[Federal Register Volume 84, Number 213 (Monday, November 4, 2019)]
[Proposed Rules]
[Pages 59452-59516]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23870]



[[Page 59451]]

Vol. 84

Monday,

No. 213

November 4, 2019

Part II





Department of Health and Human Services





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Food and Drug Administration





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21 CFR Parts 1, 11, 16, et al.





Laboratory Accreditation for Analyses of Foods; Proposed Rule

  Federal Register / Vol. 84 , No. 213 / Monday, November 4, 2019 / 
Proposed Rules  

[[Page 59452]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1, 11, 16, and 129

[Docket No. FDA-2019-N-3325]
RIN 0910-AH31


Laboratory Accreditation for Analyses of Foods

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
proposing to amend its regulations to establish a program for the 
testing of food in certain circumstances by accredited laboratories, as 
required under the Federal Food, Drug, and Cosmetic Act (FD&C Act). 
Establishing such a program will help FDA improve the safety of the 
U.S. food supply and protect U.S. consumers by helping ensure that 
certain food testing of importance to public health is conducted 
subject to appropriate oversight and in accordance with appropriate 
model standards, and produces reliable and valid test results.

DATES: Submit either electronic or written comments on the proposed 
rule by March 3, 2020. Submit comments on information collection issues 
under the Paperwork Reduction Act of 1995 by March 3, 2020 (see the 
``Paperwork Reduction Act of 1995'' section of this document).

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before March 3, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of March 3, 2020. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions.'')

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2019-N-3325 for Laboratory Accreditation for Analyses of Foods. 
Received comments will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at Dockets Management Staff between 9 a.m. and 
4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    Submit comments on information collection issues under the 
Paperwork Reduction Act of 1995 to the Office of Management and Budget 
(OMB) in the following ways:
     Fax to the Office of Information and Regulatory Affairs, 
OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or email to 
oira_submission@omb.eop.gov. All comments should be identified with the 
title, ``Laboratory Accreditation for Analyses of Foods.''

FOR FURTHER INFORMATION CONTACT: Timothy McGrath, Staff Director, Food 
and Feed Laboratory Operations, Office of Regulatory Affairs, Food and 
Drug Administration, 12420 Parklawn Dr., Rm. 3142, Rockville, MD 20857, 
301-796-6591, email: timothy.mcgrath@fda.hhs.gov.
    With regard to the information collection: Domini Bean, Office of 
Operations, Food and Drug Administration, Three White Flint North, 
10A63, 11601 Landsdown Street, North Bethesda, MD 20852, 301-796-5733, 
email: PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
    A. Purpose and Coverage of the Proposed Rule
    B. Summary of the Major Provisions of the Proposed Rule
    C. Legal Authority
    D. Costs and Benefits
II. Table of Abbreviations/Commonly Used Acronyms in This Document
III. Background
    A. FDA Food Safety Food Modernization Act
    B. Food Testing Under FSMA

[[Page 59453]]

    C. Import-Related Food Testing and Detention Without Physical 
Examination (DWPE) Procedures
    D. Testing of Imported Food by Private Laboratories
    E. Current Industry Practices Relating to Accreditation Bodies, 
Accreditation of Laboratories, and Food Testing
    F. U.S. Government Policies on Consensus Standards
    G. Incorporation by Reference
IV. FSMA Public Meetings, Comments Related to Other FSMA 
Rulemakings, and Stakeholder Input
V. Legal Authority
VI. Description of the Proposed Rule
    A. Proposed General Provisions (Proposed Sec. Sec.  1.1102 
Through 1.1103)
    B. Proposed Provisions About General Requirements of This Rule 
(Proposed Sec. Sec.  1.1107 Through 1.1109)
    C. Proposed Provisions About Recognition of Accreditation Bodies 
(Proposed Sec. Sec.  1.1113)
    D. Proposed Provisions About Requirements for Recognized 
Accreditation Bodies (Proposed Sec. Sec.  1.1118 Through 1.1125)
    E. Proposed Provisions About Procedures for Recognition of 
Accreditation Bodies (Proposed Sec. Sec.  1.1128 Through 1.1133)
    F. Proposed Provisions About Accreditation of Laboratories 
(Proposed Sec. Sec.  1.1138)
    G. Proposed Provisions About Requirements for Accredited 
Laboratories (Proposed Sec. Sec.  1.1146 Through 1.1153)
    H. Proposed Provisions About Procedures for Accreditation of 
Laboratories (Proposed Sec. Sec.  1.1158 Through 1.1165)
    I. Proposed Provisions About Requesting FDA Reconsideration, FDA 
Internal Review, or Regulatory Hearings of FDA Decisions Under This 
Rule (Proposed Sec. Sec.  1.1171 Through 1.1174)
    J. Proposed Provisions About Electronic Records and Public 
Disclosure Requirements Under This Rule (Proposed Sec. Sec.  1.1199 
Through 1.1200)
    K. Proposed Revisions to 21 CFR Part 1, Subpart M
    L. Proposed Revisions to 21 CFR Part 11
    M. Proposed Revisions to 21 CFR Part 16
    N. Proposed Revisions to 21 CFR Part 129
VII. Proposed Effective Date and Implementation Steps
VIII. Preliminary Economic Analysis of Impacts
    Summary of Costs and Benefits
IX. Analysis of Environmental Impact
X. Paperwork Reduction Act of 1995
XI. Federalism
XII. References

I. Executive Summary

A. Purpose and Coverage of the Proposed Rule

    This proposed rule, if finalized, would establish a new program for 
food testing by accredited laboratories. The FDA Food Safety 
Modernization Act (FSMA) (Pub. L. 111-353), section 202(a), added 
section 422 to the FD&C Act (21 U.S.C. 350k), which requires us to 
establish this program.
    You would be subject to this rule, if finalized, if you are a 
recognized accreditation body, an entity seeking to be a recognized 
accreditation body, an accredited laboratory, or an entity seeking to 
be an accredited laboratory, for purposes of food testing as specified 
in this proposed rule. You would also be subject to this rule if you 
are an owner or consignee required to use an accredited laboratory to 
conduct food testing as specified in this proposed rule. Although 
participation in this program is voluntary for laboratories, 
laboratories would only be able to conduct testing described in 
proposed Sec.  1.1107 if they are accredited under this proposed 
program.
    Under this proposed rule FDA would recognize accreditation bodies 
that would accredit laboratories to conduct food testing. The program 
structure is portrayed in the following diagram:
[GRAPHIC] [TIFF OMITTED] TP04NO19.000

    This proposed program for the testing of food by accredited 
laboratories would establish the oversight, uniformity, and standards 
necessary to help ensure that the results of certain food testing of 
importance to public health are reliable and accurate, and, in turn, 
establishment of the program would substantially improve our capability 
to protect U.S. consumers from unsafe food.

B. Summary of the Major Provisions of the Proposed Rule

    The proposed rule contains model standards that laboratories must 
meet in order to be and stay accredited. The proposed rule, if 
finalized, would establish a publicly available list of accreditation 
bodies and laboratories that have been recognized or accredited under 
this program. Results of food testing conducted by laboratories under 
the program would be required to be sent directly to FDA. Laboratories 
accredited under this program would be required to submit to FDA some 
analytical reports, but for certain laboratories less documentation 
would

[[Page 59454]]

be required than we currently expect as part of a private laboratory 
analytic package.
    This proposal contains eligibility requirements for accreditation 
bodies to qualify for recognition and requirements that accreditation 
bodies must meet once recognized, such as requirements related 
competency and conflict of interest safeguards. The proposed rule also 
contains eligibility requirements for laboratories to qualify for 
accreditation by a recognized accreditation body and requirements that 
laboratories must meet once accredited, such as requirements related to 
conflicts of interest, analysis, and records. These requirements will 
help ensure the effectiveness of the recognized accreditation bodies 
and accredited laboratories under this program. This proposal also 
contains procedures we would follow to recognize accreditation bodies 
under this program and procedures for accreditation bodies to follow to 
accredit laboratories under this program. This proposed rule also 
contains regulatory procedures and requirements relating to our 
monitoring and oversight of recognized accreditation bodies and 
accredited laboratories.
    This proposed rule would apply when food testing is conducted in 
certain circumstances. ``Food testing'' and ``testing of food'' would 
include the analysis of human or animal food. ``Food testing'' and 
``testing of food'' would also include testing of the food growing or 
manufacturing environment (i.e., ``environmental testing'').
    We seek comments on all aspects of this proposed rule.

C. Legal Authority

    Section 422(a)(1)(A) the FD&C Act, which was added by section 
202(a) of FSMA, directs us to establish a program for the testing of 
food by accredited laboratories. Therefore, section 422 of the FD&C Act 
provides FDA with authority for these proposed requirements, which 
outline what would be required of participants in the program for the 
testing of food by accredited laboratories. FDA also derives authority 
for these proposed requirements from section 701(a) of the FD&C Act (21 
U.S.C. 371(a)), which authorizes FDA to issue regulations for the 
efficient enforcement of the FD&C Act.

D. Costs and Benefits

    The costs of the proposed rule, if finalized, would be incurred 
primarily by participating accreditation bodies, participating labs, 
shell-egg producers, sprouts producers, bottled water manufacturers, 
and owners and consignees of human and animal food offered for import 
covered by the proposed rule. We would incur costs to establish and 
maintain the program for recognizing accreditation bodies hoping to 
participate in our program, assessing participating accreditation 
bodies and participating labs, and for reviewing associated documents 
and reports. The present value of the cost of the proposed rule, if 
finalized, would range from $34 million to $78 million when discounted 
by 7 percent over 10 years. When discounted by 3 percent over 10 years 
the present value of the cost would range from $39 million to $92 
million.
    The proposed rule, if finalized, would generate some quantified and 
unquantified benefits. Quantified benefits include cost-savings from 
the proposed clarifications of the process for compiling, submitting 
and reviewing analytical reports for human and animal food offered for 
import covered under the proposed rule, and a reduced burden from the 
proposed abbreviated reporting requirements. In addition, there would 
be savings from fewer false positive test results. We anticipate a 
reduction in the number of foodborne illnesses from fewer false 
negative test results for human and animal food offered for import 
covered under the proposed rule and for shell eggs, sprouts, bottled 
water, and other food subject to specific testing requirements covered 
under the proposed rule. Unquantified benefits could include fewer 
illnesses from deterring unsafe manufacturing practices by all entities 
affected by the proposed rule. The present value of the quantified 
benefits of the proposed rule, if finalized, would range from $26 
million to $81 million when discounted by 7 percent over 10 years. When 
discounted by 3 percent over 10 years the present value of the 
quantified benefits would range from $32 million to $98 million.

II. Table of Abbreviations and Acronyms Commonly Used in This Document

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      Abbreviation/ acronym                    What it means
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ANSI.............................  American National Standards
                                    Institute.
BAM..............................  Bacteriological Analytical Manual.
CFR..............................  Code of Federal Regulations.
CPSC.............................  Consumer Product Safety Commission.
DWPE.............................  Detention Without Physical
                                    Examination.
EO...............................  Executive Order.
E. coli..........................  Escherichia coli.
FDA..............................  United States Food and Drug
                                    Administration.
FD&C Act.........................  Federal Food, Drug, and Cosmetic Act.
FR...............................  Federal Register.
FSMA.............................  FDA Food Safety Modernization Act.
FSVP.............................  Foreign Supplier Verification
                                    Programs.
GAO..............................  Government Accountability Office.
HHS..............................  Health and Human Services.
IBR..............................  Incorporation by Reference.
IEC..............................  International Electrotechnical
                                    Commission.
ILAC.............................  International Laboratory
                                    Accreditation Cooperation.
ISO..............................  International Organization for
                                    Standardization.
MRA..............................  Mutual Recognition Arrangement.
NIST.............................  National Institute of Standards and
                                    Technology.
NTTAA............................  National Technology Transfer and
                                    Advancement Act of 1995.
OMB..............................  Office of Management and Budget.
ORA..............................  Office of Regulatory Affairs.
PLAP.............................  Private Laboratory Analytical
                                    Package.
PRA..............................  Paperwork Reduction Act.
PRIA.............................  Preliminary Regulatory Impact
                                    Analysis.
IEC..............................  International Electrotechnical
                                    Commission.
U.S.C............................  United States Code.
WTO..............................  World Trade Organization.
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III. Background

A. FDA Food Safety Modernization Act

    On January 4, 2011, President Obama signed FSMA into law. FSMA is 
intended to allow FDA to better protect public health by helping ensure 
the safety and security of the U.S. food supply and enables us to focus 
more on preventing food safety problems rather than primarily reacting 
to them once they surface. FSMA also provides us with new enforcement 
authorities designed to 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, FSMA gives us 
important new tools to better ensure the safety of imported foods and 
encourages partnerships with State, local, tribal, and territorial 
authorities. In implementing FSMA, we prioritized the development of 
seven foundational rules that provide the framework for risk-based 
preventive controls and enhance our ability to oversee their 
implementation by industry for both domestic and imported food. We have 
finalized these foundational rules and begun their implementation while 
also developing additional programs required by FSMA, including a 
program for food testing by accredited laboratories, as proposed in 
this document.

B. Food Testing Under FSMA

    FSMA recognized that food testing could perform different roles in 
supporting a modern food safety system. For example, section 418(f)(4) 
of the

[[Page 59455]]

FD&C Act (21 U.S.C. 350g) provides for the use of environmental and 
product testing programs as part of required verification that 
preventive controls are effectively and significantly minimizing or 
preventing the occurrence of identified hazards (food testing under 
such requirements may be conducted for biological, chemical, physical, 
radiological hazards, or, most commonly, microbiological hazards). 
Section 805(c)(4) of the FD&C Act (21 U.S.C. 384a) states that 
verification activities under a foreign supplier verification program 
may include periodically testing and sampling shipments. Under these 
provisions, food testing is used to verify that control measures, 
including those related to suppliers, are controlling the identified 
hazards. In implementing these provisions in the regulations for 
preventive controls for human food and foreign supplier verification 
programs, we attempted to provide flexibility by specifying that they 
apply as appropriate to the facility, the food, and the nature of the 
preventive control and its role in the facility's food safety system. 
21 CFR 117.165(a); accord 21 CFR 507.49(a) (parallel provision in the 
regulation for preventive controls for animal food); 21 CFR 
1.506(d)(1)(ii)(B) (including sampling and testing of a food among 
other appropriate supplier verification activities).
    FSMA, in establishing section 422 of the FD&C Act, also underscores 
that food testing can play a role in detecting and responding to food 
safety problems. Section 422(b)(1) of the FD&C Act requires that food 
be tested by accredited laboratories in four circumstances:
     In response to a specific testing requirement under the 
FD&C Act or implementing regulations, when applied to address an 
identified or suspected food safety problem;
     As required by the Secretary of Health and Human Services 
(HHS), as the Secretary deems appropriate, to address an identified or 
suspected food safety problem;
     In support of admission of an article of food under 
section 801(a) of the FD&C Act (21 U.S.C. 381(a)); and
     Under an import alert through successful consecutive 
tests.

With one exception, section 422(b)(2) of the FD&C Act requires the 
results of food testing conducted under section 422(b)(1) to be sent 
directly to FDA, thereby allowing FDA to review the test results.
    In food manufacturing or processing facilities, followup or 
corrective action testing is often conducted as part of corrective 
actions when an environmental pathogen or indicator organism (i.e., an 
organism that indicates conditions in which an environmental pathogen 
may be present) is found during environmental monitoring. See current 
good manufacturing practice and hazard analysis and risk-based 
preventive controls for human food proposed rule, 78 FR 3646 at 3816, 
January 16, 2013. Corrective action testing may also occur in response 
to the results of product testing, although testing cannot ensure the 
absence of a hazard. Id. at 3819. The accredited laboratory testing 
requirement in this proposed rule would not apply to all corrective 
action testing, but would apply to food testing conducted under 
specific testing requirements in the FD&C Act and implementing 
regulations that ``address an identified or suspected food safety 
problem'', and in food testing orders that we would issue ``to address 
an identified or suspected food safety problem.'' As discussed in 
section VI.B.1, we have tentatively determined that an ``identified 
food safety problem'' could be present where a specific article of food 
violates a provision of the FD&C Act that relates to food safety and a 
``suspected food safety problem'' could be present where there is 
reasonable suspicion that a specific article of food violates a 
provision of the FD&C Act that relates to food safety or where there is 
particularized suspicion of a food safety problem that does not 
necessarily render food violative. An example of a specific testing 
requirement in our FD&C Act regulations that would ``address an 
identified or suspected food safety problem'' and be subject to section 
422(b)(1)(A)(i) of the FD&C Act is a requirement for bottled water 
producers to test, after corrective measures have been applied, 5 
samples collected over a 24-hour period from the same site that 
previously tested positive for Escherichia coli (E.coli). See Sec.  
129.35(a)(3)(i) (21 CFR 129.35(a)(3)(i)). In this example, the presence 
of E. coli in the tested source water would constitute an ``identified 
or suspected food safety problem'' because its presence in the source 
water is not considered water of a safe quality as is required for 
bottled drinking water by Sec.  129.35(a)(1).

C. Import-Related Food Testing and Detention Without Physical 
Examination (DWPE) Procedure

    Section 422(b)(1)(B) of the FD&C Act requires accredited laboratory 
food testing where testing of food is conducted as part of testimony 
for the purposes of section 801(a) of the FD&C Act. Under section 
801(a)(3) of the FD&C Act, we may refuse admission of an imported food 
into the United States if the food is, or appears to be, adulterated or 
misbranded. Pending our decision to refuse admission, section 801(a) of 
the FD&C Act allows the owner or consignee of the imported article of 
food to introduce evidence regarding the admissibility of the food. See 
also 21 CFR 1.94(a). Owners and consignees often hire private 
laboratories to test the food product and submit the results of the 
testing, along with associated analysis and data, to us to show that 
the imported food complies with the FD&C Act. If we determine that the 
food testing results are valid and that they demonstrate the detained 
food product does not violate the FD&C Act, we will release the food 
from detention and allow it to proceed into the United States.
    The DWPE procedure allows us to detain a product without physically 
examining it at the time of entry. We use the DWPE procedure when there 
exists a history of the importation of violative products, or products 
that may appear violative, or when other information indicates that 
future entries may appear violative. Import alerts inform FDA field 
staff and the public that we have enough evidence to allow for DWPE of 
products that appear to be in violation of FDA laws and regulations. 
Depending on the reason for DWPE, owners and consignees may hire 
private laboratories to test a food product in an attempt to overcome 
the appearance of the violation and release the food from detention.\1\
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    \1\ In both the domestic and import arenas, the owner or 
consignee of a food may accept that a food product is violative and 
offer to recondition the food to make it nonviolative (e.g., by 
subjecting an adulterated food to a treatment that cures the 
adulteration), divert human food for use as animal food, and/or 
recondition the food to make the food not subject to our enforcement 
authorities (e.g., by processing the food in a manner that makes it 
into a type of product we do not regulate). After food has been 
reconditioned and/or identified for diversion to animal food, the 
owner or consignee of the food (who we also refer to herein as the 
``importer'' in the import context) may have food testing conducted 
on the product to demonstrate to us that the product is safe for the 
intended use.
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D. Testing of Imported Food by Private Laboratories

    As the volume of food offered for import to the United States 
increased in recent decades, our use of the DWPE procedure also 
increased, as did concomitant food testing by private laboratories on 
behalf of importers. From January 1, 2016, through December 31, 2017, 
we received food testing submissions, known as private laboratory 
analytical packages (PLAPs),

[[Page 59456]]

from approximately 100 different private laboratories. See FDA 
Memorandum, ``Assessment of DWPE Sampling and Analysis Data to 
Determine What Portion of Sampling and Analysis of Food under DWPE is 
Conducted by Accredited Entities'' (Ref. 1). Historically, we relied on 
Agency procedural documents and communications from FDA offices that 
review PLAPs to encourage private laboratories to meet certain 
standards for testing and sampling. We previously have observed that 
our recommended procedures for private laboratories were ``not 
sufficiently specific,'' which may have contributed to a lack of 
consistency in standards for testing and sampling across FDA districts 
(requirements pertaining to sampling services and private laboratories 
used in connection with imported food proposed rule, 69 FR 23460 at 
23468, April 29, 2004). In addition, the lack of regulatory 
requirements for PLAP content has sometimes complicated our scientific 
review of PLAP submissions from private laboratories.
    Concerns also have periodically arisen regarding importers' 
manipulation or substitution of the samples a private laboratory tests, 
and practices such as ``testing into compliance,'' in which multiple 
samples from a shipment are tested, but only those results that would 
allow the shipment to enter the United States are submitted to us. See, 
e.g., ``The Safety of Food Imports: Fraud & Deception in the Food 
Import Process; Hearings Before the Senate Committee on Governmental 
Affairs, Permanent Subcommittee on Investigations,'' September 10, 1998 
(statement of ``Former Customs Broker'') (Ref. 2, pages 26-35 and 137-
140).
    In attempts to address these issues, FDA and others have taken 
several actions to improve coordination between FDA and private 
laboratories and improve the safety of food imports. This section 
describes several of these activities up to and including the enactment 
of FSMA section 202(a).
    In 1996 we held several public meetings across the country to 
discuss how FDA might improve its policies and procedures relating to 
the use of private laboratories to test food offered for import. (61 FR 
29416, June 10, 1996). These public meetings resulted in an action plan 
which suggested, among other things, that we establish consistent and 
objective standards for the format and content of food testing results 
and analytical information that private laboratories submit to us, that 
we require independent sampling of such food prior to the food's 
analysis by a private laboratory, and that we require the laboratory to 
send the results of all such food testing directly to us (see 
discussion of the plan in the 2004 proposed rule, 69 FR 23460, at 
23460, April 29, 2004).
    In 2003, we added a section on ``Private Laboratory Guidance'' to 
FDA's Office of Regulatory Affairs (ORA) Laboratory Manual (ORA 
Laboratory Manual) (Ref. 3). This document updated procedures for 
reviewing PLAPs (which contain sampling collection reports, testing 
results, and associated analytical information) submitted to us as 
testimony relevant to the admissibility, destruction, or reconditioning 
of FDA-regulated articles offered for import.
    Recognizing a need for oversight over sampling services and private 
laboratories testing of imported food on behalf of importers, in the 
Federal Register of April 29, 2004, we proposed a rule on 
``Requirements Pertaining to Sampling Services and Private Laboratories 
Used in Connection With Imported Food'' (the 2004 proposed rule). We 
designed the 2004 proposed rule with the goals of deterring the 
importation of unsafe food, establishing uniformity in the practices of 
samplers and laboratories testing imported food for FDA regulatory 
purposes, and improving the reliability and scientific validity of the 
food testing analytical information that FDA uses to make food import 
admissibility decisions. The proposed rule would have required, among 
other requirements, that samples of food to be tested be properly 
identified, collected, and maintained; that laboratories conducting 
food testing use validated or recognized analytical methods; and that 
laboratories conducting food testing submit the analytical results of 
the food testing directly to FDA. Id.
    The 2004 proposed rule would not have required laboratories 
conducting food testing to be accredited because we determined that 
doing so would have been premature. Id. at 23464. We did, however, in 
the preamble to the 2004 proposed rule strongly encourage laboratories 
conducting such food testing to become accredited. Id. Most comments on 
the accreditation issue contended that accreditation to International 
Organization for Standardization/International Electrotechnical 
Commission (ISO/IEC) 17025:2005, ``General Requirements for the 
Competence of Testing and Calibration Laboratories'' (Ref. 4), would 
substantially enhance the effectiveness of the rule. We withdrew the 
2004 proposed rule on August 5, 2005 (see 70 FR 64553 at 64590, October 
31, 2005).\2\
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    \2\ See https://www.govinfo.gov/content/pkg/GPO-UA-2005-10-31/pdf/GPO-UA-2005-10-31-8.pdf.
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    In November 2007, an Interagency Working Group on Import Safety, 
made up of representatives from 12 federal departments and agencies, 
presented an Action Plan for Import Safety to President Bush containing 
recommendations and action steps to further improve the safety of 
imports entering the United States (Ref. 5). One of these action steps 
was that we issue guidance setting ``standards for the sampling and 
testing of imported products, including the use of accredited 
laboratories submitting data to FDA to assist in evaluating whether an 
appearance of a violation may be resolved.''
    On January 29, 2008, the Government Accountability Office (GAO) 
recommended, in testimony to the Subcommittee on Oversight and 
Investigations of the House Committee on Energy and Commerce, that we 
consider accrediting private laboratories to test seafood. See GAO, 
``Federal Oversight of Food Safety: FDA's Food Protection Plan Proposes 
Positive First Steps, but Capacity to Carry Them Out Is Critical,'' 
GAO-08-435T (Ref. 6), at page 7). This recommendation, which GAO had 
originally made in 2004, was intended to help us leverage outside 
resources and provide greater assurance about the quality of the 
laboratories importers use for seafood products subject to DWPE. See 
GAO, ``Food Safety: FDA's Imported Seafood Safety Program Shows Some 
Progress, but Further Improvements are Needed,'' GAO-04-246 (Ref. 7), 
at page 6.
    On January 16, 2009, under the Action Plan for Import Safety, we 
issued a draft guidance document entitled ``Guidance for Industry: 
Submission of Laboratory Packages by Accredited Laboratories'' (the 
2009 draft guidance) (Ref. 8), in which we recommended a voluntary 
accreditation program for laboratories conducting testing to support 
the admissibility of articles offered for import of all product types 
that FDA regulates. (See 74 FR 3056, January 16, 2009).
    We acknowledged in the 2009 draft guidance that the landscape of 
laboratory accreditation had changed since we published the 2004 
proposed rule, including a general trend toward laboratory 
accreditation and wider industry adoption of the ISO/IEC 17025 
standard, as well as accreditation of FDA's own laboratories to the 
ISO/IEC 17025 standard. The 2009 draft guidance also noted that 
rigorous

[[Page 59457]]

accreditation standards provide FDA and industry with greater 
confidence that laboratories receiving accreditation have sufficient 
technical capability, trained personnel, and quality management systems 
to perform the specific testing methods for which they are accredited. 
We further noted in the 2009 draft guidance that laboratory 
accreditation bodies' continuing oversight over accredited laboratories 
would enhance the Agency's confidence in the accredited laboratories' 
analyses and results. To encourage laboratories to voluntarily seek 
accreditation, the 2009 draft guidance recommended that laboratories 
that became accredited would be permitted to submit ``abbreviated'' 
laboratory packages to FDA in lieu of full PLAPs. Under the 2009 draft 
guidance, abbreviated laboratory packages consisted of documents 
identifying the entry from the importer of record, a summary of 
analysis, and affirmation from the laboratory director regarding the 
accuracy of the sampling and analysis. Full PLAPs, in turn, include the 
details of the analyses performed, including underlying raw data and 
supporting materials such as sample collection reports, validation and 
verification studies, analyst training records, etc.
    The 2009 draft guidance further recommended that accreditation 
bodies that accredit laboratories conducting import admissibility 
testing on FDA-regulated products should operate in accordance with 
ISO/IEC 17011:2004 ``General Requirements for Accreditation Bodies 
Accrediting Conformity Assessment Bodies'', as this would help ensure 
the competency of the accreditation bodies. The 2009 draft guidance 
additionally recommended that accreditation bodies should be 
signatories to the International Laboratory Accreditation Cooperation 
(ILAC) Mutual Recognition Arrangement (MRA), by which they would agree 
to maintain conformity with the current version of ISO/IEC 17011 and 
ensure that all laboratories they accredit comply with appropriate 
laboratory standards. The 2009 draft guidance also recommended that 
accreditation bodies accredit laboratories for specific testing 
methodologies used to generate test results submitted to FDA, and that 
they do so by assessing laboratories' conformance to ISO/IEC 
17025:2005.\3\ The 2009 draft guidance noted ``widespread agreement,'' 
including by our own laboratories, that ISO/IEC 17025 was the most 
internationally recognized and accepted standard for testing 
laboratories.
---------------------------------------------------------------------------

    \3\ FDA also recommended that laboratories incorporate in their 
implementation of ISO/IEC 17025 the factors established in the AOAC 
International's ``Guidelines for Laboratories Performing 
Microbiological and Chemical Analyses of Food, Dietary Supplements, 
and Pharmaceuticals, and Aid to Interpretation of ISO/IEC 
17025:2005'' (Ref. 9).
---------------------------------------------------------------------------

    On the issue of sampling, the 2009 draft guidance recommended that 
accreditation bodies review laboratories' sampling procedures to ensure 
the integrity, accuracy, and representative quality of samples, 
including samples collected by laboratories themselves and samples 
collected by sampling services under contract to the laboratory. The 
2009 draft guidance further recommended that importers provide us with 
advance notice that they intend to use a particular accredited 
laboratory and that an abridged laboratory package would be submitted 
under the guidance, and that accredited laboratories conducting the 
analysis directly submit to us the results of all testing on the 
articles at issue.
    Almost all comments we received in response to the 2009 draft 
guidance supported our recommendation for laboratory accreditation. The 
2009 draft guidance was never finalized and was withdrawn in May 2015 
(see 80 FR 26059, May 6, 2015). However, we considered both the 2004 
proposed rule and the 2009 draft guidance and the comments we received 
in response to both documents, in developing this proposal.

E. Current Industry Practices Relating to Accreditation Bodies, 
Accreditation of Laboratories, and Food Testing

    FDA has not had a policy of weighing food testing results 
differently depending on whether the laboratory that conducted the food 
testing is accredited, and therefore we generally do not track the 
accreditation status of private laboratories that conduct food testing 
in either the domestic or import arenas. However, we are able to make 
some reasonable inferences and conclusions regarding the laboratories 
that have conducted testing related to imports, with the data we do 
have.
    With regards to the testing of imported foods, our analysis of the 
data in our internal systems (Ref. 1) indicates that just over one 
hundred different private laboratories submitted (although in some 
cases the laboratory would submit the results and supporting 
information to the importer, who would then submit them to us) analyses 
and results to us between January 1, 2016, and December 31, 2017, of 
food offered for import that we had detained. Ten of those laboratories 
submitted approximately 84 percent of the analyses. By examining 
publicly available records from accreditation bodies regarding the 
accreditation status of those laboratories, we concluded that all 10 of 
those laboratories are accredited to ISO/IEC 17025. This indicates that 
the large majority of import-related food testing results that we 
receive come from laboratories that are accredited to ISO/IEC 17025. We 
found no laboratories conducting analyses in support of food offered 
for import that we had detained that were accredited to any standard 
other than ISO/IEC 17025. We also found that all of the accredited 
laboratories that submitted import-related food testing results were 
accredited by accreditation bodies that are full members of ILAC and 
signatories to the ILAC MRA, which requires signatories to have been 
peer evaluated in accordance with ISO/IEC 17011 to demonstrate 
competence. ILAC MRA signatories must maintain conformance with ISO/IEC 
17011 (see, e.g., IAF/ILAC ``Multi-Lateral Mutual Recognition 
Arrangements (Arrangements): Requirements and Procedures for Evaluation 
of a Single Accreditation Body'' (Ref. 10, p. 8)).

F. U.S. Government Policies on Consensus Standards

    Implementation of section 422 of the FD&C Act occurs against the 
backdrop of broader U.S. federal policies on consensus standards under 
the National Technology Transfer and Advancement Act of 1995 (NTTAA) 
(Pub. L. 104-113).
    The NTTAA, together with the Office of Management and Budget (OMB) 
Circular A-119, ``Federal Participation in the Development and Use of 
Voluntary Consensus Standards and in Conformity Assessment Activities'' 
(most recently revised on January 27, 2016) (Ref. 11), directs federal 
agencies to use voluntary consensus standards in their procurement and 
regulatory activities in lieu of government-unique standards, except 
where inconsistent with law or otherwise impractical. OMB Circular A-
119 states that the use of voluntary consensus standards, whenever 
practicable and appropriate, is intended to: (1) Eliminate the cost to 
government of developing its own standards and decrease the cost of 
goods procured and the burden of complying with Agency regulation, (2) 
provide incentives and opportunities to establish standards that serve 
national needs, encouraging long-term growth for U.S. enterprises and 
promoting efficiency, economic competition, and trade, and (3) further 
the reliance upon private sector expertise to supply the

[[Page 59458]]

Federal government with cost-efficient goods and services.
    Additionally, as directed by OMB in Circular A-119 (Ref. 11), the 
National Institute of Standards and Technology issued policy guidance 
on Federal conformity assessment activities \4\ (Federal conformity 
assessment guidance), published in the Federal Register of August 10, 
2000 (65 FR 48894), and codified at 15 CFR part 287. The guidance 
recommends that, as appropriate, Federal Agencies use relevant guides 
or standards for conformity assessment practices from domestic and 
international standardizing bodies (e.g., the ISO, the IEC, and the 
Codex Alimentarius Commission).\5\ The guidance also notes that each 
agency retains the responsibility, and authority, to select the 
conformity assessment activities and procedures (i.e., guides and 
standards) that will best meet its legislative mandates and 
programmatic objectives.
---------------------------------------------------------------------------

    \4\ The Federal conformity assessment guidance defines 
conformity assessment activities, in part, as ``any activity 
concerned with determining directly or indirectly that requirements 
are fulfilled'' (see 15 CFR 287.2).
    \5\ The Codex Alimentarius Commission, established by Food and 
Agriculture Organization of the United Nations and the World Health 
Organization (WHO) in 1963 develops harmonized international food 
standards, guidelines, and codes of practice to protect the health 
of the consumers and ensure fair trade practices in the food trade. 
The Commission also promotes coordination of all food standards work 
undertaken by international governmental and non-governmental 
organizations.
---------------------------------------------------------------------------

    Further, section 422(a)(6) of the FD&C Act requires us to ``consult 
existing standards for guidance'' in the course of developing model 
standards that a laboratory must meet to be accredited by a recognized 
accreditation body for a specified sampling or analytical testing 
methodology.
    In developing this proposed rule, two relevant voluntary consensus 
standards stood out as containing globally-recognized and widely-used 
requirements relevant to the program for food testing by accredited 
laboratories: ISO/IEC 17011:2017, ``Conformity Assessment--Requirements 
for Accreditation Bodies Accrediting Conformity Assessment Bodies'' 
(ISO/IEC 17011:2017) (Ref. 12), for accreditation bodies that would be 
recognized under the program, and ISO/IEC 17025:2017, ``General 
Requirements for the Competence of Testing and Calibration 
Laboratories'' (ISO/IEC 17025:2017) (Ref. 13), for laboratories that 
would be accredited under the program.
    Although we are proposing to require accreditation bodies to meet 
ISO/IEC 17011:2017 entirely, we are proposing to not require accredited 
laboratories to meet certain aspects of ISO/IEC 17025:2017 that would 
be inconsistent with section 422 of the FD&C Act or would be 
impractical for use in our program. We are also proposing to require 
accredited laboratories to meet certain requirements in addition to 
ISO/IEC 17025:2017. For further discussion on this issue, please see 
sections VI.C and VI.D (regarding the proposed requirements under this 
program for accreditation bodies) and sections VI.F and VI.G (regarding 
the proposed requirements under this program for laboratories). For 
information on accessing these consensus standards, please see section 
III.G.
    We invite public comment on whether the voluntary consensus 
standards we cite are the appropriate standards upon which to base this 
rulemaking.

G. Incorporation by Reference

    We are proposing to incorporate the following consensus standards 
by reference, with the approval of the Director of the Federal Register 
in accordance with 5 U.S.C. 553(a) and 1 CFR part 51:
     ISO/IEC 17011:2017, ``Conformity Assessment--Requirements 
for Accreditation Bodies Accrediting Conformity Assessment Bodies,'' 
Second edition, November 2017 (Ref. 12), and
     ISO/IEC 17025:2017, ``General Requirements for the 
Competence of Testing and Calibration Laboratories,'' Third edition, 
November 2017 (Ref. 13).

For an overview of ISO/IEC 17011:2017, please see section VI.C. of the 
preamble. For an overview of ISO/IEC 17025:2017, please see section 
VI.F of the preamble.
    The consensus standards proposed to be incorporated by reference 
are available to the public in four different ways: (1) Generally, the 
most convenient way for interested parties to view these consensus 
standards is via the special link created by the American National 
Standards Institute (ANSI), which is a private non-profit organization 
that supports the U.S. voluntary standards and conformity assessment 
system. ISO/IEC 17011:2017 and ISO/IEC 17025:2017 are available to view 
through the following link free of charge: https://www.surveymonkey.com/r/KFJMZ67. Please note that you must have certain 
software on your computer (available free of charge through following 
the process on this website) and complete a registration form (when 
prompted by the process on this website) to view these consensus 
standards via the website facilitated by ANSI. Alternatively, 
interested parties may: (2) Examine these standards at Dockets 
Management Staff at FDA at the locations listed in proposed Sec. Sec.  
1.1113(b) and 1.1138(a)(2), (3) purchase copies of these standards from 
ISO or from IEC, or (4) purchase copies of these standards from any 
other source from which the user is assured that the copy to be 
received is an accurate and current version of the standard.

IV. FSMA Public Meetings, Comments Related to Other FSMA Rulemakings, 
and Stakeholder Input

    Since the enactment of FSMA, we have reached out to stakeholders in 
the food industry, the international community, standards 
organizations, accreditation and certification bodies, consumer groups, 
government agencies, and other interested parties to gain input and 
perspective on how to best implement FSMA. Such interested parties have 
also provided comments to us at their own initiative and requested 
meetings with us at their own initiative to discuss our implementation 
of FSMA. The input and perspectives we gained through these comments 
and meetings helped shape this proposed rule.
    Since the enactment of FSMA, we have also received several comments 
from interested parties specifically regarding our implementation of 
section 422 of the FD&C Act. We received many such comments in response 
to our solicitation of comments regarding our implementation of other 
aspects of FSMA, for example, with regards to the accreditation of 
third-party auditors (see section 808 of the FD&C Act, added by FSMA 
section 307), hazard analysis and risk-based preventative controls (see 
section 418 of the FD&C Act, added by FSMA section 103), and standards 
for produce safety (see section 805 of the FD&C Act, added by FSMA 
section 105). The most common issue discussed in those comments related 
to what scenarios should require food testing to be conducted by 
accredited laboratories under section 422(b)(1) of the FD&C Act. Other 
issues discussed in such comments include the circumstances under which 
we should allow variance from the requirement to submit to FDA the 
results of all tests conducted under this proposed program. There were 
also a small number of comments regarding the implementation of section 
422 of the FD&C Act submitted to the docket established to help FDA 
identify existing ways of achieving meaningful burden reduction while 
still allowing us to achieve our public health mission and fulfill our 
statutory obligations. To the extent practicable, we tried to consider 
all comments in drafting this

[[Page 59459]]

proposed rule. However, to ensure that we consider your comment in the 
context of this rulemaking, you should resubmit in response to this 
proposed rule any comment(s) you previously submitted regarding our 
implementation of section 422 of the FD&C Act.
    Since the enactment of FSMA, we have also met with several 
stakeholders, some of who requested meetings with FDA to discuss their 
current programs and to share their views and recommendations for our 
implementation of section 422 of the FD&C Act, and others whom we 
contacted in order to learn from their relevant experience and subject 
matter expertise. Topics for our meetings with these stakeholders 
included the general structure and function of the program, the 
standards to which accreditation bodies, sampling services, and 
laboratories should adhere in order to be recognized or accredited 
under this proposed program, and how sampling services should be 
addressed in the program. We discuss issues relevant to this rulemaking 
that were covered during these meetings in Section VI, Description of 
the Proposed Rule of this NPRM.
    In this proposed rule we have intended to draft a practical, 
flexible, and effective approach to the program for the testing of 
foods by accredited laboratories. We seek comments on all aspects of 
this proposal, including comments about any potential impacts of this 
proposed rule.

V. Legal Authority

    We are issuing this proposed rule under the FD&C Act and FSMA. As 
noted, section 202(a) of FSMA, ``Laboratory Accreditation for Analyses 
of Foods'', amends the FD&C Act to create a new provision, section 422, 
under the same name. Section 422 of the FD&C Act directs us to 
establish a program for the testing of food by accredited laboratories 
and provides several requirements for the program.
    Additionally, section 701(a) of the FD&C Act gives FDA the 
authority to publish regulations for the efficient enforcement of the 
FD&C Act. The requirements discussed in this proposed rule would allow 
FDA to efficiently enforce section 422 of the FD&C Act. Thus, our legal 
authority for this proposed rule is derived primarily from section 422 
and section 701(a) of the FD&C Act. Further, we also note that this 
rule is consistent with section 404 of FSMA (21 U.S.C. 2252), which 
states that nothing in FSMA should be construed in a manner that is 
inconsistent with the agreement establishing the World Trade 
Organization (WTO) or any other treaty or international agreement to 
which the United States is a party.

VI. Description of the Proposed Rule

    In section 422 of the FD&C Act Congress directs us to establish a 
program for the testing of food by accredited laboratories. We are 
proposing to add new subpart R, ``Accreditation of Laboratories to 
Conduct Food Testing,'' to part 1 (21 CFR part 1) (``General 
Enforcement Regulations'') and amend our regulations in parts 11 
(``Electronic Records; Electronic Signatures''), and 16 (``Regulatory 
Hearing before the Food and Drug Administration'') (21 CFR parts 11 and 
16) to establish and implement a program for food testing by accredited 
laboratories, as required by section 422 of the FD&C Act. We are also 
proposing to amend part 129 (21 CFR part 129) (``Processing and 
Bottling of Bottled Drinking Water'') to ensure that the requirements 
in part 129 are consistent with the requirements of section 422 of the 
FD&C Act. We are also proposing to revise certain testing provisions in 
part 1, Subpart M (``Accreditation of Third-Party Certification Bodies 
to Conduct Food Safety Audits and to Issue Certifications''), in the 
interest of consistency with this proposed rule and in response to 
additional information we have gathered, in developing this proposed 
rule, about the number and capacity of laboratories accredited under 
ISO/IEC 17025 to conduct food testing.
    We also note that in November 2017, ISO/IEC released new versions 
of ISO/IEC 17011 and ISO/IEC 17025. ISO/IEC 17011 and ISO/IEC 17025 
were last revised in 2004 and 2005, respectively. The new versions of 
ISO/IEC 17011 and 17025--ISO/IEC 17011:2017 and 17025:2017--do not 
represent fundamental changes to the previous versions of ISO/IEC 17011 
and ISO/IEC 17025. Rather, the new versions of ISO/IEC 17011 and ISO/
IEC 17025 have been technically revised to more accurately reflect 
current best practices of accreditation bodies and of testing and 
calibration laboratories.

A. Proposed General Provisions (Proposed Sec. Sec.  1.1102 Through 
1.1103)

1. What definitions apply to this subpart? (Proposed Sec.  1.1102)
    We propose to define several terms used in this rule (see proposed 
Sec.  1.1102). Where possible, we propose to rely on existing statutory 
and regulatory definitions. Proposed Sec.  1.1102 states that 
definitions and interpretations contained in section 201 of the FD&C 
Act (21 U.S.C. 321) will apply to this rule, except as those terms are 
otherwise defined in this section. We also note here that grammatical 
variations of the terms defined in proposed Sec.  1.1102 have the same 
meaning as the defined term, modified as grammatically appropriate. For 
example, the term to ``accredit,'' although not specifically defined by 
proposed section Sec.  1.1102, would mean to bestow accreditation, in 
accordance with how the term ``accreditation'' would be defined by this 
rule.
    Where necessary to provide clarity to this rule, we have developed 
some additional definitions that align with existing law and 
regulations, as well as with current practices of the international 
community, accreditation bodies, food testing laboratories, and the 
food industry. We seek comments on these proposed definitions, 
including with respect to whether any of the proposed definitions are 
unnecessary and with respect to whether any additional terms we use in 
this proposed rule should be defined.
    We propose to define ``accreditation'' to mean a determination by a 
recognized accreditation body that a laboratory meets the applicable 
requirements of this program to conduct food testing under this program 
using one or more methods of analysis. In developing the definition of 
accreditation, we considered the use of the term accreditation in 
section 422 of the FD&C Act. Specifically, section 422(a)(6) of the 
FD&C Act directs us to develop model standards that a laboratory shall 
meet to be accredited by a recognized accreditation body for a 
specified sampling or analytical testing methodology and section 
422(b)(1) of the FD&C Act provides that food testing under this program 
may only be conducted by laboratories that have been accredited for the 
appropriate sampling or analytical testing methodology or methodologies 
by a recognized accreditation body. These provisions indicate that 
accreditation under section 422 of the FD&C Act requires a 
determination by a recognized accreditation body that a laboratory 
meets our model standards for a specified analytical testing 
methodology. We also considered the meaning of accreditation in 
international standards on accreditation, including ISO/IEC 17011:2017 
(Ref. 12), which defines accreditation as an attestation ``conveying 
formal demonstration'' of a conformity assessment body's competence to 
carry out specific conformity assessment tasks. In the context of the 
proposed

[[Page 59460]]

rule, recognized accreditation bodies would accredit laboratories that 
they determine meet the applicable requirements of the rule.
    The term accreditation as it is used in the proposed rule, refers 
only to a recognized accreditation body's determination that a 
laboratory meets the applicable requirements of this program and does 
not refer to any accreditation outside of this program. For example, 
although conformance to certain aspects of ISO/IEC 17025:2017 is a 
prerequisite to becoming accredited by a recognized accreditation body 
under this proposed rule, the term accreditation, as used in this 
proposed rule, does not refer to accreditation to ISO/IEC 17025 or to 
any other standard.
    We propose to define ``accredited laboratory'' to mean a laboratory 
that a recognized accreditation body has determined meets the 
applicable requirements of this program and has been accredited to 
conduct food testing using one or more methods of analysis under this 
program.
    We propose to define ``analyst'' to mean an individual who analyzes 
samples. The term refers to a single individual and does not refer to 
any other type of entity that is treated as a person for certain legal 
purposes.
    Proposed Sec.  1.1102 would define ``food,'' as having the meaning 
given in section 201(f) of the FD&C Act, except that it would not 
include pesticides as defined in 7 U.S.C. 136(u), consistent with the 
definition of food used in the FSMA Foreign Supplier Verification 
Programs for Importers of Food for Humans and Animals (FSVP) (part 1, 
Subpart L) and Accreditation of Third-Party Certification Bodies To 
Conduct Food Safety Audits and To Issue Certifications (accredited 
third-party certification) (part 1, Subpart M) regulations. We have 
tentatively determined there is no significant reason to define food 
differently in this proposal. We have not identified a need for food 
testing under this program to address pesticides as articles of food.
    We propose to define ``food testing'' and ``testing of food'' to 
mean the analysis of food product samples or environmental samples. The 
terms food testing in sections 422(b)(1) and 422(d) of the FD&C Act, 
and testing of food in section 422(a)(1)(A) of the FD&C Act, are not 
defined in the statute. We see two possible ways to interpret and apply 
these terms. As noted, the FD&C Act has a definition of food at section 
201(f), and it therefore may be a reasonable assumption that food 
testing means only the testing of food as food is defined under section 
201(f). Under this approach, food testing would mean only product 
testing (where product testing includes testing of any food product, 
including raw materials or other ingredients, in-process foods, or 
finished products).
    The alternative interpretation, which we propose, would interpret 
food testing to include product testing as well as environmental 
testing (e.g., testing from the growing, harvesting, manufacturing, 
processing, packing, or holding environment). We have tentatively 
concluded that the meaning of food testing, a term that appears only in 
section 422 of the FD&C Act, is ambiguous and may be interpreted to 
encompass both product testing and testing that is related to food, 
that is, environmental testing. Food testing is distinct from ``product 
testing,'' used in section 418(f)(4) of the FD&C Act, and 
``environmental testing programs'' and ``environmental monitoring 
programs,'' which are used in sections 418(f)(4) and 418(o)(3)(C) of 
the FD&C Act, respectively. We note that section 202(a) of FSMA is 
located in title II of FSMA, which is entitled improving capacity to 
detect and respond to food safety problems, and section 422(b)(1)(A) of 
the FD&C Act requires accredited laboratory performance of food testing 
to address an identified or suspected food safety problem. Given the 
role of environmental testing in determining both the source of 
contamination and in determining whether such contamination has been 
eliminated, interpreting food testing to exclude environmental testing 
would not cover an important method to detect and respond to identified 
and suspected food safety problems. Additionally, if food testing does 
not include environmental testing, our laboratory accreditation program 
would be unable to accredit laboratories to perform environmental 
testing or to issue model laboratory standards for environmental 
testing even though the food testing industry performs both food 
product tests and environmental tests. We invite comment on this 
interpretation.
    We propose to define ``food testing order'' to mean an order issued 
by FDA under Sec.  1.1108 of this subpart requiring food testing to be 
conducted under this program by or on behalf of an owner or consignee. 
We are proposing specific requirements related to food testing orders 
in Sec. Sec.  1.1107, 1.1108, and 1.1174 of this proposed rule.
    We propose to define ``owner or consignee'' as any person with an 
ownership or consignment interest in: The food product or environment 
that is the subject of food testing conducted under Sec.  1.1107(a)(1); 
the food product or environment that is the subject of the order issued 
under Sec.  1.1107(a)(2); the food product or environment that is the 
subject of food testing conducted under Sec.  1.1107(a)(3); the article 
of food for which food testing is being conducted under Sec.  
1.1107(a)(4); or the food subject to an import alert for which food 
testing is conducted under Sec.  1.1107(a)(5). Anyone meeting this 
definition of owner or consignee would be required to use an accredited 
laboratory to conduct food testing as specified in this proposed rule.
    We propose to define ``recognition'' to mean a determination by FDA 
that an accreditation body meets the applicable requirements of the 
program and is authorized to accredit laboratories under the program. 
This definition aligns with the use of the term recognition and 
``recognized'' in section 422 of the FD&C Act, which uses these terms 
to describe the status we will accord to an accreditation body that we 
have determined meets certain requirements and may therefore accredit 
laboratories to conduct food testing under this program.
    We propose to define ``recognized accreditation body'' to mean an 
accreditation body that FDA has determined meets the applicable 
requirements of the program and is authorized to accredit laboratories 
under the program. As previously discussed, this definition aligns with 
the use of the term recognition and recognized in section 422 of the 
FD&C Act, which uses these terms to describe the status we will accord 
to an accreditation body that we have determined meets certain 
requirements and may therefore accredit laboratories to conduct food 
testing under this program. This proposed definition of recognized 
accreditation body follows from our proposed definitions of recognition 
and accreditation body.
    We propose to define ``representative sample'' to mean ``a sample 
that accurately, to a scientifically acceptable degree, represents the 
characteristics and qualities of the food product or environment the 
sample was collected from.'' If food testing is required to be 
conducted on a specific food product or environment under this rule, 
and the sample that is collected from that food or environment is not 
representative of the food or environment at issue, then analysis of 
the sample would not produce information that is meaningful. We propose 
to use the qualifier ``to a scientifically acceptable degree'' because 
we acknowledge there are practical limits to how accurately a sample 
can represent the characteristics and qualities of the food product or 
environment from which it was

[[Page 59461]]

collected. Furthermore, what constitutes a representative sample in the 
context of a certain food product or environment may be a scientific 
determination that depends on the environment, food matrix, and analyte 
at issue, among other potential factors. FDA's Investigations 
Operations Manual, Chapter 4--Sampling, includes some considerations 
which may inform the identification and collection of a representative 
sample (https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/investigations-operations-manual).
    Depending on the food testing to be conducted, it may be 
appropriate to analyze a single sample that is representative of the 
food product or environment from which it was collected, to analyze a 
composite of multiple samples collected from the food product or 
environment from which it was collected, and/or to analyze a 
representative sample, taken in the laboratory, of the original 
representative sample.
    We propose to define ``sampler'' as an individual or individuals 
who perform sampling. The term sampler would refer to single 
individuals and would not refer to any other type of entity that is 
treated as a person for certain legal purposes.
    We propose to define ``scope of accreditation'' as referring to the 
methods of analysis for which the accredited laboratory is accredited. 
We also propose to clarify that references in this rule to 
accreditation ``in-whole'' refers to all methods in the accredited 
laboratory's scope of accreditation and accreditation ``in-part'' 
refers to only certain methods in the accredited laboratory's scope of 
accreditation. We note that section 7.8 of ISO/IEC 17011:2017 (Ref. 12) 
requires accreditation bodies to provide information to the 
laboratories they accredit that identifies their scope of 
accreditation.
2. Who is subject to this subpart? (Proposed Sec.  1.1103)
    The proposed rule would apply to recognized accreditation bodies, 
entities seeking to become recognized accreditation bodies, accredited 
laboratories, entities seeking to become accredited laboratories, and 
owners and consignees who are required to use accredited laboratories 
for the food testing under this program. Although participation by 
accreditation bodies and laboratories in this program is voluntary, 
only accreditation bodies recognized by us under this program would be 
able to accredit laboratories to conduct food testing under this 
program, and only laboratories accredited by an accreditation body 
recognized by us under this program would be able to conduct food 
testing under this program. However, if finalized, it will not be 
voluntary for owners and consignees to conduct food testing conducted 
as described in proposed Sec.  1.1107(a).

B. Proposed Provisions About General Requirements of This Rule 
(Proposed Sec. Sec.  1.1107 Through 1.1109)

    We have proposed various provisions outlining the general 
requirements of the food testing program, including when food testing 
would have to be conducted under this rule, when and how we would issue 
food testing orders, and how we would make information about recognized 
accreditation bodies and accredited laboratories available to the 
public.
1. Under what circumstances must food testing be conducted under this 
subpart by an accredited laboratory? (Proposed Sec.  1.1107)
    Proposed Sec.  1.1107 would require that food testing must be 
conducted under this rule whenever food testing is conducted by or on 
behalf of an owner or consignee in any of the following five 
circumstances: (1) In response to explicit testing requirements (in the 
FD&C Act or implementing regulations) that address an identified or 
suspected food safety problem (we elaborate on these explicit 
corrective action testing requirements below, but, in short, they are 
located at 21 CFR 112.146(a), (c) and (d), 118.4(a)(2)(iii), 
118.5(a)(2)(ii), 118.5(b)(2)(ii), 118.6(a)(2), 118.6(e), and 
129.35(a)(3)(i) (regarding the requirement to test five samples from 
the same sampling site that originally tested positive for E. coli)); 
(2) as required by FDA in a food testing order (issued under Sec.  
1.1108 of this rule); (3) to address an identified or suspected food 
safety problem and presented to FDA as part of evidence for a hearing 
under section 423(c) of the FD&C Act (21 U.S.C. 350l) prior to the 
issuance of a mandatory food recall order, as part of a corrective 
action plan under section 415(b)(3)(A) of the FD&C Act (21 U.S.C. 350d) 
submitted after an order suspending the registration of a food 
facility, or as part evidence submitted for an appeal of an 
administrative detention order under section 304 (h)(4)(A) of the FD&C 
Act (21 U.S.C. 334(h)(4)(A)); (4) in support of admission of an article 
of food under section 801(a) of the FD&C Act; and (5) to support 
removal from an import alert through successful consecutive testing.
    a. Ownership of laboratories that may conduct food testing.
    We note that section 422(b)(1)(A) of the FD&C Act provides that 
food testing must be conducted under this proposed program whenever 
food testing is conducted ``by or on behalf'' of an owner or consignee, 
while section 422(b)(1)(B) of the FD&C Act provides that food testing 
must be conducted under this rule whenever such testing is conducted on 
behalf of an owner or consignee in support of admission of an imported 
article of food and to support removal from an import alert through 
successful consecutive testing. We tentatively conclude that the ``by 
or on behalf'' language of section 422(b)(1)(A) of the FD&C Act means 
that both laboratories owned by owners or consignees and independent, 
or third-party laboratories, that conduct food testing ``on behalf of'' 
owners and consignees, must be accredited under this proposed program 
in order to conduct food testing under section 422(b)(1)(A) of the FD&C 
Act. Similarly, the ``on behalf of'' language of section 422(b)(1)(B) 
of the FD&C Act requires independent laboratories to be accredited 
under this proposed program in order to conduct food testing ``on 
behalf'' of owners and consignees under section 422(b)(1)(B) of the 
FD&C Act.
    Section 422(b)(1)(B) of the FD&C Act is silent with respect to 
testing conducted on imports by owners or consignees. Under one 
possible interpretation, the absence of ``by or'' in this provision 
would mean that only independent laboratories may be accredited to 
conduct food testing of imports under section 422(b)(1)(B) of the FD&C 
Act. Under this interpretation, laboratories owned by owners or 
consignees would be prohibited from conducting such import-related food 
testing. Otherwise, such ``in-house'' laboratories would be able to 
conduct import-related food testing without being accredited through 
our proposed program, which seems to be contrary to the intent of this 
program.
    Under this interpretation, laboratories owned by owners or 
consignees would be eligible to conduct food testing under section 
422(b)(1)(A) of the FD&C Act but not section 422(b)(1)(B), thereby 
raising the prospect that section 422(b)(1) would not apply equally to 
domestic and foreign goods (section 422(b)(1)(A) of the FD&C Act would 
generally apply to domestic owners or consignees and potentially 
foreign owners or consignees). Such a difference in treatment could 
raise potential concerns under U.S. international trade obligations. In 
this regard, we note that section 404 of FSMA provides that

[[Page 59462]]

nothing in the FD&C Act shall be construed in a manner inconsistent 
with the agreement establishing the WTO or any other treaty or 
international agreement to which the United States is a party.
    In considering section 422(b)(1)(B) of the FD&C Act and section 404 
of FSMA together, and to avoid any inconsistency with treaties or 
international agreements to which the United States is a party, we 
tentatively conclude that it is reasonable to interpret section 
422(b)(1)(B) of the FD&C Act to allow laboratories owned by owners or 
consignees to conduct food testing that falls under section 
422(b)(1)(B) of the FD&C Act, provided that such laboratories meet the 
accreditation requirements proposed. In addition, we are not aware of 
information indicating that laboratories owned by owners or consignees 
of foreign foods are less able to become accredited under this proposed 
program or to conduct food testing under section 422(b)(1)(B) of the 
FD&C Act than independent laboratories.
    b. Considerations in interpreting ``identified or suspected food 
safety problem'' in section 422(b)(1)(A) of the FD&C Act.
    Section 422(b)(1)(A)(i) and (ii) of the FD&C Act both require, in 
relevant part, that food testing must be conducted by a laboratory 
accredited under the food testing program that would be established by 
this proposed rule, if finalized, when applied to address an identified 
or suspected food safety problem. Because the circumstances that may 
constitute a food safety problem are highly fact dependent, we are not 
proposing an exhaustive list of circumstances that would constitute an 
``identified or suspected food safety problem.'' Instead, in proposed 
Sec.  1.1107(a)(1), we are proposing to codify the circumstances in 
existing FD&C Act regulations that address an identified or suspected 
food safety problem and thus trigger the requirement to use an 
accredited laboratory under this program. We also discuss as part of 
this rulemaking additional examples of identified or suspected food 
safety problems to explain the circumstances in which we tentatively 
conclude would allow for the issuance of food testing orders under 
proposed Sec.  1.1107(a)(2). In proposed Sec.  1.1107(a)(3) we are 
proposing to require the use of an accredited laboratory in additional 
circumstances where FDA determines it is appropriate to address an 
identified or suspected food safety problem.
    The statute does not define the terms ``identified or suspected 
food safety problem'' or ``food safety problem'' and the term ``food 
safety problem'' is not used elsewhere in the FD&C Act. However, the 
section titles of FSMA indicate that ``food safety problems'' are the 
problems that FSMA is intended to address: Title I of FSMA is entitled 
``Improving Capacity to Prevent Food Safety Problems,'' while Title II 
is entitled ``Improving Capacity to Detect and Respond to Food Safety 
Problems.'' In the preamble to the preventive controls for human food 
proposed rule, we noted that food safety problems may be associated 
with biological, chemical, physical, or radiological hazards (78 FR 
3646 at 3667). (We subsequently categorized radiological hazards as a 
subset of chemical hazards, see 80 FR 55908 at 55950, September 17, 
2015).
    In considering the circumstances that could constitute an 
identified or suspected food safety problem, we note that Congress did 
not require the presence of specific health risks, as in the reasonable 
probability of serious adverse health consequences or death to humans 
or animals standard, as a prerequisite to requiring the use of an 
accredited laboratory under section 422(b)(1)(A) of the FD&C Act. In 
the preventive controls for human food rule, we indicated that an 
``unanticipated food safety problem'' could occur where a preventive 
control is not properly implemented, including circumstances where a 
pathogen or appropriate indicator organism is present in a ready-to-eat 
product detected through product testing, or an environmental pathogen 
or appropriate indicator organism is detected through environmental 
monitoring, or where a preventive control is found to be ineffective. 
See 21 CFR 117.150(b)(1)(i) and (ii) and 117.150(a)(1)(i) and (ii). 
Depending on the circumstances, we tentatively conclude that a positive 
indicator organism test would not necessarily constitute even a 
``suspected'' food safety problem. For example, because Listeria spp. 
will occasionally be found in a food production environment, our 
current thinking is that, depending on certain factors, a single 
positive Listeria spp. on a food-contact surface in a facility would 
not necessarily constitute a suspected food safety problem. We 
tentatively conclude that an ``identified food safety problem'' could 
be present when a specific article of food violates a provision of the 
FD&C Act that relates to food safety, such as certain violations of 
section 402 of the FD&C Act (21 U.S.C. 342).
    Section 422(b)(1)(A) of the FD&C Act does not limit the factors 
that can generate suspicion of a food safety problem, and we believe a 
variety of circumstances could generate such suspicion depending on the 
circumstances, including the presence of Listeria monocytogenes on a 
food-contact surface; the presence of multiple positives for Listeria 
spp. on a food-contact surface; and potential contamination events. We 
are proposing that the element of suspicion in a ``suspected food 
safety problem'' typically be particularized, that is, have a basis in 
fact about a particular article or articles of food (e.g., a lot or 
batch) or food production environment (e.g., a specific facility), as 
opposed to being satisfied by the common or usual characteristics of a 
food (e.g., whether a food is considered ``high-risk'' because of its 
inherent characteristics, such as pH or water activity) or the manner 
in which such food is typically produced. Under this proposal, 
suspicion that a specific article of food violates a provision of the 
FD&C Act or implementing regulations related to food safety would 
constitute a suspected food safety problem.
    For these reasons, we tentatively conclude that the routine product 
testing and environmental monitoring requirements at Sec.  
117.165(a)(2) and (3), respectively, are not conducted to address a 
suspected (or identified) food safety problem, because this testing is 
conducted to verify the implementation and effectiveness of preventive 
controls and not because a food safety problem is suspected or 
identified. See 80 FR 55908 at 56062.
    Although we are not proposing an exhaustive list of identified or 
suspected food safety problems, in proposed Sec.  1.1107(a)(1), (a)(2), 
or (a)(3), we are proposing to codify testing requirements in Sec.  
1.1107(a)(1) and (a)(3) that address an identified or suspected food 
safety problem, which provides examples of circumstances that would 
constitute an identified or suspected food safety problem.
    c. Proposed Sec.  1.1107(a)(1) and section 422(b)(1)(A)(i) of the 
FD&C Act.
    Because section 422(b)(1)(A)(i) of the FD&C Act applies to 
``specific'' testing requirements, we propose to interpret section 
422(b)(1)(A)(i) to apply only to provisions of the FD&C Act or its 
implementing regulations that explicitly require food testing.
    We have identified nine explicit testing requirements in our 
regulations that we tentatively conclude address an identified or 
suspected food safety problem. Each of these explicit testing 
requirements is required as followup, or corrective action, testing 
after a routine test is positive for a pathogen or indicator organism. 
Five of these testing requirements are in our regulations on 
production, storage, and transportation

[[Page 59463]]

of shell eggs (specifically, the testing requirements of Sec. Sec.  
118.4(a)(2)(iii), 118.5(a)(2)(ii), 118.5(b)(2)(ii), 118.6(a)(2), and 
118.6(e)), three are in our standards for the growing, harvesting, 
packing, and holding of sprouts (specifically, the testing requirements 
of Sec.  112.146(a), (c), and (d)), and one is in our regulations on 
the processing and bottling of bottled drinking water (specifically, 
one of the testing requirements of Sec.  129.35(a)(3)(i)). More 
specifically, testing would have to be conducted under this program 
under proposed Sec.  1.1107(a)(1), if finalized, under the following 
circumstances:
    With respect to production, storage, transportation of shell eggs:
     Section 118.4(a)(2)(iii) requires that if the 
environmental test required in paragraph (a)(2)(i) of Sec.  118.4 is 
positive, you must begin egg testing, as specified in Sec.  118.6, 
within 2 weeks of the start of egg laying.
     Section 118.5(a)(2)(ii) requires that if the environmental 
test at 40 to 45 weeks is positive, then you must begin egg testing 
(described in Sec.  118.6), unless you divert eggs to treatment as 
defined in Sec.  118.3 for the life of the flock in that poultry house. 
Results of egg testing must be obtained within 10 calendar days of 
receiving notification of the positive environmental test.
     Section 118.5(b)(2)(ii) requires that if the environmental 
test at 4 to 6 weeks after the end of a molting process is positive, 
then you must begin egg testing (described in Sec.  118.6), unless you 
divert eggs to treatment as defined in Sec.  118.3 for the life of the 
flock in that poultry house. Results of egg testing, when conducted, 
must be available within 10 calendar days of receiving notification of 
the positive environmental test.
     Section 118.6(a)(2) requires that if you have an SE-
positive environmental test at any time during the life of a flock, you 
must divert eggs to treatment (defined in Sec.  118.3) for the life of 
the flock in that positive poultry house or conduct egg testing as 
specified in paragraphs (b) through (e) of this section.
     Section 118.6(e) requires that if you have a positive egg 
test in a flock and divert eggs from that flock and later meet the 
negative test result requirements described in paragraph (c) of this 
section and return to table egg production, you must conduct one egg 
test per month on that flock, using sampling and methodology in 
Sec. Sec.  118.7 and 118.8, for the life of the flock.
    With respect to our standards for the growing, harvesting, packing, 
and holding of sprouts:
     Section 112.146 requires that, if you detect Listeria 
species or L. monocytogenes in the growing, harvesting, packing, or 
holding environment you must conduct additional testing of surfaces and 
areas surrounding the areas where Listeria species or L. monocytogenes 
was detected to evaluate the extent of the problem, including the 
potential for Listeria species or L. monocytogenes to have become 
established in a niche; conduct additional sampling and testing to 
determine whether the Listeria species or L. monocytogenes has been 
eliminated; and conduct finished product testing when appropriate.
    With respect to the processing and bottling of bottled drinking 
water:
     Section 129.35(a)(3)(i) requires that a source previously 
found to contain E. coli will be considered negative for E. coli after 
five samples collected over a 24-hour period from the same sampling 
site that originally tested positive for E. coli are tested and found 
to be E. coli negative.
    Many explicit testing requirements in our regulations are not 
subject to section 422(b)(1)(A)(i) of the FD&C Act because they require 
routine or verification testing, as opposed to testing to address an 
identified or suspect food safety problem. For example, none of the 
various testing requirements in our infant formula regulations at 21 
CFR part 106 would require the use of an accredited laboratory under 
this program because they are routine testing requirements for each 
production aggregate of infant formula manufactured.
    Section 422(b)(1)(A)(ii) of the FD&C Act requires, in pertinent 
part, that food testing must be conducted under this proposed rule 
whenever food testing is conducted by or on behalf of an owner or 
consignee as required by the Secretary of HHS, as the Secretary deems 
appropriate, to address an identified or suspected food safety problem. 
As such, we are interpreting section 422(b)(1)(A)(ii) of the FD&C Act 
to give FDA the authority to specify additional circumstances where 
food testing will be required to be conducted under this program, 
provided that the food testing is conducted to address an identified or 
suspected food safety problem. Unlike our authority under section 
422(b)(1)(A)(i) of the FD&C Act, which gives us the authority to 
require food testing to be conducted under this program in response to 
``specific testing requirements,'' we are interpreting section 
422(b)(1)(A)(ii) to give us authority to require testing to be 
conducted under this program in the absence of an existing explicit 
requirement to conduct testing under the FD&C Act or its implementing 
regulations. Therefore, we are proposing in Sec.  1.1107(a)(2) to 
require that food testing be conducted under this rule whenever food 
testing is conducted by or on behalf of an owner or consignee as 
required by FDA in a food testing order. We explain food testing orders 
in more detail in section VI.B.2 where we discuss proposed Sec.  1.1108 
(which addresses the question of when and how FDA will issue a food 
testing order).
    Proposed Sec.  1.1107(a)(3) would require that food testing be 
conducted under this program when food testing is conducted to address 
an identified or suspected food safety problem and presented to FDA as 
part of evidence for an informal hearing before a mandatory recall 
order under section 423(c) of the FD&C Act, as part of a corrective 
action plan under section 415(b)(3)(A) of the FD&C Act submitted after 
an order suspending the registration of a food facility, or as part of 
evidence submitted for an appeal of an administrative detention order 
under section 304(h)(4)(A) of the FD&C Act. Although these three 
enforcement authorities do not require food testing, if owners and 
consignees elect to conduct food testing in response to proceedings 
under these authorities, and such food testing addresses an identified 
or suspected food safety problem, this proposal would require such food 
testing to be conducted by a laboratory accredited under this proposed 
program.
    This proposed requirement is authorized under section 
422(b)(1)(A)(ii) of the FD&C Act, which states that testing must be 
conducted under the accredited laboratory program whenever such testing 
is conducted as required by the Secretary of HHS, as the Secretary 
deems appropriate, to address an identified or suspected food safety 
problem. As explained previously in the discussion of food testing 
orders under proposed section Sec.  1.1107(a)(2), we are interpreting 
section 422(b)(1)(A)(ii) of the FD&C Act to give FDA the authority to 
specify additional circumstances where food testing will be required to 
be conducted under this program in the absence of an explicit 
requirement to conduct food testing under the FD&C Act or its 
implementing regulations, provided that the food testing is conducted 
to address an identified or suspected food safety problem. As such, we 
are proposing in Sec.  1.1107(a)(3) to require owners or consignees to 
conduct food testing under this program whenever they elect to conduct 
food testing under the circumstances specified in Sec.  1.1107(a)(3). 
We tentatively conclude that it is

[[Page 59464]]

appropriate to require food testing related to these important public 
health enforcement authorities to be conducted under this program 
because all three of those circumstances could involve situations where 
food testing might be conducted to address an identified or suspected 
food safety problem.
    Specifically, FDA's mandatory food recall authority gives us the 
authority to order a responsible party to recall an article of food 
where we determine that there is a reasonable probability that the 
article of food (other than infant formula) is adulterated under 
section 402 of the FD&C Act or misbranded under section 403(w) of the 
FD&C Act (21 U.S.C. 343(w)) and there is a reasonable probability that 
the use of or exposure to such article will cause serious adverse 
health consequences or death to humans or animals. Before such an order 
is issued, FDA must provide the responsible party with an opportunity 
to request an informal hearing. Under the provision proposed here, if 
the results of food testing intended to address an identified or 
suspected food safety problem are submitted as evidence for the 
hearing, such tests must be conducted by a laboratory accredited under 
this program.
    Section 415(b)(1) of the FD&C Act provides that if the Secretary of 
HHS determines that food manufactured, processed, packed, received, or 
held by a facility registered under section 415 of the FD&C Act has a 
reasonable probability of causing serious adverse health consequences 
or death to humans or animals, the Secretary may by order suspend the 
registration of a facility that: (1) Created, caused, or was otherwise 
responsible for such reasonable probability or (2) packed, received, or 
held such food. Section 415(b)(3)(A) of the FD&C Act provides that if, 
after providing opportunity for an informal hearing, the Secretary of 
HHS determines that the suspension of registration remains necessary, 
the Secretary shall require the registrant to submit a corrective 
action plan to demonstrate how the registrant plans to correct the 
conditions found by the Secretary. We are proposing in Sec.  
1.1107(a)(3), that if any such corrective action plan includes food 
testing to address an identified or suspected food safety problem, such 
food testing must be conducted by a laboratory accredited under this 
program.
    Under section 304(h) of the FD&C Act, FDA can order administrative 
detention of food if there is reason to believe that an article of food 
is adulterated or misbranded. If FDA issues an order to 
administratively detain food, FDA will provide an opportunity to appeal 
the detention as specified under section 304(h)(4)(A) of the FD&C Act. 
We are proposing that if the results of testing intended to address an 
identified or suspected food safety problem are submitted to appeal the 
detention, such tests must be conducted by a laboratory accredited 
under this program. See proposed Sec.  1.1107(a)(3).
    Use of a laboratory accredited under this program in the context of 
these three enforcement authorities will increase our confidence in the 
food testing conducted in response to identified or suspected food 
safety problems of great significance to public health. By requiring 
that food testing be conducted in a manner in which we have added 
confidence, we will be in a better position to make appropriate 
decisions that protect public health.
    Section 422(b)(1)(B)(i) of the FD&C Act requires, in pertinent 
part, that food testing must be conducted under the food testing 
program that would be established by this proposed rule, if finalized, 
whenever food testing is conducted on behalf of an owner or consignee 
in support of admission of an article of food under section 801(a) of 
the FD&C Act (i.e., food that is imported or offered for import into 
the United States). We are proposing this requirement in Sec.  
1.1107(a)(4) of this proposed rule.
    As explained in section III.C., under section 801(a)(3) of the FD&C 
Act, we may refuse admission of an article of food imported or offered 
for import into the United States if the food is, or appears to be, 
adulterated or misbranded. Pending our decision to refuse admission, 
section 801(a) of the FD&C Act allows the owner or consignee of the 
imported article of food to introduce testimonial evidence regarding 
the admissibility of the food. Under Sec.  1.94(a), such testimony must 
be confined to matters relevant to the admissibility or destruction of 
the article of food and may be introduced orally or in writing.
    Owners and consignees often hire private laboratories to test the 
food and submit to us the results of the testing, along with associated 
analysis and data, as testimony to establish that the imported food 
complies with the FD&C Act. Currently, if we determine that the 
sampling methods and testing results are valid and that they 
demonstrate the detained food product does not appear to violate the 
FD&C Act, we will release the food from detention and allow it to 
proceed into the United States. Again, if this rule is finalized, an 
owner or consignee whose entry has been detained under 801(a) of the 
FD&C Act would need to use a lab accredited under this program in order 
to use the test results as testimonial evidence supporting admission.
    We note that to the extent that a question exists as to whether 
section 422(b)(1)(B)(i) of the FD&C Act applies to food testing to 
demonstrate compliance with section 805 of the FD&C Act for purposes of 
supporting admission of an article of food under section 801(a)(3) of 
the FD&C Act, we tentatively conclude that it does not apply. FSMA 
amended the FD&C Act to add section 805 to require persons who import 
food into the United States to perform risk-based foreign supplier 
verification activities for the purpose of verifying that imported food 
meets applicable U.S. safety requirements (the FSVP regulation, 
codified in Sec. Sec.  1.500 through 1.514, specifies the foods and 
importers to which the FSVP regulation applies and establishes 
requirements related to supplier verification). An article of food is 
subject to refusal of admission under section 801(a)(3) of the FD&C Act 
if it appears that the importer of the food ``is in violation of such 
section 805,'' that is, fails to comply with the FSVP regulations with 
respect to that food. See also Sec.  1.514(a). Significantly, this 
provision in section 801(a)(3) of the FD&C Act relates to the 
compliance status of the importer, and not the food. Consequently, the 
relevant inquiry for purposes of this provision of section 801(a)(3) of 
the FD&C Act is whether an importer has followed FSVP requirements. By 
contrast, section 422(b)(1)(B)(i) of the FD&C Act relates directly to 
the compliance status of articles of food.
    Given the different focus of the FSVP provision in section 
801(a)(3) of the FD&C Act from the focus of section 422(b)(1)(B)(i) of 
the FD&C Act, we tentatively conclude that it is reasonable to not 
apply section 422(b)(1)(B)(i) of the FD&C Act to food testing related 
to FSVP. That is, we tentatively conclude that it is reasonable to not 
require accredited laboratory to conduct food testing under this 
program for purposes of the FSVP rule.
    Section 422(b)(1)(B)(ii) of the FD&C Act requires that food testing 
must be conducted under the food testing program that would be 
established by this proposed rule, if finalized, whenever food testing 
is conducted on behalf of an owner or consignee to support the removal 
of food from an import alert through successful consecutive testing. We 
are proposing this food testing requirement in Sec.  1.1107(a)(5) of 
this proposed rule.
    An import alert conveys evidence that FDA can use to detain, 
without first

[[Page 59465]]

physically examining, incoming products that appear to violate the FD&C 
Act. The alert communicates that the Agency has enough evidence or 
other information to refuse admission of future shipments of an 
imported article, without first physically examining (sampling) the 
shipments. Put another way, the import alert indicates that there is 
enough evidence to detain the product without physical examination. 
There are a variety of factors that could lead FDA to place a product, 
manufacturer, shipper, grower, geographical area, and/or country on 
import alert. For example, questions could have been raised in an 
inspection of the manufacturing site, concerns might be raised by a 
recall, or there could be a history of problems and no signs that 
appropriate actions were taken to remedy the cause. In order for FDA to 
consider removing a product and/or firm from import alert, FDA must 
have evidence that the conditions that gave rise to the appearance of a 
violation have been resolved and the Agency has confidence that future 
entries will be in compliance with FDA laws and regulations. Often, 
individual import alerts include specific information regarding removal 
from DWPE. At the present time, many import alerts indicate that it 
would be helpful for responsible entities to present to FDA evidence of 
at least five shipments to the United States that have been found to 
not be violation.
    In contrast to section 422(b)(1)(B)(i) of the FD&C Act, which 
applies exclusively to specific articles of food that are imported or 
offered for import into the United States, section 422(b)(1)(B)(ii) of 
the FD&C Act applies to food generally. As such, we tentatively 
conclude that section 422(b)(1)(B)(ii) of the FD&C Act applies whenever 
successful consecutive testing supports the removal of food from an 
import alert, including testing on specific articles of food that are 
imported or offered for import into the United States and less common 
situations where food testing is conducted on food that is not being 
imported or offered for import into the United States. For example, 
section 422(b)(1)(B)(ii) of the FD&C Act would also apply if the 
results from successful consecutive testing of environmental swabs or 
of food that is being imported or offered for import in a foreign 
country are presented as evidence demonstrating that a manufacturer 
should be removed from an import alert. At present, most successful 
consecutive testing conducted for food under an import alert is 
conducted on specific articles of food that are imported or offered for 
import into the United States--and thus fall under both sections 
422(b)(1)(B)(i) and (ii) of the FD&C Act (and proposed Sec. Sec.  
1.1107(a)(4) and (a)(5)). However, we assume that Congress intended 
section 422(b)(1)(B)(ii) of the FD&C Act to have an independent 
meaning. (Norman J. Singer & J.D. Shambie Singer, 1A Sutherland 
Statutory Construction Sec.  21:1 (7th ed. 2018) which states that 
``[c]ourts should construe a statute, if possible, so no term is 
rendered superfluous or meaningless.'') Therefore, we interpret section 
422(b)(1)(B)(ii) of the FD&C Act to apply in part to food testing not 
covered by section 422(b)(1)(B)(i) of the FD&C Act, including 
successful consecutive testing for food under import alert that is not 
conducted on specific articles of food that are imported or offered for 
import into the United States.
    Finally, we note that we are not, as part of this rulemaking, 
defining the number of successful consecutive tests that would be 
required or recommended to support removal from import alert. Instead, 
this proposed rule would require that if you use successful consecutive 
testing as a means to support removal of food from an import alert, 
then such testing must be conducted under this program. (For procedural 
information on removal from DWPE, see section 9-8 of FDA's Regulatory 
Procedures Manual at https://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/default.htm.)
    In accordance with section 422(b)(1) of the FD&C Act, proposed 
Sec.  1.1107(b) would require that whenever food testing is required to 
be conducted in accordance with this program, as described in proposed 
Sec.  1.1107(a), analysis of the collected samples must be conducted by 
accredited laboratories that are accredited for the appropriate 
analytical method or methods by a recognized accreditation body.
    Proposed Sec.  1.1107(c) would require, with one exception, that 
such food testing may only be conducted on samples taken after the 
articles of food have arrived in the United States. As part of our 
import admissibility process, this policy allows us to verify that the 
requirements of Sec.  1.94(a) are met--i.e., that the testimony is 
relevant to admissibility in that the article(s) of food that is 
sampled and tested is the same article(s) of food being offered for 
import into the United States. Importantly, this policy would also help 
to ensure that the tested sample(s) accurately represents the condition 
of the article when presented for admission, thereby ensuring the 
evidence presented by the owner or consignee is representative of the 
article(s) offered for import. Proper and valid analysis of a sample is 
not relevant testimony about admissibility if the analyzed sample is 
not representative of the article of food imported or offered for 
import into the United States. Based on best available science and 
grounded in years of experience, we know that the process of getting a 
food item from where it was produced abroad to a U.S. port of entry is 
such that change in the item or analyte may occur. For example, 
bacteria may grow in the time it takes to transport an article of food 
from the point of export to the United States, or a new contaminant may 
be intentionally or inadvertently introduced in transit. Accordingly, 
when specific articles of food are imported or offered for import into 
the United States, our general policy would be that the sample must be 
taken after arrival.
    We are also proposing, however, an exception to that sampling 
policy for circumstances in which we determine that a sample taken 
prior to arrival is representative of the article of food offered for 
import into the United States and thereby satisfies those evidentiary 
requirements. We would make such a determination on a case-by-case 
basis, based on clear evidence that the product sampled and analyzed is 
actually the product offered for import. We would communicate our 
determination in writing to the owner/consignee. We invite comment on 
this proposed exception and whether, in addition to applying the 
exception on a case-by-case basis, we could extend the exception to 
apply to a set of defined circumstances. We invite comment on whether 
there are specific circumstances under which we could make a 
determination that could be applied broadly, say to a particular 
commodity or analyte generally, that sampling taken prior to export is 
representative of the article(s) offered for import? If so, what are 
those circumstances, and what evidence would give us assurance that 
sampling of all such articles prior to export would be representative 
of all articles arriving in the United States?
    As discussed above, we are proposing to interpret section 
422(b)(1)(B)(ii) of the FD&C Act such that testing conducted under 
paragraph (ii) (under an import alert that requires successful 
consecutive tests) would encompass both testing of specific articles of 
food imported or offered for import and other testing related to an 
import alert. For import alerts where food product testing

[[Page 59466]]

is generally sufficient evidence to overcome the appearance of the 
violation(s), although at present it is standard practice for a 
responsible entity seeking to have a food product removed from import 
alert to submit evidence of at least five non-violative shipments, it 
is possible that in some circumstances other testing could constitute 
relevant evidence. Examples of other, potentially relevant, testing 
might be environmental swabbing of a production facility, or food 
testing unconnected to a shipment of food offered for import into the 
United States. Our proposed sampling policy in Sec.  1.1107(c) would 
not apply to testing under an import alert that is unrelated to 
articles of food offered for import, because in circumstances unrelated 
to shipments, transit and timing issues would not present likely 
barriers to the relevance of the testing evidence.
2. When and how will FDA issue a food testing order? (Proposed Sec.  
1.1108)
    Proposed Sec.  1.1108 would, if finalized, establish our procedure 
for issuing food testing orders. Specifically, proposed Sec.  1.1108(a) 
provides that we may require an owner or consignee of an article of 
food to conduct food testing, or to have food testing conducted on 
their behalf, under this program, to address an identified or suspected 
food safety problem related to the article of food. As described 
previously, our authority for proposed Sec.  1.1108 comes from section 
422(b)(1)(A)(ii) of the FD&C Act, which provides that food testing must 
be conducted under the food testing program described in section 422 of 
the FD&C Act, whenever such testing is conducted by or on behalf of an 
owner or consignee, as required by FDA, as FDA deems appropriate, to 
address an identified or suspected food safety problem.
    Proposed Sec.  1.1108(b) elaborates that the food testing order 
will specify the food product or environment to be tested; whether the 
food testing may be conducted using an accredited laboratory that is 
owned, operated, or controlled by the owner or consignee; the timeframe 
in which the food testing must be conducted; and the manner of the food 
testing, such as the methods that must be used. We tentatively conclude 
that the language in section 422(b)(1)(A)(ii) of the FD&C Act stating 
that food testing must be conducted as required by FDA and as FDA deems 
appropriate grants FDA discretion to specify the terms and conditions 
of a food testing order to address an identified or suspected food 
safety problem.
    Proposed Sec.  1.1108(c) provides that food testing orders would 
contain all of the elements required by 21 CFR 16.22(a) and would 
thereby constitute notice of an opportunity for a regulatory hearing 
under 21 CFR part 16. Proposed Sec.  1.1108 further provides that an 
affected owner or consignee would be able to request a regulatory 
hearing on a food testing order under proposed Sec.  1.1174.
3. How will FDA make information about recognized accreditation bodies 
and accredited laboratories available to the public? (Proposed Sec.  
1.1109)
    Proposed Sec.  1.1109 provides that (except as provided by proposed 
Sec.  1.1109(b), which we discuss below) we would place on our website 
a list, which would be readily accessible to the public, of recognized 
accreditation bodies and accredited laboratories in the food testing 
program. We would establish and display this list in accordance with 
section 422(a)(1)(B) of the FD&C Act, which requires us to establish a 
publicly available registry of accreditation bodies recognized by FDA 
and laboratories accredited by a recognized accreditation body, 
including the name of, contact information for, and other information 
deemed appropriate by the FDA about such bodies and laboratories.
    The proposed list would include the name of and contact information 
for each recognized accreditation body and accredited laboratory in our 
program. We propose that it is also appropriate for the list to 
include, for each recognized accreditation body, the duration of the 
recognized accreditation body's recognition, and, for each accredited 
laboratory, the scope of accreditation, as well as the name and contact 
information of the recognized accreditation body that accredited the 
accredited laboratory. We also propose that the list include the 
recognition status of each accreditation body that has been recognized 
(i.e., whether the accreditation body's recognition is active, or 
whether it has been put on probation or revoked by FDA, relinquished by 
the accreditation body, or allowed to expire by the accreditation 
body), the date of any such change in recognition status, the 
accreditation status of each laboratory that has been accredited (i.e., 
whether the laboratory's accreditation is active, or whether the 
laboratory's accreditation is withdrawn or revoked or it has been put 
on probation by a recognized accreditation body or FDA (including 
whether by FDA or by a recognized accreditation body), or the 
laboratory has relinquished its accreditation (in-whole or in-part)), 
and the date of any such change in accreditation status.
    We believe this additional information beyond the name and contact 
information of recognized accreditation bodies and accredited 
laboratories would be appropriate to include in the list because it 
would make the list more useful and increase transparency. For example, 
if we did not include information about whether an accreditation body 
had its recognition revoked by FDA, and we instead simply deleted the 
accreditation body from the list, there could be ambiguity with respect 
to whether the deletion was for cause or whether the accreditation body 
voluntarily relinquished its recognition. We believe that users of the 
list would find the distinction between those two alternatives to be 
important. In addition, if a laboratory voluntarily relinquished its 
accreditation in-part, it might want the list to make clear that the 
reduction in its scope of accreditation was a voluntary action.
    Proposed Sec.  1.1109(b) reiterates section 422(a)(4) of the FD&C 
Act, which grants us the authority to, when in the interest of national 
security, determine in coordination with the Secretary of Homeland 
Security the time, manner, and form in which the list described in 
proposed Sec.  1.1109(a) is made publicly available. In the absence of 
a determination to the contrary under proposed Sec.  1.1109(b), the 
list would remain publicly and readily available at all times on our 
website and display all information specified by proposed Sec.  
1.1109(a).

C. Proposed Provisions About Recognition of Accreditation Bodies 
(Proposed Sec.  1.1113)

    Section 422(a)(2) of the FD&C Act requires that FDA provide for the 
recognition of laboratory accreditation bodies that meet the criteria 
established by FDA for accreditation of laboratories to conduct food 
testing. Accordingly, this proposed rule proposes certain criteria that 
accreditation bodies must meet to become recognized by FDA to accredit 
laboratories under this program.
1. What requirements must an accreditation body meet to be recognized 
by FDA? (Proposed Sec.  1.1113)
    Proposed Sec.  1.1113 would require that, to become recognized by 
FDA, an accreditation body seeking recognition by FDA must: (a) Be a 
full member of ILAC and a signatory to the ILAC MRA that has 
demonstrated competence to ISO/IEC 17011:2017; (b) demonstrate it meets 
the requirements of ISO/IEC 17011:2017 (Ref. 12); (c) demonstrate

[[Page 59467]]

that it possesses sufficient scientific/technical expertise to be able 
to substantively assess certain work of the laboratories it accredits; 
and (d) demonstrate it is capable of complying with this rule's 
proposed requirements for recognized accreditation bodies.
    ILAC was established to create an international arrangement between 
member accreditation bodies to develop and harmonize laboratory and 
inspection body accreditation practices. Currently more than 90 
accreditation bodies are signatories to the ILAC MRA. To become an ILAC 
MRA signatory, an accreditation body must commit itself to maintaining 
conformity with the current version of ISO/IEC 17011 and to ensuring 
that all laboratories it accredits comply with appropriate laboratory 
standards. Under this proposed rule, accreditation bodies would be 
required to meet ISO/IEC 17011:2017, which is incorporated by 
reference. Therefore, we are proposing that in order to be recognized 
as an accreditation body, an accreditation body must be a signatory to 
the ILAC MRA that has demonstrated competence to ISO/IEC 17011:2017. If 
at some point in the future ISO/IEC 17011:2017 is updated, FDA would 
consider whether to amend the codified consistent with that update, 
allowing an adequate transition period.
    Requiring recognized accreditation bodies to be signatories to the 
ILAC MRA that have demonstrated competence to ISO/IEC 17011:2017 and to 
be members in good standing of ILAC would also be consistent with our 
withdrawn 2009 draft guidance, in which we recommended that accredited 
laboratories be ILAC MRA signatories. We also considered the rationale 
stated by the Consumer Product Safety Commission (CPSC) in its 2013 
rule, ``Requirements Pertaining to Third Party Conformity Assessment 
Bodies'' (78 FR 15836, March 12, 2013), for requiring accreditation 
bodies to be signatories to the ILAC MRA. In particular, we agree with 
CPSC that requiring accreditation bodies to be signatories to the ILAC 
MRA that have demonstrated competence to ISO/IEC 17011, and not 
accepting any other arrangement, would: (1) Keep the accreditation 
program as simple as possible for use by interested parties (in our 
case, owners and consignees, accreditation bodies, and laboratories); 
(2) avoid any perceived notions of barriers to fair trade practices; 
establish a program that is manageable within Agency resources; and (3) 
maintain consistency in the procedures used by the recognized 
accreditation bodies (see 78 FR 15836 at 15857).
    Proposed Sec.  1.1113(b) would require that, to become recognized 
by FDA, an accreditation body seeking recognition by FDA must 
demonstrate that it meets the requirements of ISO/IEC 17011:2017. ISO/
IEC 17011:2017 specifies the general requirements for accreditation 
bodies assessing and accrediting conformity assessment bodies 
(``conformity assessment bodies'' are organizations providing testing, 
inspection, management system certification, personnel certification, 
or product certification). ISO/IEC 17011 is widely accepted, both 
domestically and internationally, and its incorporation by reference 
should allow us to utilize a framework that is familiar to 
accreditation bodies and the food industry.
    Proposed paragraph (c) would require that to be recognized under 
this program, an accreditation body must possess certain scientific/
technical expertise. Because the food testing that occurs under this 
program is important to public health, the laboratories conducting 
these food tests must be able to properly and accurately apply a 
particular test method, in an appropriate circumstance. Thus, it is 
vital that test methods be validated \6\ and verified as necessary (see 
Sec.  1.1151(a)), and that laboratories demonstrate their capability by 
participating in comparison programs such as proficiency testing (see 
Sec.  1.1138(a)(1)(ii)). Under this proposed rule, we would be relying 
on recognized accreditation bodies to substantively review some 
validation and verification studies, as well as accredited 
laboratories' proposed alternatives to proficiency tests, as part of 
their consideration of whether laboratories are competent to conduct 
the test methods for which they are seeking accreditation (see Sec.  
1.1138(a)(1)). Thus, we would expect recognized accreditation bodies to 
serve a function that accreditation bodies have not traditionally 
performed.
---------------------------------------------------------------------------

    \6\ The terms validate, validation, verify, and verification are 
used in this proposed rule in the specific context of conducting 
food testing. Other rules we have issued, particularly some rules we 
have issued pursuant to FSMA, use one or more of these terms in 
other contexts. The terms validate, validation, verify, and 
verification, as used in contexts other than the context of 
conducting food testing, may have different meanings than they do in 
the context of this proposed rule.
---------------------------------------------------------------------------

    Accordingly, to be recognized in this program, we expect an 
accreditation body to be able to substantively review validation 
studies; to have the scientific knowledge to meaningfully assess 
whether a study indicates that a proposed test method detected the 
identified hazard (or analyte) with sufficient accuracy and precision. 
We would expect recognized accreditation bodies to assess verification 
studies to determine whether the test method at issue may be properly 
applied to a particular food/analyte combination (e.g., strawberries/
salmonella). We would also expect recognized accreditation bodies to be 
able to assess an accredited laboratory's determination under proposed 
Sec.  1.1148(a)(2) that no proficiency testing program is available or 
practicable for a particular method, and to be able to assess whether a 
proposed alternative to a proficiency test would adequately demonstrate 
the laboratory's competence to conduct a test method. In these ways, we 
would expect accreditation bodies to possess and apply substantive 
scientific/technical knowledge. We acknowledge that for most if not all 
accreditation bodies, obtaining such scientific knowledge will require 
either hiring qualified in-house staff or contracting with assessors 
with the necessary experience and expertise. We have accounted for that 
cost in our proposed regulatory impact analysis.
    Again, this function of a recognized accreditation body is 
important to the public health, and we plan to robustly monitor this 
aspect of their performance. To that point, we intend to communicate 
our expectations for the assessment of validation and verification 
studies, and alternatives to proficiency tests, to the recognized 
accreditation bodies. We may consider issuing guidance on this topic, 
making ourselves available for technical assistance such as via regular 
roundtable meetings/conference calls with recognized accreditation 
bodies, and we welcome suggestions of other measures we could employ to 
support the recognized accreditation bodies in this function. We also 
welcome comments on this proposed provision.
    Proposed Sec.  1.1113(d) provides that an accreditation body 
seeking recognition must demonstrate it is capable of complying with 
this subpart's requirements for recognized accreditation bodies, which 
refers in part to requirements that are specific to this program and 
not contained in ISO/IEC 17011:2017. These requirements are primarily 
specified by proposed Sec. Sec.  1.1119 through 1.1125. For example, 
those proposed requirements specify that before we will recognize an 
accreditation body, it must demonstrate to us that it has policies, 
standard operating procedures, and other appropriate programs and 
measures in place to meet the proposed impartiality and conflict of 
interest requirements of proposed Sec.  1.1119 and to make appeals

[[Page 59468]]

procedures publicly available in accordance with proposed Sec.  1.1121.
    Another example of how paragraphs (b) and (d) of proposed Sec.  
1.1113 interact involves certain recordkeeping requirements of ISO/IEC 
17011:2017 and additional recordkeeping requirements for recognized 
accreditation bodies under this proposed rule. ISO/IEC 17011:2017 (Ref. 
12) section 9.4.2 requires accreditation bodies to have in place 
procedures by which records are retained for whatever period of time 
comports with the accreditation bodies' contractual duties, and 
proposed Sec.  1.1124 would require that recognized accreditation 
bodies electronically maintain, for 5 years after the date of creation 
of the records, records created while they are recognized. Accordingly, 
under proposed Sec.  1.1113(b) and (d) and Sec.  1.1124, an 
accreditation body seeking recognition would have to demonstrate the 
capability to implement records procedures to retain records for a 
period consistent with its contractual and legal obligations, which 
would include an obligation under proposed Sec.  1.1124 to maintain 
certain records, for at least 5 years after the date of creation of the 
records, created while the accreditation body is recognized.
    We discuss the documentation needed to meet the requirements of 
proposed Sec.  1.1113(a)-(d) where we discuss proposed Sec.  1.1128, 
below.
    We invite comment on proposed Sec.  1.1113's requirements for an 
accreditation body to become recognized under this program. If comments 
opposing these proposed requirements are submitted, we request comment 
on what alternative requirements or qualifications an accreditation 
body should have to be eligible for recognition to accredit 
laboratories under this program.

D. Proposed Provisions About Requirements for Recognized Accreditation 
Bodies (Proposed Sec. Sec.  1.1118 Through 1.1125)

    Section 422 of the FD&C Act provides that food testing under this 
program may only be conducted by laboratories accredited by 
accreditation bodies that we have recognized. Section 422(a)(2) of the 
FD&C Act directs us to establish the criteria for recognition of 
accreditation bodies and section 422(a)(7)(B) directs us to promptly 
revoke the recognition of any accreditation body found not to be in 
compliance with the requirements of section 422 of the FD&C Act. 
Accordingly, this proposed rule would establish certain criteria and 
obligations that recognized accreditation bodies must continue to meet 
to remain recognized. We have proposed these general requirements for 
recognized accreditation bodies to remain recognized at Sec. Sec.  
1.1118 through 1.1125, and we discuss these requirements below.
1. What are the general requirements for recognized accreditation 
bodies to remain recognized? (Proposed Sec.  1.1118)
    For recognized accreditation bodies to remain recognized, proposed 
Sec.  1.1118 would require them to continue to: (a) Be a full member of 
the ILAC and a signatory to the ILAC MRA that has demonstrated 
competence to ISO/IEC 17011:2017; (b) meet, with respect to activities 
under this subpart, the requirements of ISO/IEC 17011:2017, which would 
be incorporated by reference under this rule; (c) demonstrate that it 
possesses sufficient scientific/technical expertise to be able to 
substantively assess certain work of the laboratories it accredits; and 
(d) comply with the proposed requirements for recognized accreditation 
bodies. The additional requirements referenced by proposed Sec.  
1.1118(d) are primarily specified by proposed Sec. Sec.  1.1119 through 
1.1125. See our discussion at section VI.C, above, for more information 
about these proposed criteria.
2. What requirements apply to how a recognized accreditation body must 
protect against conflicts of interest? (Proposed Sec.  1.1119)
    We believe that protecting against conflicts of interest among 
participants in this program is critical to the integrity of this 
proposed program. We are proposing that recognized accreditation bodies 
take certain steps to safeguard against conflicts of interest in 
addition to meeting the impartiality requirements of ISO/IEC 
17011:2017. Under proposed Sec.  1.1119(a)(1), a recognized 
accreditation body would need to ensure that it, and its officers, 
employees, or other agents involved in accreditation activities, does 
not own or have a financial interest in, manage, or otherwise control 
any laboratory (or any affiliate, parent, or subsidiary) it accredits. 
Section 4.4.11 of ISO/IEC 17011:2017 (Ref. 12) prohibits an 
accreditation body from offering or providing any food testing services 
(and from offering or providing any other services that may affect its 
impartiality). However, we have tentatively concluded that it is also 
important to prevent a recognized accreditation body from having a 
financial interest in, managing, or otherwise controlling any 
laboratory (or any affiliate, parent, or subsidiary) that it accredits, 
and to explicitly extend that prohibition to officers, employees, and 
other agents of the recognized accreditation body, in order to protect 
against conflicts of interest. To ensure the effectiveness of proposed 
Sec.  1.1119(a)(1), we also have tentatively concluded that it is 
important to extend the conflict of interest safeguards in this 
provision to subsidiaries, affiliates, and parent organizations of the 
laboratory. We seek comments with regards to whether proposed Sec.  
1.1119(a)(1) would impose an undue burden on any existing financial, 
managerial, or control interest that accreditation bodies may currently 
have in food testing laboratories and/or whether there are other 
measures that could prevent such an interest from creating a conflict 
of interest.
    Under proposed Sec.  1.1119(a)(2), a recognized accreditation body 
would be required to prohibit officers, employees, or other agents 
involved in accreditation activities of the recognized accreditation 
body from accepting any money, gift, gratuity, or other item of value 
from any laboratory that they accredit or that are seeking their 
accreditation that conducts food testing. We seek comment on whether 
this proposal is sufficient to protect against conflicts of interest 
related to money, gifts, gratuity, and other items of value.
    Proposed Sec.  1.1119(b) provides that the prohibited money, gift, 
gratuity, or other item of value described by proposed Sec.  
1.1119(a)(2) does not include payment of fees for accreditation 
services, reimbursement of direct costs associated with an onsite 
assessment or reassessment of the laboratory, and onsite lunch, of a de 
minimis value, provided during the course of an assessment or 
reassessment, if necessary to facilitate the efficient conduct of the 
assessment.
    Under proposed Sec.  1.1119(c), the financial interests of spouses 
and children younger than 18 years of age would be imputed to a 
recognized accreditation body's officers, employees, and other agents 
involved in its accreditation activities. We have included a similar 
imputation provision in other regulations, including the FSMA 
accredited third-party certification regulation. See 21 CFR 1.657(c)) 
and 21 CFR 516.141(g). We believe this provision would help ensure the 
integrity of the food testing program.
    We seek comment on proposed Sec.  1.1119 and whether there are any 
other potential conflicts interest for recognized accreditation bodies 
that should be addressed in this proposed program. For any comment 
recommending that we address other types of conflicts, we request

[[Page 59469]]

recommended measures to address such conflicts, and any references or 
documents that are available to support the recommendation.
3. How must a recognized accreditation body evaluate laboratories 
seeking accreditation and oversee the performance of laboratories it 
accredits? (Proposed Sec.  1.1120)
    We anticipate that many laboratories that seek accreditation in our 
proposed program already will be accredited to ISO/IEC 17025:2017 by an 
accreditation body to which we have granted recognition. To provide 
flexibility to such participants, we are proposing laboratory 
assessment requirements for our program that build upon, and could be 
combined with, the existing assessments of laboratories that 
accreditation bodies conduct under ISO/IEC 17011:2017 during an 
accreditation cycle. For example, if an accreditation body has 
conducted an onsite assessment of an ISO/IEC 17025:2017 accredited 
laboratory in the past 2 years, proposed Sec.  1.1120(c) would 
potentially allow the initial assessment for accreditation to our 
program to be conducted remotely, and to only address whether the 
laboratory meets the unique requirements of our program that are not 
required by ISO/IEC 17025:2017 (see proposed Sec.  1.1138(a)(1) and 
(c)). If such an onsite assessment has not been conducted in the past 2 
years, an accreditation body's initial assessment of a laboratory for 
accreditation in our program would be required to be conducted onsite 
and would be required to address whether the laboratory meets all the 
requirements of our program, including the requirements of ISO/IEC 
17025:2017 specified in proposed Sec.  1.1138(a)(2) and (b).
    Where the initial assessment for accreditation to our program is 
conducted remotely under proposed Sec.  1.1120(c), proposed Sec.  
1.1120(e) and (f) would require the recognized accreditation body to 
conduct its first assessment of the sample of the scope of 
accreditation of the accredited laboratory onsite, and no later than 2 
years after the accreditation body last conducted an onsite assessment 
of the laboratory, in accordance with ISO/IEC 17011:2017. These 
proposed requirements are intended to ensure that recognized 
accreditation bodies conduct onsite assessments of accredited 
laboratories in our program at least every 2 years. We regard periodic 
onsite assessments as necessary to effectively evaluating a laboratory. 
In addition, proposed Sec.  1.1120(g) would require that the 
reassessment of an accredited laboratory (see ISO/IEC 17011:2017 (Ref. 
12, at section 7.9.4)) at the end of the laboratory's accreditation 
cycle be conducted onsite.
    However, when conducting an ``onsite'' assessment, if conducting a 
particular assessment activity onsite will not aid in the assessment of 
a laboratory, proposed Sec.  1.1120(b), (e), and (g), would allow such 
activities to be conducted remotely. Our intent is that this exception 
would allow assessment activities such as document review or followup 
inquiries to a laboratory after an onsite visit to be conducted 
remotely. Proposed Sec.  1.1120(h) would allow any assessments 
conducted by a recognized accreditation body other than the assessments 
referred to in Sec.  1.1120(a), (e), and (g)--that is, the initial 
assessment, sample of the scope of accreditation, and reassessment--to 
be conducted entirely remotely if it will not aid the assessment to 
conduct them onsite.
4. What appeal procedures must a recognized accreditation body provide 
for appeals of decisions to not grant accreditation? (Proposed Sec.  
1.1121)
    Proposed Sec.  1.1121 provides that a laboratory may appeal a 
decision by the recognized accreditation body to not grant the 
accreditation (in-whole or in-part) that the laboratory sought, and the 
recognized accreditation body must consider the appeal, in accordance 
with the requirements of Sec.  1.1118(b). We are proposing this 
provision because ISO/IEC 17011:2017 does not explicitly state what 
actions by the accreditation body a laboratory may appeal.
    Proposed Sec.  1.1121 would require recognized accreditation bodies 
to establish and implement certain written procedures for addressing 
appeals from laboratories challenging a recognized accreditation body's 
decision to not grant the accreditation (in-whole or in-part) that the 
laboratory sought. Specifically, proposed Sec.  1.1121 provides that, 
in addition to meeting the requirements of Sec.  1.1118(b) related to 
appeals, the recognized accreditation body must establish and implement 
written procedures to make the appeals procedures publicly available, 
and use a competent person(s), who may or may not be external to the 
recognized accreditation body, is free from bias or prejudice and has 
not participated in the accreditation decision, and is not the 
subordinate of a person who participated in the accreditation decision, 
to review and decide appeals. We have tentatively concluded that the 
requirements of proposed Sec.  1.1121 are important supplemental 
requirements to ISO/IEC 17011:2017 (Ref. 12) section 7.13 that would 
provide additional protections to laboratories and help ensure 
transparency of the program. We seek comments on these proposed 
requirements, including with respect to whether these proposed 
requirements would significantly differ from the current appeals 
practices of accreditation bodies.
5. When must a recognized accreditation body withdraw or reduce the 
scope of the accreditation of a laboratory, and when may a recognized 
accreditation body put an accredited laboratory on probation? (Proposed 
Sec.  1.1122)
    Proposed Sec.  1.1122(a) would require recognized accreditation 
bodies to withdraw the accreditation of a laboratory it accredits when 
the accredited laboratory substantially fails to comply with this rule. 
Although section 7.11 of ISO/IEC 17011:2017 (Ref. 12) specifies certain 
circumstances that would require the accreditation body to initiate the 
process for withdrawing the accreditation of the laboratory--including 
fraudulent behavior--it does not articulate a general standard for when 
accreditation bodies should initiate the process for withdrawing 
accreditation.
    Although we are proposing that withdrawal of accreditation be 
initiated by a ``substantial'' failure to comply with this subpart--and 
not by minor or de minimis violations--we note that the failure or 
refusal by the accredited laboratory to take appropriate corrective 
action (as it is required to do under ISO/IEC 17025:2017 (Ref. 13) at 
section 8.7) to prevent subsequent minor violations may rise to the 
level of substantial failure to comply with this rule. For example, if 
on a single occasion an accredited laboratory fails to provide FDA with 
documentation of the sampler's qualifications as required by Sec.  
1.1152(c)(2), that in and of itself would not generally be considered a 
substantial violation. However, frequent and recurring failure by a 
laboratory to submit all required components of a full analytical 
report, even when each instance constitutes a minor violation, combined 
with a failure or refusal by the accredited laboratory to take 
appropriate corrective action to prevent such mistakes from recurring, 
may in certain circumstances be grounds for withdrawal of 
accreditation.
    Proposed Sec.  1.1122(b) provides that a recognized accreditation 
body may put an accredited laboratory it accredits on probation if the 
recognized accreditation body determines that the laboratory 
demonstrates deficiencies in performing

[[Page 59470]]

its functions under this program that are less serious than would 
justify withdrawal of the accredited laboratory's accreditation (in-
whole or in-part) under proposed Sec.  1.1122(a), and it is reasonably 
likely that the accredited laboratory will be able to correct such 
deficiencies within a reasonable specified period of time. Our intent 
is that probation would allow recognized accreditation bodies to work 
with laboratories they accredit to bring such laboratories into 
compliance with the program without having to resort to withdrawing 
accreditation.
    As noted, this proposed rule refers to reduction of an accredited 
laboratory's scope of accreditation by a recognized accreditation body 
as withdrawal of accreditation in-part. Proposed Sec.  1.1122(c) 
clarifies that when there are grounds for withdrawal of accreditation, 
but the deficiencies affect only certain analytical methods within the 
accredited laboratory's scope of accreditation, the recognized 
accreditation body may withdraw the accredited laboratory's scope of 
accreditation for only those affected analytical methods. This 
provision is meant to facilitate limited withdrawal of accreditation 
when warranted.
    Under proposed Sec.  1.1122(d) a recognized accreditation body may 
require from a laboratory that it accredits the submission of records 
that the accredited laboratory would be required to maintain under 
proposed Sec.  1.1153, in order to assist the recognized accreditation 
body in determining whether a withdrawal of accreditation (in-whole or 
in-part) or probation is warranted.
    Proposed Sec.  1.1122(e) describes the process a recognized 
accreditation body must follow when withdrawing the accreditation of an 
accredited laboratory under this program. Under proposed Sec.  
1.1122(e), the recognized accreditation body must notify the laboratory 
of the withdrawal of the laboratory's accreditation, and the 
notification must specify whether the withdrawal of accreditation is 
in-whole or in-part, and if it is in-part, to which testing methods it 
applies. The notification must also describe the grounds on which the 
accreditation was withdrawn and state the procedures for appealing the 
withdrawal.
    Proposed Sec.  1.1122(f) provides that the recognized accreditation 
body would have to: (1) Notify the laboratory of its probationary 
status; (2) describe the grounds for the probation; (3) identify all 
deficiencies that the laboratory must correct for the recognized 
accreditation body to lift the probation; and (4) either inform the 
laboratory that it has a specific timeframe to take particular 
corrective actions with respect to the identified deficiencies or 
require the laboratory to submit a plan to the recognized accreditation 
body for approval that identifies the appropriate corrective actions 
the laboratory will take to resolve the identified deficiencies and 
that identifies appropriate timeframes for resolution. Our intent is 
that while probation is in effect, the recognized accreditation body 
will work with the accredited laboratory to bring it into compliance 
with the requirements of the program.
    Proposed Sec.  1.1122(g) describes the consequences of withdrawal 
of accreditation (in-whole or in-part) or probation. If a recognized 
accreditation body withdraws the accreditation of a laboratory in-
whole, the laboratory would be immediately ineligible to conduct food 
testing under this rule. If the recognized accreditation body withdraws 
the accreditation of a laboratory in-part, the laboratory would be 
immediately ineligible to conduct food testing under this rule with 
respect to only the specific methods for which accreditation was 
withdrawn. An accredited laboratory's substantial failure to comply 
with this rule would undermine the integrity and validity of this 
proposed program and of the laboratory's affected food testing 
conducted under this proposed rule. Withdrawal of the laboratory's 
accreditation would ensure that the laboratory does not continue to 
conduct the affected food testing under this rule. This consequence is 
in accordance with the requirement in section 422(b)(1) of the FD&C Act 
that food testing under section 422 may only be conducted by 
laboratories that are accredited by recognized accreditation bodies for 
the methods of analysis appropriate for such food testing. An 
accredited laboratory that is put on probation by an accreditation body 
under this proposed rule would be permitted to continue to conduct food 
testing under this subpart, because it would still be accredited under 
this program. However, an accredited laboratory that is put on 
probation under this proposed rule would not be able to submit abridged 
analytical reports under Sec.  1.1152(d).
    Proposed Sec.  1.1122(h) discusses requirements related to how the 
recognized accreditation body must handle appeals of withdrawals of 
accreditation (in-whole or in-part). Under proposed Sec.  1.1122(h), a 
laboratory may appeal a decision by the recognized accreditation body 
to withdraw the accreditation (in-whole or in-part) of the laboratory, 
and the recognized accreditation body must consider the appeal in 
accordance with the requirements of ISO/IEC 17011:2017 (Ref. 12) 
(specifically, ISO/IEC 17011:2017 at section 7.13). In addition to 
meeting the requirements of ISO/IEC 17011:2017 related to appeals, the 
recognized accreditation body must establish and implement written 
procedures to make the appeals procedures publicly available; and to 
use a competent person(s), who may or may not be external to the 
recognized accreditation body, who is free from bias or prejudice and 
has not participated in the withdrawal decision, and is not the 
subordinate of a person who participated in the withdrawal decision, to 
review and decide appeals.
6. What reports and notifications must a recognized accreditation body 
submit to FDA? (Proposed Sec.  1.1123)
    Proposed Sec.  1.1123 would require recognized accreditation bodies 
to submit to FDA reports of their internal audits and notices of 
matters affecting their recognition and the accreditation status of 
laboratories they accredit, among other notices.
    In proposed Sec.  1.1123 and other provisions in this proposed 
rule, we are proposing that information submitted to FDA be submitted 
electronically and in English. Electronic submission of information 
will help ensure we have ready access to information needed for 
monitoring and oversight of the program and promote the overall 
efficiency of the program. We have also tentatively concluded that 
requiring electronic submission would not be significantly burdensome 
for the accreditation bodies and laboratories in this program. FDA 
plans to establish an electronic portal for this program and recognized 
accreditation bodies would be able to submit all required notification 
and reports through that portal.
    Proposed Sec.  1.1123(a) would require all reports and 
notifications submitted to FDA under this proposed section to include 
contact information for the accreditation body associated with the 
report or notification and, if applicable, contact information for the 
laboratory associated with the report or notification. Proposed Sec.  
1.1123(b) would require recognized accreditation bodies to submit to 
FDA electronically, in English, a report of the results of the internal 
audit required by section 9.7 of ISO/IEC 17011:2017 (Ref. 12) and the 
results of the audit of its compliance with the requirements of Sec.  
1.1118(c) and (d), which would be required by proposed Sec.  1.1125, no 
later than 45 days after completing the internal audit. Proposed Sec.  
1.1123(b) further provides that the report of the recognized

[[Page 59471]]

accreditation body's internal audit must include a description of the 
internal audit conducted; a description of any identified deficiencies; 
a description of any corrective actions taken and any corrective action 
the recognized accreditation body will take, including the timeline for 
such corrective actions; and a statement disclosing the extent to which 
the internal audit was conducted by personnel different from those who 
perform the activity or activities that were audited. The report does 
not have to be the same report used internally by the recognized 
accreditation body, but must be comprehensive enough to demonstrate 
whether the accreditation body is complying with the requirements of 
ISO/IEC 17011:2017 and the requirements of Sec.  1.1118(c) and (d). 
Such reports would provide us with important information about the 
extent to which the recognized accreditation body is monitoring its own 
performance under this program, any deficiencies the recognized 
accreditation body discovered about its activities, and any corrective 
actions implemented to address such deficiencies.
    Because recognized accreditation bodies must conduct such internal 
audits under ISO/IEC 17011:2017 and to maintain their ILAC membership, 
proposed Sec.  1.1123(b) would not require the recognized accreditation 
body to engage in duplicative internal audits. We also believe that 
providing 45 days for the recognized accreditation body to compile and 
submit this report is a reasonable amount of time that strikes a 
balance between our interest in reviewing information that is important 
to our oversight of the program and providing the recognized 
accreditation body sufficient time to initiate any appropriate 
corrective actions and develop a meaningful internal audit report. If 
the internal audit results in the recognized accreditation body 
discovering information that must be submitted to FDA immediately under 
proposed Sec.  1.1123(c), we expect the recognized accreditation body 
to submit that particular information to us immediately, within 48 
hours, in accordance with proposed Sec.  1.1123(c).
    Section 422(a)(1)(C) of the FD&C Act requires, as a condition of 
recognition, that recognized accreditation bodies report to us any 
changes that would affect the recognition of such recognition body. To 
implement this provision, proposed Sec.  1.1123(c)(1) would require the 
recognized accreditation body to notify us immediately of any changes 
it is aware of that would affect its recognition, including a 
description of the change, and, if the change is one made by the 
recognized accreditation body, an explanation for the purpose of the 
change. Proposed Sec.  1.1123(c)(1) would cover changes in the name or 
operations of a recognized accreditation body, such as the purchase of 
a recognized accreditation body by a company, as well as changes that 
would cause the recognized accreditation body to no longer meet the 
requirements of this proposed program, including if the recognized 
accreditation body ceases membership in ILAC or is no longer a 
signatory of the ILAC MRA demonstrating competence to ISO/IEC 
17011:2017. A change that prevents or undermines the accreditation 
body's compliance with this proposed program may result in revocation 
of recognition under proposed Sec.  1.1131. We would encourage 
recognized accreditation bodies to contact us if there are 
uncertainties about whether a change should be reported under proposed 
Sec.  1.1123(c)(1).
    Proposed Sec.  1.1123(c)(2) through (6) would require recognized 
accreditation bodies to immediately notify us, within 48 hours, of 
certain information related to the accreditation status of laboratories 
they accredit or that have sought their accreditation. Immediate notice 
is essential so that we can take timely action to update the public 
website described by proposed Sec.  1.1109; accept food testing results 
from newly accredited laboratories; refuse to accept food testing 
results from laboratories that are no longer accredited for the food 
testing at issue; and take any other actions as appropriate based on 
such information.
    Proposed Sec.  1.1123(c)(2) and (3) would require recognized 
accreditation bodies to submit information to us about their grants and 
denials of accreditation (in-whole or in-part) of laboratories. If a 
recognized accreditation body received a request for accreditation 
(which includes a request from a laboratory to add testing methods to 
its scope of accreditation) from a laboratory, and the recognized 
accreditation body granted accreditation for certain testing methods in 
the laboratory's request but denied accreditation for other testing 
methods in the laboratory's request, proposed Sec.  1.1123 would only 
require that a recognized accreditation body provide us with a single 
notification encompassing this information, as long as the notification 
includes all of the information that would be required under proposed 
Sec.  1.1123(c)(2) and (3).
    Proposed Sec.  1.1123(c)(2) and (3) would require the notification 
to include the scope of accreditation requested by the laboratory, the 
scope of accreditation granted and/or denied, and the ground for such 
denial, and the date of such grant. This information would be useful 
for our program oversight. For example, it would allow us to monitor 
accreditation activities, including situations where a laboratory 
appears to be successively applying for, and being denied, 
accreditation from different recognized accreditation bodies without 
changing its practices or application to remedy the basis or bases for 
the previous denial(s).
    Proposed Sec.  1.1123(c)(4) would require a recognized 
accreditation body to notify us immediately if it receives notice that 
an accredited laboratory it accredits intends to relinquish its 
accreditation (in-whole or in-part). Proposed Sec.  1.1123(c)(4) would 
also require such notification to include the scope of accreditation to 
which the relinquishment applies, and the effective date of the 
relinquishment.
    Proposed Sec.  1.1123(c)(5) would require a recognized 
accreditation body to notify us immediately when it withdraws (in-whole 
or in-part) its accreditation of a laboratory. Proposed Sec.  
1.1123(c)(5) would also require such notification to include the scope 
of accreditation to which the withdrawal applies, and the grounds for 
the withdrawal.
    Proposed Sec.  1.1123(c)(6) would require a recognized 
accreditation body to notify us immediately when it puts an accredited 
laboratory on probation. Proposed Sec.  1.1123(c)(6) would also require 
such notification to include the grounds for the probation, and any 
date by which the recognized accreditation body has determined the 
accredited laboratory must take appropriate corrective action.
    Having information on the reason(s) for probation or withdrawal of 
accreditation, and whether such withdrawal is in-whole or in-part, is 
important to us because it may affect whether and how we conduct any 
followup actions with regards to the laboratory in question or how we 
review food testing results from the laboratory in the future.
    Proposed Sec.  1.1123(c)(7) would require recognized accreditation 
bodies to notify us immediately when the recognized accreditation body 
knows that an accredited laboratory it accredits has committed fraud or 
submitted material false statements to FDA. We note that we would also 
typically expect the recognized accreditation body to initiate its 
process to withdraw accreditation of the laboratory in this 
circumstance (in accordance with ISO/IEC 17011:2017 (Ref. 12) section 
7.11.2). Proposed Sec.  1.1123(c)(7) would require the notification to 
include a description

[[Page 59472]]

of the basis for the accreditation body's knowledge of the fraud or 
material false statements, a description of the alleged fraud or 
material false statements, and the actions taken by the accreditation 
body with respect to such laboratory. Recognized accreditation bodies 
may be in a better position than us in many cases to determine whether 
an accredited laboratory has committed fraud or submitted material 
false statements to the FDA, due to recognized accreditation bodies' 
role in monitoring the laboratories they accredit. Furthermore, 
although proposed Sec.  1.1152(j) would require accredited laboratories 
to immediately notify us of any changes that would affect an accredited 
laboratory's compliance with the program requirements or that would 
otherwise affect the laboratory's accreditation, an accredited 
laboratory that has committed fraud or submitted material false 
statements to us may be unlikely to notify us that it did so.
7. What records requirements must a recognized accreditation body meet? 
(Proposed Sec.  1.1124)
    This proposed rule identifies specific types of records a 
recognized accreditation body would be required to control and maintain 
to document compliance with applicable requirements. The recognized 
accreditation body also would be required to provide FDA access to such 
records.
    Proposed Sec.  1.1124(a) provides that, in addition to meeting the 
records requirements of ISO/IEC 17011:2017 (as required by proposed 
Sec.  1.1118(b)), an accreditation body that has been recognized must 
electronically maintain records demonstrating its compliance with the 
program, created while it is recognized, for 5 years after the date of 
creation of the record. The requirements of Sec.  1.1124 would apply to 
accreditation bodies that have been recognized even if they later are 
no longer recognized. We are proposing this requirement because 
maintenance of such records could be vital to our management of this 
program.
    We are not proposing to require records subject to this proposed 
section to be maintained in English. In accordance with our position on 
this issue in the accredited third-party certification final rule, we 
are proposing to allow recognized accreditation bodies to maintain and 
submit records in languages other than English, provided that they 
electronically submit an English translation within a reasonable time 
thereafter. We decline to set a specific timeframe for submission of 
the translation because the circumstances surrounding each request will 
differ (e.g., varying number of documents/pages). Further, we are 
proposing under Sec.  1.1124(b) to require that if FDA requests records 
electronically, the records must be submitted no later than 10 business 
days after the date of the request, with the exception that records 
covered by the immediate notification provision in Sec.  1.1123(c) 
would be required to be submitted within 48 hours. By allowing records 
to be submitted in a language other than English, we think that it will 
not be unduly burdensome for recognized accreditation bodies to provide 
most requested records electronically within 10 days.
    We have tentatively concluded that the records maintenance and 
access requirements in proposed Sec.  1.1124 are necessary for us to 
adequately monitor recognized accreditation bodies, as we are directed 
to do by section 422(a)(7) of the FD&C Act. For example, access to such 
records could facilitate our determination of whether revocation of the 
accreditation body's recognition is warranted.
    Proposed Sec.  1.1124(c) further clarifies that recognized 
accreditation bodies must not prevent or interfere with FDA's access to 
the records accredited laboratories it accredits are required to 
maintain under proposed Sec.  1.1153. When FDA requests, under proposed 
Sec.  1.1153 or proposed Sec.  1.1159, that a laboratory submit or 
provide FDA access to records the laboratory would be required to 
maintain under proposed Sec.  1.1146(b) or proposed Sec.  1.1153, we 
expect that the recognized accreditation body that accredits the 
laboratory would not interfere with our access to such records. 
Maintaining freedom of access to such records is important to 
facilitate FDA's ability to provide general oversight of the food 
testing program, with respect to both recognized accreditation bodies 
and accredited laboratories.
8. What internal audit requirements must a recognized accreditation 
body meet? (Proposed Sec.  1.1125)
    Proposed Sec.  1.1125 would require a recognized accreditation body 
to audit its compliance with the requirements under Sec.  1.1118(c) and 
(d) as part of the internal audit that a recognized accreditation body 
conducts under Sec.  1.1118(b). Requiring recognized accreditation 
bodies to monitor their conformance to the requirements that are 
specific to this program, as well as to the requirements of ISO/IEC 
17011:2017, would ensure that accreditation bodies' internal audits 
cover all the requirements of this program. As discussed, proposed 
Sec.  1.1123(b)(1) would require the results of this audit to be 
submitted to us.

E. Proposed Provisions About Procedures for Recognition of 
Accreditation Bodies (Proposed Sec. Sec.  1.1128 Through 1.1133)

    In these sections we propose how an accreditation body may apply 
for recognition under this rule, propose procedures for recognition, 
probation, revocation, and relinquishment of recognition of 
accreditation bodies, and propose how FDA would oversee recognized 
accreditation bodies.
1. How does an accreditation body apply to FDA for recognition or 
renewal of recognition? (Proposed Sec.  1.1128)
    This proposed rule would establish procedures for accreditation 
bodies to follow when applying to FDA for recognition or renewal of 
recognition. Proposed Sec.  1.1128(a) would provide that an 
accreditation body seeking recognition must submit an application to 
FDA demonstrating that it meets the eligibility requirements of 
proposed Sec.  1.1113, which describes the proposed requirements for 
accreditation bodies to become recognized to accredit laboratories to 
conduct food testing under this program.
    Similarly, proposed Sec.  1.1128(b) would require an accreditation 
body seeking renewal of its recognition to submit a renewal application 
to us demonstrating that it continues to meet the requirements of this 
program.
    Proposed Sec.  1.1128(c) clarifies that accreditation bodies 
applying for recognition or renewal of recognition must submit 
documentation of conformance with ISO/IEC 17011:2017, and documentation 
of ILAC MRA signatory status demonstrating competence to ISO/IEC 
17011:2017, in meeting the requirements of proposed Sec.  1.1113(a) and 
(b) or proposed Sec.  1.1118(a) and (b), as applicable. Although we 
recognize that documentation of ILAC MRA signatory status under this 
program represents a determination that an accreditation body has 
demonstrated competence to ISO/IEC 17011:2017, proposed Sec.  1.1128(c) 
would require independent documentation that an accreditation body 
demonstrates competence to ISO/IEC 17011:2017 to provide us additional 
assurance that an accreditation body meets the specific requirements of 
the standard. Independent documentation of ISO/IEC 17011:2017 
competence could include the report of a peer evaluation by a regional 
cooperation group or ILAC conducted as part of the

[[Page 59473]]

ILAC MRA application and evaluation process. An accreditation body 
applying for recognition or renewal of recognition also would be 
required to submit documentation demonstrating it meets the 
requirements for accreditation bodies that are specific to this program 
under proposed Sec.  1.1113(c) and (d) or proposed Sec.  1.1118(c) and 
(d), as applicable. We would expect documentation of proposed Sec.  
1.1113(c) and (d) to come in the form of documents such as standard 
operating procedures, records procedures, the resumes of the scientific 
and technical staff or contractors who review validation and 
verification studies, and examples of contracts the accreditation body 
uses in its activities, while documentation of proposed Sec.  1.1118(c) 
and (d) would consist of documents created during the accreditation 
body's term of recognition, such as the internal audit required under 
proposed Sec.  1.1125. We request comments on what additional documents 
would demonstrate that an accreditation body meets the requirements of 
proposed Sec.  1.1113(c) and (d) and proposed Sec.  1.1118(c) and (d).
    Where the application for recognition or renewal of recognition 
does not sufficiently demonstrate that the accreditation body meets the 
requirements for recognition by FDA, it may be necessary for FDA to 
review additional documentation to determine whether the accreditation 
body meets the recognition requirements of the program, and FDA also 
may, as is noted by proposed Sec.  1.1129(b), request and conduct an 
onsite assessment of the applicant if necessary. Such additional 
documentation may include the accreditation body's reviews, 
assessments, and investigations of laboratories; results of the 
accreditation body's self-monitoring and internal audits; documents and 
other information regarding the accreditation body's authority, 
qualifications (including the expertise and training of its employees 
that assess laboratories that conduct food testing), resources, quality 
assurance program, and recordkeeping, reporting, notification, and 
monitoring procedures. For applications for renewal of recognition, FDA 
may also review documents and other information of one or more of the 
laboratories that are accredited by the recognized accreditation body.
    Applications for recognition and renewal are subject to certain 
requirements for the form and manner of submission. Under paragraphs 
(d) and (e) of proposed Sec.  1.1128 the accreditation body must submit 
to FDA a signed application (signed by the applicant or by an 
individual authorized to act on behalf of the applicant for purposes of 
seeking recognition or renewal of recognition), accompanied by any 
supporting documents, electronically and in English. We also propose to 
require an applicant to provide any translation or interpretation 
services we need to process the application. This may include providing 
translators or interpreters for FDA staff conducting onsite assessments 
of the applicant. We invite comment on our proposal to require 
submissions in English and to require translation or interpretation 
services as necessary.
2. How will FDA review applications for recognition and applications 
for renewal of recognition? (Proposed Sec.  1.1129)
    Under proposed Sec.  1.1129(a), FDA would review an accreditation 
body's recognition or renewal application for completeness and would 
notify the applicant of any deficiencies. We are proposing to review 
applications on a first-in, first-out basis according to the date the 
accreditation body submits the completed application. However, we may 
prioritize the review of specific applications based on program needs. 
To encourage applicants to supply any missing information promptly, we 
will not place an application in the queue for review until it is 
complete. Allowing incomplete applications in the queue might hold up 
applications that are ready for review, but were submitted later in 
time.
    Under proposed Sec.  1.1129(b), FDA would evaluate applications to 
determine whether the applicant meets the requirements for recognition 
or renewal of recognition. The evaluation may include an onsite 
assessment of the accreditation body. For renewal applications, if FDA 
does not reach a final decision before an accreditation body's 
recognition terminates by expiration, FDA may extend the terms of 
recognition for a specified period of time or until FDA reaches a final 
decision on the renewal application. Proposed Sec.  1.1129(b) further 
provides that FDA would notify the applicant, in writing, regarding 
whether the application has been approved or denied, and that we may 
make such notification electronically.
    Under proposed Sec.  1.1129(c), we would notify applicants of our 
decision to approve the application for recognition or renewal through 
issuance of recognition that would list any conditions associated with 
the recognition, including the duration of recognition.
    Proposed Sec.  1.1129(d) would allow us to grant recognition to an 
accreditation body for up to 5 years at a time (except if FDA needs to 
extend the term of recognition while it makes a renewal determination, 
as described at proposed Sec.  1.1129(b)), although we will determine 
the length of recognition on a case-by-case basis. We are proposing the 
5-year upper limit in accordance with section 422(a)(7) of the FD&C 
Act, which requires us to (in pertinent part), periodically, and in no 
case less than once every 5 years, reevaluate accreditation bodies 
recognized under this program to assess whether they meet the criteria 
for recognition. We do not necessarily expect to grant every 
recognition at the maximum 5-year duration. We believe that shorter 
terms of recognition may potentially be appropriate in the initial 
years of the food testing program or for any accreditation bodies with 
fewer years of experience accrediting laboratories to conduct food 
testing. When we proposed the same duration for recognition of 
accreditation bodies for the accredited third-party certification 
regulation, we received support for the proposal and for the 
flexibility to determine the length of recognition on a case-by-case 
basis, although we also did receive some comments expressing concern 
that we did not propose a fixed duration of recognition (80 FR 74570 at 
74601). As we noted in the accredited third-party certification final 
rule, where appropriate, we would grant recognition for the maximum 
duration of 5 years. Id. However, we also recognize it may be 
appropriate for the duration of recognition to vary depending on a 
number of factors, such as accreditation body experience and, for 
example, whether the accreditation body has had problems meeting the 
recognition requirements in the past.
    Under proposed Sec.  1.1129(e), if we deny a recognition or renewal 
application, we would notify the applicant, through an issuance of a 
notification of denial of recognition or denial of renewal application, 
that the accreditation body's recognition or renewal application has 
been denied. The notification of denial of recognition or denial of 
renewal application would state the basis for the denial and describe 
the procedures for requesting reconsideration of the application under 
Sec.  1.1171.
    Proposed Sec.  1.1129(f) provides that an applicant whose 
application for renewal or recognition was denied by FDA must notify 
FDA electronically, in English, within 10 business days of the date of 
issuance of a denial of a renewal application, of the name and contact 
information of the custodian who will maintain the records it is 
required to

[[Page 59474]]

maintain under proposed Sec.  1.1124(a) and to make them available to 
FDA as required by proposed Sec.  1.1124(b). Proposed Sec.  1.1129(f) 
would also require that the contact information for the custodian must 
include, at a minimum, an email address and the street address where 
the records required by proposed Sec.  1.1124 will be located. As noted 
previously, under proposed Sec.  1.1124 accreditation bodies that have 
been recognized must electronically maintain, for at least 5 years 
after the date of creation of the records, records subject to proposed 
Sec.  1.1124 that were created during the term of recognition.
    Under proposed Sec.  1.1129(g), FDA would promptly issue a notice 
of the denial of the application for renewal of recognition of the 
accreditation body to all laboratories accredited by the accreditation 
body whose application for renewal of recognition was denied.
    Under proposed Sec.  1.1129(h), FDA would provide public notice on 
the website described in proposed Sec.  1.1109 of the issuance of a 
denial of a renewal application and include the date of the issuance of 
the denial of a renewal application. This is the same approach we took 
in the accredited third-party certification regulation with respect to 
denials of renewal applications. See 21 CFR 1.631(h). We believe 
notification of denial of renewal would be important information to 
make easily available to interested parties and the public.
3. How will FDA oversee recognized accreditation bodies? (Proposed 
Sec.  1.1130)
    As noted above, section 422(a)(7)(A) of the FD&C Act requires us to 
periodically, and in no case less than once every 5 years, reevaluate 
recognized accreditation bodies. Section 422(a)(7)(B) of the FD&C Act 
requires us to promptly revoke the recognition of a recognized 
accreditation body for failure to meet the requirements of section 422 
of the FD&C Act.
    As we discuss above, proposed Sec.  1.1129(d) provides that we may 
grant recognition of an accreditation body for a period not to exceed 5 
years from the date of recognition. Proposed Sec.  1.1130(a) provides 
that we will assess each recognized accreditation body to determine its 
compliance with the applicable requirements of this proposed rule by no 
later than 4 years after the date of recognition for a 5-year 
recognition period, or by no later than the midterm point for a 
recognition period of less than 5 years. Accordingly, we propose to 
assess recognized accreditation bodies at least once during their 
period of recognition, in addition to any assessment we may have 
conducted during our review of an application for recognition and in 
addition to any assessment we may conduct during a review of an 
application for renewal of recognition. Proposed Sec.  1.1130(a) 
provides that our assessment of a recognized accreditation body may 
include review of records, an onsite assessment of the accreditation 
body, and onsite assessments of accredited laboratories the recognized 
accreditation body accredits, with or without the recognized 
accreditation body present (we would conduct such onsite assessments 
under proposed Sec.  1.1159).
    Proposed Sec.  1.1130(b) provides that we may conduct additional 
assessments of a recognized accreditation body, at any time, to 
determine the recognized accreditation body's compliance with the 
applicable requirements of the program. We may or may not notify the 
recognized accreditation body that we will be conducting such an 
assessment, which may be onsite.
    Our assessments of recognized accreditation bodies under proposed 
Sec.  1.1130 may be as brief or as extensive as is warranted and may 
include our review of an accreditation body's accreditations, 
assessments, and investigations of laboratories; results of an 
accreditation body's internal audits; documents and other information 
accreditation bodies are required maintain under Sec. Sec.  1.1118 and 
1.1124 regarding the accreditation body's authority, qualifications, 
resources, quality assurance program, and recordkeeping, reporting, 
notification, and monitoring procedures.
4. When will FDA revoke the recognition of an accreditation body or put 
a recognized accreditation body on probation? (Proposed Sec.  1.1131)
    This proposed rule would establish the criteria and procedures for 
revocation of recognition of an accreditation body. Section 
422(a)(7)(B) of the FD&C Act requires us to promptly revoke the 
recognition of any accreditation body found not to be in compliance 
with the requirements of section 422 of the FD&C Act. Accordingly, if a 
recognized accreditation body ceases to meet the criteria for 
recognition we establish under section 422 of the FD&C Act, we must 
revoke the recognized accreditation body's recognition.
    Under proposed Sec.  1.1131(a), we would revoke the recognition of 
an accreditation body if it fails to meet the requirements of this 
program, or where FDA determines the accreditation body has committed 
fraud or submitted material false statements to FDA.
    Examples of what would qualify as a failure by a recognized 
accreditation body to meet the requirements of this program would 
include:
     Refusing to allow FDA to access records as required by 
proposed Sec.  1.1124, to allow FDA to conduct an onsite assessment 
under proposed Sec.  1.1130, or to allow FDA to otherwise conduct an 
assessment under proposed Sec.  1.1130. Denial of access and ability to 
perform our oversight functions would prevent us from meeting our 
statutory responsibilities under section 422 of the FD&C Act to 
periodically reevaluate accreditation bodies and to promptly revoke the 
recognition of an accreditation body found not to be in compliance with 
section 422 of the FD&C Act.
     Demonstrating bias or lack of objectivity when conducting 
activities under this rule would violate the impartiality requirements 
of ISO/IEC 17011:2017, which recognized accreditation bodies must meet 
in accordance with Sec.  1.1118(b).
     Failing to take timely and appropriate corrective action 
in accordance with ISO/IEC 17011:2017 (Ref. 12) section 9.5 (which 
proposed Sec.  1.1118(b) of this rule would require the recognized 
accreditation body to comply with) after the recognized accreditation 
body identifies, or should have identified, that the recognized 
accreditation body is not operating in conformance with one or more 
requirements of this proposed rule.
    Fraud or the submission of material false statements by recognized 
accreditation bodies would undermine our ability to implement the 
program and would undermine the program's integrity and credibility. We 
request comment on whether this section should also allow for FDA to 
revoke a recognized accreditation body's recognition for ``other good 
cause.'' If you submit a comment in favor of adding such a provision, 
we request the comment provide one or more examples of what would 
constitute such other good cause (and yet would not otherwise support 
revocation under the proposed Sec.  1.1131(a)).
    Proposed Sec.  1.1131(b)(1) provides that, when we revoke an 
accreditation body's recognition we would notify the accreditation body 
that its recognition has been revoked through the issuance of a 
revocation stating the grounds for revocation, the procedures for 
requesting a regulatory hearing on the revocation under proposed Sec.  
1.1173, and the procedures for requesting reinstatement of recognition 
under proposed Sec.  1.1133.

[[Page 59475]]

    Proposed Sec.  1.1131(b)(2) would require the accreditation body 
to, within 10 business days of the date of issuance of revocation, 
notify us electronically, in English, of the name of the custodian who 
will maintain records and make them available to FDA as required by 
proposed Sec.  1.1124. Proposed Sec.  1.1131(b)(2) further provides 
that the contact information for the custodian must include, at a 
minimum, an email address and the street address where the records will 
be located. As we have discussed previously, the accreditation body's 
responsibility under this proposed rule to maintain certain records 
created while it was recognized does not end when the accreditation 
body is no longer recognized.
    Proposed Sec.  1.1131(c) provides that if we determine that a 
recognized accreditation body has demonstrated deficiencies in 
performing its functions under this proposed rule that are less serious 
and more limited than those identified in proposed Sec.  1.1131(a), and 
it is reasonably likely that the accreditation body will be able to 
correct such deficiencies within a reasonable period of time, we may 
temporarily put the recognized accreditation body on probation, rather 
than revoke its recognition, and request that the accreditation body 
take appropriate corrective actions. We expect that the probationary 
status of a recognized accreditation body would allow us to work with 
the recognized accreditation body to bring it into compliance with the 
requirements of the program without having to resort to the more 
permanent remedy of revoking recognition.
    Proposed Sec.  1.1131(d) provides that the probationary status of 
the recognized accreditation body would remain in effect until the 
recognized accreditation body demonstrates to our satisfaction that it 
has successfully addressed the deficiencies specified by FDA within the 
time period identified by FDA. Proposed Sec.  1.1131(d) also provides 
that, alternatively, the probationary period would end if we determine 
that revocation of recognition is warranted. We would likely determine 
that revocation of recognition is appropriate if the accreditation body 
fails or refuses to take appropriate corrective actions, or otherwise 
does not comply with the conditions specified by the notification of 
probation within the timeframe specified, or if appropriate, an 
otherwise reasonable timeframe.
    Proposed Sec.  1.1131(e) provides that if we put the recognized 
accreditation body on probation, we would formally notify the 
accreditation body of its probation. The notification would describe 
the grounds for the probation, identify all deficiencies that must be 
corrected for us to lift the probation, would identify a specified 
period of time to take certain corrective actions to address the 
deficiencies specified by us.
    Proposed Sec.  1.1131(f) would provide that an accreditation body 
that has had its recognition revoked may not accredit laboratories 
under this program or continue to oversee the laboratories it has 
previously accredited. This provision would also clarify that a 
recognized accreditation body that has been put on probation by FDA is 
expected to continue to oversee laboratories that it has accredited 
under this subpart and is permitted to continue to accredit 
laboratories under Sec.  1.1120 of this subpart. We would normally 
anticipate that such an accreditation body would continue to fulfill 
its responsibilities under this program during the probationary period. 
Note that FDA may conduct additional oversight of recognized 
accreditation bodies that are on probation, to help ensure quality and 
competency on the part of that particular accreditation body (and by 
extension for the integrity of the overall program).
    Proposed Sec.  1.1131(g) provides that FDA would issue a notice of 
the probation or revocation of recognition to all laboratories 
accredited by the accreditation body whose recognition was revoked or 
who was put on probation. In proposed Sec.  1.1164, we address the 
effects on accredited laboratories of the revocation of the recognition 
of their accreditation bodies.
    Proposed Sec.  1.1131(h) clarifies that we would also provide 
notice on the website described in proposed Sec.  1.1109, in accordance 
with proposed Sec.  1.1109, of our issuance of probation or revocation 
of recognition of the accreditation body. This is consistent with the 
provisions of proposed Sec.  1.1109.
    We solicit comments on our tentative conclusions regarding possible 
grounds for probation and revocation of recognition, and with respect 
to the procedures and requirements we have proposed here related to 
revocation and probation of recognition.
5. What must a recognized accreditation body do if it wants to 
voluntarily relinquish its recognition or does not want to renew its 
recognition? (Proposed Sec.  1.1132)
    Proposed Sec.  1.1132 requires a recognized accreditation body that 
voluntarily relinquishes its recognition before the recognition period 
terminates by expiration to follow certain procedures. Relinquishment 
on the initiative of the accreditation body is distinct from revocation 
of recognition under proposed Sec.  1.1131 and is a mechanism provided 
to recognition bodies in the accredited third-party certification 
regulation and under FDA's mammography program. See 21 CFR 1.635 and 21 
CFR 900.3(e). We are proposing certain procedural requirements, similar 
to those in the mammography and third-party accreditation programs, 
which accreditation bodies would be required to follow in relinquishing 
recognition or when a recognized accreditation body intends to allow 
its recognition to expire without seeking renewal. We believe these 
procedures are necessary to ensure an orderly transition for 
laboratories accredited by an accreditation body that is relinquishing 
its recognition or allowing it to expire and for us to make necessary 
adjustments in the program based on that relinquishment or expiration.
    Proposed Sec.  1.1132(a) describes the procedures that a recognized 
accreditation body would need to follow when it intends to relinquish 
its recognition or when it wishes to allow its recognition to expire 
without seeking renewal. In order to voluntarily relinquish its 
recognition or allow it to expire, a recognized accreditation body 
would need to notify FDA electronically and in English at least 60 days 
before voluntarily relinquishing its recognition or allowing its 
recognition to expire.
    Proposed Sec.  1.1132(a) would also require the recognized 
accreditation body to provide the name and contact information of the 
custodian who will maintain the records required under proposed Sec.  
1.1124 after the date of relinquishment or the date its recognition 
expires, as applicable, and make such records available to FDA as 
required by proposed Sec.  1.1124. The contact information for the 
custodian must include, at a minimum, an email address and the street 
address where the records required by proposed Sec.  1.1124 will be 
located.
    Under proposed Sec.  1.1132(b), we would require the accreditation 
body to notify the laboratories it had accredited that the 
accreditation body intends to relinquish its recognition or to allow 
its recognition to expire, specifying the date on which relinquishment 
or expiration will occur, and at least 60 days in advance.
    Proposed Sec.  1.1132(c) states that we would provide notice on the 
website described in proposed Sec.  1.1109 of the voluntary 
relinquishment or expiration of recognition of an accreditation body. 
This provision is consistent with the provisions of proposed Sec.  
1.1109, which

[[Page 59476]]

would establish what information we would display on the website 
described by Sec.  1.1109.
6. How does an accreditation body request reinstatement of recognition? 
(Proposed Sec.  1.1133)
    This proposed section describes the procedures that an 
accreditation body would have to follow when seeking reinstatement of 
its recognition. The procedures the accreditation body would be 
required to follow would differ depending on whether we revoked the 
accreditation body's recognition or the accreditation body voluntarily 
relinquished its recognition or allowed its recognition to expire.
    Under proposed Sec.  1.1133(a), an accreditation body that has had 
its recognition revoked may seek reinstatement of recognition by 
submitting a new application for recognition under proposed Sec.  
1.1128. The accreditation body must also submit evidence to us that the 
grounds for revocation have been resolved, including evidence 
addressing the cause(s) or condition(s) that were the basis for 
revocation, and it must identify measures it implemented to help ensure 
that such cause(s) or condition(s) are unlikely to recur.
    Under proposed Sec.  1.1133(b), an accreditation body that 
previously relinquished its recognition or allowed its recognition to 
expire may seek recognition by submitting a new application for 
recognition under proposed Sec.  1.1128.

F. Proposed Provisions About Accreditation of Laboratories (Proposed 
Sec.  1.1138)

    This proposed rule would establish the requirements for a 
laboratory seeking accreditation by a recognized accreditation body to 
test food in this program. Section 422(a)(2) and (a)(5) of the FD&C Act 
mention independent private laboratories, laboratories run and operated 
by Federal agencies, States, localities, and foreign laboratories, as 
examples of laboratories that recognized accreditation bodies may 
accredit under this program, so long as they meet accreditation 
requirements for our program. We expect a variety of these types of 
laboratories would apply to this program. With regard to States in 
particular, it is our understanding that State and public university 
laboratories currently conduct a significant portion of the shell egg 
testing which would be covered by this proposed rule. We therefore 
believe some state laboratories would apply.
    Section 422 of the FD&C Act contains requirements for laboratories 
to be accredited, including that they have a demonstrated capability to 
conduct one or more sampling and analytical testing methodologies for 
food (section 422(a)(2)) and that they meet model laboratory standards 
that FDA is required to develop (section 422(a)(6)).
    Section 422(a)(6) of the FD&C Act further requires that the model 
laboratory standards include methods to ensure that: (1) Appropriate 
analytical procedures (including rapid analytical procedures), and 
commercially available techniques are followed and reports of analyses 
are certified as true and accurate (section 422(a)(6)(A)(i)); (2) 
internal quality systems are established and maintained (section 
422(a)(6)(A)(ii)); (3) procedures exist to evaluate and respond 
promptly to complaints regarding analyses and other activities for 
which the laboratory is accredited (section 422(a)(6)(A)(iii)); and (4) 
individuals who conduct the analyses are qualified by training and 
experience to do so (section 422(a)(6)(A)(iv)). Section 422(a)(6)(B) of 
the FD&C Act also authorizes us to include in the model laboratory 
standards any other criteria we determine are appropriate.
    Section 422(a)(6) of the FD&C Act directs us to consult existing 
standards for guidance in developing the model laboratory standards for 
use in qualifying laboratories for accreditation. As discussed, we have 
consulted, and propose to incorporate by reference, ISO/IEC 17025:2017. 
The model laboratory standards we are proposing consist of ISO/IEC 
17025:2017, which laboratories would be required to meet (except for a 
few provisions, as we discuss in more detail below) to become 
accredited in accordance with proposed Sec.  1.1138(a)(2), and our 
additional proposed requirements in Sec. Sec.  1.1146 through 1.1158. 
For example, ISO/IEC 17025:2017 (Ref. 13) section 7.9 requires 
accredited laboratories to establish a process for evaluating and 
responding to complaints, which we tentatively conclude would fulfill 
the model laboratory standard requirement of section 422(a)(6)(A)(iii) 
of the FD&C Act.
    We carefully considered whether to include a sampling accreditation 
requirement in the proposed rule. Proper sampling procedures are 
essential in order for analytical testing results to convey meaningful 
information about the food product or environment at issue. 
Accreditation for sampling could increase confidence in the training 
and procedures of samplers and potentially help ensure the collection 
of representative samples.
    According to our analysis (Ref. 1) of the applicable data stored in 
our internal systems, from January 1, 2016, to December 31, 2017, 
approximately 63 percent of sampling conducted for analysis in support 
of admission of food offered for import that we had detained without 
physical examination was conducted by five entities accredited for 
sampling under ISO/IEC 17025. Approximately 37 percent of such sampling 
conducted during that time was conducted by more than 300 entities not 
accredited for sampling under any standard.
    It is our understanding that whereas under the 2005 version of ISO/
IEC 17025 only laboratories are eligible for accreditation, starting 
with the 2017 version of ISO/IEC 17025, entities that do not conduct 
any analyses (i.e., an entity that solely collects samples) may be 
considered for accreditation for sampling under ISO/IEC 17025. It is 
also our understanding that it will take some time to develop and 
implement this new policy. Some of the larger laboratory accreditation 
bodies in the United States indicated that demand for accrediting 
entities that only conduct sampling is still relatively small, and thus 
far, these accreditation bodies have not performed accreditation 
assessments of such entities. (See Meeting Minutes, ``Sampling 
Accreditation Discussion with A[ccreditation] B[odie]s,'' November 13, 
2017 (Ref. 14).) As the ISO/IEC 17025 revision is still relatively new, 
FDA is not able to adequately assess the accreditation of entities that 
only conduct sampling at this time.
    Given these considerations, we are not proposing requirements for 
the accreditation of sampling in this proposed rule. However, we 
strongly encourage all samplers to consider accreditation, and we may 
reassess our position after accreditation bodies have gained experience 
with accrediting entities that only conduct sampling. We will watch 
developments in this area with interest, and would be willing to 
consider expanding the proposed program to include accreditation of 
laboratories and sampling services to perform sampling in the future.
    While we are not proposing requirements for accreditation of 
samplers, we invite comment on the matter. More specifically, what is 
the current capacity of accredited sampling entities, both laboratories 
and sampling services (i.e., entities that only perform sampling)? Are 
there attributes unique to sampling that present challenges in terms of 
the continued development of this field? What existing standards (e.g.,

[[Page 59477]]

ISO/IEC 17025, ISO 9001, ISO/IEC 17020) would be best to use as a basis 
for developing a more comprehensive and focused consensus sampling 
standard? What are the critical detailed requirements that should be 
included in a consensus sampling standard to ensure food safety? What 
standards are currently employed to assess samplers, are they 
effective, and in what ways are they insufficient?
    We note that because we are not proposing accreditation for 
sampling under this proposed rule, we would not expect laboratories 
seeking to become accredited under this program to demonstrate the 
capability to conduct sampling methods under this program if finalized. 
If we were to propose to require accreditation for sampling under the 
authority of section 422 of the FD&C Act in the future, at that time we 
would likely propose that entities seeking to become accredited for 
sampling would have to demonstrate the capability to conduct one or 
more methods of sampling for food testing.
What requirements must a laboratory meet to become accredited by a 
recognized accreditation body? (Proposed Sec.  1.1138)
    Proposed Sec.  1.1138 states the requirements a laboratory must 
meet to be accredited by a recognized accreditation body to conduct 
food testing under this program.
    Section 422(a)(2) of the FD&C Act requires, in pertinent part, that 
this program provide for the accreditation of laboratories with a 
demonstrated capability to conduct one or more analytical testing 
methodologies for food and section 422(b)(1) of the FD&C Act requires, 
in pertinent part, that food testing under this program be conducted by 
laboratories that have been accredited for the appropriate analytical 
testing methodology. We have considered these two provisions and 
propose to interpret section 422(b)(1) as requiring laboratories to be 
accredited on a method-specific basis, and to interpret section 
422(a)(2) of the FD&C Act to mean that a laboratory may become 
accredited even if it seeks to be accredited for a single method. 
Accordingly, proposed Sec.  1.1138(a)(1) would require that a 
laboratory seeking to be accredited must demonstrate that it is capable 
of conducting each method of food testing for which it seeks to be 
accredited. The laboratory would have to do so by meeting the 
requirements described under proposed Sec.  1.1138(a)(1)(i) and (ii).
    Proposed Sec.  1.1138(a)(1)(i) and (ii) clarify how an accredited 
laboratory must demonstrate it is capable of conducting each method for 
which it seeks to be accredited. Proposed Sec.  1.1138(a)(1)(i) 
provides that a laboratory must do so by submitting information related 
to validation or verification studies.
    Validation studies are required in certain circumstances by ISO/IEC 
17025:2017 (Ref. 13) section 7.2, which we have already incorporated by 
reference, but which we would explicitly require in proposed Sec.  
1.1151(c)(1). For example, a validation study would be required when a 
laboratory seeks to be accredited for a non-standard method or for a 
standard method it will use outside the method's intended application. 
Validation is meant to demonstrate that a method is suitable for the 
intended purpose.
    Method verification is meant to verify that the laboratory can 
properly apply the method for a specific intended use, specifically 
with respect to the limit of detection or probability of detection. We 
would require verification studies in proposed Sec.  1.1151(d)(1), and 
proposed Sec.  1.1151(d)(2) would require an accredited laboratory to 
record certain information related to a verification study (e.g., the 
results of the verification, supporting analytical data) (we discuss 
proposed Sec.  1.1151(d)(1) and (2) in more detail in section VI.G.7). 
Under this program, a laboratory may demonstrate that it is capable of 
conducting a particular method by submitting to the recognized 
accreditation body the verification study information required in 
proposed Sec.  1.1151(d)(2).
    To be clear, under this program a laboratory may fulfill the 
requirements of proposed Sec.  1.1138(a)(1)(i) by submitting to the 
recognized accreditation body either validation study information or 
verification study information.
    Proposed Sec.  1.1138(a)(1)(ii) provides that the laboratory must 
also, in order to demonstrate it is capable of conducting a method of 
food testing for which it seeks to be accredited, pass, or have passed 
within the past year, a proficiency test for the method(s), subject to 
the exception that if the laboratory determines there is no proficiency 
testing program available that addresses the method, or that 
proficiency testing for the method is otherwise impracticable, the 
accredited laboratory may instead subject, or have subjected in the 
past year, the method to an appropriate comparison program. This 
proposed requirement and exception reflect a similar requirement and 
exception in AOAC International's Guidelines for Laboratories 
Performing Microbiological and Chemical Analyses of Food, Dietary 
Supplements, and Pharmaceuticals, An Aid to Interpretation of ISO/IEC 
17025:2005 (April 2015 revision) (AOAC 17025 Guidelines) (Ref. 9) at 
section 5.9.1. Proposed Sec.  1.1138(a)(1)(ii) further provides that 
the laboratory's determination there is no proficiency testing program 
available that addresses the method must be reviewed, and approved or 
denied (as appropriate), by the recognized accreditation body from 
which the laboratory is seeking accreditation. For more information 
about the exception in proposed Sec.  1.1138(a)(1)(ii), please see our 
discussion of proposed Sec.  1.1148(a)(2) below at section VI.G.3.
    Under proposed Sec.  1.1138(a)(2) a laboratory seeking 
accreditation under this program must demonstrate it meets (or, with 
respect to activities the laboratory may only conduct once accredited, 
is capable of meeting) the requirements of ISO/IEC 17025:2017. ISO/IEC 
17025:2017 sets general standards for the competence of testing 
laboratories, including general management requirements such as 
impartiality and quality assurance. There are, however, a few 
provisions in ISO/IEC 17025:2017 that we propose to exclude from our 
requirements, as reflected in proposed Sec.  1.1138(b). Section 7.3 of 
ISO/IEC 17025:2017 (Ref. 13), which addresses sampling, would be 
excluded because, as discussed previously, we are not proposing 
accreditation of sampling (see the introduction to section VI.F for 
additional discussion of this issue). We also are not proposing to 
require laboratories to meet ISO/IEC 17025:2017 section 7.8, which 
describes requirements for reporting test results to customers, to 
avoid potential conflicts with proposed Sec.  1.1152, which contains 
requirements for the food testing results and supporting documentation 
that are necessary for us to assess the validity of food testing 
conducted under this program. We are also proposing in Sec.  1.1138(b) 
that laboratories seeking accreditation are not required to meet, or 
demonstrate that they are capable of meeting, requirements of ISO/IEC 
17025:2017 that relate to the relationship between the laboratory and 
its customers, to the extent that such provisions establish obligations 
that conflict with the requirements of this rule. For example, ISO/IEC 
17025:2017 section 7.1.1(d) would require the laboratory to ensure that 
the methods it uses are capable of meeting the customers' requirements, 
ISO/IEC 17025:2017 section 7.2.1.4 indicates that the laboratory's 
customer may choose

[[Page 59478]]

the method of analysis to be used for food testing, and ISO/IEC 
17025:2017 section 7.2.1.7 would restrict the laboratory from deviating 
from a method if the customer does not accept the deviation. As such, 
requiring accredited laboratories to meet all of the customer 
requirement provisions of ISO/IEC 17025:2017 could create potential 
conflicts with the requirements of section 422 of the FD&C Act.
    Proposed Sec.  1.1138(c) would require laboratories seeking 
accreditation to demonstrate they are capable of meeting and operating 
in conformance with all of this subpart's requirements for accredited 
laboratories. For example, under proposed Sec. Sec.  1.1152 and 1.1153 
laboratories would have to meet certain requirements specific to this 
program relating to reporting, notifications, and records, and under 
proposed Sec.  1.1148 laboratories would have to meet certain quality 
assurance requirements specific to this program and beyond the 
requirements in ISO/IEC 17025:2017. A laboratory would have to 
demonstrate that it has implemented written procedures to meet those 
requirements of this proposed rule so that it will be able to comply 
with such requirements once it is accredited.

G. Proposed Requirements for Accredited Laboratories (Proposed 
Sec. Sec.  1.1146 Through 1.1153)

    Proposed Sec. Sec.  1.1146 through 1.1153 would establish certain 
model laboratory standards that accredited laboratories must meet to 
remain accredited. In accordance with section 422(a)(6)(A) of the FD&C 
Act, these model laboratory standards would help ensure that 
appropriate analytical procedures and commercially available techniques 
are followed and reports of analyses are certified as true and 
accurate; internal quality systems are established and maintained; 
procedures exist to evaluate and respond promptly to complaints 
regarding analyses for which the laboratory is accredited; and 
individuals who conduct analyses are qualified by training and 
experience to do so. In accordance with section 422(a)(6)(B) of the 
FD&C Act, we have also proposed additional requirements that 
laboratories would have to meet to remain accredited, such as certain 
requirements relating to methods of analysis, notifications and 
submissions to FDA, and recordkeeping.
1. What are the general requirements for accredited laboratories to 
remain accredited? (Proposed Sec.  1.1146)
    Proposed Sec.  1.1146 provides that for an accredited laboratory to 
remain accredited, the accredited laboratory must be capable of 
conducting each method of analysis for the testing of food for which it 
is accredited, continue to conform to the applicable provisions of ISO/
IEC 17025:2017, and fulfill the additional requirements of this 
subpart. For a discussion of why we believe these ISO/IEC 17205:2017 
requirements are important for laboratories to meet to be accredited 
under this proposed rule, please see our previous discussion of 
proposed Sec.  1.1138 in section VI.F.1.
2. What impartiality and conflict of interest requirements must 
accredited laboratories meet? (Proposed Sec.  1.1147)
    Proposed Sec.  1.1147 would require accredited laboratories to meet 
certain requirements related to impartiality and conflicts of interest 
in addition to those impartiality and conflict of interest requirements 
of ISO/IEC 17025:2017 they would have to meet in accordance with 
proposed Sec.  1.1146(b).
    ISO/IEC 17025:2017 contains several requirements related to 
impartiality and conflicts of interest that accredited laboratories 
would have to meet under proposed Sec.  1.1146(b). For example, ISO/IEC 
17025:2017 (Ref. 13) section 4.1 requires the laboratory to conduct its 
activities impartially and to be structured and managed so as to 
safeguard impartiality, to not allow commercial, financial, or other 
pressures to compromise its impartiality, and that, if a risk to 
impartiality is identified, the laboratory must be able to demonstrate 
how the laboratory eliminates or minimizes the risk.
    However, we have tentatively determined that additional 
requirements related to impartiality and conflicts of interest are 
appropriate in the context of this rule. With certain exceptions, 
proposed Sec.  1.1147(a) would prohibit the accredited laboratory's 
officers, employees, contractors, and agents involved in food testing 
and related activities from accepting any money, gift, gratuity, or 
other item of value from the owner or consignee of the food that is 
being tested or will be tested by the accredited laboratory. Proposed 
Sec.  1.1147(b)(1) and (2) provide the caveats that the prohibited 
items of value specified in proposed Sec.  1.1147(a) do not include 
payment of fees for food testing services or reimbursement of direct 
costs associated with the food testing by the accredited laboratory. 
With respect to accredited laboratories that are owned by the owner or 
consignee of the food that is tested or to be tested, proposed Sec.  
1.1147(b)(3) provides that the prohibited items of value specified in 
proposed Sec.  1.1147(a) also do not include the officer's, employee's, 
contractor's, or agent's compensation in the normal course of business.
    Proposed Sec.  1.1147(c) would require the owner or consignee's 
payment to the accredited laboratory for food testing services and/or 
reimbursement of direct costs associated with food testing to be 
independent of whether the test results indicate the tested food is or 
appears to be violative. It is crucial that the accredited laboratory 
be able to conduct its testing without fear of receiving reduced 
payment or no payment from the owner or consignee if the food testing 
results are violative. We seek comment with respect to whether there 
are more effective provisions that might achieve the aim of impartial 
food testing.
3. What quality assurance requirements must accredited laboratories 
meet? (Proposed Sec.  1.1148)
    Proposed Sec.  1.1148 would establish quality assurance 
requirements accredited laboratories must meet for proficiency testing 
and the use of reference materials and quality control samples, in 
addition to the ISO/IEC 17025:2017 quality assurance requirements 
accredited laboratories would need to meet under proposed Sec.  
1.1146(b). Specifically, under proposed Sec.  1.1146(b), accredited 
laboratories would have to develop, maintain, and implement a 
complaints program (see ISO/IEC 17025:2017 (Ref. 13) section 7.9), a 
program to control nonconforming testing work (see ISO/IEC 17025:2017 
section 7.10), a program to continually improve (see ISO/IEC 17025:2017 
section 8.6), a corrective action program (see ISO/IEC 17025:2017 
section 8.7), an internal audit program (see ISO/IEC 17025:2017 section 
8.8), a management review program (see ISO/IEC 17025:2017 section 8.9), 
and policies for ensuring the validity of test results (see ISO/IEC 
17025:2017 section 7.7).
    As described by ISO/IEC 17025:2017, proficiency testing evaluates 
laboratory performance against established criteria. ISO/IEC 17025:2017 
(Ref. 13) section 7.7.2 provides that accredited laboratories must 
participate in proficiency testing and/or interlaboratory comparison 
programs other than proficiency testing. ISO/IEC 17011:2017 (which 
applies to accreditation bodies), indicates that the accreditation 
body's review of proficiency test results may help it assess 
laboratories, but ISO/IEC 17011:2017 does not require accreditation 
bodies to require the laboratories they accredit to participate in a 
proficiency testing program (ISO/

[[Page 59479]]

IEC 17011:2017 (Ref. 12) at section 3.24 n.1). Although both ISO/IEC 
standards address proficiency testing, we are proposing more specific 
proficiency testing requirements in this document to support the 
regular evaluation of the performance of accredited laboratories in 
this program.
    Proposed Sec.  1.1148(a)(1) would require accredited laboratories 
to participate in a proficiency testing program or programs, provided 
by a competent proficiency testing organization, and ensure that 
proficiency testing is conducted at least once per year for each method 
within the accredited laboratory's scope of accreditation (subject to 
an exception in proposed Sec.  1.1148(a)(2), which we discuss below). 
In developing proposed Sec.  1.1148(a), we considered how various 
existing standards address the frequency and coverage of laboratory 
proficiency testing. Some accreditation bodies that accredit food 
testing laboratories require laboratories they accredit to conduct 
proficiency testing on their entire scope of accreditation over a four-
year accreditation period and participate in at least one proficiency 
testing activity per year. (See, e.g., ``R103--General Requirements: 
Proficiency Testing for ISO/IEC Laboratories,'' American Association 
for Laboratory Accreditation (Ref. 15), at p. 6; and ``Accreditation 
Requirements: ISO/IEC 17025 Testing Laboratories (Non-Forensics),'' 
ANSI/ASQ National Accreditation Board (Ref. 16), at pp. 4-5). We note 
that if only one proficiency testing activity takes place each year, 
the bulk of proficiency testing for a laboratory's scope of 
accreditation could occur at one time during the laboratory's 
accreditation period. We tentatively conclude that requiring yearly 
proficiency testing for each method on a laboratory's scope of 
accreditation would encourage more periodic proficiency testing 
throughout the accreditation period. This element of proposed Sec.  
1.1148(a) is based on the AOAC 17025 Guidelines (Ref. 9) at section 
5.9.1, which provides that laboratories participate in at least one 
proficiency test annually for each ``test, type of test/method, and/or 
technique on the scope of accreditation''. Periodic proficiency testing 
throughout the four-year accreditation period should also help the 
accredited laboratory manage its other ongoing quality assurance 
activities (e.g., its control of nonconforming testing work under ISO/
IEC 17025:2017 (Ref. 13) section 7.10 and its program to continually 
improve under ISO/IEC 17025:2017 section 8.6). We seek comments on our 
proposed requirements for the frequency of proficiency testing.
    We are proposing to require in Sec.  1.1148(a)(1) that the 
proficiency test provider be ``competent.'' We note that ISO/IEC 
17043:2010, ``Conformity Assessment--General Requirements for 
Proficiency Testing'' (Ref. 17) provides specific standards for 
proficiency test providers. We are requesting comment on whether, and 
if so, under what circumstances, we should require accredited 
laboratories to only use proficiency test providers accredited to ISO/
IEC 17043 for proficiency testing under this proposed rule.
    Proposed Sec.  1.1148(a)(2) describes an exception to the proposed 
proficiency testing requirement. Proposed Sec.  1.1148(a)(2) states 
that if the accredited laboratory determines there is no proficiency 
testing program available that addresses a particular method of 
analysis in the accredited laboratory's scope of accreditation, or that 
participating in a proficiency testing program for the particular 
method is otherwise impracticable, the accredited laboratory may 
subject that method to an appropriate comparison program. The 
laboratory's determination must be reviewed, and approved or denied (as 
appropriate), by the recognized accreditation body that accredits the 
laboratory. The AOAC 17025 Guidelines (Ref. 9) at section 5.9.1 provide 
a helpful list of examples of such alternative comparison programs.
    Proposed Sec.  1.1148(b) would require accredited laboratories to 
ensure their procedures for monitoring the validity of the results of 
testing it conducts under this program include the use of reference 
materials or quality control samples with each batch of samples it 
tests under this program. This requirement reflects a similar 
requirement in the AOAC 17025 Guidelines (Ref. 9), at section 5.9.1. 
ISO/IEC 17025:2017 (Ref. 13) section 7.7, which accredited laboratories 
must comply with under proposed Sec.  1.1146(b), requires that 
laboratories' procedures for monitoring the validity of their results 
``include, where appropriate'' use of reference materials or quality 
control materials. We tentatively agree with the AOAC 17025 Guidelines 
that it is always appropriate to use of reference materials or quality 
control samples when conducting food testing. Therefore, to encourage 
clarity and consistency with respect to the use of reference materials 
and quality control samples under this program, we have proposed to 
adopt the AOAC 17025 Guidelines' position on this issue.
4. What oversight standards apply to sampling? (Proposed Sec.  1.1149)
    Because we are not proposing accreditation for sampling, we are not 
proposing model standards for sampling. However, whether a sample is 
collected and maintained properly is integral to whether analysis of 
that sample will produce information that is of regulatory 
significance. For example, if the analyzed sample(s) is not 
representative of the food product or environment at issue, the 
analysis of the sample(s) will not result in information that is 
meaningful with respect to the food product or environment at issue. 
Accordingly, we are proposing provisions that would allow us to 
exercise oversight over the sampling conducted as part of this program. 
Proposed Sec.  1.1149 would require the accredited laboratory to 
develop or obtain (depending on whether the accredited laboratory or a 
different entity collected the sample) and submit to FDA certain 
information about the sampler and sampling before the accredited 
laboratory analyzes the collected sample.
    Specifically, proposed Sec.  1.1149(a) would require that, before 
the accredited laboratory analyzes the sample, it must either develop 
(if it collected the sample) or obtain (if another entity collected the 
sample) the following documentation:
     Written documentation of the sampler's applicable 
qualifications by training and experience. If the accredited laboratory 
collects the sample, the accredited laboratory would need to develop 
such documentation the first time the individual collects a sample 
under this subpart. If another entity collects the sample, the 
accredited laboratory would need to obtain such documentation the first 
time it receives a sample collected under this subpart from that 
sampler. The accredited laboratory must also develop or obtain such 
documentation if the accredited laboratory learns that the sampler's 
qualifications have significantly changed since the accredited 
laboratory last developed or obtained documentation of the sampler's 
qualifications.
     A written sampling plan used to conduct the sampling. The 
written sampling plan must identify the sampler and must list factors 
that will be controlled to ensure the sampling does not impact the 
validity of the subsequent analytical testing, including controlling 
for the representational nature of the sample. This information would 
help us determine whether the sampling conducted would result in a

[[Page 59480]]

sample that is representative of the food product or environment in 
question. Identification of the sampler would allow us to determine 
whether we have the sampler's qualifications on file already and/or 
whether their qualifications may now be significantly different.
     A written sample collection report for each sample 
collected. The written sample collection report must, at a minimum, 
include:
    [cir] The product code of the food product sampled (if product is 
being sampled) or the location of and a description of the environment 
(if environment is being sampled). This information would help us 
determine whether the correct lot or lots were sampled and whether the 
sample is otherwise representative of the food product or environment 
in question.
    [cir] The date(s) of the sampling. This information would help us, 
in part, identify whether certain lots were sampled and help us review 
the chain of custody of the sample. For example, if the sample was 
collected a significant amount of time before the analysis, we may 
evaluate whether the documented chain of custody procedures for the 
sample would have preserved the sample's integrity.
    [cir] The size, identity, and quantity of the sample(s). This 
information would help us determine whether the sample is 
representative of the food product or environment in question.
    [cir] Documentation of sample collection procedures and any sample 
preparation techniques. This information would help us determine 
whether the sampling resulted in a sample that is representative of the 
food product or environment at issue.
    [cir] Documentation of the chain of custody of the sample(s), and 
of measures taken, to not impact the validity of the subsequent 
analytical testing, including controlling for the representational 
nature of the sample(s). This information would help us determine 
whether the sample received by the laboratory is the sample that was 
collected from the product or environment at issue and whether the 
integrity of the collected sample was compromised between collection of 
the sample and its analysis. Documentation of the chain of custody 
should account for the continuous custody of the sample and indicate 
any gaps in the chain of custody. Documentation of measures taken to 
not impact the validity of the subsequent analytical testing, including 
controlling for the representational nature of the sample(s), might 
include, for example, documentation of the use of tamper-evident 
containers, use of secure storage spaces, and any refrigeration or 
freezing of the sample. The documentation should indicate at what point 
in the chain of custody such measures were taken.
    Proposed Sec.  1.1149(b) clarifies that we may consider the 
analysis of a sample to be invalid if the requirements of Sec.  
1.1149(a) are not met.
5. What requirements apply to analysis of samples by an accredited 
laboratory? (Proposed Sec.  1.1150)
    Proposed Sec.  1.1150 would establish standards that laboratory 
analysis conducted under this proposed rule would need to meet, 
procedures the analysis would need to follow, and other requirements 
such as the qualifications of the individuals who perform the analysis. 
Proposed Sec.  1.1150 explicitly states that accredited laboratories 
must meet the requirements of this section in addition meeting to the 
requirements in ISO/IEC 17025:2017 relating to analysis that an 
accredited laboratory is required to meet under Sec.  1.1146(b).
    Proposed Sec.  1.1150(a) would require the analysis to be conducted 
on either the sample(s) received, or, if appropriate for the analysis, 
on a representative sample of the sample(s) received. Because the 
sample(s) received may consist of too much material to analyze in its 
entirety, a laboratory will often take a subsample(s) from the 
sample(s) received. The laboratory must ensure that it follows 
appropriate procedures so that the subsample(s) they analyze are 
representative of the lot. For example, in some circumstances it may be 
appropriate to homogenize the sample(s) by grinding, sieving, blending, 
or mixing the original sample(s) and taking a subsample(s) from the 
resulting mixture.
    Proposed Sec.  1.1150(b) would require that the analyst(s) that 
conducts the analysis be qualified by appropriate education, training, 
and/or experience to conduct the analysis; to have appropriately 
demonstrated their ability to conduct the method properly in the 
specific context of the food testing to be conducted; and to be in 
compliance with the conflict of interest requirements of proposed Sec.  
1.1146(b) (i.e., the applicable sections of ISO/IEC 17025:2017) and 
proposed Sec.  1.1147. Of note, under proposed Sec.  1.1152(g)(12) 
(which we discuss in more detail at section VI.G.8), the laboratory 
must provide certain information about the analyst's or analysts' 
qualifications to us at our request.
    Proposed Sec.  1.1150(c) clarifies that the method used to conduct 
the food testing must meet the requirements of proposed Sec.  1.1151 
(requirements for methods of analysis, which we discuss at section 
VI.G.7).
    Proposed Sec.  1.1150(d) requires that the accredited laboratory 
document the testing information and test results to the extent 
necessary to account for all information that is required to be 
included in a full analytical report. Please see our discussion of 
proposed Sec.  1.1152(g) for more information about what information 
full analytical reports must contain.
5. What requirements apply to the methods of analysis an accredited 
laboratory uses to conduct food testing under this subpart? (Proposed 
Sec.  1.1151)
    Food testing subject to section 422(b)(1) of the FD&C Act must be 
conducted by accredited laboratories that have been accredited for the 
appropriate analytical testing methodology or methodologies.'' Proposed 
Sec.  1.1151 would establish certain requirements with regard to 
methods of analysis, which would apply in addition to the requirements 
in ISO/IEC 17025:2017 (Ref. 13) section 7.2 relating to selection, 
validation, and verification of methods (under proposed Sec.  
1.1146(b)).
    Proposed Sec.  1.1151(a) would require that analysis under this 
program be conducted using a method(s) of analysis that: (1) Is fit for 
purpose, (2) is within the accredited laboratory's scope of 
accreditation, (3) has been appropriately validated for use in such 
food testing, in accordance with Sec.  1.1146(b) (i.e., the applicable 
ISO/IEC 17025:2017 provisions) and paragraph (c) of Sec.  1.1151, and 
(4) has been appropriately verified by the accredited laboratory for 
use in such food testing, in accordance with paragraph (d) of Sec.  
1.1151.
    As we noted above, proposed Sec.  1.1151(a)(1) would state that all 
methods of analysis used in food testing under this rule would have to 
be fit for purpose, in that they may only be applied for the food 
testing to which they are intended to apply and for the purpose for 
which they are validated. For example, if a method of analysis was 
developed and validated only for determining the presence and level of 
chloramphenicol in shrimp, the method may only be used to determine the 
presence and level of chloramphenicol in shrimp. The concept of fit for 
purpose is related to the concept of validation, in that successful 
validation of a method for a purpose for which the method had not yet 
been validated would typically demonstrate that the method is in fact 
fit for that purpose. For example, if the method that has

[[Page 59481]]

been validated only for determining the presence and level of 
chloramphenicol in shrimp is subsequently validated for determining the 
presence and level of chloramphenicol in fish, the method could then be 
applied as fit for the purpose of determining the presence and level of 
chloramphenicol in fish.
    Proposed Sec.  1.1151(a)(2) would require that the method used be 
included within the accredited laboratory's scope of accreditation. 
This requirement flows from section 422(a)(6) of the FD&C Act, which 
requires laboratories to be accredited for the specified testing 
methods they use for food testing in this program. Note that while some 
of the food testing that would be covered by this program is static 
(e.g., the testing of shell eggs described in Sec.  118.4(a)(2)(i)) 
other testing scenarios covered by this program are dynamic and will 
change with different circumstances (e.g., testing to support removal 
from Import Alert). Therefore, we are not proposing a defined inventory 
of possible scopes; rather, under this program laboratories would be 
able to become accredited for a variety of food analytical methods, 
such as methods listed in the Bacteriological Analytical Manual (BAM) 
of procedures preferred by FDA for the detection of pathogens and 
microbial toxins in food (see https://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm2006949.htm).
    Proposed Sec.  1.1151(a)(3) and (4), respectively, would require 
that the method must have been appropriately validated for use in the 
food testing to be conducted and have been appropriately verified by 
the accredited laboratory for use in such food testing. We have issued 
procedures for our laboratories on these issues (e.g., ``Methods, 
Method Verification and Validation,'' ORA Laboratory Manual Vol. II 
Section 2, document number 5.4.5 (Ref. 18) and ``Guidelines for the 
Validation of Chemical Methods for the FDA FVM Program, 2nd Edition'' 
(Ref. 19)), and we note that many food testing laboratories currently 
adhere to voluntary consensus standards and procedures issued by 
organizations, such as ISO and AOAC International, that address how to 
ensure analytical methods used by the laboratory are fit for purpose 
and appropriately validated and verified. Depending on the needs of the 
program as it develops, in the future we may issue guidance on this 
topic. Note that FDA maintains a website listing of all the FDA 
regulatory methods currently being used for food and feed safety 
programs, including links to other online manuals/compendia of methods 
(at https://www.fda.gov/food/science-research-food/laboratory-methods-food). On that web page we also provide links to the method 
development, validation, and implementation guidelines of FDA's Office 
of Food Policy and Response, and a list of methods currently undergoing 
validation.
    Proposed Sec.  1.1151(b) provides that with respect to food testing 
conducted under proposed Sec.  1.1107(a)(1), the method or methods of 
analysis (if any) prescribed by the applicable testing requirement in 
the FD&C Act or implementing regulations are the only appropriate 
methods for the food testing to be conducted; and with respect to food 
testing conducted under proposed Sec.  1.1107(a)(2), the method or 
methods of analysis (if any) prescribed by the food testing order are 
the only appropriate methods for the food testing to be conducted. In 
such cases, the statute, regulation, or food testing order would 
dictate the appropriate method for the food testing.
    Proposed Sec.  1151.1(c)(1) would make explicit for this program 
the validation requirement in ISO/IEC 17025:2017 (Ref. 13) section 
7.2.2, which accredited laboratories must follow in accordance with 
proposed Sec.  1.1146(b). As stated in ISO/IEC 17025:2017 section 
7.2.2, accredited laboratories would be required to validate ``non-
standard methods, laboratory-developed methods and standard methods 
used outside their intended scope or otherwise modified.''
    Proposed Sec.  1.1151(c)(2) would require an accredited laboratory 
validating a method under this subpart to record all the information 
required by ISO/IEC 17025:2017 (Ref. 13) section 7.2.2.4 as well as the 
supporting analytical data. In the context of validation studies, 
supporting analytical data may include information about the detection 
limit, selectivity of method, linearity, limit of repeatability and/or 
reproducibility (accuracy and precision), robustness against external 
influences and/or cross sensitivity against interference from the 
matrix of sample. We have tentatively determined that this information 
is necessary for us to assess the validation and determine whether it 
demonstrates that the accredited laboratory can properly apply the 
method for the specific intended use.
    Proposed Sec.  1.1151(d)(1) provides that before an accredited 
laboratory conducts food testing under this program using a method for 
a specific intended use for which the method has been validated, but 
for which the laboratory has not previously applied the method under 
this program, the accredited laboratory must have verified it can 
properly perform the method for the specific intended use. We propose 
to make this requirement explicit for this program; and believe it is 
consistent with ISO/IEC 17025:2017 (Ref. 13) section 7.2.1 (which 
accredited laboratories must follow in accordance with proposed Sec.  
1.1146(b)), which requires that accredited laboratories verify a method 
before they introduce the method.
    Proposed Sec.  1.1151(d)(2) would require that an accredited 
laboratory performing verification of a method under this subpart must 
record: The method that is the subject of the verification, the 
intended purpose of the analysis, the results of the verification, the 
procedure used for the verification, supporting analytical data, and 
whether the accredited laboratory is able to properly perform the 
method. We have tentatively determined that this information is 
necessary for us to determine whether the verification is valid.
    Section 422(b)(3) of the FD&C Act provides that FDA may waive 
requirements of section 422(b) if a new methodology or methodologies 
have been developed and validated but a laboratory has not yet been 
accredited to perform such methodology or methodologies; and the use of 
such methodology or methodologies are necessary to prevent, control, or 
mitigate a food emergency or foodborne illness outbreak. In accordance 
with this statutory provision, proposed Sec.  1.1151(e) provides that 
an accredited laboratory may submit a written request to FDA requesting 
FDA's permission to use a method or methods outside of its scope of 
accreditation for food testing. FDA may approve the request if both of 
the following conditions are satisfied: (1) A new methodology or 
methodologies have been developed and validated but no reasonably 
available laboratory has been accredited to perform such methodology or 
methodologies and (2) the use of such method or methods is necessary to 
prevent, control, or mitigate a food emergency or foodborne illness 
outbreak. We propose to interpret section 422(b)(3)(A) of the FD&C Act 
to allow waiver of section 422(b)'s requirements when no ``reasonably 
available'' laboratory has been accredited to perform such a 
methodology. If an accredited laboratory exists but is not reasonably 
available (e.g., due to geographic location, capacity constraints, or 
other factors), such a laboratory would not be able to address the 
emergent circumstances in which section 422(b)(3) applies. Therefore, 
if no ``reasonably available'' laboratory has been accredited to

[[Page 59482]]

perform the methodology in question, we believe section 422(b)(3)(A) of 
the FD&C Act may be interpreted to permit waiver of section 422(b)'s 
requirements. We have tentatively determined that any laboratory that 
conducts food testing under the exception of section 422(b)(3) of the 
FD&C Act must be accredited for at least one method under this program, 
because such accreditation would ensure that all of the requirements 
for this program apply to the laboratory and would ensure an important 
level of general competence and reliability.
7. What notifications, results, and reports must accredited 
laboratories submit to FDA? (Proposed Sec.  1.1152)
    Proposed Sec.  1.1152 would require that accredited laboratories 
submit test results, sampling reports, analytical reports, validation 
and verification studies, and certain other notifications to FDA about 
food testing they conduct under this program. Proposed Sec.  1.1152 
would also establish requirements for such submissions, including 
requirements about what information the submissions must contain. Under 
section 422(b)(2) of the FD&C Act, the results of food testing 
conducted under this program must be submitted directly to FDA. To 
facilitate our meaningful review of such test results, it is critical 
that we receive supporting information necessary for us to understand 
the test results and to assess the validity of the underlying testing 
conducted in that instance. Section 422 of the FD&C Act acknowledges 
that other information may be sent to FDA under this program, 
specifically requiring that the model standards we establish under this 
program must ensure that reports of analyses, which laboratories 
currently routinely submit to us as testimony in the circumstances 
described by section 422(b)(1)(B) of the FD&C Act, are certified as 
true and accurate (see section 422(a)(6) of the FD&C Act).
    Proposed Sec.  1.1152(a) through (c) address what information 
(e.g., test results, sample collection reports, and analytical reports) 
about the food testing conducted under this program must be submitted 
to FDA. We have proposed in Sec.  1.1152(d) that accredited 
laboratories that meet certain requirements may submit abridged 
analytical reports in lieu of full analytical reports, subject to 
certain exceptions in proposed Sec.  1.1152(e). Proposed Sec.  
1.1152(f) would establish what information must be in an abridged 
analytical report, and proposed Sec.  1.1152(g) would establish what 
information must be in a full analytical report. Proposed Sec.  
1.1152(h) would require an accredited laboratory using a non-standard 
method to provide FDA with documentation of the method. By 
``documentation'' we mean the method standard operating procedure, or 
some other document that describes the steps within the method. 
Proposed Sec.  1.1152(i) would establish requirements for the 
submission of advance notices of sampling to FDA. Proposed Sec.  
1.1152(j) would establish requirements for notifications to FDA of 
significant changes affecting the accreditation of the accredited 
laboratory. Proposed Sec.  1.1152(k) would state if FDA does not 
receive all information required under this section we may consider the 
related testing to be invalid.
    Proposed Sec.  1.1152(a) would require all documentation submitted 
to us by accredited laboratories under the subpart, which includes test 
results, sampling reports, analytical reports, validation and 
verification studies, and certain notifications, to be submitted to us 
electronically and in English, and to contain certain generally 
applicable information. More specifically, proposed Sec.  
1.1152(a)(1)(i) would require all such notifications, results, reports, 
and studies submitted to us to include the legal name and street 
address of the accredited laboratory submitting the information, and 
would require the documents to identify an appropriate point-of-contact 
for the accredited laboratory who FDA may contact with questions or 
comments regarding the notification, result, report, or study, and to 
include the email address and telephone number of the point of contact. 
Identification of the accredited laboratory submitting the report would 
help us identify which accredited laboratory is responsible for the 
submissions. The identification of a point-of-contact for the 
accredited laboratory, and the email address and telephone number of 
the point-of-contact, would help us efficiently conduct any followup 
communications, as appropriate, with the accredited laboratory that 
submitted the information. Proposed Sec.  1.1152(a)(1) would also 
require all documents submitted to FDA under this section to display an 
identification unique to each test result, report, notification, or 
study. Of note, proposed Sec.  1.1152(b)(3) would require the test 
results to cross reference the unique identifiers of all associated 
reports, notifications, and studies. These requirements are intended to 
help us quickly identify which submissions are related to each other as 
we receive them. This provision also reflects a similar provision in 
ISO/IEC 17025:2017 (Ref. 13) at section 7.8.2, ``Common requirements 
for reports.'' The last general requirement for submissions, per 
proposed Sec.  1.1152(a)(iii), is that each submission must be true, 
accurate, unambiguous, and objective. This requirement would implement 
the requirement underlying section 422(a)(6)(A)(i) of the FD&C Act that 
the model standards established by this program for accredited 
laboratories must ensure that ``reports of analyses are certified as 
true and accurate,'' and help ensure that accredited laboratories 
submissions clearly and correctly communicate the information the 
submission is based on and is intended to communicate. We have 
tentatively concluded that it is appropriate to establish such a 
requirement for all submissions under this program to FDA from 
accredited laboratories.
    Proposed Sec.  1.1152(a)(2) would clarify that the accredited 
laboratory that conducts the analysis of the sample under this program 
is responsible for the submission of all related notifications, 
results, reports, and studies to FDA as required by this section.
    Proposed Sec.  1.1152(a)(3) provides that if the accredited 
laboratory that is responsible for the submission becomes aware that 
any aspect of the submission is inaccurate, the accredited laboratory 
or sampling service must immediately inform FDA and submit a corrected 
version. Proposed Sec.  1.1152(a)(3) further provides that such 
corrections to the notification, result, report, or study must meet the 
requirements for amendments to reports specified by ISO/IEC 17025:2017 
(Ref. 13) section 7.8.8 (incorporated by reference, see Sec.  
1.1138(a)(2)). This requirement is important so that we may easily 
determine when and how a submission has been amended and to which prior 
submissions the amended submission relates.
    Proposed Sec.  1.1152(a)(4) would require that any opinions and 
interpretations in any notification, result, report, or study submitted 
to FDA must meet the requirements in ISO/IEC 17025:2017 (Ref. 13) 
section 7.8.7 (which is incorporated by reference, see proposed Sec.  
1.1138(a)(2)), and any statements of conformity to a specification or 
standard in any notification, result, report, or study submitted to FDA 
under this subpart must meet the requirements of ISO/IEC 17025:2017 
section 7.8.6 (incorporated by reference, see proposed Sec.  
1.1138(a)(2)). We have tentatively determined that ISO/IEC 17025:2017 
section 7.8.7 provides rules that will be effective at ensuring that 
opinions and interpretations in submissions to FDA are appropriate and 
clearly identified. Similarly, we have tentatively determined that ISO/
IEC 17025:2017

[[Page 59483]]

section 7.8.6 provides rules that will be effective at ensuring that 
statements of conformity in submissions to FDA under this section are 
accompanied by appropriate disclosures.
    Proposed Sec.  1.1152(b) would establish requirements for 
submission of test results to FDA. In accordance with section 422(b)(2) 
of the FD&C Act, proposed Sec.  1.1152(b)(1) provides that the results 
of all tests conducted under this subpart must be directly submitted to 
FDA. Proposed Sec.  1.1152(b)(2) specifies that the accredited 
laboratory that conducted the analysis must submit the results of the 
food testing to FDA via the website described by Sec.  1.1109, unless 
FDA has directed a different method of submission in connection with 
the testing conducted under Sec.  1.1107(a)(2) or (3).
    Proposed Sec.  1.1152(b)(3) would require the test results 
submitted to FDA under this section to be clear, and identify the 
unique identification of the associated notifications, reports, and 
studies. These requirements would help us ensure that we can 
efficiently review the test results and associated submissions as one 
package.
    Proposed Sec.  1.1152(c) would require certain documentation to be 
submitted with the test results. Specifically, we would require 
submission to FDA of the following documentation with each test 
results:
     All sampling plans and sample collection reports related 
to the food testing conducted, as obtained or developed by the 
accredited laboratory in accordance with proposed Sec.  1.1149.
     Written documentation of the sampler's qualifications, if 
proposed Sec.  1.1149(a)(1) requires the accredited laboratory to 
obtain or develop such documentation.
     The analytical report or reports documenting the analysis 
related to the food testing. The analytical reports would have to be 
either abridged or full, depending on whether the accredited laboratory 
is permitted under proposed Sec.  1.1152(d) to submit abridged 
analytical reports to FDA. For more information about our proposed 
requirements for abridged and full analytical reports, see our 
discussion of proposed Sec.  1.1152(d) through (g) below.
     For any validation studies required by proposed Sec.  
1.1151(c)(1), any documentation required by proposed Sec.  
1.1151(c)(2), except when the circumstances of proposed Sec.  
1.1152(c)(6) (which we discussed in connection with Sec.  
1.1138(a)(1)(a), previously) apply with respect to the validation 
study.
     For any verification studies required by Sec.  
1.151(d)(1), the documentation required by Sec.  1.1151(d)(2), except 
when the circumstances of proposed Sec.  1.1152(c)(6) (which we 
discussed in connection with Sec.  1.1138(a)(1)(A), previously) apply 
with respect to the verification study.
     Proposed Sec.  1.1152(c)(6) would establish an important 
exception to the above two validation and verification study 
documentation requirements. Proposed Sec.  1.1152(c)(6) provides that 
we would not require the accredited laboratory to submit the validation 
or verification study to FDA if the accredited laboratory submitted the 
validation or verification study to its recognized accreditation body 
as required by proposed Sec.  1.1138(a)(1) (which addresses certain 
requirements a laboratory must meet to become accredited by a 
recognized accreditation body). We have tentatively determined that it 
is not appropriate under this program for us to duplicate, on a routine 
basis, the accreditation efforts of accredited laboratory's recognized 
accreditation body. If the accredited laboratory submitted the 
validation or verification study to its accreditation body as required 
by Sec.  1.1138(a)(1), the accreditation body must instead submit to 
FDA, in lieu of the validation or verification study, a statement that 
the validation or verification study has been submitted to its 
recognized accreditation body in accordance with Sec.  1.1138(a)(1), 
and the accredited laboratory must identify the method, analyte, and 
matrix that were the subject of the validation or verification study. 
This information would provide us with sufficient information to 
determine whether the accredited laboratory's invocation of this 
exception is appropriate. As discussed in relation to proposed Sec.  
1.1113(c), we expect recognized accreditation bodies to substantively 
review the validation and verification studies they receive from 
laboratories participating in this program.
     A certification from one or more members of the accredited 
laboratory's management certifying that the test results, 
notifications, reports, and studies are true and accurate, and that the 
documentation includes the results of all tests conducted under this 
subpart. The certification must specify the name, title, and signature 
of the certifier or certifiers. The certification that reports are true 
and accurate is required by section 422(a)(6)(A)(i) of the FD&C Act, 
but we propose to require the certification to also extend to the test 
results and related submissions. We propose to include a certification 
that the laboratory has submitted all tests conducted under this 
subpart not only because direct submission of test results to FDA is a 
statutory directive, but because it is vital to the integrity of this 
program. We expect this certification to help ensure that appropriate 
laboratory personnel have confirmed the accuracy of the statement.
    Note that we do not intend for this certification to mean that the 
laboratory is attesting that the tested product satisfies regulatory 
requirements as it is FDA's purview (and not the laboratory's) to 
determine whether the product meets our regulatory standards. Although 
the word ``certification'' has such meaning in conformity assessment 
terminology, we intend a different meaning here. We are using the word, 
``certification'' to mean that the management of the laboratory 
acknowledges that the test was conducted and vouches that the test was 
conducted properly according to laboratory defined procedures, that the 
report is true and accurate, and that the report represents all the 
testing conducted by that laboratory of that particular product for 
this program.
    We propose in Sec.  1.1152(d) that accredited laboratories that 
meet certain requirements may submit abridged analytical reports under 
this program in lieu of full analytical reports. We would require full 
analytical reports to document, in full and step-by-step, the analysis 
conducted by the accredited laboratory, so that we can engage in a 
meaningful indepth scientific review of the analysis to determine 
whether, in that instance, the analysis was valid. For example, we 
propose in Sec.  1.1152(g) that a full analytical report must include 
all original compilations of raw data, identify and describe negative 
and positive quality controls, and include all calculations, among 
other documentation. Abridged analytical reports, in contrast to full 
analytical reports, would only need to include certain more limited 
information describing the analysis.
    We view the standards we are creating in this program as relatively 
rigorous. Accreditation to ISO/IEC 17025:2017, along with the quality 
assurance, conflict of interest, and other additional requirements 
contained in this proposed rule, enhance our confidence in the 
laboratories that participate. In addition, the recognized 
accreditation bodies will serve an ongoing role monitoring the 
laboratories they have accredited under this program, helping ensure 
that the required standards are maintained and serving as an additional 
observer of the laboratories. For those reasons, and contingent on a 
positive experience with the accredited laboratories' initial

[[Page 59484]]

reports, we would have adequate assurance in the validity of the test 
results to permit abridged analytical reports, and we tentatively 
conclude that such abridged analytical reports will provide an adequate 
basis for FDA to make regulatory decisions.
    In addition, we believe that allowing the submission of abridged 
analytical reports under this food testing program may provide 
advantages to FDA and the public. We should be able to review abridged 
analytical reports more quickly than we review full analytical reports, 
and this may enable us to decide more quickly whether a food safety 
problem has been addressed and whether to admit an article of food into 
the United States. This may further allow us to allocate our own 
laboratory and field resources more efficiently. Furthermore, not 
requiring accredited laboratories to compile and submit a full 
analytical report every time they conduct food testing under this 
program may reduce some of the paperwork and administrative costs of 
food testing conducted under this program.
    At the same time, we note that this laboratory accreditation 
program would not guarantee that testing by participating laboratories 
will be valid in every instance. Indeed, a single false negative test 
result submitted to us under this program could lead us to admit 
violative food into the United States, or to incorrectly determine that 
a food safety problem has been adequately addressed, thus potentially 
harming U.S. consumers. Accordingly, we do not propose to automatically 
or always allow all accredited laboratories to submit abridged 
analytical reports under this program. Instead, we have proposed that 
only accredited laboratories that have fulfilled certain conditions may 
submit abridged analytical reports to us under this program, and that 
in certain circumstances we may require such accredited laboratories to 
submit full analytical reports.
    Proposed Sec.  1.1152(e)(1) provides that FDA will occasionally 
require an accredited laboratory permitted to submit abridged 
analytical reports to submit to FDA, within 48 hours of the request, 
the full version of the analytical report. Such a policy will serve the 
purposes of auditing abridged analytical reports and otherwise 
protecting the public health and the integrity of this food testing 
program. By ``occasionally,'' we tentatively conclude that we would not 
invoke the exception for more than approximately 10 percent of the 
abridged analytical reports that any given accredited laboratory 
submits to us per year. We would invoke this exception at our 
discretion, sometimes on a random basis and sometimes based on risk. 
With regard to risk, we may be more likely to invoke this requirement 
where the analysis conducted is for an analyte that presents a 
relatively high risk to public health (e.g., Clostridium botulinum). We 
may also invoke the exception where something in the abridged 
laboratory report appears to be amiss (e.g., the method used does not 
appear to be appropriate). However, we may also invoke the exception on 
a random basis and in relatively low-risk situations to ensure 
consistent laboratory performance across the program. At a minimum, we 
expect to invoke this exception to require each accredited laboratory 
permitted to submit abridged analytical reports to us to submit at 
least one full analytical report to us per year. We also note that this 
provision (along with proposed Sec.  1.1150(d)) would effectively 
require that accredited laboratories permitted to submit abridged 
analytical reports to us must still consistently document their 
analyses internally to such a degree that the accredited laboratory 
would be able to complete and submit a full analytical report for the 
analysis to FDA within forty-eight hours of when FDA requests the full 
analytical report.
    We have proposed an additional exception, in proposed Sec.  
1.1152(e)(2), to accredited laboratories' ability to submit abridged 
analytical reports to us under this program. Proposed Sec.  
1.1152(e)(2) provides that FDA may require an accredited laboratory 
that is permitted to submit abridged analytical reports to submit full 
analytical reports to FDA under this program if such analytical reports 
relate to an FDA investigation or FDA enforcement proceeding. We may 
invoke this exception, for example, in the case of a food testing order 
involving a potentially high risk to public health, or as part of 
evidence for a hearing under section 423(c) of the FD&C Act, in which 
case we would have determined that not only does a suspected or 
identified food safety problem exist but that there is also reasonable 
probability that the use of or exposure to an article of food will 
cause serious adverse health consequences or death to humans or 
animals.
    Proposed Sec.  1.1152(d)(1) describes the criteria for an 
accredited laboratory seeking initial permission to submit abridged 
analytical reports. Accredited laboratories that are not currently 
disqualified from submitting abridged analytical reports (see our 
discussion about disqualification under proposed Sec.  1.1152(d)(6) and 
(7)) and that are not on probation would become permitted to submit 
abridged analytical reports to FDA under this program on an ongoing 
basis after FDA has given notice that all four of the following 
conditions are fulfilled: (1) The accredited laboratory submits 10 
consecutive full analytical reports to FDA under this program, (2) the 
consecutive full analytical reports include at least one full 
analytical report relating to each major food testing discipline 
represented by the methods in the accredited laboratory's scope of 
accreditation for which it seeks to submit abridged analytical reports, 
(3) none of the consecutive full analytical reports demonstrate any 
material substantive shortcoming in the food testing, and (4) the 
consecutive full analytical reports submitted by the accredited 
laboratory do not contain repeated administrative deficiencies. 
Accordingly, when laboratories become accredited under the program they 
must first submit full laboratory analytical reports under Sec.  
1.1152(g), along with the test results and the other documentation 
required under proposed Sec.  1.1152(c), which FDA will assess to 
determine whether the four conditions are fulfilled. FDA will track 
whether the accredited laboratory has fulfilled the four conditions.
    As we state above, we are proposing to require that the 10 
consecutive full analytical reports includes least one full analytical 
report relating to each major food testing discipline represented by 
the methods in the accredited laboratory's scope of accreditation for 
which the accredited laboratory seeks to submit abridged analytical 
reports. Three examples of the ``major food testing disciplines'' 
relevant in this context are microbiology, chemistry, and physical 
(filth).
    Proposed Sec.  1.1152(d)(2) addresses the impact of an accredited 
laboratory's failure to initially satisfy the four criteria of Sec.  
1.1152(d)(1). Under proposed Sec.  1.1152(d)(2)(i), if any analytical 
report submitted by the accredited laboratory to FDA under this program 
demonstrates a material substantive shortcoming in the food testing, 
the accredited laboratory would become disqualified from submitting 
abridged analytical reports, in accordance with proposed Sec.  
1.1152(d)(6)(i). If the 10 full analytical reports submitted by an 
accredited laboratory are substantively satisfactory but suffer from 
repeated administrative deficiencies, the accredited laboratory would 
have another chance to submit consecutive full analytical reports that 
fulfill the criteria in Sec.  1.1152(d)(1)(i) through (iv). Repeated 
administrative deficiencies during the second set of 10 full analytical 
reports would result in

[[Page 59485]]

disqualification in accordance with proposed Sec.  1.1152(d)(6)(i).
    We propose that a single material substantive shortcoming in the 
food testing in any of the initial 10 full analytical reports would 
disqualify an accredited lab, for the period described in Sec.  
1.1152(d)(6). We would consider a material substantive shortcoming in 
the food testing to be incompetence or dishonesty resulting in an 
invalid test result. FDA will be relying on the food testing conducted 
under this program to make regulatory decisions, which will impact 
public health. It is critical that the testing be valid. We have a duty 
to monitor the testing conducted by an accredited laboratory that 
submits a full analytical report containing a material substantive 
shortcoming, so it is appropriate that such a laboratory be 
disqualified from the privilege of submitting abridged analytical 
reports (see Sec.  1.1152(d)(6)). Note also that under proposed Sec.  
1.1160(a) and (b), if we find a material substantive shortcoming in the 
food testing, we may consider the analysis to be invalid, and will 
notify the accredited laboratory, and potentially its recognized 
accreditation body and the owner or consignee of the food, of the 
deficiency. For further information on proposed Sec.  1.1160, see 
section VI.I.3. Note also that under proposed Sec.  1.1146(b), the 
accredited laboratory would have to treat the feedback as a complaint, 
in accordance with sections 3.2 and 7.9 of ISO/IEC 17025:2017 (Ref. 
13).
    Proposed Sec.  1.1152(d)(3) discusses the criteria that 
laboratories, already submitting abridged analytical reports, must meet 
in order to begin submitting abridged analytical reports for additional 
disciplines. Specifically, proposed Sec.  1.1152(d)(3) allows 
accredited laboratories, not on probation and already permitted to 
submit abridged analytical reports for at least one major food testing 
discipline, to submit to abridged analytical reports relating to 
additional major food testing discipline(s), after FDA has given notice 
that the following conditions are fulfilled: (1) The accredited 
laboratory submits to FDA at least one full analytical report for each 
additional major food testing discipline for which the accredited 
laboratory seeks to submit abridged analytical reports; (2) there is no 
material substantive shortcoming in the full analytical report(s) for 
the additional major food testing discipline(s); and (3) the full 
analytical reports for the additional major food testing discipline(s) 
do not contain repeated administrative deficiencies.
    Proposed Sec.  1.1152(d)(4) addresses the impact of an accredited 
laboratory's failure to initially satisfy the three criteria of Sec.  
1.1152(d)(3). Under proposed Sec.  1.1152(d)(4)(i), if any analytical 
report submitted by the accredited laboratory to FDA under this program 
demonstrates a material substantive shortcoming in the food testing, 
the accredited laboratory would become disqualified from submitting 
abridged analytical reports for the food testing discipline that was 
represented in the analytical report containing the material 
substantive shortcoming, in accordance with proposed Sec.  
1.1152(d)(6)(ii). If any full analytical reports relating to a food 
testing discipline submitted by an accredited laboratory are 
substantively satisfactory but suffer from repeated administrative 
deficiencies, the accredited laboratory would have another chance to 
submit a full analytical report for that food testing discipline that 
fulfills the criteria in Sec.  1.1152(d)(3)(i) through (iii). Repeated 
administrative deficiencies in the second full analytical report would 
result in disqualification in accordance with proposed Sec.  
1.1152(d)(6)(ii).
    Proposed Sec.  1.1152(d)(5) provides that if an accredited 
laboratory, permitted to submit abridged analytical reports for a 
particular discipline, submits one or more test results, notifications, 
reports, and/or studies that demonstrate a single material substantive 
shortcoming in testing or repeated significant administrative 
deficiencies, the accredited laboratory would be disqualified for that 
discipline. The period of disqualification should be governed by Sec.  
1.1152(d)6)(ii) if the accredited laboratory is permitted to submit 
abridged analytical reports for other disciplines, and with Sec.  
1.1152(d)(6)(i) if not.
    For accredited laboratories that currently do not have permission 
to submit any abridged analytical reports for any disciplines, proposed 
Sec.  1.1152(d)(6)(i) states that the period of disqualification is 
either 2 years or until the accredited laboratory submits 20 more 
satisfactory full analytical reports to FDA under this program, 
whichever period is longer. During this period of disqualification the 
accredited laboratory would be ineligible to submit, and to request 
permission to submit, abridged analytical reports under this program. 
It is important that this period of disqualification be of sufficient 
length to establish a meaningful consequence for accredited 
laboratories that are seeking permission to submit abridged analytical 
reports but who demonstrate a single material substantive shortcoming 
in testing or repeated significant administrative deficiencies. We also 
propose that shortcomings during the disqualification period under 
Sec.  1.1152(d)(6)(i) would extend the disqualification. Such a policy 
would help ensure that disqualified laboratories have every incentive 
to maintain excellent performance during the disqualification period. 
We propose that any material substantive shortcoming in testing would 
extend the disqualification period by 6 months, and repeated 
administrative deficiencies would extend the disqualification period by 
2 months.
    For an accredited laboratory that currently is permitted to submit 
abridged analytical reports for at least one food testing discipline 
and is subject to disqualification for at least one additional food 
testing discipline, proposed Sec.  1.1152(d)(6)(ii) states that the 
period of disqualification is either 2 years or until the accredited 
laboratory submits two or more satisfactory full analytical reports to 
FDA under this program, whichever period is longer. During this period 
of disqualification, the accredited laboratory would be ineligible to 
submit, and to request permission to submit, abridged analytical 
reports for the testing discipline(s) that is subject to the 
disqualification period. We also propose that shortcomings during the 
disqualification period under Sec.  1.1152(d)(6)(ii) would extend the 
disqualification. Such a policy would help ensure that disqualified 
laboratories have every incentive to maintain excellent performance 
during the disqualification period. We propose that any material 
substantive shortcoming in testing would extend the disqualification 
period by 6 months, and repeated administrative deficiencies would 
extend the disqualification period by 2 months.
    While the policy in proposed Sec.  1.1152(d)(1) for becoming 
permitted to submit abridged analytical reports to FDA under this 
program would apply to newly accredited laboratories that have never 
been disqualified under proposed Sec.  1152(d)(1), the policy and 
procedures would be somewhat different for accredited laboratories that 
have been disqualified. Proposed Sec.  1.1152(d)(7) provides that an 
accredited laboratory that has fulfilled the criteria under Sec.  
1.1152(d)(6), as applicable, and is not on probation, may submit a 
request (via a portal we would establish on our website) to FDA to 
submit abridged analytical reports under Sec.  1.1152(d)(1) or (3), as 
applicable. After FDA receives the request, FDA will consider 
permitting the accredited laboratory to

[[Page 59486]]

fulfill the conditions of proposed Sec.  1.1152(d)(1) or (3), as 
applicable. If FDA grants permission, and once the conditions described 
by proposed Sec.  1.1152(d)(1) and (3), as applicable, are fulfilled, 
FDA will provide notice that the accredited laboratory is permitted to 
submit to FDA on an ongoing basis abridged analytical reports relating 
to the discipline(s) for which the conditions are fulfilled.
    As we have noted above, if an accredited laboratory submits one or 
more test results, notifications, reports, and/or studies that 
demonstrate a single material substantive shortcoming in testing or 
repeated significant administrative deficiencies we may also take other 
appropriate action under this proposed rule, including notifying the 
accredited laboratory's recognized accreditation body (in accordance 
with proposed Sec.  1.1160) and/or, in more egregious cases, even 
putting an accredited laboratory on probation or revoking the 
accredited laboratory's accreditation, if appropriate under proposed 
Sec.  1.1161.
    We request comment on all aspects of our proposed approach to 
allowing accredited laboratories to submit abridged analytical reports 
to FDA, including with respect to the practicality and potential 
consequences of the approach.
    Abridged analytical reports, in contrast to full analytical 
reports, would have to include only certain limited information 
describing the analysis. Proposed Sec.  1.1152(f) provides that 
abridged analytical reports must contain:
     All information described by ISO/IEC 17025:2017 (Ref. 13) 
sections 7.8.2.1(a) through (p) and 7.8.3.1(a) through (d).
     The justification for any modification or deviation to the 
method(s) of analysis used, and documentation of the accredited 
laboratory's authorization for the modification or deviation. Although 
ISO/IEC 17025:2017 (Ref. 13) section 7.8.2.1 requires disclosure of 
additions to, deviations, or exclusions from the method, we have 
tentatively determined that abridged analytical reports should also 
include the justification and authorization for any modification or 
deviation to the method. This proposed requirement should help us 
understand whether the method, although modified, is within the 
accredited laboratory's scope of accreditation, and otherwise help us 
determine whether we should require submission of the full analytical 
report version of the abridged analytical report.
    Although the information in abridged analytical reports are not 
sufficient to allow us to engage in a meaningful indepth scientific 
review of the analysis, and ISO/IEC 17025:2017 section 7.8 appears to 
relate more to reports laboratories submit to their customers rather 
than reports laboratories submit to regulatory authorities, we have 
tentatively determined that the information in abridged analytical 
reports, as proposed by Sec.  1.1152(f), would be sufficient 
information for us to make other meaningful decisions related to the 
analysis, such as whether the method used is appropriate or whether 
certain risks are present that warrant the submission of the full 
analytical report. We request comments on what other information 
should, or should not be, in an abridged analytical report.
    Proposed Sec.  1.1152(g) establishes what information full 
analytical reports submitted under this program must contain. We 
developed the proposed requirements for what information full 
analytical reports must contain based on what information we have found 
is necessary for us to assess the validity of the analyses that private 
laboratories currently conduct in support of admission of an article of 
food under section 801(a) of the FD&C Act and to support removal from 
an import alert through successful consecutive testing. We have 
tentatively determined that the information we propose full analytical 
reports must contain is necessary for us to engage in a meaningful 
indepth scientific review of the analysis to determine that the 
analysis is valid. Proposed Sec.  1.1152(g) would require full 
analytical reports to include the following information:
     All information that must be included in an abridged 
analytical report. As noted previously, this information consists 
primarily of administrative items and limited substantive information 
about the analysis performed. It also includes the justification for 
any modification or deviation to the method(s) of analysis used and 
documentation of the accredited laboratory's authorization for the 
modification or deviation.
     Documentation of references for the method or methods of 
analysis used. Here we simply mean that the package must include the 
name (e.g., ``Concentration, Extraction, and Detection of Norovirus and 
Hepatitis A Virus in Molluscan Shellfish'') and source (e.g., AOAC, FDA 
BAM) of the method used.
     Identification of the analyst or analysts who conducted 
each analytical step, validation step (if applicable), and verification 
step (if applicable), including the analyst's or analysts' legal name 
and signature, and the date each analytical step, validation step (if 
applicable), and verification step (if applicable) was performed. This 
information is important because, in accordance with section 
422(a)(6)(A)(iv) of the FD&C Act and proposed Sec.  1.1150(b), the 
analysts must be appropriately qualified.
     Calculations presented in a legible and logical manner. We 
may need to verify the calculations to verify whether the results of 
the testing are valid.
     As applicable, references to chromatograms, charts, 
graphs, observations, photographs of thin layer chromatographic plates, 
and spectra. References must be in color when appropriate and made in a 
clear order. These items represent objective evidence and raw data 
supporting the test results. We may need to review such information to 
understand and verify the validity of the results of the testing.
     Identification of the source and purity of reference 
standards used, and, as applicable: Certified reference materials, 
certified reference cultures traceable to a nationally or 
internationally recognized type culture collection, including 
concentration, units preparation, and storage conditions, and reference 
standard preparation information, including who prepared, date of 
preparation, expiration date, chemical balance, and solvent used.
     A copy of the label from any immediate container sampled 
and any additional labeling needed to evaluate the product. Many 
products are shipped in a variety of different forms, container 
quantities, and may have varying packaging or labels. The label would 
likely include important information about the form, unit quantity, or 
packaging of the food, which we may use to verify that the laboratory 
analyzed the samples using an appropriate method. The label and 
labeling would provide additional information which may be helpful to 
the analysis and our review, such as the ingredient list of the food. 
For example, if the ingredient list indicates that the food contains an 
ingredient, additive, or pesticide at a violative level, we may subject 
to higher scrutiny test results that indicate the food is free from the 
ingredient, additive, or pesticide or that indicate the food contains 
the ingredient, additive, or pesticide at a lower level than the 
ingredient list indicates.
     All original compilations of raw data secured in the 
course of the analysis, including discarded, unused,

[[Page 59487]]

or reworked data with the justification for discarding or reworking 
such data, corresponding supporting data, and quality control results 
all identified with unique sample identification, date and time, 
associated with the test. This information is important for us to 
understand and to verify the validity of the test results. Furthermore, 
requiring submission of discarded, unused, or reworked data, along with 
a justification for discarding, not using, or reworking such data, 
should discourage testing into compliance.
     Any other relevant additional supporting information such 
as the storage location of analyzed samples, appropriate attachments 
such as instrument printouts, computer generated charts and data 
sheets, and photocopies or original labels for the product analyzed.
     Identification of any software used, including any 
certificate or certificates of analysis for standards and software 
used. This information helps us understand the associated test results 
and verify that the standards used are valid and that the software used 
is functioning properly.
     The following information about the qualifications of the 
analyst or analysts who were involved in the analysis conducted under 
this program, if the accredited laboratory has not previously submitted 
documentation of the analyst's qualifications to FDA or the analyst's 
qualifications have significantly changed since the accredited 
laboratory last submitted documentation of the analyst's qualifications 
to FDA:
    [cir] The analyst's curriculum vitae;
    [cir] Training records with regards to methods that the analyst is 
qualified to perform, including the dates of such training and the name 
of the trainer or training provider;
    [cir] Any other documentation of analyst's ability to perform the 
method properly in the specific context of the food testing to be 
conducted, under Sec.  1.1150(b) (e.g., a certificate of completion of 
a relevant training and/or documentation that the analyst was the 
investigator for the relevant validation or verification study); and
    [cir] Individual proficiency test worksheets relevant to the 
analysis being performed.
    We invite comment on our proposed requirements for what information 
full analytical reports must contain. If commenters believe we are 
proposing to require too much information to be included in full 
analytical reports, please specifically address in your comments which 
requirements of Sec.  1.1152(g) we should delete or revise, and why 
that piece of information is not necessary for us to engage in a 
meaningful indepth scientific review of the analysis to determine 
whether the analysis is valid. For commenters who believe we have not 
proposed sufficient information to be included in full analytical 
reports, please specify what additional information we should require 
and why it is critical to our assessment of the analysis and test 
results.
    Proposed Sec.  1.1152(h) would require that if the accredited 
laboratory conducts the analysis using a method that is not published 
in a reputable international or national standard or that is otherwise 
not publicly and readily available, upon request by FDA the accredited 
laboratory must submit documentation of the method to FDA. If the 
method used has been published in a reputable international or national 
standard (e.g., in the Official Methods of Analysis of AOAC 
International) or the method is otherwise publicly available (readily 
available, so that a reasonable analyst would be able to easily find 
the method), we would be able to look up the method ourselves. However, 
if the method is not published in a reputable international or national 
standard or otherwise readily publicly available, the accredited 
laboratory would need to share information about the method with us, if 
requested, as we may have no other way to access the information. For 
example, in the case of a method developed by the laboratory, the 
laboratory would need to submit to us sufficient information about the 
method for us to understand how the method is applied, such as the 
method standard operating procedure, or some other document that 
describes the steps within the method. Such information would be in 
addition to the validation or verification information that would be 
required under proposed Sec.  1.1152(c)(4), (5), or (6).
    Proposed Sec.  1.1152(i) addresses advance notice of sampling. We 
are proposing to require advance notice of sampling in certain 
circumstances as an additional technique to exercise oversight over 
sampling conducted for food testing in this program. Under proposed 
Sec.  1.1152(i)(1), if we determine that the sampling conducted by a 
sampler may materially differ from the sampling documented in the 
associated sampling plan or sample collection report, or if we 
determine that the sampling may have been otherwise improper, we may 
require the accredited laboratory that analyzed the associated 
sample(s), and other accredited laboratories under this program that 
have analyzed samples collected by the sampler previously, to request 
and receive from the sampler, and submit or require the sampler to 
submit, an advance notice of sampling to the destination specified by 
the laboratory accreditation program website portal 48 hours before 
each of the 10 occasions that the sampler will collect a sample that 
the accredited laboratory will analyze under this program. As we 
discuss below, we also propose at Sec.  1.1152(i)(2)(ii) and (iii) to 
be able to specify certain timeframes other than 48 hours and to 
specify a number other than 10 occasions.
    We intend advance notice of sampling to encourage the use of 
sampling techniques that will allow for a meaningful analysis, by 
facilitating our observation of sampling and collection of audit 
samples before we receive the test results with the accompanying sample 
collection report. Audit samples are samples we collect from the lot or 
environment at issue, which we then analyze, and compare our test 
results with the test results of the accredited laboratory. We believe 
it is reasonable to generally require the notice of sampling to be 
submitted to us 48 hours prior to collection of the sample(s) to allow 
us time to determine whether to observe the sampling and/or take an 
audit sample, and assign appropriate personnel to the task. Note that 
we may take audit samples (as we currently do) even if we have not 
required advance notice of sampling.
    Proposed Sec.  1.1152(i)(2) elaborates that we may, as appropriate 
(based on the relevant circumstances): Specify the type of food product 
or environment that requires advance notice of sampling under this 
section; determine that an amount of time other than 48 hours in 
advance is required, to a minimum of 24 hours and up to 7 business days 
in advance; determine that a number of occasions other than 10 are 
required, to a minimum of one occasion and up to a maximum of 20 
occasions; and notify affected accredited laboratories that submission 
of additional notices of sampling are not required. We would typically 
notify affected accredited laboratories that submission of additional 
notices of sampling are not required after we have observed and/or 
audit an amount of sampling conducted by the sampler sufficient for us 
to determine whether the sampler appears to be conducting sampling 
properly.
    Proposed Sec.  1.1152(i)(3) would require that the advance notice 
of sampling include the following information:
     A unique identification code for the notice of sampling. 
This would help us identify, review, and record the notification 
efficiently and would help

[[Page 59488]]

us identify associated submissions. The test results would reference 
the identification numbers of each associated submission.
     The name of the accredited laboratory that will conduct 
analysis of the sample. This would allow us to, for example, followup 
with the accredited laboratory that will conduct the analysis, if 
appropriate, before or during the accredited laboratory's analysis of 
the samples.
     The name and street address of the sampler that will 
conduct the sampling. This information will help us organize our review 
of notices of sampling as they are submitted to us.
     A primary contact (name and phone number) for the sampler. 
This information would be necessary if we need to contact the sampler. 
For example, we may need to contact the sampler if we choose to observe 
or audit the sampling, but the food product or environment at issue is 
not at the location specified on the notice of sampling.
     The reason(s) why the food product or environment will be 
sampled. We would want to know, for example, if the sample to be 
collected will be analyzed by an accredited laboratory with regards to 
a particular import alert. We expect this information to help us 
determine whether to observe or audit the sampling.
     The location of the food product or environment that will 
be sampled, including sufficient information to identify the food 
product or environment to be sampled. This would help us locate the 
food product or environment in the case we would want to observe the 
sampling or take an audit sample.
     As applicable, the U.S. Customs and Border Protection 
entry and line number(s) and the product code(s) of the food. This 
would help us identify the food product at issue if we choose to 
observe or audit the sampling. In the import context, we would want to 
know the FDA product code. In the domestic context, the U.S. Customs 
and Border Protection entry and line number(s) would be inapplicable, 
and we would instead want to know the product code assigned by the 
manufacturer, packager, labeler, as applicable. In the context of 
environmental sampling, both items are inapplicable.
     The date and approximate time the sampling will begin. The 
date must be correct and we would expect the estimated time to be as 
close to the actual time of the sampling as reasonably possible.
    Proposed Sec.  1.1152(j) provides that when any changes occur that 
affect the accreditation of the accredited laboratory, the accredited 
laboratory must immediately send FDA, within 48 hours, and the 
accreditation body that accredited it notice of such changes, a 
detailed description of such changes, and an explanation of how such 
changes affect the accreditation of the accredited laboratory. This 
provision would cover changes in the name or operations of an 
accredited laboratory, such as the purchase of an accredited laboratory 
by a company, as well as changes that would cause the accredited 
laboratory to no longer meet the requirements of this program. We have 
proposed this requirement in accordance with section 422(a)(1)(C) of 
the FD&C Act, which requires that, in pertinent part, as a condition of 
accreditation, as appropriate, accredited laboratories must report to 
FDA any changes that would affect the accreditation of the laboratory. 
Proposed Sec.  1.1152(j) would not require accredited laboratories to 
notify us of changes covered by proposed Sec.  1.1123(c), which 
requires recognized accreditation bodies to immediately notify us of 
certain information related to the accreditation status of laboratories 
they accredit or that have sought their accreditation (e.g., certain 
changes initiated by the recognized accreditation body, and findings of 
fraud).
    Proposed Sec.  1.1152(k) provides that if FDA does not receive all 
information required to be submitted to FDA by proposed Sec.  1.1152(a) 
through (j), FDA may consider the related food testing to be invalid. 
For example, if we do not receive a validation study when its 
submission to FDA is required, we would not be able to determine 
whether the method is appropriate for the intended use; if we do not 
receive a full analytical report when we require its submission, we 
would be unable to conduct the necessary indepth scientific review of 
the analysis to determine whether, in that instance, the analysis was 
valid; and if we do not receive all the required information about the 
sampling, we would not be able to determine whether the sample that was 
analyzed was representative of the food product or environment at 
issue.
8. What other records requirements must an accredited laboratory meet? 
(Proposed Sec.  1.1153)
    This proposed rule would establish requirements for accredited 
laboratories to establish, control, and retain records relating to 
their food testing activities under this program. In addition to 
meeting the ISO/IEC 17025:2017 records requirements (in accordance with 
proposed Sec.  1.1146(b)), accredited laboratories would have to meet 
the additional records requirements of this proposed section.
    Proposed Sec.  1.1153(a) would require laboratories that have been 
accredited to maintain electronically, for 5 years after the date of 
creation, certain records created and received during their period of 
accreditation that relate to compliance with this proposed rule. Even 
if no longer accredited, laboratories that used to be accredited would 
have an obligation under this proposed rule to maintain records created 
and received during their period of accreditation. Proposed Sec.  
1.1153(a) elaborates that these records include: (1) Documents related 
to the accredited laboratory's grant (and, if applicable, extensions) 
of accreditation from its accreditation body; (2) documentation of food 
testing the accredited laboratory conducted under this program, in 
accordance with proposed Sec.  1.1150(d); (3) all documents that the 
accredited laboratory was required to submit to FDA under Sec.  1.1152, 
and associated correspondence by the accredited laboratory (and its 
officers, employees, and other agents) with the owner or consignee (and 
its officer, employees, and other agents) of the tested food product or 
environment; (4) all requests for food testing from an owner or 
consignee that would be conducted under this proposed rule; (5) 
documentation of any internal investigations, internal audits, and 
corrective actions taken to address any problems or deficiencies 
related to activities under this proposed rule; (6) documentation 
related to probation or withdrawal from accreditation under this 
program; and (7) documentation of changes to its management system or 
food testing activities that may affect its compliance with this 
proposed rule. We believe it appropriate to require maintenance of 
these records for purposes of this proposed rule.
    Proposed Sec.  1.1153(b) provides that within 30 days of the 
receipt of proficiency testing results by the accredited laboratory, 
the accredited laboratory must submit the proficiency testing results 
to the recognized accreditation body that accredits the accredited 
laboratory, and, if the accredited laboratory failed the proficiency 
test, also to FDA, via the destination specified by the website 
described by Sec.  1.1109. During our conversations with certain 
laboratories and accreditation bodies, we received feedback that this 
proposed rule would benefit from a requirement that proficiency testing 
results be submitted to the recognized accreditation body that 
accredits the laboratory. See

[[Page 59489]]

``Record of Outreach Sessions on FDA Proposed Rules, Conference call 
between the FSMA Lab Accreditation Workgroup and the Food Laboratory 
Alliance, July 21, 2015'' (Ref. 20), and attached meeting minutes. Our 
understanding is that there is currently no such requirement, and 
accredited laboratories may decline to submit proficiency test results 
to their accreditation body. Proficiency test results would provide 
accreditation bodies with valuable information about the food testing 
capabilities and proficiencies of the accredited laboratories they 
accredit. Furthermore, because proficiency testing providers are 
typically uninterested third parties, there is little risk that 
submitting the proficiency test results to the accreditation body and 
potentially FDA would affect the conduct of the proficiency testing. We 
also believe we may find proficiency testing results helpful as well, 
particularly if the proficiency testing was unsuccessful and related to 
food testing results submitted to us under proposed Sec.  1.1152.
    Proposed Sec.  1.1153(c) provides that laboratories that have been 
accredited must make these records available for inspection and copying 
upon written request of an authorized officer or employee of FDA. The 
authorized officer or employee of FDA may request that the laboratory 
submit such records to FDA electronically or that the laboratory make 
such records promptly available at the physical location of the 
laboratory or at another reasonably accessible location. If the 
authorized officer or employee of FDA requests the records be submitted 
electronically, the records must be submitted electronically not later 
than 10 business days after the date of the request. However, records 
related to the immediate notification requirements in Sec.  1.1152(j) 
must be submitted within 48 hours. If the authorized FDA officer or 
employee requests records that are maintained in a language other than 
English, the laboratory must electronically submit an English 
translation of the records to FDA within a reasonable time. We are not 
proposing that the records themselves be maintained in English, as we 
believe such an approach would be unduly burdensome, particularly for 
foreign laboratories.
    Proposed Sec.  1.1153(d) would require laboratories that have been 
accredited to ensure that significant amendments to records described 
by proposed Sec.  1.1153(a) and (b) can be tracked to previous and 
original versions. Proposed Sec.  1.1153(d) further provides that if 
such a significant amendment is made, both the original document and 
amended document must be maintained by the laboratory that has been 
accredited during the time period that the amended document must be 
maintained. Further, the laboratory must also document the date of 
amendment, the personnel responsible for the amendment, and a 
conspicuous indication on the original document stating that the 
document has been altered and a more recent version of the document 
exists. This provision is based on ISO/IEC 17025:2017 (Ref. 13) at 
section 7.5.2. However, section 7.5.2 of ISO/IEC 17025:2017 applies to 
``technical records,'' while proposed Sec.  1.1153 applies to a wider 
category of records.
    We acknowledge that the requirements of proposed Sec.  1.1153 may 
require revisions to contracts and perhaps other documents establishing 
the scope of a laboratory's authority with respect to granting records 
access. We nonetheless have tentatively concluded that the records 
maintenance and access requirements in proposed Sec.  1.1153 are 
necessary for us to maintain an appropriate degree of oversight over 
accredited laboratories (in accordance with proposed Sec.  1.1159) and 
for recognized accreditation bodies to monitor and assess laboratories 
they accredit.

H. Proposed Provisions About Procedures for Accreditation of 
Laboratories (Proposed Sec. Sec.  1.1158 Through 1.1165)

    This proposed rule would establish procedures for laboratories to 
apply for accreditation or relinquish accreditation, and for our 
oversight of accredited laboratories, including procedures for our 
review of test results and supporting information, and for probation 
and revocation of the accreditation of laboratories.
1. How does a laboratory apply for accreditation or modification of its 
scope of accreditation by a recognized accreditation body? (Proposed 
Sec.  1.1158)
    Proposed Sec.  1.1158 explains how laboratories must apply for 
accreditation; reinstatement of accreditation or modification of their 
scope of accreditation; addresses the duration of accreditation; and 
describes the effects of a denial of an application for accreditation. 
Section 422 of the FD&C Act establishes a structure whereby FDA 
recognizes accreditation bodies, who, in turn, accredit laboratories 
that meet the applicable requirements of the program. As we indicate in 
proposed Sec.  1.1109, we will maintain a list of recognized 
accreditation bodies, who may perform accreditation, along with the 
contact information of these recognized accreditation bodies, so that 
laboratories would be able to use our website as a resource to find a 
recognized accreditation body that can assess whether the laboratory is 
eligible for accreditation.
    Proposed Sec.  1.1158(a) provides that a laboratory seeking 
accreditation must submit its application for accreditation to a 
recognized accreditation body identified on the website described in 
proposed Sec.  1.1109. Proposed Sec.  1.1158(a) further provides that 
the recognized accreditation body will review and assess the 
application in accordance with the applicable requirements of this 
program. Proposed Sec.  1.1158(a) also provides that if the laboratory 
seeking accreditation had its accreditation (in-whole or in-part) 
withdrawn by a recognized accreditation body, or revoked by FDA the 
previous time it was accredited under this program, the laboratory must 
meet the additional requirements specified by proposed Sec.  1.1165 
(which addresses the question of how a laboratory requests 
reinstatement of accreditation).
    Proposed Sec.  1.1158(b) clarifies that a laboratory may use 
documentation of conformance with ISO/IEC 17025:2017, as applicable and 
supplemented as necessary, in meeting the applicable requirements of 
this program. For example, if a laboratory is already accredited to 
ISO/IEC 17025:2017 by a recognized accreditation body, the recognized 
accreditation body could accept this accreditation as evidence that the 
laboratory meets the requirements of ISO/IEC 17025:2017 the laboratory 
must meet under proposed Sec.  1.1138 to become accredited under this 
proposed rule.
    Proposed Sec.  1.1158(c) clarifies that an accredited laboratory's 
accreditation continues until withdrawn, revoked, or relinquished under 
this program. It is our understanding that the current practice by 
accreditation bodies and laboratories is that the laboratory's intent 
to remain accredited is generally assumed, and the accreditation body 
continues to accredit the laboratory and conduct assessments and 
reassessments under that understanding. We seek comment with regards to 
whether this is correct.
2. How will FDA oversee accredited laboratories? (Proposed Sec.  
1.1159)
    Proposed Sec.  1.1159 would establish certain requirements related 
to our oversight of accredited laboratories. Although the recognized 
accreditation

[[Page 59490]]

bodies have primary oversight responsibility over accredited 
laboratories, we would also exercise some ability to oversee accredited 
laboratories, via requesting records and, if appropriate, conducting 
onsite assessments. We note that in contrast to recognized 
accreditation bodies, under section 422(b)(2) of the FD&C Act, FDA will 
routinely receive the results of food testing conducted under section 
422(b)(1), along with supporting information, which will provide us 
with information on accredited laboratories' compliance with this 
program.
    Proposed Sec.  1.1159(a) provides that we may assess accredited 
laboratories at any time to determine whether they continue to comply 
with the applicable requirements of the program and whether there are 
any deficiencies in the performance of the accredited laboratory that, 
if not corrected, would warrant probation or revocation of its 
accreditation.
    Proposed Sec.  1.1159(b) clarifies that, in the course of our 
evaluation of the performance of an accredited laboratory, we may 
review any of the following: Records the accredited laboratory would be 
required to maintain under this proposed rule; records the recognized 
accreditation body that accredited the accredited laboratory is 
required to maintain under this proposed rule; information we obtain 
during an onsite assessment of the accredited laboratory (conducted 
under proposed Sec.  1.1159(c)); information we obtain during our 
assessment of the recognized accreditation body that accredited the 
laboratory; and any other information we obtain, including during FDA's 
inspections or investigations of one or more owners or consignees of 
food subject to food testing under this proposed rule.
    Proposed Sec.  1.1159(c) provides that our assessment may include 
our own onsite assessment of the accredited laboratory at any 
reasonable time, with or without a recognized accreditation body (or 
its officers, employees, and other agents) present, to assess an 
accredited laboratory. We would exercise this authority as appropriate 
to followup on potential problems that come to our attention, for which 
referral to a recognized accreditation body may be inefficient or 
otherwise inappropriate, and to otherwise verify compliance with the 
program. Proposed Sec.  1.1159(d) clarifies that we will also report 
any of our observations and findings of our assessment to the 
accredited laboratory's recognized accreditation body.
    We seek comments regarding this proposed section and how 
accreditation bodies and FDA should share oversight of accredited 
laboratories under this proposed program.
3. How will FDA review submitted test results and analytical reports? 
(Proposed Sec.  1.1160)
    Proposed Sec.  1.1160(a) clarifies that if we find that any test 
results, analytical report, related documents (for example, the 
sampling plan, verification studies, and validation studies) or the 
associated analysis, contains deficiencies or otherwise indicates that 
any aspect of the food testing is not being conducted in compliance 
with the program, FDA may consider the analysis to be invalid. We will 
notify the accredited laboratory that appears to be responsible for the 
deficiency, and we may also notify the owner or consignee of the food 
of the deficiency. When we notify the accredited laboratory that 
appears to be responsible for the deficiency, our notice would be 
considered a complaint that would be treated in accordance with the 
laboratory's established procedures for complaints under section 7.9 of 
ISO/IEC 17025:2017 (Ref. 13). When we notify the laboratory of the 
deficiency, the laboratory must respond, in writing, to us regarding 
the deficiency within 30 days or an agreed-upon timeframe, including a 
statement with respect to how the accredited laboratory intends to 
address the deficiency, and/or a statement describing the extent to 
which the laboratory has addressed the deficiency.
    Proposed Sec.  1.1160(b) clarifies that we may also report any of 
our determinations of deficiencies resulting from our review of any 
test results, reports, and related documents under this rule to the 
recognized accreditation body that accredits the accredited laboratory.
    Proposed Sec.  1.1160(c) clarifies that if the deficiency in the 
test result, analytical report, and/or the associated analysis 
demonstrates a material substantive shortcoming in the related food 
testing or demonstrates repeated administrative deficiencies, FDA will 
also consider whether disqualification from being eligible for 
permission to submit abridged analytical reports under proposed Sec.  
1.1152(d), and/or other action under this program, is appropriate.
    Proposed Sec.  1.1160(d) reiterates the language of section 422(d) 
of the FD&C Act, stating that nothing in this rule shall be construed 
to limit our ability to review and act upon information from food 
testing, including determining the sufficiency of such information and 
testing. For example, we would typically consider analysis of a non-
representative sample to be invalid.
4. When will FDA put an accredited laboratory on probation or revoke 
the accreditation of a laboratory? (Proposed Sec.  1.1161)
    This proposed rule would establish the conditions under which we 
could put an accredited laboratory on probation or revoke a 
laboratory's accreditation to conduct food testing under this proposed 
program. Under this proposal, we could put an accredited laboratory on 
probation or revoke accreditation only in limited circumstances, 
including where the recognized accreditation body that accredits the 
accredited laboratory does not withdraw accreditation itself.
    Proposed Sec.  1.1161(a) provides that we may revoke the 
accreditation (in whole or in part) of an accredited laboratory program 
for good cause, which may include any of the following reasons: (1) 
Demonstrated bias or lack of objectivity when conducting food testing 
under this subpart where the laboratory's recognized accreditation body 
fails to withdraw accreditation of the laboratory; (2) performance that 
calls into question the validity or reliability of its food testing 
under this subpart where the laboratory's recognized accreditation body 
fails to withdraw accreditation of the laboratory; or (3) other failure 
to substantially comply with this rule where the laboratory's 
recognized accreditation body fails to withdraw accreditation of the 
laboratory.
    Proposed Sec.  1.1161(b) provides that if we determine that an 
accredited laboratory has demonstrated deficiencies in performing its 
functions that are less serious and more limited than would warrant 
revocation of accreditation, and it is reasonably likely that the 
accredited laboratory will be able to correct such deficiencies within 
a specified period of time, we may temporarily put the laboratory on 
probation and request that the laboratory take appropriate corrective 
actions.
    Proposed Sec.  1.1161(c) further clarifies that when there are 
grounds for revocation of accreditation, but the deficiencies are 
associated with or affect only certain methods within the accredited 
laboratory's scope of accreditation, we may revoke the accredited 
laboratory's accreditation only for those affected methods.
    Proposed Sec.  1.1161(d) clarifies that our probation of a 
laboratory's accreditation shall remain in effect until the laboratory 
demonstrates to our satisfaction that the laboratory has

[[Page 59491]]

successfully implemented appropriate corrective actions, or until we 
determine that revocation of accreditation is warranted.
    If we determine that revocation is warranted, under proposed Sec.  
1.1161(e) we would notify the laboratory and its recognized 
accreditation body of the revocation of its accreditation through the 
issuance of a revocation notice. The revocation notice would state the 
grounds for revocation; whether the revocation of accreditation is in-
whole or in-part, and if it is in-part, to which methods it applies; 
state the procedures for requesting a regulatory hearing on the 
revocation under proposed Sec.  1.1173; and state the procedures for 
requesting reinstatement of accreditation under proposed Sec.  1.1165.
    Similarly, if we determine that probation of an accredited 
laboratory is warranted, under proposed Sec.  1.1161(f) we would notify 
the laboratory and its recognized accreditation body of the probation, 
describe the grounds for the probation, and specify other key details, 
including all deficiencies that must be corrected for FDA to lift the 
probation. Furthermore, the probation notice would either inform the 
laboratory that the laboratory has a specified time period to take 
corrective actions specified by FDA; or request that the laboratory 
submit a corrective action plan to FDA for FDA's approval that 
identifies the corrective actions it will take to address deficiencies 
identified in the notice and identify timeframes for completion.
    Proposed Sec.  1.1161(g) provides that we may revoke (in-whole or 
in-part) the accreditation of the laboratory that has been put on 
probation if we determine that the laboratory is not implementing 
appropriate corrective actions.
    Proposed Sec.  1.1161(h) reiterates the provision of proposed Sec.  
1.1109 that we will provide notice on the website described in proposed 
Sec.  1.1109 of our probation or revocation of the laboratory's 
accreditation.
5. What are the consequences if FDA puts an accredited laboratory on 
probation or revokes the accreditation of a laboratory? (Proposed Sec.  
1.1162)
    Under proposed Sec.  1.1162(a), if we revoke the accreditation in 
whole of a laboratory, the laboratory would be immediately ineligible 
to conduct food testing under this rule. Proposed Sec.  1.1162(a) 
further provides that if we revoke the accreditation of laboratory in-
part, the laboratory is immediately ineligible to use the methods that 
are subject to the revocation to conduct food testing under this 
subpart. An accredited laboratory that is put on probation by FDA would 
be permitted to continue to conduct food testing under this proposed 
program.
    Proposed Sec.  1.1162(b) further provides that, with respect to 
food testing conducted by the laboratory prior to our revocation of 
accreditation, we may refuse to consider specific food testing results 
and associated reports of food testing conducted under this program by 
the accredited laboratory if the basis for our revocation of 
accreditation of the laboratory indicates that the specific food 
testing conducted by the laboratory may not be reliable.
    Proposed Sec.  1.1162(c) would require that within 10 business days 
of the date of issuance of the revocation of accreditation, the 
laboratory must notify us electronically, in English, of the name of 
the custodian who will maintain the records required by proposed Sec.  
1.1153, and the contact information for the custodian, which must 
include an email address, and the street address where the records will 
be located.
    Proposed Sec.  1.1162(d) would require that within 10 business days 
of the date of issuance of the probation or revocation the laboratory 
notify any owners or consignees for whom it is conducting food testing 
under this proposed rule that it is on probation or its accreditation 
has been revoked.
6. What if a laboratory wants to voluntarily relinquish its 
accreditation? (Proposed Sec.  1.1163)
    This proposed rule would offer accredited laboratories a mechanism 
for voluntarily relinquishing their accreditation. We are proposing 
certain procedural requirements, similar to those in the accredited 
third-party certification regulation, that accredited laboratories must 
follow to relinquish their accreditation. We believe these procedures 
are necessary to ensure an orderly accreditation relinquishment process 
and so that we may exercise appropriate oversight and timely update the 
website described by proposed Sec.  1.1109.
    Proposed Sec.  1.1163(a) would require accredited laboratories to 
notify us electronically, in English, and notify their recognized 
accreditation body, at least 60 days before voluntarily relinquishing 
its accreditation in whole or in part. The notice would need to include 
the date on which relinquishment will occur. If the relinquishment is 
of the laboratory's accreditation in-whole, the notification must also 
include the name and contact information of the custodian who will 
maintain the records required under proposed Sec.  1.1153 after the 
date of relinquishment or the date accreditation expires, as 
applicable, and make them available to FDA as required by proposed 
Sec.  1.1153. The contact information for the custodian must include, 
at a minimum, an email address and the street address where the records 
required by proposed Sec.  1.1153 will be located.
    For food testing that is subject to proposed Sec.  1.1107(a), we 
would consider food testing conducted by a laboratory that is not 
accredited at the time of the food testing to be invalid. This position 
is in accordance with section 422(b)(1) of the FD&C Act, which requires 
such food testing to be conducted only by accredited laboratories.
    Proposed Sec.  1.1163(b) reiterates that we will provide notice on 
the website described in Sec.  1.1109 of the voluntary relinquishment 
of accreditation of the laboratory.
7. What is the effect on accredited laboratories if their accreditation 
body voluntarily or involuntarily loses its recognition? (Proposed 
Sec.  1.1164)
    Section 422(a)(7)(B) of the FD&C Act provides that we must promptly 
revoke the recognition of any accreditation body found not to be in 
compliance with the requirements of section 422 of the FD&C Act, 
specifying, as appropriate, any terms and conditions necessary for 
laboratories accredited by such body to continue to perform food 
testing under this proposed program. We would establish those terms and 
conditions in Sec.  1.1164 of this proposed rule. Accordingly, proposed 
Sec.  1.1164(a) provides that when an accreditation body has its 
recognition revoked, relinquishes its recognition, allows its 
recognition to expire, or has its application for renewal of 
recognition denied, a laboratory accredited by the accreditation body 
must take the following actions (subject to an exception in paragraph 
(b), which we discuss below): (1) No later than 30 days after FDA 
issues the notice to the laboratory under proposed Sec.  1.1129, Sec.  
1.1130, or Sec.  1.1131 that its accreditation body is no longer 
recognized, the laboratory submits to FDA documentation of the 
accredited laboratory's most recent internal audit, which all 
accredited laboratories would be required to maintain under proposed 
Sec.  1.1153(a)(5), documentation showing compliance with the conflict 
of interest requirements in proposed Sec.  1.1147, and documentation of 
the most recent proficiency test for each test method for which the 
laboratory is accredited under this subpart, to show compliance with 
proposed Sec.  1.1138(a)(1)(ii); and (2) no

[[Page 59492]]

later than 1 year after FDA issues the applicable notice under proposed 
Sec.  1.1129, Sec.  1.1130, or Sec.  1.1131 to the laboratory, the 
laboratory becomes accredited by a recognized accreditation body.
    Our review of accredited laboratories' quality assurance records in 
accordance with proposed Sec.  1.1164(a)(1) would allow us to ensure 
that the accredited laboratory is in compliance with this rule while it 
transitions. We believe a period of one year, in accordance with 
proposed Sec.  1.1164(a)(2), gives the laboratory sufficient time to 
find a recognized accreditation body and complete its accreditation 
process while limiting the time the laboratory conducts food testing 
without the oversight of a recognized accreditation body. We may be 
more proactive in our oversight of such accredited laboratories during 
the period they are not subject to the oversight of a recognized 
accreditation body.
    Proposed Sec.  1.1164(b) would establish an exception to the above-
described requirements. Under proposed Sec.  1.1164(b), the accredited 
laboratory may choose to relinquish its accreditation in lieu of 
meeting the requirements of proposed Sec.  1.1164(a). In such case, the 
accredited laboratory would have to initiate relinquishment of its 
accreditation in-whole under proposed Sec.  1.1163 not later than 15 
days after FDA issues the applicable notice to the accredited 
laboratory under proposed Sec.  1.1129, Sec.  1.1130, or Sec.  1.1131, 
and the relinquishment would need to occur within 90 days. Of note, 
proposed Sec.  1.1163(a) would typically require an accredited 
laboratory to submit the relinquishment notice to its recognized 
accreditation body and to FDA.
    However, for a relinquishment initiated in accordance with proposed 
Sec.  1.1164(b), the accredited laboratory would submit the 
relinquishment notice under proposed Sec.  1.1163(a) to FDA only, as 
the accredited laboratory would have no recognized accreditation body 
at the time.
    Generally, if the accredited laboratory does not meet the 
requirements of either proposed Sec.  1.1164(a) or (b), the accredited 
laboratory would no longer be in substantial compliance with this 
proposed rule and its accreditation would generally be subject to 
revocation under proposed Sec.  1.1161.
8. How does a laboratory request reinstatement of accreditation? 
(Proposed Sec.  1.1165)
    Proposed Sec.  1.1165 describes how a laboratory may obtain 
reinstatement of its accreditation if we revoked its accreditation, if 
a recognized accreditation body withdrew its accreditation, or if the 
laboratory voluntarily relinquished its accreditation.
    Proposed Sec.  1.1165(a) addresses how a laboratory may obtain 
reaccreditation if its accreditation was withdrawn (in whole or in 
part) by a recognized accreditation body or revoked (in-whole or in-
part) by FDA. The laboratory may seek reaccreditation by submitting a 
new application for accreditation (in-whole or in-part, as applicable) 
under proposed Sec.  1.1158 to a recognized accreditation body. 
Proposed Sec.  1.1165(a) further provides that the laboratory must 
also: (1) Notify us, before it submits the new application for 
accreditation to the recognized accreditation body, that the laboratory 
will be submitting a new application for accreditation to the 
recognized accreditation body, including in the notification the legal 
name of the laboratory, valid contact information for the laboratory, 
the legal name of the recognized accreditation body the laboratory will 
be submitting the application to, and the date that the laboratory 
expects to submit the new application for accreditation; and (2) 
demonstrate, to the satisfaction of the recognized accreditation body 
it is submitting the new application to, that the grounds for the 
withdrawal of accreditation have been resolved and that the laboratory 
has implemented measures to prevent such grounds from recurring. If the 
laboratory's accreditation had been withdrawn by a recognized 
accreditation body, the requirement to notify us would allow us to 
check whether the laboratory had been recently denied reaccreditation 
by a different recognized accreditation body, which could possibly 
indicate whether the laboratory is successively seeking approval of 
accreditation without changing its practices. Alternatively, if we 
revoked the laboratory's accreditation, we may want to contact the 
recognized accreditation body to which the laboratory is applying, to, 
for example, explain to the accreditation body why we found it 
necessary to revoke the laboratory's accreditation.
    Proposed Sec.  1.1165(b) addresses how a laboratory may obtain 
reaccreditation after it voluntarily relinquishes its accreditation. A 
laboratory that voluntarily relinquished its accreditation may seek 
reinstatement of accreditation by submitting a new application for 
accreditation under proposed Sec.  1.1158 to a recognized accreditation 
body.

I. Proposed Provisions About Requesting FDA Reconsideration, FDA 
Internal Review, or Regulatory Hearings of FDA Decisions Under This 
Rule (Proposed Sec. Sec.  1.1171 Through 1.1174)

    This proposed rule would establish requirements and procedures an 
accreditation body would have to follow to request that we reconsider 
our decision to deny its application for recognition, to request we 
internally review our decision to deny its request to reconsider its 
application for recognition, and to request a regulatory hearing on our 
decision to take adverse action with respect to its recognition. This 
proposed rule would also establish requirements and procedures a 
laboratory would have to follow to request a regulatory hearing on our 
decision to take an adverse action with respect to the laboratory's 
accreditation. Further, this proposed rule would establish requirements 
and procedures owners and consignees would have to follow to request a 
regulatory hearing on a food testing order. Finally, this proposed rule 
would establish procedures for the conduct of such reconsiderations, 
internal reviews, and regulatory hearings.
    1. How does an accreditation body request reconsideration by FDA of 
a decision to deny its application for recognition, renewal, or 
reinstatement? (Proposed Sec.  1.1171)
    This proposed rule would establish procedures for an accreditation 
body to seek reconsideration of our denial of its application for 
recognition, renewal of recognition, or reinstatement of recognition.
    The procedures described by proposed Sec.  1.1171 require 
submission of the request for reconsideration within 10 business days 
of the issuance of such denial. The request for reconsideration must be 
submitted to us electronically, in English, and in accordance with the 
procedures described in the notice of denial. The request must also be 
signed by the accreditation body or by an individual authorized to act 
on its behalf. Within a reasonable time after we complete our review 
and evaluation of the request for reconsideration and the supporting 
information submitted, we would notify the requestor through the 
issuance of the recognition upon reconsideration or through the 
issuance of a denial of recognition upon reconsideration. We note that 
should FDA issue a denial after a request for reconsideration, the 
accreditation body would be able to request the review of such decision 
under 21 CFR 10.75.

[[Page 59493]]

2. How does an accreditation body or laboratory request a regulatory 
hearing on FDA's decision to revoke the recognized accreditation body's 
recognition or revoke the accredited laboratory's accreditation? 
(Proposed Sec.  1.1173)
    This proposed rule explains the procedures that would be used for 
challenges to our revocation of an accreditation body's recognition or 
our revocation of a laboratory's accreditation.
    Under proposed Sec.  1.1173(a), an accreditation body whose 
recognition was revoked or a laboratory whose accreditation was revoked 
(or an individual authorized to act on the accreditation body's or 
laboratory's behalf) may submit a request for a regulatory hearing, 
under part 16, on the revocation. The request must be submitted within 
10 business days of the date of revocation. Written notices of 
revocation will contain all the elements required by Sec.  16.22 and 
will thereby constitute the notice of an opportunity for hearing under 
part 16.
    Under proposed Sec.  1.1173(b), the request for a regulatory 
hearing must be submitted with a written appeal that responds to the 
bases for our decision described in the written notice of revocation 
together with any supporting information upon which the requestor is 
relying. The request, appeal, and supporting information must be 
submitted to us electronically, in English, and in accordance with the 
procedures described in the notice of revocation.
    Proposed Sec.  1.1173(c) makes clear that the submission of a 
request for a regulatory hearing under this rule will not operate to 
delay or stay the effect of our decision to revoke recognition of an 
accreditation body or to revoke accreditation of a laboratory unless we 
determine that delay or a stay is in the public interest.
    Under proposed Sec.  1.1173(d) and (e), the presiding officer for a 
regulatory hearing under this proposed rule will be designated after 
the request for a regulatory hearing is submitted to us. The presiding 
officer may deny a request for regulatory hearing under this proposed 
rule under 21 CFR 16.26(a) when no genuine or substantial issue of fact 
has been raised.
    Proposed Sec.  1.1173(f) states that if a hearing request is 
granted, the hearing will be held within 10 business days after the 
date the request was filed or, if applicable, within a timeframe agreed 
upon in writing by requestor and the presiding officer and FDA.
    The presiding officer must conduct the hearing under part 16, 
except that, under Sec.  16.5(b), the procedures for a regulatory 
hearing described in part 16 apply only to the extent that such 
procedures are supplementary and not in conflict with the procedures 
specified for the conduct of regulatory hearings under this rule. The 
following requirements of part 16 are inapplicable to regulatory 
hearings conducted under this rule: Sec.  16.22 (Initiation of a 
regulatory hearing); Sec.  16.24(e) (Timing) and (f) (Contents of 
notice); Sec.  16.40 (Commissioner); Sec.  16.60(a) (public process); 
Sec.  16.95(b) (Administrative decision and record for decision); and 
Sec.  16.119 (Reconsideration and stay of action).
    Proposed Sec.  1.1173(f)(3) clarifies that a decision by the 
presiding officer to affirm the revocation of recognition or the 
revocation of accreditation that served as the basis for the request 
for a regulatory hearing is considered a final Agency action for 
purposes of 5 U.S.C. 702.
3. How does an owner or consignee request a regulatory hearing on a 
food testing order? (Proposed Sec.  1.1174)
    This proposed rule explains the procedures that would be used for 
challenges to our issuance of a food testing order.
    Proposed Sec.  1.1174(a) provides that no later than 24 hours after 
we issue the food testing order, the owner or consignee who is the 
subject of the food testing order may submit a request for a regulatory 
hearing, conducted under part 16, on the food testing order. The food 
testing order will contain all of the elements required by Sec.  
16.22(a) and will thereby constitute the notice of an opportunity for 
hearing under part 16.
    Proposed Sec.  1.1174(b) provides that the request for a regulatory 
hearing must be submitted with a written appeal that responds to the 
bases for our determinations described in the food testing order, 
together with any supporting information upon which the requestor is 
relying. The request, appeal, and supporting information must be 
submitted in English to the address specified in such notice and in 
accordance with the procedures described therein. The request, appeal, 
and supporting information may be submitted electronically.
    Proposed Sec.  1.1174(c) states that the presiding officer for the 
regulatory hearing will be designated after a request for the 
regulatory hearing is submitted to FDA. Proposed Sec.  1.1174(c) states 
that the presiding officer may deny a request for regulatory hearing 
under this rule under Sec.  16.26(a).
    Proposed Sec.  1.1174 provides that if the presiding officer grants 
a request for a regulatory hearing, the hearing will be held within 2 
business days after the date the request was filed or, if applicable, 
within a time frame agreed upon in writing by requestor and the 
presiding officer and FDA. Furthermore, the presiding officer may 
require that a hearing conducted under this proposed rule be completed 
within one business day, as appropriate. We believe that it is in the 
interest of both public health and the owner and consignee that 
regulatory hearings on food testing orders be resolved quickly and 
efficiently. As noted, however, this proposed rule would allow for 
flexibility by allowing the requestor, the presiding officer, and FDA 
to agree on an alternative timeframe for holding the hearing.
    Proposed Sec.  1.1174(e)(3) provides that the presiding officer 
must conduct the hearing in accordance with part 16, except that, 
consistent with Sec.  16.5(b), the procedures for a regulatory hearing 
described in part 16 apply only to the extent that such procedures are 
supplementary and not in conflict with the procedures specified for the 
conduct of regulatory hearings under this proposed rule. Accordingly, 
the following requirements of part 16 would be inapplicable to 
regulatory hearings conducted under this proposed rule: The 
requirements of Sec. Sec.  16.22 (Initiation of a regulatory hearing); 
16.24(e) (timing) and (f) (contents of notice); 16.26(a) (denial of 
hearing); 16.40 (Commissioner); 16.42(a) (presiding officer); 16.60(a) 
(public process); 16.95(b) (Administrative decision and record for 
decision); and 16.120 (Reconsideration and stay of action) of this 
chapter.
    Proposed Sec.  1.1174 clarifies that a decision by the presiding 
officer to affirm the testing order would be considered a final Agency 
action under 5 U.S.C. 702.

J. Proposed Provisions About Electronic Records and Public Disclosure 
Requirements Under This Rule (Proposed Sec. Sec.  1.1199 Through 
1.1200)

1. Are electronic records created under this rule subject to the 
electronic records requirements of part 11 of this chapter? (Proposed 
Sec.  1.1199)
    We are proposing to exempt from the requirements of 21 CFR part 11 
records that meet the definition of electronic records in Sec.  
11.3(b)(6) and are established or maintained to satisfy the 
requirements of this proposed rule. We believe it would be 
unnecessarily burdensome to require such records to

[[Page 59494]]

comply with the requirements in part 11. However, records that are 
established or maintained to satisfy the requirements of this program 
but that also are required under other applicable statutory provisions 
or regulations remain subject to part 11 of this chapter. This is the 
same approach we took when finalizing our rule on accredited third-
party certification.
2. Are the records obtained by FDA under this rule subject to public 
disclosure? (Proposed Sec.  1.1200)
    We understand that notifications, records, and reports required 
under this program will often contain commercially sensitive 
information. Information submitted to the Agency, including reports and 
notifications submitted under proposed Sec. Sec.  1.1123 and 1.1152, 
becomes an Agency record. We are proposing to clarify at proposed Sec.  
1.1200 that records under this proposed rule are subject to 21 CFR part 
20, which provides protections for trade secrets and confidential 
commercial information from public disclosure (see, e.g., Sec.  20.61, 
``Trade secrets and commercial or financial information which is 
privileged or confidential''). This is the same approach we took when 
finalizing our rule on accredited third-party certification.

K. Proposed Revisions to 21 CFR Part 1, Subpart M

    On November 27, 2015, FDA published in the Federal Register a final 
rule, ``Accreditation of Third-Party Certification Bodies to Conduct 
Food Safety Audits and to Issue Certifications'' (accredited third-
party certification regulation), to implement section 808 of the FD&C 
Act on accreditation of third-party certification bodies to conduct 
food safety audits and to certify that eligible foreign entities 
(including registered food facilities) and the human and animal food 
produced by such entities meet applicable FDA food safety requirements 
(80 FR 74570). The accredited third-party certification regulation, 
codified at part 1, subpart M, establishes the requirements for how an 
accredited third-party certification body must conduct a food safety 
audit--i.e., a regulatory audit or a consultative audit that is 
conducted to determine compliance with the applicable requirements of 
the FD&C Act, FDA regulations, and for consultative audits, also 
includes conformance with industry standards and practices.
    Under the accredited third-party certification regulation, an 
accredited third-party certification body must use an accredited 
laboratory when sampling and analysis is conducted for a regulatory 
audit (Sec.  1.651(c)(2)). Laboratories may be accredited in accordance 
with ISO/IEC 17025:2005 or another laboratory accreditation standard 
that provides at least a similar level of assurance in the validity and 
reliability of the sampling methodologies, analytical methodologies, 
and analytical results (Sec.  1.651(b)(3)). For consistency between the 
accredited third-party certification regulation and this rulemaking, we 
propose to revise Sec.  1.651(b)(3) to cite the current version of the 
ISO/IEC laboratory accreditation standard by striking ``ISO/IEC 
17025:2005'' and inserting ``ISO/IEC 17025:2017.'' This would mean that 
a laboratory accredited under this proposed rule, if finalized, would 
be among the laboratories that a third-party certification body could 
use to perform analysis.
    In addition, we propose to remove the option in Sec.  
1.651(b)(3)(ii) for an accredited third-party certification body to use 
a laboratory accredited under a standard other than ISO/IEC 17025 when 
sampling and analysis is conducted for a regulatory audit. In 
developing this proposed rule, we have gathered additional information 
about the number and capacity of laboratories accredited under ISO/IEC 
17025 to conduct food testing. Based on this information and in the 
interest of consistency, we are proposing to remove the option in Sec.  
1.651(b)(3)(ii) for an accredited third-party certification body to use 
a laboratory accredited under a standard other than ISO/IEC 17025 when 
sampling and analysis is conducted for a regulatory audit.
    Finally, we are proposing clarifying edits to Sec. Sec.  
1.651(b)(3) and 1.651(c)(2) make it clear that the requirement to use a 
laboratory accredited under ISO/IEC 17025 to conduct food testing 
applies only to the analysis of the sample and not the collection of 
the sample itself. As discussed previously in this rule, we are not at 
this time proposing requirements for the accreditation of samplers.
    We solicit comment on the effect, if any, of these proposed changes 
on an accredited third-party certification body's ability to meet the 
requirements in Sec. Sec.  1.651(b)(3) and 1.651(c)(2) to use an 
accredited laboratory when analyzing samples collected during a 
regulatory audit.

L. Proposed Revisions to 21 CFR Part 11

    As we discussed in section VI.K.2, we are proposing to exempt from 
the requirements of part 11 records that meet the definition of 
electronic records in Sec.  11.3(b)(6) and are established or 
maintained to satisfy the requirements of this proposed rule. 
Consistent with that provision, we are making a conforming change in 
part 11 by adding a paragraph (p) to Sec.  11.1 to that effect. The new 
paragraph (p) would also clarify that records that satisfy the 
requirements of this program but that also are required under other 
statutory provisions or regulations remain subject to part 11 to the 
extent that they are not separately exempted.

M. Proposed Revisions to 21 CFR Part 16

    As we discussed in section VI.J, at proposed Sec. Sec.  1.1171 
through 1.1174 we have proposed to establish procedures for regulatory 
hearings for certain actions we may take under this proposed rule. We 
are proposing a conforming change to part 16, which describes 
procedures for regulatory hearings, to add revocation of recognition of 
an accreditation body, revocation of accreditation of a laboratory, and 
issuance of a food testing order to the list of actions for which a 
regulation hearing under part 16 may be held. The affected section is 
Sec.  16.1.

N. Proposed Revisions to 21 CFR Part 129

    As noted above at section VI.B.1, where we discuss proposed Sec.  
1.1107, the regulations on the processing and bottling of bottled 
drinking water at part 129 contain an explicit testing requirement that 
addresses an identified or suspected food safety problem and that 
therefore would have to be conducted by a laboratory accredited under 
this proposed rule. Specifically, Sec.  129.35(a)(3)(i) contains a 
requirement that a source previously found to contain E. coli will be 
considered negative for E. coli after five samples collected over a 24-
hour period from the same sampling site that originally tested positive 
for E. coli are tested and found to be E. coli negative. Section 
129.35(a)(3)(i) contains additional routine testing requirements that 
do not address an identified or suspected food safety problem and are 
not subject to this proposed rule.
    Section 129.35(a)(3)(iii) provides that the analysis of samples 
taken under Sec.  129.35(a)(3)(i) ``may be performed for the plant by 
competent commercial laboratories (e.g., Environmental Protection 
Agency and State-certified laboratories).'' Section 129.35(a)(3)(iii) 
has the potential to conflict with this proposed rule because section 
422(b)(1)(A)(i) of the FD&C Act requires food testing conducted in 
response to the explicit testing requirement that ``address[es] an 
identified or suspected food safety problem'' in Sec.  129.35(a)(3)(i)

[[Page 59495]]

to be conducted by a laboratory accredited under this proposed program. 
A laboratory may qualify as a ``competent commercial laboratory'' but 
not be accredited under this proposed program. Accordingly, we are 
proposing a conforming change to Sec.  129.35(a)(3)(iii) to clarify 
that the explicit testing requirement in Sec.  129.35(a)(3)(i) that 
addresses an identified or suspected food safety problem must be 
conducted under this proposed program, which would require, in 
pertinent part, the laboratory conducting the testing to be accredited 
under this proposed program.

VII. Proposed Effective Date and Implementation Steps

    The effective date is the date that provisions in the rule affect 
the current Code of Federal Regulations. We propose that the effective 
date of this rule would be 60 days after publication of the final rule 
in the Federal Register.
    FDA intends to implement this program as expeditiously as 
practicable. Implementation of this laboratory accreditation program 
will necessarily need to occur in a stepwise fashion. We would announce 
when, after the effective date, we are prepared to accept applications 
for recognition from accreditation bodies. We would announce when we 
have recognized a sufficient number of accreditation bodies, at which 
point laboratories could then apply to the recognized accreditation 
bodies for accreditation. FDA would publish in the Federal Register, at 
least 6 months in advance, notice that we have attained sufficient 
laboratory capacity such that owners/consignees in the circumstances 
described in proposed Sec.  1.1107 will be required to utilize 
laboratories accredited under this program.

VIII. Preliminary Economic Analysis of Impacts

    We have examined the impacts of the proposed rule under Executive 
Order (E.O.) 12866, E.O. 13563, E.O. 13771, the Regulatory Flexibility 
Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 
(Pub. L. 104-4). E.O.s 12866 and 13563 direct us 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). 
E.O. 13771 requires that the costs associated with significant new 
regulations ``shall, to the extent permitted by law, be offset by the 
elimination of existing costs associated with at least two prior 
regulations.'' We believe that this proposed rule is not a significant 
regulatory action as defined by E.O. 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. Because a significant number of testing laboratories are 
small businesses and due to initial one-time costs we find that the 
proposed rule may have a significant economic impact on a substantial 
number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires 
us to 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 $154 million, using the most current (2018) Implicit 
Price Deflator for the Gross Domestic Product. This proposed rule would 
not result in an expenditure in any year that meets or exceeds this 
amount.

Summary of Costs and Benefits

    The proposed rule, if finalized, would require that testing of food 
in certain circumstances be performed by an accredited laboratory 
(participating lab) accredited to the proposed standards by a 
recognized accreditation body (participating accreditation body), and 
for the results to be submitted to us. The costs of the proposed rule, 
if finalized, would be incurred primarily by participating 
accreditation bodies, participating labs, shell-egg producers, sprouts 
producers, bottled water manufacturers, and owners and consignees of 
human and animal food offered for import covered by the proposed rule. 
We would incur costs to establish and maintain the program for 
recognizing accreditation bodies hoping to participate in our program, 
assessing participating accreditation bodies and participating labs, 
and for reviewing associated documents and reports. The present value 
of the cost of the proposed rule, if finalized, would range from $34 
million to $78 million when discounted by 7 percent over 10 years. When 
discounted by 3 percent over 10 years the present value of the cost 
would range from $39 million to $92 million.
    The proposed rule, if finalized, would generate some quantified and 
unquantified benefits. Quantified benefits include cost-savings from 
the proposed clarifications of the process for compiling, submitting 
and reviewing analytical reports for human and animal food offered for 
import covered under the proposed rule, and a reduced burden from the 
proposed abbreviated reporting requirements. In addition, there would 
be savings from fewer false positive test results. We anticipate a 
reduction in the number of foodborne illnesses from fewer false 
negative test results for human and animal food offered for import 
covered under the proposed rule and for shell eggs, sprouts, bottled 
water, and other food subject to specific testing requirements covered 
under the proposed rule. Unquantified benefits could include fewer 
illnesses from deterring unsafe manufacturing practices by all entities 
affected by the proposed rule. The present value of the quantified 
benefits of the proposed rule, if finalized, would range from $26 
million to $81 million when discounted by 7 percent over 10 years. When 
discounted by 3 percent over 10 years the present value of the 
quantified benefits would range from $32 million to $98 million. We 
expect that specific test reporting requirements would result in more 
accurate analytical reports and reporting.\7\
---------------------------------------------------------------------------

    \7\ There are currently no reporting requirements for tests of 
shell eggs, sprouts, or bottled water.
---------------------------------------------------------------------------

    We have developed a comprehensive Preliminary Economic Analysis of 
Impacts that assesses the impacts of the proposed rule. In table 1, we 
provide the Regulatory Information Service Center and Office of 
Information and Regulatory Affairs Consolidated Information System 
accounting information.

[[Page 59496]]



                                   Table 1--Summary of Benefits, Costs and Distributional Effects of Proposed Rule \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                    Units
                                                                                   ---------------------------------------
                  Category                     Primary        Low          High                                  Period                Notes
                                               estimate     estimate     estimate       Year       Discount     covered
                                                                                      dollars      rate (%)     (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized Monetized $millions/year....        $7.56        $3.71       $11.52         2016            7           10  Cost savings.
                                                    7.56         3.71        11.52         2016            3           10  Cost savings.
    Annualized Quantified..................  ...........  ...........  ...........  ...........            7  ...........
                                             ...........  ...........  ...........  ...........            3  ...........
                                            ------------------------------------------------------------------------------------------------------------
    Qualitative............................  Reduced risk of food-related illness
                                             from improper test reporting
                                             practices imported human and animal
                                             food covered under the proposed rule,
                                             and shell eggs, sprouts and bottled
                                             water and other tests subject to
                                             specific testing requirements.
                                             Reduced risk of food-related illness
                                             from unsafe food manufacturing
                                             practices.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs:
    Annualized Monetized $millions/year....        $6.73        $4.64        $9.27         2016            7           10
                                                    6.76         4.73         9.28         2016            3           10
    Annualized Quantified..................  ...........  ...........  ...........  ...........            7  ...........
                                             ...........  ...........  ...........  ...........            3  ...........
    Qualitative............................  ...........  ...........  ...........  ...........  ...........  ...........
--------------------------------------------------------------------------------------------------------------------------------------------------------
Transfers:
    Federal Annualized Monetized $millions/  ...........  ...........  ...........  ...........            7  ...........
     year.
                                             ...........  ...........  ...........  ...........            3  ...........
                                            ------------------------------------------------------------------------------
    From/To................................  From:
                                             To:
                                            ------------------------------------------------------------------------------
    Other Annualized Monetized $millions/    ...........  ...........  ...........  ...........            7  ...........
     year.
                                             ...........  ...........  ...........  ...........            3  ...........
                                            ------------------------------------------------------------------------------
    From/To................................  From:
                                             To:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects:
    State, Local or Tribal Government: None.............................................................................................................
    Small Business: Potential impacts on laboratories currently not accredited to ISO/IEC 17025 that would participate in the labs program described by
     the proposed rule..
    Wages: None.........................................................................................................................................
    Growth: None........................................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The lower bound equals the 5th percentile and the upper bound equals the 95th percentile.

    In line with E.O. 13771, in table 2 we estimate present and 
annualized values of costs and cost savings over an infinite time 
horizon.

                                                            Table 2--E.O. 13771 Summary Table
                                        [in $ millions 2016 dollars discounted over an infinite time horizon] \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                            Lower bound     Upper bound                     Lower bound     Upper bound
                                                           Primary (7%)        (7%)            (7%)        Primary (3%)        (3%)            (3%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Present Value of Costs..................................         $100.29          $56.49         $144.54         $216.92         $115.07         $319.32
Present Value of Cost Savings...........................          101.85           71.15          134.87          237.65          172.25          307.92
Present Value of Net Costs..............................           -1.56          -57.43           53.51          -20.73         -149.76          110.77
Annualized Costs........................................            7.02            3.95           10.12            6.51            3.45            9.58
Annualized Cost Savings.................................            7.13            5.17            9.24            7.13            5.17            9.24
Annualized Net Costs....................................           -0.11           -3.99            3.84           -0.62           -4.49            3.32
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The lower bound equals the 5th percentile and the upper bound equals the 95th percentile.

    We have developed a comprehensive Preliminary Economic Analysis of 
Impacts that assesses the impacts of the proposed rule. The full 
preliminary analysis of economic impacts is available in the docket for 
this proposed rule (Ref. 21) and at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

IX. Analysis of Environmental Impact

    We have carefully considered the potential environmental effects of 
this action. We have concluded, under 21 CFR 25.30(h), that this action 
is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required (Ref. 22).

X. Paperwork Reduction Act of 1995

    This proposed rule contains information collection provisions that 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). 
This analysis provides a description of these

[[Page 59497]]

provisions and an estimate of the annual reporting and recordkeeping 
burden associated with the proposed rule. Included in the estimate is 
the time for reviewing instructions, searching existing data sources, 
gathering and maintaining the data needed, and completing and reviewing 
each collection of information.
    We invite comments on these topics: (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: Laboratory Accreditation for Analyses of Foods.
    Description: As mandated by section 422 of the FD&C Act, we are 
establishing of a program for the testing of food by accredited 
laboratories; establishing a publicly available registry of recognized 
accreditation bodies and accredited laboratories; and establishing 
procedures for reporting any changes affecting the recognition of such 
accreditation bodies or accreditation of such laboratories.
    Description of Respondents: Respondents to the collection of 
information are accreditation bodies seeking recognition from FDA, 
recognized accreditation bodies, laboratories seeking accreditation 
from recognized accreditation bodies, and accredited laboratories. We 
estimate the burden of the information collection as follows:
    Reporting Burden: Consistent with figures discussed in our 
Preliminary Regulatory Impact Analysis (PRIA) (see Section II.D, Number 
of Entities), we estimate a total of 66 respondents. We estimate that 
five to 80 accreditation bodies would apply for FDA recognition under 
the rule, with a mean distribution of 17.5 accreditation bodies. For 
this analysis we round up to 18. Similarly, we estimate of a mean of 48 
laboratories will participate in the program, for a total of 66 
respondents to the information collection. The reporting burden 
includes a burden of 8,820 hours associated with one-time submissions. 
In this analysis, we annualize the one-time submission burden using a 
3-year period horizon and zero percent discount rate, for an annualized 
one-time reporting burden of 2,940 hours. Cumulatively, this results in 
a total annual reporting burden of 15,049.05 hours, as reflected in 
table 3.

                                   Table 3--Estimated Annual Reporting Burden
----------------------------------------------------------------------------------------------------------------
                                                                                          Average
    21 CFR part 1, subpart R citation; IC      Number of      Number of       Total      burden per
                  activity                    respondents   responses per     annual      response   Total hours
                                                             respondent     responses    (in hours)
----------------------------------------------------------------------------------------------------------------
Sec.  Sec.   1.1113/1.1128(a); Accreditation           18               1           18           20          360
 bodies (ABs) application for recognition
 (one-time submission)......................
Sec.   1.1123(b) and (c); ABs--general                 18              12          216         * .5          108
 reporting requirements.....................
Sec.   1.1128(b); ABs--application for                 18               1           18          3.6         64.8
 renewal of recognition.....................
Sec.  Sec.   1.1138 and 1.1158;                        48               1           48           20          960
 laboratories--submission of application for
 accreditation (one-time submission)........
Sec.   1.1152(c)(1) and (2); laboratories--            48           88.48        4,247         1.75        7,432
 Submission of sampling plan, sample
 collection report, and sampler
 qualifications.............................
Sec.   1.1152(d); laboratories--                       48              10          480            2          960
 qualification to submit abridged analytical
 reports (one-time submission)..............
Sec.   1. 1152(c)(3); laboratories--abridged           48           88.48        4,247         1.16        4,927
 analytical reports submissions.............
Sec.   1.1152(c)(4) and (5); laboratories--             9               1            9  [dagger].25         2.25
 validation and verification studies
 submissions................................
Sec.   1.1152(i); laboratories--advance                48               3          144          1.5          216
 notice of sampling submissions.............
Sec.   1.1152(j); laboratories--immediate              48             1.5           72          .25           18
 notification...............................
Sec.  Sec.   1.1165; 1.1171; 1.1173; and                1               1            1            1            1
 1.1174; requests in response to FDA action.
                                             -------------------------------------------------------------------
    Total...................................  ...........  ..............  ...........  ...........    15,049.05
----------------------------------------------------------------------------------------------------------------
* (30 mins.)
[dagger] (15 mins.)

    Proposed Sec.  1.1128(a) would require accreditation bodies that 
wish to be recognized to submit an application to FDA that demonstrates 
their qualifications (those qualifications are specified by proposed 
Sec.  1.1113) to accredit laboratories under this rule. We estimate 
this process would take one analyst between 40 and 80 hours to compile 
all the relevant information, prepare for an assessment, and complete 
initial application process, and submit the application. For this 
analysis we assume a middle value of 60 hours. Also for this analysis, 
we use a 3-year period horizon and zero percent discount rate to 
convert the one-time submission burden to an annualized figure (i.e., 
60 hours / by 3 = 20 hours). Annually this results in 360 hours of 
burden for initial applications submitted by 18 accreditation bodies 
(18 applications x 20 hours per application), as reflected in row 1.
    Proposed Sec.  1.1123 would require a recognized accreditation body 
to report information, including significant changes affecting its 
accreditation program or the accreditation status of laboratories it 
accredits, and ensure FDA has access to these and other records. We 
estimate recognized accreditation bodies would incur a burden of 1 hour 
per month, or 12 hours per year, complying with both the reporting 
requirements of proposed Sec.  1.1123 and the recordkeeping 
requirements of proposed Sec.  1.1124. For this analysis, we identify 
recordkeeping and reporting burdens separately and assume 6 of the 12 
hours (i.e., 30 minutes per month) would be spent meeting the reporting 
requirements of Sec.  1.1123. Annually, this results in 108 hours (18 
recognized accreditation bodies x 6 hours per year), as reflected in 
row 2.
    Proposed Sec.  1.1128(b) would require accreditation bodies to 
apply for renewal of recognition at least every 5 years. We believe 
renewal would take less time than an initial application because much 
of the information will have already been compiled and therefore assume 
between 20 and 40 hours. For this analysis we use a middle value and 
calculate that each recognized accreditation body will spend 30 hours 
every 5 years to complete and submit an application for renewal of its

[[Page 59498]]

recognition. This results in 6 hours per year (30 hours / 5 years) for 
each accreditation body. Because we use a 3-year period horizon and 
zero percent discount rate for this analysis, we annualize that figure 
to three-fifths or 3.6. We multiply this figure by 18 accreditations 
bodies for a total of 64.8 hours annually for the submission of renewal 
of applications (18 applications x 3.6 hours per application), as 
reflected in row 3.
    Proposed Sec.  1.1158 would require a laboratory seeking 
accreditation to submit an application for accreditation to a 
recognized accreditation body, demonstrating that it meets the 
requirements for accreditation under the proposed rule (those 
requirements are specified by proposed Sec.  1.1138). We estimate 48 
laboratories will apply and assume it would take one analyst an average 
of 60 hours to compile all the relevant information, however we regard 
the burden as a one-time burden and therefore have annualized it by 3 
years (20 hours annually). This results in an annual reporting burden 
for initial applications by 48 laboratories would be 960 hours (48 
applications x 20 hours per application), as reflected in row 4.
    Proposed Sec.  1.1152(a) through (i) would require accredited 
laboratories to submit testing results of testing conducted under the 
program and include supporting documentation. However, as discussed in 
our supporting statement, only a percentage of that testing would be 
defined as information collection under the PRA. For this analysis we 
assume a mean figure of 4,197, as the basis for factoring a 
corresponding information collection burden. This figure is derived 
using lower and upper bound estimates of submissions we expect under 
the rule. To allow for adjustment and potential increase we have added 
a count of 50 submissions for a total of 4,247.
    Proposed Sec.  1.1152(c)(1) would require accredited laboratories 
to obtain, or develop, and submit a sample collection plan and sample 
collection report (the contents of which would be prescribed by 
proposed Sec.  1.1149) with each test result. Under proposed Sec.  
1.1152(c)(2), laboratories would also be required to include 
documentation of the sampler's qualifications the first time the 
sampler collects a sample, or when the sampler's qualifications have 
significantly changed. We assume that it would take 30 minutes to 1 
hour to compile a sampling plan, 30 minutes to one hour to compile a 
sample collection report, and an average of 10 to 20 minutes to obtain 
the sampling plan, sample collection report, and sampler's credentials. 
Using a middle value of 1.5 hours to generate the sampling plan and the 
sample collection report, and a middle value of 15 minutes (.25 hours) 
to obtain those two documents and documentation of the sampler's 
qualifications, we calculate a total of time per test results of 1.75 
hours (1.5 + .25). When multiplied together the total reporting burden 
for the submission of sampling plans, sample collection reports, and 
sampler credential requirements (48 accredited laboratories x 88.48 
sampling plans and sample collection reports x 1.75 hours) is 7,432 
hours, as reflected in row 5.
    Proposed Sec.  1.1152(d) would allow accredited laboratories to 
qualify to submit abridged analytical reports in lieu of full 
analytical reports. At this time we expect this would be a one-time 
burden, but we may revisit this assumption in the future based on 
actual disqualification rates if the proposed rule is finalized and 
implemented. We assume that each accredited laboratory would submit 10 
consecutive full analytical reports to qualify to submit abbreviated 
reports. We also assume accredited laboratories spend 4 to 8 hours to 
compile and submit a full analytical report, and we use the middle 
value of 6 hours for this analysis. For initial or one-time burdens we 
use a 3-year period horizon and zero percent discount rate to convert 
the one-time burden to an annualized figure (2 hours). When multiplied 
together, this results in a total reporting burden for the accredited 
laboratories to qualify to submit abridged analytical reports of 960 
hours (48 laboratories x 10 full analytical reports each x 2 hours per 
analytical report), as reflected in row 6.
    After an accredited laboratory qualifies to submit abridged 
analytical reports, we assume it would submit abridged analytical 
reports to us thereafter. We may revisit this assumption in the future 
based on actual disqualification rates if the proposed rule is 
finalized and implemented. We estimate the burden to compile and submit 
an abridged analytical report to be between 25 percent and 33 percent 
of the burden of compiling and submitting a full analytical report, and 
we use a middle value of 29 percent here. Thus, using these figures we 
calculate it would take an accredited laboratory 1.74 hours to compile 
and submit an abridged analytical report (29 percent x 6 hours). This 
results in an annual total reporting burden for the 48 accredited 
laboratories to compile and submit abridged analytical reports of 
approximately 4,927 hours (48 laboratories x 88.48 abridged analytical 
reports x 1.16 hours per abridged analytical report), as reflected in 
row 7.
    The proposed rule would also require the participating lab to 
submit verification and validation studies to FDA as part of an 
analytical report, or to an accreditation body as a prerequisite for 
participation in the labs program. The ISO/IEC 17025 standard requires 
the use of validated and verified methods for testing foods. However, 
the proposed rule, if finalized, would require additional verification 
studies over and above the requirements of ISO/IEC 17025. Additional 
studies may include information to verify that a method previously 
validated for a specific food item is also valid for a different food 
item, in what is called a ``matrix extension.'' We estimate that the 
additional time burden of requiring laboratories to submit verification 
studies such as matrix extensions under this proposed rule to be a 
middle value of approximately 3 percent of the time burden incurred by 
laboratories to maintain accreditation to ISO/IEC 17025 (the PRIA 
estimates a range of 1 percent to 5 percent). In the PRIA we also note 
that internal FDA experts suggest that between 5 percent and 30 percent 
of import food testing results require verification studies such as 
matrix extensions. We use a middle value of 17.5 percent for this 
analysis.
    With regard to validation requirements, we assume that methods used 
to test shell eggs, sprouts, and bottled water are either already 
validated or the costs to doing so would be included in the costs to 
maintain accreditation to the ISO/IEC 17025 standard. Consequently, we 
assume that shell eggs, sprouts, and bottled water producers would 
incur no burden from this requirement beyond the burden of the proposed 
rule's requirements to meet the validation requirements of ISO/IEC 
17025.
    We estimate the time required to perform a matrix extension is a 
middle value of 34 hours (the PRIA estimates a range of 22 to 46 
hours). We do not distinguish between the burden of reporting the study 
and the burden of conducting the study. We assume 25 percent of the 34 
hours (8.5 hours) is attributable to the associated reporting burden. 
Because we estimate that the additional time burden of requiring 
laboratories to submit verification studies such as matrix extensions 
under this proposed rule would be approximately 3 percent of the time 
burden incurred by laboratories to maintain accreditation to ISO 17025, 
we multiply 8.5 hours by 3 percent to get the additional reporting 
burden of .255 hours (15.3 minutes, which we round to

[[Page 59499]]

15 minutes, which is .25 hours) per study imposed by the verification 
study submission requirements of the proposed rule. To estimate the 
number of test results that would require matrix extensions, we 
multiply the number of import testing results that would be submitted 
to us under this rule annually that are subject to PRA requirements 
(50) by the share of test results submitted to us for import food 
testing that require matrix extensions (17.5 percent), for a total of 
8.75 matrix extensions per year. This equates to an average of .17708 
matrix extensions per accredited laboratory (8.5 / 48). Because the 
number of respondents and the annual responses per respondent in a PRA 
analysis must be whole numbers, we instead estimate that nine 
accredited laboratories (48 x .17708, rounded to 9 from 8.5) will 
submit one full verification study to FDA annually. Therefore, the 
annual reporting burden of requiring the submission of validation and 
verification studies under this proposed rule is 2.25 hours (9 
accredited laboratories x 1 verification studies x .25 hours per 
study), as reflected in row 8.
    Proposed Sec.  1.1152(i) would provide that, under certain 
circumstances, FDA may require one or more accredited laboratories to 
submit an advance notice of sampling to FDA before each of the next 
several occasions that the sampler will a collect a sample that the 
accredited laboratory will analyze under this program. We assume that 
it would take a laboratory analyst between 1 and 2 hours to compile the 
required information and submit the information, and we assume that 
between one percent and five percent of all test results submitted 
annually under this program would be subject to the notice of sampling 
requirement. For this analysis we assume middle values of 1.5 hours and 
three percent, respectively. Thus, we estimate that 127.41 test results 
(4,247 x 3%) would require submission of advance notice of sampling 
under the proposed rule. For this analysis we assume that each of the 
estimated 48 accredited laboratories would be required to submit three 
notices of advance sampling annually under the proposed rule (127.41 / 
48 = 2.65; rounded to 3). Thus, the annual reporting burden on 
accredited laboratories due to the proposed advance notice of sampling 
requirement would be 216 hours (48 laboratories x 3 advance notices of 
sampling x 1.5 hours), as reflected in row 9.
    Proposed Sec.  1.1152(j) would require accredited laboratories to 
notify FDA and the accreditation body of any changes that affect the 
laboratory's accreditation. Note, however, that under Sec.  1.1123(c), 
recognized accreditation bodies also have a duty to immediately notify 
FDA of changes in an accredited laboratory's status. Thus, an 
accredited laboratory is not required to notify FDA of changes that 
fall under Sec.  1.1123(c). To be conservative we estimate that every 
lab that participates will have some change about which it must notify 
its accreditation body, and for half of those changes the accredited 
laboratory will also need to notify FDA. We estimate it will take an 
accredited laboratory 15 minutes per notification. Thus we estimate the 
burden associated with Sec.  1.1152(j) would be 18 hours (48 accredited 
laboratories x 1.5 notifications x 0.25 hours per notification), as 
reflected in row 10.
    Proposed Sec. Sec.  1.1165, 1.1171, 1.1173, and 1.1174 provide for 
requests to FDA. Specifically, Sec.  1.1165 provides for requests for 
reinstatement of accreditation; Sec.  1.1171 provides for requests for 
reconsideration of denials; and Sec. Sec.  1.1173 and 1.1174 provide 
for requests for hearings. Because this is a new collection, we are 
estimating a cumulative total of 1 respondent and 1 burden hour, as 
reflected in row 11, however we invite specific comment in this regard. 
Upon implementation of any final rule, we will reevaluate our burden 
estimate in light of overall submissions to the Agency and public 
comments received.
    Recordkeeping Burden: Recordkeeping requirements associated with 
the proposed rule include a one-time burden of 1,366.05 hours and 
annual burden of 41,912.74 hours. In this analysis, we annualize the 
one-time recordkeeping burden using a 3-year period horizon and zero 
percent discount rate, for an annualized one-time recordkeeping burden 
of 455.35. Cumulatively, we estimate an annual recordkeeping burden 
under this proposed rule of 43,278.79 hours, as reflected in table 4.

                                 Table 4--Estimated Annual Recordkeeping Burden
----------------------------------------------------------------------------------------------------------------
                                                                                         Average
   Proposed 21 CFR part 1, subpart R; IC      Number of      Number of      Total       burden per
                 activity                   recordkeepers   records per     annual    recordkeeping  Total hours
                                                           recordkeeper    records      (in hours)
----------------------------------------------------------------------------------------------------------------
Sec.  Sec.   1.113 and 1.1118;                        18              1           18             1            18
 recordkeeping associated with ISO/IEC
 17011....................................
Sec.   1.1124; ABs--additional                        18              1           18             6           108
 recordkeeping requirements...............
Sec.   1.1138; laboratories--becoming                  5              1            5         91.06        455.35
 accredited to ISO/IEC 17025 (one-time)...
Sec.   1.1146; laboratories--maintaining              48              1           48        889.53     42,697.44
 ISO/IEC 17025 accreditation..............
                                           ---------------------------------------------------------------------
    Total.................................  .............  ............  ...........  .............    43,278.79
----------------------------------------------------------------------------------------------------------------

    Proposed Sec.  1.1113 and Sec.  1.1118 would require accreditation 
bodies to meet the requirements of ISO/IEC 17011 to be recognized. 
While ISO/IEC 17011 includes recordkeeping requirements, as noted above 
we estimate that all of the 18 accreditation bodies that would become 
recognized under the proposed rule currently adhere to ISO/IEC 17011. 
We therefore regard these activities as usual and customary, however we 
include a place holder of one response and one burden hour for each 
respondent, as reflected in row 1.
    Proposed Sec.  1.1124, however, provides for the maintenance of 
certain records in addition to those required by ISO/IEC 17011. We 
estimate recognized accreditation bodies would incur a burden of 12 
hours per year to comply with both the recordkeeping requirements of 
proposed Sec.  1.1124 and the reporting requirements of proposed Sec.  
1.1123. For this analysis, we identify the recordkeeping and reporting 
burdens separately, assuming six of those 12 annual hours would be 
spent complying with the recordkeeping requirements of proposed Sec.  
1.1124. Thus, the annual recordkeeping burden for the 18 recognized 
accreditation bodies to meet the additional recordkeeping requirements 
of proposed Sec.  1.1124 would be 108 hours, as reflected in row 2.
    Proposed Sec.  1.1138 would require laboratories to meet certain 
requirements of ISO/IEC 17025, including its recordkeeping 
requirements, to be accredited under the proposed rule. We estimate 
that between two to eight laboratories not

[[Page 59500]]

currently accredited to ISO/IEC 17025 would become accredited. We use a 
middle estimate of five laboratories and also estimate that it would 
take a mean of 91.06 hours for the associated recordkeeping activities. 
This results in an annualized burden of 455.35, as reflected in row 3.
    Proposed Sec.  1.1146 would require laboratories to maintain 
conformance with ISO/IEC 17025, including its recordkeeping 
requirements. Based on available data, and as discussed in our PRIA, we 
estimate a mean of 889.53 hours for this recordkeeping. This results in 
an annual burden of 42,697.44 hours, as reflected in row 4.
    The proposed rule also affects currently approved information 
collections. Information collection provisions found in part 11 of our 
regulations are currently approved under OMB Control No. 0910-0303. 
Information collection provisions found in part 129 of our regulations 
are currently approved under OMB Control No. 0910-0658. Although no new 
information collection or no material modification is being introduced 
by the proposed rule, upon implementation of any final rule we will 
reevaluate our burden estimates for these collections accordingly. 
Finally, information collection provisions found in part 16 of our 
regulations are exempt from OMB review and approval under the PRA, as 
the information collection occurs during the conduct of an official 
administrative action (see 5 CFR 1320.4(a)(2)).
    To ensure that comments on this information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB (see ADDRESSES). All 
comments should be identified with the title of the information 
collection.
    In compliance with the PRA, the Agency has submitted the 
information collection provisions of this proposed rule to OMB for 
review. These information collection requirements will not be effective 
until FDA publishes a final rule, OMB approves the information 
collection requirements, and the rule goes into effect. We will publish 
a notice concerning OMB approval of these requirements in the Federal 
Register.

XI. Federalism

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

XII. References

    The following references marked with an asterisk (*) are on display 
at the Dockets Management Staff (see ADDRESSES) and are available for 
viewing by interested persons between 9 a.m. and 4 p.m., Monday through 
Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public 
display at https://www.regulations.gov because they have copyright 
restriction. Some may be available at the website address, if listed. 
References without asterisks are available for viewing only at the 
Dockets Management Staff. FDA has verified the website addresses, as of 
the date this document publishes in the Federal Register, but websites 
are subject to change over time.

* 1. FDA Memorandum, ``Assessment of DWPE Sampling and Analysis Data 
to Determine what Portion of Sampling and Analysis of Food under 
DWPE is Conducted by Accredited Entities.'' Toni Morales and Tyler 
Scandalios, FDA. November 20, 2018.
* 2. Congressional Hearing, ``The Safety of Food Imports: Fraud & 
Deception in the Food Import Process; Hearings Before the Senate 
Committee on Governmental Affairs, Permanent Subcommittee on 
Investigations.'' September 10, 1998. https://www.gpo.gov/fdsys/pkg/CHRG-105shrg51562/pdf/CHRG-105shrg51562.pdf. Accessed on June 17, 
2019.
* 3. ``Private Laboratory Guidance,'' ORA Laboratory Manual, Vol. 
III, Section 7, document number III-07. FDA. January 30, 2013. 
https://www.fda.gov/media/81810/download. Accessed on June 17, 2019.
4. ``ISO/IEC 17025:2005 ``General Requirements for the Competence of 
Testing and Calibration Laboratories'' (withdrawn). International 
Organization for Standardization/International Electrotechnical 
Commission. May 2005. Copies are available from the International 
Organization for Standardization, Chemin de Blandonnet 8, 1214 
Vernier, Geneva, Switzerland, or on the internet at https://www.iso.org/standard/39883.html, or may be viewed on the internet 
through, https://www.surveymonkey.com/r/KFJMZ67 or may be examined 
at the Dockets Management Staff (Ref. Docket No. FDA-2019-N-3325 
and/or RIN 0910-AH31).
*5. ``Action Plan for Import Safety.'' Interagency Working Group on 
Import Safety. November 2007. http://www.itagc.org/docs/ITAGC-2010-11-10-FDA-4.pdf. Accessed June 17, 2019.
* 6. GAO Report, ``Federal Oversight of Food Safety: FDA's Food 
Protection Plan Proposes Positive First Steps, but Capacity to Carry 
Them Out Is Critical (GAO-08-435T).'' Government Accountability 
Office. January 29, 2008. https://www.gao.gov/assets/120/118821.pdf. 
Accessed on June 17, 2019.
* 7. GAO Report, ``Food Safety: FDA's Imported Seafood Safety 
Program Shows Some Progress, but Further Improvements are Needed 
(GAO-04-246).'' Government Accountability Office. January 30, 2004. 
https://www.gao.gov/assets/250/241327.pdf. Accessed on June 17, 
2019.
* 8. FDA Draft Guidance for Industry, ``Submission of Laboratory 
Packages by Accredited Laboratories'' (withdrawn). FDA. January 16, 
2009.
9. ``Guidelines for Laboratories Performing Microbiological and 
Chemical Analyses of Food, Dietary Supplements, and Pharmaceuticals, 
An Aid to Interpretation of ISO/IEC 17025:2005.'' AOAC 
International. April 2015. Copies are available from AOAC 
International, 2275 Research Blvd., Ste. 300, Rockville, MD 20850-
3250, USA, or on the internet at http://www.aoac.org/aoac_prod_imis/AOAC/AOAC_Member/PUBSCF/ALACCCF/ALACC_M.aspx, or may be examined at 
the Dockets Management Staff (Ref. Docket No. FDA-2019-N-3325 and/or 
RIN 0910-AH31).
* 10. ``IAF/ILAC Multi-Lateral Mutual Recognition Arrangements 
(Arrangements): Requirements and Procedures for Evaluation of a 
Single Accreditation Body.'' International Accreditation Forum/
International Laboratory Accreditation Cooperation. January 2018. 
Available at https://ilac.org/publications-and-resources/joint-ilac-iaf-series/. Accessed on June 17, 2019.
* 11. ``OMB Circular A-119: Federal Participation in the Development 
and Use of Voluntary Consensus Standards and in Conformity 
Assessment Activities.'' Office of Management and Budget. January 
2016. https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/inforeg/inforeg/revised_circular_a-119_as_of_1_22.pdf. Accessed on 
June 17, 2019.
* 12. ``ISO/IEC 17011:2017(E), ``Conformity Assessment--Requirements 
for Accreditation Bodies Accrediting Conformity Assessment Bodies.'' 
International Organization for Standardization/International 
Electrotechnical Commission. November 2017. Copies are available 
from the International Organization for Standardization, Chemin de 
Blandonnet 8, 1214 Vernier, Geneva, Switzerland, or on the internet 
at https://www.iso.org/standard/67198.html, or may be examined at 
the Dockets Management Staff (Ref. Docket No. FDA-2019-N-3325 and/or 
RIN 0910-AH31).
13. ISO/IEC 17025:2017(E), ``General Requirements for the Competence 
of

[[Page 59501]]

Testing and Calibration Laboratories.'' International Organization 
for Standardization/International Electrotechnical Commission. 
November 2017. Copies are available from the International 
Organization for Standardization, Chemin de Blandonnet 8, 1214 
Vernier, Geneva, Switzerland, or on the internet at https://www.iso.org/standard/66912.html, or may be examined at the Dockets 
Management Staff (Ref. Docket No. FDA-2019-N-3325 and/or RIN 0910-
AH31).
* 14. Meeting Minutes, ``Sampling Accreditation Discussion with 
ABs.'' FDA. November 13, 2017.
* 15. ``R103--General Requirements: Proficiency Testing for ISO/IEC 
Laboratories.'' American Association for Laboratory Accreditation. 
September 19, 2013. https://portal.a2la.org/requirements/R103_2013.pdf. Accessed on June 17, 2019.
*16. ``Accreditation Requirements: ISO/IEC 17025 Testing 
Laboratories (Non-Forensics).'' ANSI/ASQ National Accreditation 
Board. October 9, 2018. https://anab.qualtraxcloud.com/ShowDocument.aspx?ID=8160. Accessed on June 17, 2019.
17. ISO/IEC 17043:2010, ``Conformity Assessment--General 
Requirements for Proficiency Testing.'' International Organization 
for Standardization/International Electrotechnical Commission. 
February 2010. Copies are available from the International 
Organization for Standardization, Chemin de Blandonnet 8, 1214 
Vernier, Geneva, Switzerland, or on the internet at https://www.iso.org/standard/29366.html, or may be examined at the Dockets 
Management Staff (Ref. Docket No. FDA-2019-N-3325 and/or RIN 0910-
AH31).
* 18. ``Methods, Method Verification and Validation,'' ORA 
Laboratory Manual, Vol. II, Section 2, document number ORA-
LAB.5.4.5. FDA. August 29, 2014. https://www.fda.gov/media/73920/download. Accessed on June 17, 2019.
* 19. FDA Memorandum, ``Guidelines for the Validation of Chemical 
Methods for the FDA FVM Program, 2nd Edition.'' FDA Foods and 
Veterinary Medicine Science and Research Steering Committee. May 19, 
2015. https://www.fda.gov/media/81810/download. Accessed on June 17, 
2019.
* 20. Meeting Record, ``FSMA Lab Accreditation/Food Laboratory 
Alliance Meeting Record August 21, 2015.'' FDA. July 21, 2015.
* 21. FDA. Accreditation of Laboratories to Conduct Food Testing: 
Preliminary Regulatory Impact Analysis, Initial Regulatory 
Flexibility Analysis, Unfunded Mandates Reform Act Analysis, 2019. 
https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.
* 22. FDA Memorandum. ``Proposed Rule: Amendment of 21 CFR parts 1, 
11, 16, and 129 to Establish a Program for Laboratory Accreditation 
for Analyses of Foods as Required by FD&C Act.'' Leah D. Proffitt, 
FDA, June 14, 2019.

List of Subjects

21 CFR Part 1

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

21 CFR Part 11

    Computer technology, Reporting and recordkeeping requirements.

21 CFR Part 16

    Administrative practice and procedure.

21 CFR Part 129

    Beverages, Bottled water, Food packaging, Reporting and 
recordkeeping requirements.

    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 parts 1, 11, 16, and 129 be amended as follows:

PART 1--GENERAL ENFORCEMENT REGULATIONS

0
1. The authority citation for 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, 350e, 350j, 350k, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 
362, 371, 373, 374, 381, 382, 384a, 384b, 384d, 387, 387a, 387c, 
393; 42 U.S.C. 216, 241, 243, 262, 264, 271.

0
2. In Sec.  [thinsp]1.651, revise paragraphs (b)(3) and (c)(2) to read 
as follows:


Sec.  1.651  How must an accredited third-party certification body 
conduct a food safety audit of an eligible entity?

* * * * *
    (b) * * *
    (3) When, for a regulatory audit, sampling and analysis is 
conducted, the accredited third-party certification body must use a 
laboratory that is accredited in accordance with ISO/IEC 17025:2017 to 
perform the analysis.
* * * * *
    (c) * * *
    (2) The audit must include records review prior to the onsite 
examination; an onsite examination of the facility, its process(es), 
and the food that results from such process(es); and where appropriate 
or when required by FDA, environmental or product sampling and 
analysis. When, for a regulatory audit, sampling and analysis is 
conducted, the accredited third-party certification body must use a 
laboratory that is accredited in accordance with paragraph (b)(3) of 
this section to conduct the analysis. The audit may include any other 
activities necessary to determine compliance with applicable food 
safety requirements of the Federal Food, Drug, and Cosmetic Act and FDA 
regulations, and, for consultative audits, also includes conformance 
with applicable industry standards and practices.
* * * * *
0
3. Add subpart R, consisting of Sec. Sec.  1.1102 through 1.1200, to 
read as follows:

Subpart R--Accreditation of Laboratories to Conduct Food Testing

General Provisions

Sec.
1.1102 What definitions apply to this subpart?
1.1103 Who is subject to this subpart?

General Requirements of this Subpart

1.1107 Under what circumstances must food testing be conducted under 
this subpart by an accredited laboratory?
1.1108 When and how will FDA issue a food testing order?
1.1109 How will FDA make information about recognized accreditation 
bodies and accredited laboratories available to the public?

Recognition of Accreditation Bodies

1.1113 What requirements must an accreditation body meet to be 
recognized by FDA?

Requirements for Recognized Accreditation Bodies

1.1118 What are the general requirements for recognized 
accreditation bodies to remain recognized?
1.1119 What requirements apply to how a recognized accreditation 
body must protect against conflicts of interests?
1.1120 How must a recognized accreditation body evaluate 
laboratories seeking accreditation and oversee the performance of 
laboratories it accredits?
1.1121 What appeal procedures must a recognized accreditation body 
provide for appeals of decisions to not grant accreditation?
1.1122 When must a recognized accreditation body withdraw or reduce 
the scope of the accreditation of a laboratory, and when may a 
recognized accreditation body put an accredited laboratory on 
probation?
1.1123 What reports and notifications must a recognized 
accreditation body submit to FDA?
1.1124 What records requirements must a recognized accreditation 
body meet?
1.1125 What internal audit requirements must a recognized 
accreditation body meet?

Procedures for Recognition of Accreditation Bodies

1.1128 How does an accreditation body apply to FDA for recognition 
or renewal of recognition?

[[Page 59502]]

1.1129 How will FDA review applications for recognition and 
applications for renewal of recognition?
1.1130 How will FDA oversee recognized accreditation bodies?
1.1131 When will FDA revoke the recognition of an accreditation body 
or put a recognized accreditation body on probation?
1.1132 What must a recognized accreditation body do if it wants to 
voluntarily relinquish its recognition or does not want to renew its 
recognition?
1.1133 How does an accreditation body request reinstatement of 
recognition?

Accreditation of Laboratories

1.1138 What requirements must a laboratory meet to become accredited 
by a recognized accreditation body?

Requirements for Accredited Laboratories

1.1146 What are the general requirements for accredited laboratories 
to remain accredited?
1.1147 What impartiality and conflict of interest requirements must 
accredited laboratories meet?
1.1148 What quality assurance requirements must accredited 
laboratories meet?
1.1149 What oversight standards apply to sampling?
1.1150 What requirements apply to analysis of samples by an 
accredited laboratory?
1.1151 What requirements apply to the methods of analysis an 
accredited laboratory uses to conduct food testing under this 
subpart?
1.1152 What notifications, results, and reports must accredited 
laboratories submit to FDA?
1.1153 What other records requirements must an accredited laboratory 
meet?

Procedures for Accreditation of Laboratories

1.1158 How does a laboratory apply for accreditation or modification 
of its scope of accreditation by a recognized accreditation body?
1.1159 How will FDA oversee accredited laboratories?
1.1160 How will FDA review submitted test results and analytical 
reports?
1.1161 When will FDA put an accredited laboratory on probation or 
revoke the accreditation of a laboratory?
1.1162 What are the consequences if FDA puts an accredited 
laboratory on probation or revokes the accreditation of a 
laboratory?
1.1163 What if a laboratory wants to voluntarily relinquish its 
accreditation?
1.1164 What is the effect on accredited laboratories if their 
accreditation body voluntarily or involuntarily loses its 
recognition?
1.1165 How does a laboratory request reinstatement of accreditation?

Requesting FDA Reconsideration, FDA Internal Review, or Regulatory 
Hearings of FDA Decisions Under This Subpart

1.1171 How does an accreditation body request reconsideration by FDA 
of a decision to deny its application for recognition, renewal, or 
reinstatement?
1.1173 How does an accreditation body or laboratory request a 
regulatory hearing on FDA's decision to revoke the recognized 
accreditation body's recognition or revoke the accredited 
laboratory's accreditation?
1.1174 How does an owner or consignee request a regulatory hearing 
on a food testing order?

Electronic Records and Public Disclosure Requirements Under This 
Subpart

1.1199 Are electronic records created under this subpart subject to 
the electronic records requirements of part 11 of this chapter?
1.1200 Are the records obtained by FDA under this subpart subject to 
public disclosure?

Subpart R--Accreditation of Laboratories To Conduct Food Testing

General Provisions


Sec.  1.1102  What definitions apply to this subpart?

    The definitions of terms in section 201 of the Federal Food, Drug, 
and Cosmetic Act apply to such terms when used in this subpart, unless 
otherwise specified. For the purposes of this subpart, the following 
definitions also apply:
    Accreditation means a determination by a recognized accreditation 
body that a laboratory meets the applicable requirements of this 
subpart to conduct food testing under this subpart using one or more 
methods of analysis.
    Accredited laboratory means a laboratory that a recognized 
accreditation body has determined meets the applicable requirements of 
this subpart and has been accredited to conduct food testing using one 
or more methods of analysis under this subpart.
    Analyst means an individual who analyzes samples.
    Food has the meaning given in section 201(f) of the Federal Food, 
Drug, and Cosmetic Act, except that food does not include pesticides 
(as defined in 7 U.S.C. 136(u)).
    Food testing and testing of food means the analysis of food product 
samples or environmental samples.
    Food testing order means an order issued by FDA under Sec. Sec.  
1.1107(a)(2) and 1.1108 requiring food testing to be conducted under 
this subpart by or on behalf of an owner or consignee.
    Owner or consignee means any person with an ownership or 
consignment interest in:
    (1) The food product or environment that is the subject of food 
testing conducted under Sec.  1.1107(a)(1);
    (2) Food product or environment that is the subject of the order 
issued under Sec.  1.1107(a)(2);
    (3) The food product or environment that is the subject of food 
testing conducted under Sec.  1.1107(a)(3);
    (4) The article of food for which food testing is being conducted 
under Sec.  1.1107(a)(4); or
    (5) The food subject to an import alert for which food testing is 
conducted under Sec.  1.1107(a)(5).
    Recognition means a determination by FDA that an accreditation body 
meets the applicable requirements of this subpart and is authorized to 
accredit laboratories under this subpart.
    Recognized accreditation body means an accreditation body that FDA 
has determined meets the applicable requirements of this subpart and is 
authorized to accredit laboratories under this subpart.
    Representative sample means a sample that accurately, to a 
scientifically acceptable degree, represents the characteristics and 
qualities of the food product or environment that the sample was 
collected from.
    Sampler means an individual or individuals who perform sampling.
    Scope of accreditation refers to the methods of analysis for which 
the accredited laboratory is accredited. References in this subpart to 
accreditation ``in-whole'' refers to all methods in the accredited 
laboratory's scope of accreditation and references to accreditation 
``in-part'' refers to only certain methods in the accredited 
laboratory's scope of accreditation.


Sec.  1.1103  Who is subject to this subpart?

    (a) Accreditation bodies. An accreditation body is subject to this 
subpart if it has been recognized by FDA, or is seeking to be 
recognized by FDA, to accredit laboratories to conduct food testing 
under this subpart.
    (b) Laboratories. A laboratory is subject to this subpart if it has 
been accredited by a recognized accreditation body, or is seeking to be 
accredited by a recognized accreditation body, to conduct food testing 
under this subpart.
    (c) Owners and consignees. An owner or consignee is subject to this 
subpart if they are required to use an accredited laboratory to conduct 
food testing under this subpart.

General Requirements of This Subpart


Sec.  1.1107  Under what circumstances must food testing be conducted 
under this subpart by an accredited laboratory?

    (a) Food testing must be conducted under this subpart whenever such 
testing is conducted by or on behalf of an owner or consignee:
    (1) In response to explicit testing requirements that address an 
identified

[[Page 59503]]

or suspected food safety problem, which are contained in the following 
provisions:
    (i) Sprouts. 21 CFR 112.146(a), (c) and (d);
    (ii) Shell eggs. 21 CFR 118.4(a)(2)(iii), 118.5(a)(2)(ii) and 
(b)(2)(ii), and 118.6(a)(2) and (e); and
    (iii) Bottled drinking water. 21 CFR 129.35(a)(3)(i) (for the 
requirement to test five samples from the same sampling site that 
originally tested positive for Escherichia coli);
    (2) As required by FDA in a food testing order;
    (3) To address an identified or suspected food safety problem and 
presented to FDA as part of evidence for a hearing under section 423(c) 
of the Federal Food, Drug, and Cosmetic Act prior to the issuance of a 
mandatory food recall order, as part of a corrective action plan under 
section 415(b)(3)(A) of the Federal Food, Drug, and Cosmetic Act 
submitted after an order suspending the registration of a food 
facility, or as part evidence submitted for an appeal of an 
administrative detention order under section 304(h)(4)(A) of the 
Federal Food, Drug, and Cosmetic Act.
    (4) In support of admission of an article of food under section 
801(a) of the Federal Food, Drug, and Cosmetic Act;
    (5) To support removal from an import alert through successful 
consecutive testing;
    (b) When food testing is conducted under paragraph (a) of this 
section, analysis of samples must be conducted by accredited 
laboratories that are accredited for the appropriate analytical method 
or methods by a recognized accreditation body.
    (c) Food testing conducted on articles of food offered for import 
into the United States under section 801(a) of the Federal Food, Drug, 
and Cosmetic Act pursuant to paragraph (a)(4) or (a)(5) of this section 
may only be conducted after the articles offered for import have 
arrived in the United States unless FDA has determined, and responded 
in writing to the owner/consignee, that a sample(s) taken prior to 
arrival is or would be representative sample(s) of such article(s) 
offered for import into the United States.


Sec.  1.1108   When and how will FDA issue a food testing order?

    (a) FDA may require the owner or consignee of an article of food to 
conduct food testing, or to have food testing conducted on their 
behalf, under this subpart to address an identified or suspected food 
safety problem related to the article of food.
    (b) The food testing order will specify the food product or 
environment to be tested; whether the food testing may be conducted 
using an accredited laboratory that is owned, operated, or controlled 
by the owner or consignee; the timeframe in which the food testing must 
be conducted; and the manner of the food testing, such as the methods 
that must be used.
    (c) The food testing order will contain all the elements required 
by Sec.  16.22(a) of this chapter and will thereby constitute the 
notice of an opportunity for hearing under part 16 of this chapter. An 
affected owner or consignee may request a regulatory hearing on a food 
testing order, pursuant to Sec.  1.1174 of this subpart.


Sec.  1.1109  How will FDA make information about recognized 
accreditation bodies and accredited laboratories available to the 
public?

    (a) Except as provided by paragraph (b) of this section, FDA will 
place on its website a list of:
    (1) Recognized accreditation bodies, including for each recognized 
accreditation body: The name, contact information, and duration of 
recognition of the recognized accreditation body;
    (2) Accreditation bodies that have their recognition revoked by FDA 
or are put on probation, and accreditation bodies that have 
relinquished their recognition or have allowed their recognition to 
expire, including for each accreditation body: The name of the 
accreditation body, whether FDA revoked recognition of the 
accreditation body or put the recognized accreditation body on 
probation, or whether the accreditation body relinquished its 
recognition or allowed its recognition to expire, and the date of the 
probation, revocation, relinquishment, or expiration;
    (3) Laboratories accredited under this subpart, including for each 
laboratory: The name, contact information, and scope of accreditation 
of the accredited laboratory, and the name and contact information of 
the accreditation body that accredits the accredited laboratory; and
    (4) Laboratories that have been put on probation or have had their 
accreditation withdrawn or revoked (in-whole or in-part) by a 
recognized accreditation body or by FDA, or have relinquished their 
accreditation (in-whole or in-part), including for each laboratory: The 
name of the laboratory, whether a recognized accreditation body or FDA 
put the laboratory on probation, or withdrew or revoked the 
accreditation of the laboratory, or whether the laboratory relinquished 
its accreditation, and the date of the probation, withdrawal, 
revocation, or relinquishment.
    (b) In the interest of national security, FDA, in coordination with 
the Secretary of Homeland Security, may determine an alternate time, 
manner, and form in which the list described in paragraph (a) of this 
section is made publicly available.

Recognition of Accreditation Bodies


Sec.  1.1113   What requirements must an accreditation body meet to 
become recognized by FDA?

    To become recognized by FDA, an accreditation body seeking 
recognition by FDA must:
    (a) Be a full member of the International Laboratory Accreditation 
Cooperative (ILAC) and a signatory to the ILAC Mutual Recognition 
Arrangement (MRA) that has demonstrated competence to ISO/IEC 
17011:2017;
    (b) Demonstrate it complies with ISO/International Electrotechnical 
Commission (IEC) 17011:2017, ``Conformity assessment--Requirements for 
accreditation bodies accrediting conformity assessment bodies,'' Second 
edition, November 2017. The Director of the Federal Register approves 
this incorporation by reference under 5 U.S.C. 552(a) and 1 CFR part 
51. The approved material is available for inspection at Dockets 
Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852, 301-827-6860, and is available 
from International Organization for Standardization (ISO), Chemin de 
Blandonnet 8, 1214 Vernier, Geneva, Switzerland; Telephone 41 22 749 01 
11, https://www.iso.org/home.html. It is also available for inspection 
at the National Archives and Records Administration (NARA). For 
information on the availability of this material at NARA, email 
fedreg.legal@nara.gov or go to www.archives.gov/federal-register/cfr/ibr-locations; and
    (c) Demonstrate that it possesses sufficient scientific/technical 
expertise to be able to:
    (1) Review the validation and verification studies required by 
Sec.  1.1138(a)(1), including reviewing the verification studies for 
fitness for purpose;
    (2) Assess an accredited laboratory's determination under Sec.  
1.1148(a)(2) that no proficiency testing program is available or 
practicable for a particular method of analysis; and
    (3) Assess whether the comparison program proposed by the 
accredited laboratory under Sec.  1.1148(a)(2) would provide the 
recognized accreditation

[[Page 59504]]

body with the ability to monitor the quality of the laboratory's 
performance to a degree comparable to a proficiency test.
    (d) Demonstrate it is capable of complying with all requirements 
under this subpart for recognized accreditation bodies.

Requirements for Recognized Accreditation Bodies


Sec.  1.1118  What are the general requirements for recognized 
accreditation bodies to remain recognized?

    To remain recognized, a recognized accreditation body must:
    (a) Be a full member of the International Laboratory Accreditation 
Cooperative (ILAC) and a signatory to the ILAC Mutual Recognition 
Arrangement (MRA) that has demonstrated competence to ISO/IEC 
17011:2017;
    (b) Meet, with respect to activities under this subpart, the 
requirements of ISO/IEC 17011:2017, which is incorporated by reference 
(see Sec.  1.1113(b)); and
    (c) Demonstrate that it possesses sufficient scientific/technical 
expertise to be able to:
    (1) Review the validation and verification studies required by 
Sec.  1.1138(a)(1), including reviewing the verification studies for 
fitness for purpose;
    (2) Assess an accredited laboratory's determination under Sec.  
1.1148(a)(2) that no proficiency testing program is available or 
practicable for a particular method of analysis; and
    (3) Assess whether the comparison program proposed by the 
accredited laboratory under Sec.  1.1148(a)(2) would provide the 
recognized accreditation body with the ability to monitor the quality 
of the laboratory's performance to a degree comparable to a proficiency 
test.
    (d) Comply with all of the additional requirements under this 
subpart for recognized accreditation bodies.


Sec.  1.1119   What requirements apply to how a recognized 
accreditation body must protect against conflicts of interests?

    (a) In addition to meeting the impartiality and conflict of 
interest requirements of Sec.  1.1118(b), the recognized accreditation 
body must:
    (1) Ensure that the recognized accreditation body (and its 
officers, employees, or other agents involved in accreditation 
activities) does not own or have a financial interest in, manage, or 
otherwise control any laboratory (or any affiliate, parent, or 
subsidiary) it accredits; and
    (2) Prohibit, subject to the exceptions in paragraph (b) of this 
section, officers, employees, or other agents involved in accreditation 
activities of the recognized accreditation body from accepting any 
money, gift, gratuity, or other item of value from any laboratory they 
accredit or that is seeking their accreditation that conducts food 
testing.
    (b) The prohibited items of value specified in paragraph (a)(2) of 
this section do not include:
    (1) Money representing payment of fees for accreditation services 
or reimbursement of direct costs associated with an onsite assessment 
or reassessment of the laboratory; or
    (2) Lunch of de minimis value provided during the course of an 
assessment or reassessment and on the premises where the assessment or 
reassessment is conducted, if necessary to facilitate the efficient 
conduct of the assessment or reassessment.
    (c) The financial interests of the spouses and children younger 
than 18 years of age of a recognized accreditation body's officers, 
employees, and other agents involved in accreditation activities are 
considered the financial interests of such officers, employees, and 
other agents involved in accreditation activities.


Sec.  1.1120   How must a recognized accreditation body evaluate 
laboratories seeking accreditation and oversee the performance of 
laboratories it accredits?

    (a) A recognized accreditation body must conduct an initial 
assessment of a laboratory seeking accreditation in accordance with the 
requirements of Sec.  1.1118(b), to determine whether the laboratory 
meets the requirements of Sec.  1.1138.
    (b) Subject to the exception in paragraph (c) of this section, the 
initial assessment must be conducted onsite, although certain 
assessment activities may be conducted remotely if it will not aid the 
assessment to conduct them onsite.
    (c) If, within the previous 2 years, the accreditation body 
conducted an onsite assessment of the laboratory in accordance with 
ISO/IEC 17011:2017 to assess whether the laboratory meets the 
requirements of ISO/IEC 17025:2017, then the initial assessment under 
this section:
    (1) May be conducted remotely, and
    (2) Need only address whether the laboratory meets the requirements 
of Sec.  1.1138(a)(1) and (c).
    (d) A recognized accreditation body must oversee the performance of 
a laboratory it accredits in accordance with the applicable 
requirements of Sec.  1.1118(b), except as otherwise provided by this 
subpart, to determine whether the accredited laboratory continues to 
meet the applicable requirements of this subpart.
    (e) The assessment of the sample of the scope of accreditation of 
the accredited laboratory, which the recognized accreditation body must 
conduct at least every 2 years in accordance with Sec.  1.1118(b), must 
be conducted onsite, although certain assessment activities may be 
conducted remotely if it will not aid the assessment to conduct them 
onsite.
    (f) If the recognized accreditation body conducted the initial 
assessment of the laboratory remotely in accordance with paragraph (c) 
of this section, the recognized accreditation body must conduct its 
first assessment of the sample of the scope of accreditation of the 
accredited laboratory no later than 2 years after the recognized 
accreditation body last conducted an onsite assessment of the 
laboratory in accordance with ISO/IEC 17011:2017 to assess whether the 
laboratory meets the requirements of ISO/IEC 17025:2017.
    (g) The reassessment at the end of the accredited laboratory's 
accreditation cycle, which the recognized accreditation body must 
conduct in accordance with Sec.  1.1118(b), must be conducted onsite, 
although certain assessment activities may be conducted remotely if it 
will not aid the assessment to conduct them onsite.
    (h) Any assessments conducted by a recognized accreditation body 
that are in addition to the assessments referred to in paragraphs (a), 
(e), and (g) of this section may be conducted remotely if it will not 
aid the assessment to conduct them onsite.


Sec.  1.1121   What appeal procedures must a recognized accreditation 
body provide for appeals of decisions to not grant accreditation?

    A laboratory may appeal a decision by the recognized accreditation 
body to not grant the accreditation (in-whole or in-part) that the 
laboratory sought, and the recognized accreditation body must consider 
the appeal in accordance with the requirements of Sec.  1.1118(b). In 
addition to meeting the requirements of Sec.  1.1118(b) relating to 
appeals, the recognized accreditation body must make the appeals 
procedures publicly available. It must also establish and implement 
written procedures to use a competent person(s) who may or may not be 
external to the recognized accreditation body, who is free from bias or 
prejudice and has not participated in the accreditation decision and is 
not the subordinate of a person who participated in the accreditation 
decision, to review and decide appeals.

[[Page 59505]]

Sec.  1.1122   When must a recognized accreditation body withdraw or 
reduce the scope of the accreditation of a laboratory, and when may a 
recognized accreditation body put an accredited laboratory on 
probation?

    (a) Grounds for withdrawal of accreditation. A recognized 
accreditation body must withdraw the accreditation of a laboratory it 
accredits when the accredited laboratory substantially fails to comply 
with this subpart.
    (b) Grounds for probation. If a recognized accreditation body 
determines that an accredited laboratory it accredits demonstrates 
deficiencies in performing its functions under this subpart that are 
less serious than those identified in paragraph (a) of this section, 
and it is reasonably likely that the accredited laboratory will be able 
to correct such deficiencies within a specified period of time, the 
recognized accreditation body may temporarily put the accredited 
laboratory on probation.
    (c) Withdrawal in-part. When there are grounds for withdrawal of 
accreditation of an accredited laboratory that the recognized 
accreditation body accredits, but the deficiencies affect only certain 
methods within the accredited laboratory's scope of accreditation, the 
recognized accreditation body may withdraw the accredited laboratory's 
accreditation for only for those affected methods.
    (d) Records request associated with withdrawal of accreditation or 
probation. To assist the recognized accreditation body in determining 
whether a withdrawal of accreditation (in-whole or in-part) or 
probation is warranted under paragraph (a), (b), or (c) of this 
section, the recognized accreditation body may require from a 
laboratory that it accredits the submission of records that the 
accredited laboratory is required to maintain under Sec.  1.1153.
    (e) Notification of withdrawal of accreditation. The recognized 
accreditation body must notify the laboratory of the withdrawal (in-
whole or in-part) of the laboratory's accreditation, and such 
notification must:
    (1) Specify whether the withdrawal of accreditation is in-whole or 
in-part, and if it is in-part, to which method or methods it applies;
    (2) Describe the grounds for withdrawal; and
    (3) State the procedures for appealing the withdrawal.
    (f) Notification of probation. The recognized accreditation body 
must notify the laboratory of the laboratory's probation, and such 
notification must:
    (1) Describe the grounds for the probation;
    (2) Identify all deficiencies that the laboratory must correct for 
the recognized accreditation body to lift the probation; and either
    (i) Inform the laboratory that it has a specific timeframe to take 
particular corrective actions with respect to the deficiencies 
identified by the recognized accreditation body, or
    (ii) Require the laboratory to submit a plan to the recognized 
accreditation body for approval that identifies the appropriate 
corrective actions the laboratory will take to resolve the deficiencies 
identified by the recognized accreditation body, and identify 
appropriate timeframes for resolution; and
    (g) Consequences of probation or withdrawal of accreditation, in-
whole or in-part. If the recognized accreditation body withdraws the 
accreditation of a laboratory in-whole, the laboratory is immediately 
ineligible to conduct food testing under this subpart. If the 
recognized accreditation body withdraws the accreditation of a 
laboratory in-part, the laboratory is immediately ineligible to conduct 
food testing under this subpart with respect to only the specific 
method or methods for which accreditation was withdrawn. An accredited 
laboratory that is put on probation by an accreditation body is 
permitted to continue to conduct food testing under this subpart.
    (h) Appeals procedures. A laboratory may appeal a decision by the 
recognized accreditation body to withdraw the accreditation (in-whole 
or in-part) of the laboratory, and the recognized accreditation body 
must consider the appeal in accordance with Sec.  1.1118(b). In 
addition to meeting the requirements of Sec.  1.1118(b) related to 
appeals, the recognized accreditation body must establish and implement 
written procedures to:
    (1) Make the appeals procedures publicly available; and
    (2) Use a competent person or persons, who may or may not be 
external to the recognized accreditation body, who are free from bias 
or prejudice and have not participated in the withdrawal decision, and 
are not the subordinate of a person who participated in the withdrawal 
decision, to review and decide appeals.


Sec.  1.1123   What reports and notifications must a recognized 
accreditation body submit to FDA?

    (a) General requirements. All reports and notifications required by 
this section to be submitted to FDA must be submitted to FDA 
electronically and in English, and include:
    (1) The name, street address, telephone number, and email address 
of the accreditation body associated with the report or notification, 
and the name of an appropriate point-of-contact for the accreditation 
body, and
    (2) If there is a laboratory associated with the report or 
notification, the name, street address, telephone number, and email 
address of the laboratory associated with the report or notification, 
and the name of an appropriate point-of-contact for the laboratory.
    (b) Reporting results of recognized accreditation body internal 
audits. A recognized accreditation body must submit to FDA a report of 
the results of the internal audit it is required to conduct pursuant to 
Sec.  1.1118(b), including results of the audit of its compliance with 
the requirements of Sec.  1.1118(c) and (d), conducted pursuant to 
Sec.  1.1125, no later than 45 days after completing such internal 
audit, and the report must include:
    (1) A description of the internal audit conducted;
    (2) A description of any identified deficiencies;
    (3) A description of any corrective actions taken and any 
corrective action the recognized accreditation body will take, 
including the timeline for such corrective actions; and
    (4) A statement disclosing the extent to which the internal audit 
was conducted by personnel different from those who perform the 
activity or activities that were audited.
    (c) Immediate notification to FDA. A recognized accreditation body 
must immediately, within 48 hours, notify FDA when the recognized 
accreditation body:
    (1) Is aware of a change that would affect the recognition of such 
accreditation body, and the notification must include:
    (i) A description of the change, and
    (ii) If the change is one made by the recognized accreditation 
body, an explanation of the purpose of the change;
    (2) Grants accreditation of a laboratory, and the notification must 
include:
    (i) The scope of accreditation requested by the laboratory,
    (ii) The scope of accreditation granted, and
    (iii) The date on which accreditation was granted;
    (3) Denies accreditation (in-whole or in-part) of a laboratory, and 
the notification must include:
    (i) The scope of accreditation requested by the laboratory,

[[Page 59506]]

    (ii) The scope of accreditation denied, and
    (iii) The grounds for the denial;
    (4) Receives notice that an accredited laboratory it accredited 
intends to relinquish its accreditation (in-whole or in-part), and the 
notification must include:
    (i) The scope of accreditation to which the relinquishment applies, 
as applicable, and
    (ii) The effective date of the relinquishment;
    (5) Withdraws (in-whole or in-part) the accreditation of a 
laboratory; and the notification must include:
    (i) The scope of accreditation to which the withdrawal applies, and
    (ii) The grounds for the withdrawal;
    (6) Puts an accredited laboratory on probation, and the 
notification must include:
    (i) The grounds for the probation, and
    (ii) Any date by which the recognized accreditation body has 
determined the accredited laboratory must take appropriate corrective 
action; and
    (7) Knows that an accredited laboratory it accredits has committed 
fraud or submitted material false statements to FDA, and the 
notification must include:
    (i) A description of the basis for the accreditation body's 
knowledge of the fraud or material false statements,
    (ii) A description of the alleged fraud or material false 
statements, and
    (iii) The actions taken by the recognized accreditation body with 
respect to such laboratory.


Sec.  1.1124   What records requirements must a recognized 
accreditation body meet?

    (a) In addition to meeting the requirements of Sec.  1.1118(b) 
related to records, a recognized accreditation body must maintain 
electronically, for 5 years after the date of creation of the records, 
records created while it is recognized demonstrating its compliance 
with this subpart, including records relating to:
    (1) Applications for accreditation;
    (2) Assessments, reassessments, and decisions to grant, renew, 
deny, withdraw, expand, or reduce the scope of an accreditation or 
place an accredited laboratory on probation;
    (3) Appeals of probation and denials and withdrawals of 
accreditation, final decisions on such appeals, and the bases for such 
final decisions;
    (4) Its oversight of accredited laboratories it accredited;
    (5) Its oversight of its own performance, including all records 
related to internal audits, complaints, and corrective actions;
    (6) Any reports or notifications required to be submitted to FDA 
under Sec.  1.1123, including any supporting information; and
    (7) Records of fee payments and reimbursement of direct costs.
    (b) An accreditation body that has been recognized must make 
records it is required to maintain under paragraph (a) of this section 
available to FDA for inspection and copying promptly upon written 
request by an authorized FDA officer or employee at the place of 
business of the accreditation body or at a reasonably accessible 
location. If the records required by paragraph (a) of this section are 
requested by FDA electronically, the records must be submitted to FDA 
electronically not later than 10 business days after the date of the 
request. Additionally, if the requested records are maintained in a 
language other than English, the accreditation body must electronically 
submit an English translation within a reasonable time.
    (c) A recognized accreditation body must not prevent or interfere 
with FDA's access to the records the accredited laboratories it 
accredits are required to maintain under Sec.  1.1153.


Sec.  1.1125  What internal audit requirements must a recognized 
accreditation body meet?

    As part of the internal audit a recognized accreditation body is 
required to conduct pursuant to Sec.  1.1118(b), the recognized 
accreditation body must audit its compliance with the requirements of 
Sec.  1.1118(c) and (d).

Procedures for Recognition of Accreditation Bodies


Sec.  1.1128   How does an accreditation body apply to FDA for 
recognition or renewal of recognition?

    (a) Applicant for recognition. An accreditation body seeking 
recognition must submit an application to FDA demonstrating that it 
meets the eligibility requirements in Sec.  1.1113.
    (b) Applicant for renewal of recognition. An accreditation body 
seeking renewal of its recognition must submit a renewal application 
demonstrating that it continues to meet the requirements of this 
subpart.
    (c) Documentation of conformance with requirements. The 
accreditation body must submit documentation of conformance with ISO/
IEC 17011:2017 and separate documentation of ILAC MRA signatory status 
demonstrating competence to ISO/IEC 17011:2017, in meeting the 
requirements of Sec.  1.1113(a) and (b) or Sec.  1.1118(a) and (b), as 
applicable. The accreditation body also must submit documentation of 
its compliance with Sec.  1.1113(c) and (d) or Sec.  1.1118(c) and (d), 
as applicable.
    (d) Submission. An accreditation body must submit recognition and 
renewal applications and any documents provided as part of the 
application process to FDA electronically, in English. The applicant 
must provide any translation and interpretation services needed by FDA 
during the processing of the application, including during any onsite 
assessments of the applicant by FDA.
    (e) Signature. An accreditation body must sign the recognition and 
renewal applications in the manner designated by FDA. Recognition and 
renewal application must be signed by the applicant or by an individual 
authorized to act on behalf of the applicant for purposes of seeking 
recognition or renewal of recognition.


Sec.  1.1129   How will FDA review applications for recognition and 
applications for renewal of recognition?

    (a) Review of application for recognition or renewal of 
recognition. FDA will examine an accreditation body's application for 
recognition or renewal of recognition for completeness and notify the 
applicant of any deficiencies. FDA will review an accreditation body's 
application for recognition or renewal of recognition on a first in, 
first out basis according to the date on which the completed 
application was submitted; however, FDA may prioritize the review of 
specific applications to meet program needs.
    (b) Evaluation of application for recognition or renewal of 
recognition. FDA will evaluate any submitted application for 
recognition or renewal of recognition to determine whether the 
applicant meets the requirements for recognition. Such evaluation may 
include an onsite assessment of the accreditation body. FDA will notify 
the applicant, in writing, regarding whether the application has been 
approved or denied. FDA may make such notification electronically. If 
FDA does not reach a final decision on a renewal application before an 
accreditation body's recognition terminates by expiration, FDA may 
extend the existing term of recognition for a specified period of time 
or until FDA reaches a final decision on the renewal application.
    (c) Issuance of recognition. FDA will notify the applicant that its 
application for recognition or renewal of recognition has been approved 
through issuance of recognition that will list any conditions 
associated with the recognition.
    (d) Duration of recognition. FDA may grant recognition of an 
accreditation body for a period not to exceed 5 years

[[Page 59507]]

from the date of recognition, except under the circumstances described 
in paragraph (b) of this section.
    (e) Issuance of denial of application for recognition or renewal of 
recognition. If FDA denies an applicant's application for recognition 
or renewal of recognition, FDA will notify the applicant, through an 
issuance of a notification of denial of recognition or denial of 
renewal of recognition. The notification of denial of recognition or 
denial of renewal of recognition will state the basis for such denial 
and describe the procedures for requesting reconsideration of the 
application under Sec.  1.1171.
    (f) Notice of records custodian after denial of an application for 
renewal of recognition. An applicant whose application for renewal of 
recognition was denied by FDA must notify FDA electronically, in 
English, within 10 business days of the date of issuance of a denial of 
a renewal application, of the name and contact information of the 
custodian who will maintain the records required by Sec.  1.1124 and 
make them available to FDA as required by Sec.  1.1124. The contact 
information for the custodian must include, at a minimum, an email 
address and the street address where the records required by Sec.  
1.1124 will be located.
    (g) FDA notice to accredited laboratories. FDA will promptly issue 
a notice of the denial of the application for renewal of recognition of 
the accreditation body to all laboratories accredited by the 
accreditation body whose application for renewal of recognition was 
denied.
    (h) Public notice of denial of an application for renewal of 
recognition of an accreditation body. FDA will provide public notice on 
the website described in Sec.  1.1109 of the issuance of a denial of a 
renewal application and will include the date of the issuance of the 
denial of a renewal application.


Sec.  1.1130   How will FDA oversee recognized accreditation bodies?

    (a) FDA will assess each recognized accreditation body to determine 
its compliance with the applicable requirements of this subpart. Such 
assessment will occur by at least 4 years after the date of recognition 
for a 5-year recognition period, or by no later than the mid-term point 
for a recognition period of less than 5 years. An FDA assessment of a 
recognized accreditation body may include review of records, an onsite 
assessment of the accreditation body, and onsite assessments of one or 
more accredited laboratories the recognized accreditation body 
accredits, with or without the recognized accreditation body present.
    (b) FDA may conduct additional assessments of a recognized 
accreditation body at any time to determine the recognized 
accreditation body's compliance with the applicable requirements of 
this subpart.


Sec.  1.1131   When will FDA revoke the recognition of an accreditation 
body or put a recognized accreditation body on probation?

    (a) Grounds for revocation of recognition. FDA will revoke the 
recognition of an accreditation body if it fails to meet the 
requirements of this subpart, or where FDA determines the accreditation 
body has committed fraud or submitted material false statements to FDA.
    (b) Issuance of revocation. (1) FDA will notify the accreditation 
body that its recognition has been revoked through the issuance of a 
revocation that will state the grounds for revocation, the procedures 
for requesting a regulatory hearing under Sec.  1.1173 on the 
revocation, and the procedures for requesting reinstatement of 
recognition under Sec.  1.1133.
    (2) Within 10 business days of the date of issuance of revocation, 
the accreditation body must notify FDA electronically, in English, of 
the name of the custodian who will maintain records and make them 
available to FDA as required by Sec.  1.1124. The contact information 
for the custodian must provide, at a minimum, an email address and the 
street address where the records will be located.
    (c) Grounds for probation. If FDA determines that a recognized 
accreditation body has demonstrated deficiencies in performing its 
functions that are less serious and more limited than those identified 
in paragraph (a) of this section, and it is reasonably likely that the 
accreditation body will be able to correct such deficiencies within a 
reasonable period of time, FDA may temporarily put the recognized 
accreditation body on probation and request that the accreditation body 
take appropriate corrective actions.
    (d) Length of probation. FDA's probation of an accreditation body's 
recognition shall remain in effect until the accreditation body 
demonstrates to FDA's satisfaction that the accreditation body has 
successfully implemented appropriate corrective actions to address the 
deficiencies specified by FDA within the time period identified by FDA, 
or until FDA revokes the recognition of the accreditation body.
    (e) Notification of probation. FDA will notify the accreditation 
body of its probation and such notification will:
    (1) Describe the grounds for the probation;
    (2) Identify all deficiencies that must be corrected for FDA to 
lift the probation and identify a specified period of time to take 
corrective actions to address the deficiencies specified by FDA.
    (f) Effect of revocation of recognition or probation on the 
accreditation body. (1) An accreditation body that has had its 
recognition revoked by FDA may not accredit laboratories under this 
subpart or continue to oversee the laboratories it has previously 
accredited.
    (2) A recognized accreditation body that is put on probation by FDA 
will be expected to continue to oversee laboratories that it has 
accredited under this subpart and is permitted to continue to accredit 
laboratories under Sec.  1.1120 of this subpart.
    (g) FDA notice to the accredited laboratories. FDA will issue a 
notice of the probation or revocation of recognition to all 
laboratories accredited by the recognized accreditation body that was 
put on probation or the accreditation body whose recognition was 
revoked.
    (h) Public notice of probation or revocation of recognition. FDA 
will provide notice on the website described in Sec.  1.1109 of the 
issuance of the probation or revocation of recognition of an 
accreditation body.


Sec.  1.1132   What must a recognized accreditation body do if it wants 
to voluntarily relinquish its recognition or does not want to renew its 
recognition?

    (a) Notice to FDA of intent to relinquish or not to renew 
recognition. A recognized accreditation body must notify FDA 
electronically, in English, at least 60 days before voluntarily 
relinquishing its recognition or before allowing its recognition to 
expire without seeking renewal. The recognized accreditation body must 
provide the name and contact information of the custodian who will 
maintain the records required under Sec.  1.1124 after the date of 
relinquishment or the date recognition expires, as applicable, and make 
them available to FDA as required by Sec.  1.1124. The contact 
information for the custodian must include, at a minimum, an email 
address and the street address where the records required by Sec.  
1.1124 will be located.
    (b) Notice to accredited laboratories of intent to relinquish or 
not to renew recognition. At least 60 days before voluntarily 
relinquishing its recognition

[[Page 59508]]

or before allowing its recognition to expire without seeking renewal, a 
recognized accreditation body must notify the laboratories it 
accredited of its intention to leave the program, specifying the date 
on which relinquishment or expiration will occur.
    (c) Public notice of voluntary relinquishment or expiration of 
recognition. FDA will provide notice on the website described in Sec.  
1.1109 of the voluntary relinquishment or expiration of recognition of 
an accreditation body.


Sec.  1.1133   How does an accreditation body request reinstatement of 
recognition?

    (a) Application following revocation of recogniion. An 
accreditation body that has had its recognition revoked by FDA may seek 
reinstatement by submitting a new application for recognition under 
Sec.  1.1128. The accreditation body must also submit evidence to FDA 
with its application that the grounds for revocation have been 
resolved, including evidence addressing the cause(s) or condition(s) 
that were the grounds for revocation and must identify measures that 
have been implemented to help ensure that such cause(s) or condition(s) 
are unlikely to recur.
    (b) Application following relinquishment or expiration of 
recognition. An accreditation body that previously relinquished its 
recognition or allowed its recognition to expire may seek recognition 
by submitting a new application for recognition under Sec.  1.1128.

Accreditation of Laboratories


Sec.  1.1138   What requirements must a laboratory meet to become 
accredited by a recognized accreditation body?

    (a) To become accredited by a recognized accreditation body, an 
accredited laboratory must:
    (1) Demonstrate it is capable of conducting each method of food 
testing for which it seeks to be accredited, by:
    (i) Submitting information to demonstrate appropriate verification 
or validation of the method(s), including the information required by 
Sec.  1.1151(c)(2) and (d)(2), and a statement by the laboratory based 
on the verification or validation results of whether the laboratory is 
able to properly apply the method; and
    (ii) Passing, or having passed within the past year, a proficiency 
test for the method, subject to the exception that if the laboratory 
determines there is no proficiency testing program available that 
addresses the method, or that proficiency testing for the method is 
otherwise impracticable, the accredited laboratory may instead subject, 
or have subjected in the past year, the method to an appropriate 
comparison program. The laboratory's determination must be reviewed by, 
and approved or denied (as appropriate) by, the recognized 
accreditation body from which the laboratory is seeking accreditation.
    (2) Except as provided in paragraph (b) of this section, 
demonstrate it complies with ISO/IEC 17025:2017, ``General Requirements 
for the Competence of Testing and Calibration Laboratories,'' Third 
edition, November 2017. The Director of the Federal Register approves 
this incorporation by reference under 5 U.S.C. 552(a) and 1 CFR part 
51. The approved material is available for inspection at Dockets 
Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852, 301-827-6860, and is available 
from International Organization for Standardization (ISO), Chemin de 
Blandonnet 8, 1214 Vernier, Geneva, Switzerland; Telephone 41 22 749 01 
11, https://www.iso.org/home.html. It is also available for inspection 
at the National Archives and Records Administration (NARA). For 
information on the availability of this material at NARA, email 
fedreg.legal@nara.gov or go to www.archives.gov/federal-register/cfr/ibr-locations.
    (b) For purposes of this program the laboratory is not required to 
satisfy the following provisions of ISO/IEC 17025:2017:
    (1) That relate to the relationship between the laboratory and its 
customers, to the extent that such provisions establish obligations 
that conflict with the requirements of this subpart;
    (2) In section 7: 7.3; or
    (3) In section 7: 7.8.
    (c) Demonstrate it is capable of meeting and operating in 
conformance with all of this subpart's additional requirements for 
accredited laboratories.

Requirements for Accredited Laboratories


Sec.  1.1146   What are the general requirements for accredited 
laboratories to remain accredited?

    To remain accredited, the accredited laboratory must:
    (a) Be capable of conducting the methods of analysis for the 
testing of food for which it is accredited;
    (b) Maintain conformance with the provisions of ISO/IEC 17025:2017, 
``General Requirements for the Competence of Testing and Calibration 
Laboratories,'' Third edition, November 2017. The Director of the 
Federal Register approves this incorporation by reference under 5 
U.S.C. 552(a) and 1 CFR part 51. The approved material is available for 
inspection at Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 301-
827-6860, and is available from International Organization for 
Standardization (ISO), Chemin de Blandonnet 8, 1214 Vernier, Geneva, 
Switzerland; Telephone 41 22 749 01 11, https://www.iso.org/home.html. 
It is also available for inspection at the National Archives and 
Records Administration (NARA). For information on the availability of 
this material at NARA, email fedreg.legal@nara.gov or go to 
www.archives.gov/federal-register/cfr/ibr-locations. This requirement 
is subject to the exceptions in Sec.  1.1138(b); and
    (c) Operate in conformance with the additional requirements of this 
subpart.


Sec.  1.1147   What impartiality and conflict of interest requirements 
must accredited laboratories meet?

    (a) In addition to the requirements relating to impartiality and 
conflict of interest an accredited laboratory is required to meet under 
Sec.  1.1146(b), the accredited laboratory must, subject to the 
exceptions in paragraph (b) of this section, prohibit the accredited 
laboratory's employees, contractors, and agents involved in food 
testing and related activities from accepting any money, gift, 
gratuity, or other item of value from the owner or consignee of the 
food that is being tested or will be tested by the accredited 
laboratory.
    (b) The prohibited items of value specified in paragraph (a) of 
this section do not include:
    (1) Payment of fees for food testing services;
    (2) Reimbursement of direct costs associated with the food testing 
by the accredited laboratory; and
    (3) With respect to accredited laboratories that are owned by the 
owner or consignee of the food that is tested or to be tested, payment 
of the officer's, employee's, contractor's, or agent's compensation in 
the normal course of business.
    (c) The owner or consignee's payment to the accredited laboratory 
of fees for food testing services and/or reimbursement of direct costs 
associated with food testing must be independent of whether the test 
results indicate that food is or appears to be violative.


Sec.  1.1148   What quality assurance requirements must accredited 
laboratories meet?

    In addition to the requirements relating to quality assurance an 
accredited laboratory is required to meet by Sec.  1.1146(b), 
accredited labs must:

[[Page 59509]]

    (a) Meet the following proficiency testing requirements:
    (1) Accredited laboratories must participate in a proficiency 
testing program or programs provided by a competent proficiency testing 
organization, except as provided in paragraph (a)(2) of this section. 
The accredited laboratory must ensure such proficiency testing is 
conducted at least once per year for each method within the accredited 
laboratory's scope of accreditation.
    (2) If the accredited laboratory determines there is no proficiency 
testing program available that addresses a particular method of 
analysis in the accredited laboratory's scope of accreditation, or that 
participating in a proficiency testing program for the particular 
method of analysis is otherwise impracticable, the accredited 
laboratory may subject that method of analysis to an appropriate 
comparison program. The determination must be reviewed, and approved or 
denied (as appropriate), by the recognized accreditation body that 
accredits the accredited laboratory.
    (b) Ensure its procedures for monitoring the validity of the 
results of testing it conducts under this subpart include the use of 
reference materials or quality control samples with each batch of 
samples it tests under this subpart.


Sec.  1.1149   What oversight standards apply to sampling?

    (a) Before analyzing a sample, the accredited laboratory must 
develop (if it collected the sample) or obtain (if another entity 
collected the sample):
    (1) Written documentation of the sampler's applicable 
qualifications by training and experience. An accredited laboratory 
only needs to develop or obtain documentation of a sampler's 
qualifications the first time that individual collects a sample under 
this subpart, unless the accredited laboratory learns that the 
sampler's qualifications have significantly changed since the 
accredited laboratory last obtained documentation of the sampler's 
qualifications;
    (2) A written sampling plan used to conduct the sampling. The 
written sampling plan must identify the sampler and must list factors 
that will be controlled to ensure the sampling does not impact the 
validity of the subsequent analytical testing, including controlling 
for the representational nature of the sample; and
    (3) A written sample collection report for each sample collected. 
The written sample collection report must, at a minimum, include:
    (i) The product code of the food product sampled (if product is 
being sampled) or the location of and a description of the environment 
(if environment is being sampled);
    (ii) The date(s) of the sampling;
    (iii) The size, identity, and quantity of the sample(s);
    (iv) Documentation of sample collection procedures and any sample 
preparation techniques; and
    (v) Documentation of the chain of custody of the sample(s), and of 
measures taken, to not impact the validity of the subsequent analytical 
testing, including controlling for the representational nature of the 
sample(s).
    (b) If any of the requirements in paragraph (a) of this section are 
not met, FDA may consider the analysis of the sample to be invalid.


Sec.  1.1150   What requirements apply to analysis of samples by an 
accredited laboratory?

    In addition to meeting the requirements of Sec.  1.1146(b):
    (a) The analysis must be conducted on either the sample(s) received 
from the sampler or, if appropriate, on a representative sample of the 
sample(s) received from the sampler.
    (b) The analyst(s) that conducts the analysis must:
    (1) Be qualified by appropriate education, training, and/or 
experience to conduct the analysis;
    (2) Have appropriately demonstrated their ability to perform the 
method properly in the specific context of the food testing to be 
conducted; and
    (3) Be in compliance with the conflict of interest requirements of 
Sec. Sec.  1.1146(b) and 1.1147.
    (c) The method used to conduct the food testing must meet the 
requirements of Sec.  1.1151.
    (d) The accredited laboratory must document the testing information 
and test results to the extent necessary to account for all information 
that is required to be included in a full analytical report (see Sec.  
1.1152(g)).


Sec.  1.1151   What requirements apply to the methods of analysis an 
accredited laboratory uses to conduct food testing under this subpart?

    In addition to meeting the requirements of Sec.  1.1146(b), an 
accredited laboratory must meet the following requirements:
    (a) Analysis under this subpart must be conducted using a method of 
analysis that:
    (1) Is fit for purpose;
    (2) Is within the accredited laboratory's scope of accreditation;
    (3) Has been appropriately validated for use in such food testing, 
in accordance with paragraph (c) of this section; and
    (4) Has been appropriately verified by the accredited laboratory 
for use in such food testing, in accordance with paragraph (d) of this 
section.
    (b) With respect to food testing conducted under:
    (1) Section 1.1107(a)(1), if the Federal Food, Drug, and Cosmetic 
Act or implementing regulations prescribes a test method, that is the 
only appropriate method that may be conducted for such food testing;
    (2) Section 1.1107(a)(2), if the food testing order prescribes a 
test method, that is the only appropriate method that may be conducted 
for such food testing.
    (c)(1) An accredited laboratory must validate methods in accordance 
with the requirements of Sec.  1.1146(b).
    (2) An accredited laboratory performing validation of a method 
under this subpart must record the information required by the 
requirements of Sec.  1.1146(b), and the supporting analytical data.
    (d)(1) Before an accredited laboratory conducts food testing under 
this subpart using a method for a specific intended use for which the 
method has been validated, but for which the laboratory has not 
previously applied the method under this subpart, the accredited 
laboratory must have verified it can properly perform the method for 
the specific intended use.
    (2) An accredited laboratory performing verification of a method 
under this subpart must record the method that is the subject of the 
verification, the intended purpose of the analysis, the results of the 
verification, the procedure used for the verification, supporting 
analytical data, and whether the accredited laboratory is able to 
properly perform the method.
    (e) An accredited laboratory may submit a written request to FDA 
requesting FDA's permission to use a method or methods outside of its 
scope of accreditation for food testing. FDA may approve the request if 
both following conditions are satisfied:
    (1) A new methodology or methodologies have been developed and 
validated but no reasonably available laboratory has been accredited to 
perform such methodology or methodologies, and
    (2) The use of such method or methods is necessary to prevent, 
control, or mitigate a food emergency or foodborne illness outbreak.


Sec.  1.1152   What notifications, results, and reports must accredited 
laboratories submit to FDA?

    (a) General requirements. (1) All notifications, results, reports, 
and

[[Page 59510]]

studies required to be submitted to FDA by accredited laboratories 
under this subpart must be submitted to FDA electronically and in 
English, and:
    (i) Include the legal name and street address of the accredited 
laboratory, identify a point-of-contact for the accredited laboratory 
that FDA may contact with questions or comments regarding the 
notification, result, report, or study, and include the email address 
and telephone number of the point-of-contact;
    (ii) Display an identification unique to the test results, report, 
notification, or study; and
    (iii) Be true, accurate, unambiguous, and objective.
    (2) The accredited laboratory that conducts the analysis of the 
sample under this subpart is responsible for the submission of all 
notifications, results, reports, and studies to FDA as required by this 
section.
    (3) If the accredited laboratory that is responsible for the 
submission of same becomes aware that any aspect of the submitted 
material is inaccurate, the accredited laboratory must immediately 
inform FDA and submit a corrected version. Such corrections must meet 
the requirements for amendments to reports specified by ISO/IEC 
17025:2017 section 7.8.8. ISO/IEC 17025:2017, ``General Requirements 
for the Competence of Testing and Calibration Laboratories,'' Third 
edition, November 2017. The Director of the Federal Register approves 
this incorporation by reference under 5 U.S.C. 552(a) and 1 CFR part 
51. The approved material is available for inspection at Dockets 
Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852, 301-827-6860, and is available 
from International Organization for Standardization (ISO), Chemin de 
Blandonnet 8, 1214 Vernier, Geneva, Switzerland; Telephone 41 22 749 01 
11, https://www.iso.org/home.html. It is also available for inspection 
at the National Archives and Records Administration (NARA). For 
information on the availability of this material at NARA, email 
fedreg.legal@nara.gov or go to www.archives.gov/federal-register/cfr/ibr-locations.
    (4) Any opinions and interpretations in any notification, result, 
report, or study submitted to FDA under this subpart must meet the 
requirements in ISO/IEC 17025:2017 section 7.8.7 and any statements of 
conformity to a specification or standard in any notification, result, 
report, or study submitted to FDA under this subpart must meet the 
requirements of ISO/IEC 17025:2017 section 7.8.6.
    (b) Test results. (1) The results of any and all tests conducted by 
an accredited laboratory under this subpart must be submitted directly 
to FDA.
    (2) The accredited laboratory must submit the results of testing 
conducted under this subpart directly to FDA via the destination 
specified by the website described by Sec.  1.1109, unless directed to 
use a different method of submission by FDA regarding testing conducted 
under Sec.  1.1107(a)(2) or (3).
    (3) The test results must be clear and identify the associated 
notifications, reports, and studies required to be submitted with the 
test results under this subpart.
    (c) Documentation required to be submitted with test results. The 
following documentation must be submitted to FDA with each test result 
submitted to FDA under this subpart:
    (1) All sampling plans and sample collection reports related to the 
food testing conducted, as developed or obtained by the accredited 
laboratory in accordance with Sec.  1.1149;
    (2) Written documentation of the sampler's qualifications, if Sec.  
1.1149(a)(1) requires the accredited laboratory to obtain such 
documentation;
    (3) The full analytical report required by paragraph (g) of this 
section, documenting the analysis related to the food testing, except 
that if the accredited laboratory is permitted in accordance with 
paragraph (d) of this section to submit abridged analytical reports, 
the accredited laboratory may instead submit an abridged analytical 
report, which must contain the information required by paragraph (f) of 
this section;
    (4) For any validation studies required by Sec.  1.1151(c)(1), the 
documentation required by Sec.  1.1151(c)(2), except when the 
circumstances of paragraph (c)(6) of this section apply with respect to 
the validation study.
    (5) For any verification studies required by Sec.  1.1151(d)(1), 
the documentation required by Sec.  1.1151(d)(2), except when the 
circumstances of paragraph (c)(6) of this section apply with respect to 
the verification study.
    (6) Paragraphs (c)(4) and (5) of this section do not require the 
accredited laboratory to submit the validation or verification study to 
FDA if the accredited laboratory submitted the validation or 
verification study to its accreditation body as required by Sec.  
1.1138(a)(1)(i). If the accredited laboratory submitted the validation 
or verification study to its accreditation body as required by Sec.  
1.1138(a)(1)(i), the accredited laboratory must instead submit to FDA, 
in lieu of the validation or verification study, a statement that the 
validation or verification study has been submitted to its recognized 
accreditation body in accordance with Sec.  1.1138(a)(1)(i), and the 
accredited laboratory must identify the method, analyte, and matrix 
that were the subject of the validation or verification study;
    (7) A certification from one or more members of the accredited 
laboratory's management certifying that the test results, 
notifications, reports, and studies are true and accurate; and that the 
documentation includes the results of all tests conducted under this 
subpart. The certification must include the name, title, and signature 
of the certifier(s).
    (d) Permission to submit abridged analytical reports. (1) 
Accredited laboratories that are not disqualified under paragraphs 
(d)(6)(i) and (d)(7) of this section or on probation are permitted to 
submit to FDA on an ongoing basis abridged analytical reports relating 
to a specific major food testing discipline(s) that is represented in 
the reports described in paragraph (d)(1)(ii) of this section, after 
FDA has given notice that the following conditions are fulfilled:
    (i) The accredited laboratory submits 10 consecutive full 
analytical reports to FDA under this subpart;
    (ii) The consecutive full analytical reports include at least one 
full analytical report relating to each major food testing discipline 
for which the accredited laboratory seeks to submit abridged analytical 
reports;
    (iii) None of the consecutive full analytical reports demonstrate 
any material substantive shortcoming in the food testing; and
    (iv) The consecutive full analytical reports do not contain 
repeated administrative deficiencies.
    (2)(i) Accredited laboratories that fail to satisfy the condition 
in paragraph (d)(1)(iii) of this section are subject to the 
disqualification period described in paragraph (d)(6)(i) of this 
section.
    (ii) Accredited laboratories that fail to satisfy the condition in 
paragraph (d)(1)(iv) of this section have a second attempt to satisfy 
the conditions in paragraphs (d)(1)(i) to (iv) of this section with 10 
subsequent consecutive full analytic reports. If one of those 
subsequent consecutive full analytical reports demonstrate any material 
substantive shortcoming in the food testing, or the subsequent 
consecutive full analytical reports contain repeated administrative 
deficiencies, the accredited laboratory is subject to the 
disqualification period described in paragraph (d)(6)(i) of this 
section.

[[Page 59511]]

    (3) Accredited laboratories that are not on probation and are 
currently permitted to submit abridged analytical reports for at least 
one major food testing discipline under this paragraph are permitted to 
submit to FDA on an ongoing basis abridged analytical reports relating 
to any additional major food testing disciplines that were not 
represented in the reports described in paragraph (d)(1)(ii) of this 
section, after FDA has given notice that the following conditions are 
fulfilled:
    (i) The accredited laboratory submits to FDA at least one full 
analytical report for each additional major food testing discipline for 
which the accredited laboratory seeks to submit abridged analytical 
reports;
    (ii) None of the full analytical reports for each additional major 
food testing discipline demonstrate any material substantive 
shortcoming in the food testing; and
    (iii) None of the full analytical reports for each additional major 
food testing discipline contain repeated administrative deficiencies.
    (4)(i) Accredited laboratories that fail to satisfy the condition 
in paragraph (d)(3)(ii) of this section for an additional major food 
testing discipline(s) are subject to the disqualification period 
described in paragraph (d)(6)(ii) of this section for such additional 
major food testing discipline(s).
    (ii) Accredited laboratories that fail to satisfy the condition in 
paragraph (d)(3)(iii) of this section for an additional major food 
testing discipline(s) have a second attempt to satisfy the conditions 
in paragraphs (d)(3)(i) to (iii) of this section with at least one full 
analytic report for each additional major food testing discipline for 
which the accredited laboratory is seeking to submit abridged 
analytical reports. If that subsequent full analytical report(s) 
demonstrates any material substantive shortcoming in the food testing, 
or the subsequent full analytical report(s) contains repeated 
administrative deficiencies, the accredited laboratory is subject to 
the disqualification period described in paragraph (d)(6)(ii) of this 
section for the major food testing discipline that was the subject of 
the full analytical report containing the shortcoming or deficiencies.
    (5) If one or more test results, notifications, reports, and/or 
studies relating to a specific major food testing discipline submitted 
to FDA under this subpart by an accredited laboratory that is permitted 
to submit abridged analytical reports for that major food testing 
discipline demonstrates any material substantive shortcoming in the 
related food testing or demonstrates repeated administrative 
deficiencies, the accredited laboratory is disqualified to submit 
abridged reports for that specific major food testing discipline in 
accordance with either paragraph (d)(6)(ii) of this section (if the 
accredited laboratory is permitted to submit abridged analytical 
reports for another discipline) or paragraph (d)(6)(i) of this section 
(if the accredited laboratory is not permitted to submit abridged 
analytical reports for any another discipline).
    (6)(i) The period of disqualification is either 2 years or until 
the accredited laboratory submits 20 more full analytical reports to 
FDA under this subpart, whichever period of time is longer, after which 
time the accredited laboratory may request permission under paragraph 
(d)(7) of this section to fulfill the eligibility conditions under 
paragraph (d)(1) of this section.
    (ii) The period of disqualification is either 2 years or until the 
accredited laboratory submits two more full analytical reports to FDA 
under this subpart, whichever period of time is longer, after which 
time the accredited laboratory may request permission under paragraph 
(d)(7) of this section to fulfill the eligibility conditions under 
paragraph (d)(3) of this section.
    (iii) Whenever, during the period of disqualification described 
under paragraph (d)(6)(i) or (ii) of this section, a full analytical 
report submitted by an accredited laboratory demonstrates any material 
substantive shortcoming in the food testing, that accredited 
laboratory's disqualification period is extended by 6 months.
    (iv) Whenever, during the period of disqualification described 
under paragraph (d)(6)(i) or (ii) of this section, the full analytical 
reports submitted by an accredited laboratory contain repeated 
administrative deficiencies, that accredited laboratory's 
disqualification period is extended by 2 months.
    (7) An accredited laboratory that has fulfilled the conditions of 
paragraph (d)(6)(i) or (ii) of this section, as applicable, and that is 
not on probation, may submit a request to FDA via the destination 
specified by the website described by Sec.  1.1109 to attempt to 
fulfill the conditions as described in paragraphs (d)(1) and (3) of 
this section, as applicable. FDA will consider permitting the 
accredited laboratory to again try and fulfill the conditions of 
paragraph (d)(1) or (3) of this section, as applicable. If FDA grants 
permission and upon fulfillment of those conditions, FDA will provide 
notice that the accredited laboratory is permitted to submit to FDA on 
an ongoing basis abridged analytical reports relating to the 
disciplines for which the conditions are fulfilled.
    (e) Exceptions to permission to submit abridged analytical reports. 
(1) Occasionally, for the purposes of auditing abridged analytical 
reports and otherwise protecting the public health and the integrity of 
this food testing program, FDA will require that an accredited 
laboratory that is permitted to submit abridged analytical reports 
additionally submit to FDA the full analytical report within 48 hours 
of FDA's notice.
    (2) FDA may require an accredited laboratory that is permitted to 
submit abridged analytical reports under this subpart to submit full 
analytical reports if such analytical reports relate to an FDA 
investigation or FDA enforcement proceeding.
    (f) Abridged analytical report contents. Abridged analytical 
reports must contain:
    (1) All information described by ISO/IEC 17025:2017 sections 
7.8.2.1(a) through (p) and 7.8.3.1(a) through (d). ISO/IEC 17025:2017, 
``General Requirements for the Competence of Testing and Calibration 
Laboratories,'' Third edition, November 2017. The Director of the 
Federal Register approves this incorporation by reference under 5 
U.S.C. 552(a) and 1 CFR part 51. The approved material is available for 
inspection at Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 301-
827-6860, and is available from International Organization for 
Standardization (ISO), Chemin de Blandonnet 8, 1214 Vernier, Geneva, 
Switzerland; Telephone 41 22 749 01 11, https://www.iso.org/home.html. 
It is also available for inspection at the National Archives and 
Records Administration (NARA). For information on the availability of 
this material at NARA, email fedreg.legal@nara.gov or go to 
www.archives.gov/federal-register/cfr/ibr-locations; and
    (2) The justification for any modification or deviation to the 
method(s) of analysis used and documentation of the accredited 
laboratory's authorization for the modification or deviation.
    (g) Full analytical report contents. Full analytical reports must 
contain:
    (1) All information described by paragraphs (f)(1) and (2) of this 
section;
    (2) Documentation of references for the method or methods of 
analysis used;
    (3) Identification of the analyst or analysts who conducted each 
analytical step, validation step (if applicable), and verification step 
(if applicable),

[[Page 59512]]

including the analyst's or analysts' legal name and signature, and the 
date each analytical step, validation step (if applicable), and 
verification step (if applicable) was performed;
    (4) Calculations, presented in a legible and logical manner;
    (5) As applicable, references to chromatograms; charts; graphs; 
observations; photographs of thin layer chromatographic plates; and 
spectra. References must be in color when appropriate and made in a 
clear order;
    (6) Identification of the source and purity of reference standards 
used, and, as applicable: Certified reference materials, certified 
reference cultures traceable to a nationally or internationally 
recognized type culture collection (including concentration, units 
preparation, and storage conditions), and reference standard 
preparation information (including who prepared the reference standard, 
date of preparation, expiration date, chemical balance, and solvent 
used);
    (7) A copy of the label from any immediate container sampled and 
any additional labeling needed to evaluate the product;
    (8) All original compilations of raw data secured in the course of 
the analysis, including discarded, unused or re-worked data, with the 
justification for discarding or re-working such data, corresponding 
supporting data, and quality control results all identified with unique 
sample identification, date and time, associated with the test;
    (9) Any other relevant additional supporting information such as 
the storage location of analyzed samples, appropriate attachments such 
as instrument printouts, computer generated charts and data sheets, and 
photocopies or original labels for the product analyzed;
    (10) Identification of any software used;
    (11) Any certificate or certificates of analysis for standards and 
software; and
    (12) The following information about the qualifications of the 
analyst or analysts who were involved in the analysis conducted under 
this subpart, if the accredited laboratory has not previously submitted 
documentation of the analyst's qualifications to FDA or the analyst's 
qualifications have significantly changed since the accredited 
laboratory last submitted documentation of the analyst's qualifications 
to FDA:
    (i) The analyst's curriculum vitae;
    (ii) Training records with regards to methods that the analyst is 
qualified to perform, including the dates of such training and the name 
of the trainer or training provider;
    (iii) Any other documentation of the analyst's ability to perform 
the method properly in the context of the food testing to be conducted, 
pursuant to Sec.  1.1150(b); and
    (iv) Individual proficiency test worksheets relevant to the 
analysis being performed.
    (h) Additional information about non-standard methods. If the 
accredited laboratory conducts the analysis using a method that is not 
published in a reputable international or national standard or that is 
otherwise not publicly and readily available, upon request by FDA the 
accredited laboratory must submit documentation of the method to FDA.
    (i) Advance notice of sampling. (1) If FDA determines that the 
sampling conducted by a sampler may materially differ from the sampling 
documented in the associated sampling plan or sample collection report, 
or if FDA determines that the sampling may have been otherwise 
improper, FDA may require the accredited laboratory that analyzed the 
associated sample(s), and other accredited laboratories that have 
analyzed samples collected by the sampler previously, to request and 
receive from the sampler, and submit or require the sampler to submit, 
an advance notice of sampling to FDA 48 hours before each of the next 
10 occasions that the sampler will collect a sample that the accredited 
laboratory will analyze under this subpart.
    (2) FDA may, as appropriate:
    (i) Specify the type of food product or environment that requires 
advance notice of sampling under this subpart,
    (ii) Determine that an amount of time other than 48 hours in 
advance is required, to a minimum of 24 hours and up to 7 business days 
in advance, and
    (iii) Determine that a number of occasions other than 10 are 
required, to a minimum of 1 occasion and up to a maximum of 20 
occasions.
    (iv) Notify affected accredited laboratories that submission of 
additional notices of sampling are not required.
    (3) The advance notice of sampling must contain:
    (i) A unique identification code for the advance notice of 
sampling;
    (ii) The name of the accredited laboratory that will conduct 
analysis of the sample;
    (iii) The name and street address of the sampler that will conduct 
the sampling;
    (iv) A primary contact (name and phone number) for the sampler;
    (v) The reason(s) why the food product or environment will be 
sampled;
    (vi) The location of the food product or environment that will be 
sampled, including sufficient information to identify the food product 
or environment to be sampled;
    (vii) As applicable, the U.S. Customs and Border Protection entry 
and line number(s) and the FDA product code(s) of the food; and
    (viii) The date and approximate time the sampling will begin.
    (j) Immediate notification of significant changes. When any changes 
occur that affect the accreditation of the accredited laboratory, the 
accredited laboratory must immediately, within 48 hours, send FDA and 
the accreditation body that accredited it notice of such changes, a 
detailed description of such changes, and an explanation of how such 
changes affect the accreditation of the accredited laboratory. 
Accredited laboratories are not required to notify FDA of changes that 
recognized accreditation bodies must provide notification of under 
Sec.  1.1123(c).
    (k) Consequence of omission. If FDA does not receive all 
information required to be submitted to FDA by paragraphs (a) through 
(j) of this section, FDA may consider the related food testing to be 
invalid.


Sec.  1.1153   What other records requirements must an accredited 
laboratory meet?

    In addition to meeting the requirements of Sec.  1.1146(b) related 
to records, laboratories that have been accredited must meet the 
following requirements:
    (a) Maintain electronically, for 5 years after the date of 
creation, records created and received while they are accredited that 
relate to compliance with this subpart, including:
    (1) Documents related to the accredited laboratory's grant (and, if 
applicable, expansions and reductions) of accreditation from its 
recognized accreditation body;
    (2) Documentation of food testing the accredited laboratory 
conducted under this subpart, in accordance with Sec.  1.1150(d);
    (3) All documents that the accredited laboratory was required to 
submit to FDA under Sec.  1.1152, and associated correspondence by the 
accredited laboratory (and its officers, employees, and other agents) 
with the owner or consignee (and its officer, employees, and other 
agents) of the tested food product or environment;
    (4) All requests for food testing from an owner or consignee that 
would be conducted under this subpart;
    (5) Documentation of any internal investigations, internal audits, 
and corrective actions taken to address any

[[Page 59513]]

problems or deficiencies related to activities under this subpart;
    (6) Any and all documentation related to probation or withdrawal 
from accreditation under this subpart; and
    (7) Documentation of changes to its management system or food 
testing activities that may affect its compliance with this subpart.
    (b) Within 30 days of the receipt of proficiency testing results, 
submit the results:
    (1) To the recognized accreditation body that accredits the 
accredited laboratory; and
    (2) If the accredited laboratory failed the proficiency test, to 
FDA, via the destination specified by the website described by Sec.  
1.1109.
    (c) Make the records required by paragraphs (a) and (b) of this 
section available for inspection and copying upon written request of an 
authorized officer or employee of FDA. The authorized officer or 
employee of FDA may request that the laboratory that has been 
accredited submit such records to FDA electronically or that the 
laboratory make such records promptly available at the physical 
location of the laboratory or at another reasonably accessible 
location. If the authorized officer or employee of FDA requests the 
records be submitted electronically, the records must be submitted 
electronically not later than 10 business days after the date of the 
request, except that records related to the immediate notification 
provision in Sec.  1.1152(j) must be submitted within 48 hours. 
Additionally, if the authorized FDA officer or employee requests 
records that are maintained in a language other than English, the 
laboratory that has been accredited must electronically submit an 
English translation of the records to FDA within a reasonable time.
    (d) Ensure that significant amendments to records described by 
paragraphs (a) and (b) of this section can be tracked to previous and 
original versions. If such a significant amendment is made, both the 
original document and amended document must be maintained by the 
laboratory that has been accredited during the time period that the 
amended document must be maintained under this subpart. The laboratory 
must also document the date of amendment, the personnel responsible for 
the amendment, and a conspicuous indication on the original document 
stating that the document has been altered and a more recent version of 
the document exists.

Procedures for Accreditation of Laboratories


Sec.  1.1158   How does a laboratory apply for accreditation or 
modification of its scope of accreditation by a recognized 
accreditation body?

    (a) Submission of application for accreditation to a recognized 
accreditation body. A laboratory seeking accreditation must submit its 
application for accreditation to a recognized accreditation body 
identified on the website described in Sec.  1.1109. The recognized 
accreditation body will review and assess the application in accordance 
with the requirements of this subpart. If the laboratory seeking 
accreditation had its accreditation (in-whole or in-part) withdrawn by 
a recognized accreditation body or revoked by FDA the previous time it 
was accredited under this subpart, the laboratory must meet the 
additional requirements specified by Sec.  1.1165.
    (b) Documentation of conformance with ISO/IEC 17025:2017. The 
laboratory may use documentation of conformance with ISO/IEC 
17025:2017, as applicable and supplemented as necessary, in meeting the 
applicable requirements of this subpart.
    (c) Duration of accreditation. If an accredited laboratory 
maintains compliance with all requirements of this subpart including 
maintaining accreditation to ISO/IEC 17025:2017, the laboratory's 
accreditation does not end until withdrawn, revoked, or relinquished 
under this subpart.


Sec.  1.1159   How will FDA oversee accredited laboratories?

    (a) FDA may assess accredited laboratories at any time to determine 
whether the accredited laboratory continues to comply with the 
applicable requirements of this subpart and whether there are 
deficiencies in the performance of the accredited laboratory that, if 
not corrected, would warrant probation or revocation of its 
accreditation under Sec.  1.1161.
    (b) In evaluating the performance of an accredited laboratory under 
paragraph (a) of this section, FDA may review any of the following:
    (1) Records the accredited laboratory is required to maintain under 
this subpart;
    (2) Records the accreditation body that accredited the accredited 
laboratory is required to maintain under this subpart;
    (3) Information obtained by FDA during an onsite assessment by FDA 
of the accredited laboratory conducted pursuant to paragraph (c) of 
this section;
    (4) Information obtained by FDA during an assessment of the 
recognized accreditation body that accredited the laboratory; and
    (5) Any other information obtained by FDA, including during FDA's 
inspections or investigations of one or more owners or consignees of 
food subject to food testing under this subpart.
    (c) FDA may conduct an onsite assessment of an accredited 
laboratory at any reasonable time, with or without a recognized 
accreditation body (or its officers, employees, and other agents) 
present, to assess an accredited laboratory.
    (d) FDA will report any of its observations and findings of its 
assessment to the accredited laboratory's recognized accreditation 
body.


Sec.  1.1160   How will FDA review submitted test results and 
analytical reports?

    (a) If FDA finds that any test result, analytical report, related 
documents, or the associated analysis contains deficiencies or 
otherwise indicates that any aspect of the food testing is not being 
conducted in compliance with this subpart, FDA:
    (1) May consider the analysis to be invalid; and/or
    (2) Will notify the accredited laboratory that appears to be 
responsible for the deficiency and may also notify the owner or 
consignee of the food of the deficiency. When we notify the accredited 
laboratory that appears to be responsible for the deficiency, the 
accredited laboratory must respond, in writing, to FDA regarding the 
deficiency within 30 days or an agreed-upon timeframe, including a 
statement with respect to how the accredited laboratory intends to 
address the deficiency, and/or a statement describing the extent to 
which the laboratory has addressed the deficiency.
    (b) FDA may report FDA's determinations of any deficiencies 
resulting from its review of any test results, reports, and related 
documents under this subpart to the recognized accreditation body that 
accredits the accredited laboratory.
    (c) If the deficiency in the test result, analytical report, and/or 
associated analysis demonstrates a material substantive shortcoming in 
the related food testing or demonstrates repeated administrative 
deficiencies, FDA will also consider whether disqualification from 
being eligible for permission to submit abridged analytic reports under 
Sec.  1.1152(d), and/or other action under this subpart, is 
appropriate.
    (d) Nothing in this subpart shall be construed to limit the ability 
of FDA to review and act upon information

[[Page 59514]]

received about food testing, including determining the sufficiency of 
such information and testing.


Sec.  1.1161   When will FDA put an accredited laboratory on probation 
or revoke the accreditation of a laboratory?

    (a) Grounds for revocation of accreditation. FDA may revoke the 
accreditation (in-whole or in-part) of an accredited laboratory to 
conduct food testing under this subpart for good cause, which may 
include any of the following reasons:
    (1) Demonstrated bias or lack of objectivity when conducting food 
testing under this subpart where the laboratory's recognized 
accreditation body fails to withdraw accreditation of the laboratory.
    (2) Performance that calls into question the validity or 
reliability of its food testing under this subpart where the 
laboratory's recognized accreditation body fails to withdraw 
accreditation of the laboratory.
    (3) Other failure to substantially comply with this subpart where 
the laboratory's recognized accreditation body fails to withdraw 
accreditation of the laboratory.
    (b) Grounds for probation. If FDA determines that an accredited 
laboratory has demonstrated deficiencies in performing its functions 
that are less serious and more limited than those identified in 
paragraph (a) of this section, and it is reasonably likely that the 
accredited laboratory will be able to correct such deficiencies within 
a specified period of time, FDA may temporarily put the accredited 
laboratory on probation and request that the laboratory take 
appropriate corrective actions.
    (c) Revocation in-part. When there are grounds for revocation of 
accreditation of a laboratory, but the deficiencies affect only certain 
methods within the accredited laboratory's scope of accreditation, FDA 
may revoke the accredited laboratory's accreditation only for those 
affected methods.
    (d) Length of probation. FDA's probation of a laboratory's 
accreditation shall remain in effect until the laboratory demonstrates 
to FDA's satisfaction that the laboratory has successfully implemented 
appropriate corrective actions, or until FDA determines that revocation 
of accreditation is warranted.
    (e) Notice to the accredited laboratory of revocation of 
accreditation. FDA will notify a laboratory and its accreditation body 
of the revocation of its accreditation through issuance of a revocation 
notice that will state:
    (1) The grounds for revocation;
    (2) Whether the revocation of accreditation is in-whole or in-part, 
and if it is in-part, to which method or methods it applies;
    (3) The procedures for requesting a regulatory hearing under Sec.  
1.1173 on the revocation; and
    (4) The procedures for requesting reinstatement of accreditation 
under Sec.  1.1165.
    (f) Notification of probation. FDA will notify a laboratory and its 
accreditation body of the probation and such notification will:
    (1) Describe the grounds for the probation; and
    (2) Identify all deficiencies that must be corrected for FDA to 
lift the probation; and will either:
    (i) Inform the laboratory that the laboratory has a specified time 
period to take corrective actions specified by FDA; or
    (ii) Request that the laboratory submit a corrective action plan to 
FDA for FDA's approval that identifies the corrective actions it will 
take to address deficiencies identified in the notice and identify 
timeframes for completion.
    (g) Revocation following probation. FDA may revoke (in-whole or in-
part) the accreditation of a laboratory that has been put on probation 
if FDA determines that the laboratory is not implementing appropriate 
corrective actions.
    (h) Public notice of probation or revocation of accreditation. FDA 
will provide notice on the website described in Sec.  1.1109 of 
probation or revocation of accreditation of a laboratory.


Sec.  1.1162   What are the consequences if FDA puts an accredited 
laboratory on probation or revokes the accreditation of a laboratory?

    (a) If FDA revokes the accreditation of a laboratory in-whole, the 
laboratory is immediately ineligible to conduct food testing under this 
subpart. If FDA revokes the accreditation of a laboratory in-part, the 
laboratory is immediately ineligible to use the methods that are 
subject to the revocation to conduct food testing under this subpart. 
An accredited laboratory that is put on probation by FDA is permitted 
to continue to conduct food testing under this subpart.
    (b) With respect to food testing conducted by the laboratory prior 
to the revocation of accreditation, FDA may refuse to consider specific 
food testing results and associated reports of food testing conducted 
under this subpart by the laboratory if the basis for the revocation of 
accreditation of the laboratory indicates that the specific food 
testing conducted by the laboratory may not be reliable.
    (c) Within 10 business days of the date of issuance of revocation, 
the laboratory must notify FDA electronically, in English, of the name 
of the custodian who will maintain the records required by Sec.  
1.1153, and provide contact information for the custodian, which will 
at least include an email address, and the street address where the 
records will be located.
    (d) Within 10 business days of the date of issuance of probation or 
revocation, the laboratory must notify any owners or consignees that it 
is conducting food testing on behalf of under this subpart that it is 
on probation or its accreditation has been revoked.


Sec.  1.1163   What if a laboratory wants to voluntarily relinquish its 
accreditation?

    (a) Notice to FDA and the recognized accreditation body of intent 
to relinquish. An accredited laboratory must notify FDA electronically, 
in English, and must notify its recognized accreditation body at least 
60 days before voluntarily relinquishing accreditation (in-whole or in-
part). The notice must include the date on which relinquishment will 
occur. If the relinquishment is of the laboratory's accreditation in-
whole, the notification must also include the name and contact 
information of the custodian who will maintain the records required 
under Sec.  1.1153 after the date of relinquishment, and the laboratory 
must make such records available to FDA as required by Sec.  1.1153. 
The contact information for the custodian must include, at a minimum, 
an email address and the street address where the records required by 
Sec.  1.1153 will be located.
    (b) Public notice of voluntary relinquishment of accreditation. FDA 
will provide notice on the website described in Sec.  1.1109 of the 
voluntary relinquishment of accreditation of a laboratory.


Sec.  1.1164   What is the effect on accredited laboratories if their 
accreditation body voluntarily or involuntarily loses its recognition?

    (a) If an accreditation body has its recognition revoked, 
relinquishes its recognition, allows its recognition to expire, or has 
its application for renewal of recognition denied, the laboratory 
accredited by the accreditation body must take the following actions 
(subject to the exception in paragraph (b) of this section):
    (1) No later than 30 days after FDA issues the notice to the 
accredited laboratory under Sec.  1.1129, Sec.  1.1130, or Sec.  1.1131 
that the accreditation body that accredits the laboratory has had its

[[Page 59515]]

recognition revoked, has relinquished its recognition, has allowed its 
recognition to expire, or has had its application for renewal of 
recognition denied, the accredited laboratory submits to FDA 
documentation of the accredited laboratory's most recent internal 
audit, which all accredited laboratories are required to maintain under 
Sec.  1.1153(a)(5), documentation showing compliance with the conflict 
of interest requirements in Sec.  1.1147, and documentation of the most 
recent proficiency test for each test method for which the laboratory 
is accredited under this subpart, to show compliance with Sec.  
1.1138(a)(1)(ii); and
    (2) No later than 1 year after FDA issues the applicable notice 
under Sec.  1.1129, Sec.  1.1130, or Sec.  1.1131 to the accredited 
laboratory, the laboratory becomes accredited under this subpart by a 
recognized accreditation body.
    (b) The accredited laboratory does not have to comply with 
paragraph (a) of this section if, no later than 15 days after FDA 
issues the applicable notice to the accredited laboratory under Sec.  
1.1129, Sec.  1.1130, or Sec.  1.1131, the accredited laboratory 
initiates relinquishment of its accreditation in-whole under Sec.  
1.1163, with the relinquishment to occur within no more than 90 days.


Sec.  1.1165   How does a laboratory request reinstatement of 
accreditation?

    (a) Application following withdrawal of accreditation by a 
recognized accreditation body or revocation of accreditation by FDA. A 
laboratory that had its accreditation (in-whole or in-part) withdrawn 
by a recognized accreditation body or revoked by FDA may seek 
reinstatement of accreditation by submitting a new application for 
accreditation (in-whole or in-part, as applicable) to a recognized 
accreditation body under Sec.  1.1158, and the laboratory must also:
    (1) Notify FDA, before it submits the new application for 
accreditation to the recognized accreditation body, that the laboratory 
will be submitting a new application for accreditation to the 
recognized accreditation body, including in the notification the legal 
name of the laboratory, valid contact information for the laboratory, 
the legal name of the recognized accreditation body the laboratory will 
be submitting the application to, and the date that the laboratory 
expects to submit the new application for accreditation; and
    (2) Demonstrate, to the satisfaction of the recognized 
accreditation body it is submitting the new application to, that the 
grounds for the withdrawal of accreditation have been resolved and that 
the laboratory has implemented measures to prevent such grounds from 
recurring.
    (b) Application following voluntary relinquishment of 
accreditation. A laboratory that voluntarily relinquished its 
accreditation (in-whole or in-part), pursuant to Sec.  1.1163, may seek 
reaccreditation by submitting a new application for accreditation to a 
recognized accreditation body under Sec.  1.1158.

Requesting FDA Reconsideration, FDA Internal Review, or Regulatory 
Hearings of FDA Decisions Under This Subpart


Sec.  1.1171   How does an accreditation body request reconsideration 
by FDA of a decision to deny its application for recognition, renewal, 
or reinstatement?

    (a) Timing of request. An accreditation body may seek 
reconsideration of FDA's decision to deny its application for 
recognition, renewal of recognition, or reinstatement of recognition no 
later than 10 business days after the date of the issuance of such 
denial.
    (b) Submission of request. The request to reconsider an application 
under paragraph (a) of this section must be signed by the accreditation 
body, as appropriate, or by an individual authorized to act on its 
behalf. The accreditation body must submit the request to FDA 
electronically, in English, and in accordance with the procedures 
described in the notice of denial.
    (c) Notification of FDA's decision. After completing its review and 
evaluation of the request for reconsideration and any supporting 
information submitted pursuant to paragraph (b) of this section, FDA 
will notify the accreditation body of its decision to grant recognition 
upon reconsideration or deny recognition upon reconsideration.


Sec.  1.1173   How does an accreditation body or laboratory request a 
regulatory hearing on FDA's decision to revoke the recognized 
accreditation body's recognition or revoke the accredited laboratory's 
accreditation?

    (a) Request for hearing. No later than 10 business days after the 
date FDA issued a revocation of recognition of an accreditation body 
pursuant to Sec.  1.1131 or revocation of accreditation of a laboratory 
pursuant to Sec.  1.1161, the accreditation body, laboratory, or an 
individual authorized to act on the accreditation body's or 
laboratory's behalf, may submit a request for a regulatory hearing, 
conducted pursuant to part 16 of this chapter, on the revocation. The 
notice of revocation issued under Sec.  1.1131 or Sec.  1.1161, as 
applicable, will contain all the elements required by Sec.  16.22(a) of 
this chapter and will thereby constitute the notice of an opportunity 
for hearing under part 16 of this chapter.
    (b) Submission of request for regulatory hearing. The request for a 
regulatory hearing under this subpart must be submitted with a written 
appeal that responds to the bases for the FDA decision described in the 
written notice of revocation, together with any supporting information 
upon which the requestor is relying. The request, appeal, and 
supporting information must be submitted to FDA electronically, in 
English, in accordance with the procedures described in the notice of 
revocation.
    (c) Effect of submitting a request for a regulatory hearing on an 
FDA decision. The submission of a request for a regulatory hearing 
under this subpart will not operate to delay or stay the effect of a 
decision by FDA to revoke recognition of an accreditation body or 
revoke the accreditation of laboratory unless FDA determines that delay 
or a stay is in the public interest.
    (d) Presiding officer. The presiding officer for a regulatory 
hearing under this subpart will be designated after a request for a 
regulatory hearing is submitted to FDA.
    (e) Denial of a request for regulatory hearing. The presiding 
officer may deny a request for regulatory hearing under this subpart 
pursuant to Sec.  16.26(a) of this chapter when no genuine or 
substantial issue of fact has been raised.
    (f) Conduct of regulatory hearing. (1) If the presiding officer 
grants a request for a regulatory hearing, the hearing will be held 
within 10 business days after the date the request was filed or, if 
applicable, within a timeframe agreed upon in writing by the 
accreditation body, laboratory, and the presiding officer and FDA.
    (2) The presiding officer must conduct the hearing in accordance 
with part 16 of this chapter, except that, pursuant to Sec.  16.5(b) of 
this chapter, the procedures for a regulatory hearing apply only to the 
extent that such procedures are supplementary and do not conflict with 
the procedures specified for regulatory hearings under this subpart. 
Accordingly, the following requirements of part 16 of this chapter are 
inapplicable to regulatory hearings conducted under this subpart: The 
requirements of Sec.  16.22 (Initiation of a regulatory hearing); Sec.  
16.24(e) (timing) and (f) (contents of notice); Sec.  16.40 
(Commissioner); Sec.  16.60(a) (public process); Sec.  16.95(b) 
(administrative decision and record for decision); and

[[Page 59516]]

Sec.  16.119 (Reconsideration and stay of action).
    (3) A decision by the presiding officer to affirm the revocation of 
recognition or revocation of accreditation is considered a final agency 
action under 5 U.S.C. 702.


Sec.  1.1174   How does an owner or consignee request a regulatory 
hearing on a food testing order?

    (a) Request for hearing. No later than 24 hours after the time at 
which FDA issued the food testing order, an owner or consignee may 
submit a request for a regulatory hearing, conducted pursuant to part 
16 of this chapter, on the food testing order. The food testing order 
will contain all of the elements required by Sec.  16.22 of this 
chapter and will thereby constitute the notice of an opportunity for 
hearing under part 16 of this chapter.
    (b) Submission of request for regulatory hearing. The request for a 
regulatory hearing must be submitted with a written appeal that 
responds to the bases, as appropriate, for FDA's determinations 
described in the food testing order, together with any supporting 
information upon which the requestor is relying. The request, appeal, 
and supporting information must be submitted in English to the 
destination specified in such notice and in accordance with the 
procedures described therein. The request, appeal, and supporting 
information may be submitted electronically.
    (c) Presiding officer. The presiding officer for a regulatory 
hearing under this subpart will be designated after a request for a 
regulatory hearing is submitted to FDA.
    (d) Denial of a request for regulatory hearing. The presiding 
officer may deny a request for regulatory hearing under this subpart 
pursuant to Sec.  16.26(a) of this chapter.
    (e) Conduct of regulatory hearing. (1) If the presiding officer 
grants a request for a regulatory hearing, such hearing will be held 
within 2 business days after the date the request was filed or, if 
applicable, within a timeframe agreed upon in writing by the requestor 
and the presiding officer and FDA.
    (2) The presiding officer may require that a hearing conducted 
under this subpart be completed within 1 business day, as appropriate.
    (3) The presiding officer must conduct the hearing in accordance 
with part 16 of this chapter, except that, pursuant to Sec.  16.5(b) of 
this chapter, the procedures for a regulatory hearing described in part 
16 of this chapter apply only to the extent that such procedures are 
supplementary and not in conflict with the procedures specified for the 
conduct of regulatory hearings under this subpart. Accordingly, the 
following requirements of part 16 of this chapter are inapplicable to 
regulatory hearings conducted under this subpart: Sec.  16.22 
(Initiation of a regulatory hearing); Sec.  16.24(e) (timing) and (f) 
(contents of notice); Sec.  16.40 (Commissioner); Sec.  16.60(a) 
(public process); Sec.  16.95(b) (administrative decision and record 
for decision); and Sec.  16.119 (Reconsideration and stay of action).
    (4) A decision by the presiding officer to affirm the food testing 
order is considered a final agency action under 5 U.S.C. 702.

Electronic Records and Public Disclosure Requirements Under This 
Subpart


Sec.  1.1199   Are electronic records created under this subpart 
subject to the electronic records requirements of part 11 of this 
chapter?

    Records that are established or maintained to satisfy the 
requirements of this subpart and that meet the definition of electronic 
records in Sec.  11.3(b)(6) of this chapter are exempt from the 
requirements of part 11 of this chapter. Records that satisfy the 
requirements of this subpart, but that also are required under other 
applicable statutory provisions or regulations, remain subject to part 
11 of this chapter.


Sec.  1.1200   Are the records obtained by FDA under this subpart 
subject to public disclosure?

    Records obtained by FDA under this subpart are subject to the 
disclosure requirements under part 20 of this chapter.

PART 11--ELECTRONIC RECORDS; ELECTRONIC SIGNATURES

0
4. The authority citation for part 11 continues to read as follows:

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

0
5. In Sec.  11.1, add paragraph (p) to read as follows:


Sec.  11.1   Scope.

* * * * *
    (p) This part does not apply to records required to be established 
or maintained by subpart R of part 1 of this chapter. Records that 
satisfy the requirements of subpart R of part 1 of this chapter, but 
that also are required under other applicable statutory provisions or 
regulations, remain subject to this part.

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

0
6. The authority citation for 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
7. In Sec.  16.1, add the following entries in numerical order to 
paragraph (b)(2) to read as follows:


Sec.  16.1   Scope.

* * * * *
    (b) * * *
    (2) * * *
    Sec.  1.1173, relating to the revocation of recognition of an 
accreditation body, and revocation of accreditation of a laboratory, 
with respect to food testing conducted under part 1, subpart R of this 
chapter.
    Sec.  1.1174, relating to the issuance of a food testing order by 
FDA pursuant to Sec.  1.1107(a)(2).
* * * * *

PART 129--PROCESSING AND BOTTLING OF BOTTLED DRINKING WATER

0
8. The authority citation for part 129 is revised to read as follows:

    Authority:  21 U.S.C. 342, 348, 350k, 371, 374, 42 U.S.C. 264.

0
9. Amend Sec.  129.35 by revising paragraph (a)(3)(iii) to read as 
follows:


Sec.  129.35   Sanitary facilities.

* * * * *
    (a) * * *
    (3) * * *
    (iii) Analysis of the sample may be performed for the plant by 
competent commercial laboratories (e.g., Environmental Protection 
Agency (EPA) and State-certified laboratories), except that the 
analysis of the five samples from the same sampling site that 
originally tested positive for E. coli, as required by paragraph (a)(3) 
of this section, must be conducted under part 1, subpart R of this 
chapter.
* * * * *

    Dated: September 30, 2019.
Norman E. Sharpless,
Acting Commissioner of Food and Drugs.
    Dated: October 25, 2019.
Eric D. Hargan,
Deputy Secretary, Department of Health and Human Services.
[FR Doc. 2019-23870 Filed 11-1-19; 8:45 am]
 BILLING CODE 4164-01-P


