manufacture/
process RACs by drying/dehydrating to create a distinct commodity 
(e.g., drying grapes to create raisins), and package and label the 
dried commodity, as long as there was no additional processing. An 
example of additional processing might include slicing fruit and then 
drying it, which would require additional manufacturing/processing 
prior to drying. Because drying/dehydrating RACs to create a distinct 
commodity creates a processed food, the packing and holding of raisins 
would be subject to the CGMP requirements for human food rather than to 
standards that we have separately proposed to apply to produce RACs. 
Given the nature of this processed food (i.e., dried RACs), we 
tentatively conclude that the requirements we separately proposed for 
packing and holding produce RACs would be sufficiently similar to the 
CGMP requirements to make it appropriate to specify in the regulatory 
text that compliance with the CGMP requirements may be achieved by 
complying with subpart B or with the applicable requirements for 
packing and holding produce RACs in the separate produce safety rule.

[[Page 58526]]

    The previously proposed requirements for hazard analysis and risk-
based preventive controls applied a construct we previously used in our 
Hazard Analysis and Critical Control Point (HACCP) regulations for 
seafood and juice--i.e., whether a known or reasonably foreseeable 
hazard was ``reasonably likely to occur.'' In general, our HACCP 
regulations for seafood and juice focus on critical control points to 
control hazards that are ``reasonably likely to occur.'' We are 
proposing to eliminate the term ``hazard reasonably likely to occur'' 
throughout the proposed requirements to reduce the potential for a 
misinterpretation that all necessary preventive controls must be 
established at critical control points (CCPs). The revised regulations 
would use a new term (``significant hazard'') in its place.
    The defined term ``significant hazard'' would be linked to the 
facility's hazard analysis, which addresses risk (i.e., both the 
severity of a potential hazard and the probability that the hazard will 
occur). Thus, this term would reflect the risk-based nature of the 
requirements. In addition, the revised regulations would provide 
additional flexibility relative to the previous proposal by providing 
that a facility can take into account the nature of a preventive 
control in determining when and how to establish and implement 
appropriate preventive control management components, including 
monitoring, corrections or corrective actions, verification, and 
records. Table 6 in the document provides examples of flexibility 
provided by the rule, including flexibility provided for a facility to 
take into account the nature of the preventive control when determining 
the appropriate preventive control management components.
    The proposed requirements for product testing would, if included in 
a final rule, require that a facility conduct product testing as an 
activity for verification of implementation and effectiveness as 
appropriate to the facility, the food, and the nature of the preventive 
control. The facility would be required to have written procedures for 
product testing, corrective action procedures to address the presence 
of a pathogen or appropriate indicator organism in a ready-to-eat 
product detected as a result of product testing, and records of product 
testing.
    The proposed requirements for environmental monitoring would, if 
included in a final rule, require that a facility conduct environmental 
monitoring as an activity for verification of implementation and 
effectiveness as appropriate to the facility, the food, and the nature 
of the preventive control if contamination of a ready-to-eat food with 
an environmental pathogen is a significant hazard. The facility would 
be required to have written procedures for environmental monitoring, 
corrective action procedures to address the presence of an 
environmental pathogen or appropriate indicator organism detected 
through the environmental monitoring, and records of environmental 
monitoring.
    The proposed requirements for a potential supplier program would, 
if included in a final rule, require supplier controls when the 
facility's hazard analysis identifies a significant hazard for a raw 
material or ingredient, and that hazard is controlled before the 
facility receives the raw material or ingredient (e.g., if a supplier 
roasts the nuts that a facility would use to manufacture an energy 
bar). A facility would not need to establish supplier controls if it 
controls that hazard, or if its customer controls that hazard. The 
supplier program would be written. With one exception, the receiving 
facility would have flexibility to determine the appropriate 
verification activity (e.g., onsite audit; sampling and testing of the 
raw material or ingredient; review of the supplier's food safety 
records; or other appropriate verification activity). The exception 
would be when there is a reasonable probability that exposure to the 
hazard will result in serious adverse health consequences or death to 
humans. In this circumstance, the receiving facility would be required 
to have documentation of an onsite audit of the supplier before using 
the raw material or ingredient from the supplier and at least annually 
thereafter, unless the receiving facility determines and documents that 
that other verification activities and/or less frequent onsite auditing 
of the supplier provide adequate assurance that the hazards are 
controlled. 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.
    The proposed requirements regarding potential hazards that may be 
intentionally introduced for economic reasons would, if included in a 
final rule, require that a facility consider in its hazard analysis 
hazards that may be intentionally introduced for purposes of economic 
gain.
    We seek comment on whether these potential requirements discussed 
above should be included in a final rule.
    The previously proposed requirements provided for an exemption for 
certain facilities defined by FSMA as ``qualified facilities.'' As 
required by FSMA, the previously proposed requirements also included an 
administrative procedure whereby we could withdraw that exemption under 
certain circumstances. In this document, we are proposing a series of 
modifications to the proposed withdrawal provisions. These 
modifications include describing the steps we would take before 
withdrawing an exemption, including advance notification to the 
facility; a procedure for re-instatement of a withdrawn exemption; and 
an additional 60 days for a facility whose exemption is withdrawn to 
comply with the full requirements for hazard analysis and risk-based 
preventive controls.

Costs and Benefits

    We summarize the domestic annualized costs of the proposed 
regulation with the revised provisions, including the potential 
requirements for product testing, environmental monitoring, a supplier 
program, and potential requirements regarding hazards that may be 
intentionally introduced for economic reasons, using both a discount 
rate of 3 percent and 7 percent, discounted over a 7 year period in the 
following table. The revised proposed regulation uses a very small 
business definition of $1,000,000 and includes potential additional 
requirements for facilities subject to subpart C to institute risk-
based environmental monitoring, product testing and a supplier program 
as appropriate to the food, the facility and the nature of the 
preventive controls, and controls to help prevent hazards associated 
with economically motivated adulteration. As described in the updated 
Preliminary Regulatory Impact Analysis, for the final rule we 
anticipate making several modifications to our estimate of the cost of 
our proposed rule (see section XVII).
    As in our original proposal, we lack sufficient information to 
fully estimate the proposed rule's likely benefits. Instead we attempt 
to estimate the total economic burden of the domestic illnesses that 
could potentially be prevented by this rule. We do not expect that all 
of these illnesses will be prevented; rather, we expect that the rule 
would prevent some portion from occurring. We estimate that there are 
close to 1,000,000 illnesses each year that are attributable to FDA-
regulated

[[Page 58527]]

food products that would fall under the scope of this proposed rule. 
The monetized cost of these illnesses is estimated to be nearly $2 
billion. This ignores the costs to foreign firms and benefits to 
foreign consumers.
    For the proposed rule to break even, by which we mean for the 
proposed rule to reduce the health burden to consumers by approximately 
the same amount as the compliance costs to industry, and if we include 
the costs to foreign firms but ignore the benefits to foreign 
consumers, the rule would have to reduce the annual social cost of the 
illnesses by approximately $471 million. We estimate that the average 
cost per illness is $2,063, so reducing the cost of illness by $471 
million requires reducing the number of illnesses by at least 228,000 
each year.

                          Original and Revised Estimated Total Costs Based on Additional Provisions and Revised Facility Count
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              20 or fewer          20 to 99          100 to 499        500 or more
                                                               employees          employees          employees          employees            Total
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Original Total Annualized Costs without additional              $208 million        $67 million        $43 million         $1 million      $319 million*
 provisions discounted at 7%.............................
Original Total Annualized Costs without additional              $200 million        $65 million        $42 million         $1 million      $307 million*
 provisions discounted at 3%.............................
Additional costs because of new provisions discounted at         $19 million        $20 million        $10 million         $2 million       $52 million*
 7%......................................................
Additional costs because of new provisions discounted at         $19 million        $20 million        $10 million         $2 million       $52 million*
 3%......................................................
Revised Total Annualized Costs discounted at 7%..........       $227 million        $87 million        $53 million         $3 million      $371 million*
Revised Total Annualized Costs discounted at 3%..........       $219 million        $85 million        $52 million         $3 million      $359 million*
Total Costs to Foreign Facilities (most likely cost)       .................  .................  .................  .................       $100 million
 annualized at 7%........................................
Total Costs to Foreign Facilities (most likely cost)       .................  .................  .................  .................       $100 million
 annualized at 3%........................................
Benefits.................................................  .................  .................  .................  .................       Unquantified
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I. Background

A. Introduction

    The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353), 
signed into law by President Obama on January 4, 2011, enables us to 
better protect public 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 us with 
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 gives us important new tools to better ensure the safety of 
imported foods and encourages us to form partnerships with State, 
local, tribal, and territorial authorities. Table 1 identifies five 
proposed rules, issued to implement FSMA, that we discuss in this 
document.

      Table 1--Published Proposed Rules for Implementation of FSMA
------------------------------------------------------------------------
              Title                  Abbreviation         Publication
------------------------------------------------------------------------
Current Good Manufacturing        2013 proposed       78 FR 3646,
 Practice and Hazard Analysis      preventive          January 16, 2013.
 and Risk-Based Preventive         controls rule.
 Controls for 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.
Focused Mitigation Strategies To  2013 proposed       78 FR 78014,
 Protect Food Against              intentional         December 24,
 Intentional Adulteration.         adulteration rule.  2013.
Current Good Manufacturing        2013 proposed       78 FR 64736,
 Practice and Hazard Analysis      animal food rule.   October 29, 2013.
 and Risk-Based Preventive
 Controls for Food for Animals.
------------------------------------------------------------------------

B. 2013 Proposed Preventive Controls Rule

    In the 2013 proposed preventive controls rule, we:
    Proposed to amend our regulation for Current Good Manufacturing 
Practice in Manufacturing, Packing, or Holding Human Food (CGMPs; 
currently established in part 110 (21 CFR part 110)) to modernize it;
    Proposed to adjust and clarify what activities fall within the 
current exemption from the CGMP requirements for establishments engaged 
solely in the harvesting, storage, or distribution of one or more RACs 
based on experience and changes in related areas of the law since 
issuance of the CGMP regulation;
    Proposed to re-establish the provisions of current part 110 in new 
part 117 (21 CFR part 117);
    Proposed to delete some non-binding provisions of current part 110 
and requested comment on whether to revise other non-binding provisions 
to

[[Page 58528]]

establish new requirements in proposed part 117, or to simply retain 
them as useful provisions of a comprehensive CGMP;
    Requested comment on additional proposed revisions or 
clarifications to our CGMP regulations, including whether to further 
implement opportunities for CGMP modernization, such as on how best to 
revise the current provisions for training;
    Proposed to add, in newly established part 117, requirements for 
domestic and foreign facilities that are required to register under 
section 415 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) 
to establish and implement hazard analysis and risk-based preventive 
controls for human food;
    Proposed to add a definition for the term ``mixed-type 
facilities,'' to add or modify definitions for certain activities 
(i.e., for ``harvesting,'' ``holding,'' ``manufacturing/processing,'' 
and ``packing'' activities), and to revise the definition of ``farm'' 
as a conforming revision in light of the proposed new definition of 
``harvesting'' in our current regulation for Registration of Food 
Facilities (21 CFR part 1, subpart H; the section 415 registration 
regulations) to clarify the scope of the exemption from the section 415 
registration requirements for ``farms;''
    Proposed to revise the definitions, in our current regulation 
(implementing section 414 of the FD&C Act) for Establishment and 
Maintenance of Records for Foods (21 CFR part 1, subpart J; the section 
414 recordkeeping requirements);
    Requested comment on when and how product testing programs, 
environmental monitoring programs, and supplier approval and 
verification are an appropriate means of implementing the statutory 
framework of FSMA; and
    Requested comment on whether a final rule should address potential 
hazards that may be intentionally introduced for economic reasons.
    We proposed to establish the requirements for CGMPs, for hazard 
analysis and risk-based preventive controls, and related requirements 
in new part 117 as shown in Table 2:

               Table 2--Proposed Subparts in New Part 117
------------------------------------------------------------------------
                Subpart                               Title
------------------------------------------------------------------------
A......................................  General Provisions.
B......................................  Current Good Manufacturing
                                          Practice.
C......................................  Hazard Analysis and Risk- Based
                                          Preventive Controls.
D......................................  Modified Requirements.
E......................................  Withdrawal of an Exemption
                                          Applicable to a Qualified
                                          Facility.
F......................................  Requirements Applying to
                                          Records That Must Be
                                          Established and Maintained.
G......................................  Reserved.
------------------------------------------------------------------------

    In the 2013 proposed preventive controls rule, we provided an 
extensive background discussing:
    The provisions of FSMA most directly applicable to the proposed 
requirements, particularly the statutory provisions of section 103 of 
FSMA (established in section 418 of the FD&C Act);
    Hazard Analysis and Critical Control Points (HACCP) Systems;
    Food Safety Problems Associated With Manufacturing, Processing, 
Packing, and Holding Food for Human Consumption;
    The Role of Testing as a Verification Measure in a Food Safety 
System (including discussions about environmental monitoring as well as 
testing raw materials, ingredients, and finished product), largely in 
an Appendix to the 2013 proposed preventive controls rule (the 
Appendix)); and
    The Role of Supplier Approval and Verification Programs in a Food 
Safety System (largely in the Appendix).
    We also issued for public comment a ``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'' (the draft risk assessment) (78 FR 3824, January 16, 2013). The 
purpose of the draft risk assessment was to provide a science-based 
risk analysis of those activity/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 draft risk assessment 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 also issued a document correcting several typographical and 
stylistic errors in the 2013 proposed preventive controls rule and a 
mistake in the date of a reference (78 FR 17142, March 20, 2013). In 
that correction document, we republished the Appendix in its entirety 
(78 FR 17142 at 17143 through 17155; the corrected Appendix) because 
all the references to the Appendix as published in the 2013 proposed 
preventive controls rule (78 FR 3646 at 3812 through 3824) had been 
numbered incorrectly.

C. Definition of ``Retail Food Establishment''

    An establishment that meets the definition of ``retail food 
establishment'' is exempt from the requirements of the section 415 
registration regulations and, thus, from FSMA's requirements for hazard 
analysis and risk-based preventive controls. Section 102(c) of FSMA 
requires that we revise the definition of ``retail food establishment'' 
in Sec.  1.227 to clarify its intent. Some comments express concern 
that we did not address the requirements of section 102(c) of FSMA in 
the 2013 proposed preventive controls rule.
    We are addressing the requirements of section 102(c) of FSMA in a 
separate rulemaking and plan to issue a proposed rule to amend the 
definition of ``retail food establishment'' in the section 415 
registration regulations and the section 414 recordkeeping regulations 
in a future issue of the Federal Register.

II. Public Comments

A. Opportunities for Public Comment

    We requested comments on the 2013 proposed preventive controls rule 
by May 16, 2013. We extended the comment periods for the 2013 proposed 
preventive controls rule, its information collection provisions, and 
the draft risk assessment in response to several requests that we do so 
(see Table 3).
    Since issuing the 2013 proposed preventive controls rule, we 
conducted numerous outreach activities. For example, we held three 
public meetings to solicit oral stakeholder and public comments on the 
2013 proposed preventive controls rule, inform the public about the 
rulemaking process (including how to submit comments, data, and other 
information to the rulemaking dockets), and respond to questions about 
the 2013 proposed preventive controls rule (see Table 3) (Ref. 1) (Ref. 
2) (Ref. 3) (Ref. 4) (Ref. 5) (Ref. 6). We also traveled across the 
country and around the world to discuss the 2013 proposed preventive 
controls rule, as well as the other foundational FSMA proposed rules 
listed in section I.A, with persons who would be affected by them (Ref. 
7) (Ref. 8) (Ref. 9).

[[Page 58529]]



    Table 3--List of Federal Register Publications Regarding the 2013
                    Proposed Preventive Controls Rule
------------------------------------------------------------------------
                Description                          Publication
------------------------------------------------------------------------
2013 proposed preventive controls rule,     78 FR 3646, January 16,
 requesting comments by May 16, 2013.        2013.
Notice of availability of the draft risk    78 FR 3824, January 16,
 assessment, requesting comments by          2013.
 February 15, 2013.
Notice of public meeting (held in           78 FR 6762, January 31,
 Washington D.C. on February 28, 2013) on    2013.
 the 2013 proposed preventive controls
 rule and the 2013 proposed produce safety
 rule.
Notice of public meetings (held in          78 FR 10107, February 13,
 Chicago, IL on March 11, 2013 and in        2013.
 Portland, OR on March 27, 2013) on the
 2013 proposed preventive controls rule
 and the 2013 proposed produce safety rule.
Notice extending comment period, until May  78 FR 11611, February 19,
 16, 2013, for the information collection    2013.
 provisions of the 2013 proposed
 preventive controls rule.
Reopening of the comment period, until May  78 FR 15894, March 13, 2013.
 16, 2013, for the draft risk assessment.
Notice of correction for the 2013 proposed  78 FR 17142, March 20, 2013.
 preventive controls rule.
Notice extending the comment period, until  78 FR 24691, April 26, 2013.
 September 16, 2013, for the 2013 proposed
 preventive controls rule and its
 information collection provisions.
Notice extending the comment period, until  78 FR 24693, April 26, 2013.
 September 16, 2013, for the draft risk
 assessment.
Notice extending the comment period, until  78 FR 48636, August 9, 2013.
 November 15, 2013, for the 2013 proposed
 preventive controls rule and its
 information collection provisions.
Notice extending the comment period, until  78 FR 69604, November 20,
 November 22, 2013, for the 2013 proposed    2013.
 preventive controls rule and its
 information collection provisions.
------------------------------------------------------------------------

B. Overview of Public Comments on the 2013 Proposed Preventive Controls 
Rule

    We received more than 8000 submissions on the proposed rule by the 
close of the comment period, each containing one or more comments. We 
received submissions from diverse members of the public, including 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; consumer groups; Congress, Federal, State, local, and tribal 
Government Agencies; and other organizations. Some submissions included 
signatures and statements from multiple individuals.
    Comments address virtually every provision of the 2013 proposed 
preventive controls rule, including our requests for comment on 
including additional provisions that we did not include in the proposed 
regulatory text. Although some comments focus on specific details of 
the proposed requirements (such as whether the rule should define the 
term ``allergen cross-contact'' rather than the term ``cross-
contact''), other comments are broad in nature (such as comments 
addressing the overall framework of the proposed requirements for 
hazard analysis and risk-based preventive controls in proposed subpart 
C). Some comments question whether the proposed requirements reflected 
a risk-based approach (such as comments about how the requirements for 
hazard analysis and risk-based preventive controls would apply to 
facilities co-located on farms). Some comments assert that additional 
public comment would be warranted before any consideration of whether a 
final rule should or should not include provisions discussed in the 
proposed rule, but for which we had not included proposed regulatory 
text, such as potential requirements for product testing, environmental 
monitoring, a supplier approval and verification program, and potential 
hazards that may be intentionally introduced for economic reasons.

C. Our Decision To Issue a Supplemental Notice of Proposed Rulemaking 
for Public Comment

    In December 2013, we issued a statement noting the extensive input 
we have received from produce farmers and others in the agricultural 
sector on the 2013 proposed produce safety rule and the 2013 proposed 
preventive controls rule (Ref. 8). We stated that we believe that 
significant changes will be needed in key provisions of the two 
proposed rules affecting small and large farmers, such as certain 
provisions affecting mixed-use facilities (i.e., facilities co-located 
on a farm). We also announced our intent to propose revised regulatory 
requirements and request comment on them, allowing the public the 
opportunity to provide input on our new thinking. We noted that there 
may be other revisions to the proposed rules that we would issue for 
public comment, and that we would determine the scope of the revised 
proposals after we complete our initial review of written comments.

III. Scope of the Supplemental Notice and Our Request for Public 
Comment

    In this document, we are proposing:
    Modifications to our proposed revisions to the definitions, in the 
section 415 registration regulations, for ``farm,'' ``harvesting,'' 
holding,'' and ``packing,'' with conforming changes in the section 414 
recordkeeping regulations and the proposed preventive controls rule;
    Modifications to our proposed revisions to the current exemption, 
in the CGMP regulations, for establishments engaged solely in the 
harvesting, storage, or distribution of one or more RACs;
    Revisions to several definitions we proposed to apply to the 
requirements for hazard analysis and risk-based preventive controls, 
including definitions for ``environmental pathogen,'' ``hazard,'' 
``reasonably foreseeable hazard,'' and ``very small business'';
    New definitions for ``significant hazard,'' ``pathogen,'' and 
``you'';
    Revisions to the proposed procedures that would govern withdrawal 
of an exemption from a ``qualified facility,'' including clarifications 
about the steps we would take before issuing an order to withdraw the 
exemption, an expanded timeframe for a facility to comply with an order 
withdrawing an exemption, and a mechanism for a withdrawn exemption to 
be re-instated; and
    A series of revisions to the proposed requirements for hazard 
analysis and risk-based preventive controls (proposed subpart C) to:
    Emphasize the risk-based nature of the preventive controls and 
requirements for monitoring, corrective actions, and verification 
activities;
    Reduce the potential for misinterpretation that the rule requires

[[Page 58530]]

that all necessary preventive controls be established at CCPs for all 
hazards that a facility addresses in its food safety plan;
    Increase flexibility for a facility to determine, based on the 
nature of a preventive control, when requirements for ``preventive 
control management components'' (i.e., monitoring, corrective actions, 
and verification) are appropriate;
    Substitute the pronoun ``you'' for ``the owner, operator, or agent 
in charge of the facility'' throughout these proposed requirements;
    Substitute the term ``adequate'' (which is a term we proposed to 
define) in place of the term ``sufficient'' (which we did not propose 
to define);
    Improve readability, through rearrangement of some of the proposed 
regulatory text and editorial revisions (such as increased use of 
active voice).
    In this document, we also are providing 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, including definitions of 
terms (i.e., ``qualified auditor,'' ``receiving facility,'' and 
``supplier'') that would be used in some of those potential 
requirements. We are seeking comment on whether such requirements 
should be included in a final rule and, if so, what (if any) 
modifications to the proposed regulatory text would be appropriate.
    In this document, we also are informing stakeholders of a 
supplemental notice of proposed rulemaking, published elsewhere in this 
issue of the Federal Register, to amend the 2013 proposed animal food 
rule. That supplemental notice includes proposed revisions that would 
address comments about the practice of human food manufacturers sending 
by-products to local farmers or animal food manufacturers for use as 
animal food.
    We discuss these proposed requirements in sections V through XV. 
Because several of the proposed revisions relate to the overall 
framework in subpart C for hazard analysis and risk-based preventive 
controls, we are including the complete regulatory text for proposed 
subpart C. However, in this document, we are reopening the comment 
period only with respect to the issues specified in this section III.
    Importantly, the proposed revisions to the provisions we have 
included in the regulatory text are based on a preliminary review of 
the comments. We will complete our review of comments previously 
submitted and consider the comments responsive to this supplemental 
notice of proposed rulemaking in developing the final rule.

IV. Legal and Regulatory Framework Under Sections 415 and 418 of the 
FD&C Act and Regulations Implementing Section 415 of the FD&C Act

    In the 2013 proposed preventive controls rule, we described 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. We 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.'' When we implemented the statutory 
requirements for registration of food facilities, we established a 
definition for ``farm'' that first describes a farm as a facility 
devoted to the growing and harvesting of crops, the raising of animals 
(including seafood), or both (Sec.  1.227; 68 FR 58894, October 10, 
2003). Although that definition of ``farm'' then provides that farms 
also pack or hold food, it limits facilities that fall within the 
definition of ``farm'' to those that pack or hold food grown, raised, 
or consumed on that farm or another farm under the same ownership. 
Thus, under the current framework, an establishment that is devoted to 
the growing and harvesting of crops, but also packs and holds food not 
grown or raised on that farm or on another farm under the same 
ownership, would fall outside the definition of ``farm'' and be 
required to register as a food facility. Because an establishment that 
is required to register as a food facility is subject to the 
requirements of section 418 of the FD&C Act, under the current 
framework a determination of whether an establishment devoted to the 
growing and harvesting of crops is subject to FSMA's requirements for 
hazard analysis and risk-based preventive controls depends, in part, on 
where the food that the establishment packs or holds is grown or 
raised.
    Under the current 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 farm fall within definitions of 
``harvesting,'' ``packing'' or ``holding'' (which are within the 
``farm'' definition). As discussed in the 2013 proposed preventive 
controls rule, section 103 of FSMA directs us to conduct rulemaking to 
clarify the on-farm manufacturing, processing, packing and holding 
activities that would trigger a requirement for an establishment that 
is also a farm to register as a food facility and, thus, be subject to 
the requirements for hazard analysis and risk-based preventive controls 
with regard to its non-farm activities (78 FR 3646 at 3674). In the 
2013 proposed preventive controls rule, we explained how the status of 
a food as a raw agricultural commodity (RAC) or a processed food 
affects the requirements applicable to a farm under sections 415 and 
418 of the FD&C Act.
    In the 2013 proposed preventive controls rule, we also articulated 
a comprehensive set of organizing principles that formed the basis for 
proposed revisions to definitions that classify activities on-farm and 
off-farm in the section 415 registration regulations (the 2013 
organizing principles; see Table 3 in the 2013 proposed preventive 
controls rule). Because these definitions also are established in the 
section 414 recordkeeping regulations, these organizing principles also 
would form the basis for proposed revisions to definitions that 
classify activities on-farm and off-farm in the section 414 
recordkeeping regulations.
    In the 2013 proposed preventive controls rule, we proposed to add a 
definition for the term ``mixed-type facilities,'' to add or modify 
definitions for certain activities (i.e., for ``harvesting,'' 
``holding,'' ``manufacturing/processing,'' and ``packing'' activities), 
and to revise the definition of ``farm'' as a conforming revision in 
light of the proposed new definition of ``harvesting.''
    In sections V and VI, we discuss comments on these and other 
provisions of the 2013 proposed preventive controls rule that are 
leading us to propose revised definitions for ``farm,'' ``harvesting,'' 
``packing,'' and ``holding''; and re-classify some activities as 
harvesting, packing, or holding. Briefly, the proposed changes would:
    Provide for on-farm packing and holding of RACs to remain within 
the farm definition regardless of ownership of the RACS;
    Include, within the ``farm'' definition, a description of packing 
activities that include packaging RACs grown or raised on a farm 
without additional manufacturing/processing;
    Provide for ``field coring'' as an example of a harvesting activity 
to make clear that on farm ``field coring'' of a RAC is an activity 
that is within the ``farm'' definition;

[[Page 58531]]

    Provide that activities performed incidental to packing a food 
would be ``packing'' activities;
    Provide that activities performed incidental to holding a food 
would be ``holding'' activities;
    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;
    Seek comment on whether we should retain, remove, or modify the 
phrase ``in one general physical location'' in the ``farm'' definition;
    Subject the packaging, packing, and holding of dried RACs by farms 
and farm mixed-type facilities to the CGMP requirements in subpart B of 
proposed part 117 as well as provide that compliance with these CGMP 
requirements may be achieved by complying with the applicable 
requirements for packing and holding produce RACs in the separate 
produce safety rule; and
    Reconsidered the classification of specific activities as 
harvesting, packing, holding, or manufacturing/processing, when 
conducted on farms or on farm mixed-type facilities. These changes in 
activity classification would result in a single circumstance (drying/
dehydrating RACs to create a distinct commodity without additional 
manufacturing/processing) where a farm conducting manufacturing/
processing would no longer be required to register as a food facility, 
but would not result in any new circumstance where a farm would now be 
required to register as a food facility.
    Elsewhere in this issue of the Federal Register, we are issuing a 
supplemental notice of proposed rulemaking to amend the 2013 proposed 
animal food rule. That supplemental notice includes a discussion of 
farming models for raising animals, including contract farming, fully 
vertically integrated farming, and cooperative farming. That 
supplemental notice asks for comment on whether feed mills associated 
with fully vertically integrated farming operations, including 
cooperatives that fit this model, that meet the farm definition 
(current or proposed revision) should be required to register as a food 
facility under section 415 of the FD&C Act and, if so, what revisions 
to the farm definition would be necessary.

V. The ``Farm'' Definition

    In this section of this document, we are:
    Proposing modifications to our proposed revisions to the ``farm'' 
definition;
    Proposing modifications to our proposed revisions to the 
definitions of ``harvesting,'' ``holding,'' and ``packing'' as 
conforming amendments to the revised ``farm'' definition''; and
    Proposing modifications to our proposed revisions to the current 
exemption, in the CGMP regulations, for establishments engaged solely 
in the harvesting, storage, or distribution of one or more RACs.
    We are reopening the comment period with respect to these revised 
definitions (proposed Sec.  117.3) and this revised exemption (proposed 
Sec.  117.3(k)). See section VI for additional revisions that we are 
proposing to the definitions of ``holding'' and ``packing.''

A. 2013 Proposed Definitions of ``Farm,'' ``Harvesting,'' ``Holding,'' 
and ``Packing''

    Consistent with the organizing principles regarding classification 
of activities on-farm and off-farm, we proposed to define 
``harvesting,'' as a new definition in Sec. Sec.  1.227 and 1.328, to 
apply to farms and farm 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 the farm on which they were grown or raised, or another 
farm under the same ownership, 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. As 
a conforming change to the proposed definition of ``harvesting,'' we 
proposed to revise the definition of ``farm'' in current Sec. Sec.  
1.227(b)(3) and 1.328 to delete examples of harvesting that currently 
appear in the ``farm'' definition.
    We proposed to revise the definition of ``holding'' in Sec. Sec.  
1.227 and 1.328 so that it would be a two-part definition that would 
include, for farms and farm mixed-type facilities, activities 
traditionally performed by farms for the safe or effective storage of 
RACs grown or raised on the same farm or another farm under the same 
ownership, but would not include activities that transform a RAC into a 
processed food.
    We proposed to revise the definition of ``packing'' in Sec. Sec.  
1.227 and 1.328 so that it would be a two-part definition that would 
include, for farms and farm mixed-type facilities, activities (which 
may include packaging) traditionally performed by farms to prepare RACs 
grown or raised on a farm or another farm under the same ownership for 
storage and transport, but would not include activities that transform 
a RAC into a processed food.

B. Conducting Packing and Holding Activities on Others' RACs

1. Comments
    Some stakeholders expressed concern, in public sessions and in 
written comments, about how the proposed requirements for packing and 
holding RACs would apply to a farm that would be subject to the 
requirements for hazard analysis and risk-based preventive controls 
because the farm packs or holds produce grown on others' farms. 
Comments assert 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. These 
comments also compare the requirements that would apply to a farm when 
packing produce in accordance with the 2013 proposed preventive 
controls rule to the requirements that would apply to a farm when 
packing produce in accordance with the 2013 proposed produce safety 
rule. In general, these comments express concern about the lack of 
clarity and consistency in the requirements for packing and holding 
RACs under the 2013 proposed preventive controls rule and the 2013 
proposed produce safety rule. Some of these comments assert that 
treating on-farm packing and holding of RACs differently depending on 
whether the RACs are grown on that farm (or another farm under the same 
ownership) or grown on a different farm under different ownership, 
fails to reflect modern, cooperative farming practices and to be risk-
based. Comments also assert that it unreasonable to force many farms to 
comply with two different sets of requirements depending on whether 
they are packing and holding their own produce or packing and holding 
produce from another farm. In essence, comments assert it would be more 
appropriate for farm activities such as packing and holding produce to 
be treated consistently under the two rules. Comments also generally 
assert that the requirements in the 2013 proposed produce safety rule 
for packing and holding activities (which would not require hazard 
analysis and risk-based preventive controls) are more appropriate for 
farms than the requirements in the 2013 proposed preventive controls 
rule for packing and holding activities (which would require

[[Page 58532]]

hazard analysis and risk-based preventive controls).
    Some comments find it confusing for the definition of ``farm'' to 
start by describing a farm as a ``facility'' in light of the definition 
of ``facility'' in section 415(o)(2) of the FD&C Act as a facility 
required to register under section 415 of the FD&C Act.
2. Proposed Revisions to the Definitions of ``Farm,'' ``Harvesting,'' 
``Holding,'' and ``Packing''
    In the rulemakings to establish the section 415 registration 
regulations and the section 414 recordkeeping regulations, we defined 
``farm'' with the goal of doing so in a manner recognizing the 
traditional activities of establishments commonly recognized to be 
farms (see the discussions at 78 FR 3646 at 3676-3677 and 3679). As 
already noted (see section V.A), we proposed to expand the definition 
of ``packing'' to include activities traditionally performed by a farm 
to prepare its own RACs for storage and transport and to expand the 
definition of ``holding'' to include activities traditionally performed 
by a farm for the safe or effective storage of its own RACs. Comments 
assert that the packing and holding of others' RACs is a traditional 
and common activity by farms and that the definition should not 
distinguish between activities performed by a farm on its own RACs and 
activities performed on RACs from other farms.
    We tentatively conclude that it is appropriate for packing and 
holding of RACs, including produce, conducted on farms to remain within 
the farm definition. This would result in packing and holding of 
covered produce being subject to the proposed produce safety rule, 
regardless of whether the activity is conducted on the farm's own 
produce or whether the activity is conducted on others' produce. This 
also would have consequences beyond the preventive controls rule and 
the produce safety rule. For example, the revised ``farm'' definition 
would be established in both the section 415 registration regulations 
and in the section 414 recordkeeping regulations (see the revised 
regulatory text for proposed Sec. Sec.  1.227 and 1.328, respectively). 
Under the revised ``farm'' definition in the section 414 recordkeeping 
regulations, an establishment that packs and holds others' RACs would 
no longer be required to establish and maintain records identifying the 
immediate previous sources of those RACs and immediate subsequent 
recipients of those RACs. In addition, the scope of covered 
establishments would change for other statutory requirements that 
depend, in relevant part, on whether an establishment is a facility 
subject to the section 415 registration regulations. For example, this 
would be the case for requirements for the Reportable Food Registry 
(under section 417 of the FD&C Act), mandatory recall (under section 
423 of the FD&C Act), and regulations that we have proposed to 
establish regarding intentional contamination related to terrorism 
(under sections 418 and 420 of the FD&C Act; see the proposed 
intentional adulteration rule, 78 FR 78014). We tentatively conclude 
that impacts such as these, while not always optimal, are necessary to 
establish a sensible framework of risk-based regulations that both 
implement FSMA and reflect common farm activities. Elsewhere in this 
issue of the Federal Register, a supplemental notice of proposed 
rulemaking regarding the produce safety rule (the produce safety 
supplemental notice) discusses impacts such as these, including a 
request for comment on whether to include in the final produce safety 
rule a requirement that a farm supplying produce to another farm that 
will pack or hold that produce should provide to the farm that receives 
the produce its name, complete business address, and description of the 
produce in any individual shipment. The produce safety supplemental 
notice also requests comment on whether it would be appropriate to also 
require the farm that receives the shipment maintain such record of 
information and, if so, for what specified period of time.
    Therefore, taking into account the comments we have reviewed so far 
we are proposing to revise the ``farm'' definition so that it would no 
longer limit establishments that fall within the ``farm'' definition to 
those that pack or hold food grown, raised, or consumed on that farm or 
another farm under the same ownership. Under the revised ``farm'' 
definition, an establishment devoted to the growing of crops, the 
raising of animals, or both, would remain within the ``farm'' 
definition (and, thus, not be subject to the section 415 registration 
regulations and the proposed requirements for hazard analysis and risk-
based preventive controls) even if it packs and holds RACs grown on 
another farm. To limit the potential for confusion related to the term 
``facility,'' we are proposing to substitute the term ``establishment'' 
for the term ``facility'' in the revised definition of ``farm.'' As a 
conforming change relevant to this substitution, we are adding to the 
``farm'' definition the criterion, in the definition of ``facility,'' 
that the establishment is ``under one ownership,'' to retain that 
aspect of the current ``farm'' definition in the revised definition. 
For additional discussion about manufacturing/processing activities 
that would make an establishment subject to the section 415 
registration regulations, see sections V.D and VII.
    We also are proposing that the packing activities (which may 
include packaging) that we had proposed to include in the expanded 
definition of ``packing'' for farms and farm mixed-type facilities be 
included in the ``farm'' definition rather than in an expanded 
definition of ``packing.'' Under the revised ``farm'' definition, it 
will be clear that an establishment devoted to the growing of crops, 
the raising of animals, or both, can remain within the ``farm'' 
definition if it packages RACs grown or raised on a farm to prepare 
them for storage and transport, without additional manufacturing/
processing. Packaging activities would continue to be considered 
manufacturing/processing (78 FR 3646 at 3681-3682); however, packaging 
a RAC would not transform the RAC into a processed food (see the 
discussion in the 2013 proposed preventive controls rule about whether 
an activity transforms a RAC into a processed food (78 FR 3646 at 3678-
3679)). Importantly, we are proposing limitations on what would be 
included within this addition to the ``farm'' definition. This proposed 
provision would not provide that packaging RACs would remain within the 
``farm'' definition if the packaging includes additional manufacturing/
processing (e.g., the application of ``modified atmosphere 
packaging''). Such additional processing activities are not akin to 
packing (see the discussion in the 2013 proposed preventive controls 
rule (78 FR 3646 at 3686) that certain packaging activities conducted 
on a farm are akin to packing).
    We are not proposing any changes to the ``farm'' definition that we 
would establish in part 117, because the proposed ``farm'' definition 
for the purpose of part 117 simply referred to the ``farm'' definition 
in the section 415 registration regulations.
    The revised ``farm'' definition would require conforming changes to 
the proposed definitions of ``harvesting,'' ``holding,'' and 
``packing'' (in the section 415 registration regulations, the section 
414 recordkeeping regulations, and the proposed preventive controls 
rule) to remove limitations that the food be grown on the same farm or 
a farm under the same ownership. (See the revised regulatory text for 
proposed Sec. Sec.  1.227, 1.328, and 117.3). In addition:

[[Page 58533]]

    The revised regulatory text for the definition of ``harvesting'' 
includes ``field coring'' as an additional example of a harvesting 
activity. See section V.C for a discussion of this proposed additional 
example.
    The revised regulatory text for the definition of ``holding'' 
includes revisions that we are proposing in response to comments about 
how the definition of ``holding'' would apply to facilities such as 
grain elevators and warehouses. See section VI.A through VI.E for a 
discussion of those proposed revisions.
    The revised regulatory text for the definition of ``packing'' 
includes changes that we are proposing to provide for activities 
performed incidental to packing a food. See section VI.F for 
discussions of those proposed revisions.
    The revised definitions of ``farm,'' ``harvesting,'' ``holding,'' 
and ``packing'' would, if finalized, require changes to guidance 
documents we issued regarding the section 415 registration regulations 
and the section 414 recordkeeping regulations, including specific 
examples of circumstances that would make an establishment subject to 
those requirements (e.g., Ref. 10, Ref. 11, Ref. 12, and Ref. 13). We 
intend to update affected guidance documents to reflect the final 
definitions.

C. Field Coring as a Harvesting Activity

1. Comments
    Some comments ask us to specify that activities such as ``core in 
field'' and ``clean and core'' are considered harvesting, because these 
activities are no different from an example (i.e., ``trimming of outer 
leaves of'') included in the regulatory text of the definition of 
``harvesting.''
2. Proposed Revision to the Definition of ``Harvesting''
    We are proposing revisions to the definition of ``harvesting'' in 
addition to the revisions, discussed in section V.B.2, that would be 
conforming amendments in light of the revised ``farm'' definition. We 
are proposing to include ``field coring'' as an example of a harvesting 
activity to make clear that on farm ``field coring'' of a RAC (e.g., 
removing the core of lettuce in the field at the same time the stem is 
cut and wrapper leaves removed) is a harvesting activity, even though 
``coring'' outside of ``field coring'' (e.g., during the production of 
fresh-cut lettuce) is a manufacturing/processing activity. Under the 
revised ``harvesting'' definition, it would be clear that an 
establishment devoted to the growing of crops, the raising of animals, 
or both, would remain within the ``farm'' definition (and, thus, not be 
subject to the section 415 registration regulations and the proposed 
requirements for hazard analysis and risk-based preventive controls) 
even if it conducts field coring of produce. The revised definition of 
``harvesting'' would be included in the section 415 registration 
regulations, the section 414 recordkeeping regulations, and the 
preventive controls rule. In this section of this document, we are 
reopening the comment period with respect to including ``field coring'' 
as an example of a harvesting activity in this revised definition of 
``harvesting'' (proposed Sec.  117.3).

D. Drying/Dehydrating Raw Agricultural Commodities To Create a Distinct 
Commodity

1. Comments
    Some comments refer to our discussion, in the 2013 proposed 
preventive controls rule, about guidance jointly developed by FDA and 
the U.S. Environmental Protection Agency (EPA) regarding whether or not 
various activities transform RACs into processed foods, including a 
joint conclusion that drying a RAC causes it to become a processed 
food, unless the drying is for the purpose of facilitating storage or 
transportation of the commodity (78 FR 3646 at 3678-3679). In our 
discussion, we described a series of policy statements and guidance 
documents, issued by FDA and EPA regarding whether or not various 
activities transform RACs into processed foods (78 FR 3646 at 3678-
3679). We noted that FDA and EPA have jointly concluded that drying a 
RAC causes it to become a processed food, unless the drying is for the 
purpose of facilitating storage or transportation of the commodity 
(see, e.g., (Ref. 14). We referenced a policy statement issued by EPA 
on the status of dried commodities as RACs (the 1996 EPA policy 
statement; 61 FR 2386, January 25, 1996). We also gave two examples of 
when we would consider that drying a RAC created a processed food: (1) 
Drying grapes to create raisins; and (2) drying fresh herbs (such as 
peppermint) to create dried herbs, because in both these instances 
drying creates a distinct commodity and therefore a processed food.
    The comments contrast the growing and harvesting (including drying) 
of ``natural condition raisins'' (produced with sun-drying or 
artificial dehydration) with raisins subject to additional processing 
and packing (e.g., sorting, cleaning or seeding) at an off-farm 
facility. The comments maintain that the traditional activities of 
raisin grape farmers associated with growing and harvesting ``natural 
condition raisins'' on farm are completely separate and distinct from 
the processing and packing of ``processed raisins'' at a raisin 
processing facility. They note that raisin grape farmers generally dry 
their grapes either by cutting the grape clusters and placing them on 
trays to be naturally sun dried, or by allowing the grapes to dry 
naturally on the vine. In both instances, there is no intervention by 
the farmer in the drying process; rather, the drying process occurs 
naturally through the action of the sun. These comments ask us to 
recognize this distinction and provide in the final rule that on-farm 
activities such as drying ``natural condition raisins'' in the field 
are exclusively subject to the produce safety rule and that processing 
facility operations are subject to the preventive controls rule. They 
also specifically mention the 1996 EPA policy statement and ask us to 
determine that it does not apply for the purposes of implementing FSMA.
2. Proposed Revisions to the ``Farm Definition'' Regarding Drying/
Dehydrating RACs To Create a Distinct Commodity When the Drying/
Dehydrating Is Akin to Harvesting and There Is No Additional Processing
    The processes described in the comments for drying grapes to 
``natural condition raisins'' are akin to other harvesting activities 
traditionally conducted by farms on RACs grown and harvested on farms, 
because they 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 (see 78 FR 3646 at 3681 and the proposed 
definition of harvesting in proposed Sec.  117.3).
    We continue to consider that drying a RAC to create a distinct 
commodity causes it to become a processed food and, thus, is a 
manufacturing/processing activity for the purpose of the section 415 
registration regulations. However, to the extent that the comments are 
asking us to determine that drying a RAC to create a distinct commodity 
can, under circumstances such as those described in the comments, 
remain within the ``farm'' definition, we tentatively conclude that it 
is appropriate to do so, provided that the drying/dehydrating process 
is akin to harvesting. However, we would continue to classify drying 
RACs to create a distinct commodity as manufacturing/processing rather 
than re-classify this activity as harvesting.

[[Page 58534]]

We do not consider it necessary or prudent to classify this activity in 
two different ways for the purposes of the ``farm'' definition and 
determining our responsibilities for antimicrobial substances.
    To provide for drying/dehydrating that is akin to harvesting to 
remain within the farm definition, taking into account the comments we 
have reviewed so far we are proposing that farms include establishments 
that, in addition to growing and harvesting crops, raising animals, or 
both, manufacture/process RACs by drying/dehydrating the RACs to create 
a distinct commodity, and/or packaging and/or labeling such 
commodities, without additional manufacturing/processing (see the 
revised regulatory text for the ``farm'' definition in proposed 
Sec. Sec.  1.227 and 1.328). This revised ``farm'' definition would 
specifically address this circumstance because otherwise it would not 
be within the ``farm'' definition. Drying/dehydrating that is akin to 
harvesting would not trigger the requirement to register as a facility 
and would not trigger the requirements for hazard analysis and risk-
based preventive controls. Likewise, packaging and/or labeling the 
dried commodities (which are processed food), would not trigger the 
requirement to register as a facility and would not trigger the 
requirements for hazard analysis and risk-based preventive controls. As 
a companion change, we are proposing that the ``farm'' definition 
explicitly provide that packing and holding the dried commodities 
(which are processed food) is within the ``farm'' definition. Whether a 
farm would be subject to the produce safety rule would depend on 
factors included in the produce safety rule, such as whether the RACs 
satisfy criteria for ``covered produce.''
    Importantly, we are proposing limitations on when this special 
circumstance would apply. This proposed provision would not provide 
that drying/dehydrating fruit would remain within the ``farm'' 
definition if the dried/dehydrated fruit is subject to additional 
manufacturing/processing, such as cutting the fruit or applying 
sulfites (e.g., when manufacturing/processing dried apples). Such 
additional processing activities are not akin to harvesting. They also 
are not necessary for safe storage of the crop (which would be holding; 
see sections VI.C., VI.E, and VII.C and Table 1 in the Appendix to this 
document). A farm that also manufactures/processes products such as 
dried, cut apples would be a farm mixed-type facility, subject to the 
section 415 registration regulations and FSMA's requirements for hazard 
analysis and risk-based preventive controls for such activities.

E. One General Physical Location

1. Comments on Whether the ``Farm'' Definition Should Specify That a 
Farm Is in ``One General Physical Location''
    Some comments emphasize that farms throughout the country are now 
made up of multiple, often non-contiguous fields due to geographic and 
topographic conditions, local development patterns, and the fact that a 
single ``farm'' today often derives from multiple previous farms due to 
the need to achieve economic efficiencies. Some comments explain that 
as farm land increasingly is partitioned into smaller and smaller 
parcels through estate divisions or for other reasons, farmers 
purchasing land find that they are rarely able to purchase adjacent 
parcels. These comments ask us to modify or remove the phrase ``in one 
general physical location'' in the ``farm'' definition. One suggested 
modification is to replace the phrase ``in one general physical 
location'' with an explanatory sentence, such as one clarifying that a 
farm may consist of one or more parcels of land (or water) and may 
include one or more structures (e.g., outbuildings, barns, greenhouses, 
etc.).
2. Request for Additional Comment on Whether the ``Farm'' Definition 
Should Specify That a Farm Is in ``One General Physical Location''
    During the rulemaking to establish the ``farm'' definition in the 
section 415 registration regulations, we explained that a farm may 
consist of contiguous parcels of land, ponds located on contiguous 
parcels of land, or, in the case of netted or penned areas located in 
large bodies of water, contiguous nets or pens (68 FR 5378 at 5381, 
February 3, 2003). However, we did not propose to include this 
explanatory sentence in the regulatory text. Comments addressing ``one 
general physical location'' focused on how specifying ``in one general 
physical location'' would affect whether the farm would be subject to 
the section 415 registration regulations. Our response to those 
comments focused on the nature of the activities being conducted rather 
than on the contiguous or non-contiguous nature of parcels of land or 
nets (68 FR 58894 at 58906, October 10, 2003).
    The definition of ``facility'' in the section 415 registration 
regulations likewise specifies that a facility means ``any 
establishment, structure, or structures under one ownership at one 
general physical location . . .'' However, this definition specifically 
adds an explanatory statement that a facility may consist of one or 
more contiguous structures (Sec.  1.227). During the rulemaking to 
establish this definition of ``facility,'' we explained that we 
proposed to include this explanatory sentence in the regulatory text as 
a result of comments that we received during our early outreach efforts 
(68 FR 5378 at 5381, February 3, 2003).
    We are seeking comment on whether we should retain, remove, or 
modify the phrase ``in one general physical location'' in the ``farm'' 
definition. In responding to our request for comment on this issue, we 
ask commenters to carefully consider what, if any, impacts removing or 
modifying this phrase could have on other rules that already include 
(or have proposed to include) the same definition of ``farm'' as would 
be established in the section 415 registration regulations, as well as 
how such impacts would best be addressed. For example, elsewhere in 
this issue of the Federal Register the produce safety supplemental 
notice seeks comment on how we should interpret ``in one general 
physical location'' for the purposes of enforcing that rule. The 
produce safety supplemental notice explains that specifying that a farm 
is in ``one general physical location'' could impact classification of 
farms subject to the produce safety rule as a ``small business'' or 
``very small business'' and, thus affect the compliance date for that 
farm.

F. Proposed Revisions to the Exemption From CGMP Requirements for 
``Farms'' and Activities of ``Farm Mixed-Type Facilities'' That Fall 
Within the ``Farm'' Definition

1. 2013 Proposed Revisions to the Exemption From the CGMP Requirements 
for Establishments Engaged Solely in the Harvesting, Storage, or 
Distribution of One or More RACs
    In the 2013 proposed preventive controls rule, we proposed to 
adjust and clarify what activities fall within the current exemption 
from the CGMP requirements for establishments engaged solely in the 
harvesting, storage, or distribution of one or more RACs (``RAC 
exemption'') based on experience and changes in related areas of the 
law since issuance of the CGMP regulation. We proposed to provide that 
the CGMP requirements of subpart B would not apply to ``farms,'' 
activities of ``farm mixed-type facilities'' that fall within the 
``farm'' definition, or the

[[Page 58535]]

holding or transportation of one or more RACs (proposed Sec.  
117.5(k)).
    In the 2013 proposed produce safety rule, we proposed to implement 
section 419 of the FD&C Act (standards for produce safety) by 
establishing, in part 112, standards for the growing, harvesting, 
packing, and holding of produce for human consumption. The proposed 
standards for produce safety would apply only to RACs (see proposed 
Sec.  112.1(a) and section 419(a)(1)(A) of the FD&C Act).
2. Consequential Revision to the RAC Exemption in Light of Proposed 
Changes to the ``Farm'' Definition
    As discussed in section V.D of this document, we are proposing that 
an establishment that is devoted to the growing and harvesting of 
crops, the raising of animals, or both can remain within the farm 
definition if it dries/dehydrates RACs to create a distinct commodity, 
and/or packages and/or labels such commodities, without additional 
manufacturing/processing. A farm that does so would transform a RAC 
into a processed food. The growing and harvesting of produce RACs that 
would be covered by the proposed produce safety rule would be subject 
to the standards for produce safety, but the dried commodities that are 
processed food would not. Like any other processed food, such dried 
commodities would be subject to the CGMP requirements (proposed subpart 
B) and would not be eligible for a ``RAC exemption,'' whether the 
current RAC exemption in Sec.  110.19 or the proposed ``RAC exemption'' 
in proposed Sec.  117.5(k).
    Therefore, as a consequence of our proposal to provide for drying/
dehydrating that is akin to harvesting to remain within the farm 
definition, we also are proposing to revise the exemption from CGMP 
requirements for ``farms'' and activities of ``farm mixed-type 
facilities'' that fall within the ``farm'' definition to provide that 
if a ``farm'' or ``farm mixed-type facility'' dries/dehydrates RACs to 
create a distinct commodity, the CGMP requirements apply to the 
packaging, packing, and holding of the dried commodities. As discussed 
in section V.G of this document, we tentatively conclude that the 
specific steps that are necessary to ensure the safety of produce that 
an establishment packs and holds would be the same regardless of the 
specific regulatory framework applicable to the establishment. Given 
the nature of the processed food that would be subject to the CGMP 
requirements (i.e., dried RACs), we tentatively conclude that the 
requirements we separately proposed for packing and holding produce 
RACs would be sufficiently similar to the CGMP requirements to make it 
appropriate to specify in the regulatory text that compliance with the 
CGMP requirements may be achieved by complying with subpart B or with 
the applicable requirements for packing and holding produce RACs in the 
separate produce safety rule. However, we do not intend to issue a 
final rule on this specific option for achieving compliance with the 
CGMP requirements that would apply to processed food produced through 
drying/dehydrating RACs until we issue the final produce safety rule.
3. Comments on the Proposed RAC Exemption
    Some comments ask us to exempt the harvest and immediate transport 
of raw fishery commodities from the CGMP requirements. Other comments 
ask us to exempt facilities that conduct hulling and drying operations 
on shell nuts from the CGMP requirements.
4. Proposed Additional Revisions to the RAC Exemption To Clarify 
Applicability to Certain RACs
    We are proposing to clarify how the RAC exemption applies to 
seafood RACs by specifying that subpart B does not apply to fishing 
vessels that are not subject to the registration requirements of part 
1, subpart H of this part in accordance with Sec.  1.226(f). Section 
1.226(f) describes fishing vessels that are exempt from the 
registration requirements as those that not only harvest and transport 
fish but also engage in practices such as heading, eviscerating, or 
freezing intended solely to prepare fish for holding on board a harvest 
vessel. Section 1.226(f) also specifies that fishing vessels otherwise 
engaged in processing fish are subject to the registration 
requirements, and describes ``processing'' for the purpose of 
determining the exemption to mean handling, storing, preparing, 
shucking, changing into different market forms, manufacturing, 
preserving, packing, labeling, dockside unloading, holding, or heading, 
eviscerating, or freezing other than solely to prepare fish for holding 
on board a harvest vessel. The practices identified in Sec.  117.226(f) 
(heading, eviscerating, or freezing intended solely to prepare fish for 
holding on board a harvest vessel) that warrant an exemption from 
registration are activities conducted by establishments engaged solely 
in the harvesting, storage, or distribution of one or more RACs and, 
thus, fall within the current RAC exemption in Sec.  110.19.
    We also are proposing to clarify how this exemption applies to 
activities commonly conducted on nuts at a facility that is not a farm 
or farm-mixed type facility by specifying that subpart B does not apply 
to hulling, shelling, and drying nuts (without manufacturing/
processing, such as roasting nuts). Hulling, shelling, and drying nuts 
(without additional manufacturing/processing), are activities conducted 
by establishments engaged solely in the harvesting, storage, or 
distribution of one or more RACs and, thus, fall within the current RAC 
exemption in Sec.  110.19.

G. Comparing Proposed Requirements for Packing Produce Under the 2013 
Proposed Preventive Controls Rule to Proposed Requirements for Packing 
Produce Under the 2013 Proposed Produce Safety Rule

1. Comments
    Some stakeholders expressed concern, in public sessions and in 
written comments, about the proposed requirements that would apply to 
an off-farm facility that packs and holds produce. These comments focus 
on how the proposed requirements for an off-farm facility that packs 
and holds produce under the requirements of the 2013 proposed 
preventive controls rule would be different from the requirements, 
under the 2013 proposed produce safety rule, that would apply to on-
farm packing and holding of produce. These comments assert that the 
status of an establishment as a facility subject to the section 415 
registration requirements should not be used as justification to 
subject packing and holding activities to different standards if there 
is no risk-based reason to do so. Some comments assert that the 
standards described in the 2013 proposed produce safety rule are ``more 
than adequate'' for the safe handling and packing of raw, intact fresh 
produce, regardless of commodity, size of operation, or source of 
produce. These comments also assert that there is no evidence to 
suggest that different requirements for off-farm establishments that 
pack and hold produce are needed to prevent contamination.
2. Summary of the Similarities and Differences for Off-Farm Packing and 
Holding Compared to On-Farm Packing and Holding
    The specific steps that are necessary to ensure the safety of 
produce that an establishment packs and holds generally would be the 
same regardless of whether the establishment is on-farm or off-farm. 
For example, several of the

[[Page 58536]]

CGMP requirements that would apply to an off-farm packing facility 
(e.g., provisions for employee health and hygiene, the plant and its 
grounds, sanitary operations and facilities, and equipment and 
utensils) have an analogous counterpart in the 2013 proposed produce 
safety rule. In addition, although an off-farm packing facility would 
be required to establish and implement a food safety plan, we expect 
that its food safety plan would focus on a few key preventive controls, 
including some that would have counterparts in the proposed produce 
safety rule. For example, we expect that the food safety plan for an 
off-farm packing facility would include preventive controls such as 
maintaining and monitoring the temperature of water used during 
packing. These preventive controls would have counterparts under the 
2013 proposed produce safety rule (see, e.g., proposed Sec.  
112.46(c)). We also expect that an off-farm packing facility would 
establish sanitation controls to address the cleanliness of food-
contact surfaces (including food-contact surfaces of utensils and 
equipment) and the prevention of cross-contamination from insanitary 
objects and from personnel to food, food packaging material, and other 
food-contact surfaces. See the discussion in the 2013 proposed 
preventive controls rule about an outbreak of listeriosis from 
cantaloupes, which was attributed to insanitary conditions at a 
facility that washed, packed, cooled, and stored intact cantaloupes (78 
FR 3646 at 3814). On-farm packing facilities would be subject to 
similar, but not identical, requirements (see e.g., proposed Sec.  
112.111(b) for cleanliness of food contact surfaces and proposed Sec.  
112.113 for protection against contamination).
    An off-farm packing facility also would be required to establish 
and implement appropriate preventive control management components, 
including monitoring, corrections or corrective actions, and 
verification as appropriate to the nature of the preventive control, 
and would establish and maintain records relative to these preventive 
controls. Some of these management components also would have 
counterparts under the 2013 proposed produce safety rule (see, e.g., 
proposed Sec.  112.46(a) and (b)). Moreover, we consider it likely that 
industry associations and coalitions would develop a generic food 
safety plan applicable to off-farm packing and holding of produce 
covered by the produce rule, based in large part on the final 
provisions of the produce safety rule. An off-farm packing and holding 
facility would be able to start from such a generic food safety plan, 
or to start from the provisions of the final produce safety rule, in 
generating its own food safety plan, and to tailor its own food safety 
plan to its particular circumstances, such as the commodities it packs 
and holds.
    The FD&C Act makes the status of an establishment as a facility 
subject to the section 415 registration requirements, rather than a 
farm, relevant to which requirements apply to packing and holding 
activities. Section 418(a) of the FD&C Act, which applies to facilities 
required to register, 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 such facility, identify and 
implement preventive controls, monitor the performance of those 
controls, and maintain records of this monitoring as a matter of 
routine practice. Section 418(h) of the FD&C Act requires the owner, 
operator, or agent in charge of a facility to prepare a written plan 
that documents and describes the procedures used by the facility to 
comply with the requirements of section 418 of the FD&C Act (see 
section 418(h) of the FD&C Act). In contrast, section 419 of the FD&C 
Act directs FDA (rather than the owner, operator, or agent in charge of 
a farm) to establish science-based minimum standards for the safe 
production and harvesting of those types of fruits and vegetables, 
including specific mixes or categories of fruits and vegetables, that 
are RACs for which FDA has determined that such standards minimize the 
risk of serious adverse health consequences or death.

VI. Definitions of ``Holding'' and ``Packing''

A. 2013 Proposed Definition of ``Holding''

    We proposed to revise the definition of ``holding'' in Sec. Sec.  
1.227 and 1.328 (see section V.A).

B. 2013 Proposed Exemptions Relevant to the Definition of ``Holding''

    We proposed two exemptions directed to facilities ``solely 
engaged'' in the storage (i.e., holding) of certain types of food, and 
explained our reasons for doing so.
    First, we proposed to exempt facilities that are solely engaged in 
the storage of RACs (other than fruits and vegetables) intended for 
further distribution or processing from the requirements for hazard 
analysis and risk-based preventive controls, and explained our reasons 
for proposing to do so (proposed Sec.  117.5(j); see discussion at 78 
FR 3646 at 3709). We intended this provision to exempt, for example, 
facilities that only store whole grains (such as corn, wheat, barley, 
rye, grain sorghum, oats, rice, wild rice, and soybeans), unpasteurized 
shell eggs, and unpasteurized milk from the requirements for hazard 
analysis and risk-based preventive controls, provided that such 
facilities do not conduct other activities subject to FSMA's 
requirements for hazard analysis and risk-based preventive controls (78 
FR 3646 at 3709).
    Second, we proposed to exempt a ``facility solely engaged in the 
storage of packaged food that is not exposed to the environment'' from 
the requirements for hazard analysis and risk-based preventive controls 
that would be established in subpart C (proposed Sec.  117.7(a); see 
discussion at 78 FR 3646 at 3713). We intended this provision to 
exempt, for example, facilities that store packaged food in containers 
in a warehouse. However, a facility solely engaged in the storage of 
packaged food that is not exposed to the environment and that requires 
time/temperature control to significantly minimize or prevent the 
growth of, or toxin production by, pathogens would be subject to 
modified requirements (see proposed Sec. Sec.  117.7(b) and Sec.  
117.206).
    In this section of this document, we are proposing revisions to the 
definition of ``holding'' in addition to the revisions, discussed in 
section V.B.2, that would be conforming amendments in light of the 
revised ``farm'' definition. In this section of this document, we are 
reopening the comment period with respect to the revised definition of 
``holding'' (proposed Sec.  117.3).

C. Comments on the 2013 Proposed Exemption for a Facility Solely 
Engaged in the Storage of RACs (Other Than Fruits and Vegetables) 
Intended for Further Distribution or Processing

    Some comments support the proposed exemption for a facility solely 
engaged in the storage of RACs (other than fruits and vegetables) 
intended for further distribution or processing. However, some 
stakeholders expressed concern, during outreach activities such as the 
public meetings and in written comments, that the proposed definition 
of ``holding'' would preclude facilities such as grain elevators from 
being eligible for the exemption in proposed Sec.  117.5(j) because 
most such facilities conduct a variety of activities in addition to 
``storage.'' For example, comments note that grain elevators typically 
conduct the following activities that could be characterized as being 
practical necessities, either for the

[[Page 58537]]

purposes of safe or effective storage or for meeting customer 
specifications:

Fumigate grain to control pest infestation during storage;
Clean grain using various mechanisms (sifting, sieving, and 
screening);
Convey grain throughout the facility;
Dry grain received with high moisture content; and
Blend lots of grain.

    Some comments recommend that we modify the proposed definition for 
``holding'' to (1) encompass activities performed for the safe or 
effective storage of RACs (such as drying, screening, conditioning, and 
fumigating) off-farm and (2) encompass activities performed on RACs as 
a practical necessity for product distribution (such as blending 
different lots of the same commodity to meet a customer's quality 
specifications).

D. Comments on the 2013 Proposed Exemption for a Facility Solely 
Engaged in the Storage of Packaged Food That Is Not Exposed to the 
Environment

    Some comments support the proposed exemption for a facility 
``solely engaged in the storage of packaged food that is not exposed to 
the environment.'' These comments note that warehouses typically 
conduct the following activities that could be characterized as being 
practical necessities, either for the purposes of storage or for 
product distribution, including:

Affix tracking labels;
Transport to a storage location in the warehouse;
Hold non-food products, including toys and beauty aids;
Break down pallets of packaged food for distribution to the retail 
level in less-than-pallet quantities;
Assemble ``sales kits'' for use in fundraising drives;
Assemble variety packs by packing; and
Use packaged food to build store displays.

    Some of these comments recommend that we modify the proposed 
definition for ``holding'' to encompass activities that are performed 
on packaged food that is not exposed to the environment (1) incidental 
to storage of the food (such as transport and storage of non-food 
products); and (2) as a practical necessity for product distribution 
(such as affixing tracking labels, breaking down pallets, assembling 
sales kits and variety packs, and building store displays).

E. Proposed Revisions to the Definition of ``Holding''

    Taking into account the comments we have reviewed so far, we 
tentatively conclude that we should revise the definition of 
``holding'' to encompass activities performed incidental to storage of 
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). In addition to the activities specifically 
identified in the comments, we are aware of other activities (Ref. 15) 
that can be considered incidental to storage of RACs, either for the 
purposes of safe or effective storage or for meeting customer 
specifications, including:
    Treating stored grain with protectant chemicals and pesticide 
alternatives (other than by fumigation) to control infestation;
    Using modified atmosphere treatments to control pests;
    Using biological controls for pests;
    Applying chemical preservatives to grain to prevent growth of 
mycotoxin-producing molds;
    Weighing grain;
    Sampling and grading grain; and
    Aerating grain to control temperature.
    The revised definition of ``holding'' would be included in the 
section 415 registration regulations, the section 414 recordkeeping 
regulations, and the preventive controls rule. Our previously proposed 
revisions already included activities traditionally performed by farms 
and farm mixed-type facilities for the safe or effective storage of 
RACs (78 FR 3646 at 3681). In this document, we are proposing to revise 
the definition of holding in all three regulations to:
    Clarify that holding also includes 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 commodity));
    Broaden ``activities . . . performed for the safe or effective 
storage of raw agricultural commodities'' to apply to all food, not 
just RACs;
    Broaden ``activities . . . performed for the safe or effective 
storage'' to apply to all establishments that hold food, not just farms 
and farm mixed-type activities;
    Add ``breaking down pallets'' to the examples in the revised 
definition of ``holding'' so that the examples reflect activities 
conducted on packaged food as well as activities conducted on RACs; and
    Specify that holding facilities ``could'' include the listed types 
of facilities to clarify that some of these facilities might not meet 
the definition of a holding facility if they perform other activities 
not included in the definition of holding (e.g., if a grain elevator 
mixes different commodities to prepare animal feed).
    As discussed in section V.B.2, the revised definition of 
``holding'' also would remove limitations on where the food is grown or 
raised (as a conforming change to the revised definition of ``farm''). 
The revised definition of ``holding'' would now be a one-part 
definition that applies to all facilities that hold food, rather than a 
two-part definition that first specifies activities that are within the 
definition regardless of the type of establishment and then specifies 
additional activities that would apply only to establishments that are 
farms or farm mixed-type facilities. See the proposed regulatory text 
for the definition of holding in proposed Sec. Sec.  1.227, 1.328, and 
117.3.
    With this revised definition of ``holding,'' facilities such as 
grain elevators and silos would, in most cases, satisfy the criteria 
for the proposed exemption for facilities solely engaged in the storage 
of RACs (other than fruits and vegetables) intended for further 
distribution or processing (proposed Sec.  117.5(j)), because the 
definition would encompass activities performed as a practical 
necessity for the distribution of RACs. Other facilities that conduct 
operations similar to those conducted at grain elevators and silos, 
such as some facilities that hold oilseeds, also may satisfy these 
criteria for exemption.
    With this revised definition of ``holding,'' facilities such as 
warehouses would, in many cases, satisfy the criteria for the proposed 
exemption for facilities solely engaged in the storage of packaged food 
that is not exposed to the environment (proposed Sec.  117.7(a)), 
because the definition would encompass activities that are a practical 
necessity for product distribution (such as breaking down pallets and 
affixing tracking labels). We are adding ``breaking down pallets'' to 
the examples in the revised definition of ``holding'' so that the 
examples reflect activities conducted on packaged food as well as 
activities conducted on RACs. Although we are not adding more examples 
to reflect activities conducted on packaged food, the revised 
definition of ``holding'' also would include activities such as 
assembling sales kits and variety packs, because such activities are 
similar to breaking down pallets except that the order of activities is 
reversed.

F. Proposed Revisions to the Definition of ``Packing''

    Just as there are some activities that are performed incidental to 
storing a food, there are some activities that are performed incidental 
to packing a food. For example, sorting, culling, and grading RACs 
could be an activity

[[Page 58538]]

incidental to packing on a farm or farm mixed-type facility, whereas 
off-farm some sorting or similar activities such as culling or grading 
may be required to ensure that like items are packed together, or to 
remove damaged items. As another example, food may need to be conveyed 
(moved) about an establishment for the purpose of packing it, and may 
need to be weighed to ensure that appropriate amounts are packed. We 
tentatively conclude that we should revise the definition of 
``packing'' so that it includes activities performed incidental to 
packing a food. The revised definition of ``packing'' would be included 
in the section 415 registration regulations, the section 414 
recordkeeping regulations, and the preventive controls rule. Our 
previously proposed revisions already included activities traditionally 
performed by farms and farm mixed-type facilities for the safe or 
effective packing of RACs (78 FR 3646 at 3681-3682). In this document, 
we are proposing to revise the definition of packing in all three 
regulations to:
    Clarify that packing also includes 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));
    Provide that activities performed incidental to packing a food 
would apply to all establishments that pack food, not just to farms and 
farm mixed-type facilities; and
    Delete the provision, in the 2013 proposed preventive controls 
rule, that packing would include activities (which may include 
packaging) traditionally performed on a farm on RACs grown on a farm 
for storage or transport, because this issue would be addressed in the 
revised ``farm'' definition.
    See the revised regulatory text for the definition of packing in 
proposed Sec. Sec.  1.227, 1.328, and 117.3.

VII. Impact of the Proposed Revisions to the Farm-Related Definitions 
on the Classification of On-Farm Activities

A. Comments on the 2013 Organizing Principles for Classifying 
Activities Conducted on Farms and on Farm Mixed-Type Facilities

    Some comments object to one or more of the 2013 organizing 
principles. As previously discussed, some comments focused on the 
distinction (in the ``farm'' definition, and reflected in Organizing 
Principle No. 4) that conducting packing and holding activities on a 
farm's own RACs would be within the ``farm'' definition, but conducting 
packing and holding activities on others' RACs would be outside the 
``farm'' definition (see section V.B.1). Other comments focused on 
Organizing Principle No. 3--i.e., that activities should be classified 
based in part on whether the food operated on is a RAC or a processed 
food, and on whether the activity transforms a RAC into a processed 
food (see section V.C.1). One comment asserts that the 2013 organizing 
principles rest on a flawed understanding of how farming works because 
they assume that farms exist simply to grow crops and that getting 
those crops to market is something that ``farms'' don't do. This 
comment also asserts that the reality is that a farm cannot stay in 
business without marketing its crops and preparing those crops for 
market, and that the imperative to maximize the value a farm receives 
for its crops creates the need for value-added marketing and 
cooperative distribution. This comment recommends that we revise the 
organizing principles to reflect the realities and range of activities 
that farms do to their crops to prepare those crops and get them to 
markets.

B. Updated Organizing Principles That Would Apply to the ``Farm'' 
Definition

    We articulated the 2013 organizing principles for classifying on-
farm activities to operate within the framework, already established in 
the section 415 registration regulations, in which an establishment 
that packs and holds others' RACs would be outside the ``farm'' 
definition and, thus, be required to register as a food facility. Our 
proposed revisions to the ``farm'' definition would change that 
framework and, as a consequence, require that we reconsider those 
organizing principles.
    Organizing Principles Nos. 1, 3 and 5 remain fully consistent with 
the proposed revisions to the ``farm'' definition. However, there would 
be no need to specify, in Organizing Principle No. 2, that activities 
that farms traditionally do relate only to their own RACs. In addition, 
Organizing Principle No. 4 would no longer apply, because the revised 
``farm'' definition would no longer classify an activity as within (or 
outside of) the ``farm'' definition based, in part, on whether an 
activity is conducted on a farm's own RACs or on others' RACs. 
Therefore, we tentatively conclude it is appropriate to delete 
Organizing Principle No. 4 in light of the proposed revisions to the 
``farm'' definition.
    Taking into account the comments we have reviewed so far, Table 4 
shows our current thinking regarding the organizing principles 
applicable to the revised ``farm'' definition.

 Table 4--Updated Organizing Principles That Would Apply to the Revised
                           ``Farm'' Definition
------------------------------------------------------------------------
           No.                         Organizing principle
------------------------------------------------------------------------
1.......................  The basic purpose of farms is to produce RACs,
                           and RACs are the essential products of farms.
2.......................  Activities that involve RACs and that farms
                           traditionally do for the purposes of growing
                           RACs, removing them from the growing areas,
                           and preparing them for use as a food RAC, and
                           for packing, holding and transporting them,
                           should all be within the definition of
                           ``farm.''
3.......................  Activities should be classified based in part
                           on whether the food operated on is a RAC or a
                           processed food, and on whether the activity
                           transforms a RAC into a processed food.
4.......................  Manufacturing/processing, packing, or holding
                           food--whether RACs or processed foods, from
                           any source--for consumption on the farm
                           should remain within the farm definition.
------------------------------------------------------------------------

C. Changes to Classification of On-Farm Activities

    We reconsidered the classification of specific activities as 
harvesting, packing, holding, or manufacturing/processing, when 
conducted on farms or on farm mixed-type facilities. See the Appendix 
to this document for a comprehensive table comparing the classification 
of on-farm activities as harvesting, packing, holding, or 
manufacturing/processing in the 2013 proposed preventive controls rule 
to our current thinking on the classification of these on-farm 
activities. As can be seen in the Appendix, several on-farm activities 
can be classified in more than one way, and most of the changes in 
activity classification merely reflect additional activities (relative 
to the 2013 proposed preventive controls rule) that

[[Page 58539]]

could be classified in more than one way. For example, in the 2013 
proposed preventive controls rule, we classified ``washing'' as a 
harvesting activity (e.g., if RACs are washed while they are being 
removed from the field) as well as a manufacturing/processing activity 
(e.g., during the production of fresh-cut produce). In this 
supplemental notice of proposed rulemaking, we also consider 
``washing'' to be a packing activity (e.g., if RACs are washed in a 
flume or dump tank located at the farm's packing shed). (Because the 
definition of manufacturing/processing specifies that for farms and 
farm mixed-type facilities, manufacturing/processing does not include 
activities that are part of harvesting, packing, or holding, including 
``washing'' as an example of a manufacturing/processing activity would 
not mean that a farm is conducting a manufacturing/processing activity 
when it washes RACs in its packing shed on its farm, because washing 
RACs on a farm would be a packing activity.)
    See Table 5 in this document for a list of the activity 
classifications that would change in light of the proposed revisions to 
the ``farm'' definition and our reconsideration of activity 
classification. As shown in Table 5, changes in activity classification 
as a result of the proposed revisions to the ``farm'' definition would 
result in a single circumstance (drying/dehydrating RACs to create a 
distinct commodity without additional manufacturing/processing) where a 
farm conducting manufacturing/processing would no longer be required to 
register as a food facility. Importantly, the revised ``farm'' 
definition would not result in any new circumstance where a farm would 
now be required to register as a food facility.
    Table 5 includes one activity (i.e., field coring) that we did not 
address in the 2013 proposed preventive controls rule. As discussed in 
section V.C, we are including this activity to make clear that on farm 
``field coring'' of produce (e.g., removing the core of lettuce in the 
field at the same time the stem is cut and wrapper leaves removed) is a 
harvesting activity, even though ``coring'' outside of ``field coring'' 
(e.g., during the production of fresh-cut lettuce) is a manufacturing/
processing activity.
    Table 5 includes one activity (i.e., drying/dehydrating (incidental 
to holding) that we now would classify in fewer ways than we did in the 
2013 proposed preventive controls rule. In the 2013 proposed preventive 
controls rule, we classified drying/dehydrating (for purposes of 
storage or transport, rather than to create a distinct commodity) 
(e.g., drying alfalfa) as being either a packing activity or a holding 
activity, depending on when the drying/dehydrating took place. After 
reconsidering all of the activity classifications, we tentatively 
conclude that such drying/dehydrating should continue to be classified 
as ``holding,'' but does not constitute ``packing.'' We request comment 
on this narrowed classification of drying/dehydrating when the drying/
dehydrating does not create a distinct commodity.
    Table 5 includes one activity (i.e., fermenting cocoa beans and 
coffee beans) that we would now classify differently than we did in the 
draft risk assessment (issued in conjunction with the 2013 proposed 
preventive controls rule). In the draft risk assessment (Ref. 16), we 
classified fermenting cocoa beans and coffee beans as harvesting 
activities (see Footnote 2 in Table 23 of the draft risk assessment). 
After reconsidering all of the activity classifications, we tentatively 
conclude that fermenting cocoa beans and coffee beans should be 
classified as ``holding'' rather than as ``harvesting,'' because 
fermentation generally happens after cocoa beans and coffee beans are 
removed from the plants. We request comment on this reclassification of 
fermenting cocoa beans and coffee beans.

  Table 5--Changes in Classification of Activities Conducted on Farms or on Farm Mixed-Type Facilities Based on
                                the Proposed Revisions to the ``Farm'' Definition
----------------------------------------------------------------------------------------------------------------
                                                                                           Why would the re-
                                      Classified in 2013   Classified in supplemental   classification represent
             Activity                proposed preventive       notice of proposed        a change from the 2013
                                        controls rule              rulemaking             proposed preventive
                                                                                           controls rule? \2\
----------------------------------------------------------------------------------------------------------------
Cooling...........................  Harvesting; (Sec.       Harvesting (e.g.,  Acknowledge that cooling
                                     117.3); Mfg \1\/       hydro-cooling leafy         can occur during many
                                     Processing (Sec.       vegetables in the field).   farm operations.
                                     117.3).                Packing (e.g.,
                                                            hydro-cooling in a
                                                            packing shed).
                                                            Holding (e.g.,
                                                            cold storage).
                                                            Mfg/processing
                                                            (e.g., refrigeration of
                                                            processed food).
Drying/dehydrating (incidental to   Packing or Holding      Holding (e.g.,     Because we would no
 holding).                           (Tables 4 and 5).      drying hay or alfalfa).     longer consider drying/
                                                                                        dehydrating to be a
                                                                                        packing activity.
Drying/dehydrating to create a      Mfg/Processing          Mfg/processing     Because we are including
 distinct commodity (transforms a    (Tables 4 and 5).      (e.g., drying grapes to     this specific mfg/
 RAC into a processed food).                                create raisins, and         processing activity
                                                            drying herbs to create a    within the ``farm''
                                                            distinct commodity)         definition, provided
                                                            (because it transforms a    that there is no
                                                            RAC into a processed        additional manufacturing/
                                                            food) (but allowed within   processing.
                                                            the farm definition).
Fermenting cocoa beans and coffee   Harvesting (Footnote    Holding..........  Because fermentation
 beans.                              2 in Table 23 of the                               generally happens after
                                     draft Risk                                         cocoa beans and coffee
                                     Assessment (Ref.                                   beans are removed from
                                     16)).                                              the plants.
Field coring......................  N/A \3\..............   Harvesting (e.g.,  Because FDA is addressing
                                                            coring lettuce in the       the activity for the
                                                            field).                     first time.
Filtering.........................  Harvesting (Sec.        Harvesting (e.g.,  Acknowledge that
                                     117.3).                filtering honey).           filtering can occur
                                                            Packing (e.g.,      during more than
                                                            before packing honey).      harvesting operations.
Removing stems and husks..........  Harvesting (Sec.        Harvesting (e.g.,  Acknowledge that removing
                                     117.3).                in the field).              stems/husks can occur
                                                            Packing (e.g., in   during more than
                                                            a packing shed).            harvesting operations.
Sifting...........................  Harvesting (Sec.        Harvesting (e.g.,  Acknowledge that sifting
                                     117.3).                in the field).              can occur during more
                                                            Packing (e.g., in   than harvesting
                                                            a packing shed).            operations.

[[Page 58540]]

 
Using pesticides in wash water....  Harvesting (Table 5).   Harvesting (e.g.,  Acknowledge that using
                                                            in the field).              pesticides in wash water
                                                            Packing (e.g., in   can occur during more
                                                            a packing shed).            than harvesting
                                                                                        operations.
Washing...........................  Harvesting (Sec.        Harvesting (e.g.,  Acknowledge that washing
                                     117.3), and Mfg/       in the field).              can occur during packing
                                     Processing (Sec.       Packing (e.g., in   operations.
                                     117.3).                a dump tank or flume in
                                                            the farm's packing shed).
                                                            Mfg/processing
                                                            (e.g., during production
                                                            of fresh-cut produce)
----------------------------------------------------------------------------------------------------------------
\1\ Mfg = Manufacturing
\2\ This table focuses on any change in classification in this document compared to the classification, in the
  2013 proposed preventive controls rule, for activities conducted on a farm's own RACs. The proposed revisions
  to the ``farm'' definition would make the distinction between whether a farm conducted an activity on its own
  RACs or on others' RACs irrelevant.
\3\ N/A = Not applicable.

VIII. Proposed Exemptions for On-Farm Low-Risk Activity/Food 
Combinations

A. The 2013 Proposed Exemptions

    In the 2013 proposed preventive controls rule, we described 
provisions of FSMA that direct us to (1) 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 (78 FR 3646 at 3674 and 3689-3691); 
and (2) consider the results of that science-based risk analysis and 
exempt facilities that are small or very small businesses from these 
requirements (or modify these requirements, as we determine 
appropriate), if such facilities are engaged only in specific types of 
on- activities that we determine to be low risk involving specific 
foods that we determine to be low risk. Consistent with this statutory 
direction, we developed the draft risk assessment and made it available 
for public comment (Ref. 16 and 78 FR 3824) and 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.  117.5(g), (h)(1), and (h)(2)).

B. Comments on the 2013 Proposed Exemptions for On-Farm Low-Risk 
Activity/Food Combinations

    Some comments request clarification on whether an establishment 
that conducts more than one activity/food combination listed in the 
proposed exemptions for on-farm low-risk activity/food combinations 
would be eligible for the exemption. Other comments recommend including 
additional on-farm packing and holding activity/food combinations, or 
on-farm manufacturing/processing activity/food combinations, as low-
risk activity/food combinations eligible for inclusion in the proposed 
exemptions.
    We are confirming that an establishment that conducts more than one 
activity/food combination listed in the proposed exemptions for on-farm 
low-risk activity/food combinations would be eligible for the 
exemption. The regulatory text is written in the plural (e.g., ``if the 
only packing and holding activities . . . that the business conducts 
are the following low-risk packing or holding activity/food 
combinations''; and ``if the only manufacturing/processing activities . 
. . that the business conducts are the following'').
    We have not yet completed either our review of comments asking us 
to include additional activity/food combinations in the proposed 
exemptions or our analysis of whether each of the recommended additions 
would satisfy the criteria, described in the draft risk assessment, for 
a low-risk activity/food combination. However, based on our experience 
with the draft risk assessment, and the similarity of some of the 
recommended activity/food combinations to activity/food combinations we 
evaluated in the draft risk assessment, we consider it likely that we 
will, after fully considering comments, include additional activity/
food combinations in these exemptions when we issue the final rule.

C. Impact of the Proposed Revisions to the Definitions for ``Farm,'' 
``Harvesting,'' Holding,'' and ``Packing'' on the 2013 Proposed 
Exemptions for On-Farm Low-Risk Activity/Food Combinations

    The proposed revisions to the definitions of ``farm,'' 
``harvesting,'' ``holding,'' and ``packing,'' if finalized, would have 
three principal effects on the proposed exemptions.
    First, the proposed exemption for on-farm packing or holding of 
food by a small or very small business would no longer identify any 
packing or holding activities for any RACs, because an on-farm 
establishment would no longer be subject to the requirements for hazard 
analysis and risk-based preventive controls when it packs or holds 
RACs, regardless of whether it is packing and holding its own RACs or 
others' RACs. The proposed exemption would continue to apply to on-farm 
packing and holding of processed foods (e.g., packing and holding of 
hard candy, fudge, taffy and toffee when conducted by a farm mixed-type 
facility).
    Second, the proposed exemption for on-farm low-risk manufacturing/
processing activities conducted by a small or very small business would 
no longer distinguish between manufacturing/processing activities 
conducted on a farm mixed-type facility's own RACs and manufacturing/
processing activities conducted on food other than the farm mixed-type 
facility's own RACs.
    Third, the proposed exemption for on-farm low-risk manufacturing/
processing activities conducted by a small or very small business would 
be revised to eliminate activities, conducted on others' RACs, which 
would no longer be classified as manufacturing/processing and instead 
would be classified as harvesting, packing, or holding. For example, 
mixing different lots of the same RACs (e.g., cocoa beans, coffee 
beans, intact fruits and vegetables, grain, honey, maple sap, and 
peanuts and tree nuts) would remain within the ``farm'' definition, and 
not be considered manufacturing/processing, regardless of whether the 
RACs being mixed are the farm's own RACs or others' RACs.

[[Page 58541]]

However, mixing grain products and maple syrup (which are processed 
foods rather than RACs) would be considered manufacturing/processing 
and, thus, would continue to be considered a low-risk manufacturing/
processing activity listed within the exemption for on-farm low-risk 
manufacturing/processing activities conducted by a small or very small 
business.
    We will update these proposed exemptions when we issue the final 
rule, after considering comments, and reaching a decision in light of 
those comments, on the proposed revisions to the definitions that 
impact the proposed exemptions for low-risk activity/food combinations.

IX. Overall Framework for Hazard Analysis and Risk-Based Preventive 
Controls

A. 2013 Overall Framework for Hazard Analysis and Risk-Based Preventive 
Controls

    In general, in the 2013 proposed preventive controls rule we 
proposed that the owner, operator, or agent in charge of a facility:
    Prepare and implement a food safety plan, which would include 
documentation such as a written hazard analysis and various written 
procedures;
    Conduct a hazard analysis to identify and evaluate known or 
reasonably foreseeable hazards to determine whether there are hazards 
that are ``reasonably likely to occur'';
    Identify and implement preventive controls, including at CCPs, if 
any, to provide assurances that hazards identified as ``reasonably 
likely to occur'' will be significantly minimized or prevented;
    Establish a written recall plan for food with a hazard identified 
as ``reasonably likely to occur'';
    Monitor the preventive controls with adequate frequency to provide 
assurance that they are consistently performed;
    Establish and implement written corrective action procedures that 
must be taken if preventive controls are not properly implemented;
    Take appropriate corrective action in the event of an unanticipated 
problem if a preventive control is not properly implemented and a 
specific corrective action procedure has not been established;
    Conduct certain verification activities; and
    Establish and maintain certain records.
    These proposed provisions applied a construct we previously used in 
our Hazard Analysis and Critical Control Point (HACCP) regulations for 
seafood (21 CFR part 123) and juice (21 CFR part 120)--i.e., whether a 
known or reasonably foreseeable hazard was ``reasonably likely to 
occur.'' In general, our HACCP regulations for seafood and juice focus 
on CCPs to control hazards that are ``reasonably likely to occur.''

B. Comments on the ``Reasonably Likely To Occur'' Construct Within the 
2013 Overall Framework for Hazard Analysis and Risk-Based Preventive 
Controls

    Some stakeholders expressed concern, during outreach activities 
such as the public meetings and in written comments, about including 
the ``reasonably likely to occur'' approach in the 2013 proposed 
preventive controls rule. Some comments express concern that using the 
phrase ``reasonably likely to occur'' in two different contexts (i.e., 
within our HACCP regulations as well as in our proposed preventive 
controls regulations) would be confusing. Some comments assert that the 
``reasonably likely to occur'' approach was already so closely linked 
to our HACCP regulations that the 2013 proposed preventive controls 
rule would be interpreted as requiring that all necessary preventive 
controls be established at CCPs. These comments note that such an 
interpretation would be inconsistent with FSMA. For example, FSMA 
requires that the owner, operator, or agent in charge of a facility 
identify and implement preventive controls, including at critical 
control points, if any (emphasis added) (section 418(c) of the FD&C 
Act). In addition, the definition of ``preventive controls'' in FSMA is 
broader than CCPs (section 418(o)(3) of the FD&C Act). The comments ask 
that we more explicitly provide for implementation of a range of 
preventive controls (not just at CCPs.) These comments also express 
concern that a facility that already had established controls to 
address hazards--but not at CCPs--would need to revise its food safety 
plan and re-create any applicable records (e.g., various written 
procedures) to satisfy the recordkeeping requirements of the rule, 
which would add costs but no food safety benefits. Some comments 
suggest that the framework be clearer that the requirements for 
preventive controls apply to hazards that are of such a nature that 
control measures to significantly minimize or prevent them are 
necessary for the production of a safe food and therefore must be 
addressed in the food safety plan.
    Other comments on the overall framework for hazard analysis and 
risk-based preventive controls express concern that the regulatory 
text, as proposed, would limit a facility's flexibility to develop and 
implement a food safety system that was indeed risk-based. For example, 
some comments assert that regulatory text such as ``[p]reventive 
controls must include, as appropriate to the facility and the food'' 
appears to provide flexibility, but the practical effect of the term 
``must'' preceding the phrase ``include, as appropriate to the facility 
and the food'' is to remove any flexibility as to what preventive 
controls must be established and implemented. As another example, these 
comments emphasize that the proposed requirements did not sufficiently 
emphasize the risk-based nature of each component of the overall 
framework for hazard analysis and preventive controls, including 
monitoring, corrective action procedures, and verification activities, 
in addition to the hazard analysis and preventive controls. In general, 
these comments recommend that we provide greater flexibility to manage 
the control of hazards based on an assessment of both the severity of 
the hazard and the probability that the hazard will occur in the 
absence of preventive controls and that we recognize the role of 
prerequisite programs in the management of hazards. (One definition of 
``prerequisite program'' is the ``procedures, including good 
manufacturing practices, that address operational conditions providing 
the foundation for the HACCP system'' (Ref. 17).)

C. Proposed Revisions to the Overall Framework for Hazard Analysis and 
Risk-Based Preventive Controls

    The 2013 proposed preventive controls rule would not have required 
that all preventive controls be established at CCPs. However, we 
acknowledge that it could be confusing to use the same phrase 
``reasonably likely to occur'' in both our HACCP regulations and in the 
regulations we are proposing to establish to implement FSMA's 
requirements for hazard analysis and risk-based preventive controls, 
because the phrase ``reasonably likely to occur'' has been used as the 
basis for determining hazards that need to be addressed in a HACCP plan 
at CCPs.
    Likewise, the 2013 proposed preventive controls rule would not have 
limited a facility's flexibility to develop and implement a food safety 
system that was indeed risk-based. However, we acknowledge that some 
specific changes to the proposed regulatory text could help to clarify 
the risk-based nature of all provisions of subpart C.

[[Page 58542]]

    We have not used the term ``prerequisite program'' in the proposed 
regulatory text because, like ``hazard reasonably likely to occur,'' it 
has a connotation with respect to our seafood and juice HACCP programs, 
that is, it connotes activities that a facility may do that have an 
impact on product safety but which are outside the scope of the 
regulatory program. However, comments are not suggesting that 
prerequisite programs that are essential to ensuring food safety should 
be outside the scope of this proposed regulatory scheme. In fact, 
comments asking that we recognize the role of prerequisite programs in 
the management of hazards point out that preventive controls include 
control measures that do not include CCPs and that companies would 
consider many of these to be prerequisite programs. We acknowledge that 
oftentimes preventive controls, other than those at critical control 
points, are important parts of a food safety system, and must therefore 
be included in the food safety plan that would be required by this 
proposed rule. We attempted to make that clear in the proposed 
requirement for preventive controls in Sec.  117.135(a) by 
incorporating reference to ``controls, other than those at critical 
control points, that are necessary for food safety.''
    We did not intend to require that a facility re-create or duplicate 
existing records associated with controls; we simply laid out in the 
2013 proposed preventive controls rule the activities for which we 
expect there to be records and the information we expect to find in 
those records.
    Taking into account the comments we have reviewed so far, we are 
proposing a series of revisions to proposed subpart C and are reopening 
the comment period specifically with respect to these proposed 
revisions. These proposed revisions include:
    Eliminating the term ``hazard reasonably likely to occur'' 
throughout proposed subpart C (and, thus, deleting the definition we 
had proposed for this term).
    Adding a new defined term, ``significant hazard,'' and, in general, 
using this new term instead of ``hazard reasonably likely to occur'' 
throughout the proposed regulations. ``Significant hazard'' would mean 
a known or reasonably foreseeable hazard for which a person 
knowledgeable about the safe manufacturing, processing, packing, or 
holding of food would, based on the outcome of a hazard analysis, 
establish controls to significantly minimize or prevent the hazard in a 
food and components to manage those controls (such as monitoring, 
corrections or corrective actions, verification, and records) as 
appropriate to the food, the facility, and the nature of the control.
    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'';
    Providing additional flexibility to address concerns about re-
writing existing plans or programs to conform with the requirement of 
the preventive controls rule by explicitly providing that:
    Preventive controls include controls, other than those at critical 
control points, that knowledgeable persons commonly recognize as 
appropriate for food safety;
    The preventive control management components (i.e., monitoring, 
corrective actions, and verification) depend on the nature of the 
control; and
    The recordkeeping requirements do not require duplication of 
existing records if those records contain all of the required 
information and satisfy the recordkeeping requirements of the 
regulation. Existing records may be supplemented as necessary to 
include all of the required information. In addition, the required 
information 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 the preventive controls rule may be kept either separately 
or combined with the existing records.
    The framework provided by ``significant hazard'' would reflect a 
two-part analysis on the part of a facility. First, the facility would 
narrow ``hazards'' to those hazards that are known or reasonably 
foreseeable--i.e., those biological, chemical (including radiological), 
or physical hazards that have the potential to be associated with the 
facility or the food. Second, the facility would narrow the known or 
reasonably foreseeable hazards to those that a person knowledgeable 
about the safe manufacturing, processing, packing, or holding of food 
would, based on the outcome of a hazard analysis, establish controls to 
significantly minimize or prevent the hazard in a food as well as 
components to manage those controls (such as monitoring, corrections or 
corrective actions, verification, and records) as appropriate to the 
food, the facility, and the nature of the control.
    The framework established by ``significant hazard'' also would 
incorporate the concept of risk by specifying that ``significant 
hazards'' are based on the outcome of a hazard analysis. The hazard 
analysis would require an evaluation of known or reasonably foreseeable 
hazards to assess two key aspects of 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.
    See the revised regulatory text for the proposed new definition of 
``significant hazard'' (proposed Sec.  117.3). The term ``significant 
hazard'' has sometimes been used in the context of HACCP to refer to 
the hazards to be addressed in a HACCP plan through CCPs. However, this 
term is not used in the seafood, juice or meat and poultry HACCP 
regulations, which focus on ``hazards reasonably likely to occur.'' We 
request comment on both the proposed name of the term and the proposed 
meaning of the term. See also the proposed new provision for the use of 
existing records (proposed Sec.  117.330, which would be established in 
subpart F). Table 6 provides some examples of the flexibility that a 
facility would have in complying with the revised requirements that 
would be established in subpart C.

Table 6--Examples of Flexibility for Complying With the Requirements for
    Hazard Analysis and Risk-Based Preventive Controls in the Revised
                   Requirements in Proposed Subpart C
------------------------------------------------------------------------
      Flexibility related to . . .                   Example
------------------------------------------------------------------------
Controls other than those at CCPs......  Dividing a facility into zones
                                          based on the risk with respect
                                          to contamination of product
                                          can be a preventive control,
                                          but would not be required to
                                          have a CCP.
Controls other than those at CCPs......  Preventive maintenance that
                                          inspects and changes chopper
                                          blades on a regular intervals
                                          may be considered a preventive
                                          control in some instances but
                                          would not be required to have
                                          a CCP.

[[Page 58543]]

 
Circumstances that do not require        Preventive controls for
 process controls.                        allergen cross-contact.
Circumstances that do not require        Supplier controls.
 process controls.
Monitoring activity that generally       Monitoring for foreign material
 would not require monitoring records.    with x-rays.
Corrections that generally would not     Re-cleaning and sanitizing
 require records.                         inadequately cleaned food
                                          contact surfaces before start
                                          up.
Preventive controls that would not       Zoning controls.
 require validation.
Preventive controls that would not       Segregation of allergens during
 require validation.                      storage.
Preventive controls that would not       Training.
 require validation.
Preventive controls that would not       Preventive maintenance.
 require validation.
Preventive controls that would not       Refrigerated storage.
 require validation.
Corrective action that generally would   Replacement of equipment.
 not require verification.
------------------------------------------------------------------------

X. Potential Requirements for Product Testing and Environmental 
Monitoring

A. Our Request for Comment on Including Requirements for Product 
Testing and Environmental Monitoring in a Final Rule

    In the 2013 proposed preventive controls rule, we described the 
statutory framework of FSMA for product testing and environmental 
monitoring as verification measures. We also requested comment on when 
and how product testing programs and environmental monitoring are an 
appropriate means of implementing section 418 of the FD&C Act (78 FR 
3646 at 3762-3765). We specifically requested comment on including 
requirements for product testing programs and environmental monitoring 
in a final rule. Although we did not propose specific regulatory text, 
we asked a series of questions about what such requirements should 
include. Our discussions and questions about ``product testing'' 
focused on ``finished product testing.'' The Appendix contained 
extensive background on the role of testing as a verification measure 
in a modern food safety system (78 FR 3646 at 3812-3820; see also the 
corrected Appendix, 78 FR 17142 at 17143 to 17151).

B. Product Testing

1. Comments on Product Testing
    Some comments support product testing as a verification activity 
and make recommendations for what should be tested, how testing could 
be tied to risk, and how product testing could be used in a food safety 
plan. Some of these comments emphasize that product testing would not 
be appropriate as a control measure. Other comments do not support 
including requirements for ``finished product testing'' as a 
verification measure, but support including requirements for ``product 
testing'' in the final rule if the focus is broader than ``finished 
product testing,'' the use of product testing is tied to risk, and the 
regulations provide flexibility in how product testing is used in a 
food safety plan. Some comments assert that product testing is required 
by section 418 of the FD&C Act and that it is an appropriate means of 
verifying overall control, especially for products that support 
pathogen growth. In the following paragraphs, we describe some of the 
key recommendations in the comments regarding what should be tested, 
how testing could be tied to risk, and how product testing could be 
used in a food safety plan.
    Some comments recommend that product testing include testing raw 
materials and ingredients, as well as in-line testing of product during 
production. Some comments recommend that requirements encompassing more 
than ``finished product testing'' would provide facilities with the 
flexibility to establish a risk-based testing program. For example, a 
facility that adds seasoning to chips after the chips have been cooked 
using a process that would significantly minimize pathogens may 
conclude that testing the seasoning used as an ingredient would be a 
more appropriate verification activity than testing finished product 
(i.e., the chips with the added seasoning). These comments also assert 
that requirements for ``product testing'' would be more consistent with 
the statutory direction in section 418 of the FD&C Act than 
requirements for ``finished product testing.''
    Some comments that emphasize the risk-based nature of any 
requirements for product testing assert that product testing may be of 
limited value for a product that will undergo a ``kill step'' (a 
treatment to significantly minimize pathogens) later in processing or 
that does not support the survival or growth of environmental pathogens 
(because such organisms are unlikely to pose a risk in the finished 
food). Other comments note that product testing would not be 
appropriate for certain types of facilities, such as distributors. Some 
comments question whether product testing would be appropriate for 
products with a short shelf life (such as produce).
    Some comments identify circumstances where product testing would--
or would not--be appropriate to include as a verification activity in a 
food safety plan. For example, comments state that product testing 
would be an appropriate verification activity to include in a food 
safety plan in plants that produce high-risk products; when there is a 
risk of contamination of the product or product contact surfaces; when 
the outcome of a hazard analysis demonstrates that a hazard can remain 
or be placed on ready-to-eat (RTE) products; when an environmental 
pathogen is considered a hazard reasonably likely to occur; when a 
positive result is obtained as a result of environmental monitoring; 
after a corrective action has been implemented (such as after a product 
has been reworked because it tested positive for a pathogen); and in 
circumstances where testing is the only practical way to verify the 
absence of a contaminant (such as aflatoxin). Some comments state that 
product testing would not be an appropriate verification activity to 
include in a food safety plan if a positive result from environmental 
monitoring is found on a non-product-contact surface.
    Some comments recommend written procedures for product testing. 
Some of these comments emphasize that any requirements for such written 
procedures should not be prescriptive.
    Some comments question whether it would be appropriate to require 
product testing in light of known limitations such as those discussed 
in section I.F of the Appendix. For example, it is generally recognized 
that testing cannot

[[Page 58544]]

ensure the absence of a hazard, particularly when the hazard is present 
at very low levels and is not uniformly distributed. Moreover, these 
comments point out that the number of samples used for routine testing 
often is statistically inadequate to provide confidence in the safety 
of an individual lot in the absence of additional information about 
adherence to validated control measures (78 FR 3646 at 3819). Some 
commenters with varying views on the issue nonetheless asked FDA to 
issue proposed regulatory text for product testing for consideration.
2. Potential Requirements for Product Testing
    We acknowledge that there are limitations to product testing. 
Nonetheless, product testing programs, when implemented appropriately 
based on the facility, the food, and the nature of the preventive 
control, could be used to verify that the preventive controls are 
effectively and significantly minimizing or preventing the occurrence 
of identified hazards. Taking into account the comments we have 
reviewed so far, we are providing an opportunity for public comment on 
potential requirements for product testing. Such requirements would be 
tied to risk and addressed through flexible written procedures that 
would address both test procedures and corrective action plans.
    In this section of this document, we are reopening the comment 
period with respect to our previous request for comment on when and how 
product testing programs are an appropriate means of implementing FSMA. 
We are seeking comment on whether requirements for product testing 
should be included in a final rule and, if so, what (if any) 
modifications to the proposed regulatory text would be appropriate. The 
proposed regulatory text would, if included in a final rule, establish 
requirements for:
    Product testing as an activity for verification of implementation 
and effectiveness as appropriate to the facility, the food, and the 
nature of the preventive control (proposed Sec.  117.165(a)(2));
    Written procedures for product testing (proposed Sec.  
117.165(b)(2));
    Corrective action procedures for product testing (proposed Sec.  
117.150(a)(1)(ii)(A)); and
    Records of product testing (proposed Sec.  117.155(b));
    See the proposed regulatory text for proposed subpart C for the 
full text of such potential requirements. Consistent with the requests 
of the comments, the proposed regulatory text would provide flexibility 
for a facility to make risk-based decisions on when product testing 
would be appropriate by providing that the facility can take into 
account the facility, the food, and the nature of the preventive 
control (e.g., whether the control is a kill step) rather than 
prescribe product testing in specific circumstance, or require that all 
types of facilities (including warehouses) conduct product testing. For 
supplementary information relevant to product testing, see the 2013 
proposed preventive controls rule (78 FR 3646 at 3763-3764), the 
corrected Appendix (78 FR 17142 at 17143 to 17151), and Ref. 18.

C. Environmental Monitoring

1. Comments on Environmental Monitoring
    Some comments support environmental monitoring as a verification 
activity. In general, these comments recommend that the final rule 
specifically require environmental monitoring when RTE product is 
exposed to the environment prior to packaging and the packaged food 
does not receive a treatment that would significantly minimize an 
environmental pathogen that could contaminate the food when it is 
exposed. Comments emphasize the need for flexible requirements that 
would allow facilities to tailor their programs based on risk.
    Some comments that generally support environmental monitoring as a 
verification activity nonetheless express concern about the potential 
for such requirements to be overly prescriptive. Comments particularly 
express concern about potentially prescriptive requirements for 
corrective actions if an environmental pathogen or appropriate 
indicator organism is detected. Some comments express concern about how 
potentially prescriptive requirements would impact products (such as 
produce) with a short shelf life.
    Some comments do not support including requirements for 
environmental monitoring as a verification measure. Some of these 
comments assert that requirements for environmental monitoring would 
not be in accord with guidelines issued by the Codex Alimentarius 
Commission (Codex). Some comments note that environmental monitoring 
would not be relevant to all products, such as products that will be 
heat-treated or otherwise subject to a kill-step. Other comments note 
that environmental monitoring would not be relevant to facilities such 
as food distributors, due to the low likelihood of product 
contamination occurring in storage and distribution centers. Some of 
these comments express concern about broad requirements that would 
require environmental monitoring in a manner that was not risk-based, 
such as when an environmental pathogen is not reasonably likely to 
occur. Some commenters with varying views on the issue nonetheless 
asked FDA to issue proposed regulatory text for environmental 
monitoring for consideration.
2. Potential Requirements for Environmental Monitoring
    Although the HACCP Annex of the Codex General Principles of Food 
Hygiene (Ref. 19) does not specifically recommend environmental 
monitoring as a verification activity in HACCP systems, the Codex 
General Principles of Food Hygiene (Ref. 20) does indicate that 
sanitation systems should be monitored for effectiveness and 
periodically verified, where appropriate, by microbiological sampling 
of environment and food contact surfaces, and regularly reviewed and 
adapted to reflect changed circumstances. Environmental monitoring is 
recommended in Codex Guidelines on the Application of General 
Principles of Food Hygiene to the Control of Listeria monocytogenes in 
Foods (see Annex I) (Ref. 21) and the Code of Hygienic Practice for 
Powdered Formulae for Infants and Young Children (see Annex III) (Ref. 
22). Moreover, currently available data and information support the 
role of environmental monitoring in a food safety system that 
incorporates hazard analysis and risk-based preventive controls. (See, 
e.g., the 2013 proposed preventive controls rule (78 FR 3646 at 3764-
3765), the corrected Appendix (78 FR 17142 at 17143 to 17151), and 
(Ref. 23). Environmental monitoring programs, when implemented 
appropriately based on the facility, the food, and the nature of the 
preventive control, could be used to verify that the preventive 
controls are effectively and significantly minimizing or preventing the 
occurrence of identified hazards.
    Taking into account the comments we have reviewed so far, we are 
providing an opportunity for public comment on potential requirements 
for environmental monitoring. The potential requirements would provide 
flexibility for facilities to tailor their environmental monitoring 
programs based on risk. Environmental monitoring would be required in 
the specific circumstances where RTE product is exposed to the 
environment prior to packaging and the packaged

[[Page 58545]]

food does not receive a treatment that would significantly minimize an 
environmental pathogen that could contaminate the food when it is 
exposed. However, the potential requirements would not otherwise 
specify circumstances where environmental monitoring would be required 
and would instead require that the facility conduct environmental 
monitoring as appropriate to the facility, the food, and the nature of 
the preventive control. The potential requirements would also not be 
prescriptive in the types of corrective actions needed in response to 
detecting an environmental pathogen or appropriate indicator organism 
in the environment; they would provide flexibility for facilities to 
establish and implement written corrective action procedures to 
identify and correct the problem, reduce the likelihood that the 
problem will recur, evaluate all affected food for safety, and, as 
necessary, prevent affected food from entering commerce.
    In this section of this document, we are reopening the comment 
period with respect to our previous request for comment on when and how 
environmental monitoring is an appropriate means of implementing FSMA. 
We are seeking comment on whether requirements for environmental 
monitoring should be included in a final rule and, if so, what (if any) 
modifications to the proposed regulatory text would be appropriate. The 
proposed regulatory text would, if included in a final rule, establish 
requirements for:
    Performing, as part of the hazard evaluation, an evaluation of 
environmental pathogens whenever an RTE food is exposed to the 
environment prior to packaging and the packaged food does not receive a 
treatment that would significantly minimize the pathogen (proposed 
Sec.  117.130(c)(1)(ii));
    Environmental monitoring, for an environmental pathogen (e.g., L. 
monocytogenes) or for an appropriate indicator organism (e.g., Listeria 
spp.), as an activity for verification of implementation and 
effectiveness as appropriate to the facility, the food, and the nature 
of the preventive control, if contamination of an RTE food with an 
environmental pathogen is a significant hazard (proposed Sec.  
117.165(a)(3));
    Records of environmental monitoring (proposed Sec.  117.155(b));
    Written procedures for environmental monitoring (proposed Sec.  
117.165(b)(3)); and
    Corrective action procedures for environmental monitoring (proposed 
Sec.  117.150(a)(1)(ii)(B)).
    See the proposed regulatory text for proposed subpart C for the 
full text of such potential requirements. For supplementary information 
relevant to environmental monitoring programs, see the 2013 proposed 
preventive controls rule (78 FR 3646 at 3764-3765), the corrected 
Appendix (78 FR 17142 at 17143 to 17151), and Ref. 23.

XI. Potential Requirements for a Supplier Program

A. Our Request for Comment on When and How Supplier Verification 
Activities Are an Appropriate Means of Implementing the Statutory 
Framework of Section 418 of the FD&C Act

    In the 2013 proposed preventive controls rule, we described the 
statutory framework of FSMA for supplier controls--i.e., the supplier 
verification activities that section 418 of the FD&C Act includes as an 
example of preventive controls. We also requested comment on when and 
how supplier verification activities are an appropriate means of 
implementing section 418 (78 FR 3646 at 3763-3767). We specifically 
requested comment on including requirements for supplier approval and 
other verification activities in a final rule. Although we did not 
propose specific regulatory text, we asked a series of questions about 
what such requirements should include. The Appendix contained extensive 
background on the role of supplier programs in a modern food safety 
system (78 FR 3646 at 3820-3821; see also the corrected Appendix, 78 FR 
17142 at 17151 to 17152).

B. Comments on When and How Supplier Verification Activities Are an 
Appropriate Means of Implementing the Statutory Framework of Section 
418 of the FD&C Act

    Some comments support including requirements for a supplier program 
in a final rule. These comments emphasize the need for flexible 
requirements that would allow facilities to tailor their programs based 
on risk, including risk inherent to raw materials and ingredients and 
risk that may be associated with a particular supplier (e.g., as 
reflected by the supplier's performance history). These comments 
provide many specific recommendations for what such requirements 
should--and should not--include. We summarize these recommendations in 
Table 7.

  Table 7--Summary of Specific Recommendations in Comments That Support
                   Requirements for a Supplier Program
------------------------------------------------------------------------
                                          Most comments do not support a
  Most comments support a requirement:             requirement:
------------------------------------------------------------------------
For receiving raw material and           For a written list of approved
 ingredients from approved suppliers.     suppliers (because the list
                                          would be subject to frequent
                                          (perhaps daily) change).
For verification of a facility's         For verification of the
 immediate supplier.                      supplier's supplier (because
                                          the facility has the greatest
                                          knowledge, leverage and
                                          ability to conduct meaningful
                                          oversight of its immediate
                                          supplier and because it is the
                                          supplier who is accountable to
                                          verify back one more step).
For records documenting that the basic   For documents such as an
 requirements are being carried out.      underlying audit report
                                          (because of concerns about
                                          confidential information).
For audits as a verification activity,   Prescribing the frequency of
 provided that the requirements are       audits (particularly an annual
 flexible and audits are not over-        frequency) (because an audit
 emphasized at the expense of other       is only one tool and audits
 verification activities.                 should be based on risk and on
                                          the performance of the
                                          supplier).
Limiting a supplier program to           Specifying that some hazards
 facilities that manufacture or process   require more than one
 food.                                    verification activity (because
                                          doing so would be too
                                          prescriptive and would not
                                          allow the facility the
                                          flexibility to determine the
                                          appropriate risk-based
                                          approach).
For oversight of a supplier program by   For a receiving facility to
 a qualified individual.                  identify the regulations to
                                          which the supplier is subject
                                          (because the distinction would
                                          not be material to food
                                          safety).
That would be consistent with the        ...............................
 Foreign Supplier Verification Program
 being established in a separate
 rulemaking

[[Page 58546]]

 
Specifying that a supplier program may   ...............................
 be managed at a corporate level
 (rather than by specific facilities),
 because supplier programs are often
 managed at the corporate level. Some
 comments specifically recommend that
 inspection of a supplier program take
 place at the location where the
 program is managed, including at a
 corporate location rather than at an
 individual facility.
------------------------------------------------------------------------

    Comments also address several other issues, such as whether the 
final rule should:
    Be limited to circumstances where a hazard is controlled by the 
supplier, or be required even if the hazard would be controlled by the 
receiving facility or by the receiving facility's customer.
    Include requirements for specific types of verification activities 
based only on the seriousness of hazards. Although some comments 
support such requirements, other comments do not because the basis 
should be risk (which includes probability as well as severity).
    Allow substitution of an inspection (e.g., by FDA) for an audit. 
Although some comments support such a substitution, others do not 
because they assert that an inspection and an audit are different in 
nature.
    Require a receiving facility to consider relevant regulatory 
information about the supplier. Although some comments support such 
requirements, others do not (e.g., because the information (which can 
be part of an overall supplier assessment) may not be available in a 
timely manner, is narrow in scope, and would diminish the importance of 
the supplier's food safety plan and the effectiveness of its 
implementation).
    Include requirements related to supplier non-conformance. Although 
some comments support such requirements, others maintain that supplier 
non-conformance would be better suited to guidance. Some comments 
specifically oppose a requirement for ``discontinuing use of the 
supplier'' and recommend flexibility for how a receiving facility would 
address supplier non-conformance.
    Provide for alternative verification requirements when a supplier 
is a qualified facility (which is subject to modified requirements; see 
proposed Sec.  117.201 in the 2013 proposed preventive controls rule). 
Although some comments support alternative requirements for suppliers 
that are qualified facilities, others express concern about whether 
alternative requirements can be practically implemented. Some comments 
state that the supplier verification requirements should not prevent 
facilities from sourcing ingredients from suppliers that are qualified 
facilities.
    In general, comments that simply oppose including a supplier 
program in the final rule express concern about cost, ingredient 
diversity, and duplication of efforts. Some of these comments recommend 
that we issue guidance on supplier verification activities rather than 
establish requirements in the final rule. Some commenters, including 
those with varying views about the issue, nonetheless requested that 
FDA propose regulatory language for consideration.

C. Potential Requirements for a Supplier Program

    Section 418 of the FD&C Act specifically identifies supplier 
verification activities as a preventive control (see section 418(o)(3) 
of the FD&C Act), Supplier controls, when implemented appropriately, 
are an important preventive control that can ensure that significant 
hazards will be significantly minimized or prevented 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. Taking into account the 
comments we have reviewed so far, we are providing an opportunity for 
public comment on potential requirements for a supplier program as a 
preventive control. In this section of this document, we are reopening 
the comment period with respect to our previous request for comment on 
when and how supplier programs are an appropriate means of implementing 
FSMA. We are seeking comment on whether requirements for a supplier 
program should be included in a final rule and, if so, what (if any) 
modifications to the proposed regulatory text would be appropriate. 
Elsewhere in this issue of the Federal Register, we are issuing a 
supplemental notice of proposed rulemaking to amend the 2013 proposed 
FSVP rule. In that supplemental notice we request comment, in light of 
the statutory provisions, on the manner and extent to which the FSVP 
and preventive controls supplier verification provisions--as well as 
other aspects of the FSVP and preventive controls regulations--should 
be aligned in the final rules.
    See the proposed regulatory text (proposed Sec.  117.136 and the 
applicable definitions in proposed Sec.  117.3) for the full text of 
such potential requirements. Briefly, the proposed regulatory text 
would, if included in a final rule:
    Establish definitions for terms used in the potential requirements 
for a supplier program (i.e., receiving facility; supplier; and 
qualified auditor) (proposed Sec.  117.3)
    Establish a risk-based requirement for a written supplier program 
that:
    Would require, with some exceptions, a supplier program for raw 
materials and ingredients for which the receiving facility has 
identified a significant hazard when the hazard is controlled before 
receipt of raw material or ingredient (proposed Sec.  117.136(a)(1) and 
(2); and
    Would not apply to raw materials and ingredients for which there 
are no significant hazards, the preventive controls at the receiving 
facility are adequate, or the receiving facility relies on the customer 
and obtains written assurance (proposed Sec.  117.136(a)(1)(ii));
    Require verification activities, as appropriate to the hazard, and 
documentation of such 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.  117.136(a)(3)(i));
    Require verification activities to verify that the hazard is 
significantly minimized or prevented, the incoming raw material or 
ingredient is not adulterated under section 402 of the FD&C Act or 
misbranded under section 403(w) of the FD&C Act, and the incoming raw 
material or ingredient is

[[Page 58547]]

produced in compliance with the requirements of applicable FDA food 
safety regulations (proposed Sec.  117.136(a)(3)(ii));
    Provide flexibility for a receiving facility to determine and 
document the appropriate verification activities for raw materials and 
ingredients from particular suppliers, based on a series of factors, 
except when there is a reasonable probability that exposure to a 
significant hazard will result in serious adverse health consequences 
or death to humans (proposed Sec. Sec.  117.136(b) and 117.136(c)(1)) 
(see next bullet);
    Require an annual audit as a verification activity when there is a 
reasonable probability that exposure to the hazard will result in 
serious adverse health consequences or death to humans, unless 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.  
117.136(c)(2));
    Provide for an alternative verification activity when the supplier 
is a qualified facility (proposed Sec.  117.136(c)(3));
    Provide for alternative verification activities when the supplier 
is a farm that would not be subject to the requirements in the final 
produce safety rule under proposed Sec.  112.4 (proposed Sec.  
117.136(c)(4));
    Require that an audit be conducted by a qualified individual who 
has technical expertise obtained by a combination of training and 
experience appropriate to perform the auditing function (proposed Sec.  
117.136(d)(1)) and proposed Sec.  117.180);
    Provide that inspection by FDA or an officially recognized or 
equivalent food safety authority may substitute for an audit (proposed 
Sec.  117.136(e));
    Require action to address supplier non-conformance (proposed Sec.  
117.136(f)); and
    Require documentation of verification activities in records (listed 
in proposed Sec.  117.136(g)), 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 (proposed Sec.  117.136(g)(5), 
(6), and (7), respectively).
    In addition, the potential addition of requirements for a supplier 
program would require conforming amendments to other provisions of the 
rule, including the requirements for a food safety plan, preventive 
controls, validation, verification of implementation and effectiveness, 
and the list of implementation records for subpart C (see proposed 
Sec. Sec.  117.126(b)(3), 117.135(c)(4), 117.140(b), 117.160(b)(3), 
117.165(a)(4), and 117.190(a)(4), respectively). For supplementary 
information relevant to a supplier program, see the 2013 proposed 
preventive controls rule (78 FR 3646 at 3765-3767), the corrected 
Appendix (78 FR 17142 at 17151- 17152), and Ref. 24. In the following 
paragraphs, we provide additional information about the potential 
proposed requirements for a supplier program.
    Reflecting the risk-based (including severity as well as 
probability) nature of a supplier program, a receiving facility's 
program would be limited to those raw materials and ingredients for 
which the receiving facility has identified a significant hazard. As 
discussed in section IX.C, ``significant hazard'' would be defined in 
the rule. Under the definition, hazards are determined to be 
significant based on the outcome of a hazard analysis and, thus the 
determination would incorporate the concept of risk. In addition, a 
receiving facility would establish and implement a supplier program 
only when a significant hazard is controlled before receipt; a 
receiving facility would not be required to establish and implement a 
supplier program if the receiving facility, or the receiving facility's 
customer, controls the hazard (and the customer provides assurances as 
to the control). Under this risk-based approach, a processor of fresh-
cut produce generally would be required to establish a supplier program 
for hazards associated with the fresh produce it processes (which would 
be controlled by the supplier during growing and harvesting), but a 
manufacturer of an acidified food would not be required to establish a 
supplier program for peppers that it uses to produce salsa if it will 
control any significant hazard for the peppers during manufacture of 
the salsa.
    The potential supplier program would include requirements 
applicable to a ``receiving facility'' and the proposed definition of 
``receiving facility'' would describe a receiving facility as a 
facility that manufactures/processes a raw material or ingredient that 
it receives from a supplier. A supplier would be defined as 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 consist solely of the addition of 
labeling or similar activity of a de minimis nature. The supplier could 
be an ``establishment'' rather than a ``facility'' because a supplier 
may be an entity that is not required to register under section 415 of 
the act and, thus, would not be a ``facility'' as that term would be 
defined for the purpose of this rule. Under this definition, a facility 
that packs or holds the food without any type of manufacturing/
processing would not be a supplier. Under this approach, a facility 
would not be required to establish a supplier program for food products 
that it only packs or distributes. For example, a receiving facility 
might receive a raw material or ingredient from a distribution center 
that receives the raw material or ingredient from a manufacturing 
facility or a farm. The distribution center, which is the immediate 
previous source of the raw material or ingredient, would not be 
required to establish a supplier program and would not be considered 
the supplier; rather the supplier would be the manufacturer or the farm 
(which manufactured/processed the food or harvested the food that was 
provided to the distribution center and subsequently to the receiving 
facility). In such instance, if the receiving facility has identified a 
significant hazard for the raw material or ingredient, and that hazard 
is controlled by the supplier (the manufacturer or the farm), the 
receiving facility would establish verification activities related to 
the manufacturer or the farm that provided the raw material or 
ingredient to the distribution center.
    If a facility receives an ingredient from a supplier, but the 
control of the hazard is by the supplier's supplier, the receiving 
facility would conduct supplier verification activities that would 
include verifying that the supplier has conducted appropriate 
verification that its supplier has controlled the hazard, i.e., the 
receiving facility would review the supplier's food safety records for 
its supplier's control of the hazard. For example, if a salad 
manufacturer is receiving cut produce such as celery from a fresh-cut 
produce supplier that receives celery from a farm, the salad 
manufacturer could conduct verification activities related to the on-
farm controls by reviewing the supplier program of, and verification 
activities conducted by, the fresh-cut produce supplier for its 
supplier, the farm (in addition to verifying the fresh-cut produce 
supplier's control of pathogens).
    We understand that, particularly for RACs, there may be multiple 
establishments, including cooperatives, packing houses, and 
distributers, between a receiving facility and the establishment that 
would be considered the supplier, which would make

[[Page 58548]]

supplier verification very challenging under certain circumstances. 
However, we believe that supplier verification is very important for 
RACs, in particular produce that will be further processed or consumed 
without a treatment that will significantly minimize or prevent 
pathogens. We request 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. For example if a receiving facility is a 
fresh-cut processing facility that receives produce from a distributor, 
who receives produce 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, what supplier controls 
should be applied for the produce coming from the farms? We request 
comment on whether and how the requirements for supplier verification 
should address such situations.
    In addition, we seek comment regarding whether (and, if so, how) 
the final preventive controls rule should address the potential for 
gaps in supplier controls when a hazard is controlled at Point A in the 
supply chain (e.g., by Supplier A, a farm), and Point B in the supply 
chain is a facility (such as Warehouse B, Distributor B, or Packing 
Shed B) that only packs or holds food, but does not manufacture/process 
food (and therefore would not be required to have a supplier program) 
before passing it on to Point C in the supply chain, which also would 
not be required to have a supplier program (e.g., Retail Food 
Establishment C or Consumer C). For example, if Packing Shed B 
distributes produce it packs after receiving the produce from Farm A 
directly to retail facilities (which would not be subject to the 
requirements of this preventive controls rule), no supplier controls 
would be applied to Farm A. Should verification activities be required 
in circumstances in which a RAC such as fresh produce will not be sent 
to any facilities that would be required to have preventive controls 
before reaching consumers?
    The potential supplier program would be included in the food safety 
plan and, thus, would be prepared (or overseen) by a qualified 
individual (see proposed Sec.  117.126(b)(7)). A supplier program could 
be established and maintained by a facility's corporate headquarters or 
parent entity. The recordkeeping requirements would specify that 
electronic records are considered to be onsite if they are accessible 
from an onsite location, and we expect that many records for the 
supplier program would be in electronic form (and thus easily 
retrievable by a facility during an inspection).
    Rather than specifically require a written list of approved 
suppliers, the potential requirements would specify that the supplier 
program be written and include verification activities, as appropriate 
to the hazard, and documentation of such activities, to ensure products 
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). Such a program could include, 
for example, written procedures for approving suppliers, for approving 
(or rejecting) specific raw materials and ingredients, and for 
documenting that raw materials or ingredients are only received from 
approved suppliers. The potential requirements would recognize that 
there can be circumstances that would require a facility to receive raw 
materials or ingredients on a temporary basis from an unapproved 
supplier (e.g., if there is a disruption in delivery of raw materials 
and ingredients from approved suppliers due to circumstances such as 
localized flooding or malfunctioning equipment). We request comment on 
examples of circumstances when it would be necessary and appropriate to 
receive raw materials and ingredients on a temporary basis from an 
unapproved supplier and on the types of verification activities that a 
facility should conduct on food from an unapproved supplier.
    The potential requirements would provide flexibility for the 
verification activities that the receiving facility would conduct for 
raw materials and ingredients. With one exception, the receiving 
facility would have flexibility to select one or more of four possible 
activities: (1) onsite audit; (2) sampling and testing of the raw 
material or ingredient, which could be conducted by either the supplier 
or the receiving facility; (3) review by the receiving facility of the 
supplier's relevant food safety records; and (4) other appropriate 
supplier verification activities based on the risk associated with the 
ingredient and the supplier. To determine which option is appropriate, 
the receiving facility could consider (1) the severity of the hazards; 
(2) where the preventive controls for those hazards are applied (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 
materials 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 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. Thus, a 
receiving facility would have flexibility to select a verification 
activity based on the circumstances.
    The exception would be when there is a reasonable probability that 
exposure to the hazard will result in serious adverse health 
consequences or death to humans. In this circumstance, under the 
potential supplier program, the receiving facility would be required to 
have documentation of an onsite audit of the supplier before using the 
raw material or ingredient from the supplier and at least annually 
thereafter. The potential requirement for an annual audit is limited to 
when there is a reasonable probability that exposure to the hazard will 
result in serious adverse health consequences or death to humans. 
Further, the receiving facility could select less frequent audits or a 
different verification activity, if it documented its determination 
that the less frequent onsite auditing or other verification activity 
provides adequate assurance that the hazards are controlled. The 
potential recordkeeping requirements that would apply to audits would 
identify specific information that the records must provide about the 
audit, including the conclusions of the audit, but would not specify 
that the underlying audit report is part of the required documentation 
of an audit.
    A person who conducts an audit would need to be qualified to do so. 
To be qualified, a person who conducts an audit (``qualified auditor'') 
would be required to satisfy the criteria for a ``qualified 
individual'' (a person who has successfully completed training in the 
development and application of risk-based preventive controls 
equivalent to that of an FDA-recognized standardized curriculum or is 
otherwise qualified through job experience to develop and apply a food 
safety system) and have technical expertise obtained

[[Page 58549]]

by a combination of training and experience appropriate to perform the 
auditing function.
    The potential supplier program would require the receiving facility 
to know the FDA food safety regulations that apply to the supplier, and 
relevant information about the supplier's compliance with those 
regulations. The focus of section 418 of the FD&C Act is on preventing 
food safety problems rather than on reacting to them. Section 418 of 
the FD&C Act requires the owner, operator, or agent in charge of a 
facility to establish and implement preventive controls to 
significantly minimize or prevent known or reasonably foreseeable 
hazards. By specifying that supplier verification activities are a 
preventive control, section 418 requires the receiving facility to take 
necessary actions to ensure that raw materials and ingredients are not 
adulterated. To determine whether incoming raw materials and 
ingredients are adulterated, a receiving facility would need to know 
the regulatory framework that applies to the raw materials and 
ingredients, and to have confidence that its supplier is complying with 
that regulatory framework.
    The potential supplier program would include provisions to address 
non-conformance by a supplier. This potential requirement would not 
prescribe when a particular corrective action (such as discontinuing a 
supplier) is necessary. A facility could substitute an inspection 
(whether by FDA or 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) for an audit. Even 
though inspection procedures and audit procedures are not identical, we 
tentatively conclude that a facility should have flexibility to 
determine whether an inspection could substitute for an audit based on 
characteristics such as the severity of the hazard, how the supplier 
controls the hazard, and the supplier's performance history. For 
example, a facility that receives pickles from a facility subject to 
the acidified foods regulations in 21 CFR 114 may conclude that an FDA 
inspection for compliance with acidified foods regulations (concluding 
that no action is indicated) provides adequate assurance that the 
facility is producing pickles in compliance with the requirements of 
applicable FDA food safety regulations and that the pickles are not 
adulterated under section 402 of the FD&C Act. For additional 
discussion of our reasons for tentatively concluding that it would be 
appropriate to substitute an inspection (whether by FDA or 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) for an audit, see the discussion in the 
proposed FSVP rule (78 FR 45730 at 45758). In addition, we are asking 
for comment on whether it would be appropriate to substitute an 
inspection in another country (Country A) for an audit when, for 
example, it is the food safety authority of Country B (whose food 
safety system FDA has officially recognized as comparable or determined 
to be equivalent to that of the United States) that conducted the 
inspection in Country A.
    The potential requirements would provide for alternative 
verification requirements when a supplier subject to the requirements 
of section 418 of the FD&C Act is a qualified facility subject to 
modified requirements. Section 418 provides different requirements for 
qualified facilities, which are reflected in the different potential 
verification requirements for such facilities. Although the potential 
requirements would allow a receiving facility to conduct an alternative 
verification activity when the supplier is a qualified facility, they 
would not require this.
    Likewise, the potential requirements would provide for alternative 
verification requirements when a supplier is a farm that would not be 
subject to the requirements of proposed Sec.  112.4 regarding the raw 
material or ingredient that the receiving facility receives from the 
farm. Some of these farms would be not be subject to the requirements 
of proposed Sec.  112.4 because they satisfy the criteria, in section 
419(f) of the FD&C Act, for an exemption for direct farm marketing. 
Other farms would not be subject to the requirements of proposed Sec.  
112.4 because the crops they grow would not be covered by the proposed 
produce safety rule, either based on the findings of a qualitative 
assessment of risk associated with growing, harvesting, packing, and 
holding of produce (see the discussion of this qualitative assessment 
of risk in the 2013 proposed produce safety rule, 78 FR 3504 at 3508 
and 3522-3529) or because they account for a very small percentage of 
covered produce (see proposed Sec.  112.4 and the discussion at 78 FR 
3504 at 3549). Although the potential requirements would allow a 
receiving facility to conduct an alternative verification activity for 
such farms, they would not require this. Although the potential 
requirements would provide for alternative verification requirements 
for farms that would not be subject to the produce safety rule, we 
would not issue a final rule on such alternative verification 
requirements until we issue the final produce safety rule.

D. Request for Additional Comment on Requirements To Address Conflicts 
of Interest for Persons Conducting Verification Activities

    In the 2013 proposed FSVP rule, we tentatively concluded that it 
would be appropriate to address the independence of individuals 
conducting verification activities (78 FR 45730 at 45759). We proposed 
that an individual who conducts any verification activity must not have 
a financial interest in the foreign supplier and payment must not be 
related to the results of the activity, and provided that this would 
not prohibit an importer, or the importer's employee, from conducting 
the verification activity (proposed Sec.  1.506(g)). As discussed in 
the 2013 proposed FSVP rule, we considered such requirements necessary 
to prevent bias, or the appearance of bias, on the part of a person 
conducting a verification activity (78 FR 45730 at 45759).
    We request 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. For example, should such requirements be 
directed to a subset of persons who conduct verification activities 
(such as auditors) or should they be directed more broadly? Would a 
requirement such as in the 2013 proposed FSVP rule be appropriate, or 
would some other requirement be more appropriate (such as a requirement 
that persons be free of conflicts of interest that are relevant to the 
outcome of the activity)? What would constitute a financial interest in 
a company sufficient to constitute a conflict of interest for a person 
conducting a supplier verification activity (e.g., conducting an audit 
of that company or conducting laboratory tests of that company's food)?

XII. Potential Requirements for the Hazard Analysis To Address 
Economically Motivated Adulteration

A. Our Request for Comment on Whether the Final Rule Should Address 
Economically Motivated Adulteration

    In the 2013 proposed preventive controls rule, we announced our 
intent to implement the statutory requirements for hazards that may be 
intentionally introduced, including by acts of terrorism, in a separate 
rulemaking rather than include them in the requirements for hazard 
analysis and

[[Page 58550]]

risk-based preventive controls (78 FR 3646 at 3659). We tentatively 
concluded that intentional hazards, which are not addressed in 
traditional HACCP or other food safety systems, likely will require 
different kinds of controls and would be best addressed in a separate 
rulemaking. However, we also acknowledged that some kinds of 
intentional adulterants could be viewed as reasonably likely to occur, 
e.g., in foods concerning which there is a widely recognized risk of 
economically motivated adulteration in certain circumstances. We 
provided an example of this kind of hazard--i.e., the addition of the 
chemical melamine to certain food products, apparently to enhance the 
measured protein content and/or perceived quality. We requested comment 
on whether to include potential hazards that may be intentionally 
introduced for economic reasons. We also requested comment on when an 
economically motivated adulterant can be considered reasonably likely 
to occur.
    When we developed the 2013 proposed intentional contamination rule, 
we tentatively concluded that economically motivated adulteration would 
be best addressed through the approach in the preventive controls rules 
for human food and for animal food (including hazard analysis, 
preventive controls, monitoring, corrective action, verification, and 
recordkeeping) rather than through the vulnerability assessment-type 
approach for intentional adulteration, where the intent is to cause 
wide-spread public health harm, such as acts of terrorism (see the 2013 
proposed intentional adulteration rule, 78 FR 78014 at 7802). We also 
explained our view that the primary purpose of economically motivated 
adulteration is to obtain economic gain rather than to impact public 
health, although public health harm may occur (78 FR 78014 at 78020).

B. Comments on Economically Motivated Adulteration

    Some comments oppose including requirements directed to 
economically motivated adulteration in the preventive controls rule. 
These comments assert that the vast majority of economically motivated 
adulterants affect quality and value rather than safety. These comments 
also point out that the majority of food products could, in theory, be 
subject to economically motivated adulteration but that it would be 
difficult to determine if such adulteration is reasonably foreseeable. 
One comment recommends that we draw a clear distinction between hazards 
that are intentionally introduced and those that are not. Another 
comment expresses the view that food fraud is fundamentally different 
from both food safety and food defense. However, some comments do 
support including ``expected intentional adulterants'' in the 
preventive controls rule and note that the U.S. Pharmacopeial 
Convention (USP) has a free on-line food fraud database (Ref. 25). (USP 
is a scientific nonprofit organization that sets standards for the 
identity, strength, quality, and purity of medicines, food ingredients, 
and dietary supplements manufactured, distributed and consumed 
worldwide.)

C. Potential Requirements To Address Economically Motivated 
Adulteration

    Taking into account the comments we have reviewed so far, we are 
providing an opportunity for public comment on a potential requirement 
for the hazard identification to consider hazards that may be 
intentionally introduced for purposes of economic gain (see proposed 
Sec.  117.130(b)(2)(iii) in proposed subpart C). In this section of 
this document, we are reopening the comment period with respect to our 
previous request for comment on whether to include potential hazards 
that may be intentionally introduced for economic reasons. We are 
seeking comment on whether this preventive controls rule would be the 
most appropriate rule to address FSMA's requirements to address hazards 
that may be intentionally introduced (for purposes of economic gain) 
and, if so, what (if any) modifications to the proposed regulatory text 
would be appropriate. We note that the preliminary regulatory impact 
analysis (PRIA) that presents the benefits and costs of this proposed 
rule (Ref. 26) describes certain assumptions we are making about the 
preventive controls, and their implementation, that would be 
established and implemented by a facility that identifies a potential 
hazard that may be intentionally introduced for economic reasons as a 
significant hazard. We are seeking comment on alternative ways to 
control such hazards.
    Under the definitions that would be established in the rule, a 
hazard would be an agent that is reasonably likely to cause illness or 
injury in the absence of its control. Thus, the focus of the potential 
requirement would be on those economically motivated adulterants that 
are reasonably likely to cause illness or injury in the absence of 
their control, not on economically motivated adulterants that solely 
affect quality and value with little or no potential for public health 
harm.
    We believe that it is practicable to determine whether economically 
motivated adulteration is reasonably foreseeable. Importantly, we would 
not expect facilities to consider hypothetical economically motivated 
adulteration scenarios for their food products. As discussed in the 
2013 proposed intentional adulteration rule, we would expect facilities 
to focus on circumstances where there has been a pattern of such 
adulteration in the past, suggesting a potential for intentional 
adulteration even though the past occurrences may not be associated 
with the specific supplier or the specific food product (78 FR 78014 at 
78027). For example, in both the 2013 proposed preventive controls rule 
and the 2013 proposed intentional contamination rule we discussed a 
widespread incident of economically motivated adulteration in which 
some milk firms in one country added melamine, a nitrogen-rich 
industrial by-product, to diluted dairy products to increase the 
apparent protein content (78 FR 3646 at 3659 and 78 FR 78014 at 78021, 
respectively). This adulteration resulted in significant public health 
consequences, with more than 290,000 ill infants and 6 deaths in that 
country. In light of this incident, a prudent person would include in 
its hazard analysis the potential for melamine to be an economically 
motivated adulterant in a facility's food products when using milk 
products from a country where melamine adulteration had occurred and, 
based on the outcome of that hazard analysis, determine whether 
melamine is a hazard that must be addressed in the food safety plan. As 
none of this adulterated milk was exported to the United States and no 
US suppliers have been a source of food safety problems due to milk 
products adulterated for economic gain, FDA does not expect a facility 
to consider the potential for melamine to be a significant hazard when 
using domestic milk products, or milk products from other countries 
when there is no history of melamine adulteration associated with those 
countries.
    There are other well-known substances that have been used in 
economically motivated adulteration schemes, have potential to cause 
public health harm, and would be prudent to consider in the types of 
food products that have been the subject of these schemes. For example, 
dyes containing the heavy metal lead have been added to ingredients 
such as spices to enhance color. Lead can accumulate in the body over 
time and can cause health problems, including such as impaired

[[Page 58551]]

cognitive development in children (Ref. 27). Lead chromate is a 
chemical with a vibrant yellow color that has been used as an 
adulterant in turmeric to change the color of the spice to suggest that 
it is of a higher quality (Ref. 28). Lead oxide is a red chemical that 
has been used as an adulterant in paprika to change the color of the 
spice to suggest that it is of a higher quality; in 1995, an incident 
was reported in Hungary in which dozens of people were made ill and 
several people died as a result of consuming contaminated paprika (Ref. 
29). Sudan I is an orange-red powder that had been added to chili 
powder as a coloring agent, but is now banned in many countries because 
the International Agency for Research on Cancer has classified it as a 
category 3 carcinogen (not classifiable as to its carcinogenicity to 
humans) (Ref. 30); in 2005, contamination of an ingredient prepared 
using chili powder containing Sudan I led to a massive recall of food 
products in the United Kingdom (Ref. 31).
    In addition to the food-fraud database mentioned in the comments, a 
recent report from the Congressional Research Service provides 
additional information on economically motivated adulteration of food 
and food ingredients (Ref. 32). A recent report identified 137 unique 
incidents in 11 food categories (Ref. 33).

XIII. Provisions for Withdrawal of an Exemption for a Qualified 
Facility

A. 2013 Proposed Provisions for Withdrawal of an Exemption for a 
Qualified Facility

    In the 2013 proposed preventive controls rule, we explained the 
provisions of FSMA that establish criteria for a facility to be a 
qualified facility, establish an exemption for qualified facilities, 
establish modified requirements for qualified facilities, and provide 
that we may withdraw the exemption otherwise granted to qualified 
facilities in specified circumstances (section 418(l) of the FD&C Act; 
see 78 FR 3646 at 3657). We proposed to establish:
    Definitions relevant to these provisions (proposed Sec.  117.3);
    An exemption from the requirements for hazard analysis and risk-
based preventive controls for qualified facilities (proposed Sec.  
117.5(a));
    Modified requirements for qualified facilities (proposed Sec.  
117.201); and
    Procedural requirements that would govern our withdrawal of an 
exemption for a qualified facility (proposed subpart E; the 2013 
proposed withdrawal provisions) (see 78 FR 3702-3703, 3768-3771, and 
3775-3780).
    The 2013 proposed withdrawal provisions would:
    Specify the circumstances under which we would withdraw an 
exemption for a qualified facility (proposed Sec.  117.251);
    Establish procedures for us to issue an order to withdraw the 
exemption, including information that would be in the order (proposed 
Sec. Sec.  117.254 and 117.257);
    Establish procedures whereby a qualified facility may submit a 
written appeal of our order to withdraw an exemption (proposed Sec.  
117.260 and 117.264);
    Establish procedures for appeals, hearings, and decisions on 
appeals and hearings (proposed Sec. Sec.  117.267, 117.270, 117.274, 
and 117.277); and
    Specify the circumstances in which an order to withdraw an 
exemption is revoked (proposed Sec.  117.280).

B. Proposed Clarification of What FDA Will Do Before Issuing an Order 
and Proposed Mechanism for Re-Instating an Exemption

1. Comments
    Some comments generally support the overall framework of the 2013 
proposed withdrawal provisions and express the view that withdrawal of 
exemption should be both prompt and permanent to protect public health. 
Some comments ask us to explain the difference between withdrawal of an 
exemption and suspension of registration. One comment asks us to 
clarify the effect a suspension has on a qualified facility and 
recommends that suspension automatically result in loss of the 
exemption. One comment recommends that we withdraw an exemption at the 
earliest signs of problems, because doing so would be most protective 
of public health and would be consistent with the principle that a 
broad interpretation of statutory exemptions is disfavored when they 
affect public health and safety. This comment also asserts that section 
418 of the FD&C Act provides a very low threshold for initiating a 
withdrawal action, makes that withdrawal permanent, and was designed to 
operate on a ``one strike, you're out'' principle. This comment asserts 
that the exemption section 418 provides to qualified facilities has no 
basis in food safety science or sound policy and endangers consumers 
and that withdrawal of an exemption would not result in overly harsh 
consequences because it would not close the facility. One comment 
discusses our authority to suspend the registration of a facility 
(section 102 of FSMA). This comment contrasts FSMA's provisions for 
withdrawal with those for suspension, noting that FSMA's provisions for 
suspension specify a method to lift that suspension (i.e., submission 
of a corrective action plan) but FSMA's provisions for withdrawal of an 
exemption provide no remedy for an exemption that is withdrawn.
    In contrast, other comments express concern that the 2013 proposed 
withdrawal provisions fail to establish a fair and clear process for 
withdrawing a qualified facility's exempt status and recommend that we 
revise the 2013 proposed withdrawal provisions to provide a more 
flexible framework that would be both fair and clear. Some of these 
comments express concern that withdrawal of an exemption would subject 
very small and small facilities to unexpectedly high compliance costs 
that could put them out of business. Some comments recommend that we 
add a provision allowing a facility to voluntarily withdraw its 
exemption. Some comments recommend more safeguards to ensure that the 
process to withdraw an exemption is not abused. In general, these 
comments recommend the following three principal revisions to the 2013 
proposed withdrawal provisions:
    Establish a high threshold for withdrawing an exemption, including 
an evidentiary standard that would apply to the criteria for 
withdrawing an exemption;
    Provide for ``due process'' before we take steps to withdraw an 
exemption, including an opportunity for a qualified facility to 
maintain its exempt status (e.g., by addressing the specified issues of 
concern); and
    Provide an opportunity for reinstatement of a withdrawn exemption.
    In the following paragraphs, we provide more detail about comments 
recommending these three principal revisions.
    Threshold for withdrawing an exemption. Some comments assert that 
the 2013 proposed withdrawal provisions are extremely vague and appear 
to give us broad authority to withdraw an exemption from a qualified 
facility without adequate evidence of an actual harm or likely severe 
problem related to the facility's practices. Some comments assert that 
we should narrowly interpret the statutory criteria for withdrawing an 
exemption to avoid action that is arbitrary and capricious, and that to 
do so we must show necessity and direct linkage between an active 
investigation of a foodborne illness outbreak and the qualified 
facility. Some of these comments

[[Page 58552]]

recommend that we define and clarify key terms (including ``directly 
linked,'' ``necessary,'' ``associated,'' and ``material to the safety 
of food''). Some of these comments also recommend that we introduce a 
standard (such as ``credible evidence'' or ``credible and substantial 
evidence'' that shows direct linkage to a problem at a specific 
facility) that would require us to meet an explicit evidentiary 
threshold when we find that conduct or conditions exist in a qualified 
facility sufficient to warrant withdrawal of an exemption. Some 
comments recommend that the final withdrawal provisions explicitly 
provide that the credible and substantial evidence would only apply to 
an individual facility, and would not apply to a group or class of 
facilities.
    Due process before withdrawing an exemption. Some comments note 
that we have many enforcement tools that we can use in lieu of 
withdrawing an exemption, particularly if there is an immediate risk to 
public health. These include seeking an injunction (21 U.S.C. 332; 
section 302 of the FD&C Act); seizing the food at issue (21 U.S.C. 
334(a)-(f); section 304(a)-(f) of the FD&C Act); and administrative 
detention of the food (21 U.S.C. 334(h); section 304(h) of the FD&C 
Act). Other comments note that we have a history of providing a 
facility with opportunities to fix a problem before starting such an 
enforcement action (e.g., by issuing a warning letter). These comments 
recommend that we provide such opportunities to qualified facilities 
before we take steps to withdraw an exemption.
    Some comments recommend that the final withdrawal provisions allow 
for partial withdrawal of an exemption in which FDA would indicate 
specific sections of the rule that the facility must comply with. These 
comments assert that small businesses should be able to seek targeted 
solutions as needed without falling under all the substantive, costly 
provisions of the rule. Some comments recommend that the final 
withdrawal provisions establish a three-tiered process--Tier 1: Warning 
letter; Tier 2: Temporary conditional withdrawal of an exemption; and 
Tier 3: Full withdrawal of an exemption. For example, a warning letter 
would identify the material conduct or conditions in question or how 
the facility is directly linked to an active investigation of a 
foodborne illness outbreak; include information about how the facility 
could remedy the situation; and notify the facility that it has 15 
calendar days from receipt of the warning letter to respond with a plan 
for remedying the problem within a suitable timeframe. These comments 
state that if the facility does not adequately address the problem in 
its response to the warning letter and subsequent actions to correct 
the problem, we would issue a temporary (e.g., six months) conditional 
withdrawal, targeted to a particular issue, outlining how the facility 
can remedy the problem. These comments further state that if the 
facility still fails to correct the problem after receiving the 
temporary conditional withdrawal, we would proceed with steps for full 
withdrawal of an exemption.
    Reinstatement of an exemption that was withdrawn. Some comments 
recommend that we provide a process for each of three situations in 
which a qualified facility might regain its exemption status:
    Before reaching the deadline for compliance specified in the 
withdrawal order, if the facility demonstrates that the conduct or 
conditions that triggered the withdrawal order have been sufficiently 
resolved;
    After the compliance deadline passes if, during an informal 
hearing, the facility can show that the conduct or conditions that 
triggered the withdrawal have been sufficiently resolved; or
    Automatically if we determine, after finishing an active 
investigation of a foodborne illness outbreak, that the outbreak is not 
directly linked to the facility.
    2. Specific Proposed Additions and Modifications to the 2013 
Proposed Withdrawal Provisions
    As discussed more fully in the following paragraphs, taking into 
account the comments we have reviewed so far we are proposing to modify 
the 2013 proposed withdrawal provisions to:
    Include specific regulatory actions that we must take, and other 
regulatory actions that we may consider, before we issue an order to 
withdraw an exemption (proposed Sec.  117.251(b));
    Clarify that an order to withdraw an exemption must be approved by 
an FDA District Director before it can be issued (proposed Sec.  
117.254(a) and (b)); and
    Provide a process for reinstating an exemption that has been 
withdrawn (proposed Sec.  117.287).
    See the revised regulatory text for proposed Sec. Sec.  117.251(b), 
117.254(a) and (b), and 117.287. In this section of this document, we 
are reopening the comment period with respect to these specific 
proposed provisions.
    Both of the proposed circumstances for withdrawal of an exemption 
specify significant public health reasons for doing so, related to an 
outbreak of foodborne illness, or being necessary to protect the public 
health and prevent or mitigate a foodborne illness outbreak based on 
conduct or conditions associated with the qualified facility that are 
material to the safety of the food manufactured, processed, packed, or 
held at such facility (proposed Sec. Sec.  117.251(a) and (b), 
respectively). We do not consider it necessary to define terms such as 
``directly linked,'' ``necessary,'' ``associated,'' or ``material to 
the safety of food,'' or to introduce a standard (such as ``credible 
evidence'' or ``credible and substantial evidence'' that shows direct 
linkage to a problem on a specific farm or facility) to provide for a 
fair process that is neither arbitrary nor capricious.
    We may suspend the registration of a facility if we determine that 
food manufactured, processed, packed, received, or held by the facility 
has a reasonable probability of causing serious adverse health 
consequences or death to humans or animals. If we suspend a facility's 
registration, no person can import or export food into the U.S. from 
such facility, offer to import or export food into the U.S. from such 
facility, or otherwise introduce food from such facility into 
intrastate or interstate commerce in the U.S. (See section 415(b) of 
the FD&C Act (21 U.S.C. 350d(b)). In contrast, we may withdraw an 
exemption from a qualified facility in two circumstances: (1) In the 
event of an active investigation of a foodborne illness outbreak that 
is directly linked to the qualified facility; or (2) if we determine 
that it is necessary to protect the public 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 food manufactured, processed, packed, or held at such facility. 
(See section 418(l)(3) of the FD&C Act). A facility that loses its 
exemption may distribute food if it is in compliance with applicable 
requirements.
    The statutory criteria for suspension of registration are separate 
and distinct from the statutory criteria for withdrawal of an exemption 
and must be considered separately. Suspension of a facility's 
registration does not change a facility's status as a qualified 
facility. If we take steps to suspend a qualified facility's 
registration, we may also separately consider whether the circumstances 
that may lead us to withdraw the facility's exemption exist and, if so, 
may follow the process that would be established in the final 
withdrawal provisions for doing so.
    As the comments point out, in many circumstances we have provided 
facilities with opportunities to fix a

[[Page 58553]]

problem before starting an enforcement action. Indeed, we consider that 
issuing an order to withdraw an exemption would be a rare event, in 
part because alternative actions may provide a more expeditious 
approach to correcting a problem than withdrawing an exemption. 
However, taking into account the concerns expressed in the comments we 
have reviewed so far, we are proposing to include specific actions that 
we must take, and other actions that we may consider, before we issue 
an order to withdraw an exemption. (See the revised regulatory text for 
proposed Sec.  117.251(b)). Briefly, the proposed regulatory text would 
provide that we:
    Notify a qualified facility in writing of circumstances that may 
lead us to withdraw its exemption, and provide an opportunity for the 
facility to respond, before we issue an order to withdraw the 
exemption;
    May consider alternative regulatory actions before issuing an order 
to withdraw an exemption; and
    Consider actions taken by the facility to address the circumstances 
that may lead us to withdraw its exemption before issuing an order to 
withdraw the exemption.
    We are not proposing that we always must take steps to withdraw an 
exemption at the earliest signs of problems. Not all problems would 
satisfy the statutory threshold for withdrawal of the exemption. 
Further, we believe it is appropriate to consider each situation on its 
individual merits, such as whether there are illnesses, whether there 
are significant violations that could have contributed to the problem, 
whether the facility has taken corrective actions to address the 
problem, and whether the actions taken are likely to prevent a 
reoccurrence of the situation. Moreover, FDA has other tools that may 
be available to more quickly protect public health, including recall 
and administrative detention.
    Regarding reinstatement, we tentatively conclude that the absence 
of a specific provision in section 418 of the FD&C Act for the re-
instatement of an exemption that is withdrawn does not preclude us from 
providing for such a process, by which a facility may regain its status 
as a qualified farm. The proposed regulatory text (see proposed Sec.  
117.287) would:
    Provide that we could reinstate an exemption on our own initiative 
or in response to a written request from the facility;
    Require that a written request from a facility include such data 
and information as are necessary to demonstrate that the facility has 
adequately resolved the problems with the conditions or conduct that 
are material to the safety of the food manufactured, processed, packed, 
or held at the facility, such that continued withdrawal of the 
exemption is not necessary to protect public health and prevent or 
mitigate a foodborne illness outbreak;
    Provide that if we had withdrawn the exemption due, in whole or in 
part, to an active investigation of a foodborne illness outbreak that 
had been directly linked to the qualified facility and later determine, 
after finishing the active investigation, that the outbreak was not 
directly linked to the facility, we would either;
    Reinstate the exemption (if the only reason for the withdrawal had 
been the outbreak investigation); or
    Inform the facility of our finding that the outbreak investigation 
was not directly linked to the facility, and provide an opportunity for 
the facility to request reinstatement (if the exemption was withdrawn, 
in part, due to conditions and conduct that are material to the safety 
of the food manufactured, processed, packed, or held at the facility).
    We are not proposing to provide for partial withdrawal of an 
exemption or establish the three-tiered process recommended in the 
comments (i.e., Warning letter; Temporary conditional withdrawal of an 
exemption; and Full withdrawal of an exemption). Such a process is not 
required by section 418 and would deprive FDA of needed flexibility to 
address the varying circumstances that might give rise to a possible 
withdrawal of the exemption. Further, the revised regulatory text 
provides for a qualified facility to receive written notification that 
circumstances may lead us to withdraw an exemption, and provides an 
opportunity for the facility to respond. FDA will consider this 
response and actions taken by the facility in determining whether to 
withdraw the exemption. In addition the newly proposed provision for 
reinstatement of an exemption provides an opportunity for a facility to 
return to its status as a qualified facility.

C. Proposed Revisions to the Content of an Order To Withdraw an 
Exemption

    In this section of this document, we are reopening the comment 
period with respect to proposed Sec.  117.257(d).
    Some comments recommend that the order explicitly state that the 
facility has the option to either comply with the order or appeal the 
order (with a request for an informal hearing) within 10 calendar days.
    We tentatively conclude that it would be useful for the order to 
itself specify the two options that a facility has upon receipt of the 
order, even though the order would otherwise include this information 
(because the order will contain the full text of the withdrawal 
provisions). Therefore, we are proposing to revise the requirements for 
the contents of an order to explicitly mention these two options. See 
the revised regulatory text of proposed Sec.  117.257(d).

D. Proposed Revisions to the Timeframes for a Facility To Comply With, 
or Appeal, an Order

    In this section of this document, we are reopening the comment 
period with respect to the timeframes in proposed Sec. Sec.  117.257(d) 
and 117.260(a) and (c).
1. Comments
    Some comments ask us to specify that a facility's timeframe for 
taking action begins when the facility receives the order, not when we 
issue the order. Other comments address the timeframes for a facility 
to compile information needed to appeal an order for withdrawal. These 
comments assert that the proposed timeframe of 10 days is insufficient, 
and recommend timeframes such as 30 days or 90 days.
    Some comments contrast the proposed 60-day timeframe to comply with 
the requirements for hazard analysis and risk-based preventive controls 
when a facility loses its exemption as a qualified facility with the 
timeframe that a facility would have to comply with these requirements 
when the final rule first becomes effective. As discussed in the 2013 
proposed preventive controls rule, we proposed compliance dates that 
would be 2 years and 3 years after the date of the final rule for small 
and very small businesses, respectively. These comments assert that 
these two situations are parallel, because a qualified facility that 
has had its exemption withdrawn would be coming into compliance with 
the full requirements for hazard analysis and risk-based preventive 
controls for the first time. These comments recommend that we change 
the timeframes in the 2013 proposed withdrawal provisions to better 
align with the compliance dates contemplated by the proposed rule and 
by FSMA for small and very small businesses. Some of these comments 
recommend that a small business have 6 months, and that a very small 
business have 18 months, to comply with the order. Other comments 
recommend that any business (whether small or very small) have two 
years to comply with

[[Page 58554]]

the order. Some of these comments recommend that the timeframe be tied 
to the date of the final determination rather than to the date of the 
order.
2. Proposed Revisions to Timeframes
    We tentatively conclude that the nature of what a facility would 
need to do to comply with an order--i.e., comply with the full 
requirements for hazard analysis and risk-based preventive controls--
makes the timeframes in the 2013 proposed withdrawal provisions 
insufficient. However, it is relevant that in contrast to the general 
compliance dates, the proposed withdrawal provisions would only apply 
when a significant public health concern has been identified for a 
particular facility.
    We also tentatively conclude that it is appropriate to link the 
timeframe for compliance to the date of receipt of the order, rather 
than to the date the order was issued. Doing so would be consistent 
with our other administrative procedures, such as appeal of an order 
for administrative detention (Sec.  1.402).
    Taking into account the comments we have reviewed so far, we are 
proposing to require that a facility comply with an order to withdraw 
an exemption within 120 days of the date of receipt of the order. See 
the revised regulatory text for proposed Sec. Sec.  117.257(d) and 
117.260(a) and (c).

XIV. Definition of Very Small Business

A. The 2013 Proposed Options for Definition of Very Small Business

    We proposed three options for the definition of a very small 
business based on total annual sales of food, adjusted for inflation: 
Option 1, $250,000; Option 2, $500,000; and Option 3, $1,000,000. The 
2013 proposed preventive controls rule contained several provisions 
relevant to very small businesses, including exemptions from subpart C 
in Sec.  117.5(g) and Sec.  117.5(h) for very small (and small) 
facilities engaged only in specific types of on-farm activities 
involving low-risk activity/food combinations, the exemption inSec.  
117.5(a) and modified requirements in Sec.  117.201 for a very small 
business as a qualified facility, and extended time to comply with the 
rule. In defining a very small business, we took into consideration the 
study of the food processing sector required by section 418(l)(5) of 
the FD&C Act (``Food Processing Sector Study'' (Ref. 34); see 78 FR 
3646 at 3700-3701). In the 2013 proposed preventive controls rule we 
requested comment regarding the three proposed options for the 
definition of ``very small business.'' We also requested comment on 
whether a dollar amount of sales that is more than, or less than, the 
$250,000, $500,000, or $1,000,000 amounts would be appropriate.

B. Comments on the 2013 Proposed Options for Definition of Very Small 
Business

    Comments support a variety of dollar limits of total annual sales 
of food for defining a very small business, including each of the three 
proposed options ($250,000, $500,000, and $1,000,000) as well as other 
dollar limits that we did not include as proposed options (i.e., 
$2,000,000, $5,000,000 and $10,000,000). Comments assert that very 
small facilities will incur a large portion of the costs associated 
with implementing the 2013 proposed preventive controls rule because 
very small facilities lack experience with HACCP-based models.
    Some comments support defining a very small business as one with 
total annual food sales up to $1,000,000. Some of these comments 
express concern that using lower dollar sales amounts to define a very 
small business would discourage growth of very small processing 
facilities (especially those co-located on a farm), would unfairly 
burden very small facilities, and could cause them to fail due to the 
estimated high cost of compliance; whereas setting a higher dollar 
sales amount would encourage growth, innovation and diversification. 
Some of these comments note that adopting the threshold of $1,000,000 
would establish that the full preventive controls requirements would 
apply to the businesses that produce the vast majority of food products 
and that modified requirements would apply to smaller businesses that 
represent the majority of producers but the minority of the food 
supply.
    Other comments support defining a very small business as one with 
total annual food sales up to $500,000. These comments maintain that 
the $500,000 limit would simplify the definition of a qualified 
facility, and make it easier for us to enforce than a lower dollar 
amount, because facilities would not need to calculate how much of 
their sales were to qualified end-users (as they would under section 
418(l)(1)(C) of the FD&C Act).
    Other comments support defining a very small business as one with 
total annual food sales up to $250,000. These comments maintain that 
the $250,000 limit would exempt the fewest facilities among the three 
proposed options and that this would be in the interest of public 
health. Comments assert that higher dollar limits would remove from the 
coverage of the 2013 proposed preventive controls rule precisely those 
companies whose practices would be most improved by it. Some of these 
comments evaluate the $250,000 limit in the context of section 418(l) 
of the FD&C Act, which defines a qualified facility as either a very 
small business or a business with annual sales of less than $500,000, 
provided a majority of its sales are made directly to qualified end-
users. These comments note that the options with a limit higher than 
$250,000 would equal or exceed the amount allowed for sales by 
qualified facilities to nonqualified end users under section 
418(l)(1)(C) of the FD&C Act and assert that statutory structure and 
intent of section 418(l) of the FD&C Act make the proposed $250,000 
limit the only available option from among the three options we 
proposed. The comments also assert that the close producer-customer 
relationship was a control for safety when a business is smaller than 
$500,000 in sales and primarily sells directly to consumers or locally 
to food retailers and restaurants.
    Some comments support defining a very small business as one with 
total annual food sales up to $2,000,000, $5,000,000 or $10,000,000. In 
general, these comments express concern about the costs associated with 
implementing the requirements for hazard analysis and risk-based 
preventive controls. For example, the comments assert that these costs 
would deter small farms with gross annual sales between $250,000 and $5 
million from expanding their businesses (e.g., to develop value-added 
products), particularly when annual food sales include foods that would 
not be not covered by the requirements for hazard analysis and risk-
based preventive controls (such as for animal food, whole produce, and 
low-risk activity/food combinations conducted by a small or very small 
business co-located on a farm), and the sales would largely be to 
qualified end-users. A comment recommending a $10,000,000 limit 
expresses concern that the costs associated with implementing the 
requirements for hazard analysis and risk-based preventive controls 
would be passed on to consumers.
    Some comments do not support defining a very small business based 
on total annual food sales and recommend an alternative definition 
based on the number of employees (e.g., fewer than 20 employees). These 
comments assert that defining very small business based on number of 
employees would be consistent with the proposed definition of small 
business (which is based on number of employees) and with the smallest 
establishment size in the Food

[[Page 58555]]

Processing Sector Study. Other comments support using a combination of 
criteria for defining a very small business, including gross sales, 
number of employees and risk level of the food being prepared.
    Some comments support using the volume of food rather than total 
annual food sales. Some comments express concern that the dollar sales 
would be applied to all food sold, including food for animals, and 
recommend that we base the value on food subject to the preventive 
controls for human food rule, on produce and processed food, on human 
food (excluding animal feed) or on ``high-risk processed foods.''

C. Proposed Revisions to the Definition of Very Small Business

    In this supplemental notice of proposed rulemaking, we are 
proposing the definition of very small business as a business that has 
less than $1,000,000 in total annual sales of human food adjusted for 
inflation. This definition would, as recommended by some comments, 
simplify a facility's determination of whether it is a qualified 
facility because the facility would only need to calculate its total 
sales of human food rather than determine how much food was sold to 
qualified end-users. The statutory construct does not prevent us from 
establishing a definition for very small business that would include 
more facilities than those that would be included under the statutory 
provision that considers sales to qualified end-users (section 
418(l)(1)(C) of the FD&C Act). Section 418(n)(1)(B) of the FD&C Act 
directs FDA to define the term ``very small business'' for the purposes 
of determining whether a facility is a ``qualified facility'' eligible 
for modified requirements. Further, section 418(n)(1)(B) requires us to 
consider the Food Processing Sector Study for the purpose of defining 
``very small business.'' FDA notes that section 418 of the FD&C Act 
does not otherwise limit how FDA may define ``very small business.''
    We tentatively conclude that it is reasonable for the sales limit 
in the definition of ``very small business'' to be directed to human 
food rather than all food, including animal food. The proposed 
definition of ``very small business'' in this document is consistent 
with the proposed definition of ``very small business'' in the 2013 
proposed rule ``Current Good Manufacturing Practice and Hazard Analysis 
and Risk-Based Preventive Controls for Food for Animals'' (78 FR 64736, 
October 29, 2013), which would define such a business with respect to 
sales of animal food rather than all food. We do not expect that this 
proposed change would have a significant effect on the number of 
facilities that satisfy the definition of ``very small business,'' 
because most facilities subject to the statutory requirements for 
hazard analysis and risk-based preventive controls do not make both 
human and animal food. However, some facilities co-located on a farm 
that would not satisfy the definition of ``very small business'' if the 
limit on the sales of food includes animal food as well as human food 
may fall within the revised definition that would include a limit only 
on the sales of human food.
    We tentatively conclude that it is not necessary for the dollar 
limit in the definition of ``very small business'' to be $250,000 or 
less to protect public health. In the 2013 proposed preventive controls 
rule, we estimated the number of facilities that would be affected by 
the size specified in the definition of ``very small business.'' The 
size specified in the definition of ``very small business'' would 
affect the compliance dates, the exemptions for qualified facilities, 
and the exemptions for on-farm low-risk packing and holding activity 
food/combinations and on-farm low-risk manufacturing/processing 
activity food/combinations (proposed Sec. Sec.  117.5(a), (g), and (h), 
respectively) (see 78 FR 3646 at 3702). We noted that as a group, 
businesses with less than $1,000,000 in total annual sales of foods 
produce less than two percent of all food produced in the United States 
when measured by dollar value. We acknowledge that this estimate of all 
food produced in the United States is higher than the estimates for 
lower dollar limits (one-half of one percent of all food produced in 
the United States, or less than one-half of one percent of all food 
produced in the United States, for limits of $500,000 or $250,000, 
respectively). Regardless, under the revised definition 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.
    In the proposed rule, we calculated the costs of the rule, and 
estimated the percent of food produced in the United States that would 
be subject to modified requirements (i.e., produced by qualified 
facilities), by determining which facilities would be qualified based 
on ``per facility'' sales. We believe our current calculation based on 
firm sales rather than facility sales is more consistent with section 
418(l)(1)(B). In the updated PRIA (Ref. 26), we compare the numbers and 
their market share of qualified and non-qualified facilities under 
different definitions for a very small business using (1) the method in 
our original PRIA (the number of facilities with less than $1 million 
in annual sales) and (2) the number of firms with less than $1 million 
in annual sales (in which multiple facilities may be under the 
ownership of one firm). As noted in the updated PRIA (Ref. 26), in the 
final rule we will calculate the number of qualified facilities based 
on sales on a ``per firm'' basis. Calculating sales at the ``per firm'' 
level, we estimate that, as a group, those businesses that have less 
than $1,000,000 in total annual sales of foods produce less than one 
percent of the dollar value of food produced in the United States that 
would be covered by the rule without any special provisions for such 
businesses (Ref. 26), roughly equivalent to the percentage of food 
produced by very small businesses when the level for such entities is 
set at $250,000 if the ``per facility'' method of calculation is used. 
In contrast, higher dollar limits for very small business (such as the 
$2,000,000 or $5,000,000 limits recommended in some of the comments) 
using the ``per firm'' method would affect more of the food produced in 
the United States (approximately one percent and two percent, 
respectively, roughly equivalent to the levels of food affected when 
the level is set at $500,000 and $1,000,000, respectively, using the 
``per facility'' method) (Ref. 26). We tentatively conclude that the 
definition of very small business should exempt from the rule only a 
small percent of food to minimize the risk of foodborne illness and, 
thus, are proposing a very small business definition of $1,000,000, 
which would exempt less than one percent of the dollar value of food 
produced in the United States. We request comment on this tentative 
conclusion and whether we should consider other dollar limits for very 
small business.
    A dollar limit in the definition of ``very small business'' greater 
than $250,000 would not necessarily exempt those companies whose 
practices would be most improved by complying with the requirements for 
hazard analysis and risk-based preventive controls. The Food Processing 
Sector Study (Ref. 34) concluded that there was no consistent pattern 
across food categories in terms of which sizes of establishments 
contribute most to foodborne illness risk (78 FR 3646 at 3701). 
Moreover, the facilities that would be classified as qualified 
facilities would be subject to modified requirements (see proposed

[[Page 58556]]

Sec.  117.201). Furthermore, all facilities that would be exempt from 
the requirements for hazard analysis and risk-based preventive controls 
would continue to be subject to the prohibitions in the Federal Food, 
Drug, and Cosmetic Act against causing food to be adulterated or 
misbranded and against distributing such food and to inspection by FDA.
    We are not proposing that the definition of ``very small business'' 
consider number of employees as well as dollar limits, be based on 
number of employees for consistency with the definition of ``small 
business,'' or be based on volume of food sold rather than on dollar 
limits associated with sales of food. There are two alternative sets of 
criteria to be a qualified facility. The criteria in section 
418(l)(1)(C) of the FD&C Act are set out with regard to sales. We 
believe it is appropriate for the other criteria (related to being a 
``very small business'') similarly to be related to sales. As discussed 
in the 2013 proposed preventive controls rule, we proposed number of 
employees for the definition of ``small business'' in part because it 
would be the same definition for small business as that which has been 
established by the U.S. Small Business Administration under 13 CFR 121 
for most food manufacturers. We continue to believe that the proposed 
definition of ``small business,'' based on number of employees, is 
appropriate.
    We are not proposing that the definition of ``very small business'' 
consider the risk associated with the food manufactured, processed, 
packed or held by the facility. The description ``very small'' 
addresses size of a business, not risk associated with food the 
facility manufactures, processes, packs, or holds.

XV. Other New and Revised Proposed Provisions

A. Proposed New Definitions

1. Proposed Definition of ``Pathogen''
    In the 2013 proposed rule, we proposed to define ``environmental 
pathogen'' to mean a microorganism that is of public health 
significance and is capable of surviving and persisting within the 
manufacturing, processing, packing, or holding environment. Variations 
of the phrase ``microorganism of public health significance'' appear in 
several places in the existing CGMP regulations and in the 2013 
proposed preventive controls rule. To both simplify the regulations and 
use the same term (i.e., ``pathogen'') when we mean a microorganism of 
public significance, we are proposing to define the term ``pathogen'' 
to mean a microorganism that is of public health significance and to 
replace variations of the phrase ``microorganism of public health 
significance'' with ``pathogen'' throughout the regulations.
2. Proposed Definition of ``You''
    In the 2013 proposed preventive controls rule, we requested comment 
on whether there is any meaningful difference between the persons 
identified in current part 110 (i.e., ``plant management'' and 
``operator'') and the ``owner, operator, or agent in charge'' 
identified in section 418 of the FD&C Act. We also requested comment on 
whether it would be appropriate to refer to the ``owner, operator, or 
agent in charge'' of a plant, establishment, or facility throughout 
proposed part 117 and, if so, whether the requirements would be clear 
if we revised the proposed rule to use pronouns (such as ``you'' and 
``your'') within proposed part 117.
    Comments that responded to this request for comment focused on an 
approach that would make the regulations clear. However, the comments 
were divided in terms of how to best provide clarity, particularly with 
respect to use of pronouns such as ``you'' and ``your.'' Some of these 
comments express concern that it would be confusing if the phrase 
``owner, operator, or agent in charge'' applied both to plant 
management and operators in the CGMP requirements (proposed subpart B, 
derived from current part 110) and to the ``owner, operator, or agent 
in charge of a facility'' in the requirements for hazard analysis and 
risk-based preventive controls (proposed subpart C). Other comments do 
not express this concern and note that the use of pronouns would, as we 
suggested, make the regulations more clear.
    We acknowledge the potential for confusion if the phrase ``owner, 
operator, or agent in charge'' applies to both plant management and 
operators in proposed subpart B and to the ``owner, operator, or agent 
in charge of a facility'' in proposed subpart C. Most of the provisions 
of proposed subpart B do not specify the role of ``plant management'' 
or the ``operator'' of a plant or establishment. To prevent confusion, 
we tentatively conclude it is prudent to retain terms such as ``plant 
management'' and ``operator'' in proposed subpart B.
    However, we tentatively conclude that we can simplify the 
regulations directed to the ``owner, operator, or agent in charge of a 
facility'' in provisions in subparts C, D, and E by using pronouns, 
without creating confusion, if we (1) define the term ``you'' to mean, 
for purposes of part 117, the owner, operator, or agent in charge of a 
facility and (2) limit use of the term ``you'' to provisions in 
proposed subparts C, D, and E. See the revised regulatory text for the 
definition of you (in proposed Sec.  117.3) and its use throughout 
revised subpart C.
3. Proposed Definition of ``Significant Hazard''
    As discussed in section IX.C, we are proposing to delete the 
proposed definition ``hazard reasonably likely to occur'' and instead 
establish a definition for ``significant hazard.'' See the revised 
regulatory text in proposed Sec.  117.3.
4. Proposed Definition of ``Known or Reasonably Foreseeable Hazard''
    As discussed in section IX.C, we are proposing to delete the 
proposed definition ``reasonably foreseeable hazard'' and instead 
establish a definition for ``known or reasonably foreseeable hazard.'' 
See the revised regulatory text in proposed Sec.  117.3.
5. Potential Definitions of ``Qualified Auditor,'' ``Receiving 
Facility,'' and ``Supplier''
    As discussed in section XI.C, we are providing an opportunity for 
public comment on potential requirements for a supplier program. If 
such requirements are included in a final rule, we would establish 
definitions for three terms used in the potential requirements for a 
supplier program--i.e., ``qualified auditor,'' ``receiving facility,'' 
and ``supplier.'' See the proposed regulatory text in proposed Sec.  
117.3.

B. Proposed Revisions to Definitions

    In the 2013 proposed preventive controls rule, we proposed to:
    Delete the definition of the term ``shall'' from the existing CGMP 
regulations;
    Revise the definitions of several other terms in the existing CGMP 
regulations;
    Retain the definitions of several other terms in the existing CGMP 
regulations, with no changes; and
    Establish several new definitions.
    We received comment on many of these proposed definitions. Taking 
into account the comments we have reviewed so far, we are proposing to 
revise the definitions for three of these terms.
1. Revised Definition of ``Cross-contact''
    We proposed to define the term ``cross-contact'' to mean the 
unintentional incorporation of a food

[[Page 58557]]

allergen into a food. Some comments recommend that we define the term 
to be ``allergen cross-contact'' rather than ``cross-contact'' to 
reduce the potential for confusion with the term ``cross-
contamination.'' We tentatively conclude that the term ``allergen 
cross-contact'' may reduce the potential for confusion with the term 
``cross-contamination'' and are proposing to establish a definition for 
the term ``allergen cross-contact'' rather than the term ``cross-
contact.''
2. Revised Definition of ``Hazard'' and ``Reasonably Foreseeable 
Hazard''
    Some comments recommend that we include radiological hazards as a 
subset of chemical hazards in the definition ``hazard.'' Although 
radiological hazards would not be common, we believe that facilities in 
the past have considered them as chemical hazards when conducting a 
hazard analysis for the development of HACCP plans. The revised 
regulatory text uses the phrase ``chemical (including radiological) '' 
in the definition of ``hazard'' and as applicable throughout the 
regulations. As a conforming change, we are proposing to revise the 
definition of ``reasonably foreseeable hazard'' to mean a potential 
biological, chemical (including radiological), or physical hazard that 
may be associated with the facility or the food.
3. Revised Definition of Environmental Pathogen
    We proposed to define the term ``environmental pathogen'' to mean a 
microorganism that is of public health significance and is capable of 
surviving and persisting within the manufacturing, processing, packing, 
or holding environment. We identified Salmonella spp. and Listeria 
monocytogenes as examples of environmental pathogens. Some comments 
express concern that our proposed definition of ``environmental 
pathogen'' would capture organisms such as pathogenic sporeformers 
whose presence in and of itself would not constitute a risk to public 
health.
    We are proposing to revise the definition of an environmental 
pathogen to mean a pathogen capable of surviving and persisting within 
the manufacturing, processing, packing, or holding environment such 
that food may be contaminated and may result in foodborne illness if 
that food is consumed without treatment to significantly minimize the 
environmental pathogen. The revised definition of ``environmental 
pathogen'' would specify that an environmental pathogen does not 
include the spores of pathogenic sporeformers and, thus, recognizes 
that consumption of food contaminated by the spores of a pathogenic 
sporeformer that is in the environment may not result in foodborne 
illness. For example, if food is contaminated with spores of 
Clostridium botulinum, the microorganism would not produce the 
botulinum toxin that causes illness unless these spores are subject to 
conditions that allow them to germinate into vegetative cells that 
produce the toxin. Pathogenic sporeformers are normally present in 
foods, and unless the foods are subjected to conditions that allow 
multiplication, they present minimal risk of causing illness.

C. Proposed Editorial Changes

    The revised regulatory text includes several changes that we are 
making to make the requirements more clear and improve readability. We 
summarize the principal editorial changes in Table 8.

                                       Table 8--Proposed Editorial Changes
----------------------------------------------------------------------------------------------------------------
     Designation in the revised
regulatory text  (Proposed Sec.   )            Proposed revision                         Explanation
----------------------------------------------------------------------------------------------------------------
Throughout part 117................  Substitute the term ``adequate'' for   For the purposes of part 117, there
                                      the term ``sufficient''.               is no meaningful difference between
                                                                             ``adequate'' and ``sufficient.'' We
                                                                             proposed to retain the definition
                                                                             of ``adequate'' that is in the
                                                                             existing CGMP requirements in
                                                                             current part 110, but did not
                                                                             propose to define ``sufficient.''
                                                                             We tentatively conclude that the
                                                                             regulations will be clearer if we
                                                                             use the single term ``adequate''
                                                                             throughout the regulations.
Throughout subparts C, D, and E....  Substitute the defined term ``you''    Improve clarity and readability.
                                      for ``owner, operator, or agent in
                                      charge of a facility''.
117.126(c), 117.170(a)(4),           Re-phrase the proposed requirements    Improve clarity and readability.
 117.170(a)(5), 117.170(d).           in active voice.
117.126(d).........................  Specify that the food safety plan is   Distinguish the requirements for the
                                      a record that is subject to the        contents of the food safety plan
                                      requirements of subpart F within the   from implementation records, which
                                      requirements for the food safety       continue to be listed in Sec.
                                      plan (Sec.   117.126) rather than      117.190.
                                      together with the requirements for
                                      other records required by the rule
                                      (Sec.   117.190).
117.130(b)(1) and (b)(2)...........  Switch the order of paragraphs (b)(1)  We tentatively conclude that it is
                                      and (b)(2) compared to the order in    more logical to specify what
                                      the 2013 proposed preventive           hazards must be considered (i.e.,
                                      controls rule.                         biological, chemical (including
                                                                             radiological), and physical) before
                                                                             specifying the reasons for how the
                                                                             hazards could get into the food
                                                                             products (i.e., naturally
                                                                             occurring, unintentionally
                                                                             introduced, or intentionally
                                                                             introduced for purposes of economic
                                                                             gain).
117.135............................  Shorten the title from ``Preventive    Simplify the presentation of the
                                      controls for hazards that are          requirements and conform with the
                                      reasonably likely to occur'' to        proposed deletion of the term
                                      ``Preventive Controls''.               ``hazards that are reasonably
                                                                             likely to occur''.

[[Page 58558]]

 
117.135(c)(1)......................  Rearrange the requirements for (1)     It is more logical to place these
                                      parameters associated with the         requirements with process controls
                                      control of the hazard and (2) the      since their parameters and their
                                      maximum or minimum value, or           values are associated with process
                                      combination of values, to which any    controls.
                                      biological, chemical, or physical
                                      parameter must be controlled to be
                                      associated with process controls
                                      rather than be a standalone
                                      requirement.
117.135(c)(3) and 117.150(c).......  Move requirements for corrections for  Improve clarity and readability.
                                      sanitation controls from the
                                      requirements for preventive controls
                                      (proposed Sec.   117.135) to the
                                      requirements for corrective actions
                                      (proposed Sec.   117.150).
117.137............................  Shorten the title from ``Recall plan   Simplify the presentation of the
                                      for hazards that are reasonably        requirements and conform with the
                                      likely to occur'' to ``Recall plan''.  proposed deletion of the term
                                                                             ``hazards that are reasonably
                                                                             likely to occur''.
117.145, 117.150, 117.155..........  Redesignate the section numbers from   Accommodate insertions of new Sec.
                                      the original section numbers in the    117.136 (supplier program) and new
                                      2013 proposed preventive controls      Sec.   117.140 (preventive control
                                      rule (proposed Sec.  Sec.   117.140,   management components).
                                      117.145, and 117.150, respectively).
117.155, 117.160, 117.165, and       Move the more extensive verification   Improve clarity and readability.
 117.170.                             requirements for validation,
                                      implementation and effectiveness,
                                      and reanalysis from the single
                                      proposed section (proposed Sec.
                                      117.150) to separate sections
                                      (proposed Sec.  Sec.   117.160,
                                      117,165, and 117.170, respectively).
117.170(a)(4)......................  Revise the requirements for            Simplify the presentation of
                                      reanalysis of the food safety plan     requirements and reduce redundancy
                                      after an unanticipated event in        in regulatory text for inter-
                                      which a preventive control is not      related requirements.
                                      properly implemented to refer to the
                                      requirements for corrective actions
                                      in light of such an event rather
                                      than repeat the full text of those
                                      requirements for corrective actions.
117.170(c).........................  Specify the ``written food safety      Use the term ``food safety plan''
                                      plan'' rather than the ``written       for consistency throughout subpart
                                      plan.''.                               C.
117.170(c).........................  Specify ``document the basis for the   Improve clarity and readability.
                                      conclusion that no revisions are
                                      needed'' rather than ``document the
                                      basis for the conclusion that no
                                      additional or revised preventive
                                      controls are needed''.
117.170(e).........................  Specify ``You must conduct a           Improve clarity by specifying what
                                      reanalysis of the food safety plan     the owner, operator, or agent in
                                      when FDA determines it is necessary    charge of the facility must do in
                                      to respond to new hazards and          certain circumstances rather than
                                      developments in scientific             what FDA may require.
                                      understanding'' rather than ``FDA
                                      may require a reanalysis of the food
                                      safety plan to respond to new
                                      hazards and developments in
                                      scientific understanding.''
117.190............................  Change the title from ``Records        Accurately reflect the nature of the
                                      required for subpart C'' to            listed records after moving
                                      ``Implementation records''.            recordkeeping requirements for the
                                                                             food safety plan to Sec.   117.126.
117.190(a)(3)(ii) and (iii)........  Add ``verification of'' in front of    Distinguish these requirements for
                                      ``monitoring'' and ``corrective        records applying to ``verification
                                      actions''.                             of monitoring'' and ``verification
                                                                             of corrective actions'' from other
                                                                             requirements for ``records of
                                                                             monitoring'' and ``records of
                                                                             corrective actions''.
----------------------------------------------------------------------------------------------------------------

XVI. Holding Human Food By-Products Intended for Use in Animal Food

    Section 116 of FSMA (21 U.S.C. 2206) (Alcohol-Related Facilities) 
provides a rule of construction for certain facilities engaged in the 
manufacturing, processing, packing, or holding of alcoholic beverages 
and other food. Based on our interpretation of section 116, we proposed 
that subpart C would not apply with respect to alcoholic beverages at 
facilities meeting two specified conditions (proposed Sec.  117.5(i); 
78 FR 3646 at 3707 to 3709). We also proposed that subpart C would not 
apply with respect to food other than alcoholic beverages at facilities 
described in the exemption, provided such food is in prepackaged form 
that prevents direct human contact with the food and constitutes not 
more than 5 percent of the overall sales of the facility. However, we 
did note that in the case of a brewery manufacturing animal feed, 
section 418 of the FD&C Act would apply to the spent grain sold as 
animal feed once the spent grain is physically separated from the beer.
    Some comments ask us to include the production of by-products of 
the alcoholic beverage manufacturing process (such as spent grains, 
distillers' grains, and grape pomace) within the exemption applicable 
to alcoholic beverages. These comments argue that the mere act of 
separating and disposing of those by-products by sale or otherwise 
should not trigger an

[[Page 58559]]

obligation to meet onerous and expensive food safety regulations.
    The byproducts described in these comments appear to be products 
that would be used in food for animals rather than in human food. In 
response to the 2013 proposed animal food rule, we received many 
comments expressing concerns from brewers and distillers about whether 
that rule would allow them to continue providing spent grains for 
animal food. These spent grains are very commonly used as animal food, 
and are a subset of the much broader practice of human food 
manufacturers sending their peels, trimmings, and other by-products to 
local farmers or animal food manufacturers rather than to landfills.
    Elsewhere in this issue of the Federal Register, we are issuing a 
supplemental notice of proposed rulemaking to amend the 2013 proposed 
animal food rule. Human food processors already complying with human 
food safety requirements would not need to implement additional 
preventive controls or Current Good Manufacturing Practice regulations 
when supplying a by-product (e.g., wet spent grains, fruit or vegetable 
peels, liquid whey) for animal food, except for proposed CGMPs to 
prevent physical and chemical contamination when holding and 
distributing the by-product (e.g., ensuring the by-product it is not 
comingled with garbage when being held or distributed). However, 
further processing a by-product for use as animal food (e.g., drying, 
pelleting, heat-treatment) would require compliance with the Preventive 
Controls for Animal Food rule. If any requirement regarding preventing 
physical and chemical contamination in human food by-products for use 
as animal food is finalized, it will be finalized as part of a final 
preventive controls rule for human food.

XVII. Preliminary Regulatory Impact Analysis

A. Overview

    FDA has examined the impacts of this proposed 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). FDA has developed a PRIA that presents the benefits and costs 
of this proposed rule (Ref. 26). FDA believes that the proposed rule 
will be a significant regulatory action as defined by Executive Order 
12866. FDA requests comments on the PRIA.
    The summary analysis of benefits and costs included in this 
document is drawn from the detailed PRIA (Ref. 26) which is available 
at http://www.regulations.gov (enter Docket No. FDA-2011-N-0920), and 
is also available on FDA's Web site at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

B. Regulatory Flexibility Act

    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because many small businesses will need to implement 
a number of new preventive controls, FDA acknowledges that the final 
rules resulting from this proposed rule will have a significant 
economic impact on a substantial number of small entities.

C. Small Business Regulatory Enforcement Fairness Act of 1996

    The Small Business Regulatory Enforcement Fairness Act of 1996 
(Public Law 104-121) defines a major rule for the purpose of 
congressional review as having caused or being likely to cause one or 
more of the following: An annual effect on the economy of $100 million 
or more; a major increase in costs or prices; significant adverse 
effects on competition, employment, productivity, or innovation; or 
significant adverse effects on the ability of United States-based 
enterprises to compete with foreign-based enterprises in domestic or 
export markets. In accordance with the Small Business Regulatory 
Enforcement Fairness Act, the Office of Management and Budget (OMB) has 
determined that this proposed rule is a major rule for the purpose of 
congressional review.

D. Unfunded Mandates Reform Act of 1995

    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 proposing ``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 (2013) Implicit 
Price Deflator for the Gross Domestic Product. FDA expects that the 
proposed rule will result in a 1-year expenditure that would exceed 
this amount.

XVIII. Paperwork Reduction Act of 1995

    This proposed rule contains information collection provisions that 
are subject to review by OMB under the Paperwork Reduction Act of 1995 
(44 U.S.C. 3501-3520). The collections of information in the proposed 
rule have been submitted to OMB for review under Section 3507(d) of the 
Paperwork Reduction Act of 1995. FDA invites comments on: (1) Whether 
the proposed collection of information is necessary for the proper 
performance of FDA's functions, including whether the information will 
have practical utility; (2) the accuracy of FDA's estimate of the 
burden of the proposed collection of information, including the 
validity of the methodology and assumptions used; (3) ways to enhance 
the quality, utility, and clarity of the information to be collected; 
and (4) ways to minimize the burden of the collection of information on 
respondents, including through the use of automated collection 
techniques, when appropriate, and other forms of information 
technology.
    Title: Current Good Manufacturing Practice and Hazard Analysis and 
Risk-Based Preventive Controls for Human Food Proposed Rule and 
Amendments to Proposed Rule
    Description: FDA is proposing to amend its proposed regulation for 
Current Good Manufacturing Practice In Manufacturing, Packing, Or 
Holding Human Food (CGMPs) to add requirements for domestic and foreign 
facilities that are required to register under section 415 of the FD&C 
Act. The amendments include potential provisions that would require 
facilities to establish and implement, as necessary, the following 
verification activities: product testing, environmental monitoring, and 
a supplier program. In addition, FDA is amending its proposed rule to 
require that the hazard analysis and risk-based preventive controls for 
human food take into account the possibility of economically motivated 
adulteration of food.
    Description of Respondents: Section 418 of the FD&C Act is 
applicable to the owner, operator or agent in charge of a food facility 
required to register under section 415 of the FD&C Act. Generally, a 
facility is required to register if it

[[Page 58560]]

manufactures, processes, packs, or holds food for consumption in the 
United States. There are 97,646 such facilities; 74,900 of which are 
considered ``qualified'' facilities under a very small business 
definition with a $1 million threshold and thus have reduced 
requirements in regards to this rule-making.
    The information collection estimate for the preventive controls for 
human food proposed rule may increase if the potential requirements 
(the addition of provisions for product testing, environmental 
monitoring, a supplier program, and identifying any potential hazards 
caused because of economically motivated adulteration) are finalized. 
The information collection burden was previously estimated to be 
3,686,897 hours; the revised estimate includes an additional 74,692 
hours should the newly proposed provisions be finalized. To see the 
calculations for these additional burden hours, see Table 9. For more 
information on the original calculation of the information burden 
estimate please refer to the proposed rule PRA (See Ref. 194 in Docket 
FDA-2011-N-0920).
Information Collection Burden Estimate
Supplemental Notice of Proposed Rulemaking Burden
    FDA estimates the burden for this information collection as 
follows:
Recordkeeping Burden
    Should the potential provisions in this proposed rule be included 
in any final rule, we estimate 1,867 facilities subject to subpart C--
Hazard Analysis and Risk-Based Preventive Controls will choose to 
include environmental monitoring procedures as a verification activity 
under Sec.  117.165(a)(3). These facilities would need to write-up such 
procedures; a one-time burden of 16 hours (5.33 hours annualized). We 
also estimate that 319 food manufacturers would choose to make use of 
product testing as a verification activity under Sec.  117.165(a)(2). 
These facilities would create written procedures for such testing. This 
is a one-time potential burden of 16 hours (5.33 hours annualized). 
These potential burdens are shown in Table 9 rows 1 and 2.
    Should the potential supplier program discussed above be finalized 
a receiving facility would establish and implement a risk-based 
supplier program for those raw materials and ingredients for which the 
receiving facility has identified a hazard that needs to be addressed 
in the food safety plan; this includes whenever the receiving facility 
determines that a hazard that needs to be addressed in the food safety 
plan is controlled before receipt of the raw material or ingredient. We 
estimate that should this potential provision be included, about 2,417 
receiving facilities would incur a one-time burden of 16 hours (5.33 
hours annualized) to write up such a program. This potential burden is 
shown in Table 9 row 3.
    Should product testing, environmental monitoring, and supplier 
programs be finalized, records would need to be reviewed and 
maintained. We estimate that there are 689 facilities that would review 
and keep such records as a result. These records would require on 
average about 30 minutes a month to review and file. There are 
operating and maintenance costs associated with the creation of these 
records in the form of product testing costs ($6,400,000 annually) and 
environmental monitoring sampling costs ($7,200,000 annually) and 
audits and ingredient testing costs of/for suppliers ($7,000,000 audits 
annually + $1,000,000 testing annually). This potential burden is shown 
in Table 9 row 4.
    Under Sec.  117.130(b)(2)(iii) the supplemental notice of proposed 
rulemaking adds a new element to the required hazard analysis to be 
performed by each facility. Facilities must now also consider hazards 
that may be intentionally introduced for purposes of economic gain. We 
estimate that this added requirement will increase the one-time needed 
to write up the hazard analysis by 1 to 5 hours (average 3 hours; 1 
hour annualized burden over 3 years) depending on facility size and 
number of processes for 16,000 facilities. The operating and 
maintenance costs associated with conducting the initial hazard 
analysis to assess the possibility of EMA are $5,100,000. These 
estimates are shown in Table 9 row 5.
    We estimate on an annual basis that all 16,000 facilities will 
spend 0.1 hours per year updating the EMA section of their hazard 
analyses and that this recurring burden has an associated operating and 
maintenance cost of $1,300,000. This burden is shown in Table 9 row 6.
    Some receiving facilities will have supplying facilities that meet 
the definition of ``qualified'' facilities; these facilities are not 
required to comply with subpart C of the proposed rule. In addition, in 
some cases the supplier may be a farm not subject to the requirements 
in part 112 regarding the raw material or ingredient that the receiving 
facility receives from the farm. Under proposed Sec.  117.136(c)(3) and 
Sec.  117.136(c)(4) these qualified facilities and exempt farms will 
need to create written assurances (to be given to their receiving 
facility customers) to describe the processes and procedures that the 
supplier is following to ensure the safety of the food. We estimate 
that there are 14,212 facility suppliers and farms that would need to 
create these documents. We estimate that it will take 2 hours annually 
to prepare such documentation. This burden is shown in Table 9, row 7.

                                                Table 9--Estimated Potential Annual Recordkeeping Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                     Average burden
                                                  Number of         Number of       Total annual           per                           Total operating
         21 CFR Part 117, subpart C             recordkeepers      records per         records        recordkeeping      Total hours     and maintenance
                                                                  recordkeeper                         (in hours)                             costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Potential product testing written procedures               319                 1               319              5.33             1,700  ................
 (potential Sec.   117.165(a)(2))...........
Potential environmental monitoring written               1,867                 1             1,867              5.33             9,951  ................
 procedures (potential Sec.   117.165(a)(3))
Potential supplier program written                       2,417                 1             2,417              5.33            12,883  ................
 (potential Sec.   117.136(a)(2))...........

[[Page 58561]]

 
Sec.   117.136(a)(3); Sec.   117.165(a)(4)                 689                12             8,268               0.5             4,134       $21,600,000
 verification records.......................
Sec.   117.130(b)(2)(iii) written HA for EMA            16,000                 1            16,000                 1            16,000        $5,100,000
Sec.   117.130(b)(2)(iii) updating written              16,000                 1            16,000               0.1             1,600        $1,300,000
 HA for EMA.................................
Sec.   117.136(c)(3); Sec.   117.136(c)(4)              14,212                 1            14,212                 2            28,424  ................
 qualified or exempt suppliers assurances...
                                             -----------------------------------------------------------------------------------------------------------
    Total annual burden hours and costs.....  ................  ................  ................  ................            74,692       $28,000,000
--------------------------------------------------------------------------------------------------------------------------------------------------------

Reporting Burden
    There is no additional reporting burden under this supplemental 
notice of proposed rulemaking.
Third Party Disclosure Burden
    There is no additional third party disclosure burden under this 
supplemental notice of proposed rulemaking.
    To ensure that comments on information collection are received, OMB 
recommends that written comments be faxed to the Office of Information 
and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, 
or emailed to oirasubmission@omb.eop.gov. All comments should 
be identified with the title ``Current Good Manufacturing Practice And 
Hazard Analysis And Risk-Based Preventive Controls For Human Food.''
    In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 
3407(d)), the Agency has submitted the information collection 
provisions of this proposed rule to OMB for review. These requirements 
will not be effective until FDA obtains OMB approval. FDA will publish 
a notice concerning OMB approval of these requirements in the Federal 
Register.

XIX. 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. 35) (Ref. 36). Therefore, neither 
an environmental assessment nor an environmental impact statement is 
required.

XX. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

XXI. 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. 
These references are also available electronically at http://www.regulatons.gov. We have verified the Web site addresses, but we are 
not responsible for any subsequent changes to Web sites after this 
document publishes in the Federal Register.

1. FDA, ``Transcript: FSMA Proposed Rules On Produce Safety And 
Preventive Controls For Human Food Facilities. Public Meeting, Day 
One. February 28, 2013.'' Available at http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm336329.htm and in Docket No. FDA-2011-N-
0920.
2. FDA, ``Transcript: FSMA Proposed Rules On Produce Safety And 
Preventive Controls For Human Food Facilities. Public Meeting, Day 
Two. March 1, 2013.'' Available at http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm336329.htm and in Docket No. FDA-2011-N-
0920.
3. FDA, ``Transcript: FSMA Proposed Rules On Produce Safety And 
Preventive Controls For Human Food Facilities. Public Meeting, Day 
One. March 11, 2013.'' Available at http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm339097.htm and in Docket No. FDA-2011-N-
0920.
4. FDA, ``Transcript: FSMA Proposed Rules On Produce Safety And 
Preventive Controls For Human Food Facilities. Public Meeting, Day 
Two. March 12, 2013.'' Available at http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm339097.htm and in Docket No. FDA-2011-N-
0920.
5. FDA, ``Transcript: FSMA Proposed Rules On Produce Safety And 
Preventive Controls For Human Food Facilities. Public Meeting, Day 
One. March 27, 2013. Available at http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm339096.htm and in Docket No. FDA-2011-N-
0920.
6. FDA, ``Transcript: FSMA Proposed Rules On Produce Safety And 
Preventive Controls For Human Food Facilities. Public Meeting, Day 
Two. March 28, 2013. Available at http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm339096.htm and in Docket No. FDA-2011-N-
0920.
7. FDA, ``Record of Outreach Sessions on FDA Proposed Rules,'' 2013. 
Available in Docket No. FDA-2011-N-0920.
8. Taylor, M., ``Statement From FDA Deputy Commissioner for Foods 
and Veterinary Medicine, Michael Taylor, on Key Provisions of the 
Proposed FSMA Rules Affecting Farmers,'' December 19, 2013. 
Available at http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm379397.htm. Accessed and printed on January 29, 2014.
9. Taylor, M., ``Your Input Is Bringing Change to Food Safety 
Rules,'' December 19, 2013. Available at http://blogs.fda.gov/fdavoice/index.php/2013/12/your-input-is-bringing-change-to-food-safety-rules. Accessed and printed on January 29, 2014.
10. FDA, ``Guidance for Industry: Questions and Answers Regarding 
Food Facility Registration (Fifth Edition),'' 2012.
11. FDA, ``Guidance for Industry: What You Need to Know About 
Registration of Food Facilities; Small Entity Compliance Guide,'' 
2012.
12. FDA, ``Guidance for Industry: Questions and Answers Regarding 
Establishment and Maintenance of Records By Persons Who Manufacture, 
Process, Pack, Transport,

[[Page 58562]]

Distribute, Receive, Hold, or Import Food (Edition 5),'' 2012.
13. FDA, ``What You Need to Know About Establishment and Maintenance 
of Records,'' 2014.
14. FDA, ``Guidance for Industry: Antimicrobial Food Additives,'' 
1999.
15. Cooperative Extension Service, Division of Agricultural Sciences 
and Natural Resources, Oklahoma State University; USDA, Federal 
Grain Inspection Service; USDA, Extension Service; USDA, Animal and 
Plant Health Inspection Service, ``Stored Product Management,'' 
Circular No. E-912, January 1995. Available at http://entomology.k-
state.edu/doc/extension--crop-pests/
E912AllStoredProductMay3.pdf. 
Accessed and printed on August 14, 2014.
16. FDA, ``Draft Qualitative Risk Assessment. Risk of Activity/Food 
Combinations for Activities (Outside the Farm Definition) Conducted 
in a Facility Co-Located on a Farm,'' 2012.
17. 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.
18. FDA Memorandum, ``Product Testing,'' 2014.
19. Codex Alimentarius Commission, ``Hazard Analysis And Critical 
Control Point (HACCP) System And Guidelines For Its Application. 
Annex to CAC/RCP 1-1969 (Rev. 4-2003),'' 2003.
20. Codex Alimentarius Commission, ``General Principles of Food 
Hygiene, CAC/RCP 1-1969 (Rev. 4-2003),'' 2003.
21. Codex Alimentarius Commission, ``Guidelines on the Application 
of General Principles of Food Hygiene to the Control of Listeria 
monocytogenes in Ready-to-Eat Foods, CAC/GL 61--2007,'' 2007.
22. Codex Alimentarius Commission, ``Code of Hygienic Practice for 
Powdered Formulae for Infants and Young Children, CAC/RCP 66-2008,'' 
2008.
23. FDA Memorandum, ``Environmental Monitoring,'' 2014.
24. FDA Memorandum, ``Supplier Program,'' 2014.
25. U.S. Pharmacopeial Convention, ``U.S. Pharmacopeial Convention 
(USP) Food Fraud Database,'' March 6, 2014. Available at http://www.usp.org/food-ingredients/food-fraud-database. Accessed and 
printed on February 20, 2014.
26. FDA, ``FSMA Supplemental Notice of Proposed Rulemaking for 
Current Good Manufacturing Practice and Hazard Analysis and Risk-
Based Preventive Controls for Human Food. Preliminary Regulatory 
Impact Analysis,'' 2014.
27. FDA, ``Supporting Document for Recommended Maximum Level for 
Lead in Candy Likely to Be Consumed Frequently by Small Children,'' 
November, 2006.
28. FDA, ``Best Value, Inc., Recalls PRAN Bran[d] Turmeric Powder 
Due to Elevated Levels of Lead,'' October 16, 2013. Available at 
http://www.fda.gov/safety/recalls/ucm371042.htm. Accessed and 
printed on February 25, 2014.
29. LEAD Action News, ``Adulteration of Paprika in Hungary,'' 1995. 
Available at http://www.lead.org.au/lanv3n3/lanv3n3-6.html. Accessed 
and printed on February 20, 2014.
30. International Agency for Research on Cancer, ``Agents Classified 
by the IARC Monographs, Volumes 1-109,'' January 14, 2014. Available 
at http://monographs.iarc.fr/ENG/Classification/ClassificationsAlphaOrder.pdf. Accessed and printed on August 13, 
2014.
31. U.K. Food Standards Agency, ``Sudan I Timeline,'' February 24, 
2005. http://webarchive.nationalarchives.gov.uk/20111206002505/http://www.food.gov.uk/safereating/chemsafe/sudani/sudanitimeline. 
Accessed and printed on February 25, 2014.
32. Congressional Research Service, ``Food Fraud and ``Economically 
Motivated Adulteration'' of Food and Food Ingredients,'' January 10, 
2014. Available at http://www.fas.org/sgp/crs/misc/R43358.pdf. 
Accessed and printed on March 6, 2014.
33. Everstine, K., J. Spink, and S. Kennedy, ``Economically 
Motivated Adulteration (EMA) of Food: Common Characteristics of EMA 
Incidents,'' Journal of Food Protection, 76:723-735, 2013.
34. Muth, M.K., C. Zhen, M. Coglaiti, S. Karns, and C. Viator, 
``Food Processing Sector Study, Contract HHSF 22320101745G, Task 
Order 13, Final Report,'' 2011.
35. FDA Memorandum, ``Re-proposal of select provisions of the 
Proposed Rule: Current Good Manufacturing Practice and Hazard 
Analysis and Risk-Based Preventive Controls for Human Food,'' 2014.
36. FDA Memorandum, ``Modernization of food current Good 
Manufacturing Practices (cGMP) as required by the Food Safety 
Modernization Act of 2011,'' 2011.

List of Subjects

21 CFR Part 1

    Cosmetics, Drugs, Exports, Food labeling, Imports, Labeling, 
Reporting and recordkeeping requirements.

21 CFR Part 16

    Administrative practice and procedure.

21 CFR Part 117

    Food packaging, Foods.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, it is 
proposed that 21 CFR chapter I, as proposed to be amended on January 
16, 2013 (78 FR 3646), be further amended as follows:

PART 1--GENERAL ENFORCEMENT REGULATIONS

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

    Authority: 15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C. 
1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 343, 350c, 
350d, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 362, 371, 374, 
381, 382, 387, 387a, 387c, 393; 42 U.S.C. 216, 241, 243, 262, 264.

0
2. Section 1.227 is amended by revising the definitions for ``Farm'', 
``Harvesting'', ``Holding'', and ``Packing'' to read as follows:


Sec.  1.227  What definitions apply to this subpart?

* * * * *
    Farm means an establishment under one ownership in one general 
physical location devoted to the growing and harvesting of crops, the 
raising of animals (including seafood), or both. The term ``farm'' 
includes establishments that, in addition to these activities:
    (1) Pack or hold raw agricultural commodities;
(2) Pack or hold processed food, provided that all processed food used 
in such activities is either consumed on that farm or another farm 
under the same ownership, or is processed food identified in paragraph 
(3)(ii)(A) of this definition; and
    (3) Manufacture/process food, provided that:
    (i) All food used in such activities is consumed on that farm or 
another farm under the same ownership; or
    (ii) Any manufacturing/processing of food that is not consumed on 
that farm or another farm under the same ownership consists only of:
    (A) Drying/dehydrating raw agricultural commodities to create a 
distinct commodity, and packaging and labeling such commodities, 
without additional manufacturing/processing; and
    (B) Packaging and labeling raw agricultural commodities, when these 
activities do not involve additional manufacturing/processing.
* * * * *
    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 food. Harvesting is 
limited to activities performed on raw agricultural commodities on a 
farm. Harvesting does not include activities that transform a raw 
agricultural commodity, as defined in section 201(r) of the Federal 
Food, Drug, and Cosmetic Act, into a processed food as defined in 
section 201(gg) of the Federal Food, Drug, and Cosmetic Act. Gathering, 
field coring, washing, trimming of outer leaves of, removing stems and 
husks from, sifting, filtering, threshing, shelling, and

[[Page 58563]]

cooling raw agricultural commodities grown on a farm are examples of 
harvesting.
    Holding means storage of food and also includes 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 raw agricultural commodity and breaking down 
pallets)), but does not include activities that transform a raw 
agricultural commodity, as defined in section 201(r) of the Federal 
Food, Drug, and Cosmetic Act, 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.
* * * * *
    Packing means placing food into a container other than packaging 
the food and also includes 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 does not include 
activities that transform a raw agricultural commodity, as defined in 
section 201(r) of the Federal Food, Drug, and Cosmetic Act, into a 
processed food as defined in section 201(gg) of the Federal Food, Drug, 
and Cosmetic Act.
* * * * *
0
3. Section 1.328 is amended by revising the definitions for ``Farm'', 
``Harvesting'', ``Holding'', and ``Packing'' to read as follows:


Sec.  1.328  What definitions apply to this subpart?

* * * * *
    Farm means an establishment under one ownership in one general 
physical location devoted to the growing and harvesting of crops, the 
raising of animals (including seafood), or both. The term ``farm'' 
includes establishments that, in addition to these activities:
    (1) Pack or hold raw agricultural commodities;
    (2) Pack or hold processed food, provided that all processed food 
used in such activities is either consumed on that farm or another farm 
under the same ownership, or is processed food identified in paragraph 
(3)(ii)(A) of this definition; and
    (3) Manufacture/process food, provided that:
    (i) All food used in such activities is consumed on that farm or 
another farm under the same ownership; or
    (ii) Any manufacturing/processing of food that is not consumed on 
that farm or another farm under the same ownership consists only of:
    (A) Drying/dehydrating raw agricultural commodities to create a 
distinct commodity, and packaging and labeling such commodities, 
without additional manufacturing/processing; and
    (B) Packaging and labeling raw agricultural commodities, when these 
activities do not involve additional manufacturing/processing.
* * * * *
    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 food. Harvesting is 
limited to activities performed on raw agricultural commodities on a 
farm. Harvesting does not include activities that transform a raw 
agricultural commodity, as defined in section 201(r) of the Federal 
Food, Drug, and Cosmetic Act, into a processed food as defined in 
section 201(gg) of the Federal Food, Drug, and Cosmetic Act. Gathering, 
field coring, washing, trimming of outer leaves of, removing stems and 
husks from, sifting, filtering, threshing, shelling, and cooling raw 
agricultural commodities grown on a farm are examples of harvesting.
    Holding means storage of food and also includes 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 raw agricultural commodity and breaking down 
pallets)), but does not include activities that transform a raw 
agricultural commodity, as defined in section 201(r) of the Federal 
Food, Drug, and Cosmetic Act, 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.
* * * * *
    Packing means placing food into a container other than packaging 
the food and also includes 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 does not include 
activities that transform a raw agricultural commodity, as defined in 
section 201(r) of the Federal Food, Drug, and Cosmetic Act, into a 
processed food as defined in section 201(gg) of the Federal Food, Drug, 
and Cosmetic Act.
* * * * *

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

0
4. 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
5. Section 16.1 is amended by revising the entry for ``Sec. Sec.  
117.251 through 117.284'' in paragraph (b)(2) to read as follows:


Sec.  16.1  Scope.

* * * * *
    (b) * * *
    (2) * * *
    Sec. Sec.  117.251 through 117.287 (part 117, subpart E), relating 
to withdrawal of an exemption applicable to a qualified facility.
* * * * *

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

0
6. The authority citation for part 117, as proposed to be added on 
January 16, 2013 (78 FR 3646), continues to read as follows:

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

Subpart A--General Provisions


Sec.  117.3  [Amended]

0
7. Section 117.3 is amended as follows:
0
a. By removing the definitions for ``cross-contact'', ``hazard 
reasonably likely to occur'', and ``reasonably foreseeable hazard'';
0
b. By adding definitions for ``allergen-cross contact'', ``known or 
reasonably foreseeable hazard'', ``pathogen'', ``qualified auditor'', 
``receiving facility'', ``significant hazard'', ``supplier'', and ``you 
``; and
0
c. By revising the definitions for ``environmental pathogen'', 
``harvesting'', ``hazard,'' ``holding'', ``packing'', and ``very small 
business''.
    The additions and revisions read as follows:


Sec.  117.3  Definitions.

* * * * *

[[Page 58564]]

    Allergen cross-contact means the unintentional incorporation of a 
food allergen into a food.
* * * * *
    Environmental pathogen means a pathogen capable of surviving and 
persisting within the manufacturing, processing, packing, or holding 
environment such that food may be contaminated and may result in 
foodborne illness if that food is consumed without treatment to 
significantly minimize the environmental pathogen. Environmental 
pathogen does not include the spores of pathogenic sporeformers.
* * * * *
    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 food. Harvesting is 
limited to activities performed on raw agricultural commodities on a 
farm. Harvesting does not include activities that transform a raw 
agricultural commodity, as defined in section 201(r) of the Federal 
Food, Drug, and Cosmetic Act, into a processed food as defined in 
section 201(gg) of the Federal Food, Drug, and Cosmetic Act. Gathering, 
field coring, washing, trimming of outer leaves of, removing stems and 
husks from, sifting, filtering, threshing, shelling, and cooling raw 
agricultural commodities grown on a farm are examples of harvesting.
    Hazard means any biological, chemical (including radiological), or 
physical agent that is reasonably likely to cause illness or injury in 
the absence of its control.
    Holding means storage of food and also includes 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 raw agricultural commodity and breaking down 
pallets)), but does not include activities that transform a raw 
agricultural commodity, as defined in section 201(r) of the Federal 
Food, Drug, and Cosmetic Act, 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 has the potential to 
be associated with the facility or the food.
* * * * *
    Packing means placing food into a container other than packaging 
the food and also includes 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 does not include 
activities that transform a raw agricultural commodity, as defined in 
section 201(r) of the Federal Food, Drug, and Cosmetic Act, into a 
processed food as defined in section 201(gg) of the Federal Food, Drug, 
and Cosmetic Act.
    Pathogen means a microorganism of public health significance.
* * * * *
    Qualified auditor means a person who is a 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.  117.180(c)(2).
* * * * *
    Receiving facility means 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.
* * * * *
    Significant hazard means a known or reasonably foreseeable hazard 
for which a person knowledgeable about the safe manufacturing, 
processing, packing, or holding of food would, based on the outcome of 
a hazard analysis, establish controls to significantly minimize or 
prevent the hazard in a food and components to manage those controls 
(such as monitoring, corrections or corrective actions, verification, 
and records) as appropriate to the food, the facility, and the control.
* * * * *
    Supplier means 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.
* * * * *
    Very small business means, for purposes of this part, a business 
that has less than $1,000,000 in total annual sales of human food, 
adjusted for inflation.
* * * * *
    You means, for purposes of this part, the owner, operator, or agent 
in charge of a facility.
0
8. Amend Sec.  117.5 by revising paragraph (k) to read as follows:


Sec.  117.5  Exemptions.

* * * * *
    (k)(1) Except as provided by paragraph (k)(2) of this section, 
subpart B of this part does not apply to any of the following:
    (i) ``Farms'' (as defined in Sec.  1.227 of this chapter);
    (ii) Fishing vessels that are not subject to the registration 
requirements of part 1, subpart H of this part in accordance with Sec.  
1.226(f);
    (iii) The holding or transportation of one or more ``raw 
agricultural commodities,'' as defined in section 201(r) of the Federal 
Food, Drug, and Cosmetic Act;
    (iv) Activities of ``farm mixed-type facilities'' (as defined in 
Sec.  1.227) that fall within the definition of ``farm''; or
    (v) Hulling, shelling, and drying nuts (without manufacturing/
processing, such as roasting nuts).
    (2) If a ``farm'' or ``farm mixed-type facility'' dries/dehydrates 
raw agricultural commodities to create a distinct commodity, subpart B 
of this part applies to the packaging, packing, and holding of the 
dried commodities. Compliance with this requirement may be achieved by 
complying with subpart B or with the applicable requirements for 
packing and holding in part 112 of this chapter.
0
9. Revise subpart C to read as follows:

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

Sec.
117.126 Food safety plan.
117.130 Hazard analysis.
117.135 Preventive controls.
117.136 Supplier program.
117.137 Recall plan.
117.140 Preventive control management components.
117.145 Monitoring.
117.150 Corrective actions and corrections.
117.155 Verification.
117.160 Validation.
117.165 Verification of implementation and effectiveness.
117.170 Reanalysis.
117.180 Requirements applicable to a qualified individual and a 
qualified auditor.
117.190 Implementation records.


Sec.  117.126  Food safety plan.

    (a) Requirement for a food safety plan. (1) You must prepare, or 
have prepared, and implement a written food safety plan.
    (2) The food safety plan must be prepared, or its preparation 
overseen, by one or more qualified individuals.
    (b) Contents of a food safety plan. The written food safety plan 
must include:

[[Page 58565]]

    (1) The written hazard analysis as required by Sec.  117.130(a)(2);
    (2) The written preventive controls as required by Sec.  
117.135(b);
    (3) The written supplier program as required by Sec.  
117.136(a)(2);
    (4) The written recall plan as required by Sec.  117.137(a); and
    (5) The written procedures for monitoring the implementation of the 
preventive controls as required by Sec.  117.145(a)(1);
    (6) The written corrective action procedures as required by Sec.  
117.150(a)(1); and
    (7) The written verification procedures as required by Sec.  
117.165(b).
    (c) Records. The food safety plan required by this section is a 
record that is subject to the requirements of subpart F of this part.


Sec.  117.130  Hazard analysis.

    (a) Requirement for a hazard analysis. (1) You must identify and 
evaluate, based on experience, illness data, scientific reports, and 
other information, known or reasonably foreseeable hazards for each 
type of food manufactured, processed, packed, or held at your facility 
to determine whether there are significant hazards.
    (2) The hazard analysis must be written.
    (b) Hazard identification. The hazard identification must consider:
    (1) 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 food allergens; and
    (iii) Physical hazards; and
    (2) Hazards that may be present in the 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) Hazard evaluation. (1)(i) 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.
    (ii) The hazard evaluation required by paragraph (c)(1)(i) of this 
section must include an evaluation of environmental pathogens whenever 
a ready-to-eat food is exposed to the environment prior to packaging 
and the packaged food does not receive a treatment that would 
significantly minimize the pathogen.
    (2) The hazard evaluation must consider the effect of the following 
on the safety of the finished food for the intended consumer:
    (i) The formulation of the food;
    (ii) The condition, function, and design of the facility and 
equipment;
    (iii) Raw materials and ingredients;
    (iv) Transportation practices;
    (v) Manufacturing/processing procedures;
    (vi) Packaging activities and labeling activities;
    (vii) Storage and distribution;
    (viii) Intended or reasonably foreseeable use;
    (ix) Sanitation, including employee hygiene; and
    (x) Any other relevant factors.


Sec.  117.135  Preventive controls.

    (a)(1) You must identify and implement preventive controls to 
provide assurances that significant hazards will be significantly 
minimized or prevented and the food manufactured, processed, packed, or 
held by your facility will not be adulterated under section 402 of the 
Federal Food, Drug, and Cosmetic Act or misbranded under section 403(w) 
of the Federal Food, Drug, and Cosmetic Act.
    (2) Preventive controls required by paragraph (a)(1) of this 
section include, as appropriate to the facility and the food:
    (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 food safety.
    (b) Preventive controls must be written.
    (c) Preventive controls include, as appropriate to the facility and 
the food:
    (1) Process controls. Process controls include procedures, 
practices, and processes to ensure the control of parameters during 
operations such as heat processing, acidifying, irradiating, and 
refrigerating foods. Process controls must include, as appropriate to 
the applicable control:
    (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 significant hazard.
    (2) Food allergen controls. Food allergen controls include 
procedures, practices, and processes to control food allergens. Food 
allergen controls must include those procedures, practices, and 
processes employed for:
    (i) Ensuring protection of food from allergen cross-contact, 
including during storage and use; and
    (ii) Labeling the finished food, including ensuring that the 
finished food is not misbranded under section 403(w) of the Federal 
Food, Drug, and Cosmetic Act.
    (3) 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, biological hazards due to 
employee handling, and food allergen hazards. Sanitation controls must 
include, as appropriate to the facility and the food, procedures, 
practices, and processes for the:
    (i) Cleanliness of food-contact surfaces, including food-contact 
surfaces of utensils and equipment;
    (ii) Prevention of allergen cross-contact and cross-contamination 
from insanitary objects and from personnel to food, food packaging 
material, and other food-contact surfaces and from raw product to 
processed product.
    (4) Supplier controls. Supplier controls include the supplier 
program as required by Sec.  117.136.
    (5) Recall plan. Recall plan as required by Sec.  117.137.
    (6) Other controls. 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.


Sec.  117.136  Supplier program.

    (a) Supplier program. (1)(i) Except as provided in paragraph 
(a)(1)(ii) of this section, 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.
    (ii) The receiving facility is not required to establish and 
implement a supplier program for raw materials and ingredients for 
which:
    (A) There are no significant hazards;
    (B) The preventive controls at the receiving facility are adequate 
to significantly minimize or prevent each of the significant hazards; 
or
    (C) 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

[[Page 58566]]

will significantly minimize or prevent the hazard.
    (2) The supplier program must be written.
    (3) The supplier program must include:
    (i) 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); and
    (ii) Verification activities and documentation of these activities, 
as required by paragraph (b) of this section, to verify that:
    (A) The hazard is significantly minimized or prevented;
    (B) The incoming raw material or ingredient is not adulterated 
under section 402 of the Federal Food, Drug, and Cosmetic Act or 
misbranded under section 403(w) of the Federal Food, Drug, and Cosmetic 
Act: and
    (C) The incoming raw material or ingredient is produced in 
compliance with the requirements of applicable FDA food safety 
regulations.
    (4) When supplier verification activities are required under 
paragraph (c) of this section 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.
    (5) For some hazards, in some situations under paragraph (b) 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.
    (b) Determination and documentation of the appropriate verification 
activities. 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 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. Examples of 
factors that a receiving facility may determine are appropriate and 
necessary are storage and transportation practices.
    (c) Supplier verification activities for raw materials and 
ingredients. (1) Except as provided in paragraph (c)(2) or (3) of this 
section, the receiving facility must conduct and document one or more 
of the following supplier verification activities as determined by the 
receiving facility under paragraph (b) of this section, for each 
supplier before using the raw material or ingredient and periodically 
thereafter:
    (i) Onsite audits;
    (ii) Sampling and testing of the raw material or ingredient, which 
may be conducted by either the supplier or receiving facility.
    (iii) Review by the receiving facility of the supplier's relevant 
food safety records; or
    (iv) Other appropriate supplier verification activities based on 
the risk associated with the ingredient and the supplier.
    (2)(i) Except as provided by paragraph (c)(2)(ii) of this section, 
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, 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.
    (ii) The requirements of paragraph (c)(2)(i) of this section do 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.
    (3) If a supplier is a qualified facility as defined by Sec.  
117.3, the receiving facility need not comply with paragraphs (c)(1) 
and (2) of this section if the receiving facility:
    (i) Documents, at the end of each calendar year, that the supplier 
is a qualified facility as defined by Sec.  117.3; and
    (ii) 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 Federal Food, 
Drug, and Cosmetic Act or misbranded under section 403(w) of the 
Federal Food, Drug, and Cosmetic 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 food.
    (4) If a supplier is a farm that is not subject to the requirements 
established in part 112 of this chapter in accordance with 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 paragraphs (c)(1) and (2) of this section if the receiving 
facility:
    (i) Documents, at the end of each calendar year, that the raw 
material or ingredient provided by the supplier is not subject to part 
112 of this chapter; and
    (ii) 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 Federal Food, 
Drug, and Cosmetic Act.
    (d) Onsite audit. (1) An onsite audit of a supplier must be 
performed by a qualified auditor.
    (2) If the raw material or 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., HACCP plan or other food safety plan), if any, including its 
implementation, for the hazard being audited.
    (e) Substitution of inspection by FDA or an officially recognized 
or equivalent food safety authority. (1) 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.
    (2) For inspections conducted by the food safety authority of a 
country whose

[[Page 58567]]

food safety system FDA has officially recognized as comparable or 
determined to be equivalent, the 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.
    (f) Supplier non-conformance. 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.  
117.150 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 Federal Food, Drug, 
and Cosmetic Act or misbranded under section 403(w) of the Federal 
Food, Drug, and Cosmetic Act.
    (g) Records. The receiving facility must document the following in 
records and review such records in accordance with Sec.  117.165(a)(4).
    (1) The written supplier program;
    (2) Documentation of the appropriate verification activities;
    (3) The annual written assurance that a receiving facility's 
customer who is controlling a significant hazard has established and is 
following procedures (identified in the written assurance) that will 
significantly minimize or prevent the hazard;
    (4) Documentation demonstrating that products are received only 
from approved suppliers;
    (5) Documentation of an onsite audit. This documentation must 
include:
    (i) Documentation of audit procedures;
    (ii) The dates the audit was conducted;
    (iii) The conclusions of the audit;
    (iv) Corrective actions taken in response to significant 
deficiencies identified during the audit; and
    (v) Documentation that the audit was conducted by a qualified 
auditor.
    (6) Records of sampling and testing. These records must include:
    (i) Identification of the raw material or 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;
    (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.
    (7) Records of the review by the receiving facility of the 
supplier's relevant food safety records. These records must include:
    (i) The date(s) of review;
    (ii) Corrective actions taken in response to significant 
deficiencies identified during the review; and
    (iii) Documentation that the review was conducted by a qualified 
individual.
    (8) Records of other appropriate supplier verification activities 
based on the risk associated with the ingredient.
    (9) Documentation of 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;
    (10) Documentation of an alternative verification activity for a 
supplier that is a qualified facility, including:
    (i) The documentation that the supplier is a qualified facility as 
defined by Sec.  117.3; and
    (ii) 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 Federal Food, Drug, and Cosmetic Act or 
misbranded under section 403(w) of the Federal Food, Drug, and Cosmetic 
Act.
    (11) Documentation of an alternative verification activity for a 
supplier that is a farm that supplies a raw material or ingredient that 
is not subject to part 112 of this chapter, including:
    (i) The documentation that the raw material or ingredient provided 
by the supplier is not subject to part 112 of this chapter; and
    (ii) 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 Federal Food, Drug, and Cosmetic Act.
    (12) Evidence of an inspection of the supplier by FDA or the food 
safety authority of another country.
    (13) Documentation of actions taken with respect to supplier non-
conformance.


Sec.  117.137  Recall plan.

    For food with a significant hazard:
    (a) You must establish a written recall plan for the food.
    (b) The written 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 food being 
recalled, including how to return or dispose of the affected food;
    (2) Notify the public about any hazard presented by the food when 
appropriate to protect public health;
    (3) Conduct effectiveness checks to verify that the recall is 
carried out; and
    (4) Appropriately dispose of recalled food (e.g., through 
reprocessing, reworking, diverting to a use that does not present a 
safety concern, or destroying the food).


Sec.  117.140  Preventive control management components.

    (a) Except as provided by paragraphs (b) and (c) of this section, 
the preventive controls required under Sec.  117.135 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:
    (1) Monitoring in accordance with Sec.  117.145;
    (2) Corrective actions and corrections in accordance with Sec.  
117.150; and
    (3) Verification in accordance with Sec.  117.155.
    (b) The supplier program established in Sec.  117.136 is 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 in accordance with Sec.  
117.150, taking into account the nature of any supplier non-
conformance;
    (2) Review of records in accordance with Sec.  117.165(a)(4); and
    (3) Reanalysis in accordance with Sec.  117.170.
    (c) The recall plan established in Sec.  117.137 is not subject to 
the requirements of paragraph (a) of this section.


Sec.  117.145  Monitoring.

    (a) As appropriate to the preventive control, you must:
    (1) Establish and implement written procedures, including the 
frequency with which they are to be performed, for monitoring the 
preventive controls; and
    (2) Monitor the preventive controls with adequate frequency to 
provide assurance that they are consistently performed.
    (b) All monitoring of preventive controls in accordance with this 
section

[[Page 58568]]

must be documented in records that are subject to verification in 
accordance with Sec.  117.155(a)(2) and records review in accordance 
with Sec.  117.165(a)(4)(i).


Sec.  117.150  Corrective actions and corrections.

    (a) Corrective action procedures. As appropriate to the preventive 
control, except as provided by paragraph (c) of this section:
    (1)(i) You must establish and implement written corrective action 
procedures that must be taken if preventive controls are not properly 
implemented.
    (ii) The corrective action procedures required by paragraph 
(a)(1)(i) of this section must include procedures to address, as 
appropriate:
    (A) The presence of a pathogen or appropriate indicator organism in 
a ready-to-eat product detected as a result of product testing 
conducted in accordance with Sec.  117.165(a)(2); and
    (B) The presence of an environmental pathogen or appropriate 
indicator organism detected through the environmental monitoring 
conducted in accordance with Sec.  117.165(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 food is evaluated for safety; and
    (iv) All affected food is prevented from entering into commerce, if 
you cannot ensure that the affected food is not adulterated under 
section 402 of the Federal Food, Drug, and Cosmetic Act or misbranded 
under section 403(w) of the Federal Food, Drug, and Cosmetic Act.
    (b) Corrective action in the event of an unanticipated food safety 
problem. (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 specific 
corrective action procedure has not been established;
    (ii) A preventive control is found to be ineffective; or
    (iii) A review of records in accordance with Sec.  117.165(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, 
reduce the likelihood that the problem will recur, evaluate all 
affected food for safety, and, as necessary, prevent affected food from 
entering commerce as would be done following a corrective action 
procedure under paragraphs (a)(2)(i) through (iv) of this section; and
    (ii) When appropriate, reanalyze the food safety plan in accordance 
with Sec.  117.170 to determine whether modification of the food safety 
plan is required.
    (c) Corrections applicable to food allergen controls and sanitation 
controls. You do not need to comply with the requirements of paragraphs 
(a) and (b) of this section for conditions and practices that are not 
consistent with the food allergen controls in Sec.  117.135(c)(2)(i) or 
the sanitation controls in Sec.  117.135(c)(3)(i) or (ii) if you take 
action, in a timely manner, to correct such conditions and practices.
    (d) Documentation. 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.  117.155(a)(3) and records review in accordance with Sec.  
117.165(a)(4)(i).


Sec.  117.155  Verification.

    (a) Verification activities. Verification activities must include, 
as appropriate to the preventive control:
    (1) Validation in accordance with Sec.  117.160.
    (2) Verification that monitoring is being conducted as required by 
Sec.  117.140 (and in accordance with Sec.  117.145).
    (3) Verification that appropriate decisions about corrective 
actions are being made as required by Sec.  117.140 (and in accordance 
with Sec.  117.150).
    (4) Verification of implementation and effectiveness in accordance 
with Sec.  117.165; and
    (5) Reanalysis in accordance with Sec.  117.170.
    (b) Documentation. All verification activities conducted in 
accordance with this section must be documented in records.


Sec.  117.160  Validation.

    (a) Except as provided by paragraph (b)(3) of this section, you 
must validate that the preventive controls identified and implemented 
in accordance with Sec.  117.135 to control the significant hazards are 
adequate to do so as appropriate to the nature of the preventive 
control.
    (b) The validation of the preventive controls:
    (1) Must be performed (or overseen) by a qualified individual:
    (i) Prior to implementation of the food safety plan or, when 
necessary, during the first 6 weeks of production; and
    (ii) Whenever a reanalysis of the food safety plan reveals the need 
to do so;
    (2) 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; and
    (3) Need not address:
    (i) The food allergen controls in Sec.  117.135(c)(2);
    (ii) The sanitation controls in Sec.  117.135(c)(3);
    (iii) The supplier program in Sec.  117.136; and
    (iv) The recall plan in Sec.  117.137.


Sec.  117.165  Verification of implementation and effectiveness.

    (a) Verification activities. You must verify that the preventive 
controls are consistently implemented and are effectively and 
significantly minimizing or preventing the significant hazards. To do 
so you must conduct activities that include the following, as 
appropriate to the facility, the food, and the nature of the preventive 
control:
    (1) Calibration of process monitoring instruments and verification 
instruments;
    (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 a ready-to-eat 
food with an environmental pathogen is a significant hazard, by 
collecting and testing environmental samples; and
    (4) Review of the following records within the specified 
timeframes, by (or under the oversight of) a 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:
    (i) Records of monitoring and corrective action records within a 
week after the records are created.
    (ii) Records of calibration, product testing, environmental 
monitoring, and supplier verification activities within a reasonable 
time after the records are created.
    (b) Written procedures. As appropriate to the facility, the food, 
and

[[Page 58569]]

the nature of the preventive control, you must establish and implement 
written procedures for the following activities:
    (1) The method and frequency of calibrating process monitoring 
instruments and verification instruments 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.  
117.150(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.  
117.150(a)(1).


Sec.  117.170  Reanalysis.

    (a) You must conduct a reanalysis of the food safety plan:
    (1) At least once every 3 years;
    (2) Whenever a significant change is made in the activities 
conducted at your facility if the change 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 food;
    (4) Whenever appropriate after an unanticipated food safety problem 
in accordance with Sec.  117.150(b); and
    (5) Whenever you find that a preventive control is ineffective.
    (b) You must complete the reanalysis required by paragraph (a) of 
this section 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.
    (c) 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.
    (d) A qualified individual must perform (or oversee) the 
reanalysis.
    (e) 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.  117.180  Requirements applicable to a qualified individual and a 
qualified auditor.

    (a) One or more qualified individuals must do or oversee the 
following:
    (1) Preparation of the food safety plan (Sec.  117.126(a)(2));
    (2) Validation of the preventive controls (Sec.  117.160(b)(1));
    (3) Review of records (Sec.  117.165(a)(4)); and
    (4) Reanalysis of the food safety plan (Sec.  117.170(d)).
    (b) A qualified auditor must conduct an onsite audit (Sec.  
117.136(d)).
    (c)(1) To be a 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.
    (2) To be a qualified auditor, a qualified individual must have 
technical expertise obtained by a combination of training and 
experience appropriate to perform the auditing function.
    (d) All applicable training must be documented in records, 
including the date of the training, the type of training, and the 
person(s) trained.


Sec.  117.190  Implementation records.

    (a) You must establish and maintain the following records 
documenting implementation of the food safety plan:
    (1) Records that document the monitoring of preventive controls;
    (2) Records that document corrective actions;
    (3) 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;
    (v) Product testing;
    (vi) Environmental monitoring;
    (vii) Records review; and
    (viii) Reanalysis;
    (4) Records that document the supplier program; and
    (5) Records that document applicable training for the 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.
0
10. Revise Sec.  117.251 to read as follows:


Sec.  117.251  Circumstances that may lead FDA to withdraw an exemption 
applicable to a qualified facility.

    (a) FDA may withdraw the exemption applicable to a qualified 
facility under Sec.  117.5(a):
    (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 
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 food manufactured, processed, packed, or 
held at such facility.
    (b) Before FDA issues an order to withdraw an exemption applicable 
to a qualified facility, FDA:
    (1) May consider one or more other actions to protect the public 
health or mitigate a foodborne illness outbreak, including, a warning 
letter, recall, administrative detention, suspension of registration, 
import alert, 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 10 
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.
0
11. Revise Sec.  117.254 to read as follows:

[[Page 58570]]

Sec.  117.254  Issuance of an order to withdraw an exemption applicable 
to a qualified facility.

    (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 Office of Compliance in the Center for Food Safety and 
Applied Nutrition), or an FDA official senior to 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.
0
12. Amend Sec.  117.257 by revising paragraph (d) to read as follows:


Sec.  117.257  Contents of an order to withdraw an exemption applicable 
to a qualified facility.

* * * * *
    (d) A statement that the facility must either:
    (1) Comply with subpart C of this part on the date that is 120 
calendar days after the date of receipt of the order; or
    (2) Appeal the order within 10 calendar days of the date of receipt 
of the order in accordance with the requirements of Sec.  117.264.
* * * * *
0
13. Amend Sec.  117.260 by revising paragraphs (a) and (c) to read as 
follows:


Sec.  117.260  Compliance with, or appeal of, an order to withdraw an 
exemption applicable to a qualified facility.

    (a) If you receive an order under Sec.  117.254 to withdraw an 
exemption applicable to that facility under Sec.  117.5(a), you must 
either:
    (1) Comply with applicable requirements of this part within 120 
calendar days of the date of receipt of the order; or
    (2) Appeal the order within 10 calendar days of the date of receipt 
of the order in accordance with the requirements of Sec.  117.264.
* * * * *
    (c) If you appeal the order, and FDA confirms the order, you must 
comply with applicable requirements of this part within 120 calendar 
days of the date of receipt of confirmation of the order.
0
14. Amend Sec.  117.264 by revising paragraphs (a) introductory text 
and (a)(1) to read as follows:


Sec.  117.264  Procedure for submitting an appeal.

    (a) To appeal an order to withdraw an exemption applicable to a 
qualified facility under Sec.  117.5(a), 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 Office of Compliance in the Center for 
Food Safety and Applied Nutrition), at the mailing address, email 
address, or facsimile number identified in the order within 10 calendar 
days of the date of receipt of the order;
* * * * *
0
15. Amend Sec.  117.267 by revising paragraph (a) to read as follows:


Sec.  117.267  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.  117.264 within 
10 calendar days of the date of receipt of the order.
* * * * *
0
16. Add Sec.  117.287 to subpart E to read as follows:


Sec.  117.287  Reinstatement of an 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 
Office of Compliance in the Center for Food Safety and Applied 
Nutrition) determines that a facility has adequately resolved problems 
with the conditions and conduct that are material to the safety of the 
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 Office of 
Compliance in the Center for Food Safety and Applied Nutrition) 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 of a foreign 
facility, the Director of the Office of Compliance in the Center for 
Food Safety and Applied Nutrition); and
    (2) Present data and information to demonstrate that you have 
adequately resolved the problems with the conditions or conduct that 
are material to the safety of the food manufactured, processed, packed, 
or held at your facility, such that continued withdrawal of the 
exemption is not necessary to protect public health and prevent or 
mitigate a foodborne illness outbreak.
    (c) If your exemption was withdrawn under Sec.  117.251(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.  117.5(a), 
and FDA will notify you in writing that your exempt status has been 
reinstated.
    (d) If your exemption was withdrawn under both Sec.  117.251(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.  117.5(a) in 
accordance with the requirements of paragraph (b) of this section.
0
17. Amend Sec.  117.305 by revising paragraph (b) to read as follows:


Sec.  117.305  General requirements applying to records.

* * * * *
    (b) Contain the actual values and observations obtained during 
monitoring and, as appropriate, during verification activities;
* * * * *
0
18. Add Sec.  117.330 to subpart F to read as follows:


Sec.  117.330  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 F. Existing 
records may be supplemented as necessary to include all of the required 
information and satisfy the requirements of this subpart F.
    (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.


[[Page 58571]]


    Dated: September 16, 2014.
Peter Lurie,
Associate Commissioner for Policy and Planning.

    Note: The following appendix will not appear in the Code of 
Federal Regulations.

Appendix

    The proposed rule that is the subject of this document includes 
a discussion of our reconsideration of the classification of 
specific activities as harvesting, packing, holding, or 
manufacturing/processing, when conducted on farms or on farm mixed-
type facilities (see the discussion of the proposed additional 
example of a harvesting activity in the definition of ``harvesting'' 
in section V.C and the discussion and Table 5 in section VII.C). 
Table 1 in this Appendix compares the classification of on-farm 
activities as harvesting, packing, holding, or manufacturing/
processing in the 2013 proposed preventive controls rule to our 
current thinking on the classification of these on-farm activities 
as a result of the proposed revisions to the ``farm'' definition. As 
can be seen in Table 1, several on-farm activities can be classified 
in more than one way, and most of the changes in activity 
classification merely reflect additional activities (relative to the 
2013 proposed preventive controls rule) that could be classified in 
more than one way.

             Table 1--Classification of Activities Conducted On-Farms and Farm Mixed-Type Facilities
----------------------------------------------------------------------------------------------------------------
                                                                                 Examples using the proposed
            Classification                Examples using the 2013 proposed        revisions to the ``farm''
                                               ``farm'' definition *                      definition
----------------------------------------------------------------------------------------------------------------
Harvesting: Activities traditionally     Cooling RACs.                Cooling RACs.
 performed by farms for the purpose of   Fermenting cocoa beans and   Field coring RACs ** (new
 removing RACs from growing areas and    coffee beans ** (would change to     example, not previously
 preparing them for use as food.         ``holding'').                        classified).
 Harvesting does not include             Filtering RACs.              Filtering RACs.
 activities that change a RAC into       Gathering RACs.              Gathering RACs.
 processed food.                         Removing stems and husks     Removing stems and husks
                                         from RACs.                           from RACs.
                                         Shelling RACs.               Shelling RACs.
                                         Sifting RACs.                Sifting RACs.
                                         Threshing RACs.              Threshing RACs.
                                         Trimming of outer leaves     Trimming outer leaves from
                                         from RACs.                           RACs.
                                         Using pesticides in wash     Using pesticides in wash
                                         water on RACs.                       water on RACs.
                                         Washing RACs.                Washing RACs.
Packing: Placing food in a container     Coating RACs with wax/oil/   Coating RACs with wax/oil/
 other than packaging the food and       resin for the purpose of storage     resin for the purpose of storage
 activities performed incidental to      or transport.                        or transport.
 packing a food (e.g., activities        Drying RACs for the          Cooling RACs ** (add'l
 performed for the safe or effective     purpose of storage or transport **   classification) ***.
 packing of that food (such as           (would change to only be             Filtering RACs ** (add'l
 sorting, culling and grading)), but     classified as ``holding'').          classification).
 does not include activities that        Labeling RACs.               Labeling RACs.
 transform a RAC into a processed food.  Mixing RACs.                 Mixing RACs.
                                         Packaging a farm's or farm   Packaging RACs regardless
                                         mixed-type facility's own RACs **    of ownership ** (expanded to
                                         (would no longer be limited to       include others' RACs).
                                         ``own RACs'').                       Putting RACs or individual
                                         Putting RACs or individual   unit cartons into non-consumer
                                         unit cartons into non-consumer       containers.
                                         containers.                          Removing stems and husks
                                         Sorting/grading/culling      from RACs ** (add'l
                                         RACs.                                classification).
                                         Stickering RACs.             Sifting RACS ** (add'l
                                                                              classification).
                                                                              Sorting/culling/grading
                                                                              RACs.
                                                                              Stickering RACs.
                                                                              Using pesticides in wash
                                                                              water on RACs ** (add'l
                                                                              classification).
                                                                              Washing RACs ** (add'l
                                                                              classification).
Holding: Storage of food and             Drying/dehydrating RACs      Cooling RACs ** (add'l
 activities performed incidental to      during storage (incidental to        classification).
 storage of a food (e.g., activities     packing or storing when the drying/  Drying/dehydrating RACs
 performed for the safe or effective     dehydrating does not create a        (incidental to storing when the
 storage of that food, and activities    distinct commodity) ** (would no     drying/dehydrating does not create
 performed as a practical necessity      longer be incidental to packing,     a distinct commodity).
 for the distribution of that food       would only be incidental to          Fermenting cocoa beans and
 (such as blending of the same           holding).                            coffee beans (change from previous
 commodity and breaking down             Fumigating RACs during       classification as harvesting).
 pallets)). Holding does not include     storage.                             Fumigating RACs during
 activities that change a RAC into a     Sorting/culling/grading      storage to control pests.
 processed food.                         RACs.                                Sorting/culling/grading
                                         Storing food.                RACs.
                                                                              Storing food.

[[Page 58572]]

 
Manufacturing/Processing: Making food    Artificial ripening.         Artificial ripening.
 from one or more ingredients, or        Baking.                      Baking.
 synthesizing, preparing, treating,      Boiling/Evaporating.         Boiling/Evaporating.
 modifying, or manipulating food,        Bottling.                    Bottling.
 including food crops or ingredients.    Canning.                     Canning.
 Examples of manufacturing/processing    Chopping.                    Chopping.
 activities are cutting, peeling,        Coating RACs for purposes    Coating RACs for purposes
 trimming, washing, waxing,              other than storage/transport.        other than storage/transport.
 eviscerating, rendering, cooking,       Cooking.                     Cooking.
 baking, freezing, cooling,              Cooling.                     Cooling.
 pasteurizing, homogenizing, mixing,     Coring.                      Coring (except field
 formulating, bottling, milling,         Cracking.                    coring) ** (because field coring
 grinding, extracting juice,             Crushing.                    would be newly classified as
 distilling, labeling, or packaging.     Cutting.                     harvesting).
 For farms and farm mixed-type           Distilling.                  Cracking.
 facilities, manufacturing/processing    Drying/dehydrating RACS to   Crushing.
 does not include activities that are    create a distinct commodity.         Cutting.
 part of harvesting, packing, or         Eviscerating.                Distilling.
 holding.                                Extracting.                  Drying/dehydrating RACs to
                                         Formulating.                 create a distinct commodity.
                                         Freezing.                    Eviscerating.
                                         Grinding.                    Extracting.
                                         Homogenizing.                Formulating.
                                         Infusing.                    Freezing.
                                         Irradiating.                 Grinding.
                                         Labeling (other than         Homogenizing.
                                         RACs).                               Infusing.
                                         Milling.                     Irradiating.
                                         Mixing.                      Labeling (other than
                                         Packaging (other than        RACs).
                                         RACs).                               Milling.
                                         Pasteurizing.                Mixing.
                                         Peeling.                     Packaging (other than
                                         Rendering.                   RACs).
                                         Roasting.                    Pasteurizing.
                                         Salting.                     Peeling.
                                         Slaughtering and post-       Rendering.
                                         slaughter operations.                Roasting.
                                         Slicing.                     Salting.
                                         Smoking.                     Slaughtering and post-
                                         Sorting, culling, grading    slaughter operations.
                                         (not incidental to packing or        Slicing.
                                         holding).                            Smoking.
                                         Trimming.                    Sorting, culling, grading
                                         Washing.                     (not incidental to packing or
                                         Waxing.                      holding).
                                                                              Trimming.
                                                                              Washing.
                                                                              Waxing.
----------------------------------------------------------------------------------------------------------------
* Examples were included in Table 4, Table 5, and/or Proposed Sec.  Sec.   117.3 and 117.5(g) and (h) in the
  2013 Proposed Preventive Controls Rule and/or in the Draft Risk Assessment (Ref. 1).
** Activities listed in italics represent a change between the 2013 ``farm'' definition and our current thinking
  in light of the proposed revisions to the ``farm'' definition.
*** Add'l = additional.

    The following reference has 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. 
This reference is also available electronically at http://www.regulatons.gov.
    1. FDA, ``Draft Qualitative Risk Assessment. Risk of Activity/
Food Combinations for Activities (Outside the Farm Definition) 
Conducted in a Facility Co-Located on a Farm,'' 2012.

[FR Doc. 2014-22446 Filed 9-19-14; 8:45 am]
BILLING CODE 4164-01-P


