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Rule2021-25716

Laboratory Accreditation for Analyses of Foods

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Published

December 3, 2021

Effective

February 1, 2022

Issuing agencies

Health and Human Services DepartmentFood and Drug Administration

Abstract

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.

Full Text

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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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;
<a href="/cdn-cgi/l/email-protection#8ddef9eceee4e8a3c5ece0e0eceee6cdebe9eca3e5e5fea3eae2fb">[email&#160;protected]</a>.
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,
<a href="/cdn-cgi/l/email-protection#19494b584a6d787f7f597f7d783771716a377e766f">[email&#160;protected]</a>.

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\
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\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:
<bullet> 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;
<bullet> 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;
<bullet> 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
<bullet> 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
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General provisions General provisions
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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, <a href="/cdn-cgi/l/email-protection#ed8e8883999f8c81ad849e82c3829f8a">[email&#160;protected]</a> (<a href="https://www.iso.org/store.html">https://www.iso.org/store.html</a>) 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 <a href="https://www.fda.gov/food/sampling-protect-food-supply/microbiological-surveillance-sampling">https://www.fda.gov/food/sampling-protect-food-supply/microbiological-surveillance-sampling</a>. 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 <a href="https://www.fda.gov/food/importing-food-products-united-states/accredited-third-party-certification-program">https://www.fda.gov/food/importing-food-products-united-states/accredited-third-party-certification-program</a>.
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 <a href="https://www.fda.gov/industry/import-program-food-and-drug-administration-fda">https://www.fda.gov/industry/import-program-food-and-drug-administration-fda</a>; for more
information on DWPE, see https://<a href="http://www.fda.gov/media/71776/download">www.fda.gov/media/71776/download</a>.
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 <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-compliance-and-recommendations-implementation-standards-growing-harvesting">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-compliance-and-recommendations-implementation-standards-growing-harvesting</a>.
---------------------------------------------------------------------------

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 <a href="https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals">https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals</a>.
---------------------------------------------------------------------------

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

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