Document ID: FDA-2019-N-3325-0124
Agency: fda
Document Type: Rule
Title: Laboratory Accreditation for Analyses of Foods
Posted Date: 2021-12-03T05:00Z

[Federal Register Volume 86, Number 230 (Friday, December 3, 2021)]
[Rules and Regulations]
[Pages 68728-68831]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-25716]

[[Page 68727]]

Vol. 86

Friday,

No. 230

December 3, 2021

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, and 129

Laboratory Accreditation for Analyses of Foods; Final Rule

  Federal Register / Vol. 86, No. 230 / Friday, December 3, 2021 / 
Rules and Regulations  

[[Page 68728]]

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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: Final rule.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
amending 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 this 
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 to produce 
reliable and valid test results.

DATES: This rule is effective February 1, 2022. The incorporation by 
reference of certain publications listed in the rule is approved by the 
Director of the Federal Register as of February 1, 2022.

ADDRESSES: For access to the docket to read background documents or 
comments received, go to https://www.regulations.gov and insert the 
docket number found in brackets in the heading of this final rule into 
the ``Search'' box and follow the prompts, and/or go to the Dockets 
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 
240-402-7500.

FOR FURTHER INFORMATION CONTACT:
    With regard to the final rule: Stacie Hammack, Chemist, Food and 
Feed Laboratory Operations, Office of Regulatory Affairs, Food and Drug 
Administration, 60 8th Street NE, Atlanta, GA 30309, 301-796-5817; 
[email protected].hhs.gov.
    With regard to the information collection: Domini Bean, Office of 
Operations, Food and Drug Administration, Three White Flint North 10A-
12M, 11601 Landsdown Street, North Bethesda, MD 20852, 301-796-5733, 
[email protected].

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
    A. Purpose and Coverage of the Final Rule
    B. Summary of the Major Provisions of the Final Rule
    C. Legal Authority
    D. Costs and Benefits
II. Table of Abbreviations/Commonly Used Acronyms in This Document
III. Background
    A. Need for the Regulation
    B. Summary of Comments to the Proposed Rule
    C. General Overview of Final Rule
    D. Incorporation by Reference
IV. Legal Authority
V. Comments on the Proposed Rule and FDA's Response
    A. Introduction
    B. General Comments
    C. Comments Regarding General Provisions
    D. Comments Regarding General Requirements
    E. Comments Regarding FDA Recognition of Accreditation Bodies
    F. Comments Regarding Requirements for Recognized Accreditation 
Bodies
    G. Comments Regarding FDA Oversight of Recognized Accreditation 
Bodies
    H. Comments Regarding LAAF-Accreditation of Laboratories
    I. Comments Regarding Requirements for LAAF-Accredited 
Laboratories
    J. Comments Regarding FDA Oversight of LAAF-Accredited 
Laboratories
    K. Comments Regarding Requesting FDA Reconsideration or 
Regulatory Hearings of FDA Decisions Under This Subpart
    L. Comments Regarding Electronic Records and Public Disclosure 
Requirements
    M. Comments on Conforming and Technical Amendments and FDA 
Response
VI. Effective Date
VII. Economic Analysis of Impacts
VIII. Analysis of Environmental Impact
IX. Paperwork Reduction Act of 1995
X. Federalism
XI. Consultation and Coordination With Indian Tribal Governments
XII. References

I. Executive Summary

A. Purpose and Coverage of the Final Rule

    This rule is part of FDA's implementation of the FDA Food Safety 
Modernization Act (FSMA) (Pub. L. 111-353), through which the Agency 
intends to better protect public health by, among other things, 
adopting a modern, preventive, and risk-based approach to food safety 
regulation. In this document we establish the Laboratory Accreditation 
for Analyses of Foods (LAAF) program as required by FSMA section 
202(a), which added section 422 to the FD&C Act (21 U.S.C. 350k). Under 
the LAAF program, FDA will recognize accreditation bodies that will 
accredit laboratories to the standards established in this final rule. 
Laboratories accredited to the LAAF standard (``LAAF-accredited 
laboratories'') are authorized to conduct certain food testing as 
described in this rule.
    The program structure is portrayed in the following diagram:\1\
---------------------------------------------------------------------------

    \1\ For a description of how the program structure diagram has 
been revised, see (Response 11).

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[[Page 68729]]

[GRAPHIC] [TIFF OMITTED] TR03DE21.000

    You are subject to this rule if you are an accreditation body 
seeking recognition to accredit laboratories under this subpart, a 
recognized accreditation body, a laboratory seeking accreditation to 
conduct food testing under this subpart, or an accredited laboratory 
conducting food testing under this subpart. This rule also applies to 
owners or consignees that must have certain food testing conducted by a 
laboratory accredited under this subpart. Although participation in 
this program is voluntary for accreditation bodies and laboratories, 
only recognized accreditation bodies may accredit laboratories to 
conduct the testing of food covered under this subpart.
    This program for the testing of food by accredited laboratories 
establishes oversight, uniformity, and standards necessary to help 
ensure that the results of certain food testing of importance to public 
health are reliable and accurate. Establishing this program will 
substantially improve our capability to protect U.S. consumers from 
unsafe food.

B. Summary of the Major Provisions of the Final Rule

    This rule contains model standards that laboratories must meet in 
order to participate and conduct certain food testing covered by this 
subpart. The rule will establish a publicly available registry listing 
accreditation bodies and laboratories that have been recognized or 
accredited under this program. Results of food testing conducted by 
laboratories under the program must be sent directly to FDA. 
Laboratories accredited under this program (``LAAF-accredited 
laboratories'') are required to submit to FDA analytical reports as 
specified in this final rule.
    This rule contains eligibility requirements for accreditation 
bodies to qualify for FDA recognition and requirements that 
accreditation bodies must meet once recognized, such as requirements 
related to assessing and overseeing laboratories, conflicts of 
interest, reporting, and records. The rule contains eligibility 
requirements for laboratories to qualify for LAAF-accreditation by a 
recognized accreditation body and requirements that laboratories must 
meet once LAAF-accredited, such as requirements related to conflicts of 
interest, analysis, reporting, and records. These requirements will 
help ensure the effectiveness of the recognized accreditation bodies 
and LAAF-accredited laboratories under this program. This rule contains 
procedures we will follow to recognize accreditation bodies under this 
program and procedures for accreditation bodies to follow to LAAF-
accredit laboratories under this program. This rule contains regulatory 
procedures and requirements relating to our oversight of recognized 
accreditation bodies and LAAF-accredited laboratories.
    This rule applies when food testing is conducted in certain 
circumstances. ``Food testing'' and ``testing of food'' include the 
analysis of human or animal food, as well as testing of the food 
growing or manufacturing environment (i.e., ``environmental testing'').

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 final regulations, which outline 
requirements for participants in the program for the testing of food by 
LAAF-accredited laboratories. FDA also derives authority for these 
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.

[[Page 68730]]

D. Costs and Benefits

    The rule will require that testing of food in certain circumstances 
be performed by a laboratory that is LAAF-accredited by a recognized 
accreditation body, and for the testing results to be submitted 
directly to us. The costs of the rule primarily will be incurred by 
participating accreditation bodies, participating laboratories, shell 
egg producers, sprouts producers, bottled drinking water manufacturers, 
owners and consignees of certain import-related food, and FDA. Rarely, 
certain firms will have participating laboratories conduct tests for 
other reasons including as part of a corrective action plan after an 
order suspending registration, as part of evidence for a hearing prior 
to issuance of a mandatory recall order, as part of evidence for an 
appeal of an administrative detention order, and as required under a 
directed food laboratory order (formerly, a food testing order). We 
will incur costs to, among other things, establish and maintain the 
program for recognizing accreditation bodies that apply to participate 
in our program, evaluate participating accreditation bodies and review 
the performance of participating laboratories, and review associated 
documents and reports. The present value of the costs of the rule 
ranges from $38 million to $66 million when discounted by 7 percent 
over 10 years and from $43 million to $77 million when discounted by 3 
percent over 10 years. Annualized costs over 10 years range from $5.8 
million to $9.6 million when discounted by 7 percent, and from $5.9 
million to $9.7 million when discounted by 3 percent.
    The rule will generate some quantified and unquantified benefits. 
Quantified benefits include a reduction in the number of foodborne 
illnesses from fewer false negative test results for import-related 
food covered under the rule and for shell eggs, sprouts, and bottled 
drinking water testing covered under the rule. We anticipate cost 
savings from the clarification of the process for compiling, 
submitting, and reviewing analytical reports for import-related food 
covered under this rule, including reduced reporting burden. There 
would be less revenue lost from fewer false positive test results for 
import-related food covered under the rule and for tests of shell eggs, 
sprouts, and bottled drinking water testing covered under the rule. The 
present value of the benefits of the rule ranges from $46 million to 
$88 million when discounted at 7 percent over 10 years and ranges from 
$56 million to $106 million when discounted at 3 percent over 10 years. 
Annualized benefits over 10 years range from $6.6 million to $12.5 
million when discounted by both 7 and 3 percent.

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

------------------------------------------------------------------------
       Abbreviation/acronym                     What it means
------------------------------------------------------------------------
AAVLD.............................  American Association of Veterinary
                                     Laboratory Diagnosticians.
ANSI..............................  American National Standards
                                     Institute.
AOAC..............................  AOAC International.
APA...............................  Administrative Procedure Act.
CFR...............................  Code of Federal Regulations.
CPSC..............................  Consumer Product Safety Commission.
CVM...............................  Center for Veterinary Medicine.
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.
FOIA..............................  Freedom of Information Act.
FR................................  Federal Register.
FRIA..............................  Final Regulatory Impact Analysis.
FSMA..............................  FDA Food Safety Modernization Act.
FSVP..............................  Foreign Supplier Verification
                                     Program.
HACCP.............................  Hazard Analysis and Critical Control
                                     Point.
IBR...............................  Incorporation by Reference.
IEC...............................  International Electrotechnical
                                     Commission.
ILAC..............................  International Laboratory
                                     Accreditation Cooperation.
IOM...............................  Investigations Operations Manual.
ISO...............................  International Organization for
                                     Standardization.
LAAF..............................  Laboratory Accreditation for
                                     Analyses of Foods.
MRA...............................  Mutual Recognition Arrangement.
NIST..............................  National Institute of Standards and
                                     Technology.
NRTE..............................  Not Ready to Eat.
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 of 1995.
PRIA..............................  Preliminary Regulatory Impact
                                     Analysis.
SAHCODHA..........................  Serious Adverse Health Consequences
                                     or Death to Humans or Animals.
U.S.C.............................  United States Code.
Vet-LIRN..........................  Veterinary Laboratory Investigation
                                     and Response Network.
WTO...............................  World Trade Organization.
------------------------------------------------------------------------

[[Page 68731]]

III. Background

A. Need for the Regulation

    FSMA is transforming the nation's food safety system by shifting 
the focus from responding to foodborne illness to preventing it. 
Congress enacted FSMA in response to dramatic changes in the global 
food system and in our understanding of foodborne illness and its 
consequences, including the realization that preventable foodborne 
illness is both a significant public health problem and a threat to the 
economic well-being of the food system. FSMA 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 this 
program for food testing by accredited laboratories.
    FSMA, in establishing section 422 of the FD&C Act, 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 laboratories accredited to the standards we are establishing 
in this final rule 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 
(Secretary), 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 that requires 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.
    Direct receipt of food testing results in these circumstances is of 
particular importance to the Agency and to public health. This rule 
applies 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 directed food 
laboratory orders that we will issue ``as required by the Secretary, as 
the Secretary deems appropriate, to address an identified or suspected 
food safety problem.'' Further, owners and consignees often engage 
private laboratories to test their food products 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. 
We use the detention without physical examination (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. Concerns periodically have 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. 1, pages 26-34 and 137-
140).

B. Summary of Comments to the Proposed Rule

    We published a proposed rule for ``Laboratory Accreditation for 
Analyses of Foods'' (the proposed rule) in the Federal Register on 
November 4, 2019 (84 FR 59452). The comment period was extended twice 
(85 FR 11893 (February 28, 2020); 85 FR 19114 (April 6, 2020)). Upon 
close of the comment period on July 6, 2020, we had received 
approximately 70 comment submissions that covered almost every aspect 
of the proposed rule.

C. General Overview of the Final Rule

    We have made changes in the final rule in response to public 
comments; these changes are discussed in greater detail in section V 
below. Additionally, we have revised the final rule to improve clarity 
and readability. We also have reorganized the final rule as described 
in the following table.

     Table 1--Summary of Section Numbering Changes in the Final Rule
------------------------------------------------------------------------
               Final rule                         Proposed rule
------------------------------------------------------------------------
           General provisions                   General provisions
------------------------------------------------------------------------
Sec.   1.1101 What documents are         N/A.
 incorporated by reference in this
 subpart?
Sec.   1.1102 What definitions apply to  Sec.   1.1102 What definitions
 this subpart?.                           apply to this subpart?
Sec.   1.1103 Who is subject to this     Sec.   1.1103 Who is subject to
 subpart?.                                this subpart?
------------------------------------------------------------------------
          General Requirements             General Requirements of this
                                                      Subpart
------------------------------------------------------------------------
Sec.   1.1107 When must food testing be  Sec.   1.1107 Under what
 conducted under this subpart?.           circumstances must food
                                          testing be conducted under
                                          this subpart by an accredited
                                          laboratory?
Sec.   1.1108 When and how will FDA      Sec.   1.1108 When and how will
 issue a directed food laboratory         FDA issue a food testing
 order?                                   order?
Sec.   1.1109 How will FDA make          Sec.   1.1109 How will FDA make
 information about recognized             information about recognized
 accreditation bodies and LAAF-           accreditation bodies and
 accredited laboratories available to     accredited laboratories
 the public?                              available to the public?

[[Page 68732]]

 
Sec.   1.1110 What are the general       N/A.
 requirements for submitting
 information to FDA under this subpart?
------------------------------------------------------------------------
FDA Recognition of Accreditation Bodies    Recognition of Accreditation
                                                      Bodies
------------------------------------------------------------------------
Sec.   1.1113 What are the eligibility   Sec.   1.1113 What requirements
 requirements for a recognized            must an accreditation body
 accreditation body?                      meet to be recognized by FDA?
                                         Sec.   1.1118 What are the
                                          general requirements for
                                          recognized accreditation
                                          bodies to remain recognized?
Sec.   1.1114 How does an accreditation  Sec.   1.1128 How does an
 body apply to FDA for recognition or     accreditation body apply to
 renewal of recognition?                  FDA for recognition or renewal
                                          of recognition?
Sec.   1.1115 How will FDA evaluate      Sec.   1.1129 How will FDA
 applications for recognition and         review applications for
 renewal of recognition?                  recognition and applications
                                          for renewal of recognition?
Sec.   1.1116 What must a recognized     Sec.   1.1132 What must a
 accreditation body do to voluntarily     recognized accreditation body
 relinquish or not renew its              do if it wants to voluntarily
 recognition?                             relinquish its recognition or
                                          does not want to renew its
                                          recognition?
Sec.   1.1117 How may an accreditation   Sec.   1.1133 How does an
 body request reinstatement of            accreditation body request
 recognition?                             reinstatement of recognition?
------------------------------------------------------------------------
      Requirements for Recognized          Requirements for Recognized
          Accreditation Bodies                 Accreditation Bodies
------------------------------------------------------------------------
N/A--(contents combined with Sec.        Sec.   1.1118 What are the
 1.1113).                                 general requirements for
                                          recognized accreditation
                                          bodies to remain recognized?
Sec.   1.1119 What are the conflict of   Sec.   1.1119 What requirements
 interest requirements for a recognized   apply to how a recognized
 accreditation body?                      accreditation body must
                                          protect against conflicts of
                                          interests?
Sec.   1.1120 How must a recognized      Sec.   1.1120 How must a
 accreditation body assess laboratories   recognized accreditation body
 seeking LAAF-accreditation and oversee   evaluate laboratories seeking
 LAAF-accredited laboratories?            accreditation and oversee the
                                          performance of laboratories it
                                          accredits?
Sec.   1.1121 When must a recognized     Sec.   1.1121 What appeal
 accreditation body require corrective    procedures must a recognized
 action, suspend a LAAF-accredited        accreditation body provide for
 laboratory, reduce the scope of or       appeals of decisions to not
 withdraw the LAAF-accreditation of a     grant accreditation?
 laboratory?                             Sec.   1.1122(h) Appeals
                                          procedures.
Sec.   1.1122 What procedures must a     Sec.   1.1122 When must a
 recognized accreditation body provide    recognized accreditation body
 for appeals of decisions to suspend,     withdraw or reduce the scope
 reduce the scope of, withdraw, or deny   of the accreditation of a
 LAAF-accreditation?                      laboratory, and when may a
                                          recognized accreditation body
                                          put an accredited laboratory
                                          on probation?
Sec.   1.1123 What reports,              Sec.   1.1123 What reports and
 notifications, and documentation must    notifications must a
 a recognized accreditation body submit   recognized accreditation body
 to FDA?                                  submit to FDA?
Sec.   1.1124 What are the records       Sec.   1.1124 What records
 requirements for a recognized            requirements must a recognized
 accreditation body?                      accreditation body meet?
Sec.   1.1125 What are the internal      Sec.   1.1125 What internal
 audit requirements for a recognized      audit requirements must a
 accreditation body?                      recognized accreditation body
                                          meet?
------------------------------------------------------------------------
      FDA Oversight of Recognized         Procedures for Recognition of
          Accreditation Bodies                 Accreditation Bodies
------------------------------------------------------------------------
Sec.   1.1130 How will FDA oversee       Sec.   1.1130 How will FDA
 recognized accreditation bodies?.        oversee recognized
                                          accreditation bodies?
Sec.   1.1131 When will FDA require      Sec.   1.1131 When will FDA
 corrective action, put a recognized      revoke the recognition of an
 accreditation body on probation, or      accreditation body or put a
 revoke the recognition of an             recognized accreditation body
 accreditation body?                      on probation?
------------------------------------------------------------------------
   LAAF-Accreditation of Laboratories     Accreditation of Laboratories
------------------------------------------------------------------------
Sec.   1.1138 What are the eligibility   Sec.   1.1138 What requirements
 requirements for a LAAF-accredited       must a laboratory meet to
 laboratory?                              become accredited by a
                                          recognized accreditation body?
                                         Sec.   1.1146 What are the
                                          general requirements for
                                          accredited laboratories to
                                          remain accredited?
Sec.   1.1139 How does a laboratory      Sec.   1.1158 How does a
 apply for LAAF-accreditation or extend   laboratory apply for
 its scope of LAAF-accreditation?         accreditation or modification
                                          of its scope of accreditation
                                          by a recognized accreditation
                                          body?
Sec.   1.1140 What must a LAAF-          Sec.   1.1163 What if a
 accredited laboratory do to              laboratory wants to
 voluntarily relinquish its LAAF-         voluntarily relinquish its
 accreditation?                           accreditation?
Sec.   1.1141 What is the effect on a    Sec.   1.1164 What is the
 LAAF-accredited laboratory if its        effect on accredited
 recognized accreditation body is no      laboratories if their
 longer recognized by FDA?                accreditation body voluntarily
                                          or involuntarily loses its
                                          recognition?
Sec.   1.1142 How does a laboratory      Sec.   1.1165 How does a
 request reinstatement of LAAF-           laboratory request
 accreditation?                           reinstatement of
                                          accreditation?
------------------------------------------------------------------------
    Requirements for LAAF-Accredited       Requirements for Accredited
              Laboratories                         Laboratories
------------------------------------------------------------------------
Content added to Sec.   1.1138.........  Sec.   1.1146 What are the
                                          general requirements for
                                          accredited laboratories to
                                          remain accredited?
Sec.   1.1147 What are the impartiality  Sec.   1.1147 What impartiality
 and conflict of interest requirements    and conflict of interest
 for a LAAF-accredited laboratory?        requirements must accredited
                                          laboratories meet?

[[Page 68733]]

 
Content moved to Sec.   1.1138.........  Sec.   1.1148 What quality
                                          assurance requirements must
                                          accredited laboratories meet?
Sec.   1.1149 What oversight standards   Sec.   1.1149 What oversight
 apply to sampling?.                      standards apply to sampling?
Sec.   1.1150 What are the requirements  Sec.   1.1150 What requirements
 for analysis of samples by a LAAF-       apply to analysis of samples
 accredited laboratory?                   by an accredited laboratory?
Sec.   1.1151 What requirements apply    Sec.   1.1151 What requirements
 to the methods of analysis a LAAF-       apply to the methods of
 accredited laboratory uses to conduct    analysis an accredited
 food testing under this subpart?         laboratory uses to conduct
                                          food testing under this
                                          subpart?
Sec.   1.1152 What notifications,        Sec.   1.1152 What
 results, reports, and studies must a     notifications, results, and
 LAAF-accredited laboratory submit to     reports must accredited
 FDA?                                     laboratories submit to FDA?
Sec.   1.1153 What are the requirements  N/A.
 for submitting abridged analytical
 reports?
Sec.   1.1154 What other records         Sec.   1.1153 What other
 requirements must a LAAF-accredited      records requirements must an
 laboratory meet?                         accredited laboratory meet?
------------------------------------------------------------------------
    FDA Oversight of LAAF-Accredited     Procedures for Accreditation of
              Laboratories                         Laboratories
------------------------------------------------------------------------
Sec.   1.1159 How will FDA oversee LAAF- Sec.   1.1159 How will FDA
 accredited laboratories?.                oversee accredited
                                          laboratories?
Sec.   1.1160 How will FDA review test   Sec.   1.1160 How will FDA
 results and analytical reports?.         review submitted test results
                                          and analytical reports?
Sec.   1.1161 When will FDA require      Sec.   1.1161 When will FDA put
 corrective action, put a LAAF-           an accredited laboratory on
 accredited laboratory on probation, or   probation or revoke the
 disqualify a LAAF-accredited             accreditation of a laboratory?
 laboratory from submitting analytical
 reports?
Sec.   1.1162 What are the consequences  Sec.   1.1162 What are the
 if FDA puts a LAAF-accredited            consequences if FDA puts an
 laboratory on probation or               accredited laboratory on
 disqualifies a LAAF-accredited           probation or revokes the
 laboratory?                              accreditation of a laboratory?
------------------------------------------------------------------------
   Requesting FDA Reconsideration or     Requesting FDA Reconsideration,
  Regulatory Hearings of FDA Decisions        FDA Internal Review, or
           Under This Subpart               Regulatory Hearings of FDA
                                           Decisions Under This Subpart
------------------------------------------------------------------------
Sec.   1.1171 How does an accreditation  Sec.   1.1171 How does an
 body request reconsideration by FDA of   accreditation body request
 a decision to deny its application for   reconsideration by FDA of a
 recognition, renewal, or                 decision to deny its
 reinstatement?                           application for recognition,
                                          renewal, or reinstatement?
Sec.   1.1173 How does an accreditation  Sec.   1.1173 How does an
 body or laboratory request a             accreditation body or
 regulatory hearing on FDA's decision     laboratory request a
 to revoke the accreditation body's       regulatory hearing on FDA's
 recognition or disqualify a LAAF-        decision to revoke the
 accredited laboratory?                   recognized accreditation
                                          body's recognition or revoke
                                          the accredited laboratory's
                                          accreditation?
Sec.   1.1174 How does an owner or       Sec.   1.1174 How does an owner
 consignee request a regulatory hearing   or consignee request a
 on a directed food laboratory order?     regulatory hearing on a food
                                          testing order?
------------------------------------------------------------------------
     Electronic Records and Public        Electronic Records and Public
        Disclosure Requirements            Disclosure Requirements under
                                                   This Subpart
------------------------------------------------------------------------
Sec.   1.1199 Are electronic records     Sec.   1.1199 Are electronic
 created under this subpart subject to    records created under this
 the electronic records requirements of   subpart subject to the
 part 11 of this chapter?                 electronic records
                                          requirements of part 11 of
                                          this chapter?
Sec.   1.1200 Are the records obtained   Sec.   1.1200 Are the records
 by FDA under this subpart subject to     obtained by FDA under this
 public disclosure?                       subpart subject to public
                                          disclosure?
------------------------------------------------------------------------

    Also, in one location in the proposed rule we inadvertently 
misstated the title of this subpart (the third codified instruction, 84 
FR 59452 at 59501). Throughout the final rule we correctly state the 
subpart title (``Laboratory Accreditation for Analyses of Foods'').

D. Incorporation by Reference

    FDA is incorporating by reference two consensus standards, which 
were approved by the Office of the Federal Register in accordance with 
5 U.S.C. 552(a) and 1 CFR part 51. Both standards are widely accepted 
globally. The consensus standards may be examined at FDA's Dockets 
Management Staff (see ADDRESSES).
    The standards listed below are available for purchase from the 
International Organization for Standardization (ISO), Chemin de 
Blandonnet 8, CP 401, 1214 Vernier, Geneva, Switzerland, +41 22 749 01 
11, [email protected] (https://www.iso.org/store.html) or from any other 
source from which the user is assured that the copy to be received is 
an accurate version of the standard.
    ISO/IEC 17011:2017, Conformity assessment--Requirements for 
accreditation bodies accrediting conformity assessment bodies, Second 
edition, November 2017 (Ref. 2). ISO/IEC 17011:2017 specifies the 
general standards 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). Its 
incorporation by reference should allow us to use a framework that is 
familiar to accreditation bodies and the laboratory industry.
    ISO/IEC 17025:2017, General requirements for the competence of 
testing and calibration laboratories, Third edition, November 2017 
(Ref. 3). ISO/IEC 17025:2017 sets general standards for the competence 
of testing laboratories, including general management requirements such 
as impartiality and quality assurance. It is

[[Page 68734]]

very familiar to the testing laboratories that may be interested in 
applying to conduct food testing under this subpart.

IV. Legal Authority

    We are issuing this final 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 final rule will allow FDA 
to efficiently enforce section 422 of the FD&C Act. Thus, our legal 
authority for this final 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, 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.
    Section 379j-31 of the FD&C Act (21 U.S.C. 743) is one of many 
statutory provisions that provide authority for FDA's regulations 
contained in part 1 (21 CFR part 1). We inadvertently omitted that 
citation from the authority citation in the proposed rule, but have 
included it in the final rule.

V. Comments on the Proposed Rule and FDA Response

A. Introduction

    We received approximately 70 comment submissions on the proposed 
rule by the close of the comment period, each containing one or more 
comments on one or more issues. We received comments from consumers, 
food associations, accreditation bodies, laboratory associations, 
laboratories, consumer groups, and other organizations.
    In the remainder of this document, we describe the comments that 
are within the scope of this rulemaking, respond to them, and explain 
any revisions we made to the proposed rule.
    We have numbered each comment to help distinguish between different 
comments. We have grouped similar comments together under the same 
number, and, in some cases, we have separated different issues 
discussed in the same comment and designated them as distinct comments 
for purposes of our responses. The number assigned to each comment or 
comment topic is purely for organizational purposes and does not 
signify the comment's value or importance or the order in which 
comments were received.
    Note that summaries of and responses to comments on the estimated 
costs and benefits of the proposed rule and other topics covered by the 
Preliminary Regulatory Impact Analysis (PRIA) may be found in the Final 
Regulatory Impact Analysis (FRIA) (Ref. 4).

B. General Comments

    Many comments made general remarks supporting or opposing the 
proposed rule without focusing on a particular proposed provision. 
Further, several comments made overarching comments that pertain to the 
rule more generally, focusing on issues throughout the rule such as 
program structure, FDA's role, terminology, and implementation. In the 
following paragraphs, we discuss and respond to such general comments.
    (Comment 1) We received many comments expressing general support 
for the proposed rule, most expressing the view that the LAAF program 
would help to ensure the safety of food. Some of these comments stress 
the importance of accurate and reliable food testing results, and the 
role of valid results in enhancing food safety. Some comments focus on 
the advantages of setting quality standards and establishing 
accountability for food testing laboratories. Some comments opine that 
the laboratory accreditation program will increase U.S. consumer 
confidence in the safety of the food supply. Other comments maintain 
that the program will result in fewer illnesses, thus reducing 
healthcare costs. Other comments express support for implementation of 
FSMA section 202 and the underlying goals of the laboratory 
accreditation program, e.g., improved safety of imported food, 
trustworthy testing results. A few comments opine that the rule would 
lead to more efficient food imports by clarifying what information 
needs to be in a laboratory analytical report, which should in turn 
expedite FDA review of those reports. These comments assert that such 
efficiencies are particularly valuable when the imported food is 
perishable, such as produce. Some of these comments further suggest 
that a more efficient review process for FDA could allow FDA to focus 
its limited resources on imports that generally are not subject to 
testing under this subpart.
    (Response 1) We appreciate the comments in support of the proposed 
rulemaking and moving forward to implement the LAAF program. We agree 
that the program established by the final rule will help ensure the 
safety of food and should increase U.S. consumer confidence in the food 
supply. We also agree that requiring analyses to be performed by LAAF-
accredited laboratories that meet the standards set forth in the final 
rule will make tests consistently more accurate and prevent illnesses. 
Further, setting model standards for LAAF-accredited laboratories will 
improve the reliability and accountability of test results on which we 
rely to make regulatory decisions regarding certain foods.
    We agree with comments predicting fewer illnesses as a result of 
this final rule. For additional discussion of the cost benefit analysis 
associated with this final rule, see section VII. We also agree there 
will be efficiencies gained for industry and FDA from clarifying the 
requirements in an analytical report and from the process that allows 
submission of abridged analytical reports.
    (Comment 2) Some comments question whether the LAAF program 
established by this final rule would make a food safety impact because 
only a small fraction of food testing laboratories are likely to 
participate.
    (Response 2) Although the laboratory accreditation rule does not 
set mandatory standards for all food testing laboratories, the program 
will make an important difference for the food testing subject to the 
rule, as the testing situations covered by the rule all involve 
heightened food safety concerns. Therefore, the food testing covered by 
the rule addresses the specific circumstances in which accurate and 
reliable test results are especially important to protect public 
health. We also anticipate that some owners or consignees who are not 
covered by the rule may choose to use a LAAF-accredited laboratory 
because these laboratories will have met the program standards; this 
would create a benefit incidental to the program. Finally, we expect 
that creating model laboratory standards based on ISO/IEC 17025:2017 
accreditation may encourage other laboratories to work toward these 
standards, including accreditation.
    (Comment 3) Some comments are generally supportive of the proposed 
rule but state that FDA already regulates food safety, and because it 
is unclear how much safer food would be as a result of the proposed 
rule, the resources necessary for this program may be better spent 
elsewhere. A subset

[[Page 68735]]

of these comments states that the proposed rule would make food safety 
regulations more complicated for small food businesses and would also 
burden small food businesses with additional costs.
    (Response 3) As described in section 422 of the FD&C Act, this 
final rule will establish a program for the accreditation of 
laboratories the use of which will be required in certain circumstances 
where heightened food safety concerns exist. We estimate the benefits 
outweigh the costs of the rule. For additional information on the 
estimated costs and benefits of this final rule, see section VII and 
the FRIA (Ref. 4). As mentioned in the preceding response, there may be 
other benefits incidental to the LAAF program.
    Some comments express concern that this rule may complicate the 
regulatory landscape for small business owners and consignees that are 
also subject to other food safety regulations. It is true that some 
small owners and consignees will be required to use a LAAF-accredited 
laboratory for the testing described in Sec.  1.1107. However, this 
rule does not create new testing requirements; it merely requires 
certain tests that are already occurring to be conducted by a LAAF-
accredited laboratory. Further, in some cases the regulation creating 
the underlying testing requirement addresses this issue in its 
application to small businesses. For example, Sec.  1.1107(a)(1)(ii) 
provides that certain shell egg tests required by the egg safety rule 
(see part 118 (21 CFR part 118)) are covered by this final rule. 
However, the egg safety rule does not apply to producers with less than 
3,000 laying hens at a particular farm (see Sec.  118.1(a)). 
Accordingly, those small egg producers are unaffected by this provision 
of the final rule. We also expect that the online registry of LAAF-
accredited laboratories, described in Sec.  1.1109, will make it easy 
for all owners and consignees to locate laboratories LAAF-accredited to 
conduct the tests covered by this subpart.
    Regarding the concern that this final rule will burden small owners 
and consignees with additional costs, see the discussion below in 
section VII and the FRIA (Ref. 4).
    (Comment 4) Some comments express support for specific aspects of 
the proposed rule, including the provisions protecting against 
conflicts of interest, and state that the program would improve 
transparency and consistency in the food testing that falls within its 
scope. Some comments contend that there have been situations in which a 
food is described in terms such as ``safe'' based on biased testing 
conducted by the food's producer.
    (Response 4) We appreciate the supportive comments regarding the 
conflict of interest provisions. FDA anticipates that the model 
laboratory standards being established in this final rule, as well as 
the program requirements for LAAF-accreditation of laboratories by 
recognized accreditation bodies, will increase the reliability of tests 
conducted under this subpart. Ensuring that both accreditation bodies 
and laboratories are free from conflicts of interest is critical to the 
integrity of food testing conducted under this subpart. For more 
information on the conflict of interest requirements applicable to 
recognized accreditation bodies, see the discussion of Sec.  1.1119 
below; for more information on the conflict of interest requirements 
applicable to LAAF-accredited laboratories, see the discussion of Sec.  
1.1147 below.
    (Comment 5) Some comments support the establishment of laboratory 
standards and appreciate the transparency of the public registry that 
will list recognized accreditation bodies and LAAF-accredited 
laboratories but express concern that laboratories would conform to the 
standards only while being actively monitored by the Agency. These 
comments encourage the Agency to address this risk.
    (Response 5) We acknowledge a hypothetical risk that LAAF-
accredited laboratories might conform to standards only while being 
actively monitored by FDA; however, we believe that the model 
laboratory standards and reporting requirements we are establishing in 
this final rule, as well as oversight of LAAF-accredited laboratories 
by both recognized accreditation bodies and FDA, will adequately 
address this risk. For example, under this subpart, FDA will recognize 
accreditation bodies that will LAAF-accredit laboratories to conduct 
certain testing of food under this subpart. Recognized accreditation 
bodies' assessment of LAAF-accredited laboratories involves onsite and 
remote assessments as described in Sec.  1.1120 of the rule. FDA may 
conduct an onsite or remote review of a LAAF-accredited laboratory at 
any reasonable time to review performance (see Sec.  1.1159(c)). LAAF-
accredited laboratories must submit quality control results with each 
analytical report (see Sec. Sec.  1.1152(d)(8), 1.1153(c)(2)), so FDA 
will be able to review the quality control results to ensure that 
methods are performed correctly. Further, for LAAF-accredited 
laboratories that submit abridged analytical reports, FDA may audit 
these reports by requesting that additional documentation or a full 
analytical report be submitted within 72 hours of the request (see 
Sec.  1.1153(d)(2)).
    In sum, in this final rule, FDA is establishing requirements for 
accreditation bodies and laboratories that will provide sufficient 
oversight of LAAF-accredited laboratories such that we expect 
consistent quality test results to be the norm.
    (Comment 6) A few comments philosophically disagree with defining 
and regulating food at all, and thus oppose the establishment of a 
program to require any laboratory testing of food.
    (Response 6) Congress defined ``food'' in section 201(f) of the 
FD&C Act (21 U.S.C. 321(f)) and by statute has authorized FDA to 
regulate food, including in section 422 of the FD&C Act, which directs 
FDA to establish this program.
    (Comment 7) Some comments ask what effect the final rule will have 
on existing food testing laboratories. Other comments express a concern 
that some individuals may perceive that test results from laboratories 
not participating in the LAAF program are suspect or less valuable.
    (Response 7) Food testing laboratories are not required to 
participate in this program; however, owners and consignees will be 
required to use a LAAF-accredited laboratory for the food testing 
covered by this rule, such as testing to support removal from import 
alert and the shell egg testing required by part 118 (see Sec.  
1.1107). Laboratories that wish to conduct the food testing covered by 
this rule will need to apply to a recognized accreditation body and 
must satisfy the standards established in this final rule in order to 
voluntarily participate in the program. A LAAF-accredited laboratory 
engaged by an owner or consignee to conduct the food testing covered by 
this final rule will conduct the test and send the results directly to 
FDA, in accordance with the requirements of this subpart.
    Food testing laboratories that do not wish to conduct the testing 
described in Sec.  1.1107 are not required to participate in the 
program.
    We do not expect this program to decrease confidence in food 
laboratories that choose not to become LAAF-accredited, in part due to 
the very large number of food testing laboratories that exist and 
conduct all sorts of food testing for myriad customers and purposes. We 
view the program as beneficial to the food testing industry, as an 
explicit goal of the statute is to increase the number of qualified 
food testing laboratories. See section 422(a)(3) of the FD&C Act.

[[Page 68736]]

    (Comment 8) Some comments advocate for expanded roles for the 
laboratories that participate in this program. Some of these comments 
suggest that LAAF-accredited laboratories could conduct tests for FDA's 
surveillance sampling program and argue that sufficient capacity exists 
in the United States for ISO/IEC 17025:2017-accredited laboratories to 
conduct all DWPE and FDA surveillance sampling and testing. Under the 
surveillance sampling program, FDA focuses its sampling and testing 
efforts on a few commodities at a time with the goals of keeping 
contaminated products from reaching consumers and facilitating a 
greater understanding of hazards. For more information on FDA's 
surveillance sampling, see https://www.fda.gov/food/sampling-protect-food-supply/microbiological-surveillance-sampling. These comments also 
suggest that FDA should create a program whereby private laboratories 
meet the standards of FDA laboratories, such that FDA could rely on 
those private laboratories for its testing needs and therefore focus 
its resources elsewhere. Finally, these comments suggest that 
independent accredited laboratories could also conduct sampling and 
testing on imported food, most of which is not sampled and tested by 
FDA prior to entry.
    (Response 8) This final rule establishes the LAAF program, the 
scope of which is specified in FD&C Act section 422(b)(1) and described 
in Sec.  1.1107. All the tests that will be conducted by LAAF-
accredited laboratories are currently being conducted by non-FDA 
laboratories (e.g., private laboratories). Expanding the scope of this 
program to include testing currently conducted by FDA laboratories, 
such as surveillance sampling, was not proposed because it is not 
contemplated by the statute. Any future expansion of this program will 
be accomplished via rulemaking and will include an opportunity for 
public comment.
    (Comment 9) Some comments offer general support for this subpart, 
stating that it will improve the defensibility of the resulting test 
data by ensuring that all participating laboratories operate in 
accordance with a robust quality management system. These comments 
suggest that as we continue to develop the LAAF program, we consider 
two documents that were developed to improve the defensibility of human 
and animal food laboratory data: The Partnership for Food Protection 
document, ``Human and Animal Food Testing Laboratories Best Practices 
Manual,'' (Ref. 5) and the Association for Public Health Laboratories 
document, ``Best Practices for Submission of Actionable Human and 
Animal Food Testing Data Generated in State and Local Laboratories'' 
(Ref. 6). The former document is based on ISO/IEC 17025:2017 and its 
purpose is to ``promote mutual acceptance and assurance of quality 
laboratory data shared among Federal, State, local, territorial, and 
tribal human and animal food regulatory agencies.'' (Ref. 5). The 
latter document, focused on unaccredited laboratories, provides 
information on the minimum elements of a quality management system.
    (Response 9) FDA appreciates this support and information. As an 
active member of the Partnership for Food Protection initiative, FDA is 
particularly familiar with the former document. We consider both 
documents to be helpful resources for the intended audiences.
1. FDA's Role and Related Terminology
    In the proposed rule, FDA sought to define ``accreditation'' to 
mean, ``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'' 
(emphasis added). We then proceeded to use the word ``accreditation'' 
to mean that a laboratory had been approved to conduct testing under 
this subpart. For example, we wrote that the proposed rule ``would 
establish certain model laboratory standards that accredited 
laboratories must meet to remain accredited'' (84 FR 59452 at 59478). 
By way of another example, we wrote that the proposed provision on 
duration of accreditation under this subpart, ``clarifies that an 
accredited laboratory's accreditation continues'' until there is a 
voluntary or involuntary separation from the program (id. at 59489).
    Consequently, when we used phrases such as, ``FDA may revoke 
accreditation,'' we intended to communicate that FDA could cause the 
involuntary separation of a laboratory from this program. For example, 
we wrote that ``if we revoke the accreditation in whole of a 
laboratory, the laboratory would be immediately ineligible to conduct 
food testing under this rule'' (id. at 59491).
    We did not propose to define the term ``assess.'' However, we 
generally used it interchangeably with ``evaluate.'' For example, we 
entitled one section, ``[h]ow must a recognized accreditation body 
evaluate laboratories seeking accreditation and oversee the performance 
of laboratories it accredits?'' (Proposed Sec.  1.1120, 84 FR 59452 at 
59469). By way of additional examples, we also wrote, ``[a]s 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'' (id. at 59476); we said it was critical that we 
receive sufficient supporting information ``for us to understand the 
test results and to assess the validity of the underlying testing'' 
(id. at 59482) and we asserted authority to ``exercise some ability to 
oversee accredited laboratories, via requesting records and, if 
appropriate, conducting onsite assessments'' (id. at 59490).
    (Comment 10) Numerous comments request that FDA address and clarify 
the roles and relationships among the Agency, recognized accreditation 
bodies, and LAAF-accredited laboratories under this subpart.
    Several comments contend that the Agency should not use the words 
``assess'' or ``accredit'' to describe Agency actions toward 
laboratories. Similarly, comments argued that FDA could not revoke a 
laboratory's ``accreditation.'' We understand several comments to be 
suggesting that the words ``accredit'' and ``assess'' have particular 
meaning in the accreditation body and laboratory community, and in the 
context of food testing, that meaning is always and necessarily related 
to the voluntary consensus standard ISO/IEC 17025:2017. For example, 
some comments state that FDA should limit its onsite ``assessments'' of 
laboratories to matters pertaining to this subpart. Comments explain 
that failure by FDA to use key terms as they are understood in the 
industry will lead to market confusion, e.g., regarding the ISO/IEC 
17025:2017 accreditation status of laboratories.
    Some comments express concern that FDA may be under the impression 
that it can affect the ISO/IEC 17025:2017 accreditation of 
laboratories, either by ``assessing'' against the ISO/IEC 17025:2017 
standard or by withdrawing a laboratory's ISO/IEC 17025:2017 
accreditation. Comments argue that such a role is contrary to the 
Congressional intent underlying section 422 of the FD&C Act. Comments 
state that Congress did not intend for FDA to be an accreditation body. 
Some comments contend that FDA's role in the rule as proposed would be 
redundant of or ``above'' the role of the recognized accreditation 
bodies. Some comments express concern that FDA would be able to coerce 
a recognized accreditation body into withdrawing a laboratory's ISO/IEC 
17025:2017 accreditation.

[[Page 68737]]

    Some comments suggest that FDA's role should be administering a 
program that evaluates data or program integrity. Some comments suggest 
that FDA reframe its relationship with the laboratories in terms of an 
agreement to list and de-list the laboratories on our online registry. 
Some comments recommend that FDA grant each laboratory a license to 
conduct testing under this subpart. In this framework, comments state 
that FDA's role with regard to the laboratories would be limited to the 
review of test results and analytical reports submitted to FDA by the 
laboratories. Some comments suggest that FDA should perform some level 
of review, even if brief, of laboratory applications approved by 
recognized accreditation bodies. Finally, some comments offer to work 
with FDA to more clearly define roles and responsibilities under this 
program.
    (Response 10) We agree that substantial revisions and considerable 
clarification are in order.
    In proposing to define ``accreditation,'' to reflect a positive 
assessment by a recognized accreditation body under this subpart, we 
failed to sufficiently appreciate that in the context of food testing, 
many parties may perceive ``accreditation,'' to mean accreditation to 
ISO/IEC 17025:2017. Similarly, when we used the word, ``assess,'' we 
did not intend to communicate, ``assess against ISO/IEC 17025:2017.'' 
Instead, we used the word as consistent with its more general use: The 
Cambridge Dictionary defines ``assess'' as, ``to judge or decide the 
amount, value, quality, or importance of something.'' (Ref. 7).
    Accordingly, it was not our intent to communicate that FDA had the 
authority to assess laboratories against the ISO/IEC 17025:2017 
standard. For example, when we said in the proposed rule that we had 
the authority to conduct an ``onsite assessment'' of a laboratory 
participating in this program, we did not mean that our visit would be 
for the purpose of assessing against ISO/IEC 17025:2017. Nor did we 
intend to communicate that we had the authority to withdraw ISO/IEC 
17025:2017 accreditation, or to pressure or demand an accreditation 
body to take such an action. We agree such a role would not be 
appropriate or consistent with section 422 of the FD&C Act.
    To communicate our intent more effectively, we have taken several 
steps. First, we removed the definition of ``accreditation'' and no 
longer refer to laboratories that have been approved by a recognized 
accreditation body to conduct testing under this subpart as merely 
``accredited.'' Instead, we use the more precise term ``LAAF-
accredited,'' where ``LAAF'' is an acronym for the title of this 
subpart, ``Laboratory Accreditation for Analyses of Foods.'' We added a 
definition for ``LAAF-accreditation'' to Sec.  1.1102. Where we do use 
the word, ``accredited'' in this final rule without further 
qualification, we generally mean accredited to ISO/IEC 17025:2017.
    Second, we no longer use the verb ``assess'' to refer to an action 
that FDA takes regarding laboratories. We reserve the word ``assess'' 
to refer to the action a recognized accreditation body takes toward a 
laboratory. We employ the word ``evaluate'' to mean an activity FDA 
takes with regard to an accreditation body seeking to become recognized 
or already recognized under this subpart. Largely accepting the 
suggestion of some comments, we describe our relationship with regard 
to the laboratories under this subpart as ``reviewing'' the performance 
of LAAF-accredited laboratories.
    Third, we do not use the word ``revoke'' in the final rule to mean 
an action FDA may take to remove a LAAF-accredited laboratory from this 
program. Instead, although an accreditation body may withdraw or reduce 
the scope of LAAF-accreditation, we say that FDA may ``disqualify'' a 
laboratory from conducting testing under this subpart. We note that 
although ``disqualify'' was used in the proposed rule in connection 
with permission to submit abridged analytical reports, we have revamped 
that process such that there is no longer a disqualification period. In 
the final rule, ``disqualify'' is used to describe the action FDA may 
take to remove a laboratory from the program; we say that FDA may 
``disqualify a LAAF-accredited laboratory from submitting analytical 
reports under this subpart'' (see Sec.  1.1161). For further 
information on the process related to submitting abridged analytical 
reports, see the discussion of Sec.  1.1153 below at Response 124.
    We agree in part with the comments suggesting that FDA perform some 
level of review of laboratory applications approved by recognized 
accreditation bodies. Although we have just explained that it is not 
appropriate for FDA to assess or accredit laboratories ourselves, we 
nevertheless have a responsibility to ensure that the laboratories we 
list on our website have been properly assessed by a recognized 
accreditation body. To that end, we will require the accreditation 
bodies to submit certain information to us concerning their assessment 
of a laboratory, including the resulting certificate listing the scope 
of LAAF-accreditation (see Sec.  1.1123(d)). We decline the suggestion 
to reframe FDA's relationship with LAAF-accredited laboratories in 
terms of FDA granting a license to such laboratories, or in terms of 
entering into a listing agreement with the laboratories. We note that 
some comments suggest that such a construct could prove helpful in 
relation to FDA granting permission for certain laboratories to submit 
abridged analytical reports. Nevertheless, we have determined that such 
a construct would present complications (e.g., could be legally 
cumbersome for the FDA to ``license'' laboratories) and is unnecessary 
to achieve the goals of this program.
    We have implemented the revised terminology described here 
throughout the final rule. We also have tried to avoid describing the 
proposed rule using the now-discarded terminology (e.g., FDA 
``assessing'' a laboratory), even if that is the language we originally 
used in the proposed rule, because we wish to reduce confusion and 
communicate more clearly. We thank the commenters for their feedback on 
this important topic and we look forward to contributions of all 
interested shareholders as we implement the LAAF program.
2. Program Structure
    (Comment 11) In the proposed rule, FDA proposed evaluating and 
recognizing accreditation bodies, and then those accreditation bodies 
would assess and LAAF-accredit laboratories. We received several 
comments on this proposed structure. Some comments express support 
because the rule relies on the current accreditation body-laboratory 
conformity assessment structure and leverages existing public-private 
partnerships in the United States.
    Alternatively, some comments contend that the structure was 
unnecessary or ineffective. Some of these comments advocate that 
laboratories should simply send their analytical reports to FDA and the 
Agency would ensure the testing of food was properly conducted. Some 
comments contend that the only requirement should be that accreditation 
bodies are signatories to the International Laboratory Accreditation 
Cooperation (ILAC), and then let the accreditation bodies assess the 
laboratories for LAAF-accreditation, applying the accreditation bodies' 
usual standards. Some comments argue that FDA should not have any 
authority over accreditation bodies, because such authority would 
result in two entities overseeing the laboratories, which these

[[Page 68738]]

comments view as both confusing and intrusive.
    (Response 11) The structure of the LAAF program is specified by the 
statute, per section 422(a)(1)(B) and (a)(2) of the FD&C Act. FDA will 
recognize accreditation bodies, which in turn will accredit 
laboratories. Further, there are advantages and efficiencies to relying 
on the structure of the existing conformity assessment industry (i.e., 
accreditation bodies assess laboratories) for the structure of this 
program. For example, this familiarity may make it easier for these 
stakeholders to participate in the program. At the same time that we 
are glad to leverage widely accepted international voluntary consensus 
standards as foundational requirements, we are supplementing those 
standards with certain requirements that we have determined will help 
ensure the integrity of the testing under this program. As a reminder, 
all the testing that we are requiring be conducted by a LAAF-accredited 
laboratory is occurring in the context of increased food safety concern 
(see Sec.  1.1107(a). For example, under Sec.  1.1107(a)(4), testing to 
support the release of food detained at the border because it is or 
appears to be adulterated or misbranded, is covered by this rule. 
Accordingly, we have determined that it is appropriate to impose some 
requirements in addition to those of the international voluntary 
consensus standards.
    Regarding the concern that FDA's exercise of authority over 
recognized accreditation bodies for purposes of this program will be 
confusing and intrusive, we have structured the program such that FDA 
evaluates the recognized accreditation bodies, and the accreditation 
bodies assess the laboratories against the model standards established 
in this rule, including conformity to ISO/IEC 17025:2017. FDA will not 
be assessing laboratory applicants.
    As shown in section I.A. above, we have revised the program 
structure diagram from the proposed rule (see 84 FR 59452 at 59453) to 
reflect changes made in the final rule. The program structure diagram 
incorporates revised program terminology throughout (i.e., ``LAAF-
accredited''; see discussion at Response 10). We also include a second 
box representing FDA to better illustrate our roles of recognizing 
accreditation bodies and reviewing results and supporting information 
submitted by LAAF-accredited laboratories.
    (Comment 12) Some comments opine that the framework of the proposed 
rule is inappropriate. These comments contend that it is not 
appropriate for FDA to oversee accreditation bodies because FDA is not 
an ILAC signatory. These comments further state that only accreditation 
bodies should oversee the laboratories they accredit and that therefore 
FDA's involvement would be both unnecessary and confusing. These 
comments recommend that FDA simply maintain a list of ILAC-signatory 
accreditation bodies, and have laboratories accredited by those listed 
accreditation bodies submit test results to us.
    (Response 12) We disagree that the framework of the rule, and FDA's 
oversight of both recognized accreditation bodies and LAAF-accredited 
laboratories, is inappropriate. Section 422 of the FD&C Act directs FDA 
to establish this program and, in relevant part, provide for the 
recognition of laboratory accreditation bodies that meet criteria 
established by the Secretary (see section 422(a)(2) of the FD&C Act). 
The Agency has established that being an ILAC signatory is a necessary, 
but not sufficient, condition to being recognized by FDA to LAAF-
accredit laboratories. We have determined it necessary and appropriate 
to set additional standards for accreditation bodies, such as the 
conflict of interest requirements in Sec.  1.1119. FDA must also 
evaluate the work of the accreditation bodies to ensure the integrity 
of the program. Further, the statute directs the Agency to periodically 
review a recognized accreditation body's compliance with the 
requirements of the program.
    Similarly, section 422(a)(6) of the FD&C Act directs the Agency to 
develop model standards that a laboratory must meet to be LAAF-
accredited to conduct testing under this subpart. We have adopted ISO/
IEC 17025:2017 accreditation as a baseline requirement, but given the 
specific circumstances in which food testing is required to be 
conducted by a LAAF-accredited laboratory and since we use the results 
of such tests to inform regulatory decisions and protect public health, 
we have included FDA oversight of LAAF-accredited laboratories among 
the components of the program (see section 422(a)(6)(B) of the FD&C 
Act).
    Therefore, FDA oversight of recognized accreditation bodies is not 
only appropriate, but it is also required by statute. Further, FDA has 
determined that oversight of LAAF-accredited laboratories submitting 
test results to FDA is appropriate given the Agency's use of the test 
results. The alternative framework proposed by the comment is not a 
viable option for a comprehensive and effective program that is 
sufficiently protective of public health.
    (Comment 13) A few comments encourage FDA to reassess our proposal 
to place laboratories or accreditation bodies in probationary status, 
which is noted on the public registry, after finding one or more 
nonconformances. These comments suggest that we consider the variety of 
circumstances that may surround nonconformance, including that the 
entity may be in the process of actively addressing the nonconformance. 
The comments express a concern that publication of probationary status 
on the online registry may negatively and unfairly impact the entity, 
as the entity may be in the process of addressing the issue that 
resulted in a non-conformance.
    (Response 13) We agree that entities should have an opportunity to 
address concerns before those concerns cause the entity to be placed on 
probation, particularly as probation will be noted on the online 
registry. Accordingly, we have revised the final rule such that 
generally an entity will be notified of deficiencies and provided an 
opportunity to take corrective action prior to being placed on 
suspension or probation. Consistent with our decision to incorporate by 
reference ISO/IEC 17011:2017 and ISO/IEC 17025:2017, we have decided to 
leverage the corrective action processes described in those standards 
to provide such an opportunity.
    Under these ISO/IEC standards, the corrective action process 
requires the entity to do more than simply correct a non-conformity. 
Instead, the entity is required to consider the non-conformity from a 
process perspective, including identifying the cause of the non-
conformity and considering whether internal process changes are needed 
to prevent its recurrence. FDA's view is that that this focus on 
looking for and addressing any systemic weaknesses in the entity's 
procedures, rather than simply remedying a single error or lapse, will 
serve to strengthen both the accreditation bodies and the laboratories 
that participate in this program, and therefore the LAAF program 
itself.
    Section 1.1121(a) of the final rule states that if a recognized 
accreditation body observes a deficiency in a LAAF-accredited 
laboratory, the recognized accreditation body may require corrective 
action using the procedures described by ISO/IEC 17025:2017 section 8.7 
(Ref. 3). Similarly, we have revised Sec. Sec.  1.1131 and 1.1161 
regarding FDA oversight actions regarding recognized accreditation 
bodies and LAAF-accredited laboratories, respectively, such that 
generally entities will be provided an opportunity to take

[[Page 68739]]

corrective action prior to being placed on probation.
    Some problems may warrant immediate action by a recognized 
accreditation body to suspend, reduce the scope of, or withdraw the 
LAAF-accreditation of a laboratory or by FDA to immediately disqualify 
a LAAF-accredited laboratory. For additional information, see Sec.  
1.1121 (``When must a recognized accreditation body require corrective 
action, suspend a LAAF-accredited laboratory, reduce the scope of, or 
withdraw the LAAF-accreditation of a laboratory?''); Sec.  1.1131 
(``When will FDA require corrective action, put a recognized 
accreditation body on probation, or revoke the recognition of an 
accreditation body?''); and Sec.  1.1161 (``When will FDA require 
corrective action, put a LAAF-accredited laboratory on probation, or 
disqualify a LAAF-accredited laboratory from submitting analytical 
reports?'').
    Finally, note that we have revised the final rule to refer to 
``suspension'' of LAAF-accredited laboratories by recognized 
accreditation bodies instead of ``probation'' as proposed. The final 
rule retains and limits the term ``probation'' to refer to an action 
that FDA may take with respect to a recognized accreditation body or a 
LAAF-accredited laboratory in certain circumstances (see Sec. Sec.  
1.1131 and 1.1161). For more information on this terminology change, 
see Comments 58, 71, and 82 and Responses.
3. Implementation
    (Comment 14) Several comments address implementation. In section 
VII of the proposed rule, we proposed that implementation would occur 
in a stepwise fashion; we would focus first on accreditation bodies and 
subsequently, laboratories. See 84 FR 59452 at 59495. We proposed that 
after the program attains sufficient laboratory capacity, we would 
publish a notice in the Federal Register giving 6 months' notice that 
owners and consignees would be required to use laboratories approved 
for participation in this program. All comments on this aspect of our 
proposal endorse a stepwise approach to implementation. These comments 
also agree with providing notice to affected entities via a Federal 
Register document. Some comments encourage the Agency to also issue 
Federal Register notices to announce when we will commence accepting 
applications from accreditation bodies, and when recognized 
accreditation bodies are able to start accepting applications from 
laboratories.
    (Response 14) We appreciate comments supporting our proposed 
implementation steps. As we stated in the preamble to the proposed 
rule, implementation of the LAAF program will necessarily occur in a 
stepwise fashion. We will announce when accreditation bodies may apply 
for recognition. When we have recognized a sufficient number of 
accreditation bodies, we will announce that laboratories may apply to 
the recognized accreditation bodies for LAAF-accreditation. When we 
have sufficient LAAF-accredited laboratory capacity for the testing 
covered by Sec.  1.1107, we will publish a document in the Federal 
Register giving owners and consignees 6 months' notice that they will 
be required to use a LAAF-accredited laboratory for such testing.
    We decline to commit to publishing notices in the Federal Register 
to announce that we are ready to accept applications from accreditation 
bodies and that laboratories may apply to recognized accreditation 
bodies. There are a variety of methods to communicate effectively with 
stakeholders and the interested public; at the appropriate time we will 
determine which methods best advance the Agency's interest in 
transparency and the needs of the LAAF program.
    (Comment 15) Some comments recommend that in addition to the 
stepwise approach discussed in the previous comment and response, we 
also take a phased-in approach to implementation. That means that FDA 
would only require testing under the rule for the various categories of 
tests described in Sec.  1.1107 as sufficient laboratory capacity is 
attained for each. Some comments suggest that we refrain from requiring 
testing under the rule until we have achieved sufficient laboratory 
capacity for a majority of the tests covered by the rule.
    Some comments maintain that there will be sufficient laboratory 
capacity for the DWPE-related testing covered by the final rule, 
because as we noted in the proposed rule, 10 laboratories that conduct 
the majority of such testing already are ISO/IEC17025-accredited (see 
84 FR 59452 at 59457). These comments state that there are ``hundreds'' 
of ISO/IEC 17025-accredited independent food laboratories in the United 
States that potentially could participate in the program, which would 
expand capacity. These comments expect that the program we are 
establishing in this final rule would also increase incentives for ISO/
IEC17025 accreditation and therefore expand capacity even further.
    Some comments question whether, and some comments ask when, 
sufficient laboratory capacity will be reached for all the tests 
covered by this final rule. Other comments inquire how FDA will 
determine when sufficient laboratory capacity has been reached. Some 
comments urge that when FDA considers whether there is sufficient 
laboratory capacity, we take into account whether laboratories can 
perform the testing in a timely manner. Other comments suggest that 
when we consider capacity, we take into account laboratory location 
relative to owners and consignees. Some comments predict that it will 
take a long time to achieve sufficient laboratory capacity, and some 
comments request that we explain what will happen if sufficient 
laboratory capacity is not attained for a particular category of 
testing. Some comments encourage FDA to identify the LAAF-accredited 
laboratories publicly once sufficient capacity is reached.
    Further, some comments express skepticism that the program would 
ever be able to attain sufficient capacity to implement the bottled 
drinking water followup testing covered by the rule (see Sec.  
1.1107(a)(1)(iii)). These comments state that such followup tests occur 
rarely and suggest that no water testing laboratory will find it 
worthwhile to participate in this program for the relatively little 
bottled drinking water followup testing business it might gain by doing 
so.
    Other comments focus on laboratories that currently test shell eggs 
and maintain that many such laboratories are not currently ISO/IEC 
17025-accredited. These comments question whether those laboratories 
would choose to become ISO/IEC 17025-accredited in order to participate 
in this program, as, according to these comments, such laboratories 
would be unlikely to test any commodities covered by this final rule 
other than shell eggs. These comments state it is unclear how quickly 
additional laboratories would be able to get approved for participation 
in the program and predict there could be a logistical problem of 
bottlenecking if sufficient laboratory capacity for a particular test 
is not attained. These comments encourage FDA to consult with the 
National Poultry Improvement Plan at the U.S. Department of Agriculture 
and other Agencies that have experience testing agricultural products. 
Finally, these comments ask that FDA allow adequate time for a 
sufficient number of laboratories to become LAAF-accredited to conduct 
the shell egg testing described in Sec.  1.1107(a)(1)(ii) before we 
require owners and consignees to have those tests conducted under this 
program.

[[Page 68740]]

    (Response 15) We agree that given the breadth of matrices and 
methods covered by the rule it may be necessary to separately consider 
whether sufficient laboratory capacity has been attained for the 
variety of tests described in Sec.  1.1107. As discussed in the 
preceding comment and response, the first implementation step is for 
FDA to receive, review, and evaluate applications from accreditation 
bodies. Once we have recognized a sufficient number of accreditation 
bodies, we anticipate that many laboratories will be interested in 
becoming LAAF-accredited, but it is impossible for us to predict 
various relevant factors including how many laboratories will apply, 
the methods for which they will be successful, and the associated 
timeframes. Perhaps sufficient laboratory capacity will be promptly 
attained for all tests covered by the rule; that would allow us to 
issue a single Federal Register document notifying owners and 
consignees that in 6 months they must use a LAAF-accredited laboratory 
for all tests described in Sec.  1.1107. That outcome is not assured, 
however, and therefore we may phase in implementation as suggested by 
some comments. To the extent that some comments suggest we wait to 
implement any of the rule until we have attained sufficient capacity 
for a majority of all the tests covered by the rule, we decline the 
suggestion due to the many variables that are not entirely within our 
control (the number of laboratories that apply as soon as they are 
able, the number and capacity of recognized accreditation bodies that 
will be assessing the initial laboratory applications, etc.).
    We appreciate the comments contending that there will be more than 
sufficient laboratory capacity for all the testing under this rule. 
This program represents the least amount of change for those private 
laboratories that are already ISO/IEC 17025-accredited and have been 
conducting the tests that support admission of a food under section 
801(a) of the FD&C Act and removal from DWPE under an import alert and 
sending their test results and associated analyses to FDA, some for 
many years. Further, as indicated by some comments, the data we 
analyzed for the proposed rule indicated that many of the laboratories 
that have been conducting tests to support admission of a food and 
removal from DWPE under import alerts are already ISO/IEC 17025-
accredited; the cost for such laboratories to become LAAF-accredited is 
relatively low. We agree with comments maintaining that our reliance on 
ISO/IEC 17025 as a foundational requirement for LAAF-accreditation 
provides an incentive for laboratories to become ISO/IEC 17025-
accredited and we note that an explicit goal of section 422 is to 
increase the number of laboratories qualified to conduct testing under 
this subpart (see section 422(a)(3) of the FD&C Act).
    Determining whether the program has attained sufficient laboratory 
capacity may appear to be a simple comparison of the number of a 
particular type of test that is needed, to the number of laboratories 
LAAF-accredited for that method. The reality is far different. Test 
demand cannot be predicted with certainty; in part it is a result of 
the prevalence of circumstances presenting heightened food safety 
concerns (e.g., the number and breadth of import alerts; how much food 
product is or appears to be violative when offered for import) and in 
part it is a result of business choices outside of our control or 
knowledge (e.g., how much food subject to DWPE is offered for import; 
whether a shell egg producer's environment tests positive for 
Salmonella Enteritidis and whether the producer then chooses to test 
its shell eggs or divert them to treatment (see Sec. Sec.  
118.5(a)(2)(ii) and (b)(2)(ii); 118.6(a)(2)). Some laboratories are 
much bigger than others, and bigger laboratories presumably can conduct 
more tests than smaller laboratories, so simply knowing how many 
laboratories are LAAF-accredited for a given method does not present a 
complete picture of capacity. We acknowledge that location is a 
relevant factor in choosing a laboratory, in large part due to the time 
and cost implications of shipping samples to a laboratory that is 
relatively far away, but the degree to which this factor is relevant to 
laboratory capacity may vary depending on the test at issue (e.g., size 
of sample, whether there are time and temperature requirements, the 
degree to which a product is perishable). Similarly, although 
timeliness may be an important factor for one sort of food test, it may 
be less critical in other food testing contexts. Other factors may also 
be relevant, and as noted above, it is infeasible for us to predict 
them all.
    FDA is committed to implementing this program promptly and, as in 
other FSMA contexts, in a practical manner. In determining laboratory 
capacity we will take all relevant information and factors into 
account. We remain committed to providing owners and consignees 6 
months' notice via a document in the Federal Register before requiring 
them to use a LAAF-accredited laboratory for the testing covered by 
this rule. We will not preclude the possibility that we may issue more 
than one Federal Register document as laboratory capacity is attained 
for various tests described in Sec.  1.1107.
    The publication of this final rule in the Federal Register arguably 
marks the beginning of the implementation of this program. Although we 
expect to reach sufficient laboratory capacity for all the tests 
covered by this rule, we decline the invitation of some comments to 
predict how long it will take to achieve that milestone. If sufficient 
laboratory capacity is not reached for a particular category or 
subcategory of the tests described in Sec.  1.1107, then the immediate 
result would be that we not require owners and consignees to use a 
LAAF-accredited laboratory to conduct those particular tests.
    We anticipate a sufficient number of LAAF-accredited laboratories 
for the bottled drinking water tests covered by this final rule (see 
Sec.  1.1107(a)(1)(iii)). For a related discussion, please see Comment 
and (Response 87.
    Some comments claim that the laboratories that currently conduct 
shell egg testing tend not to be accredited to ISO/IEC 17025. These 
comments express concern that such laboratories may not become LAAF-
accredited, which may result in a bottleneck effect (due to 
insufficient laboratory capacity). First, as discussed earlier in this 
response, FDA does not intend to require owners and consignees to use a 
LAAF-accredited laboratory for the testing described in Sec.  1.1107 
until the program has attained sufficient laboratory capacity for the 
relevant testing, even if that means that a LAAF-accredited laboratory 
is required for some categories or subcategories of testing described 
in Sec.  1.1107 sooner than for other categories or subcategories. 
Accordingly, the implementation of this program should not result in a 
bottleneck for shell egg testing.
    The research supporting the FRIA for this final rule (Ref. 4), and 
the information we gleaned from our consultations with the National 
Poultry Improvement Plan, is consistent with comments' claim that the 
majority of laboratories that currently conduct the shell egg testing 
described in Sec.  1.1107(a)(1)(ii) are not accredited to ISO/IEC 
17025. Although we believe some of those laboratories will pursue ISO/
IEC 17025 and LAAF-accreditation as a result of this final rule, we 
have no way of knowing with certainty.
    We estimate that once this final rule is fully implemented, FDA 
will receive about 3,771 analytical reports of shell egg testing per 
year (Ref. 4). Due to the testing regime required under the FDA

[[Page 68741]]

egg safety rule, each analytical report will consist of 50 tests (each 
shell egg sample of 1,000 eggs is separated into 50 pools of 20 eggs 
each). (See Sec.  118.6.) Accordingly, we expect that more than 188,000 
FDA-required shell egg tests currently conducted each year to comply 
with Sec.  118.6 will eventually be conducted by LAAF-accredited 
laboratories. If the laboratory market responds rationally, a 
sufficient number of laboratories will react to the business 
opportunity those shell egg tests create and choose to become LAAF-
accredited. If a sufficient number of laboratories that currently 
conduct shell egg tests choose not to become LAAF-accredited, then 
other laboratories will emerge to seize this opportunity. The costs of 
becoming LAAF-accredited for laboratories new to shell egg testing will 
be lowest for those laboratories that are already accredited to ISO/IEC 
17025; it would therefore be reasonable to expect such laboratories to 
pursue LAAF-accreditation to conduct shell egg testing. The FRIA in 
section II.F.3.f. accounts for the costs for some shell egg producers 
to switch laboratories if the one they are currently using is not LAAF-
accredited (Ref. 4).
    Shell egg testing is only required if the poultry house has tested 
positive for Salmonella Enteritidis, and the producer chooses not to 
divert the eggs to treatment. The central purpose of this final rule is 
to help ensure that the results of certain food testing that takes 
place amidst just this sort of heightened food safety concern, are 
reliable and accurate. No comments suggest that shell egg testing 
should be excluded from the coverage of this final rule, or subject to 
less stringent standards. We expect to avoid the logistical problem 
identified by these comments. And as noted above, we are committed to 
providing 6 months' notice via a Federal Register document before shell 
egg producers are required to use a LAAF-accredited laboratory to 
conduct the testing described in Sec.  1.1107(a)(1)(ii).

C. Comments Regarding General Provisions

                 Table 2--Changes to General Provisions
------------------------------------------------------------------------
           Final rule                Proposed rule           Note
------------------------------------------------------------------------
Sec.   1.1101 What documents are  N/A...............  New section for
 incorporated by reference in                          centralized
 this subpart?                                         incorporation by
                                                       reference (IBR).
Sec.   1.1102 What definitions    Sec.   1.1102 What  See preamble table
 apply to this subpart?            definitions apply   below for
                                   to this subpart?    specific changes
                                                       to Sec.   1.1102.
Sec.   1.1103 Who is subject to   Sec.   1.1103 Who   See preamble
 this subpart?.                    is subject to       discussion below
                                   this subpart?.      for specific
                                                       changes to Sec.
                                                       1.1103.
------------------------------------------------------------------------

1. What documents are incorporated by reference in this subpart (Sec.  
1.1101)?
    In the proposed rule, we proposed to incorporate by reference two 
international voluntary consensus standards: ISO/IEC 17011, Conformity 
assessment--Requirements for accreditation bodies accrediting 
conformity assessment bodies, Second edition, November 2017 (Ref. 2), 
for accreditation bodies, and ISO/IEC 17025, General requirements for 
the competence of testing and calibration laboratories, Third edition, 
November 2017 (Ref. 3), for laboratories.
    This final rule implements section 422 of the FD&C Act against the 
backdrop of the broader Federal policies on consensus standards and 
conformity assessment 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, revised 
January 27, 2016 (81 FR 4673), directs Federal Agencies to use 
voluntary consensus standards in lieu of government-unique standards 
except where inconsistent with law or otherwise impractical. OMB 
Circular A-119 states that the use of voluntary standards, whenever 
practicable and appropriate, is intended to eliminate the cost to 
government of developing its own standards; decrease the cost of goods 
procured and the burden of complying with Agency regulation; provide 
incentives and opportunities to establish standards that serve national 
needs, and encourage long-term growth for U.S. enterprises and promote 
efficiency and economic competition through harmonization of standards; 
and further the policy of reliance upon the private sector to supply 
the government with cost-effective goods and services (Ref. 8).
    As directed by OMB in Circular A-119, the National Institute of 
Standards and Technology (NIST), in the Federal Register of September 
29, 2020 (85 FR 60904), issued updated policy guidance on Federal 
conformity assessment activities. The Federal conformity assessment 
guidance is codified at 15 CFR part 287 and applies to all Federal 
Agencies that set policy for, manage, operate, or use conformity 
assessment activities or results (85 FR 60904 at 60905). The guidance 
advises Agencies on using conformity assessment to meet government 
needs in a manner that is efficient and cost-effective for both the 
Agency and its stakeholders (15 CFR 287.1(a)). In keeping with these 
national policies, FDA has determined that it is appropriate and will 
be beneficial to both the Agency and the public if we rely on voluntary 
consensus standards to provide the baseline requirements for both 
accreditation bodies and laboratories wishing to participate in the 
LAAF program.
    In the proposed rule, the incorporation by reference information 
was repeated throughout the codified text (e.g., Sec.  1.1113(b) (ISO/
IEC 17011:2017); Sec.  1.1138(a)(2) (ISO/IEC 17025:2017)). On our own 
initiative, for readability we have revised the final rule to include a 
centralized incorporation by reference section at Sec.  1.1101. Note 
that throughout the codified, after the year of each standard, we 
included the letter ``E'' to clarify that we are incorporating the 
standard in English (e.g., ``ISO/IEC 170211:2017(E)).'' However for 
readability, we did not repeat the ``E'' after each mention of the 
standards throughout the preamble.
    We received a few comments regarding the proposal to incorporate by 
reference the two consensus standards. These comments are addressed 
below.
    (Comment 16) Several comments support our reliance on existing 
international voluntary consensus standards: ISO/IEC 17011:2017 for 
accreditation bodies and ISO/IEC 17025:2017 for laboratories.
    (Response 16) Voluntary consensus standards such as ISO/IEC 
17011:2017 and ISO/IEC 17025:2017 are developed by organizations with 
the involvement of interested parties representing various roles, 
concerns, and perspectives, via a robust process that seeks to achieve 
consensus (Ref. 9). As noted in the immediately preceding

[[Page 68742]]

section, Federal law and policy direct us to use voluntary consensus 
standards rather than creating our own unique standards whenever 
practical and consistent with our legal obligations. Further, section 
422(a)(6) of the FD&C Act specifically directs the FDA to ``consult 
existing standards'' in the course of developing model standards for 
this rulemaking.
    Comments do not suggest that we consider any other standard for 
accreditation bodies wishing to participate in this program. And 
although some comments recommend that we permit the participation of 
laboratories that meet certain industry-specific standards (see Comment 
87 and Comment 88), no comment suggests a standard other than ISO/IEC 
17025:2017 as a baseline requirement. We appreciate support for our 
position that ISO/IEC 17011:2017 and ISO/IEC 17025:2017 are the most 
appropriate globally recognized and widely used standards for the LAAF 
final rule.
2. What definitions apply to this subpart (Sec.  1.1102)?

     Table 3--Revisions to the Proposed Definitions in Sec.   1.1102
------------------------------------------------------------------------
              Term                               Revision
------------------------------------------------------------------------
Accreditation...................  Term revised to ``laboratory
                                   accreditation for analyses of foods
                                   (LAAF) accreditation'' to clarify
                                   that decisions regarding
                                   accreditation under this subpart are
                                   limited to the LAAF program.
Accredited laboratory...........  Term revised to ``LAAF-accredited
                                   laboratory.''
Analyst.........................  No change.
Corrective action...............  New term that we define as an action
                                   taken by an accreditation body or
                                   laboratory to investigate and
                                   eliminate the cause of a deficiency
                                   so that it does not recur.
Food............................  No change.
Food testing, testing of food...  No change.
Food testing order..............  Term revised to ``directed food
                                   laboratory order'' to more accurately
                                   describe the order. Revised the
                                   definition to strike reference to
                                   Sec.   1.1107(a)(2); the definition
                                   now states the order is issued only
                                   under Sec.   1.1108.
Owner or consignee..............  Definition revised to refer to the
                                   circumstances in Sec.   1.1107(a)
                                   instead of repeating the
                                   circumstances in Sec.   1.1107(a) in
                                   the definition.
Recognition.....................  Definition revised to refer to LAAF-
                                   accreditation of laboratories.
Recognized accreditation body...  Definition revised to refer to the
                                   accreditation body's authority with
                                   respect to LAAF-accredited
                                   laboratories.
Representative sample...........  Definition revised to clarify that
                                   accuracy is to a ``statistically
                                   acceptable degree'' in response to
                                   comments and a grammatical revision
                                   made on our own initiative.
Sampler.........................  Definition revised to reference the
                                   individual who collects a sample.
Sampling firm...................  New term that we define as an entity
                                   that provides sampling services.
Scope of accreditation..........  Term revised to ``scope of LAAF-
                                   accreditation'' and definition
                                   revised to delete the second sentence
                                   of the definition to remove the
                                   phrases, ``in-whole'' and ``in-part''
                                   from the definition and throughout
                                   the rule.
------------------------------------------------------------------------

    We proposed to apply the definitions in section 201 of the FD&C Act 
unless otherwise specified. Additionally, we proposed to codify several 
terms used in the LAAF regulations. We received several comments on 
this section. As discussed in the following paragraphs, we have revised 
many of the terms and proposed definitions in response to comments 
received, as well as on our own initiative. Where we disagree with 
comments or decline a suggested revision, we offer an explanation in 
response. Some definitions were finalized as proposed.
    The definitions for terms used in the laboratory accreditation for 
analyses of foods regulations are codified in Sec.  1.1102.
Accreditation, Accredited Laboratory
    We proposed to define accreditation and accredited laboratory to 
relate to determinations regarding a laboratory under this subpart. On 
our own initiative, we moved the phrase, ``under this subpart'' in the 
definition of the term, ``LAAF-accredited laboratory'' to clarify that 
food testing is conducted under this subpart as opposed to using 
methods of analysis under this subpart, as proposed.
    (Comment 17) A number of comments express concern with the proposed 
definitions of ``accreditation'' and ``accredited laboratory,'' 
suggesting that they may result in confusion with similar terms already 
being used by industry. Some comments recommend aligning the 
definitions of ``accreditation'' and ``accredited laboratory'' under 
this regulation with their meaning in the conformity assessment 
industry to avoid potential confusion. Others propose that we 
differentiate the terms under this regulation from those used elsewhere 
and suggest the more specific terms, ``Section 422 accreditation'' and 
``Section 422 accredited laboratory'' as potential options.
    (Response 17) We acknowledge the potential for confusion regarding 
the terms, ``accreditation'' and ``accredited laboratory'' under this 
subpart with the use and understanding of these terms by industry. 
Accordingly, we have revised the terms to be specific to the LAAF 
program. Therefore, the terms have been revised to ``LAAF-
accreditation'' and ``LAAF-accredited laboratory'' respectively in 
Sec.  1.1102 and throughout the rule to clarify the impacts and 
limitations of accreditation decisions under this subpart. See also 
Comment and Response 10.
Analyst
    We received no comments on the proposed definition of ``analyst'' 
and therefore have finalized the definition as proposed.
Corrective Action
    We have added a definition for corrective action to clarify that in 
this subpart, it means, ``an action taken by an accreditation body or 
laboratory to investigate and eliminate the cause of a deficiency so 
that it does not recur.'' For additional discussion, see Comment and 
Response 31.
Food
    In the proposed rule, we defined ``food'' as having the meaning 
given in section 201(f) of the FD&C Act, except that food does not 
include pesticides (as defined in 7 U.S.C. 136(u)). The proposed 
definition would align with the definition of ``food'' in the 
``Accreditation of Third-Party Certification Bodies to Conduct Food 
Safety Audits and to Issue Certifications'' (21 CFR 1.600 et seq.) 
(Accredited Third-Party Certification Program) and the ``Foreign 
Supplier Verification Programs for Food Importers'' (21 CFR 1.500 et 
seq.) (FSVP) regulations.

[[Page 68743]]

    (Comment 18) Some comments express support for the proposed 
definition of ``food,'' which the comments characterize as being the 
same as the definition in section 201(f) of the FD&C Act.
    (Response 18) We appreciate the support for our proposed definition 
of ``food'' and we are retaining it without change. We note that for 
the purposes of this subpart, we are not giving the term, ``food,'' the 
same meaning as in section 201(f) of the FD&C Act. Under section 
201(f), ``food'' is not defined to exclude pesticides, whereas the 
definition in this subpart expressly indicates that food does not 
include pesticides. As we stated in the proposed rule, we have not 
identified a need for ``food'' to include pesticides for purposes of 
this final rule, and no comment suggests otherwise.
Food Testing, Testing of Food
    We proposed to define ``food testing'' and ``testing of food'' to 
mean the analysis of food product samples or environmental samples.
    (Comment 19) Numerous comments indicate support for the inclusion 
of environmental testing within the definition for ``food testing'' and 
``testing of food'' in the proposed rule. These comments assert that 
both food product and environmental testing are important to protecting 
public health. Conversely, multiple comments oppose the proposal to 
include environmental testing within the definition of ``food testing'' 
and ``testing of food.'' Some of these comments suggest that because 
FSMA section 202 did not explicitly mention environmental testing, the 
statute only permits the testing of food product samples, and not 
environmental samples, within the scope of this regulation. Other 
comments suggest that the definition of ``food testing'' and ``testing 
of food'' should be consistent in scope with the statutory definition 
of ``food'' in section 201(f) of the FD&C Act and limited to the 
analysis of food product samples only. Some comments further specify 
that although they oppose the inclusion of environmental testing within 
the definition for ``food testing'' and ``testing of food,'' they 
recognize the utility of environmental monitoring in ensuring food 
safety. Similarly, some comments state that the food industry has 
conducted environmental testing for a long time and argue that industry 
does not need this final rule to cover environmental testing to 
continue conducting such testing.
    (Response 19) After carefully considering the comments and the 
statute, we define ``food testing'' and ``testing of food'' to mean, 
``the analysis of food product samples or environmental samples.''
    As discussed in the proposed rule, the terms, ``food testing'' and 
``testing of food,'' used in section 422 of the FD&C Act, are not 
defined in the statute (84 FR 59452 at 59460). We find these terms 
ambiguous and rely on context for their interpretation. Section 202(a) 
of FSMA is located in Title II of FSMA, which is titled ``improving 
capacity to detect and respond to food safety problems.'' Further, in 
describing some of the testing to be covered by this subpart, section 
422(b)(1)(A) of the FD&C Act twice includes testing that addresses, 
``an identified or suspected food safety problem.'' This context 
indicates the critical importance of ``food testing'' and ``testing of 
food'' being interpreted to include the analysis of environmental 
samples, so that this final rule will cover an important method of 
detecting and responding to identified and suspected food safety 
problems. We acknowledge and appreciate those comments asserting that 
including environmental testing is important to addressing food safety 
concerns and protecting public health. We also note that even some 
comments that oppose defining ``food testing'' and ``testing of food'' 
to include environmental testing state that such testing plays a 
valuable role in identifying potential pathways for contamination and 
helping to ensure food safety.
    We agree with aspects of comments that acknowledge the importance 
of testing food production environments (e.g., the environment where 
food is grown, harvested, packed, held, processed, or manufactured). 
The term, ``environment'' includes food contact surfaces such as 
utensils and table surfaces. Pathogens in the environment can be (and 
unfortunately, sometimes are) transmitted to food. Therefore, 
environmental testing is sometimes used as a followup test to verify 
that cleaning and sanitizing designed to eliminate an identified 
pathogen, was sufficient to eradicate that pathogen. Environmental 
testing may also be employed to determine the source of an identified 
pathogen (e.g., in circumstances where a food product tested positive 
for a pathogen but it is not yet known how the food became 
adulterated). It is important that FDA be able to utilize this subpart 
to help ensure valid testing in the context of those sorts of 
heightened food safety concerns.
    Some comments indicate that Congress used the term, ``environmental 
testing'' in other parts of the statute and could have done so here. 
Although we do not disagree with that statement, we note that Congress 
also used the term, ``product testing,'' in other parts of the statute, 
and could have done so here. We do not believe the absence of these 
phrases implies a lack of statutory authority to include both product 
and environmental testing within the scope of this final rule. 
Furthermore, the inclusion of both types of testing within the scope of 
the final rule serves a central purpose of section 422 of the FD&C Act, 
which is to improve FDA's access to reliable and accurate results of 
public health significance, thus improving our capability to protect 
U.S. consumers from unsafe food.
    Some comments contend that the statutory definition of ``food'' 
limits our definitions of ``food testing'' and ``testing of food,'' to 
product samples. As we acknowledged in the preamble to the proposed 
rule, that is one, but not the only, reasonable interpretation of the 
statute. For the reasons discussed, we are adopting a different and 
more public health-protective interpretation and therefore finalize the 
definition of ``food testing'' and ``testing of food'' without change.
    Finally, we appreciate that many in the food industry have long 
monitored their production environment through environmental testing. 
We applaud and encourage the continued practices of firms that conduct 
robust environmental monitoring programs. As discussed further in 
Response 35, this final rule does not cover routine environmental 
testing.
Food Testing Order
    We proposed to define ``food testing order'' as 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. Although we did not receive specific comments regarding the 
proposed definition, we received many comments about the food testing 
order provisions in proposed Sec. Sec.  1.1107 and 1.1108. We discuss 
those comments in section V.D. below; however, we are also making a 
change to the related terminology. We have revised the term, ``food 
testing order'' to ``directed food laboratory order'' throughout the 
rule to more accurately reflect the order and its impact. To reduce 
confusion, we generally use the term, ``directed food laboratory 
order,'' throughout this document, even when referring to discussions 
in the proposed rule.
    On our own initiative, we revised the definition to strike the 
reference to Sec.  1.1107(a)(2) and now state the order is issued 
solely under Sec.  1.1108, as this provision directly describes FDA's 
issuance of such orders.

[[Page 68744]]

Owner or Consignee
    We proposed to define ``owner or consignee'' as a person with an 
ownership interest in the food or environment samples in the 
circumstances described in proposed Sec.  1.1107. On our own 
initiative, we have revised the definition to refer more generally to 
the circumstances described in Sec.  1.1107 instead of repeating the 
circumstances in the definition.
Recognition
    We proposed to define ``recognition'' to mean a determination by 
FDA that an accreditation body meets the applicable requirements of the 
LAAF program and is authorized to accredit laboratories under this 
subpart. As a result of revising the terms, ``accreditation'' and 
``accredited laboratory'' to be specific to the LAAF program, we have 
revised the definition of ``recognition'' to reflect that a recognized 
accreditation body will LAAF-accredit laboratories to conduct food 
testing under this subpart.
    (Comment 20) Some comments state that having a definition for 
``recognition'' specific to this regulation may result in confusion, as 
the term is already used by the conformity assessment industry in other 
contexts outside of this regulation.
    (Response 20) In contrast to the many comments that argue that our 
proposed use of the terms ``accreditation,'' ``accredited laboratory,'' 
and ``assessment,'' created confusion, only a small number of comments 
claim that our proposed use of the term, ``recognition,'' would create 
the potential for confusion. Further, these comments provide no 
specific examples of how the term, ``recognition,'' would be confusing, 
and do not offer alternative terms or definitions.
    In addition, the FDA Foods Program uses the term, ``recognition,'' 
in the same way as proposed in our Accredited Third-Party Certification 
Program (see 21 CFR 1.600), and has not heard from those program 
participants that the term has proved problematic. For more information 
on the Accredited Third-Party Certification Program, see https://www.fda.gov/food/importing-food-products-united-states/accredited-third-party-certification-program.
    Therefore, we are retaining the definition of the term, 
``recognition'' in the final rule.
Recognized Accreditation Body
    We proposed to define ``recognized accreditation body'' as an 
accreditation body that FDA has determined meets the applicable 
requirements of this subpart and is authorized to accredit laboratories 
under this subpart. We have revised the definition to state that the 
recognized accreditation body is authorized to LAAF-accredit 
laboratories under this subpart. This change aligns with our overall 
revisions to terminology throughout the rule.
Representative Sample
    We proposed 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.''
    (Comment 21) Several comments contend that the proposed definition 
of ``representative sample'' is vague and impractical. Some comments 
suggest we clarify that determining whether a sample is 
``representative'' involves an assessment of various factors. Others 
suggest that FDA clarify the Agency's expectations regarding 
``representative sample'' by specifying sampling protocols within 
import alerts or including specific procedures and sampling plans for 
different foods and analyses within the final rule. Some comments 
suggest the addition of a definition for ``representative sampling,'' 
based on the concern that if sampling is not performed appropriately, 
results may be invalidated.
    Some comments specify that the phrase, ``to a scientifically 
acceptable degree'' is difficult to understand and vague; these 
comments suggest that we replace the phrase, ``to a scientifically 
acceptable degree,'' with the phrase, ``based on a scientific risk-
based rationale.'' These comments also suggest we add a second sentence 
to the definition to explain that the suggested phrase, ``includes 
consideration of the environment, food matrix, and analyte of interest, 
among other factors.''
    (Response 21) We agree that whether a food testing sample is 
representative depends on a variety of factors. Relevant factors 
include what is being sampled, the population from which the sample is 
taken, the dispersion pattern of potential adulterants, and adherence 
to any time and temperature controls, to name just a few. We also 
appreciate the desire for clarity expressed in the comments suggesting 
that we specify sampling protocols for the samples that will be tested 
under this final rule. However, the purpose of defining 
``representative sample'' in this subpart is not to prescribe how to 
achieve a representative sample either generally or specifically for 
the testing conducted under this program. Instead, it is to accurately 
communicate the concept of a representative sample. We considered 
altering the definition, but because every food product and 
environmental testing circumstance is slightly different, and as 
already noted, there are many relevant factors that also vary, our 
attempts to add specificity to the definition resulted in unnecessarily 
complex language or the introduction of some inaccuracy. Accordingly, 
although we understand that some comments describe the proposed 
definition as vague and impractical, we are retaining it with limited 
changes because we conclude that it broadly satisfies the purpose for 
which it was created. We also consider the definition to be similar to 
and consistent with definitions that are accepted nationally and 
internationally. (See, e.g., Codex Alimentarius Commission, General 
Guidelines on Sampling document CAC/GL-50-2004, Sec.  2.2.3: ``A 
representative sample is a sample in which the characteristics of the 
lot from which it is drawn are maintained. It is in particular the case 
of a simple random sample where each of the items or increments of the 
lot has been given the same probability of entering the sample'' (Ref. 
10).
    Some comments suggest that the proposed phrase, ``to a 
scientifically acceptable degree,'' is difficult to understand and 
vague, and suggest instead the phrase, ``based on a scientific risk-
based rationale.'' We agree that the proposed phrase could be improved. 
However, we do not believe the proffered alternative phrase is the best 
choice, because it would not always be applicable and also, is less 
common in the laboratory industry and therefore not widely understood. 
Instead, we have replaced ``to a scientifically acceptable degree,'' 
with, ``to a statistically acceptable degree,'' which we believe 
communicates with more precision than the proposed phrase the need for 
samples to be selected based on a statistical sampling design. A sample 
that represents the whole to a statistically significant degree will 
yield information about the average composition of the whole, and 
therefore enable valid, accurate test results.
    We decline the suggestion to add a second sentence to the 
definition to explain the phrase at issue but have already agreed with 
the concept it expressed, which is that determining whether a sample is 
representative involves considering a host of varying factors. We also 
decline the suggestion to add a definition of ``representative 
sampling,'' to this subpart. Although we certainly agree that sampling 
techniques are critical to obtaining a representative

[[Page 68745]]

sample, this final rule does not set standards for those techniques and 
therefore our discussion of them is not so extensive as to justify the 
need to define the term.
    On our own initiative, we also made grammatical changes to this 
definition.
    See our discussion of Sec.  1.1149 below for additional information 
on sampling requirements and resources.
Sampler
    We proposed to define ``sampler'' as an individual or individuals 
who perform sampling.
    (Comment 22) A few comments disagree with the proposed definition 
of ``sampler,'' and state that a sampler may also be an entity (for 
example, in the case of laboratories that are commercially liable for 
the performance of the persons collecting the samples). These comments 
suggest that FDA include definitions for both ``sampler'' (an entity) 
and ``sample collector'' (individual(s)) within the final rule to 
clarify this distinction.
    (Response 22) We agree that it would be clearer to use two distinct 
terms throughout the rule regarding activities related to sampling. 
First, we have clarified the definition of the term, ``sampler'' to 
mean an individual who collects samples. Second, we have added a new 
term, ``sampling firm,'' which we define as an entity that provides 
sampling services. Accordingly, we have revised the final rule to use 
the term, ``sampling firm'' where appropriate.
Scope of Accreditation
    We proposed to define this term to refer to the methods of analysis 
for which the laboratory is accredited. The proposed definition went on 
to state that ``[r]eferences in this subpart to accreditation `in-
whole' refers [sic] to all methods in the accredited laboratory's scope 
of accreditation and references to accreditation `in-part' refers [sic] 
to only certain methods in the accredited laboratory's scope of 
accreditation.'' 84 FR 59452 at 59502. We received no comments on this 
proposed definition; however, we have revised the proposed term and 
definition to be consistent with our terminology changes throughout the 
final rule. The term has been revised to ``scope of LAAF-
accreditation'' and the definition of the term has been revised to 
refer to ``. . . the methods of analysis for which the laboratory is 
LAAF-accredited.''
    We have omitted the proposed second sentence in the definition 
which removes the terms, ``in-whole'' and ``in-part.'' Instead, in the 
final rule we generally employ the construct that changes in LAAF-
accreditation relate to specific methods, or apply to all methods, 
within a laboratory's scope of LAAF-accreditation. Additionally, in the 
final rule, to better align with the ISO/IEC conformity assessment 
paradigm, we consistently use the word, ``withdraw'' to refer to the 
action a recognized accreditation body takes to remove all methods 
within the laboratory's scope of LAAF-accreditation, and we use the 
phrase, ``reduce the scope of LAAF-accreditation'' to refer to 
recognized accreditation body actions which remove only certain methods 
from the laboratory's scope of LAAF-accreditation.
Additional Definitions
    On our own initiative, we have included a definition for the term 
``street address'' which appears throughout the final rule. We define 
the term to mean the full physical address, including the country. We 
go on to clarify that, for purposes of this rule, a post office box 
number alone is insufficient; however, a post office box number may be 
provided in addition to the street address.
    We received comments requesting that we include and define 
additional terms in the final rule. We address these comments below.
    (Comment 23) Multiple comments suggest adding a definition for 
``identified or suspected food safety problem,'' stating that doing so 
would help to clarify when it would be necessary to use a LAAF-
accredited laboratory for testing.
    (Response 23) For the reasons stated in the preamble to the 
proposed rule, we decline the recommendation to include a specific 
definition for ``identified or suspected food safety problem'' (see 84 
FR 59452 to 59462). Instead, we proposed codifying the specific 
circumstances in which use of a LAAF-accredited laboratory would be 
required under this subpart. As discussed below in section V.D, we have 
revised some of the circumstances in response to public comments and 
have added additional discussion in the preamble.
    (Comment 24) Some comments suggest adding definitions for ``quality 
assurance'' and ``raw data,'' stating that similar terms are used by 
other programs, entities, and regulations--such as FDA's Good 
Laboratory Practice for Nonclinical Laboratory Studies at 21 CFR part 
58--that may serve as a basis for developing a definition under this 
subpart.
    (Response 24) We decline to add definitions for these terms to the 
final rule.
    Quality assurance is a critical pursuit that must undergird both 
recognized accreditation body and LAAF-accredited laboratory processes. 
Indeed, we consider the integral nature of quality assurance in ISO/IEC 
17011:2017 and ISO/IEC 17025:2017 to be among the standards' greatest 
strengths (Ref. 2, Ref. 3). In this final rule we are establishing 
requirements consistent with our perspective that quality assurance 
must be nurtured (e.g., incorporation of the corrective action process 
for both recognized accreditation bodies and LAAF-accredited 
laboratories, submission by recognized accreditation bodies of their 
internal audit reports, proficiency test requirements for each method 
within the laboratories' scope of LAAF-accreditation at least every 12 
months). Nevertheless, we decline the suggestion to define ``quality 
assurance'' in this subpart because we conclude a definition is neither 
necessary nor would it meaningfully add to the final rule. We prefer 
instead to include in our standards provisions that will require the 
quality assurance processes and actions we deem necessary for this 
program.
    We note that the term, ``quality assurance'' appeared in Sec.  
1.1148 of the proposed rule (``What quality assurance requirements must 
accredited laboratories meet?''). In the final rule, we have omitted 
the specific section regarding quality assurance requirements and 
incorporated those requirements into Sec.  1.1138, which addresses the 
eligibility requirements for LAAF-accredited laboratories.
    The term, ``raw data'' is not used so extensively in the final rule 
as to warrant a definition. In fact, it only appears once in the 
codified text, in Sec.  1.1152(d)(8), where we require as part of a 
full analytical report, ``[a]ll original compilations of raw data 
secured in the course of the analysis.'' We explain the term in two 
ways. First, section 1.1152(d)(8) includes some examples of raw data, 
and second, in our discussion of that provision at Response 119, below, 
we have expounded on our thinking regarding this requirement. We 
consider these forms of explanation to be sufficient in the context of 
this subpart.
    (Comment 25) Some comments state that the term, ``specific major 
food testing discipline'' is used throughout the proposed rule and 
suggest that a definition for the term be added to the regulation for 
additional clarity.
    (Response 25) We included the term, ``specific major food testing 
discipline'' in proposed Sec.  1.1152(d) regarding permission to submit 
abridged

[[Page 68746]]

analytical reports. To clarify the term, we have included detail in the 
final rule at Sec.  1.1153(a) regarding the three major food testing 
disciplines under this rule for purposes of submitting abridged 
analytical reports. We identified these in the preamble to the proposed 
rule regarding Sec.  1.1152(d) (see 84 FR 59484 (Nov. 4, 2019)) using 
slightly different terms: ``microbiology, chemistry, and physical 
(filth).'' In the final rule at 21 CFR 1.1153(a), we have codified the 
specific major food testing disciplines that will be used to categorize 
analytical reports for purposes of determining permission to submit 
abridged analytical reports as ``biological, chemical, and physical.''
3. Who is subject to this subpart (Sec.  1.1103)?
    Proposed Sec.  1.1103 listed the entities subject to the subpart: 
recognized accreditation bodies, entities seeking to become recognized 
accreditation bodies, LAAF-accredited laboratories, entities seeking to 
become LAAF-accredited laboratories, and owners and consignees who are 
required to use LAAF-accredited laboratories for the food testing under 
this program.
    We have made minor changes throughout this section to reflect 
revised program terminology. Specifically, we have modified the term, 
``accreditation'' to ``LAAF-accreditation'' in this section and 
throughout the rule. Additionally, we have made minor editorial changes 
on our own initiative to improve clarity. Comments regarding this 
section are discussed below.
    (Comment 26) Some comments request clarification of which owners 
and consignees will be covered by this final rule, stating that there 
may be multiple owners and consignees in the context of imported food.
    (Response 26) FDA-regulated products imported into the United 
States must comply with the same FDA laws and regulations that apply to 
domestic products. Entries are submitted to U.S. Customs and Border 
Protection which then refers entries of FDA-regulated products to FDA 
for review. Imported items may not be distributed into commerce until 
FDA has determined admissibility.
    If FDA detains a food product at the border under section 801(a) of 
the FD&C Act because the food is or appears to be adulterated or 
misbranded, but FDA has not yet refused admission, the owner or 
consignee of the food may introduce testimonial evidence that the food 
is admissible. Owners and consignees often engage laboratories to test 
the food and submit to FDA the results of the testing, as testimony to 
support admission. If FDA determines that the food testing results are 
valid and that they demonstrate the detained product does not violate 
the FD&C Act, FDA will release the food from detention and allow it to 
proceed into the United States. The testing of detained product at the 
direction of such owners and consignees is covered by this final rule 
(see Sec.  1.1107(a)(4)).
    The DWPE procedure allows FDA to detain an imported product without 
physically examining it at the time of entry. FDA employs the DWPE 
procedure when there is a history of product that violates or appears 
to violate the FD&C Act, or when other information indicates that 
future entries may be violative. Import alerts inform FDA staff and the 
public that we have enough evidence to allow for DWPE of particular 
products. Testing to support removal from an import alert is also 
covered by this final rule (see Sec.  1.1107(a)(5)). For more 
information on FDA's import program generally see https://www.fda.gov/industry/import-program-food-and-drug-administration-fda; for more 
information on DWPE, see https://www.fda.gov/media/71776/download.
    It is true that for a particular food shipment or entry being 
offered for import into the United States, multiple parties may be 
considered owners and/or consignees of the entry or of particular 
products within that entry (i.e., line items or lines). However, there 
is generally only one importer of record for each entry,\2\ and it is 
the importer of record that is ultimately responsible for ensuring that 
the product(s) complies with the FD&C Act and implementing regulations 
at the time of entry. (See Sec.  1.83(a), where the term, ``owner or 
consignee'' is defined for the purposes of articles offered for 
import.) The importer of record may negotiate or contract with another 
party such that the other party agrees to engage the laboratory to test 
the product. Such arrangements are purely between the parties to the 
shipment; at the end of the day the importer of record remains the 
party ultimately responsible for the compliance of that entry and 
therefore is ultimately responsible for amassing any testimonial 
evidence (e.g., test results and associated analytical documentation) 
in support of admission of the food.
---------------------------------------------------------------------------

    \2\ There may not be an importer of record for some informal 
entries. (Informal entries, as defined by U.S. Customs and Border 
Protection regulations, are usually valued at less than $2,500 
(value subject to change) (19 CFR 143.21), and usually do not 
require a bond. Some products are restricted from informal entry 
(for example, high risk products), regardless of value.) For such 
shipments that are not accompanied by an importer of record when 
making entry, the owner or consignee of the line(s) will serve as 
the responsible party when presenting evidence to FDA in support of 
admission of the food.
---------------------------------------------------------------------------

D. Comments Regarding General Requirements

               Table 4--Revisions to General Requirements
------------------------------------------------------------------------
           Final rule                Proposed rule           Notes
------------------------------------------------------------------------
Sec.   1.1107 When must food      Sec.   1.1107       Revised section
 testing be conducted under this   Under what          title to simplify
 subpart?                          circumstances       language and
                                   must food testing   incorporate
                                   be conducted        revised
                                   under this          terminology.
                                   subpart by an
                                   accredited
                                   laboratory?
Sec.   1.1108 When and how will   Sec.   1.1108 When  Revised section
 FDA issue a directed food         and how will FDA    title to reflect
 laboratory order?                 issue a food        revised
                                   testing order?      terminology.
Sec.   1.1109 How will FDA make   Sec.   1.1109 How   Revised section
 information about recognized      will FDA make       title to reflect
 accreditation bodies and LAAF-    information about   revised
 accredited laboratories           recognized          terminology.
 available to the public?          accreditation
                                   bodies and
                                   accredited
                                   laboratories
                                   available to the
                                   public?
Sec.   1.1110 What are the        N/A...............  New section which
 general requirements for                              consolidates
 submitting information to FDA                         requirements from
 under this subpart?                                   throughout the
                                                       proposed rule.
------------------------------------------------------------------------

[[Page 68747]]

1. When must food testing be conducted under this subpart (Sec.  
1.1107)?
    Proposed Sec.  1.1107(a) stated that food testing must be conducted 
under this subpart 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 that address an 
identified or suspected food safety problem in existing FDA regulations 
covering sprouts (21 CFR 112.146(a), (c) and (d)), shell eggs 
(Sec. Sec.  118.4(a)(2)(iii), 118.5(a)(2)(ii), 118.5(b)(2)(ii), 
118.6(a)(2), 118.6(e)), and bottled drinking water (Sec.  
129.35(a)(3)(i) (21 CFR 129.35(a)(3)(i))) (regarding the requirement to 
test five samples from the same sampling site that originally tested 
positive for Escherichia coli (E. coli)); (2) as required by FDA in a 
directed food laboratory 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 of 
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.
    Section 1.1107(b) of the proposed rule stated that when food 
testing is conducted under paragraph (a), analysis of samples must be 
conducted by a laboratory that is LAAF-accredited for the appropriate 
method(s). Proposed paragraph (c) stated the requirement for food 
testing on articles of food offered for import into the United States 
to be conducted after the articles have arrived in the United States 
unless FDA has provided prior written authorization to the owner or 
consignee that a sample(s) of the article(s) taken prior to arrival in 
the United States is or would be representative of the article(s) 
offered for import.
    We revised the proposed rule section title, ``Under what 
circumstances must food testing be conducted under this subpart by an 
accredited laboratory?'' to ``When must food testing be conducted under 
this subpart?'' in the final rule. We have made changes throughout this 
section to incorporate revised terminology. We also have made non-
substantive revisions to paragraph (a)(2) (to add the word, 
``issued''), to paragraph (a)(3) to add an inadvertently omitted word 
(``of''), and to paragraph (c) to improve clarity and readability. 
Comments regarding this section are discussed below.
    (Comment 27) We received several comments regarding the proposed 
policy to allow all testing under this subpart to be conducted ``by or 
on behalf of an owner or consignee.'' Some comments contend that 
laboratories operated by owners or consignees (``in-house'' 
laboratories) should be ineligible to conduct some or all tests 
described in Sec.  1.1107. Other comments voice agreement with the 
proposal.
    (Response 27) After considering the comments in light of the 
statute, we are retaining the proposed policy such that in-house 
laboratories may become LAAF-accredited to conduct any or all the 
testing described in Sec.  1.1107 as long as those laboratories meet 
all the laboratory requirements of this subpart. Please see the 
discussion of this issue in Response 101 where we address the general 
eligibility of these laboratories, as well as the impartiality and 
conflict of interest requirements contained in Sec.  1.1147.
    (Comment 28) We received a few comments asking us to clarify the 
foods to which the testing requirements in the final rule will apply. 
Some of these comments ask whether any commodities would be exempt from 
the final rule and state that seafood, juice, and low-acid canned foods 
are exempt from certain requirements of the ``Current Good 
Manufacturing Practice, Hazard Analysis, and Risk-based Preventive 
Controls for Human Food'' (preventive controls for human food) 
regulation (part 117 (21 CFR part 117)). Other comments inquire whether 
the final rule would apply to any commodities other than sprouts, shell 
eggs, and bottled drinking water.
    (Response 28) Proposed Sec.  1.1107(a) described the specific 
circumstances under which food testing would need to be conducted under 
this subpart by a LAAF-accredited laboratory. Sprouts, shell eggs, and 
bottled drinking water are the only commodities for which specific 
testing requirements contained in existing regulations are currently 
covered by the final rule (see Sec.  1.1107(a)(1)(i) through (iii)). 
The remaining circumstances in Sec.  1.1107(a) could require food 
testing under this subpart for any food or environment within FDA's 
jurisdiction. We note that hazards addressed by hazard analysis and 
critical control point (HACCP) regulations for seafood (21 CFR part 
123) and juice (21 CFR part 120), and those addressed by regulations 
for low-acid canned food (21 CFR part 113), are exempt from certain 
requirements of the preventive controls for human food regulation 
because those commodities and hazards are covered by commodity-specific 
HACCP or other regulations that predate the preventive controls for 
human food regulation. Seafood, juice, and low-acid canned foods are 
not exempt from this final rule. If seafood, juice, low-acid canned 
foods, or any article of food or environment within FDA's jurisdiction 
are covered by any of the circumstances described in Sec.  1.1107(a)(2) 
through (5), then food testing must be conducted under this subpart by 
a LAAF-accredited laboratory. For a discussion of program 
implementation, see Response 14.
    (Comment 29) Some comments agree with our proposal regarding the 
scope of testing that would be covered by the final rule. Some comments 
express alignment with the general notion of FDA requiring the use of 
LAAF-accredited laboratories in circumstances where heightened food 
safety concerns exist. Other comments support the proposed requirement 
that testing prescribed by certain explicit testing requirements in FDA 
regulations to address an identified or suspected food safety problem 
should be covered by this final rule. Specifically, some comments 
support the inclusion of the bottled drinking water testing required in 
Sec.  129.35(a)(3)(i) and agree that other bottled drinking water 
testing required by FDA regulations does not constitute testing in 
connection with an ``identified or suspected food safety problem'' and 
therefore was properly excluded from coverage in the proposed rule.
    (Response 29) Section 422 of the FD&C Act prescribes several 
circumstances in which testing must be conducted by a LAAF-accredited 
laboratory. First, section 422(b)(1)(A)(i) of the FD&C Act requires 
testing under this subpart to be conducted, ``in response to a specific 
testing requirement under this Act or implementing regulations, when 
applied to address an identified or suspected food safety problem.'' As 
discussed in the proposed rule, we proposed to interpret section 
422(b)(1)(A)(i) to apply to provisions of the FD&C Act or its 
implementing regulations that explicitly require food testing. 84 FR 
59452 at 59462. We identified nine explicit testing requirements in our 
regulations that we tentatively concluded address an identified or 
suspected food safety problem because each of those testing 
requirements was a followup test after a

[[Page 68748]]

routine test indicated the presence of a pathogen or indicator organism 
(i.e., an organism that indicates conditions in which an environmental 
pathogen may be present). For example, Sec.  118.4(a)(2)(i) of our 
shell egg safety regulation requires an environmental test for 
Salmonella Enteritidis when the pullets are 14 to 16 weeks of age. If 
the environmental test is positive, Sec.  118.4(a)(2)(iii) requires 
shell egg testing to commence within 2 weeks of the start of egg laying 
(unless the eggs are diverted to treatment, see Sec.  118.6(a)(2)). We 
tentatively concluded that the followup shell egg testing would be 
covered by the rule, but the initial environmental testing would not. 
Section 422(b)(1)(A)(i) of the FD&C Act is implemented in Sec.  
1.1107(a)(1) of this final rule. For a discussion of FDA's 
interpretation of ``identified and suspected food safety problem,'' see 
Response 35.
    Section 422(b)(1)(A)(ii) of the FD&C Act requires testing to be 
conducted under this subpart, ``as required by the Secretary, as the 
Secretary deems appropriate, to address an identified or suspected food 
safety problem.'' Section 422(b)(1)(A)(ii) of the FD&C Act is 
implemented in Sec.  1.1108 of this final rule, which addresses the 
directed food laboratory order. (For discussion of the directed food 
laboratory order, see Comment 41 through Comment 56 and Responses, 
below.) Section 422(b)(1)(A)(ii) of the FD&C Act also authorizes Sec.  
1.1107(a)(3) of this final rule, which requires that food testing be 
conducted under this program when it is conducted to address an 
identified or suspected food safety problem and is presented to FDA in 
three administrative procedural settings: As part of evidence for a 
hearing under section 423(c) of the FD&C Act prior to the issuance of a 
mandatory recall order, 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.
    Section 422(b)(1)(B)(i) of the FD&C Act requires testing to be 
conducted under this subpart, ``in support of admission of an article 
of food under section 801(a).'' Section 422(b)(1)(B)(i) of the FD&C Act 
is implemented in Sec.  1.1107(a)(4) of this final rule. Section 
422(b)(1)(B)(ii) of the FD&C Act requires testing to be conducted under 
this subpart when such testing is to support removal from an import 
alert through successful consecutive testing, and is implemented in 
Sec.  1.1107(a)(5) of this final rule.
    We appreciate those aspects of comments that express support for 
the proposed testing provisions.
    (Comment 30) Some comments note that there have been foodborne 
illnesses associated with shell eggs produced at farms with less than 
3,000 laying hens. These comments also note that food safety recalls 
associated with shell eggs, including from cage-free and free-range egg 
farms that have less than 3,000 laying hens, affect all egg farms. In 
the view of these comments, FDA's egg safety rule should therefore not 
exclude shell egg producers with less than 3,000 laying hens, and all 
egg farms regardless of size should be subject to this rule for the 
testing described in Sec.  1.1107(a)(1)(ii).
    (Response 30) This final rule requires use of a LAAF-accredited 
laboratory for certain followup tests that already are required by 
other food safety regulations (Sec.  1.1107(a)(1)). Because shell egg 
farms that have less than 3,000 laying hens are exempt from the egg 
safety rule, such farms are not subject to this final rule for the egg 
safety rule testing that falls within the scope of this subpart.
    (Comment 31) Some comments opine that our use of the term, 
``corrective action testing'' with respect to followup testing in 
response to an identified or suspected food safety problem appears to 
mean something different than it does in the world of conformity 
assessment. These comments assert that for conformity assessment 
purposes, ``corrective action'' means that a laboratory takes an 
``action to eliminate the cause of a nonconformity and to prevent 
recurrence;'' these comments cite ISO/IEC 9001.
    (Response 31) In the proposed rule, we used the term, ``corrective 
action'' to refer to actions taken by a conformity assessment entity in 
response to a deficiency (see, e.g., 84 FR 59452 at 59491 (``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 proposed rule, 
we also used the term, ``corrective action'' to describe followup 
activities undertaken by a food manufacturer or processor after product 
or environmental testing indicates the presence of a pathogen or 
indicator organism (84 FR 59452 at 59455).
    We understand why comments express the view that it may have been 
confusing for the term, ``corrective action'' to mean two different 
things in the proposed rule. In addition, in the proposed rule, we 
could have been more precise in our use of the term, ``explicit 
corrective action testing'' to describe testing covered by section 
422(b)(1)(A)(i) of the FD&C Act. Section 422(b)(1)(A)(i) directs this 
program to cover testing ``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.'' 
Not all the testing described by this statutory language may be 
properly categorized as corrective action testing, (e.g., the sprouts 
environmental tests at 21 CFR 112.146(c) are considered verification 
tests within the sprouts regulatory framework; see Sec.  
1.1107(a)(1)(i)).\3\ To improve clarity and precision, we use the 
phrase, ``explicit followup testing'' in the final rule to mean the 
testing that we have determined will be subject to this subpart under 
our section 422(b)(1)(A)(i) authority.
---------------------------------------------------------------------------

    \3\ For more information on sprouts environmental testing, see 
the ``Compliance with and Recommendations for Implementation of the 
Standards for the Growing, Harvesting, Packing, and Holding of 
Produce for Human Consumption for Sprout Operations'' draft 
guidance, available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-compliance-and-recommendations-implementation-standards-growing-harvesting.
---------------------------------------------------------------------------

    For the foregoing reasons, including to minimize risk of confusion 
and to improve the final rule, we generally reserve use of the term, 
``corrective action,'' to the conformity-assessment context, in this 
document. Exceptions include discussion related to the preventive 
controls regulations; see Comment and Response 37. For clarity we have 
added the following definition of ``corrective action'' to Sec.  
1.1102: ``Corrective action means an action taken by an accreditation 
body or laboratory to investigate and eliminate the cause of a 
deficiency so that it does not recur.'' Relatedly, in Sec. Sec.  
1.1121, 1.1131, and 1.1161 of the final rule, we have added references 
to the specific sections of the relevant ISO/IEC standard to clarify 
the process a recognized accreditation body or LAAF-accredited 
laboratory must take to address deficiencies through corrective action.
    (Comment 32) In the proposed rule, we described the circumstances 
under which testing of imported food would be subject to the 
requirements of this final rule. In brief, we proposed that an owner or 
consignee whose entry has been detained because the food is or appears 
to be adulterated or misbranded must use a LAAF-accredited laboratory 
to conduct the food testing used as testimonial evidence supporting 
admission to the United States. The

[[Page 68749]]

other import testing that we proposed to cover in this final rule is 
testing to support the removal of food from import alert through 
successful consecutive testing. Import alerts inform FDA's field staff 
and the public that the Agency has enough evidence to allow for DWPE of 
products that appear to be in violation of FDA's laws and regulations.
    Some comments express appreciation that the proposed rule included 
information on when imported foods would need to be tested. Some 
comments support our proposal to require the use of a LAAF-accredited 
laboratory for testing conducted to support removal from import alert. 
These comments endorse the portion of the proposed rule preamble that 
discussed the importance of reliable testing of imports and indicate 
that in the past, food commodities subject to import alert have caused 
multiple foodborne illness outbreaks. These comments state that 
although it will take many tools and approaches to ensure the safety of 
imported foods, reliable testing is a critical component of a 
successful strategy.
    (Response 32) With appreciation for these supportive comments, we 
confirm that the import-related circumstances under which food testing 
is required by this subpart in the proposed rule remain unchanged in 
the final rule: Testing in support of admission of an article of food 
under section 801(a) of the FD&C Act (Sec.  1.1107(a)(4)) and testing 
to support removal from an import alert through successful consecutive 
testing (Sec.  1.1107(a)(5)).
    (Comment 33) Some comments express confusion about when this final 
rule would apply and asked when the requirements of the final rule 
would apply to regulatory feed testing laboratories.
    (Response 33) A regulatory feed testing laboratory may choose to 
seek LAAF-accreditation to conduct testing under this subpart. If 
animal food were the subject of testing required to be conducted under 
this program (i.e., the subject of food testing under Sec.  
1.1107(a)(2) through (5)), then an owner or consignee would need to use 
a LAAF-accredited laboratory to conduct the test. For a discussion of 
program implementation, see Response 14.
    (Comment 34) Some comments express the erroneous understanding that 
the laboratory accreditation final rule would apply only when food 
testing is conducted in a food manufacturing or processing facility. 
These comments express the concern that adulteration may occur after 
the food leaves the production facility, in which case testing 
conducted during production is outdated and inaccurate, and potentially 
masks a food safety problem.
    (Response 34) We first clarify that the testing covered by this 
rule is not limited to testing in a food manufacturing or processing 
facility. Certain testing at farms is also covered; for example, Sec.  
1.1107(a)(1)(ii) describes shell egg testing, and those eggs originate 
on a poultry farm. In addition, this rule covers a significant number 
of tests of imported food (Sec.  1.1107(a)(4) and (5)). Because FDA 
agrees that adulteration may occur while food is in transit, the final 
rule generally requires imported food products subject to this final 
rule to be sampled and tested after the food has arrived in the United 
States. (See Sec.  1.1107(c) and Response 40 for more on this topic.) 
Thus, testing of imported food subject to this final rule generally 
will occur at or near the U.S. border.
    FDA also has other tools to address adulteration that occurs 
outside of production establishments, including another FSMA 
regulation, the ``Sanitary Transportation of Human and Animal Food'' 
regulation (part 1, subpart O), which requires shippers, carriers by 
motor vehicle or rail vehicle, receivers, and other persons engaged in 
the transportation of food, to use sanitary transportation practices to 
ensure that the food is not transported under conditions that may 
render the food adulterated.
    (Comment 35) In the preamble to the proposed rule, we discussed 
considerations in our interpretation of the phrase, ``identified or 
suspected food safety problem,'' which appears in section 
422(b)(1)(A)(i) and (ii) of the FD&C Act and is therefore important in 
determining which testing will be covered by this subpart. Among other 
things, we explored other uses of similar phrases elsewhere in FSMA. We 
tentatively concluded 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. We tentatively concluded that a 
``suspected food safety problem'' typically would have a basis in fact 
about a particular article of food (e.g., a lot or batch) or food 
production environment (e.g., a specific facility). We reasoned that 
the requisite suspicion would not be satisfied by the common or usual 
characteristics of food (e.g., whether a food is considered ``high 
risk'') or the manner in which the food is typically produced. We 
tentatively concluded that the routine product testing and 
environmental monitoring requirements required by the preventive 
controls for human food regulation (see 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 (``verification 
testing'') and not because a food safety problem is suspected or 
identified. 84 FR 59452 at 59462. This same tentative conclusion would 
apply to the routine product testing and environmental monitoring 
requirements required by the Current Good Manufacturing Practice, 
Hazard Analysis, and Risk-based Preventive Controls for Food for 
Animals (preventive controls for animal food) regulation (Sec.  
507.49(a)(2) and (3) (21 CFR 507.49(a)(2)) and (3), respectively).
    In the proposed rule we explained that, in the preventive controls 
for human food regulation, FDA indicated that an ``unanticipated food 
safety problem'' could occur where a preventive control is not properly 
implemented, including where a pathogen or indicator organism is 
detected during routine product or environmental testing (verification 
testing). In the proposed rule we tentatively concluded that, depending 
on the circumstances, a routine test that indicated the presence of an 
indicator organism would not necessarily constitute a suspected food 
safety problem. 84 FR 59452 at 59462.
    Some comments dispute our interpretation of ``identified or 
suspected food safety problem.'' From their perspective, there is no 
need for the problem to be particularized to an article of food or a 
facility. These comments state that the statute does not direct that 
``an identified or suspected food safety problem,'' could only be 
present in relation to a specific article of food or facility. The 
comments argue that the appearance of the phrase, ``food safety 
problems'' in two FSMA titles that cover multifaceted approaches to 
food safety (Title I: ``Improving Capacity to Prevent Food Safety 
Problems'' and Title II: ``Improving Capacity to Detect and Respond to 
Food Safety Problems'') supports the position that Congress did not 
intend for the same terms to be read narrowly in the context of section 
422 of the FD&C Act. These comments indicate that the economic analysis 
accompanying the proposed rule estimated that far fewer tests would be 
subject to the LAAF program under section 422(b)(1)(A) than under 
section 422(b)(1)(B) of the FD&C Act.
    (Response 35) The phrase, ``identified or suspected food safety 
problem,'' appears twice in section 422(b)(1)(A) of

[[Page 68750]]

the FD&C Act and therefore helps demarcate which testing will be 
covered by this subpart. The statute does not define either 
``identified or suspected food safety problem,'' or ``food safety 
problem,'' nor do those phrases appear elsewhere in the body of FSMA. 
As referenced above, the phrase, ``food safety problem'' appears in the 
FSMA titles: Title I, ``Improving Capacity to Prevent Food Safety 
Problems,'' and Title II, ``Improving Capacity to Detect and Respond to 
Food Safety Problems.'' Comments urge us to infer from the breadth of 
the various provisions within each of those two titles, that when 
Congress used the same phrase in section 422(b)(1)(A) of the FD&C Act, 
it intended the phrase to be broadly interpreted. However, we cannot 
impute such an intention to Congress without some indication of that 
intent in section 422 of the FD&C Act or the legislative history. 
Indeed, one could reasonably infer the opposite--that from the breadth 
of the provisions within FSMA Titles I and II, Congress must have 
intended for the phrase, ``food safety problems'' to have different 
meanings in different contexts. In sum, ``food safety problem'' is not 
defined in the statute, and thus it falls to FDA to elaborate on its 
meaning.
    In the proposed rule, we looked at other FSMA standards and other 
FSMA regulations, before making the tentative conclusions described 
above in Comment 35. We finalize those conclusions without change.
    In this vein, we observe that the purpose of routine product and 
environmental testing under the preventive controls regulations is to 
verify that preventive controls are consistently implemented and are 
effective (Sec. Sec.  117.165(a) and 507.49(a)). Accordingly, such 
testing does not address an identified or suspected food safety 
problem, and is not covered by this subpart.
    (Comment 36) In the proposed rule, we tentatively concluded that 
although section 422(b)(1)(B)(i) of the FD&C Act requires testing, ``in 
support of admission of an article of food under section 801(a)'' to be 
conducted under this subpart, it was reasonable not to apply section 
422(b)(1)(B)(i) to food testing related to FSVP. We explained that 
under section 801(a)(3) of the FD&C Act, FDA may refuse admission of an 
article of food if the food is, or appears to be, adulterated or 
misbranded. When FDA determines that an article of food is, or appears 
to be, adulterated or misbranded, we must notify the owner or consignee 
of our determination, and state the reason(s) for such determination 
(Sec.  1.94(a)). FDA must also specify a period of time during which 
the owner or consignee may introduce testimony relevant to the 
admissibility of the article of food. Id. Owners or consignees often 
engage laboratories to test the food and then introduce the test 
results (along with associated data and analysis) as evidence that the 
food is admissible. If FDA determines that the sampling methods and 
testing results are valid and indicate that the article of food does 
not appear to violate the FD&C Act, FDA will determine that the article 
of food is admissible, release it from detention, and permit its 
entrance into the United States. Thus, the focus of section 
422(b)(1)(B)(i) of the FD&C Act is the characteristics of an article of 
food that is pending at the border. Under Sec.  1.1107(a)(4) of this 
final rule, the testing obtained by the owner or consignee and 
submitted as testimony to support release of the article of food from 
detention, must be conducted under this subpart.
    FSMA amended the FD&C Act to add section 805, ``Foreign Supplier 
Verification Program,'' 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. Depending on the circumstances, sampling and 
testing of a food may be an appropriate supplier verification activity. 
See Sec.  1.506(d)(1)(ii)(B). If an FSVP importer fails to comply with 
the FSVP regulations for a particular food, that food may be refused 
admission under section 801(a)(3) of the FD&C Act.\4\ However, such 
refusal is not because the article of food pending at the border is, or 
appears to be, adulterated or misbranded. Instead, the refusal is a 
consequence of the importer's failure to comply with its FSVP 
obligations. Testing the article of food detained at the border in this 
instance would have no impact on its admissibility under section 
801(a)(3) of the FD&C Act, because the detention is due to the 
characteristics of the importer. In the proposed rule we tentatively 
concluded that, because the focus of the FSVP provision in section 
801(a)(3) of the FD&C Act is entirely different than the focus of the 
circumstances addressed by section 422(b)(1)(B)(i) of the FD&C Act, it 
is reasonable not to apply the latter subpart to the testing of food 
conducted under FSVP.
---------------------------------------------------------------------------

    \4\ For more information on FSVP, see https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals.
---------------------------------------------------------------------------

    Several comments agree with our reasoning regarding testing under 
FSVP and our proposal that such testing not require use of a LAAF-
accredited laboratory. However, other comments disagree, expressing the 
perspective that as the proposed rule would cover testing to support 
removal from import alert, it seems more consistent with the FSMA 
framework to also require testing related to FSVP to be conducted under 
this subpart. We understand these comments to mean that, because FSVP 
addresses the safety of food imports, and testing related to import 
alerts also addresses the safety of food imports, FDA is being 
inconsistent in covering import alert testing under this subpart, but 
not testing related to FSVP. These comments further suggest that we not 
require test results related to FSVP to be sent directly to FDA. The 
comments do not explain why FSVP tests, which they argue should be 
subject to this subpart, should nevertheless be excepted from the 
requirement that all test results under this subpart be submitted 
directly to FDA.
    (Response 36) We disagree that our determinations regarding testing 
related to FSVP are inconsistent with covering testing to support 
removal from import alert under this subpart. As an initial matter, the 
section of the statute authorizing the LAAF program explicitly directs 
that testing to support removal from import alert be subject to this 
program, and does not mention FSVP. Further, for the reasons discussed 
in the proposed rule and briefly described in the comment summary 
above, we conclude that it is reasonable not to apply section 
422(b)(1)(B)(i) of the FD&C Act to food testing related to FSVP. These 
comments do not explain why FSVP test results would warrant an 
exception from the Sec.  1.1152(b) requirement to submit all tests 
results under this program directly to FDA, and as the final rule will 
not cover testing related to FSVP, the suggestion is inapplicable.
    (Comment 37) Some comments agree with our tentative conclusion in 
the proposed rule that the routine product and environmental testing 
that occurs pursuant to a preventive controls food safety plan should 
not require the use of a LAAF-accredited laboratory. Some of these 
comments encourage FDA to make explicit in the final rule that routine 
product testing under the preventive control regulations is performed 
to verify that applied controls have been

[[Page 68751]]

effective, and not to address an identified or suspected food safety 
problem, and therefore is not covered by the laboratory accreditation 
final rule. Some comments also request that FDA clarify that 
environmental testing conducted in response to routine environmental 
monitoring results indicating the presence of a pathogen or indicator 
organism would not typically be considered testing conducted to address 
an identified or suspected food safety problem, and would therefore 
typically fall outside the scope of the laboratory accreditation final 
rule. According to these comments, facilities should have an 
opportunity to perform an analysis of the root cause for the 
environmental positive, take corrective actions and conduct additional 
testing as needed, before FDA determines that an identified or 
suspected food safety problem exists and possibly warrants testing by a 
LAAF-accredited laboratory.
    On the other hand, some comments urge FDA to include within the 
purview of this final rule all food testing required by our 
regulations, and at a minimum the verification testing and followup 
testing conducted under the preventive controls and FSVP 
regulations.\5\ Some of these comments contend that FDA has 
misinterpreted the statute, and claim that section 422(b)(1)(A) of the 
FD&C Act grants broad discretion to FDA to require use of a 
participating laboratory in such circumstances.\6\ Some comments 
highlight the language in section 422(b)(1)(A)(ii) of the FD&C Act, 
which states in relevant part, ``as the Secretary deems appropriate, to 
address an identified or suspected food safety problem,'' and argue 
that such language grants FDA ``expansive'' authority for the final 
rule to cover circumstances where either FDA or facilities themselves 
have identified a food safety hazard and are using testing as part of 
the approach to address the hazard. Such comments express the view that 
if FDA does not require more domestic food testing to be conducted 
under this program, FDA is failing to address food safety problems as 
Congress intended. Comments encourage the Agency to adopt a broader 
statutory interpretation of section 422(b)(1)(A) of the FD&C Act even 
if we do not expand the testing subject to the final rule, so that we 
may preserve the authority to add more testing to Sec.  1.1107 in the 
future.
---------------------------------------------------------------------------

    \5\ Some comments refer to ``corrective action testing;'' we 
have changed the phrase to ``explicit followup testing.'' See 
Response 31.
    \6\ Some comments imply that the testing required under section 
422(b)(1)(A) of the FD&C Act is limited to domestic food production 
circumstances. However there is nothing in the statute that limits 
section 422(b)(1)(A) to testing of food produced domestically, and 
accordingly Sec.  1.1107(a)(1)-(3) of this final rule also refrains 
from imposing that limitation.
---------------------------------------------------------------------------

    In support of their contentions, some comments offer an example of 
a Georgia food processing facility that was conducting environmental 
testing as required by the preventive controls for human food 
regulation but whose products (boiled eggs) nevertheless caused an 
outbreak, which, according to the comments, calls into question the 
accuracy of the test results and the quality of the facility's testing 
program.
    These comments posit that perhaps FDA did not propose to include 
testing related to the preventive controls or FSVP regulations within 
the scope of this subpart because testing under those regulations is 
not always required; depending on the circumstances the facility or 
importer may find other actions sufficient. These comments find such 
reasoning unpersuasive because in their view, whenever testing is 
required as a verification or followup activity under the preventive 
controls or FSVP regulations, the testing is being conducted ``in 
response'' to a regulatory requirement and so is covered by section 
422(b)(1)(A) of the FD&C Act.
    These comments alternatively posit that perhaps FDA did not propose 
to cover preventive controls and FSVP testing because this approach 
might be burdensome for industry. According to these comments, if that 
is the case, then such concerns could be addressed by providing 
additional time for implementation; further, any such concerns would be 
offset by the positive health and economic benefits that they suggest 
testing would create by preventing outbreaks.
    (Response 37) Some comments contend that section 422(b)(1)(A) of 
the FD&C Act grants FDA broad discretion to require testing to be 
conducted under this subpart. We address the two subparagraphs of 
section 422(b)(1)(A) in turn.
Section 422(b)(1)(A)(i) of the FD&C Act
    Section 422(b)(1)(A)(i) of the FD&C Act provides that testing must 
be covered by this program when the testing is conducted, ``in response 
to a specific testing requirement under this Act or implementing 
regulations, when applied to address an identified or suspected food 
safety problem.'' We discussed our interpretation of ``identified and 
suspected food safety problem'' in Response 35, above, and concluded 
that routine product and environmental testing that occurs pursuant to 
a preventive controls food safety plan (Sec. Sec.  117.165(a) and 
507.49(a)) is not covered by this subpart. We turn now to our 
interpretation of the phrase, ``in response to a specific testing 
requirement under this Act or implementing regulations.''
    In the proposed rule, we tentatively interpreted, ``specific 
testing requirement under this Act or implementing regulations'' to 
mean that this subpart would cover food testing explicitly required by 
a statutory or regulatory provision. 84 FR 59452 at 59462. We 
identified nine testing requirements in FDA regulations that were both 
explicit and address an identified or suspected food safety problem: 
Five testing requirements in the egg safety rule (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 in the standards for the growing, harvesting, packing, 
and holding of sprouts (Sec.  112.146(a), (c), and (d)), and one in our 
regulations on the processing and bottling of bottled drinking water 
(Sec.  129.35(a)(3)(i)).
    Comments do not directly dispute our proposed interpretation of the 
term, ``specific,'' but some contend that all food testing requirements 
in our regulations should be covered by this subpart. However, the 
statute only authorizes testing to be covered by this subpart if it is 
both an explicit testing requirement and a testing requirement that 
addresses an identified or suspected food safety problem. Not all food 
testing requirements in FDA regulations satisfy those two prongs of 
section 422(b)(1)(A)(i) of the FD&C Act. Indeed, if Congress had 
intended for all food testing required by FDA regulations to be covered 
by this program, they could have said so.
    Some comments argue that testing under the preventive controls and 
FSVP regulations falls within the purview of section 422(b)(1)(A)(i) of 
the FD&C Act. More specifically, these comments identify the testing 
done to verify the effectiveness of controls, or as part of corrective 
actions taken when issues are identified, as testing that should be 
covered by this subpart.
    First, these comments discuss testing in relation to FSVP jointly 
with testing under the preventive controls regulations. However, we 
have already concluded that testing related to FSVP is not covered by 
this subpart (see Response 36); for the remainder of this response we 
consider comments just in relation to the preventive controls 
regulations.
    Some comments acknowledge that the preventive controls regulations 
do not always require testing. Briefly, the preventive controls 
regulations apply to most registered food facilities. A wide variety of 
registered food facilities process, manufacture, pack, or hold all

[[Page 68752]]

kinds of foods, so these regulations are structured to address a 
plethora of circumstances. Under the preventive controls regulations, 
facilities are responsible for analyzing food safety hazards to 
determine if there are hazards requiring a control and then developing 
and implementing a plan for the control of those hazards. The 
regulations are written to provide significant flexibility to 
facilities, and that flexibility is reflected in the provisions that 
address testing.
    For example, facilities must verify that their controls are being 
consistently implemented and are effective at minimizing or preventing 
the identified hazards. The regulations identify testing as one 
verification activity, but the facility is responsible for determining 
which verification activities are appropriate in their particular 
circumstances. By way of another example, facilities must establish and 
implement corrective action procedures that must be taken if a 
preventive control was not properly implemented. See Sec. Sec.  
117.150(a) and 507.42(a). A routine verification test indicating the 
presence of a pathogen or indicator organism in a ready-to-eat product 
would signal that a preventive control was not properly implemented. 
See Sec.  117.150(a)(1). In certain circumstances, followup testing 
would be one appropriate corrective action a facility could take in 
response to such a signal. However, the regulations do not prescribe 
exactly when followup testing is required, instead placing the 
responsibility for making that determination on the facility.
    Comments argue that because any verification or followup testing 
that occurs under the preventive controls regulations is ``in 
response'' to the regulations, such tests fall within the purview of 
section 422(b)(1)(A)(i) of the FD&C Act. These comments may prefer that 
the word, ``specific'' not appear in section 422(b)(1)(A)(i) of the 
FD&C Act, but it does, and it must be given meaning. Regulatory 
provisions that confer significant discretion on regulated entities for 
determining when food testing is necessary, are not explicit testing 
requirements and therefore are not covered by this subpart. We finalize 
our proposed interpretation of ``specific'' testing requirements 
without change and conclude that neither routine verification testing 
nor followup testing under the preventive controls regulations is 
covered by this subpart using our section 422(b)(1)(A)(i) authority.
    Some comments opposing our interpretation of section 
422(b)(1)(A)(i) of the FD&C Act discuss whether we chose not to include 
verification and followup testing under the preventive controls 
regulations because it would place a greater burden on those 
facilities. Comments state that if that is the case, our concerns could 
be addressed by providing more time for such entities to comply with 
this final rule. Comments also state that there would be public health 
benefits from requiring the use of a LAAF-accredited laboratory for 
such testing. However, as discussed above, we have determined that the 
regulatory provisions describing verification and followup testing in 
the preventive controls regulations are not explicit testing 
requirements, and therefore we do not interpret them to satisfy the 
statutory requirements of section 422(b)(1)(A)(i).
    For the foregoing reasons, we conclude that we have properly 
identified the nine FD&C Act testing requirements that are currently 
covered by this subpart under our section 422(b)(1)(A)(i) authority. It 
is possible that in the future, FDA may require additional specific 
followup testing in FD&C Act regulations, and that testing would be 
covered by this subpart. However for now, we finalize Sec.  
1.1107(a)(1) without change.
Section 422(b)(1)(A)(ii) of the FD&C Act
    Section 422(b)(1)(A)(ii) authorizes FDA to require testing to be 
conducted under this subpart, ``as required by the Secretary, as the 
Secretary deems appropriate, to address an identified or suspected food 
safety problem.'' In the final rule we rely on this statutory provision 
to require that testing conducted pursuant to a directed food 
laboratory order be conducted under this subpart; see Sec.  1.1108. 
Very briefly, as we interpret this statutory provision, directed food 
laboratory orders will generally be limited to the rare situations when 
we have reason to question the accuracy or reliability of past or 
present test results, and an identified or suspected food safety 
problem exists. (The directed food laboratory order is discussed in 
Comment 41 through Comment 56 and Responses, below.) We also rely on 
our section 422(b)(1)(A)(ii) authority to require in the final rule 
that testing related to certain administrative proceedings be conducted 
under this subpart; see Sec.  1.1107(a)(3). (For discussion of the use 
of section 422(b)(1)(A)(ii) authority to cover certain administrative 
proceedings testing under this subpart, see the proposed rule (84 FR 
59452 at 59463-64)). We agree with those aspects of comments noting 
that the language of section 422(b)(1)(A) of the FD&C Act is broad 
enough that, in the future, we could cover additional testing under 
this subpart by relying on that authority. This could occur if we deem 
it appropriate to expand this program to cover additional testing, and 
the additional testing addresses an identified or suspected food safety 
problem. Further, we intend to make such a change only through notice-
and-comment rulemaking.
    Some comments request that FDA clarify that environmental testing 
conducted in response to routine environmental monitoring results 
indicating the presence of a pathogen or indicator organism would not 
typically be considered testing conducted to address an identified or 
suspected food safety problem, and would therefore typically fall 
outside the scope of the laboratory accreditation final rule. We have 
determined that the routine verification and followup testing 
provisions in the preventive controls regulations do not state explicit 
testing requirements and are therefore not appropriate to include in 
Sec.  1.1107(a)(1); therefore, they will typically fall outside the 
scope of this final rule. We have also determined that routine 
verification testing that occurs pursuant to a preventive controls food 
safety plan (Sec. Sec.  117.165(a) and 507.49(a)) does not address an 
identified or suspected food safety problem (Response 35). However, 
followup testing in response to routine verification test results 
indicating the presence of a pathogen or indicator organism in either a 
food product or the food production environment may qualify as testing 
that addresses an identified or suspected food safety problem, 
depending on the circumstances. We affirm the statement we made in the 
proposed rule that, depending on the circumstances, a positive 
indicator organism test would not necessarily constitute a suspected 
food safety problem; for example, a single positive Listeria spp. on a 
food contact surface in a facility would not necessarily constitute a 
suspected food safety problem. However, when a routine verification 
test of a food product indicates the presence of a pathogen, in many 
circumstances we would conclude that there is at least a suspicion of a 
food safety problem. For example, the presence of Salmonella in nuts 
indicates a suspicion of a food safety problem, but the presence of 
Bacillus cereus in tree nuts is not likely to indicate a food safety 
problem, since the organism cannot grow to the high numbers needed to 
cause illness due to the low water activity of tree nuts. Additionally, 
in many circumstances a

[[Page 68753]]

routine environmental monitoring test result indicating the presence of 
a pathogen in a facility producing a ready-to-eat product could be 
classified at least as a suspected food safety problem.
    Followup testing that addresses an identified or suspected food 
safety problem under the preventive controls regulations--or in the 
context of the FD&C Act, or any FDA food safety regulation--may fall 
within the purview of section 422(b)(1)(A)(ii) of the FD&C Act. Under 
this final rule, this means that such testing may be the subject of a 
directed food laboratory order under Sec.  1.1107(a)(2), and may be the 
subject of the testing in certain administrative proceedings described 
in Sec.  1.1107(a)(3). We do not anticipate frequent testing under 
Sec.  1.1107(a)(2) or (3); as a result, under this final rule, followup 
testing that addresses an identified or suspected food safety problem, 
but that is not expressed in an explicit testing requirement, will 
typically fall outside the scope of this subpart. Again, were we to 
seek to expand the testing subject to this final rule, we would go 
through the rulemaking process. (For discussion of the circumstances in 
which we anticipate issuing a directed food laboratory order, see 
Response 47.)
    We do not agree that the 2019 foodborne illness outbreak linked to 
hard-boiled eggs and cited in comments is evidence that this final rule 
should generally cover routine verification and followup testing under 
the preventive controls regulations. In the above-referenced situation, 
the facility was processing shell eggs into hard-boiled egg products; 
the hard-boiled eggs were linked to an outbreak of Listeria 
monocytogenes infections. The facility was processing a ready-to-eat 
product that was exposed to the facility environment prior to 
packaging; in those circumstances, the preventive controls for human 
food regulation generally requires that the facility establish 
sanitation controls verified in part by an environmental monitoring 
program that involves regularly testing the facility environment. See 
Sec.  117.165(a)(3). We thus maintain the view that the existing 
preventive controls for human food regulation adequately covers this 
situation. When FDA collected environmental samples as part of its 
investigation, the facility did as well. There would be no point in 
requiring tests such as those taken by the facility to be subject to 
this subpart when FDA was onsite to conduct its own investigational 
tests. Indeed, the tests of environmental samples the facility 
collected alongside FDA inspectors would not be categorized as 
verification or followup tests, and thus would not fall within the 
purview of this final rule, even if the rule did cover these test 
categories.\7\
---------------------------------------------------------------------------

    \7\ Comments also state that the facility in question engaged a 
laboratory to validate a process control, but comments do not 
suggest that this final rule should cover such testing.
---------------------------------------------------------------------------

    As support for their argument that FDA is applying section 
422(b)(1)(A) of the FD&C Act too narrowly, some comments state that the 
economic analysis accompanying the proposed rule indicated that many 
more tests would be conducted under this subpart stemming from section 
422(b)(1)(B) than section 422(b)(1)(A). The economic analysis 
accompanying a rule simply reflects the rule it analyzes; this point 
appears to be another facet of the argument that we have misinterpreted 
the statute. We disagree for the reasons already stated.
    We also disagree that in issuing this final rule FDA is falling 
short of addressing important food safety problems. For the reasons 
discussed throughout this response, we believe we have interpreted the 
statute appropriately, and we look forward to achieving significant 
public health benefits as a result of this rule (Ref. 4).
    (Comment 38) Some comments generally urge a broader scope for the 
laboratory accreditation final rule. Some of these comments discuss the 
critical role food laboratories play in helping to keep the food supply 
safe, including the corresponding need for accurate and reliable 
results, and therefore seek Federal oversight of all food testing 
laboratories. Some of these comments advocate for a requirement that 
all food testing laboratories be accredited, which we understand to 
mean either that these comments express the belief that all food 
testing laboratories should be required to be accredited to ISO/IEC 
17025:2017, or should be subject to LAAF-accreditation under this 
subpart. Other comments suggest that all laboratories that test food 
for human consumption should be required to satisfy the baseline 
requirement of this final rule and be accredited to ISO/IEC 17025:2017. 
These latter comments suggest that the additional requirements of this 
final rule could then be reserved just for the testing identified in 
Sec.  1.1107(a).
    (Response 38) We appreciate the critical role that all food testing 
laboratories play in helping to keep the food supply safe, and we 
acknowledge the importance of accurate and reliable test results. 
However, section 422 of the FD&C Act does not contemplate FDA 
regulation of all food testing laboratories, or of all laboratories 
that test food for human consumption. We therefore do not require that 
all food testing, or human food testing, laboratories be accredited to 
ISO/IEC 17025:2017 or comply with the laboratory requirements in this 
subpart.
    (Comment 39) Some comments request additional information about the 
role the LAAF-accredited laboratories will play in relation to food 
manufacturing facilities that are subject to required product or 
environmental testing under the final rule. These comments assert that 
the proposed rule was ``not clear regarding the level of authority an 
accredited lab has in order to perform on-site collection activities at 
food manufacturing facilities.'' These comments recommend that FDA 
clarify in the final rule the roles and responsibilities of the 
participating laboratory and facility, such as which information and 
records the facility would be required to make available to the 
laboratory.
    (Response 39) We believe these comments misunderstood the proposed 
rule. When food testing is required to be conducted under this subpart, 
an owner or consignee must use a LAAF-accredited laboratory. However, 
the owner or consignee will select a LAAF-accredited laboratory from 
the online registry (see Sec.  1.1109), and engage the laboratory, and 
that laboratory will have no more authority over the owner or consignee 
than specified in the business arrangement between the parties. The 
final rule requires that the sample be collected by a person qualified 
by training or experience to do so, and requires certain sampling 
documents (Sec.  1.1149), but the owner or consignee may select any 
sampler or sampling firm it likes, as long as the entity or person is 
qualified and will provide the documentation required under the final 
rule. Sometimes owners or consignees collect their own samples, 
sometimes they engage third-party sampling firms, and sometimes they 
pay the laboratory that will analyze the sample to collect the sample. 
Under this subpart, that choice remains with the owner or consignee. 
Therefore, FDA declines to further articulate any roles or 
responsibilities of these parties beyond the requirements of the final 
rule.
    (Comment 40) In the proposed rule, for imported food, we provided 
that testing under this rule generally could only be conducted on 
samples taken after the articles of food have arrived in the United 
States. We proposed one exception to that policy, where FDA determines 
that a sample taken prior to arrival is representative of the article 
of food offered for import. We said that we would make such a 
determination on a

[[Page 68754]]

case-by-case basis. We received several comments on this aspect of our 
proposal.
    First, some comments appear to understand that we proposed that 
sampling prior to arrival may be allowed in certain circumstances, but 
they seem unsure whether testing prior to arrival may also be allowed. 
These comments ask whether foreign laboratories could participate in 
this program and encourage FDA to clarify the extent to which the 
requirements of this final rule would apply to such foreign 
laboratories.
    Some comments support allowing sampling and testing prior to 
arrival in certain circumstances, such as sampling for removal from 
import alert. Other comments maintain that we should allow no 
exceptions to the policy that sampling of imports occur after arrival 
in the United States. These comments opine that allowing sampling prior 
to entry would amount to ``self-policing'' by the owner or consignee. 
They also argue that allowing sampling prior to entry would ignore the 
risk that changes may occur during transit that would impact the test 
results. They view the proposed exception as creating a public health 
concern.
    Additionally, some comments in favor of the proposed policy suggest 
that when FDA determines that a sample taken prior to entry is or would 
be representative of the article of food offered for import, FDA should 
make its determination publicly and widely available (i.e., ``publish'' 
it).
    (Response 40) To clarify, foreign laboratories may seek LAAF-
accreditation to conduct food testing under this subpart. All 
laboratories that choose to participate, whether foreign or domestic, 
must meet the same accreditation standards and comply with all 
provisions of the final rule (see section 422(a)(5) of the FD&C Act). 
There is no requirement that testing of imports subject to this rule 
must be conducted by a laboratory in the United States; testing may be 
conducted by any LAAF-accredited laboratory, regardless of location. 
However, we are finalizing the proposed policy that under this subpart, 
sampling generally must occur after arrival in the United States, 
unless FDA has granted an exception. This requirement protects public 
health by helping to ensure that the test results we are relying on to 
make admissibility decisions accurately reflect the conditions of the 
article of food when offered for import into the United States.
    At the same time, we disagree with the comments contending that all 
import sampling should occur after arrival without exception. We are 
finalizing the proposed exception for those situations in which we 
determine that food sampled prior to export is representative of the 
article offered for import (Sec.  1.1107(c)). The FDA determination to 
grant the exception must be received by the owner or consignee, in 
writing, prior to testing of samples taken prior to arrival in the 
United States (id.). We generally would base such a determination on 
specific circumstances of each shipment (e.g., characteristics of the 
product and analyte, specifics of packaging and transportation) and 
grant any exceptions on a case-by-case basis. We decline the suggestion 
to publish our determinations of scenarios where a sample taken prior 
to arrival is or would be representative of the article of food offered 
for import because we expect our determinations to be situation-
specific. We may consider issuing guidance in the future on the factors 
we evaluate in making such determinations, which we believe would be 
more useful to our constituents than case-by-case publication.
    It is possible that we could make such a determination for an 
article of food subject to DWPE (on an import alert). Again, any such 
determination generally would be made on a case-by-case basis, based on 
clear evidence that the product sampled is representative of the 
product offered for import (see Sec.  1.1107(c); 84 FR 59452 at 59465). 
In the proposed rule, we solicited feedback on whether circumstances 
warrant application of the exception broadly, for instance, to a 
particular commodity or analyte generally. We received no comments with 
suggestions for broader applications of the exception.
    As discussed in Response 101, the rule does not prohibit owners or 
consignees from collecting a sample or conducting their own test, as 
long as all the requirements of the rule are satisfied.
2. When and how will FDA issue a directed food laboratory order (Sec.  
1.1108)?
    Proposed Sec.  1.1108 described the circumstances under which we 
would issue a food testing order. Paragraph (a) described when we would 
require an owner or consignee to have food testing conducted under this 
subpart (``. . . to address an identified or suspected food safety 
problem related to the article of food.'') Proposed Sec.  1.1108(b) and 
(c) also specified what we would include in the order (e.g., the food 
product or environment to be tested, any particular methods, and other 
elements required by part 16 (21 CFR part 16) related to a regulatory 
hearing). As previously discussed, we have changed the terminology in 
this section from ``food testing order'' to ``directed food laboratory 
order,'' and to avoid confusion we use the new term throughout this 
document, even when referring to discussions in the proposed rule.
    On our own initiative, we made a few revisions to this section. We 
revised the proposed rule section title, ``When and how will FDA issue 
a food testing order?'' to ``When and how will FDA issue a directed 
food laboratory order?'' in the final rule and made changes in the 
section to incorporate revised terminology. We removed the unnecessary 
phrase, ``related to the article of food'' in Sec.  1.1108(a). We also 
removed the phrase, ``of an article of food'' from Sec.  1.1108(a) 
since the definition of owner or consignee in Sec.  1.1102 specifies 
interest related to the food product or environment subject to food 
testing. We also made minor editorial changes to this section.
    Many comments support the rulemaking and the Agency's efforts to 
implement section 422 of the FD&C Act; however, they do not support the 
directed food laboratory order provision. Some comments raise 
``substantial'' concerns with the Agency's proposal, specifically 
legal, policy, and practical aspects of the proposed rule with respect 
to directed food laboratory orders. We address these comments below.
    (Comment 41) A number of comments argue that the Agency lacks 
explicit and implied statutory authority in FSMA and the FD&C Act to 
issue directed food laboratory orders. The comments conclude that the 
Agency is limited by the authority delegated by Congress in FSMA and 
under the FD&C Act, and that because neither the plain terms nor the 
core purpose of the relevant sections of the statute contemplate 
directed food laboratory orders, there is no explicit authority to 
issue a directed food laboratory order.
    The comments further argue that the Agency has misinterpreted 
section 422(b)(1)(A)(ii) of the FD&C Act as providing implied authority 
to issue directed food laboratory orders. Comments explain that section 
422(b)(1)(A)(ii) is limited by section 422(b)(1)(A)(i) because the 
clauses are linked by the word, ``and'' and therefore must be read 
conjunctively. To support this interpretation, several comments cite 
the plain language of the statute and case law in support of the 
associated canon of statutory interpretation. Comments assert a 
presumption that Congress intended ``and'' to be read

[[Page 68755]]

conjunctively. Some comments indicate that even though sections 
422(b)(1)(A)(i) and 422(b)(1)(A)(ii) of the FD&C Act repeat the phrase, 
``to address an identified or suspected food safety problem,'' this 
repetition does not support reading the ``and'' disjunctively to 
signify ``or.'' To support this position, the comments cite the case of 
Loving v. IRS (917 F. Supp.2d 67), in which the D.C. Circuit Court 
rejected the IRS argument that existence of overlapping or redundant 
statutory language should override the plain meaning of ``and.'' The 
comments thus conclude that the statute may only be read to require 
food testing under this subpart in two circumstances, as opposed to the 
five circumstances specified in Sec.  1.1107 of the proposed rule.
    Interpreting the statute in this way to require food testing in 
only two circumstances, some comments claim that the two circumstances 
when LAAF-accredited laboratories must be used are when food testing is 
conducted: (1) 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 and as required by the 
Secretary, as the Secretary deems appropriate, to address an identified 
or suspected food safety problem or (2) in support of admission of an 
article of food under section 801(a) of the FD&C Act and under an 
import alert that requires successful consecutive tests. Comments add 
that even if the plain meaning is proven otherwise to read the ``and'' 
disjunctively, it still does not provide the Agency with discretionary 
authority to issue directed food laboratory orders. Comments urge that 
this authority cannot be expanded even if the intent is to further the 
goals of Congress.
    Comments explain that the plain language of the statute requires 
that section 422(b)(1)(A) of the FD&C Act apply only ``in response to'' 
and ``to address'' a food safety problem, not to seek one out. Were 
directed food laboratory orders implemented as proposed, comments argue 
that this approach would create an additional investigative tool not 
contemplated by the statute. Comments express that FDA already has the 
authority to conduct food testing and to choose a laboratory. Comments 
state further that there is no evidence that Congress intended to shift 
the Agency's responsibilities to owners and consignees.
    Some comments state that any authority provided under section 422 
of the FD&C Act to require food testing under this subpart, absent an 
explicit requirement in statute or regulation to conduct testing, must 
only apply in narrow circumstances where the basis for the food safety 
problem has been established. These comments state they would support 
testing by accredited laboratories as part of evidence for a hearing 
prior to the issuance of a mandatory recall order, an order suspending 
a food facility's registration, or an administrative detention order. 
Likewise, other comments add support for the Agency to issue a directed 
food laboratory order as part of the corrective action plan after a 
facility's registration has been suspended.
    Some comments echo the call for FDA to keep the scope of the rule 
narrow and support applying the rule to specific testing requirements 
in FDA's regulations, e.g., certain post-remediation testing after E. 
coli has been identified in the source water for bottled drinking 
water.
    A few comments characterize Congress's grant of authority to the 
FDA to address an ``identified or suspected food safety problem'' in 
FSMA as broad and state that these terms were not defined; however, the 
comments do not support the use of the statute to add what they view as 
a new enforcement tool, namely, the directed food laboratory order. 
These comments seek additional background regarding how this tool fits 
with other FDA authorities as they did not anticipate the Agency 
implementing the statute through the use of directed food laboratory 
orders as set forth in the proposed rule.
    (Response 41) We disagree with the assertions in the comments that 
the Agency lacks the statutory authority to issue directed food 
laboratory orders. Section 422(b)(1)(A)(ii) provides authority for 
testing under this subpart ``as required by the Secretary, as the 
Secretary deems appropriate, to address an identified or suspected food 
safety problem.'' The ``and'' joining the two clauses in sections 
422(b)(1)(A) and (B) is appropriately read as joining lists containing 
two separate and distinct circumstances. Reading the ``and'' 
conjunctively as some comments urge would create an absurd result since 
both clauses of 422(b)(1)(A) repeat the phrase, ``to address an 
identified or suspected food safety problem.''
    We also disagree with the notion that directed food laboratory 
orders would inappropriately shift the burden of testing to owners or 
consignees. The responsibility to produce safe food rests with the food 
producers. Food testing by LAAF-accredited laboratories under this 
subpart will provide assurance of the accuracy of the results conducted 
in response to identified or suspected food safety problems of 
significance to public health and will better enable both the Agency 
and the owner or consignee to act in the best interest of public 
health.
    As we discuss below in Response 47, we believe the circumstances in 
which we anticipate using a directed food laboratory order and the 
examples provided demonstrate that a directed food laboratory order 
will be used ``to address'' an identified or suspected food safety 
problem.
    We also disagree with aspects of comments asserting that the basis 
for the food safety problem must be ``established'' in order for food 
testing to be subject to this subpart. The statutory standard for when 
the Agency may issue a directed food laboratory order is explicitly set 
forth in section 422(b)(1)(A)(ii) of the FD&C Act: Such an order may be 
issued ``as required by the Secretary, as the Secretary deems 
appropriate, to address an identified or suspected food safety 
problem.''
    As proposed, we agree that this subpart will apply to testing in 
relation to certain administrative proceedings. Under Sec.  
1.1107(a)(3), certain testing as part of evidence for a hearing prior 
to the issuance of a mandatory recall order, as part of the corrective 
action plan after a food facility's registration has been suspended, as 
well as an appeal of an administrative detention order, is subject to 
this subpart.
    (Comment 42) Several comments argue that the directed food 
laboratory order provision violates the Administrative Procedure Act (5 
U.S.C. 551 et seq.) (APA), because the proposal lacked a reasoned 
explanation for the provision and contained insufficient detail to 
facilitate meaningful public comment. These comments conclude that 
finalizing the directed food laboratory order provision as proposed 
would put this tool at risk of being invalidated if challenged as 
arbitrary and capricious under the APA. Some comments state that the 
Agency can finalize the laboratory accreditation rule and meet all 
statutory obligations without issuing directed food laboratory orders 
and therefore conclude directed food laboratory orders are not ``fit 
for purpose.''
    Many comments state that directed food laboratory orders are not 
aligned with the purpose and principles of FSMA and the intent of 
section 422 of the FD&C Act. Comments state that Congress's purpose in 
section 422 of the FD&C Act is to address the practice of importers 
engaging in ``laboratory shopping'' (i.e., a practice whereby an owner 
or consignee sends samples to several laboratories in hopes that one 
will return results indicating the sample complies with FDA 
requirements and if

[[Page 68756]]

so, the owner or consignee submits only that result to FDA) by 
requiring that food testing results be sent directly to the Agency; 
these comments argue that the directed food laboratory order provision 
of the proposed rule does not advance this objective.
    Other comments frame the purpose of section 422 of the FD&C Act as 
ensuring reliable and accurate test results. These comments counter 
that instead of supporting this purpose, the proposed directed food 
laboratory order creates a new investigatory and enforcement tool for 
FDA, which is unnecessary given the Agency's existing enforcement 
tools; namely, that FDA may already sample the product and the 
environment and choose the laboratory to conduct the analysis. Comments 
state that Congress carefully considered which additional tools were 
necessary through FSMA and did not contemplate a duplicative 
enforcement tool. Comments state that there is no indication that 
Congress intended to shift this burden to industry through directed 
food laboratory orders in section 422 of the FD&C Act and that doing so 
would be unfair. Comments suggest that additional Agency funding is the 
more appropriate solution to address limited Agency resources. Several 
comments offer revisions to the directed food laboratory order 
provision that they consider necessary to link the proposed provision 
to the purpose of the statute. Additionally, some comments indicate 
that facilities must implement environmental and product testing 
according to food safety plans under other FSMA provisions and FDA may 
review this information during routine inspections; comments express 
the belief that this represents sufficient oversight into testing 
methodology, laboratory choice, procedures, and test results. In sum, 
comments argue that without a demonstrated concern with laboratory 
integrity and a public health need, directed food laboratory orders are 
inappropriate and outside the scope of section 422 of the FD&C Act.
    Comments argue that the proposed rule preamble provided limited 
information regarding the Agency's need or justification for directed 
food laboratory orders, such as historical events or situations when 
such orders would have been useful. Regarding the justification, many 
comments state that the preamble fails to explain the problem directed 
food laboratory orders are intended to address, as there is no 
documented issue regarding the reliability of test results that would 
warrant testing by LAAF-accredited laboratories. Some comments state 
that without a clear explanation for the Agency's need for what they 
perceive as a potentially expansive enforcement tool, comments cannot 
support the directed food laboratory order provision. Additionally, 
some comments state that the Agency has not considered how the proposed 
directed food laboratory order provision would harm industry, including 
by increasing costs to food companies associated with the use of LAAF-
accredited laboratories and disrupting production to hold product while 
waiting for test results.
    Some comments state that in the proposed rule we did not address 
operational details of the directed food laboratory order such as who 
in FDA would issue such orders, how the orders would be delivered; how 
long the directed food laboratory order would be in place; and when and 
how a directed food laboratory order would be lifted. We understand 
some comments to argue that it was legally necessary for FDA to 
describe these operational details in the proposed rule. Finally, 
according to some comments, the proposed rule should have reflected 
that we considered alternative approaches to the directed food 
laboratory order.
    (Response 42) The proposed rule contained a reasoned explanation 
and sufficient detail on this topic to facilitate meaningful comment 
and therefore fully satisfied APA requirements. In the proposed rule we 
articulated the legal authority for the directed food laboratory order, 
a description of the tool, and the substantive issues involved. We 
stated that we were interpreting section 422(b)(1)(A)(ii) of the FD&C 
Act to give FDA authority to propose the directed food laboratory 
order. We described the proposed content of the directed food 
laboratory order (e.g., it will specify the timeframe for the testing, 
and any method that must be used). We communicated that the proposed 
directed food laboratory order addresses an identified or suspected 
food safety problem, and we discussed the meaning of that phrase at 
some length. We made clear that the proposed tool could be used to 
compel either product or environmental testing and explained our basis 
for including environmental testing within the proposed definition of 
``food testing.'' We also explained that under the proposed rule owners 
or consignees subject to a directed food laboratory order may request a 
regulatory hearing.
    Comments also argue that the proposed rule was insufficient because 
the Agency failed to explain a need for the directed food laboratory 
order, for example by describing past enforcement cases in which the 
Agency would have found it helpful to employ such a tool. It is true 
that we did not describe a past case, but it was clear from the 
proposed rule that the tool is directed at unreliable test results in 
circumstances where we have reason to suspect, or have identified, a 
particular food safety problem for which a particular owner or 
consignee is responsible. Further, although we did not discuss our 
consideration of alternative approaches in the proposed rule, based on 
our knowledge and experience implementing FSMA, we have determined that 
the directed food laboratory order is an appropriate application of 
section 422(b)(1)(A)(ii) of the FD&C Act. See also, Response 41 and the 
analysis of regulatory alternatives to this rule in the FRIA (Ref. 4).
    With regard to comments expressing concern that we did not justify 
an expansive new tool in the proposed rule, we believe this reflects a 
misperception: The directed food laboratory order is a precise new tool 
that will help us protect public health in a relatively narrow set of 
circumstances. Section 422(b)(1)(A)(ii) of the FD&C Act gives FDA 
authority to require testing to be conducted under this subpart as we 
deem appropriate, to address an identified or suspected food safety 
problem. As we interpret this statutory provision, directed food 
laboratory orders will generally be limited to the rare situations when 
we have reason to question the accuracy or reliability of past or 
present test results, and an identified or suspected food safety 
problem exists. (See Response 47 for discussion of the standard; see 
Response 35 for discussion of ``identified or suspected food safety 
problem.'')
    Some comments appear to express doubt that there are ever any 
problems with the reliability of food testing conducted by or for 
owners or consignees, and claim that because the proposed rule did not 
document that such problems exist, and threaten public health, there is 
insufficient justification for the directed food laboratory order. We 
suspect that this reflects the misperception in some comments regarding 
the directed food laboratory order as an expansive new tool, which in 
turn may have created a belief that the proposed rule should contain a 
lengthy description of widespread problems with the validity of an 
array of test results. As clarified above, however, the directed food 
laboratory order is not a tool that we expect to apply broadly or 
frequently. Rather, it will be applied in particularized circumstances. 
If there were never any particularized problems

[[Page 68757]]

with the reliability of food testing conducted by or for owners and 
consignees, Congress would not have enacted section 422 of the FD&C 
Act. However, in this provision of the FD&C Act, Congress has 
specifically reserved for the Agency the authority to require testing 
to be conducted under this subpart in circumstances beyond just those 
defined by Congress. And, given some of the egregious situations and 
behaviors FDA has encountered in enforcing the food safety provisions 
of the FD&C Act, many of which have been widely publicized, we do not 
believe anyone could reasonably doubt the existence of particular 
circumstances in which owners or consignees failed to use a quality, 
reliable laboratory and where public health harm resulted. (See 
Response 47 for examples of situations in which a directed food 
laboratory order may be appropriate.)
    Similarly, some comments claim that registered food facilities 
conduct routine testing consistent with their obligations under the 
preventive controls regulations, and there is no evidence that, ``as a 
general matter,'' those test results are unreliable. Again, the 
directed food laboratory order is not intended to be applied generally; 
it will be applied in response to a particular set of circumstances. 
Unfortunately, some registered food facilities do not perform routine 
testing in a manner that is consistent with their preventive controls 
obligations. We also note that the directed food laboratory order may 
be applied to entities that are not subject to the preventive controls 
regulations.
    One piece of evidence indicating the sufficiency of the proposed 
rule with respect to the directed food laboratory order is the quality 
of the public comments on the topic. We appreciate commenters' robust 
feedback and assure them we have carefully considered their input. 
Several comments contained questions, suggestions, and requests 
regarding the details of the application of the directed food 
laboratory order; to the extent possible, we respond to those comments 
in the subsequent responses in this section of the preamble. However, 
the fact that such details, including operational details, did not 
appear in the proposed rule does not call into question the legal 
sufficiency of the proposal. In sum, the proposal adequately apprised 
the public of the proposal under consideration in a manner that allowed 
for meaningful comment on the directed food laboratory order.
    We reject the contention that, because it would be possible to 
implement other portions of section 422 of the FD&C Act without the 
directed food laboratory order, the tool must not be ``fit for 
purpose.'' The degree to which the directed food laboratory order 
affects the success of the overall LAAF program framework does not 
define its fitness for purpose. The relevant question is whether the 
statute authorizes FDA to implement the directed food laboratory order, 
which it does, as discussed in Response 41.
    In contrast to the contention of some comments, the directed food 
laboratory order squarely aligns with both the purpose of FSMA and the 
intent of section 422 of the FD&C Act. We particularly agree with those 
aspects of comments stating that a central purpose of section 422 of 
the FD&C Act is to help ensure accurate and reliable test results in 
certain circumstances identified in the statute. Directed food 
laboratory orders will serve that purpose by increasing confidence in 
testing results in particular circumstances when we have reason to 
question the accuracy or reliability of past or present test results 
and an identified or suspected food safety problem exists. To the 
extent that preventing ``laboratory shopping'' was a purpose of section 
422(b)(2) of the FD&C Act, which requires all test results to be 
submitted directly to FDA, such purpose must be consistent with the 
rest of section 422, including the provision granting discretion to the 
Agency to include in this final rule testing, ``as the Secretary deems 
appropriate, to address an identified or suspected food safety 
problem.'' Section 422(b)(1)(A)(ii) of the FD&C Act.
    The central purpose of FSMA was to shift the focus of food safety 
efforts to preventing contamination of the food supply, rather than 
primarily responding to problems after they occur. Directed food 
laboratory orders serve this purpose by addressing the need for 
reliable food testing when there are particular circumstances where 
past or current testing is suspect and FDA has determined there is an 
identified or suspected food safety problem. Testing in such 
circumstances would be aimed at gathering trustworthy scientific 
information to help FDA and others avoid or mitigate a food safety 
event.
    Some comments categorize the proposed directed food laboratory 
order as a new investigatory and enforcement tool, and maintain that 
FDA already has the authority to collect samples and send those samples 
to the laboratory of the Agency's choosing. They also state that, 
through the preventive controls regulations, FDA already has the 
authority to review records of test results when inspecting a 
registered food facility, which provides sufficient oversight of such 
testing. Again, the directed food laboratory order is a tool that may 
be applied to owners and consignees that are not registered food 
facilities subject to the preventive controls regulations. Further, 
section 422(b)(1)(A) of the FD&C Act makes plain that Congress intended 
to require entities to be subject to this subpart even though FDA 
already regulates testing for that industry. Accordingly, it is 
irrelevant that FDA may already have the authority to collect samples 
at an enterprise or review the enterprise's testing records; the 
directed food laboratory order is an appropriate new tool authorized by 
section 422(b)(1)(A)(ii) of the FD&C Act.
    It is also irrelevant whether Congress specifically contemplated 
the existence of the directed food laboratory order because Congress 
delegated authority to the FDA to require testing to be conducted under 
this subpart, as we deem appropriate, when an identified or suspected 
food safety problem exists and the codified use of directed food 
laboratory orders is fully consistent with the text and purpose of the 
statute. We disagree that the directed food laboratory order is a 
mechanism to shift the burden of enforcement and investigation onto 
private industry or stretch FDA's budget; it is a precise tool that 
will be rarely used and is not anticipated to impose significant burden 
on regulated entities. We discuss comments on the estimated costs of 
the directed food laboratory order in the FRIA (Ref. 4). (For more 
information on all the estimated costs and benefits of the final rule, 
see the FRIA (Ref. 4).)
    (Comment 43) Several comments raise concerns that directed food 
laboratory orders will have negative policy implications that the 
Agency has not considered. These comments state the belief that 
directed food laboratory orders could disincentivize facilities from 
implementing ``seek and destroy'' pathogen environmental monitoring. 
These comments assert that in response to FSMA, the industry already 
has implemented robust environmental monitoring programs. These 
comments further argue that the food safety and public health benefits 
of these programs could be jeopardized by directed food laboratory 
orders and the possibility that a facility's own routine testing could 
result in issuance of a directed food laboratory order. These comments 
state that uncertainty regarding the timing, duration, and cost 
associated with directed food laboratory orders will cause facilities 
to avoid routine testing for fear of triggering such an order. A few 
comments state that some firms may modify their environmental testing 
programs to avoid finding

[[Page 68758]]

positive results, negating what the comments characterize as the 
``positive steps'' FDA has taken ``to encourage aggressive 
environmental sampling in the 2017 publication of the (``Control of 
Listeria monocytogenes in Ready-To-Eat Foods: Guidance for Industry'' 
draft guidance (Ref. 11)), through the acknowledgment that a finding 
for Listeria species on a food contact surface does not render product 
adulterated.'' \8\
---------------------------------------------------------------------------

    \8\ The ``Control of Listeria monocytogenes in Ready-To-Eat 
Foods: Guidance for Industry'' draft guidance describes followup 
actions a facility should take in response to a finding of Listeria 
spp. on a food contact surface. Although it is true that the draft 
guidance indicates that we expect to find Listeria in certain food 
facilities, we also expect that such facilities will implement 
environmental monitoring plans to find Listeria when present and 
take followup actions to ensure that Listeria does not contaminate 
food. Our investigators will inspect a facility's environmental 
monitoring results and the followup activities the facility performs 
in the event of an environmental positive, to ensure that product 
does not become adulterated. If we have concerns about the 
facility's application of current good manufacturing practices and 
preventive controls with respect to L. monocytogenes, we may perform 
our own sampling of the facility's environment and may also take 
food samples.
---------------------------------------------------------------------------

    Some comments express concern that basing a directed food 
laboratory order on environmental results increases the risk that the 
test results could be taken out of context; several of these comments 
mention that there would be a lack of information connecting the test 
result to a product. A few comments request that FDA reiterate that 
routine testing of product and environment related to a facility's food 
safety plan is not required to be performed by LAAF-accredited 
laboratories under this subpart and that followup sampling and testing 
in response to routine environmental monitoring positive results for 
pathogen/indicator organisms should not be covered by this subpart.
    Some comments express concern that the LAAF program will cause 
testing by laboratories not participating in the program to be devalued 
or viewed as suspect. Some comments warn that widespread use of 
directed food laboratory orders could cause testing performed by 
laboratories not LAAF-accredited under FDA's program to be scrutinized. 
These comments assert that many in-house and external laboratories are 
not ISO-accredited; however, the laboratories still ensure integrity 
and accuracy of test results and data. These comments stress the 
important role in-house and other laboratories play in providing timely 
test results on which food safety decisions are made. These comments 
suggest that these laboratories may choose not to participate in the 
LAAF program. Further, some comments are concerned that FDA and 
investigators may question analytical results from non-LAAF-accredited 
laboratories. Overall, comments assert there is no evidence to suspect 
that non-ISO-accredited laboratories produce inaccurate or suspect 
results.
    Some comments urge FDA to consider the potential significant costs 
associated with directed food laboratory orders as well as the 
potential business disruption that may occur if product subject to 
testing is placed on hold pending results. A few comments explain that 
holding product under a directed food laboratory order could challenge 
the company's hold capacity and disrupt both production and the supply 
chain, as well as have additional costs for industry. Several comments 
state that the preliminary economic impact analysis did not include any 
costs for directed food laboratory orders and should be revised 
accordingly.
    (Response 43) We disagree that the directed food laboratory order 
provision, as clarified, will have negative policy implications. The 
authority under section 422 of the FD&C Act is intended to increase 
confidence in receiving accurate and reliable test results. As stated 
in Response 35, the purpose of routine environmental testing under the 
preventive controls regulations (Sec. Sec.  117.165(a) and 507.49(a)) 
is to verify that preventive controls are consistently implemented and 
are effective. Therefore, such testing does not address an identified 
or suspected food safety problem and is not covered by this subpart. 
The additional clarity we are providing in this final rule regarding 
the directed food laboratory order in terms of the standard of 
issuance, authority to issue such orders, and procedural details, 
should provide sufficient boundaries to enable firms to continue or 
expand robust environmental monitoring programs developed in the wake 
of FSMA and in support of an overall culture of food safety, without 
fearing that such programs will invite issuance of a directed food 
laboratory order. We expect that it will be uncommon for us to issue a 
directed food laboratory order. Further, we expect that facilities that 
have implemented robust environmental monitoring programs and that are 
taking appropriate corrective actions in response to positive findings 
(``seek and destroy'') generally are not likely to be subject to such 
an order.
    However, as discussed in Response 37, followup testing in response 
to routine environmental test results that indicate the presence of a 
pathogen or indicator organism in the food production environment may 
qualify as testing that addresses an identified or suspected food 
safety problem, and therefore could warrant issuance of a directed food 
laboratory order, depending on the circumstances. We disagree with the 
contention that use of a directed food laboratory order for 
environmental testing could cause results to be taken out of context. 
As explained in Response 47, the use of a directed food laboratory 
order is appropriate only in a narrowly defined set of circumstances. 
Accordingly, in our view, the context (including relevant product(s)) 
for any environmental tests required by a directed food laboratory 
order) will be sufficiently clear.
    Absent a specific reason to question the reliability and accuracy 
of results from a particular firm or laboratory, we do not believe that 
testing from an in-house, third-party private, or other laboratory that 
is not LAAF-accredited would be questioned solely based on the decision 
of that laboratory not to participate in this program, and certainly 
not as a result of the directed food laboratory order tool. We discuss 
examples of circumstances in which we would employ a directed food 
laboratory order in Response 47. As reiterated throughout our 
discussion of the directed food laboratory order in this preamble, and 
as reflected in the FRIA, we do not expect widespread use of such 
orders (Ref. 4). We address costs related to a directed food laboratory 
order in the FRIA, see (Ref. 4).
    (Comment 44) Several comments state that the proposed rule does not 
specify who has the authority to issue a directed food laboratory 
order, nor does it indicate whether such authority could be delegated. 
These comments recommend that the authority to issue a directed food 
laboratory order remain a non-delegable function of the FDA 
Commissioner. A subset of these comments mentions that this 
recommendation aligns with section 415(b)(7) of the FD&C Act (regarding 
the authority to issue an order to suspend a registration or vacate an 
order of suspension [of a food facility]) and mandatory recall 
authority. Some comments assert that the authority to issue a directed 
food laboratory order would not be appropriate for FDA investigators or 
State inspectors. A few comments ask whether State regulators 
inspecting farms under the produce safety rule would have authority to 
issue a directed food laboratory order.
    (Response 44) In proposed Sec.  1.1108, we stated that a directed 
food laboratory order may be issued by FDA. Although we agree that the 
authority to issue a directed food laboratory order would

[[Page 68759]]

not be delegated to FDA investigators or State inspectors, we decline 
to make the issuance of a directed food laboratory order a non-
delegable function of the FDA Commissioner. Section 415(b)(7) of the 
FD&C Act and section 423(h) of the FD&C Act contain explicit provisions 
limiting certain authority to the Commissioner. Section 422 of the FD&C 
Act (21 U.S.C. 350k) does not include a similar limitation. Absent an 
explicit statutory limitation regarding delegation, we find no reason 
to impose one for the issuance of a directed food laboratory order. 
Consistent with longstanding Agency practice and the APA, we intend to 
limit the delegation of authority to issue a directed food laboratory 
order under this subpart to FDA officials with the appropriate level of 
responsibility. See 5 U.S.C. 553(a)(2).
    (Comment 45) Several comments state that the proposed directed food 
laboratory order procedures raise due process concerns for the 
potential recipient of such an order. In support of this position, the 
comments describe their perception of the uncertain standards and the 
Agency's unfettered discretion to issue a directed food laboratory 
order. Some comments urge FDA to have a transparent process and clear 
standards with a documented sound scientific basis for issuance of a 
directed food laboratory order. Some comments request more specific 
examples of when the Agency would issue a directed food laboratory 
order. These comments argue that without specifying who in the Agency 
may issue a directed food laboratory order, it appears that FDA 
investigators could issue them. The comments state that the perceived 
lack of a process prior to issuance and the perceived lack of a 
guaranteed process once a directed food laboratory order has been 
received contribute to the overall insufficient due process associated 
with the proposed provision.
    (Response 45) We address several aspects of these concerns 
elsewhere in this preamble, in Response 44 and Response 47. 
Specifically, we clarify the standard of issuance for a directed food 
laboratory order, who has the authority to issue such an order, and 
certain procedural aspects associated with issuance of such an order. 
With these details and the applicable procedures of part 16 in place, 
we believe there is sufficient due process associated with the directed 
food laboratory order provision.
    (Comment 46) Several comments state that food testing pursuant to a 
directed food laboratory order should be limited to product testing and 
should not include environmental testing. These comments state that 
FSMA section 202, Laboratory Accreditation for Analyses of Foods, 
refers only to ``food testing'' and ``testing of food,'' without 
defining these terms. The comments indicate that while environmental 
testing is not specifically mentioned in section 202, Congress 
explicitly refers to environmental testing elsewhere in FSMA (section 
103, which creates section 418(f)(4) of the FD&C Act). Further, some 
comments suggest that including environmental testing would create the 
potential for test results to be taken out of context; several of these 
comments state that there would be a lack of information connecting the 
test result to a product. A few comments explain that routine testing, 
including environmental testing, is covered by FDA guidance and 
considers multiple variables; these comments state that it is not clear 
whether and how all variables will be considered in determining when a 
directed food laboratory order is issued. Some comments conclude that 
there is no legal basis for requiring environmental testing under a 
directed food laboratory order and that directed food laboratory orders 
must only be used for food product testing.
    (Response 46) We decline to limit directed food laboratory orders 
to product testing. As already discussed in Response 19, FDA defines 
``food testing'' and ``testing of food'' to include environmental 
testing for purposes of this subpart. As stated in Response 19 and 
discussed further in Response 35, routine environmental testing 
(Sec. Sec.  117.165(a)(3) and 507.49(a)(3)) is not covered by this 
subpart. As we noted in Response 43, we do not believe the directed 
food laboratory order will cause environmental test results to be taken 
out of context. For these reasons, in light of our legal authorities 
under section 422 of the FD&C Act, and for the policy reasons already 
discussed in relation to both environmental testing and the directed 
food laboratory order, under this final rule and as appropriate, FDA 
may issue a directed food laboratory order subjecting either product 
testing or environmental testing to the requirements of this subpart.
    (Comment 47) Some comments state that the proposed rule did not 
provide enough information regarding the standard for issuance of a 
directed food laboratory order. These comments express concern that the 
proposed standard, an identified or suspected food safety problem, 
could be present regardless of whether the article of food violates the 
FD&C Act. Comments state that the examples provided in the preamble to 
the proposed rule suggest that mere suspicion of a food safety problem, 
such as the presence of Listeria monocytogenes on a food contact 
surface, could lead to issuance of a directed food laboratory order 
when there is no violative article involved. Comments argue that 
issuance of a directed food laboratory order when there is no violative 
product would exceed FDA's authority. Otherwise, comments suggest the 
results of a food facility's routine testing could inappropriately 
trigger a directed food laboratory order. Comments propose instead that 
an identified or suspected food safety problem should only give rise to 
a directed food laboratory order when there is a public health need or 
when the food has a reasonable probability of serious adverse health 
consequences or death to humans or animals (SAHCODHA).
    A few comments express concerns that although FDA notes the 
suspicion will ``typically be particularized'' as it relates to 
specific articles of food or a specific portion of the food production 
environment, it is not clear that this will always be the case. Several 
comments suggest that the suspicion standard could lead to bias or 
subjective determinations by an investigator where no problem exists. 
Some comments propose instead that directed food laboratory orders 
should include a direct reference to a violation. Other comments state 
that issuance of a directed food laboratory order should require a 
reasonable belief that the food is violative, similar to the standard 
set forth in FSMA section 101 (relating to inspections of records).
    These comments recommend that if the directed food laboratory order 
provision remains in the final rule, it should be limited to 
circumstances when both of the following factors are met: (1) An 
identified or suspected food safety problem representing a SAHCODHA 
hazard is established and (2) a substantiated concern exists regarding 
the adequacy of the laboratory used by the owner or consignee such that 
testing by an accredited laboratory under this program is necessary to 
determine the food safety problem has been resolved. Comments state 
that a concern about laboratory adequacy is necessary as Congress 
intended section 202 of FSMA to address ``laboratory shopping'' and 
other situations which raise questions about the validity of laboratory 
results. The comments state that the directed food laboratory order 
should not be used by FDA as an investigative tool.
    Some comments recommend that issuance of the directed food 
laboratory order be limited to cases where the pathogen risk is 
immediate and FDA's

[[Page 68760]]

existing enforcement tools are not adequate to address the situation.
    A few comments ask FDA to specifically exempt from a directed food 
laboratory order pathogen/indicator organism positive results from 
routine environmental testing since the manufacturer should have the 
opportunity to resolve any associated concerns through corrective 
actions.
    A few comments request that the Agency provide additional 
information, guidance, and examples for when a food safety problem is 
``suspected'' in animal food, as well as more specific examples of when 
a directed food laboratory order would be issued under the rule.
    (Response 47) Per section 422(b)(1)(A)(ii) of the FD&C Act, the 
standard for issuance of a directed food laboratory order is ``as 
required by the Secretary, as the Secretary deems appropriate, to 
address an identified or suspected food safety problem.'' We disagree 
that SAHCODHA should be the standard, as Congress explicitly specified 
a different standard here. For the same reason, we decline to use the 
standard set forth in FSMA section 101 (reasonable belief that the food 
is violative). The statutory clause in the section related to the LAAF 
program, ``identified or suspected food safety problem'' specifically 
allows for issuance of a directed food laboratory order when there is 
no violative product.
    Regarding the standard of issuance, we believe the phrase, ``as the 
Secretary deems appropriate,'' in the context of the FSMA laboratory 
accreditation program, generally would limit our issuance of a directed 
food laboratory order to situations where we have evidence or 
experience with a firm or laboratory which calls test results into 
question, i.e., situations in which we have reason to question the 
accuracy or reliability of past or present test results. In such 
circumstances, there would be a clear benefit to receiving analytical 
results directly from a LAAF-accredited laboratory. Ensuring accurate 
and reliable test results is the precise issue Congress intended to 
address in section 202 of FSMA. In the final rule, we have revised the 
language in Sec.  1.1108(a) to better align with the statutory text by 
adding the qualifying language, ``as FDA deems appropriate.''
    In terms of the comment expressing apprehension that FDA will use 
the directed food laboratory order as a tool to gather testing 
information in the absence of heightened food safety concerns, we 
reiterate that the order is only appropriate to address an identified 
or suspected food safety problem. Similarly, regarding the contention 
in some comments that a directed food laboratory order should only be 
issued if there are concerns with laboratory adequacy, as just noted, 
we interpret, ``as the Secretary deems appropriate'' to mean that the 
tool would generally only be appropriate if we have reason to question 
past or present test results.
    Further, we intend to use a directed food laboratory order within 
the context of other Agency authorities and tools, FSMA-related and 
otherwise; accordingly, positive results from routine testing would not 
normally trigger a directed food laboratory order absent other 
circumstances (e.g., suspect test results) necessitating a directed 
food laboratory order. Therefore, we decline to include specific 
exemptions for pathogen/indicator organism positive results from 
routine environmental testing or to limit issuance of a directed food 
laboratory order to cases when the pathogen risk is immediate and the 
Agency's other enforcement tools are not adequate to address the 
situation.
    We offer the following examples of the types of situations in which 
we believe a directed food laboratory order would be useful and 
appropriate ``as required by the Secretary, as the Secretary deems 
appropriate, to address an identified or suspected food safety 
problem.'' Some of these descriptions are modeled on our experience 
with past compliance cases.
     Following a for-cause inspection of a human food firm with 
a documented history of falsified laboratory reports, after the 
Agency's receipt of information from an employee informant indicating 
that the firm continued to provide false or misleading certificates of 
analysis to conceal the production of adulterated human food;
     Following a recall by an animal food firm because the 
firm's laboratory historically used an inappropriate method and 
reported results that differed from FDA laboratory results; and
     If FDA laboratories have on multiple occasions obtained 
positive pathogen results on food products in past years that conflict 
with the company's contract laboratory's results. Given a pattern of 
past ineffective monitoring by the company, coupled with the public 
health risk, on the next positive finding by FDA that leads to a 
voluntary recall for pathogen adulteration in this company's food 
products, FDA might issue a directed food laboratory order.
    In light of the additional parameters for issuance of a directed 
food laboratory order discussed above and limitations on who can issue 
a directed food laboratory order (discussed in Response 44), we believe 
issuance of directed food laboratory order would be insulated from 
bias.
    (Comment 48) A few comments state that pathogens in not ready to 
eat (NRTE) food, and specifically in raw agricultural commodities such 
as grains, which do not undergo a kill step in the mill, should not be 
considered an identified or suspected food safety problem subject to a 
directed food laboratory order. These comments state further that the 
preamble to the proposed rule offered few examples of circumstances 
that could generate a suspected food safety problem and mentioned 
``potential contamination events'' as an example although we did not 
define this phrase. These comments request that the Agency define that 
phrase and explicitly state that the presence of pathogens in NRTE 
foods is not considered an identified or suspected food safety problem. 
The comments express the concern that directed food laboratory orders 
could be used as a basis for requiring the milling industry generally 
to sample food manufacturing environments or products through use of 
LAAF-accredited laboratories. The comments suggest that any testing in 
these circumstances would not be appropriate, regardless of whether the 
use of a LAAF-accredited laboratory is required.
    (Response 48) The proposed rule explored the meaning of the 
statutory phrases, ``identified food safety problem,'' and ``suspected 
food safety problem.'' (84 FR 59452 at 59455, 59462). In Response 35, 
above, we finalize our tentative conclusions about the meaning of those 
phrases.
    A number and variety of factors impact food safety risk (e.g., the 
pathogen, the history of foodborne illness outbreaks associated with 
the pathogen in the food, whether the food undergoes further processing 
with a kill step at a registered food facility). In some circumstances 
a pathogen in an NRTE food may be considered an identified or suspected 
food safety problem. For example, foodborne illness outbreaks have been 
associated with Salmonella in raw tuna (https://www.cdc.gov/salmonella/newport-04-19/index.html) and Shiga-toxin producing E. coli in raw 
bison burgers (https://www.cdc.gov/ecoli/2019/bison-07-19/index.html). 
The strains of pathogens associated with the outbreaks are capable of 
causing severe illnesses (both outbreaks resulted in hospitalizations), 
and these raw foods were consumed without a treatment to significantly 
minimize the hazard and

[[Page 68761]]

prevent illnesses. Consistent with the broader food safety regulatory 
framework, which includes the preventive controls for human food 
regulation and the preventive controls for animal food regulation, FDA 
will consider all applicable regulations and relevant circumstances in 
determining whether an identified or suspected food safety problem 
exists. As explained in Response 47, a directed food laboratory order 
is appropriate in situations in which an identified or suspected food 
safety problem exists along with specific evidence or experience with a 
firm or laboratory which calls past or present test results into 
question. Accordingly, we expect to employ the directed food laboratory 
order rarely. In many cases involving a pathogen in an NRTE food, other 
food safety regulations or tools outside the scope of the LAAF program 
may adequately address the risk.
    We decline the request to define ``potential contamination event.'' 
We have defined the terms that describe the standard of issuance for a 
directed food laboratory order (see Response 35). Consistent with these 
definitions, a directed food laboratory order may be appropriate in 
circumstances related to potential contamination events; e.g., where a 
pathogen in the food production environment is transmitted to the food, 
thereby causing the food to be adulterated, and where we have specific 
evidence or experience with a firm or laboratory which calls past or 
present test results into question.
    (Comment 49) A few comments suggest that neither chemical nor 
physical hazards would be appropriate for a directed food laboratory 
order. According to such comments, the directed food laboratory order 
should be limited to circumstances where there is a reasonable 
likelihood of serious adverse health consequences or death to humans or 
animals due to the potential for pathogens to be present in the food 
product.
    (Response 49) We decline to exempt chemical or physical hazards 
from a potential directed food laboratory order. As previously stated, 
a directed food laboratory order will generally be limited to the rare 
situation when we have reason to question the accuracy or reliability 
of past or present test results and where an identified or suspected 
food safety problem exists. In addition to biological hazards, both 
chemical and physical hazards are capable of causing food safety 
problems. Therefore it is possible that any of the three types of 
hazard could, in certain circumstances, form the basis for issuance of 
a directed food laboratory order.
    We also note that chemical and physical hazards are specifically 
covered by other FSMA regulations such as the preventive controls 
regulations (Sec. Sec.  117.130 and 507.33). We believe it is 
appropriate to align coverage of a potential directed food laboratory 
order with the potential hazards covered by those regulations.
    (Comment 50) Several comments raise questions about operational 
details related to the issuance of directed food laboratory orders. 
These comments ask about the intended recipient of the directed food 
laboratory order (corporate parent, facility, or both), means of 
transmission (electronic, in-person, mail), and whether the issuance 
would change based on multiple owner or consignee scenarios. Comments 
state that these details are critical given the proposed 24-hour appeal 
deadline for directed food laboratory order recipients.
    (Response 50) FDA intends to provide the most legally responsible 
person at the firm that day with written notice of a directed food 
laboratory order, generally via email. We will make every attempt to 
call to inform the firm of the order prior to its arrival.
    In the imports context, there are sometimes multiple owners or 
consignees. In such a case, we would generally deliver the written 
notice to the importer of record. (See Response 26 for additional 
discussion of multiple owner or consignee scenarios.)
    As discussed in Response 138, we have extended the appeal deadline 
from 24 hours to within 3 business days of receipt of a directed food 
laboratory order.
    (Comment 51) Several comments suggest that the lack of detail 
surrounding the duration and termination of directed food laboratory 
orders raises due process issues. These comments recommend that a 
directed food laboratory order should be ``closed'' once the identified 
or suspected food safety problem has been resolved. These comments also 
request that FDA include a hearing process to permit owners or 
consignees to submit evidence in support of the resolution to terminate 
a directed food laboratory order or to have the directed food 
laboratory order vacated. Additionally, some comments request that 
directed food laboratory orders include a timeframe for the order and 
frequency for testing. Further, a few comments suggest that FDA use a 
hearing process if the Agency seeks to modify a directed food 
laboratory order once issued. Some comments request that FDA provide 
additional information on what is considered a reasonable timeline to 
conduct testing required by a directed food laboratory order.
    (Response 51) In general, a directed food laboratory order would 
last until we have adequate assurances that the underlying known or 
suspected food safety problem has been resolved. However, we agree that 
the order will be ``closed'' once the identified or suspected food 
safety problem has been resolved. We anticipate that this approach will 
incentivize firms to resolve issues quickly. However, details regarding 
the duration and termination of a directed food laboratory order will 
be contingent on the specific facts and circumstances of the order, 
which will vary greatly. For example, whether the order covers product 
or environmental testing, whether it is designed to address a very 
discrete issue or a system-wide issue, the applicable regulations, and 
the role of other resources and tools applied to the circumstances, are 
just a few of the factors that may impact the length of time a directed 
food laboratory order would be appropriate. Some orders may initially 
define the timeframe and testing frequency, but again, we will 
determine these matters on a case-by-case basis.
    At present we do not believe it necessary to create a hearing 
process around the conclusion of a directed food laboratory order; 
however, we expect to be in dialogue with the entity subject to the 
order and intend to take their feedback into consideration.
    (Comment 52) Some comments state that the proposed rule did not 
include details regarding whether or how directed food laboratory 
orders would be made public. These comments request that FDA clarify 
that directed food laboratory orders will not be made public. The 
comments argue that only the owner or consignee must take action under 
a directed food laboratory order, so there is no need to make a 
directed food laboratory order public.
    (Response 52) We may include directed food laboratory orders on an 
Agency website such as the data dashboard (see https://www.fda.gov/about-fda/transparency/fda-data-dashboard), so that other entities in 
the supply chain can be aware of their existence as they research and 
evaluate suppliers. We similarly publicize injunctions, seizures, and 
warning letters on the data dashboard and believe that inclusion of 
directed food laboratory orders would contribute to the overarching 
goals of FDA's food safety communication strategy.
    We also note that a directed food laboratory order generally would 
be subject to the Freedom of Information

[[Page 68762]]

Act (FOIA). Any disclosures would be made in accordance with our 
regulations in part 20 (21 CFR part 20) (i.e., redacting any 
confidential commercial information as necessary).
    (Comment 53) A few comments request additional information 
regarding whether directed food laboratory orders only apply 
domestically. These comments argue that directed food laboratory orders 
must apply to both domestic and foreign facilities producing food for 
consumption in the United States to comply with international 
commitments. The comments state that, as proposed, directed food 
laboratory orders will be issued more frequently to domestic entities, 
resulting in unfair treatment, since the FDA conducts more domestic 
inspections, therefore giving rise to more opportunities to issue such 
orders domestically. These comments state that there may be 
significantly fewer LAAF-accredited laboratories outside of the United 
States, which could make it more difficult for foreign manufacturers to 
comply with the requirements of a directed food laboratory order. These 
comments argue there is an inherent unfairness to the lack of parity 
and ask FDA to consider this when determining the need for directed 
food laboratory orders.
    (Response 53) We agree that a directed food laboratory order could 
be used in both foreign and domestic settings; however, we disagree 
that conducting more domestic inspections necessarily will mean there 
are more opportunities to issue a directed food laboratory order 
domestically. As discussed in Response 44, FDA investigators will not 
be able to issue directed food laboratory orders. This limitation and 
the additional clarifications provided regarding the standard of 
issuance (see Response 47) will limit use of a directed food laboratory 
order to those limited circumstances discussed and address the 
potential for unfairness.
    LAAF-accredited laboratory capacity for testing under this subpart 
is addressed in Response 15 and will include consideration of both 
foreign and domestic laboratories.
    (Comment 54) Some comments request additional information regarding 
whether FDA will specify the method to the owner or consignee of the 
food subject to a directed food laboratory order so that the owner or 
consignee can provide such information to the LAAF-accredited 
laboratory.
    (Response 54) We will specify the method to the owner or consignee 
and, in some circumstances, may provide flexibility to use equivalent 
methods, so that there may be access to a greater number of LAAF-
accredited laboratories that may conduct the food testing. See Sec.  
1.1151(b)(2).
    (Comment 55) Some comments maintain that directed food laboratory 
orders should be issued only where a validated test method exists and 
where there is sufficient LAAF-accredited laboratory capacity for that 
method and the specific food matrix.
    These comments are concerned that if a directed food laboratory 
order were issued for a method requiring validation, it could 
effectively prohibit the facility from operating until a method is 
validated. Comments estimate validation of a single method could take 6 
months or more and cost between $35,000 and $300,000, depending on the 
complexity of the method. Comments contend that the proposed rule was 
not clear regarding who bears the cost of validating a method; these 
comments argue industry should not have to bear such costs as a result 
of the issuance of a directed food laboratory order. Comments state 
further that costs to validate a method were not included in the 
preliminary economic impact analysis. A few comments assert that if 
directed food laboratory orders are limited to SAHCODHA hazards posed 
by pathogens, there would be fewer method validation concerns.
    Some comments state that proposed Sec.  1.1151(e) would allow an 
accredited laboratory to request FDA's permission to use a method 
outside its scope of accreditation but FDA would only approve the 
request if there is a ``food emergency.'' These comments express 
concern that FDA could define a ``food emergency'' to exclude 
circumstances specific to a particular food or facility. If narrowly 
construed in this manner, the comments argue the lack of a validated 
method or LAAF-accredited laboratory availability necessary under a 
directed food laboratory order could effectively block a facility from 
operating. Further, these comments assert that this provision would not 
mitigate the concerns raised regarding the impact of a directed food 
laboratory order for a method requiring validation.
    (Response 55) We intend to issue a directed food laboratory order 
when there exist both a validated method and sufficient laboratories 
LAAF-accredited to that method. Under Sec.  1.1108(b), FDA will specify 
the test method in a directed food laboratory order.
    As discussed above in Response 47, the general standard for 
issuance of a directed food laboratory order is that FDA has reason to 
question the accuracy or reliability of past or present test results 
and an identified or suspected food safety problem exists. Necessarily, 
then, if a directed food laboratory order has been issued, the food 
testing at issue is not novel because it has been happening for at 
least long enough that FDA has reason to question the results. In such 
circumstances, we believe a validated method will exist. Section 
422(b)(3) of the FD&C Act expressly gives FDA the authority to waive 
requirements of the LAAF program if: (1) 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 (2) the use of such methodology or methodologies are necessary to 
prevent, control, or mitigate a food emergency or foodborne illness 
outbreak.
    (Comment 56) Many comments assert, based on legal, policy, and 
practical concerns with the proposed rule, that directed food 
laboratory orders should be removed from the final rule. Some of these 
comments suggest that since FSMA section 202 does not contemplate 
directed food laboratory orders, inclusion of the directed food 
laboratory order provisions in the final rule is not required as part 
of the rulemaking. Comments suggest that removing the directed food 
laboratory order provision will help FDA meet its deadline to issue a 
final rule.
    Several comments argue that if FDA can establish both statutory 
authority and a justified public health need for directed food 
laboratory orders, either an independent rulemaking or a supplemental 
notice of proposed rulemaking would be necessary to allow for 
additional input, to clarify the proposal in terms of scope, 
procedures, and policy concerns, and to avoid litigation. Some comments 
suggest FDA has good cause to request modification of the consent 
decree deadline to extend the deadline due to the issues raised in the 
comments and the COVID-19 pandemic's impact on the Agency. Some of 
these comments raise the concern that additional time is needed to 
allow the Agency to give due consideration to the issues raised and to 
engage industry on the food safety concerns addressed by directed food 
laboratory orders.
    However, some comments recommend revisions to directed food 
laboratory orders to limit their scope and otherwise address procedural 
aspects that they believe would make directed food laboratory orders 
feasible if not removed from the final rule. These comments insist that 
a supplemental notice of proposed rulemaking is necessary to fully vet 
any revised proposal. A few comments ask that

[[Page 68763]]

directed food laboratory orders be used judiciously with specific 
guidance for use, should FDA confirm it has authority to issue directed 
food laboratory orders.
    Some comments suggest that FDA should publish additional guidance 
on directed food laboratory orders prior to issuing a directed food 
laboratory order.
    (Response 56) We decline the recommendation to remove the directed 
food laboratory order from the final rule. As discussed above 
throughout the comments and responses related to directed food 
laboratory orders, we have addressed the necessary legal, policy, and 
practical concerns raised. Additionally, we received meaningful 
comments which we have carefully considered in developing the directed 
food laboratory order provision of the final rule. Therefore, we do not 
agree a supplemental rulemaking is necessary. We will consider issuing 
additional guidance on directed food laboratory orders.
4. How will FDA make information about recognized accreditation bodies 
and LAAF-accredited laboratories available to the public (Sec.  
1.1109)?
    Proposed Sec.  1.1109(a) provided that FDA would place on our 
website a publicly available registry listing recognized accreditation 
bodies and LAAF-accredited laboratories in the LAAF program. The 
proposed list would include certain information regarding each 
recognized accreditation body and LAAF-accredited laboratory such as 
the name, contact information, duration of an accreditation body's 
recognition, and the scope of accreditation for each laboratory. We 
also proposed including certain information about changes in 
recognition of an accreditation body, including probation, revocation, 
voluntary relinquishment, or expiration and the effective date for any 
change. Likewise, we proposed including certain information regarding 
changes in LAAF-accreditation of laboratories, such as withdrawal, 
revocation, probation, voluntary relinquishment and the effective date 
for any change. Proposed Sec.  1.1109(b) reiterated the statutory 
requirement for FDA to coordinate with the Department of Homeland 
Security regarding the online registry.
    On our own initiative, we have revised the section title to include 
``LAAF-accredited laboratories,'' consistent with terminology changes 
throughout the rule. We also have clarified in the final rule that FDA 
will place on its website a publicly available registry listing 
information about recognized accreditation bodies and LAAF-accredited 
laboratories. As discussed at Response 10, we have revised the 
terminology used in the final rule to better clarify roles and actions 
taken by recognized accreditation bodies and FDA under this subpart. As 
discussed in section V.C. regarding of the definition of ``scope of 
LAAF-accreditation'' above, in the final rule we also changed the 
verbiage, ``withdraw in part,'' to ``reduce the scope of LAAF-
accreditation.'' This section has been updated to reflect the revised 
terminology. For transparency, we added denial of renewal of 
recognition to the changes in recognition that will be included on the 
website (see Sec.  1.1109(b) of the final rule); we stated we would 
post information about denial of renewal of recognition in Sec.  
1.1129(h) of the proposed rule, which appears in Sec.  1.1115(h) of the 
final rule. Additionally, on our own initiative, we removed the 
language that appeared in Sec.  1.1109(b) of the proposed rule. Section 
422(a)(4) of the FD&C Act directs FDA to coordinate with the Department 
of Homeland Security on the time, manner, and form of the online 
registry of recognized accreditation bodies and LAAF-accredited 
laboratories; we have done so. It is unnecessary to reiterate this duty 
in the codified text and so we have removed that text from the final 
rule. We also revised the section to improve clarity and readability. 
Comments regarding this section are discussed below.
    (Comment 57) Several comments support our proposal to maintain on 
our website a registry of recognized accreditation bodies and 
participating laboratories. Some comments request that the registry 
include information regarding the methods to which specific 
laboratories are accredited. Some comments suggest that the registry 
include hyperlinks to the websites of the recognized accreditation 
bodies, as those are updated regularly with information on LAAF-
accredited laboratories, including current scope information.
    Some comments request that the registry include information beyond 
that related to recognized accreditation bodies and LAAF-accredited 
laboratories; they advocate for FDA to maintain a list of all ISO/IEC 
17011:2017 accreditation bodies that are ILAC-Mutual Recognition 
Arrangement (MRA) signatories and accredit food laboratories, as well 
as all food laboratories that are accredited to ISO/IEC 17025:2017. 
These comments express the view that such a listing would be a helpful 
public service.
    Some comments propose that the registry indicate which 
participating laboratories are permitted to submit abridged analytical 
reports; from their perspective, such information would be helpful to 
industry in choosing a laboratory.
    Other comments ask how the public will know which laboratories are 
LAAF-accredited, and some comments consider the proposed rule to be 
unclear regarding how the public will know the methods for which each 
laboratory is LAAF-accredited and recommend this information be posted 
on the public website.
    (Response 57) We appreciate the support for the public registry and 
note that its establishment is required by section 422(a)(1)(B) of the 
FD&C Act. To be clear, under the final rule, the online registry will 
list all LAAF-accredited laboratories and the scope of LAAF-
accreditation for each, among other things. See Sec.  1.1109.
    We decline the recommendation to include on the public registry 
hyperlinks to the websites of recognized accreditation bodies and LAAF-
accredited laboratories. Recognized accreditation bodies and LAAF-
accredited laboratories must report changes that impact their 
recognition and LAAF-accreditation as specified in this final rule. 
This will ensure the public registry contains accurate and up-to-date 
information for use by owners and consignees.
    We also decline the recommendation to expand the registry to 
include a list of all ISO/IEC 17011:2017 accreditation bodies that are 
ILAC-MRA signatories that accredit food laboratories and all ISO/IEC 
17025:2017-accredited laboratories; expansion of the registry in this 
manner is not specified in section 422(a)(1)(B) of the FD&C Act, which 
describes the registry as including information regarding accreditation 
bodies recognized by the FDA and the laboratories which are LAAF-
accredited by the recognized accreditation bodies.
    Finally, we also decline the recommendation to indicate on the 
public registry which LAAF-accredited laboratories are permitted to 
submit abridged analytical reports. We do not consider testing 
conducted by laboratories permitted to submit abridged analytical 
reports to be of a higher quality than testing conducted by 
laboratories without such permission. Nor do we have any reason to 
conclude that owners and consignees would get test results faster from 
a laboratory with permission to submit abridged analytical reports. 
Note that under Sec.  1.1153(d), FDA may request that a LAAF-accredited 
laboratory that is

[[Page 68764]]

permitted to submit abridged analytical reports submit additional 
documentation or a full analytical report within 72 hours of FDA's 
request. As stated in Sec.  1.1150(d) of the proposed and final rule, a 
LAAF-accredited laboratory must document the testing information and 
test results to the extent necessary to account for all information 
that is required to be in a full analytical report.
    (Comment 58) Regarding the public registry that lists recognized 
accreditation bodies and participating laboratories, some comments 
express concern about our proposal to include revocation or probation 
information in the registry. These comments take issue with our 
proposed use of both terms, and those issues are discussed at Response 
10. Specifically, regarding the term, ``probation,'' the comments 
indicate that including references to this status on the public 
registry would inaccurately convey that such organizations are in poor 
standing, given what the term, ``probation'' normally means in the 
conformity assessment arena. Regarding the term, ``revocation,'' the 
comments express the belief that attaching such a label to laboratories 
in the public registry would cause confusion because it would imply 
that FDA can revoke the ISO/IEC 17025:2017 accreditation of a 
laboratory, which is not the case.
    (Response 58) We have made revisions throughout the final rule to 
address terminology concerns (see Response 10). As discussed in 
Responses 13, 71, and 82, we revised the final rule so that a 
recognized accreditation body may suspend a LAAF-accredited laboratory 
under Sec.  1.1121 whereas FDA may place a recognized accreditation 
body or a LAAF-accredited laboratory on probation under Sec. Sec.  
1.1131 and 1.1161, respectively. We also revised the final rule to 
allow corrective action under Sec.  1.1161 prior to any public change 
in LAAF-accreditation status (see Response 133). With these 
clarifications, the status information contained on the public registry 
is more clearly limited to the LAAF-accreditation status of the 
laboratory as opposed to the laboratory's ISO/IEC 17025 accreditation 
status. Given the revisions throughout the final rule, we will retain, 
with clarifications, the provision which makes public a LAAF-accredited 
laboratory's probationary status to maintain transparency for the 
public and specifically for the owners and consignees with food testing 
subject to this subpart.
5. What are the general requirements for submitting information to FDA 
under this subpart (Sec.  1.1110)?
    On our own initiative, we added Sec.  1.1110 to consolidate 
information previously repeated throughout the proposed codified text 
regarding the requirement to submit applications, reports, 
notifications, and records required by this subpart to FDA 
electronically and in English, unless otherwise specified. The section 
states further that if records are maintained in a language other than 
English, the recognized accreditation body or LAAF-accredited 
laboratory must provide an English translation within a reasonable 
time. Paragraph (b) specifies that a program applicant must provide 
translation and interpretation services needed by FDA during the 
processing of the application, including during any onsite assessments 
of the applicant. See table 5 for a list of consolidated sections in 
Sec.  1.1110.

 Table 5--Consolidation of Proposed Rule Sections Related to Submitting
                  Information to FDA Under This Subpart
------------------------------------------------------------------------
                Final rule                          Proposed rule
------------------------------------------------------------------------
Sec.   1.1110 What are the general          Sec.   1.1123(a)
 requirements for submitting information    Sec.   1.1124(b)
 to FDA under this subpart?                 Sec.   1.1128(d)
                                            Sec.   1.1129(f)
                                            Sec.   1.1131(b)(2)
                                            Sec.   1.1132(a)
                                            Sec.   1.1152(a)
                                            Sec.   1.1153(c)
                                            Sec.   1.1162(c)
                                            Sec.   1.1163(a)
                                            Sec.   1.1171(b)
                                            Sec.   1.1173(b)
                                            Sec.   1.1174(b)
------------------------------------------------------------------------

E. Comments Regarding FDA Recognition of Accreditation Bodies

    Table 6--Reorganization of Sections Regarding FDA Recognition of
                          Accreditation Bodies
------------------------------------------------------------------------
           Final rule                Proposed rule           Notes
------------------------------------------------------------------------
FDA Recognition of Accreditation  Recognition of      Added ``FDA'' to
 Bodies.                           Accreditation       clarify that FDA
                                   Bodies.             is making
                                                       recognition
                                                       determinations.
Sec.   1.1113 What are the        Sec.   1.1113 What  Consolidated these
 eligibility requirements for a    requirements must   two proposed
 recognized accreditation body?    an accreditation    sections and
                                   body meet to be     revised the
                                   recognized by       section title.
                                   FDA?               Made conforming
                                  Sec.   1.1118 What   changes to
                                   are the general     reflect
                                   requirements for    eligibility
                                   recognized          requirements as
                                   accreditation       opposed to
                                   bodies to remain    requirements for
                                   recognized?.        seeking
                                                       recognition and
                                                       remaining
                                                       recognized.
Sec.   1.1114 How does an         Sec.   1.1128 How   Moved section to
 accreditation body apply to FDA   does an             1.1114 of the
 for recognition or renewal of     accreditation       final rule.
 recognition?                      body apply to FDA
                                   for recognition
                                   or renewal of
                                   recognition?
Sec.   1.1115 How will FDA        Sec.   1.1129 How   Moved section to
 evaluate applications for         will FDA review     1.1115 of the
 recognition and renewal of        applications for    final rule.
 recognition?                      recognition and    Changed ``review''
                                   applications for    to ``evaluate''
                                   renewal of          in the section
                                   recognition?        title.
                                                      Removed second
                                                       instance of
                                                       ``applications
                                                       for'' in the
                                                       section title.
Sec.   1.1116 What must a         Sec.   1.1132 What  Moved section to
 recognized accreditation body     must a recognized   1.1116 of the
 do to voluntarily relinquish or   accreditation       final rule.
 not renew its recognition?        body do if it      Minor editorial
                                   wants to            changes to
                                   voluntarily         section title.
                                   relinquish its
                                   recognition or
                                   does not want to
                                   renew its
                                   recognition?
Sec.   1.1117 How may an          Sec.   1.1133 How   Moved section to
 accreditation body request        does an             1.1117 of the
 reinstatement of recognition?     accreditation       final rule.
                                   body request       Minor editorial
                                   reinstatement of    changes to
                                   recognition?        section title.
------------------------------------------------------------------------

[[Page 68765]]

1. What are the eligibility requirements for a recognized accreditation 
body (Sec.  1.1113)?
    Proposed Sec.  1.1113, ``What requirements must an accreditation 
body meet to be recognized by FDA?'' included the requirements an 
accreditation body must meet to become recognized by FDA under this 
subpart, including the following: (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; (c) demonstrate 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. Similarly, proposed Sec.  1.1118, ``What are the 
general requirements for recognized accreditation bodies to remain 
recognized?'' included the requirement that recognized accreditation 
bodies continue to meet the requirements of Sec.  1.1113 in order to 
remain recognized by FDA.
    In the final rule, FDA has consolidated proposed Sec. Sec.  1.1113 
and 1.1118. The new consolidated section is titled ``What are the 
eligibility requirements for a recognized accreditation body?'' and is 
located at Sec.  1.1113 of the final rule. Accordingly, FDA has revised 
the section title to refer to eligibility requirements for recognized 
accreditation bodies and has made minor conforming changes throughout 
the section to accommodate the change. We also have reordered the list 
of eligibility requirements and split the requirement that appeared in 
paragraph (a) of the proposed sections into two distinct items, i.e., 
separating the requirement of full membership of ILAC from status as a 
signatory to the ILAC-MRA that has demonstrated competence to ISO/IEC 
17011:2017 with a scope of ``Testing: ISO/IEC 17025.'' FDA has added 
the clarification that a scope of ``Testing: ISO/IEC 17025'' is 
required; this requirement previously appeared only among the LAAF-
accredited laboratory requirements against which a recognized 
accreditation body must assess a laboratory seeking LAAF-accreditation.
    FDA also has removed the requirement in proposed Sec.  1.1113(c)(1) 
through (3) regarding a recognized accreditation body's scientific and 
technical expertise to review certain validation and verification 
required by proposed Sec.  1.1138(a)(1), to review laboratory 
determinations regarding the availability of proficiency testing 
program, and to assess the adequacy of a laboratory's proposal to use a 
comparison program in lieu of a proficiency. For additional discussion 
regarding this change, see Comment 62 and Response. Finally, FDA has 
revised the section to modify ``accreditation'' with the prefix ``LAAF-
'' to incorporate revised terminology for the final rule discussed at 
Response 10. Comments regarding this section are discussed below.
    (Comment 59) Some accreditation bodies, including ones located 
outside of the United States, express interest in participating in this 
program and request information about their role.
    (Response 59) We appreciate global interest in the LAAF program. An 
accreditation body that meets the eligibility requirements in Sec.  
1.1113 may apply to FDA to become recognized, regardless of where the 
accreditation body is located. See Response 14 for our implementation 
discussion.
    Recognized accreditation bodies will assess and oversee 
laboratories seeking LAAF-accreditation against the requirements in 
this final rule. The requirements for recognized accreditation bodies 
are in Sec. Sec.  1.1113-1.1131 and the requirements for LAAF-
accredited laboratories are in Sec. Sec.  1.1138-1.1162.
    (Comment 60) Many comments endorse the proposed requirement that a 
recognized accreditation body must be an ILAC-MRA signatory that has 
demonstrated competence to ISO/IEC 17011:2017. They support the use of 
both ISO/IEC 17011:2017 and ISO/IEC 17025:2017 as the foundational 
requirements for this rule. Some of the comments express the belief 
that reliance on the ILAC framework and ISO standards will ensure an 
efficient and effective food testing program by FDA.
    Some comments mention that the rigorous ILAC-MRA process provides 
ongoing reassurance to regulators that ILAC-MRA signatories and their 
accredited laboratories are meeting relevant international standards 
and criteria for competence. Some comments provide examples of other 
Federal government Agencies and programs that rely on ILAC member 
accreditation bodies including the Consumer Product Safety Commission 
(CPSC), Environmental Protection Agency (EPA) National Lead Laboratory 
Accreditation Program, and Department of Defense Environmental 
Laboratory Accreditation Program. Other comments refer to the analysis 
we described in the proposed rule which indicated that all the 
accredited laboratories that submitted import-related food testing 
results in 2016 and 2017 were accredited by accreditation bodies that 
are full members of ILAC and signatories to the ILAC-MRA. According to 
these comments, it is unsurprising that owners and consignees choose to 
rely on laboratories accredited by ILAC-MRA signatories.
    Similarly, some comments state that accreditation bodies already 
satisfy the foundational requirements for participating in the LAAF 
program. Further, these comments state that accreditation bodies are 
willing to establish internal procedures and processes to ensure that 
they and the laboratories they LAAF-accredit meet all additional 
program requirements beyond ISO/IEC 17011:2017, ILAC-MRA signatory 
status, and ISO/IEC 17025:2017. Finally, some comments encourage FDA to 
collaborate with NIST as we establish this accreditation program. Some 
comments applaud FDA's proposed adoption of voluntary consensus 
standards and state that such action is in furtherance of the NTTAA.
    (Response 60) We appreciate the support expressed for the selected 
standards and requirements for recognized accreditation bodies in the 
LAAF program. We also appreciate the information provided regarding the 
accreditation landscape, as well as the support expressed in these 
comments for the LAAF program generally. We have consulted with NIST 
throughout this rulemaking process and appreciate their technical 
assistance and support.
    (Comment 61) In the proposed rule, when we discussed our proposal 
to require accreditation bodies to be ILAC-MRA signatories, we 
mentioned the laboratory accreditation program established by the CPSC 
(84 FR 59452 at 59467). We restated with approval the CPSC's rationale 
for establishing the same requirement.
    A few comments suggest that we also consider emulating the CPSC's 
laboratory accreditation program. Some comments particularly appreciate 
that, according to these comments, CPSC relies solely on ILAC-MRA 
signatory status to determine whether an accreditation body may 
accredit laboratories under CPSC's program; CPSC imposes no additional 
standards or requirements for accreditation bodies. According to these 
comments, CPSC also exercises very minimal oversight of accreditation 
bodies.
    We note that the CPSC does not directly regulate accreditation 
bodies, but instead requires that laboratories participating in its 
program be accredited to ISO/IEC 17025 by an

[[Page 68766]]

accreditation body that is an ILAC-MRA signatory (see Sec.  
1112.13(a)(2)(i)). Comments contend that a similar approach by FDA 
would provide accreditation bodies with more flexibility and reduce 
FDA's costs related to accreditation body oversight. These comments 
suggest that even with a reduced oversight role, FDA still could 
participate in accreditation body assessments and ILAC peer 
evaluations, as do other Federal Agencies with accreditation programs. 
Other comments appear to misunderstand our discussion related to the 
CPSC in the proposed rule and perceive it as a potential framework FDA 
intends to use as a model for our relationship with accreditation 
bodies under this subpart.
    (Response 61) Under Federal law, children's products must be tested 
by a third party, CPSC-accepted laboratory to ensure compliance with 
relevant safety requirements. The CPSC established requirements for 
third party conformity assessment bodies wishing to conduct these tests 
and maintains on its website a list of those conformity assessment 
bodies that have been accepted by the CPSC for that purpose. (For more 
information on the CPSC program, see https://www.cpsc.gov/Regulations-Laws-Standards/Rulemaking/Final-and-Proposed-Rules/Third-Party-Conformity-Assessment-Bodies/.)
    Emulating the framework of the CPSC program is not feasible for the 
LAAF program. Whereas the CPSC does not have a formal relationship with 
accreditation bodies, section 422 of the FD&C Act requires that FDA 
establish standards for, and recognize, accreditation bodies. The 
statute also directs FDA to periodically review the recognition of 
accreditation bodies and to provide a public registry of recognized 
accreditation bodies. Therefore, we believe the statutory requirements 
for the LAAF program preclude using the CPSC framework as a model for 
our program.
    (Comment 62) In proposed Sec.  1.1113(c), we provided that 
accreditation bodies seeking recognition demonstrate sufficient 
scientific and technical expertise to be able to review validation and 
verification studies, assess a laboratory's determination that no 
proficiency test is available for a given method, and assess the 
adequacy of a laboratory's proposed alternative to a proficiency test, 
where none is available. In the preamble we stated that we did not 
consider such reviews and determinations to be traditional functions of 
accreditation bodies and that accreditation bodies may need to hire or 
contract with additional persons possessing this scientific/technical 
expertise.
    Many comments support the notion that accreditation bodies must 
have the expertise to conduct substantive reviews of validation and 
verification studies, as well as alternatives to proficiency testing 
when a proficiency test is not available. However, several comments 
express the view that FDA need not include such a requirement in this 
rule because an equivalent requirement already exists, albeit in 
general terms, in ISO/IEC 17011:2017, and in order to be an ILAC-MRA 
signatory. Further, several of these comments disagree with FDA's 
statement that conducting a substantive review of validation and 
verification studies and assessing proposed alternatives to proficiency 
testing constitute non-traditional functions for accreditation bodies. 
Instead, these comments clarify that accreditation bodies routinely 
conduct those activities as part of the ISO/IEC 17025:2017 assessment 
and routinely hire qualified staff and assessors to carry out this 
work. They also state that satisfying the ILAC requirement is enforced 
and ensured by way of ILAC's robust peer evaluation process. Other 
comments offer conditional support for the proposed requirement that 
accreditation bodies demonstrate that they possess scientific/technical 
expertise, as long as our requirements do not impair the ability of 
accreditation bodies to fulfill their mission.
    Some comments stress the robust nature of the peer evaluation 
system that provides evaluation and surveillance of ILAC-MRA 
signatories. Some comments express the belief that an ILAC-MRA 
signatory accreditation body necessarily would possess the scientific/
technical expertise that FDA described in proposed Sec.  1.1113(c).
    (Response 62) Upon consideration of these comments, we agree that 
the requirement in proposed Sec.  1.1113(c) regarding scientific and 
technical expertise is unnecessary; it does not appear in the final 
rule. Also, as described above, we proposed to require that 
accreditation bodies seeking recognition demonstrate sufficient 
scientific and technical expertise in part to support their review of 
certain validation and verification studies that would be required in 
connection with the testing conducted under this subpart. Under the 
final rule FDA will review all verification and validation studies that 
are required in connection with the testing conducted under this 
subpart. See Comment and Response 122.
    (Comment 63) In the proposed rule, in connection with our 
discussion of recognized accreditation bodies assessing certain 
validation and verification studies required under this subpart as well 
as alternatives to proficiency tests, we stated that we may consider a 
variety of activities such as issuing guidance and regular roundtable 
meetings with recognized accreditation bodies, to communicate our 
expectations for such assessments. (See 84 FR 59452 at 59467). Several 
comments encourage FDA to provide such guidance. Some comments request 
a defined list of the items FDA considers necessary for a complete 
validation report. These comments state that an accreditation body's 
recognition may be revoked if the accreditation body allows a 
laboratory to use a method and the method was not appropriate due to 
errors or omissions in the validation study. Several comments suggest 
that clearly communicated expectations from FDA would better ensure 
consistency among laboratories and accreditation bodies and increase 
the likelihood that the studies and alternatives would be satisfactory 
to the Agency.
    (Response 63) We acknowledge that these comments encourage FDA to 
issue guidance communicating our expectations for the validation and 
verification studies required under this subpart. Although we may do 
so, there is information already available on our website regarding FDA 
expectations for validation studies: Foods Program Methods Validation 
Processes and Guidelines are available at https://www.fda.gov/food/laboratory-methods-food/foods-program-methods-validation-processes-and-guidelines.
2. How does an accreditation body apply to FDA for recognition or 
renewal of recognition (Sec.  1.1114)?
    Section 1.1128 of the proposed rule concerned how an accreditation 
body would apply to FDA for recognition or renewal of recognition. 
Paragraphs (a) and (b) of proposed Sec.  1.1128 included the 
requirement for an accreditation body to submit its application for 
recognition or renewal of recognition to FDA. Paragraph (c) of the 
proposed section discussed the specific documentation requirements for 
an accreditation body applicant, including documentation of conformance 
with ISO/IEC 17011:2017, separate documentation of ILAC-MRA signatory 
status demonstrating competence to ISO/IEC 17011:2017, and 
documentation of compliance with proposed Sec.  1.1113(c) and (d) 
(concerning the requirement to possess sufficient scientific and 
technical expertise: (1) To review certain

[[Page 68767]]

validation and verification studies, (2) to assess a laboratory's 
determination regarding proficiency test availability, and (3) to 
assess a laboratory's proposed comparison program; and the requirement 
to meet all additional requirements of the subpart) or proposed Sec.  
1.1118(c) and (d) (which covered the same provisions as proposed Sec.  
1.1113(c) and (d) for recognized accreditation bodies seeking renewal 
of recognition). Paragraph (d) of proposed Sec.  1.1128 included the 
requirement to submit the application electronically and in English and 
to provide any required translation services needed by FDA during the 
processing of the application or an onsite assessment of the 
accreditation body. Finally, paragraph (e) of proposed Sec.  1.1128 
covered requirements for signing the application for recognition or 
renewal of recognition.
    As part of our overall reorganization of the final rule, we have 
moved the contents of proposed Sec.  1.1128 to Sec.  1.1114 of the 
final rule. We received no comments directly related to this section of 
the rule; however, we have made several editorial and conforming 
changes to improve clarity and readability and to streamline the 
section. We combined proposed paragraphs (a) and (b) into a single 
paragraph (a) of the final rule to cover both initial and renewal 
applications. Paragraph (c) of the proposed rule regarding 
documentation has been updated to reflect correct cross-references 
since proposed Sec. Sec.  1.1113 and 1.1118 were combined; the 
documentation paragraph of the final rule is now paragraph (b). We 
relocated the contents of proposed paragraph (d) (regarding submitting 
documents to FDA electronically and in English) to Sec.  1.1110 of the 
final rule. Finally, proposed paragraph (e) is now paragraph (c) of the 
final rule.
3. How will FDA evaluate applications for recognition and renewal of 
recognition (Sec.  1.1115)?
    Section 1.1129 of the proposed rule, ``How will FDA review 
applications for recognition and applications for renewal of 
recognition?'' concerned FDA evaluation of applications for recognition 
and renewal of recognition. Paragraph (a) of proposed Sec.  1.1129 
stated that FDA would notify an accreditation body applicant if the 
application is incomplete and would review completed applications in 
the order in which the completed application is received; however, FDA 
reserved discretion to prioritize review to meet program needs. 
Paragraph (b) of proposed Sec.  1.1129 stated that FDA would evaluate 
applications and may include an onsite visit to determine whether the 
accreditation body applicant meets the requirements for recognition. We 
also noted that we may extend the term of recognition for an 
accreditation body if FDA's review of the application for renewal of 
recognition was not complete prior to the term's expiration. In 
paragraphs (c) and (d), we stated that we would notify an accreditation 
body if the application is approved and that we may grant recognition 
for a period up to 5 years from the date of recognition, unless our 
review of the application extends past the expiration of the term of 
recognition (as covered in proposed paragraph (b)). Proposed Sec.  
1.1129 also provided that we would notify an accreditation body 
applicant if we deny the application for recognition or renewal of 
recognition, including the basis for the denial and procedures for 
requesting reconsideration (see proposed Sec.  1.1129(e)). If we deny 
an application for renewal of recognition, paragraph (f) stated that 
the accreditation body applicant would have to identify a records 
custodian to maintain records pursuant to proposed Sec.  1.1124, and 
provide the custodian's contact information including email and street 
address. As discussed above regarding changes to Sec.  1.1102, 
throughout this subpart when we say, ``street address,'' we mean full 
physical address including country; a mailing address that is not a 
physical address (e.g., post office number) is insufficient, though 
supplying both types of address is acceptable (see new definition of 
street address in Sec.  1.1102 of the final rule). Paragraphs (g) and 
(h) of proposed Sec.  1.1129 stated that when the application for 
renewal of recognition is denied FDA would provide notice to 
laboratories accredited by the accreditation body and public notice on 
the website described in proposed Sec.  1.1109.
    As part of our overall reorganization of the final rule, we have 
moved the contents of proposed Sec.  1.1129 to Sec.  1.1115 of the 
final rule and revised the section title to ``How will FDA evaluate 
applications for recognition and renewal of recognition?'' We relocated 
the requirement in proposed Sec.  1.1129(f) regarding submitting 
notifications electronically and in English to Sec.  1.1110 of the 
final rule. We have made several revisions to the contents of this 
section to incorporate revised terminology and to improve clarity and 
readability. Comments regarding this section are discussed below.
    (Comment 64) Some comments suggest that FDA establish an initial 
accreditation body application deadline, and an approval date for all 
the accreditation bodies that apply for recognition by that deadline. 
They state that this approach would avoid any competitive advantage 
that might otherwise accrue to the accreditation body that first gains 
FDA recognition. The comments also suggest that FDA set up additional 
rounds of accreditation body application deadlines and recognition 
decisions.
    (Response 64) As discussed in Response 14, we intend to implement 
the LAAF program in a stepwise fashion. The first step will be 
announcing that accreditation bodies may apply for recognition. We 
understand and acknowledge the concern that a competitive advantage may 
accrue to the first accreditation body recognized. We will consider 
this matter and communicate further on the details of the accreditation 
body application process when we announce that applications may be 
submitted.
4. What must a recognized accreditation body do to voluntarily 
relinquish or not renew its recognition (Sec.  1.1116)?
    Section 1.1132 of the proposed rule, ``What must a recognized 
accreditation body do if it wants to voluntarily relinquish its 
recognition or does not want to renew its recognition?'' concerned the 
procedures for voluntary relinquishment of recognition and non-renewal 
of recognition of a recognized accreditation body, including the 
requirement to provide to FDA a notice of intent 60 days prior to 
relinquishing recognition as well as a records point of contact for 
records required by proposed Sec.  1.1124 (see proposed Sec.  
1.1132(a)). Paragraph (b) required the accreditation body to provide 
notice of intent to relinquish recognition to the laboratories the 
accreditation body LAAF-accredits, and paragraph (c) noted that FDA 
would provide notice of the same on the website described in proposed 
Sec.  1.1109.
    As part of our overall reorganization of the final rule, we have 
moved the contents of proposed Sec.  1.1132 to Sec.  1.1116 of the 
final rule. We received no comments directly related to this section of 
the rule; however, we made certain changes on our own initiative. 
First, we revised the section title to read, ``What must a recognized 
accreditation body do to voluntarily relinquish or not renew its 
recognition?'' In paragraph (a) we clarified that when a recognized 
accreditation body notifies FDA of its intention to leave the program 
it must specify the date on which the relinquishment or expiration will 
occur.

[[Page 68768]]

We also deleted ``electronically, in English'' in paragraph (a) since 
this is covered by the new Sec.  1.1110 in the final rule. We also made 
several conforming changes to update cross-references throughout the 
section to reflect the reorganized structure of the final rule and to 
update terminology, such as the change to ``LAAF-accreditation.'' We 
revised paragraphs (a) and (b) of the final rule to specify 
``calendar'' days. Finally, we have made revisions to improve clarity 
and readability of the final rule.
5. How may an accreditation body request reinstatement of recognition 
(Sec.  1.1117)?
    Section 1.1133 of the proposed rule, ``How does an accreditation 
body request reinstatement of recognition?'' concerned an accreditation 
body's request for reinstatement of recognition. Under proposed Sec.  
1.1133(a), an accreditation body that had its recognition revoked could 
seek reinstatement of recognition by submitting a new application along 
with evidence that the grounds for revocation have been resolved. As 
described in proposed Sec.  1.1133(b), an accreditation body that 
allowed its recognition to expire or voluntarily relinquished 
recognition could submit a new application without additional 
requirements.
    As part of our overall reorganization of the final rule, we have 
moved the contents of proposed Sec.  1.1133 to Sec.  1.1117 of the 
final rule and revised the title to read, ``How may an accreditation 
body request reinstatement of recognition?'' We received no comments 
directly related to this section of the rule; however, we revised the 
section to update cross-references to reflect the reorganized structure 
of the final rule and have made revisions to improve the clarity and 
readability of the final rule.

F. Comments Regarding Requirements for Recognized Accreditation Bodies

 Table 7--Changes to the Sections Regarding Requirements for Recognized
                          Accreditation Bodies
------------------------------------------------------------------------
           Final rule                Proposed rule           Notes
------------------------------------------------------------------------
N/A (contents combined with Sec.  Sec.   1.1118 What
   1.1113).                        are the general
                                   requirements for
                                   recognized
                                   accreditation
                                   bodies to remain
                                   recognized?
Sec.   1.1119 What are the        Sec.   1.1119 What  Editorial changes
 conflict of interest              requirements        to section title.
 requirements for a recognized     apply to how a
 accreditation body?               recognized
                                   accreditation
                                   body must protect
                                   against conflicts
                                   of interests?
Sec.   1.1120 How must a          Sec.   1.1120 How   Revised section
 recognized accreditation body     must a recognized   title to change
 assess laboratories seeking       accreditation       ``evaluate'' to
 LAAF-accreditation and oversee    body evaluate       ``assess'' and to
 LAAF-accredited laboratories?     laboratories        modify
                                   seeking             ``accreditation''
                                   accreditation and   with the prefix
                                   oversee the         ``LAAF-''.
                                   performance of
                                   laboratories it
                                   accredits?
Sec.   1.1121 When must a         Sec.   1.1121 What  Relocated section
 recognized accreditation body     appeal procedures   and revised
 require corrective action,        must a recognized   section title to
 suspend a LAAF-accredited         accreditation       reflect
 laboratory, or reduce the scope   body provide for    opportunity for
 of or withdraw the LAAF-          appeals of          corrective
 accreditation of a laboratory?    decisions to not    action, to revise
                                   grant               this use of
                                   accreditation?      ``probation'' to
                                  Sec.   1.1122(h)     ``suspension,''
                                   Appeals             to modify
                                   procedures..        ``accreditation''
                                                       with the prefix
                                                       ``LAAF-,'' to
                                                       refer to scope
                                                       reduction, and to
                                                       re-order the
                                                       terms.
Sec.   1.1122 What procedures     Sec.   1.1122 When  Relocated section
 must a recognized accreditation   must a recognized   and revised
 body provide for appeals of       accreditation       section title to
 decisions to suspend, reduce      body withdraw or    include appeals
 the scope of, withdraw, or deny   reduce the scope    for suspension,
 LAAF-accreditation?               of the              scope reduction,
                                   accreditation of    withdrawal, or
                                   a laboratory, and   denial of LAAF-
                                   when may a          accreditation.
                                   recognized
                                   accreditation
                                   body put an
                                   accredited
                                   laboratory on
                                   probation?
Sec.   1.1123 What reports,       Sec.   1.1123 What  Revised title to
 notifications, and                reports and         include
 documentation must a recognized   notifications       ``documentation''
 accreditation body submit to      must a recognized   to more
 FDA?                              accreditation       accurately
                                   body submit to      reflect the
                                   FDA?                contents of the
                                                       section.
Sec.   1.1124 What are the        Sec.   1.1124 What  Editorial changes
 records requirements for a        records             to section title.
 recognized accreditation body?    requirements must
                                   a recognized
                                   accreditation
                                   body meet?
Sec.   1.1125 What are the        Sec.   1.1125 What  Editorial changes
 internal audit requirements for   internal audit      to section title.
 a recognized accreditation        requirements must
 body?                             a recognized
                                   accreditation
                                   body meet?
------------------------------------------------------------------------

1. What are the conflict of interest requirements for a recognized 
accreditation body (Sec.  1.1119)?
    Proposed Sec.  1.1119 concerned conflict of interest requirements 
for recognized accreditation bodies. In addition to meeting the 
impartiality and conflict of interest requirements in ISO/IEC 
17011:2017, proposed Sec.  1.1119(a)(1) stated the following 
requirements: An accreditation body, including its officers, employees, 
and other agents involved in accreditation activities, could not own, 
have a financial interest in, manage, or otherwise control a 
laboratory, including affiliates, parents, or subsidiary, that it LAAF-
accredits. Paragraph (a)(2) prohibited the acceptance of money, gifts, 
gratuities, and other items of value by an accreditation body's 
officers, employees, and other agents from a laboratory it LAAF-
accredits. Proposed Sec.  1.1119(b) excluded the following from 
prohibited items of value: (1) Money representing payment for 
accreditation fees and services, (2) reimbursement of direct costs 
associated with an onsite assessment, and (3) lunch of a de minimis 
value in certain circumstances. Proposed Sec.  1.1119(c) stated that 
the financial interest of a spouse or child under 18 years of age of 
any recognized accreditation body officer, employee, or other agent 
involved in accreditation activities would be considered the financial 
interest of such officer, employee, or other agent for purposes of the 
rule.
    In addition to the changes discussed below, we have revised cross-
references and terminology throughout the final rule to reflect the 
reorganization and revised terms in the final rule. We revised the 
title of the section to read, ``What are the conflict of interest 
requirements for a recognized accreditation body?'' We have relocated 
the contents of proposed paragraph (c) to paragraph (b) of the final 
rule to better accommodate the addition of two

[[Page 68769]]

new paragraphs described below. We also changed the phrase ``lunch of 
de minimis value'' (see proposed Sec.  1.1119(b)(2)) to ``meal of de 
minimis value'' in Sec.  1.1119(e)(2) of the final rule to provide 
flexibility. We also have revised this section to improve clarity and 
readability. Comments regarding this section are discussed below.
    (Comment 65) Many comments agree with the proposed accreditation 
body conflict of interest provisions in Sec.  1.1119. Some comments 
express particular support that our proposed policy would allow 
individuals involved in accreditation decisions to accept both; (1) 
payment for accreditation services, including reimbursement for direct 
costs, and (2) lunch of de minimis value during an onsite assessment. 
However, some comments state that our proposed requirements would be 
duplicative of requirements in ISO/IEC 17011:2017.
    (Response 65) We appreciate comments in support of the conflict of 
interest provisions. We disagree that the requirements of Sec.  1.1119 
are duplicative of ISO/IEC 17011:2017. The ISO/IEC 17011:2017 
requirements for conflict of interest are stated in general terms and 
included in the sections on impartiality. ISO/IEC 17011:2017 section 
4.4.4 specifically addresses financial conflict of interest as follows: 
``All accreditation body personnel and committees who could influence 
the accreditation process shall act objectively and shall be free from 
any undue commercial, financial and other pressures that could 
compromise impartiality. The accreditation body shall require all 
personnel and committee members to disclose any potential conflict of 
interest whenever it may arise'' (Ref. 2). In contrast, Sec.  1.1119 
offers more detailed and specific information than specified by ISO/IEC 
17011:2017 with respect to what is permitted.
    (Comment 66) Among the proposed conflict of interest provisions for 
accreditation bodies, one would prohibit the officers, employees, or 
other agents of an accreditation body from owning or having a financial 
interest in any laboratory (including an affiliate, parent, or 
subsidiary) LAAF-accredited by the accreditation body. Some comments 
specifically applaud this proposed policy. Other comments express 
concern that this proposed provision contains a much broader 
interpretation of ``conflict'' than is either the industry standard or 
practical in application. They state that, as proposed, this provision 
may apply to accreditation body board members, decision panel members, 
and technical committee members, among others, and could prohibit such 
individuals from investing in a mutual fund that includes a company 
with a financial interest in a laboratory accredited by the 
accreditation body, even if that laboratory is not LAAF-accredited and 
conducts no food testing. These comments suggest that FDA limit its 
conflict of interest provisions in two ways. First, they suggest that 
we limit our financial conflict of interest restrictions for 
accreditation bodies to the more limited cases of owning or having a 
financial interest in food testing laboratories LAAF-accredited by the 
accreditation body under this program, or that are in direct 
competition with listed laboratories, rather than all laboratories the 
accreditation body has accredited. Second, they seem to imply that the 
conflict of interest restrictions should apply only to individuals 
involved in assessments and LAAF-accreditation decisions. Certain 
comments from accreditation bodies explain that their practice is to 
ask the laboratories being assessed to declare that no conflict exists 
between the laboratory and the individual assessor(s) or accreditor(s). 
Finally, these comments mention that their conflict of interest 
policies have been deemed sufficient by other regulators as well as 
peer evaluators.
    (Response 66) We appreciate support for the conflict of interest 
provisions proposed in Sec.  1.1119. As a threshold matter, we note 
that the proposed rule defined ``accreditation'' in Sec.  1.1102, in 
relevant part, as being limited to accreditation under this subpart. 
Therefore, proposed section 1.1119(a)(1) was intended only to prevent 
an accreditation body's ownership, financial interest in, management 
of, or control of any laboratory it LAAF-accredits under this subpart. 
As discussed at Response 10, we understand the potential for confusion 
and have updated the terminology to better clarify the scope of the 
rule and these conflict of interest provisions. With revisions to 
reflect these terminology changes, Sec.  1.1119(a)(1) of the final rule 
specifies that the prohibited interests relate solely to laboratories 
that are LAAF-accredited by the recognized accreditation body. We 
decline the suggestion to apply the conflict of interest requirements 
for accreditation bodies as a prohibition against having a financial 
interest in laboratories in direct competition with LAAF-accredited 
laboratories because such a provision would be extremely challenging to 
monitor and enforce.
    In response to concerns raised in these comments, we have added new 
paragraph (c) to this section in the final rule to permit a recognized 
accreditation body, including officers, employees, or other agents 
involved in LAAF-accreditation activities to have interest in a 
publicly traded or publicly available fund (such as a mutual fund), or 
a widely held pension or similar fund if the accreditation body 
exercises no control over the financial interests in the funds. We 
believe this type of interest to be low-risk and not to pose a 
meaningful conflict of interest for a recognized accreditation body.
    However, we decline to only apply these and other conflict of 
interest restrictions to those individuals involved in LAAF-
accreditation or LAAF assessment decisions. If any officer, employee, 
or other agent of the accreditation body owns or has a financial 
interest in, manages or otherwise controls a laboratory that the 
accreditation body LAAF-accredits, a conflict of interest exists. 
Protecting against conflicts of interest is critical to the integrity 
of this program.
    (Comment 67) With regard to the proposed conflict of interest 
provisions for accreditation bodies, some comments indicate that 
whereas our proposed rule focused solely on financial conflicts of 
interest, ISO/IEC 17011:2017 also addresses other types of conflicts of 
interest such as consultation. We understand these comments to be 
asking whether individuals who provide consulting services to a LAAF-
accredited laboratory apart from, or in preparation for, an assessment 
by an accreditation body (e.g., the consultant who assists the 
laboratory with determining how to design their quality management 
system, or the consultant who provides services to the laboratory such 
as performing the laboratory's required internal audit) will be 
prohibited from serving as the consulting assessor that assesses the 
laboratory on behalf of the recognized accreditation body.
    (Response 67) Proposed Sec.  1.1119(a) stated that the conflict of 
interest requirements in that section were in addition to the conflict 
of interest requirements in proposed Sec.  1.1118(b), which 
incorporated by reference, in its entirety, ISO/IEC 17011:2017. 
Likewise, in the final rule, Sec.  1.1119(a) states that the conflict 
of interest requirements in that section are in addition to the 
conflict of interest requirements in Sec.  1.1113(a), which 
incorporates by reference, in its entirety, ISO/IEC 17011:2017. Thus, 
all the requirements in ISO/IEC 17011:2017, including those regarding 
other conflicts of interest, are required by the final rule. Sections 
4.4.11 through 4.4.13 of ISO/IEC 17011:2017 address consultancy among

[[Page 68770]]

the activities an accreditation body is restricted from performing. In 
addition to consultancy, this section of ISO/IEC 17011:2017 also 
addresses testing; calibration; inspection; certification of management 
systems, persons, products, processes and services; provision of 
proficiency testing; production of reference materials; and validations 
and verifications (Ref. 2).
    (Comment 68) Some comments on the proposed section regarding 
conflict of interest requirements for accreditation bodies request that 
FDA clarify the term, ``other agents.'' These comments ask whether our 
proposal to include ``other agents'' among the actors prohibited from 
having a financial interest in any laboratory the accreditation body 
accredits, is intended to prohibit the accreditation body from 
contracting with technical assessors who may also work for a laboratory 
that the accreditation body LAAF-accredits. These comments state that 
the use of contract assessors who work in accredited laboratories is 
common in the industry. If we intended to prohibit that practice, these 
comments recommend that we instead allow it to continue. They further 
recommend that the applicant laboratory be made aware that the contract 
assessor is from another accredited laboratory and be given an 
opportunity to object to that assessor.
    (Response 68) In light of these concerns, we have revised the final 
rule to include new Sec.  1.1119(d) which permits a recognized 
accreditation body to use a contract assessor with a specified 
financial interest in a laboratory the recognized accreditation body 
assesses for LAAF-accreditation, if all the following circumstances 
apply: First, the contract assessor's primary occupation is owning or 
having a financial interest in, managing, or otherwise controlling a 
LAAF-accredited laboratory. Second, the assessor contracts with the 
recognized accreditation body to provide assessment services on an 
intermittent or part-time basis. Third, the contract assessor does not 
assess the LAAF-accredited laboratory that the assessor owns or has a 
financial interest in, manages, or otherwise controls. Finally, the 
contract assessor and the recognized accreditation body inform any 
laboratory that the contract assessor may assess or reassess for LAAF-
accreditation, that the contract assessor owns or has a financial 
interest in, manages, or otherwise controls a LAAF-accredited 
laboratory. The laboratory seeking LAAF-accreditation assessment or 
reassessment must acknowledge that the contract assessor owns or has a 
financial interest in, manages, or otherwise controls a LAAF-accredited 
laboratory and be provided the option to be assessed by a different 
representative of the recognized accreditation body.
    The addition of this paragraph to the final rule is intended to 
facilitate the existing industry practice of accreditation bodies using 
contract assessors from LAAF-accredited laboratories. We believe that 
any potential conflict of interest arising from this narrow exception 
is mitigated by the disclosure of the financial interest of the 
contract assessor to the laboratory subject to assessment for purposes 
of LAAF-accreditation, as well as an acknowledgement by the laboratory 
and the option to request a different assessor.
    To accommodate changes to the final rule regarding the excepted 
interests described in Sec.  1.1119(c) and (d) (see Responses 66 and 
67) we have revised Sec.  1.1119(a)(1) to expressly reference the new 
exceptions.
2. How must a recognized accreditation body assess laboratories seeking 
LAAF-accreditation and oversee LAAF-accredited laboratories (Sec.  
1.1120)?
    Section 1.1120 of the proposed rule, ``How must a recognized 
accreditation body evaluate laboratories seeking accreditation and 
oversee the performance of laboratories it accredits?'' concerned 
recognized accreditation body assessment of LAAF-accredited 
laboratories. This proposed section stated that recognized 
accreditation bodies would need to conduct an initial assessment of a 
laboratory seeking LAAF-accreditation onsite, unless the recognized 
accreditation body had conducted an onsite assessment of the laboratory 
in the last 2 years in accordance with ISO/IEC 17025:2017. The proposed 
section stated in paragraph (c) that a recognized accreditation body 
that had conducted an onsite assessment of a laboratory in the last 2 
years in accordance with ISO/IEC 17025:2017 could conduct the initial 
assessment of such laboratory seeking LAAF-accreditation remotely and 
need only address the requirements beyond ISO/IEC 17025:2017. Once 
LAAF-accredited, proposed paragraph (d) required that a recognized 
accreditation body oversee the performance of a laboratory it LAAF-
accredits in accordance with the requirements of this subpart. Proposed 
paragraph (e) required the assessment of the sample of the scope of 
LAAF-accreditation to be conducted onsite and at least every 2 years, 
unless, as proposed paragraph (f) stated, the initial assessment was 
conducted remotely under the exception in proposed paragraph (c), in 
which case the first assessment of the sample of the scope of LAAF-
accreditation must be conducted within 2 years of the last onsite 
assessment in accordance with ISO/IEC 17025:2017. Proposed Sec.  
1.1120(g) also required that the reassessment of at the end of the 
LAAF-accredited laboratory's LAAF-accreditation cycle be conducted 
onsite. In all assessment scenarios in this proposed section, certain 
assessment activities could be conducted remotely if it would not aid 
the assessment to conduct them onsite. Finally, in paragraph (h), we 
proposed that any additional assessments beyond those referred to in 
the section could be conducted remotely.
    We have updated cross-references and terminology throughout the 
section and, correspondingly, we revised the section title to read, 
``How must a recognized accreditation body assess laboratories seeking 
LAAF-accreditation and oversee LAAF-accredited laboratories?'' On our 
own initiative, we revised Sec.  1.1120(e) to improve clarity and 
readability. To better distinguish between initial assessment 
activities and activities conducted in subsequent assessments, we 
replaced several instances of ``assessment'' with ``reassessment.'' We 
also deleted references to assessing ``in accordance with'' ISO/IEC 
17011:2017 because such references were redundant of the foundational 
ISO/IEC 17011:2017 requirement (Sec.  1.1113). Comments regarding this 
section are discussed below.
    (Comment 69) Some comments praise FDA for the clarity of the 
requirements in Sec.  1.1120. These comments state that the 
accreditation body would be responsible for deciding, within the 
parameters set by the rule, whether and when remote assessment would be 
sufficient.
    A few comments indicate that the proposed rule did not distinctly 
address a laboratory's request to expand or extend its scope of LAAF-
accreditation or propose requirements for how a recognized 
accreditation body would assess such a request. These comments suggest 
that a remote assessment should be allowed if the laboratory is simply 
adding analytes to a technique or method for which it is already LAAF-
accredited. In contrast, these comments recommend that an onsite 
assessment be required if the request to extend the scope of LAAF-
accreditation involves techniques or methods that are new to that 
laboratory.
    (Response 69) We appreciate the support and agree that this section 
indicates minimum requirements but does not prevent a recognized

[[Page 68771]]

accreditation body from conducting additional site visits or remote 
visits if they so choose, provided they are not in conflict with our 
requirements.
    Proposed Sec.  1.1120 did not explicitly address assessments for 
extensions of LAAF accreditation. However, such assessments would be 
governed by the terms of Sec.  1.1120, meaning that if such an 
assessment was not required to be onsite under paragraphs (a), (e), or 
(g), it would be covered by paragraph (h) and the recognized 
accreditation body would determine whether going onsite would aid the 
assessment. In most circumstances FDA would recommend that recognized 
accreditation bodies go onsite to assess a LAAF-laboratory for 
techniques, technology, and types of instrumentation that have not been 
previously observed during an onsite assessment. In our view, remote 
off-cycle assessments are generally sufficient in circumstances such as 
the addition of analyte(s) to a method previously evaluated during an 
onsite assessment, the addition of matrices to a method previously 
evaluated during an onsite assessment, and the addition of a method for 
a technique or technology that the laboratory has been determined to 
have competence to perform based on a previous onsite assessment.
3. When must a recognized accreditation body require corrective action, 
suspend a LAAF-accredited laboratory, or reduce the scope of or 
withdraw the LAAF-accreditation of a laboratory (Sec.  1.1121)?
    Proposed Sec.  1.1122 concerned the probation, withdrawal, and 
reduction of scope of a laboratory's LAAF-accreditation. Paragraphs (a) 
and (c) of this proposed section described the grounds for withdrawal 
of LAAF-accreditation as when a laboratory substantially fails to 
comply with this subpart; it also provided that withdrawal may be 
limited to certain methods if the deficiencies only impact those 
methods within the scope of LAAF-accreditation. Paragraph (b) of this 
proposed section described grounds for probation as when a laboratory 
demonstrates deficiencies less serious than those warranting withdrawal 
that are reasonably likely to be fixed within a specified period of 
time. Proposed Sec.  1.1122(d) stated the provision to submit required 
records as requested by the recognized accreditation body to assist in 
determining whether withdrawal or probation is warranted. This proposed 
section also included the procedures for withdrawal of LAAF-
accreditation and for probation of a LAAF-accredited laboratory as well 
as the consequences of each: specifically, a laboratory would not be 
eligible to conduct testing under this subpart for any methods for 
which LAAF-accreditation had been withdrawn and a laboratory on 
probation could continue to conduct testing under this subpart. 
Paragraph (h) of this proposed section included the requirements for 
appeals procedures a recognized accreditation body would need to 
establish and implement for a laboratory to appeal any decision to 
withdraw LAAF-accreditation.
    As a threshold matter, we moved the contents of proposed Sec.  
1.1122 to Sec.  1.1121 in the final rule. Additionally, we have revised 
this section to remove proposed Sec.  1.1122(h) regarding appeals 
procedures for reducing the scope of or withdrawal of LAAF-
accreditation; this content has been incorporated into Sec.  1.1122 of 
the final rule regarding appeals procedures for decisions to suspend, 
reduce the scope of, withdraw, or deny LAAF-accreditation. We have also 
revised the section to clarify that a recognized accreditation body can 
use suspension on a method-specific basis; we believe this change 
better aligns LAAF-accreditation with ISO/IEC 17025:2017 accreditation.
    In response to comments, we have made substantial revisions to this 
section. In addition to updating terminology, we also have revised the 
section to include the opportunity to implement corrective action prior 
to suspension of a LAAF-accredited laboratory. See Sec.  1.1121(a). A 
laboratory with its LAAF-accreditation suspended also has a corrective 
action opportunity before its LAAF-accreditation is withdrawn by the 
recognized accreditation body. We revised the section title to read, 
``When must a recognized accreditation body require corrective action, 
suspend a LAAF-accredited laboratory, or reduce the scope of or 
withdraw the LAAF-accreditation of a laboratory?'' to incorporate 
revised terminology and to better reflect the contents of the section 
in the final rule.
    (Comment 70) Section 1.1122(a) of the proposed rule provided that a 
recognized accreditation body must withdraw a laboratory's LAAF-
accreditation if the laboratory substantially fails to comply with this 
rule. We have addressed in Response 10 the confusion and concern some 
comments express regarding our proposed use of the word, 
``accreditation'' to mean the laboratory had been approved to conduct 
testing under this subpart. Here we address the proposed requirement 
that an accreditation body act to remove a laboratory from this program 
if the laboratory substantially fails to comply with this rule.
    Some comments state support for this proposed requirement, stating 
that it reflects common industry practice.
    (Response 70) We appreciate support for the proposed requirements 
and note that the final rule is limited to impact on a laboratory's 
LAAF-accreditation, as opposed to having any impact on ISO/IEC 
17025:2017 accreditation.
    (Comment 71) Many comments highlight that the term, ``probation'' 
typically is not used in conformity assessment. Many comments also 
argue that marketplace confusion and commercial harm would likely 
result from use of the term, ``probation'' to describe an action that a 
recognized accreditation body could take against a laboratory--
particularly in combination with our proposed specialized definition of 
the term, ``accreditation'' to mean that the laboratory satisfies the 
requirements of this subpart and the proposal that laboratories be 
labeled publicly with ``probation'' status via our online registry.
    Some comments recommend that the rule allow for three actions that 
could be taken against a LAAF-accredited laboratory: probation, 
suspension, and withdrawal. Some comments recommend that FDA not 
establish another accreditation status outside of the ILAC-MRA and ISO/
IEC 17011:2017, which provides for suspension, withdrawal, and 
reduction of the scope of accreditation. Some comments urge that, if 
FDA does use the term, ``probation'' in this subpart, we use the term 
solely to describe an action we might take, e.g., in relation to the 
online registry, rather than an action taken by the accreditation body.
    Some comments contend that a laboratory should not be placed on 
``inactive'' status if it has been cited for noncompliance during an 
assessment. We understand this comment to mean that a laboratory should 
not be placed on probation or suspension from this program until after 
the laboratory has had an opportunity to take corrective action.
    (Response 71) We understand that the term, ``probation'' typically 
is not used in this context and appreciate the recommendations for 
other terms. We have revised the terminology used here and throughout 
the rule to be more specific to LAAF-accreditation. In Sec.  1.1121, we 
have revised the section to refer to ``suspension'' instead of 
``probation,'' as we understand this to be a more appropriate term 
based on context. We also agree that the opportunity for corrective 
action should

[[Page 68772]]

be afforded prior to suspending a laboratory and we have revised the 
section to include such opportunity prior to a recognized accreditation 
body suspending a LAAF-accredited laboratory or withdrawing or reducing 
the laboratory's scope of LAAF-accreditation. We have retained the 
term, ``probation'' in the final rule to refer to an action taken by 
FDA with respect to a recognized accreditation body (see Sec.  1.1131) 
or a LAAF-accredited laboratory (see Sec.  1.1161).
    We also acknowledge that laboratory suspension may occur at the 
request of the laboratory to accommodate temporary circumstances 
unrelated to deficiencies, such as to move locations, remodel, or while 
certain equipment is inoperable or otherwise unavailable. A suspension 
of ISO/IEC 17025 accreditation for any reason would necessarily impact 
LAAF-accreditation and therefore must be reported to FDA by the 
recognized accreditation body under Sec.  1.1123. We intend to 
accurately maintain the information contained on the public registry 
described in Sec.  1.1109.
    Although we proposed in Sec.  1.1122(g) that a LAAF-accredited 
laboratory would be permitted to continue to conduct food testing under 
this subpart while on probation, we have also revised the final rule to 
better align with the consequences of suspension in section 4.3.1 of 
ISO/IEC 17011:2017 (Ref. 2). Since a laboratory would not be able to 
hold itself out as accredited for a method subject to suspension, Sec.  
1.1121(f)(1) of the final rule states that a LAAF-accredited laboratory 
may not conduct food testing under this subpart using suspended 
methods.
    (Comment 72) Some comments express concern about the proposed 
provisions regarding recognized accreditation bodies placing 
laboratories on probation or withdrawing LAAF-accreditation for the 
laboratory's failure to comply with the rule, when combined with what 
these comments describe as ``punitive and excessive'' documentation and 
reporting proposed requirements associated with analytical reports. We 
understand these comments to be expressing concern that if FDA applies 
exacting standards to all contents of the full analytical report, a 
laboratory may be deemed out of compliance with the rule for failing to 
satisfy those reporting requirements, at which point the recognized 
accreditation body may place the laboratory on probation or withdraw 
LAAF-accreditation.
    (Response 72) We have revised the final rule to clarify that 
probation is an action that only FDA will take; under Sec.  1.1121, a 
recognized accreditation body may suspend a LAAF-accredited laboratory. 
(See Response 10 for additional discussion of clarifying terminology 
changes in the final rule.)
    It remains true in the final rule that a recognized accreditation 
body ``must reduce the scope of or withdraw the LAAF-accreditation of a 
laboratory it LAAF-accredits when the laboratory substantially fails to 
comply with this subpart'' (Sec.  1.1121(c)). However, the word, 
``substantially'' is included in this regulatory provision for a 
reason, and that is to distinguish minor or isolated infractions from 
more serious failings. In the context of laboratory reporting 
requirements, ``substantially'' means that it would be unnecessary and 
inappropriate for an accreditation body to place a LAAF-accredited 
laboratory on probation, or to reduce the scope of or withdraw its 
LAAF-accreditation, for minor administrative errors in analytical 
reports. Nor would such errors ordinarily result in FDA placing the 
laboratory on probation or disqualifying the laboratory. Further, it is 
FDA's responsibility, and not the recognized accreditation body's, to 
review the performance of LAAF-accredited laboratories, including 
reviewing submitted analytical reports.
    For more information on laboratory reporting requirements, see our 
discussion of Sec.  1.1152, below. For more information on FDA review 
of analytical reports, see our discussion of Sec.  1.1160 below.
4. What procedures must a recognized accreditation body provide for 
appeals of decisions to suspend, reduce the scope of, withdraw, or deny 
LAAF-accreditation (Sec.  1.1122)?
    Proposed Sec.  1.1121 concerned the procedures for appeals of 
decisions to deny LAAF-accreditation. This proposed section specified 
requirements for appeals procedures in addition to those in ISO/IEC 
17011:2017, including the requirement to make appeals procedures 
publicly available, and to use a competent person free from bias who 
has not participated in the accreditation decision and is not the 
subordinate of a person who participated in the accreditation decision.
    As mentioned above, we have moved the contents of proposed Sec.  
1.1121 to Sec.  1.1122 in the final rule. Considering the overlap 
between proposed Sec. Sec.  1.1121 and 1.1122(h) (regarding appeals 
procedures for withdrawal of LAAF-accreditation), we have revised Sec.  
1.1122 of the final rule to cover appeals of denial, reduction of 
scope, and withdrawal of LAAF-accreditation. Additionally, we include 
appeals of suspension decisions in this section of the final rule; this 
requirement previously only appeared in Sec.  1.1124 of the proposed 
rule. Accordingly, we have revised the section title to reflect the 
contents of the section in the final rule (``What procedures must a 
recognized accreditation body provide for appeals of decisions to 
suspend, reduce the scope of, withdraw, or deny LAAF-accreditation?'') 
We also have revised the section in the final rule to update cross-
references and to make minor editorial changes to improve clarity and 
readability. Comments regarding this section are discussed below.
    (Comment 73) Several comments support the proposed provision 
describing the appeal procedures that a recognized accreditation body 
must provide. Some comments state that ISO/IEC 17011:2017 does not 
specify which accreditation body actions may be appealed, and thus 
appreciate that the proposed rule would create appeal rights for 
accreditation decisions. Some comments also support our proposed 
requirement that an accreditation body's appeal procedures be written 
and publicly available. Some comments mention that at least some 
accreditation bodies already have internal appeals policies and 
procedures, some of which meet our proposed requirements, and some 
comments state that our proposed requirements describe the current 
appeals practices of ILAC-MRA accreditation bodies.
    However, some comments disagree with the proposed policy that would 
render subordinates of the person who made the initial accreditation 
decision ineligible to decide the appeal. These comments suggest bias 
would be sufficiently avoided as long as the rule requires someone 
different than the initial decision-maker to decide an appeal.
    (Response 73) We appreciate the comments in support of the proposed 
appeals procedures. Since publication of the proposed rule we have 
learned that ISO/IEC 17011:2017 specifies which actions an accredited 
laboratory may appeal within the definitions section of the standard. 
ISO/IEC 17011:2017 definitions, section 3.21 defines ``appeal'' as: 
``request by a conformity assessment body (3.4) for reconsideration of 
any adverse accreditation decision (3.13) related to its desired 
accreditation (3.1) status''. Section 3.13 then defines ``accreditation 
decision'' as: ``decision on granting (3.14), maintaining (3.15), 
extending (3.16), reducing (3.17), suspending (3.18) and withdrawing 
(3.19) accreditation (3.1)'' (Ref. 2). We nevertheless specify the 
actions a

[[Page 68773]]

LAAF-accredited laboratory may appeal in Sec.  1.1122 to maintain 
consistency and clarity within the subpart.
    Furthermore, we also have come to appreciate that the requirement 
for a written and publicly available appeals procedure is required by 
ISO/IEC 17011:2017 as follows: section 7.13.1 requires ``The 
accreditation body shall have a documented process to receive, evaluate 
and make decisions on appeals''; 8.2.1(b)(5) states that ``[t]he 
accreditation body shall make publicly available . . . information on 
procedures for lodging and handling complaints and appeals.'' (Ref. 2). 
We are deleting from the final rule the requirement for a recognized 
accreditation body to make its appeals procedure publicly available 
because that requirement is already addressed by ISO/IEC 17011:2017.
    Regarding the additional requirement in the proposed rule that 
would prohibit subordinates of the person who made the initial 
accreditation decision from hearing the appeal, we decline to remove 
this requirement because subordinates are generally not free to 
exercise authority that is fully independent of the supervisor, and are 
to some extent under the control and influence of the supervisor. 
Prohibiting subordinates from hearing the appeal will therefore better 
ensure a fair and unbiased review.
    (Comment 74) A few comments request clarification as to whether an 
accredited laboratory can continue to conduct food testing under the 
LAAF program while appealing a recognized accreditation body's 
withdrawal of LAAF-accreditation. The comments opine that laboratories 
should not be permitted to conduct testing under this subpart during 
the appeal process.
    (Response 74) We agree that laboratories should not be permitted to 
conduct testing under this subpart during the appeal process. 
Consistent with the intent of the proposed rule, the final rule 
provides that if a recognized accreditation body withdraws the LAAF-
accreditation of a laboratory, the laboratory is immediately ineligible 
to conduct food testing under this rule. If the recognized 
accreditation body reduces the scope of LAAF-accreditation, the 
laboratory is immediately ineligible to conduct food testing under this 
rule with respect to the specific methods for which LAAF-accreditation 
was withdrawn. See Sec.  1.1121(f)(2). The proposed rule would have 
allowed LAAF-accredited laboratories to continue to conduct tests under 
this subpart even if the recognized accreditation body had placed the 
laboratory on what we then called ``probation'' (and now call 
``suspension''). To align with how suspension is handled under ISO/IEC 
17011:2017 (see, e.g., section 3.18 (Ref. 2)), the final rule provides 
that a LAAF-accredited laboratory may not conduct food testing under 
this subpart for any suspended methods. See Sec.  1.1121(f)(1). 
Although the final rule requires the recognized accreditation body to 
provide an appeals process for decisions to suspend, reduce the scope 
of, or withdraw, LAAF-accreditation (Sec.  1.1122), pending such 
appeal, the laboratory is still suspended, has had its scope reduced, 
or has had its LAAF-accreditation withdrawn, and therefore cannot 
conduct applicable testing under this subpart.
5. What reports, notifications, and documentation must a recognized 
accreditation body submit to FDA (Sec.  1.1123)?
    Proposed Sec.  1.1123 concerned reports and notifications a 
recognized accreditation body must submit to FDA. Proposed paragraph 
(a) of this section included the general requirements for all reports 
and notifications under this subpart and specific recognized 
accreditation body and LAAF-accredited laboratory identifying 
information to be included as applicable. Proposed paragraph (b) of 
this section described the internal audit reporting requirements for a 
recognized accreditation body. Proposed Sec.  1.1123(c) required 
immediate notification (within 48 hours) to FDA of the following: 
changes that affect the recognition status of the accreditation body 
and any LAAF-accreditation decisions such as granting, denying, or 
withdrawing LAAF-accreditation, putting a LAAF-accredited laboratory on 
probation, learning of a LAAF-accredited laboratory's intent to 
voluntarily relinquish LAAF-accreditation, and awareness of LAAF-
accredited laboratory fraud. The proposed section included specific 
information to be included with each item requiring immediate 
notification.
    On our own initiative, we revised the section title to read, ``What 
reports, notifications, and documentation must a recognized 
accreditation body submit to FDA?'' to more accurately reflect the 
contents of the section in the final rule. We have revised subsection 
(a) to remove the requirement to submit reports and notifications to 
FDA electronically and in English; this requirement is now in Sec.  
1.1110 of the final rule. We also revised paragraph (b) to specify 
``calendar'' days. We have reorganized the section by the category of 
information to be submitted (e.g., changes affecting recognition, 
changes in LAAF-accreditation) and have made revisions to improve 
clarity and readability, incorporate revised terminology, and update 
cross-references. Also, in Sec.  1.1123(d) we have clarified that a 
certificate reflecting the scope of accreditation must be submitted by 
a recognized accreditation body within 48 hours of a change in LAAF-
accreditation (e.g., grant of LAAF accreditation, reduction in scope). 
We note that there will not be such a certificate when the recognized 
accreditation body denies LAAF-accreditation for all methods requested 
by the laboratory. In that scenario, the recognized accreditation body 
need only submit the information described in Sec.  1.1123(d)(2): (i) 
The scope of LAAF-accreditation requested by the laboratory, (ii) the 
scope of LAAF-accreditation denied, and (iii) the grounds for denial.
    On further review of the proposed rule, we identified a potentially 
duplicative notification regarding a laboratory relinquishing LAAF-
accreditation; under the proposed rule, the LAAF-accredited laboratory 
would have to notify the recognized accreditation body and FDA 60 days 
prior to relinquishing LAAF-accreditation. Additionally, proposed Sec.  
1.1123(c)(4) required the recognized accreditation body to notify FDA 
within 48 hours after it receives notice a LAAF-accredited laboratory 
intends to relinquish LAAF-accreditation. We have clarified in the 
final rule that the recognized accreditation body must only provide 
notice to FDA if the laboratory has not provided notice to FDA 60 
calendar days prior to relinquishment as required by Sec.  1.1140 (see 
Sec.  1.1123(d)(3) of the final rule). For clarity and to align with 
common conformity assessment terminology, in the final rule we 
consistently use the verb, ``extend,'' rather than sometimes also using 
the term, ``expand,'' to refer to the action of adding a method to the 
scope of LAAF-accreditation. That change is reflected in paragraph 
(d)(1)(iii) of Sec.  1.1123, (``the effective date of the . . . 
extension''). We deleted the word ``alleged'' that appeared in Sec.  
1.1123(c)(7)(ii) of the proposed rule so that the requirements related 
to reporting laboratory fraud or false statements to FDA are internally 
consistent and clearly communicate the requirements for submitting such 
information; see Sec.  1.1123(e)(2) of the final rule. Finally, we have 
clarified in Sec.  1.1123(d)(4)(iii) that notification of a reduction 
of scope or withdrawal of LAAF-accreditation must include the

[[Page 68774]]

effective date. We have also made other conforming terminology and 
minor editorial revisions in this section. Comments regarding this 
section are discussed below.
    (Comment 75) Proposed Sec.  1.1123 listed the reports and 
notifications that a recognized accreditation body would be required to 
submit to FDA and contained proposed timeframes for submission of the 
reports and notifications. In Sec.  1.1123(b) we proposed that a 
recognized accreditation body must submit results of an internal audit 
to FDA no later than 45 days after completing the audit. Some comments 
suggest we extend the deadline to 90 days, contending that 45 days may 
be insufficient for the resolution of some corrective actions.
    (Response 75) Although 45 days may be insufficient time for the 
complete resolution of some corrective actions, we believe it is 
sufficient time to complete the investigation required by the 
corrective action process unless information is needed from an outside 
source that is not within the control of the accreditation body. 
Proposed Sec.  1.1123(b)(3) required a description of any corrective 
action taken and any corrective action that the accreditation body will 
take; this provision of the proposed rule acknowledged that 
implementation or monitoring of a proposed corrective action may not 
have been completed within 45 calendar days but expected that a 
recommendation for a proposed corrective action should reasonably be 
completed within the 45 calendar day window. Accordingly, we decline to 
revise the final rule to extend the deadline to 90 calendar days.
    (Comment 76) Section 1.1123(c)(1) proposed to require a recognized 
accreditation body to immediately notify FDA if the recognized 
accreditation body was aware of a change that would affect their 
recognition under this subpart. Comments seek clarification of what we 
meant by changes that would ``affect recognition.'' Some comments 
suggest it would be clearer if we require recognized accreditation 
bodies to submit to FDA reports resulting from evaluations of adherence 
to ISO/IEC 17011:2017.
    (Response 76) The preamble discussed specific examples of ``any 
changes it is aware of that would affect its recognition'' as 
referenced in 1.1123(c) of the proposed rule. The changes listed were 
not exclusively those changes that would be included in the reports 
resulting from evaluations of adherence to ISO/IEC 17011:2017. As 
stated in the preamble to the proposed rule, some examples of changes 
that affect recognition include, but are not limited to, ``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'' (84 FR 59452 at 59471).
    (Comment 77) In Sec.  1.1123(c)(2) through (7), we proposed to 
require that a recognized accreditation body immediately notify FDA of 
certain information related to the LAAF-accreditation status of 
laboratories it LAAF-accredits or laboratories that have sought LAAF-
accreditation. Proposed Sec.  1.1123(c)(2) through (6) addressed 
information related to accreditation or status (e.g., grants or denials 
of accreditation). Proposed Sec.  1.1123(c)(7) addressed information 
indicating that a LAAF-accredited laboratory committed fraud or 
submitted to FDA a material false statement. We proposed a timeframe of 
48 hours for a recognized accreditation body to notify FDA of 
information covered by Sec.  1.1123(c)(2) through (7).
    Some comments request clarification of when the 48-hour clock 
starts for purposes of proposed Sec.  1.1123(c)(2) through (6); 
comments ask whether the clock starts from the date the LAAF-
accreditation decision is made or the date the recognized accreditation 
body issues the laboratory's certificate of LAAF-accreditation. These 
comments state that there can be a lag between when the decision is 
made and when the certificate is issued and appears on the 
accreditation body's website. These comments recommend that the 48-hour 
timeframe commence when the LAAF-accreditation certificate is issued to 
the laboratory.
    With regard to proposed Sec.  1.1123(c)(7), some comments familiar 
with accreditation body practice explain that, if an accreditation body 
is notified of potential fraud by an accredited laboratory, the 
accreditation body would conduct a full investigation prior to deciding 
whether to withdraw accreditation. According to these comments, 
accreditation bodies may place laboratories on suspension until the 
investigation is complete. The comments further state that the 
suspension would be lifted if and when the accreditation body receives 
evidence of ``sufficient corrective action'' from the laboratory and 
conducts followup onsite visits.
    (Response 77) We understand that some comments ask when the 48-hour 
notification deadline starts in matters relating to LAAF accreditation. 
To clarify, the 48-hour window begins when the recognized accreditation 
body issues the certificate of LAAF-accreditation. Note that in the 
final rule, we have clarified that within those 48 hours, the 
recognized accreditation body must notify and submit to FDA the 
certificate reflecting the scope of LAAF-accreditation (Sec.  
1.1123(d)). When the recognized accreditation body denies LAAF-
accreditation for all methods requested by a laboratory, there is no 
scope certificate, and the 48-hour notification window begins when the 
recognized accreditation body makes the denial decision.
    If a recognized accreditation body places a LAAF-accredited 
laboratory on suspension while it investigates potential fraud, then 
both the suspension and the fraud allegation would need to be reported 
within 48 hours. Any further decision regarding withdrawal of LAAF-
accreditation or lifting of the suspension would in turn be an 
additional change in the laboratory's accreditation status that would 
trigger the 48-hour reporting requirement.
6. What are the records requirements for a recognized accreditation 
body (Sec.  1.1124)?
    Proposed Sec.  1.1124 concerned records requirements for recognized 
accreditation bodies in addition to those required by ISO/IEC 
17011:2017. Proposed Sec.  1.1124(a) required recognized accreditation 
bodies to maintain electronically, for 5 years after the date of 
creation, certain records related to compliance with this subpart, 
including records regarding: Applications for LAAF-accreditation; LAAF-
accreditation decisions; appeals of adverse LAAF-accreditation 
decisions; oversight of LAAF-accredited laboratories; oversight of the 
recognized accreditation body's compliance with this subpart; reports, 
notifications, and supporting documents required under this subpart; 
and records of fee payments and direct costs. Records relating to a 
recognized accreditation body's oversight of laboratories it has LAAF-
accredited include records of related to proficiency testing and 
comparison programs (see Sec.  1.1138(a)(2)). Proposed Sec.  1.1124(b) 
stated the requirement that a recognized accreditation body make 
required records available to FDA upon request for copying and 
inspection or electronically, if requested as such; the recognized 
accreditation body would be

[[Page 68775]]

responsible for submitting an English translation of any records 
maintained in another language. Proposed Sec.  1.1124(c) stated that a 
recognized accreditation body must not prevent or interfere with FDA's 
access to the records of the laboratories it LAAF-accredits.
    We have updated the applicable section in the final rule to 
incorporate revised terminology and to update cross-references. On our 
own initiative, we made minor editorial changes to the section title to 
read, ``What are the records requirements for a recognized 
accreditation body?'' Additionally, we removed the word, 
``electronically,'' from paragraph (a) to allow flexibility around how 
recognized accreditation bodies maintain records. We revised paragraph 
(a)(2) to specify that records of decisions to suspend or lift the 
suspension of a LAAF-accredited laboratory must be maintained under 
this section. We revised paragraph (a)(3) to reflect changes to Sec.  
1.1122 of the final rule to incorporate each type of appeal. We also 
removed the requirement in paragraph (b) to submit an English 
translation of records electronically since that requirement is covered 
by Sec.  1.1110 of the final rule. Also, as a result of the new 
accommodation added to manage conflicts of interest associated with 
contract assessor activities (see Sec.  1.1119(d) of the final rule), 
we have added as a required record documentation demonstrating 
compliance with the requirements for assessment activities by contract 
assessors with certain financial interests described in Sec.  
1.1119(d). See Sec.  1.1124(a)(8) of the final rule. Comments regarding 
this section are discussed below.
    (Comment 78) A few comments request that FDA specify those records 
that are to be retained for 5 years, and caution that without a clear 
list, accreditation bodies may be delayed in submitting the documents 
to FDA. The comments suggest the following records be included in a 
specific list of records subject to 5-year retention: 1. Assessment 
report; 2. Corrective actions related to the assessment; 3. Complaints 
records; 4. Dispute/appeals records; 5. Proficiency testing results.
    (Response 78) Proposed Sec.  1.1124(a) lists the records that a 
recognized accreditation body must maintain for 5 years and remains 
unchanged in the final rule. We note that the recommended list aligns 
with our proposed and final requirements.
7. What are the internal audit requirements for a recognized 
accreditation body (Sec.  1.1125)?
    Section 1.1125 of the proposed rule concerned internal audit 
requirements for a recognized accreditation body, including the 
requirements in ISO/IEC 17011:2017 and the requirement to audit 
compliance with the additional requirements of this subpart for 
recognized accreditation bodies. We received no comments directly 
related to this section of the rule. On our own initiative, we revised 
the section to update cross-references to reflect the reorganized 
structure of the final rule and made minor revisions to improve clarity 
and readability, including revising the section title (``What are the 
internal audit requirements for a recognized accreditation body?'').

G. Comments Regarding FDA Oversight of Recognized Accreditation Bodies

   Table 8--Changes to Sections Regarding FDA Oversight of Recognized
                          Accreditation Bodies
------------------------------------------------------------------------
           Final rule                Proposed rule           Notes
------------------------------------------------------------------------
FDA Oversight of Recognized       Procedures for      Revised section
 Accreditation Bodies.             Recognized          title to reflect
                                   Accreditation       revised
                                   Bodies.             terminology.
Sec.   1.1130 How will FDA        Sec.   1.1130 How   No changes to the
 oversee recognized                will FDA oversee    section title.
 accreditation bodies?             recognized
                                   accreditation
                                   bodies?
Sec.   1.1131 When will FDA       Sec.   1.1131 When  Revised section
 require corrective action, put    will FDA revoke     title to reflect
 a recognized accreditation body   the recognition     opportunity for
 on probation, or revoke the       of an               corrective action
 recognition of an accreditation   accreditation       and to re-order
 body?                             body or put a       actions to match
                                   recognized          the section
                                   accreditation       contents.
                                   body on
                                   probation?
------------------------------------------------------------------------

1. How will FDA oversee recognized accreditation bodies (Sec.  1.1130)?
    Proposed Sec.  1.1130 concerned FDA oversight of recognized 
accreditation bodies to determine compliance with this subpart. 
Proposed Sec.  1.1130(a) stated that FDA's evaluation of a recognized 
accreditation body would occur by at least 4 years after the date of a 
recognition for a 5-year term or by the mid-term point for a 
recognition period less than 5 years. This section stated that FDA 
oversight could include review of records, an onsite assessment of the 
recognized accreditation body, and an onsite assessment of one or more 
laboratories it LAAF-accredits, with or without the recognized 
accreditation body present. Proposed Sec.  1.1130(b) reserved the right 
of FDA to conduct additional evaluations of a recognized accreditation 
body at any time to review compliance with this subpart.
    Consistent with the discussion in Response 10, we have updated the 
section to refer to FDA's actions as ``evaluations'' instead of 
``assessments'' to further distinguish the role of FDA from that of a 
recognized accreditation body. Additionally, we have made explicit that 
FDA may conduct certain evaluation activities remotely if it will not 
aid in the evaluation to conduct them onsite. We also restructured and 
revised this section in the final rule to update terminology and to 
make minor changes to improve clarity and readability. Comments 
regarding this section are discussed below.
    (Comment 79) Some comments agree that FDA should have the authority 
to schedule onsite visits to observe recognized accreditation bodies, 
but they contend FDA should not conduct such site visits unannounced. 
In their view, it would be unproductive for FDA to make an unannounced 
onsite visit to a recognized accreditation body, because recognized 
accreditation bodies need notice to ensure staff will be there to 
answer FDA questions about the program or else risk wasting Agency time 
and resources. Comments also state that FDA may review accreditation 
body records and reports remotely and thus would not gain any further 
information from unannounced visits.
    (Response 79) Onsite evaluations of accreditation bodies are one of 
several tools we will use for LAAF program oversight. Flexibility to 
conduct unannounced onsite evaluations will support program integrity 
as there may be cases where such visits may be the only way the Agency 
can be assured an accurate assessment of the situation. The Agency 
recognizes that some personnel may be not be onsite and would 
necessarily take this into account when planning unannounced visits. We 
view this as a rare but necessary tool.

[[Page 68776]]

    (Comment 80) A few comments recommend that it would be preferable 
for FDA to evaluate a recognized accreditation body's program 
performance by observing the accreditation body while they are 
conducting an accreditation assessment for a laboratory. Similarly, 
some comments recommend that FDA observe the ILAC peer evaluation of 
accreditation bodies. In the view of these comments, FDA has the right 
to review all aspects of the accreditation program at any time.
    (Response 80) We appreciate these suggestions. As stated in the 
proposed and final rule, we will make evaluations through a wide 
variety of means and the recommended approaches could be used.
2. When will FDA require corrective action, put a recognized 
accreditation body on probation, or revoke the recognition of an 
accreditation body (Sec.  1.1131)?
    Proposed Sec.  1.1131 concerned FDA revocation of recognition and 
probation of a recognized accreditation body. Proposed Sec.  1.1131(a) 
and (b) stated the grounds and process for revocation of recognition; 
FDA would revoke recognition if the accreditation body failed to meet 
the requirements of this subpart or if FDA determined the accreditation 
body committed fraud or submitted material false statements to FDA. The 
proposed process for revocation of recognition included issuance of a 
notice with a statement of the grounds for revocation and the 
procedures for requesting a hearing or reinstatement of recognition as 
well as the requirement for an accreditation body to provide a records 
point of contact for provision of records once the accreditation body 
is no longer recognized. Proposed Sec.  1.1131(c) stated that FDA may 
place a recognized accreditation body on probation if there are 
deficiencies that are less serious and more limited than those for 
revocation and the deficiencies are reasonably likely to be corrected 
within a reasonable amount of time. Under paragraph (d) of this 
proposed section, we stated that probation would remain in effect until 
the identified deficiencies are sufficiently addressed or until FDA 
revokes recognition. Proposed Sec.  1.1131(e) stated the procedures for 
probation and proposed paragraph (f) stated the effect of probation or 
revocation: an accreditation body that has had its recognition revoked 
may not LAAF-accredit laboratories or continue to oversee the 
laboratories it has LAAF-accredited; a recognized accreditation body on 
probation would be expected to continue to oversee the laboratories it 
has LAAF-accredited and permitted to continue to LAAF-accredit 
laboratories. Paragraphs (g) and (h) of this section stated that FDA 
would notify impacted LAAF-accredited laboratories of the probation or 
revocation of recognition of the accreditation body that LAAF-accredits 
the laboratory and that FDA would provide notice on the public website 
described in proposed Sec.  1.1109.
    We have revised the section title of the final rule to more 
accurately reflect the contents of the revised section, to read as 
``When will FDA require corrective action, put a recognized 
accreditation body on probation, or revoke the recognition of an 
accreditation body?'' We also clarify in Sec.  1.1131(d)(1) of the 
final rule that in the revocation of recognition procedures, FDA's 
notice will include the date on which the revocation is effective. We 
have revised the section to incorporate revised terminology and to 
update cross-references. We have made several changes in response to 
comments, discussed below.
    (Comment 81) A few comments assert that it is not a usual 
conformity assessment practice to place an accreditation body on 
``probation'' (proposed Sec.  1.1131(c), (g), and (h)), especially if 
the accreditation body has only demonstrated deficiencies in matters 
that are less serious and do not raise concerns about the accreditation 
decisions of the accreditation body. These comments also state that 
public notice of probationary status, if done without adequate 
justification, may be undeserved and could potentially damage both the 
accreditation body and the LAAF program. We understand these comments 
to be expressing the concern that if the registry indicates an 
accreditation body is on probation, such a characterization could cause 
harm to the accreditation body's reputation and business interests. 
Further, such comments express the view that if probation was 
undeserved, such harm would be unwarranted. We further understand these 
comments to be expressing that accreditation bodies may hesitate to 
participate in this program if they are concerned that they may be 
characterized unfairly on the registry. Similarly, a few comments 
recommend that FDA provide an accreditation body with an opportunity to 
take corrective action before FDA revokes recognition. These comments 
argue that revocation of an accreditation body's recognition without 
first providing such an opportunity would adversely impact both the 
accreditation body and the laboratories it LAAF-accredits and would 
represent a ``very aggressive approach.''
    (Response 81) We agree that it is appropriate to afford a 
recognized accreditation body the opportunity to take corrective action 
prior to putting the recognized accreditation body on probation and 
notifying the public. We have revised Sec.  1.1131 to reflect this 
position. Although the opportunity for corrective action and probation 
may be appropriate prior to revocation of recognition, we maintain that 
some circumstances warrant more immediate revocation of recognition. As 
described in the proposed and final rule, circumstances that may 
warrant immediate revocation of recognition include failure to meet the 
requirements of the subpart or a determination that the recognized 
accreditation body has committed fraud or submitted material false 
statements to FDA.
    (Comment 82) A few comments request that we clarify exactly when a 
recognized accreditation body will be placed in probationary status.
    (Response 82) We understand from various comments that 
``probation'' is not a status term typically utilized in the conformity 
assessment arena. We intend the status to be an intermediary step after 
corrective action and before we proceed to revoke our recognition of an 
accreditation body.
    As revised, Sec.  1.1131 provides that if FDA identifies a 
deficiency, utilizes the recognized accreditation body's complaint 
process (under ISO/IEC 17011:2017 section 7.12), but determines that 
the corrective action (under ISO/IEC 17011:2017 section 9.5) is not 
acceptable, we may place the accreditation body on probation. Section 
1.1131(b) states that probation may be appropriate when FDA determines 
that a recognized accreditation body, ``has not effectively implemented 
corrective action or otherwise fails to address deficiencies 
identified.''
    Under Sec.  1.1131(b)(1), FDA will notify the recognized 
accreditation body that it is on probation, will provide the grounds 
for the probation, and list all deficiencies that must be corrected. 
Note that under Sec.  1.1131(b)(2), probationary status will be 
reflected on the online registry described in Sec.  1.1109. 
Probationary status will endure until either FDA is satisfied with the 
recognized accreditation body's corrective actions or FDA revokes the 
recognition under Sec.  1.1131(c) and (d).

H. Comments on LAAF-Accreditation of Laboratories

[[Page 68777]]

      Table 9--Changes to Sections Regarding LAAF-Accreditation of
                              Laboratories
------------------------------------------------------------------------
           Final rule                Proposed rule           Notes
------------------------------------------------------------------------
LAAF-Accreditation of             Accreditation of    Revised to reflect
 Laboratories.                     Laboratories.       new terminology.
Sec.   1.1138 What are the        Sec.   1.1138 What  Combined sections
 eligibility requirements for a    requirements must   in the final
 LAAF-accredited laboratory?       a laboratory meet   rule.
                                   to become
                                   accredited by a
                                   recognized
                                   accreditation
                                   body?
                                  Sec.   1.1146 What
                                   are the general
                                   requirements for
                                   accredited
                                   laboratories to
                                   remain
                                   accredited?.
Sec.   1.1139 How does a          Sec.   1.1159 How   Relocated section,
 laboratory apply for LAAF-        does a laboratory   revised section
 accreditation or extend its       apply for           title to
 scope of LAAF-accreditation?      accreditation or    incorporate new
                                   modification of     terminology and
                                   its scope of        improve clarity.
                                   accreditation by
                                   a recognized
                                   accreditation
                                   body?
Sec.   1.1140 What must a LAAF-   Sec.   1.1163 What  Relocated the
 accredited laboratory do to       if a laboratory     section, revised
 voluntarily relinquish its LAAF-  wants to            section title to
 accreditation?                    voluntarily         incorporate new
                                   relinquish its      terminology and
                                   accreditation?      improve clarity.
Sec.   1.1141 What is the effect  Sec.   1.1164 What  Relocated the
 on a LAAF-accredited laboratory   is the effect on    section, revised
 if its recognized accreditation   accredited          section title to
 body is no longer recognized by   laboratories if     incorporate new
 FDA?                              their               terminology and
                                   accreditation       improve clarity.
                                   body voluntarily
                                   or involuntarily
                                   loses its
                                   recognition?
Sec.   1.1142 How does a          Sec.   1.1165 How   Relocated the
 laboratory request                does a laboratory   section, revised
 reinstatement of LAAF-            request             section title to
 accreditation?                    reinstatement of    incorporate new
                                   accreditation?      terminology.
------------------------------------------------------------------------

1. What are the eligibility requirements for a LAAF-accredited 
laboratory (Sec.  1.1138)?
    In proposed Sec.  1.1138 we stated the baseline requirements for a 
laboratory to participate in the LAAF program. In paragraph (a)(1)(i) 
we proposed that a laboratory must demonstrate to a recognized 
accreditation body that a laboratory is capable of conducting the 
method(s) it wishes to perform under this subpart by submitting 
information to demonstrate appropriate verification or validation of 
each method. In paragraph (a)(1)(ii) we proposed that a laboratory must 
annually pass a proficiency test (or comparison program, where no 
proficiency test is available or practicable) for each method. In 
paragraph (a)(2) we proposed that a laboratory must be accredited to 
ISO/IEC 17025:2017 and we incorporated that standard by reference; in 
paragraph (b) we proposed to except certain provisions of ISO/IEC 
17025:2017. In paragraph (c) we proposed that a laboratory must 
demonstrate it is capable of meeting and operating in conformance with 
all other requirements for laboratories under this subpart.
    On our own initiative, we made some organizational changes. The 
proposed title for the section was, ``What requirements must a 
laboratory meet to become accredited by a recognized accreditation 
body?'' We proposed a separate section, Sec.  1.1146, to address the 
requirements for accredited laboratories to remain accredited. There 
was significant overlap between the two sections. To improve efficiency 
and readability, we combined Sec.  1.1146 with this section and made 
certain editorial changes to effect the merge, including revising the 
section title to read, ``What are the eligibility requirements for a 
LAAF-accredited laboratory?''
    Proposed Sec.  1.1148 addressed quality assurance requirements for 
LAAF-accredited laboratories. Proposed Sec.  1.1148(a) required, in 
brief, annual proficiency testing for each method. Proposed Sec.  
1.1148(b) required a LAAF-accredited laboratory to ``[e]nsure 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.'' There was significant overlap between the proficiency test 
provisions in proposed Sec.  1.1138(a)(1)(ii) and those in Sec.  
1.1148(a). For clarity and efficiency, we merged the proficiency test 
content from proposed Sec.  1.1148(a) into what is now Sec.  
1.1138(a)(2) of the final rule. We also moved to this section the 
requirement for laboratory quality assurance procedures to include the 
use of reference materials or quality control samples with each batch 
of samples tested under this subpart, because we view these tools as 
vital to a laboratory's demonstration of capability to conduct a 
method. (Relatedly, we have added quality control results to the 
required contents of an abridged analytical report; see the discussion 
of Sec.  1.1153(c)(2), below.)
    Also, as explained in our discussion of Sec.  1.1101 above, we 
moved the language formally incorporating ISO/IEC 17025:2017 from this 
section to Sec.  1.1101. Finally, we made conforming and minor 
editorial changes, including specifying calendar days in Sec.  
1.1138(a)(2)(iii) (this requirement appeared in Sec.  1.1153(b) of the 
proposed rule and did not specify ``calendar'' days). We discuss 
additional changes to the section made in response to comments below.
    (Comment 83) Some comments inquire about the laboratory standards 
we are establishing in this final rule. Some ask which criteria should 
be set. A few comments appear to ask how FDA would determine which of 
the many existing food testing laboratories satisfy the standards we 
are establishing.
    Some comments encourage us to ensure that all laboratory 
requirements are clear and concise. Other comments urge FDA to avoid 
what they perceive as vague and ambiguous phrases such as ``strongly 
encourage'' and instead to use clearer language such as ``must.''
    (Response 83) The laboratory standards we are establishing are 
contained in this final rule, specifically in Sec. Sec.  1.1138 through 
1.1142. We agree that clear and concise requirements will benefit the 
LAAF program and we have done our best to achieve that goal. The task 
of determining which laboratories satisfy our requirements is the 
responsibility of the recognized accreditation bodies which will assess 
laboratories against our standards.
    In the proposed rule, after stating that we would not propose to 
require the accreditation of sampling, we said that we ``strongly 
encourage all samplers to consider accreditation'' 84 FR 59452 at 
59476. When we use such language, we do not intend to state a 
requirement, nor do we create any obligation. Only the codified section 
of a rule becomes the regulation. The preamble discussion

[[Page 68778]]

represents our current thinking on the matters addressed in the text of 
the regulation.
    (Comment 84) In the proposed rule, a laboratory would be required 
to demonstrate it is capable of conducting each method it wishes to use 
in food testing under this subpart by submitting verification or 
validation information to a recognized accreditation body, as well as a 
statement that the laboratory was able to properly apply the method. 
The proposed rule would also have required a laboratory to pass a 
proficiency test (or comparison program when no proficiency testing is 
available or practicable) for each method it wishes to use to conduct 
food testing under this subpart once per year. Some comments express 
support for these requirements. Some comments state that these 
requirements are similar to existing ISO/IEC 17025:2017 requirements.
    (Response 84) We are gratified that several comments support these 
requirements.
    We agree that these requirements are similar to provisions in ISO/
IEC 17025:2017. With regard to validation and verification information, 
ISO/IEC 17025:2017 requires a laboratory to submit to the accreditation 
body verification or validation information on each method for which it 
is seeking accreditation. Our requirement would accomplish the same. 
However, although the validation information we require a laboratory to 
send to a recognized accreditation body aligns with information 
required in ISO/IEC 17025:2017, we specify (in Sec.  1.1151(d)(2)) the 
verification information in greater detail than does ISO/IEC 17025:2017 
(Ref. 3).
    At the same time, as discussed above at Response 10, after careful 
consideration of the comments we are clarifying in this subpart the 
roles of the FDA and recognized accreditation bodies with respect to 
LAAF-accredited laboratories. Consistent with our clarified role of 
reviewing the performance of LAAF-accredited laboratories via 
individual analytical reports, we have determined that it is 
appropriate for LAAF-accredited laboratories to submit the verification 
and validation studies relevant to their analytical reports to FDA (see 
Sec.  1.1152(c) and discussion at Response 122). This change means FDA 
will receive the more detailed verification information that, under the 
proposed rule, we would have required a laboratory to send to the 
recognized accreditation body. Given that the specified verification 
information will be submitted to FDA, we are comfortable removing the 
requirement that it be submitted to the recognized accreditation body.
    Having resolved that difference between proposed Sec.  
1.1138(a)(1)(i) and ISO/IEC 17025:2017, there remains no substantive 
difference between the two standards with regard to the validation and 
verification information to be submitted to an accreditation body. 
Accordingly, we have removed from the final rule the provision in 
proposed Sec.  1.1138(a)(1)(i) requiring laboratories to send 
validation or verification information to the recognized accreditation 
body and will rely on ISO/IEC 17025:2017 for that requirement.
    With regard to the proposed requirement that a laboratory pass a 
proficiency test for each method (or a comparison program, where no 
proficiency test is available or practicable) ``once per year,'' the 
provision in ISO/IEC 17025:2017 is similar. Section 7.7.2 of ISO/IEC 
17025:2017 requires a laboratory to monitor its performance by engaging 
in either proficiency testing or interlaboratory comparisons but does 
not indicate a frequency (Ref. 3). We remain committed to the frequent 
nature of this requirement and therefore the final rule requires that a 
LAAF-accredited laboratory must successfully pass a proficiency test 
(or where one is not available or practicable, a comparison program) 
for each LAAF-accredited method at least once every 12 months. For 
additional discussion of the proficiency testing requirements under 
this subpart, see Responses 92-94, below.
    (Comment 85) Some comments support the proposed policy that LAAF-
accreditation should be awarded on a method-by-method basis. In fact, 
some comments consider method-specific LAAF-accreditation so important 
that they suggest we communicate that requirement more clearly in the 
final rule. Some comments encourage us to clarify the use of open or 
flexible scopes under this subpart.
    (Response 85) We agree that it is essential that the competency of 
laboratories be assessed, and LAAF-accreditation awarded, on a method-
specific basis. Test methods vary widely and even within the same 
discipline, competence to one method does not correlate or imply 
competence to another method. Further, laboratory competence to the 
particular method employed is integral to the validity of the test 
result. Accordingly, we accept the suggestion in the comments 
summarized above and have revised Sec.  1.1138 to include ``each 
method'' in paragraph (a) and (a)(1).
    ISO/IEC 17011:2017 defines a flexible scope (sometimes referred to 
as an open scope), as a ``scope of accreditation . . . expressed to 
allow [laboratories] to make changes in methodology and other 
parameters which fall within the competence of the [laboratory] . . . 
as confirmed by the accreditation body.'' (ISO/IEC 17011:2017 section 
3.7, (Ref. 2)). Flexible scopes can have flexibility for analytes, 
matrices, and methods. ISO/IEC 17011:2017 requires accreditation bodies 
to have written procedures describing how the accreditation body will 
administer flexible scopes. As relevant to this discussion, these 
written procedures must include a description of how the accreditation 
body will maintain for the laboratories they LAAF-accredit certificates 
of scope that include matrix (materials or products); analyte(s) 
(component, parameter or characteristic); and method or technology 
(Ref. 2).
    An open or flexible scope is employed when an accreditation body 
assesses a laboratory's competency in using a particular technology or 
technique. Once the laboratory proves that competency, it is able to 
add methods, analytes, or matrices to its scope without the need for an 
additional assessment by the accreditation body as long as those 
additions fall within the broader scope of the accredited technology 
and meet the requirements of ISO/IEC 17025:2017.
    Given that ISO/IEC 17011:2017 requires accreditation bodies to 
maintain certificates of accreditation that communicate which analytes, 
matrices, and methods are covered by the flexible scope, and Sec.  
1.1123(c)(2) requires that a recognized accreditation body must 
immediately notify FDA when it grants or extends a laboratory's LAAF-
accreditation, we are prepared to accommodate open or flexible scopes 
under this subpart.
    (Comment 86) We proposed in Sec.  1.1138(a)(2) that, as a baseline 
matter, laboratories wishing to conduct testing under this subpart must 
be accredited to ISO/IEC 17025:2017, and we proposed to incorporate 
ISO/IEC 17025:2017 by reference into our regulation. We proposed in 
Sec.  1.1138(b) to exclude three portions of ISO/IEC 17025:2017 from 
the incorporation by reference, and from the requirements under this 
subpart. First, we proposed to exclude provisions 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 subpart. Second, we 
proposed to exclude section 7.3

[[Page 68779]]

because, we reasoned, it addresses sampling and we did not propose to 
require the accreditation of samplers. Finally, we proposed to exclude 
section 7.8, which describes requirements for reporting test results to 
customers, based on a concern that it might conflict with the test 
reporting requirements in this subpart (Ref. 3).
    Many comments support the baseline laboratory requirement of 
accreditation to ISO/IEC 17025:2017. Some comments commend the use of 
this standard, noting that it may be a means to improve the quality of 
tests, and is accepted globally. Some comments maintain that 
accreditation to ISO/IEC 17025:2017 increases confidence in a 
laboratory's data. Some comments indicate that many laboratories that 
test imported food have already sought ISO/IEC 17025:2017 accreditation 
voluntarily to improve the quality of their test results. Some comments 
assert that conformance to ISO/IEC 17025:2017 helps ensure scientific 
integrity in food testing. Some comments state that relying on ISO/IEC 
17025:2017 accreditation will be more efficient for FDA. A few comments 
express the belief that all private laboratories should be required to 
be ISO/IEC 17025:2017-accredited.
    A few comments agree that ISO/IEC 17025:2017 is currently the 
predominant standard for the type of laboratory that would conduct 
testing under this subpart, but encourage FDA to allow more 
flexibility, stating that over time ISO/IEC 17025:2017 might become 
less predominant.
    Some comments encourage FDA to rely solely and entirely on ISO/IEC 
17025:2017; we understand these comments to discourage us from adding 
any additional requirements or varying at all from ISO/IEC 17025:2017. 
(To the extent that some comments reference ISO/IEC 17065, which is a 
conformity assessment standard for bodies that certify products, that 
standard does not apply here.) These comments express preference for a 
single uniform accreditation standard and contend that varying 
standards can present challenges both to laboratories attempting to 
maintain multiple differing accreditation schemes and to their 
customers. Some comments state a risk that variations in standards, 
even different standards based on ISO/IEC 17025:2017, may result in a 
need for laboratories to be accredited by more than one accreditation 
body, and encourage FDA to reduce or eliminate redundant 
accreditations. Some comments encourage FDA to work with leading 
standard and scientific organizations so that the various standards 
align and have scientific integrity.
    With regard to the ISO/IEC 17025:2017 sections that we proposed to 
exclude from our requirements, some comments support some or all the 
exclusions. Some of these comments agree with our proposal not to 
require the accreditation of samplers and express consequent support 
for the exclusion of ISO/IEC 17025:2017 section 7.3, which addresses 
sampling. Some comments concur with our proposed exclusion of customer-
related ISO/IEC 17025:2017 provisions, but disagree with the proposed 
exclusions related to sampling and reporting results because these 
comments state the belief that FDA should require the accreditation of 
samplers and better align its reporting requirements with those of ISO/
IEC 17025:2017.
    On the other hand, many comments encourage us not to exclude 
certain or any ISO/IEC 17025:2017 provisions. Some comments 
specifically suggest that we include ISO/IEC 17025:2017 requirements 
related to customers, as owners and consignees under this rule could be 
considered the customers of LAAF-accredited laboratories. Some of these 
comments disagree that the provisions we proposed to exclude conflict 
with the requirements in this subpart, and suggest that even if they 
do, any conflicts can be effectively addressed without excluding ISO/
IEC 17025:2017 provisions.
    Relatedly, some comments state that adherence to certain 
requirements contained in ISO/IEC 17025:2017 is required only by 
specific customers; these comments request that we clarify who is the 
customer of a LAAF-accredited laboratory (i.e., FDA or the owner or 
consignee). These comments also ask whether ISO/IEC 17025:2017 
requirements with which the customer requires adherence will apply to 
State laboratories that become LAAF-accredited.
    A few comments express the belief that documents can be developed 
to supplement ISO/IEC 17025:2017 accreditation, and that such documents 
would cover the additional requirements codified in this subpart. Some 
comments argue that excluding certain parts of the ISO/IEC 17025:2017 
standard from our requirements while still labeling a laboratory, 
``accredited,'' would cause confusion and would conflict with 
established business and operational models in laboratories fully 
compliant with ISO/IEC 17025:2017. Similarly, some comments request 
that FDA require ISO/IEC 17025:2017 as a baseline matter, and then 
indicate additional requirements to clarify or expand upon the 
standard. Comments also state that FDA should stay current with any 
changes to ISO/IEC 17025:2017.
    (Response 86) We remain committed to ISO/IEC 17025:2017 as a 
baseline requirement for laboratories that wish to conduct food testing 
under this subpart. Many comments agree with that aspect of the 
proposed rule and identify various benefits of this policy such as 
improved test quality; greater scientific integrity; and global 
acceptance of, and increased confidence in, the test results. We 
concur. As described in the FRIA (Ref. 4), we also agree that FDA will 
experience certain efficiencies as a result of this rule. And while we 
encourage all food testing laboratories to consider becoming accredited 
to ISO/IEC 17025:2017, we lack the authority to compel such action.
    Regarding the possibility that ISO/IEC 17025:2017 may not always be 
the predominant standard for food testing laboratories, we are 
confident that ISO/IEC 17025:2017 will be an appropriate baseline for 
the foreseeable future. Other parts of FDA, and many other Federal 
Agencies, also rely on ISO/IEC 17025:2017 to establish baseline 
requirements for their laboratory accreditation programs (e.g., FDA 
Center for Devices and Radiological Health Accreditation Scheme for 
Conformity Assessment, CPSC, Department of Defense Environmental 
Laboratory Program). Every time ISO/IEC updates the 17025 standard, we 
will consider whether to update this subpart (through notice-and-
comment rulemaking) to require accreditation to the updated standard. 
If during those considerations we conclude that ISO/IEC 17025:2017 is 
no longer an appropriate baseline for our requirements, we will revise 
this subpart accordingly (through notice-and-comment rulemaking).
    Some comments encourage us to simply rely on ISO/IEC 17025:2017 and 
neither add nor subtract any requirements. Comments advocating that we 
not add requirements to ISO/IEC 17025:2017 discuss the advantages of a 
uniform standard. We do not discount those advantages or the challenges 
that laboratories face in satisfying varying accreditation schemes. 
Nevertheless each laboratory requirement that we add to the ISO/IEC 
17025:2017 baseline serves an important program purpose. For example, 
requiring successful proficiency tests for each method at least every 
12 months (Sec.  1.1138(a)(2)) provides increased quality assurance, 
and requiring at least the creation and retention of the records that 
comprise a full analytical report will preserve FDA's ability to 
conduct a meaningful

[[Page 68780]]

indepth scientific review of the test (Sec. Sec.  1.1150(d), 
1.1154(a)(2)). As a reminder, all the food testing that takes place 
under this subpart occurs in the context of heightened public health 
concern. Laboratories that wish to conduct food testing under this 
subpart will be required to satisfy requirements in addition to those 
specified in ISO/IEC 17025:2017 (Ref. 3).
    After carefully considering the comments, we have decided not to 
exclude any provisions of ISO/IEC 17025:2017. Comments successfully 
argued that our proposed exclusions would unnecessarily complicate the 
work of the recognized accreditation bodies and LAAF-accredited 
laboratories and provide limited benefit. We also appreciate the 
comments remarking that market confusion could result from our 
exclusion of portions of ISO/IEC 17025:2017 while labeling laboratories 
``accredited.'' Although we doubt our proposed exclusion of a small 
number of ISO/IEC 17025:2017 provisions would result in a need for 
duplicative accreditation body assessments, we need not belabor that 
issue raised in the comments, given our decision.
    In particular, we are persuaded that we do not need to formally 
exclude from our regulation ISO/IEC 17025:2017 section 7.3, which 
addresses sampling, even though we are not requiring sampling 
accreditation (Ref. 3). Section 7.3 is not necessary to ISO/IEC 
17025:2017 accreditation. Indeed, many laboratories are accredited to 
ISO/IEC 17025 for diverse types of methods and yet not for sampling. 
When a recognized accreditation body assesses a laboratory for LAAF-
accreditation, the recognized accreditation body may simply note 
section 7.3 as not applicable.
    We also proposed to exclude any provisions of ISO/IEC 17025:2017 
that relate to the relationship between the laboratory and its 
customer, to the extent that the provision would conflict with the 
requirements of this subpart. For example, in the preamble to the 
proposed rule we expressed concern that including ISO/IEC 17025:2017 
section 7.2.1.4, which indicates that the customer may specify the test 
method, could create a conflict for the laboratory (see 84 FR 59452 at 
59477 to 59478). We are now convinced that provisions of ISO/IEC 
17025:2017 that mention the customer do not conflict with obligations 
under this subpart because under ISO/IEC 17025:2017, ``customer'' has a 
broader meaning than simply the entity who pays the laboratory, and FDA 
qualifies as a customer alongside the owner or consignee that engages 
the laboratory (Ref. 3). We appreciate comments noting that the owners 
or consignees are customers and we should therefore not exclude the 
ISO/IEC 17025:2017 customer provisions on that basis. We agree that 
owners and consignees are appropriately considered customers of the 
laboratory and appreciate that under this subpart, LAAF-accredited 
laboratories will fulfill their obligations to owners and consignees, 
as well as their obligations to FDA. This is ensured by the requirement 
in ISO/IEC 17025:2017 section 5.4 that ``Laboratory activities shall be 
carried out in such a way as to meet the requirements of this document, 
the laboratory's customers, regulatory authorities and organizations 
providing recognition'' (Ref. 3). Regarding the question of whether 
state or other public laboratories that become LAAF-accredited will be 
bound by the customer provisions in ISO/IEC 17025:2017, we confirm that 
they will. The many public laboratories that are or will become ISO/IEC 
17025:2017-accredited are required to meet the same requirements of 
ISO/IEC 17025:2017 as private laboratories, including both customer 
provisions and the requirements of section 5.4.
    Finally, we proposed to exclude ISO/IEC 17025:2017 section 7.8, 
which addresses reports, based on a concern that it would conflict with 
the reporting requirements under this subpart. Again, we have come to 
appreciate that a laboratory's reporting duties under ISO/IEC 
17025:2017 do not present any conflict for the laboratory also 
fulfilling the reporting requirements under this subpart (Ref. 3).
    Accordingly, the final rule incorporates ISO/IEC 17025:2017 in its 
entirety.
    (Comment 87) Some comments recommend that FDA allow the bottled 
drinking water tests in Sec.  1.1107(a)(1)(iii) (i.e., the requirement 
in Sec.  129.35(a)(3)(i) to test five samples from the same sampling 
site that originally tested positive for E. coli) to be conducted by 
laboratories certified or accredited to other water-related laboratory 
accreditation or oversight programs such as the National Environmental 
Laboratory Accreditation Program, or EPA or State water testing 
certification programs. From the perspective of these comments, the EPA 
and State water testing certification programs are an existing 
laboratory oversight system and FDA should leverage those 
certifications, in place of LAAF-accreditation, for purposes of the 
bottled drinking water testing subject to this final rule. These 
comments predict that if we fail to do so, an insufficient number of 
laboratories will become LAAF-accredited to conduct the bottled 
drinking water testing required by Sec.  1.1107(a)(1)(iii). Relatedly, 
these comments disagree with our proposed conforming revision in the 
bottled drinking water regulations. Instead of revising the bottled 
drinking water regulation to require that the testing required in Sec.  
129.35(a)(3) be conducted under this subpart, these comments recommend 
that the bottled drinking water regulations be revised to require that 
the testing in Sec.  129.35(a)(3) be conducted by a competent 
commercial water testing laboratory that is EPA or State-certified for 
E.coli testing and sends the results directly to FDA.
    (Response 87) For a variety of reasons, we decline this request.
    First, FDA lacks the authority under section 422 of the FD&C Act to 
directly accredit laboratories or otherwise approve them to conduct the 
food testing described in Sec.  1.1107. FSMA section 202 directed that 
FDA recognize accreditation bodies, establish standards for 
laboratories, and create a public registry of recognized accreditation 
bodies and LAAF-accredited laboratories (section 422(a)(1)(b) and 
(a)(6) of the FD&C Act). FSMA section 202 describes only the recognized 
accreditation bodies as having the ability to accredit a laboratory 
(see, e.g., section 422(a)(1)(B), (a)(2), (a)(5), (a)(6), and (b)(1) of 
the FD&C Act). In contrast, FSMA section 307 directed FDA to establish 
a very similar program: ``a system for the recognition of accreditation 
bodies that accredit third-party auditors'' \9\ (Section 
808(b)(1)(A)(i) of the FD&C Act). However FSMA section 307 specifically 
granted FDA authority to directly accredit third-party auditors if, 2 
years after establishing the required system, FDA had not recognized an 
accreditation body (section 808(b)(1)(A)(ii) of the FD&C Act). As 
Congress specifically provided FDA with authority to directly accredit 
third-party auditors in FSMA section 307, we presume their decision not 
to provide FDA with similar authority in FSMA section 202 was 
intentional. Accordingly, we lack the authority to directly accredit or 
otherwise approve laboratories for inclusion in the LAAF program 
generally or the public registry in particular.
---------------------------------------------------------------------------

    \9\ Under that authority we issued the ``Accreditation of Third-
Party Certification Bodies To Conduct Food Safety Audits and To 
Issue Certifications Final Rule,'' 80 FR 74569 (Nov. 27, 2015) which 
established the Accredited Third-Party Certification Program (see 
https://www.fda.gov/food/importing-food-products-united-states/accredited-third-party-certification-program).
---------------------------------------------------------------------------

    The only way a laboratory may conduct the food testing described in

[[Page 68781]]

Sec.  1.1107, then, is through a favorable assessment by a recognized 
accreditation body. In conducting such an assessment, a recognized 
accreditation body assesses the laboratory against the model laboratory 
standards we are creating in this final rule. Theoretically we could 
tailor our model standards to allow for sector-specific standards, if 
we were confident that those sector-specific standards provided equal 
rigor and public health protections. For example, theoretically we 
could allow laboratories that conduct the testing described in Sec.  
1.1107(a)(1)(iii) to substitute our laboratory requirements based on 
accreditation to ISO/IEC 17025:2017 with a sector-specific 
accreditation standard such as the standard of the National 
Environmental Laboratory Accreditation Program, or the standard of the 
EPA water testing certification programs. However, FDA lacks the 
resources to perform indepth comparisons of various program standards, 
whether related to bottled drinking water or any other sector, with 
ISO/IEC 17025:2017 and the remainder of our requirements. Indeed, a 
prime advantage of relying on an international voluntary consensus 
standard for our baseline requirement is uniformity. ISO/IEC 17025:2017 
is a single standard that addresses technical competency and quality 
management universally; its requirements mean the same thing in every 
country and context in which it is used. For those practical and 
philosophical reasons, we decline the comments' suggestion that we 
allow bottled drinking water sector-specific laboratory standards in 
place of the model laboratory standards established in this subpart.
    In declining this suggestion, we offer a few additional notes. To 
the extent a sector-specific standard is also based on ISO/IEC 
17025:2017, it should not be difficult or costly for a laboratory 
accredited to such a sector-specific standard to become LAAF-
accredited. Further, the tests described in Sec.  1.1107(a)(1)(iii) 
(and methods deemed acceptable under Sec.  129.35(a)(3)(ii)) involve 
analyzing water for the presence of E. coli, which is not an uncommon 
capability among food laboratories accredited to biological methods. 
Meanwhile, we estimate that there will be one testing occasion per year 
resulting in five separate tests under Sec.  1.1107(a)(1)(iii). (Ref. 
4). We therefore believe it is reasonable to anticipate sufficient 
capacity among LAAF-accredited laboratories to handle the bottled 
drinking water testing covered by this final rule.
    (Comment 88) Some comments describe the positive features of the 
American Association of Veterinary Laboratory Diagnosticians (AAVLD) 
laboratory accreditation standard. These comments state that results 
from AAVLD laboratories are accepted by Federal Agency laboratory 
networks focused on disease surveillance, and that AAVLD laboratories 
already perform research and emergency response work for FDA. These 
comments further state that the AAVLD standard is aligned with ISO/IEC 
17025:2017.
    (Response 88) AAVLD-accredited laboratories play a critical role in 
FDA programs. Many of the veterinary diagnostic laboratories that are 
part of FDA's Veterinary Laboratory Investigation and Response Network 
(Vet-LIRN) are AAVLD-accredited. Vet-LIRN laboratories enhance public 
health by providing testing of food and animal feed products for 
zoonotic pathogens. These laboratories also perform pathogen and 
chemical toxin testing in response to foodborne and animal 
feed[hyphen]associated illnesses. Vet[hyphen]LIRN laboratories respond 
to requests for testing as directed by FDA resulting from consumer 
complaints, and participate in surveillance studies, method development 
activities, and proficiency tests. These laboratories primarily analyze 
animal samples (e.g., stool, urine, blood, tissue) and nonregulatory 
animal food samples (e.g., leftover opened foods and feed) to help 
FDA's Center for Veterinary Medicine (CVM) investigate potential 
problems with CVM-regulated products (such as animal feeds or animal 
drugs). Use of a LAAF-accredited laboratory is required for those tests 
described in Sec.  1.1107, but the vast majority of the analyses 
performed as part of the Vet-LIRN do not fall under Sec.  1.1107. 
Accordingly, it is not necessary for laboratories participating in the 
Vet-LIRN to become LAAF-accredited.
    To the extent that an AAVLD-accredited laboratory wishes to 
participate in the food testing described in Sec.  1.1107, it would 
need to meet all the requirements for a LAAF-accredited laboratory in 
this subpart. For reasons discussed above in Response 87, FDA cannot 
admit laboratories meeting other standards into this program. The only 
way a laboratory may become LAAF-accredited is through a favorable 
assessment by an accreditation body recognized under this subpart. That 
construct does not comport with the structure of the AAVLD laboratory 
accreditation program. AAVLD laboratory accreditation is awarded by 
AAVLD itself, following an assessment by a committee of laboratory 
professionals from other AAVLD laboratories. However, AAVLD is not an 
ILAC-MRA signatory accreditation body that comports with ISO/IEC 
17011:2017. Accordingly, it is not eligible for recognition under this 
subpart.
    Moreover, our analysis of the AAVLD standard indicates that 
although the AAVLD standard is aligned with ISO/IEC 17025:2017, 
differences remain. For example, the AAVLD standard is designed to 
assess the laboratory as a whole, rather than particular testing 
methods. Also, the AAVLD reassessments occur at least once every 5 
years, whereas ISO/IEC 17011:2017 section 7.9.3 requires that 
laboratories be reassessed at least every 2 years (Ref. 2).
    For the foregoing reasons, an AAVLD laboratory wishing to conduct 
the food testing described in Sec.  1.1107 would need to be accredited 
to ISO/IEC 17025:2017 and satisfy the other laboratory requirements 
described in this final rule. However, LAAF-accreditation is not 
required for an AAVLD laboratory to continue to participate in the Vet-
LIRN.
    (Comment 89) Some comments request that we consider a modified set 
of requirements for small specialized laboratories such as those that 
solely analyze DWPE samples to determine the presence of filth and 
decomposition in seafood. These comments suggest that we not require 
ISO/IEC 17025:2017 accreditation for small specialized laboratories; 
instead, such laboratories should be required to provide the laboratory 
analyst's qualifications, the materials and methods used to conduct the 
test, and be subject to random FDA audits. A subset of these comments 
states that, for small specialized laboratories, the ISO/IEC 17025:2017 
accreditation requirement would be too onerous for such laboratories to 
continue operating. Specifically, comments list the cost of initial 
certification, annual fee, training, internal program writing, and 
corrective action responses as examples of particularly onerous 
requirements. These comments emphasize the over-representation of small 
laboratories in the total number of laboratories that conduct analyses 
of food subject to DWPE by referring to estimates reported in the 
preamble to the proposed rule that 84 percent of the current DWPE 
analyses are performed by 10 laboratories, while about 90 laboratories 
performed the remaining 16 percent of the analyses. The comments assert 
that providing modified requirements for small businesses would be 
consistent with other FSMA regulations.

[[Page 68782]]

    (Response 89) We decline to provide a modified set of requirements 
for specialized laboratories of any size. The purpose of the LAAF 
program is to help ensure quality testing in the context of heightened 
food safety concerns. To achieve this public health goal, we have 
determined that without exception, only laboratories that satisfy all 
applicable laboratory standards may conduct the tests covered by this 
subpart. We reach the same conclusion when we consider the specific 
testing mentioned in some of these comments: DWPE testing of seafood 
for filth and decomposition. FDA places products on DWPE when we have 
evidence that such products appear to be in violation of FDA's laws and 
regulations. Moreover, seafood products which were filthy and 
decomposed have been implicated in past foodborne illness outbreaks 
(e.g., scombrotoxin fish poisoning; (Ref. 12)). Filth and decomposition 
are specified as the reasons some seafood products are subject to DWPE 
(e.g., https://www.accessdata.fda.gov/cms_ia/importalert_19.html; 
https://www.accessdata.fda.gov/cms_ia/importalert_43.html). We cannot 
find any basis for concluding that DWPE testing of seafood for filth 
and decomposition should be subject to different quality standards.
    ISO/IEC 17025:2017 includes technical competency, impartiality, and 
quality management system standards, and we view these components as 
critical in the context of testing covered by this subpart. By way of 
example, section 4.1 of ISO/IEC 17025:2017 provides that laboratory 
activities must be managed to safeguard impartiality and states that 
the laboratory may not allow commercial and financial pressures to 
compromise its impartiality (Ref. 3). The testing covered by this 
subpart involves heightened food safety concerns, and we can find no 
basis to justify modifying these standards or the other protections 
included in ISO/IEC 17025:2017 accreditation.
    Next we address the data analysis supporting the proposed rule, 
which indicated that 96 laboratories conducted about 16 percent of the 
analyses on food products detained when offered for import because the 
food was or appeared to be violative (84 FR 59452 at 59457) (Ref. 15). 
The same data analysis indicated that 34 of those 96 laboratories were 
accredited to ISO/IEC 17025, and that 44 laboratories already 
accredited to ISO/IEC 17025 conducted about 95 percent of the analyses. 
The same data analysis indicated that 62 unaccredited laboratories 
accounted for the remaining 5 percent of import-related analyses.
    To the extent that comments requesting modified standards for 
specialized laboratories intend to imply that most or all of the 62 
unaccredited laboratories that conducted import-related food testing 
were small, we do not have enough information to reach this conclusion. 
In addition, we have no way of knowing how specialized these 62 
laboratories are; some may conduct only DWPE testing, but we cannot 
tell the range of analyses each conducts.
    Even if we assume a high proportion of small, specialized 
laboratories that focus on DWPE testing, we expect the costs for such 
laboratories to become ISO/IEC 17025:2017-accredited to be less than 
the costs for larger laboratories and those with a more diverse set of 
testing capabilities. Reasoned assumptions which may reduce the cost of 
ISO/IEC 17025 accreditation for small, specialized laboratories 
include: (1) The ability to efficiently manage data collection and 
maintenance using relatively simpler in-house databases, particularly 
for seafood filth and decomposition testing, which generates discrete 
data; (2) lower onsite assessment costs since an accreditation body 
necessarily will spend less time assessing a smaller scope of 
accreditation (e.g., 1-3 methods); \10\ and (3) reduced costs for 
equipment and proficiency samples due to the small number of methods 
performed.
---------------------------------------------------------------------------

    \10\ A laboratory that is ``specialized'' necessarily performs a 
narrow range of methods.
---------------------------------------------------------------------------

    All testing covered by this subpart, including filth and 
decomposition testing in seafood for DWPE purposes, is of critical 
public health significance. As described above, we estimate that the 
costs of ISO/IEC 17025:2017 accreditation generally should be lower for 
laboratories with very few methods in their scope. On balance, we do 
not think the costs of requiring relatively small laboratories that 
conduct specialized testing to become ISO/IEC 17025:2017-accredited to 
perform covered testing outweigh the benefits that will be derived from 
doing so.
    For these reasons, we decline the request to modify LAAF program 
standards for certain laboratories.
    (Comment 90) Some comments recommend that FDA require laboratories 
wishing to conduct food testing under this subpart to be accredited to 
both ISO/IEC 17025:2017 and the supplemental document, ``AOAC 
International Guidelines for Laboratories Performing Microbiological 
and Chemical Analyses of Food, Dietary Supplements, and 
Pharmaceuticals, An Aid to Interpretation of ISO/IEC 17025:2017'' (the 
AOAC 17025 Guidelines) (Ref. 13). Other comments maintain that the AOAC 
17025 Guidelines are not appropriate for laboratories that test only 
animal food or feed, and not human food. Instead, these latter comments 
suggest that for laboratories testing animal food or feed, FDA should 
require the accreditation to ISO/IEC 17025:2017 and ``Quality 
Assurance/Quality Control Guidelines for Feed Laboratories,'' the 
guidance on interpreting ISO/IEC 17025:2017 issued by the Association 
of American Feed Control Officials (AAFCO) (Ref. 14). For laboratories 
that test both human food and animal food or feed, these comments 
recommend FDA require accreditation to both supplemental guidelines.
    (Response 90) In several places in the preamble to the proposed 
rule, FDA took note of how a matter is addressed in the AOAC 17025 
Guidelines. For example, in our discussion of our proposed requirement 
that laboratories pass a proficiency test (or a comparison program if 
no proficiency test is available or practicable) annually for each 
method to which they are LAAF-accredited, we noted that the AOAC 17025 
Guidelines contain a similar requirement and exception (84 FR 59452 at 
59477). It appears that some readers may have misunderstood these 
discussion points, and mistakenly believed that we proposed to require 
laboratories to comply with all AOAC 17025 Guidelines or to be 
accredited to both ISO/IEC 17025:2017 and the AOAC 17025 Guidelines. 
Although we found it instructive to consider the approach taken by the 
AOAC 17025 Guidelines on certain matters, we did not propose that 
laboratories must be accredited to both ISO/IEC 17025:2017 and the AOAC 
17025 Guidelines. In addition, we acknowledge the AAFCO guidelines 
provide equally useful supplemental information in animal food testing 
matters. The AAFCO guidelines share best practices which would assure 
that data of appropriate quality are generated by laboratories for feed 
programs and may be useful for producing reliable and defensible 
analytical test results. After careful consideration, we decline the 
suggestion to require either the AOAC or AAFCO guidelines in this 
subpart, but agree that both provide useful supplemental information. 
We do not presently perceive a need for such a requirement, and as some 
comments have pointed out, there may be challenges around the breadth 
of the AOAC 17025 Guidelines considering the wide variety of tests 
required to be conducted by LAAF-accredited laboratories under this 
subpart.

[[Page 68783]]

    (Comment 91) A few comments seek clarification of the roles of 
Federal, State, and local regulatory laboratories with respect to this 
rule. Some comments seek clarification on whether State and local 
regulatory laboratories that are already accredited to ISO/IEC 
17025:2017 by an ILAC-MRA signatory and may have agreements with FDA 
for testing related to food safety inspections, will need to do 
anything differently as a result of this rule. Some comments posit that 
only a few public laboratories are conducting the testing covered by 
this subpart, and those laboratories may already operate under quality 
management systems, and perhaps even ISO/IEC 17025:2017.
    Some comments suggest that Federal laboratories (e.g., a laboratory 
within a Federal Agency) should be considered equivalent to LAAF-
accredited laboratories. Stated differently, these comments recommend 
that if an owner or consignee uses a Federal laboratory, the result 
should be acceptable to FDA even if the laboratory is not LAAF-
accredited.
    (Response 91) Federal, State, and local regulatory laboratories 
perform the vital function of testing product samples of human food, 
and animal food and feed, collected by public health officials either 
in the course of an investigation or as part of routine market 
surveillance. Over the years great strides have been made at all levels 
of government to build an integrated food safety system; improving 
coordination with and among public regulatory laboratories has been an 
important part of that work. This subpart does not impact those tests 
and so it may be irrelevant to many public regulatory laboratories.
    On the other hand, in addition to testing samples collected by 
public health officials, some public regulatory laboratories may also 
currently conduct some of the food testing that is covered by this 
subpart. For full details see Sec.  1.1107, but the bulk of the testing 
covered by this subpart falls within the categories of certain tests of 
bottled drinking water, shell eggs, and sprouts; testing to support 
removal from import alert; and testing to support admission of an 
imported food product detained at the border because FDA has determined 
that the food is, or appears to be, adulterated or misbranded. Once 
this subpart is fully implemented, all testing covered by this rule 
must be conducted by a LAAF-accredited laboratory. Public regulatory 
laboratories may become LAAF-accredited laboratories; indeed, the 
statute specifically contemplates public laboratories participating in 
this program (``laboratories, including independent private 
laboratories and laboratories run and operated by a Federal Agency 
(including the Department of Commerce), State, or locality'' (section 
422(a)(2) of the FD&C Act)). All laboratories, including public 
regulatory laboratories, that wish to become LAAF-accredited must 
satisfy the requirements of this subpart.
    Similarly, an array of laboratories throughout the Federal 
government conduct a variety of tests in service to the missions of 
their organizations. Any Federal laboratories that wish to become LAAF-
accredited to conduct the testing covered by this subpart will need to 
satisfy the requirements of this subpart.
    (Comment 92) We received several comments regarding the frequency 
with which we should require proficiency testing (or a comparison 
program, where no proficiency test is available or practicable). Some 
comments applaud the proposed requirement for an annual proficiency 
test for each method (or comparison program, where no proficiency test 
is available or practicable). Some comments suggest that the annual 
frequency be set as a minimum requirement, as even more frequent 
proficiency testing would allow for trending of results. Other comments 
suggest FDA defer to ISO/IEC 17025:2017 for proficiency testing 
frequency. Some of these comments seek to clarify how the FDA will 
handle the annual proficiency testing requirement in the case of open 
or flexible scopes. Some comments express that it is hard to find a 
proficiency test provider that includes all analytes for such a method. 
Other comments state that owners or consignees may have a difficult 
time finding laboratories that are both ISO/IEC 17025:2017-accredited 
and have performed a proficiency test for the analyte/method 
combination within the last year for emerging issues, new methods, or 
novel matrices being sampled and tested.
    (Response 92) Proficiency testing is a quality assurance mechanism 
provided by an independent provider that results in an indication of a 
laboratory's performance of a method. A successful proficiency test 
round indicates that a laboratory can competently analyze samples by 
that method whereas an unsatisfactory result indicates that the 
laboratory needs to investigate and correct the cause(s) of the 
unsatisfactory result.
    Although participation in proficiency testing provided by an 
outside, independent provider is desired for all testing, we recognize 
that it is not available for all test methods, specific analytes, or 
matrices; or that, where available, it may not occur at the required 
frequency. Therefore, we allow as an option a similarly designed 
comparison program which will provide a demonstration of the 
laboratory's competence to perform a method not covered by an available 
proficiency test program. The comparison program should be an 
independent or blind test of the laboratory's performance of a method 
that is evaluated against the expected performance of the method 
resulting in a conclusion of the laboratory's performance as acceptable 
or unacceptable. All the testing covered by this subpart is occurring 
in the context of heightened public health concern. We must therefore 
be assured that LAAF-accredited laboratories are producing accurate 
test results. For example, the results of testing conducted under Sec.  
1.1107(a)(4) are used as evidence to overcome an appearance that a 
product detained at the border violates FDA laws and regulations.
    We agree that requiring LAAF-accredited laboratories to 
successfully complete an annual proficiency test (or a comparison 
program, where no proficiency test is available or practicable) for 
each LAAF-accredited method is important to support the testing under 
this subpart. We have determined that deferring to the proficiency test 
requirement in ISO/IEC 17025:2017 will not meet the needs of this 
program, given the context of heightened public health concern. As 
noted in the proposed rule, our proficiency testing frequency 
requirement is similar to that of the AOAC 17025 Guidelines.\11\ 
Although even more frequent proficiency testing may be instructive, we 
are not requiring it under this subpart. Accordingly, we are finalizing 
the requirement that a LAAF-accredited laboratory must successfully 
complete a proficiency test or comparison program for each method every 
12 months. We avoid stating the requirement must be satisfied every 
``year,'' to avoid implying that the proficiency tests or comparison 
programs requirement applies per calendar-year.
---------------------------------------------------------------------------

    \11\ Some comments explain that although we stated in the 
proposed rule that section 5.9.1 of the AOAC 17025 Guidelines 
addresses proficiency testing, the AOAC 17025 Guidelines have been 
updated. The updated AOAC 17025 Guidelines address proficiency 
testing in section 7.7.2. FDA appreciates the comments.
---------------------------------------------------------------------------

    In light of the comments, and considering the critical role that 
proficiency testing plays in the context of this final rule to help 
ensure both the integrity of specific tests conducted under this 
subpart and this laboratory accreditation program as a whole, we are 
revising the proficiency testing provisions so that positive results 
are

[[Page 68784]]

explicitly required. In the language of the proposed rule LAAF-
accredited laboratories were required to ``participate'' and 
``conduct'' a proficiency test annually, per method. The final rule 
requires that a proficiency test for each method must be ``successfully 
passed'' within a 12-month cycle, unless one is not available or 
practicable. Sec.  1.1138(a)(2)(i). In that case, the final rule 
requires that the LAAF-accredited laboratory ``demonstrate competency 
through participation in [a] comparison program.'' Sec.  
1.1138(a)(2)(ii). As we discuss further below in (Response 96, the 
LAAF-accredited laboratory must submit all proficiency test and 
comparison program results, regardless of outcome, to the recognized 
accreditation body within 30 calendar days of receipt. Sec.  
1.1138(a)(2)(iii).
    For laboratories LAAF-accredited to an open or flexible scope, the 
requirement would be for a proficiency test or comparison program 
within 12 months for each method within the open or flexible scope.
    With regard to comments expressing concern that it may be hard for 
an owner or consignee to find a laboratory that is ISO/IEC 17025:2017-
accredited and meets our proficiency test requirements, we note that we 
will be maintaining an public registry of all LAAF-accredited 
laboratories (and recognized accreditation bodies) online; see Sec.  
1.1109 for additional discussion of the public registry.
    (Comment 93) Some comments express confusion regarding whether FDA 
expects each analyst performing a method in the LAAF-accredited 
laboratory to annually fulfill the proficiency testing requirement for 
that method. These comments reference the requirement proposed at Sec.  
1.1152(g)(12)(iv) that a full analytical report include, ``[i]ndividual 
proficiency test worksheets'' and suggest that we clarify our 
requirement.
    (Response 93) The requirement is for the laboratory to successfully 
pass a proficiency test for each LAAF-accredited method within the last 
12 months. We have revised the full analytical report requirement to 
clarify; for more information see the discussion of Sec.  1.1152, 
below.
    (Comment 94) Some comments express confusion regarding whether FDA 
expects the LAAF-accredited laboratory to inform the recognized 
accreditation body that the laboratory has determined that a 
proficiency test is either not available or practicable, and so the 
laboratory intends to participate in a comparison program instead. 
Comments speculate regarding whether FDA might have intended that the 
recognized accreditation body review such determinations when it audits 
the laboratory.
    (Response 94) The LAAF-accredited laboratory's determination that a 
proficiency test is not available or practicable must be approved by 
its recognized accreditation body; we revised the proficiency test 
provisions of the final rule to clarify this requirement; see Sec.  
1.1138(a)(2)(ii). The LAAF-accredited laboratory's proposed alternative 
to a proficiency test also must be approved by its recognized 
accreditation body, prior to the laboratory's participation in the 
alternative.
    We consider quality assurance measures vital to the integrity of 
the LAAF program and the testing that occurs under this subpart. 
Although one aspect of that quality assurance is requiring proficiency 
testing for each LAAF-accredited method within each 12-month period, an 
additional aspect is having the recognized accreditation body concur 
with both the laboratory's determination that no proficiency test is 
available to the laboratory, and the alternative proposed by the 
laboratory.
    (Comment 95) In the proposed rule, we noted that ISO/IEC 17043:2010 
``Conformity Assessment--General Requirements for Proficiency Testing'' 
(Ref. 16) provides specific standards for proficiency test providers. 
We requested comment on whether FDA should require the use of 
proficiency test providers accredited to ISO/IEC 17043:2010.
    Some comments support the proposed requirement that proficiency 
testing providers must be ``competent,'' and do not recommend that we 
specify accreditation to ISO/IEC 17043:2010. Some comments state that 
many proficiency test providers that are not accredited to the ISO/IEC 
17043:2010 standard have equivalent quality systems and are established 
programs in the industry or in government organizations. Some comments 
state that international proficiency test providers are less likely to 
be accredited to ISO/IEC 17043:2010 as this standard is not utilized 
very much outside of the United States. Some comments suggest that 
recognized accreditation bodies can institute processes for determining 
equivalency for such proficiency test providers.
    Other comments recommend that we require the use of proficiency 
test providers accredited to ISO/IEC 17043:2010. Some assert that 
accreditation of proficiency test providers provides assurances 
regarding both the accuracy of the proficiency test and the technical 
competence of the laboratories that successfully participate. Some 
comments suggest that FDA could require the use of ISO/IEC 17043:2010 
accredited proficiency test providers when available. Other comments 
suggest that the FDA adopt the stance taken in AOAC 17025 Guidelines 
section 7.7.2 which states that an ISO/IEC 17043 accredited proficiency 
test provider should be given preference. Some comments ask FDA to 
clarify which steps should be taken if we require ISO/IEC 17043:2010 
accreditation for proficiency test providers, but where none is 
available for certain methods.
    (Response 95) FDA appreciates the detailed responses to our 
question on this matter.
    Having considered the comments, we have decided against requiring 
the use of proficiency test providers accredited to ISO/IEC 17043:2010. 
We agree with the specification in the AOAC 17025 Guidelines that such 
providers should be given preference, and we encourage laboratories to 
seek providers with such accreditation. However, at the present time 
there are many methods for which no proficiency test provider exists at 
all, let alone one accredited to ISO/IEC 17043:2010. Given the 
importance of an independent, third-party evaluation of a laboratory's 
competence--as provided by a proficiency test within every 12-month 
cycle--we have decided to allow a wide selection of proficiency test 
providers to cover as many of the testing methods covered by this 
regulation as possible. Although the use of an ISO/IEC 17043:2010 
accredited proficiency test provider may give the laboratory confidence 
in the quality and consistency of the proficiency test material and the 
evaluation of laboratory test results, at the present time, the breadth 
of testing covered by ISO/IEC 17043:2010 providers is not sufficient to 
support making this a requirement.
    (Comment 96) Some comments disagree with the proposed requirements 
in Sec.  1.1153(b)(1) and (2) that within 30 days of receipt, the LAAF-
accredited laboratory must submit proficiency test results to the 
recognized accreditation body and that failing proficiency test results 
must also be submitted to the FDA; comments state that this deviates 
from current ISO/IEC 17025:2017 procedures. Comments explain that 
proficiency test results for an ISO/IEC 17025:2017-accredited 
laboratory are assessed annually by an accrediting body. Comments 
further explain that ISO/IEC 17025:2017-accredited laboratories address 
unsatisfactory results by conducting a

[[Page 68785]]

root cause analysis and taking corrective action.
    Some comments agree with proposed Sec.  1.1153(b)(2), which 
required the LAAF-accredited laboratory to submit failing proficiency 
test results to FDA within 30 days of receipt. Other comments state 
that requiring recognized accreditation bodies to review proficiency 
test results without specified timeframes is not efficient, and the 30-
day timeframe may not provide enough time for the laboratory to 
complete its corrective action process. Comments express concern that 
failing results submitted to the recognized accreditation body and FDA 
could be used against the laboratory without consideration of the 
laboratory's corrective action procedures.
    Comments state that FDA should defer to ISO/IEC 17025:2017 
proficiency test reporting requirements and that recognized 
accreditation bodies can submit non-conforming laboratory results to 
the FDA during their onsite assessments. Comments also state that some 
accreditation bodies require that the proficiency testing data be 
submitted directly to the accreditation body from the proficiency test 
provider and that procedures already are in place for review of 
proficiency testing schemes. A few comments have asked FDA to clarify 
what would be considered a ``questionable'' or failing proficiency test 
result. Comments state that some proficiency test providers consider 
consecutive questionable results when determining a laboratory's 
proficiency test performance and comments ask for clarification on how 
FDA would evaluate consecutive questionable results.
    (Response 96) We have moved the proficiency test result reporting 
requirements from Sec.  1.1153(b) to Sec.  1.1138(a)(2)(iii) so that 
they appear alongside the main proficiency test requirements.
    After considering the comments, we have decided to revise the 
requirements regarding LAAF-accredited laboratories' sharing results of 
proficiency tests (or a comparison program, where no proficiency test 
is available or practicable) with the recognized accreditation body and 
FDA. First, we have determined that it is sufficient for the LAAF-
accredited laboratory to share results with the recognized 
accreditation body and have therefore deleted the requirement that 
failing results also be submitted to FDA. Upon consideration of the 
comments on these provisions, the comments encouraging greater 
delineation of FDA's role, and the requirements in Sec.  
1.1138(a)(2)(ii) that recognized accreditation bodies must concur in 
both the determination that no proficiency test is available and the 
alternative chosen, we conclude that it better suits the role of the 
accreditation body to review proficiency test results.
    We acknowledge that current ISO/IEC procedures only require the 
accreditation body to review a laboratory's proficiency test results 
annually, and that reviewing all results, and on an ongoing basis, will 
not be as efficient for the accreditation body. (According to the 
comments, some accreditation bodies go beyond what is required under 
the ISO/IEC standard and so, may already receive results of all 
proficiency test results, sometimes directly from the proficiency test 
provider itself; our requirements may not be as much of a change for 
those accreditation bodies.) However, we view proficiency testing (or 
comparison programs, where no proficiency test is available or 
practicable) as a very important tool to either reflect the continued 
competence of a laboratory with regard to a particular method or 
provide an opportunity for the laboratory to determine why it did not 
receive a fully acceptable result and address any related need for 
process improvements. We believe that providing the recognized 
accreditation body with proficiency test results on an ongoing basis 
will allow the recognized accreditation body to maintain greater and 
more timely awareness of a laboratory's competency.
    At the same time, we take the point of the comments stating that if 
the result is less than fully acceptable, it is unlikely that the LAAF-
accredited laboratory will complete its corrective action process 
within 30 calendar days of receiving the result. In addition, as 
explained above, we want recognized accreditation bodies to be in 
possession of additional information about laboratory competency in a 
timelier fashion than annual reviews provide. Therefore in the final 
rule we are retaining the 30 calendar day timeframe for submission to 
the recognized accreditation body of the results of the proficiency 
test (or comparison program, where no proficiency test is available or 
practicable).
    We note that a LAAF-accredited laboratory must successfully pass a 
proficiency test (or comparison program, if a proficiency test is not 
available or practicable) as described in Sec.  1.1138(a)(2) to gain or 
maintain LAAF-accreditation for a particular method.
    Finally, with regard to the proposed requirement that a LAAF-
accredited laboratory submit to FDA results of ``failed'' proficiency 
tests, comments request that we clarify what would be considered a 
failing result. We acknowledge and agree with comments indicating that 
proficiency test results generally are phrased in terms such as 
``satisfactory'' or ``fully acceptable,'' or ``unsatisfactory'' or 
``questionable.'' We have revised the requirement in the final rule to 
require that a laboratory submit all proficiency test and comparison 
program results, regardless of outcome, to the recognized accreditation 
body within 30 calendar days of receipt (see Sec.  1.1138(a)(2)(iii)).
    (Comment 97) We received several comments regarding the quality 
assurance requirements in proposed Sec.  1.1148. Some comments agree 
with the proposed requirement that reference materials or quality 
control samples be used with each test conducted under this subpart. 
Some comments ask that FDA provide more details of the requirements for 
a quality assurance process, including how quality is assured and by 
whom, who performs audits and how they are issued, and, regarding 
proposed Sec.  1.1148, who is accountable for findings and corrective 
action. Some comments include for FDA's consideration examples of how 
quality assurance is defined and implemented in other organizations, 
including mention of the AOAC 17025 Guidelines' treatment of reference 
materials and quality control samples.
    (Response 97) FDA considers quality assurance to be vital to the 
integrity of this program and the testing that occurs under this 
subpart. We have included various requirements throughout this subpart 
that address quality assurance precisely because confidence in LAAF-
accredited testing is essential. One example is the requirement that 
LAAF-accredited laboratories ensure that policies and procedures for 
monitoring the validity of the results of testing they conduct under 
this subpart include the use of reference materials or quality control 
samples with each batch of samples tested under this subpart (Sec.  
1.1138(a)(3)), a policy that aligns with the AOAC 17025 Guidelines 
(Ref. 13). Relatedly, we have revised the final rule to require 
submission of quality control results even with abridged analytical 
reports, again, because of the importance we place on quality 
assurance. ISO/IEC 17025:2017 similarly contains quality assurance 
requirements, and not as a stand-alone provision, but integrated 
throughout the standard (Ref. 3).
    In our view, quality assurance is most effective when it is not 
treated as a distinct activity or addendum, but rather as a commitment 
that should be

[[Page 68786]]

reflected in many facets of laboratory operations. Accordingly, we 
decline the invitation to include a definition of ``quality 
assurance.'' We do not believe a definition would significantly advance 
the degree to which LAAF-accredited laboratories pursue and conduct 
quality assurance.
    Commenters interested in additional details about the quality 
assurance process under this subpart need only become more familiar 
with its provisions. Both the recognized accreditation bodies and LAAF-
accredited laboratories are subject to requirements that we believe 
will promote quality assurance.
    (Comment 98) We received many comments regarding whether FDA should 
require LAAF-accreditation for the entities that collect the samples 
that get tested under this subpart.
    In the proposed rule we chose not to include requirements for the 
accreditation of samplers. We acknowledged the importance of proper 
sampling procedures and that accreditation for sampling could 
potentially help ensure the collection of representative samples. We 
stated that although only laboratories were eligible for ISO/IEC 17025 
accreditation under the 2005 version of that standard, the 2017 version 
of the standard allows for the accreditation of entities that only 
collect and do not analyze samples (``stand-alone sampling entities'') 
(see 84 FR 59452 at 59476). As the revision was relatively new at the 
time of the proposed rule, we were not able to adequately assess the 
accreditation of such entities. We solicited comments on several 
related issues, such as the capacity of accredited samplers (both 
laboratories and stand-alone sampling entities), which international 
voluntary consensus standard would serve as the optimal basis for a 
consensus sampling standard, and which standards are currently employed 
to assess samplers and whether such standards are effective and 
sufficient. We proposed instead, in Sec.  1.1149, to require LAAF-
accredited laboratories to develop or obtain certain sampling documents 
that would allow FDA to exercise oversight of the sampling conducted as 
part of this program. Comments on proposed Sec.  1.1149 are addressed 
below.
    Several comments endorse not requiring the accreditation of 
samplers at the present time. Some of these comments contend samplers 
are adequately qualified and therefore an accreditation requirement is 
not warranted. These comments consider that the FDA oversight of 
samples made possible by proposed Sec.  1.1149 will provide adequate 
assurance of samplers' qualification and will provide helpful 
flexibility in allowing different entities to collect the sample. Some 
comments claim that for many food facilities, the preventive controls 
regulations already require that sampling activities be performed by a 
qualified individual and be overseen by a person with specialized 
training in food safety preventive controls (i.e., a preventive 
controls qualified individual).
    We understand some comments to argue that without substantive 
sampling protocols to which samplers could refer, it would be difficult 
for accreditation bodies to accredit samplers to ISO/IEC 17025:2017 or 
assess against proposed Sec.  1.1149. These comments recommend that, at 
a minimum, FDA should provide a mechanism whereby samplers could verify 
sampling protocols with FDA. See discussion of this point with respect 
to Sec.  1.1149, below.
    Some comments agree with our assessment in the proposed rule that 
accreditation of stand-alone samplers is still relatively new. Some 
comments agree that we should review this issue in the future. Some 
comments contend that requiring the accreditation of samplers would 
necessitate significant investments of time and expense by industry to 
obtain such accreditation but would not result in significant public 
health benefit.
    Other comments disagree with FDA's proposed decision and instead 
argue that the final rule should require the accreditation of samplers. 
Some of these comments contend that the statute requires samplers to be 
accredited under this subpart; comments specifically quoted or 
referenced section 422(a)(6)(A)(iv) and (b)(1) of the FD&C Act.
    Some comments contend that allowing sampling by unaccredited 
entities would fail to provide the clarity needed for proper sample 
collection, which can have a significant impact on the quality of the 
test results and related uncertainty. These comments state that 
analysis of an improper sample can invalidate the test results, and 
argue that requiring accredited samplers is crucial to the integrity of 
both the sample itself and the resulting test data. A few comments 
claim that requiring the accreditation of samplers would ensure 
traceability, which we understand to mean the ability to connect the 
sample back to a lot or shipment.
    Some comments contend that aspects of ISO/IEC 17025:2017 are 
necessary to ensure quality sampling. Some comments reason that, if 
samplers are not required to be ISO/IEC 17025:2017-accredited, there is 
a risk they may be connected to owners and consignees, and thus have an 
interest in the outcome of the sampling and food testing. These 
comments express the concern that allowing unaccredited samplers may 
lead to the analysis of biased, substituted, or manipulated samples. 
Comments suggest that accreditation to the ISO/IEC 17025:2017 standard 
would protect against such conflict of interest concerns. Some comments 
also champion the value of ISO/IEC 17025:2017 to establish standards 
for sampler qualifications.
    Some comments disagree with the Agency's assessment in the proposed 
rule that ISO/IEC 17025:2017 accreditation for stand-alone sampling 
entities is relatively new and the FDA does not have enough information 
to assess their accreditation. Comments disagree that accreditation 
bodies do not have the experience or bandwidth to satisfy a requirement 
under this subpart that samplers be ISO/IEC 17025:2017-accredited.
    Regarding current capacity among ISO/IEC 17025:2017-accredited 
samplers, some comments assert that there is more than sufficient 
accredited-sampler capacity to conduct all the DWPE sampling that would 
be required under this subpart. They claim that current ISO/IEC 
17025:2017-accredited sampling providers can expand their workforce as 
needed to meet increased demand. They also contend that if we were to 
require the accreditation of samplers under this subpart, we would be 
creating additional incentive for sampling entities to become ISO/
IEC17025:2017-accredited, which would further increase capacity. Other 
comments seem to suggest that accredited sampling capacity will 
increase over time for market reasons (as accreditation generates 
revenue), regardless of whether we incentivize by requiring sampling 
accreditation under this subpart.
    Certain comments suggest that the sampling requirements in ISO/IEC 
17025:2017 in conjunction with FDA's Investigations Operations Manual 
(IOM) (Ref. 17) would provide comprehensive standards for sampling. 
Comments also maintain that ILAC is in the process of considering the 
circumstances in which it may be appropriate to require accredited 
sampling.
    (Response 98) As discussed at some length in the proposed rule, 
proper sampling procedures are essential to meaningful test results. 
Accordingly, it is important that this subpart address samplers' 
training and procedures. After careful consideration of the comments, 
we have decided that the most appropriate way to support those goals at 
the present time is through the

[[Page 68787]]

oversight provisions at Sec.  1.1149 rather than by requiring ISO/IEC 
17025:2017-accreditation of samplers.
    Although we have decided not to require the accreditation of 
sampling at this time, it should be noted that with the adoption of 
ISO/IEC 17025:2017 without exclusions, those laboratories that include 
sampling on their scope of accreditation will be assessed by their 
accreditation body to the requirements of ISO/IEC 17025:2017 section 
7.3 on sampling. Even though many sampling entities are not part of an 
ISO/IEC 17025:2017-accredited laboratory, we conclude that the general 
requirements in ISO/IEC 17025:2017 section 7.3 are sufficiently 
addressed in Sec.  1.1149 (Ref. 3). There currently is no other 
consensus standard specific to sampling of which we are aware; nor is 
there a single, widely accepted sampling standard for us to incorporate 
or on which to rely. Instead, there are several publications that 
address the appropriate statistical sampling that is required to obtain 
the representative sample referred to in Sec.  1.1149. Some comments 
suggest that the FDA IOM could serve as the substantive standard. 
However, while the FDA Compliance Programs \12\ and the IOM define the 
general process for all sampling to ensure that the sample is 
representative of the entire lot and in conformance with FDA sampling 
procedures and methods, many of the instructions in these documents are 
specific to FDA operations and would not be appropriate for 
incorporation within this subpart. We also acknowledge the point of the 
comments that argue that the 2017 version of ISO/IEC 17025 is not still 
``new,'' and the comments that maintain that accreditation bodies have 
the capacity to accredit entities for sampling. Nevertheless, in the 
absence of any other consensus standard specific to sampling of which 
we are aware; nor a single, widely accepted standard on sampling 
criteria and specifications, we believe more time is needed for 
industry to flesh out, and for us to assess, the ISO/IEC 17025:2017 
accreditation of entities (including non-testing entities) for 
sampling. Additionally, due to the absence of a predominant substantive 
sampling standard, we do not agree with the position expressed in 
comments that accreditation alone would provide sufficient clear 
direction on sampling protocols to ensure proper sample collection. For 
additional discussion regarding FDA substantive sampling resources, see 
FDA Compliance Programs and IOM Ch. 4.
---------------------------------------------------------------------------

    \12\ For more information on FDA Compliance Programs, see 
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-manuals/compliance-program-guidance-manual-cpgm.
---------------------------------------------------------------------------

    Despite the contentions of some comments, the statute does not 
specify that FDA must require the accreditation of samplers in this 
subpart. Comments point to section 422(a)(6)(A)(iv) and (b)(1) of the 
FD&C Act to support the argument that sampling accreditation is 
necessary. Section 422(a)(6)(A)(iv) of the FD&C Act states that the 
model standards established in this subpart must include methods to 
ensure that (among other things), ``individuals who conduct the 
sampling and analysis are qualified by training and experience to do 
so.'' This language does not mention accreditation; instead, it 
provides (in relevant part) that FDA require samplers to be qualified. 
We are fulfilling that obligation in Sec.  1.1149. Section 422(b)(1) of 
the FD&C Act lists the tests that must be covered by this subpart; the 
introductory text reads (in relevant part), ``food testing shall be 
conducted by Federal laboratories or non-Federal laboratories that have 
been accredited for the appropriate sampling or analytical testing 
methodology or methodologies.'' This provision refers to accreditation, 
but the ``or'' is important; by stating ``sampling or analytical 
testing methodology,'' the statute allows for the satisfaction of just 
one type of accreditation. Thus, this language explicitly allows for 
testing to be conducted by laboratories accredited for just the 
appropriate test method.
    As we stated in the proposed rule, in the 2-year period from 2016-
2017, about 63 percent of DWPE sampling was conducted by 5 entities 
accredited for sampling under ISO/IEC 17025:2017 (see 84 FR 59452 at 
59476). About 37 percent of DWPE sampling was conducted by more than 
300 entities not accredited for sampling (see id.). In the proposed 
rule, we specifically solicited feedback regarding the current capacity 
of accredited samplers. Some comments respond that there is sufficient 
capacity among already-accredited samplers to conduct all DWPE 
sampling, and that it would be relatively easy for such entities to 
expand capacity much further. We appreciate the time taken by 
commenters to thoroughly address our specific inquiries.
    This subpart reaches beyond testing to support removal from import 
alert, and entities focused on the sampling and testing needs at ports 
of entry may not be convenient choices for non-import related owners 
and consignees needing the services of a LAAF-accredited entity. We 
note incidentally that some of the non-import sampling needs under this 
subpart are unique; there are serious biosecurity concerns that would 
need to be addressed by any outside entity collecting the shell egg 
samples the testing of which is covered by this subpart under Sec.  
1.1107(a)(1)(ii). See, e.g., Biosecurity Basics for Poultry Growers 
(Ref. 18). We did not receive any comments describing the current 
capacity of accredited samplers to collect non-import samples, though 
as stated, some comments express the view that it would be relatively 
easy to expand capacity, and some comments make the point that if we 
require the accreditation of samplers we would be creating an incentive 
to become accredited for sampling.
    Some comments suggest that there is no indication current samplers 
are unqualified. For current purposes it is sufficient to acknowledge 
that the statute directs FDA to address sampler qualifications in this 
subpart. Some comments claim that sampling that takes place pursuant to 
the FSMA preventive controls regulations is already required to be 
conducted by a trained individual, and overseen by another person with 
specialized food safety preventive controls training. (See the 
definition of preventive controls qualified individual in Sec. Sec.  
117.3 and 507.3.) It is true that each of those regulations requires 
sampling to be conducted by an individual qualified by education, 
training, or experience to carry out such sampling (Sec. Sec.  117.3, 
117.4(b); Sec. Sec.  507.3, 507.4(b)), but the preventive controls 
regulations only require a preventive controls qualified individual to 
prepare or oversee the preparation of the food safety plan that would 
detail the sampling regimen, not to oversee the sampling activity 
(Sec. Sec.  117.180, 507.53). In addition, very few of the samples that 
must be tested by a LAAF-accredited laboratory would be collected from 
registered food facilities subject to either of the preventive controls 
regulations; we estimate that almost all of the laboratory analytical 
reports submitted in accordance with this subpart will be related to 
sprouts (see Sec.  1.1107(a)(1)(i)), shell eggs (see Sec.  
1.1107(a)(1)(ii)), and imports under section 801(a) (see Sec.  
1.1107(a)(4), (5)) (Ref. 4).
    Some comments raise concerns about biased sampling. These comments 
contend that the conflict of interest provisions in ISO/IEC 17025:2017 
protect against samplers that have an interest in the outcome of the 
test from submitting unrepresentative (e.g., ``cherry picked'' or 
manipulated) samples. Although we also appreciate that ISO/IEC 
17025:2017 contains conflict of interest provisions, the requirements 
in Sec.  1.1149(a)(2) and (3)

[[Page 68788]]

for a sampling plan and collection report will ensure that the sample 
collection procedures and preparation techniques, as well as the chain 
of custody including controlling for the representative nature of the 
sample, are documented and reviewed by FDA. For more information on the 
sampling documentation required by this final rule, see the discussion 
of Sec.  1.1149, below.
    Regarding sampler qualifications, ISO/IEC 17025:2017 section 6.2 
requires accredited entities to document (among other things) the 
educational, training, and experiential needs of each position and 
ensure that personnel possess the necessary competence to perform their 
function (Ref. 3). Although we do not dispute that these aspects of 
ISO/IEC 17025:2017's quality management system are valuable, we are 
addressing sampler qualifications, albeit using a different approach, 
in this rule. Section 1.1149(a)(1) requires the qualifications of each 
sampler to be submitted to FDA. Reviewing the documentation of 
samplers' training and experience will provide FDA with a means of 
helping to ensure that each sampler possesses qualifications sufficient 
for the task.
    A few comments claim that requiring the accreditation of samplers 
would facilitate connecting a sample back to a lot or shipment. 
However, the requirements in Sec.  1.1149(a)(1) through (3) for the 
written documentation of the sampler's qualifications by training and 
experience, the written sampling plan used to conduct the sampling, and 
the collection report combined should include the information required 
to allow for tracing back to the lot or shipment.
    A number of pending developments may cause us to revisit this 
issue. Contrary to the assertion of some comments, our understanding is 
that ILAC is not considering developing standards or advice regarding 
the circumstances in which it would be appropriate to require sampling 
accreditation. However, a number of other developments may cause us to 
revisit this issue, including our experience administering this 
program, which will include reviewing sampling documents from both 
LAAF-accredited laboratories and unaccredited samplers. Any change we 
propose to this subpart will be effected through rulemaking and include 
an opportunity for public comment.
2. How does a laboratory apply for LAAF-accreditation or extend its 
scope of LAAF-accreditation (Sec.  1.1139)?
    This topic appeared in Sec.  1.1158 of the proposed rule. In the 
proposed rule, paragraph (a) of this section directed a laboratory 
seeking LAAF-accreditation to apply to a recognized accreditation body. 
It also noted that a laboratory that had previously been disqualified 
from the program by FDA or had its LAAF-accreditation withdrawn by a 
recognized accreditation body must meet additional requirements to be 
reinstated; those requirements are contained in Sec.  1.1142 of the 
final rule (proposed Sec.  1.1165).
    In the proposed rule, paragraph (b) of this section stated that a 
laboratory seeking LAAF-accreditation may use documentation of 
conformance with ISO/IEC 17025:2017 in meeting the requirements of this 
subpart.
    In the proposed rule, paragraph (c) of this section provided that 
LAAF-accreditation endures as long as the laboratory maintains 
compliance with all requirements of this subpart, unless the laboratory 
relinquishes its LAAF-accreditation, FDA disqualifies the laboratory 
from the program, or the recognized accreditation body withdraws the 
laboratory's LAAF-accreditation.
    On our own initiative, we specified the relevant paragraph in the 
cross-reference to Sec.  1.1142 and made other conforming and minor 
editorial changes. Conforming terminology changes include adding the 
phrase, ``reduced in scope,'' and the term, ``disqualified'' to the 
list of ways LAAF-accreditation may end, in paragraph (c). Whereas in 
the proposed rule, the words, ``withdrawn'' and ``revoked'' included 
``in part'' withdrawal or reduction, in the final rule we use the word, 
``reduce,'' to mean that some (but not all) methods are removed from 
the scope of LAAF-accreditation and we use ``disqualify'' to refer to 
the action FDA takes with respect to a LAAF-accredited laboratory. 
Additionally, we have revised the section to remove reference to 
``modification of scope,'' instead referring to extension of scope in 
the final rule. We also revised the section title accordingly to read, 
``How does a laboratory apply for LAAF-accreditation or extend its 
scope of LAAF-accreditation?'' Comments regarding this section are 
discussed below.
    (Comment 99) We received a few comments on this section; they 
concern paragraph (c). Comments state that as proposed, LAAF-
accreditation would continue indefinitely, and accreditation bodies may 
approach this policy differently. Some accreditation bodies take a 
proactive approach and prompt laboratories to begin the renewal 
accreditation process for ISO/IEC 17025:2017 well in advance of 
expiration.
    (Response 99) We acknowledge that accreditation bodies vary in 
their approaches to the duration and renewal of ISO/IEC 17025:2017 
accreditation. Nevertheless, we are comfortable with the policy that 
LAAF-accreditation for a particular method endures indefinitely for a 
variety of reasons including that ISO/IEC 17011:2017 section 7.9.1 
prescribes that ISO/IEC 17025:2017 accreditation may be for a maximum 
of 5 years (Ref. 2); Sec.  1.1120(e) of this subpart requires 
recognized accreditation bodies to conduct an onsite assessment of a 
sample of the laboratory's scope every 2 years; and we have included 
various quality assurance requirements in this subpart such as the 
requirement in Sec.  1.1138(a)(2) for a successful proficiency test at 
least every 12 months for each method to which a laboratory is LAAF-
accredited.
3. What must a LAAF-accredited laboratory do to voluntarily relinquish 
its LAAF-accreditation (Sec.  1.1140)?
    This topic appeared in Sec.  1.1163 in the proposed rule. We 
proposed to title this section, ``What if a laboratory wants to 
voluntary relinquish its accreditation?'' For precision and in keeping 
with the terminology changes described above at Response 10, the title 
has been reworded to read, ``What must a LAAF-accredited laboratory do 
to voluntarily relinquish its LAAF-accreditation?''.
    In the proposed rule, paragraph (a) of this section provided that a 
LAAF-accredited laboratory must notify FDA and its recognized 
accreditation body at least 60 days before relinquishing its LAAF-
accreditation either in whole or in part. We proposed that the notice 
must include the date on which the relinquishment will occur, and if 
the laboratory is relinquishing its LAAF-accreditation in whole, 
certain information on a records custodian.
    In the proposed rule, paragraph (b) stated that FDA will provide 
notice of the relinquishment on the public registry described in Sec.  
1.1109.
    On our own initiative, we made a few changes to this section. 
First, we removed the language requiring the notice of relinquishment 
to be electronic and in English; requirements for submitting 
information to FDA under this subpart are now addressed in Sec.  
1.1110. We also removed mention of the fact that the relinquishing 
laboratory must make its records available to FDA as required by Sec.  
1.1153 because it was superfluous. We also made minor editorial changes 
and specified ``calendar'' days in paragraph (a).
    We received no comments solely related to this section and made no 
further changes to it.

[[Page 68789]]

4. What is the effect on a LAAF-accredited laboratory if its recognized 
accreditation body is no longer recognized by FDA (Sec.  1.1141)?
    This topic appeared in Sec.  1.1164 in the proposed rule. We 
proposed to title this section, ``What is the effect on accredited 
laboratories if their accreditation body voluntarily or involuntarily 
loses its recognition?'' We rephrased the title for efficiency and in 
keeping with the terminology changes described above at Response 10 so 
that it now reads, ``What is the effect on a LAAF-accredited laboratory 
if its recognized accreditation body is no longer recognized by FDA?''.
    In the proposed rule, paragraph (a)(1) of this section explained 
the actions a LAAF-accredited laboratory must take if its recognized 
accreditation body departs the program. Within 30 days of FDA issuing a 
notice informing the LAAF-accredited laboratory of the recognized 
accreditation body's departure, the laboratory must submit to FDA its 
most recent internal audit (see Sec.  1.1154(a)(5) of the final rule), 
documentation showing compliance with the conflict of interest 
requirements in Sec.  1.1147, and documentation of the most recent 
proficiency test for each method to which the laboratory is LAAF-
accredited (see proposed Sec.  1.1148(a), (b)). Proposed paragraph 
(a)(2) stated that within 1 year of receiving FDA's notice informing 
the laboratory of its accreditation body's departure from the program, 
the laboratory must become LAAF-accredited by a recognized 
accreditation body.
    In the proposed rule, paragraph (b) provided that the laboratory 
need not comply with paragraph (a) if, within 15 days of receiving 
FDA's notice informing the laboratory of its accreditation body's 
departure from the program, the laboratory initiates relinquishment of 
its LAAF-accreditation in whole (see proposed Sec.  1.1163, final rule 
Sec.  1.1140) with the relinquishment to occur within no more than 90 
days.
    In addition to changes made in response to comments discussed 
below, we made several changes to this section on our own initiative in 
the final rule. We restructured the section to change proposed 
paragraph (a) to a chapeau introducing paragraphs (a) and (b) of the 
final rule and reordered the language of the chapeau to match the order 
in which the notifications are listed in the final rule. On our own 
initiative we replaced the phrase, ``30 days after FDA issues the 
notice to the accredited laboratory'' with, ``30 calendar days after 
receiving the notice,'' because these notices do not always come from 
FDA and it is clearer to specify ``calendar'' days here and in 
paragraph (b) of this section. In the case of a recognized 
accreditation body that chooses to allow its recognition to expire or 
voluntarily relinquishes its recognition, Sec.  1.1116(b) requires the 
recognized accreditation body to notify the laboratories it has LAAF-
accredited. We also updated cross-references to the sections requiring 
notice to the LAAF-accredited laboratories. In addition, we corrected 
the reference to the section addressing a recognized accreditation body 
allowing expiration of, or voluntarily relinquishing, its recognition. 
Comments regarding this section are discussed below.
    (Comment 100) Comments state that the 15-day timeframe proposed in 
Sec.  1.1164(b), during which time a LAAF-accredited laboratory 
``orphaned'' by its recognized accreditation body may inform FDA that 
the laboratory intends to relinquish its LAAF-accreditation, instead of 
taking the actions required by paragraph (a), is inconsistent with the 
timeframes established in the section on relinquishment (see Sec.  
1.1140 of the final rule). Section 1.1140 of the final rule states that 
a LAAF-accredited laboratory that chooses to voluntarily relinquish its 
LAAF-accreditation must provide at least 60 calendar days advance 
notice of the intention to relinquish. Comments indicate that the 15-
day timeframe in proposed Sec.  1.1164(b) seems irrelevant because a 
laboratory could decide to depart the program on the 25th day after 
receiving FDA's notice and still comply with the timeframes established 
in Sec.  1.1140.
    (Response 100) We agree with these aspects of the comments and so 
have revised the introduction of this section to provide that the LAAF-
accredited laboratory has 30 calendar days to either provide to FDA the 
required documentation (i.e., its most recent internal audit (see Sec.  
1.1154(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 method to which the laboratory is 
LAAF-accredited (see Sec.  1.1138(a)) or inform FDA of its intent to 
relinquish under Sec.  1.1140(a).
5. How does a laboratory request reinstatement of LAAF-accreditation 
(Sec.  1.1142)?
    This topic appeared in Sec.  1.1165 in the proposed rule. In the 
proposed rule, paragraph (a) of this section provided that a laboratory 
that had any portion of its LAAF-accreditation withdrawn by the 
recognized accreditation body or was disqualified by FDA for any 
portion of its LAAF-accreditation, may seek reinstatement by submitting 
a new application for LAAF-accreditation. We also proposed that the 
laboratory take additional actions: Notify FDA of certain information 
prior to submitting the application to the recognized accreditation 
body and demonstrate to the recognized accreditation body to which the 
laboratory is newly applying that the grounds for the withdrawal or 
disqualification have been resolved and the laboratory has implemented 
measures to prevent recurrence.
    In the proposed rule, paragraph (b) of this section stated that a 
LAAF-accredited laboratory that voluntarily relinquished any portion of 
its LAAF-accreditation may seek reaccreditation by submitting a new 
application to a recognized accreditation body.
    We revised the section and section title to reflect updated 
terminology and made other conforming and minor editorial changes 
within the section. In this section and throughout the final rule, we 
removed ``legal'' as a modifier for certain names required to be 
submitted (for example, names of the laboratory and recognized 
accreditation body in this section and the analyst names in other 
sections) as the distinction was unnecessary and inconsistently used in 
the proposed rule. We also removed ``valid'' as a modifier for contact 
information in Sec.  1.1142(a)(1) as it was also unnecessary. We 
received no comments solely related to this section.

I. Comments Regarding Requirements for LAAF-Accredited Laboratories

Table 10--Changes to Sections Regarding Requirements for LAAF-Accredited
                              Laboratories
------------------------------------------------------------------------
           Final rule                Proposed rule           Notes
------------------------------------------------------------------------
Requirements for LAAF-Accredited  Requirements for    Revised to reflect
 Laboratories.                     Accredited          new terminology.
                                   Laboratories.

[[Page 68790]]

 
N/A.............................  Sec.   1.1146 What  Merged contents of
                                   are the general     proposed section
                                   requirements for    with Sec.
                                   accredited          1.1138.
                                   laboratories to
                                   remain
                                   accredited?
Sec.   1.1147 What are the        Sec.   1.1147 What  Revised to reflect
 impartiality and conflict of      impartiality and    new terminology
 interest requirements for a       conflict of         and to improve
 LAAF-accredited laboratory?       interest            clarity.
                                   requirements must
                                   accredited
                                   laboratories
                                   meet?
N/A.............................  Sec.   1.1148 What  Removed this
                                   quality assurance   section and
                                   requirements must   relocated content
                                   accredited          to Sec.   1.1138.
                                   laboratories
                                   meet?
Sec.   1.1149 What oversight      Sec.   1.1149 What  Section title
 standards apply to sampling?      oversight           remains the same.
                                   standards apply
                                   to sampling?
Sec.   1.1150 What are the        Sec.   1.1150 What  Revised to reflect
 requirements for analysis of      requirements        new terminology
 samples by a LAAF-accredited      apply to analysis   and to improve
 laboratory?                       of samples by an    clarity.
                                   accredited
                                   laboratory?
Sec.   1.1151 What requirements   Sec.   1.1151 What  Revised to reflect
 apply to the methods of           requirements        new terminology.
 analysis a LAAF-accredited        apply to the
 laboratory uses to conduct food   methods of
 testing under this subpart?       analysis an
                                   accredited
                                   laboratory uses
                                   to conduct food
                                   testing under
                                   this subpart?
Sec.   1.1152 What                Sec.   1.1152 What  Revised to reflect
 notifications, results,           notifications,      new terminology
 reports, and studies must a       results, and        and include
 LAAF-accredited laboratory        reports must        ``studies''.
 submit to FDA?                    accredited
                                   laboratories
                                   submit to FDA?
Sec.   1.1153 What are the        New section.......  Created new stand-
 requirements for submitting                           alone section for
 abridged analytical reports?                          the portions of
                                                       Sec.   1.1152
                                                       related to
                                                       abridged reports.
Sec.   1.1154 What other records  Sec.   1.1153 What  Relocated records
 requirements must a LAAF-         other records       section and
 accredited laboratory meet?       requirements must   revised to
                                   an accredited       reflect new
                                   laboratory meet?    terminology.
------------------------------------------------------------------------

1. What are the impartiality and conflict of interest requirements for 
a LAAF-accredited laboratory (Sec.  1.1147)?
    In the proposed rule, Sec.  1.1147(a) required LAAF-accredited 
laboratories to generally prohibit employees, contractors, and agents 
involved in food testing and related activities from accepting any 
money or other item of value from the owner or consignee of the food 
that is being, or will be, tested by the laboratory. Proposed paragraph 
(b) excepted from the general prohibition the payment of fees for 
testing services; reimbursement of direct costs associated with the 
testing; and for laboratories owned by the owner or consignee, payment 
of salary. Proposed paragraph (c) required that payment by the owner or 
consignee for the testing service, and any direct reimbursement related 
to the testing, must be independent of the test outcome.
    On our own initiative we revised paragraph (b)(1). In the proposed 
rule, paragraph (b)(1) excepted, ``payment of fees for food testing 
services.'' In the final rule, it excepts, ``[p]ayment of fees for food 
testing under this subpart and related services,'' because owners and 
consignees may pay a LAAF-accredited laboratory for services incidental 
to testing, such as to collect a sample or for shipping and handling 
costs.
    We have revised the text of this section to update terminology and 
to make other conforming and editorial changes. We also revised the 
section title to read, ``What are the impartiality and conflict of 
interest requirements for a LAAF-accredited laboratory?'' We discuss 
additional changes to the section made in response to comments below.
    (Comment 101) We proposed to allow laboratories owned by the owner 
or consignee (``in-house'' laboratories) to become LAAF-accredited. We 
received several comments regarding this proposed policy.
    Some comments express support for the proposed policy. These 
comments state that the LAAF-accreditation process and other 
requirements in the proposed rule would protect against potential 
conflicts of interest. Some of these comments express the view that 
although in-house laboratories should be permitted to become LAAF-
accredited, they should not be required to do so.
    Some comments oppose the proposed policy. Some of these comments 
contend in-house laboratories cannot be free from conflicts of 
interest. Some comments contend that this conflict of interest may 
place public health at risk since owners or consignees testing their 
food would have a vested interest in the outcome of the food testing; 
some comments cite a widely-publicized foodborne illness outbreak and 
state that the risk of our proposed policy is the recurrence of such 
situations. Some comments also seem to argue that in-house laboratories 
do not, or inherently cannot, satisfy the conflict of interest 
provisions in ISO/IEC 17025:2017. These comments may have been 
attempting to address our statement in the proposed rule that we were 
unaware of any information indicating that laboratories owned by owners 
or consignees are less able to become LAAF-accredited than independent 
laboratories.
    Some comments opposing the proposed policy argue that the statute 
precludes in-house laboratories from conducting at least import-related 
testing under the LAAF program. These comments disagree with FDA's 
interpretation of ``on behalf of'' in 422(b)(1)(B) of the FD&C Act. 
These comments argue that when Congress used such language it was 
clearly Congress's intent to prohibit in-house laboratories from 
testing their own products under that 422(b)(1)(B) of the FD&C Act.
    In the proposed rule, we said that reading the statute such that 
in-house laboratories would be ineligible for import-related testing 
under this program could raise potential concerns under U.S. 
international trade obligations. (see 84 FR 59452 at 59461 through 
59462). We tentatively concluded that such a reading would not comport 
with section 404 of FSMA, which states that 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. Some comments that oppose the 
proposed policy disagree with our proposed reasoning, and state that 
there is insufficient evidence that treaties or international 
agreements apply in this instance or that they are sufficient to

[[Page 68791]]

justify, according to these comments, risking public health by allowing 
in-house laboratories to be eligible for LAAF-accreditation.
    (Response 101) After considering the comments and reviewing the 
statute, we are retaining the proposed policy such that in-house 
laboratories may become LAAF-accredited to conduct any of the testing 
described in Sec.  1.1107 as long as those laboratories meet all the 
laboratory requirements of this subpart.
    We acknowledge that opportunities may exist for owners and 
consignees to exert undue influence over an in-house laboratory; owners 
and consignees generally do not have the same amount of power and 
control over an independent or third-party laboratory. However, as we 
discussed in the proposed rule, ISO/IEC 17025:2017 contains several 
requirements relevant to conflict of interest and impartiality (see 84 
FR 59452 at 59478). For example, ISO/IEC 17025:2017 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, if a risk to impartiality is identified, the 
laboratory must be able to demonstrate how the laboratory eliminates or 
minimizes the risk (Ref. 3). We are aware that in-house laboratories 
are accredited to ISO/IEC 17025:2017, indicating that accreditation 
bodies have found sufficient safeguards in place to allow such 
laboratories to be impartial. We have no basis to question those 
accreditation body determinations.
    To further protect the integrity of the testing conducted under 
this subpart, Sec.  1.1147 imposes on laboratories impartiality and 
conflict of interest requirements that supplement those contained in 
ISO/IEC 17025:2017. With limited exceptions, we require laboratory 
employees, contractors, and agents not to accepts gifts or other items 
of value from owners or consignees whose food is tested by the 
laboratory. We also require that the owners' or consignees' payment to 
the laboratory be independent of the testing outcome. This final rule 
also contains oversight provisions which allow accreditation bodies to 
assess, and FDA to review, the performance of, laboratories. Recognized 
accreditation bodies and FDA both have the authority and the 
responsibility to exercise their oversight to help ensure that 
laboratories comply with the requirements of this subpart including the 
requirements of Sec.  1.1147.
    Some comments point to a widely publicized foodborne illness 
outbreak case as an example of the risk presented by in-house 
laboratories. In that case, several executives and employees were 
convicted and sentenced for Federal crimes related to selling peanut 
butter products that the defendants knew had tested positive for 
Salmonella. Among other misdeeds, the defendants fabricated test 
results. That is, the testing accurately indicated that the product 
contained Salmonella but the owners produced fraudulent test 
certificates stating the opposite. In addition, the firm did not use an 
in-house laboratory; rather, it sent its product to two different 
independent laboratories for analysis. Accordingly, the facts of that 
case have no direct bearing on the integrity of in-house laboratories. 
Furthermore, section 422(b)(2) of the FD&C Act, implemented by Sec.  
1.1152(b) of this final rule, requires laboratories to send the results 
of all tests covered by this subpart directly to FDA, thus protecting 
against the opportunity for owners or consignees to fabricate test 
results of independent or third-party laboratories.
    We disagree that the statute precludes in-house laboratories from 
conducting any or all testing covered by this subpart. Section 
422(b)(1) of the FD&C Act contains two paragraphs. Paragraph (A) states 
that certain testing ``by or on behalf of an owner or consignee'' must 
be conducted by a LAAF-accredited laboratory; this paragraph describes 
specific followup testing required by existing FDA regulations and 
testing ``as the Secretary deems appropriate,'' in both cases to 
address an identified or suspected food safety problem. Paragraph (B) 
states that certain testing, ``on behalf of an owner or consignee'' 
must be conducted by a LAAF-accredited laboratory; paragraph (B) 
describes testing in support of admission of detained imported food.
    First, section 422 of the FD&C Act explicitly contemplates the 
participation of in-house laboratories when it states that ``food 
testing shall be conducted . . . by or on behalf of an owner or 
consignee'' (section 422(b)(1)(A)). As we discussed in the proposed 
rule, 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 paragraph (B) 
would mean that only independent laboratories may be accredited to 
conduct food testing on detained imports (84 FR 59452 at 59461 through 
59462).\13\ Under this interpretation, laboratories owned by owners or 
consignees would be prohibited from conducting such import-related food 
testing, but laboratories owned by owners or consignees would be 
eligible to conduct food testing under section 422(b)(1)(A) of the FD&C 
Act. That would raise 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 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.
---------------------------------------------------------------------------

    \13\ Under another possible interpretation of section 422(b)(1), 
the phrase, ``on behalf of'' may be read as sufficiently broad to 
encompass in-house laboratories (i.e., an in-house laboratory 
conducts testing on behalf of the entity that owns the laboratory). 
In that case, the absence of ``by or'' is inconsequential, and we 
would again reach the conclusion that allowing in-house laboratories 
to conduct any testing under this subpart is consistent with the 
statute.
---------------------------------------------------------------------------

    In considering section 422(b)(1)(B) of the FD&C Act and section 404 
of FSMA together, we finalize the proposed conclusion 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.
    We understand some comments to question whether treaties or 
international agreements are relevant to the food testing circumstances 
covered by this subpart. Other comments appear to question whether the 
existence of such treaties or international agreements justifies 
permitting in-house laboratories to participate despite the purported 
public health risks posed by such participation. It is undisputed that 
the United States is a party to the WTO, and two WTO agreements are 
relevant to FDA's regulatory authorities: (1) The Agreement on the 
Application of Sanitary and Phytosanitary Measures and (2) the 
Agreement on Technical Barriers to Trade. More significantly, however, 
we believe we have addressed the fundamental issue at the heart of the 
opposing comments, i.e., the concern that allowing in-house 
laboratories (whether foreign or domestic) to become LAAF-accredited 
jeopardizes public health because in-house laboratories have such a 
vested interest in vouching

[[Page 68792]]

for their products that their test results are inherently suspect. 
Above, we have explained our view that robust requirements in ISO/IEC 
17025:2017 and in the final rule address conflict of interest and 
impartiality such that in-house laboratories may qualify to become 
LAAF-accredited. We also have explained our view that the statute 
appropriately may be read to permit participation by such laboratories. 
We therefore conclude that owners or consignees may become LAAF-
accredited as long as they satisfy all the relevant requirements of 
this subpart.
    Finally, to clarify, no laboratory is required to participate in 
this program; it is entirely voluntary for both accreditation bodies 
and laboratories.
    (Comment 102) Some comments agree with the requirement in Sec.  
1.1147(c) that payment for laboratory services must be independent of 
the testing result; these comments indicate that it is routine 
commercial practice to require payment in advance of testing to prevent 
non-payment for violative samples.
    (Response 102) We appreciate comments concurring with the proposed 
provision and are pleased that it is common practice for laboratories 
to require payment prior to conducting the test. On our own initiative 
and because the section discusses impartiality and conflict of interest 
requirements for a LAAF-accredited laboratory, we have clarified in 
Sec.  1.1147(c) of the final rule that the LAAF-accredited laboratory 
must require the owner's or consignee's payment to be independent of 
the outcome of the test results.
2. What are the quality assurance requirements for LAAF-accredited 
laboratories (Sec.  1.1148)?
    Proposed Sec.  1.1148 concerned the quality assurance requirements 
beyond those in ISO/IEC 17025:2017 for LAAF-accredited laboratories. 
Paragraph (a) described the annual proficiency test requirement and 
provided for the opportunity to use a comparison program if an annual 
proficiency test for the method was not available or was otherwise 
impracticable. Paragraph (b) provided that LAAF-accredited laboratories 
ensure procedures for monitoring the validity of the results of testing 
conducted under this subpart include the use of reference materials or 
quality control samples with each batch of samples it tests under this 
subpart.
    On our own initiative, we determined that the requirements in 
proposed Sec.  1.1148 are more appropriately categorized as eligibility 
requirements for LAAF-accredited laboratories. As such, these 
provisions are in Sec.  1.1138 of the final rule.
3. What oversight standards apply to sampling (Sec.  1.1149)?
    In the proposed rule, Sec.  1.1149(a) required a LAAF-accredited 
laboratory to develop (if the laboratory collected the sample) or 
obtain (if the laboratory was not the entity responsible for collecting 
the sample) certain documents related to sampling, prior to analyzing 
the sample. Proposed paragraph (b) provided that if the sampling 
documentation requirements were not met, we might consider the test to 
be invalid.
    Proposed paragraph (a)(1) required documentation of the sampler's 
qualifications by training and experience. We proposed that such 
qualification documentation need only be obtained the first time an 
individual collects a sample, unless the qualifications had changed 
significantly. Proposed paragraph (a)(2) required a written sampling 
plan that identified the sampler and listed factors the sampler would 
control to ensure sample validity. Proposed paragraph (a)(3) required a 
written sample collection report to include at least the following five 
elements: The product code or, if collecting an environmental sample, 
the location and a description of the environment; the date of 
sampling; the size, identity, and quantity of the sample; documentation 
of the sample collection procedures and any sample preparation 
techniques; and documentation of the chain of custody and measures 
taken to secure the validity of the subsequent test, including 
controlling for the representational nature of the sample. On our own 
initiative, we added, ``lot number'' to the information required in a 
sample collection report. This information is consistent with the other 
types of information required in a sample collection report and will 
provide us with better visibility into how the sample was collected, as 
well as additional information to allow us to trace the sample back to 
its origin.
    In terms of the requirement that the sample collection report 
include a product code, for domestic products we mean the product code 
assigned by the manufacturer, packager, or labeler, as applicable. In 
the import context, a product code is a string of letters and numbers 
that represent certain information such as which industry produced the 
item. For more information on product codes for imports, see https://www.fda.gov/industry/import-program-resources/product-codes-and-product-code-builder#whatcode. On our own initiative, we moved the 
provisions addressing the advance notice of sampling from proposed 
Sec.  1.1152(i) to a new paragraph (c) in Sec.  1.1149 of the final 
rule. In the proposed rule, these provisions required that in certain 
circumstances FDA may require a LAAF-accredited laboratory to request 
and obtain from a sampler advance notice of sampling. We proposed that 
we may require advance notice of sampling if we determine that sampling 
may materially differ from the sampling documented in the associated 
sampling plan or sample collection report, or, if we determine that the 
sampling may otherwise have been improper.
    When we require advance notice of sampling, either the LAAF-
accredited laboratory must submit, or it must require the sampler to 
submit, the notice to FDA 48 hours before each of that sampler's next 
10 LAAF program sampling collections. We proposed that the notice must 
contain:
     A unique identification code for the advance notice of 
sampling;
     The name of the accredited laboratory that will conduct 
analysis of the sample;
     The name and street address of the sampler that will 
conduct the sampling;
     A primary contact (name and phone number) for the sampler;
     The reason(s) why the food product or environment will be 
sampled;
     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;
     As applicable, the U.S. Customs and Border Protection 
entry and line number(s) and the FDA product code(s) of the food; and
     The date and approximate time the sampling will begin.
    We also proposed that FDA may, as appropriate, specify the type of 
food product or environment that requires advance notice of sampling. 
We proposed that we might specify an amount of time other than 48 hours 
advance notice is required, between 24 hours and 7 business days. We 
proposed that we might require a number of sampling occasions other 
than 10, between 1 and 20. Finally, we proposed that we might notify 
the LAAF-accredited laboratory that additional advance notice is not 
required.
    As discussed previously in Response 22, we added the term, 
``sampling firm'' in Sec.  1.1102 and defined it to mean an entity that 
provides sampling services. We have updated the references to sampler 
in Sec.  1.1149 to more accurately distinguish between requirements for 
the sampler and the sampling firm.

[[Page 68793]]

    On our own initiative, for clarity, we added the phrase, ``at 
least'' before ``48 hours.'' We clarify in Sec.  1.1149(c)(2)(i) that 
FDA may, as appropriate, specify that the requirement regarding the 
advance notice of sampling applies to samples collected by a particular 
sampler. We also deleted the word, ``code,'' after, ``identification,'' 
because it was unnecessary and inconsistent with other uses of 
``identification'' in this subpart. We also clarify in the final rule 
that ``the FDA product code(s) of the food'' contained in proposed 
Sec.  1.1152(i)(3)(vii) must include the product code of the food 
product (if product is being sampled) or the location and a description 
of the environment (if environment is being sampled). See Sec.  
1.1149(c)(3)(viii) of the final rule. Finally, we made terminology, 
conforming, and minor editorial changes to this section. We discuss 
changes made in response to comments below.
    (Comment 103) Some comments ask FDA to clarify what constitutes an 
acceptable sampling plan. Some comments state that our sampling 
requirements are different for different types of commodity and test, 
that FDA commonly rejects results due to sampling variations, and that 
we should publish all FDA Laboratory Information Bulletin methods and 
refer to them in import alerts as applicable. Some comments recommend 
that we align sampling requirements under this subpart with certain 
existing documents that describe a scientific approach to creating or 
assessing sampling protocol: The AAFCO/Association of Public Health 
Laboratories/Association of Food and Drug Officials documents 
``GOODSamples'' (Ref. 19) and ``GOOD Test Portions'' (Ref. 20).
    (Response 103) As we discussed in the proposed rule, proper 
sampling procedures are essential to meaningful test results and it is 
therefore important that this subpart address the training and 
procedures of samplers. After careful consideration of the comments, we 
have decided that the most appropriate way to support those goals at 
the present time is through the oversight provisions in this section, 
rather than by requiring ISO/IEC 17025:2017-accreditation of samplers. 
Accordingly, we are not establishing model standards for sampling in 
this subpart. For more information on our decision not to require the 
accreditation of samplers, see (Response 98.
    Regarding comments' suggestion that FDA publish all Laboratory 
Information Bulletin methods, we note that although we have published 
some (see https://www.fda.gov/science-research/field-science-and-laboratories/laboratory-information-bulletins), Laboratory Information 
Bulletins typically do not include sampling collection information. 
However, there are a variety of other publicly available FDA resources 
concerning sampling. Generally applicable sampling procedures and 
methods are described in the FDA Food Compliance Programs (https://www.fda.gov/food/compliance-enforcement-food/food-compliance-programs) 
and the sampling chapter of the IOM, Ch. 4. The IOM section 4.3.7.2 
addresses random sampling. A random representative sample should 
reflect the average composition of the entire lot to ensure that 
analytical results are meaningful. This is particularly imperative when 
potential foodborne adulterants that pose a public health risk are not 
homogeneous in the product.
    FDA also provides more specific information on sampling in certain 
circumstances.
    Some import alerts contain more customized information on sampling 
(see https://www.fda.gov/science-research/field-science-and-laboratories/private-laboratory-testing). Sampling for the testing of 
bottled drinking water, shell eggs, and sprouts required under Sec.  
1.1107(a)(1) is impacted by the product-specific regulations and/or may 
be informed by product-specific guidance. See e.g., Sec. Sec.  118.7 
(addresses shell egg sampling); 129.35(a)(3)(ii) (addresses bottled 
drinking water sampling); and ``Compliance with and Recommendations for 
Implementation of the Standards for the Growing, Harvesting, Packing, 
and Holding of Produce for Human Consumption for Sprout Operations: 
Draft Guidance for Industry,'' available at https://www.fda.gov/media/102430/download (addresses product and environmental sampling for 
sprouts). When finalized, this guidance will represent FDA's current 
thinking on this issue.
    FDA appreciates the suggestion that we consult reputable industry 
sampling guidance documents. We note that the ``GOODSamples'' and 
``GOOD Test Portions'' documents were generally written for use by 
State and local regulatory laboratories and not for private laboratory 
use. Nevertheless, we are aware of these documents and agree they are 
helpful resources.
    (Comment 104) Some comments disagree with, or request additional 
clarification about, certain provisions within Sec.  1.1149. Some 
comments express concern that requirements in Sec.  1.1149(a) for 
documentation before analyzing the sample will lead to delays in 
testing and obtaining results, and some comments express concern that 
the delay could interfere with the sample's integrity. Some of those 
comments suggest that instead, FDA should have a mechanism in place to 
approve the sampling method or plan prior to sample collection.
    A few comments ask FDA to clarify how a laboratory is to evaluate 
the effectiveness of a sampling plan. Comments also request that FDA 
clarify what would constitute a ``significant change'' in a sampler's 
qualifications and how a laboratory would learn about such a change.
    Some comments contend that FDA should not collect all the proposed 
sampling documentation in Sec.  1.1149(a) in every instance, and argue 
that the documentation need not be collected if the sample is collected 
at a domestic food facility, because such entities are subject to 
preventive controls regulations and we could allow the preventive 
controls qualified individual to attest to the sufficiency of the 
sampler's qualifications and the sampling procedures.
    Other comments suggest the documentation in Sec.  1.1149(a) should 
be submitted to the laboratory's recognized accreditation body. Some 
comments express the view that recognized accreditation bodies are 
noticeably absent from the sample document collection process and this 
could be rectified by either requiring that samplers be accredited or 
by establishing clear substantive sampling requirements against which 
recognized accreditation bodies could assess sampling documents.
    (Response 104) The submission to FDA of the sampler's 
qualifications, the sampling plan, and the sampling collection report 
will allow the Agency to exercise oversight over the sampling that 
occurs under this subpart. We acknowledge that the proposed rule could 
have been clearer on this point, but there is no requirement that the 
sampling documents be submitted to or approved by FDA prior to the 
LAAF-accredited laboratory conducting the test. Nor does the LAAF-
accredited laboratory need to evaluate the documents or do anything 
with them prior to conducting the test; the laboratory need only submit 
the documents to FDA with the analytical report, after the testing is 
complete (see Sec.  1.1152(c)). As long as the LAAF-accredited 
laboratory possesses the documents, it can proceed to conduct the test, 
and we presume that in most instances the documents will either be 
developed by the laboratory (if it collected the sample) or delivered 
with the sample (if another entity collected

[[Page 68794]]

the sample). Either way, once the LAAF-accredited laboratory possesses 
the sample we expect it will usually also possess the documentation 
required under Sec.  1.1149(a). Relatedly, at the present time the 
Agency does not perceive a need to require or create a pathway for 
routine preapproval of the sample method or plan prior to sampling.
    After considering the comments, we are removing from the final rule 
the requirement that the LAAF-accredited laboratory obtain 
documentation of an individual sampler's qualifications more than once 
if that person's qualifications have ``significantly changed.'' We no 
longer view the information as necessary and agree that often the LAAF-
accredited laboratory would be unaware of it. We have also clarified 
that a LAAF-accredited laboratory may refer to the previously submitted 
qualifications if the LAAF-accredited laboratory has previously 
submitted them to FDA under Sec.  1.1152(c). We do not expect many 
samples collected under this program to come from food facilities 
subject to the preventive controls regulations and so decline the 
invitation to create an exception to Sec.  1.1149(a) for such 
establishments. We discourage samplers and LAAF-accredited laboratories 
from submitting to us an individual's social security number, or other 
unnecessary personally identifiable information.
    For the reasons discussed above at Response 98, we have decided not 
to require the accreditation of samplers at the present time, and we 
also do not perceive a reviewing role for the recognized accreditation 
bodies with regard to the documents required under Sec.  1.1149(a). As 
noted above, submission of those documents to FDA is the mechanism 
whereby we may exercise oversight of the sampling that occurs under 
this subpart.
    (Comment 105) Some comments express concern with the proposed 
provisions on advance notice of sampling. Comments ask for 
clarification regarding how these requirements might work in the 
context of the directed food laboratory order and the other testing 
conducted under this subpart. Comments also indicate that delays 
associated with this requirement could lead to significant losses for 
entities, particularly regarding perishable foods. A few comments 
suggest that requiring advance notice of sampling may not be 
appropriate when resolving a food safety issue that needs rapid testing 
and that it is commercially and logistically impractical to regularly 
specify an exact date and approximate time of sampling.
    (Response 105) FDA has concluded it is reasonable for public health 
reasons to require advance notice of sampling when the Agency suspects 
a sampler previously has failed to follow proper protocols. Again, 
utilizing appropriate sampling techniques is essential to generating a 
representative sample, which is in turn essential to producing a 
meaningful test result. FDA generally will require the advance notice 
of sampling to be submitted to us at least 48 hours prior to collection 
of the sample(s) to allow us time to determine whether to observe the 
sampling or to take an audit sample and assign appropriate personnel to 
the task. However, under Sec.  1.1149(c)(2)(iii), we may require an 
amount of time other than 48 hours, perhaps as little as 24. In 
tailoring the requirements to a particular situation, we would consider 
a variety of factors including product shelf life.
    It is possible that we could require advance notice of sampling in 
connection with any test required to be conducted by a LAAF-accredited 
laboratory, including a directed food laboratory order. As the 
circumstances in which we might require advance notice of sampling vary 
widely, it is impossible to predict or generalize regarding how these 
requirements will be implemented, e.g., depending on the provision of 
Sec.  1.1107 under which the testing falls. However, FDA will take into 
consideration such factors as the type of product, its shelf life, 
timing requirements of the test method, public health context for the 
testing, etc., and will use the options under Sec.  1.1149(c)(2) to 
customize the requirements accordingly.
    (Comment 106) Some comments recommend that FDA clarify how we will 
notify a LAAF-accredited laboratory that a sampler must provide advance 
notice of sampling under Sec.  1.1149(c) (proposed Sec.  1.1152(i)), 
and how we will track the subsequent 10 samples from that sampler. Some 
comments suggest that we share with owners or consignees the pending 
requirement for advance notice of sampling. Some comments emphasize the 
logistical and operational challenges of several entities coordinating 
around the collection of a sample. With regard to the requirements in 
Sec.  1.1149(c)(3)(iii) (proposed Sec.  1.1152(i)(3)(iii)) that the 
advance notice include the sampler's name and street address, some 
comments seek clarification as to why we would require the sampler's 
street address. Some comments recommend that we clarify that the 
requirement is for a business name and address for the sampling entity, 
and not an individual's name and address. In addition, these comments 
suggest we clarify that the primary contact required by Sec.  
1.1149(c)(3)(iv) (proposed Sec.  1.1152(i)(3)(iv)) should be the 
individual managing the sampling operation.
    (Response 106) First, we note that under Sec.  1.1149(c), the LAAF-
accredited laboratory is not simply communicating a requirement to the 
sampler. Instead, the LAAF-accredited laboratory is the entity required 
either to obtain the advance notice of sampling from the sampler and 
submit it to FDA itself, or to require the sampler to submit the notice 
directly to FDA.
    In terms of our communications with LAAF-accredited laboratories 
regarding Sec.  1.1149(c), such communications may occur by email but 
regardless, will be tailored to the circumstances. Further, we may use 
a variety of methods to track subsequent collections by a sampler 
identified under Sec.  1.1149(c); one method will be to review the 
documents we receive under Sec.  1.1149(a).
    Regarding the suggestion that we inform owners and consignees when 
we will require advance notice of sampling from a particular sampler, 
we have revised the codified text to state that we may, as appropriate, 
notify the owner or consignee that advance notice of sampling applies 
to food testing conducted on its behalf. Such notification is 
consistent with current FDA practice in the context of reviewing 
import-related private laboratory analytical packages (PLAPs), which we 
have been doing for years. If FDA identifies a deficiency in a PLAP, we 
routinely inform the owner or consignee the basis for FDA's concern 
(i.e., we would inform the owner or consignee if we identified a 
sampling problem that may have impacted the test result).
    FDA has experience auditing samplers and we acknowledge that it can 
be a logistical challenge. Nevertheless, when we have cause for concern 
with a particular sampler, especially given the public health context 
in which testing under this subpart occurs, it is reasonable to require 
advance notice of sampling.
    Finally, after considering the comments regarding the sampler's 
name and address required by Sec.  1.1149(c)(3)(iii) and the primary 
contact required by Sec.  1.1149(c)(3)(iv), we note that we have 
revised this section to incorporate the new term, ``sampling firm'' 
(see Sec.  1.1102). We have revised these sections to refer instead to 
the sampling firm information in the final rule.
    Our general purpose in requiring a sampling entity's address in an 
advance

[[Page 68795]]

notice of sampling is to clearly identify the commercial operation 
responsible for conducting the sampling. Again, we would only require 
an individual sampler's name and street address if that person has been 
contracted to provide sampling services for testing conducted under 
this subpart. If an individual has assumed responsibility for that 
task, then we have an interest in ensuring that we can properly 
identify that individual and a street address helps us to do so. We 
again emphasize that all the tests required to be conducted by a LAAF-
accredited laboratory occur in the context of heightened public health 
concern. Although we are not requiring the accreditation of samplers, 
we nevertheless require that any individuals collecting samples under 
this subpart be properly qualified. Owners and consignees risk having 
us reject test results if the sample that was analyzed, was collected 
using improper sampling methods or procedures. If we have cause to 
believe that past sampling conducted by an individual has, for example, 
materially differed from the sampling described in the sample 
collection report, this may constitute a reasonable need to clearly 
identify that individual and may also provide a reasonable basis on 
which to audit that person's future sampling activities.
4. What are the requirements for analysis of samples by a LAAF-
accredited laboratory (Sec.  1.1150)?
    Proposed Sec.  1.1150 concerned requirements for analysis of 
samples by a LAAF-accredited laboratory. Paragraph (a) required 
analysis to be conducted on the sample received from the sampler or a 
representative sample of the sample received from the sampler. 
Paragraph (b) provided requirements for the analyst conducting the 
analysis: (1) To be qualified by appropriate education, training or 
experience; (2) to 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 in this subpart. Paragraph (c) required that the method 
used to conduct food testing meet the requirements of Sec.  1.1151. 
Paragraph (d) stated that the LAAF-accredited laboratory must document 
testing information and test results to account for all the information 
that is required to be included in a full analytical report. We note 
that this requirement concerns all testing under this subpart, 
regardless of whether the LAAF-accredited laboratory submits full or 
abridged analytical reports (see Sec. Sec.  1.1152 and 1.1153 of the 
final rule).
    We have made revisions to the section to update terminology and 
cross-references to reflect the reorganization of the final rule. We 
revised the section title to read, ``What are the requirements for 
analysis of samples by a LAAF-accredited laboratory?'' and made minor 
editorial changes to the section. We received no comments specific to 
this section and made no further changes.
5. What requirements apply to the methods of analysis a LAAF-accredited 
laboratory uses to conduct food testing under this subpart (Sec.  
1.1151)?
    Proposed Sec.  1.1151 concerned requirements for methods of 
analysis a LAAF-accredited laboratory uses to conduct food testing 
under this subpart. Paragraph (a) required that analysis conducted 
under this subpart must be conducted using a method of analysis that is 
fit for purpose, within the laboratory's scope of LAAF-accreditation, 
and has been appropriately validated and verified for use in such food 
testing. In paragraph (b), we stated that if a method is prescribed by 
the FD&C Act or implementing regulations for the testing under Sec.  
1.1107(a)(1), or by the directed food laboratory order for the testing 
under Sec.  1.1107(a)(2), then that method must be used to conduct food 
testing under this subpart. Paragraph (c) stated that a LAAF-accredited 
laboratory must validate methods and record the information. Paragraph 
(d) stated that before a LAAF-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 LAAF-
accredited laboratory must have verified it can properly perform the 
method for the specific intended use. Further, a LAAF-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. Paragraph 
(e) provided that a LAAF-accredited laboratory may submit a request to 
FDA to use a method outside its scope of LAAF-accreditation. FDA may 
approve the request if: (1) A new method has been developed and 
validated, but no reasonably available laboratory has been accredited 
to perform the method and (2) use of the method is necessary to 
prevent, control, or mitigate a food emergency or foodborne illness 
outbreak.
    We made several revisions to this section on our own initiative to 
improve clarity and readability of the section. We also have updated 
terminology and revised cross-references throughout the section, 
including the section title. Comments regarding this section are 
discussed below.
    (Comment 107) Some comments ask FDA to identify the criteria that 
will be used to assess whether a method is ``fit for purpose'' in Sec.  
1.1151(a)(1). Other comments request that FDA provide a list of 
validated methods deemed fit for purpose. These comments state that 
since there may be more than one method that could be classified as 
such, there may be inconsistent test results from use of different 
methodologies.
    In the proposed rule, we referenced a page on our website that 
lists methods currently being used for food and feed safety programs: 
https://www.fda.gov/food/science-research-food/laboratory-methods-food 
(84 FR 59452 at 59481). Some comments argue that this website is often 
outdated or incomplete, and that FDA should publish a complete list and 
reference it in import alerts. Other comments urge FDA to specify 
methods in import alerts. These comments state that some import alerts 
cover perishable food items such as produce, and it would be impossible 
to validate a new method quickly enough to test such perishable goods.
    (Response 107) As a preliminary matter, we describe some key terms. 
Validation is meant to demonstrate that a method is suitable for the 
intended purpose, and verification is meant to show that the laboratory 
can properly apply the method for a specific intended use, and meet the 
performance criteria of the method for the matrix and analyte being 
tested. When we say a method is ``fit for purpose,'' we mean that it 
may only be applied for the food testing to which it is intended to 
apply, for the purpose for which it is validated, and that the method 
performance is suitable for the intended use--specifically with respect 
to the limit of detection or probability of detection, specificity, 
reproducibility, and accuracy. Due to the broad range of testing under 
this subpart, it is not possible for us to provide a more specific set 
of criteria for determining whether a method is fit for purpose. (See 
also, section 7.2.1.4 of ISO/IEC 17025:2017 (Ref. 3).)
    Standard methods must be verified and non-standard methods or a 
standard method applied outside its original scope (for example, 
applied in a different food matrix) must be validated.

[[Page 68796]]

If a LAAF-accredited laboratory wishes to use a method that is already 
validated, the laboratory must verify that the laboratory is able to 
run the method and achieve an acceptable detection limit. If a method 
validation was not performed on a particular food category (i.e., 
validation performed on dairy but the new matrix is fruit or 
vegetables) then the laboratory will need to perform a ``matrix 
extension'' either through a single laboratory validation or an 
independent validation study. We will review laboratory analytical 
reports to determine whether the food matrix tested fits into a 
validated matrix, and if not, the laboratory will need to perform a 
matrix extension. (For additional discussion of matrix extensions, see 
Response 108.) FDA guidelines for validations can be found at: https://www.fda.gov/science-research/field-science-and-laboratories/method-validation-guidelines. LAAF-accredited laboratories may use these 
guidelines in performing validation studies, or they may use other 
established and recognized protocols, such as those published by AOAC. 
We request that a LAAF-accredited laboratory cite the protocol used 
when submitting a validation.
    Regarding the request that FDA provide a list of validated methods 
deemed fit for purpose, we decline to provide a list or to include 
specific methods in import alerts. It is simply not practical for FDA 
to try and provide an exhaustive list of all methods that may be 
appropriate in food testing circumstances. The website provided above 
(and in the proposed rule) is one example of a potential resource for 
methods of analysis; we endeavor to keep it current. Also, a method 
prescribed for use in a compliance program is considered to have 
already been validated. (See https://www.fda.gov/food/compliance-enforcement-food/food-compliance-programs and https://www.fda.gov/animal-veterinary/compliance-enforcement/cvm-compliance-programs.) 
However, laboratories are not required to use these methods.
    Regarding specifying methods in import alerts, in most cases it not 
necessary to limit testing to a single specific method where there are 
multiple acceptable methods of analysis. Further, we do not agree with 
the comments expressing concern that use of different methodologies may 
produce inconsistent results; validated methods that are fit for 
purpose and conducted properly by a laboratory should yield consistent 
results. Indeed, that concept lies at the base of all validation 
studies; if the new method works properly, the result should be 
consistent with the result produced using the standard method.
    Finally, we agree that validating a new method takes time. It is 
anticipated that products under import alert will already have 
appropriate methods available. For import alerts concerning time-
sensitive products, we expect that owners and consignees will refer to 
the online registry described in Sec.  1.1109 (once it is up and 
running) to locate a LAAF-accredited laboratory that is able to conduct 
the desired test promptly.
    (Comment 108) Many comments agree with the requirements in proposed 
Sec.  1.1151(a)(3) and (4) that methods used under this rule must be 
appropriately validated or verified. However, some comments state that 
it would be very onerous for a laboratory to validate every single 
potential food matrix. Some of these comments discuss the example in 
the preamble to the proposed rule regarding chloramphenicol in shrimp 
(see 84 FR 59452 at 59480) and assert that this example conflicts with 
FDA validation guidance and use of the AOAC Food Matrix Triangle to 
group like foods into one validation. Other comments request that we 
clarify when a matrix extension or further validation would be 
necessary, especially if other validated methods are available.
    (Response 108) Appropriate method validation and verification, as 
just discussed in Response 107, is critical to data acceptability. 
Although tools such as the AOAC Food Triangle are commonly used to 
group like foods, there are sometimes limits to this approach as 
provided in the example of the chloramphenicol analysis that performs 
differently for fish and shrimp which are similar matrices within the 
same food group. Though it is generally assumed that the more closely 
related a new food matrix is to a previously validated matrix from the 
same food group for the detection of a defined analyte, the greater the 
probability that the method will perform similarly with the new matrix, 
the method must nonetheless be verified for all new matrices. This is 
to ensure that the new matrix will neither produce high false positive 
rates (e.g., matrix is free from cross reactive substances) nor high 
false negative rates (e.g., matrix is free of inhibitory substances). 
As we agree that it would be onerous for a laboratory to validate every 
single potential food matrix, an acceptable approach for a matrix 
verification within the same food group as the validated matrices is 
the use of spiked samples and blank matrix (if available) as described 
in the ``matrix extension'' sections of the validation guidance 
documents provided at: https://www.fda.gov/science-research/field-science-and-laboratories/method-validation-guidelines. Note that 
matrices falling within food groups not previously validated cannot use 
this approach and will require validation.
    Some comments asking about our requirements for verification and 
validation studies reference the portion of the PRIA in which we 
estimated the cost of requiring LAAF-accredited laboratories to submit 
additional verification studies to be between 1 percent and 5 percent 
of the costs for verification and validation activities required to 
maintain ISO/IEC 17025:2017 accreditation. To the extent that such 
comments are questioning why we would estimate between 1 percent and 5 
percent of the costs for verification and validation studies over and 
above verification and validation costs required to maintain 
accreditation to ISO/IEC 17025:2017, we note that the additional costs 
acknowledge the possibility of differing requirements for matrix 
extensions between this subpart and ISO/IEC 17025:2017 on a case-by-
case basis.
    Finally, we agree that in most cases it is not necessary to limit 
testing to a single specific method where there are multiple acceptable 
methods of analysis.
    (Comment 109) A few comments state that proposed Sec.  1.1108(b) 
provided that the directed food laboratory order would specify, among 
other things, ``the manner of the food testing, such as the methods 
that must be used'' whereas proposed Sec.  1.1151(b)(2) stated that 
``if the [directed food laboratory] order prescribes a test method, 
that is the only appropriate method. . . .'' These comments explain 
that, read in conjunction, these proposed sections indicate that FDA 
may not specify a method in the directed food laboratory order and may 
allow a LAAF-accredited laboratory to use an appropriate method within 
its scope of LAAF-accreditation.
    (Response 109) As discussed above in Response 54, in a directed 
food laboratory order, we would specify the method to the owner or 
consignee and, in some circumstances, may provide flexibility to use 
equivalent methods, so that an owner or consignee may have access to a 
greater number of LAAF-accredited laboratories that could conduct the 
testing. If a directed food laboratory order allows for flexibility to 
use equivalent methods, a LAAF-accredited laboratory could use an 
appropriate method within its scope of LAAF-accreditation which meets 
the requirements of this section.
    (Comment 110) Proposed Sec.  1.1151(e) implemented the waiver 
provision of

[[Page 68797]]

section 422(b)(3) of the FD&C Act and stated that a LAAF-accredited 
laboratory could submit a written request to FDA requesting permission 
to use a method outside its scope of LAAF-accreditation. The proposed 
rule went on to state that FDA may approve the request if two 
conditions were met: (1) A new method had been developed and validated 
but no reasonably available laboratory had been accredited to perform 
the method and (2) the use of the new method is necessary to prevent, 
control, or mitigate a food emergency or foodborne illness outbreak.
    Some comments agree that FDA should decide whether to allow a LAAF-
accredited laboratory to use a method outside its scope; they state, 
however, that the recognized accreditation body is not involved in the 
decision and should be notified. Other comments urge FDA to clearly 
define ``reasonably available'' to avoid improper use of this exception 
and an unfair barrier to competition among laboratories if, for 
example, one LAAF-accredited laboratory is not reasonably available due 
to a longer turnaround time than another.
    (Response 110) We appreciate the supportive comments. Given the 
narrow circumstances in which the statute contemplates FDA waiving the 
requirements of this subpart (e.g., new method and either a food 
emergency or a foodborne illness outbreak), we disagree that a 
definition of ``reasonably available,'' is necessary to avoid our abuse 
of this provision. Further, we hesitate to limit our authority to rely 
on this subpart in the context of either an outbreak or an emergency.
    We expect that in most circumstances, we would notify a recognized 
accreditation body if we authorize a laboratory it has LAAF-accredited 
to use a method outside the scope of the laboratory's LAAF-
accreditation. However, because food emergencies and outbreaks may 
necessitate fast action, we decline to add to the final rule a 
commitment that we will notify the recognized accreditation body in 
every situation.
6. What notifications, results, reports, and studies must a LAAF-
accredited laboratory submit to FDA (Sec.  1.1152)?
    Proposed Sec.  1.1152 concerned the notifications, results, and 
reports a LAAF-accredited laboratory must submit to FDA. Note that in 
the final rule we devote a separate section to abridged analytical 
reports (Sec.  1.1153), and so the content from proposed Sec.  
1.1152(d), (e), and (f) is now located in Sec.  1.1153 of the final 
rule. In the final rule we also relocated the contents of Sec.  
1.1152(i), on advance notice of sampling, to Sec.  1.1149.
    In the proposed rule, paragraph (a) of Sec.  1.1152 stated general 
requirements such as that all LAAF-accredited laboratory notifications, 
results, reports, and studies must display a unique identification 
(e.g., an alphanumeric identifier unique to each analytical report, to 
clarify which pages comprise the report), and that the LAAF-accredited 
laboratory must submit corrected versions if the LAAF-accredited 
laboratory becomes aware that the originals were in some way 
inaccurate.
    Briefly, in proposed paragraph (b) we stated that test results must 
generally be submitted by the LAAF-accredited laboratory directly to 
FDA via a destination we will specify on the website described in Sec.  
1.1109. Also briefly, in paragraph (c) we listed the documentation 
required to be submitted to FDA with each test result: All sampling 
documentation required by Sec.  1.1149, a full analytical report unless 
permitted to submit an abridged analytical report, validation or 
verification information required by Sec.  1.1151 unless submitted to 
the recognized accreditation body under proposed Sec.  1.1138, and a 
signed certification from the laboratory's management that the 
submissions are true, accurate, and include the results of all the 
tests conducted under this subpart. Note that in the final rule, we 
moved the requirement for submission of justification and authorization 
for deviating from or modifying the method of analysis to paragraph 
(c). In the proposed rule, that requirement was stated once for 
abridged analytical reports (Sec.  1.1152(f)(2)) and also referenced 
for full analytical reports (Sec.  1.1152(g)(1)); for efficiency and 
clarity it is now stated once in Sec.  1.1152(c).
    Proposed paragraph (g) listed the required contents of a full 
analytical report, such as documentation of references to the test 
method used, identification and qualifications of the analyst(s), 
calculations, and identification of any software used. Proposed 
paragraph (h) stated that if the LAAF-accredited laboratory used a 
method not published in a reputable standard or that is otherwise not 
publicly or readily available, the LAAF-accredited laboratory must 
submit documentation of the method to FDA upon request. Proposed 
paragraph (j) required LAAF-accredited laboratories to immediately 
(within 48 hours) notify FDA and the recognized accreditation body of 
any changes that affect LAAF-accreditation. Proposed paragraph (k) 
provided that if FDA does not receive all the information required in 
Sec.  1.1152, we may consider the related testing to be invalid.
    On our own initiative, we made several revisions to this section in 
the final rule. We revised the title of the section to include 
``studies'' to more accurately reflect the contents of the section. We 
revised paragraph (a) to remove the requirement here for notifications, 
results, and reports to be submitted electronically and in English; the 
requirement remains and is now in Sec.  1.1110 of the final rule. We 
have also revised the list of general requirements for all 
notifications, results, reports, and studies required to be submitted 
to FDA in paragraph (a)(1) to improve clarity and readability. We 
revised paragraph (b) to clarify that a LAAF-accredited laboratory must 
identify on the test results the name and street address of the owner 
or consignee for which the testing was conducted and, as appropriate, 
the U.S. Customs and Border Protection entry number and line number(s). 
The entry and line numbers link import-related tests with related 
product shipments; they are inapplicable in the domestic context. 
Although ISO/IEC 17025:2017 provides that test reports include the name 
and contact information for the customer, FDA needs the level of detail 
we have specified in the final rule so that we may precisely identify 
the entity and/or article of food to which the test results relate. We 
have also revised the section to reflect revised terminology, to update 
cross-references, to improve the clarity and readability of the 
section, and to make minor editorial changes. We discuss additional 
changes made in response to comments below.
    (Comment 111) Some comments recommend that FDA establish uniform 
analytical data requirements by adopting international accreditation 
standards and appropriate national scientific technical standards as 
the main basis for qualifying laboratories and sampling organizations 
to sample and submit analytical data to FDA.
    (Response 111) We agree with the aspects of these comments stating 
that it can be beneficial to rely on international standards in the 
right circumstances. Accordingly, we are relying on the international 
voluntary consensus standards ISO/IEC 17025:2017 and ISO/IEC 17011:2017 
as the foundational requirements for laboratories and accreditation 
bodies, respectively, under this subpart. Further, we agree with the 
aspects of comments stating that the LAAF program will benefit from 
uniform requirements for test records and the data, analysis, and 
information supporting the test result. However, we

[[Page 68798]]

do not agree that such requirements in a voluntary consensus standard 
or national scientific technical standard alone would meet the unique 
needs of the LAAF program. Accordingly, we have established in 
Sec. Sec.  1.1152, 1.1153, and 1.1154 the notifications, results, 
records, and reports that a LAAF-accredited laboratory must create, 
maintain, and submit under this subpart.
    For our discussion regarding the decision not to require ISO/IEC 
17025:2017 accreditation of samplers, see Response 98.
    (Comment 112) Some comments express the mistaken impression that 
results from tests conducted under this subpart will be made publicly 
available.
    (Response 112) Information on the recognized accreditation bodies 
and LAAF-accredited laboratories participating in the LAAF program will 
be made available via the online registry described in Sec.  1.1109. 
However, test results will not be made public. All the testing 
conducted under this subpart is initiated by an owner, such as a food 
producer or a consignee, such as an importer of food. The owner or 
consignee contracts with a LAAF-accredited laboratory to conduct a food 
test. Due to the public heath significance of the test, various 
provisions of the FD&C Act grant FDA the authority to require the test 
results and associated records and reports to be submitted to us, but 
these documents contain confidential business information. FDA will 
treat such information in accordance with the requirements of 
applicable information disclosure laws, such as FOIA and its 
implementing regulations.
    (Comment 113) Some comments recommend clarifications to proposed 
Sec.  1.1152(b). As proposed, section 1.1152(b)(1) stated that, ``the 
results of any and all tests conducted by an accredited laboratory 
under this subpart must be submitted directly to FDA''; some comments 
contend that this provision could be misinterpreted to mean that all 
testing from a LAAF-accredited laboratory must be submitted to FDA. 
These comments recommend that this section be revised to clearly state 
that LAAF-accredited laboratories only need to send test results to FDA 
if the testing is conducted under this subpart.
    Other comments urge FDA to address when LAAF-accredited 
laboratories should send test results to the owner or consignee of the 
product, e.g., at the same time as the results are submitted to FDA. 
Comments state that given the importance of the results, owners and 
consignees need this information to make informed decisions about the 
products to protect public health.
    (Response 113) Proposed Sec.  1.1152(b)(1) was intended to apply 
only to the results of tests required to be conducted by LAAF-
accredited laboratories under this subpart. We have revised the 
provision as follows: ``The LAAF-accredited laboratory must submit the 
results of all testing required to be conducted under this subpart 
directly to FDA via the location specified by the website described in 
Sec.  1.1109, unless another location is specified by FDA regarding 
testing conducted under Sec.  1.1107(a)(2) or (a)(3).'' See Sec.  
1.1152(b)(1) of the final rule.
    We decline to address the timing of when a LAAF-accredited 
laboratory sends results to the owner or consignee. Section 422(b)(2) 
of the FD&C Act states that testing results under this subpart shall be 
sent directly to FDA. Nothing in section 422 of the FD&C Act addresses 
sharing test results with an owner or consignee. Therefore, we decline 
to regulate or opine on this matter. In short, the issue of when the 
LAAF-accredited laboratory shares test results with the food owner or 
consignee is strictly a matter of negotiation between those two 
parties. We note that nothing in the final rule would prohibit the 
LAAF-accredited laboratory from sending the results of testing required 
to be conducted under this subpart to the owner or consignee at the 
same time results are sent to FDA in accordance with this subpart.
    (Comment 114) Regarding the testing described in Sec.  1.1107(a)(1) 
(explicit followup testing requirements in existing FDA regulations), 
some comments express concern that requiring such tests to be conducted 
by LAAF-accredited laboratories may delay products moving into 
commerce. We understand these comments to reason that the use of 
different methods by different laboratories may result in confusion and 
therefore delay the release of product being held pending the test 
results. These comments recommend that FDA specify testing requirements 
and timelines for each product subject to testing under Sec.  
1.1107(a)(1). These comments also request that we provide owners and 
consignees with guidance on any product hold requirements during 
testing.
    (Response 114) Section 1.1107(a)(1) requires that certain followup 
tests required by existing product-specific FDA regulations be 
conducted by a LAAF-accredited laboratory. There are three commodities 
for which existing FDA regulations require followup testing that is 
covered under this subpart: Sprouts, shell eggs, and bottled drinking 
water. Producers of these three commodities have been required to 
conduct the particular followup tests referenced in Sec.  1.1107(a)(1) 
for years; under this final rule, the new requirement is for producers 
to have the tests conducted by a LAAF-accredited laboratory.
    There is no reason to suspect that LAAF-accredited laboratories 
will be slower than other laboratories, nor is there any reason to 
suspect that test results from LAAF-accredited laboratories will be 
more confusing than results from other laboratories. In fact, we 
anticipate less confusion with results from LAAF-accredited 
laboratories because such laboratories must meet the standards we are 
establishing in this rule. For example, all LAAF-accredited 
laboratories will be ISO/IEC 17025:2017-accredited and will participate 
in the proficiency test and other quality assurance activities required 
under this subpart.
    Further, wide variation in test methods is less probable in the 
context of testing under Sec.  1.1107(a)(1). Existing sprouts, shell 
eggs, and bottled drinking water regulations and guidances address the 
test methods for the tests referenced in Sec.  1.1107(a)(1) (see 
Sec. Sec.  129.35(a)(3)(ii) (bottled drinking water), 118.8 (shell 
eggs), 112.152 (sprouts)).
    For the foregoing reasons, there is no need for us to further 
specify testing requirements and timelines for these products, nor is 
additional guidance on these specific test requirements necessary as a 
result of this rulemaking.
    (Comment 115) Some comments disagree with proposed Sec.  1.1152(h), 
which stated that LAAF-accredited laboratories that use non-standard 
methods that are not publicly available in a reputable international or 
national standard must submit documentation of the method to FDA upon 
request and caution that laboratories may be hesitant to provide 
proprietary method information to the FDA. Others question whether we 
should allow use of non-standard methods for testing under this subpart 
at all, arguing that results generated for regulatory purposes should 
be transparent to the regulated industry and the public.
    Other comments agree with the requirement to submit documentation 
of a non-standard method in proposed Sec.  1.1152(h) but believe the 
information would be redundant since it would be included on the 
certificate of analysis. Comments also contend that FDA does not have a 
mechanism for reviewing the requested information on non-standard 
methods.

[[Page 68799]]

    (Response 115) First, we note that this provision appears in Sec.  
1.1152(e) in the final rule.
    We decline to prohibit use of non-standard methods in the LAAF 
program. First, given the breadth of food testing covered by this rule, 
it is not practical to rely solely on standard methods. Moreover, test 
methods, test results, and analytical reports submitted to FDA under 
this program will not be made publicly available regardless of whether 
a standard method was applied; accordingly we do not believe use of 
non-standard methods is problematic. Therefore, LAAF-accredited 
laboratories can use any validated and verified method within the scope 
of their LAAF-accreditation. LAAF-accredited laboratories are not 
limited to using methods FDA has developed or uses; they can use any 
properly validated and verified method as long as the method achieves 
the same performance specifications as the FDA method. Any standard or 
FDA official methods need verification to ensure that the LAAF-
accredited laboratory is capable of performing the analysis, and all 
non-standard and laboratory-developed methods need method validation. 
If a standard method has been modified significantly, it requires 
revalidation. We acknowledge the concerns regarding submitting 
proprietary information method information to FDA and will protect such 
information.
    We disagree that the information FDA would request under Sec.  
1.1152(e) is redundant. The certificate of analysis includes a 
reference to the method used; for published or standard methods, FDA 
can use the reference to determine the technology and methods used 
without requesting additional information. Section 1.1152(e) will allow 
FDA to request documentation of a non-standard method and will ensure 
that we have access to the same type of information on which to base 
our review as we would for published or standard methods.
    We also disagree that FDA does not have a mechanism for reviewing 
requested information on non-standard methods. For decades, FDA field 
scientists have been assessing the scientific credibility, reliability, 
and validity of each analytical testing result, and the analytical 
methods used to obtain these results, as part of reviewing the PLAPs 
submitted to FDA (see ORA Laboratory Manual Volume II, ORA-LAB.5.4.5 
``Methods, Method Verification and Validation'' (Ref. 21)).
    (Comment 116) Comments suggest that it is unnecessary and 
burdensome for FDA to request that the qualifications of the laboratory 
analyst be submitted as part of a full analytical report in proposed 
Sec.  1.1152(g)(12), as the recognized accreditation body would have 
already reviewed and vetted the analyst as part of their accreditation 
process. A few comments question how FDA will use the analyst 
information requested in the full analytical report. Other comments 
state that personal analyst information is not needed if individual 
proficiency testing worksheets are collected. Several comments seek 
clarification on how FDA intends to use such information and how FDA 
will protect individual analyst information from disclosure.
    (Response 116) Under final Sec.  1.1152(d)(12), we are requiring 
that certain information on the qualification of individual analysts be 
submitted to FDA the first time that analyst conducts testing under 
this subpart and to account for any significant changes (e.g., new 
competencies gained). Briefly, we require the analyst's curriculum 
vitae, training records for the methods that the analyst is qualified 
to perform, and any other documentation of the analyst's ability to 
perform the method properly (see Sec.  1.1150(b)). Note that in the 
final rule we are not requiring individual proficiency test worksheets 
as part of the full analytical report; for that discussion see Response 
93, and we have clarified that analyst training information is limited 
to the applicable methods (we are not requiring submission of all an 
analyst's training records).
    Analyst-specific information is essential to our review of the 
LAAF-accredited laboratory's performance; it allows us to verify the 
technical competence of the individual conducting the test. Further, 
while recognized accreditation bodies assess LAAF-accredited 
laboratories every 2 years (see Sec.  1.1120), there may be significant 
analyst turnover and changes in responsibilities in the interim. We 
note that analyst-specific information is not required for abridged 
analytical reports (see Sec.  1.1153(c) of the final rule).
    We have been routinely collecting information on individual 
analysts as part of the PLAPs submitted to support admission of an 
article of imported food and removal from import alert. FDA is 
critically aware of protecting individual personally identifiable 
information, and FDA information technology systems have safeguards in 
place to ensure this information remains confidential. Having said 
that, we discourage LAAF-accredited laboratories from submitting to us 
an individual analyst's social security number or any other unnecessary 
personally identifiable information.
    (Comment 117) Several comments express concern with FDA collecting 
and reviewing test results and analytical reports. Some comments state 
concern with the resources required for the Agency to review test 
results and analytical reports and the mechanisms to ensure consistent 
review across FDA.
    (Response 117) FDA has been collecting and reviewing the private 
laboratory test results and analytical packages used to support 
admission of an article of imported food and removal from import alert 
for decades. To implement the LAAF program described in section 422 of 
the FD&C Act, FDA will collect and review additional test results and 
analytical packages as well (e.g., shell egg testing) (see Sec.  
1.1107). This program is designed to further protect the U.S. food 
supply and FDA is committed to implementing this program and realizing 
the public health benefits associated with the improved confidence in 
these test results. See the FRIA (Ref. 4) for additional discussion of 
the estimated costs (and cost savings) to FDA associated with this 
rule.
    For discussion of how we ensure consistent review of analytical 
reports, please see Response 132.
    (Comment 118) Some comments ask whether the justification for any 
modification to or deviation from the method of analysis and the 
recognized accreditation body's authorization therefore should be 
submitted as an extra document or as part of a full or abridged 
analytical report.
    (Response 118) ISO/IEC 17025:2017 requires the laboratory to 
justify and authorize any method deviation or modification (e.g., 
sections 5.6.b and 5.6.c require personnel to have the authority and 
resources to identify and prevent or minimize deviations; section 
7.2.1.7 requires deviations to be technically justified and authorized) 
(Ref. 3). Final Sec.  1.1152(c)(5) requires the LAAF-accredited 
laboratory to submit documentation of any such justification and 
authorization to FDA as part of the documentation required to be 
submitted with test results. Regarding the method of submission, the 
justification and authorization should be a distinct document, clearly 
marked, within the analytical report.
    Again, note that in the final rule this requirement appears at 
Sec.  1.1152(c)(5), which is the provision detailing information 
required with every analytical report (whether full or abridged); in 
the proposed rule the requirement was repeated in the separate lists of 
what is required in a full and what is required in an abridged 
analytical report.

[[Page 68800]]

    (Comment 119) Some comments state that the reporting requirements 
under Sec.  1.1152 should be modified, suggesting that they are 
duplicative, onerous, and can create unnecessary delays and increases 
in both laboratory administrative time and FDA review. Under the 
proposed rule, laboratories would be required to be accredited by 
recognized accreditation bodies that are full members of the ILAC (see 
Sec.  1.1113); some comments state this means that FDA should require 
less documentation under Sec.  1.1152. Some comments state that testing 
procedures within the scope of LAAF-accreditation are assessed by 
auditors and that certificates of analysis of test medium and equipment 
calibration are reviewed before LAAF-accreditation is granted. Further, 
comments question the need for the analyst name and signature for each 
analytical step. Comments overall question the added value of 
collecting what they view as a large amount of information.
    Some comments express concern over the burden of submitting the 
full analytical reports as required under proposed Sec.  1.1152(g). To 
decrease this burden, the comments recommend that FDA reduce the level 
of detail in each report since ISO/IEC 17025:2017 already includes 
periodic audits by the accreditation body for many of these analytical 
report requirements, such as proficiency testing and verification and 
validation studies required by proposed Sec.  1.1152(c). The comments 
also suggest that the frequency of reporting to FDA could be adjusted 
and reduced based on risk.
    A few comments also suggest that an official certificate of 
analysis from a laboratory accredited by a recognized accreditation 
body and submission of an analytical report meeting the requirements of 
ISO/IEC 17025:2017 should be sufficient to serve as the full analytical 
report required in proposed Sec.  1.1152(g).
    Some comments express the belief that certain documents listed 
below should not be required to be submitted to FDA with each test 
result under proposed Sec.  1.1152:
     All sampling plans and sample collection reports related 
to food testing conducted and written documentation of the sampler's 
qualifications (proposed Sec.  1.1152(c)(1) and (2));
     Certification from one or more members of the accredited 
laboratory's management certifying that test results, notifications, 
reports and studies are true and accurate (proposed Sec.  
1.1152(c)(7));
     Documentation of references for the method or methods of 
analysis used (proposed Sec.  1.1152(g)(2));
     Identification of the analyst(s) who conducted each 
analytical step, validation step, and verification step, including 
analyst(s) legal name and signature (proposed Sec.  1.1152(g)(3));
     Calculations (proposed Sec.  1.1152(g)(4));
     References, in color, of chromatograms, charts, graphs, 
observations, photographs of thin layer chromatographic plates, and 
spectra (proposed Sec.  1.1152(g)(5));
     Copy of the label from any immediate container sampled and 
any additional labeling needed to evaluate the product (proposed Sec.  
1.1152(g)(7));
     All original compilations of raw data secured in the 
course of analysis, including discarded, unused, 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 (proposed Sec.  1.1152(g)(8));
     Any other relevant additional supporting information, 
storage location of analyzed samples, and appropriate attachments such 
as instrument printouts, computer generated charts and data sheets, 
photocopies or original labels for the product analyzed (proposed Sec.  
1.1152(g)(9));
     Curriculum vitae of testing analysts, training records for 
analyst(s), including dates of training, name of trainer; any other 
documentation of the analyst(s)' ability to perform the method properly 
in the context of the food testing (proposed Sec.  1.1152(g)(12);
     ``Documents related to the accredited laboratory's grant'' 
(proposed Sec.  1.1153(a)(1)).
    A few comments support the submission of the remaining items in 
proposed Sec.  1.1152(a), (c), and (g), with the exception of the 
modifiers ``all'' and ``any'' throughout Sec.  1.1152 since comments 
contend the language is unclear and may put participating laboratories 
at unreasonable risk.
    (Response 119) After considering the comments, FDA is making 
limited changes to the required contents of a full analytical report. 
We note that documents related to the LAAF-accredited laboratory's 
grant of LAAF-accreditation are not required to be submitted as part of 
an analytical report. Next, we note that we have removed the individual 
proficiency test worksheet requirement from among the documents to be 
submitted as part of a full analytical report. Also, we have clarified 
in the final rule that analyst training information is only for the 
applicable methods, not all training records. We also added a 
parenthetical clarification after ``quality control results,'' which 
states, ``including the expected result and whether it is acceptable.'' 
Note that we have added corresponding text to the required contents of 
an abridged analytical report; see our discussion of Sec.  1.1153 
below.
    According to some comments, FDA is asking for too much information 
in a full analytical report or is asking for LAAF-accredited 
laboratories to prepare and maintain too much information or 
documentation for each test. The reason we disagree with both 
contentions is based on our mission of protecting the public health 
from adulterated food products; namely, in order for FDA to responsibly 
carry out its duties with regard to the food testing described in Sec.  
1.1107, we need to be able to assess the scientific credibility, 
reliability, and validity of each test result. When a LAAF-accredited 
laboratory submits a full analytical report, we are able to conduct a 
meaningful scientific review of the LAAF-accredited laboratory's work. 
When a laboratory submits an abridged analytical report, we must be 
able to promptly access the information that would facilitate our 
substantive scientific review; hence, we require its creation and 
maintenance under this subpart (see Sec.  1.1150(d)).
    To the extent that we are allowing for the submission of abridged 
analytical reports under this subpart, we are allowing laboratories 
that have been LAAF-accredited by a recognized accreditation body to 
submit less documentation under this rule than we have routinely 
accepted for import-related PLAPs. We do not agree with comments 
arguing that because a recognized accreditation body reviews some 
laboratory documentation during its biennial assessment, we should 
decline to review documentation related to individual test results; the 
purpose of an assessment by a recognized accreditation body is entirely 
different than the purpose of our review of analytical reports and 
naturally the scope and depth of the two activities will reflect those 
differences.
    With regard to the particular documents the comments suggest we 
should not require:
     The information related to the sampling plan, sample 
collection, and sampler qualifications are required since the 
accreditation of sampling is not required under this rule; therefore, 
FDA uses this documentation to ensure that sampling was performed 
correctly.
     The certification of results is a requirement of ISO/IEC 
17025:2017 section 6.2.6.c (``authorization'');

[[Page 68801]]

however since this is not one of the required reporting elements in 
ISO/IEC 17025:2017 section 7.8, it is specified as a required document 
in this rule to ensure that FDA receives the information (Ref. 3).
     Where standard methods have not been referenced on a 
report, it is critical for FDA to be able to determine the test method 
used and therefore we require that the reference method is listed in 
order to make that determination.
     Identification of analysts performing specific steps are a 
requirement for an audit trail in laboratory records.
     The calculations are needed for the review of data to 
ensure that no errors affecting the reported results occurred due to 
math errors.
     The compilation of all raw data along with the 
chromatograms, charts, graphs, observations, photographs of thin layer 
chromatographic plates, and spectra and other attachments such as 
instrument printouts, computer generated charts and data sheets 
requested are records that are required by ISO/IEC 17025:2017 to be 
retained as technical records and should be readily accessible by the 
laboratories. This information provides the necessary evidence to 
support the analytical conclusion of the test results. Note that, as 
long as a record of the processed data file is submitted, we do not 
consider instrument data files maintained on the instrument computer as 
originally obtained to be ``raw data'' and so do not require their 
submission (or their maintenance under Sec.  1.1154(a)(3)).
     The requirement for the label from any immediate container 
sampled and any additional labeling needed to evaluate the product as 
well as photocopies or original labels for the product analyzed are 
important components for any analysis in making a determination on the 
acceptability of the specific product tested in relationship to the 
test result obtained.
     The storage location of the sample is important to assure 
that samples were stored in a manner which protected the integrity of 
the sample prior to and during analysis so that test results were not 
adversely impacted.
     Curriculum vitae, training records, and other records of 
analyst competence are discussed in Response 116.
    Finally, while FDA agrees that use of the words, ``any'' (e.g., 
``any other relevant supporting information'') and ``all'' (``all 
original compilations of raw data'') is broad, we have retained their 
use in this section of the final rule because it is not possible to 
generate a full list of the potential information or data that might be 
needed to review the testing data due to the broad scope of analysis 
covered by this rule. The intent is for the LAAF-accredited laboratory 
to submit any records needed for a thorough technical review of the 
testing data.
    (Comment 120) A few comments ask for FDA to define ``individual 
proficiency testing worksheets'' in proposed Sec.  1.1152(g)(12)(iv) 
and to clarify whether each analyst who submits test results must have 
participated in proficiency testing each year on the method used.
    (Response 120) As discussed in Response 92, the requirement that a 
LAAF-accredited laboratory must meet the proficiency test requirements 
on an annual basis for each method within the scope of LAAF-
accreditation is on a per laboratory basis. Also, we have revised the 
final rule to delete from the full analytical package the relevant 
proficiency test worksheets. The recognized accreditation bodies will 
be reviewing proficiency testing results and any related corrective 
actions under Sec.  1.1138(a)(2)(iii) of the final rule.
    (Comment 121) A few comments recommend that FDA modify the language 
requiring a copy of the container label to be submitted to FDA as part 
of a full analytical report under Sec.  1.1152(g)(7) of the proposed 
rule to include the qualifier, ``if available,'' as foods taken from 
bulk containers may not have a label.
    (Response 121) We appreciate this suggestion and have revised the 
final rule to include ``if available'' (see Sec.  1.1152(d)(7)).
    (Comment 122) A few comments request clarification of what is 
required to be submitted to the recognized accreditation body or FDA as 
part of analytical method verification or validation studies in 
proposed Sec.  1.1152 (c)(4) through (6). These comments recommend 
that, at a minimum, accuracy, precision, recovery, detection limits and 
in-matrix studies be included.
    (Response 122) Note that under the final rule, all validation and 
verification studies required by Sec.  1.1151(c) and (d) are required 
to be submitted to FDA (see Sec.  1.1152(c)(3) and (4)). In the 
proposed rule, we proposed to require that some validation and 
verification studies be submitted to the recognized accreditation body; 
specifically, those validation and verification studies that were 
necessary for the recognized accreditation body to assess competence to 
the method for purposes of granting LAAF-accreditation. However, we 
believe it better clarifies the role of FDA as distinct from the role 
of the recognized accreditation body if we do not share the 
responsibility of reviewing those studies. When FDA reviews validation 
and verification studies, it is for the purpose of determining whether 
such a study, such as a matrix extension, demonstrates laboratory 
performance sufficient to support the particular analytical report 
under review. In contrast, recognized accreditation bodies review 
validation and verification studies for the purpose of assessing 
whether to award accreditation. Therefore, upon further consideration, 
in light of the comments, and in keeping with our role as reviewer of 
the performance of LAAF-accredited laboratories, we have determined it 
to be appropriate for all such studies to be submitted to FDA as a 
component of an analytical report.
    Note that because of the differences in types of testing (chemical, 
biological, or physical) and the purpose of the testing, it is not 
practical to provide a single concise list of elements needed in a 
specific validation or verification study. In terms of clarifying what 
a LAAF-accredited laboratory needs to submit to FDA as part of a 
validation or verification study, we direct interested parties to the 
existing FDA Food Program's guidelines on performing validation and 
verification studies located at the following web link: https://www.fda.gov/science-research/field-science-and-laboratories/method-validation-guidelines. Laboratories may use these guidelines in 
performing validation studies or they may use other established and 
recognized protocols such as AOAC. Please identify the protocol that is 
being used when submitting a validation.
7. What are the requirements for submitting abridged analytical reports 
(Sec.  1.1153)?
    Proposed Sec.  1.1153 covered records requirements for LAAF-
accredited laboratories; we have relocated those provisions to Sec.  
1.1154 in the final rule. Section 1.1153 in the final rule addresses 
abridged analytical reports and is comprised of provisions that 
appeared in Sec.  1.1152(d) through (f) in the proposed rule.
    In the proposed rule, an abridged analytical report was comprised 
of most of the information required in a report by ISO/IEC 17025:2017 
and the justification and documented authorization for any modification 
to or deviation from the method used. Note that in the proposed rule, 
the justification and authorization information was also required as 
part of a full analytical report. On our own initiative and for 
efficiency and clarity, we moved this requirement to

[[Page 68802]]

Sec.  1.1152(c), which is the provision describing documentation 
required to be submitted with test results (whether full or abridged 
analytical reports).
    Additionally, in the final rule we have added a component to the 
abridged analytical report contents: Quality control results (including 
the expected result and whether it is acceptable). The addition of 
quality control results to the abridged analytical report will provide 
FDA with important contextual information for the certificate of 
analysis and may reduce our need to request other documentation or a 
full analytical report pursuant to Sec.  1.1153(d). Finally, in Sec.  
1.1153(e) of the final rule, we reiterate that we may consider the 
testing to be invalid if the LAAF-accredited laboratory fails to submit 
all required testing-related documentation. This appeared in Sec.  
1.1152(k) of the proposed rule and applied to all analytical reports; 
it appears in Sec.  1.1152(g) of the final rule as it applies to full 
analytical reports and all other information required to be submitted 
to FDA under Sec.  1.1152.
    Briefly, in the proposed rule a LAAF-accredited laboratory would 
have gained permission to submit abridged analytical reports after 
submitting 10 successful consecutive full analytical reports to FDA. Of 
the full analytical reports, at least one would have needed to be from 
each of the major food testing discipline for which the laboratory 
sought permission. LAAF-accredited laboratories that failed to submit 
10 successful consecutive analytical reports would be required to wait 
a minimum of 2 years before again attempting to submit the 10 
successful consecutive analytical reports. Similarly, if an abridged 
analytical report contained material substantive shortcomings or 
repeated administrative deficiencies, that laboratory would be required 
to wait a minimum of 2 years before reapplying for permission to submit 
abridged analytical reports. Comments regarding the abridged analytical 
report provisions of the proposed rule are discussed below.
    (Comment 123) Many comments support allowing laboratories to submit 
shorter and simpler abridged analytical reports to FDA after meeting 
certain requirements, as outlined in proposed Sec.  1.1152(d). These 
comments suggest that FDA may be able to more quickly review abridged 
analytical reports. A few comments request clarification on whether the 
requirements for abridged analytical reports apply to governmental 
accredited laboratories and if not, whether FDA would consider 
developing a similar process for them. Some comments state that the 
opportunity to submit abridged analytical reports should apply to all 
accredited laboratories, public and private.
    A few comments contend that the ability to submit abridged 
analytical reports to FDA is of limited benefit because LAAF-accredited 
laboratories would have to submit a full analytical report to FDA 
within 48 hours if requested, as proposed under Sec.  1.1152(e)(1). 
Some comments also recommend that the timeframe for providing FDA with 
the full analytical report should be at least 72 hours, as 48 hours is 
not enough time to compile the large amount of information needed for a 
full analytical report.
    Other comments mention that the circumstances necessitating the 
exceptions described in the preamble to the proposed rule, (``. . . 
[for] the purposes of auditing abridged analytical reports and 
otherwise protecting the public health and the integrity of this food 
testing program . . . .'' (84 FR 59452 at 59484)) are vague and request 
that FDA clarify the standard it will use in requesting full analytical 
reports.
    (Response 123) We appreciate the support for the proposal to allow 
the submission of abridged analytical reports and we agree that this 
approach may promote certain efficiencies for LAAF-accredited 
laboratories and FDA.
    As a threshold matter, the final rule requirements regarding 
abridged analytical reports apply to all LAAF-accredited laboratories 
conducting food testing under this subpart. Government laboratories may 
apply to a recognized accreditation body to become LAAF-accredited to 
conduct food testing under this subpart and may request permission to 
submit abridged analytical reports as described in Sec.  1.1153.
    Regarding the 48-hour timeframe in which laboratories permitted to 
submit abridged analytical reports may need to produce and submit to 
FDA a full analytical report, we are making two changes in response to 
comments. First, we are changing the timeframe in which a LAAF-
accredited laboratory would need to submit a full analytical report 
pursuant to the exception from 48 to 72 hours to provide additional 
time to prepare documents for submission to FDA. Second, we are 
clarifying that we may request one or more additional documents up to a 
full analytical report under the exception. This will enable the Agency 
to tailor the request to the specific circumstances and likewise will 
reduce the burden on LAAF-accredited laboratories under this exception.
    With those changes, we are maintaining the exception as it remains 
an important tool by which we may audit abridged analytical reports and 
otherwise protect public health and LAAF program integrity (see 
discussion at 84 FR 59452 at 59484). Under this exception and as stated 
in the preamble to the proposed rule, we may request additional 
documentation or a full report under this exception at our discretion, 
which may be based on the underlying public health risk of the analyte, 
if we have a question about something in the abridged analytical 
report, something in the abridged analytical report appears to be 
amiss, or on a random basis to spot-check LAAF-accredited laboratory 
performance. We estimated making these requests for no more than 10 
percent of abridged analytical reports submitted, but at least once per 
year (see 84 FR 59452 at 59484).
    Finally, we note that the analytical steps should not change when 
producing an abridged analytical report, only the amount of information 
submitted to FDA (see Sec.  1.1150(d)).
    (Comment 124) Several comments state that FDA should simplify the 
process for granting permission to submit abridged analytical reports 
as it is overly burdensome on both LAAF-accredited laboratories and FDA 
and diverts resources away from protecting public health. These 
comments recommend that FDA consider as few as one or two full 
analytical reports per major food testing discipline. These comments 
contend that the proposed process, requiring 10 full reports, would 
give larger LAAF-accredited laboratories an advantage and that these 
larger laboratories are better able to absorb the increased cost of 
full analytical reports without the need to pass the higher cost on to 
the owner or consignee.
    Many comments argue that the proposed disqualification periods from 
submitting abridged analytical reports or even the failure to gain 
permission would be detrimental to LAAF-accredited laboratories and 
overly punitive. These comments state that corrective action to address 
deficiencies would be more appropriate and would afford the LAAF-
accredited laboratory due process. Some comments recommend that FDA 
issue a warning letter to LAAF-accredited laboratories with material 
substantive shortcomings so that corrective action could be taken in 
response. Comments state further that FDA should meet with the LAAF-
accredited laboratory and recognized accreditation body or allow for an 
appeals process prior to taking further action to use probation or 
disqualification especially since this could be based on minor repeated

[[Page 68803]]

administrative deficiencies yet would result in a long disqualification 
period.
    Comments also request additional details regarding ``material 
substantive shortcomings'' and ``administrative deficiencies'' and 
argue that interpretation of these terms, if not clearly defined, could 
be inconsistently applied when reviewing abridged analytical reports. 
Further, comments express concerns that, as proposed, repeated 
administrative deficiencies could become a material substantive 
shortcoming and lead to disqualification, which would have a large 
financial impact on LAAF-accredited laboratories. These comments urge 
FDA to consider what public health benefit, if any, would accrue from 
focusing on administrative deficiencies and the resulting burden on 
LAAF-accredited laboratories.
    Some comments indicate that permission to submit abridged reports 
represents a direct relationship between FDA and LAAF-accredited 
laboratories where the recognized accreditation body is not involved. 
Other comments contend that the LAAF-accreditation process should be 
considered evidence of a laboratory's ability to submit full analytical 
reports and ultimately reduce or eliminate the number of full 
analytical reports required to be submitted to gain permission from FDA 
to submit abridged analytical reports.
    (Response 124) We agree with comments regarding the need to 
simplify the proposed process for seeking permission to submit abridged 
analytical reports and the need to revisit the consequences of 
deficiencies in abridged analytical reports. We have made significant 
changes to both aspects of the abridged analytical report process in 
the final rule. In simplifying the process, we decline the 
recommendation to rely on recognized accreditation bodies to evaluate a 
LAAF-accredited laboratory's ability to submit abridged analytical 
reports. We agree that recognized accreditation bodies will play a 
crucial role with respect to LAAF-accrediting laboratories and 
continuing oversight of the laboratories they LAAF-accredit; however, 
FDA's role is to review the performance of those laboratories and in 
particular, to do so by reviewing analytical reports. Moreover, we 
maintain that FDA's experience with LAAF-accredited laboratories' full 
analytical reports and the Agency's confidence in reliance on such 
analytical reports to make regulatory decisions are imperative factors 
in the decision to grant permission to submit abridged analytical 
reports. Therefore, although we have revised the processes related to 
abridged analytical reports, it remains FDA, rather than the recognized 
accreditation bodies, that will have the authority to grant permission 
to submit abridged reports.
    In terms of gaining permission to submit reports, on request of the 
LAAF-accredited laboratory, FDA will review the last five full 
analytical reports for a major food testing discipline (biological, 
chemical, and physical) to determine whether the LAAF-accredited 
laboratory will be granted permission to submit abridged analytical 
reports for that major food testing discipline. In reviewing the last 
five analytical reports, FDA will check that the reports contain no 
shortcomings that call into question the validity of the test result or 
repeated administrative errors. Additionally, FDA will confirm that the 
LAAF-accredited laboratory requesting permission is not on suspension 
or probation for any method within the major food testing discipline 
for which the laboratory is requesting permission and that the 
laboratory has successfully implemented any required corrective action 
(see Sec. Sec.  1.1121 and 1.1161). FDA will notify the LAAF-accredited 
laboratory if permission has been granted or denied.
    The revised process for requesting permission should reduce the 
burden for both FDA and LAAF-accredited laboratories and will still 
ensure that there is requisite experience with full analytical reports 
for each major food testing discipline for which permission to submit 
abridged analytical reports is sought. We recognize that the proposed 
process of submitting 10 full analytical reports and granting 
permission for the major food testing disciplines included in those 10 
reports could result in a grant of permission for a major food testing 
discipline based on as few as 1 full analytical report if it was 
included among a group of 9 other full analytical reports for another 
major food testing discipline. Changing the process to review five full 
analytical reports per major food testing discipline provides for more 
equal oversight of, and experience with, full analytical reports, 
reduces the potential competitive advantage of larger laboratories, and 
reduces the overall barrier to permission. It also alleviates the need 
for a separate process for adding a major food testing discipline as 
proposed (see Sec.  1.1152(d)(3) of the proposed rule). Finally, in 
response to comments and on our own initiative, we have revised and 
simplified the oversight process for abridged analytical reports to 
leverage existing program oversight tools, including corrective action, 
described in Sec.  1.1161 as opposed to relying on the separate process 
proposed. Thus, we have removed disqualification periods specific to 
issues with submitting abridged analytical reports (see proposed Sec.  
1.1152(d)(2) and (d)(4) through (6)). Section 1.1153(b) of the final 
rule describes the process by which FDA will review and communicate 
issues with abridged analytical reports and when FDA may require 
corrective action, probation, or may revoke permission to submit 
abridged analytical reports. We believe the revised process will be 
fairer and more transparent for LAAF-accredited laboratories and easier 
for FDA to implement.
    In response to concerns that a LAAF-accredited laboratory's failure 
to gain permission to submit abridged analytical reports will 
negatively impact the laboratory, we note that, as discussed above in 
Response 57, permission to submit abridged analytical reports will not 
be included on the public registry described in Sec.  1.1109.
    We decline the request to define the terms, ``material substantive 
shortcomings'' and ``repeated administrative deficiencies''; however, 
we have made the following modifications which we believe will address 
the underlying concerns: We revised the final rule to specify that 
substantive shortcomings are those that call into question the validity 
of the results and clarified the section to refer to repeated 
administrative errors. In addition, we have specified that FDA will 
notify the LAAF-accredited laboratory of any deficiencies as described 
in Sec.  1.1153(b)(2).
8. What other records requirements must a LAAF-accredited laboratory 
meet (Sec.  1.1154)?
    The other records requirements for a LAAF-accredited laboratory 
appeared in Sec.  1.1153 of the proposed rule but appear in Sec.  
1.1154 of the final rule. In paragraph (a) we proposed that LAAF-
accredited laboratories be required to maintain electronically for 5 
years, records created and received under this subpart, such as 
documents relating to the grant of LAAF-accreditation and documentation 
of testing conducted under this subpart. In paragraph (b) we proposed 
that within 30 days of the receipt of proficiency testing results, the 
LAAF-accredited laboratory submit the results to the recognized 
accreditation body and, if the laboratory failed the test, to FDA. 
Proposed paragraph (c) stated that a LAAF-accredited laboratory must 
make records available for FDA inspection and copying upon written 
request, and addressed related details.

[[Page 68804]]

Proposed paragraph (d) stated that a LAAF-accredited laboratory must 
ensure that significant amendments to records can be tracked to 
previous and original versions, and addressed related details.
    We have revised the section to update terminology and cross-
references and to make other minor editorial changes to improve the 
clarity and readability of the section. We also have made several 
conforming changes to reflect changes elsewhere in the final rule: We 
have revised paragraph (a)(1) to specify proficiency test and 
comparison program records; this information was previously required by 
proposed Sec.  1.1153(b)(1). Accordingly, paragraph (b) has been 
removed and the requirement to submit proficiency test results to the 
recognized accreditation body has been incorporated in Sec.  
1.1138(a)(2)(iii). We removed reference to the English language and 
English translation requirement and electronic submission as this is 
now included in Sec.  1.1110 of the final rule. Additionally, we 
removed the word, ``electronically,'' from paragraph (a) to allow 
flexibility around how LAAF-accredited laboratories maintain records 
and to align with the same revision for recognized accreditation bodies 
in Sec.  1.1124(a). We revised paragraph (a)(3) so that it now says, 
``associated correspondence between the LAAF-accredited laboratory . . 
. and the owner or consignee'' rather than, ``associated correspondence 
by the LAAF-accredited laboratory . . . with the owner or consignee;'' 
to clarify that correspondence to the laboratory related to food 
testing under this subpart is among the records the laboratory must 
maintain. Finally, we clarify in Sec.  1.1154(a)(2) that the 
documentation of food testing that a LAAF-accredited laboratory 
conducted under this subpart must account for all information required 
by Sec.  1.1152(d) of the final rule. This addition better clarifies 
the contents of the cross-reference to Sec.  1.1150(d) in the proposed 
and final rule. We discuss additional changes made in response to 
comments below.
    (Comment 125) Some comments agree that the requirement to maintain 
records for 5 years is reasonable and agree with the 10-business day 
record submission requirement in proposed Sec.  1.1153(c).
    A few comments request that FDA clarify that food testing records 
required in proposed Sec.  1.1153(a)(2) are limited to records related 
to testing covered by this subpart and would not apply to routine 
testing that is performed outside the scope of the rule. Some comments 
request clarification as to why all requests for food testing from an 
owner or consignee are necessary as stated in proposed Sec.  
1.1153(a)(4).
    (Response 125) We appreciate the supportive comments and agree that 
records a LAAF-accredited laboratory must maintain under this rule 
(proposed Sec.  1.1153, final rule Sec.  1.1154) are only those related 
to food testing covered by this subpart. Per the request from comments, 
we clarify in the final rule that LAAF-accredited laboratories maintain 
all requests for food testing from an owner or consignee that would be 
conducted under this subpart. These records would help FDA ascertain 
compliance with the requirement to submit all test results to FDA 
(under Sec.  1.1152(b)).

J. Comments Regarding FDA Oversight of LAAF-Accredited Laboratories

Table 11--Changes to Sections Regarding FDA Oversight of LAAF-Accredited
                              Laboratories
------------------------------------------------------------------------
           Final rule                Proposed rule           Notes
------------------------------------------------------------------------
FDA Oversight of LAAF-Accredited  Procedures for      Revised to reflect
 Laboratories.                     Accreditation of    new terminology
                                   Laboratories.       and
                                                       reorganization of
                                                       the final rule.
Sec.   1.1159 How will FDA        Sec.   1.1159 How   Revised to reflect
 oversee LAAF-accredited           will FDA oversee    new terminology.
 laboratories?                     accredited
                                   laboratories?
Sec.   1.1160 How will FDA        Sec.   1.1160 How   Minor editorial
 review test results and           will FDA review     change.
 analytical reports?               submitted test
                                   results and
                                   analytical
                                   reports?
Sec.   1.1161 When will FDA       Sec.   1.1161 When  Revised to reflect
 require corrective action, put    will FDA put an     new terminology
 a LAAF-accredited laboratory on   accredited          and revised
 probation, or disqualify a LAAF-  laboratory on       contents of the
 accredited laboratory from        probation or        section.
 submitting analytical reports?    revoke the
                                   accreditation of
                                   a laboratory?
Sec.   1.1162 What are the        Sec.   1.1162 What  Revised to reflect
 consequences if FDA puts a LAAF-  are the             new terminology.
 accredited laboratory on          consequences if
 probation or disqualifies a       FDA puts an
 LAAF-accredited laboratory?       accredited
                                   laboratory on
                                   probation or
                                   revokes the
                                   accreditation of
                                   a laboratory?
------------------------------------------------------------------------

1. How will FDA oversee LAAF-accredited laboratories (Sec.  1.1159)?
    This section of the proposed rule described three broad mechanisms 
FDA might employ to oversee LAAF-accredited laboratories. First, in 
proposed paragraph (a) we stated that we ``may assess accredited 
laboratories at any time to determine whether . . . there are 
deficiencies . . . that, if not corrected, would warrant . . . 
revocation of its accreditation.''
    In proposed paragraph (b), we listed various records and 
information that we may review in evaluating the performance of a LAAF-
accredited laboratory, such as records the laboratory is required to 
maintain under this subpart. Proposed paragraph (c) stated that we may 
conduct an onsite ``assessment'' of the LAAF-accredited laboratory. 
Proposed paragraph (d) stated that we will report our observations and 
findings to the recognized accreditation body.
    As discussed above at Response 10, FDA has revised terminology 
throughout this rule to clarify that our role with regard to LAAF-
accredited laboratories is not to ``assess'' them but is to review 
their performance, primarily by reviewing analytical reports and test 
results. In final Sec.  1.1159 we revised the language accordingly, to 
more clearly communicate our role. This section now consistently refers 
to FDA reviewing the performance of a LAAF-accredited laboratory and 
explicitly includes analytical reports and test results submitted to 
FDA among the things we may review in Sec.  1.1159(b)(5).
    We have also revised paragraph (c) of the final rule to explicitly 
state that certain FDA review activities may be conducted remotely if 
it will not aid in the review to conduct them onsite. For example, 
records reviews or auditing filth plates are common review activities 
that may be conducted remotely. The ability to conduct remote reviews 
of LAAF-accredited laboratory performance under this subpart will 
provide a more efficient, cost-effective, and less intrusive option for 
reviews. This may also allow for continued

[[Page 68805]]

oversight of LAAF-accredited laboratories when onsite visits are 
otherwise impracticable.
    We also made other conforming and minor editorial changes to this 
section and section title, including deletion of the phrase, ``of food 
subject to food testing under this subpart'' in proposed Sec.  
1.1159(b)(5) because the phrase is included in the definition of owner 
or consignee in Sec.  1.1102 and therefore need not be repeated; see 
Sec.  1.1159(b)(6) if the final rule. Comments regarding this section 
are discussed below.
    (Comment 126) A few comments state that FDA onsite reviews under 
Sec.  1.1159(c) should be limited to work performed under this subpart 
and should not extend to other work conducted by the LAAF-accredited 
laboratory, even work related to other FDA regulations (e.g., testing 
under part 117). These comments further contend that when FDA conducts 
onsite reviews, we may not examine privileged or proprietary records or 
laboratory practices not directly related to this subpart.
    (Response 126) We agree that an onsite review of a LAAF-accredited 
laboratory and any review activities conducted remotely would be 
limited to work performed under this subpart. We have revised Sec.  
1.1159(c) to further clarify that FDA's onsite review is limited to a 
LAAF-accredited laboratory's performance under this subpart. As such, 
it would not include review of privileged or proprietary records or 
laboratory practices outside the scope of this final rule.
    (Comment 127) Some comments encourage FDA to communicate with the 
recognized accreditation body if during the course of our review of a 
LAAF-accredited laboratory we obtain information causing us to place 
the LAAF-accredited laboratory on probation or disqualify the LAAF-
accredited laboratory from conducting food testing under this subpart. 
The recognized accreditation body could then perform an assessment of 
its own related to the laboratory's ISO/IEC 17025:2017 accreditation 
and LAAF-accreditation status.
    (Response 127) Section 1.1159(d) of the final rule states that 
``FDA may report any observations and deficiencies identified during 
its review of LAAF-accredited laboratory performance under this subpart 
to the recognized accreditation body.'' This would include information 
that causes us to place the LAAF-accredited laboratory or disqualify 
the laboratory from conducting testing under this subpart.
    (Comment 128) Some comments express concern that the proposed rule 
did not communicate more detailed information about the processes 
around FDA review of LAAF-accredited laboratories. These comments ask 
what the impact would be if FDA found a deficiency in the course of its 
review; for example, whether FDA would invalidate past test results 
and, if so, how far back in time the invalidation would extend.
    (Response 128) The impact of any deficiency identified in the 
course of an FDA review of a LAAF-accredited laboratory's performance 
under this subpart would depend on the deficiency found. Section 1.1160 
describes what would happen if FDA finds a deficiency in an analytical 
report. As described in Sec.  1.1161(a) of the final rule, FDA may 
require corrective action to address any deficiencies identified. In 
the case of certain serious deficiencies such as those described in 
Sec.  1.1161(c) of the final rule, FDA may disqualify a LAAF-accredited 
laboratory from submitting analytical reports for one or more methods 
within the scope of LAAF-accreditation. The consequences of probation 
or disqualification are described in Sec.  1.1162 of the final rule. 
Paragraph (c) states in relevant part that FDA may refuse to consider 
specific food testing results if the basis for disqualification of the 
laboratory indicates that the specific food testing conducted by the 
laboratory may not be reliable.
2. How will FDA review test results and analytical reports (Sec.  
1.1160)?
    Proposed Sec.  1.1160(a) through (c) described how FDA would 
proceed if it finds deficiencies in any test result, analytical report, 
related documents (e.g., related to sampling), or the associated 
analysis indicates that any aspect of the testing under this subpart is 
not being conducted in compliance with the requirements of this 
subpart. In paragraph (a), we proposed that we may consider the 
analysis to be invalid and/or will notify the LAAF-accredited 
laboratory and may also notify the owner or consignee, of the 
deficiency. The LAAF-accredited laboratory would be required to respond 
to FDA within 30 days. Proposed paragraph (b) stated that we may report 
our determination of a deficiency to the recognized accreditation body. 
Proposed paragraph (c) stated that if the deficiency demonstrates a 
material substantive shortcoming in the related food testing, or 
demonstrates repeated administrative deficiencies, we may also consider 
disallowing the LAAF-accredited laboratory from submitting abridged 
analytical reports, or other actions under this subpart. Proposed 
paragraph (d) noted that nothing in this subpart limits FDA's ability 
to review and act upon information received about food testing.
    We revised this section to incorporate updated terminology, to make 
conforming changes, and to improve clarity and readability. We discuss 
additional changes made in response to comments below.
    (Comment 129) Some comments indicate that proposed Sec.  1.1160(b) 
did not state that recognized accreditation bodies ``will'' be informed 
when FDA finds a deficiency as a result of reviewing a LAAF-accredited 
laboratory's test results, analytical reports, related documents, or 
the associated analysis; instead we used the word, ``may.'' These 
comments urge FDA to inform the recognized accreditation body of 
findings of deficiency. Other comments appear to encourage us to notify 
the recognized accreditation body when we learn of a possible 
deficiency, before we reach a conclusion that a deficiency has 
occurred. Comments generally urge FDA to have transparent communication 
with recognized accreditation bodies regarding the LAAF-accredited 
laboratories.
    (Response 129) We agree that communication between the FDA and the 
recognized accreditation bodies will be beneficial for this program. At 
the same time, we do not want to overwhelm a recognized accreditation 
body with details concerning analytical reports that are unlikely to be 
relevant to their oversight of a LAAF-accredited laboratory. To that 
end, final Sec.  1.1160(b) provides FDA with discretion regarding which 
observations and deficiencies we will report to a recognized 
accreditation body. We anticipate deciding on a case-by-case basis 
which deficiencies are significant enough to warrant notifying a 
recognized accreditation body. By way of two examples, while a 
deficiency such as failure to run quality control samples as required 
in Sec.  1.1138(a)(3), that would call into question the validity of 
the test result, likely would be reported to the recognized 
accreditation body, a deficiency that does not call into question the 
validity of the test, such as FDA requesting a missing document, 
generally would not require notification of the recognized 
accreditation body. Relatedly, we have clarified in Sec.  1.1160(a) 
that we may require that a laboratory correct the test result, 
analytical report, related documents, or the associated analysis. Such 
correction would not require additional corrective action; however, FDA 
may require corrective action for certain deficiencies.

[[Page 68806]]

    (Comment 130) Some comments request that in the event that FDA 
identifies a deficiency in an analytical report, FDA not notify the 
owner or consignee if the deficiency can be immediately resolved and 
human health is not directly affected.
    (Response 130) The potential circumstances surrounding FDA 
identification of a deficiency in a test result, analytical report, or 
related documents are numerous and varied. It would be imprudent for us 
to try to categorize deficiencies and establish different notification 
requirements for the various categories. Instead, we will approach each 
instance of deficiency under Sec.  1.1160(a) on a case-by-case basis, 
in terms of determining whether it is appropriate to inform the owner 
or consignee. We do take the point of the comment, though, and agree 
that owners or consignees need not always be informed when FDA 
identifies a deficiency in a test result, analytical report, or related 
documents. Accordingly, we are retaining the conditional language of 
the proposed rule in Sec.  1.1160(a) of the final rule by stating that 
FDA ``may'' report such deficiencies to the owner or consignee.
    (Comment 131) Some comments state that FDA should expedite review 
of analytical reports and test results from all LAAF-accredited 
laboratories. These comments contend that this will benefit both 
importers and their customers and will result in more efficient use of 
FDA resources during review.
    (Response 131) We acknowledge these comments and intend to review 
analytical reports in a timely fashion.
    (Comment 132) Some comments express the concern that FDA's review 
of analytical reports submitted in relation to testing to support 
removal from import alert has been inconsistent, both between FDA 
regions and within single facilities. Comments contend that over time 
FDA has required increasing amounts of information. Comments express 
frustration that it has been difficult to gain clarity from FDA 
regarding what our standards are for the documents comprising a full 
analytical report. Comments recommend that FDA develop a document that 
clearly communicates to FDA staff as well as laboratories submitting 
reports, our requirements for each component of a full analytical 
report; comments assert this should be done before holding laboratories 
accountable for failure to satisfy such requirements.
    Other comments express frustration regarding working with FDA to 
resolve issues identified in analytical reports submitted in relation 
to testing to support removal from import alert. These comments assert 
that such resolution requires the participation of more than one office 
within FDA's Office of Regulatory Affairs. In the view of these 
comments, the cumbersome FDA resolution process results in delayed 
admissibility decisions.
    Other comments request that we clarify how we will ensure that 
analytical reports are reviewed by qualified FDA personnel.
    (Response 132) The review of the laboratory analytical reports and 
test results is a very structured process. Reviewers complete technical 
reviews using the Laboratory Manual Volume III Section 7--Private 
Laboratory Guidance, corresponding import alerts, and other appropriate 
guidance documents ensuring that the technical reviews are consistent 
across reviewers and that testimony submitted contains all pertinent 
elements needed for the specified analysis to assure FDA that the 
scientific data is credible, reliable, and valid. Reviewing personnel 
are highly qualified and have gone through extensive training to 
perform these reviews. The use of technical lead review panels further 
aids in preventing inconsistencies and in standardizing the review 
process by insuring a uniform, systematic, and effective approach to 
package review across the FDA. The periodic auditing of the technical 
review process in accordance with FDA's quality system and Laboratory 
Manual Volume III Section 7--Private Laboratory Guidance (https://www.fda.gov/media/73540/download) provides another layer of consistency 
to the process. Average turnaround time for a review is generally 2 
days including the technical lead review assignments. The required 
elements for full and abridged analytical reports, along with the 
documents required to be submitted with test results, are set forth in 
this final rule. This process is designed to mitigate inconsistencies.
    Finally, it is true that more than one FDA office may have a role 
to play when we work with laboratories to resolve questions regarding 
an analytical report. We endeavor to work efficiently across the 
involved FDA offices to resolve such issues and communicate the 
resolution to impacted internal and external entities.
3. When will FDA require corrective action, put a LAAF-accredited 
laboratory on probation, or disqualify a LAAF-accredited laboratory 
from submitting analytical reports (Sec.  1.1161)?
    Proposed Sec.  1.1161 described the grounds necessary for FDA to 
place a LAAF-accredited laboratory on probation or disqualify it from 
the program and the processes for taking such action. In paragraph (a) 
we stated that we may disqualify a laboratory in whole or in part for 
good cause and when the recognized accreditation body fails to withdraw 
LAAF-accreditation. We stated that the reasons may include demonstrated 
bias or lack of objectivity in testing, performance that calls into 
question the validity or reliability of testing, or other failure to 
substantially comply with this subpart.
    In proposed paragraph (b) we described the grounds for probation as 
deficiencies that are less serious and more limited than those 
identified in paragraph (a), when it is reasonably likely that the 
LAAF-accredited laboratory will be able to correct them within a 
specified period of time. We stated that under such circumstances we 
would temporarily place the laboratory on probation and request 
appropriate corrective action. In proposed paragraph (c) we clarified 
that we may disqualify a LAAF-accredited laboratory in part (for just 
some methods).
    In proposed paragraph (d) we stated that a LAAF-accredited 
laboratory's probationary status would last either until the deficiency 
is corrected or FDA determines that disqualification is warranted. In 
proposed paragraph (e) we described the notice of disqualification that 
we would provide to a LAAF-accredited laboratory. In proposed paragraph 
(f) we described the notice of probation that we would provide to a 
LAAF-accredited laboratory. In proposed paragraph (g) we stated that if 
we place a LAAF-accredited laboratory on probation and determine that 
the laboratory is not implementing appropriate corrective actions we 
may disqualify the laboratory in whole or in part. In proposed 
paragraph (h) we stated that probationary status and disqualification 
will be noted on the public registry described in Sec.  1.1109.
    We revised the section to incorporate updated terminology and to 
specify that probation can be method-specific, to be consistent with 
disqualification which is also method-specific (see Sec.  1.1161(b) of 
the final rule). We also revised the section title to more accurately 
reflect the section contents of the final rule (``When will FDA require 
corrective action, put a LAAF-accredited laboratory on probation, or 
disqualify a LAAF-accredited laboratory from submitting analytical 
reports?'') We discuss additional changes made in response to comments 
below.
    (Comment 133) Some comments disagree with the processes we proposed 
in Sec.  1.1161 regarding how FDA would follow up with a LAAF-
accredited laboratory if we identify a

[[Page 68807]]

concern with the laboratory's performance. Some comments disagree with 
the ordering of our actions because in the proposed rule, we described 
first notifying a LAAF-accredited laboratory that we were placing it on 
probation, and then allowing an opportunity for the laboratory to 
correct. Some comments assert that such a process is not consistent 
with processes in the conformity assessment arena.
    Several comments state that under the proposed rule, probationary 
status would be publicly noted on the online registry; several comments 
argue that sharing that status publicly could impede the LAAF-
accredited laboratory's business. Comments contend that professional 
courtesy and due process should dictate that the Agency provide notice 
before imposing any status changes or restrictions on a LAAF-accredited 
laboratory. These comments argue it would be unfair of FDA to imply on 
the public registry that the laboratory's performance had been 
unacceptable without first allowing the laboratory an opportunity to 
take corrective action.
    Several comments recommend that, instead, FDA should notify the 
LAAF-accredited laboratory of our concern and provide an opportunity 
for the laboratory to correct, before the Agency imposes any status 
changes. In particular some comments recommend that, if FDA has a 
concern with the LAAF-accredited laboratory's performance, FDA should 
utilize the laboratory complaint process (required by ISO/IEC 
17025:2017 section 7.9 (Ref. 3)). In the view of these comments, if 
FDA's concern has not yet been adequately addressed via the LAAF-
accredited laboratory's complaint process, then the matter should be 
raised to the recognized accreditation body. For example, some comments 
suggest that if FDA is not satisfied with a LAAF-accredited 
laboratory's corrective action, then there should be a meeting between 
FDA, the LAAF-accredited laboratory, and the recognized accreditation 
body to try and resolve the issue, before FDA proceeds to probation or 
disqualification. Some comments suggest that, after FDA places a LAAF-
accredited laboratory on probation, the laboratory be afforded an 
additional opportunity to remedy the deficiency.
    Some comments maintain that LAAF-accredited laboratories should 
have an opportunity to defend against a potentially ``hypercritical 
review'' that raises only minor problems or mistakes that do not impact 
the test results. These comments further contend that such problems or 
mistakes should not impact the laboratory's LAAF-accreditation status.
    Finally, comments encourage FDA to establish a single process for 
following up on concerns with the performance of a LAAF-accredited 
laboratory, and that process should lead only to potential probation or 
disqualification. In this view, potential or actual deficiencies in the 
performance of a LAAF-accredited laboratory should not impact the 
laboratory's eligibility to submit abridged analytical reports.
    (Response 133) After considering the comments, we agree that a 
LAAF-accredited laboratory should be afforded the opportunity to take 
corrective action on FDA notification of a deficiency prior to being 
placed on probation by FDA. Thus, we have revised Sec.  1.1161 of the 
final rule to reflect this position. Specifically, Sec.  1.1161(a) 
describes a corrective action process which relies on the complaint and 
corrective action processes required by ISO/IEC 17025:2017 sections 7.9 
and 8.7, respectively. As stated in Sec.  1.1161(b) of the final rule, 
FDA will only proceed to probation if ``FDA determines that a LAAF-
accredited laboratory has not effectively implemented corrective action 
or otherwise fails to address deficiencies identified.'' Similarly, FDA 
will only proceed to disqualify a laboratory from the LAAF program if 
we determine that ``a LAAF-accredited laboratory on probation [failed] 
to effectively implement correction action or otherwise address 
identified deficiencies.'' Id. at (c)(2). Thus, a LAAF-accredited 
laboratory will have at least two opportunities to respond to FDA 
regarding an identified deficiency before FDA disqualifies the 
laboratory from submitting analytical reports under the LAAF program.
    Some comments suggest that if the initial complaint and corrective 
action process fails to satisfy FDA, FDA should involve the recognized 
accreditation body. FDA agrees and accordingly, final Sec.  
1.1161(b)(1) provides that FDA will notify both the LAAF-accredited 
laboratory and its recognized accreditation body if we have grounds for 
probation. It is possible that a meeting between the FDA, the 
recognized accreditation body, and the LAAF-accredited laboratory may 
be beneficial at that stage, but as deficiency circumstances will vary 
greatly, we will consider that option on a case-by-case basis.
    We accept the point made in some comments that minor deficiencies 
should not result in probationary status, and agree that a small number 
of administrative errors would not form the basis for FDA to require 
corrective action. However, in the case of submissions from a LAAF-
accredited laboratory that evidence a pattern of inattention with 
regard to any requirements, it may not be unreasonable for FDA to grow 
concerned that the laboratory may also be failing to observe other, 
more substantive, details.
    Finally, after considering the comments we agree that it will be 
clearer and more efficient to forego a separate set of disciplinary 
actions regarding permission for a LAAF-accredited laboratory to submit 
abridged analytical reports. Accordingly, final Sec.  1.1161 describes 
the single path of actions that FDA can pursue against a LAAF-
accredited laboratory. For more information on permission to submit 
abridged analytical reports, see above discussion of Sec.  1.1153 at 
Response 124.
    (Comment 134) Several comments express concern with FDA's proposed 
use of the words, ``probation'' and ``revoke'' in Sec.  1.1161. Some 
comments advise that FDA should better distinguish between actions the 
FDA may take against a LAAF-accredited laboratory under this subpart, 
and the actions an accreditation body might take against a laboratory 
with regard to that laboratory's ISO/IEC 17025:2017 accreditation. Some 
comments suggest that, because FDA lacks authority to impact a 
laboratory's ISO/IEC 17025:2017 accreditation, we should clarify that 
if we place a LAAF-accredited laboratory on probation, the impact of 
our action is limited to this subpart, and not the laboratory's ISO/IEC 
17025:2017 accreditation.
    (Response 134) We agree that FDA authority under this subpart does 
not directly impact or relate to the laboratory's ISO/IEC 17025:2017 
accreditation. We have made changes throughout the final rule to 
clarify that actions taken under this subpart against LAAF-accredited 
laboratories by recognized accreditation bodies are limited to 
impacting a laboratory's LAAF-accreditation and actions taken by FDA 
are limited to impacting the laboratory's ability to conduct the tests 
described in Sec.  1.1107. Additionally, we have revised the language 
used in Sec.  1.1161 to better distinguish FDA and recognized 
accreditation body actions under this subpart. For example, we use the 
terms, ``reduce the scope'' and ``withdraw'' to describe the actions a 
recognized accreditation body may take with respect to LAAF-
accreditation and we use the word, ``disqualify'' to describe the 
action FDA may take with regard to a laboratory's eligibility to 
conduct the testing described in Sec.  1.1107. For a full discussion of

[[Page 68808]]

terminology revisions in the final rule, see Response 10, above.
    (Comment 135) A few comments request clarification of exactly when 
a LAAF-accredited laboratory would be placed on probation. We 
understand these comments to be expressing confusion over what 
``probation'' means in this context, because it is not a familiar 
concept in the realm of conformity assessment (e.g., neither ISO/IEC 
17011:2017 or ISO/IEC 17025:2017 contemplate probation).
    (Response 135) We first note that in light of the comments, FDA 
changed several terms in the final rule. We are now using separate 
terms for actions taken by FDA and recognized accreditation bodies with 
regard to LAAF-accredited laboratories, to better delineate the roles 
of FDA and the recognized accreditation bodies under this subpart. In 
the final rule, FDA may place a LAAF-accredited laboratory on 
``probation'' but the recognized accreditation body ``suspends'' a 
laboratory's LAAF-accreditation.
    Also in light of the comments, we substantively revised the grounds 
for probation of a LAAF-accredited laboratory. In the proposed rule, 
probation was reserved for less serious laboratory deficiencies than 
the deficiencies that might lead to FDA disqualification of the LAAF-
accredited laboratory. In the final rule, FDA will use a single path 
for all laboratory deficiencies and that single path will typically 
involve at least a three-step process: Corrective action, then 
probation if the corrective action is not effective, followed by 
disqualification if additional actions taken during probation are 
ineffective. Thus, final Sec.  1.1161(b) provides that probation may 
occur when ``FDA determines that a LAAF-accredited laboratory has not 
effectively implemented corrective action or otherwise fails to address 
deficiencies identified.'' Note, however, that we reserve the option to 
disqualify a LAAF-accredited laboratory without prior corrective action 
or probation in certain egregious cases described in Sec.  1.1161(c)(1) 
of the final rule.
4. What are the consequences if FDA puts a LAAF-accredited laboratory 
on probation or disqualifies a LAAF-accredited laboratory (Sec.  
1.1162)?
    Proposed Sec.  1.1162 describes the consequences of FDA placing a 
LAAF-accredited laboratory on probation or disqualifying the laboratory 
from submitting analytical reports under the program. Proposed 
paragraph (a) stated that the disqualified laboratory is immediately 
ineligible to conduct testing under this subpart either in part or in 
whole, depending on the extent of the disqualification, and a 
laboratory on probation may continue to conduct testing under this 
subpart.
    Proposed paragraph (b) stated that FDA may refuse to consider 
testing conducted prior to disqualification if the basis for the 
disqualification indicates that the specific food testing previously 
conducted may not be reliable. Proposed paragraph (c) provided that a 
disqualified laboratory must notify FDA of a records custodian within 
10 days. Proposed paragraph (d) stated that a laboratory on probation 
or that has been disqualified must notify any owners or consignees for 
whom it is conducting testing under this subpart, that it is on 
probation or has been disqualified.
    We have updated this section of the final rule to incorporate 
updated terminology and to make other conforming changes to denote that 
probation and disqualification by FDA can be on a method-specific 
basis. On our own initiative, we relocated the requirement that the 
laboratory notification regarding the records custodian be submitted to 
FDA electronically and in English in Sec.  1.1162(c) of the proposed 
rule to Sec.  1.1110 in the final rule. We also made minor editorial 
changes to improve clarity and readability of the section. We received 
no comments solely related to this section.

K. Comments Regarding Requesting FDA Reconsideration or Regulatory 
Hearings of FDA Decisions Under This Subpart

Table 12--Changes Regarding Requesting FDA Reconsideration or Regulatory
              Hearings of FDA Decisions Under This Subpart
------------------------------------------------------------------------
           Final rule                Proposed rule           Notes
------------------------------------------------------------------------
Requesting FDA Reconsideration    Requesting FDA      Revised to reflect
 or Regulatory Hearings of FDA     Reconsideration,    the contents of
 Decisions Under This Subpart.     FDA Internal        the sections
                                   Review, or          included.
                                   Regulatory
                                   Hearings of FDA
                                   Decisions Under
                                   This Subpart.
Sec.   1.1171 How does an         Sec.   1.1171 How   No changes to the
 accreditation body request        does an             section title.
 reconsideration by FDA of a       accreditation
 decision to deny its              body request
 application for recognition,      reconsideration
 renewal, or reinstatement?        by FDA of a
                                   decision to deny
                                   its application
                                   for recognition,
                                   renewal, or
                                   reinstatement?
Sec.   1.1173 How does an         Sec.   1.1173 How   Revised to reflect
 accreditation body or             does an             new terminology.
 laboratory request a regulatory   accreditation
 hearing on FDA's decision to      body or
 revoke the accreditation body's   laboratory
 recognition or disqualify a       request a
 LAAF-accredited laboratory?       regulatory
                                   hearing on FDA's
                                   decision to
                                   revoke the
                                   recognized
                                   accreditation
                                   body's
                                   recognition or
                                   revoke the
                                   accredited
                                   laboratory's
                                   accreditation?
Sec.   1.1174 How does an owner   Sec.   1.1174 How   Revised to reflect
 or consignee request a            does an owner or    new terminology.
 regulatory hearing on a           consignee request
 directed food laboratory order?   a regulatory
                                   hearing on a food
                                   testing order?
------------------------------------------------------------------------

    (Comment 136) Some comments suggest that regulatory hearings be 
held for decisions relating to FDA acceptance of test reports (full or 
abridged) from LAAF-accredited laboratories.
    (Response 136) We decline to expand the availability of regulatory 
hearings to this situation. The mere acceptance of test reports from 
LAAF-accredited laboratories does not constitute regulatory action for 
which a hearing under part 16 is available or would be warranted. To 
the extent comments suggest a regulatory hearing should be available 
regarding whether a LAAF-accredited laboratory has met the criteria 
specified in Sec.  1.1153 and thus may submit abridged analytical 
reports, as discussed in Response 124, we have revised the final rule 
based on the comments received to facilitate a more streamlined process 
for obtaining FDA permission to submit abridged analytical reports. In 
addition, under the final rule, if FDA identifies a deficiency in an 
abridged analytical report, such deficiencies are handled the same way

[[Page 68809]]

we would handle a deficiency in a full analytical report. Under Sec.  
1.1161 of the final rule, that means the laboratory generally has an 
opportunity to pursue corrective action before experiencing any 
negative consequences such as probation and loss of permission to 
submit abridged analytical reports. In our view, this process will be 
more productive and efficient than holding regulatory hearings in each 
case. Further, as discussed above in Response 57, permission to submit 
abridged analytical reports will not be included on the public registry 
described in Sec.  1.1109. This decision mitigates any potential 
negative impact on a LAAF-accredited laboratory and obviates the need 
for a formal regulatory hearing.
1. How does an accreditation body request reconsideration by FDA of a 
decision to deny its application for recognition, renewal, or 
reinstatement (Sec.  1.1171)?
    Proposed Sec.  1.1171 described the processes for an accreditation 
body to request that FDA reconsider its decision to deny an application 
either for recognition, renewal, or reinstatement. In paragraph (a), we 
proposed that an accreditation body must submit a reconsideration 
request within 10 business days after FDA issues the denial. In 
paragraph (b), we proposed that the reconsideration request must be 
signed and submitted in English, electronically, and in compliance with 
whatever procedures are described in the denial notice. In paragraph 
(c), we proposed that after reviewing and evaluating the 
reconsideration request, FDA would notify the accreditation body of our 
decision.
    On our own initiative, we relocated the requirement that the 
reconsideration request be submitted to FDA electronically and in 
English in Sec.  1.1171(b) of the proposed rule to Sec.  1.1110 in the 
final rule. Additionally, we clarify in Sec.  1.1171(b) that the 
request must include any supporting information. Comments regarding 
this section are discussed below.
    (Comment 137) Some comments suggest that prior to denying an 
accreditation body's application for recognition, renewal, or 
reinstatement, FDA should provide the reason for the proposed denial 
and allow the accreditation body the opportunity to address FDA's 
concerns.
    (Response 137) Procedures outlined in other sections of this final 
rule provide the notice and opportunity requested by these comments. 
With regard to an application for recognition or renewal, Sec.  
1.1115(a) provides that FDA will notify the applicant of any 
insufficiencies. FDA views the accreditation body application process 
as iterative; as stated in 1.1115(a), we will notify the applicant of 
any insufficiencies and provide an opportunity for the accreditation 
body to complete the application, before we evaluate it under Sec.  
1.1115(b).
    With regard to reinstatement, under Sec.  1.1117 an accreditation 
body seeks recognition by submitting a new application. The new 
application would be processed as described under Sec.  1.1115. Note 
that an accreditation body that has had its recognition revoked by FDA 
is also required to submit evidence that the ground(s) for revocation 
have been resolved; for more information see the discussion of Sec.  
1.1117(a), above.
2. How does an accreditation body or laboratory request a regulatory 
hearing on FDA's decision to revoke the accreditation body's 
recognition or disqualify a LAAF-accredited laboratory (Sec.  1.1173)?
    Proposed Sec.  1.1173 described the processes for a regulatory 
hearing concerning a decision by the Agency to revoke an accreditation 
body's recognition or disqualify a laboratory from the LAAF program.
    In paragraph (a) we proposed that an entity must submit a request 
for a regulatory hearing within 10 business days after FDA issued a 
revocation of recognition or disqualification. We proposed that the 
hearing would be conducted under part 16 and that the revocation or 
disqualification notice would contain all necessary elements to 
constitute the notice of an opportunity for hearing under part 16 of 
this chapter. In brief, in paragraph (b) we proposed that the hearing 
request must be written and respond to the bases for FDA's 
determinations described in the notice.
    Proposed paragraph (c) stated that the submission of a request for 
a hearing will not operate to delay or stay FDA's decision to revoke or 
disqualify, unless FDA determines that delay or a stay is in the public 
interest. Proposed paragraph (d) stated that the presiding officer 
would be designated after the hearing request is submitted to FDA and 
proposed paragraph (e) stated that the presiding officer may deny the 
hearing request under Sec.  16.26(a). Proposed paragraph (f) addressed 
the conduct of the hearing.
    In the proposed rule, we used the word, ``revocation'' in this 
section, to refer to FDA removing a laboratory from the program. We 
received comments expressing concern with that terminology and have 
revised our phrasing in light of such concerns, as discussed above at 
Response 10. On our own initiative, we relocated the requirement that 
the reconsideration request be submitted to FDA electronically and in 
English in Sec.  1.1173(b) of the proposed rule to Sec.  1.1110 in the 
final rule. We received no other comments solely related to this 
section and so have only made minor editorial and conforming changes 
(e.g., FDA may ``disqualify'' a laboratory rather than ``revoke the 
laboratory's accreditation'') to the section, including the section 
title.
3. How does an owner or consignee request a regulatory hearing on a 
directed food laboratory order (Sec.  1.1174)?
    Proposed Sec.  1.1174 described the processes for a regulatory 
hearing concerning a directed food laboratory order. In paragraph (a) 
we proposed that an owner or consignee must submit a request for a 
regulatory hearing within 24 hours. We proposed that the hearing would 
be conducted under part 16 and that the directed food laboratory order 
would contain all necessary elements to constitute the notice of an 
opportunity for hearing under part 16 of this chapter.
    In brief, in paragraph (b) we proposed that the hearing request 
must be written and respond to the bases for FDA's determinations 
described in the directed food laboratory order. Proposed paragraph (c) 
stated that the presiding officer would be designated after the hearing 
request is submitted to FDA and proposed paragraph (d) stated that the 
presiding officer may deny the hearing request under Sec.  16.26(a). 
Proposed paragraph (e) addressed the conduct of the hearing.
    On our own initiative, we relocated the requirement that the 
reconsideration request be submitted to FDA electronically and in 
English in Sec.  1.1174(b) of the proposed rule to Sec.  1.1110 in the 
final rule. We also revised the section to incorporate updated 
terminology and made minor editorial changes to improve the clarity and 
readability of the section. We discuss changes made in response to 
comments below.
    (Comment 138) Several comments disagree with the proposed hearing 
process for a directed food laboratory order because they contend it 
would not afford sufficient due process protections to owners or 
consignees. Specifically, comments raise concerns that the hearing 
process under part 16 is discretionary and that an owner or consignee 
must request a hearing by filing an appeal within 24 hours. These 
comments state that the hearing should be guaranteed if requested. 
Further,

[[Page 68810]]

these comments argue that 24 hours is not enough time to request the 
hearing upon receipt of a directed food laboratory order, and that this 
timeframe is also not warranted from a public health standpoint. 
Instead, comments recommend more time, up to 10 days, as a reasonable 
timeframe in which to review the directed food laboratory order and 
prepare the request. Comments state the hearing should provide the 
opportunity to determine the appropriate scope of the directed food 
laboratory order and the ability to lift or vacate the directed food 
laboratory order. Comments suggest that the hearing process used for 
the facility registration suspension and mandatory recalls would be 
more appropriate.
    (Response 138) After considering the comments, we agree that 24 
hours may not be sufficient time to request a regulatory hearing on a 
directed food laboratory order. Part 16 of this chapter, which provides 
for regulatory hearings before the FDA, provides not less than 3 
working days after receipt of the notice to request a hearing (see 
Sec.  16.22(b)). We have therefore revised Sec.  1.1174(a) to state 
that the hearing request under this subpart must be submitted within 3 
business days, to align with the intent of part 16 of this chapter. We 
decline the request to establish a 10-day deadline because we consider 
the 3 business days applicable in other part 16 contexts to be 
sufficient in the directed food laboratory order context as well.
    We also decline to adopt the hearing processes for facility 
registration suspension and mandatory recalls. The statute guarantees 
the opportunity for a hearing on the suspension of a food facility 
registration ``to be held as soon as possible, but not later than two 
business days after the issuance of the order . . .'' unless FDA and 
the registrant agree otherwise (section 415(b)(2) of the FD&C Act). 
Similarly, the statute guarantees the opportunity for an informal 
hearing regarding a mandatory recall order ``to be held as soon as 
possible, but not later than 2 days after the issuance of the order . . 
. . '' (section 423(c) of the FD&C Act). In contrast, section 422 of 
the FD&C Act does not provide for a guaranteed hearing process. 
Therefore we believe the discretionary hearing process proposed, which 
incorporates existing procedures in 21 CFR part 16, is appropriate with 
respect to directed food laboratory orders. Under Sec.  16.26(a), a 
hearing request may be denied, in whole or in part, if ``no genuine and 
substantial issue of fact has been raised by the material submitted.''
    With regard to the comments' contention that the hearing should 
provide the opportunity to determine the appropriate scope of the 
directed food laboratory order and the ability to lift or vacate the 
directed food laboratory order, we believe this is inherent in the 
procedure specified in Sec.  16.60, which permits the presentation of 
any oral or written information relevant to the hearing, and which 
grants the presiding officer power to take any actions necessary or 
appropriate to conduct a fair, expeditious, and impartial hearing.

L. Comments Regarding Electronic Records and Public Disclosure 
Requirements

1. Are electronic records created under this subpart subject to the 
electronic records requirements of part 11 of this chapter (Sec.  
1.1199)?
    In Sec.  1.1199 of the proposed rule, we proposed to exempt from 
the requirements of part 11 (21 CFR part 11) those records that meet 
the definition of electronic records in Sec.  11.3(b)(6) and were 
established or maintained to satisfy the requirements of this subpart.
    (Comment 139) Comments on this aspect of the proposed rule voice 
support for the proposed exemption. Comments contend that requiring 
such records to comply with the requirements in 21 CFR part 11 would be 
unnecessarily burdensome.
    (Response 139) We appreciate support for this section and have 
finalized it without change.
2. Are the records obtained by FDA under this subpart subject to public 
disclosure (Sec.  1.1200)?
    Proposed Sec.  1.1200 stated that records obtained by FDA under 
this subpart are subject to the disclosure requirements under 21 CFR 
part 20. We received no comments on this section and have finalized the 
section without change.

M. Comments on Conforming and Technical Amendments and FDA Response

    The proposed rule contained several conforming and technical 
amendments.
    We proposed revising the requirements for certain analyses under 
the Accredited Third-Party Certification Program. Specifically, we 
proposed to revise Sec.  1.651(b)(3) to require use of a laboratory 
that is accredited in accordance with ISO/IEC 17025:2017 to perform 
certain analyses for a regulatory audit. We also proposed to update the 
cross-reference in paragraph (c)(2) of the same section.
    We received no comments on these proposed changes. Thus, we have 
finalized these changes as proposed, with one minor exception. In final 
Sec.  1.651(c)(2), we changed, ``Federal Food, Drug, and Cosmetic 
Act,'' to ``FD&C Act'' to be consistent with references to the statute 
in the regulations for the Accredited Third-Party Certification Program 
in part 1, subpart M.
    We proposed to amend Sec.  11.1 regarding the scope of the 
electronic records and electronic signatures regulations to add 
paragraph (p) which states that part 11 does not apply to records 
required to be established or maintained by part 1, subpart R of this 
chapter (i.e., the LAAF regulations). However, records that satisfy the 
requirements of subpart R of part 1 of this chapter (i.e., the LAAF 
regulations), but that are also required under other applicable 
statutory provisions or regulations, remain subject to part 11.
    We received no comments regarding this conforming amendment. Thus, 
we have finalized these changes as proposed.
    We proposed conforming amendments to revise FDA's regulatory 
hearing regulations at Sec.  16.1(b)(2) to include Sec. Sec.  1.1173 
and 1.1174 in the list of regulations covered by this part. We received 
no comments directly related to these conforming amendments. On our own 
initiative, we changed, ``revocation of accreditation'' to 
``disqualification,'' consistent with the terminology changes discussed 
in Response 10, and ``food testing order'' to ``directed food 
laboratory order,'' consistent with the change in terminology discussed 
in the definitions section (Sec.  1.1102). In relation to the directed 
food laboratory order, we also replaced the reference to Sec.  
1.1107(a)(2) with a reference to Sec.  1.1108, consistent with the 
reference we are providing in the definition of directed food 
laboratory order (see Sec.  1.1102).
    We proposed revising the bottled drinking water regulations in 21 
CFR 129.35 to state 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.'' We received a few comments on that 
proposal and are finalizing the revision without change; see comment 
and Response 87.

VI. Effective Date

    This final rule will be effective 60 days after publication in the 
Federal Register. For information on implementation of the final rule, 
see the discussion under that subheading in section V.B. of this 
preamble.

[[Page 68811]]

VII. Economic Analysis of Impacts

    We have examined the impacts of the final rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). Executive Orders 12866 and 13563 direct 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). We 
believe that this final rule is not a significant regulatory action as 
defined by Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. Because the per-entity one-time costs of the rule may exceed 
one percent of revenues for accreditation bodies that choose to 
participate in the LAAF program, we find that the final rule will 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 $158 million, using the most current (2020) Implicit 
Price Deflator for the Gross Domestic Product. This final rule would 
not result in an expenditure in any year that meets or exceeds this 
amount.
    We have developed a comprehensive Economic Analysis of Impacts that 
assesses the impacts of this rule. In table 13 we provide the 
Regulatory Information Service Center and Office of Information and 
Regulatory Affairs Consolidated Information System accounting 
information.

                Table 13--Summary of Benefits, Costs and Distributional Effects of Final Rule \1\
----------------------------------------------------------------------------------------------------------------
                                                                            Units
                                    Primary     Low      High   ----------------------------
             Category              estimate  estimate  estimate    Year   Discount   Period         Notes
                                                                 dollars  rate (%)  covered
----------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized Monetized               $9.1      $6.6     $12.5     2020         7       10  Cost savings and
     $millions/year.                                                                  years   avoided QALD
                                                                                              losses.
                                        9.1       6.6      12.5     2020         3       10  Cost savings and
                                                                                      years   avoided QALD
                                                                                              losses.
    Annualized Quantified........  ........  ........  ........  .......         7  .......  ...................
                                   ........  ........  ........  .......         3  .......  ...................
                                  ------------------------------------------------------------------------------
    ,nQualitative................  Reduced risk of food-related
                                   illness from improved test
                                   performance for covered
                                   tests. Cost savings from
                                   clarifying reporting
                                   requirements and from
                                   allowing abridged analytical
                                   reports.
                                   Reduced risk of food-related
                                   illness from unsafe food
                                     manufacturing practices.
 
----------------------------------------------------------------------------------------------------------------
Costs:
    Annualized Monetized                7.9       5.8       9.6     2020         7       10
     $millions/year.                    7.9       5.9       9.7     2020         3    years
                                                                                         10
                                                                                      years
    Annualized Quantified........  ........  ........  ........  .......         7           ...................
                                                                                 3
    Qualitative..................  ........  ........  ........  .......  ........           ...................
----------------------------------------------------------------------------------------------------------------
Transfers
    Federal Annualized Monetized   ........  ........  ........  .......         7           ...................
     $millions/year.                                                             3
                                  ------------------------------------------------------------------------------
    From/To......................  From:
                                   To:                           .......  ........  .......  ...................
                                  ------------------------------------------------------------------------------
    Other........................  ........  ........  ........  .......         7           ...................
                                  ------------------------------------------------------------------------------
    Annualized Monetized           ........  ........  ........  .......         3           ...................
     $millions/year.
    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 LAAF program described by this rule.
    Wages: None.................................................................................................
    Growth: None................................................................................................
----------------------------------------------------------------------------------------------------------------
\1\ The lower bound equals the 5th percentile and the upper bound equals the 95th percentile.

[[Page 68812]]

    The full analysis of economic impacts is available in the docket 
for this final rule (Ref. 4) and at https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.

VIII. Analysis of Environmental Impact

    We previously considered the environmental effects of this rule, as 
stated in the proposed rule (84 FR 59452 at 59496). We stated that we 
had determined, 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'' such that neither an environmental assessment 
nor an environmental impact statement is required. We have not received 
any new information or comments that would affect our previous 
determination (Ref. 22).

IX. Paperwork Reduction Act of 1995

    This final rule contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The title, 
description, and respondent description of the information collection 
provisions are shown in the following paragraphs with an estimate of 
the annual reporting and recordkeeping burden. Included in the estimate 
is the time for reviewing instructions, searching existing data 
sources, gathering and maintaining the data needed, and completing and 
reviewing each collection of information.
    Title: Laboratory Accreditation for Analyses of Foods; OMB Control 
Number 0910-0898.
    Description: As mandated by section 422 of the FD&C Act, we are 
establishing a program for the testing of food by accredited 
laboratories (LAAF program); establishing the standards and procedures 
for recognizing accredited laboratories and for recognized 
accreditation bodies that LAAF-accredit laboratories; establishing a 
publicly available registry of recognized accreditation bodies and 
LAAF-accredited laboratories; and establishing procedures for reporting 
any changes affecting the recognition of such accreditation bodies or 
LAAF-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 LAAF-
accreditation from recognized accreditation bodies, and LAAF-accredited 
laboratories.
    We estimate the burden of the information collection as follows:

                                   Table 14--Estimated Annual Reporting Burden
----------------------------------------------------------------------------------------------------------------
                                                   Number of                     Average burden
  Part 1, Subpart R Citation;      Number of     responses per   Total annual   per response (in    Total hours
           Activity               respondents     respondent       responses         hours)
----------------------------------------------------------------------------------------------------------------
Sec.  Sec.   1.1113 and                      4               1               4  20..............              80
 1.1114; Accreditation bodies
 (ABs) application for
 recognition (one-time
 submission).
Sec.  Sec.   1.1113 and                      4               1               4  3.6.............            14.4
 1.1114; ABs--application for
 renewal of recognition.
Sec.   1.1116(a) and (b); ABs--              0               3               0  3...............               0
 notices of intent to
 relinquish, records custodian.
Sec.   1.1123; ABs--reports,                 4              42             168  1.75............             294
 notifications, and
 documentation requirements.
Sec.  Sec.   1.1138 and                    170               1             170  20..............           3,400
 1.1139; laboratories--
 submission of application for
 LAAF-accreditation (one-time
 submission).
Sec.   1.1140(a);                            2               3               6  1...............               6
 laboratories--notices of
 intent to relinquish, records
 custodian.
Sec.  Sec.   1.1149(a) and                 170              25           4,250  1.75............         7,437.5
 1.1152(c)(1), (2);
 laboratories--submission of
 sampling plan, sample
 collection report, and
 sampler qualifications.
Sec.  Sec.   1.1152(d) and                 170              10           1,700  2...............           3,400
 1.1153(a); laboratories--
 qualification to submit
 abridged analytical reports
 (one-time submission).
Sec.   1.1153; laboratories--              170              25           4,250  1.16............           4,930
 abridged analytical reports
 submissions.
Sec.   1.1152(c)(3), (4), and                9               1               9  .25 (15 minutes)            2.25
 (5); laboratories--validation
 and verification studies
 submissions.
Sec.   1.1149(c);                          170               1             170  1.5.............             255
 laboratories--advance notice
 of sampling submissions.
Sec.   1.1152(f);                          170             1.5             255  .25 (15 minutes)           63.75
 laboratories--immediate
 notification.
Sec.  Sec.   1.1142; 1.1171;                 1               1               1  1...............               1
 1.1173; and 1.1174--requests
 in response to FDA action.
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................        19,883.9
----------------------------------------------------------------------------------------------------------------

    Reporting Burden: Consistent with estimates in our FRIA (see 
section II.F, Costs of this Rule (Ref. 4)), we estimate a total of 174 
respondents. We estimate that 5 to 80 accreditation bodies could apply 
for FDA recognition under this final rule and assume that 4 
accreditation bodies will apply for FDA recognition. We estimate 170 
laboratories will participate in the program. The reporting burden 
includes a burden of 20,640 hours associated with one-time submissions. 
In this analysis, we annualize the one-time submission burden using a 
3-year

[[Page 68813]]

period horizon and zero percent discount rate, for an annualized one-
time reporting burden of 6,880 hours. Cumulatively, this results in a 
total annual reporting burden of 19,883.9 hours, as reflected in table 
14.
    Section 1.1114 requires an accreditation body seeking initial 
recognition to submit an application to FDA demonstrating it meets the 
eligibility requirements described in Sec.  1.1113 of the final rule. 
The burden to prepare and submit an application is an initial burden 
and, once realized, would apply only to respondents new to the program. 
We estimate this process would take one analyst between 40 and 80 hours 
to compile all the relevant information, prepare for an assessment, 
complete the 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 80 hours 
of burden for initial applications submitted by 4 accreditation bodies 
(4 applications x 20 hours per application), as reflected in row 1.
    Section 1.1114 requires a recognized accreditation body 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 
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 4 accreditation 
bodies for a total of 14.4 hours annually for the submission of renewal 
of applications (4 applications x 3.6 hours per application), as 
reflected in row 2.
    Section 1.1116 requires that if a recognized accreditation body 
voluntarily chooses to relinquish or not renew its recognition, it must 
notify FDA and the laboratories it LAAF-accredits of its intention to 
depart the program at least 60 days ahead of the departure. The 
recognized accreditation body must also provide FDA with the name and 
contact information of the custodian who will maintain and make 
available to FDA requisite program records. We estimate a 1 percent 
voluntary departure rate, which equates to the departure of 0.04 
recognized accreditation body annually. We estimate it would take a 
recognized accreditation body one hour for each of the three required 
notices. Accordingly, with rounding, the estimate for the burden 
associated with Sec.  1.1116 is zero (0.04 recognized accreditation 
body x 3 notices = .12 annual responses, which rounds to 0; 0 annual 
response x 3 hours = 0 total hours), as reflected in row 3.
    Section 1.1123 requires a recognized accreditation body to submit 
certain reports, notifications, and documentation to FDA, including 
significant changes affecting its accreditation program or the 
accreditation status of laboratories it LAAF-accredits, and to ensure 
FDA has access to these and other records. We estimate recognized 
accreditation bodies would incur a burden of 3.5 hours per month, or 42 
hours per year, complying with the reporting requirements of Sec.  
1.1123 and the recordkeeping requirements of Sec.  1.1124. For this 
analysis, we identify recordkeeping and reporting burdens separately 
and assume 21 of the 42 hours (i.e., 1.75 hours per month) would be 
spent meeting the reporting requirements of Sec.  1.1123. Annually, 
this results in 294 hours (4 recognized accreditation bodies x 42 
responses per accreditation body x 1.75 hours per response), as 
reflected in row 4.
    Section 1.1139 requires a laboratory seeking LAAF-accreditation to 
submit an application to a recognized accreditation body, demonstrating 
that it meets the eligibility requirements specified in Sec.  1.1138. 
We estimate 170 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 170 laboratories being 
3,400 hours (170 applications x 20 hours per application), as reflected 
in row 5.
    Section 1.1140 provides that if a laboratory voluntarily chooses to 
relinquish or not renew its LAAF-accreditation, it must notify FDA and 
its recognized accreditation body of its intention to do so at least 60 
days ahead of the departure. If the laboratory is voluntarily 
relinquishing or not renewing all methods within its scope, it must 
also provide FDA with the name and contact information of the custodian 
who will maintain and make available to FDA requisite program records. 
We estimate a 1 percent program departure rate, which equates to the 
departure of 1.70 LAAF-accredited laboratories each year, which we 
round to 2. We estimate it would take a laboratory one hour for each of 
the three required notices. Accordingly, we estimate a burden of 6 
hours per year under Sec.  1.1140 (2 laboratories x 3 notices = 6 
annual responses; 6 annual responses x 1 hour = 6 total hours), as 
reflected in row 6.
    Section 1.1152(a) through (e) requires a LAAF-accredited laboratory 
to submit results of testing required to be conducted under the LAAF 
program and include supporting documentation. 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 4,065 test result and supporting documentation 
submissions (4,065.2 rounded to the nearest integer) 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 50 submissions for a total of 4,115.
    Section 1.1152(c)(1) requires a LAAF-accredited laboratory to 
submit a sample collection plan and sample collection report (the 
contents of which are described in Sec.  1.1149(a)) with each test 
result. Under Sec.  1.1152(c)(2), a LAAF-accredited laboratory must 
include documentation of the sampler's qualifications the first time 
the sampler collects a sample. We assume that it would take 30 minutes 
to 1 hour to compile a sampling plan, 30 minutes to 1 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 
qualifications. 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 time per test 
result 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 qualification requirements (170 
accredited laboratories x 25 sampling plans and sample collection 
reports x 1.75 hours) is 7,437.5 hours, as reflected in row 7.
    Section 1.1153(a) allows a LAAF-accredited laboratory to qualify to 
submit abridged analytical reports in lieu of full analytical reports. 
We expect

[[Page 68814]]

this will be a one-time burden, but we may revisit this assumption in 
the future based on actual rates of revocation of permission to submit 
abridged analytical reports. We assume that each LAAF-accredited 
laboratory would submit 10 consecutive full analytical reports (for the 
middle value of 2 major food testing disciplines per laboratory) to 
qualify to submit abridged analytical reports. We also assume that a 
LAAF-accredited laboratory will 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 LAAF-accredited 
laboratories to qualify to submit abridged analytical reports of 3,400 
hours (170 laboratories x 10 full analytical reports each x 2 hours per 
analytical report), as reflected in row 8.
    Once a LAAF-accredited laboratory qualifies to submit abridged 
analytical reports, we assume it will submit abridged analytical 
reports to us thereafter. We may revisit this assumption in the future 
based on actual rates of revocation of permission to submit abridged 
analytical reports. 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 a LAAF-accredited laboratory 1.16 hours to 
compile and submit an abridged analytical report (29 percent x 4 
hours). This results in an annual total reporting burden for the 170 
LAAF-accredited laboratories to compile and submit abridged analytical 
reports of approximately 4,930 hours (170 laboratories x 25 abridged 
analytical reports x 1.16 hours per abridged analytical report), as 
reflected in row 9.
    The final rule also requires a LAAF-accredited laboratory to submit 
verification and validation studies to FDA as part of an analytical 
report. The ISO/IEC 17025:2017 standard requires the use of validated 
and verified methods for food testing. However, the final rule requires 
additional verification studies over and above the requirements of ISO/
IEC 17025:2017. 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 a 
LAAF-accredited laboratory to submit verification studies such as 
matrix extensions under this final rule to be a middle value of 
approximately 3 percent of the time burden incurred by laboratories to 
maintain accreditation to ISO/IEC 17025:2017 (the FRIA estimates a 
range of 1 percent to 5 percent). In the FRIA 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.
    Regarding validation requirements, we assume that methods used to 
test shell eggs, sprouts, and bottled drinking water are either already 
validated or that the costs of doing so would be included in the costs 
to maintain ISO/IEC 17025:2017 accreditation. Consequently, we assume 
that shell eggs, sprouts, and bottled drinking water producers would 
incur no burden from this requirement beyond the burden of the final 
rule's requirement to meet the validation requirements of ISO/IEC 
17025:2017.
    We estimate the time required to perform a matrix extension is a 
middle value of 34 hours (the FRIA 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 final rule would be approximately 3 percent of the time 
burden incurred by laboratories to maintain accreditation to ISO/IEC 
17025:2017, we multiply 8.5 hours by 3 percent to get the additional 
reporting burden of .255 hours (15.3 minutes, which we round to 15 
minutes, which is .25 hours) per study imposed by the verification 
study submission requirements of the final 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 .3241 matrix 
extensions per LAAF-accredited laboratory conducting food testing for 
imports (8.75 / 27). Because the number of respondents and the annual 
responses per respondent in a PRA analysis must be whole numbers, we 
instead estimate that nine LAAF-accredited laboratories (27 x .3241, 
rounded to 9 from 8.75) 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 final rule 
is 2.25 hours (9 accredited laboratories x 1 verification studies x .25 
hours per study), as reflected in row 10.
    Under section 1.1149(c), FDA may require under certain 
circumstances, that a LAAF-accredited laboratory 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 LAAF-accredited 
laboratory will analyze under the LAAF program. We assume that it would 
take a laboratory analyst between 1 and 2 hours to compile and submit 
the required information, and we assume that between one percent and 
five percent of all test results submitted annually under the LAAF 
program will be subject to the advance notice of sampling requirement. 
For this analysis we assume middle values of 1.5 hours and three 
percent, respectively. Thus, we estimate that 123.45 test results 
(4,115 x 3%) will require submission of advance notice of sampling 
under the final rule. For this analysis we assume that each of the 
estimated 170 LAAF-accredited laboratories will be required to submit 
three advance notices sampling annually under the final rule (123.45 / 
170 = 0.74; rounded to 1). Thus, the annual reporting burden on LAAF-
accredited laboratories for the advance notice of sampling requirement 
would be 255 hours (170 laboratories x 1 advance notices of sampling x 
1.5 hours), as reflected in row 11.
    Section 1.1152(f) requires a LAAF-accredited laboratory to notify 
FDA and the recognized accreditation body of any changes that affect 
the laboratory's LAAF-accreditation. Note, however, that a LAAF-
accredited laboratory is not required to notify FDA of changes that the 
recognized accreditation body must provide to FDA under Sec.  
1.1123(d). As a conservative estimate, we assume that each LAAF-
accredited laboratory will have some change requiring notification of 
its recognized accreditation body, and for half of those changes the 
LAAF-accredited laboratory will also need to notify FDA. We estimate it 
will take a LAAF-accredited laboratory 15 minutes per notification. 
Thus, we estimate the burden associated with Sec.  1.1152(f) would be 
63.75 hours (170 accredited laboratories x 1.5 notifications x 0.25 
hours per notification), as reflected in row 12.

[[Page 68815]]

    Sections 1.1142, 1.1171, 1.1173, and 1.1174 provide for requests to 
FDA. Specifically, Sec.  1.1142 provides for requests for reinstatement 
of LAAF 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 
estimate a cumulative total of 1 respondent and 1 burden hour, as 
reflected in row 13.

                                 Table 15--Estimated Annual Recordkeeping Burden
----------------------------------------------------------------------------------------------------------------
                                                                                  Average burden
    21 CFR part 1, subpart R;        Number of       Number of     Total annual         per
            activity               recordkeepers    records per       records      recordkeeping    Total hours
                                                   recordkeeper                     (in hours)
----------------------------------------------------------------------------------------------------------------
Sec.   1.1113; recordkeeping                   4               1               4               1               4
 associated with ISO/IEC
 17011:2017.....................
Sec.   1.1124; ABs--additional                 4               1               4              21              84
 recordkeeping requirements.....
Sec.   1.1138; laboratories--                  9               1               9           91.06          819.54
 becoming accredited to ISO/IEC
 17025:2017 (one-time)..........
Sec.   1.1138; laboratories--                170               1             170          889.53      151,220.10
 maintaining ISO/IEC 17025:2017
 accreditation..................
Sec.   1.1154; laboratories--                170               1             170              12           2,040
 additional recordkeeping
 requirements...................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............      154,167.64
----------------------------------------------------------------------------------------------------------------

    Recordkeeping Burden: We estimate the annual recordkeeping 
requirements associated with the final rule to be 154,167.64 hours, as 
reflected in table 15.
    Section 1.1113 requires a recognized accreditation body to meet the 
requirements of ISO/IEC 17011:2017. While ISO/IEC 17011:2017 includes 
recordkeeping requirements, as noted above we anticipate that all 4 of 
the accreditation bodies that we estimate will apply to become 
recognized currently adhere to ISO/IEC 17011:2017. 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.
    Section 1.1124 requires maintenance of certain records in addition 
to those required by ISO/IEC 17011:2017. We estimate that a recognized 
accreditation body will incur a burden of 12 hours per year to comply 
with both the recordkeeping requirements of Sec.  1.1124 and the 
reporting requirements of Sec.  1.1123. For this analysis, we identify 
the recordkeeping and reporting burdens separately, assuming 21 of 
those 42 annual hours would be spent complying with the recordkeeping 
requirements of Sec.  1.1124. Thus, the annual recordkeeping burden for 
the 4 recognized accreditation bodies to meet the additional 
recordkeeping requirements of Sec.  1.1124 would be 84 hours, as 
reflected in row 2.
    Section 1.1138 requires a laboratory to be ISO/IEC 17025:2017-
accredited, including meeting its recordkeeping requirements, to become 
LAAF-accredited under the rule. We estimate that 7 to 10 laboratories 
not currently accredited to ISO/IEC 17025:2017 would become so 
accredited to participate in the LAAF program. For this estimate, we 
assume the middle value of 8.5 laboratories, which we round up to 9, 
would become ISO/IEC 17025-accredited to participate in the LAAF 
program. The burden to become ISO/IEC 17025:2017-accredited is an 
initial burden and, once realized, would apply only to respondents 
becoming accredited to ISO/IEC 17025:2017 to participate in the LAAF 
program. We estimate that it would take a mean of 91.06 hours for the 
associated recordkeeping activities. In this analysis, we annualize 
this recordkeeping burden using a 3-year period horizon and zero 
percent discount rate, for an annualized recordkeeping burden of 819.54 
hours, as reflected in row 3.
    Section 1.1138 requires a LAAF-accredited laboratory to maintain 
conformance with ISO/IEC 17025:2017, including its recordkeeping 
requirements. As discussed in the proposed rule, we estimate a mean of 
889.53 hours for this recordkeeping. This results in an annual burden 
of 151,220.10 hours, as reflected in row 4.
    Section 1.1154 requires maintenance of certain records in addition 
to those required by ISO/IEC 17025:2017. We estimate that a LAAF-
accredited laboratory will incur a burden of about 1 hour per month (12 
hours per year) to comply with the recordkeeping requirements in Sec.  
1.1154. This results in an annual burden of 2,040 hours, as reflected 
in row 5.
    The information collection provisions in this final rule have been 
submitted to OMB for review as required by section 3507(d) of the 
Paperwork Reduction Act of 1995.
    Before the effective date of this final rule, FDA will publish a 
notice in the Federal Register announcing OMB's decision to approve, 
modify, or disapprove the information collection provisions in this 
final rule. An Agency may not conduct or sponsor, and a person is not 
required to respond to, a collection of information unless it displays 
a currently valid OMB control number.

X. Federalism

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

XI. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this rule in accordance with the principles set 
forth in Executive Order 13175. We have determined that the rule does 
not contain policies that have substantial direct effects on one or 
more Indian Tribes, on the relationship between the Federal Government 
and Indian Tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian Tribes. Accordingly, we 
conclude that the rule

[[Page 68816]]

does not contain policies that have tribal implications as defined in 
the Executive Order and, consequently, a tribal 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.

    * Ref. 1. 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 November 4, 
2021.
    Ref. 2. ISO/IEC 17011:2017(E), ``Conformity Assessment--
Requirements for Accreditation Bodies Accrediting Conformity 
Assessment Bodies.'' ISO/IEC. 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).
    Ref. 3. ISO/IEC 17025:2017(E), ``General Requirements for the 
Competence of Testing and Calibration Laboratories.'' ISO/IEC. 
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).
    * Ref. 4. FDA. LAAF: Final Regulatory Impact Analysis, Final 
Regulatory Flexibility Analysis, Unfunded Mandates Reform Act 
Analysis, 2021. https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.
    * Ref. 5. Partnership for Food Protection, ``Human and Animal 
Food Testing Laboratories Best Practices Manual,'' December 2018, 
available at https://www.pfp-ifss.org/ifss-resources/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018/. Accessed November 4, 2021.
    * Ref. 6. Association for Public Health Laboratories, ``Best 
Practices for Submission of Actionable Human and Animal Food Testing 
Data Generated in State and Local Laboratories,'' January 2019, 
available at https://www.aphl.org/aboutAPHL/publications/Documents/FS-2019Jan-Best-Practices-Human-Animal-Food-Data.pdf. Accessed 
November 4, 2021.
    * Ref. 7. The Cambridge Dictionary, https://dictionary.cambridge.org/us/dictionary/english/assess. Accessed 
November 4, 2021.
    * Ref. 8. ``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.nist.gov/system/files/revised_circular_a-119_as_of_01-22-2016.pdf. Accessed November 4, 2021.
    * Ref. 9. National Institute of Standards and Technology Special 
Publication 2000-02, ``Conformity Assessment Considerations for 
Federal Agencies,'' September 2018. https://doi.org/10.6028/NIST.SP.2000-02. Accessed November 4, 2021.
    * Ref. 10. Codex Alimentarius Commission, ``General Guidelines 
on Sampling,'' CAC/GL-50-2004. http://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXG%2B50-2004%252FCXG_050e.pdf. Accessed November 
4, 2021.
    * Ref. 11. FDA, ``Control of Listeria monocytogenes in Ready-To-
Eat Foods: Guidance for Industry,'' Draft Guidance, January 2017. 
https://www.fda.gov/media/102633/download. Accessed November 4, 
2021.
    * Ref. 12. FDA, ``Outbreak Investigation of Scombrotoxin Fish 
Poisoning: Yellowfin/Ahi Tuna (November 2019).'' https://
www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-
scombrotoxin-fish-poisoning-yellowfinahi-tuna-november-
2019#:~:text=%2C%20WV%20(1)-
,What%20is%20Scombrotoxin%20Fish%20Poisoning%3F,eating%20mishandled%2
0and%20decomposed%20fish. Accessed November 4, 2021.
    Ref. 13. AOAC International, ``Guidelines for Laboratories 
Performing Microbiological and Chemical Analyses of Food, Dietary 
Supplements, and Pharmaceuticals, An Aid to Interpretation of ISO/
IEC 17025:2017.'' August 2018. Copies are available from AOAC 
International, 2275 Research Blvd., Ste. 300, Rockville, MD 20850-
3250, USA, or on the internet at https://www.aoac.org/aoac-accreditation-guidelines-for-laboratories-alacc/, or may be examined 
at the Dockets Management Staff (Ref. Docket No. FDA-2019-N-3325 
and/or RIN 0910-AH31).
    Ref. 14. Association of American Feed Control Officials, ``2014 
Quality Assurance/Quality Control Guidelines for Feed Laboratories, 
2014.'' Copies are available from Association of American Feed 
Control Officials, 1800 South Oak St., Suite 100, Champaign, IL 
61820 or on the internet at https://www.aafco.org/Publications/QA-QC-Guidelines-for-Feed-Laboratories, or may be examined at the 
Dockets Management Staff (Ref. Docket No. FDA-2019-N-3325 and/or RIN 
0910-AH31).
    * Ref. 15. 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.
    Ref. 16. ISO/IEC 17043:2010, ``Conformity Assessment--General 
Requirements for Proficiency Testing.'' ISO/IEC. 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).
    * Ref. 17. FDA, Investigations Operations Manual, 2021. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/investigations-operations-manual. Accessed November 4, 2021.
    * Ref. 18. University of Georgia Extension, Bulletin 1306, 
``Biosecurity Basics for Poultry Growers,'' March 2020. https://secure.caes.uga.edu/extension/publications/files/pdf/B%201306_6.PDF. 
Accessed November 4, 2021.
    * Ref. 19. Association of American Food Control Officials, 
``GOODSamples: Guidance On Obtaining Defensible Samples,'' October 
2015. https://www.aafco.org/Portals/0/SiteContent/Publications/GOODSamples.pdf. Accessed November 4, 2021.
    * Ref. 20. Association of American Food Control Officials, 
``GOOD Test Portions: Guidance On Obtaining Defensible Test 
Portions,'' June 2018. http://www.aafco.org/Publications/GOODTestPortions. Accessed November 4, 2021.
    * Ref. 21. FDA, ``Methods, Method Verification and Validation,'' 
ORA Laboratory Manual, Vol. II, Section 2, document number ORA-
LAB.5.4.5. June 30, 2020. https://www.fda.gov/media/73920/download. 
Accessed November 4, 2021.
    * Ref. 22. FDA Memorandum, ``Categorical Exclusion--Final Rule 
Laboratory Accreditation for Analyses of Foods [Docket No. FDA-2019-
N-3325].'' Mariellen Pfeil, FDA. July 21, 2021.

List of Subjects

21 CFR Part 1

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

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

[[Page 68817]]

authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 
1, 11, 16, and 129 are 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, 379j-31, 381, 382, 384a, 384b, 384d, 387, 387a, 
387c, 393; 42 U.S.C. 216, 241, 243, 262, 264, 271; Pub. L. 107-188, 
116 Stat. 594, 668-69; Pub. L. 111-353, 124 Stat. 3885, 3889.

0
2. In Sec.  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 FD&C 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.  1.1101 through 1.1201, to 
read as follows:
Subpart R--Laboratory Accreditation for Analyses of Foods

General Provisions

Sec.
1.1101 What documents are incorporated by reference in this subpart?
1.1102 What definitions apply to this subpart?
1.1103 Who is subject to this subpart?

General Requirements

1.1107 When must food testing be conducted under this subpart?
1.1108 When and how will FDA issue a directed food laboratory order?
1.1109 How will FDA make information about recognized accreditation 
bodies and LAAF-accredited laboratories available to the public?
1.1110 What are the general requirements for submitting information 
to FDA under this subpart?

FDA Recognition of Accreditation Bodies

1.1113 What are the eligibility requirements for a recognized 
accreditation body?
1.1114 How does an accreditation body apply to FDA for recognition 
or renewal of recognition?
1.1115 How will FDA evaluate applications for recognition and 
renewal of recognition?
1.1116 What must a recognized accreditation body do to voluntarily 
relinquish or not renew its recognition?
1.1117 How may an accreditation body request reinstatement of 
recognition?

Requirements for Recognized Accreditation Bodies

1.1119 What are the conflict of interest requirements for a 
recognized accreditation body?
1.1120 How must a recognized accreditation body assess laboratories 
seeking LAAF-accreditation and oversee LAAF-accredited laboratories?
1.1121 When must a recognized accreditation body require corrective 
action, suspend a LAAF-accredited laboratory, or reduce the scope of 
or withdraw the LAAF-accreditation of a laboratory?
1.1122 What procedures must a recognized accreditation body provide 
for appeals of decisions to suspend, reduce the scope of, withdraw, 
or deny LAAF-accreditation?
1.1123 What reports, notifications, and documentation must a 
recognized accreditation body submit to FDA?
1.1124 What are the records requirement for a recognized 
accreditation body?
1.1125 What are the internal audit requirements for a recognized 
accreditation body?

FDA Oversight of Recognized Accreditation Bodies

1.1130 How will FDA oversee recognized accreditation bodies?
1.1131 When will FDA require corrective action, put a recognized 
accreditation body on probation, or revoke the recognition of an 
accreditation body?

LAAF-Accreditation of Laboratories

1.1138 What are the eligibility requirements for a LAAF-accredited 
laboratory?
1.1139 How does a laboratory apply for LAAF-accreditation or extend 
its scope of LAAF-accreditation?
1.1140 What must a LAAF-accredited laboratory do to voluntarily 
relinquish its LAAF-accreditation?
1.1141 What is the effect on a LAAF-accredited laboratory if its 
recognized accreditation body is no longer recognized by FDA?
1.1142 How does a laboratory request reinstatement of LAAF-
accreditation?

Requirements for LAAF-Accredited Laboratories

1.1147 What are the impartiality and conflict of interest 
requirements for a LAAF-accredited laboratory?
1.1149 What oversight standards apply to sampling?
1.1150 What are the requirements for analysis of samples by a LAAF-
accredited laboratory?
1.1151 What requirements apply to the methods of analysis a LAAF-
accredited laboratory uses to conduct food testing under this 
subpart?
1.1152 What notifications, results, reports, and studies must a 
LAAF-accredited laboratory submit to FDA?
1.1153 What are the requirements for submitting abridged analytical 
reports?
1.1154 What other records requirements must a LAAF-accredited 
laboratory meet?

FDA Oversight of LAAF-Accredited Laboratories

1.1159 How will FDA oversee LAAF-accredited laboratories?
1.1160 How will FDA review test results and analytical reports?
1.1161 When will FDA require corrective action, put a LAAF-
accredited laboratory on probation, or disqualify a LAAF-accredited 
laboratory from submitting analytical reports?
1.1162 What are the consequences if FDA puts a LAAF-accredited 
laboratory on probation or disqualifies a LAAF-accredited 
laboratory?

Requesting FDA Reconsideration 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'sdecision to revoke the accreditation 
body's recognition or disqualify a LAAF-accredited laboratory?
1.1174 How does an owner or consignee request a regulatory hearing 
on a directed food laboratory order?

Electronic Records and Public Disclosure Requirements

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?

[[Page 68818]]

Subpart R--Laboratory Accreditation for Analyses of Foods

General Provisions

Sec.  1.1101  What documents are incorporated by reference in this 
subpart

    (a) Certain material is incorporated by reference into this subpart 
with the approval of the Director of the Federal Register under 5 
U.S.C. 552(a) and 1 CFR part 51. All approved material is available for 
inspection at the Food and Drug Administration's Dockets Management 
Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, 
and is available from the source listed elsewhere in this section. 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 [email protected] or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.
    (b) International Organization for Standardization (ISO), Chemin de 
Blandonnet 8, CP 401, 1214 Vernier, Geneva, Switzerland; Telephone 41 
22 749 01 11, https://www.iso.org/home.html.
    (1) ISO/IEC 17011:2017(E), Conformity assessment--Requirements for 
accreditation bodies accrediting conformity assessment bodies, Second 
edition, November 2017, IBR approved for Sec. Sec.  1.1113(a) and (c), 
1.1114(b), 1.1120(c), 1.1131(a).
    (2) ISO/IEC 17025:2017(E), General requirements for the competence 
of testing and calibration laboratories, Third edition, November 2017, 
IBR approved for Sec. Sec.  1.1120(c), 1.1121(a), 1.1138(a), 1.1139(b) 
and (c), 1.1141(a), 1.1152(a) and (d), 1.1153(c), and 1.1161(a).

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:
    Analyst means an individual who analyzes samples.
    Corrective action means an action taken by an accreditation body or 
laboratory to investigate and eliminate the cause of a deficiency so 
that it does not recur.
    Directed food laboratory order means an order issued by FDA under 
Sec.  1.1108 requiring food testing to be conducted under this subpart 
by or on behalf of an owner or consignee.
    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.
    Laboratory accreditation for analyses of foods (LAAF)-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.
    LAAF-accredited laboratory means a laboratory that a recognized 
accreditation body has determined meets the applicable requirements of 
this subpart and has been LAAF-accredited to conduct food testing under 
this subpart using one or more methods of analysis.
    Owner or consignee means 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).
    Recognition means a determination by FDA that an accreditation body 
meets the applicable requirements of this subpart and is authorized to 
LAAF-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 LAAF-accredit laboratories under this subpart.
    Representative sample means a sample that accurately, to a 
statistically acceptable degree, represents the characteristics and 
qualities of the food product or environment from which the sample was 
collected.
    Sampler means an individual who collects samples.
    Sampling firm means an entity that provides sampling services.
    Scope of LAAF-accreditation refers to the methods of analysis for 
which the laboratory is LAAF-accredited.
    Street address means the full physical address, including the 
country. For purposes of this rule, a post office box number alone is 
insufficient; however, a post office box number may be provided in 
addition to the street address.

Sec.  1.1103  Who is subject to this subpart?

    (a) Accreditation bodies. An accreditation body is subject to this 
subpart if it has been or is seeking to be recognized by FDA to LAAF-
accredit laboratories to conduct food testing under this subpart.
    (b) Laboratories. A laboratory is subject to this subpart if it has 
been or is seeking to be LAAF-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 it is required to use a LAAF-accredited laboratory to 
conduct food testing under this subpart.

General Requirements

Sec.  1.1107  When must food testing be conducted under this subpart?

    (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 or suspected food safety problem, which are contained in the 
following provisions:
    (i) Sprouts. Section 112.146(a), (c), and (d) of this chapter;
    (ii) Shell eggs. Sections 118.4(a)(2)(iii), 118.5(a)(2)(ii) and 
(b)(2)(ii), and 118.6(a)(2) and (e) of this chapter; and
    (iii) Bottled drinking water. Section 129.35(a)(3)(i) of this 
chapter (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 directed food laboratory order issued 
under Sec.  1.1108;
    (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 of 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; and
    (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 a laboratory that is 
LAAF-accredited for the appropriate analytical method by a recognized 
accreditation body under this subpart.
    (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

[[Page 68819]]

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 the owner or consignee has written approval from 
FDA that a sample taken prior to arrival is or would be a 
representative sample of the article offered for import into the United 
States.

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

    (a) FDA may require the owner or consignee 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, as FDA deems 
appropriate.
    (b) The directed food laboratory order will specify the food 
product or environment to be tested; whether the food testing may be 
conducted using a LAAF-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 directed food laboratory 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 directed food laboratory order pursuant to Sec.  1.1174.

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

    FDA will place on its website a publicly available registry listing 
of:
    (a) Recognized accreditation bodies, including for each: the name, 
contact information, and duration of recognition of the recognized 
accreditation body;
    (b) Accreditation bodies that have a change in recognition, 
including for each: the name of the accreditation body, the specific 
change in recognition (i.e., probation, revocation of recognition, 
denial of renewal of recognition, relinquishment of recognition, or 
expiration of recognition) and the effective date of the change;
    (c) LAAF-accredited laboratories, including for each: the name, 
contact information, and scope of LAAF-accreditation, and the name and 
contact information of the recognized accreditation body that has LAAF-
accredited the laboratory; and
    (d) Laboratories that have a change in LAAF-accreditation, 
including for each: the name of the laboratory, the specific change in 
LAAF-accreditation (i.e., suspension, reduction of scope, or withdrawal 
of LAAF-accreditation by the recognized accreditation body, probation 
or disqualification by FDA, or relinquishment of LAAF-accreditation), 
and the effective date of the change.

Sec.  1.1110  What are the general requirements for submitting 
information to FDA under this subpart?

    (a) All applications, reports, notifications, and records submitted 
to FDA under this subpart must be submitted electronically and in 
English unless otherwise specified. If FDA requests inspection or 
submission of records that are maintained in any language other than 
English, the recognized accreditation body or LAAF-accredited 
laboratory must provide an English translation within a reasonable 
time.
    (b) A program 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.

FDA Recognition of Accreditation Bodies

Sec.  1.1113  What are the eligibility requirements for a recognized 
accreditation body?

    A recognized accreditation body or an accreditation body seeking 
recognition must meet all of the following requirements:
    (a) Demonstrates compliance with ISO/IEC 17011:2017(E) 
(incorporated by reference, see Sec.  1.1101).
    (b) Demonstrates that it is a full member of the International 
Laboratory Accreditation Cooperative (ILAC).
    (c) Demonstrates that it is a signatory to the ILAC Mutual 
Recognition Arrangement (MRA) that has demonstrated competence to ISO/
IEC 17011:2017(E) with a scope of ``Testing: ISO/IEC 17025.''
    (d) Will comply with all additional requirements for recognized 
accreditation bodies under this subpart while recognized.

Sec.  1.1114  How does an accreditation body apply to FDA for 
recognition or renewal of recognition?

    (a) Application for recognition or renewal of recognition. An 
accreditation body seeking initial recognition or renewal of 
recognition must submit an application to FDA demonstrating that it 
meets the eligibility requirements in Sec.  1.1113.
    (b) Documentation of conformance with requirements. The 
accreditation body must submit documentation of conformance with ISO/
IEC 17011:2017(E) (incorporated by reference, see Sec.  1.1101) and 
separate documentation of ILAC membership and ILAC MRA signatory status 
demonstrating competence to ISO/IEC 17011:2017(E) with a scope of 
``Testing: ISO/IEC 17025,'' in meeting the requirements of Sec.  
1.1113(a) through (c). The accreditation body also must submit 
documentation of its compliance with Sec.  1.1113(d).
    (c) Signature. An application for recognition or renewal of 
recognition must be signed in the manner designated by FDA by an 
individual authorized to act on behalf of the applicant for purposes of 
seeking recognition or renewal of recognition.

Sec.  1.1115  How will FDA evaluate applications for recognition and 
renewal of recognition?

    (a) Review of application for recognition or renewal of 
recognition. FDA will review an accreditation body's application for 
recognition or renewal of recognition for completeness and notify the 
applicant of any insufficiencies. FDA generally will review 
accreditation body applications for recognition or renewal of 
recognition in the order in which completed applications are received; 
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 a complete application for recognition 
or renewal of recognition to determine whether the applicant meets the 
requirements for recognition. Such evaluation may include an onsite 
evaluation of the accreditation body. If FDA does not reach a final 
decision on an application for renewal of recognition before an 
accreditation body's recognition expires, FDA may extend the existing 
term of recognition for a specified period of time or until FDA reaches 
a final decision on the application for renewal of recognition.
    (c) Grant of recognition. FDA will notify the applicant that its 
application for recognition or renewal of recognition has been approved 
and will include 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 from the date of 
recognition, except under the circumstances described in paragraph (b) 
of this section.
    (e) Denial of application for recognition or renewal of 
recognition. FDA will notify the applicant that its

[[Page 68820]]

application for recognition or renewal of recognition has been denied 
and 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. Within 10 business days of the date of FDA's 
issuance of a denial of an application for renewal of recognition, the 
applicant must provide the name and contact information of the 
custodian who will maintain required records and make them available to 
FDA under Sec.  1.1124. The contact information must include an email 
address for the records custodian and the street address where the 
records required under Sec.  1.1124 will be located.
    (g) FDA notice to LAAF-accredited laboratories. FDA will promptly 
notify all laboratories LAAF-accredited by the accreditation body whose 
application for renewal of recognition was denied, informing them of 
such denial.
    (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 an 
application for renewal of recognition and will include the date of the 
issuance of such denial.

Sec.  1.1116  What must a recognized accreditation body do to 
voluntarily relinquish or not renew its recognition?

    (a) Notice to FDA of intent to relinquish or not to renew 
recognition. At least 60 calendar days before voluntarily relinquishing 
its recognition or before allowing its recognition to expire without 
seeking renewal, a recognized accreditation body must notify FDA of its 
intention to leave the program, specifying the date on which the 
relinquishment or expiration will occur. The recognized accreditation 
body must provide the name and contact information of the custodian who 
will maintain and make available to FDA the records required by Sec.  
1.1124 after the date of relinquishment or the date recognition 
expires, as applicable. The contact information must include an email 
address for the records custodian and the street address where the 
records required under Sec.  1.1124 will be located.
    (b) Notice to LAAF-accredited laboratories of intent to relinquish 
or not to renew recognition. At least 60 calendar days before 
voluntarily relinquishing its recognition or before allowing its 
recognition to expire without seeking renewal, a recognized 
accreditation body must notify the laboratories it LAAF accredits 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.  1.1117  How may an accreditation body request reinstatement of 
recognition?

    (a) Application following revocation of recognition. An 
accreditation body that has had its recognition revoked by FDA (as 
described in Sec.  1.1131) may seek reinstatement by submitting a new 
application for recognition under Sec.  1.1114. The accreditation body 
must also submit evidence to FDA with its application to demonstrate 
that the issues resulting in revocation of recognition have been 
resolved, including evidence addressing the cause or condition of the 
grounds for revocation of recognition. The evidence also must identify 
measures that have been implemented to help ensure that such cause or 
condition is 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 (as described in Sec.  
1.1116) may seek reinstatement by submitting a new application for 
recognition under Sec.  1.1114.

Requirements for Recognized Accreditation Bodies

Sec.  1.1119  What are the conflict of interest requirements for a 
recognized accreditation body?

    (a) In addition to meeting the impartiality and conflict of 
interest requirements of Sec.  1.1113(a), a recognized accreditation 
body must:
    (1) Ensure that the recognized accreditation body (and its 
officers, employees, or other agents involved in LAAF-accreditation 
activities) does not own or have a financial interest in, manage, or 
otherwise control any laboratory (or any affiliate, parent, or 
subsidiary) it LAAF-accredits, subject to the exceptions in paragraphs 
(c) and (d) of this section; and
    (2) Prohibit, subject to the exceptions in paragraph (e) of this 
section, officers, employees, or other agents involved in LAAF-
accreditation activities of the recognized accreditation body from 
accepting any money, gift, gratuity, or other item of value from any 
laboratory the recognized accreditation body LAAF-accredits or assesses 
for LAAF-accreditation.
    (b) The financial interests of any children younger than 18 years 
of age or a spouse of a recognized accreditation body's officers, 
employees, and other agents involved in LAAF-accreditation activities 
are considered the financial interests of such officers, employees, and 
other agents involved in LAAF-accreditation activities.
    (c) An accreditation body (and its officers, employees, or other 
agents involved in LAAF-accreditation activities) may have an interest 
in a publicly traded or publicly available investment fund (e.g., a 
mutual fund), or a widely held pension or similar fund if the 
accreditation body (and its officers, employees, or other agents 
involved in LAAF-accreditation activities) neither exercises control 
nor has the ability to exercise control over the financial interests 
held in the fund.
    (d) A recognized accreditation body's agent that is a contract 
assessor will be permitted to own or have a financial interest in, 
manage, or otherwise control a LAAF-accredited laboratory if all of the 
following circumstances apply:
    (1) The contract assessor's primary occupation is owning or having 
a financial interest in, managing, or otherwise controlling a LAAF-
accredited laboratory;
    (2) The assessor contracts with the recognized accreditation body 
to provide assessment services on an intermittent or part-time basis;
    (3) The contract assessor does not assess the LAAF-accredited 
laboratory that the assessor owns or has a financial interest in, 
manages, or otherwise controls; and
    (4) The contract assessor and the recognized accreditation body 
inform any laboratory that the contract assessor may assess or reassess 
for LAAF-accreditation that the contract assessor owns or has a 
financial interest in, manages, or otherwise controls a LAAF-accredited 
laboratory. The laboratory seeking LAAF-accreditation assessment or 
reassessment must acknowledge that the contract assessor owns or has a 
financial interest in, manages, or otherwise controls a LAAF-accredited 
laboratory and be provided the option to be assessed by a different 
representative of the recognized accreditation body.
    (e) The prohibited items of value specified in paragraph (a)(2) of 
this section do not include:
    (1) Money representing payment of fees for LAAF-accreditation 
services or reimbursement of direct costs associated with an onsite 
assessment or reassessment of the laboratory; or
    (2) Meal of de minimis value provided during the course of an 
assessment or reassessment and on the premises where

[[Page 68821]]

the assessment or reassessment is conducted, if necessary for the 
efficient conduct of the assessment or reassessment.

Sec.  1.1120  How must a recognized accreditation body assess 
laboratories seeking LAAF-accreditation and oversee LAAF-accredited 
laboratories?

    (a) A recognized accreditation body must conduct an initial 
assessment of a laboratory seeking LAAF-accreditation in accordance 
with the requirements of this subpart, 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 recognized accreditation 
body conducted an onsite assessment of the laboratory in accordance 
with ISO/IEC 17011:2017(E) (incorporated by reference, see Sec.  
1.1101) to assess whether the laboratory meets the requirements of ISO/
IEC 17025:2017(E) (incorporated by reference, see Sec.  1.1101), 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)(2) and (3) and (b).
    (d) A recognized accreditation body must oversee the performance of 
a laboratory it LAAF-accredits in accordance with the requirements of 
Sec.  1.1113(a), except as otherwise provided by this subpart, to 
determine whether the LAAF-accredited laboratory continues to meet the 
applicable requirements of this subpart.
    (e) A recognized accreditation body must conduct a reassessment of 
a LAAF-accredited laboratory in accordance with this subpart at least 
every 2 years. Such reassessment must be conducted onsite, although 
certain reassessment activities may be conducted remotely if it will 
not aid in the reassessment to conduct the activities onsite.
    (f) If the recognized accreditation body conducted the initial 
assessment of the LAAF-accredited laboratory remotely in accordance 
with paragraph (c) of this section, the recognized accreditation body 
must conduct its first reassessment of the LAAF-accredited laboratory 
no later than 2 years after the recognized accreditation body last 
conducted an onsite assessment of the laboratory.
    (g) The reassessment at the end of the LAAF-accredited laboratory's 
ISO/IEC 17025:2017-accreditation cycle, which the recognized 
accreditation body must conduct in accordance with this subpart, must 
be conducted onsite, although certain reassessment activities may be 
conducted remotely if it will not aid the reassessment to conduct them 
onsite.
    (h) Any assessments or reassessments conducted by a recognized 
accreditation body in addition to the assessments or reassessments 
referred to in paragraphs (a), (e), and (g) of this section may be 
conducted remotely if it will not aid the assessment or reassessment to 
conduct it onsite.

Sec.  1.1121  When must a recognized accreditation body require 
corrective action, suspend a LAAF-accredited laboratory, or reduce the 
scope of or withdraw the LAAF-accreditation of a laboratory?

    (a) Corrective action. A recognized accreditation body may require 
corrective action using the procedures described by ISO/IEC 
17025:2017(E) (incorporated by reference, see Sec.  1.1101) section 8.7 
to address any deficiencies identified while assessing and overseeing a 
LAAF-accredited laboratory.
    (1) The recognized accreditation body must notify the LAAF-
accredited laboratory of all deficiencies requiring corrective action 
and will either specify a deadline to implement corrective action or 
will require the LAAF-accredited laboratory to submit a corrective 
action plan and timeframe for implementation to the recognized 
accreditation body for approval.
    (2) The LAAF-accredited laboratory must implement appropriate 
corrective action under ISO/IEC 17025:2017(E) section 8.7, and submit 
the results of the corrective action to the recognized accreditation 
body.
    (3) The recognized accreditation body will review the corrective 
action and will notify the LAAF-accredited laboratory whether the 
corrective action is acceptable.
    (b) Suspension. If a recognized accreditation body determines that 
a laboratory it LAAF-accredits has not effectively implemented 
corrective action or otherwise fails to address deficiencies 
identified, the recognized accreditation body may temporarily suspend 
the LAAF-accredited laboratory for one or more LAAF-accredited methods, 
and require corrective action under paragraph (a) of this section.
    (1) The recognized accreditation body must notify the LAAF-
accredited laboratory of the grounds for the suspension, the LAAF-
accredited methods subject to the suspension, and all deficiencies that 
must be addressed via the process described in paragraph (a) of this 
section.
    (2) The recognized accreditation body must notify FDA of the 
suspension under this section in accordance with the requirements of 
Sec.  1.1123(d)(5). FDA will provide notice of the LAAF-accredited 
laboratory's suspension on the website described in Sec.  1.1109.
    (3) The recognized accreditation body will review the corrective 
action required under paragraph (b) of this section and will notify the 
LAAF-accredited laboratory whether the corrective action is acceptable.
    (4) A LAAF-accredited laboratory shall remain suspended until it 
demonstrates to the recognized accreditation body's satisfaction that 
the LAAF-accredited laboratory has successfully implemented appropriate 
corrective action.
    (5) If the recognized accreditation body determines that a LAAF-
accredited laboratory on suspension has failed to implement appropriate 
corrective action or otherwise fails to address deficiencies 
identified, the recognized accreditation body may reduce the scope of 
or withdraw the LAAF-accreditation of the laboratory under paragraph 
(c) of this section.
    (c) Reduction of scope or withdrawal of LAAF-accreditation. A 
recognized accreditation body must reduce the scope of or withdraw the 
LAAF-accreditation of a laboratory it LAAF-accredits when the 
laboratory substantially fails to comply with this subpart. When only 
certain methods within the laboratory's scope of LAAF-accreditation are 
affected by the noncompliance, the recognized accreditation body may 
reduce the scope of the laboratory's LAAF-accreditation for only those 
affected methods. If all methods are affected, the recognized 
accreditation body must withdraw the laboratory's LAAF-accreditation.
    (d) Procedures for reduction of scope or withdrawal of LAAF-
accreditation. (1) The recognized accreditation body must notify the 
laboratory of any reduction of scope or withdrawal of LAAF-
accreditation, including:
    (i) The grounds for the reduction of scope or withdrawal of LAAF-
accreditation;
    (ii) The method(s) to which the reduction of scope applies;
    (iii) The procedures for appealing the reduction of scope or 
withdrawal of LAAF-accreditation as described in Sec.  1.1122; and
    (iv) The date the reduction of scope or withdrawal of LAAF-
accreditation is effective.

[[Page 68822]]

    (2) The recognized accreditation body must notify FDA of the 
reduction of scope or withdrawal of LAAF-accreditation under this 
section in accordance with the requirements in Sec.  1.1123(d)(4). FDA 
will provide notice of the reduction of scope or withdrawal of the 
laboratory's LAAF-accreditation on the website described in Sec.  
1.1109.
    (e) Records request associated with suspension, reduction of scope, 
or withdrawal of LAAF-accreditation. To assist the recognized 
accreditation body in determining whether a suspension, reduction of 
scope, or withdrawal of LAAF-accreditation is warranted under this 
section, the recognized accreditation body may require the submission 
of records that the LAAF-accredited laboratory is required to maintain 
under Sec.  1.1154.
    (f) Consequences of suspension, reduction of scope, or withdrawal 
of LAAF-accreditation. (1) A LAAF-accredited laboratory may not conduct 
food testing under this subpart using suspended methods.
    (2) If the recognized accreditation body withdraws the laboratory's 
LAAF-accreditation, the laboratory is immediately ineligible to conduct 
any food testing under this subpart. If the recognized accreditation 
body reduces the laboratory's scope of LAAF-accreditation, the 
laboratory is immediately ineligible to use the methods to which the 
reduction of scope applies to conduct food testing under this subpart.

Sec.  1.1122  What procedures must a recognized accreditation body 
provide for appeals of decisions to suspend, reduce the scope of, 
withdraw, or deny LAAF-accreditation?

    A recognized accreditation body must consider a laboratory's appeal 
regarding a decision to suspend, reduce the scope of, withdraw, or deny 
LAAF-accreditation in accordance with the requirements of Sec.  
1.1113(a). Appeals must be reviewed and decided by a competent 
person(s) free from bias or prejudice who has not participated in the 
LAAF-accreditation decision and is not the subordinate of a person who 
participated in the LAAF-accreditation decision. For the purposes of 
appeals, the competent person(s) may be external to the recognized 
accreditation body.

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

    (a) General requirements. All reports and notifications required by 
this section must include:
    (1) The name, street address, telephone number, and email address 
of the recognized accreditation body associated with the report or 
notification, and the name of an appropriate point of contact for the 
recognized accreditation body, and
    (2) If the report or notification concerns a LAAF-accredited 
laboratory, the name, street address, telephone number, and email 
address of the LAAF-accredited laboratory, and the name of an 
appropriate point of contact for the LAAF-accredited laboratory.
    (b) Internal audit reports. A recognized accreditation body must 
submit to FDA a report of the results of the internal audit conducted 
pursuant to Sec.  1.1125 within 45 calendar days of completing the 
audit. The audit report must include:
    (1) A description of the internal audit conducted;
    (2) A description of any identified deficiencies;
    (3) A description of any corrective action taken or planned, 
including the timeline for such corrective action; 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) Changes affecting recognition. A recognized accreditation body 
must notify FDA within 48 hours when the recognized accreditation body 
is aware of a change that would affect the recognition of such 
accreditation body, and the notification must include:
    (1) A description of the change, and
    (2) If the change is one made by the recognized accreditation body, 
an explanation of the purpose of the change.
    (d) Changes in LAAF-accreditation. A recognized accreditation body 
must notify FDA and submit a certificate reflecting the scope of 
accreditation within 48 hours when any of the following occur:
    (1) The recognized accreditation body grants or extends LAAF-
accreditation of a laboratory, and the notification must include:
    (i) The scope of LAAF-accreditation requested by the laboratory,
    (ii) The scope of LAAF-accreditation granted, and
    (iii) The effective date of the grant or extension;
    (2) The recognized accreditation body denies LAAF-accreditation of 
a laboratory, and the notification must include:
    (i) The scope of LAAF-accreditation requested by the laboratory,
    (ii) The scope of LAAF-accreditation denied, and
    (iii) The grounds for the denial;
    (3) The recognized accreditation body receives notice that a 
laboratory it LAAF-accredits intends to relinquish its LAAF-
accreditation and the laboratory has not provided notice to FDA 60 
calendar days prior to relinquishment as required under Sec.  1.1140. 
The recognized accreditation body's notification must include:
    (i) The scope of LAAF-accreditation to which the relinquishment 
applies, as applicable, and
    (ii) The effective date of the relinquishment;
    (4) The recognized accreditation body reduces the scope of or 
withdraws the LAAF-accreditation of a laboratory, and the notification 
must include:
    (i) The scope of LAAF-accreditation to which the reduction applies,
    (ii) The grounds for the reduction of scope or withdrawal, and
    (iii) The effective date of the reduction of scope or withdrawal;
    (5) The recognized accreditation body suspends or lifts the 
suspension of a LAAF-accredited laboratory, and the notification must 
include:
    (i) The scope of LAAF-accreditation to which the suspension 
applies,
    (ii) The grounds for the suspension or for lifting the suspension, 
and
    (iii) The effective date of the suspension or date the suspension 
is lifted.
    (e) Laboratory fraud. A recognized accreditation body must notify 
FDA within 48 hours if the recognized accreditation body knows that a 
laboratory it LAAF-accredits has committed fraud or submitted material 
false statements to FDA, and the notification must include:
    (1) A description of the basis for the recognized accreditation 
body's knowledge of the fraud or material false statements,
    (2) A description of the fraud or material false statements, and
    (3) The action(s) taken by the recognized accreditation body with 
respect to such LAAF-accredited laboratory.

Sec.  1.1124  What are the records requirements for a recognized 
accreditation body?

    (a) In addition to meeting the requirements of Sec.  1.1113(a) 
related to records, a recognized accreditation body must maintain, 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 LAAF-accreditation;
    (2) Assessments, reassessments, and decisions to grant, extend the 
scope of, renew, deny, reduce the scope of, or withdraw LAAF-
accreditation or to

[[Page 68823]]

suspend or lift the suspension of a LAAF-accredited laboratory;
    (3) Appeals of suspensions, denials, reductions of scope of, and 
withdrawals of LAAF-accreditation, final decisions on such appeals, and 
the bases for such final decisions;
    (4) Its oversight of laboratories it has LAAF-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;
    (7) Records of fee payments and reimbursement of direct costs; and
    (8) Any documents demonstrating compliance with the requirements 
for assessment activities by contract assessors with certain financial 
interests described in Sec.  1.1119(d).
    (b) A recognized accreditation body must make the records it is 
required to maintain by paragraph (a) of this section available for 
inspection and copying or for electronic submission upon written 
request of an authorized officer or employee of FDA. If FDA requests 
records for inspection and copying, the recognized accreditation body 
must make such records promptly available at the physical location of 
the recognized accreditation body or at another reasonably accessible 
location. If FDA requests electronic submission, the records must be 
submitted within 10 business days of the request.
    (c) A recognized accreditation body must not prevent or interfere 
with FDA's access to the records the LAAF-accredited laboratories it 
LAAF-accredits are required to maintain under Sec.  1.1154.

Sec.  1.1125  What are the internal audit requirements for a recognized 
accreditation body?

    As part of the internal audit a recognized accreditation body is 
required to conduct pursuant to Sec.  1.1113(a), the recognized 
accreditation body must audit its compliance with the requirements of 
Sec.  1.1113(d).

FDA Oversight of Recognized of Accreditation Bodies

Sec.  1.1130  How will FDA oversee recognized accreditation bodies?

    (a) FDA will evaluate each recognized accreditation body to 
determine its compliance with the applicable requirements of this 
subpart no later than:
    (1) Year 4 of a 5-year recognition period; or
    (2) The midpoint of a recognition period less than 5 years.
    (b) An FDA evaluation of a recognized accreditation body may 
include review of records, an onsite evaluation of the accreditation 
body, and onsite reviews of one or more LAAF-accredited laboratories 
the recognized accreditation body LAAF-accredits, with or without the 
recognized accreditation body present. Certain evaluation activities 
may be conducted remotely if it will not aid in the evaluation to 
conduct them onsite.
    (c) FDA may conduct additional evaluations of a recognized 
accreditation body at any time to determine whether the recognized 
accreditation body complies with the applicable requirements of this 
subpart.

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

    (a) Corrective action. FDA may require corrective action to address 
any deficiencies identified while evaluating a recognized accreditation 
body under this subpart.
    (1) FDA will notify the recognized accreditation body of all 
deficiencies requiring corrective action and will either specify a 
deadline to implement corrective action or will require the recognized 
accreditation body to submit a corrective action plan and timeframe for 
implementation to FDA for approval.
    (2) The recognized accreditation body must handle FDA's 
notification as a complaint under ISO/IEC 17011:2017(E) (incorporated 
by reference, see Sec.  1.1101) section 7.12, implement appropriate 
corrective action under ISO/IEC 17011:2017 section 9.5, and submit both 
the results of the complaint investigation and subsequent corrective 
action to FDA.
    (3) FDA will review the corrective action and will notify the 
recognized accreditation body whether the corrective action is 
acceptable.
    (b) Probation. If FDA determines that a recognized accreditation 
body has not effectively implemented corrective action or otherwise 
fails to address deficiencies identified, FDA may put the recognized 
accreditation body on probation and require corrective action under 
paragraph (a) of this section.
    (1) FDA will notify the recognized accreditation body of the 
grounds for the probation and all deficiencies requiring corrective 
action via the process described in paragraph (a) of this section.
    (2) FDA will notify all laboratories LAAF-accredited by the 
recognized accreditation body that the recognized accreditation body is 
on probation and will provide notice of the probation on the website 
described in Sec.  1.1109.
    (3) FDA will review the corrective action and will notify the 
recognized accreditation body whether the corrective action is 
acceptable.
    (4) A recognized accreditation body shall remain on probation until 
the recognized accreditation body demonstrates to FDA's satisfaction 
that it has successfully implemented appropriate corrective action.
    (5) If FDA determines that a recognized accreditation body on 
probation has failed to implement appropriate corrective action or 
otherwise fails to address deficiencies identified, FDA may revoke 
recognition of the recognized accreditation body under paragraph (c) of 
this section.
    (c) Revocation of recognition. FDA will revoke the recognition of 
an accreditation body if it fails to meet the requirements of this 
subpart, if FDA determines the accreditation body has committed fraud 
or submitted material false statements to FDA, or if FDA determines 
that a recognized accreditation body on probation has failed to 
implement appropriate corrective action or otherwise fails to address 
deficiencies identified.
    (d) Revocation of recognition procedures. (1) FDA will issue a 
notice of revocation of recognition to the recognized accreditation 
body that will include the grounds for revocation, the date on which 
revocation is effective, the procedures for requesting a regulatory 
hearing on the revocation under Sec.  1.1173, and the procedures for 
requesting reinstatement of recognition under Sec.  1.1117.
    (2) FDA will notify all laboratories LAAF-accredited by the 
recognized accreditation body that recognition has been revoked and 
will provide notice of the revocation of recognition of an 
accreditation body on the website described in Sec.  1.1109.
    (3) Within 10 business days of the date of issuance of revocation, 
the accreditation body must provide the name and contact information of 
the custodian who will maintain records and make them available to FDA 
as required by Sec.  1.1124. The contact information must include an 
email address for the records custodian and the street address where 
the records required by Sec.  1.1124 will be located.
    (e) Effect of probation or revocation of recognition on the 
accreditation body. (1) A recognized accreditation body that is put on 
probation by FDA must continue to oversee laboratories that it has 
LAAF-accredited under this subpart

[[Page 68824]]

and may continue to LAAF-accredit laboratories under Sec.  1.1120.
    (2) An accreditation body that has had its recognition revoked by 
FDA may not LAAF-accredit laboratories under this subpart or continue 
to oversee the laboratories it has previously LAAF-accredited while the 
accreditation body is not recognized.

LAAF-Accreditation of Laboratories

Sec.  1.1138  What are the eligibility requirements for a LAAF-
accredited laboratory?

    (a) A laboratory that is LAAF-accredited or seeking LAAF-
accreditation must demonstrate it is capable of conducting each method 
of food testing for which it is or will be LAAF-accredited by meeting 
all of the following requirements:
    (1) For each method, the laboratory is accredited by a recognized 
accreditation body to ISO/IEC 17025:2017(E) (incorporated by reference, 
see Sec.  1.1101).
    (2)(i) Except as provided in paragraph (a)(2)(ii) of this section, 
the laboratory has successfully passed a proficiency test provided by a 
competent proficiency testing organization within the last 12 months 
for each method within the scope of LAAF-accreditation.
    (ii) If the laboratory determines there is no proficiency testing 
program available or practicable for a method, it may use a comparison 
program. A laboratory must request approval from the recognized 
accreditation body regarding the determination prior to using a 
comparison program in lieu of an annual proficiency test. The 
laboratory is required to demonstrate competency through participation 
in the comparison program.
    (iii) A laboratory must submit all proficiency test and comparison 
program results, regardless of outcome, to the recognized accreditation 
body within 30 calendar days of receipt.
    (3) The laboratory ensures that 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.
    (b) Will comply with all additional requirements for LAAF-
accredited laboratories under this subpart while LAAF-accredited.

Sec.  1.1139  How does a laboratory apply for LAAF-accreditation or 
extend its scope of LAAF-accreditation?

    (a) Application for LAAF-accreditation. A laboratory seeking LAAF-
accreditation or extension of its scope of LAAF-accreditation must 
submit its application for LAAF-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 LAAF-accreditation had its LAAF-accreditation 
withdrawn or one or more methods within its scope of LAAF-accreditation 
reduced by a recognized accreditation body or has been previously 
disqualified by FDA, the laboratory must meet the additional 
requirements specified by Sec.  1.1142(a).
    (b) Documentation of conformance with ISO/IEC 17025:2017(E). The 
laboratory may use documentation of conformance with ISO/IEC 
17025:2017(E) (incorporated by reference, see Sec.  1.1101), as 
applicable and supplemented as necessary, in meeting the applicable 
requirements of this subpart.
    (c) Duration of accreditation. If a LAAF-accredited laboratory 
maintains compliance with all requirements of this subpart, including 
accreditation to ISO/IEC 17025:2017(E), the laboratory's LAAF-
accreditation will not end until reduced in scope, withdrawn, 
relinquished, or the laboratory is disqualified, under this subpart.

Sec.  1.1140  What must a LAAF-accredited laboratory do to voluntarily 
relinquish its LAAF-accreditation?

    (a) Notice to FDA and the recognized accreditation body of intent 
to relinquish. A LAAF-accredited laboratory must notify FDA and its 
recognized accreditation body at least 60 calendar days before 
voluntarily relinquishing LAAF-accreditation or any method within the 
scope of LAAF-accreditation. The notice must include the date on which 
relinquishment will occur. If the laboratory will relinquish all 
methods within its scope of LAAF-accreditation, the notification must 
also include the name and contact information of the custodian who will 
maintain the records required by Sec.  1.1154 after the date of 
relinquishment. The contact information for the records custodian must 
include an email address and the street address where the records 
required by Sec.  1.1154 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 LAAF-accreditation of a laboratory.

Sec.  1.1141  What is the effect on a LAAF-accredited laboratory if its 
recognized accreditation body is no longer recognized by FDA?

    If a recognized accreditation body has its application for renewal 
of recognition denied, relinquishes its recognition or allows its 
recognition to expire, or has its recognition revoked, any laboratory 
LAAF-accredited by the accreditation body must take either the actions 
in paragraph (a) of this section or the action in paragraph (b) of this 
section no later than 30 calendar days after receiving the notice to 
the LAAF-accredited laboratory required under Sec.  1.1115(g), Sec.  
1.1116(b), or Sec.  1.1131(d)(2):
    (a)(1) The LAAF-accredited laboratory must submit to FDA 
documentation of the LAAF-accredited laboratory's most recent internal 
audit, required under Sec.  1.1154(a)(5), documentation showing 
compliance with the conflict of interest requirements in Sec.  1.1147, 
and documentation of the most recent proficiency test or comparison 
program result for each test method within the laboratory's scope of 
LAAF-accreditation, to show compliance with Sec.  1.1138(a)(2); and
    (2) The laboratory must become LAAF-accredited by another 
recognized accreditation body before the laboratory's ISO/IEC 
17025:2017(E) (incorporated by reference, see Sec.  1.1101) 
accreditation lapses or not later than 1 year after the LAAF-accredited 
laboratory receives the applicable notice under Sec.  1.1115(g), Sec.  
1.1116(b), or Sec.  1.1131(d)(2), whichever is sooner.
    (b) The LAAF-accredited laboratory initiates relinquishment of its 
LAAF-accreditation under Sec.  1.1140, with the relinquishment to occur 
within 90 calendar days.

Sec.  1.1142  How does a laboratory request reinstatement of LAAF-
accreditation?

    (a) Application following reduction of scope or withdrawal of LAAF-
accreditation by a recognized accreditation body or disqualification by 
FDA. A laboratory that has had any methods within its scope of LAAF-
accreditation reduced or has had its LAAF-accreditation withdrawn by a 
recognized accreditation body or that has been disqualified by FDA may 
seek reinstatement of LAAF-accreditation by submitting a new 
application for LAAF-accreditation to a recognized accreditation body 
under Sec.  1.1139. The laboratory must also:
    (1) Notify FDA prior to submitting a new application for LAAF-
accreditation to the recognized accreditation body, including in the 
notification the name of the laboratory, contact information for

[[Page 68825]]

the laboratory, the name of the recognized accreditation body to which 
the laboratory will be submitting the application, and the date that 
the laboratory expects to submit the new application for LAAF-
accreditation; and
    (2) Demonstrate, to the satisfaction of the recognized 
accreditation body to which it is submitting the new application, that 
the grounds for the reduction of scope or withdrawal of LAAF-
accreditation or disqualification have been resolved and that the 
laboratory has implemented measures to prevent such grounds from 
recurring.
    (b) Application following voluntary relinquishment of LAAF-
accreditation. A laboratory that voluntarily relinquished any methods 
within the scope of its LAAF-accreditation pursuant to Sec.  1.1140, 
may seek reaccreditation by submitting a new application for LAAF-
accreditation to a recognized accreditation body under Sec.  1.1139.

Requirements for LAAF-Accredited Laboratories

Sec.  1.1147  What are the impartiality and conflict of interest 
requirements for a LAAF-accredited laboratory?

    (a) In addition to the impartiality and conflict of interest 
requirements in Sec.  1.1138(a)(1), a LAAF-accredited laboratory must, 
subject to the exceptions in paragraph (b) of this section, prohibit 
the LAAF-accredited laboratory's employees, contractors, and agents 
involved in food testing under this subpart 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 LAAF-accredited laboratory.
    (b) The prohibited items of value in paragraph (a) of this section 
do not include:
    (1) Payment of fees for food testing under this subpart and related 
services;
    (2) Reimbursement of direct costs associated with the food testing 
by the LAAF-accredited laboratory; and
    (3) With respect to a LAAF-accredited laboratory that is owned by 
the owner or consignee of the food that is or will be tested, payment 
of the officer's, employee's, contractor's, or agent's compensation in 
the normal course of business.
    (c) The LAAF-accredited laboratory must require the owner's or 
consignee's payment to the LAAF-accredited laboratory of fees for food 
testing services and reimbursement of direct costs associated with food 
testing to be independent of the outcome of the test results.

Sec.  1.1149  What oversight standards apply to sampling?

    (a) Documents. Before analyzing a sample, the LAAF-accredited 
laboratory must develop (if it collected the sample) or obtain (if 
another firm collected the sample) the following information to be 
submitted with test results (see Sec.  1.1152(c)):
    (1) Written documentation of the sampler's applicable 
qualifications by training and experience. A LAAF-accredited laboratory 
only needs to develop or obtain documentation of a sampler's 
qualifications the first time that sampler collects a sample for the 
LAAF-accredited laboratory under this subpart. If a LAAF-accredited 
laboratory has previously submitted the sampler's qualifications to FDA 
under Sec.  1.1152(c), the LAAF-accredited laboratory may refer to its 
previously submitted qualifications.
    (2) The written sampling plan used to conduct the sampling. The 
written sampling plan must identify the sampler and sampling firm 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 include:
    (i) The product code of the food product (if product is being 
sampled) or the location and a description of the environment (if 
environment is being sampled);
    (ii) The date of the sampling;
    (iii) The lot number, size, identity, and quantity of the sample;
    (iv) Documentation of sample collection procedures and any sample 
preparation techniques; and
    (v) Documentation of the chain of custody of the sample and of 
measures taken to ensure the validity of the subsequent analytical 
testing, including controlling for the representational nature of the 
sample.
    (b) Potential consequences. If any of the requirements in paragraph 
(a) of this section is not met, FDA may consider the analysis of the 
sample to be invalid.
    (c) Advance notice of sampling. (1) If FDA determines that sampling 
conducted may materially differ from the sampling documented in the 
associated sampling plan or sample collection report, or if FDA 
determines that the sampling otherwise may have been improper, FDA may 
require the LAAF-accredited laboratory that analyzed the associated 
sample, and other LAAF-accredited laboratories that have analyzed 
samples previously collected by the sampling firm, to obtain from the 
sampling firm, and submit, or require the sampling firm to submit, an 
advance notice of sampling. The advance notice of sampling must be 
submitted to FDA at least 48 hours before each of the next 10 occasions 
that the sampling firm will collect a sample that the LAAF-accredited 
laboratory will analyze under this subpart.
    (2) FDA may, as appropriate:
    (i) Specify that the requirement applies to samples collected by a 
particular sampler;
    (ii) Specify the type of food product or environment that requires 
advance notice of sampling under this subpart;
    (iii) Determine that an amount of time other than 48 hours in 
advance is required, from a minimum of 24 hours up to 7 business days 
in advance;
    (iv) Determine that a number of occasions other than 10 is 
required, from a minimum of 1 occasion to a maximum of 20 occasions;
    (v) Notify affected LAAF-accredited laboratories that submission of 
additional notices of sampling are not required; and
    (vi) Notify the owner or consignee that the advance notice applies 
to sampling for food testing being conducted on their behalf.
    (3) The advance notice of sampling must contain:
    (i) A unique identification for the advance notice of sampling;
    (ii) The name of the LAAF-accredited laboratory that will conduct 
analysis of the sample;
    (iii) The name and street address of the sampling firm that will 
conduct the sampling;
    (iv) A primary contact (name and phone number) for the sampling 
firm;
    (v) The reason 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;
    (viii) The product code of the food product (if product is being 
sampled) or the location and a description of the environment (if 
environment is being sampled); and
    (ix) The date and approximate time the sampling will begin.

Sec.  1.1150  What are the requirements for analysis of samples by a 
LAAF-accredited laboratory?

    In addition to the sample analysis requirements of Sec.  1.1138(a):
    (a) The analysis must be conducted on either the sample received 
from the

[[Page 68826]]

sampling firm or, if appropriate, on a representative sample of the 
sample received from the sampling firm.
    (b) The analyst 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.  1.1138(a) and 1.1147.
    (c) The method used to conduct the food testing must meet the 
requirements of Sec.  1.1151.
    (d) The LAAF-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(d)).

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

    In addition to the requirements of Sec.  1.1138(a), a LAAF-
accredited laboratory must meet the following requirements:
    (a) The method of analysis used to conduct food testing under this 
subpart must be:
    (1) Fit for purpose;
    (2) Within the laboratory's scope of LAAF-accreditation;
    (3) Appropriately validated for use in such food testing, in 
accordance with paragraph (c) of this section; and
    (4) Appropriately verified by the LAAF-accredited laboratory for 
use in such food testing, in accordance with paragraph (d) of this 
section.
    (b) Food testing must be conducted using the specified method:
    (1) Under Sec.  1.1107(a)(1), if the Federal Food, Drug, and 
Cosmetic Act or implementing regulations prescribe a test method.
    (2) Under Sec.  1.1107(a)(2), if the directed food laboratory order 
prescribes a test method.
    (c)(1) A LAAF-accredited laboratory must validate methods in 
accordance with the requirements of Sec.  1.1138(a).
    (2) A LAAF-accredited laboratory performing validation of a method 
under this subpart must record the information required by Sec.  
1.1138(a) and the supporting analytical data.
    (d)(1) Before a LAAF-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 LAAF-accredited 
laboratory has not previously applied the method under this subpart, 
the LAAF-accredited laboratory must have verified it can properly 
perform the method for the specific intended use.
    (2) A LAAF-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 LAAF-accredited laboratory is able to 
properly perform the method.
    (e) A LAAF-accredited laboratory may submit a written request to 
FDA requesting permission to use a method outside of its scope of LAAF-
accreditation for food testing. FDA may approve the request if both 
following conditions are satisfied:
    (1) A new method or methodology has been developed and validated 
but no reasonably available laboratory has been LAAF-accredited to 
perform such method or methodology, and
    (2) The use of such method is necessary to prevent, control, or 
mitigate a food emergency or foodborne illness outbreak.

Sec.  1.1152  What notifications, results, reports, and studies must a 
LAAF-accredited laboratory submit to FDA?

    (a) General requirements. (1) All notifications, results, reports, 
and studies required to be submitted to FDA by a LAAF-accredited 
laboratory under this subpart must:
    (i) Include the name and street address of the LAAF-accredited 
laboratory;
    (ii) Identify a point of contact for the LAAF-accredited 
laboratory, including email and telephone number, whom FDA may contact 
with questions or comments;
    (iii) Display an identification unique to the test results, report, 
notification, or study; and
    (iv) Be true, accurate, unambiguous, and objective.
    (2) The LAAF-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 LAAF-accredited laboratory becomes aware that any aspect 
of the submitted material is inaccurate, the LAAF-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(E) (incorporated by reference, see 
Sec.  1.1101) section 7.8.8.
    (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(E) 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(E) section 7.8.6.
    (b) Test results. (1) The LAAF-accredited laboratory must submit 
the results of all testing required to be conducted under this subpart 
directly to FDA via the location specified by the website described in 
Sec.  1.1109, unless another location is specified by FDA regarding 
testing conducted under Sec.  1.1107(a)(2) or (3).
    (2) The test results must be clear and identify:
    (i) The name and street address of the owner or consignee for which 
the testing was conducted,
    (ii) As appropriate, the U.S. Customs and Border Protection entry 
and line number(s), and
    (iii) 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 included with each full analytical 
report (see paragraph (d) of this section) and each abridged analytical 
report (see Sec.  1.1153) 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 LAAF-accredited 
laboratory in accordance with Sec.  1.1149;
    (2) Written documentation of the sampler's qualifications or an 
indication that the sampler's qualifications have been submitted 
previously, in accordance with Sec.  1.1149(a)(1);
    (3) For any validation studies required by Sec.  1.1151(c)(1), the 
documentation required by Sec.  1.1151(c)(2);
    (4) For any verification studies required by Sec.  1.1151(d)(1), 
the documentation required by Sec.  1.1151(d)(2);
    (5) The justification for any modification to or deviation from the 
method(s) of analysis used and documentation of the LAAF-accredited 
laboratory's authorization for the modification or deviation; and
    (6) A certification from one or more members of the LAAF-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

[[Page 68827]]

the name, title, and signature of any certifiers.
    (d) Full analytical report contents. In addition to the 
documentation required to be submitted with all test results (see 
paragraph (c) of this section), a full analytical report must include:
    (1) All information described by ISO/IEC 17025:2017(E) sections 
7.8.2.1(a) through (p) and 7.8.3.1(a) through (d);
    (2) Documentation of references for the method of analysis used;
    (3) Name and signature of the analyst who conducted each analytical 
step, including any applicable validation and verification steps, and 
the date each step 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 presented 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, if 
available, 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 (including the expected 
result and whether it is acceptable), 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 of analysis for standards and software; and
    (12) The following information about the qualifications of each 
analyst involved in the analysis conducted under this subpart, if the 
LAAF-accredited laboratory has not previously submitted documentation 
of the analyst's qualifications to FDA or the analyst's qualifications 
have significantly changed since the LAAF-accredited laboratory last 
submitted documentation of the analyst's qualifications to FDA:
    (i) The analyst's curriculum vitae;
    (ii) Training records for the applicable methods that the analyst 
is qualified to perform, including the dates of such training and the 
name of the trainer or training provider; and
    (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).
    (e) Additional information about non-standard methods. If the LAAF-
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 
LAAF-accredited laboratory must submit documentation of the method to 
FDA.
    (f) Immediate notification of significant changes. The LAAF-
accredited laboratory must notify FDA and the recognized accreditation 
body that LAAF-accredited the laboratory of changes that affect the 
LAAF-accreditation of the laboratory within 48 hours, including a 
detailed description of such changes, and an explanation of how such 
changes affect the LAAF-accreditation of the laboratory. LAAF-
accredited laboratories are not required to notify FDA of changes that 
a recognized accreditation body must provide to FDA under Sec.  
1.1123(d).
    (g) Consequence of omission. If FDA does not receive all 
information required to be submitted to FDA under this section, FDA may 
consider the related food testing to be invalid.

Sec.  1.1153  What are the requirements for submitting abridged 
analytical reports?

    (a) Requesting permission. A LAAF-accredited laboratory may request 
permission to submit abridged analytical reports for each major food 
testing discipline: Biological, chemical, and physical.
    (1) FDA will grant permission to submit abridged analytical reports 
for a single major food testing discipline if all of the following 
conditions are met:
    (i) The LAAF-accredited laboratory is not on suspension or 
probation for any method within the major food testing discipline that 
is the subject of its request (see Sec.  1.1121(b) or Sec.  1.1161(b));
    (ii) The LAAF-accredited laboratory has successfully implemented 
any required corrective action under Sec.  1.1121(a) or Sec.  
1.1161(a); and
    (iii) The last five full analytical reports for the major food 
testing discipline contain no shortcomings that call into question the 
validity of the test results or repeated administrative errors.
    (2) FDA will notify the LAAF-accredited laboratory if permission is 
granted or denied.
    (b) FDA review of abridged analytical reports. (1) FDA will review 
all abridged analytical reports submitted.
    (2) FDA will notify the LAAF-accredited laboratory if FDA 
identifies a shortcoming that calls into question the validity of the 
test results or repeated administrative errors, will require corrective 
action under Sec.  1.1161(a), and may revoke permission to submit 
abridged analytical reports for the specific major food testing 
discipline.
    (3) If FDA identifies a shortcoming that calls into question the 
validity of the test results or repeated administrative errors in 
abridged analytical reports from a LAAF-accredited laboratory that has 
previously had its permission to submit abridged analytical reports 
revoked for any major food testing discipline, FDA may put the LAAF-
accredited laboratory on probation for one or more methods under Sec.  
1.1161(b). Under Sec.  1.1162(a), a laboratory on probation for one or 
more methods may not submit abridged analytical reports for the major 
food testing disciplines of which the probationary methods are a part.
    (4) A LAAF-accredited laboratory that has had permission to submit 
abridged analytical reports revoked for one or more major food testing 
disciplines may request permission to submit abridged analytical 
reports as described in paragraph (a) of this section for each major 
food testing discipline.
    (c) Contents of abridged analytical reports. In addition to the 
documentation required to be submitted with all test results (see Sec.  
1.1152(c)), an abridged analytical report must include:
    (1) All information described by ISO/IEC 17025:2017(E) 
(incorporated by reference, see Sec.  1.1101) sections 7.8.2.1(a) 
through (p) and 7.8.3.1(a) through (d); and
    (2) Quality control results (including the expected result and 
whether it is acceptable).
    (d) Exceptions. FDA may require additional documentation or a full 
analytical report from a LAAF-accredited laboratory permitted to submit 
abridged analytical reports in the following circumstances:

[[Page 68828]]

    (1) FDA may require a full analytical report related to an FDA 
investigation or FDA enforcement proceeding.
    (2) 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 additional documentation or 
a full analytical report within 72 hours of FDA's request.
    (e) Consequence of omission. If FDA does not receive all 
information required to be submitted to FDA under paragraph (c) of this 
section, FDA may consider the related food testing to be invalid.

Sec.  1.1154  What other records requirements must a LAAF-accredited 
laboratory meet?

    (a) In addition to the records requirements of Sec.  1.1138(a), a 
LAAF-accredited laboratory must maintain, for 5 years after the date of 
creation, records created and received while it is LAAF-accredited that 
relate to compliance with this subpart, including:
    (1) Documents related to the LAAF-accredited laboratory's grant of 
LAAF-accreditation (and, if applicable, extensions and reductions of 
scope of LAAF-accreditation) from its recognized accreditation body, 
including all required proficiency test and comparison program records 
for each method within the scope of LAAF-accreditation under Sec.  
1.1138(a)(2);
    (2) Documentation of food testing the LAAF-accredited laboratory 
conducted under this subpart sufficient to account for all information 
required by Sec.  1.1152(d), in accordance with Sec.  1.1150(d);
    (3) All documents that the LAAF-accredited laboratory was required 
to submit to FDA under Sec. Sec.  1.1152 and 1.1153, and associated 
correspondence between the LAAF-accredited laboratory (and its 
officers, employees, and other agents) and the owner or consignee (and 
its officers, employees, and other agents) regarding food testing under 
this subpart;
    (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 action taken to address any problems or deficiencies 
related to activities under this subpart;
    (6) All documentation related to suspension, probation, reduction 
of scope, or withdrawal of LAAF-accreditation, or laboratory 
disqualification 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) Make the records required by paragraph (a) of this section 
available for inspection and copying or for electronic submission upon 
written request of an authorized officer or employee of FDA. If FDA 
requests records for inspection and copying, the laboratory must 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 electronic submission, 
the records must be submitted within 10 business days of the request.
    (c) Ensure that significant amendments to records described by 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 LAAF-accredited laboratory during 
the time period for which 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 that a more recent version of the document exists.

FDA Oversight of LAAF-Accredited Laboratories

Sec.  1.1159  How will FDA oversee LAAF-accredited laboratories?

    (a) FDA may review the performance of LAAF-accredited laboratories 
at any time to determine whether the LAAF-accredited laboratory 
continues to comply with the applicable requirements of this subpart 
and whether there are deficiencies in the performance of the LAAF-
accredited laboratory that, if not corrected, would warrant corrective 
action, probation, or disqualification under Sec.  1.1161.
    (b) In evaluating the performance of a LAAF-accredited laboratory, 
FDA may review any of the following:
    (1) Records the LAAF-accredited laboratory is required to maintain 
under this subpart;
    (2) Records the recognized accreditation body that LAAF-accredited 
the laboratory is required to maintain under this subpart;
    (3) Information obtained by FDA during a review of the LAAF-
accredited laboratory conducted pursuant to paragraph (c) of this 
section;
    (4) Information obtained by FDA during an evaluation of the 
recognized accreditation body that LAAF-accredits the laboratory;
    (5) Analytical reports and test results submitted to FDA; and
    (6) Any other information obtained by FDA, including during FDA's 
inspections or investigations of one or more owners or consignees.
    (c) FDA may conduct an onsite review of a LAAF-accredited 
laboratory at any reasonable time, with or without a recognized 
accreditation body (or its officers, employees, and other agents) 
present, to review the performance of a LAAF-accredited laboratory 
under this subpart. Certain review activities may be conducted remotely 
if it will not aid in the review to conduct them onsite.
    (d) FDA may report any observations and deficiencies identified 
during its review of LAAF-accredited laboratory performance under this 
subpart to the recognized accreditation body.

Sec.  1.1160  How will FDA review 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 will notify the LAAF-
accredited laboratory that submitted the analytical report of any 
deficiency and may:
    (1) Require the laboratory to correct the test result, analytical 
report, related documents, or the associated analysis;
    (2) Revoke permission to submit abridged reports for that major 
food testing discipline under Sec.  1.1153(b);
    (3) Require a corrective action under Sec.  1.1161(a);
    (4) Consider the analysis to be invalid; and/or
    (5) Notify the owner or consignee of the deficiency.
    (b) FDA may report any deficiencies identified during its review of 
any test results, reports, and related documents under this subpart to 
the recognized accreditation body that LAAF-accredits the laboratory.
    (c) Nothing in this subpart shall be construed to limit the ability 
of FDA to review and act on information received about food testing, 
including determining the sufficiency of such information and testing.

Sec.  1.1161  When will FDA require corrective action, put a LAAF-
accredited laboratory on probation, or disqualify a LAAF-accredited 
laboratory from submitting analytical reports?

    (a) Corrective action. FDA may require corrective action to address 
any deficiencies identified while reviewing a LAAF-accredited 
laboratory's performance under this subpart.
    (1) FDA will notify the LAAF-accredited laboratory of all 
deficiencies requiring corrective action and will

[[Page 68829]]

either specify a deadline to implement corrective action or will 
require the LAAF-accredited laboratory to submit a corrective action 
plan and timeframe for implementation to FDA for approval.
    (2) The LAAF-accredited laboratory must handle FDA's notification 
as a complaint under ISO/IEC 17025:2017(E) (incorporated by reference, 
see Sec.  1.1101) section 7.9, implement appropriate corrective action 
under ISO/IEC 17025:2017(E) section 8.7, and submit both the results of 
the complaint investigation and subsequent corrective action to FDA.
    (3) FDA will review the corrective action and will notify the LAAF-
accredited laboratory whether the corrective action is acceptable.
    (b) Probation. If FDA determines that a LAAF-accredited laboratory 
has not effectively implemented corrective action or otherwise fails to 
address deficiencies identified, FDA may put the LAAF-accredited 
laboratory on probation for one or more methods and require corrective 
action under paragraph (a) of this section.
    (1) FDA will notify the LAAF-accredited laboratory and its 
recognized accreditation body of the grounds for the probation, the 
method(s) covered by the probation, and all deficiencies requiring 
corrective action via the process described in paragraph (a) of this 
section.
    (2) FDA will provide notice of a LAAF-accredited laboratory's 
probation on the website described in Sec.  1.1109.
    (3) FDA will review the corrective action and will notify the LAAF-
accredited laboratory and its recognized accreditation body whether the 
corrective action is acceptable.
    (4) A LAAF-accredited laboratory will remain on probation until the 
LAAF-accredited laboratory demonstrates to FDA's satisfaction that it 
has successfully implemented appropriate corrective action.
    (5) If FDA determines that a LAAF-accredited laboratory on 
probation has failed to implement appropriate corrective action or 
otherwise fails to address deficiencies identified, FDA may disqualify 
the LAAF-accredited laboratory under paragraph (c) of this section.
    (c) Disqualification. FDA may disqualify a LAAF-accredited 
laboratory from submitting analytical reports under this subpart for 
one or more methods for good cause, which may include any of the 
following reasons:
    (1) Deliberate falsification of analytical reports, testing 
results, or other records submitted to FDA.
    (2) Failure of a LAAF-accredited laboratory on probation to 
effectively implement corrective action or otherwise address identified 
deficiencies.
    (3) Other failure to substantially comply with this subpart where 
the laboratory's recognized accreditation body has not reduced the 
scope of or withdrawn LAAF-accreditation of the laboratory.
    (d) Disqualification procedures. (1) FDA will issue a notice of 
disqualification to a LAAF-accredited laboratory and its recognized 
accreditation body, which will include:
    (i) The grounds for disqualification;
    (ii) The method or methods to which the disqualification applies;
    (iii) The date the disqualification will be effective;
    (iv) The procedures for requesting a regulatory hearing on the 
disqualification under Sec.  1.1173; and
    (v) The procedures for requesting reinstatement after 
disqualification under Sec.  1.1142.
    (2) FDA will provide notice of a LAAF-accredited laboratory's 
disqualification on the website described in Sec.  1.1109.

Sec.  1.1162  What are the consequences if FDA puts a LAAF-accredited 
laboratory on probation or disqualifies a LAAF-accredited laboratory?

    (a) A LAAF-accredited laboratory that FDA has put on probation for 
one or more methods is permitted to continue to conduct food testing 
under this subpart; however, a LAAF-accredited laboratory that is on 
probation for one or more methods is not permitted to submit abridged 
analytical reports for the major food testing discipline of which the 
probationary methods are part.
    (b) If FDA disqualifies a LAAF-accredited laboratory for all 
methods within its scope of LAAF-accreditation, the laboratory is 
immediately ineligible to conduct food testing under this subpart. If 
FDA disqualifies a LAAF-accredited laboratory for specific methods 
within the scope of LAAF-accreditation, the laboratory is immediately 
ineligible to use the methods for which the laboratory has been 
disqualified to conduct food testing under this subpart.
    (c) With respect to food testing conducted by the laboratory prior 
to its disqualification, FDA may refuse to consider results and 
associated reports of food testing conducted under this subpart if the 
basis for the disqualification of the laboratory indicates that the 
specific food testing conducted by the laboratory may not be reliable.
    (d) Within 10 business days of the date of issuance of 
disqualification, the laboratory must provide the name and email 
address of the custodian who will maintain and make available to FDA 
the records required by Sec.  1.1154, and the street address where the 
records will be located.
    (e) Within 10 business days of the date of issuance of a notice of 
probation or disqualification, the laboratory must notify any owners or 
consignees for which it is conducting food testing using methods for 
which it is being placed on probation or disqualified under this 
subpart, that it is on probation or has been disqualified.

Requesting FDA Reconsideration 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 or renewal of recognition under Sec.  1.1114, or 
reinstatement of recognition under Sec.  1.1117, 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, together with 
any supporting information, to FDA 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 or deny 
recognition upon reconsideration.

[[Page 68830]]

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

    (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 disqualification of a LAAF-accredited 
laboratory under 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 or 
disqualification. The notice of revocation issued under Sec.  1.1131 or 
notice of disqualification issued under 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 or disqualification, together with any 
supporting information. The request, appeal, and supporting information 
must be submitted to FDA in accordance with the procedures described in 
the notice of revocation or disqualification.
    (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 the recognition of an accreditation body or 
disqualify the LAAF-accredited 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 or 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 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).
    (3) A decision by the presiding officer to affirm the revocation of 
recognition or laboratory disqualification 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 directed food laboratory order?

    (a) Request for hearing. No later than 3 business days after FDA 
has issued the directed food laboratory order, an owner or consignee 
may submit a request for a regulatory hearing, conducted pursuant to 
part 16 of this chapter, on the directed food laboratory order. The 
directed food laboratory 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 directed food laboratory order, together with any 
supporting information. The request, appeal, and supporting information 
must be submitted in accordance with the procedures described in the 
directed food laboratory order.
    (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 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 directed food 
laboratory order is considered a final agency action under 5 U.S.C. 
702.

Electronic Records and Public Disclosure Requirements

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:

[[Page 68831]]

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 entries for Sec. Sec.  1.1173 and 1.1174 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 the disqualification 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 directed food 
laboratory order by FDA pursuant to Sec.  1.1108.
* * * * *

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: November 15, 2021.
Janet Woodcock,
Acting Commissioner of Food and Drugs.
[FR Doc. 2021-25716 Filed 12-1-21; 11:15 am]
BILLING CODE 4164-01-P