[Federal Register Volume 86, Number 230 (Friday, December 3, 2021)]
[Rules and Regulations]
[Pages 68728-68831]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-25716]
[[Page 68727]]
Vol. 86
Friday,
No. 230
December 3, 2021
Part II
Department of Health and Human Services
-----------------------------------------------------------------------
Food and Drug Administration
-----------------------------------------------------------------------
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]]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
amending its regulations to establish a program for the testing of food
in certain circumstances by accredited laboratories, as required under
the Federal Food, Drug, and Cosmetic Act (FD&C Act). Establishing this
program will help FDA improve the safety of the U.S. food supply and
protect U.S. consumers by helping ensure that certain food testing of
importance to public health is conducted subject to appropriate
oversight and in accordance with appropriate model standards to produce
reliable and valid test results.
DATES: This rule is effective February 1, 2022. The incorporation by
reference of certain publications listed in the rule is approved by the
Director of the Federal Register as of February 1, 2022.
ADDRESSES: For access to the docket to read background documents or
comments received, go to https://www.regulations.gov and insert the
docket number found in brackets in the heading of this final rule into
the ``Search'' box and follow the prompts, and/or go to the Dockets
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852,
240-402-7500.
FOR FURTHER INFORMATION CONTACT:
With regard to the final rule: Stacie Hammack, Chemist, Food and
Feed Laboratory Operations, Office of Regulatory Affairs, Food and Drug
Administration, 60 8th Street NE, Atlanta, GA 30309, 301-796-5817;
[email protected].
With regard to the information collection: Domini Bean, Office of
Operations, Food and Drug Administration, Three White Flint North 10A-
12M, 11601 Landsdown Street, North Bethesda, MD 20852, 301-796-5733,
[email protected].
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Executive Summary
A. Purpose and Coverage of the Final Rule
B. Summary of the Major Provisions of the Final Rule
C. Legal Authority
D. Costs and Benefits
II. Table of Abbreviations/Commonly Used Acronyms in This Document
III. Background
A. Need for the Regulation
B. Summary of Comments to the Proposed Rule
C. General Overview of Final Rule
D. Incorporation by Reference
IV. Legal Authority
V. Comments on the Proposed Rule and FDA's Response
A. Introduction
B. General Comments
C. Comments Regarding General Provisions
D. Comments Regarding General Requirements
E. Comments Regarding FDA Recognition of Accreditation Bodies
F. Comments Regarding Requirements for Recognized Accreditation
Bodies
G. Comments Regarding FDA Oversight of Recognized Accreditation
Bodies
H. Comments Regarding LAAF-Accreditation of Laboratories
I. Comments Regarding Requirements for LAAF-Accredited
Laboratories
J. Comments Regarding FDA Oversight of LAAF-Accredited
Laboratories
K. Comments Regarding Requesting FDA Reconsideration or
Regulatory Hearings of FDA Decisions Under This Subpart
L. Comments Regarding Electronic Records and Public Disclosure
Requirements
M. Comments on Conforming and Technical Amendments and FDA
Response
VI. Effective Date
VII. Economic Analysis of Impacts
VIII. Analysis of Environmental Impact
IX. Paperwork Reduction Act of 1995
X. Federalism
XI. Consultation and Coordination With Indian Tribal Governments
XII. References
I. Executive Summary
A. Purpose and Coverage of the Final Rule
This rule is part of FDA's implementation of the FDA Food Safety
Modernization Act (FSMA) (Pub. L. 111-353), through which the Agency
intends to better protect public health by, among other things,
adopting a modern, preventive, and risk-based approach to food safety
regulation. In this document we establish the Laboratory Accreditation
for Analyses of Foods (LAAF) program as required by FSMA section
202(a), which added section 422 to the FD&C Act (21 U.S.C. 350k). Under
the LAAF program, FDA will recognize accreditation bodies that will
accredit laboratories to the standards established in this final rule.
Laboratories accredited to the LAAF standard (``LAAF-accredited
laboratories'') are authorized to conduct certain food testing as
described in this rule.
The program structure is portrayed in the following diagram:\1\
---------------------------------------------------------------------------
\1\ For a description of how the program structure diagram has
been revised, see (Response 11).
---------------------------------------------------------------------------
[[Page 68729]]
[GRAPHIC] [TIFF OMITTED] TR03DE21.000
You are subject to this rule if you are an accreditation body
seeking recognition to accredit laboratories under this subpart, a
recognized accreditation body, a laboratory seeking accreditation to
conduct food testing under this subpart, or an accredited laboratory
conducting food testing under this subpart. This rule also applies to
owners or consignees that must have certain food testing conducted by a
laboratory accredited under this subpart. Although participation in
this program is voluntary for accreditation bodies and laboratories,
only recognized accreditation bodies may accredit laboratories to
conduct the testing of food covered under this subpart.
This program for the testing of food by accredited laboratories
establishes oversight, uniformity, and standards necessary to help
ensure that the results of certain food testing of importance to public
health are reliable and accurate. Establishing this program will
substantially improve our capability to protect U.S. consumers from
unsafe food.
B. Summary of the Major Provisions of the Final Rule
This rule contains model standards that laboratories must meet in
order to participate and conduct certain food testing covered by this
subpart. The rule will establish a publicly available registry listing
accreditation bodies and laboratories that have been recognized or
accredited under this program. Results of food testing conducted by
laboratories under the program must be sent directly to FDA.
Laboratories accredited under this program (``LAAF-accredited
laboratories'') are required to submit to FDA analytical reports as
specified in this final rule.
This rule contains eligibility requirements for accreditation
bodies to qualify for FDA recognition and requirements that
accreditation bodies must meet once recognized, such as requirements
related to assessing and overseeing laboratories, conflicts of
interest, reporting, and records. The rule contains eligibility
requirements for laboratories to qualify for LAAF-accreditation by a
recognized accreditation body and requirements that laboratories must
meet once LAAF-accredited, such as requirements related to conflicts of
interest, analysis, reporting, and records. These requirements will
help ensure the effectiveness of the recognized accreditation bodies
and LAAF-accredited laboratories under this program. This rule contains
procedures we will follow to recognize accreditation bodies under this
program and procedures for accreditation bodies to follow to LAAF-
accredit laboratories under this program. This rule contains regulatory
procedures and requirements relating to our oversight of recognized
accreditation bodies and LAAF-accredited laboratories.
This rule applies when food testing is conducted in certain
circumstances. ``Food testing'' and ``testing of food'' include the
analysis of human or animal food, as well as testing of the food
growing or manufacturing environment (i.e., ``environmental testing'').
C. Legal Authority
Section 422(a)(1)(A) the FD&C Act, which was added by section
202(a) of FSMA, directs us to establish a program for the testing of
food by accredited laboratories. Therefore, section 422 of the FD&C Act
provides FDA with authority for these final regulations, which outline
requirements for participants in the program for the testing of food by
LAAF-accredited laboratories. FDA also derives authority for these
requirements from section 701(a) of the FD&C Act (21 U.S.C. 371(a)),
which authorizes FDA to issue regulations for the efficient enforcement
of the FD&C Act.
[[Page 68730]]
D. Costs and Benefits
The rule will require that testing of food in certain circumstances
be performed by a laboratory that is LAAF-accredited by a recognized
accreditation body, and for the testing results to be submitted
directly to us. The costs of the rule primarily will be incurred by
participating accreditation bodies, participating laboratories, shell
egg producers, sprouts producers, bottled drinking water manufacturers,
owners and consignees of certain import-related food, and FDA. Rarely,
certain firms will have participating laboratories conduct tests for
other reasons including as part of a corrective action plan after an
order suspending registration, as part of evidence for a hearing prior
to issuance of a mandatory recall order, as part of evidence for an
appeal of an administrative detention order, and as required under a
directed food laboratory order (formerly, a food testing order). We
will incur costs to, among other things, establish and maintain the
program for recognizing accreditation bodies that apply to participate
in our program, evaluate participating accreditation bodies and review
the performance of participating laboratories, and review associated
documents and reports. The present value of the costs of the rule
ranges from $38 million to $66 million when discounted by 7 percent
over 10 years and from $43 million to $77 million when discounted by 3
percent over 10 years. Annualized costs over 10 years range from $5.8
million to $9.6 million when discounted by 7 percent, and from $5.9
million to $9.7 million when discounted by 3 percent.
The rule will generate some quantified and unquantified benefits.
Quantified benefits include a reduction in the number of foodborne
illnesses from fewer false negative test results for import-related
food covered under the rule and for shell eggs, sprouts, and bottled
drinking water testing covered under the rule. We anticipate cost
savings from the clarification of the process for compiling,
submitting, and reviewing analytical reports for import-related food
covered under this rule, including reduced reporting burden. There
would be less revenue lost from fewer false positive test results for
import-related food covered under the rule and for tests of shell eggs,
sprouts, and bottled drinking water testing covered under the rule. The
present value of the benefits of the rule ranges from $46 million to
$88 million when discounted at 7 percent over 10 years and ranges from
$56 million to $106 million when discounted at 3 percent over 10 years.
Annualized benefits over 10 years range from $6.6 million to $12.5
million when discounted by both 7 and 3 percent.
II. Table of Abbreviations/Commonly Used Acronyms in This Document
------------------------------------------------------------------------
Abbreviation/acronym What it means
------------------------------------------------------------------------
AAVLD............................. American Association of Veterinary
Laboratory Diagnosticians.
ANSI.............................. American National Standards
Institute.
AOAC.............................. AOAC International.
APA............................... Administrative Procedure Act.
CFR............................... Code of Federal Regulations.
CPSC.............................. Consumer Product Safety Commission.
CVM............................... Center for Veterinary Medicine.
DWPE.............................. Detention Without Physical
Examination.
EO................................ Executive Order.
E. coli........................... Escherichia coli.
FDA............................... United States Food and Drug
Administration.
FD&C Act.......................... Federal Food, Drug, and Cosmetic
Act.
FOIA.............................. Freedom of Information Act.
FR................................ Federal Register.
FRIA.............................. Final Regulatory Impact Analysis.
FSMA.............................. FDA Food Safety Modernization Act.
FSVP.............................. Foreign Supplier Verification
Program.
HACCP............................. Hazard Analysis and Critical Control
Point.
IBR............................... Incorporation by Reference.
IEC............................... International Electrotechnical
Commission.
ILAC.............................. International Laboratory
Accreditation Cooperation.
IOM............................... Investigations Operations Manual.
ISO............................... International Organization for
Standardization.
LAAF.............................. Laboratory Accreditation for
Analyses of Foods.
MRA............................... Mutual Recognition Arrangement.
NIST.............................. National Institute of Standards and
Technology.
NRTE.............................. Not Ready to Eat.
NTTAA............................. National Technology Transfer and
Advancement Act of 1995.
OMB............................... Office of Management and Budget.
ORA............................... Office of Regulatory Affairs.
PLAP.............................. Private Laboratory Analytical
Package.
PRA............................... Paperwork Reduction Act of 1995.
PRIA.............................. Preliminary Regulatory Impact
Analysis.
SAHCODHA.......................... Serious Adverse Health Consequences
or Death to Humans or Animals.
U.S.C............................. United States Code.
Vet-LIRN.......................... Veterinary Laboratory Investigation
and Response Network.
WTO............................... World Trade Organization.
------------------------------------------------------------------------
[[Page 68731]]
III. Background
A. Need for the Regulation
FSMA is transforming the nation's food safety system by shifting
the focus from responding to foodborne illness to preventing it.
Congress enacted FSMA in response to dramatic changes in the global
food system and in our understanding of foodborne illness and its
consequences, including the realization that preventable foodborne
illness is both a significant public health problem and a threat to the
economic well-being of the food system. FSMA provides us with new
enforcement authorities designed to achieve higher rates of compliance
with risk-based, prevention-oriented safety standards and to better
respond to and contain problems when they do occur. In addition, FSMA
gives us important new tools to better ensure the safety of imported
foods and encourages partnerships with State, local, tribal, and
territorial authorities. In implementing FSMA, we prioritized the
development of seven foundational rules that provide the framework for
risk-based preventive controls and enhance our ability to oversee their
implementation by industry for both domestic and imported food. We have
finalized these foundational rules and begun their implementation while
also developing additional programs required by FSMA, including this
program for food testing by accredited laboratories.
FSMA, in establishing section 422 of the FD&C Act, underscores that
food testing can play a role in detecting and responding to food safety
problems. Section 422(b)(1) of the FD&C Act requires that food be
tested by laboratories accredited to the standards we are establishing
in this final rule in four circumstances:
In response to a specific testing requirement under the
FD&C Act or implementing regulations, when applied to address an
identified or suspected food safety problem;
As required by the Secretary of Health and Human Services
(Secretary), as the Secretary deems appropriate, to address an
identified or suspected food safety problem;
In support of admission of an article of food under
section 801(a) of the FD&C Act (21 U.S.C. 381(a)); and
Under an import alert that requires successful consecutive
tests.
With one exception, section 422(b)(2) of the FD&C Act requires the
results of food testing conducted under section 422(b)(1) to be sent
directly to FDA, thereby allowing FDA to review the test results.
Direct receipt of food testing results in these circumstances is of
particular importance to the Agency and to public health. This rule
applies to food testing conducted under specific testing requirements
in the FD&C Act and implementing regulations that ``address an
identified or suspected food safety problem'', and in directed food
laboratory orders that we will issue ``as required by the Secretary, as
the Secretary deems appropriate, to address an identified or suspected
food safety problem.'' Further, owners and consignees often engage
private laboratories to test their food products and submit the results
of the testing, along with associated analysis and data, to us to show
that the imported food complies with the FD&C Act. If we determine that
the food testing results are valid and that they demonstrate the
detained food product does not violate the FD&C Act, we will release
the food from detention and allow it to proceed into the United States.
We use the detention without physical examination (DWPE) procedure when
there exists a history of the importation of violative products, or
products that may appear violative, or when other information indicates
that future entries may appear violative. Import alerts inform FDA
field staff and the public that we have enough evidence to allow for
DWPE of products that appear to be in violation of FDA laws and
regulations. Concerns periodically have arisen regarding importers'
manipulation or substitution of the samples a private laboratory tests,
and practices such as ``testing into compliance,'' in which multiple
samples from a shipment are tested, but only those results that would
allow the shipment to enter the United States are submitted to us. See,
e.g., ``The Safety of Food Imports: Fraud & Deception in the Food
Import Process; Hearings Before the Senate Committee on Governmental
Affairs, Permanent Subcommittee on Investigations,'' September 10, 1998
(statement of ``Former Customs Broker'') (Ref. 1, pages 26-34 and 137-
140).
B. Summary of Comments to the Proposed Rule
We published a proposed rule for ``Laboratory Accreditation for
Analyses of Foods'' (the proposed rule) in the Federal Register on
November 4, 2019 (84 FR 59452). The comment period was extended twice
(85 FR 11893 (February 28, 2020); 85 FR 19114 (April 6, 2020)). Upon
close of the comment period on July 6, 2020, we had received
approximately 70 comment submissions that covered almost every aspect
of the proposed rule.
C. General Overview of the Final Rule
We have made changes in the final rule in response to public
comments; these changes are discussed in greater detail in section V
below. Additionally, we have revised the final rule to improve clarity
and readability. We also have reorganized the final rule as described
in the following table.
Table 1--Summary of Section Numbering Changes in the Final Rule
------------------------------------------------------------------------
Final rule Proposed rule
------------------------------------------------------------------------
General provisions General provisions
------------------------------------------------------------------------
Sec. 1.1101 What documents are N/A.
incorporated by reference in this
subpart?
Sec. 1.1102 What definitions apply to Sec. 1.1102 What definitions
this subpart?. apply to this subpart?
Sec. 1.1103 Who is subject to this Sec. 1.1103 Who is subject to
subpart?. this subpart?
------------------------------------------------------------------------
General Requirements General Requirements of this
Subpart
------------------------------------------------------------------------
Sec. 1.1107 When must food testing be Sec. 1.1107 Under what
conducted under this subpart?. circumstances must food
testing be conducted under
this subpart by an accredited
laboratory?
Sec. 1.1108 When and how will FDA Sec. 1.1108 When and how will
issue a directed food laboratory FDA issue a food testing
order? order?
Sec. 1.1109 How will FDA make Sec. 1.1109 How will FDA make
information about recognized information about recognized
accreditation bodies and LAAF- accreditation bodies and
accredited laboratories available to accredited laboratories
the public? available to the public?
[[Page 68732]]
Sec. 1.1110 What are the general N/A.
requirements for submitting
information to FDA under this subpart?
------------------------------------------------------------------------
FDA Recognition of Accreditation Bodies Recognition of Accreditation
Bodies
------------------------------------------------------------------------
Sec. 1.1113 What are the eligibility Sec. 1.1113 What requirements
requirements for a recognized must an accreditation body
accreditation body? meet to be recognized by FDA?
Sec. 1.1118 What are the
general requirements for
recognized accreditation
bodies to remain recognized?
Sec. 1.1114 How does an accreditation Sec. 1.1128 How does an
body apply to FDA for recognition or accreditation body apply to
renewal of recognition? FDA for recognition or renewal
of recognition?
Sec. 1.1115 How will FDA evaluate Sec. 1.1129 How will FDA
applications for recognition and review applications for
renewal of recognition? recognition and applications
for renewal of recognition?
Sec. 1.1116 What must a recognized Sec. 1.1132 What must a
accreditation body do to voluntarily recognized accreditation body
relinquish or not renew its do if it wants to voluntarily
recognition? relinquish its recognition or
does not want to renew its
recognition?
Sec. 1.1117 How may an accreditation Sec. 1.1133 How does an
body request reinstatement of accreditation body request
recognition? reinstatement of recognition?
------------------------------------------------------------------------
Requirements for Recognized Requirements for Recognized
Accreditation Bodies Accreditation Bodies
------------------------------------------------------------------------
N/A--(contents combined with Sec. Sec. 1.1118 What are the
1.1113). general requirements for
recognized accreditation
bodies to remain recognized?
Sec. 1.1119 What are the conflict of Sec. 1.1119 What requirements
interest requirements for a recognized apply to how a recognized
accreditation body? accreditation body must
protect against conflicts of
interests?
Sec. 1.1120 How must a recognized Sec. 1.1120 How must a
accreditation body assess laboratories recognized accreditation body
seeking LAAF-accreditation and oversee evaluate laboratories seeking
LAAF-accredited laboratories? accreditation and oversee the
performance of laboratories it
accredits?
Sec. 1.1121 When must a recognized Sec. 1.1121 What appeal
accreditation body require corrective procedures must a recognized
action, suspend a LAAF-accredited accreditation body provide for
laboratory, reduce the scope of or appeals of decisions to not
withdraw the LAAF-accreditation of a grant accreditation?
laboratory? Sec. 1.1122(h) Appeals
procedures.
Sec. 1.1122 What procedures must a Sec. 1.1122 When must a
recognized accreditation body provide recognized accreditation body
for appeals of decisions to suspend, withdraw or reduce the scope
reduce the scope of, withdraw, or deny of the accreditation of a
LAAF-accreditation? laboratory, and when may a
recognized accreditation body
put an accredited laboratory
on probation?
Sec. 1.1123 What reports, Sec. 1.1123 What reports and
notifications, and documentation must notifications must a
a recognized accreditation body submit recognized accreditation body
to FDA? submit to FDA?
Sec. 1.1124 What are the records Sec. 1.1124 What records
requirements for a recognized requirements must a recognized
accreditation body? accreditation body meet?
Sec. 1.1125 What are the internal Sec. 1.1125 What internal
audit requirements for a recognized audit requirements must a
accreditation body? recognized accreditation body
meet?
------------------------------------------------------------------------
FDA Oversight of Recognized Procedures for Recognition of
Accreditation Bodies Accreditation Bodies
------------------------------------------------------------------------
Sec. 1.1130 How will FDA oversee Sec. 1.1130 How will FDA
recognized accreditation bodies?. oversee recognized
accreditation bodies?
Sec. 1.1131 When will FDA require Sec. 1.1131 When will FDA
corrective action, put a recognized revoke the recognition of an
accreditation body on probation, or accreditation body or put a
revoke the recognition of an recognized accreditation body
accreditation body? on probation?
------------------------------------------------------------------------
LAAF-Accreditation of Laboratories Accreditation of Laboratories
------------------------------------------------------------------------
Sec. 1.1138 What are the eligibility Sec. 1.1138 What requirements
requirements for a LAAF-accredited must a laboratory meet to
laboratory? become accredited by a
recognized accreditation body?
Sec. 1.1146 What are the
general requirements for
accredited laboratories to
remain accredited?
Sec. 1.1139 How does a laboratory Sec. 1.1158 How does a
apply for LAAF-accreditation or extend laboratory apply for
its scope of LAAF-accreditation? accreditation or modification
of its scope of accreditation
by a recognized accreditation
body?
Sec. 1.1140 What must a LAAF- Sec. 1.1163 What if a
accredited laboratory do to laboratory wants to
voluntarily relinquish its LAAF- voluntarily relinquish its
accreditation? accreditation?
Sec. 1.1141 What is the effect on a Sec. 1.1164 What is the
LAAF-accredited laboratory if its effect on accredited
recognized accreditation body is no laboratories if their
longer recognized by FDA? accreditation body voluntarily
or involuntarily loses its
recognition?
Sec. 1.1142 How does a laboratory Sec. 1.1165 How does a
request reinstatement of LAAF- laboratory request
accreditation? reinstatement of
accreditation?
------------------------------------------------------------------------
Requirements for LAAF-Accredited Requirements for Accredited
Laboratories Laboratories
------------------------------------------------------------------------
Content added to Sec. 1.1138......... Sec. 1.1146 What are the
general requirements for
accredited laboratories to
remain accredited?
Sec. 1.1147 What are the impartiality Sec. 1.1147 What impartiality
and conflict of interest requirements and conflict of interest
for a LAAF-accredited laboratory? requirements must accredited
laboratories meet?
[[Page 68733]]
Content moved to Sec. 1.1138......... Sec. 1.1148 What quality
assurance requirements must
accredited laboratories meet?
Sec. 1.1149 What oversight standards Sec. 1.1149 What oversight
apply to sampling?. standards apply to sampling?
Sec. 1.1150 What are the requirements Sec. 1.1150 What requirements
for analysis of samples by a LAAF- apply to analysis of samples
accredited laboratory? by an accredited laboratory?
Sec. 1.1151 What requirements apply Sec. 1.1151 What requirements
to the methods of analysis a LAAF- apply to the methods of
accredited laboratory uses to conduct analysis an accredited
food testing under this subpart? laboratory uses to conduct
food testing under this
subpart?
Sec. 1.1152 What notifications, Sec. 1.1152 What
results, reports, and studies must a notifications, results, and
LAAF-accredited laboratory submit to reports must accredited
FDA? laboratories submit to FDA?
Sec. 1.1153 What are the requirements N/A.
for submitting abridged analytical
reports?
Sec. 1.1154 What other records Sec. 1.1153 What other
requirements must a LAAF-accredited records requirements must an
laboratory meet? accredited laboratory meet?
------------------------------------------------------------------------
FDA Oversight of LAAF-Accredited Procedures for Accreditation of
Laboratories Laboratories
------------------------------------------------------------------------
Sec. 1.1159 How will FDA oversee LAAF- Sec. 1.1159 How will FDA
accredited laboratories?. oversee accredited
laboratories?
Sec. 1.1160 How will FDA review test Sec. 1.1160 How will FDA
results and analytical reports?. review submitted test results
and analytical reports?
Sec. 1.1161 When will FDA require Sec. 1.1161 When will FDA put
corrective action, put a LAAF- an accredited laboratory on
accredited laboratory on probation, or probation or revoke the
disqualify a LAAF-accredited accreditation of a laboratory?
laboratory from submitting analytical
reports?
Sec. 1.1162 What are the consequences Sec. 1.1162 What are the
if FDA puts a LAAF-accredited consequences if FDA puts an
laboratory on probation or accredited laboratory on
disqualifies a LAAF-accredited probation or revokes the
laboratory? accreditation of a laboratory?
------------------------------------------------------------------------
Requesting FDA Reconsideration or Requesting FDA Reconsideration,
Regulatory Hearings of FDA Decisions FDA Internal Review, or
Under This Subpart Regulatory Hearings of FDA
Decisions Under This Subpart
------------------------------------------------------------------------
Sec. 1.1171 How does an accreditation Sec. 1.1171 How does an
body request reconsideration by FDA of accreditation body request
a decision to deny its application for reconsideration by FDA of a
recognition, renewal, or decision to deny its
reinstatement? application for recognition,
renewal, or reinstatement?
Sec. 1.1173 How does an accreditation Sec. 1.1173 How does an
body or laboratory request a accreditation body or
regulatory hearing on FDA's decision laboratory request a
to revoke the accreditation body's regulatory hearing on FDA's
recognition or disqualify a LAAF- decision to revoke the
accredited laboratory? recognized accreditation
body's recognition or revoke
the accredited laboratory's
accreditation?
Sec. 1.1174 How does an owner or Sec. 1.1174 How does an owner
consignee request a regulatory hearing or consignee request a
on a directed food laboratory order? regulatory hearing on a food
testing order?
------------------------------------------------------------------------
Electronic Records and Public Electronic Records and Public
Disclosure Requirements Disclosure Requirements under
This Subpart
------------------------------------------------------------------------
Sec. 1.1199 Are electronic records Sec. 1.1199 Are electronic
created under this subpart subject to records created under this
the electronic records requirements of subpart subject to the
part 11 of this chapter? electronic records
requirements of part 11 of
this chapter?
Sec. 1.1200 Are the records obtained Sec. 1.1200 Are the records
by FDA under this subpart subject to obtained by FDA under this
public disclosure? subpart subject to public
disclosure?
------------------------------------------------------------------------
Also, in one location in the proposed rule we inadvertently
misstated the title of this subpart (the third codified instruction, 84
FR 59452 at 59501). Throughout the final rule we correctly state the
subpart title (``Laboratory Accreditation for Analyses of Foods'').
D. Incorporation by Reference
FDA is incorporating by reference two consensus standards, which
were approved by the Office of the Federal Register in accordance with
5 U.S.C. 552(a) and 1 CFR part 51. Both standards are widely accepted
globally. The consensus standards may be examined at FDA's Dockets
Management Staff (see ADDRESSES).
The standards listed below are available for purchase from the
International Organization for Standardization (ISO), Chemin de
Blandonnet 8, CP 401, 1214 Vernier, Geneva, Switzerland, +41 22 749 01
11, [email protected] (https://www.iso.org/store.html) or from any other
source from which the user is assured that the copy to be received is
an accurate version of the standard.
ISO/IEC 17011:2017, Conformity assessment--Requirements for
accreditation bodies accrediting conformity assessment bodies, Second
edition, November 2017 (Ref. 2). ISO/IEC 17011:2017 specifies the
general standards for accreditation bodies assessing and accrediting
conformity assessment bodies (``conformity assessment bodies'' are
organizations providing testing, inspection, management system
certification, personnel certification, or product certification). Its
incorporation by reference should allow us to use a framework that is
familiar to accreditation bodies and the laboratory industry.
ISO/IEC 17025:2017, General requirements for the competence of
testing and calibration laboratories, Third edition, November 2017
(Ref. 3). ISO/IEC 17025:2017 sets general standards for the competence
of testing laboratories, including general management requirements such
as impartiality and quality assurance. It is
[[Page 68734]]
very familiar to the testing laboratories that may be interested in
applying to conduct food testing under this subpart.
IV. Legal Authority
We are issuing this final rule under the FD&C Act and FSMA. As
noted, section 202(a) of FSMA, ``Laboratory Accreditation for Analyses
of Foods'', amends the FD&C Act to create a new provision, section 422,
under the same name. Section 422 of the FD&C Act directs us to
establish a program for the testing of food by accredited laboratories
and provides several requirements for the program.
Additionally, section 701(a) of the FD&C Act gives FDA the
authority to publish regulations for the efficient enforcement of the
FD&C Act. The requirements discussed in this final rule will allow FDA
to efficiently enforce section 422 of the FD&C Act. Thus, our legal
authority for this final rule is derived primarily from section 422 and
section 701(a) of the FD&C Act. Further, we also note that this rule is
consistent with section 404 of FSMA, which states that nothing in FSMA
should be construed in a manner that is inconsistent with the agreement
establishing the World Trade Organization (WTO) or any other treaty or
international agreement to which the United States is a party.
Section 379j-31 of the FD&C Act (21 U.S.C. 743) is one of many
statutory provisions that provide authority for FDA's regulations
contained in part 1 (21 CFR part 1). We inadvertently omitted that
citation from the authority citation in the proposed rule, but have
included it in the final rule.
V. Comments on the Proposed Rule and FDA Response
A. Introduction
We received approximately 70 comment submissions on the proposed
rule by the close of the comment period, each containing one or more
comments on one or more issues. We received comments from consumers,
food associations, accreditation bodies, laboratory associations,
laboratories, consumer groups, and other organizations.
In the remainder of this document, we describe the comments that
are within the scope of this rulemaking, respond to them, and explain
any revisions we made to the proposed rule.
We have numbered each comment to help distinguish between different
comments. We have grouped similar comments together under the same
number, and, in some cases, we have separated different issues
discussed in the same comment and designated them as distinct comments
for purposes of our responses. The number assigned to each comment or
comment topic is purely for organizational purposes and does not
signify the comment's value or importance or the order in which
comments were received.
Note that summaries of and responses to comments on the estimated
costs and benefits of the proposed rule and other topics covered by the
Preliminary Regulatory Impact Analysis (PRIA) may be found in the Final
Regulatory Impact Analysis (FRIA) (Ref. 4).
B. General Comments
Many comments made general remarks supporting or opposing the
proposed rule without focusing on a particular proposed provision.
Further, several comments made overarching comments that pertain to the
rule more generally, focusing on issues throughout the rule such as
program structure, FDA's role, terminology, and implementation. In the
following paragraphs, we discuss and respond to such general comments.
(Comment 1) We received many comments expressing general support
for the proposed rule, most expressing the view that the LAAF program
would help to ensure the safety of food. Some of these comments stress
the importance of accurate and reliable food testing results, and the
role of valid results in enhancing food safety. Some comments focus on
the advantages of setting quality standards and establishing
accountability for food testing laboratories. Some comments opine that
the laboratory accreditation program will increase U.S. consumer
confidence in the safety of the food supply. Other comments maintain
that the program will result in fewer illnesses, thus reducing
healthcare costs. Other comments express support for implementation of
FSMA section 202 and the underlying goals of the laboratory
accreditation program, e.g., improved safety of imported food,
trustworthy testing results. A few comments opine that the rule would
lead to more efficient food imports by clarifying what information
needs to be in a laboratory analytical report, which should in turn
expedite FDA review of those reports. These comments assert that such
efficiencies are particularly valuable when the imported food is
perishable, such as produce. Some of these comments further suggest
that a more efficient review process for FDA could allow FDA to focus
its limited resources on imports that generally are not subject to
testing under this subpart.
(Response 1) We appreciate the comments in support of the proposed
rulemaking and moving forward to implement the LAAF program. We agree
that the program established by the final rule will help ensure the
safety of food and should increase U.S. consumer confidence in the food
supply. We also agree that requiring analyses to be performed by LAAF-
accredited laboratories that meet the standards set forth in the final
rule will make tests consistently more accurate and prevent illnesses.
Further, setting model standards for LAAF-accredited laboratories will
improve the reliability and accountability of test results on which we
rely to make regulatory decisions regarding certain foods.
We agree with comments predicting fewer illnesses as a result of
this final rule. For additional discussion of the cost benefit analysis
associated with this final rule, see section VII. We also agree there
will be efficiencies gained for industry and FDA from clarifying the
requirements in an analytical report and from the process that allows
submission of abridged analytical reports.
(Comment 2) Some comments question whether the LAAF program
established by this final rule would make a food safety impact because
only a small fraction of food testing laboratories are likely to
participate.
(Response 2) Although the laboratory accreditation rule does not
set mandatory standards for all food testing laboratories, the program
will make an important difference for the food testing subject to the
rule, as the testing situations covered by the rule all involve
heightened food safety concerns. Therefore, the food testing covered by
the rule addresses the specific circumstances in which accurate and
reliable test results are especially important to protect public
health. We also anticipate that some owners or consignees who are not
covered by the rule may choose to use a LAAF-accredited laboratory
because these laboratories will have met the program standards; this
would create a benefit incidental to the program. Finally, we expect
that creating model laboratory standards based on ISO/IEC 17025:2017
accreditation may encourage other laboratories to work toward these
standards, including accreditation.
(Comment 3) Some comments are generally supportive of the proposed
rule but state that FDA already regulates food safety, and because it
is unclear how much safer food would be as a result of the proposed
rule, the resources necessary for this program may be better spent
elsewhere. A subset
[[Page 68735]]
of these comments states that the proposed rule would make food safety
regulations more complicated for small food businesses and would also
burden small food businesses with additional costs.
(Response 3) As described in section 422 of the FD&C Act, this
final rule will establish a program for the accreditation of
laboratories the use of which will be required in certain circumstances
where heightened food safety concerns exist. We estimate the benefits
outweigh the costs of the rule. For additional information on the
estimated costs and benefits of this final rule, see section VII and
the FRIA (Ref. 4). As mentioned in the preceding response, there may be
other benefits incidental to the LAAF program.
Some comments express concern that this rule may complicate the
regulatory landscape for small business owners and consignees that are
also subject to other food safety regulations. It is true that some
small owners and consignees will be required to use a LAAF-accredited
laboratory for the testing described in Sec. 1.1107. However, this
rule does not create new testing requirements; it merely requires
certain tests that are already occurring to be conducted by a LAAF-
accredited laboratory. Further, in some cases the regulation creating
the underlying testing requirement addresses this issue in its
application to small businesses. For example, Sec. 1.1107(a)(1)(ii)
provides that certain shell egg tests required by the egg safety rule
(see part 118 (21 CFR part 118)) are covered by this final rule.
However, the egg safety rule does not apply to producers with less than
3,000 laying hens at a particular farm (see Sec. 118.1(a)).
Accordingly, those small egg producers are unaffected by this provision
of the final rule. We also expect that the online registry of LAAF-
accredited laboratories, described in Sec. 1.1109, will make it easy
for all owners and consignees to locate laboratories LAAF-accredited to
conduct the tests covered by this subpart.
Regarding the concern that this final rule will burden small owners
and consignees with additional costs, see the discussion below in
section VII and the FRIA (Ref. 4).
(Comment 4) Some comments express support for specific aspects of
the proposed rule, including the provisions protecting against
conflicts of interest, and state that the program would improve
transparency and consistency in the food testing that falls within its
scope. Some comments contend that there have been situations in which a
food is described in terms such as ``safe'' based on biased testing
conducted by the food's producer.
(Response 4) We appreciate the supportive comments regarding the
conflict of interest provisions. FDA anticipates that the model
laboratory standards being established in this final rule, as well as
the program requirements for LAAF-accreditation of laboratories by
recognized accreditation bodies, will increase the reliability of tests
conducted under this subpart. Ensuring that both accreditation bodies
and laboratories are free from conflicts of interest is critical to the
integrity of food testing conducted under this subpart. For more
information on the conflict of interest requirements applicable to
recognized accreditation bodies, see the discussion of Sec. 1.1119
below; for more information on the conflict of interest requirements
applicable to LAAF-accredited laboratories, see the discussion of Sec.
1.1147 below.
(Comment 5) Some comments support the establishment of laboratory
standards and appreciate the transparency of the public registry that
will list recognized accreditation bodies and LAAF-accredited
laboratories but express concern that laboratories would conform to the
standards only while being actively monitored by the Agency. These
comments encourage the Agency to address this risk.
(Response 5) We acknowledge a hypothetical risk that LAAF-
accredited laboratories might conform to standards only while being
actively monitored by FDA; however, we believe that the model
laboratory standards and reporting requirements we are establishing in
this final rule, as well as oversight of LAAF-accredited laboratories
by both recognized accreditation bodies and FDA, will adequately
address this risk. For example, under this subpart, FDA will recognize
accreditation bodies that will LAAF-accredit laboratories to conduct
certain testing of food under this subpart. Recognized accreditation
bodies' assessment of LAAF-accredited laboratories involves onsite and
remote assessments as described in Sec. 1.1120 of the rule. FDA may
conduct an onsite or remote review of a LAAF-accredited laboratory at
any reasonable time to review performance (see Sec. 1.1159(c)). LAAF-
accredited laboratories must submit quality control results with each
analytical report (see Sec. Sec. 1.1152(d)(8), 1.1153(c)(2)), so FDA
will be able to review the quality control results to ensure that
methods are performed correctly. Further, for LAAF-accredited
laboratories that submit abridged analytical reports, FDA may audit
these reports by requesting that additional documentation or a full
analytical report be submitted within 72 hours of the request (see
Sec. 1.1153(d)(2)).
In sum, in this final rule, FDA is establishing requirements for
accreditation bodies and laboratories that will provide sufficient
oversight of LAAF-accredited laboratories such that we expect
consistent quality test results to be the norm.
(Comment 6) A few comments philosophically disagree with defining
and regulating food at all, and thus oppose the establishment of a
program to require any laboratory testing of food.
(Response 6) Congress defined ``food'' in section 201(f) of the
FD&C Act (21 U.S.C. 321(f)) and by statute has authorized FDA to
regulate food, including in section 422 of the FD&C Act, which directs
FDA to establish this program.
(Comment 7) Some comments ask what effect the final rule will have
on existing food testing laboratories. Other comments express a concern
that some individuals may perceive that test results from laboratories
not participating in the LAAF program are suspect or less valuable.
(Response 7) Food testing laboratories are not required to
participate in this program; however, owners and consignees will be
required to use a LAAF-accredited laboratory for the food testing
covered by this rule, such as testing to support removal from import
alert and the shell egg testing required by part 118 (see Sec.
1.1107). Laboratories that wish to conduct the food testing covered by
this rule will need to apply to a recognized accreditation body and
must satisfy the standards established in this final rule in order to
voluntarily participate in the program. A LAAF-accredited laboratory
engaged by an owner or consignee to conduct the food testing covered by
this final rule will conduct the test and send the results directly to
FDA, in accordance with the requirements of this subpart.
Food testing laboratories that do not wish to conduct the testing
described in Sec. 1.1107 are not required to participate in the
program.
We do not expect this program to decrease confidence in food
laboratories that choose not to become LAAF-accredited, in part due to
the very large number of food testing laboratories that exist and
conduct all sorts of food testing for myriad customers and purposes. We
view the program as beneficial to the food testing industry, as an
explicit goal of the statute is to increase the number of qualified
food testing laboratories. See section 422(a)(3) of the FD&C Act.
[[Page 68736]]
(Comment 8) Some comments advocate for expanded roles for the
laboratories that participate in this program. Some of these comments
suggest that LAAF-accredited laboratories could conduct tests for FDA's
surveillance sampling program and argue that sufficient capacity exists
in the United States for ISO/IEC 17025:2017-accredited laboratories to
conduct all DWPE and FDA surveillance sampling and testing. Under the
surveillance sampling program, FDA focuses its sampling and testing
efforts on a few commodities at a time with the goals of keeping
contaminated products from reaching consumers and facilitating a
greater understanding of hazards. For more information on FDA's
surveillance sampling, see https://www.fda.gov/food/sampling-protect-food-supply/microbiological-surveillance-sampling. These comments also
suggest that FDA should create a program whereby private laboratories
meet the standards of FDA laboratories, such that FDA could rely on
those private laboratories for its testing needs and therefore focus
its resources elsewhere. Finally, these comments suggest that
independent accredited laboratories could also conduct sampling and
testing on imported food, most of which is not sampled and tested by
FDA prior to entry.
(Response 8) This final rule establishes the LAAF program, the
scope of which is specified in FD&C Act section 422(b)(1) and described
in Sec. 1.1107. All the tests that will be conducted by LAAF-
accredited laboratories are currently being conducted by non-FDA
laboratories (e.g., private laboratories). Expanding the scope of this
program to include testing currently conducted by FDA laboratories,
such as surveillance sampling, was not proposed because it is not
contemplated by the statute. Any future expansion of this program will
be accomplished via rulemaking and will include an opportunity for
public comment.
(Comment 9) Some comments offer general support for this subpart,
stating that it will improve the defensibility of the resulting test
data by ensuring that all participating laboratories operate in
accordance with a robust quality management system. These comments
suggest that as we continue to develop the LAAF program, we consider
two documents that were developed to improve the defensibility of human
and animal food laboratory data: The Partnership for Food Protection
document, ``Human and Animal Food Testing Laboratories Best Practices
Manual,'' (Ref. 5) and the Association for Public Health Laboratories
document, ``Best Practices for Submission of Actionable Human and
Animal Food Testing Data Generated in State and Local Laboratories''
(Ref. 6). The former document is based on ISO/IEC 17025:2017 and its
purpose is to ``promote mutual acceptance and assurance of quality
laboratory data shared among Federal, State, local, territorial, and
tribal human and animal food regulatory agencies.'' (Ref. 5). The
latter document, focused on unaccredited laboratories, provides
information on the minimum elements of a quality management system.
(Response 9) FDA appreciates this support and information. As an
active member of the Partnership for Food Protection initiative, FDA is
particularly familiar with the former document. We consider both
documents to be helpful resources for the intended audiences.
1. FDA's Role and Related Terminology
In the proposed rule, FDA sought to define ``accreditation'' to
mean, ``a determination by a recognized accreditation body that a
laboratory meets the applicable requirements of this subpart to conduct
food testing under this subpart using one or more methods of analysis''
(emphasis added). We then proceeded to use the word ``accreditation''
to mean that a laboratory had been approved to conduct testing under
this subpart. For example, we wrote that the proposed rule ``would
establish certain model laboratory standards that accredited
laboratories must meet to remain accredited'' (84 FR 59452 at 59478).
By way of another example, we wrote that the proposed provision on
duration of accreditation under this subpart, ``clarifies that an
accredited laboratory's accreditation continues'' until there is a
voluntary or involuntary separation from the program (id. at 59489).
Consequently, when we used phrases such as, ``FDA may revoke
accreditation,'' we intended to communicate that FDA could cause the
involuntary separation of a laboratory from this program. For example,
we wrote that ``if we revoke the accreditation in whole of a
laboratory, the laboratory would be immediately ineligible to conduct
food testing under this rule'' (id. at 59491).
We did not propose to define the term ``assess.'' However, we
generally used it interchangeably with ``evaluate.'' For example, we
entitled one section, ``[h]ow must a recognized accreditation body
evaluate laboratories seeking accreditation and oversee the performance
of laboratories it accredits?'' (Proposed Sec. 1.1120, 84 FR 59452 at
59469). By way of additional examples, we also wrote, ``[a]s the ISO/
IEC 17025 revision is still relatively new, FDA is not able to
adequately assess the accreditation of entities that only conduct
sampling at this time'' (id. at 59476); we said it was critical that we
receive sufficient supporting information ``for us to understand the
test results and to assess the validity of the underlying testing''
(id. at 59482) and we asserted authority to ``exercise some ability to
oversee accredited laboratories, via requesting records and, if
appropriate, conducting onsite assessments'' (id. at 59490).
(Comment 10) Numerous comments request that FDA address and clarify
the roles and relationships among the Agency, recognized accreditation
bodies, and LAAF-accredited laboratories under this subpart.
Several comments contend that the Agency should not use the words
``assess'' or ``accredit'' to describe Agency actions toward
laboratories. Similarly, comments argued that FDA could not revoke a
laboratory's ``accreditation.'' We understand several comments to be
suggesting that the words ``accredit'' and ``assess'' have particular
meaning in the accreditation body and laboratory community, and in the
context of food testing, that meaning is always and necessarily related
to the voluntary consensus standard ISO/IEC 17025:2017. For example,
some comments state that FDA should limit its onsite ``assessments'' of
laboratories to matters pertaining to this subpart. Comments explain
that failure by FDA to use key terms as they are understood in the
industry will lead to market confusion, e.g., regarding the ISO/IEC
17025:2017 accreditation status of laboratories.
Some comments express concern that FDA may be under the impression
that it can affect the ISO/IEC 17025:2017 accreditation of
laboratories, either by ``assessing'' against the ISO/IEC 17025:2017
standard or by withdrawing a laboratory's ISO/IEC 17025:2017
accreditation. Comments argue that such a role is contrary to the
Congressional intent underlying section 422 of the FD&C Act. Comments
state that Congress did not intend for FDA to be an accreditation body.
Some comments contend that FDA's role in the rule as proposed would be
redundant of or ``above'' the role of the recognized accreditation
bodies. Some comments express concern that FDA would be able to coerce
a recognized accreditation body into withdrawing a laboratory's ISO/IEC
17025:2017 accreditation.
[[Page 68737]]
Some comments suggest that FDA's role should be administering a
program that evaluates data or program integrity. Some comments suggest
that FDA reframe its relationship with the laboratories in terms of an
agreement to list and de-list the laboratories on our online registry.
Some comments recommend that FDA grant each laboratory a license to
conduct testing under this subpart. In this framework, comments state
that FDA's role with regard to the laboratories would be limited to the
review of test results and analytical reports submitted to FDA by the
laboratories. Some comments suggest that FDA should perform some level
of review, even if brief, of laboratory applications approved by
recognized accreditation bodies. Finally, some comments offer to work
with FDA to more clearly define roles and responsibilities under this
program.
(Response 10) We agree that substantial revisions and considerable
clarification are in order.
In proposing to define ``accreditation,'' to reflect a positive
assessment by a recognized accreditation body under this subpart, we
failed to sufficiently appreciate that in the context of food testing,
many parties may perceive ``accreditation,'' to mean accreditation to
ISO/IEC 17025:2017. Similarly, when we used the word, ``assess,'' we
did not intend to communicate, ``assess against ISO/IEC 17025:2017.''
Instead, we used the word as consistent with its more general use: The
Cambridge Dictionary defines ``assess'' as, ``to judge or decide the
amount, value, quality, or importance of something.'' (Ref. 7).
Accordingly, it was not our intent to communicate that FDA had the
authority to assess laboratories against the ISO/IEC 17025:2017
standard. For example, when we said in the proposed rule that we had
the authority to conduct an ``onsite assessment'' of a laboratory
participating in this program, we did not mean that our visit would be
for the purpose of assessing against ISO/IEC 17025:2017. Nor did we
intend to communicate that we had the authority to withdraw ISO/IEC
17025:2017 accreditation, or to pressure or demand an accreditation
body to take such an action. We agree such a role would not be
appropriate or consistent with section 422 of the FD&C Act.
To communicate our intent more effectively, we have taken several
steps. First, we removed the definition of ``accreditation'' and no
longer refer to laboratories that have been approved by a recognized
accreditation body to conduct testing under this subpart as merely
``accredited.'' Instead, we use the more precise term ``LAAF-
accredited,'' where ``LAAF'' is an acronym for the title of this
subpart, ``Laboratory Accreditation for Analyses of Foods.'' We added a
definition for ``LAAF-accreditation'' to Sec. 1.1102. Where we do use
the word, ``accredited'' in this final rule without further
qualification, we generally mean accredited to ISO/IEC 17025:2017.
Second, we no longer use the verb ``assess'' to refer to an action
that FDA takes regarding laboratories. We reserve the word ``assess''
to refer to the action a recognized accreditation body takes toward a
laboratory. We employ the word ``evaluate'' to mean an activity FDA
takes with regard to an accreditation body seeking to become recognized
or already recognized under this subpart. Largely accepting the
suggestion of some comments, we describe our relationship with regard
to the laboratories under this subpart as ``reviewing'' the performance
of LAAF-accredited laboratories.
Third, we do not use the word ``revoke'' in the final rule to mean
an action FDA may take to remove a LAAF-accredited laboratory from this
program. Instead, although an accreditation body may withdraw or reduce
the scope of LAAF-accreditation, we say that FDA may ``disqualify'' a
laboratory from conducting testing under this subpart. We note that
although ``disqualify'' was used in the proposed rule in connection
with permission to submit abridged analytical reports, we have revamped
that process such that there is no longer a disqualification period. In
the final rule, ``disqualify'' is used to describe the action FDA may
take to remove a laboratory from the program; we say that FDA may
``disqualify a LAAF-accredited laboratory from submitting analytical
reports under this subpart'' (see Sec. 1.1161). For further
information on the process related to submitting abridged analytical
reports, see the discussion of Sec. 1.1153 below at Response 124.
We agree in part with the comments suggesting that FDA perform some
level of review of laboratory applications approved by recognized
accreditation bodies. Although we have just explained that it is not
appropriate for FDA to assess or accredit laboratories ourselves, we
nevertheless have a responsibility to ensure that the laboratories we
list on our website have been properly assessed by a recognized
accreditation body. To that end, we will require the accreditation
bodies to submit certain information to us concerning their assessment
of a laboratory, including the resulting certificate listing the scope
of LAAF-accreditation (see Sec. 1.1123(d)). We decline the suggestion
to reframe FDA's relationship with LAAF-accredited laboratories in
terms of FDA granting a license to such laboratories, or in terms of
entering into a listing agreement with the laboratories. We note that
some comments suggest that such a construct could prove helpful in
relation to FDA granting permission for certain laboratories to submit
abridged analytical reports. Nevertheless, we have determined that such
a construct would present complications (e.g., could be legally
cumbersome for the FDA to ``license'' laboratories) and is unnecessary
to achieve the goals of this program.
We have implemented the revised terminology described here
throughout the final rule. We also have tried to avoid describing the
proposed rule using the now-discarded terminology (e.g., FDA
``assessing'' a laboratory), even if that is the language we originally
used in the proposed rule, because we wish to reduce confusion and
communicate more clearly. We thank the commenters for their feedback on
this important topic and we look forward to contributions of all
interested shareholders as we implement the LAAF program.
2. Program Structure
(Comment 11) In the proposed rule, FDA proposed evaluating and
recognizing accreditation bodies, and then those accreditation bodies
would assess and LAAF-accredit laboratories. We received several
comments on this proposed structure. Some comments express support
because the rule relies on the current accreditation body-laboratory
conformity assessment structure and leverages existing public-private
partnerships in the United States.
Alternatively, some comments contend that the structure was
unnecessary or ineffective. Some of these comments advocate that
laboratories should simply send their analytical reports to FDA and the
Agency would ensure the testing of food was properly conducted. Some
comments contend that the only requirement should be that accreditation
bodies are signatories to the International Laboratory Accreditation
Cooperation (ILAC), and then let the accreditation bodies assess the
laboratories for LAAF-accreditation, applying the accreditation bodies'
usual standards. Some comments argue that FDA should not have any
authority over accreditation bodies, because such authority would
result in two entities overseeing the laboratories, which these
[[Page 68738]]
comments view as both confusing and intrusive.
(Response 11) The structure of the LAAF program is specified by the
statute, per section 422(a)(1)(B) and (a)(2) of the FD&C Act. FDA will
recognize accreditation bodies, which in turn will accredit
laboratories. Further, there are advantages and efficiencies to relying
on the structure of the existing conformity assessment industry (i.e.,
accreditation bodies assess laboratories) for the structure of this
program. For example, this familiarity may make it easier for these
stakeholders to participate in the program. At the same time that we
are glad to leverage widely accepted international voluntary consensus
standards as foundational requirements, we are supplementing those
standards with certain requirements that we have determined will help
ensure the integrity of the testing under this program. As a reminder,
all the testing that we are requiring be conducted by a LAAF-accredited
laboratory is occurring in the context of increased food safety concern
(see Sec. 1.1107(a). For example, under Sec. 1.1107(a)(4), testing to
support the release of food detained at the border because it is or
appears to be adulterated or misbranded, is covered by this rule.
Accordingly, we have determined that it is appropriate to impose some
requirements in addition to those of the international voluntary
consensus standards.
Regarding the concern that FDA's exercise of authority over
recognized accreditation bodies for purposes of this program will be
confusing and intrusive, we have structured the program such that FDA
evaluates the recognized accreditation bodies, and the accreditation
bodies assess the laboratories against the model standards established
in this rule, including conformity to ISO/IEC 17025:2017. FDA will not
be assessing laboratory applicants.
As shown in section I.A. above, we have revised the program
structure diagram from the proposed rule (see 84 FR 59452 at 59453) to
reflect changes made in the final rule. The program structure diagram
incorporates revised program terminology throughout (i.e., ``LAAF-
accredited''; see discussion at Response 10). We also include a second
box representing FDA to better illustrate our roles of recognizing
accreditation bodies and reviewing results and supporting information
submitted by LAAF-accredited laboratories.
(Comment 12) Some comments opine that the framework of the proposed
rule is inappropriate. These comments contend that it is not
appropriate for FDA to oversee accreditation bodies because FDA is not
an ILAC signatory. These comments further state that only accreditation
bodies should oversee the laboratories they accredit and that therefore
FDA's involvement would be both unnecessary and confusing. These
comments recommend that FDA simply maintain a list of ILAC-signatory
accreditation bodies, and have laboratories accredited by those listed
accreditation bodies submit test results to us.
(Response 12) We disagree that the framework of the rule, and FDA's
oversight of both recognized accreditation bodies and LAAF-accredited
laboratories, is inappropriate. Section 422 of the FD&C Act directs FDA
to establish this program and, in relevant part, provide for the
recognition of laboratory accreditation bodies that meet criteria
established by the Secretary (see section 422(a)(2) of the FD&C Act).
The Agency has established that being an ILAC signatory is a necessary,
but not sufficient, condition to being recognized by FDA to LAAF-
accredit laboratories. We have determined it necessary and appropriate
to set additional standards for accreditation bodies, such as the
conflict of interest requirements in Sec. 1.1119. FDA must also
evaluate the work of the accreditation bodies to ensure the integrity
of the program. Further, the statute directs the Agency to periodically
review a recognized accreditation body's compliance with the
requirements of the program.
Similarly, section 422(a)(6) of the FD&C Act directs the Agency to
develop model standards that a laboratory must meet to be LAAF-
accredited to conduct testing under this subpart. We have adopted ISO/
IEC 17025:2017 accreditation as a baseline requirement, but given the
specific circumstances in which food testing is required to be
conducted by a LAAF-accredited laboratory and since we use the results
of such tests to inform regulatory decisions and protect public health,
we have included FDA oversight of LAAF-accredited laboratories among
the components of the program (see section 422(a)(6)(B) of the FD&C
Act).
Therefore, FDA oversight of recognized accreditation bodies is not
only appropriate, but it is also required by statute. Further, FDA has
determined that oversight of LAAF-accredited laboratories submitting
test results to FDA is appropriate given the Agency's use of the test
results. The alternative framework proposed by the comment is not a
viable option for a comprehensive and effective program that is
sufficiently protective of public health.
(Comment 13) A few comments encourage FDA to reassess our proposal
to place laboratories or accreditation bodies in probationary status,
which is noted on the public registry, after finding one or more
nonconformances. These comments suggest that we consider the variety of
circumstances that may surround nonconformance, including that the
entity may be in the process of actively addressing the nonconformance.
The comments express a concern that publication of probationary status
on the online registry may negatively and unfairly impact the entity,
as the entity may be in the process of addressing the issue that
resulted in a non-conformance.
(Response 13) We agree that entities should have an opportunity to
address concerns before those concerns cause the entity to be placed on
probation, particularly as probation will be noted on the online
registry. Accordingly, we have revised the final rule such that
generally an entity will be notified of deficiencies and provided an
opportunity to take corrective action prior to being placed on
suspension or probation. Consistent with our decision to incorporate by
reference ISO/IEC 17011:2017 and ISO/IEC 17025:2017, we have decided to
leverage the corrective action processes described in those standards
to provide such an opportunity.
Under these ISO/IEC standards, the corrective action process
requires the entity to do more than simply correct a non-conformity.
Instead, the entity is required to consider the non-conformity from a
process perspective, including identifying the cause of the non-
conformity and considering whether internal process changes are needed
to prevent its recurrence. FDA's view is that that this focus on
looking for and addressing any systemic weaknesses in the entity's
procedures, rather than simply remedying a single error or lapse, will
serve to strengthen both the accreditation bodies and the laboratories
that participate in this program, and therefore the LAAF program
itself.
Section 1.1121(a) of the final rule states that if a recognized
accreditation body observes a deficiency in a LAAF-accredited
laboratory, the recognized accreditation body may require corrective
action using the procedures described by ISO/IEC 17025:2017 section 8.7
(Ref. 3). Similarly, we have revised Sec. Sec. 1.1131 and 1.1161
regarding FDA oversight actions regarding recognized accreditation
bodies and LAAF-accredited laboratories, respectively, such that
generally entities will be provided an opportunity to take
[[Page 68739]]
corrective action prior to being placed on probation.
Some problems may warrant immediate action by a recognized
accreditation body to suspend, reduce the scope of, or withdraw the
LAAF-accreditation of a laboratory or by FDA to immediately disqualify
a LAAF-accredited laboratory. For additional information, see Sec.
1.1121 (``When must a recognized accreditation body require corrective
action, suspend a LAAF-accredited laboratory, reduce the scope of, or
withdraw the LAAF-accreditation of a laboratory?''); Sec. 1.1131
(``When will FDA require corrective action, put a recognized
accreditation body on probation, or revoke the recognition of an
accreditation body?''); and Sec. 1.1161 (``When will FDA require
corrective action, put a LAAF-accredited laboratory on probation, or
disqualify a LAAF-accredited laboratory from submitting analytical
reports?'').
Finally, note that we have revised the final rule to refer to
``suspension'' of LAAF-accredited laboratories by recognized
accreditation bodies instead of ``probation'' as proposed. The final
rule retains and limits the term ``probation'' to refer to an action
that FDA may take with respect to a recognized accreditation body or a
LAAF-accredited laboratory in certain circumstances (see Sec. Sec.
1.1131 and 1.1161). For more information on this terminology change,
see Comments 58, 71, and 82 and Responses.
3. Implementation
(Comment 14) Several comments address implementation. In section
VII of the proposed rule, we proposed that implementation would occur
in a stepwise fashion; we would focus first on accreditation bodies and
subsequently, laboratories. See 84 FR 59452 at 59495. We proposed that
after the program attains sufficient laboratory capacity, we would
publish a notice in the Federal Register giving 6 months' notice that
owners and consignees would be required to use laboratories approved
for participation in this program. All comments on this aspect of our
proposal endorse a stepwise approach to implementation. These comments
also agree with providing notice to affected entities via a Federal
Register document. Some comments encourage the Agency to also issue
Federal Register notices to announce when we will commence accepting
applications from accreditation bodies, and when recognized
accreditation bodies are able to start accepting applications from
laboratories.
(Response 14) We appreciate comments supporting our proposed
implementation steps. As we stated in the preamble to the proposed
rule, implementation of the LAAF program will necessarily occur in a
stepwise fashion. We will announce when accreditation bodies may apply
for recognition. When we have recognized a sufficient number of
accreditation bodies, we will announce that laboratories may apply to
the recognized accreditation bodies for LAAF-accreditation. When we
have sufficient LAAF-accredited laboratory capacity for the testing
covered by Sec. 1.1107, we will publish a document in the Federal
Register giving owners and consignees 6 months' notice that they will
be required to use a LAAF-accredited laboratory for such testing.
We decline to commit to publishing notices in the Federal Register
to announce that we are ready to accept applications from accreditation
bodies and that laboratories may apply to recognized accreditation
bodies. There are a variety of methods to communicate effectively with
stakeholders and the interested public; at the appropriate time we will
determine which methods best advance the Agency's interest in
transparency and the needs of the LAAF program.
(Comment 15) Some comments recommend that in addition to the
stepwise approach discussed in the previous comment and response, we
also take a phased-in approach to implementation. That means that FDA
would only require testing under the rule for the various categories of
tests described in Sec. 1.1107 as sufficient laboratory capacity is
attained for each. Some comments suggest that we refrain from requiring
testing under the rule until we have achieved sufficient laboratory
capacity for a majority of the tests covered by the rule.
Some comments maintain that there will be sufficient laboratory
capacity for the DWPE-related testing covered by the final rule,
because as we noted in the proposed rule, 10 laboratories that conduct
the majority of such testing already are ISO/IEC17025-accredited (see
84 FR 59452 at 59457). These comments state that there are ``hundreds''
of ISO/IEC 17025-accredited independent food laboratories in the United
States that potentially could participate in the program, which would
expand capacity. These comments expect that the program we are
establishing in this final rule would also increase incentives for ISO/
IEC17025 accreditation and therefore expand capacity even further.
Some comments question whether, and some comments ask when,
sufficient laboratory capacity will be reached for all the tests
covered by this final rule. Other comments inquire how FDA will
determine when sufficient laboratory capacity has been reached. Some
comments urge that when FDA considers whether there is sufficient
laboratory capacity, we take into account whether laboratories can
perform the testing in a timely manner. Other comments suggest that
when we consider capacity, we take into account laboratory location
relative to owners and consignees. Some comments predict that it will
take a long time to achieve sufficient laboratory capacity, and some
comments request that we explain what will happen if sufficient
laboratory capacity is not attained for a particular category of
testing. Some comments encourage FDA to identify the LAAF-accredited
laboratories publicly once sufficient capacity is reached.
Further, some comments express skepticism that the program would
ever be able to attain sufficient capacity to implement the bottled
drinking water followup testing covered by the rule (see Sec.
1.1107(a)(1)(iii)). These comments state that such followup tests occur
rarely and suggest that no water testing laboratory will find it
worthwhile to participate in this program for the relatively little
bottled drinking water followup testing business it might gain by doing
so.
Other comments focus on laboratories that currently test shell eggs
and maintain that many such laboratories are not currently ISO/IEC
17025-accredited. These comments question whether those laboratories
would choose to become ISO/IEC 17025-accredited in order to participate
in this program, as, according to these comments, such laboratories
would be unlikely to test any commodities covered by this final rule
other than shell eggs. These comments state it is unclear how quickly
additional laboratories would be able to get approved for participation
in the program and predict there could be a logistical problem of
bottlenecking if sufficient laboratory capacity for a particular test
is not attained. These comments encourage FDA to consult with the
National Poultry Improvement Plan at the U.S. Department of Agriculture
and other Agencies that have experience testing agricultural products.
Finally, these comments ask that FDA allow adequate time for a
sufficient number of laboratories to become LAAF-accredited to conduct
the shell egg testing described in Sec. 1.1107(a)(1)(ii) before we
require owners and consignees to have those tests conducted under this
program.
[[Page 68740]]
(Response 15) We agree that given the breadth of matrices and
methods covered by the rule it may be necessary to separately consider
whether sufficient laboratory capacity has been attained for the
variety of tests described in Sec. 1.1107. As discussed in the
preceding comment and response, the first implementation step is for
FDA to receive, review, and evaluate applications from accreditation
bodies. Once we have recognized a sufficient number of accreditation
bodies, we anticipate that many laboratories will be interested in
becoming LAAF-accredited, but it is impossible for us to predict
various relevant factors including how many laboratories will apply,
the methods for which they will be successful, and the associated
timeframes. Perhaps sufficient laboratory capacity will be promptly
attained for all tests covered by the rule; that would allow us to
issue a single Federal Register document notifying owners and
consignees that in 6 months they must use a LAAF-accredited laboratory
for all tests described in Sec. 1.1107. That outcome is not assured,
however, and therefore we may phase in implementation as suggested by
some comments. To the extent that some comments suggest we wait to
implement any of the rule until we have attained sufficient capacity
for a majority of all the tests covered by the rule, we decline the
suggestion due to the many variables that are not entirely within our
control (the number of laboratories that apply as soon as they are
able, the number and capacity of recognized accreditation bodies that
will be assessing the initial laboratory applications, etc.).
We appreciate the comments contending that there will be more than
sufficient laboratory capacity for all the testing under this rule.
This program represents the least amount of change for those private
laboratories that are already ISO/IEC 17025-accredited and have been
conducting the tests that support admission of a food under section
801(a) of the FD&C Act and removal from DWPE under an import alert and
sending their test results and associated analyses to FDA, some for
many years. Further, as indicated by some comments, the data we
analyzed for the proposed rule indicated that many of the laboratories
that have been conducting tests to support admission of a food and
removal from DWPE under import alerts are already ISO/IEC 17025-
accredited; the cost for such laboratories to become LAAF-accredited is
relatively low. We agree with comments maintaining that our reliance on
ISO/IEC 17025 as a foundational requirement for LAAF-accreditation
provides an incentive for laboratories to become ISO/IEC 17025-
accredited and we note that an explicit goal of section 422 is to
increase the number of laboratories qualified to conduct testing under
this subpart (see section 422(a)(3) of the FD&C Act).
Determining whether the program has attained sufficient laboratory
capacity may appear to be a simple comparison of the number of a
particular type of test that is needed, to the number of laboratories
LAAF-accredited for that method. The reality is far different. Test
demand cannot be predicted with certainty; in part it is a result of
the prevalence of circumstances presenting heightened food safety
concerns (e.g., the number and breadth of import alerts; how much food
product is or appears to be violative when offered for import) and in
part it is a result of business choices outside of our control or
knowledge (e.g., how much food subject to DWPE is offered for import;
whether a shell egg producer's environment tests positive for
Salmonella Enteritidis and whether the producer then chooses to test
its shell eggs or divert them to treatment (see Sec. Sec.
118.5(a)(2)(ii) and (b)(2)(ii); 118.6(a)(2)). Some laboratories are
much bigger than others, and bigger laboratories presumably can conduct
more tests than smaller laboratories, so simply knowing how many
laboratories are LAAF-accredited for a given method does not present a
complete picture of capacity. We acknowledge that location is a
relevant factor in choosing a laboratory, in large part due to the time
and cost implications of shipping samples to a laboratory that is
relatively far away, but the degree to which this factor is relevant to
laboratory capacity may vary depending on the test at issue (e.g., size
of sample, whether there are time and temperature requirements, the
degree to which a product is perishable). Similarly, although
timeliness may be an important factor for one sort of food test, it may
be less critical in other food testing contexts. Other factors may also
be relevant, and as noted above, it is infeasible for us to predict
them all.
FDA is committed to implementing this program promptly and, as in
other FSMA contexts, in a practical manner. In determining laboratory
capacity we will take all relevant information and factors into
account. We remain committed to providing owners and consignees 6
months' notice via a document in the Federal Register before requiring
them to use a LAAF-accredited laboratory for the testing covered by
this rule. We will not preclude the possibility that we may issue more
than one Federal Register document as laboratory capacity is attained
for various tests described in Sec. 1.1107.
The publication of this final rule in the Federal Register arguably
marks the beginning of the implementation of this program. Although we
expect to reach sufficient laboratory capacity for all the tests
covered by this rule, we decline the invitation of some comments to
predict how long it will take to achieve that milestone. If sufficient
laboratory capacity is not reached for a particular category or
subcategory of the tests described in Sec. 1.1107, then the immediate
result would be that we not require owners and consignees to use a
LAAF-accredited laboratory to conduct those particular tests.
We anticipate a sufficient number of LAAF-accredited laboratories
for the bottled drinking water tests covered by this final rule (see
Sec. 1.1107(a)(1)(iii)). For a related discussion, please see Comment
and (Response 87.
Some comments claim that the laboratories that currently conduct
shell egg testing tend not to be accredited to ISO/IEC 17025. These
comments express concern that such laboratories may not become LAAF-
accredited, which may result in a bottleneck effect (due to
insufficient laboratory capacity). First, as discussed earlier in this
response, FDA does not intend to require owners and consignees to use a
LAAF-accredited laboratory for the testing described in Sec. 1.1107
until the program has attained sufficient laboratory capacity for the
relevant testing, even if that means that a LAAF-accredited laboratory
is required for some categories or subcategories of testing described
in Sec. 1.1107 sooner than for other categories or subcategories.
Accordingly, the implementation of this program should not result in a
bottleneck for shell egg testing.
The research supporting the FRIA for this final rule (Ref. 4), and
the information we gleaned from our consultations with the National
Poultry Improvement Plan, is consistent with comments' claim that the
majority of laboratories that currently conduct the shell egg testing
described in Sec. 1.1107(a)(1)(ii) are not accredited to ISO/IEC
17025. Although we believe some of those laboratories will pursue ISO/
IEC 17025 and LAAF-accreditation as a result of this final rule, we
have no way of knowing with certainty.
We estimate that once this final rule is fully implemented, FDA
will receive about 3,771 analytical reports of shell egg testing per
year (Ref. 4). Due to the testing regime required under the FDA
[[Page 68741]]
egg safety rule, each analytical report will consist of 50 tests (each
shell egg sample of 1,000 eggs is separated into 50 pools of 20 eggs
each). (See Sec. 118.6.) Accordingly, we expect that more than 188,000
FDA-required shell egg tests currently conducted each year to comply
with Sec. 118.6 will eventually be conducted by LAAF-accredited
laboratories. If the laboratory market responds rationally, a
sufficient number of laboratories will react to the business
opportunity those shell egg tests create and choose to become LAAF-
accredited. If a sufficient number of laboratories that currently
conduct shell egg tests choose not to become LAAF-accredited, then
other laboratories will emerge to seize this opportunity. The costs of
becoming LAAF-accredited for laboratories new to shell egg testing will
be lowest for those laboratories that are already accredited to ISO/IEC
17025; it would therefore be reasonable to expect such laboratories to
pursue LAAF-accreditation to conduct shell egg testing. The FRIA in
section II.F.3.f. accounts for the costs for some shell egg producers
to switch laboratories if the one they are currently using is not LAAF-
accredited (Ref. 4).
Shell egg testing is only required if the poultry house has tested
positive for Salmonella Enteritidis, and the producer chooses not to
divert the eggs to treatment. The central purpose of this final rule is
to help ensure that the results of certain food testing that takes
place amidst just this sort of heightened food safety concern, are
reliable and accurate. No comments suggest that shell egg testing
should be excluded from the coverage of this final rule, or subject to
less stringent standards. We expect to avoid the logistical problem
identified by these comments. And as noted above, we are committed to
providing 6 months' notice via a Federal Register document before shell
egg producers are required to use a LAAF-accredited laboratory to
conduct the testing described in Sec. 1.1107(a)(1)(ii).
C. Comments Regarding General Provisions
Table 2--Changes to General Provisions
------------------------------------------------------------------------
Final rule Proposed rule Note
------------------------------------------------------------------------
Sec. 1.1101 What documents are N/A............... New section for
incorporated by reference in centralized
this subpart? incorporation by
reference (IBR).
Sec. 1.1102 What definitions Sec. 1.1102 What See preamble table
apply to this subpart? definitions apply below for
to this subpart? specific changes
to Sec. 1.1102.
Sec. 1.1103 Who is subject to Sec. 1.1103 Who See preamble
this subpart?. is subject to discussion below
this subpart?. for specific
changes to Sec.
1.1103.
------------------------------------------------------------------------
1. What documents are incorporated by reference in this subpart (Sec.
1.1101)?
In the proposed rule, we proposed to incorporate by reference two
international voluntary consensus standards: ISO/IEC 17011, Conformity
assessment--Requirements for accreditation bodies accrediting
conformity assessment bodies, Second edition, November 2017 (Ref. 2),
for accreditation bodies, and ISO/IEC 17025, General requirements for
the competence of testing and calibration laboratories, Third edition,
November 2017 (Ref. 3), for laboratories.
This final rule implements section 422 of the FD&C Act against the
backdrop of the broader Federal policies on consensus standards and
conformity assessment under the National Technology Transfer and
Advancement Act of 1995 (NTTAA) (Pub. L. 104-113). The NTTAA, together
with the Office of Management and Budget (OMB) Circular A-119, revised
January 27, 2016 (81 FR 4673), directs Federal Agencies to use
voluntary consensus standards in lieu of government-unique standards
except where inconsistent with law or otherwise impractical. OMB
Circular A-119 states that the use of voluntary standards, whenever
practicable and appropriate, is intended to eliminate the cost to
government of developing its own standards; decrease the cost of goods
procured and the burden of complying with Agency regulation; provide
incentives and opportunities to establish standards that serve national
needs, and encourage long-term growth for U.S. enterprises and promote
efficiency and economic competition through harmonization of standards;
and further the policy of reliance upon the private sector to supply
the government with cost-effective goods and services (Ref. 8).
As directed by OMB in Circular A-119, the National Institute of
Standards and Technology (NIST), in the Federal Register of September
29, 2020 (85 FR 60904), issued updated policy guidance on Federal
conformity assessment activities. The Federal conformity assessment
guidance is codified at 15 CFR part 287 and applies to all Federal
Agencies that set policy for, manage, operate, or use conformity
assessment activities or results (85 FR 60904 at 60905). The guidance
advises Agencies on using conformity assessment to meet government
needs in a manner that is efficient and cost-effective for both the
Agency and its stakeholders (15 CFR 287.1(a)). In keeping with these
national policies, FDA has determined that it is appropriate and will
be beneficial to both the Agency and the public if we rely on voluntary
consensus standards to provide the baseline requirements for both
accreditation bodies and laboratories wishing to participate in the
LAAF program.
In the proposed rule, the incorporation by reference information
was repeated throughout the codified text (e.g., Sec. 1.1113(b) (ISO/
IEC 17011:2017); Sec. 1.1138(a)(2) (ISO/IEC 17025:2017)). On our own
initiative, for readability we have revised the final rule to include a
centralized incorporation by reference section at Sec. 1.1101. Note
that throughout the codified, after the year of each standard, we
included the letter ``E'' to clarify that we are incorporating the
standard in English (e.g., ``ISO/IEC 170211:2017(E)).'' However for
readability, we did not repeat the ``E'' after each mention of the
standards throughout the preamble.
We received a few comments regarding the proposal to incorporate by
reference the two consensus standards. These comments are addressed
below.
(Comment 16) Several comments support our reliance on existing
international voluntary consensus standards: ISO/IEC 17011:2017 for
accreditation bodies and ISO/IEC 17025:2017 for laboratories.
(Response 16) Voluntary consensus standards such as ISO/IEC
17011:2017 and ISO/IEC 17025:2017 are developed by organizations with
the involvement of interested parties representing various roles,
concerns, and perspectives, via a robust process that seeks to achieve
consensus (Ref. 9). As noted in the immediately preceding
[[Page 68742]]
section, Federal law and policy direct us to use voluntary consensus
standards rather than creating our own unique standards whenever
practical and consistent with our legal obligations. Further, section
422(a)(6) of the FD&C Act specifically directs the FDA to ``consult
existing standards'' in the course of developing model standards for
this rulemaking.
Comments do not suggest that we consider any other standard for
accreditation bodies wishing to participate in this program. And
although some comments recommend that we permit the participation of
laboratories that meet certain industry-specific standards (see Comment
87 and Comment 88), no comment suggests a standard other than ISO/IEC
17025:2017 as a baseline requirement. We appreciate support for our
position that ISO/IEC 17011:2017 and ISO/IEC 17025:2017 are the most
appropriate globally recognized and widely used standards for the LAAF
final rule.
2. What definitions apply to this subpart (Sec. 1.1102)?
Table 3--Revisions to the Proposed Definitions in Sec. 1.1102
------------------------------------------------------------------------
Term Revision
------------------------------------------------------------------------
Accreditation................... Term revised to ``laboratory
accreditation for analyses of foods
(LAAF) accreditation'' to clarify
that decisions regarding
accreditation under this subpart are
limited to the LAAF program.
Accredited laboratory........... Term revised to ``LAAF-accredited
laboratory.''
Analyst......................... No change.
Corrective action............... New term that we define as an action
taken by an accreditation body or
laboratory to investigate and
eliminate the cause of a deficiency
so that it does not recur.
Food............................ No change.
Food testing, testing of food... No change.
Food testing order.............. Term revised to ``directed food
laboratory order'' to more accurately
describe the order. Revised the
definition to strike reference to
Sec. 1.1107(a)(2); the definition
now states the order is issued only
under Sec. 1.1108.
Owner or consignee.............. Definition revised to refer to the
circumstances in Sec. 1.1107(a)
instead of repeating the
circumstances in Sec. 1.1107(a) in
the definition.
Recognition..................... Definition revised to refer to LAAF-
accreditation of laboratories.
Recognized accreditation body... Definition revised to refer to the
accreditation body's authority with
respect to LAAF-accredited
laboratories.
Representative sample........... Definition revised to clarify that
accuracy is to a ``statistically
acceptable degree'' in response to
comments and a grammatical revision
made on our own initiative.
Sampler......................... Definition revised to reference the
individual who collects a sample.
Sampling firm................... New term that we define as an entity
that provides sampling services.
Scope of accreditation.......... Term revised to ``scope of LAAF-
accreditation'' and definition
revised to delete the second sentence
of the definition to remove the
phrases, ``in-whole'' and ``in-part''
from the definition and throughout
the rule.
------------------------------------------------------------------------
We proposed to apply the definitions in section 201 of the FD&C Act
unless otherwise specified. Additionally, we proposed to codify several
terms used in the LAAF regulations. We received several comments on
this section. As discussed in the following paragraphs, we have revised
many of the terms and proposed definitions in response to comments
received, as well as on our own initiative. Where we disagree with
comments or decline a suggested revision, we offer an explanation in
response. Some definitions were finalized as proposed.
The definitions for terms used in the laboratory accreditation for
analyses of foods regulations are codified in Sec. 1.1102.
Accreditation, Accredited Laboratory
We proposed to define accreditation and accredited laboratory to
relate to determinations regarding a laboratory under this subpart. On
our own initiative, we moved the phrase, ``under this subpart'' in the
definition of the term, ``LAAF-accredited laboratory'' to clarify that
food testing is conducted under this subpart as opposed to using
methods of analysis under this subpart, as proposed.
(Comment 17) A number of comments express concern with the proposed
definitions of ``accreditation'' and ``accredited laboratory,''
suggesting that they may result in confusion with similar terms already
being used by industry. Some comments recommend aligning the
definitions of ``accreditation'' and ``accredited laboratory'' under
this regulation with their meaning in the conformity assessment
industry to avoid potential confusion. Others propose that we
differentiate the terms under this regulation from those used elsewhere
and suggest the more specific terms, ``Section 422 accreditation'' and
``Section 422 accredited laboratory'' as potential options.
(Response 17) We acknowledge the potential for confusion regarding
the terms, ``accreditation'' and ``accredited laboratory'' under this
subpart with the use and understanding of these terms by industry.
Accordingly, we have revised the terms to be specific to the LAAF
program. Therefore, the terms have been revised to ``LAAF-
accreditation'' and ``LAAF-accredited laboratory'' respectively in
Sec. 1.1102 and throughout the rule to clarify the impacts and
limitations of accreditation decisions under this subpart. See also
Comment and Response 10.
Analyst
We received no comments on the proposed definition of ``analyst''
and therefore have finalized the definition as proposed.
Corrective Action
We have added a definition for corrective action to clarify that in
this subpart, it means, ``an action taken by an accreditation body or
laboratory to investigate and eliminate the cause of a deficiency so
that it does not recur.'' For additional discussion, see Comment and
Response 31.
Food
In the proposed rule, we defined ``food'' as having the meaning
given in section 201(f) of the FD&C Act, except that food does not
include pesticides (as defined in 7 U.S.C. 136(u)). The proposed
definition would align with the definition of ``food'' in the
``Accreditation of Third-Party Certification Bodies to Conduct Food
Safety Audits and to Issue Certifications'' (21 CFR 1.600 et seq.)
(Accredited Third-Party Certification Program) and the ``Foreign
Supplier Verification Programs for Food Importers'' (21 CFR 1.500 et
seq.) (FSVP) regulations.
[[Page 68743]]
(Comment 18) Some comments express support for the proposed
definition of ``food,'' which the comments characterize as being the
same as the definition in section 201(f) of the FD&C Act.
(Response 18) We appreciate the support for our proposed definition
of ``food'' and we are retaining it without change. We note that for
the purposes of this subpart, we are not giving the term, ``food,'' the
same meaning as in section 201(f) of the FD&C Act. Under section
201(f), ``food'' is not defined to exclude pesticides, whereas the
definition in this subpart expressly indicates that food does not
include pesticides. As we stated in the proposed rule, we have not
identified a need for ``food'' to include pesticides for purposes of
this final rule, and no comment suggests otherwise.
Food Testing, Testing of Food
We proposed to define ``food testing'' and ``testing of food'' to
mean the analysis of food product samples or environmental samples.
(Comment 19) Numerous comments indicate support for the inclusion
of environmental testing within the definition for ``food testing'' and
``testing of food'' in the proposed rule. These comments assert that
both food product and environmental testing are important to protecting
public health. Conversely, multiple comments oppose the proposal to
include environmental testing within the definition of ``food testing''
and ``testing of food.'' Some of these comments suggest that because
FSMA section 202 did not explicitly mention environmental testing, the
statute only permits the testing of food product samples, and not
environmental samples, within the scope of this regulation. Other
comments suggest that the definition of ``food testing'' and ``testing
of food'' should be consistent in scope with the statutory definition
of ``food'' in section 201(f) of the FD&C Act and limited to the
analysis of food product samples only. Some comments further specify
that although they oppose the inclusion of environmental testing within
the definition for ``food testing'' and ``testing of food,'' they
recognize the utility of environmental monitoring in ensuring food
safety. Similarly, some comments state that the food industry has
conducted environmental testing for a long time and argue that industry
does not need this final rule to cover environmental testing to
continue conducting such testing.
(Response 19) After carefully considering the comments and the
statute, we define ``food testing'' and ``testing of food'' to mean,
``the analysis of food product samples or environmental samples.''
As discussed in the proposed rule, the terms, ``food testing'' and
``testing of food,'' used in section 422 of the FD&C Act, are not
defined in the statute (84 FR 59452 at 59460). We find these terms
ambiguous and rely on context for their interpretation. Section 202(a)
of FSMA is located in Title II of FSMA, which is titled ``improving
capacity to detect and respond to food safety problems.'' Further, in
describing some of the testing to be covered by this subpart, section
422(b)(1)(A) of the FD&C Act twice includes testing that addresses,
``an identified or suspected food safety problem.'' This context
indicates the critical importance of ``food testing'' and ``testing of
food'' being interpreted to include the analysis of environmental
samples, so that this final rule will cover an important method of
detecting and responding to identified and suspected food safety
problems. We acknowledge and appreciate those comments asserting that
including environmental testing is important to addressing food safety
concerns and protecting public health. We also note that even some
comments that oppose defining ``food testing'' and ``testing of food''
to include environmental testing state that such testing plays a
valuable role in identifying potential pathways for contamination and
helping to ensure food safety.
We agree with aspects of comments that acknowledge the importance
of testing food production environments (e.g., the environment where
food is grown, harvested, packed, held, processed, or manufactured).
The term, ``environment'' includes food contact surfaces such as
utensils and table surfaces. Pathogens in the environment can be (and
unfortunately, sometimes are) transmitted to food. Therefore,
environmental testing is sometimes used as a followup test to verify
that cleaning and sanitizing designed to eliminate an identified
pathogen, was sufficient to eradicate that pathogen. Environmental
testing may also be employed to determine the source of an identified
pathogen (e.g., in circumstances where a food product tested positive
for a pathogen but it is not yet known how the food became
adulterated). It is important that FDA be able to utilize this subpart
to help ensure valid testing in the context of those sorts of
heightened food safety concerns.
Some comments indicate that Congress used the term, ``environmental
testing'' in other parts of the statute and could have done so here.
Although we do not disagree with that statement, we note that Congress
also used the term, ``product testing,'' in other parts of the statute,
and could have done so here. We do not believe the absence of these
phrases implies a lack of statutory authority to include both product
and environmental testing within the scope of this final rule.
Furthermore, the inclusion of both types of testing within the scope of
the final rule serves a central purpose of section 422 of the FD&C Act,
which is to improve FDA's access to reliable and accurate results of
public health significance, thus improving our capability to protect
U.S. consumers from unsafe food.
Some comments contend that the statutory definition of ``food''
limits our definitions of ``food testing'' and ``testing of food,'' to
product samples. As we acknowledged in the preamble to the proposed
rule, that is one, but not the only, reasonable interpretation of the
statute. For the reasons discussed, we are adopting a different and
more public health-protective interpretation and therefore finalize the
definition of ``food testing'' and ``testing of food'' without change.
Finally, we appreciate that many in the food industry have long
monitored their production environment through environmental testing.
We applaud and encourage the continued practices of firms that conduct
robust environmental monitoring programs. As discussed further in
Response 35, this final rule does not cover routine environmental
testing.
Food Testing Order
We proposed to define ``food testing order'' as an order issued by
FDA under Sec. Sec. 1.1107(a)(2) and 1.1108 requiring food testing to
be conducted under this subpart by or on behalf of an owner or
consignee. Although we did not receive specific comments regarding the
proposed definition, we received many comments about the food testing
order provisions in proposed Sec. Sec. 1.1107 and 1.1108. We discuss
those comments in section V.D. below; however, we are also making a
change to the related terminology. We have revised the term, ``food
testing order'' to ``directed food laboratory order'' throughout the
rule to more accurately reflect the order and its impact. To reduce
confusion, we generally use the term, ``directed food laboratory
order,'' throughout this document, even when referring to discussions
in the proposed rule.
On our own initiative, we revised the definition to strike the
reference to Sec. 1.1107(a)(2) and now state the order is issued
solely under Sec. 1.1108, as this provision directly describes FDA's
issuance of such orders.
[[Page 68744]]
Owner or Consignee
We proposed to define ``owner or consignee'' as a person with an
ownership interest in the food or environment samples in the
circumstances described in proposed Sec. 1.1107. On our own
initiative, we have revised the definition to refer more generally to
the circumstances described in Sec. 1.1107 instead of repeating the
circumstances in the definition.
Recognition
We proposed to define ``recognition'' to mean a determination by
FDA that an accreditation body meets the applicable requirements of the
LAAF program and is authorized to accredit laboratories under this
subpart. As a result of revising the terms, ``accreditation'' and
``accredited laboratory'' to be specific to the LAAF program, we have
revised the definition of ``recognition'' to reflect that a recognized
accreditation body will LAAF-accredit laboratories to conduct food
testing under this subpart.
(Comment 20) Some comments state that having a definition for
``recognition'' specific to this regulation may result in confusion, as
the term is already used by the conformity assessment industry in other
contexts outside of this regulation.
(Response 20) In contrast to the many comments that argue that our
proposed use of the terms ``accreditation,'' ``accredited laboratory,''
and ``assessment,'' created confusion, only a small number of comments
claim that our proposed use of the term, ``recognition,'' would create
the potential for confusion. Further, these comments provide no
specific examples of how the term, ``recognition,'' would be confusing,
and do not offer alternative terms or definitions.
In addition, the FDA Foods Program uses the term, ``recognition,''
in the same way as proposed in our Accredited Third-Party Certification
Program (see 21 CFR 1.600), and has not heard from those program
participants that the term has proved problematic. For more information
on the Accredited Third-Party Certification Program, see https://www.fda.gov/food/importing-food-products-united-states/accredited-third-party-certification-program.
Therefore, we are retaining the definition of the term,
``recognition'' in the final rule.
Recognized Accreditation Body
We proposed to define ``recognized accreditation body'' as an
accreditation body that FDA has determined meets the applicable
requirements of this subpart and is authorized to accredit laboratories
under this subpart. We have revised the definition to state that the
recognized accreditation body is authorized to LAAF-accredit
laboratories under this subpart. This change aligns with our overall
revisions to terminology throughout the rule.
Representative Sample
We proposed to define ``representative sample'' to mean ``a sample
that accurately, to a scientifically acceptable degree, represents the
characteristics and qualities of the food product or environment the
sample was collected from.''
(Comment 21) Several comments contend that the proposed definition
of ``representative sample'' is vague and impractical. Some comments
suggest we clarify that determining whether a sample is
``representative'' involves an assessment of various factors. Others
suggest that FDA clarify the Agency's expectations regarding
``representative sample'' by specifying sampling protocols within
import alerts or including specific procedures and sampling plans for
different foods and analyses within the final rule. Some comments
suggest the addition of a definition for ``representative sampling,''
based on the concern that if sampling is not performed appropriately,
results may be invalidated.
Some comments specify that the phrase, ``to a scientifically
acceptable degree'' is difficult to understand and vague; these
comments suggest that we replace the phrase, ``to a scientifically
acceptable degree,'' with the phrase, ``based on a scientific risk-
based rationale.'' These comments also suggest we add a second sentence
to the definition to explain that the suggested phrase, ``includes
consideration of the environment, food matrix, and analyte of interest,
among other factors.''
(Response 21) We agree that whether a food testing sample is
representative depends on a variety of factors. Relevant factors
include what is being sampled, the population from which the sample is
taken, the dispersion pattern of potential adulterants, and adherence
to any time and temperature controls, to name just a few. We also
appreciate the desire for clarity expressed in the comments suggesting
that we specify sampling protocols for the samples that will be tested
under this final rule. However, the purpose of defining
``representative sample'' in this subpart is not to prescribe how to
achieve a representative sample either generally or specifically for
the testing conducted under this program. Instead, it is to accurately
communicate the concept of a representative sample. We considered
altering the definition, but because every food product and
environmental testing circumstance is slightly different, and as
already noted, there are many relevant factors that also vary, our
attempts to add specificity to the definition resulted in unnecessarily
complex language or the introduction of some inaccuracy. Accordingly,
although we understand that some comments describe the proposed
definition as vague and impractical, we are retaining it with limited
changes because we conclude that it broadly satisfies the purpose for
which it was created. We also consider the definition to be similar to
and consistent with definitions that are accepted nationally and
internationally. (See, e.g., Codex Alimentarius Commission, General
Guidelines on Sampling document CAC/GL-50-2004, Sec. 2.2.3: ``A
representative sample is a sample in which the characteristics of the
lot from which it is drawn are maintained. It is in particular the case
of a simple random sample where each of the items or increments of the
lot has been given the same probability of entering the sample'' (Ref.
10).
Some comments suggest that the proposed phrase, ``to a
scientifically acceptable degree,'' is difficult to understand and
vague, and suggest instead the phrase, ``based on a scientific risk-
based rationale.'' We agree that the proposed phrase could be improved.
However, we do not believe the proffered alternative phrase is the best
choice, because it would not always be applicable and also, is less
common in the laboratory industry and therefore not widely understood.
Instead, we have replaced ``to a scientifically acceptable degree,''
with, ``to a statistically acceptable degree,'' which we believe
communicates with more precision than the proposed phrase the need for
samples to be selected based on a statistical sampling design. A sample
that represents the whole to a statistically significant degree will
yield information about the average composition of the whole, and
therefore enable valid, accurate test results.
We decline the suggestion to add a second sentence to the
definition to explain the phrase at issue but have already agreed with
the concept it expressed, which is that determining whether a sample is
representative involves considering a host of varying factors. We also
decline the suggestion to add a definition of ``representative
sampling,'' to this subpart. Although we certainly agree that sampling
techniques are critical to obtaining a representative
[[Page 68745]]
sample, this final rule does not set standards for those techniques and
therefore our discussion of them is not so extensive as to justify the
need to define the term.
On our own initiative, we also made grammatical changes to this
definition.
See our discussion of Sec. 1.1149 below for additional information
on sampling requirements and resources.
Sampler
We proposed to define ``sampler'' as an individual or individuals
who perform sampling.
(Comment 22) A few comments disagree with the proposed definition
of ``sampler,'' and state that a sampler may also be an entity (for
example, in the case of laboratories that are commercially liable for
the performance of the persons collecting the samples). These comments
suggest that FDA include definitions for both ``sampler'' (an entity)
and ``sample collector'' (individual(s)) within the final rule to
clarify this distinction.
(Response 22) We agree that it would be clearer to use two distinct
terms throughout the rule regarding activities related to sampling.
First, we have clarified the definition of the term, ``sampler'' to
mean an individual who collects samples. Second, we have added a new
term, ``sampling firm,'' which we define as an entity that provides
sampling services. Accordingly, we have revised the final rule to use
the term, ``sampling firm'' where appropriate.
Scope of Accreditation
We proposed to define this term to refer to the methods of analysis
for which the laboratory is accredited. The proposed definition went on
to state that ``[r]eferences in this subpart to accreditation `in-
whole' refers [sic] to all methods in the accredited laboratory's scope
of accreditation and references to accreditation `in-part' refers [sic]
to only certain methods in the accredited laboratory's scope of
accreditation.'' 84 FR 59452 at 59502. We received no comments on this
proposed definition; however, we have revised the proposed term and
definition to be consistent with our terminology changes throughout the
final rule. The term has been revised to ``scope of LAAF-
accreditation'' and the definition of the term has been revised to
refer to ``. . . the methods of analysis for which the laboratory is
LAAF-accredited.''
We have omitted the proposed second sentence in the definition
which removes the terms, ``in-whole'' and ``in-part.'' Instead, in the
final rule we generally employ the construct that changes in LAAF-
accreditation relate to specific methods, or apply to all methods,
within a laboratory's scope of LAAF-accreditation. Additionally, in the
final rule, to better align with the ISO/IEC conformity assessment
paradigm, we consistently use the word, ``withdraw'' to refer to the
action a recognized accreditation body takes to remove all methods
within the laboratory's scope of LAAF-accreditation, and we use the
phrase, ``reduce the scope of LAAF-accreditation'' to refer to
recognized accreditation body actions which remove only certain methods
from the laboratory's scope of LAAF-accreditation.
Additional Definitions
On our own initiative, we have included a definition for the term
``street address'' which appears throughout the final rule. We define
the term to mean the full physical address, including the country. We
go on to clarify that, for purposes of this rule, a post office box
number alone is insufficient; however, a post office box number may be
provided in addition to the street address.
We received comments requesting that we include and define
additional terms in the final rule. We address these comments below.
(Comment 23) Multiple comments suggest adding a definition for
``identified or suspected food safety problem,'' stating that doing so
would help to clarify when it would be necessary to use a LAAF-
accredited laboratory for testing.
(Response 23) For the reasons stated in the preamble to the
proposed rule, we decline the recommendation to include a specific
definition for ``identified or suspected food safety problem'' (see 84
FR 59452 to 59462). Instead, we proposed codifying the specific
circumstances in which use of a LAAF-accredited laboratory would be
required under this subpart. As discussed below in section V.D, we have
revised some of the circumstances in response to public comments and
have added additional discussion in the preamble.
(Comment 24) Some comments suggest adding definitions for ``quality
assurance'' and ``raw data,'' stating that similar terms are used by
other programs, entities, and regulations--such as FDA's Good
Laboratory Practice for Nonclinical Laboratory Studies at 21 CFR part
58--that may serve as a basis for developing a definition under this
subpart.
(Response 24) We decline to add definitions for these terms to the
final rule.
Quality assurance is a critical pursuit that must undergird both
recognized accreditation body and LAAF-accredited laboratory processes.
Indeed, we consider the integral nature of quality assurance in ISO/IEC
17011:2017 and ISO/IEC 17025:2017 to be among the standards' greatest
strengths (Ref. 2, Ref. 3). In this final rule we are establishing
requirements consistent with our perspective that quality assurance
must be nurtured (e.g., incorporation of the corrective action process
for both recognized accreditation bodies and LAAF-accredited
laboratories, submission by recognized accreditation bodies of their
internal audit reports, proficiency test requirements for each method
within the laboratories' scope of LAAF-accreditation at least every 12
months). Nevertheless, we decline the suggestion to define ``quality
assurance'' in this subpart because we conclude a definition is neither
necessary nor would it meaningfully add to the final rule. We prefer
instead to include in our standards provisions that will require the
quality assurance processes and actions we deem necessary for this
program.
We note that the term, ``quality assurance'' appeared in Sec.
1.1148 of the proposed rule (``What quality assurance requirements must
accredited laboratories meet?''). In the final rule, we have omitted
the specific section regarding quality assurance requirements and
incorporated those requirements into Sec. 1.1138, which addresses the
eligibility requirements for LAAF-accredited laboratories.
The term, ``raw data'' is not used so extensively in the final rule
as to warrant a definition. In fact, it only appears once in the
codified text, in Sec. 1.1152(d)(8), where we require as part of a
full analytical report, ``[a]ll original compilations of raw data
secured in the course of the analysis.'' We explain the term in two
ways. First, section 1.1152(d)(8) includes some examples of raw data,
and second, in our discussion of that provision at Response 119, below,
we have expounded on our thinking regarding this requirement. We
consider these forms of explanation to be sufficient in the context of
this subpart.
(Comment 25) Some comments state that the term, ``specific major
food testing discipline'' is used throughout the proposed rule and
suggest that a definition for the term be added to the regulation for
additional clarity.
(Response 25) We included the term, ``specific major food testing
discipline'' in proposed Sec. 1.1152(d) regarding permission to submit
abridged
[[Page 68746]]
analytical reports. To clarify the term, we have included detail in the
final rule at Sec. 1.1153(a) regarding the three major food testing
disciplines under this rule for purposes of submitting abridged
analytical reports. We identified these in the preamble to the proposed
rule regarding Sec. 1.1152(d) (see 84 FR 59484 (Nov. 4, 2019)) using
slightly different terms: ``microbiology, chemistry, and physical
(filth).'' In the final rule at 21 CFR 1.1153(a), we have codified the
specific major food testing disciplines that will be used to categorize
analytical reports for purposes of determining permission to submit
abridged analytical reports as ``biological, chemical, and physical.''
3. Who is subject to this subpart (Sec. 1.1103)?
Proposed Sec. 1.1103 listed the entities subject to the subpart:
recognized accreditation bodies, entities seeking to become recognized
accreditation bodies, LAAF-accredited laboratories, entities seeking to
become LAAF-accredited laboratories, and owners and consignees who are
required to use LAAF-accredited laboratories for the food testing under
this program.
We have made minor changes throughout this section to reflect
revised program terminology. Specifically, we have modified the term,
``accreditation'' to ``LAAF-accreditation'' in this section and
throughout the rule. Additionally, we have made minor editorial changes
on our own initiative to improve clarity. Comments regarding this
section are discussed below.
(Comment 26) Some comments request clarification of which owners
and consignees will be covered by this final rule, stating that there
may be multiple owners and consignees in the context of imported food.
(Response 26) FDA-regulated products imported into the United
States must comply with the same FDA laws and regulations that apply to
domestic products. Entries are submitted to U.S. Customs and Border
Protection which then refers entries of FDA-regulated products to FDA
for review. Imported items may not be distributed into commerce until
FDA has determined admissibility.
If FDA detains a food product at the border under section 801(a) of
the FD&C Act because the food is or appears to be adulterated or
misbranded, but FDA has not yet refused admission, the owner or
consignee of the food may introduce testimonial evidence that the food
is admissible. Owners and consignees often engage laboratories to test
the food and submit to FDA the results of the testing, as testimony to
support admission. If FDA determines that the food testing results are
valid and that they demonstrate the detained product does not violate
the FD&C Act, FDA will release the food from detention and allow it to
proceed into the United States. The testing of detained product at the
direction of such owners and consignees is covered by this final rule
(see Sec. 1.1107(a)(4)).
The DWPE procedure allows FDA to detain an imported product without
physically examining it at the time of entry. FDA employs the DWPE
procedure when there is a history of product that violates or appears
to violate the FD&C Act, or when other information indicates that
future entries may be violative. Import alerts inform FDA staff and the
public that we have enough evidence to allow for DWPE of particular
products. Testing to support removal from an import alert is also
covered by this final rule (see Sec. 1.1107(a)(5)). For more
information on FDA's import program generally see https://www.fda.gov/industry/import-program-food-and-drug-administration-fda; for more
information on DWPE, see https://www.fda.gov/media/71776/download.
It is true that for a particular food shipment or entry being
offered for import into the United States, multiple parties may be
considered owners and/or consignees of the entry or of particular
products within that entry (i.e., line items or lines). However, there
is generally only one importer of record for each entry,\2\ and it is
the importer of record that is ultimately responsible for ensuring that
the product(s) complies with the FD&C Act and implementing regulations
at the time of entry. (See Sec. 1.83(a), where the term, ``owner or
consignee'' is defined for the purposes of articles offered for
import.) The importer of record may negotiate or contract with another
party such that the other party agrees to engage the laboratory to test
the product. Such arrangements are purely between the parties to the
shipment; at the end of the day the importer of record remains the
party ultimately responsible for the compliance of that entry and
therefore is ultimately responsible for amassing any testimonial
evidence (e.g., test results and associated analytical documentation)
in support of admission of the food.
---------------------------------------------------------------------------
\2\ There may not be an importer of record for some informal
entries. (Informal entries, as defined by U.S. Customs and Border
Protection regulations, are usually valued at less than $2,500
(value subject to change) (19 CFR 143.21), and usually do not
require a bond. Some products are restricted from informal entry
(for example, high risk products), regardless of value.) For such
shipments that are not accompanied by an importer of record when
making entry, the owner or consignee of the line(s) will serve as
the responsible party when presenting evidence to FDA in support of
admission of the food.
---------------------------------------------------------------------------
D. Comments Regarding General Requirements
Table 4--Revisions to General Requirements
------------------------------------------------------------------------
Final rule Proposed rule Notes
------------------------------------------------------------------------
Sec. 1.1107 When must food Sec. 1.1107 Revised section
testing be conducted under this Under what title to simplify
subpart? circumstances language and
must food testing incorporate
be conducted revised
under this terminology.
subpart by an
accredited
laboratory?
Sec. 1.1108 When and how will Sec. 1.1108 When Revised section
FDA issue a directed food and how will FDA title to reflect
laboratory order? issue a food revised
testing order? terminology.
Sec. 1.1109 How will FDA make Sec. 1.1109 How Revised section
information about recognized will FDA make title to reflect
accreditation bodies and LAAF- information about revised
accredited laboratories recognized terminology.
available to the public? accreditation
bodies and
accredited
laboratories
available to the
public?
Sec. 1.1110 What are the N/A............... New section which
general requirements for consolidates
submitting information to FDA requirements from
under this subpart? throughout the
proposed rule.
------------------------------------------------------------------------
[[Page 68747]]
1. When must food testing be conducted under this subpart (Sec.
1.1107)?
Proposed Sec. 1.1107(a) stated that food testing must be conducted
under this subpart whenever food testing is conducted by or on behalf
of an owner or consignee in any of the following five circumstances:
(1) In response to explicit testing requirements that address an
identified or suspected food safety problem in existing FDA regulations
covering sprouts (21 CFR 112.146(a), (c) and (d)), shell eggs
(Sec. Sec. 118.4(a)(2)(iii), 118.5(a)(2)(ii), 118.5(b)(2)(ii),
118.6(a)(2), 118.6(e)), and bottled drinking water (Sec.
129.35(a)(3)(i) (21 CFR 129.35(a)(3)(i))) (regarding the requirement to
test five samples from the same sampling site that originally tested
positive for Escherichia coli (E. coli)); (2) as required by FDA in a
directed food laboratory order (issued under Sec. 1.1108 of this
rule); (3) to address an identified or suspected food safety problem
and presented to FDA as part of evidence for a hearing under section
423(c) of the FD&C Act (21 U.S.C. 350l) prior to the issuance of a
mandatory food recall order, as part of a corrective action plan under
section 415(b)(3)(A) of the FD&C Act (21 U.S.C. 350d) submitted after
an order suspending the registration of a food facility, or as part of
evidence submitted for an appeal of an administrative detention order
under section 304(h)(4)(A) of the FD&C Act (21 U.S.C. 334(h)(4)(A));
(4) in support of admission of an article of food under section 801(a)
of the FD&C Act; and (5) to support removal from an import alert
through successful consecutive testing.
Section 1.1107(b) of the proposed rule stated that when food
testing is conducted under paragraph (a), analysis of samples must be
conducted by a laboratory that is LAAF-accredited for the appropriate
method(s). Proposed paragraph (c) stated the requirement for food
testing on articles of food offered for import into the United States
to be conducted after the articles have arrived in the United States
unless FDA has provided prior written authorization to the owner or
consignee that a sample(s) of the article(s) taken prior to arrival in
the United States is or would be representative of the article(s)
offered for import.
We revised the proposed rule section title, ``Under what
circumstances must food testing be conducted under this subpart by an
accredited laboratory?'' to ``When must food testing be conducted under
this subpart?'' in the final rule. We have made changes throughout this
section to incorporate revised terminology. We also have made non-
substantive revisions to paragraph (a)(2) (to add the word,
``issued''), to paragraph (a)(3) to add an inadvertently omitted word
(``of''), and to paragraph (c) to improve clarity and readability.
Comments regarding this section are discussed below.
(Comment 27) We received several comments regarding the proposed
policy to allow all testing under this subpart to be conducted ``by or
on behalf of an owner or consignee.'' Some comments contend that
laboratories operated by owners or consignees (``in-house''
laboratories) should be ineligible to conduct some or all tests
described in Sec. 1.1107. Other comments voice agreement with the
proposal.
(Response 27) After considering the comments in light of the
statute, we are retaining the proposed policy such that in-house
laboratories may become LAAF-accredited to conduct any or all the
testing described in Sec. 1.1107 as long as those laboratories meet
all the laboratory requirements of this subpart. Please see the
discussion of this issue in Response 101 where we address the general
eligibility of these laboratories, as well as the impartiality and
conflict of interest requirements contained in Sec. 1.1147.
(Comment 28) We received a few comments asking us to clarify the
foods to which the testing requirements in the final rule will apply.
Some of these comments ask whether any commodities would be exempt from
the final rule and state that seafood, juice, and low-acid canned foods
are exempt from certain requirements of the ``Current Good
Manufacturing Practice, Hazard Analysis, and Risk-based Preventive
Controls for Human Food'' (preventive controls for human food)
regulation (part 117 (21 CFR part 117)). Other comments inquire whether
the final rule would apply to any commodities other than sprouts, shell
eggs, and bottled drinking water.
(Response 28) Proposed Sec. 1.1107(a) described the specific
circumstances under which food testing would need to be conducted under
this subpart by a LAAF-accredited laboratory. Sprouts, shell eggs, and
bottled drinking water are the only commodities for which specific
testing requirements contained in existing regulations are currently
covered by the final rule (see Sec. 1.1107(a)(1)(i) through (iii)).
The remaining circumstances in Sec. 1.1107(a) could require food
testing under this subpart for any food or environment within FDA's
jurisdiction. We note that hazards addressed by hazard analysis and
critical control point (HACCP) regulations for seafood (21 CFR part
123) and juice (21 CFR part 120), and those addressed by regulations
for low-acid canned food (21 CFR part 113), are exempt from certain
requirements of the preventive controls for human food regulation
because those commodities and hazards are covered by commodity-specific
HACCP or other regulations that predate the preventive controls for
human food regulation. Seafood, juice, and low-acid canned foods are
not exempt from this final rule. If seafood, juice, low-acid canned
foods, or any article of food or environment within FDA's jurisdiction
are covered by any of the circumstances described in Sec. 1.1107(a)(2)
through (5), then food testing must be conducted under this subpart by
a LAAF-accredited laboratory. For a discussion of program
implementation, see Response 14.
(Comment 29) Some comments agree with our proposal regarding the
scope of testing that would be covered by the final rule. Some comments
express alignment with the general notion of FDA requiring the use of
LAAF-accredited laboratories in circumstances where heightened food
safety concerns exist. Other comments support the proposed requirement
that testing prescribed by certain explicit testing requirements in FDA
regulations to address an identified or suspected food safety problem
should be covered by this final rule. Specifically, some comments
support the inclusion of the bottled drinking water testing required in
Sec. 129.35(a)(3)(i) and agree that other bottled drinking water
testing required by FDA regulations does not constitute testing in
connection with an ``identified or suspected food safety problem'' and
therefore was properly excluded from coverage in the proposed rule.
(Response 29) Section 422 of the FD&C Act prescribes several
circumstances in which testing must be conducted by a LAAF-accredited
laboratory. First, section 422(b)(1)(A)(i) of the FD&C Act requires
testing under this subpart to be conducted, ``in response to a specific
testing requirement under this Act or implementing regulations, when
applied to address an identified or suspected food safety problem.'' As
discussed in the proposed rule, we proposed to interpret section
422(b)(1)(A)(i) to apply to provisions of the FD&C Act or its
implementing regulations that explicitly require food testing. 84 FR
59452 at 59462. We identified nine explicit testing requirements in our
regulations that we tentatively concluded address an identified or
suspected food safety problem because each of those testing
requirements was a followup test after a
[[Page 68748]]
routine test indicated the presence of a pathogen or indicator organism
(i.e., an organism that indicates conditions in which an environmental
pathogen may be present). For example, Sec. 118.4(a)(2)(i) of our
shell egg safety regulation requires an environmental test for
Salmonella Enteritidis when the pullets are 14 to 16 weeks of age. If
the environmental test is positive, Sec. 118.4(a)(2)(iii) requires
shell egg testing to commence within 2 weeks of the start of egg laying
(unless the eggs are diverted to treatment, see Sec. 118.6(a)(2)). We
tentatively concluded that the followup shell egg testing would be
covered by the rule, but the initial environmental testing would not.
Section 422(b)(1)(A)(i) of the FD&C Act is implemented in Sec.
1.1107(a)(1) of this final rule. For a discussion of FDA's
interpretation of ``identified and suspected food safety problem,'' see
Response 35.
Section 422(b)(1)(A)(ii) of the FD&C Act requires testing to be
conducted under this subpart, ``as required by the Secretary, as the
Secretary deems appropriate, to address an identified or suspected food
safety problem.'' Section 422(b)(1)(A)(ii) of the FD&C Act is
implemented in Sec. 1.1108 of this final rule, which addresses the
directed food laboratory order. (For discussion of the directed food
laboratory order, see Comment 41 through Comment 56 and Responses,
below.) Section 422(b)(1)(A)(ii) of the FD&C Act also authorizes Sec.
1.1107(a)(3) of this final rule, which requires that food testing be
conducted under this program when it is conducted to address an
identified or suspected food safety problem and is presented to FDA in
three administrative procedural settings: As part of evidence for a
hearing under section 423(c) of the FD&C Act prior to the issuance of a
mandatory recall order, as part of a corrective action plan under
section 415(b)(3)(A) of the FD&C Act submitted after an order
suspending the registration of a food facility, or as part of evidence
submitted for an appeal of an administrative detention order under
section 304(h)(4)(A) of the FD&C Act.
Section 422(b)(1)(B)(i) of the FD&C Act requires testing to be
conducted under this subpart, ``in support of admission of an article
of food under section 801(a).'' Section 422(b)(1)(B)(i) of the FD&C Act
is implemented in Sec. 1.1107(a)(4) of this final rule. Section
422(b)(1)(B)(ii) of the FD&C Act requires testing to be conducted under
this subpart when such testing is to support removal from an import
alert through successful consecutive testing, and is implemented in
Sec. 1.1107(a)(5) of this final rule.
We appreciate those aspects of comments that express support for
the proposed testing provisions.
(Comment 30) Some comments note that there have been foodborne
illnesses associated with shell eggs produced at farms with less than
3,000 laying hens. These comments also note that food safety recalls
associated with shell eggs, including from cage-free and free-range egg
farms that have less than 3,000 laying hens, affect all egg farms. In
the view of these comments, FDA's egg safety rule should therefore not
exclude shell egg producers with less than 3,000 laying hens, and all
egg farms regardless of size should be subject to this rule for the
testing described in Sec. 1.1107(a)(1)(ii).
(Response 30) This final rule requires use of a LAAF-accredited
laboratory for certain followup tests that already are required by
other food safety regulations (Sec. 1.1107(a)(1)). Because shell egg
farms that have less than 3,000 laying hens are exempt from the egg
safety rule, such farms are not subject to this final rule for the egg
safety rule testing that falls within the scope of this subpart.
(Comment 31) Some comments opine that our use of the term,
``corrective action testing'' with respect to followup testing in
response to an identified or suspected food safety problem appears to
mean something different than it does in the world of conformity
assessment. These comments assert that for conformity assessment
purposes, ``corrective action'' means that a laboratory takes an
``action to eliminate the cause of a nonconformity and to prevent
recurrence;'' these comments cite ISO/IEC 9001.
(Response 31) In the proposed rule, we used the term, ``corrective
action'' to refer to actions taken by a conformity assessment entity in
response to a deficiency (see, e.g., 84 FR 59452 at 59491 (``the
probation notice would either inform the laboratory that the laboratory
has a specified time period to take corrective actions specified by
FDA[,] or request that the laboratory submit a corrective action plan
to FDA for FDA's approval that identifies the corrective actions it
will take to address deficiencies identified''). In the proposed rule,
we also used the term, ``corrective action'' to describe followup
activities undertaken by a food manufacturer or processor after product
or environmental testing indicates the presence of a pathogen or
indicator organism (84 FR 59452 at 59455).
We understand why comments express the view that it may have been
confusing for the term, ``corrective action'' to mean two different
things in the proposed rule. In addition, in the proposed rule, we
could have been more precise in our use of the term, ``explicit
corrective action testing'' to describe testing covered by section
422(b)(1)(A)(i) of the FD&C Act. Section 422(b)(1)(A)(i) directs this
program to cover testing ``in response to a specific testing
requirement under [the FD&C Act] or implementing regulations, when
applied to address an identified or suspected food safety problem.''
Not all the testing described by this statutory language may be
properly categorized as corrective action testing, (e.g., the sprouts
environmental tests at 21 CFR 112.146(c) are considered verification
tests within the sprouts regulatory framework; see Sec.
1.1107(a)(1)(i)).\3\ To improve clarity and precision, we use the
phrase, ``explicit followup testing'' in the final rule to mean the
testing that we have determined will be subject to this subpart under
our section 422(b)(1)(A)(i) authority.
---------------------------------------------------------------------------
\3\ For more information on sprouts environmental testing, see
the ``Compliance with and Recommendations for Implementation of the
Standards for the Growing, Harvesting, Packing, and Holding of
Produce for Human Consumption for Sprout Operations'' draft
guidance, available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-compliance-and-recommendations-implementation-standards-growing-harvesting.
---------------------------------------------------------------------------
For the foregoing reasons, including to minimize risk of confusion
and to improve the final rule, we generally reserve use of the term,
``corrective action,'' to the conformity-assessment context, in this
document. Exceptions include discussion related to the preventive
controls regulations; see Comment and Response 37. For clarity we have
added the following definition of ``corrective action'' to Sec.
1.1102: ``Corrective action means an action taken by an accreditation
body or laboratory to investigate and eliminate the cause of a
deficiency so that it does not recur.'' Relatedly, in Sec. Sec.
1.1121, 1.1131, and 1.1161 of the final rule, we have added references
to the specific sections of the relevant ISO/IEC standard to clarify
the process a recognized accreditation body or LAAF-accredited
laboratory must take to address deficiencies through corrective action.
(Comment 32) In the proposed rule, we described the circumstances
under which testing of imported food would be subject to the
requirements of this final rule. In brief, we proposed that an owner or
consignee whose entry has been detained because the food is or appears
to be adulterated or misbranded must use a LAAF-accredited laboratory
to conduct the food testing used as testimonial evidence supporting
admission to the United States. The
[[Page 68749]]
other import testing that we proposed to cover in this final rule is
testing to support the removal of food from import alert through
successful consecutive testing. Import alerts inform FDA's field staff
and the public that the Agency has enough evidence to allow for DWPE of
products that appear to be in violation of FDA's laws and regulations.
Some comments express appreciation that the proposed rule included
information on when imported foods would need to be tested. Some
comments support our proposal to require the use of a LAAF-accredited
laboratory for testing conducted to support removal from import alert.
These comments endorse the portion of the proposed rule preamble that
discussed the importance of reliable testing of imports and indicate
that in the past, food commodities subject to import alert have caused
multiple foodborne illness outbreaks. These comments state that
although it will take many tools and approaches to ensure the safety of
imported foods, reliable testing is a critical component of a
successful strategy.
(Response 32) With appreciation for these supportive comments, we
confirm that the import-related circumstances under which food testing
is required by this subpart in the proposed rule remain unchanged in
the final rule: Testing in support of admission of an article of food
under section 801(a) of the FD&C Act (Sec. 1.1107(a)(4)) and testing
to support removal from an import alert through successful consecutive
testing (Sec. 1.1107(a)(5)).
(Comment 33) Some comments express confusion about when this final
rule would apply and asked when the requirements of the final rule
would apply to regulatory feed testing laboratories.
(Response 33) A regulatory feed testing laboratory may choose to
seek LAAF-accreditation to conduct testing under this subpart. If
animal food were the subject of testing required to be conducted under
this program (i.e., the subject of food testing under Sec.
1.1107(a)(2) through (5)), then an owner or consignee would need to use
a LAAF-accredited laboratory to conduct the test. For a discussion of
program implementation, see Response 14.
(Comment 34) Some comments express the erroneous understanding that
the laboratory accreditation final rule would apply only when food
testing is conducted in a food manufacturing or processing facility.
These comments express the concern that adulteration may occur after
the food leaves the production facility, in which case testing
conducted during production is outdated and inaccurate, and potentially
masks a food safety problem.
(Response 34) We first clarify that the testing covered by this
rule is not limited to testing in a food manufacturing or processing
facility. Certain testing at farms is also covered; for example, Sec.
1.1107(a)(1)(ii) describes shell egg testing, and those eggs originate
on a poultry farm. In addition, this rule covers a significant number
of tests of imported food (Sec. 1.1107(a)(4) and (5)). Because FDA
agrees that adulteration may occur while food is in transit, the final
rule generally requires imported food products subject to this final
rule to be sampled and tested after the food has arrived in the United
States. (See Sec. 1.1107(c) and Response 40 for more on this topic.)
Thus, testing of imported food subject to this final rule generally
will occur at or near the U.S. border.
FDA also has other tools to address adulteration that occurs
outside of production establishments, including another FSMA
regulation, the ``Sanitary Transportation of Human and Animal Food''
regulation (part 1, subpart O), which requires shippers, carriers by
motor vehicle or rail vehicle, receivers, and other persons engaged in
the transportation of food, to use sanitary transportation practices to
ensure that the food is not transported under conditions that may
render the food adulterated.
(Comment 35) In the preamble to the proposed rule, we discussed
considerations in our interpretation of the phrase, ``identified or
suspected food safety problem,'' which appears in section
422(b)(1)(A)(i) and (ii) of the FD&C Act and is therefore important in
determining which testing will be covered by this subpart. Among other
things, we explored other uses of similar phrases elsewhere in FSMA. We
tentatively concluded that an ``identified food safety problem'' could
be present when a specific article of food violates a provision of the
FD&C Act that relates to food safety. We tentatively concluded that a
``suspected food safety problem'' typically would have a basis in fact
about a particular article of food (e.g., a lot or batch) or food
production environment (e.g., a specific facility). We reasoned that
the requisite suspicion would not be satisfied by the common or usual
characteristics of food (e.g., whether a food is considered ``high
risk'') or the manner in which the food is typically produced. We
tentatively concluded that the routine product testing and
environmental monitoring requirements required by the preventive
controls for human food regulation (see Sec. 117.165(a)(2) and (3),
respectively), are not conducted to address a suspected (or identified)
food safety problem, because this testing is conducted to verify the
implementation and effectiveness of preventive controls (``verification
testing'') and not because a food safety problem is suspected or
identified. 84 FR 59452 at 59462. This same tentative conclusion would
apply to the routine product testing and environmental monitoring
requirements required by the Current Good Manufacturing Practice,
Hazard Analysis, and Risk-based Preventive Controls for Food for
Animals (preventive controls for animal food) regulation (Sec.
507.49(a)(2) and (3) (21 CFR 507.49(a)(2)) and (3), respectively).
In the proposed rule we explained that, in the preventive controls
for human food regulation, FDA indicated that an ``unanticipated food
safety problem'' could occur where a preventive control is not properly
implemented, including where a pathogen or indicator organism is
detected during routine product or environmental testing (verification
testing). In the proposed rule we tentatively concluded that, depending
on the circumstances, a routine test that indicated the presence of an
indicator organism would not necessarily constitute a suspected food
safety problem. 84 FR 59452 at 59462.
Some comments dispute our interpretation of ``identified or
suspected food safety problem.'' From their perspective, there is no
need for the problem to be particularized to an article of food or a
facility. These comments state that the statute does not direct that
``an identified or suspected food safety problem,'' could only be
present in relation to a specific article of food or facility. The
comments argue that the appearance of the phrase, ``food safety
problems'' in two FSMA titles that cover multifaceted approaches to
food safety (Title I: ``Improving Capacity to Prevent Food Safety
Problems'' and Title II: ``Improving Capacity to Detect and Respond to
Food Safety Problems'') supports the position that Congress did not
intend for the same terms to be read narrowly in the context of section
422 of the FD&C Act. These comments indicate that the economic analysis
accompanying the proposed rule estimated that far fewer tests would be
subject to the LAAF program under section 422(b)(1)(A) than under
section 422(b)(1)(B) of the FD&C Act.
(Response 35) The phrase, ``identified or suspected food safety
problem,'' appears twice in section 422(b)(1)(A) of
[[Page 68750]]
the FD&C Act and therefore helps demarcate which testing will be
covered by this subpart. The statute does not define either
``identified or suspected food safety problem,'' or ``food safety
problem,'' nor do those phrases appear elsewhere in the body of FSMA.
As referenced above, the phrase, ``food safety problem'' appears in the
FSMA titles: Title I, ``Improving Capacity to Prevent Food Safety
Problems,'' and Title II, ``Improving Capacity to Detect and Respond to
Food Safety Problems.'' Comments urge us to infer from the breadth of
the various provisions within each of those two titles, that when
Congress used the same phrase in section 422(b)(1)(A) of the FD&C Act,
it intended the phrase to be broadly interpreted. However, we cannot
impute such an intention to Congress without some indication of that
intent in section 422 of the FD&C Act or the legislative history.
Indeed, one could reasonably infer the opposite--that from the breadth
of the provisions within FSMA Titles I and II, Congress must have
intended for the phrase, ``food safety problems'' to have different
meanings in different contexts. In sum, ``food safety problem'' is not
defined in the statute, and thus it falls to FDA to elaborate on its
meaning.
In the proposed rule, we looked at other FSMA standards and other
FSMA regulations, before making the tentative conclusions described
above in Comment 35. We finalize those conclusions without change.
In this vein, we observe that the purpose of routine product and
environmental testing under the preventive controls regulations is to
verify that preventive controls are consistently implemented and are
effective (Sec. Sec. 117.165(a) and 507.49(a)). Accordingly, such
testing does not address an identified or suspected food safety
problem, and is not covered by this subpart.
(Comment 36) In the proposed rule, we tentatively concluded that
although section 422(b)(1)(B)(i) of the FD&C Act requires testing, ``in
support of admission of an article of food under section 801(a)'' to be
conducted under this subpart, it was reasonable not to apply section
422(b)(1)(B)(i) to food testing related to FSVP. We explained that
under section 801(a)(3) of the FD&C Act, FDA may refuse admission of an
article of food if the food is, or appears to be, adulterated or
misbranded. When FDA determines that an article of food is, or appears
to be, adulterated or misbranded, we must notify the owner or consignee
of our determination, and state the reason(s) for such determination
(Sec. 1.94(a)). FDA must also specify a period of time during which
the owner or consignee may introduce testimony relevant to the
admissibility of the article of food. Id. Owners or consignees often
engage laboratories to test the food and then introduce the test
results (along with associated data and analysis) as evidence that the
food is admissible. If FDA determines that the sampling methods and
testing results are valid and indicate that the article of food does
not appear to violate the FD&C Act, FDA will determine that the article
of food is admissible, release it from detention, and permit its
entrance into the United States. Thus, the focus of section
422(b)(1)(B)(i) of the FD&C Act is the characteristics of an article of
food that is pending at the border. Under Sec. 1.1107(a)(4) of this
final rule, the testing obtained by the owner or consignee and
submitted as testimony to support release of the article of food from
detention, must be conducted under this subpart.
FSMA amended the FD&C Act to add section 805, ``Foreign Supplier
Verification Program,'' to require persons who import food into the
United States to perform risk-based foreign supplier verification
activities for the purpose of verifying that imported food meets
applicable U.S. safety requirements. The FSVP regulation, codified in
Sec. Sec. 1.500 through 1.514, specifies the foods and importers to
which the FSVP regulation applies and establishes requirements related
to supplier verification. Depending on the circumstances, sampling and
testing of a food may be an appropriate supplier verification activity.
See Sec. 1.506(d)(1)(ii)(B). If an FSVP importer fails to comply with
the FSVP regulations for a particular food, that food may be refused
admission under section 801(a)(3) of the FD&C Act.\4\ However, such
refusal is not because the article of food pending at the border is, or
appears to be, adulterated or misbranded. Instead, the refusal is a
consequence of the importer's failure to comply with its FSVP
obligations. Testing the article of food detained at the border in this
instance would have no impact on its admissibility under section
801(a)(3) of the FD&C Act, because the detention is due to the
characteristics of the importer. In the proposed rule we tentatively
concluded that, because the focus of the FSVP provision in section
801(a)(3) of the FD&C Act is entirely different than the focus of the
circumstances addressed by section 422(b)(1)(B)(i) of the FD&C Act, it
is reasonable not to apply the latter subpart to the testing of food
conducted under FSVP.
---------------------------------------------------------------------------
\4\ For more information on FSVP, see https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals.
---------------------------------------------------------------------------
Several comments agree with our reasoning regarding testing under
FSVP and our proposal that such testing not require use of a LAAF-
accredited laboratory. However, other comments disagree, expressing the
perspective that as the proposed rule would cover testing to support
removal from import alert, it seems more consistent with the FSMA
framework to also require testing related to FSVP to be conducted under
this subpart. We understand these comments to mean that, because FSVP
addresses the safety of food imports, and testing related to import
alerts also addresses the safety of food imports, FDA is being
inconsistent in covering import alert testing under this subpart, but
not testing related to FSVP. These comments further suggest that we not
require test results related to FSVP to be sent directly to FDA. The
comments do not explain why FSVP tests, which they argue should be
subject to this subpart, should nevertheless be excepted from the
requirement that all test results under this subpart be submitted
directly to FDA.
(Response 36) We disagree that our determinations regarding testing
related to FSVP are inconsistent with covering testing to support
removal from import alert under this subpart. As an initial matter, the
section of the statute authorizing the LAAF program explicitly directs
that testing to support removal from import alert be subject to this
program, and does not mention FSVP. Further, for the reasons discussed
in the proposed rule and briefly described in the comment summary
above, we conclude that it is reasonable not to apply section
422(b)(1)(B)(i) of the FD&C Act to food testing related to FSVP. These
comments do not explain why FSVP test results would warrant an
exception from the Sec. 1.1152(b) requirement to submit all tests
results under this program directly to FDA, and as the final rule will
not cover testing related to FSVP, the suggestion is inapplicable.
(Comment 37) Some comments agree with our tentative conclusion in
the proposed rule that the routine product and environmental testing
that occurs pursuant to a preventive controls food safety plan should
not require the use of a LAAF-accredited laboratory. Some of these
comments encourage FDA to make explicit in the final rule that routine
product testing under the preventive control regulations is performed
to verify that applied controls have been
[[Page 68751]]
effective, and not to address an identified or suspected food safety
problem, and therefore is not covered by the laboratory accreditation
final rule. Some comments also request that FDA clarify that
environmental testing conducted in response to routine environmental
monitoring results indicating the presence of a pathogen or indicator
organism would not typically be considered testing conducted to address
an identified or suspected food safety problem, and would therefore
typically fall outside the scope of the laboratory accreditation final
rule. According to these comments, facilities should have an
opportunity to perform an analysis of the root cause for the
environmental positive, take corrective actions and conduct additional
testing as needed, before FDA determines that an identified or
suspected food safety problem exists and possibly warrants testing by a
LAAF-accredited laboratory.
On the other hand, some comments urge FDA to include within the
purview of this final rule all food testing required by our
regulations, and at a minimum the verification testing and followup
testing conducted under the preventive controls and FSVP
regulations.\5\ Some of these comments contend that FDA has
misinterpreted the statute, and claim that section 422(b)(1)(A) of the
FD&C Act grants broad discretion to FDA to require use of a
participating laboratory in such circumstances.\6\ Some comments
highlight the language in section 422(b)(1)(A)(ii) of the FD&C Act,
which states in relevant part, ``as the Secretary deems appropriate, to
address an identified or suspected food safety problem,'' and argue
that such language grants FDA ``expansive'' authority for the final
rule to cover circumstances where either FDA or facilities themselves
have identified a food safety hazard and are using testing as part of
the approach to address the hazard. Such comments express the view that
if FDA does not require more domestic food testing to be conducted
under this program, FDA is failing to address food safety problems as
Congress intended. Comments encourage the Agency to adopt a broader
statutory interpretation of section 422(b)(1)(A) of the FD&C Act even
if we do not expand the testing subject to the final rule, so that we
may preserve the authority to add more testing to Sec. 1.1107 in the
future.
---------------------------------------------------------------------------
\5\ Some comments refer to ``corrective action testing;'' we
have changed the phrase to ``explicit followup testing.'' See
Response 31.
\6\ Some comments imply that the testing required under section
422(b)(1)(A) of the FD&C Act is limited to domestic food production
circumstances. However there is nothing in the statute that limits
section 422(b)(1)(A) to testing of food produced domestically, and
accordingly Sec. 1.1107(a)(1)-(3) of this final rule also refrains
from imposing that limitation.
---------------------------------------------------------------------------
In support of their contentions, some comments offer an example of
a Georgia food processing facility that was conducting environmental
testing as required by the preventive controls for human food
regulation but whose products (boiled eggs) nevertheless caused an
outbreak, which, according to the comments, calls into question the
accuracy of the test results and the quality of the facility's testing
program.
These comments posit that perhaps FDA did not propose to include
testing related to the preventive controls or FSVP regulations within
the scope of this subpart because testing under those regulations is
not always required; depending on the circumstances the facility or
importer may find other actions sufficient. These comments find such
reasoning unpersuasive because in their view, whenever testing is
required as a verification or followup activity under the preventive
controls or FSVP regulations, the testing is being conducted ``in
response'' to a regulatory requirement and so is covered by section
422(b)(1)(A) of the FD&C Act.
These comments alternatively posit that perhaps FDA did not propose
to cover preventive controls and FSVP testing because this approach
might be burdensome for industry. According to these comments, if that
is the case, then such concerns could be addressed by providing
additional time for implementation; further, any such concerns would be
offset by the positive health and economic benefits that they suggest
testing would create by preventing outbreaks.
(Response 37) Some comments contend that section 422(b)(1)(A) of
the FD&C Act grants FDA broad discretion to require testing to be
conducted under this subpart. We address the two subparagraphs of
section 422(b)(1)(A) in turn.
Section 422(b)(1)(A)(i) of the FD&C Act
Section 422(b)(1)(A)(i) of the FD&C Act provides that testing must
be covered by this program when the testing is conducted, ``in response
to a specific testing requirement under this Act or implementing
regulations, when applied to address an identified or suspected food
safety problem.'' We discussed our interpretation of ``identified and
suspected food safety problem'' in Response 35, above, and concluded
that routine product and environmental testing that occurs pursuant to
a preventive controls food safety plan (Sec. Sec. 117.165(a) and
507.49(a)) is not covered by this subpart. We turn now to our
interpretation of the phrase, ``in response to a specific testing
requirement under this Act or implementing regulations.''
In the proposed rule, we tentatively interpreted, ``specific
testing requirement under this Act or implementing regulations'' to
mean that this subpart would cover food testing explicitly required by
a statutory or regulatory provision. 84 FR 59452 at 59462. We
identified nine testing requirements in FDA regulations that were both
explicit and address an identified or suspected food safety problem:
Five testing requirements in the egg safety rule (Sec. Sec.
118.4(a)(2)(iii), 118.5(a)(2)(ii), 118.5(b)(2)(ii), 118.6(a)(2), and
118.6(e)), three in the standards for the growing, harvesting, packing,
and holding of sprouts (Sec. 112.146(a), (c), and (d)), and one in our
regulations on the processing and bottling of bottled drinking water
(Sec. 129.35(a)(3)(i)).
Comments do not directly dispute our proposed interpretation of the
term, ``specific,'' but some contend that all food testing requirements
in our regulations should be covered by this subpart. However, the
statute only authorizes testing to be covered by this subpart if it is
both an explicit testing requirement and a testing requirement that
addresses an identified or suspected food safety problem. Not all food
testing requirements in FDA regulations satisfy those two prongs of
section 422(b)(1)(A)(i) of the FD&C Act. Indeed, if Congress had
intended for all food testing required by FDA regulations to be covered
by this program, they could have said so.
Some comments argue that testing under the preventive controls and
FSVP regulations falls within the purview of section 422(b)(1)(A)(i) of
the FD&C Act. More specifically, these comments identify the testing
done to verify the effectiveness of controls, or as part of corrective
actions taken when issues are identified, as testing that should be
covered by this subpart.
First, these comments discuss testing in relation to FSVP jointly
with testing under the preventive controls regulations. However, we
have already concluded that testing related to FSVP is not covered by
this subpart (see Response 36); for the remainder of this response we
consider comments just in relation to the preventive controls
regulations.
Some comments acknowledge that the preventive controls regulations
do not always require testing. Briefly, the preventive controls
regulations apply to most registered food facilities. A wide variety of
registered food facilities process, manufacture, pack, or hold all
[[Page 68752]]
kinds of foods, so these regulations are structured to address a
plethora of circumstances. Under the preventive controls regulations,
facilities are responsible for analyzing food safety hazards to
determine if there are hazards requiring a control and then developing
and implementing a plan for the control of those hazards. The
regulations are written to provide significant flexibility to
facilities, and that flexibility is reflected in the provisions that
address testing.
For example, facilities must verify that their controls are being
consistently implemented and are effective at minimizing or preventing
the identified hazards. The regulations identify testing as one
verification activity, but the facility is responsible for determining
which verification activities are appropriate in their particular
circumstances. By way of another example, facilities must establish and
implement corrective action procedures that must be taken if a
preventive control was not properly implemented. See Sec. Sec.
117.150(a) and 507.42(a). A routine verification test indicating the
presence of a pathogen or indicator organism in a ready-to-eat product
would signal that a preventive control was not properly implemented.
See Sec. 117.150(a)(1). In certain circumstances, followup testing
would be one appropriate corrective action a facility could take in
response to such a signal. However, the regulations do not prescribe
exactly when followup testing is required, instead placing the
responsibility for making that determination on the facility.
Comments argue that because any verification or followup testing
that occurs under the preventive controls regulations is ``in
response'' to the regulations, such tests fall within the purview of
section 422(b)(1)(A)(i) of the FD&C Act. These comments may prefer that
the word, ``specific'' not appear in section 422(b)(1)(A)(i) of the
FD&C Act, but it does, and it must be given meaning. Regulatory
provisions that confer significant discretion on regulated entities for
determining when food testing is necessary, are not explicit testing
requirements and therefore are not covered by this subpart. We finalize
our proposed interpretation of ``specific'' testing requirements
without change and conclude that neither routine verification testing
nor followup testing under the preventive controls regulations is
covered by this subpart using our section 422(b)(1)(A)(i) authority.
Some comments opposing our interpretation of section
422(b)(1)(A)(i) of the FD&C Act discuss whether we chose not to include
verification and followup testing under the preventive controls
regulations because it would place a greater burden on those
facilities. Comments state that if that is the case, our concerns could
be addressed by providing more time for such entities to comply with
this final rule. Comments also state that there would be public health
benefits from requiring the use of a LAAF-accredited laboratory for
such testing. However, as discussed above, we have determined that the
regulatory provisions describing verification and followup testing in
the preventive controls regulations are not explicit testing
requirements, and therefore we do not interpret them to satisfy the
statutory requirements of section 422(b)(1)(A)(i).
For the foregoing reasons, we conclude that we have properly
identified the nine FD&C Act testing requirements that are currently
covered by this subpart under our section 422(b)(1)(A)(i) authority. It
is possible that in the future, FDA may require additional specific
followup testing in FD&C Act regulations, and that testing would be
covered by this subpart. However for now, we finalize Sec.
1.1107(a)(1) without change.
Section 422(b)(1)(A)(ii) of the FD&C Act
Section 422(b)(1)(A)(ii) authorizes FDA to require testing to be
conducted under this subpart, ``as required by the Secretary, as the
Secretary deems appropriate, to address an identified or suspected food
safety problem.'' In the final rule we rely on this statutory provision
to require that testing conducted pursuant to a directed food
laboratory order be conducted under this subpart; see Sec. 1.1108.
Very briefly, as we interpret this statutory provision, directed food
laboratory orders will generally be limited to the rare situations when
we have reason to question the accuracy or reliability of past or
present test results, and an identified or suspected food safety
problem exists. (The directed food laboratory order is discussed in
Comment 41 through Comment 56 and Responses, below.) We also rely on
our section 422(b)(1)(A)(ii) authority to require in the final rule
that testing related to certain administrative proceedings be conducted
under this subpart; see Sec. 1.1107(a)(3). (For discussion of the use
of section 422(b)(1)(A)(ii) authority to cover certain administrative
proceedings testing under this subpart, see the proposed rule (84 FR
59452 at 59463-64)). We agree with those aspects of comments noting
that the language of section 422(b)(1)(A) of the FD&C Act is broad
enough that, in the future, we could cover additional testing under
this subpart by relying on that authority. This could occur if we deem
it appropriate to expand this program to cover additional testing, and
the additional testing addresses an identified or suspected food safety
problem. Further, we intend to make such a change only through notice-
and-comment rulemaking.
Some comments request that FDA clarify that environmental testing
conducted in response to routine environmental monitoring results
indicating the presence of a pathogen or indicator organism would not
typically be considered testing conducted to address an identified or
suspected food safety problem, and would therefore typically fall
outside the scope of the laboratory accreditation final rule. We have
determined that the routine verification and followup testing
provisions in the preventive controls regulations do not state explicit
testing requirements and are therefore not appropriate to include in
Sec. 1.1107(a)(1); therefore, they will typically fall outside the
scope of this final rule. We have also determined that routine
verification testing that occurs pursuant to a preventive controls food
safety plan (Sec. Sec. 117.165(a) and 507.49(a)) does not address an
identified or suspected food safety problem (Response 35). However,
followup testing in response to routine verification test results
indicating the presence of a pathogen or indicator organism in either a
food product or the food production environment may qualify as testing
that addresses an identified or suspected food safety problem,
depending on the circumstances. We affirm the statement we made in the
proposed rule that, depending on the circumstances, a positive
indicator organism test would not necessarily constitute a suspected
food safety problem; for example, a single positive Listeria spp. on a
food contact surface in a facility would not necessarily constitute a
suspected food safety problem. However, when a routine verification
test of a food product indicates the presence of a pathogen, in many
circumstances we would conclude that there is at least a suspicion of a
food safety problem. For example, the presence of Salmonella in nuts
indicates a suspicion of a food safety problem, but the presence of
Bacillus cereus in tree nuts is not likely to indicate a food safety
problem, since the organism cannot grow to the high numbers needed to
cause illness due to the low water activity of tree nuts. Additionally,
in many circumstances a
[[Page 68753]]
routine environmental monitoring test result indicating the presence of
a pathogen in a facility producing a ready-to-eat product could be
classified at least as a suspected food safety problem.
Followup testing that addresses an identified or suspected food
safety problem under the preventive controls regulations--or in the
context of the FD&C Act, or any FDA food safety regulation--may fall
within the purview of section 422(b)(1)(A)(ii) of the FD&C Act. Under
this final rule, this means that such testing may be the subject of a
directed food laboratory order under Sec. 1.1107(a)(2), and may be the
subject of the testing in certain administrative proceedings described
in Sec. 1.1107(a)(3). We do not anticipate frequent testing under
Sec. 1.1107(a)(2) or (3); as a result, under this final rule, followup
testing that addresses an identified or suspected food safety problem,
but that is not expressed in an explicit testing requirement, will
typically fall outside the scope of this subpart. Again, were we to
seek to expand the testing subject to this final rule, we would go
through the rulemaking process. (For discussion of the circumstances in
which we anticipate issuing a directed food laboratory order, see
Response 47.)
We do not agree that the 2019 foodborne illness outbreak linked to
hard-boiled eggs and cited in comments is evidence that this final rule
should generally cover routine verification and followup testing under
the preventive controls regulations. In the above-referenced situation,
the facility was processing shell eggs into hard-boiled egg products;
the hard-boiled eggs were linked to an outbreak of Listeria
monocytogenes infections. The facility was processing a ready-to-eat
product that was exposed to the facility environment prior to
packaging; in those circumstances, the preventive controls for human
food regulation generally requires that the facility establish
sanitation controls verified in part by an environmental monitoring
program that involves regularly testing the facility environment. See
Sec. 117.165(a)(3). We thus maintain the view that the existing
preventive controls for human food regulation adequately covers this
situation. When FDA collected environmental samples as part of its
investigation, the facility did as well. There would be no point in
requiring tests such as those taken by the facility to be subject to
this subpart when FDA was onsite to conduct its own investigational
tests. Indeed, the tests of environmental samples the facility
collected alongside FDA inspectors would not be categorized as
verification or followup tests, and thus would not fall within the
purview of this final rule, even if the rule did cover these test
categories.\7\
---------------------------------------------------------------------------
\7\ Comments also state that the facility in question engaged a
laboratory to validate a process control, but comments do not
suggest that this final rule should cover such testing.
---------------------------------------------------------------------------
As support for their argument that FDA is applying section
422(b)(1)(A) of the FD&C Act too narrowly, some comments state that the
economic analysis accompanying the proposed rule indicated that many
more tests would be conducted under this subpart stemming from section
422(b)(1)(B) than section 422(b)(1)(A). The economic analysis
accompanying a rule simply reflects the rule it analyzes; this point
appears to be another facet of the argument that we have misinterpreted
the statute. We disagree for the reasons already stated.
We also disagree that in issuing this final rule FDA is falling
short of addressing important food safety problems. For the reasons
discussed throughout this response, we believe we have interpreted the
statute appropriately, and we look forward to achieving significant
public health benefits as a result of this rule (Ref. 4).
(Comment 38) Some comments generally urge a broader scope for the
laboratory accreditation final rule. Some of these comments discuss the
critical role food laboratories play in helping to keep the food supply
safe, including the corresponding need for accurate and reliable
results, and therefore seek Federal oversight of all food testing
laboratories. Some of these comments advocate for a requirement that
all food testing laboratories be accredited, which we understand to
mean either that these comments express the belief that all food
testing laboratories should be required to be accredited to ISO/IEC
17025:2017, or should be subject to LAAF-accreditation under this
subpart. Other comments suggest that all laboratories that test food
for human consumption should be required to satisfy the baseline
requirement of this final rule and be accredited to ISO/IEC 17025:2017.
These latter comments suggest that the additional requirements of this
final rule could then be reserved just for the testing identified in
Sec. 1.1107(a).
(Response 38) We appreciate the critical role that all food testing
laboratories play in helping to keep the food supply safe, and we
acknowledge the importance of accurate and reliable test results.
However, section 422 of the FD&C Act does not contemplate FDA
regulation of all food testing laboratories, or of all laboratories
that test food for human consumption. We therefore do not require that
all food testing, or human food testing, laboratories be accredited to
ISO/IEC 17025:2017 or comply with the laboratory requirements in this
subpart.
(Comment 39) Some comments request additional information about the
role the LAAF-accredited laboratories will play in relation to food
manufacturing facilities that are subject to required product or
environmental testing under the final rule. These comments assert that
the proposed rule was ``not clear regarding the level of authority an
accredited lab has in order to perform on-site collection activities at
food manufacturing facilities.'' These comments recommend that FDA
clarify in the final rule the roles and responsibilities of the
participating laboratory and facility, such as which information and
records the facility would be required to make available to the
laboratory.
(Response 39) We believe these comments misunderstood the proposed
rule. When food testing is required to be conducted under this subpart,
an owner or consignee must use a LAAF-accredited laboratory. However,
the owner or consignee will select a LAAF-accredited laboratory from
the online registry (see Sec. 1.1109), and engage the laboratory, and
that laboratory will have no more authority over the owner or consignee
than specified in the business arrangement between the parties. The
final rule requires that the sample be collected by a person qualified
by training or experience to do so, and requires certain sampling
documents (Sec. 1.1149), but the owner or consignee may select any
sampler or sampling firm it likes, as long as the entity or person is
qualified and will provide the documentation required under the final
rule. Sometimes owners or consignees collect their own samples,
sometimes they engage third-party sampling firms, and sometimes they
pay the laboratory that will analyze the sample to collect the sample.
Under this subpart, that choice remains with the owner or consignee.
Therefore, FDA declines to further articulate any roles or
responsibilities of these parties beyond the requirements of the final
rule.
(Comment 40) In the proposed rule, for imported food, we provided
that testing under this rule generally could only be conducted on
samples taken after the articles of food have arrived in the United
States. We proposed one exception to that policy, where FDA determines
that a sample taken prior to arrival is representative of the article
of food offered for import. We said that we would make such a
determination on a
[[Page 68754]]
case-by-case basis. We received several comments on this aspect of our
proposal.
First, some comments appear to understand that we proposed that
sampling prior to arrival may be allowed in certain circumstances, but
they seem unsure whether testing prior to arrival may also be allowed.
These comments ask whether foreign laboratories could participate in
this program and encourage FDA to clarify the extent to which the
requirements of this final rule would apply to such foreign
laboratories.
Some comments support allowing sampling and testing prior to
arrival in certain circumstances, such as sampling for removal from
import alert. Other comments maintain that we should allow no
exceptions to the policy that sampling of imports occur after arrival
in the United States. These comments opine that allowing sampling prior
to entry would amount to ``self-policing'' by the owner or consignee.
They also argue that allowing sampling prior to entry would ignore the
risk that changes may occur during transit that would impact the test
results. They view the proposed exception as creating a public health
concern.
Additionally, some comments in favor of the proposed policy suggest
that when FDA determines that a sample taken prior to entry is or would
be representative of the article of food offered for import, FDA should
make its determination publicly and widely available (i.e., ``publish''
it).
(Response 40) To clarify, foreign laboratories may seek LAAF-
accreditation to conduct food testing under this subpart. All
laboratories that choose to participate, whether foreign or domestic,
must meet the same accreditation standards and comply with all
provisions of the final rule (see section 422(a)(5) of the FD&C Act).
There is no requirement that testing of imports subject to this rule
must be conducted by a laboratory in the United States; testing may be
conducted by any LAAF-accredited laboratory, regardless of location.
However, we are finalizing the proposed policy that under this subpart,
sampling generally must occur after arrival in the United States,
unless FDA has granted an exception. This requirement protects public
health by helping to ensure that the test results we are relying on to
make admissibility decisions accurately reflect the conditions of the
article of food when offered for import into the United States.
At the same time, we disagree with the comments contending that all
import sampling should occur after arrival without exception. We are
finalizing the proposed exception for those situations in which we
determine that food sampled prior to export is representative of the
article offered for import (Sec. 1.1107(c)). The FDA determination to
grant the exception must be received by the owner or consignee, in
writing, prior to testing of samples taken prior to arrival in the
United States (id.). We generally would base such a determination on
specific circumstances of each shipment (e.g., characteristics of the
product and analyte, specifics of packaging and transportation) and
grant any exceptions on a case-by-case basis. We decline the suggestion
to publish our determinations of scenarios where a sample taken prior
to arrival is or would be representative of the article of food offered
for import because we expect our determinations to be situation-
specific. We may consider issuing guidance in the future on the factors
we evaluate in making such determinations, which we believe would be
more useful to our constituents than case-by-case publication.
It is possible that we could make such a determination for an
article of food subject to DWPE (on an import alert). Again, any such
determination generally would be made on a case-by-case basis, based on
clear evidence that the product sampled is representative of the
product offered for import (see Sec. 1.1107(c); 84 FR 59452 at 59465).
In the proposed rule, we solicited feedback on whether circumstances
warrant application of the exception broadly, for instance, to a
particular commodity or analyte generally. We received no comments with
suggestions for broader applications of the exception.
As discussed in Response 101, the rule does not prohibit owners or
consignees from collecting a sample or conducting their own test, as
long as all the requirements of the rule are satisfied.
2. When and how will FDA issue a directed food laboratory order (Sec.
1.1108)?
Proposed Sec. 1.1108 described the circumstances under which we
would issue a food testing order. Paragraph (a) described when we would
require an owner or consignee to have food testing conducted under this
subpart (``. . . to address an identified or suspected food safety
problem related to the article of food.'') Proposed Sec. 1.1108(b) and
(c) also specified what we would include in the order (e.g., the food
product or environment to be tested, any particular methods, and other
elements required by part 16 (21 CFR part 16) related to a regulatory
hearing). As previously discussed, we have changed the terminology in
this section from ``food testing order'' to ``directed food laboratory
order,'' and to avoid confusion we use the new term throughout this
document, even when referring to discussions in the proposed rule.
On our own initiative, we made a few revisions to this section. We
revised the proposed rule section title, ``When and how will FDA issue
a food testing order?'' to ``When and how will FDA issue a directed
food laboratory order?'' in the final rule and made changes in the
section to incorporate revised terminology. We removed the unnecessary
phrase, ``related to the article of food'' in Sec. 1.1108(a). We also
removed the phrase, ``of an article of food'' from Sec. 1.1108(a)
since the definition of owner or consignee in Sec. 1.1102 specifies
interest related to the food product or environment subject to food
testing. We also made minor editorial changes to this section.
Many comments support the rulemaking and the Agency's efforts to
implement section 422 of the FD&C Act; however, they do not support the
directed food laboratory order provision. Some comments raise
``substantial'' concerns with the Agency's proposal, specifically
legal, policy, and practical aspects of the proposed rule with respect
to directed food laboratory orders. We address these comments below.
(Comment 41) A number of comments argue that the Agency lacks
explicit and implied statutory authority in FSMA and the FD&C Act to
issue directed food laboratory orders. The comments conclude that the
Agency is limited by the authority delegated by Congress in FSMA and
under the FD&C Act, and that because neither the plain terms nor the
core purpose of the relevant sections of the statute contemplate
directed food laboratory orders, there is no explicit authority to
issue a directed food laboratory order.
The comments further argue that the Agency has misinterpreted
section 422(b)(1)(A)(ii) of the FD&C Act as providing implied authority
to issue directed food laboratory orders. Comments explain that section
422(b)(1)(A)(ii) is limited by section 422(b)(1)(A)(i) because the
clauses are linked by the word, ``and'' and therefore must be read
conjunctively. To support this interpretation, several comments cite
the plain language of the statute and case law in support of the
associated canon of statutory interpretation. Comments assert a
presumption that Congress intended ``and'' to be read
[[Page 68755]]
conjunctively. Some comments indicate that even though sections
422(b)(1)(A)(i) and 422(b)(1)(A)(ii) of the FD&C Act repeat the phrase,
``to address an identified or suspected food safety problem,'' this
repetition does not support reading the ``and'' disjunctively to
signify ``or.'' To support this position, the comments cite the case of
Loving v. IRS (917 F. Supp.2d 67), in which the D.C. Circuit Court
rejected the IRS argument that existence of overlapping or redundant
statutory language should override the plain meaning of ``and.'' The
comments thus conclude that the statute may only be read to require
food testing under this subpart in two circumstances, as opposed to the
five circumstances specified in Sec. 1.1107 of the proposed rule.
Interpreting the statute in this way to require food testing in
only two circumstances, some comments claim that the two circumstances
when LAAF-accredited laboratories must be used are when food testing is
conducted: (1) In response to a specific testing requirement under the
FD&C Act or implementing regulations, when applied to address an
identified or suspected food safety problem and as required by the
Secretary, as the Secretary deems appropriate, to address an identified
or suspected food safety problem or (2) in support of admission of an
article of food under section 801(a) of the FD&C Act and under an
import alert that requires successful consecutive tests. Comments add
that even if the plain meaning is proven otherwise to read the ``and''
disjunctively, it still does not provide the Agency with discretionary
authority to issue directed food laboratory orders. Comments urge that
this authority cannot be expanded even if the intent is to further the
goals of Congress.
Comments explain that the plain language of the statute requires
that section 422(b)(1)(A) of the FD&C Act apply only ``in response to''
and ``to address'' a food safety problem, not to seek one out. Were
directed food laboratory orders implemented as proposed, comments argue
that this approach would create an additional investigative tool not
contemplated by the statute. Comments express that FDA already has the
authority to conduct food testing and to choose a laboratory. Comments
state further that there is no evidence that Congress intended to shift
the Agency's responsibilities to owners and consignees.
Some comments state that any authority provided under section 422
of the FD&C Act to require food testing under this subpart, absent an
explicit requirement in statute or regulation to conduct testing, must
only apply in narrow circumstances where the basis for the food safety
problem has been established. These comments state they would support
testing by accredited laboratories as part of evidence for a hearing
prior to the issuance of a mandatory recall order, an order suspending
a food facility's registration, or an administrative detention order.
Likewise, other comments add support for the Agency to issue a directed
food laboratory order as part of the corrective action plan after a
facility's registration has been suspended.
Some comments echo the call for FDA to keep the scope of the rule
narrow and support applying the rule to specific testing requirements
in FDA's regulations, e.g., certain post-remediation testing after E.
coli has been identified in the source water for bottled drinking
water.
A few comments characterize Congress's grant of authority to the
FDA to address an ``identified or suspected food safety problem'' in
FSMA as broad and state that these terms were not defined; however, the
comments do not support the use of the statute to add what they view as
a new enforcement tool, namely, the directed food laboratory order.
These comments seek additional background regarding how this tool fits
with other FDA authorities as they did not anticipate the Agency
implementing the statute through the use of directed food laboratory
orders as set forth in the proposed rule.
(Response 41) We disagree with the assertions in the comments that
the Agency lacks the statutory authority to issue directed food
laboratory orders. Section 422(b)(1)(A)(ii) provides authority for
testing under this subpart ``as required by the Secretary, as the
Secretary deems appropriate, to address an identified or suspected food
safety problem.'' The ``and'' joining the two clauses in sections
422(b)(1)(A) and (B) is appropriately read as joining lists containing
two separate and distinct circumstances. Reading the ``and''
conjunctively as some comments urge would create an absurd result since
both clauses of 422(b)(1)(A) repeat the phrase, ``to address an
identified or suspected food safety problem.''
We also disagree with the notion that directed food laboratory
orders would inappropriately shift the burden of testing to owners or
consignees. The responsibility to produce safe food rests with the food
producers. Food testing by LAAF-accredited laboratories under this
subpart will provide assurance of the accuracy of the results conducted
in response to identified or suspected food safety problems of
significance to public health and will better enable both the Agency
and the owner or consignee to act in the best interest of public
health.
As we discuss below in Response 47, we believe the circumstances in
which we anticipate using a directed food laboratory order and the
examples provided demonstrate that a directed food laboratory order
will be used ``to address'' an identified or suspected food safety
problem.
We also disagree with aspects of comments asserting that the basis
for the food safety problem must be ``established'' in order for food
testing to be subject to this subpart. The statutory standard for when
the Agency may issue a directed food laboratory order is explicitly set
forth in section 422(b)(1)(A)(ii) of the FD&C Act: Such an order may be
issued ``as required by the Secretary, as the Secretary deems
appropriate, to address an identified or suspected food safety
problem.''
As proposed, we agree that this subpart will apply to testing in
relation to certain administrative proceedings. Under Sec.
1.1107(a)(3), certain testing as part of evidence for a hearing prior
to the issuance of a mandatory recall order, as part of the corrective
action plan after a food facility's registration has been suspended, as
well as an appeal of an administrative detention order, is subject to
this subpart.
(Comment 42) Several comments argue that the directed food
laboratory order provision violates the Administrative Procedure Act (5
U.S.C. 551 et seq.) (APA), because the proposal lacked a reasoned
explanation for the provision and contained insufficient detail to
facilitate meaningful public comment. These comments conclude that
finalizing the directed food laboratory order provision as proposed
would put this tool at risk of being invalidated if challenged as
arbitrary and capricious under the APA. Some comments state that the
Agency can finalize the laboratory accreditation rule and meet all
statutory obligations without issuing directed food laboratory orders
and therefore conclude directed food laboratory orders are not ``fit
for purpose.''
Many comments state that directed food laboratory orders are not
aligned with the purpose and principles of FSMA and the intent of
section 422 of the FD&C Act. Comments state that Congress's purpose in
section 422 of the FD&C Act is to address the practice of importers
engaging in ``laboratory shopping'' (i.e., a practice whereby an owner
or consignee sends samples to several laboratories in hopes that one
will return results indicating the sample complies with FDA
requirements and if
[[Page 68756]]
so, the owner or consignee submits only that result to FDA) by
requiring that food testing results be sent directly to the Agency;
these comments argue that the directed food laboratory order provision
of the proposed rule does not advance this objective.
Other comments frame the purpose of section 422 of the FD&C Act as
ensuring reliable and accurate test results. These comments counter
that instead of supporting this purpose, the proposed directed food
laboratory order creates a new investigatory and enforcement tool for
FDA, which is unnecessary given the Agency's existing enforcement
tools; namely, that FDA may already sample the product and the
environment and choose the laboratory to conduct the analysis. Comments
state that Congress carefully considered which additional tools were
necessary through FSMA and did not contemplate a duplicative
enforcement tool. Comments state that there is no indication that
Congress intended to shift this burden to industry through directed
food laboratory orders in section 422 of the FD&C Act and that doing so
would be unfair. Comments suggest that additional Agency funding is the
more appropriate solution to address limited Agency resources. Several
comments offer revisions to the directed food laboratory order
provision that they consider necessary to link the proposed provision
to the purpose of the statute. Additionally, some comments indicate
that facilities must implement environmental and product testing
according to food safety plans under other FSMA provisions and FDA may
review this information during routine inspections; comments express
the belief that this represents sufficient oversight into testing
methodology, laboratory choice, procedures, and test results. In sum,
comments argue that without a demonstrated concern with laboratory
integrity and a public health need, directed food laboratory orders are
inappropriate and outside the scope of section 422 of the FD&C Act.
Comments argue that the proposed rule preamble provided limited
information regarding the Agency's need or justification for directed
food laboratory orders, such as historical events or situations when
such orders would have been useful. Regarding the justification, many
comments state that the preamble fails to explain the problem directed
food laboratory orders are intended to address, as there is no
documented issue regarding the reliability of test results that would
warrant testing by LAAF-accredited laboratories. Some comments state
that without a clear explanation for the Agency's need for what they
perceive as a potentially expansive enforcement tool, comments cannot
support the directed food laboratory order provision. Additionally,
some comments state that the Agency has not considered how the proposed
directed food laboratory order provision would harm industry, including
by increasing costs to food companies associated with the use of LAAF-
accredited laboratories and disrupting production to hold product while
waiting for test results.
Some comments state that in the proposed rule we did not address
operational details of the directed food laboratory order such as who
in FDA would issue such orders, how the orders would be delivered; how
long the directed food laboratory order would be in place; and when and
how a directed food laboratory order would be lifted. We understand
some comments to argue that it was legally necessary for FDA to
describe these operational details in the proposed rule. Finally,
according to some comments, the proposed rule should have reflected
that we considered alternative approaches to the directed food
laboratory order.
(Response 42) The proposed rule contained a reasoned explanation
and sufficient detail on this topic to facilitate meaningful comment
and therefore fully satisfied APA requirements. In the proposed rule we
articulated the legal authority for the directed food laboratory order,
a description of the tool, and the substantive issues involved. We
stated that we were interpreting section 422(b)(1)(A)(ii) of the FD&C
Act to give FDA authority to propose the directed food laboratory
order. We described the proposed content of the directed food
laboratory order (e.g., it will specify the timeframe for the testing,
and any method that must be used). We communicated that the proposed
directed food laboratory order addresses an identified or suspected
food safety problem, and we discussed the meaning of that phrase at
some length. We made clear that the proposed tool could be used to
compel either product or environmental testing and explained our basis
for including environmental testing within the proposed definition of
``food testing.'' We also explained that under the proposed rule owners
or consignees subject to a directed food laboratory order may request a
regulatory hearing.
Comments also argue that the proposed rule was insufficient because
the Agency failed to explain a need for the directed food laboratory
order, for example by describing past enforcement cases in which the
Agency would have found it helpful to employ such a tool. It is true
that we did not describe a past case, but it was clear from the
proposed rule that the tool is directed at unreliable test results in
circumstances where we have reason to suspect, or have identified, a
particular food safety problem for which a particular owner or
consignee is responsible. Further, although we did not discuss our
consideration of alternative approaches in the proposed rule, based on
our knowledge and experience implementing FSMA, we have determined that
the directed food laboratory order is an appropriate application of
section 422(b)(1)(A)(ii) of the FD&C Act. See also, Response 41 and the
analysis of regulatory alternatives to this rule in the FRIA (Ref. 4).
With regard to comments expressing concern that we did not justify
an expansive new tool in the proposed rule, we believe this reflects a
misperception: The directed food laboratory order is a precise new tool
that will help us protect public health in a relatively narrow set of
circumstances. Section 422(b)(1)(A)(ii) of the FD&C Act gives FDA
authority to require testing to be conducted under this subpart as we
deem appropriate, to address an identified or suspected food safety
problem. As we interpret this statutory provision, directed food
laboratory orders will generally be limited to the rare situations when
we have reason to question the accuracy or reliability of past or
present test results, and an identified or suspected food safety
problem exists. (See Response 47 for discussion of the standard; see
Response 35 for discussion of ``identified or suspected food safety
problem.'')
Some comments appear to express doubt that there are ever any
problems with the reliability of food testing conducted by or for
owners or consignees, and claim that because the proposed rule did not
document that such problems exist, and threaten public health, there is
insufficient justification for the directed food laboratory order. We
suspect that this reflects the misperception in some comments regarding
the directed food laboratory order as an expansive new tool, which in
turn may have created a belief that the proposed rule should contain a
lengthy description of widespread problems with the validity of an
array of test results. As clarified above, however, the directed food
laboratory order is not a tool that we expect to apply broadly or
frequently. Rather, it will be applied in particularized circumstances.
If there were never any particularized problems
[[Page 68757]]
with the reliability of food testing conducted by or for owners and
consignees, Congress would not have enacted section 422 of the FD&C
Act. However, in this provision of the FD&C Act, Congress has
specifically reserved for the Agency the authority to require testing
to be conducted under this subpart in circumstances beyond just those
defined by Congress. And, given some of the egregious situations and
behaviors FDA has encountered in enforcing the food safety provisions
of the FD&C Act, many of which have been widely publicized, we do not
believe anyone could reasonably doubt the existence of particular
circumstances in which owners or consignees failed to use a quality,
reliable laboratory and where public health harm resulted. (See
Response 47 for examples of situations in which a directed food
laboratory order may be appropriate.)
Similarly, some comments claim that registered food facilities
conduct routine testing consistent with their obligations under the
preventive controls regulations, and there is no evidence that, ``as a
general matter,'' those test results are unreliable. Again, the
directed food laboratory order is not intended to be applied generally;
it will be applied in response to a particular set of circumstances.
Unfortunately, some registered food facilities do not perform routine
testing in a manner that is consistent with their preventive controls
obligations. We also note that the directed food laboratory order may
be applied to entities that are not subject to the preventive controls
regulations.
One piece of evidence indicating the sufficiency of the proposed
rule with respect to the directed food laboratory order is the quality
of the public comments on the topic. We appreciate commenters' robust
feedback and assure them we have carefully considered their input.
Several comments contained questions, suggestions, and requests
regarding the details of the application of the directed food
laboratory order; to the extent possible, we respond to those comments
in the subsequent responses in this section of the preamble. However,
the fact that such details, including operational details, did not
appear in the proposed rule does not call into question the legal
sufficiency of the proposal. In sum, the proposal adequately apprised
the public of the proposal under consideration in a manner that allowed
for meaningful comment on the directed food laboratory order.
We reject the contention that, because it would be possible to
implement other portions of section 422 of the FD&C Act without the
directed food laboratory order, the tool must not be ``fit for
purpose.'' The degree to which the directed food laboratory order
affects the success of the overall LAAF program framework does not
define its fitness for purpose. The relevant question is whether the
statute authorizes FDA to implement the directed food laboratory order,
which it does, as discussed in Response 41.
In contrast to the contention of some comments, the directed food
laboratory order squarely aligns with both the purpose of FSMA and the
intent of section 422 of the FD&C Act. We particularly agree with those
aspects of comments stating that a central purpose of section 422 of
the FD&C Act is to help ensure accurate and reliable test results in
certain circumstances identified in the statute. Directed food
laboratory orders will serve that purpose by increasing confidence in
testing results in particular circumstances when we have reason to
question the accuracy or reliability of past or present test results
and an identified or suspected food safety problem exists. To the
extent that preventing ``laboratory shopping'' was a purpose of section
422(b)(2) of the FD&C Act, which requires all test results to be
submitted directly to FDA, such purpose must be consistent with the
rest of section 422, including the provision granting discretion to the
Agency to include in this final rule testing, ``as the Secretary deems
appropriate, to address an identified or suspected food safety
problem.'' Section 422(b)(1)(A)(ii) of the FD&C Act.
The central purpose of FSMA was to shift the focus of food safety
efforts to preventing contamination of the food supply, rather than
primarily responding to problems after they occur. Directed food
laboratory orders serve this purpose by addressing the need for
reliable food testing when there are particular circumstances where
past or current testing is suspect and FDA has determined there is an
identified or suspected food safety problem. Testing in such
circumstances would be aimed at gathering trustworthy scientific
information to help FDA and others avoid or mitigate a food safety
event.
Some comments categorize the proposed directed food laboratory
order as a new investigatory and enforcement tool, and maintain that
FDA already has the authority to collect samples and send those samples
to the laboratory of the Agency's choosing. They also state that,
through the preventive controls regulations, FDA already has the
authority to review records of test results when inspecting a
registered food facility, which provides sufficient oversight of such
testing. Again, the directed food laboratory order is a tool that may
be applied to owners and consignees that are not registered food
facilities subject to the preventive controls regulations. Further,
section 422(b)(1)(A) of the FD&C Act makes plain that Congress intended
to require entities to be subject to this subpart even though FDA
already regulates testing for that industry. Accordingly, it is
irrelevant that FDA may already have the authority to collect samples
at an enterprise or review the enterprise's testing records; the
directed food laboratory order is an appropriate new tool authorized by
section 422(b)(1)(A)(ii) of the FD&C Act.
It is also irrelevant whether Congress specifically contemplated
the existence of the directed food laboratory order because Congress
delegated authority to the FDA to require testing to be conducted under
this subpart, as we deem appropriate, when an identified or suspected
food safety problem exists and the codified use of directed food
laboratory orders is fully consistent with the text and purpose of the
statute. We disagree that the directed food laboratory order is a
mechanism to shift the burden of enforcement and investigation onto
private industry or stretch FDA's budget; it is a precise tool that
will be rarely used and is not anticipated to impose significant burden
on regulated entities. We discuss comments on the estimated costs of
the directed food laboratory order in the FRIA (Ref. 4). (For more
information on all the estimated costs and benefits of the final rule,
see the FRIA (Ref. 4).)
(Comment 43) Several comments raise concerns that directed food
laboratory orders will have negative policy implications that the
Agency has not considered. These comments state the belief that
directed food laboratory orders could disincentivize facilities from
implementing ``seek and destroy'' pathogen environmental monitoring.
These comments assert that in response to FSMA, the industry already
has implemented robust environmental monitoring programs. These
comments further argue that the food safety and public health benefits
of these programs could be jeopardized by directed food laboratory
orders and the possibility that a facility's own routine testing could
result in issuance of a directed food laboratory order. These comments
state that uncertainty regarding the timing, duration, and cost
associated with directed food laboratory orders will cause facilities
to avoid routine testing for fear of triggering such an order. A few
comments state that some firms may modify their environmental testing
programs to avoid finding
[[Page 68758]]
positive results, negating what the comments characterize as the
``positive steps'' FDA has taken ``to encourage aggressive
environmental sampling in the 2017 publication of the (``Control of
Listeria monocytogenes in Ready-To-Eat Foods: Guidance for Industry''
draft guidance (Ref. 11)), through the acknowledgment that a finding
for Listeria species on a food contact surface does not render product
adulterated.'' \8\
---------------------------------------------------------------------------
\8\ The ``Control of Listeria monocytogenes in Ready-To-Eat
Foods: Guidance for Industry'' draft guidance describes followup
actions a facility should take in response to a finding of Listeria
spp. on a food contact surface. Although it is true that the draft
guidance indicates that we expect to find Listeria in certain food
facilities, we also expect that such facilities will implement
environmental monitoring plans to find Listeria when present and
take followup actions to ensure that Listeria does not contaminate
food. Our investigators will inspect a facility's environmental
monitoring results and the followup activities the facility performs
in the event of an environmental positive, to ensure that product
does not become adulterated. If we have concerns about the
facility's application of current good manufacturing practices and
preventive controls with respect to L. monocytogenes, we may perform
our own sampling of the facility's environment and may also take
food samples.
---------------------------------------------------------------------------
Some comments express concern that basing a directed food
laboratory order on environmental results increases the risk that the
test results could be taken out of context; several of these comments
mention that there would be a lack of information connecting the test
result to a product. A few comments request that FDA reiterate that
routine testing of product and environment related to a facility's food
safety plan is not required to be performed by LAAF-accredited
laboratories under this subpart and that followup sampling and testing
in response to routine environmental monitoring positive results for
pathogen/indicator organisms should not be covered by this subpart.
Some comments express concern that the LAAF program will cause
testing by laboratories not participating in the program to be devalued
or viewed as suspect. Some comments warn that widespread use of
directed food laboratory orders could cause testing performed by
laboratories not LAAF-accredited under FDA's program to be scrutinized.
These comments assert that many in-house and external laboratories are
not ISO-accredited; however, the laboratories still ensure integrity
and accuracy of test results and data. These comments stress the
important role in-house and other laboratories play in providing timely
test results on which food safety decisions are made. These comments
suggest that these laboratories may choose not to participate in the
LAAF program. Further, some comments are concerned that FDA and
investigators may question analytical results from non-LAAF-accredited
laboratories. Overall, comments assert there is no evidence to suspect
that non-ISO-accredited laboratories produce inaccurate or suspect
results.
Some comments urge FDA to consider the potential significant costs
associated with directed food laboratory orders as well as the
potential business disruption that may occur if product subject to
testing is placed on hold pending results. A few comments explain that
holding product under a directed food laboratory order could challenge
the company's hold capacity and disrupt both production and the supply
chain, as well as have additional costs for industry. Several comments
state that the preliminary economic impact analysis did not include any
costs for directed food laboratory orders and should be revised
accordingly.
(Response 43) We disagree that the directed food laboratory order
provision, as clarified, will have negative policy implications. The
authority under section 422 of the FD&C Act is intended to increase
confidence in receiving accurate and reliable test results. As stated
in Response 35, the purpose of routine environmental testing under the
preventive controls regulations (Sec. Sec. 117.165(a) and 507.49(a))
is to verify that preventive controls are consistently implemented and
are effective. Therefore, such testing does not address an identified
or suspected food safety problem and is not covered by this subpart.
The additional clarity we are providing in this final rule regarding
the directed food laboratory order in terms of the standard of
issuance, authority to issue such orders, and procedural details,
should provide sufficient boundaries to enable firms to continue or
expand robust environmental monitoring programs developed in the wake
of FSMA and in support of an overall culture of food safety, without
fearing that such programs will invite issuance of a directed food
laboratory order. We expect that it will be uncommon for us to issue a
directed food laboratory order. Further, we expect that facilities that
have implemented robust environmental monitoring programs and that are
taking appropriate corrective actions in response to positive findings
(``seek and destroy'') generally are not likely to be subject to such
an order.
However, as discussed in Response 37, followup testing in response
to routine environmental test results that indicate the presence of a
pathogen or indicator organism in the food production environment may
qualify as testing that addresses an identified or suspected food
safety problem, and therefore could warrant issuance of a directed food
laboratory order, depending on the circumstances. We disagree with the
contention that use of a directed food laboratory order for
environmental testing could cause results to be taken out of context.
As explained in Response 47, the use of a directed food laboratory
order is appropriate only in a narrowly defined set of circumstances.
Accordingly, in our view, the context (including relevant product(s))
for any environmental tests required by a directed food laboratory
order) will be sufficiently clear.
Absent a specific reason to question the reliability and accuracy
of results from a particular firm or laboratory, we do not believe that
testing from an in-house, third-party private, or other laboratory that
is not LAAF-accredited would be questioned solely based on the decision
of that laboratory not to participate in this program, and certainly
not as a result of the directed food laboratory order tool. We discuss
examples of circumstances in which we would employ a directed food
laboratory order in Response 47. As reiterated throughout our
discussion of the directed food laboratory order in this preamble, and
as reflected in the FRIA, we do not expect widespread use of such
orders (Ref. 4). We address costs related to a directed food laboratory
order in the FRIA, see (Ref. 4).
(Comment 44) Several comments state that the proposed rule does not
specify who has the authority to issue a directed food laboratory
order, nor does it indicate whether such authority could be delegated.
These comments recommend that the authority to issue a directed food
laboratory order remain a non-delegable function of the FDA
Commissioner. A subset of these comments mentions that this
recommendation aligns with section 415(b)(7) of the FD&C Act (regarding
the authority to issue an order to suspend a registration or vacate an
order of suspension [of a food facility]) and mandatory recall
authority. Some comments assert that the authority to issue a directed
food laboratory order would not be appropriate for FDA investigators or
State inspectors. A few comments ask whether State regulators
inspecting farms under the produce safety rule would have authority to
issue a directed food laboratory order.
(Response 44) In proposed Sec. 1.1108, we stated that a directed
food laboratory order may be issued by FDA. Although we agree that the
authority to issue a directed food laboratory order would
[[Page 68759]]
not be delegated to FDA investigators or State inspectors, we decline
to make the issuance of a directed food laboratory order a non-
delegable function of the FDA Commissioner. Section 415(b)(7) of the
FD&C Act and section 423(h) of the FD&C Act contain explicit provisions
limiting certain authority to the Commissioner. Section 422 of the FD&C
Act (21 U.S.C. 350k) does not include a similar limitation. Absent an
explicit statutory limitation regarding delegation, we find no reason
to impose one for the issuance of a directed food laboratory order.
Consistent with longstanding Agency practice and the APA, we intend to
limit the delegation of authority to issue a directed food laboratory
order under this subpart to FDA officials with the appropriate level of
responsibility. See 5 U.S.C. 553(a)(2).
(Comment 45) Several comments state that the proposed directed food
laboratory order procedures raise due process concerns for the
potential recipient of such an order. In support of this position, the
comments describe their perception of the uncertain standards and the
Agency's unfettered discretion to issue a directed food laboratory
order. Some comments urge FDA to have a transparent process and clear
standards with a documented sound scientific basis for issuance of a
directed food laboratory order. Some comments request more specific
examples of when the Agency would issue a directed food laboratory
order. These comments argue that without specifying who in the Agency
may issue a directed food laboratory order, it appears that FDA
investigators could issue them. The comments state that the perceived
lack of a process prior to issuance and the perceived lack of a
guaranteed process once a directed food laboratory order has been
received contribute to the overall insufficient due process associated
with the proposed provision.
(Response 45) We address several aspects of these concerns
elsewhere in this preamble, in Response 44 and Response 47.
Specifically, we clarify the standard of issuance for a directed food
laboratory order, who has the authority to issue such an order, and
certain procedural aspects associated with issuance of such an order.
With these details and the applicable procedures of part 16 in place,
we believe there is sufficient due process associated with the directed
food laboratory order provision.
(Comment 46) Several comments state that food testing pursuant to a
directed food laboratory order should be limited to product testing and
should not include environmental testing. These comments state that
FSMA section 202, Laboratory Accreditation for Analyses of Foods,
refers only to ``food testing'' and ``testing of food,'' without
defining these terms. The comments indicate that while environmental
testing is not specifically mentioned in section 202, Congress
explicitly refers to environmental testing elsewhere in FSMA (section
103, which creates section 418(f)(4) of the FD&C Act). Further, some
comments suggest that including environmental testing would create the
potential for test results to be taken out of context; several of these
comments state that there would be a lack of information connecting the
test result to a product. A few comments explain that routine testing,
including environmental testing, is covered by FDA guidance and
considers multiple variables; these comments state that it is not clear
whether and how all variables will be considered in determining when a
directed food laboratory order is issued. Some comments conclude that
there is no legal basis for requiring environmental testing under a
directed food laboratory order and that directed food laboratory orders
must only be used for food product testing.
(Response 46) We decline to limit directed food laboratory orders
to product testing. As already discussed in Response 19, FDA defines
``food testing'' and ``testing of food'' to include environmental
testing for purposes of this subpart. As stated in Response 19 and
discussed further in Response 35, routine environmental testing
(Sec. Sec. 117.165(a)(3) and 507.49(a)(3)) is not covered by this
subpart. As we noted in Response 43, we do not believe the directed
food laboratory order will cause environmental test results to be taken
out of context. For these reasons, in light of our legal authorities
under section 422 of the FD&C Act, and for the policy reasons already
discussed in relation to both environmental testing and the directed
food laboratory order, under this final rule and as appropriate, FDA
may issue a directed food laboratory order subjecting either product
testing or environmental testing to the requirements of this subpart.
(Comment 47) Some comments state that the proposed rule did not
provide enough information regarding the standard for issuance of a
directed food laboratory order. These comments express concern that the
proposed standard, an identified or suspected food safety problem,
could be present regardless of whether the article of food violates the
FD&C Act. Comments state that the examples provided in the preamble to
the proposed rule suggest that mere suspicion of a food safety problem,
such as the presence of Listeria monocytogenes on a food contact
surface, could lead to issuance of a directed food laboratory order
when there is no violative article involved. Comments argue that
issuance of a directed food laboratory order when there is no violative
product would exceed FDA's authority. Otherwise, comments suggest the
results of a food facility's routine testing could inappropriately
trigger a directed food laboratory order. Comments propose instead that
an identified or suspected food safety problem should only give rise to
a directed food laboratory order when there is a public health need or
when the food has a reasonable probability of serious adverse health
consequences or death to humans or animals (SAHCODHA).
A few comments express concerns that although FDA notes the
suspicion will ``typically be particularized'' as it relates to
specific articles of food or a specific portion of the food production
environment, it is not clear that this will always be the case. Several
comments suggest that the suspicion standard could lead to bias or
subjective determinations by an investigator where no problem exists.
Some comments propose instead that directed food laboratory orders
should include a direct reference to a violation. Other comments state
that issuance of a directed food laboratory order should require a
reasonable belief that the food is violative, similar to the standard
set forth in FSMA section 101 (relating to inspections of records).
These comments recommend that if the directed food laboratory order
provision remains in the final rule, it should be limited to
circumstances when both of the following factors are met: (1) An
identified or suspected food safety problem representing a SAHCODHA
hazard is established and (2) a substantiated concern exists regarding
the adequacy of the laboratory used by the owner or consignee such that
testing by an accredited laboratory under this program is necessary to
determine the food safety problem has been resolved. Comments state
that a concern about laboratory adequacy is necessary as Congress
intended section 202 of FSMA to address ``laboratory shopping'' and
other situations which raise questions about the validity of laboratory
results. The comments state that the directed food laboratory order
should not be used by FDA as an investigative tool.
Some comments recommend that issuance of the directed food
laboratory order be limited to cases where the pathogen risk is
immediate and FDA's
[[Page 68760]]
existing enforcement tools are not adequate to address the situation.
A few comments ask FDA to specifically exempt from a directed food
laboratory order pathogen/indicator organism positive results from
routine environmental testing since the manufacturer should have the
opportunity to resolve any associated concerns through corrective
actions.
A few comments request that the Agency provide additional
information, guidance, and examples for when a food safety problem is
``suspected'' in animal food, as well as more specific examples of when
a directed food laboratory order would be issued under the rule.
(Response 47) Per section 422(b)(1)(A)(ii) of the FD&C Act, the
standard for issuance of a directed food laboratory order is ``as
required by the Secretary, as the Secretary deems appropriate, to
address an identified or suspected food safety problem.'' We disagree
that SAHCODHA should be the standard, as Congress explicitly specified
a different standard here. For the same reason, we decline to use the
standard set forth in FSMA section 101 (reasonable belief that the food
is violative). The statutory clause in the section related to the LAAF
program, ``identified or suspected food safety problem'' specifically
allows for issuance of a directed food laboratory order when there is
no violative product.
Regarding the standard of issuance, we believe the phrase, ``as the
Secretary deems appropriate,'' in the context of the FSMA laboratory
accreditation program, generally would limit our issuance of a directed
food laboratory order to situations where we have evidence or
experience with a firm or laboratory which calls test results into
question, i.e., situations in which we have reason to question the
accuracy or reliability of past or present test results. In such
circumstances, there would be a clear benefit to receiving analytical
results directly from a LAAF-accredited laboratory. Ensuring accurate
and reliable test results is the precise issue Congress intended to
address in section 202 of FSMA. In the final rule, we have revised the
language in Sec. 1.1108(a) to better align with the statutory text by
adding the qualifying language, ``as FDA deems appropriate.''
In terms of the comment expressing apprehension that FDA will use
the directed food laboratory order as a tool to gather testing
information in the absence of heightened food safety concerns, we
reiterate that the order is only appropriate to address an identified
or suspected food safety problem. Similarly, regarding the contention
in some comments that a directed food laboratory order should only be
issued if there are concerns with laboratory adequacy, as just noted,
we interpret, ``as the Secretary deems appropriate'' to mean that the
tool would generally only be appropriate if we have reason to question
past or present test results.
Further, we intend to use a directed food laboratory order within
the context of other Agency authorities and tools, FSMA-related and
otherwise; accordingly, positive results from routine testing would not
normally trigger a directed food laboratory order absent other
circumstances (e.g., suspect test results) necessitating a directed
food laboratory order. Therefore, we decline to include specific
exemptions for pathogen/indicator organism positive results from
routine environmental testing or to limit issuance of a directed food
laboratory order to cases when the pathogen risk is immediate and the
Agency's other enforcement tools are not adequate to address the
situation.
We offer the following examples of the types of situations in which
we believe a directed food laboratory order would be useful and
appropriate ``as required by the Secretary, as the Secretary deems
appropriate, to address an identified or suspected food safety
problem.'' Some of these descriptions are modeled on our experience
with past compliance cases.
Following a for-cause inspection of a human food firm with
a documented history of falsified laboratory reports, after the
Agency's receipt of information from an employee informant indicating
that the firm continued to provide false or misleading certificates of
analysis to conceal the production of adulterated human food;
Following a recall by an animal food firm because the
firm's laboratory historically used an inappropriate method and
reported results that differed from FDA laboratory results; and
If FDA laboratories have on multiple occasions obtained
positive pathogen results on food products in past years that conflict
with the company's contract laboratory's results. Given a pattern of
past ineffective monitoring by the company, coupled with the public
health risk, on the next positive finding by FDA that leads to a
voluntary recall for pathogen adulteration in this company's food
products, FDA might issue a directed food laboratory order.
In light of the additional parameters for issuance of a directed
food laboratory order discussed above and limitations on who can issue
a directed food laboratory order (discussed in Response 44), we believe
issuance of directed food laboratory order would be insulated from
bias.
(Comment 48) A few comments state that pathogens in not ready to
eat (NRTE) food, and specifically in raw agricultural commodities such
as grains, which do not undergo a kill step in the mill, should not be
considered an identified or suspected food safety problem subject to a
directed food laboratory order. These comments state further that the
preamble to the proposed rule offered few examples of circumstances
that could generate a suspected food safety problem and mentioned
``potential contamination events'' as an example although we did not
define this phrase. These comments request that the Agency define that
phrase and explicitly state that the presence of pathogens in NRTE
foods is not considered an identified or suspected food safety problem.
The comments express the concern that directed food laboratory orders
could be used as a basis for requiring the milling industry generally
to sample food manufacturing environments or products through use of
LAAF-accredited laboratories. The comments suggest that any testing in
these circumstances would not be appropriate, regardless of whether the
use of a LAAF-accredited laboratory is required.
(Response 48) The proposed rule explored the meaning of the
statutory phrases, ``identified food safety problem,'' and ``suspected
food safety problem.'' (84 FR 59452 at 59455, 59462). In Response 35,
above, we finalize our tentative conclusions about the meaning of those
phrases.
A number and variety of factors impact food safety risk (e.g., the
pathogen, the history of foodborne illness outbreaks associated with
the pathogen in the food, whether the food undergoes further processing
with a kill step at a registered food facility). In some circumstances
a pathogen in an NRTE food may be considered an identified or suspected
food safety problem. For example, foodborne illness outbreaks have been
associated with Salmonella in raw tuna (https://www.cdc.gov/salmonella/newport-04-19/index.html) and Shiga-toxin producing E. coli in raw
bison burgers (https://www.cdc.gov/ecoli/2019/bison-07-19/index.html).
The strains of pathogens associated with the outbreaks are capable of
causing severe illnesses (both outbreaks resulted in hospitalizations),
and these raw foods were consumed without a treatment to significantly
minimize the hazard and
[[Page 68761]]
prevent illnesses. Consistent with the broader food safety regulatory
framework, which includes the preventive controls for human food
regulation and the preventive controls for animal food regulation, FDA
will consider all applicable regulations and relevant circumstances in
determining whether an identified or suspected food safety problem
exists. As explained in Response 47, a directed food laboratory order
is appropriate in situations in which an identified or suspected food
safety problem exists along with specific evidence or experience with a
firm or laboratory which calls past or present test results into
question. Accordingly, we expect to employ the directed food laboratory
order rarely. In many cases involving a pathogen in an NRTE food, other
food safety regulations or tools outside the scope of the LAAF program
may adequately address the risk.
We decline the request to define ``potential contamination event.''
We have defined the terms that describe the standard of issuance for a
directed food laboratory order (see Response 35). Consistent with these
definitions, a directed food laboratory order may be appropriate in
circumstances related to potential contamination events; e.g., where a
pathogen in the food production environment is transmitted to the food,
thereby causing the food to be adulterated, and where we have specific
evidence or experience with a firm or laboratory which calls past or
present test results into question.
(Comment 49) A few comments suggest that neither chemical nor
physical hazards would be appropriate for a directed food laboratory
order. According to such comments, the directed food laboratory order
should be limited to circumstances where there is a reasonable
likelihood of serious adverse health consequences or death to humans or
animals due to the potential for pathogens to be present in the food
product.
(Response 49) We decline to exempt chemical or physical hazards
from a potential directed food laboratory order. As previously stated,
a directed food laboratory order will generally be limited to the rare
situation when we have reason to question the accuracy or reliability
of past or present test results and where an identified or suspected
food safety problem exists. In addition to biological hazards, both
chemical and physical hazards are capable of causing food safety
problems. Therefore it is possible that any of the three types of
hazard could, in certain circumstances, form the basis for issuance of
a directed food laboratory order.
We also note that chemical and physical hazards are specifically
covered by other FSMA regulations such as the preventive controls
regulations (Sec. Sec. 117.130 and 507.33). We believe it is
appropriate to align coverage of a potential directed food laboratory
order with the potential hazards covered by those regulations.
(Comment 50) Several comments raise questions about operational
details related to the issuance of directed food laboratory orders.
These comments ask about the intended recipient of the directed food
laboratory order (corporate parent, facility, or both), means of
transmission (electronic, in-person, mail), and whether the issuance
would change based on multiple owner or consignee scenarios. Comments
state that these details are critical given the proposed 24-hour appeal
deadline for directed food laboratory order recipients.
(Response 50) FDA intends to provide the most legally responsible
person at the firm that day with written notice of a directed food
laboratory order, generally via email. We will make every attempt to
call to inform the firm of the order prior to its arrival.
In the imports context, there are sometimes multiple owners or
consignees. In such a case, we would generally deliver the written
notice to the importer of record. (See Response 26 for additional
discussion of multiple owner or consignee scenarios.)
As discussed in Response 138, we have extended the appeal deadline
from 24 hours to within 3 business days of receipt of a directed food
laboratory order.
(Comment 51) Several comments suggest that the lack of detail
surrounding the duration and termination of directed food laboratory
orders raises due process issues. These comments recommend that a
directed food laboratory order should be ``closed'' once the identified
or suspected food safety problem has been resolved. These comments also
request that FDA include a hearing process to permit owners or
consignees to submit evidence in support of the resolution to terminate
a directed food laboratory order or to have the directed food
laboratory order vacated. Additionally, some comments request that
directed food laboratory orders include a timeframe for the order and
frequency for testing. Further, a few comments suggest that FDA use a
hearing process if the Agency seeks to modify a directed food
laboratory order once issued. Some comments request that FDA provide
additional information on what is considered a reasonable timeline to
conduct testing required by a directed food laboratory order.
(Response 51) In general, a directed food laboratory order would
last until we have adequate assurances that the underlying known or
suspected food safety problem has been resolved. However, we agree that
the order will be ``closed'' once the identified or suspected food
safety problem has been resolved. We anticipate that this approach will
incentivize firms to resolve issues quickly. However, details regarding
the duration and termination of a directed food laboratory order will
be contingent on the specific facts and circumstances of the order,
which will vary greatly. For example, whether the order covers product
or environmental testing, whether it is designed to address a very
discrete issue or a system-wide issue, the applicable regulations, and
the role of other resources and tools applied to the circumstances, are
just a few of the factors that may impact the length of time a directed
food laboratory order would be appropriate. Some orders may initially
define the timeframe and testing frequency, but again, we will
determine these matters on a case-by-case basis.
At present we do not believe it necessary to create a hearing
process around the conclusion of a directed food laboratory order;
however, we expect to be in dialogue with the entity subject to the
order and intend to take their feedback into consideration.
(Comment 52) Some comments state that the proposed rule did not
include details regarding whether or how directed food laboratory
orders would be made public. These comments request that FDA clarify
that directed food laboratory orders will not be made public. The
comments argue that only the owner or consignee must take action under
a directed food laboratory order, so there is no need to make a
directed food laboratory order public.
(Response 52) We may include directed food laboratory orders on an
Agency website such as the data dashboard (see https://www.fda.gov/about-fda/transparency/fda-data-dashboard), so that other entities in
the supply chain can be aware of their existence as they research and
evaluate suppliers. We similarly publicize injunctions, seizures, and
warning letters on the data dashboard and believe that inclusion of
directed food laboratory orders would contribute to the overarching
goals of FDA's food safety communication strategy.
We also note that a directed food laboratory order generally would
be subject to the Freedom of Information
[[Page 68762]]
Act (FOIA). Any disclosures would be made in accordance with our
regulations in part 20 (21 CFR part 20) (i.e., redacting any
confidential commercial information as necessary).
(Comment 53) A few comments request additional information
regarding whether directed food laboratory orders only apply
domestically. These comments argue that directed food laboratory orders
must apply to both domestic and foreign facilities producing food for
consumption in the United States to comply with international
commitments. The comments state that, as proposed, directed food
laboratory orders will be issued more frequently to domestic entities,
resulting in unfair treatment, since the FDA conducts more domestic
inspections, therefore giving rise to more opportunities to issue such
orders domestically. These comments state that there may be
significantly fewer LAAF-accredited laboratories outside of the United
States, which could make it more difficult for foreign manufacturers to
comply with the requirements of a directed food laboratory order. These
comments argue there is an inherent unfairness to the lack of parity
and ask FDA to consider this when determining the need for directed
food laboratory orders.
(Response 53) We agree that a directed food laboratory order could
be used in both foreign and domestic settings; however, we disagree
that conducting more domestic inspections necessarily will mean there
are more opportunities to issue a directed food laboratory order
domestically. As discussed in Response 44, FDA investigators will not
be able to issue directed food laboratory orders. This limitation and
the additional clarifications provided regarding the standard of
issuance (see Response 47) will limit use of a directed food laboratory
order to those limited circumstances discussed and address the
potential for unfairness.
LAAF-accredited laboratory capacity for testing under this subpart
is addressed in Response 15 and will include consideration of both
foreign and domestic laboratories.
(Comment 54) Some comments request additional information regarding
whether FDA will specify the method to the owner or consignee of the
food subject to a directed food laboratory order so that the owner or
consignee can provide such information to the LAAF-accredited
laboratory.
(Response 54) We will specify the method to the owner or consignee
and, in some circumstances, may provide flexibility to use equivalent
methods, so that there may be access to a greater number of LAAF-
accredited laboratories that may conduct the food testing. See Sec.
1.1151(b)(2).
(Comment 55) Some comments maintain that directed food laboratory
orders should be issued only where a validated test method exists and
where there is sufficient LAAF-accredited laboratory capacity for that
method and the specific food matrix.
These comments are concerned that if a directed food laboratory
order were issued for a method requiring validation, it could
effectively prohibit the facility from operating until a method is
validated. Comments estimate validation of a single method could take 6
months or more and cost between $35,000 and $300,000, depending on the
complexity of the method. Comments contend that the proposed rule was
not clear regarding who bears the cost of validating a method; these
comments argue industry should not have to bear such costs as a result
of the issuance of a directed food laboratory order. Comments state
further that costs to validate a method were not included in the
preliminary economic impact analysis. A few comments assert that if
directed food laboratory orders are limited to SAHCODHA hazards posed
by pathogens, there would be fewer method validation concerns.
Some comments state that proposed Sec. 1.1151(e) would allow an
accredited laboratory to request FDA's permission to use a method
outside its scope of accreditation but FDA would only approve the
request if there is a ``food emergency.'' These comments express
concern that FDA could define a ``food emergency'' to exclude
circumstances specific to a particular food or facility. If narrowly
construed in this manner, the comments argue the lack of a validated
method or LAAF-accredited laboratory availability necessary under a
directed food laboratory order could effectively block a facility from
operating. Further, these comments assert that this provision would not
mitigate the concerns raised regarding the impact of a directed food
laboratory order for a method requiring validation.
(Response 55) We intend to issue a directed food laboratory order
when there exist both a validated method and sufficient laboratories
LAAF-accredited to that method. Under Sec. 1.1108(b), FDA will specify
the test method in a directed food laboratory order.
As discussed above in Response 47, the general standard for
issuance of a directed food laboratory order is that FDA has reason to
question the accuracy or reliability of past or present test results
and an identified or suspected food safety problem exists. Necessarily,
then, if a directed food laboratory order has been issued, the food
testing at issue is not novel because it has been happening for at
least long enough that FDA has reason to question the results. In such
circumstances, we believe a validated method will exist. Section
422(b)(3) of the FD&C Act expressly gives FDA the authority to waive
requirements of the LAAF program if: (1) A new methodology or
methodologies have been developed and validated but a laboratory has
not yet been accredited to perform such methodology or methodologies
and (2) the use of such methodology or methodologies are necessary to
prevent, control, or mitigate a food emergency or foodborne illness
outbreak.
(Comment 56) Many comments assert, based on legal, policy, and
practical concerns with the proposed rule, that directed food
laboratory orders should be removed from the final rule. Some of these
comments suggest that since FSMA section 202 does not contemplate
directed food laboratory orders, inclusion of the directed food
laboratory order provisions in the final rule is not required as part
of the rulemaking. Comments suggest that removing the directed food
laboratory order provision will help FDA meet its deadline to issue a
final rule.
Several comments argue that if FDA can establish both statutory
authority and a justified public health need for directed food
laboratory orders, either an independent rulemaking or a supplemental
notice of proposed rulemaking would be necessary to allow for
additional input, to clarify the proposal in terms of scope,
procedures, and policy concerns, and to avoid litigation. Some comments
suggest FDA has good cause to request modification of the consent
decree deadline to extend the deadline due to the issues raised in the
comments and the COVID-19 pandemic's impact on the Agency. Some of
these comments raise the concern that additional time is needed to
allow the Agency to give due consideration to the issues raised and to
engage industry on the food safety concerns addressed by directed food
laboratory orders.
However, some comments recommend revisions to directed food
laboratory orders to limit their scope and otherwise address procedural
aspects that they believe would make directed food laboratory orders
feasible if not removed from the final rule. These comments insist that
a supplemental notice of proposed rulemaking is necessary to fully vet
any revised proposal. A few comments ask that
[[Page 68763]]
directed food laboratory orders be used judiciously with specific
guidance for use, should FDA confirm it has authority to issue directed
food laboratory orders.
Some comments suggest that FDA should publish additional guidance
on directed food laboratory orders prior to issuing a directed food
laboratory order.
(Response 56) We decline the recommendation to remove the directed
food laboratory order from the final rule. As discussed above
throughout the comments and responses related to directed food
laboratory orders, we have addressed the necessary legal, policy, and
practical concerns raised. Additionally, we received meaningful
comments which we have carefully considered in developing the directed
food laboratory order provision of the final rule. Therefore, we do not
agree a supplemental rulemaking is necessary. We will consider issuing
additional guidance on directed food laboratory orders.
4. How will FDA make information about recognized accreditation bodies
and LAAF-accredited laboratories available to the public (Sec.
1.1109)?
Proposed Sec. 1.1109(a) provided that FDA would place on our
website a publicly available registry listing recognized accreditation
bodies and LAAF-accredited laboratories in the LAAF program. The
proposed list would include certain information regarding each
recognized accreditation body and LAAF-accredited laboratory such as
the name, contact information, duration of an accreditation body's
recognition, and the scope of accreditation for each laboratory. We
also proposed including certain information about changes in
recognition of an accreditation body, including probation, revocation,
voluntary relinquishment, or expiration and the effective date for any
change. Likewise, we proposed including certain information regarding
changes in LAAF-accreditation of laboratories, such as withdrawal,
revocation, probation, voluntary relinquishment and the effective date
for any change. Proposed Sec. 1.1109(b) reiterated the statutory
requirement for FDA to coordinate with the Department of Homeland
Security regarding the online registry.
On our own initiative, we have revised the section title to include
``LAAF-accredited laboratories,'' consistent with terminology changes
throughout the rule. We also have clarified in the final rule that FDA
will place on its website a publicly available registry listing
information about recognized accreditation bodies and LAAF-accredited
laboratories. As discussed at Response 10, we have revised the
terminology used in the final rule to better clarify roles and actions
taken by recognized accreditation bodies and FDA under this subpart. As
discussed in section V.C. regarding of the definition of ``scope of
LAAF-accreditation'' above, in the final rule we also changed the
verbiage, ``withdraw in part,'' to ``reduce the scope of LAAF-
accreditation.'' This section has been updated to reflect the revised
terminology. For transparency, we added denial of renewal of
recognition to the changes in recognition that will be included on the
website (see Sec. 1.1109(b) of the final rule); we stated we would
post information about denial of renewal of recognition in Sec.
1.1129(h) of the proposed rule, which appears in Sec. 1.1115(h) of the
final rule. Additionally, on our own initiative, we removed the
language that appeared in Sec. 1.1109(b) of the proposed rule. Section
422(a)(4) of the FD&C Act directs FDA to coordinate with the Department
of Homeland Security on the time, manner, and form of the online
registry of recognized accreditation bodies and LAAF-accredited
laboratories; we have done so. It is unnecessary to reiterate this duty
in the codified text and so we have removed that text from the final
rule. We also revised the section to improve clarity and readability.
Comments regarding this section are discussed below.
(Comment 57) Several comments support our proposal to maintain on
our website a registry of recognized accreditation bodies and
participating laboratories. Some comments request that the registry
include information regarding the methods to which specific
laboratories are accredited. Some comments suggest that the registry
include hyperlinks to the websites of the recognized accreditation
bodies, as those are updated regularly with information on LAAF-
accredited laboratories, including current scope information.
Some comments request that the registry include information beyond
that related to recognized accreditation bodies and LAAF-accredited
laboratories; they advocate for FDA to maintain a list of all ISO/IEC
17011:2017 accreditation bodies that are ILAC-Mutual Recognition
Arrangement (MRA) signatories and accredit food laboratories, as well
as all food laboratories that are accredited to ISO/IEC 17025:2017.
These comments express the view that such a listing would be a helpful
public service.
Some comments propose that the registry indicate which
participating laboratories are permitted to submit abridged analytical
reports; from their perspective, such information would be helpful to
industry in choosing a laboratory.
Other comments ask how the public will know which laboratories are
LAAF-accredited, and some comments consider the proposed rule to be
unclear regarding how the public will know the methods for which each
laboratory is LAAF-accredited and recommend this information be posted
on the public website.
(Response 57) We appreciate the support for the public registry and
note that its establishment is required by section 422(a)(1)(B) of the
FD&C Act. To be clear, under the final rule, the online registry will
list all LAAF-accredited laboratories and the scope of LAAF-
accreditation for each, among other things. See Sec. 1.1109.
We decline the recommendation to include on the public registry
hyperlinks to the websites of recognized accreditation bodies and LAAF-
accredited laboratories. Recognized accreditation bodies and LAAF-
accredited laboratories must report changes that impact their
recognition and LAAF-accreditation as specified in this final rule.
This will ensure the public registry contains accurate and up-to-date
information for use by owners and consignees.
We also decline the recommendation to expand the registry to
include a list of all ISO/IEC 17011:2017 accreditation bodies that are
ILAC-MRA signatories that accredit food laboratories and all ISO/IEC
17025:2017-accredited laboratories; expansion of the registry in this
manner is not specified in section 422(a)(1)(B) of the FD&C Act, which
describes the registry as including information regarding accreditation
bodies recognized by the FDA and the laboratories which are LAAF-
accredited by the recognized accreditation bodies.
Finally, we also decline the recommendation to indicate on the
public registry which LAAF-accredited laboratories are permitted to
submit abridged analytical reports. We do not consider testing
conducted by laboratories permitted to submit abridged analytical
reports to be of a higher quality than testing conducted by
laboratories without such permission. Nor do we have any reason to
conclude that owners and consignees would get test results faster from
a laboratory with permission to submit abridged analytical reports.
Note that under Sec. 1.1153(d), FDA may request that a LAAF-accredited
laboratory that is
[[Page 68764]]
permitted to submit abridged analytical reports submit additional
documentation or a full analytical report within 72 hours of FDA's
request. As stated in Sec. 1.1150(d) of the proposed and final rule, a
LAAF-accredited laboratory must document the testing information and
test results to the extent necessary to account for all information
that is required to be in a full analytical report.
(Comment 58) Regarding the public registry that lists recognized
accreditation bodies and participating laboratories, some comments
express concern about our proposal to include revocation or probation
information in the registry. These comments take issue with our
proposed use of both terms, and those issues are discussed at Response
10. Specifically, regarding the term, ``probation,'' the comments
indicate that including references to this status on the public
registry would inaccurately convey that such organizations are in poor
standing, given what the term, ``probation'' normally means in the
conformity assessment arena. Regarding the term, ``revocation,'' the
comments express the belief that attaching such a label to laboratories
in the public registry would cause confusion because it would imply
that FDA can revoke the ISO/IEC 17025:2017 accreditation of a
laboratory, which is not the case.
(Response 58) We have made revisions throughout the final rule to
address terminology concerns (see Response 10). As discussed in
Responses 13, 71, and 82, we revised the final rule so that a
recognized accreditation body may suspend a LAAF-accredited laboratory
under Sec. 1.1121 whereas FDA may place a recognized accreditation
body or a LAAF-accredited laboratory on probation under Sec. Sec.
1.1131 and 1.1161, respectively. We also revised the final rule to
allow corrective action under Sec. 1.1161 prior to any public change
in LAAF-accreditation status (see Response 133). With these
clarifications, the status information contained on the public registry
is more clearly limited to the LAAF-accreditation status of the
laboratory as opposed to the laboratory's ISO/IEC 17025 accreditation
status. Given the revisions throughout the final rule, we will retain,
with clarifications, the provision which makes public a LAAF-accredited
laboratory's probationary status to maintain transparency for the
public and specifically for the owners and consignees with food testing
subject to this subpart.
5. What are the general requirements for submitting information to FDA
under this subpart (Sec. 1.1110)?
On our own initiative, we added Sec. 1.1110 to consolidate
information previously repeated throughout the proposed codified text
regarding the requirement to submit applications, reports,
notifications, and records required by this subpart to FDA
electronically and in English, unless otherwise specified. The section
states further that if records are maintained in a language other than
English, the recognized accreditation body or LAAF-accredited
laboratory must provide an English translation within a reasonable
time. Paragraph (b) specifies that a program applicant must provide
translation and interpretation services needed by FDA during the
processing of the application, including during any onsite assessments
of the applicant. See table 5 for a list of consolidated sections in
Sec. 1.1110.
Table 5--Consolidation of Proposed Rule Sections Related to Submitting
Information to FDA Under This Subpart
------------------------------------------------------------------------
Final rule Proposed rule
------------------------------------------------------------------------
Sec. 1.1110 What are the general Sec. 1.1123(a)
requirements for submitting information Sec. 1.1124(b)
to FDA under this subpart? Sec. 1.1128(d)
Sec. 1.1129(f)
Sec. 1.1131(b)(2)
Sec. 1.1132(a)
Sec. 1.1152(a)
Sec. 1.1153(c)
Sec. 1.1162(c)
Sec. 1.1163(a)
Sec. 1.1171(b)
Sec. 1.1173(b)
Sec. 1.1174(b)
------------------------------------------------------------------------
E. Comments Regarding FDA Recognition of Accreditation Bodies
Table 6--Reorganization of Sections Regarding FDA Recognition of
Accreditation Bodies
------------------------------------------------------------------------
Final rule Proposed rule Notes
------------------------------------------------------------------------
FDA Recognition of Accreditation Recognition of Added ``FDA'' to
Bodies. Accreditation clarify that FDA
Bodies. is making
recognition
determinations.
Sec. 1.1113 What are the Sec. 1.1113 What Consolidated these
eligibility requirements for a requirements must two proposed
recognized accreditation body? an accreditation sections and
body meet to be revised the
recognized by section title.
FDA? Made conforming
Sec. 1.1118 What changes to
are the general reflect
requirements for eligibility
recognized requirements as
accreditation opposed to
bodies to remain requirements for
recognized?. seeking
recognition and
remaining
recognized.
Sec. 1.1114 How does an Sec. 1.1128 How Moved section to
accreditation body apply to FDA does an 1.1114 of the
for recognition or renewal of accreditation final rule.
recognition? body apply to FDA
for recognition
or renewal of
recognition?
Sec. 1.1115 How will FDA Sec. 1.1129 How Moved section to
evaluate applications for will FDA review 1.1115 of the
recognition and renewal of applications for final rule.
recognition? recognition and Changed ``review''
applications for to ``evaluate''
renewal of in the section
recognition? title.
Removed second
instance of
``applications
for'' in the
section title.
Sec. 1.1116 What must a Sec. 1.1132 What Moved section to
recognized accreditation body must a recognized 1.1116 of the
do to voluntarily relinquish or accreditation final rule.
not renew its recognition? body do if it Minor editorial
wants to changes to
voluntarily section title.
relinquish its
recognition or
does not want to
renew its
recognition?
Sec. 1.1117 How may an Sec. 1.1133 How Moved section to
accreditation body request does an 1.1117 of the
reinstatement of recognition? accreditation final rule.
body request Minor editorial
reinstatement of changes to
recognition? section title.
------------------------------------------------------------------------
[[Page 68765]]
1. What are the eligibility requirements for a recognized accreditation
body (Sec. 1.1113)?
Proposed Sec. 1.1113, ``What requirements must an accreditation
body meet to be recognized by FDA?'' included the requirements an
accreditation body must meet to become recognized by FDA under this
subpart, including the following: (a) Be a full member of ILAC and a
signatory to the ILAC-MRA that has demonstrated competence to ISO/IEC
17011:2017; (b) demonstrate it meets the requirements of ISO/IEC
17011:2017; (c) demonstrate that it possesses sufficient scientific/
technical expertise to be able to substantively assess certain work of
the laboratories it accredits; and (d) demonstrate it is capable of
complying with this rule's proposed requirements for recognized
accreditation bodies. Similarly, proposed Sec. 1.1118, ``What are the
general requirements for recognized accreditation bodies to remain
recognized?'' included the requirement that recognized accreditation
bodies continue to meet the requirements of Sec. 1.1113 in order to
remain recognized by FDA.
In the final rule, FDA has consolidated proposed Sec. Sec. 1.1113
and 1.1118. The new consolidated section is titled ``What are the
eligibility requirements for a recognized accreditation body?'' and is
located at Sec. 1.1113 of the final rule. Accordingly, FDA has revised
the section title to refer to eligibility requirements for recognized
accreditation bodies and has made minor conforming changes throughout
the section to accommodate the change. We also have reordered the list
of eligibility requirements and split the requirement that appeared in
paragraph (a) of the proposed sections into two distinct items, i.e.,
separating the requirement of full membership of ILAC from status as a
signatory to the ILAC-MRA that has demonstrated competence to ISO/IEC
17011:2017 with a scope of ``Testing: ISO/IEC 17025.'' FDA has added
the clarification that a scope of ``Testing: ISO/IEC 17025'' is
required; this requirement previously appeared only among the LAAF-
accredited laboratory requirements against which a recognized
accreditation body must assess a laboratory seeking LAAF-accreditation.
FDA also has removed the requirement in proposed Sec. 1.1113(c)(1)
through (3) regarding a recognized accreditation body's scientific and
technical expertise to review certain validation and verification
required by proposed Sec. 1.1138(a)(1), to review laboratory
determinations regarding the availability of proficiency testing
program, and to assess the adequacy of a laboratory's proposal to use a
comparison program in lieu of a proficiency. For additional discussion
regarding this change, see Comment 62 and Response. Finally, FDA has
revised the section to modify ``accreditation'' with the prefix ``LAAF-
'' to incorporate revised terminology for the final rule discussed at
Response 10. Comments regarding this section are discussed below.
(Comment 59) Some accreditation bodies, including ones located
outside of the United States, express interest in participating in this
program and request information about their role.
(Response 59) We appreciate global interest in the LAAF program. An
accreditation body that meets the eligibility requirements in Sec.
1.1113 may apply to FDA to become recognized, regardless of where the
accreditation body is located. See Response 14 for our implementation
discussion.
Recognized accreditation bodies will assess and oversee
laboratories seeking LAAF-accreditation against the requirements in
this final rule. The requirements for recognized accreditation bodies
are in Sec. Sec. 1.1113-1.1131 and the requirements for LAAF-
accredited laboratories are in Sec. Sec. 1.1138-1.1162.
(Comment 60) Many comments endorse the proposed requirement that a
recognized accreditation body must be an ILAC-MRA signatory that has
demonstrated competence to ISO/IEC 17011:2017. They support the use of
both ISO/IEC 17011:2017 and ISO/IEC 17025:2017 as the foundational
requirements for this rule. Some of the comments express the belief
that reliance on the ILAC framework and ISO standards will ensure an
efficient and effective food testing program by FDA.
Some comments mention that the rigorous ILAC-MRA process provides
ongoing reassurance to regulators that ILAC-MRA signatories and their
accredited laboratories are meeting relevant international standards
and criteria for competence. Some comments provide examples of other
Federal government Agencies and programs that rely on ILAC member
accreditation bodies including the Consumer Product Safety Commission
(CPSC), Environmental Protection Agency (EPA) National Lead Laboratory
Accreditation Program, and Department of Defense Environmental
Laboratory Accreditation Program. Other comments refer to the analysis
we described in the proposed rule which indicated that all the
accredited laboratories that submitted import-related food testing
results in 2016 and 2017 were accredited by accreditation bodies that
are full members of ILAC and signatories to the ILAC-MRA. According to
these comments, it is unsurprising that owners and consignees choose to
rely on laboratories accredited by ILAC-MRA signatories.
Similarly, some comments state that accreditation bodies already
satisfy the foundational requirements for participating in the LAAF
program. Further, these comments state that accreditation bodies are
willing to establish internal procedures and processes to ensure that
they and the laboratories they LAAF-accredit meet all additional
program requirements beyond ISO/IEC 17011:2017, ILAC-MRA signatory
status, and ISO/IEC 17025:2017. Finally, some comments encourage FDA to
collaborate with NIST as we establish this accreditation program. Some
comments applaud FDA's proposed adoption of voluntary consensus
standards and state that such action is in furtherance of the NTTAA.
(Response 60) We appreciate the support expressed for the selected
standards and requirements for recognized accreditation bodies in the
LAAF program. We also appreciate the information provided regarding the
accreditation landscape, as well as the support expressed in these
comments for the LAAF program generally. We have consulted with NIST
throughout this rulemaking process and appreciate their technical
assistance and support.
(Comment 61) In the proposed rule, when we discussed our proposal
to require accreditation bodies to be ILAC-MRA signatories, we
mentioned the laboratory accreditation program established by the CPSC
(84 FR 59452 at 59467). We restated with approval the CPSC's rationale
for establishing the same requirement.
A few comments suggest that we also consider emulating the CPSC's
laboratory accreditation program. Some comments particularly appreciate
that, according to these comments, CPSC relies solely on ILAC-MRA
signatory status to determine whether an accreditation body may
accredit laboratories under CPSC's program; CPSC imposes no additional
standards or requirements for accreditation bodies. According to these
comments, CPSC also exercises very minimal oversight of accreditation
bodies.
We note that the CPSC does not directly regulate accreditation
bodies, but instead requires that laboratories participating in its
program be accredited to ISO/IEC 17025 by an
[[Page 68766]]
accreditation body that is an ILAC-MRA signatory (see Sec.
1112.13(a)(2)(i)). Comments contend that a similar approach by FDA
would provide accreditation bodies with more flexibility and reduce
FDA's costs related to accreditation body oversight. These comments
suggest that even with a reduced oversight role, FDA still could
participate in accreditation body assessments and ILAC peer
evaluations, as do other Federal Agencies with accreditation programs.
Other comments appear to misunderstand our discussion related to the
CPSC in the proposed rule and perceive it as a potential framework FDA
intends to use as a model for our relationship with accreditation
bodies under this subpart.
(Response 61) Under Federal law, children's products must be tested
by a third party, CPSC-accepted laboratory to ensure compliance with
relevant safety requirements. The CPSC established requirements for
third party conformity assessment bodies wishing to conduct these tests
and maintains on its website a list of those conformity assessment
bodies that have been accepted by the CPSC for that purpose. (For more
information on the CPSC program, see https://www.cpsc.gov/Regulations-Laws-Standards/Rulemaking/Final-and-Proposed-Rules/Third-Party-Conformity-Assessment-Bodies/.)
Emulating the framework of the CPSC program is not feasible for the
LAAF program. Whereas the CPSC does not have a formal relationship with
accreditation bodies, section 422 of the FD&C Act requires that FDA
establish standards for, and recognize, accreditation bodies. The
statute also directs FDA to periodically review the recognition of
accreditation bodies and to provide a public registry of recognized
accreditation bodies. Therefore, we believe the statutory requirements
for the LAAF program preclude using the CPSC framework as a model for
our program.
(Comment 62) In proposed Sec. 1.1113(c), we provided that
accreditation bodies seeking recognition demonstrate sufficient
scientific and technical expertise to be able to review validation and
verification studies, assess a laboratory's determination that no
proficiency test is available for a given method, and assess the
adequacy of a laboratory's proposed alternative to a proficiency test,
where none is available. In the preamble we stated that we did not
consider such reviews and determinations to be traditional functions of
accreditation bodies and that accreditation bodies may need to hire or
contract with additional persons possessing this scientific/technical
expertise.
Many comments support the notion that accreditation bodies must
have the expertise to conduct substantive reviews of validation and
verification studies, as well as alternatives to proficiency testing
when a proficiency test is not available. However, several comments
express the view that FDA need not include such a requirement in this
rule because an equivalent requirement already exists, albeit in
general terms, in ISO/IEC 17011:2017, and in order to be an ILAC-MRA
signatory. Further, several of these comments disagree with FDA's
statement that conducting a substantive review of validation and
verification studies and assessing proposed alternatives to proficiency
testing constitute non-traditional functions for accreditation bodies.
Instead, these comments clarify that accreditation bodies routinely
conduct those activities as part of the ISO/IEC 17025:2017 assessment
and routinely hire qualified staff and assessors to carry out this
work. They also state that satisfying the ILAC requirement is enforced
and ensured by way of ILAC's robust peer evaluation process. Other
comments offer conditional support for the proposed requirement that
accreditation bodies demonstrate that they possess scientific/technical
expertise, as long as our requirements do not impair the ability of
accreditation bodies to fulfill their mission.
Some comments stress the robust nature of the peer evaluation
system that provides evaluation and surveillance of ILAC-MRA
signatories. Some comments express the belief that an ILAC-MRA
signatory accreditation body necessarily would possess the scientific/
technical expertise that FDA described in proposed Sec. 1.1113(c).
(Response 62) Upon consideration of these comments, we agree that
the requirement in proposed Sec. 1.1113(c) regarding scientific and
technical expertise is unnecessary; it does not appear in the final
rule. Also, as described above, we proposed to require that
accreditation bodies seeking recognition demonstrate sufficient
scientific and technical expertise in part to support their review of
certain validation and verification studies that would be required in
connection with the testing conducted under this subpart. Under the
final rule FDA will review all verification and validation studies that
are required in connection with the testing conducted under this
subpart. See Comment and Response 122.
(Comment 63) In the proposed rule, in connection with our
discussion of recognized accreditation bodies assessing certain
validation and verification studies required under this subpart as well
as alternatives to proficiency tests, we stated that we may consider a
variety of activities such as issuing guidance and regular roundtable
meetings with recognized accreditation bodies, to communicate our
expectations for such assessments. (See 84 FR 59452 at 59467). Several
comments encourage FDA to provide such guidance. Some comments request
a defined list of the items FDA considers necessary for a complete
validation report. These comments state that an accreditation body's
recognition may be revoked if the accreditation body allows a
laboratory to use a method and the method was not appropriate due to
errors or omissions in the validation study. Several comments suggest
that clearly communicated expectations from FDA would better ensure
consistency among laboratories and accreditation bodies and increase
the likelihood that the studies and alternatives would be satisfactory
to the Agency.
(Response 63) We acknowledge that these comments encourage FDA to
issue guidance communicating our expectations for the validation and
verification studies required under this subpart. Although we may do
so, there is information already available on our website regarding FDA
expectations for validation studies: Foods Program Methods Validation
Processes and Guidelines are available at https://www.fda.gov/food/laboratory-methods-food/foods-program-methods-validation-processes-and-guidelines.
2. How does an accreditation body apply to FDA for recognition or
renewal of recognition (Sec. 1.1114)?
Section 1.1128 of the proposed rule concerned how an accreditation
body would apply to FDA for recognition or renewal of recognition.
Paragraphs (a) and (b) of proposed Sec. 1.1128 included the
requirement for an accreditation body to submit its application for
recognition or renewal of recognition to FDA. Paragraph (c) of the
proposed section discussed the specific documentation requirements for
an accreditation body applicant, including documentation of conformance
with ISO/IEC 17011:2017, separate documentation of ILAC-MRA signatory
status demonstrating competence to ISO/IEC 17011:2017, and
documentation of compliance with proposed Sec. 1.1113(c) and (d)
(concerning the requirement to possess sufficient scientific and
technical expertise: (1) To review certain
[[Page 68767]]
validation and verification studies, (2) to assess a laboratory's
determination regarding proficiency test availability, and (3) to
assess a laboratory's proposed comparison program; and the requirement
to meet all additional requirements of the subpart) or proposed Sec.
1.1118(c) and (d) (which covered the same provisions as proposed Sec.
1.1113(c) and (d) for recognized accreditation bodies seeking renewal
of recognition). Paragraph (d) of proposed Sec. 1.1128 included the
requirement to submit the application electronically and in English and
to provide any required translation services needed by FDA during the
processing of the application or an onsite assessment of the
accreditation body. Finally, paragraph (e) of proposed Sec. 1.1128
covered requirements for signing the application for recognition or
renewal of recognition.
As part of our overall reorganization of the final rule, we have
moved the contents of proposed Sec. 1.1128 to Sec. 1.1114 of the
final rule. We received no comments directly related to this section of
the rule; however, we have made several editorial and conforming
changes to improve clarity and readability and to streamline the
section. We combined proposed paragraphs (a) and (b) into a single
paragraph (a) of the final rule to cover both initial and renewal
applications. Paragraph (c) of the proposed rule regarding
documentation has been updated to reflect correct cross-references
since proposed Sec. Sec. 1.1113 and 1.1118 were combined; the
documentation paragraph of the final rule is now paragraph (b). We
relocated the contents of proposed paragraph (d) (regarding submitting
documents to FDA electronically and in English) to Sec. 1.1110 of the
final rule. Finally, proposed paragraph (e) is now paragraph (c) of the
final rule.
3. How will FDA evaluate applications for recognition and renewal of
recognition (Sec. 1.1115)?
Section 1.1129 of the proposed rule, ``How will FDA review
applications for recognition and applications for renewal of
recognition?'' concerned FDA evaluation of applications for recognition
and renewal of recognition. Paragraph (a) of proposed Sec. 1.1129
stated that FDA would notify an accreditation body applicant if the
application is incomplete and would review completed applications in
the order in which the completed application is received; however, FDA
reserved discretion to prioritize review to meet program needs.
Paragraph (b) of proposed Sec. 1.1129 stated that FDA would evaluate
applications and may include an onsite visit to determine whether the
accreditation body applicant meets the requirements for recognition. We
also noted that we may extend the term of recognition for an
accreditation body if FDA's review of the application for renewal of
recognition was not complete prior to the term's expiration. In
paragraphs (c) and (d), we stated that we would notify an accreditation
body if the application is approved and that we may grant recognition
for a period up to 5 years from the date of recognition, unless our
review of the application extends past the expiration of the term of
recognition (as covered in proposed paragraph (b)). Proposed Sec.
1.1129 also provided that we would notify an accreditation body
applicant if we deny the application for recognition or renewal of
recognition, including the basis for the denial and procedures for
requesting reconsideration (see proposed Sec. 1.1129(e)). If we deny
an application for renewal of recognition, paragraph (f) stated that
the accreditation body applicant would have to identify a records
custodian to maintain records pursuant to proposed Sec. 1.1124, and
provide the custodian's contact information including email and street
address. As discussed above regarding changes to Sec. 1.1102,
throughout this subpart when we say, ``street address,'' we mean full
physical address including country; a mailing address that is not a
physical address (e.g., post office number) is insufficient, though
supplying both types of address is acceptable (see new definition of
street address in Sec. 1.1102 of the final rule). Paragraphs (g) and
(h) of proposed Sec. 1.1129 stated that when the application for
renewal of recognition is denied FDA would provide notice to
laboratories accredited by the accreditation body and public notice on
the website described in proposed Sec. 1.1109.
As part of our overall reorganization of the final rule, we have
moved the contents of proposed Sec. 1.1129 to Sec. 1.1115 of the
final rule and revised the section title to ``How will FDA evaluate
applications for recognition and renewal of recognition?'' We relocated
the requirement in proposed Sec. 1.1129(f) regarding submitting
notifications electronically and in English to Sec. 1.1110 of the
final rule. We have made several revisions to the contents of this
section to incorporate revised terminology and to improve clarity and
readability. Comments regarding this section are discussed below.
(Comment 64) Some comments suggest that FDA establish an initial
accreditation body application deadline, and an approval date for all
the accreditation bodies that apply for recognition by that deadline.
They state that this approach would avoid any competitive advantage
that might otherwise accrue to the accreditation body that first gains
FDA recognition. The comments also suggest that FDA set up additional
rounds of accreditation body application deadlines and recognition
decisions.
(Response 64) As discussed in Response 14, we intend to implement
the LAAF program in a stepwise fashion. The first step will be
announcing that accreditation bodies may apply for recognition. We
understand and acknowledge the concern that a competitive advantage may
accrue to the first accreditation body recognized. We will consider
this matter and communicate further on the details of the accreditation
body application process when we announce that applications may be
submitted.
4. What must a recognized accreditation body do to voluntarily
relinquish or not renew its recognition (Sec. 1.1116)?
Section 1.1132 of the proposed rule, ``What must a recognized
accreditation body do if it wants to voluntarily relinquish its
recognition or does not want to renew its recognition?'' concerned the
procedures for voluntary relinquishment of recognition and non-renewal
of recognition of a recognized accreditation body, including the
requirement to provide to FDA a notice of intent 60 days prior to
relinquishing recognition as well as a records point of contact for
records required by proposed Sec. 1.1124 (see proposed Sec.
1.1132(a)). Paragraph (b) required the accreditation body to provide
notice of intent to relinquish recognition to the laboratories the
accreditation body LAAF-accredits, and paragraph (c) noted that FDA
would provide notice of the same on the website described in proposed
Sec. 1.1109.
As part of our overall reorganization of the final rule, we have
moved the contents of proposed Sec. 1.1132 to Sec. 1.1116 of the
final rule. We received no comments directly related to this section of
the rule; however, we made certain changes on our own initiative.
First, we revised the section title to read, ``What must a recognized
accreditation body do to voluntarily relinquish or not renew its
recognition?'' In paragraph (a) we clarified that when a recognized
accreditation body notifies FDA of its intention to leave the program
it must specify the date on which the relinquishment or expiration will
occur.
[[Page 68768]]
We also deleted ``electronically, in English'' in paragraph (a) since
this is covered by the new Sec. 1.1110 in the final rule. We also made
several conforming changes to update cross-references throughout the
section to reflect the reorganized structure of the final rule and to
update terminology, such as the change to ``LAAF-accreditation.'' We
revised paragraphs (a) and (b) of the final rule to specify
``calendar'' days. Finally, we have made revisions to improve clarity
and readability of the final rule.
5. How may an accreditation body request reinstatement of recognition
(Sec. 1.1117)?
Section 1.1133 of the proposed rule, ``How does an accreditation
body request reinstatement of recognition?'' concerned an accreditation
body's request for reinstatement of recognition. Under proposed Sec.
1.1133(a), an accreditation body that had its recognition revoked could
seek reinstatement of recognition by submitting a new application along
with evidence that the grounds for revocation have been resolved. As
described in proposed Sec. 1.1133(b), an accreditation body that
allowed its recognition to expire or voluntarily relinquished
recognition could submit a new application without additional
requirements.
As part of our overall reorganization of the final rule, we have
moved the contents of proposed Sec. 1.1133 to Sec. 1.1117 of the
final rule and revised the title to read, ``How may an accreditation
body request reinstatement of recognition?'' We received no comments
directly related to this section of the rule; however, we revised the
section to update cross-references to reflect the reorganized structure
of the final rule and have made revisions to improve the clarity and
readability of the final rule.
F. Comments Regarding Requirements for Recognized Accreditation Bodies
Table 7--Changes to the Sections Regarding Requirements for Recognized
Accreditation Bodies
------------------------------------------------------------------------
Final rule Proposed rule Notes
------------------------------------------------------------------------
N/A (contents combined with Sec. Sec. 1.1118 What
1.1113). are the general
requirements for
recognized
accreditation
bodies to remain
recognized?
Sec. 1.1119 What are the Sec. 1.1119 What Editorial changes
conflict of interest requirements to section title.
requirements for a recognized apply to how a
accreditation body? recognized
accreditation
body must protect
against conflicts
of interests?
Sec. 1.1120 How must a Sec. 1.1120 How Revised section
recognized accreditation body must a recognized title to change
assess laboratories seeking accreditation ``evaluate'' to
LAAF-accreditation and oversee body evaluate ``assess'' and to
LAAF-accredited laboratories? laboratories modify
seeking ``accreditation''
accreditation and with the prefix
oversee the ``LAAF-''.
performance of
laboratories it
accredits?
Sec. 1.1121 When must a Sec. 1.1121 What Relocated section
recognized accreditation body appeal procedures and revised
require corrective action, must a recognized section title to
suspend a LAAF-accredited accreditation reflect
laboratory, or reduce the scope body provide for opportunity for
of or withdraw the LAAF- appeals of corrective
accreditation of a laboratory? decisions to not action, to revise
grant this use of
accreditation? ``probation'' to
Sec. 1.1122(h) ``suspension,''
Appeals to modify
procedures.. ``accreditation''
with the prefix
``LAAF-,'' to
refer to scope
reduction, and to
re-order the
terms.
Sec. 1.1122 What procedures Sec. 1.1122 When Relocated section
must a recognized accreditation must a recognized and revised
body provide for appeals of accreditation section title to
decisions to suspend, reduce body withdraw or include appeals
the scope of, withdraw, or deny reduce the scope for suspension,
LAAF-accreditation? of the scope reduction,
accreditation of withdrawal, or
a laboratory, and denial of LAAF-
when may a accreditation.
recognized
accreditation
body put an
accredited
laboratory on
probation?
Sec. 1.1123 What reports, Sec. 1.1123 What Revised title to
notifications, and reports and include
documentation must a recognized notifications ``documentation''
accreditation body submit to must a recognized to more
FDA? accreditation accurately
body submit to reflect the
FDA? contents of the
section.
Sec. 1.1124 What are the Sec. 1.1124 What Editorial changes
records requirements for a records to section title.
recognized accreditation body? requirements must
a recognized
accreditation
body meet?
Sec. 1.1125 What are the Sec. 1.1125 What Editorial changes
internal audit requirements for internal audit to section title.
a recognized accreditation requirements must
body? a recognized
accreditation
body meet?
------------------------------------------------------------------------
1. What are the conflict of interest requirements for a recognized
accreditation body (Sec. 1.1119)?
Proposed Sec. 1.1119 concerned conflict of interest requirements
for recognized accreditation bodies. In addition to meeting the
impartiality and conflict of interest requirements in ISO/IEC
17011:2017, proposed Sec. 1.1119(a)(1) stated the following
requirements: An accreditation body, including its officers, employees,
and other agents involved in accreditation activities, could not own,
have a financial interest in, manage, or otherwise control a
laboratory, including affiliates, parents, or subsidiary, that it LAAF-
accredits. Paragraph (a)(2) prohibited the acceptance of money, gifts,
gratuities, and other items of value by an accreditation body's
officers, employees, and other agents from a laboratory it LAAF-
accredits. Proposed Sec. 1.1119(b) excluded the following from
prohibited items of value: (1) Money representing payment for
accreditation fees and services, (2) reimbursement of direct costs
associated with an onsite assessment, and (3) lunch of a de minimis
value in certain circumstances. Proposed Sec. 1.1119(c) stated that
the financial interest of a spouse or child under 18 years of age of
any recognized accreditation body officer, employee, or other agent
involved in accreditation activities would be considered the financial
interest of such officer, employee, or other agent for purposes of the
rule.
In addition to the changes discussed below, we have revised cross-
references and terminology throughout the final rule to reflect the
reorganization and revised terms in the final rule. We revised the
title of the section to read, ``What are the conflict of interest
requirements for a recognized accreditation body?'' We have relocated
the contents of proposed paragraph (c) to paragraph (b) of the final
rule to better accommodate the addition of two
[[Page 68769]]
new paragraphs described below. We also changed the phrase ``lunch of
de minimis value'' (see proposed Sec. 1.1119(b)(2)) to ``meal of de
minimis value'' in Sec. 1.1119(e)(2) of the final rule to provide
flexibility. We also have revised this section to improve clarity and
readability. Comments regarding this section are discussed below.
(Comment 65) Many comments agree with the proposed accreditation
body conflict of interest provisions in Sec. 1.1119. Some comments
express particular support that our proposed policy would allow
individuals involved in accreditation decisions to accept both; (1)
payment for accreditation services, including reimbursement for direct
costs, and (2) lunch of de minimis value during an onsite assessment.
However, some comments state that our proposed requirements would be
duplicative of requirements in ISO/IEC 17011:2017.
(Response 65) We appreciate comments in support of the conflict of
interest provisions. We disagree that the requirements of Sec. 1.1119
are duplicative of ISO/IEC 17011:2017. The ISO/IEC 17011:2017
requirements for conflict of interest are stated in general terms and
included in the sections on impartiality. ISO/IEC 17011:2017 section
4.4.4 specifically addresses financial conflict of interest as follows:
``All accreditation body personnel and committees who could influence
the accreditation process shall act objectively and shall be free from
any undue commercial, financial and other pressures that could
compromise impartiality. The accreditation body shall require all
personnel and committee members to disclose any potential conflict of
interest whenever it may arise'' (Ref. 2). In contrast, Sec. 1.1119
offers more detailed and specific information than specified by ISO/IEC
17011:2017 with respect to what is permitted.
(Comment 66) Among the proposed conflict of interest provisions for
accreditation bodies, one would prohibit the officers, employees, or
other agents of an accreditation body from owning or having a financial
interest in any laboratory (including an affiliate, parent, or
subsidiary) LAAF-accredited by the accreditation body. Some comments
specifically applaud this proposed policy. Other comments express
concern that this proposed provision contains a much broader
interpretation of ``conflict'' than is either the industry standard or
practical in application. They state that, as proposed, this provision
may apply to accreditation body board members, decision panel members,
and technical committee members, among others, and could prohibit such
individuals from investing in a mutual fund that includes a company
with a financial interest in a laboratory accredited by the
accreditation body, even if that laboratory is not LAAF-accredited and
conducts no food testing. These comments suggest that FDA limit its
conflict of interest provisions in two ways. First, they suggest that
we limit our financial conflict of interest restrictions for
accreditation bodies to the more limited cases of owning or having a
financial interest in food testing laboratories LAAF-accredited by the
accreditation body under this program, or that are in direct
competition with listed laboratories, rather than all laboratories the
accreditation body has accredited. Second, they seem to imply that the
conflict of interest restrictions should apply only to individuals
involved in assessments and LAAF-accreditation decisions. Certain
comments from accreditation bodies explain that their practice is to
ask the laboratories being assessed to declare that no conflict exists
between the laboratory and the individual assessor(s) or accreditor(s).
Finally, these comments mention that their conflict of interest
policies have been deemed sufficient by other regulators as well as
peer evaluators.
(Response 66) We appreciate support for the conflict of interest
provisions proposed in Sec. 1.1119. As a threshold matter, we note
that the proposed rule defined ``accreditation'' in Sec. 1.1102, in
relevant part, as being limited to accreditation under this subpart.
Therefore, proposed section 1.1119(a)(1) was intended only to prevent
an accreditation body's ownership, financial interest in, management
of, or control of any laboratory it LAAF-accredits under this subpart.
As discussed at Response 10, we understand the potential for confusion
and have updated the terminology to better clarify the scope of the
rule and these conflict of interest provisions. With revisions to
reflect these terminology changes, Sec. 1.1119(a)(1) of the final rule
specifies that the prohibited interests relate solely to laboratories
that are LAAF-accredited by the recognized accreditation body. We
decline the suggestion to apply the conflict of interest requirements
for accreditation bodies as a prohibition against having a financial
interest in laboratories in direct competition with LAAF-accredited
laboratories because such a provision would be extremely challenging to
monitor and enforce.
In response to concerns raised in these comments, we have added new
paragraph (c) to this section in the final rule to permit a recognized
accreditation body, including officers, employees, or other agents
involved in LAAF-accreditation activities to have interest in a
publicly traded or publicly available fund (such as a mutual fund), or
a widely held pension or similar fund if the accreditation body
exercises no control over the financial interests in the funds. We
believe this type of interest to be low-risk and not to pose a
meaningful conflict of interest for a recognized accreditation body.
However, we decline to only apply these and other conflict of
interest restrictions to those individuals involved in LAAF-
accreditation or LAAF assessment decisions. If any officer, employee,
or other agent of the accreditation body owns or has a financial
interest in, manages or otherwise controls a laboratory that the
accreditation body LAAF-accredits, a conflict of interest exists.
Protecting against conflicts of interest is critical to the integrity
of this program.
(Comment 67) With regard to the proposed conflict of interest
provisions for accreditation bodies, some comments indicate that
whereas our proposed rule focused solely on financial conflicts of
interest, ISO/IEC 17011:2017 also addresses other types of conflicts of
interest such as consultation. We understand these comments to be
asking whether individuals who provide consulting services to a LAAF-
accredited laboratory apart from, or in preparation for, an assessment
by an accreditation body (e.g., the consultant who assists the
laboratory with determining how to design their quality management
system, or the consultant who provides services to the laboratory such
as performing the laboratory's required internal audit) will be
prohibited from serving as the consulting assessor that assesses the
laboratory on behalf of the recognized accreditation body.
(Response 67) Proposed Sec. 1.1119(a) stated that the conflict of
interest requirements in that section were in addition to the conflict
of interest requirements in proposed Sec. 1.1118(b), which
incorporated by reference, in its entirety, ISO/IEC 17011:2017.
Likewise, in the final rule, Sec. 1.1119(a) states that the conflict
of interest requirements in that section are in addition to the
conflict of interest requirements in Sec. 1.1113(a), which
incorporates by reference, in its entirety, ISO/IEC 17011:2017. Thus,
all the requirements in ISO/IEC 17011:2017, including those regarding
other conflicts of interest, are required by the final rule. Sections
4.4.11 through 4.4.13 of ISO/IEC 17011:2017 address consultancy among
[[Page 68770]]
the activities an accreditation body is restricted from performing. In
addition to consultancy, this section of ISO/IEC 17011:2017 also
addresses testing; calibration; inspection; certification of management
systems, persons, products, processes and services; provision of
proficiency testing; production of reference materials; and validations
and verifications (Ref. 2).
(Comment 68) Some comments on the proposed section regarding
conflict of interest requirements for accreditation bodies request that
FDA clarify the term, ``other agents.'' These comments ask whether our
proposal to include ``other agents'' among the actors prohibited from
having a financial interest in any laboratory the accreditation body
accredits, is intended to prohibit the accreditation body from
contracting with technical assessors who may also work for a laboratory
that the accreditation body LAAF-accredits. These comments state that
the use of contract assessors who work in accredited laboratories is
common in the industry. If we intended to prohibit that practice, these
comments recommend that we instead allow it to continue. They further
recommend that the applicant laboratory be made aware that the contract
assessor is from another accredited laboratory and be given an
opportunity to object to that assessor.
(Response 68) In light of these concerns, we have revised the final
rule to include new Sec. 1.1119(d) which permits a recognized
accreditation body to use a contract assessor with a specified
financial interest in a laboratory the recognized accreditation body
assesses for LAAF-accreditation, if all the following circumstances
apply: First, the contract assessor's primary occupation is owning or
having a financial interest in, managing, or otherwise controlling a
LAAF-accredited laboratory. Second, the assessor contracts with the
recognized accreditation body to provide assessment services on an
intermittent or part-time basis. Third, the contract assessor does not
assess the LAAF-accredited laboratory that the assessor owns or has a
financial interest in, manages, or otherwise controls. Finally, the
contract assessor and the recognized accreditation body inform any
laboratory that the contract assessor may assess or reassess for LAAF-
accreditation, that the contract assessor owns or has a financial
interest in, manages, or otherwise controls a LAAF-accredited
laboratory. The laboratory seeking LAAF-accreditation assessment or
reassessment must acknowledge that the contract assessor owns or has a
financial interest in, manages, or otherwise controls a LAAF-accredited
laboratory and be provided the option to be assessed by a different
representative of the recognized accreditation body.
The addition of this paragraph to the final rule is intended to
facilitate the existing industry practice of accreditation bodies using
contract assessors from LAAF-accredited laboratories. We believe that
any potential conflict of interest arising from this narrow exception
is mitigated by the disclosure of the financial interest of the
contract assessor to the laboratory subject to assessment for purposes
of LAAF-accreditation, as well as an acknowledgement by the laboratory
and the option to request a different assessor.
To accommodate changes to the final rule regarding the excepted
interests described in Sec. 1.1119(c) and (d) (see Responses 66 and
67) we have revised Sec. 1.1119(a)(1) to expressly reference the new
exceptions.
2. How must a recognized accreditation body assess laboratories seeking
LAAF-accreditation and oversee LAAF-accredited laboratories (Sec.
1.1120)?
Section 1.1120 of the proposed rule, ``How must a recognized
accreditation body evaluate laboratories seeking accreditation and
oversee the performance of laboratories it accredits?'' concerned
recognized accreditation body assessment of LAAF-accredited
laboratories. This proposed section stated that recognized
accreditation bodies would need to conduct an initial assessment of a
laboratory seeking LAAF-accreditation onsite, unless the recognized
accreditation body had conducted an onsite assessment of the laboratory
in the last 2 years in accordance with ISO/IEC 17025:2017. The proposed
section stated in paragraph (c) that a recognized accreditation body
that had conducted an onsite assessment of a laboratory in the last 2
years in accordance with ISO/IEC 17025:2017 could conduct the initial
assessment of such laboratory seeking LAAF-accreditation remotely and
need only address the requirements beyond ISO/IEC 17025:2017. Once
LAAF-accredited, proposed paragraph (d) required that a recognized
accreditation body oversee the performance of a laboratory it LAAF-
accredits in accordance with the requirements of this subpart. Proposed
paragraph (e) required the assessment of the sample of the scope of
LAAF-accreditation to be conducted onsite and at least every 2 years,
unless, as proposed paragraph (f) stated, the initial assessment was
conducted remotely under the exception in proposed paragraph (c), in
which case the first assessment of the sample of the scope of LAAF-
accreditation must be conducted within 2 years of the last onsite
assessment in accordance with ISO/IEC 17025:2017. Proposed Sec.
1.1120(g) also required that the reassessment of at the end of the
LAAF-accredited laboratory's LAAF-accreditation cycle be conducted
onsite. In all assessment scenarios in this proposed section, certain
assessment activities could be conducted remotely if it would not aid
the assessment to conduct them onsite. Finally, in paragraph (h), we
proposed that any additional assessments beyond those referred to in
the section could be conducted remotely.
We have updated cross-references and terminology throughout the
section and, correspondingly, we revised the section title to read,
``How must a recognized accreditation body assess laboratories seeking
LAAF-accreditation and oversee LAAF-accredited laboratories?'' On our
own initiative, we revised Sec. 1.1120(e) to improve clarity and
readability. To better distinguish between initial assessment
activities and activities conducted in subsequent assessments, we
replaced several instances of ``assessment'' with ``reassessment.'' We
also deleted references to assessing ``in accordance with'' ISO/IEC
17011:2017 because such references were redundant of the foundational
ISO/IEC 17011:2017 requirement (Sec. 1.1113). Comments regarding this
section are discussed below.
(Comment 69) Some comments praise FDA for the clarity of the
requirements in Sec. 1.1120. These comments state that the
accreditation body would be responsible for deciding, within the
parameters set by the rule, whether and when remote assessment would be
sufficient.
A few comments indicate that the proposed rule did not distinctly
address a laboratory's request to expand or extend its scope of LAAF-
accreditation or propose requirements for how a recognized
accreditation body would assess such a request. These comments suggest
that a remote assessment should be allowed if the laboratory is simply
adding analytes to a technique or method for which it is already LAAF-
accredited. In contrast, these comments recommend that an onsite
assessment be required if the request to extend the scope of LAAF-
accreditation involves techniques or methods that are new to that
laboratory.
(Response 69) We appreciate the support and agree that this section
indicates minimum requirements but does not prevent a recognized
[[Page 68771]]
accreditation body from conducting additional site visits or remote
visits if they so choose, provided they are not in conflict with our
requirements.
Proposed Sec. 1.1120 did not explicitly address assessments for
extensions of LAAF accreditation. However, such assessments would be
governed by the terms of Sec. 1.1120, meaning that if such an
assessment was not required to be onsite under paragraphs (a), (e), or
(g), it would be covered by paragraph (h) and the recognized
accreditation body would determine whether going onsite would aid the
assessment. In most circumstances FDA would recommend that recognized
accreditation bodies go onsite to assess a LAAF-laboratory for
techniques, technology, and types of instrumentation that have not been
previously observed during an onsite assessment. In our view, remote
off-cycle assessments are generally sufficient in circumstances such as
the addition of analyte(s) to a method previously evaluated during an
onsite assessment, the addition of matrices to a method previously
evaluated during an onsite assessment, and the addition of a method for
a technique or technology that the laboratory has been determined to
have competence to perform based on a previous onsite assessment.
3. When must a recognized accreditation body require corrective action,
suspend a LAAF-accredited laboratory, or reduce the scope of or
withdraw the LAAF-accreditation of a laboratory (Sec. 1.1121)?
Proposed Sec. 1.1122 concerned the probation, withdrawal, and
reduction of scope of a laboratory's LAAF-accreditation. Paragraphs (a)
and (c) of this proposed section described the grounds for withdrawal
of LAAF-accreditation as when a laboratory substantially fails to
comply with this subpart; it also provided that withdrawal may be
limited to certain methods if the deficiencies only impact those
methods within the scope of LAAF-accreditation. Paragraph (b) of this
proposed section described grounds for probation as when a laboratory
demonstrates deficiencies less serious than those warranting withdrawal
that are reasonably likely to be fixed within a specified period of
time. Proposed Sec. 1.1122(d) stated the provision to submit required
records as requested by the recognized accreditation body to assist in
determining whether withdrawal or probation is warranted. This proposed
section also included the procedures for withdrawal of LAAF-
accreditation and for probation of a LAAF-accredited laboratory as well
as the consequences of each: specifically, a laboratory would not be
eligible to conduct testing under this subpart for any methods for
which LAAF-accreditation had been withdrawn and a laboratory on
probation could continue to conduct testing under this subpart.
Paragraph (h) of this proposed section included the requirements for
appeals procedures a recognized accreditation body would need to
establish and implement for a laboratory to appeal any decision to
withdraw LAAF-accreditation.
As a threshold matter, we moved the contents of proposed Sec.
1.1122 to Sec. 1.1121 in the final rule. Additionally, we have revised
this section to remove proposed Sec. 1.1122(h) regarding appeals
procedures for reducing the scope of or withdrawal of LAAF-
accreditation; this content has been incorporated into Sec. 1.1122 of
the final rule regarding appeals procedures for decisions to suspend,
reduce the scope of, withdraw, or deny LAAF-accreditation. We have also
revised the section to clarify that a recognized accreditation body can
use suspension on a method-specific basis; we believe this change
better aligns LAAF-accreditation with ISO/IEC 17025:2017 accreditation.
In response to comments, we have made substantial revisions to this
section. In addition to updating terminology, we also have revised the
section to include the opportunity to implement corrective action prior
to suspension of a LAAF-accredited laboratory. See Sec. 1.1121(a). A
laboratory with its LAAF-accreditation suspended also has a corrective
action opportunity before its LAAF-accreditation is withdrawn by the
recognized accreditation body. We revised the section title to read,
``When must a recognized accreditation body require corrective action,
suspend a LAAF-accredited laboratory, or reduce the scope of or
withdraw the LAAF-accreditation of a laboratory?'' to incorporate
revised terminology and to better reflect the contents of the section
in the final rule.
(Comment 70) Section 1.1122(a) of the proposed rule provided that a
recognized accreditation body must withdraw a laboratory's LAAF-
accreditation if the laboratory substantially fails to comply with this
rule. We have addressed in Response 10 the confusion and concern some
comments express regarding our proposed use of the word,
``accreditation'' to mean the laboratory had been approved to conduct
testing under this subpart. Here we address the proposed requirement
that an accreditation body act to remove a laboratory from this program
if the laboratory substantially fails to comply with this rule.
Some comments state support for this proposed requirement, stating
that it reflects common industry practice.
(Response 70) We appreciate support for the proposed requirements
and note that the final rule is limited to impact on a laboratory's
LAAF-accreditation, as opposed to having any impact on ISO/IEC
17025:2017 accreditation.
(Comment 71) Many comments highlight that the term, ``probation''
typically is not used in conformity assessment. Many comments also
argue that marketplace confusion and commercial harm would likely
result from use of the term, ``probation'' to describe an action that a
recognized accreditation body could take against a laboratory--
particularly in combination with our proposed specialized definition of
the term, ``accreditation'' to mean that the laboratory satisfies the
requirements of this subpart and the proposal that laboratories be
labeled publicly with ``probation'' status via our online registry.
Some comments recommend that the rule allow for three actions that
could be taken against a LAAF-accredited laboratory: probation,
suspension, and withdrawal. Some comments recommend that FDA not
establish another accreditation status outside of the ILAC-MRA and ISO/
IEC 17011:2017, which provides for suspension, withdrawal, and
reduction of the scope of accreditation. Some comments urge that, if
FDA does use the term, ``probation'' in this subpart, we use the term
solely to describe an action we might take, e.g., in relation to the
online registry, rather than an action taken by the accreditation body.
Some comments contend that a laboratory should not be placed on
``inactive'' status if it has been cited for noncompliance during an
assessment. We understand this comment to mean that a laboratory should
not be placed on probation or suspension from this program until after
the laboratory has had an opportunity to take corrective action.
(Response 71) We understand that the term, ``probation'' typically
is not used in this context and appreciate the recommendations for
other terms. We have revised the terminology used here and throughout
the rule to be more specific to LAAF-accreditation. In Sec. 1.1121, we
have revised the section to refer to ``suspension'' instead of
``probation,'' as we understand this to be a more appropriate term
based on context. We also agree that the opportunity for corrective
action should
[[Page 68772]]
be afforded prior to suspending a laboratory and we have revised the
section to include such opportunity prior to a recognized accreditation
body suspending a LAAF-accredited laboratory or withdrawing or reducing
the laboratory's scope of LAAF-accreditation. We have retained the
term, ``probation'' in the final rule to refer to an action taken by
FDA with respect to a recognized accreditation body (see Sec. 1.1131)
or a LAAF-accredited laboratory (see Sec. 1.1161).
We also acknowledge that laboratory suspension may occur at the
request of the laboratory to accommodate temporary circumstances
unrelated to deficiencies, such as to move locations, remodel, or while
certain equipment is inoperable or otherwise unavailable. A suspension
of ISO/IEC 17025 accreditation for any reason would necessarily impact
LAAF-accreditation and therefore must be reported to FDA by the
recognized accreditation body under Sec. 1.1123. We intend to
accurately maintain the information contained on the public registry
described in Sec. 1.1109.
Although we proposed in Sec. 1.1122(g) that a LAAF-accredited
laboratory would be permitted to continue to conduct food testing under
this subpart while on probation, we have also revised the final rule to
better align with the consequences of suspension in section 4.3.1 of
ISO/IEC 17011:2017 (Ref. 2). Since a laboratory would not be able to
hold itself out as accredited for a method subject to suspension, Sec.
1.1121(f)(1) of the final rule states that a LAAF-accredited laboratory
may not conduct food testing under this subpart using suspended
methods.
(Comment 72) Some comments express concern about the proposed
provisions regarding recognized accreditation bodies placing
laboratories on probation or withdrawing LAAF-accreditation for the
laboratory's failure to comply with the rule, when combined with what
these comments describe as ``punitive and excessive'' documentation and
reporting proposed requirements associated with analytical reports. We
understand these comments to be expressing concern that if FDA applies
exacting standards to all contents of the full analytical report, a
laboratory may be deemed out of compliance with the rule for failing to
satisfy those reporting requirements, at which point the recognized
accreditation body may place the laboratory on probation or withdraw
LAAF-accreditation.
(Response 72) We have revised the final rule to clarify that
probation is an action that only FDA will take; under Sec. 1.1121, a
recognized accreditation body may suspend a LAAF-accredited laboratory.
(See Response 10 for additional discussion of clarifying terminology
changes in the final rule.)
It remains true in the final rule that a recognized accreditation
body ``must reduce the scope of or withdraw the LAAF-accreditation of a
laboratory it LAAF-accredits when the laboratory substantially fails to
comply with this subpart'' (Sec. 1.1121(c)). However, the word,
``substantially'' is included in this regulatory provision for a
reason, and that is to distinguish minor or isolated infractions from
more serious failings. In the context of laboratory reporting
requirements, ``substantially'' means that it would be unnecessary and
inappropriate for an accreditation body to place a LAAF-accredited
laboratory on probation, or to reduce the scope of or withdraw its
LAAF-accreditation, for minor administrative errors in analytical
reports. Nor would such errors ordinarily result in FDA placing the
laboratory on probation or disqualifying the laboratory. Further, it is
FDA's responsibility, and not the recognized accreditation body's, to
review the performance of LAAF-accredited laboratories, including
reviewing submitted analytical reports.
For more information on laboratory reporting requirements, see our
discussion of Sec. 1.1152, below. For more information on FDA review
of analytical reports, see our discussion of Sec. 1.1160 below.
4. What procedures must a recognized accreditation body provide for
appeals of decisions to suspend, reduce the scope of, withdraw, or deny
LAAF-accreditation (Sec. 1.1122)?
Proposed Sec. 1.1121 concerned the procedures for appeals of
decisions to deny LAAF-accreditation. This proposed section specified
requirements for appeals procedures in addition to those in ISO/IEC
17011:2017, including the requirement to make appeals procedures
publicly available, and to use a competent person free from bias who
has not participated in the accreditation decision and is not the
subordinate of a person who participated in the accreditation decision.
As mentioned above, we have moved the contents of proposed Sec.
1.1121 to Sec. 1.1122 in the final rule. Considering the overlap
between proposed Sec. Sec. 1.1121 and 1.1122(h) (regarding appeals
procedures for withdrawal of LAAF-accreditation), we have revised Sec.
1.1122 of the final rule to cover appeals of denial, reduction of
scope, and withdrawal of LAAF-accreditation. Additionally, we include
appeals of suspension decisions in this section of the final rule; this
requirement previously only appeared in Sec. 1.1124 of the proposed
rule. Accordingly, we have revised the section title to reflect the
contents of the section in the final rule (``What procedures must a
recognized accreditation body provide for appeals of decisions to
suspend, reduce the scope of, withdraw, or deny LAAF-accreditation?'')
We also have revised the section in the final rule to update cross-
references and to make minor editorial changes to improve clarity and
readability. Comments regarding this section are discussed below.
(Comment 73) Several comments support the proposed provision
describing the appeal procedures that a recognized accreditation body
must provide. Some comments state that ISO/IEC 17011:2017 does not
specify which accreditation body actions may be appealed, and thus
appreciate that the proposed rule would create appeal rights for
accreditation decisions. Some comments also support our proposed
requirement that an accreditation body's appeal procedures be written
and publicly available. Some comments mention that at least some
accreditation bodies already have internal appeals policies and
procedures, some of which meet our proposed requirements, and some
comments state that our proposed requirements describe the current
appeals practices of ILAC-MRA accreditation bodies.
However, some comments disagree with the proposed policy that would
render subordinates of the person who made the initial accreditation
decision ineligible to decide the appeal. These comments suggest bias
would be sufficiently avoided as long as the rule requires someone
different than the initial decision-maker to decide an appeal.
(Response 73) We appreciate the comments in support of the proposed
appeals procedures. Since publication of the proposed rule we have
learned that ISO/IEC 17011:2017 specifies which actions an accredited
laboratory may appeal within the definitions section of the standard.
ISO/IEC 17011:2017 definitions, section 3.21 defines ``appeal'' as:
``request by a conformity assessment body (3.4) for reconsideration of
any adverse accreditation decision (3.13) related to its desired
accreditation (3.1) status''. Section 3.13 then defines ``accreditation
decision'' as: ``decision on granting (3.14), maintaining (3.15),
extending (3.16), reducing (3.17), suspending (3.18) and withdrawing
(3.19) accreditation (3.1)'' (Ref. 2). We nevertheless specify the
actions a
[[Page 68773]]
LAAF-accredited laboratory may appeal in Sec. 1.1122 to maintain
consistency and clarity within the subpart.
Furthermore, we also have come to appreciate that the requirement
for a written and publicly available appeals procedure is required by
ISO/IEC 17011:2017 as follows: section 7.13.1 requires ``The
accreditation body shall have a documented process to receive, evaluate
and make decisions on appeals''; 8.2.1(b)(5) states that ``[t]he
accreditation body shall make publicly available . . . information on
procedures for lodging and handling complaints and appeals.'' (Ref. 2).
We are deleting from the final rule the requirement for a recognized
accreditation body to make its appeals procedure publicly available
because that requirement is already addressed by ISO/IEC 17011:2017.
Regarding the additional requirement in the proposed rule that
would prohibit subordinates of the person who made the initial
accreditation decision from hearing the appeal, we decline to remove
this requirement because subordinates are generally not free to
exercise authority that is fully independent of the supervisor, and are
to some extent under the control and influence of the supervisor.
Prohibiting subordinates from hearing the appeal will therefore better
ensure a fair and unbiased review.
(Comment 74) A few comments request clarification as to whether an
accredited laboratory can continue to conduct food testing under the
LAAF program while appealing a recognized accreditation body's
withdrawal of LAAF-accreditation. The comments opine that laboratories
should not be permitted to conduct testing under this subpart during
the appeal process.
(Response 74) We agree that laboratories should not be permitted to
conduct testing under this subpart during the appeal process.
Consistent with the intent of the proposed rule, the final rule
provides that if a recognized accreditation body withdraws the LAAF-
accreditation of a laboratory, the laboratory is immediately ineligible
to conduct food testing under this rule. If the recognized
accreditation body reduces the scope of LAAF-accreditation, the
laboratory is immediately ineligible to conduct food testing under this
rule with respect to the specific methods for which LAAF-accreditation
was withdrawn. See Sec. 1.1121(f)(2). The proposed rule would have
allowed LAAF-accredited laboratories to continue to conduct tests under
this subpart even if the recognized accreditation body had placed the
laboratory on what we then called ``probation'' (and now call
``suspension''). To align with how suspension is handled under ISO/IEC
17011:2017 (see, e.g., section 3.18 (Ref. 2)), the final rule provides
that a LAAF-accredited laboratory may not conduct food testing under
this subpart for any suspended methods. See Sec. 1.1121(f)(1).
Although the final rule requires the recognized accreditation body to
provide an appeals process for decisions to suspend, reduce the scope
of, or withdraw, LAAF-accreditation (Sec. 1.1122), pending such
appeal, the laboratory is still suspended, has had its scope reduced,
or has had its LAAF-accreditation withdrawn, and therefore cannot
conduct applicable testing under this subpart.
5. What reports, notifications, and documentation must a recognized
accreditation body submit to FDA (Sec. 1.1123)?
Proposed Sec. 1.1123 concerned reports and notifications a
recognized accreditation body must submit to FDA. Proposed paragraph
(a) of this section included the general requirements for all reports
and notifications under this subpart and specific recognized
accreditation body and LAAF-accredited laboratory identifying
information to be included as applicable. Proposed paragraph (b) of
this section described the internal audit reporting requirements for a
recognized accreditation body. Proposed Sec. 1.1123(c) required
immediate notification (within 48 hours) to FDA of the following:
changes that affect the recognition status of the accreditation body
and any LAAF-accreditation decisions such as granting, denying, or
withdrawing LAAF-accreditation, putting a LAAF-accredited laboratory on
probation, learning of a LAAF-accredited laboratory's intent to
voluntarily relinquish LAAF-accreditation, and awareness of LAAF-
accredited laboratory fraud. The proposed section included specific
information to be included with each item requiring immediate
notification.
On our own initiative, we revised the section title to read, ``What
reports, notifications, and documentation must a recognized
accreditation body submit to FDA?'' to more accurately reflect the
contents of the section in the final rule. We have revised subsection
(a) to remove the requirement to submit reports and notifications to
FDA electronically and in English; this requirement is now in Sec.
1.1110 of the final rule. We also revised paragraph (b) to specify
``calendar'' days. We have reorganized the section by the category of
information to be submitted (e.g., changes affecting recognition,
changes in LAAF-accreditation) and have made revisions to improve
clarity and readability, incorporate revised terminology, and update
cross-references. Also, in Sec. 1.1123(d) we have clarified that a
certificate reflecting the scope of accreditation must be submitted by
a recognized accreditation body within 48 hours of a change in LAAF-
accreditation (e.g., grant of LAAF accreditation, reduction in scope).
We note that there will not be such a certificate when the recognized
accreditation body denies LAAF-accreditation for all methods requested
by the laboratory. In that scenario, the recognized accreditation body
need only submit the information described in Sec. 1.1123(d)(2): (i)
The scope of LAAF-accreditation requested by the laboratory, (ii) the
scope of LAAF-accreditation denied, and (iii) the grounds for denial.
On further review of the proposed rule, we identified a potentially
duplicative notification regarding a laboratory relinquishing LAAF-
accreditation; under the proposed rule, the LAAF-accredited laboratory
would have to notify the recognized accreditation body and FDA 60 days
prior to relinquishing LAAF-accreditation. Additionally, proposed Sec.
1.1123(c)(4) required the recognized accreditation body to notify FDA
within 48 hours after it receives notice a LAAF-accredited laboratory
intends to relinquish LAAF-accreditation. We have clarified in the
final rule that the recognized accreditation body must only provide
notice to FDA if the laboratory has not provided notice to FDA 60
calendar days prior to relinquishment as required by Sec. 1.1140 (see
Sec. 1.1123(d)(3) of the final rule). For clarity and to align with
common conformity assessment terminology, in the final rule we
consistently use the verb, ``extend,'' rather than sometimes also using
the term, ``expand,'' to refer to the action of adding a method to the
scope of LAAF-accreditation. That change is reflected in paragraph
(d)(1)(iii) of Sec. 1.1123, (``the effective date of the . . .
extension''). We deleted the word ``alleged'' that appeared in Sec.
1.1123(c)(7)(ii) of the proposed rule so that the requirements related
to reporting laboratory fraud or false statements to FDA are internally
consistent and clearly communicate the requirements for submitting such
information; see Sec. 1.1123(e)(2) of the final rule. Finally, we have
clarified in Sec. 1.1123(d)(4)(iii) that notification of a reduction
of scope or withdrawal of LAAF-accreditation must include the
[[Page 68774]]
effective date. We have also made other conforming terminology and
minor editorial revisions in this section. Comments regarding this
section are discussed below.
(Comment 75) Proposed Sec. 1.1123 listed the reports and
notifications that a recognized accreditation body would be required to
submit to FDA and contained proposed timeframes for submission of the
reports and notifications. In Sec. 1.1123(b) we proposed that a
recognized accreditation body must submit results of an internal audit
to FDA no later than 45 days after completing the audit. Some comments
suggest we extend the deadline to 90 days, contending that 45 days may
be insufficient for the resolution of some corrective actions.
(Response 75) Although 45 days may be insufficient time for the
complete resolution of some corrective actions, we believe it is
sufficient time to complete the investigation required by the
corrective action process unless information is needed from an outside
source that is not within the control of the accreditation body.
Proposed Sec. 1.1123(b)(3) required a description of any corrective
action taken and any corrective action that the accreditation body will
take; this provision of the proposed rule acknowledged that
implementation or monitoring of a proposed corrective action may not
have been completed within 45 calendar days but expected that a
recommendation for a proposed corrective action should reasonably be
completed within the 45 calendar day window. Accordingly, we decline to
revise the final rule to extend the deadline to 90 calendar days.
(Comment 76) Section 1.1123(c)(1) proposed to require a recognized
accreditation body to immediately notify FDA if the recognized
accreditation body was aware of a change that would affect their
recognition under this subpart. Comments seek clarification of what we
meant by changes that would ``affect recognition.'' Some comments
suggest it would be clearer if we require recognized accreditation
bodies to submit to FDA reports resulting from evaluations of adherence
to ISO/IEC 17011:2017.
(Response 76) The preamble discussed specific examples of ``any
changes it is aware of that would affect its recognition'' as
referenced in 1.1123(c) of the proposed rule. The changes listed were
not exclusively those changes that would be included in the reports
resulting from evaluations of adherence to ISO/IEC 17011:2017. As
stated in the preamble to the proposed rule, some examples of changes
that affect recognition include, but are not limited to, ``changes in
the name or operations of a recognized accreditation body, such as the
purchase of a recognized accreditation body by a company, as well as
changes that would cause the recognized accreditation body to no longer
meet the requirements of this proposed program, including if the
recognized accreditation body ceases membership in ILAC or is no longer
a signatory of the ILAC MRA demonstrating competence to ISO/IEC
17011:2017'' (84 FR 59452 at 59471).
(Comment 77) In Sec. 1.1123(c)(2) through (7), we proposed to
require that a recognized accreditation body immediately notify FDA of
certain information related to the LAAF-accreditation status of
laboratories it LAAF-accredits or laboratories that have sought LAAF-
accreditation. Proposed Sec. 1.1123(c)(2) through (6) addressed
information related to accreditation or status (e.g., grants or denials
of accreditation). Proposed Sec. 1.1123(c)(7) addressed information
indicating that a LAAF-accredited laboratory committed fraud or
submitted to FDA a material false statement. We proposed a timeframe of
48 hours for a recognized accreditation body to notify FDA of
information covered by Sec. 1.1123(c)(2) through (7).
Some comments request clarification of when the 48-hour clock
starts for purposes of proposed Sec. 1.1123(c)(2) through (6);
comments ask whether the clock starts from the date the LAAF-
accreditation decision is made or the date the recognized accreditation
body issues the laboratory's certificate of LAAF-accreditation. These
comments state that there can be a lag between when the decision is
made and when the certificate is issued and appears on the
accreditation body's website. These comments recommend that the 48-hour
timeframe commence when the LAAF-accreditation certificate is issued to
the laboratory.
With regard to proposed Sec. 1.1123(c)(7), some comments familiar
with accreditation body practice explain that, if an accreditation body
is notified of potential fraud by an accredited laboratory, the
accreditation body would conduct a full investigation prior to deciding
whether to withdraw accreditation. According to these comments,
accreditation bodies may place laboratories on suspension until the
investigation is complete. The comments further state that the
suspension would be lifted if and when the accreditation body receives
evidence of ``sufficient corrective action'' from the laboratory and
conducts followup onsite visits.
(Response 77) We understand that some comments ask when the 48-hour
notification deadline starts in matters relating to LAAF accreditation.
To clarify, the 48-hour window begins when the recognized accreditation
body issues the certificate of LAAF-accreditation. Note that in the
final rule, we have clarified that within those 48 hours, the
recognized accreditation body must notify and submit to FDA the
certificate reflecting the scope of LAAF-accreditation (Sec.
1.1123(d)). When the recognized accreditation body denies LAAF-
accreditation for all methods requested by a laboratory, there is no
scope certificate, and the 48-hour notification window begins when the
recognized accreditation body makes the denial decision.
If a recognized accreditation body places a LAAF-accredited
laboratory on suspension while it investigates potential fraud, then
both the suspension and the fraud allegation would need to be reported
within 48 hours. Any further decision regarding withdrawal of LAAF-
accreditation or lifting of the suspension would in turn be an
additional change in the laboratory's accreditation status that would
trigger the 48-hour reporting requirement.
6. What are the records requirements for a recognized accreditation
body (Sec. 1.1124)?
Proposed Sec. 1.1124 concerned records requirements for recognized
accreditation bodies in addition to those required by ISO/IEC
17011:2017. Proposed Sec. 1.1124(a) required recognized accreditation
bodies to maintain electronically, for 5 years after the date of
creation, certain records related to compliance with this subpart,
including records regarding: Applications for LAAF-accreditation; LAAF-
accreditation decisions; appeals of adverse LAAF-accreditation
decisions; oversight of LAAF-accredited laboratories; oversight of the
recognized accreditation body's compliance with this subpart; reports,
notifications, and supporting documents required under this subpart;
and records of fee payments and direct costs. Records relating to a
recognized accreditation body's oversight of laboratories it has LAAF-
accredited include records of related to proficiency testing and
comparison programs (see Sec. 1.1138(a)(2)). Proposed Sec. 1.1124(b)
stated the requirement that a recognized accreditation body make
required records available to FDA upon request for copying and
inspection or electronically, if requested as such; the recognized
accreditation body would be
[[Page 68775]]
responsible for submitting an English translation of any records
maintained in another language. Proposed Sec. 1.1124(c) stated that a
recognized accreditation body must not prevent or interfere with FDA's
access to the records of the laboratories it LAAF-accredits.
We have updated the applicable section in the final rule to
incorporate revised terminology and to update cross-references. On our
own initiative, we made minor editorial changes to the section title to
read, ``What are the records requirements for a recognized
accreditation body?'' Additionally, we removed the word,
``electronically,'' from paragraph (a) to allow flexibility around how
recognized accreditation bodies maintain records. We revised paragraph
(a)(2) to specify that records of decisions to suspend or lift the
suspension of a LAAF-accredited laboratory must be maintained under
this section. We revised paragraph (a)(3) to reflect changes to Sec.
1.1122 of the final rule to incorporate each type of appeal. We also
removed the requirement in paragraph (b) to submit an English
translation of records electronically since that requirement is covered
by Sec. 1.1110 of the final rule. Also, as a result of the new
accommodation added to manage conflicts of interest associated with
contract assessor activities (see Sec. 1.1119(d) of the final rule),
we have added as a required record documentation demonstrating
compliance with the requirements for assessment activities by contract
assessors with certain financial interests described in Sec.
1.1119(d). See Sec. 1.1124(a)(8) of the final rule. Comments regarding
this section are discussed below.
(Comment 78) A few comments request that FDA specify those records
that are to be retained for 5 years, and caution that without a clear
list, accreditation bodies may be delayed in submitting the documents
to FDA. The comments suggest the following records be included in a
specific list of records subject to 5-year retention: 1. Assessment
report; 2. Corrective actions related to the assessment; 3. Complaints
records; 4. Dispute/appeals records; 5. Proficiency testing results.
(Response 78) Proposed Sec. 1.1124(a) lists the records that a
recognized accreditation body must maintain for 5 years and remains
unchanged in the final rule. We note that the recommended list aligns
with our proposed and final requirements.
7. What are the internal audit requirements for a recognized
accreditation body (Sec. 1.1125)?
Section 1.1125 of the proposed rule concerned internal audit
requirements for a recognized accreditation body, including the
requirements in ISO/IEC 17011:2017 and the requirement to audit
compliance with the additional requirements of this subpart for
recognized accreditation bodies. We received no comments directly
related to this section of the rule. On our own initiative, we revised
the section to update cross-references to reflect the reorganized
structure of the final rule and made minor revisions to improve clarity
and readability, including revising the section title (``What are the
internal audit requirements for a recognized accreditation body?'').
G. Comments Regarding FDA Oversight of Recognized Accreditation Bodies
Table 8--Changes to Sections Regarding FDA Oversight of Recognized
Accreditation Bodies
------------------------------------------------------------------------
Final rule Proposed rule Notes
------------------------------------------------------------------------
FDA Oversight of Recognized Procedures for Revised section
Accreditation Bodies. Recognized title to reflect
Accreditation revised
Bodies. terminology.
Sec. 1.1130 How will FDA Sec. 1.1130 How No changes to the
oversee recognized will FDA oversee section title.
accreditation bodies? recognized
accreditation
bodies?
Sec. 1.1131 When will FDA Sec. 1.1131 When Revised section
require corrective action, put will FDA revoke title to reflect
a recognized accreditation body the recognition opportunity for
on probation, or revoke the of an corrective action
recognition of an accreditation accreditation and to re-order
body? body or put a actions to match
recognized the section
accreditation contents.
body on
probation?
------------------------------------------------------------------------
1. How will FDA oversee recognized accreditation bodies (Sec. 1.1130)?
Proposed Sec. 1.1130 concerned FDA oversight of recognized
accreditation bodies to determine compliance with this subpart.
Proposed Sec. 1.1130(a) stated that FDA's evaluation of a recognized
accreditation body would occur by at least 4 years after the date of a
recognition for a 5-year term or by the mid-term point for a
recognition period less than 5 years. This section stated that FDA
oversight could include review of records, an onsite assessment of the
recognized accreditation body, and an onsite assessment of one or more
laboratories it LAAF-accredits, with or without the recognized
accreditation body present. Proposed Sec. 1.1130(b) reserved the right
of FDA to conduct additional evaluations of a recognized accreditation
body at any time to review compliance with this subpart.
Consistent with the discussion in Response 10, we have updated the
section to refer to FDA's actions as ``evaluations'' instead of
``assessments'' to further distinguish the role of FDA from that of a
recognized accreditation body. Additionally, we have made explicit that
FDA may conduct certain evaluation activities remotely if it will not
aid in the evaluation to conduct them onsite. We also restructured and
revised this section in the final rule to update terminology and to
make minor changes to improve clarity and readability. Comments
regarding this section are discussed below.
(Comment 79) Some comments agree that FDA should have the authority
to schedule onsite visits to observe recognized accreditation bodies,
but they contend FDA should not conduct such site visits unannounced.
In their view, it would be unproductive for FDA to make an unannounced
onsite visit to a recognized accreditation body, because recognized
accreditation bodies need notice to ensure staff will be there to
answer FDA questions about the program or else risk wasting Agency time
and resources. Comments also state that FDA may review accreditation
body records and reports remotely and thus would not gain any further
information from unannounced visits.
(Response 79) Onsite evaluations of accreditation bodies are one of
several tools we will use for LAAF program oversight. Flexibility to
conduct unannounced onsite evaluations will support program integrity
as there may be cases where such visits may be the only way the Agency
can be assured an accurate assessment of the situation. The Agency
recognizes that some personnel may be not be onsite and would
necessarily take this into account when planning unannounced visits. We
view this as a rare but necessary tool.
[[Page 68776]]
(Comment 80) A few comments recommend that it would be preferable
for FDA to evaluate a recognized accreditation body's program
performance by observing the accreditation body while they are
conducting an accreditation assessment for a laboratory. Similarly,
some comments recommend that FDA observe the ILAC peer evaluation of
accreditation bodies. In the view of these comments, FDA has the right
to review all aspects of the accreditation program at any time.
(Response 80) We appreciate these suggestions. As stated in the
proposed and final rule, we will make evaluations through a wide
variety of means and the recommended approaches could be used.
2. When will FDA require corrective action, put a recognized
accreditation body on probation, or revoke the recognition of an
accreditation body (Sec. 1.1131)?
Proposed Sec. 1.1131 concerned FDA revocation of recognition and
probation of a recognized accreditation body. Proposed Sec. 1.1131(a)
and (b) stated the grounds and process for revocation of recognition;
FDA would revoke recognition if the accreditation body failed to meet
the requirements of this subpart or if FDA determined the accreditation
body committed fraud or submitted material false statements to FDA. The
proposed process for revocation of recognition included issuance of a
notice with a statement of the grounds for revocation and the
procedures for requesting a hearing or reinstatement of recognition as
well as the requirement for an accreditation body to provide a records
point of contact for provision of records once the accreditation body
is no longer recognized. Proposed Sec. 1.1131(c) stated that FDA may
place a recognized accreditation body on probation if there are
deficiencies that are less serious and more limited than those for
revocation and the deficiencies are reasonably likely to be corrected
within a reasonable amount of time. Under paragraph (d) of this
proposed section, we stated that probation would remain in effect until
the identified deficiencies are sufficiently addressed or until FDA
revokes recognition. Proposed Sec. 1.1131(e) stated the procedures for
probation and proposed paragraph (f) stated the effect of probation or
revocation: an accreditation body that has had its recognition revoked
may not LAAF-accredit laboratories or continue to oversee the
laboratories it has LAAF-accredited; a recognized accreditation body on
probation would be expected to continue to oversee the laboratories it
has LAAF-accredited and permitted to continue to LAAF-accredit
laboratories. Paragraphs (g) and (h) of this section stated that FDA
would notify impacted LAAF-accredited laboratories of the probation or
revocation of recognition of the accreditation body that LAAF-accredits
the laboratory and that FDA would provide notice on the public website
described in proposed Sec. 1.1109.
We have revised the section title of the final rule to more
accurately reflect the contents of the revised section, to read as
``When will FDA require corrective action, put a recognized
accreditation body on probation, or revoke the recognition of an
accreditation body?'' We also clarify in Sec. 1.1131(d)(1) of the
final rule that in the revocation of recognition procedures, FDA's
notice will include the date on which the revocation is effective. We
have revised the section to incorporate revised terminology and to
update cross-references. We have made several changes in response to
comments, discussed below.
(Comment 81) A few comments assert that it is not a usual
conformity assessment practice to place an accreditation body on
``probation'' (proposed Sec. 1.1131(c), (g), and (h)), especially if
the accreditation body has only demonstrated deficiencies in matters
that are less serious and do not raise concerns about the accreditation
decisions of the accreditation body. These comments also state that
public notice of probationary status, if done without adequate
justification, may be undeserved and could potentially damage both the
accreditation body and the LAAF program. We understand these comments
to be expressing the concern that if the registry indicates an
accreditation body is on probation, such a characterization could cause
harm to the accreditation body's reputation and business interests.
Further, such comments express the view that if probation was
undeserved, such harm would be unwarranted. We further understand these
comments to be expressing that accreditation bodies may hesitate to
participate in this program if they are concerned that they may be
characterized unfairly on the registry. Similarly, a few comments
recommend that FDA provide an accreditation body with an opportunity to
take corrective action before FDA revokes recognition. These comments
argue that revocation of an accreditation body's recognition without
first providing such an opportunity would adversely impact both the
accreditation body and the laboratories it LAAF-accredits and would
represent a ``very aggressive approach.''
(Response 81) We agree that it is appropriate to afford a
recognized accreditation body the opportunity to take corrective action
prior to putting the recognized accreditation body on probation and
notifying the public. We have revised Sec. 1.1131 to reflect this
position. Although the opportunity for corrective action and probation
may be appropriate prior to revocation of recognition, we maintain that
some circumstances warrant more immediate revocation of recognition. As
described in the proposed and final rule, circumstances that may
warrant immediate revocation of recognition include failure to meet the
requirements of the subpart or a determination that the recognized
accreditation body has committed fraud or submitted material false
statements to FDA.
(Comment 82) A few comments request that we clarify exactly when a
recognized accreditation body will be placed in probationary status.
(Response 82) We understand from various comments that
``probation'' is not a status term typically utilized in the conformity
assessment arena. We intend the status to be an intermediary step after
corrective action and before we proceed to revoke our recognition of an
accreditation body.
As revised, Sec. 1.1131 provides that if FDA identifies a
deficiency, utilizes the recognized accreditation body's complaint
process (under ISO/IEC 17011:2017 section 7.12), but determines that
the corrective action (under ISO/IEC 17011:2017 section 9.5) is not
acceptable, we may place the accreditation body on probation. Section
1.1131(b) states that probation may be appropriate when FDA determines
that a recognized accreditation body, ``has not effectively implemented
corrective action or otherwise fails to address deficiencies
identified.''
Under Sec. 1.1131(b)(1), FDA will notify the recognized
accreditation body that it is on probation, will provide the grounds
for the probation, and list all deficiencies that must be corrected.
Note that under Sec. 1.1131(b)(2), probationary status will be
reflected on the online registry described in Sec. 1.1109.
Probationary status will endure until either FDA is satisfied with the
recognized accreditation body's corrective actions or FDA revokes the
recognition under Sec. 1.1131(c) and (d).
H. Comments on LAAF-Accreditation of Laboratories
[[Page 68777]]
Table 9--Changes to Sections Regarding LAAF-Accreditation of
Laboratories
------------------------------------------------------------------------
Final rule Proposed rule Notes
------------------------------------------------------------------------
LAAF-Accreditation of Accreditation of Revised to reflect
Laboratories. Laboratories. new terminology.
Sec. 1.1138 What are the Sec. 1.1138 What Combined sections
eligibility requirements for a requirements must in the final
LAAF-accredited laboratory? a laboratory meet rule.
to become
accredited by a
recognized
accreditation
body?
Sec. 1.1146 What
are the general
requirements for
accredited
laboratories to
remain
accredited?.
Sec. 1.1139 How does a Sec. 1.1159 How Relocated section,
laboratory apply for LAAF- does a laboratory revised section
accreditation or extend its apply for title to
scope of LAAF-accreditation? accreditation or incorporate new
modification of terminology and
its scope of improve clarity.
accreditation by
a recognized
accreditation
body?
Sec. 1.1140 What must a LAAF- Sec. 1.1163 What Relocated the
accredited laboratory do to if a laboratory section, revised
voluntarily relinquish its LAAF- wants to section title to
accreditation? voluntarily incorporate new
relinquish its terminology and
accreditation? improve clarity.
Sec. 1.1141 What is the effect Sec. 1.1164 What Relocated the
on a LAAF-accredited laboratory is the effect on section, revised
if its recognized accreditation accredited section title to
body is no longer recognized by laboratories if incorporate new
FDA? their terminology and
accreditation improve clarity.
body voluntarily
or involuntarily
loses its
recognition?
Sec. 1.1142 How does a Sec. 1.1165 How Relocated the
laboratory request does a laboratory section, revised
reinstatement of LAAF- request section title to
accreditation? reinstatement of incorporate new
accreditation? terminology.
------------------------------------------------------------------------
1. What are the eligibility requirements for a LAAF-accredited
laboratory (Sec. 1.1138)?
In proposed Sec. 1.1138 we stated the baseline requirements for a
laboratory to participate in the LAAF program. In paragraph (a)(1)(i)
we proposed that a laboratory must demonstrate to a recognized
accreditation body that a laboratory is capable of conducting the
method(s) it wishes to perform under this subpart by submitting
information to demonstrate appropriate verification or validation of
each method. In paragraph (a)(1)(ii) we proposed that a laboratory must
annually pass a proficiency test (or comparison program, where no
proficiency test is available or practicable) for each method. In
paragraph (a)(2) we proposed that a laboratory must be accredited to
ISO/IEC 17025:2017 and we incorporated that standard by reference; in
paragraph (b) we proposed to except certain provisions of ISO/IEC
17025:2017. In paragraph (c) we proposed that a laboratory must
demonstrate it is capable of meeting and operating in conformance with
all other requirements for laboratories under this subpart.
On our own initiative, we made some organizational changes. The
proposed title for the section was, ``What requirements must a
laboratory meet to become accredited by a recognized accreditation
body?'' We proposed a separate section, Sec. 1.1146, to address the
requirements for accredited laboratories to remain accredited. There
was significant overlap between the two sections. To improve efficiency
and readability, we combined Sec. 1.1146 with this section and made
certain editorial changes to effect the merge, including revising the
section title to read, ``What are the eligibility requirements for a
LAAF-accredited laboratory?''
Proposed Sec. 1.1148 addressed quality assurance requirements for
LAAF-accredited laboratories. Proposed Sec. 1.1148(a) required, in
brief, annual proficiency testing for each method. Proposed Sec.
1.1148(b) required a LAAF-accredited laboratory to ``[e]nsure its
procedures for monitoring the validity of the results of testing it
conducts under this subpart include the use of reference materials or
quality control samples with each batch of samples it tests under this
subpart.'' There was significant overlap between the proficiency test
provisions in proposed Sec. 1.1138(a)(1)(ii) and those in Sec.
1.1148(a). For clarity and efficiency, we merged the proficiency test
content from proposed Sec. 1.1148(a) into what is now Sec.
1.1138(a)(2) of the final rule. We also moved to this section the
requirement for laboratory quality assurance procedures to include the
use of reference materials or quality control samples with each batch
of samples tested under this subpart, because we view these tools as
vital to a laboratory's demonstration of capability to conduct a
method. (Relatedly, we have added quality control results to the
required contents of an abridged analytical report; see the discussion
of Sec. 1.1153(c)(2), below.)
Also, as explained in our discussion of Sec. 1.1101 above, we
moved the language formally incorporating ISO/IEC 17025:2017 from this
section to Sec. 1.1101. Finally, we made conforming and minor
editorial changes, including specifying calendar days in Sec.
1.1138(a)(2)(iii) (this requirement appeared in Sec. 1.1153(b) of the
proposed rule and did not specify ``calendar'' days). We discuss
additional changes to the section made in response to comments below.
(Comment 83) Some comments inquire about the laboratory standards
we are establishing in this final rule. Some ask which criteria should
be set. A few comments appear to ask how FDA would determine which of
the many existing food testing laboratories satisfy the standards we
are establishing.
Some comments encourage us to ensure that all laboratory
requirements are clear and concise. Other comments urge FDA to avoid
what they perceive as vague and ambiguous phrases such as ``strongly
encourage'' and instead to use clearer language such as ``must.''
(Response 83) The laboratory standards we are establishing are
contained in this final rule, specifically in Sec. Sec. 1.1138 through
1.1142. We agree that clear and concise requirements will benefit the
LAAF program and we have done our best to achieve that goal. The task
of determining which laboratories satisfy our requirements is the
responsibility of the recognized accreditation bodies which will assess
laboratories against our standards.
In the proposed rule, after stating that we would not propose to
require the accreditation of sampling, we said that we ``strongly
encourage all samplers to consider accreditation'' 84 FR 59452 at
59476. When we use such language, we do not intend to state a
requirement, nor do we create any obligation. Only the codified section
of a rule becomes the regulation. The preamble discussion
[[Page 68778]]
represents our current thinking on the matters addressed in the text of
the regulation.
(Comment 84) In the proposed rule, a laboratory would be required
to demonstrate it is capable of conducting each method it wishes to use
in food testing under this subpart by submitting verification or
validation information to a recognized accreditation body, as well as a
statement that the laboratory was able to properly apply the method.
The proposed rule would also have required a laboratory to pass a
proficiency test (or comparison program when no proficiency testing is
available or practicable) for each method it wishes to use to conduct
food testing under this subpart once per year. Some comments express
support for these requirements. Some comments state that these
requirements are similar to existing ISO/IEC 17025:2017 requirements.
(Response 84) We are gratified that several comments support these
requirements.
We agree that these requirements are similar to provisions in ISO/
IEC 17025:2017. With regard to validation and verification information,
ISO/IEC 17025:2017 requires a laboratory to submit to the accreditation
body verification or validation information on each method for which it
is seeking accreditation. Our requirement would accomplish the same.
However, although the validation information we require a laboratory to
send to a recognized accreditation body aligns with information
required in ISO/IEC 17025:2017, we specify (in Sec. 1.1151(d)(2)) the
verification information in greater detail than does ISO/IEC 17025:2017
(Ref. 3).
At the same time, as discussed above at Response 10, after careful
consideration of the comments we are clarifying in this subpart the
roles of the FDA and recognized accreditation bodies with respect to
LAAF-accredited laboratories. Consistent with our clarified role of
reviewing the performance of LAAF-accredited laboratories via
individual analytical reports, we have determined that it is
appropriate for LAAF-accredited laboratories to submit the verification
and validation studies relevant to their analytical reports to FDA (see
Sec. 1.1152(c) and discussion at Response 122). This change means FDA
will receive the more detailed verification information that, under the
proposed rule, we would have required a laboratory to send to the
recognized accreditation body. Given that the specified verification
information will be submitted to FDA, we are comfortable removing the
requirement that it be submitted to the recognized accreditation body.
Having resolved that difference between proposed Sec.
1.1138(a)(1)(i) and ISO/IEC 17025:2017, there remains no substantive
difference between the two standards with regard to the validation and
verification information to be submitted to an accreditation body.
Accordingly, we have removed from the final rule the provision in
proposed Sec. 1.1138(a)(1)(i) requiring laboratories to send
validation or verification information to the recognized accreditation
body and will rely on ISO/IEC 17025:2017 for that requirement.
With regard to the proposed requirement that a laboratory pass a
proficiency test for each method (or a comparison program, where no
proficiency test is available or practicable) ``once per year,'' the
provision in ISO/IEC 17025:2017 is similar. Section 7.7.2 of ISO/IEC
17025:2017 requires a laboratory to monitor its performance by engaging
in either proficiency testing or interlaboratory comparisons but does
not indicate a frequency (Ref. 3). We remain committed to the frequent
nature of this requirement and therefore the final rule requires that a
LAAF-accredited laboratory must successfully pass a proficiency test
(or where one is not available or practicable, a comparison program)
for each LAAF-accredited method at least once every 12 months. For
additional discussion of the proficiency testing requirements under
this subpart, see Responses 92-94, below.
(Comment 85) Some comments support the proposed policy that LAAF-
accreditation should be awarded on a method-by-method basis. In fact,
some comments consider method-specific LAAF-accreditation so important
that they suggest we communicate that requirement more clearly in the
final rule. Some comments encourage us to clarify the use of open or
flexible scopes under this subpart.
(Response 85) We agree that it is essential that the competency of
laboratories be assessed, and LAAF-accreditation awarded, on a method-
specific basis. Test methods vary widely and even within the same
discipline, competence to one method does not correlate or imply
competence to another method. Further, laboratory competence to the
particular method employed is integral to the validity of the test
result. Accordingly, we accept the suggestion in the comments
summarized above and have revised Sec. 1.1138 to include ``each
method'' in paragraph (a) and (a)(1).
ISO/IEC 17011:2017 defines a flexible scope (sometimes referred to
as an open scope), as a ``scope of accreditation . . . expressed to
allow [laboratories] to make changes in methodology and other
parameters which fall within the competence of the [laboratory] . . .
as confirmed by the accreditation body.'' (ISO/IEC 17011:2017 section
3.7, (Ref. 2)). Flexible scopes can have flexibility for analytes,
matrices, and methods. ISO/IEC 17011:2017 requires accreditation bodies
to have written procedures describing how the accreditation body will
administer flexible scopes. As relevant to this discussion, these
written procedures must include a description of how the accreditation
body will maintain for the laboratories they LAAF-accredit certificates
of scope that include matrix (materials or products); analyte(s)
(component, parameter or characteristic); and method or technology
(Ref. 2).
An open or flexible scope is employed when an accreditation body
assesses a laboratory's competency in using a particular technology or
technique. Once the laboratory proves that competency, it is able to
add methods, analytes, or matrices to its scope without the need for an
additional assessment by the accreditation body as long as those
additions fall within the broader scope of the accredited technology
and meet the requirements of ISO/IEC 17025:2017.
Given that ISO/IEC 17011:2017 requires accreditation bodies to
maintain certificates of accreditation that communicate which analytes,
matrices, and methods are covered by the flexible scope, and Sec.
1.1123(c)(2) requires that a recognized accreditation body must
immediately notify FDA when it grants or extends a laboratory's LAAF-
accreditation, we are prepared to accommodate open or flexible scopes
under this subpart.
(Comment 86) We proposed in Sec. 1.1138(a)(2) that, as a baseline
matter, laboratories wishing to conduct testing under this subpart must
be accredited to ISO/IEC 17025:2017, and we proposed to incorporate
ISO/IEC 17025:2017 by reference into our regulation. We proposed in
Sec. 1.1138(b) to exclude three portions of ISO/IEC 17025:2017 from
the incorporation by reference, and from the requirements under this
subpart. First, we proposed to exclude provisions of ISO/IEC 17025:2017
that relate to the relationship between the laboratory and its
customers, to the extent that such provisions establish obligations
that conflict with the requirements of this subpart. Second, we
proposed to exclude section 7.3
[[Page 68779]]
because, we reasoned, it addresses sampling and we did not propose to
require the accreditation of samplers. Finally, we proposed to exclude
section 7.8, which describes requirements for reporting test results to
customers, based on a concern that it might conflict with the test
reporting requirements in this subpart (Ref. 3).
Many comments support the baseline laboratory requirement of
accreditation to ISO/IEC 17025:2017. Some comments commend the use of
this standard, noting that it may be a means to improve the quality of
tests, and is accepted globally. Some comments maintain that
accreditation to ISO/IEC 17025:2017 increases confidence in a
laboratory's data. Some comments indicate that many laboratories that
test imported food have already sought ISO/IEC 17025:2017 accreditation
voluntarily to improve the quality of their test results. Some comments
assert that conformance to ISO/IEC 17025:2017 helps ensure scientific
integrity in food testing. Some comments state that relying on ISO/IEC
17025:2017 accreditation will be more efficient for FDA. A few comments
express the belief that all private laboratories should be required to
be ISO/IEC 17025:2017-accredited.
A few comments agree that ISO/IEC 17025:2017 is currently the
predominant standard for the type of laboratory that would conduct
testing under this subpart, but encourage FDA to allow more
flexibility, stating that over time ISO/IEC 17025:2017 might become
less predominant.
Some comments encourage FDA to rely solely and entirely on ISO/IEC
17025:2017; we understand these comments to discourage us from adding
any additional requirements or varying at all from ISO/IEC 17025:2017.
(To the extent that some comments reference ISO/IEC 17065, which is a
conformity assessment standard for bodies that certify products, that
standard does not apply here.) These comments express preference for a
single uniform accreditation standard and contend that varying
standards can present challenges both to laboratories attempting to
maintain multiple differing accreditation schemes and to their
customers. Some comments state a risk that variations in standards,
even different standards based on ISO/IEC 17025:2017, may result in a
need for laboratories to be accredited by more than one accreditation
body, and encourage FDA to reduce or eliminate redundant
accreditations. Some comments encourage FDA to work with leading
standard and scientific organizations so that the various standards
align and have scientific integrity.
With regard to the ISO/IEC 17025:2017 sections that we proposed to
exclude from our requirements, some comments support some or all the
exclusions. Some of these comments agree with our proposal not to
require the accreditation of samplers and express consequent support
for the exclusion of ISO/IEC 17025:2017 section 7.3, which addresses
sampling. Some comments concur with our proposed exclusion of customer-
related ISO/IEC 17025:2017 provisions, but disagree with the proposed
exclusions related to sampling and reporting results because these
comments state the belief that FDA should require the accreditation of
samplers and better align its reporting requirements with those of ISO/
IEC 17025:2017.
On the other hand, many comments encourage us not to exclude
certain or any ISO/IEC 17025:2017 provisions. Some comments
specifically suggest that we include ISO/IEC 17025:2017 requirements
related to customers, as owners and consignees under this rule could be
considered the customers of LAAF-accredited laboratories. Some of these
comments disagree that the provisions we proposed to exclude conflict
with the requirements in this subpart, and suggest that even if they
do, any conflicts can be effectively addressed without excluding ISO/
IEC 17025:2017 provisions.
Relatedly, some comments state that adherence to certain
requirements contained in ISO/IEC 17025:2017 is required only by
specific customers; these comments request that we clarify who is the
customer of a LAAF-accredited laboratory (i.e., FDA or the owner or
consignee). These comments also ask whether ISO/IEC 17025:2017
requirements with which the customer requires adherence will apply to
State laboratories that become LAAF-accredited.
A few comments express the belief that documents can be developed
to supplement ISO/IEC 17025:2017 accreditation, and that such documents
would cover the additional requirements codified in this subpart. Some
comments argue that excluding certain parts of the ISO/IEC 17025:2017
standard from our requirements while still labeling a laboratory,
``accredited,'' would cause confusion and would conflict with
established business and operational models in laboratories fully
compliant with ISO/IEC 17025:2017. Similarly, some comments request
that FDA require ISO/IEC 17025:2017 as a baseline matter, and then
indicate additional requirements to clarify or expand upon the
standard. Comments also state that FDA should stay current with any
changes to ISO/IEC 17025:2017.
(Response 86) We remain committed to ISO/IEC 17025:2017 as a
baseline requirement for laboratories that wish to conduct food testing
under this subpart. Many comments agree with that aspect of the
proposed rule and identify various benefits of this policy such as
improved test quality; greater scientific integrity; and global
acceptance of, and increased confidence in, the test results. We
concur. As described in the FRIA (Ref. 4), we also agree that FDA will
experience certain efficiencies as a result of this rule. And while we
encourage all food testing laboratories to consider becoming accredited
to ISO/IEC 17025:2017, we lack the authority to compel such action.
Regarding the possibility that ISO/IEC 17025:2017 may not always be
the predominant standard for food testing laboratories, we are
confident that ISO/IEC 17025:2017 will be an appropriate baseline for
the foreseeable future. Other parts of FDA, and many other Federal
Agencies, also rely on ISO/IEC 17025:2017 to establish baseline
requirements for their laboratory accreditation programs (e.g., FDA
Center for Devices and Radiological Health Accreditation Scheme for
Conformity Assessment, CPSC, Department of Defense Environmental
Laboratory Program). Every time ISO/IEC updates the 17025 standard, we
will consider whether to update this subpart (through notice-and-
comment rulemaking) to require accreditation to the updated standard.
If during those considerations we conclude that ISO/IEC 17025:2017 is
no longer an appropriate baseline for our requirements, we will revise
this subpart accordingly (through notice-and-comment rulemaking).
Some comments encourage us to simply rely on ISO/IEC 17025:2017 and
neither add nor subtract any requirements. Comments advocating that we
not add requirements to ISO/IEC 17025:2017 discuss the advantages of a
uniform standard. We do not discount those advantages or the challenges
that laboratories face in satisfying varying accreditation schemes.
Nevertheless each laboratory requirement that we add to the ISO/IEC
17025:2017 baseline serves an important program purpose. For example,
requiring successful proficiency tests for each method at least every
12 months (Sec. 1.1138(a)(2)) provides increased quality assurance,
and requiring at least the creation and retention of the records that
comprise a full analytical report will preserve FDA's ability to
conduct a meaningful
[[Page 68780]]
indepth scientific review of the test (Sec. Sec. 1.1150(d),
1.1154(a)(2)). As a reminder, all the food testing that takes place
under this subpart occurs in the context of heightened public health
concern. Laboratories that wish to conduct food testing under this
subpart will be required to satisfy requirements in addition to those
specified in ISO/IEC 17025:2017 (Ref. 3).
After carefully considering the comments, we have decided not to
exclude any provisions of ISO/IEC 17025:2017. Comments successfully
argued that our proposed exclusions would unnecessarily complicate the
work of the recognized accreditation bodies and LAAF-accredited
laboratories and provide limited benefit. We also appreciate the
comments remarking that market confusion could result from our
exclusion of portions of ISO/IEC 17025:2017 while labeling laboratories
``accredited.'' Although we doubt our proposed exclusion of a small
number of ISO/IEC 17025:2017 provisions would result in a need for
duplicative accreditation body assessments, we need not belabor that
issue raised in the comments, given our decision.
In particular, we are persuaded that we do not need to formally
exclude from our regulation ISO/IEC 17025:2017 section 7.3, which
addresses sampling, even though we are not requiring sampling
accreditation (Ref. 3). Section 7.3 is not necessary to ISO/IEC
17025:2017 accreditation. Indeed, many laboratories are accredited to
ISO/IEC 17025 for diverse types of methods and yet not for sampling.
When a recognized accreditation body assesses a laboratory for LAAF-
accreditation, the recognized accreditation body may simply note
section 7.3 as not applicable.
We also proposed to exclude any provisions of ISO/IEC 17025:2017
that relate to the relationship between the laboratory and its
customer, to the extent that the provision would conflict with the
requirements of this subpart. For example, in the preamble to the
proposed rule we expressed concern that including ISO/IEC 17025:2017
section 7.2.1.4, which indicates that the customer may specify the test
method, could create a conflict for the laboratory (see 84 FR 59452 at
59477 to 59478). We are now convinced that provisions of ISO/IEC
17025:2017 that mention the customer do not conflict with obligations
under this subpart because under ISO/IEC 17025:2017, ``customer'' has a
broader meaning than simply the entity who pays the laboratory, and FDA
qualifies as a customer alongside the owner or consignee that engages
the laboratory (Ref. 3). We appreciate comments noting that the owners
or consignees are customers and we should therefore not exclude the
ISO/IEC 17025:2017 customer provisions on that basis. We agree that
owners and consignees are appropriately considered customers of the
laboratory and appreciate that under this subpart, LAAF-accredited
laboratories will fulfill their obligations to owners and consignees,
as well as their obligations to FDA. This is ensured by the requirement
in ISO/IEC 17025:2017 section 5.4 that ``Laboratory activities shall be
carried out in such a way as to meet the requirements of this document,
the laboratory's customers, regulatory authorities and organizations
providing recognition'' (Ref. 3). Regarding the question of whether
state or other public laboratories that become LAAF-accredited will be
bound by the customer provisions in ISO/IEC 17025:2017, we confirm that
they will. The many public laboratories that are or will become ISO/IEC
17025:2017-accredited are required to meet the same requirements of
ISO/IEC 17025:2017 as private laboratories, including both customer
provisions and the requirements of section 5.4.
Finally, we proposed to exclude ISO/IEC 17025:2017 section 7.8,
which addresses reports, based on a concern that it would conflict with
the reporting requirements under this subpart. Again, we have come to
appreciate that a laboratory's reporting duties under ISO/IEC
17025:2017 do not present any conflict for the laboratory also
fulfilling the reporting requirements under this subpart (Ref. 3).
Accordingly, the final rule incorporates ISO/IEC 17025:2017 in its
entirety.
(Comment 87) Some comments recommend that FDA allow the bottled
drinking water tests in Sec. 1.1107(a)(1)(iii) (i.e., the requirement
in Sec. 129.35(a)(3)(i) to test five samples from the same sampling
site that originally tested positive for E. coli) to be conducted by
laboratories certified or accredited to other water-related laboratory
accreditation or oversight programs such as the National Environmental
Laboratory Accreditation Program, or EPA or State water testing
certification programs. From the perspective of these comments, the EPA
and State water testing certification programs are an existing
laboratory oversight system and FDA should leverage those
certifications, in place of LAAF-accreditation, for purposes of the
bottled drinking water testing subject to this final rule. These
comments predict that if we fail to do so, an insufficient number of
laboratories will become LAAF-accredited to conduct the bottled
drinking water testing required by Sec. 1.1107(a)(1)(iii). Relatedly,
these comments disagree with our proposed conforming revision in the
bottled drinking water regulations. Instead of revising the bottled
drinking water regulation to require that the testing required in Sec.
129.35(a)(3) be conducted under this subpart, these comments recommend
that the bottled drinking water regulations be revised to require that
the testing in Sec. 129.35(a)(3) be conducted by a competent
commercial water testing laboratory that is EPA or State-certified for
E.coli testing and sends the results directly to FDA.
(Response 87) For a variety of reasons, we decline this request.
First, FDA lacks the authority under section 422 of the FD&C Act to
directly accredit laboratories or otherwise approve them to conduct the
food testing described in Sec. 1.1107. FSMA section 202 directed that
FDA recognize accreditation bodies, establish standards for
laboratories, and create a public registry of recognized accreditation
bodies and LAAF-accredited laboratories (section 422(a)(1)(b) and
(a)(6) of the FD&C Act). FSMA section 202 describes only the recognized
accreditation bodies as having the ability to accredit a laboratory
(see, e.g., section 422(a)(1)(B), (a)(2), (a)(5), (a)(6), and (b)(1) of
the FD&C Act). In contrast, FSMA section 307 directed FDA to establish
a very similar program: ``a system for the recognition of accreditation
bodies that accredit third-party auditors'' \9\ (Section
808(b)(1)(A)(i) of the FD&C Act). However FSMA section 307 specifically
granted FDA authority to directly accredit third-party auditors if, 2
years after establishing the required system, FDA had not recognized an
accreditation body (section 808(b)(1)(A)(ii) of the FD&C Act). As
Congress specifically provided FDA with authority to directly accredit
third-party auditors in FSMA section 307, we presume their decision not
to provide FDA with similar authority in FSMA section 202 was
intentional. Accordingly, we lack the authority to directly accredit or
otherwise approve laboratories for inclusion in the LAAF program
generally or the public registry in particular.
---------------------------------------------------------------------------
\9\ Under that authority we issued the ``Accreditation of Third-
Party Certification Bodies To Conduct Food Safety Audits and To
Issue Certifications Final Rule,'' 80 FR 74569 (Nov. 27, 2015) which
established the Accredited Third-Party Certification Program (see
https://www.fda.gov/food/importing-food-products-united-states/accredited-third-party-certification-program).
---------------------------------------------------------------------------
The only way a laboratory may conduct the food testing described in
[[Page 68781]]
Sec. 1.1107, then, is through a favorable assessment by a recognized
accreditation body. In conducting such an assessment, a recognized
accreditation body assesses the laboratory against the model laboratory
standards we are creating in this final rule. Theoretically we could
tailor our model standards to allow for sector-specific standards, if
we were confident that those sector-specific standards provided equal
rigor and public health protections. For example, theoretically we
could allow laboratories that conduct the testing described in Sec.
1.1107(a)(1)(iii) to substitute our laboratory requirements based on
accreditation to ISO/IEC 17025:2017 with a sector-specific
accreditation standard such as the standard of the National
Environmental Laboratory Accreditation Program, or the standard of the
EPA water testing certification programs. However, FDA lacks the
resources to perform indepth comparisons of various program standards,
whether related to bottled drinking water or any other sector, with
ISO/IEC 17025:2017 and the remainder of our requirements. Indeed, a
prime advantage of relying on an international voluntary consensus
standard for our baseline requirement is uniformity. ISO/IEC 17025:2017
is a single standard that addresses technical competency and quality
management universally; its requirements mean the same thing in every
country and context in which it is used. For those practical and
philosophical reasons, we decline the comments' suggestion that we
allow bottled drinking water sector-specific laboratory standards in
place of the model laboratory standards established in this subpart.
In declining this suggestion, we offer a few additional notes. To
the extent a sector-specific standard is also based on ISO/IEC
17025:2017, it should not be difficult or costly for a laboratory
accredited to such a sector-specific standard to become LAAF-
accredited. Further, the tests described in Sec. 1.1107(a)(1)(iii)
(and methods deemed acceptable under Sec. 129.35(a)(3)(ii)) involve
analyzing water for the presence of E. coli, which is not an uncommon
capability among food laboratories accredited to biological methods.
Meanwhile, we estimate that there will be one testing occasion per year
resulting in five separate tests under Sec. 1.1107(a)(1)(iii). (Ref.
4). We therefore believe it is reasonable to anticipate sufficient
capacity among LAAF-accredited laboratories to handle the bottled
drinking water testing covered by this final rule.
(Comment 88) Some comments describe the positive features of the
American Association of Veterinary Laboratory Diagnosticians (AAVLD)
laboratory accreditation standard. These comments state that results
from AAVLD laboratories are accepted by Federal Agency laboratory
networks focused on disease surveillance, and that AAVLD laboratories
already perform research and emergency response work for FDA. These
comments further state that the AAVLD standard is aligned with ISO/IEC
17025:2017.
(Response 88) AAVLD-accredited laboratories play a critical role in
FDA programs. Many of the veterinary diagnostic laboratories that are
part of FDA's Veterinary Laboratory Investigation and Response Network
(Vet-LIRN) are AAVLD-accredited. Vet-LIRN laboratories enhance public
health by providing testing of food and animal feed products for
zoonotic pathogens. These laboratories also perform pathogen and
chemical toxin testing in response to foodborne and animal
feed[hyphen]associated illnesses. Vet[hyphen]LIRN laboratories respond
to requests for testing as directed by FDA resulting from consumer
complaints, and participate in surveillance studies, method development
activities, and proficiency tests. These laboratories primarily analyze
animal samples (e.g., stool, urine, blood, tissue) and nonregulatory
animal food samples (e.g., leftover opened foods and feed) to help
FDA's Center for Veterinary Medicine (CVM) investigate potential
problems with CVM-regulated products (such as animal feeds or animal
drugs). Use of a LAAF-accredited laboratory is required for those tests
described in Sec. 1.1107, but the vast majority of the analyses
performed as part of the Vet-LIRN do not fall under Sec. 1.1107.
Accordingly, it is not necessary for laboratories participating in the
Vet-LIRN to become LAAF-accredited.
To the extent that an AAVLD-accredited laboratory wishes to
participate in the food testing described in Sec. 1.1107, it would
need to meet all the requirements for a LAAF-accredited laboratory in
this subpart. For reasons discussed above in Response 87, FDA cannot
admit laboratories meeting other standards into this program. The only
way a laboratory may become LAAF-accredited is through a favorable
assessment by an accreditation body recognized under this subpart. That
construct does not comport with the structure of the AAVLD laboratory
accreditation program. AAVLD laboratory accreditation is awarded by
AAVLD itself, following an assessment by a committee of laboratory
professionals from other AAVLD laboratories. However, AAVLD is not an
ILAC-MRA signatory accreditation body that comports with ISO/IEC
17011:2017. Accordingly, it is not eligible for recognition under this
subpart.
Moreover, our analysis of the AAVLD standard indicates that
although the AAVLD standard is aligned with ISO/IEC 17025:2017,
differences remain. For example, the AAVLD standard is designed to
assess the laboratory as a whole, rather than particular testing
methods. Also, the AAVLD reassessments occur at least once every 5
years, whereas ISO/IEC 17011:2017 section 7.9.3 requires that
laboratories be reassessed at least every 2 years (Ref. 2).
For the foregoing reasons, an AAVLD laboratory wishing to conduct
the food testing described in Sec. 1.1107 would need to be accredited
to ISO/IEC 17025:2017 and satisfy the other laboratory requirements
described in this final rule. However, LAAF-accreditation is not
required for an AAVLD laboratory to continue to participate in the Vet-
LIRN.
(Comment 89) Some comments request that we consider a modified set
of requirements for small specialized laboratories such as those that
solely analyze DWPE samples to determine the presence of filth and
decomposition in seafood. These comments suggest that we not require
ISO/IEC 17025:2017 accreditation for small specialized laboratories;
instead, such laboratories should be required to provide the laboratory
analyst's qualifications, the materials and methods used to conduct the
test, and be subject to random FDA audits. A subset of these comments
states that, for small specialized laboratories, the ISO/IEC 17025:2017
accreditation requirement would be too onerous for such laboratories to
continue operating. Specifically, comments list the cost of initial
certification, annual fee, training, internal program writing, and
corrective action responses as examples of particularly onerous
requirements. These comments emphasize the over-representation of small
laboratories in the total number of laboratories that conduct analyses
of food subject to DWPE by referring to estimates reported in the
preamble to the proposed rule that 84 percent of the current DWPE
analyses are performed by 10 laboratories, while about 90 laboratories
performed the remaining 16 percent of the analyses. The comments assert
that providing modified requirements for small businesses would be
consistent with other FSMA regulations.
[[Page 68782]]
(Response 89) We decline to provide a modified set of requirements
for specialized laboratories of any size. The purpose of the LAAF
program is to help ensure quality testing in the context of heightened
food safety concerns. To achieve this public health goal, we have
determined that without exception, only laboratories that satisfy all
applicable laboratory standards may conduct the tests covered by this
subpart. We reach the same conclusion when we consider the specific
testing mentioned in some of these comments: DWPE testing of seafood
for filth and decomposition. FDA places products on DWPE when we have
evidence that such products appear to be in violation of FDA's laws and
regulations. Moreover, seafood products which were filthy and
decomposed have been implicated in past foodborne illness outbreaks
(e.g., scombrotoxin fish poisoning; (Ref. 12)). Filth and decomposition
are specified as the reasons some seafood products are subject to DWPE
(e.g., https://www.accessdata.fda.gov/cms_ia/importalert_19.html;
https://www.accessdata.fda.gov/cms_ia/importalert_43.html). We cannot
find any basis for concluding that DWPE testing of seafood for filth
and decomposition should be subject to different quality standards.
ISO/IEC 17025:2017 includes technical competency, impartiality, and
quality management system standards, and we view these components as
critical in the context of testing covered by this subpart. By way of
example, section 4.1 of ISO/IEC 17025:2017 provides that laboratory
activities must be managed to safeguard impartiality and states that
the laboratory may not allow commercial and financial pressures to
compromise its impartiality (Ref. 3). The testing covered by this
subpart involves heightened food safety concerns, and we can find no
basis to justify modifying these standards or the other protections
included in ISO/IEC 17025:2017 accreditation.
Next we address the data analysis supporting the proposed rule,
which indicated that 96 laboratories conducted about 16 percent of the
analyses on food products detained when offered for import because the
food was or appeared to be violative (84 FR 59452 at 59457) (Ref. 15).
The same data analysis indicated that 34 of those 96 laboratories were
accredited to ISO/IEC 17025, and that 44 laboratories already
accredited to ISO/IEC 17025 conducted about 95 percent of the analyses.
The same data analysis indicated that 62 unaccredited laboratories
accounted for the remaining 5 percent of import-related analyses.
To the extent that comments requesting modified standards for
specialized laboratories intend to imply that most or all of the 62
unaccredited laboratories that conducted import-related food testing
were small, we do not have enough information to reach this conclusion.
In addition, we have no way of knowing how specialized these 62
laboratories are; some may conduct only DWPE testing, but we cannot
tell the range of analyses each conducts.
Even if we assume a high proportion of small, specialized
laboratories that focus on DWPE testing, we expect the costs for such
laboratories to become ISO/IEC 17025:2017-accredited to be less than
the costs for larger laboratories and those with a more diverse set of
testing capabilities. Reasoned assumptions which may reduce the cost of
ISO/IEC 17025 accreditation for small, specialized laboratories
include: (1) The ability to efficiently manage data collection and
maintenance using relatively simpler in-house databases, particularly
for seafood filth and decomposition testing, which generates discrete
data; (2) lower onsite assessment costs since an accreditation body
necessarily will spend less time assessing a smaller scope of
accreditation (e.g., 1-3 methods); \10\ and (3) reduced costs for
equipment and proficiency samples due to the small number of methods
performed.
---------------------------------------------------------------------------
\10\ A laboratory that is ``specialized'' necessarily performs a
narrow range of methods.
---------------------------------------------------------------------------
All testing covered by this subpart, including filth and
decomposition testing in seafood for DWPE purposes, is of critical
public health significance. As described above, we estimate that the
costs of ISO/IEC 17025:2017 accreditation generally should be lower for
laboratories with very few methods in their scope. On balance, we do
not think the costs of requiring relatively small laboratories that
conduct specialized testing to become ISO/IEC 17025:2017-accredited to
perform covered testing outweigh the benefits that will be derived from
doing so.
For these reasons, we decline the request to modify LAAF program
standards for certain laboratories.
(Comment 90) Some comments recommend that FDA require laboratories
wishing to conduct food testing under this subpart to be accredited to
both ISO/IEC 17025:2017 and the supplemental document, ``AOAC
International Guidelines for Laboratories Performing Microbiological
and Chemical Analyses of Food, Dietary Supplements, and
Pharmaceuticals, An Aid to Interpretation of ISO/IEC 17025:2017'' (the
AOAC 17025 Guidelines) (Ref. 13). Other comments maintain that the AOAC
17025 Guidelines are not appropriate for laboratories that test only
animal food or feed, and not human food. Instead, these latter comments
suggest that for laboratories testing animal food or feed, FDA should
require the accreditation to ISO/IEC 17025:2017 and ``Quality
Assurance/Quality Control Guidelines for Feed Laboratories,'' the
guidance on interpreting ISO/IEC 17025:2017 issued by the Association
of American Feed Control Officials (AAFCO) (Ref. 14). For laboratories
that test both human food and animal food or feed, these comments
recommend FDA require accreditation to both supplemental guidelines.
(Response 90) In several places in the preamble to the proposed
rule, FDA took note of how a matter is addressed in the AOAC 17025
Guidelines. For example, in our discussion of our proposed requirement
that laboratories pass a proficiency test (or a comparison program if
no proficiency test is available or practicable) annually for each
method to which they are LAAF-accredited, we noted that the AOAC 17025
Guidelines contain a similar requirement and exception (84 FR 59452 at
59477). It appears that some readers may have misunderstood these
discussion points, and mistakenly believed that we proposed to require
laboratories to comply with all AOAC 17025 Guidelines or to be
accredited to both ISO/IEC 17025:2017 and the AOAC 17025 Guidelines.
Although we found it instructive to consider the approach taken by the
AOAC 17025 Guidelines on certain matters, we did not propose that
laboratories must be accredited to both ISO/IEC 17025:2017 and the AOAC
17025 Guidelines. In addition, we acknowledge the AAFCO guidelines
provide equally useful supplemental information in animal food testing
matters. The AAFCO guidelines share best practices which would assure
that data of appropriate quality are generated by laboratories for feed
programs and may be useful for producing reliable and defensible
analytical test results. After careful consideration, we decline the
suggestion to require either the AOAC or AAFCO guidelines in this
subpart, but agree that both provide useful supplemental information.
We do not presently perceive a need for such a requirement, and as some
comments have pointed out, there may be challenges around the breadth
of the AOAC 17025 Guidelines considering the wide variety of tests
required to be conducted by LAAF-accredited laboratories under this
subpart.
[[Page 68783]]
(Comment 91) A few comments seek clarification of the roles of
Federal, State, and local regulatory laboratories with respect to this
rule. Some comments seek clarification on whether State and local
regulatory laboratories that are already accredited to ISO/IEC
17025:2017 by an ILAC-MRA signatory and may have agreements with FDA
for testing related to food safety inspections, will need to do
anything differently as a result of this rule. Some comments posit that
only a few public laboratories are conducting the testing covered by
this subpart, and those laboratories may already operate under quality
management systems, and perhaps even ISO/IEC 17025:2017.
Some comments suggest that Federal laboratories (e.g., a laboratory
within a Federal Agency) should be considered equivalent to LAAF-
accredited laboratories. Stated differently, these comments recommend
that if an owner or consignee uses a Federal laboratory, the result
should be acceptable to FDA even if the laboratory is not LAAF-
accredited.
(Response 91) Federal, State, and local regulatory laboratories
perform the vital function of testing product samples of human food,
and animal food and feed, collected by public health officials either
in the course of an investigation or as part of routine market
surveillance. Over the years great strides have been made at all levels
of government to build an integrated food safety system; improving
coordination with and among public regulatory laboratories has been an
important part of that work. This subpart does not impact those tests
and so it may be irrelevant to many public regulatory laboratories.
On the other hand, in addition to testing samples collected by
public health officials, some public regulatory laboratories may also
currently conduct some of the food testing that is covered by this
subpart. For full details see Sec. 1.1107, but the bulk of the testing
covered by this subpart falls within the categories of certain tests of
bottled drinking water, shell eggs, and sprouts; testing to support
removal from import alert; and testing to support admission of an
imported food product detained at the border because FDA has determined
that the food is, or appears to be, adulterated or misbranded. Once
this subpart is fully implemented, all testing covered by this rule
must be conducted by a LAAF-accredited laboratory. Public regulatory
laboratories may become LAAF-accredited laboratories; indeed, the
statute specifically contemplates public laboratories participating in
this program (``laboratories, including independent private
laboratories and laboratories run and operated by a Federal Agency
(including the Department of Commerce), State, or locality'' (section
422(a)(2) of the FD&C Act)). All laboratories, including public
regulatory laboratories, that wish to become LAAF-accredited must
satisfy the requirements of this subpart.
Similarly, an array of laboratories throughout the Federal
government conduct a variety of tests in service to the missions of
their organizations. Any Federal laboratories that wish to become LAAF-
accredited to conduct the testing covered by this subpart will need to
satisfy the requirements of this subpart.
(Comment 92) We received several comments regarding the frequency
with which we should require proficiency testing (or a comparison
program, where no proficiency test is available or practicable). Some
comments applaud the proposed requirement for an annual proficiency
test for each method (or comparison program, where no proficiency test
is available or practicable). Some comments suggest that the annual
frequency be set as a minimum requirement, as even more frequent
proficiency testing would allow for trending of results. Other comments
suggest FDA defer to ISO/IEC 17025:2017 for proficiency testing
frequency. Some of these comments seek to clarify how the FDA will
handle the annual proficiency testing requirement in the case of open
or flexible scopes. Some comments express that it is hard to find a
proficiency test provider that includes all analytes for such a method.
Other comments state that owners or consignees may have a difficult
time finding laboratories that are both ISO/IEC 17025:2017-accredited
and have performed a proficiency test for the analyte/method
combination within the last year for emerging issues, new methods, or
novel matrices being sampled and tested.
(Response 92) Proficiency testing is a quality assurance mechanism
provided by an independent provider that results in an indication of a
laboratory's performance of a method. A successful proficiency test
round indicates that a laboratory can competently analyze samples by
that method whereas an unsatisfactory result indicates that the
laboratory needs to investigate and correct the cause(s) of the
unsatisfactory result.
Although participation in proficiency testing provided by an
outside, independent provider is desired for all testing, we recognize
that it is not available for all test methods, specific analytes, or
matrices; or that, where available, it may not occur at the required
frequency. Therefore, we allow as an option a similarly designed
comparison program which will provide a demonstration of the
laboratory's competence to perform a method not covered by an available
proficiency test program. The comparison program should be an
independent or blind test of the laboratory's performance of a method
that is evaluated against the expected performance of the method
resulting in a conclusion of the laboratory's performance as acceptable
or unacceptable. All the testing covered by this subpart is occurring
in the context of heightened public health concern. We must therefore
be assured that LAAF-accredited laboratories are producing accurate
test results. For example, the results of testing conducted under Sec.
1.1107(a)(4) are used as evidence to overcome an appearance that a
product detained at the border violates FDA laws and regulations.
We agree that requiring LAAF-accredited laboratories to
successfully complete an annual proficiency test (or a comparison
program, where no proficiency test is available or practicable) for
each LAAF-accredited method is important to support the testing under
this subpart. We have determined that deferring to the proficiency test
requirement in ISO/IEC 17025:2017 will not meet the needs of this
program, given the context of heightened public health concern. As
noted in the proposed rule, our proficiency testing frequency
requirement is similar to that of the AOAC 17025 Guidelines.\11\
Although even more frequent proficiency testing may be instructive, we
are not requiring it under this subpart. Accordingly, we are finalizing
the requirement that a LAAF-accredited laboratory must successfully
complete a proficiency test or comparison program for each method every
12 months. We avoid stating the requirement must be satisfied every
``year,'' to avoid implying that the proficiency tests or comparison
programs requirement applies per calendar-year.
---------------------------------------------------------------------------
\11\ Some comments explain that although we stated in the
proposed rule that section 5.9.1 of the AOAC 17025 Guidelines
addresses proficiency testing, the AOAC 17025 Guidelines have been
updated. The updated AOAC 17025 Guidelines address proficiency
testing in section 7.7.2. FDA appreciates the comments.
---------------------------------------------------------------------------
In light of the comments, and considering the critical role that
proficiency testing plays in the context of this final rule to help
ensure both the integrity of specific tests conducted under this
subpart and this laboratory accreditation program as a whole, we are
revising the proficiency testing provisions so that positive results
are
[[Page 68784]]
explicitly required. In the language of the proposed rule LAAF-
accredited laboratories were required to ``participate'' and
``conduct'' a proficiency test annually, per method. The final rule
requires that a proficiency test for each method must be ``successfully
passed'' within a 12-month cycle, unless one is not available or
practicable. Sec. 1.1138(a)(2)(i). In that case, the final rule
requires that the LAAF-accredited laboratory ``demonstrate competency
through participation in [a] comparison program.'' Sec.
1.1138(a)(2)(ii). As we discuss further below in (Response 96, the
LAAF-accredited laboratory must submit all proficiency test and
comparison program results, regardless of outcome, to the recognized
accreditation body within 30 calendar days of receipt. Sec.
1.1138(a)(2)(iii).
For laboratories LAAF-accredited to an open or flexible scope, the
requirement would be for a proficiency test or comparison program
within 12 months for each method within the open or flexible scope.
With regard to comments expressing concern that it may be hard for
an owner or consignee to find a laboratory that is ISO/IEC 17025:2017-
accredited and meets our proficiency test requirements, we note that we
will be maintaining an public registry of all LAAF-accredited
laboratories (and recognized accreditation bodies) online; see Sec.
1.1109 for additional discussion of the public registry.
(Comment 93) Some comments express confusion regarding whether FDA
expects each analyst performing a method in the LAAF-accredited
laboratory to annually fulfill the proficiency testing requirement for
that method. These comments reference the requirement proposed at Sec.
1.1152(g)(12)(iv) that a full analytical report include, ``[i]ndividual
proficiency test worksheets'' and suggest that we clarify our
requirement.
(Response 93) The requirement is for the laboratory to successfully
pass a proficiency test for each LAAF-accredited method within the last
12 months. We have revised the full analytical report requirement to
clarify; for more information see the discussion of Sec. 1.1152,
below.
(Comment 94) Some comments express confusion regarding whether FDA
expects the LAAF-accredited laboratory to inform the recognized
accreditation body that the laboratory has determined that a
proficiency test is either not available or practicable, and so the
laboratory intends to participate in a comparison program instead.
Comments speculate regarding whether FDA might have intended that the
recognized accreditation body review such determinations when it audits
the laboratory.
(Response 94) The LAAF-accredited laboratory's determination that a
proficiency test is not available or practicable must be approved by
its recognized accreditation body; we revised the proficiency test
provisions of the final rule to clarify this requirement; see Sec.
1.1138(a)(2)(ii). The LAAF-accredited laboratory's proposed alternative
to a proficiency test also must be approved by its recognized
accreditation body, prior to the laboratory's participation in the
alternative.
We consider quality assurance measures vital to the integrity of
the LAAF program and the testing that occurs under this subpart.
Although one aspect of that quality assurance is requiring proficiency
testing for each LAAF-accredited method within each 12-month period, an
additional aspect is having the recognized accreditation body concur
with both the laboratory's determination that no proficiency test is
available to the laboratory, and the alternative proposed by the
laboratory.
(Comment 95) In the proposed rule, we noted that ISO/IEC 17043:2010
``Conformity Assessment--General Requirements for Proficiency Testing''
(Ref. 16) provides specific standards for proficiency test providers.
We requested comment on whether FDA should require the use of
proficiency test providers accredited to ISO/IEC 17043:2010.
Some comments support the proposed requirement that proficiency
testing providers must be ``competent,'' and do not recommend that we
specify accreditation to ISO/IEC 17043:2010. Some comments state that
many proficiency test providers that are not accredited to the ISO/IEC
17043:2010 standard have equivalent quality systems and are established
programs in the industry or in government organizations. Some comments
state that international proficiency test providers are less likely to
be accredited to ISO/IEC 17043:2010 as this standard is not utilized
very much outside of the United States. Some comments suggest that
recognized accreditation bodies can institute processes for determining
equivalency for such proficiency test providers.
Other comments recommend that we require the use of proficiency
test providers accredited to ISO/IEC 17043:2010. Some assert that
accreditation of proficiency test providers provides assurances
regarding both the accuracy of the proficiency test and the technical
competence of the laboratories that successfully participate. Some
comments suggest that FDA could require the use of ISO/IEC 17043:2010
accredited proficiency test providers when available. Other comments
suggest that the FDA adopt the stance taken in AOAC 17025 Guidelines
section 7.7.2 which states that an ISO/IEC 17043 accredited proficiency
test provider should be given preference. Some comments ask FDA to
clarify which steps should be taken if we require ISO/IEC 17043:2010
accreditation for proficiency test providers, but where none is
available for certain methods.
(Response 95) FDA appreciates the detailed responses to our
question on this matter.
Having considered the comments, we have decided against requiring
the use of proficiency test providers accredited to ISO/IEC 17043:2010.
We agree with the specification in the AOAC 17025 Guidelines that such
providers should be given preference, and we encourage laboratories to
seek providers with such accreditation. However, at the present time
there are many methods for which no proficiency test provider exists at
all, let alone one accredited to ISO/IEC 17043:2010. Given the
importance of an independent, third-party evaluation of a laboratory's
competence--as provided by a proficiency test within every 12-month
cycle--we have decided to allow a wide selection of proficiency test
providers to cover as many of the testing methods covered by this
regulation as possible. Although the use of an ISO/IEC 17043:2010
accredited proficiency test provider may give the laboratory confidence
in the quality and consistency of the proficiency test material and the
evaluation of laboratory test results, at the present time, the breadth
of testing covered by ISO/IEC 17043:2010 providers is not sufficient to
support making this a requirement.
(Comment 96) Some comments disagree with the proposed requirements
in Sec. 1.1153(b)(1) and (2) that within 30 days of receipt, the LAAF-
accredited laboratory must submit proficiency test results to the
recognized accreditation body and that failing proficiency test results
must also be submitted to the FDA; comments state that this deviates
from current ISO/IEC 17025:2017 procedures. Comments explain that
proficiency test results for an ISO/IEC 17025:2017-accredited
laboratory are assessed annually by an accrediting body. Comments
further explain that ISO/IEC 17025:2017-accredited laboratories address
unsatisfactory results by conducting a
[[Page 68785]]
root cause analysis and taking corrective action.
Some comments agree with proposed Sec. 1.1153(b)(2), which
required the LAAF-accredited laboratory to submit failing proficiency
test results to FDA within 30 days of receipt. Other comments state
that requiring recognized accreditation bodies to review proficiency
test results without specified timeframes is not efficient, and the 30-
day timeframe may not provide enough time for the laboratory to
complete its corrective action process. Comments express concern that
failing results submitted to the recognized accreditation body and FDA
could be used against the laboratory without consideration of the
laboratory's corrective action procedures.
Comments state that FDA should defer to ISO/IEC 17025:2017
proficiency test reporting requirements and that recognized
accreditation bodies can submit non-conforming laboratory results to
the FDA during their onsite assessments. Comments also state that some
accreditation bodies require that the proficiency testing data be
submitted directly to the accreditation body from the proficiency test
provider and that procedures already are in place for review of
proficiency testing schemes. A few comments have asked FDA to clarify
what would be considered a ``questionable'' or failing proficiency test
result. Comments state that some proficiency test providers consider
consecutive questionable results when determining a laboratory's
proficiency test performance and comments ask for clarification on how
FDA would evaluate consecutive questionable results.
(Response 96) We have moved the proficiency test result reporting
requirements from Sec. 1.1153(b) to Sec. 1.1138(a)(2)(iii) so that
they appear alongside the main proficiency test requirements.
After considering the comments, we have decided to revise the
requirements regarding LAAF-accredited laboratories' sharing results of
proficiency tests (or a comparison program, where no proficiency test
is available or practicable) with the recognized accreditation body and
FDA. First, we have determined that it is sufficient for the LAAF-
accredited laboratory to share results with the recognized
accreditation body and have therefore deleted the requirement that
failing results also be submitted to FDA. Upon consideration of the
comments on these provisions, the comments encouraging greater
delineation of FDA's role, and the requirements in Sec.
1.1138(a)(2)(ii) that recognized accreditation bodies must concur in
both the determination that no proficiency test is available and the
alternative chosen, we conclude that it better suits the role of the
accreditation body to review proficiency test results.
We acknowledge that current ISO/IEC procedures only require the
accreditation body to review a laboratory's proficiency test results
annually, and that reviewing all results, and on an ongoing basis, will
not be as efficient for the accreditation body. (According to the
comments, some accreditation bodies go beyond what is required under
the ISO/IEC standard and so, may already receive results of all
proficiency test results, sometimes directly from the proficiency test
provider itself; our requirements may not be as much of a change for
those accreditation bodies.) However, we view proficiency testing (or
comparison programs, where no proficiency test is available or
practicable) as a very important tool to either reflect the continued
competence of a laboratory with regard to a particular method or
provide an opportunity for the laboratory to determine why it did not
receive a fully acceptable result and address any related need for
process improvements. We believe that providing the recognized
accreditation body with proficiency test results on an ongoing basis
will allow the recognized accreditation body to maintain greater and
more timely awareness of a laboratory's competency.
At the same time, we take the point of the comments stating that if
the result is less than fully acceptable, it is unlikely that the LAAF-
accredited laboratory will complete its corrective action process
within 30 calendar days of receiving the result. In addition, as
explained above, we want recognized accreditation bodies to be in
possession of additional information about laboratory competency in a
timelier fashion than annual reviews provide. Therefore in the final
rule we are retaining the 30 calendar day timeframe for submission to
the recognized accreditation body of the results of the proficiency
test (or comparison program, where no proficiency test is available or
practicable).
We note that a LAAF-accredited laboratory must successfully pass a
proficiency test (or comparison program, if a proficiency test is not
available or practicable) as described in Sec. 1.1138(a)(2) to gain or
maintain LAAF-accreditation for a particular method.
Finally, with regard to the proposed requirement that a LAAF-
accredited laboratory submit to FDA results of ``failed'' proficiency
tests, comments request that we clarify what would be considered a
failing result. We acknowledge and agree with comments indicating that
proficiency test results generally are phrased in terms such as
``satisfactory'' or ``fully acceptable,'' or ``unsatisfactory'' or
``questionable.'' We have revised the requirement in the final rule to
require that a laboratory submit all proficiency test and comparison
program results, regardless of outcome, to the recognized accreditation
body within 30 calendar days of receipt (see Sec. 1.1138(a)(2)(iii)).
(Comment 97) We received several comments regarding the quality
assurance requirements in proposed Sec. 1.1148. Some comments agree
with the proposed requirement that reference materials or quality
control samples be used with each test conducted under this subpart.
Some comments ask that FDA provide more details of the requirements for
a quality assurance process, including how quality is assured and by
whom, who performs audits and how they are issued, and, regarding
proposed Sec. 1.1148, who is accountable for findings and corrective
action. Some comments include for FDA's consideration examples of how
quality assurance is defined and implemented in other organizations,
including mention of the AOAC 17025 Guidelines' treatment of reference
materials and quality control samples.
(Response 97) FDA considers quality assurance to be vital to the
integrity of this program and the testing that occurs under this
subpart. We have included various requirements throughout this subpart
that address quality assurance precisely because confidence in LAAF-
accredited testing is essential. One example is the requirement that
LAAF-accredited laboratories ensure that policies and procedures for
monitoring the validity of the results of testing they conduct under
this subpart include the use of reference materials or quality control
samples with each batch of samples tested under this subpart (Sec.
1.1138(a)(3)), a policy that aligns with the AOAC 17025 Guidelines
(Ref. 13). Relatedly, we have revised the final rule to require
submission of quality control results even with abridged analytical
reports, again, because of the importance we place on quality
assurance. ISO/IEC 17025:2017 similarly contains quality assurance
requirements, and not as a stand-alone provision, but integrated
throughout the standard (Ref. 3).
In our view, quality assurance is most effective when it is not
treated as a distinct activity or addendum, but rather as a commitment
that should be
[[Page 68786]]
reflected in many facets of laboratory operations. Accordingly, we
decline the invitation to include a definition of ``quality
assurance.'' We do not believe a definition would significantly advance
the degree to which LAAF-accredited laboratories pursue and conduct
quality assurance.
Commenters interested in additional details about the quality
assurance process under this subpart need only become more familiar
with its provisions. Both the recognized accreditation bodies and LAAF-
accredited laboratories are subject to requirements that we believe
will promote quality assurance.
(Comment 98) We received many comments regarding whether FDA should
require LAAF-accreditation for the entities that collect the samples
that get tested under this subpart.
In the proposed rule we chose not to include requirements for the
accreditation of samplers. We acknowledged the importance of proper
sampling procedures and that accreditation for sampling could
potentially help ensure the collection of representative samples. We
stated that although only laboratories were eligible for ISO/IEC 17025
accreditation under the 2005 version of that standard, the 2017 version
of the standard allows for the accreditation of entities that only
collect and do not analyze samples (``stand-alone sampling entities'')
(see 84 FR 59452 at 59476). As the revision was relatively new at the
time of the proposed rule, we were not able to adequately assess the
accreditation of such entities. We solicited comments on several
related issues, such as the capacity of accredited samplers (both
laboratories and stand-alone sampling entities), which international
voluntary consensus standard would serve as the optimal basis for a
consensus sampling standard, and which standards are currently employed
to assess samplers and whether such standards are effective and
sufficient. We proposed instead, in Sec. 1.1149, to require LAAF-
accredited laboratories to develop or obtain certain sampling documents
that would allow FDA to exercise oversight of the sampling conducted as
part of this program. Comments on proposed Sec. 1.1149 are addressed
below.
Several comments endorse not requiring the accreditation of
samplers at the present time. Some of these comments contend samplers
are adequately qualified and therefore an accreditation requirement is
not warranted. These comments consider that the FDA oversight of
samples made possible by proposed Sec. 1.1149 will provide adequate
assurance of samplers' qualification and will provide helpful
flexibility in allowing different entities to collect the sample. Some
comments claim that for many food facilities, the preventive controls
regulations already require that sampling activities be performed by a
qualified individual and be overseen by a person with specialized
training in food safety preventive controls (i.e., a preventive
controls qualified individual).
We understand some comments to argue that without substantive
sampling protocols to which samplers could refer, it would be difficult
for accreditation bodies to accredit samplers to ISO/IEC 17025:2017 or
assess against proposed Sec. 1.1149. These comments recommend that, at
a minimum, FDA should provide a mechanism whereby samplers could verify
sampling protocols with FDA. See discussion of this point with respect
to Sec. 1.1149, below.
Some comments agree with our assessment in the proposed rule that
accreditation of stand-alone samplers is still relatively new. Some
comments agree that we should review this issue in the future. Some
comments contend that requiring the accreditation of samplers would
necessitate significant investments of time and expense by industry to
obtain such accreditation but would not result in significant public
health benefit.
Other comments disagree with FDA's proposed decision and instead
argue that the final rule should require the accreditation of samplers.
Some of these comments contend that the statute requires samplers to be
accredited under this subpart; comments specifically quoted or
referenced section 422(a)(6)(A)(iv) and (b)(1) of the FD&C Act.
Some comments contend that allowing sampling by unaccredited
entities would fail to provide the clarity needed for proper sample
collection, which can have a significant impact on the quality of the
test results and related uncertainty. These comments state that
analysis of an improper sample can invalidate the test results, and
argue that requiring accredited samplers is crucial to the integrity of
both the sample itself and the resulting test data. A few comments
claim that requiring the accreditation of samplers would ensure
traceability, which we understand to mean the ability to connect the
sample back to a lot or shipment.
Some comments contend that aspects of ISO/IEC 17025:2017 are
necessary to ensure quality sampling. Some comments reason that, if
samplers are not required to be ISO/IEC 17025:2017-accredited, there is
a risk they may be connected to owners and consignees, and thus have an
interest in the outcome of the sampling and food testing. These
comments express the concern that allowing unaccredited samplers may
lead to the analysis of biased, substituted, or manipulated samples.
Comments suggest that accreditation to the ISO/IEC 17025:2017 standard
would protect against such conflict of interest concerns. Some comments
also champion the value of ISO/IEC 17025:2017 to establish standards
for sampler qualifications.
Some comments disagree with the Agency's assessment in the proposed
rule that ISO/IEC 17025:2017 accreditation for stand-alone sampling
entities is relatively new and the FDA does not have enough information
to assess their accreditation. Comments disagree that accreditation
bodies do not have the experience or bandwidth to satisfy a requirement
under this subpart that samplers be ISO/IEC 17025:2017-accredited.
Regarding current capacity among ISO/IEC 17025:2017-accredited
samplers, some comments assert that there is more than sufficient
accredited-sampler capacity to conduct all the DWPE sampling that would
be required under this subpart. They claim that current ISO/IEC
17025:2017-accredited sampling providers can expand their workforce as
needed to meet increased demand. They also contend that if we were to
require the accreditation of samplers under this subpart, we would be
creating additional incentive for sampling entities to become ISO/
IEC17025:2017-accredited, which would further increase capacity. Other
comments seem to suggest that accredited sampling capacity will
increase over time for market reasons (as accreditation generates
revenue), regardless of whether we incentivize by requiring sampling
accreditation under this subpart.
Certain comments suggest that the sampling requirements in ISO/IEC
17025:2017 in conjunction with FDA's Investigations Operations Manual
(IOM) (Ref. 17) would provide comprehensive standards for sampling.
Comments also maintain that ILAC is in the process of considering the
circumstances in which it may be appropriate to require accredited
sampling.
(Response 98) As discussed at some length in the proposed rule,
proper sampling procedures are essential to meaningful test results.
Accordingly, it is important that this subpart address samplers'
training and procedures. After careful consideration of the comments,
we have decided that the most appropriate way to support those goals at
the present time is through the
[[Page 68787]]
oversight provisions at Sec. 1.1149 rather than by requiring ISO/IEC
17025:2017-accreditation of samplers.
Although we have decided not to require the accreditation of
sampling at this time, it should be noted that with the adoption of
ISO/IEC 17025:2017 without exclusions, those laboratories that include
sampling on their scope of accreditation will be assessed by their
accreditation body to the requirements of ISO/IEC 17025:2017 section
7.3 on sampling. Even though many sampling entities are not part of an
ISO/IEC 17025:2017-accredited laboratory, we conclude that the general
requirements in ISO/IEC 17025:2017 section 7.3 are sufficiently
addressed in Sec. 1.1149 (Ref. 3). There currently is no other
consensus standard specific to sampling of which we are aware; nor is
there a single, widely accepted sampling standard for us to incorporate
or on which to rely. Instead, there are several publications that
address the appropriate statistical sampling that is required to obtain
the representative sample referred to in Sec. 1.1149. Some comments
suggest that the FDA IOM could serve as the substantive standard.
However, while the FDA Compliance Programs \12\ and the IOM define the
general process for all sampling to ensure that the sample is
representative of the entire lot and in conformance with FDA sampling
procedures and methods, many of the instructions in these documents are
specific to FDA operations and would not be appropriate for
incorporation within this subpart. We also acknowledge the point of the
comments that argue that the 2017 version of ISO/IEC 17025 is not still
``new,'' and the comments that maintain that accreditation bodies have
the capacity to accredit entities for sampling. Nevertheless, in the
absence of any other consensus standard specific to sampling of which
we are aware; nor a single, widely accepted standard on sampling
criteria and specifications, we believe more time is needed for
industry to flesh out, and for us to assess, the ISO/IEC 17025:2017
accreditation of entities (including non-testing entities) for
sampling. Additionally, due to the absence of a predominant substantive
sampling standard, we do not agree with the position expressed in
comments that accreditation alone would provide sufficient clear
direction on sampling protocols to ensure proper sample collection. For
additional discussion regarding FDA substantive sampling resources, see
FDA Compliance Programs and IOM Ch. 4.
---------------------------------------------------------------------------
\12\ For more information on FDA Compliance Programs, see
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-manuals/compliance-program-guidance-manual-cpgm.
---------------------------------------------------------------------------
Despite the contentions of some comments, the statute does not
specify that FDA must require the accreditation of samplers in this
subpart. Comments point to section 422(a)(6)(A)(iv) and (b)(1) of the
FD&C Act to support the argument that sampling accreditation is
necessary. Section 422(a)(6)(A)(iv) of the FD&C Act states that the
model standards established in this subpart must include methods to
ensure that (among other things), ``individuals who conduct the
sampling and analysis are qualified by training and experience to do
so.'' This language does not mention accreditation; instead, it
provides (in relevant part) that FDA require samplers to be qualified.
We are fulfilling that obligation in Sec. 1.1149. Section 422(b)(1) of
the FD&C Act lists the tests that must be covered by this subpart; the
introductory text reads (in relevant part), ``food testing shall be
conducted by Federal laboratories or non-Federal laboratories that have
been accredited for the appropriate sampling or analytical testing
methodology or methodologies.'' This provision refers to accreditation,
but the ``or'' is important; by stating ``sampling or analytical
testing methodology,'' the statute allows for the satisfaction of just
one type of accreditation. Thus, this language explicitly allows for
testing to be conducted by laboratories accredited for just the
appropriate test method.
As we stated in the proposed rule, in the 2-year period from 2016-
2017, about 63 percent of DWPE sampling was conducted by 5 entities
accredited for sampling under ISO/IEC 17025:2017 (see 84 FR 59452 at
59476). About 37 percent of DWPE sampling was conducted by more than
300 entities not accredited for sampling (see id.). In the proposed
rule, we specifically solicited feedback regarding the current capacity
of accredited samplers. Some comments respond that there is sufficient
capacity among already-accredited samplers to conduct all DWPE
sampling, and that it would be relatively easy for such entities to
expand capacity much further. We appreciate the time taken by
commenters to thoroughly address our specific inquiries.
This subpart reaches beyond testing to support removal from import
alert, and entities focused on the sampling and testing needs at ports
of entry may not be convenient choices for non-import related owners
and consignees needing the services of a LAAF-accredited entity. We
note incidentally that some of the non-import sampling needs under this
subpart are unique; there are serious biosecurity concerns that would
need to be addressed by any outside entity collecting the shell egg
samples the testing of which is covered by this subpart under Sec.
1.1107(a)(1)(ii). See, e.g., Biosecurity Basics for Poultry Growers
(Ref. 18). We did not receive any comments describing the current
capacity of accredited samplers to collect non-import samples, though
as stated, some comments express the view that it would be relatively
easy to expand capacity, and some comments make the point that if we
require the accreditation of samplers we would be creating an incentive
to become accredited for sampling.
Some comments suggest that there is no indication current samplers
are unqualified. For current purposes it is sufficient to acknowledge
that the statute directs FDA to address sampler qualifications in this
subpart. Some comments claim that sampling that takes place pursuant to
the FSMA preventive controls regulations is already required to be
conducted by a trained individual, and overseen by another person with
specialized food safety preventive controls training. (See the
definition of preventive controls qualified individual in Sec. Sec.
117.3 and 507.3.) It is true that each of those regulations requires
sampling to be conducted by an individual qualified by education,
training, or experience to carry out such sampling (Sec. Sec. 117.3,
117.4(b); Sec. Sec. 507.3, 507.4(b)), but the preventive controls
regulations only require a preventive controls qualified individual to
prepare or oversee the preparation of the food safety plan that would
detail the sampling regimen, not to oversee the sampling activity
(Sec. Sec. 117.180, 507.53). In addition, very few of the samples that
must be tested by a LAAF-accredited laboratory would be collected from
registered food facilities subject to either of the preventive controls
regulations; we estimate that almost all of the laboratory analytical
reports submitted in accordance with this subpart will be related to
sprouts (see Sec. 1.1107(a)(1)(i)), shell eggs (see Sec.
1.1107(a)(1)(ii)), and imports under section 801(a) (see Sec.
1.1107(a)(4), (5)) (Ref. 4).
Some comments raise concerns about biased sampling. These comments
contend that the conflict of interest provisions in ISO/IEC 17025:2017
protect against samplers that have an interest in the outcome of the
test from submitting unrepresentative (e.g., ``cherry picked'' or
manipulated) samples. Although we also appreciate that ISO/IEC
17025:2017 contains conflict of interest provisions, the requirements
in Sec. 1.1149(a)(2) and (3)
[[Page 68788]]
for a sampling plan and collection report will ensure that the sample
collection procedures and preparation techniques, as well as the chain
of custody including controlling for the representative nature of the
sample, are documented and reviewed by FDA. For more information on the
sampling documentation required by this final rule, see the discussion
of Sec. 1.1149, below.
Regarding sampler qualifications, ISO/IEC 17025:2017 section 6.2
requires accredited entities to document (among other things) the
educational, training, and experiential needs of each position and
ensure that personnel possess the necessary competence to perform their
function (Ref. 3). Although we do not dispute that these aspects of
ISO/IEC 17025:2017's quality management system are valuable, we are
addressing sampler qualifications, albeit using a different approach,
in this rule. Section 1.1149(a)(1) requires the qualifications of each
sampler to be submitted to FDA. Reviewing the documentation of
samplers' training and experience will provide FDA with a means of
helping to ensure that each sampler possesses qualifications sufficient
for the task.
A few comments claim that requiring the accreditation of samplers
would facilitate connecting a sample back to a lot or shipment.
However, the requirements in Sec. 1.1149(a)(1) through (3) for the
written documentation of the sampler's qualifications by training and
experience, the written sampling plan used to conduct the sampling, and
the collection report combined should include the information required
to allow for tracing back to the lot or shipment.
A number of pending developments may cause us to revisit this
issue. Contrary to the assertion of some comments, our understanding is
that ILAC is not considering developing standards or advice regarding
the circumstances in which it would be appropriate to require sampling
accreditation. However, a number of other developments may cause us to
revisit this issue, including our experience administering this
program, which will include reviewing sampling documents from both
LAAF-accredited laboratories and unaccredited samplers. Any change we
propose to this subpart will be effected through rulemaking and include
an opportunity for public comment.
2. How does a laboratory apply for LAAF-accreditation or extend its
scope of LAAF-accreditation (Sec. 1.1139)?
This topic appeared in Sec. 1.1158 of the proposed rule. In the
proposed rule, paragraph (a) of this section directed a laboratory
seeking LAAF-accreditation to apply to a recognized accreditation body.
It also noted that a laboratory that had previously been disqualified
from the program by FDA or had its LAAF-accreditation withdrawn by a
recognized accreditation body must meet additional requirements to be
reinstated; those requirements are contained in Sec. 1.1142 of the
final rule (proposed Sec. 1.1165).
In the proposed rule, paragraph (b) of this section stated that a
laboratory seeking LAAF-accreditation may use documentation of
conformance with ISO/IEC 17025:2017 in meeting the requirements of this
subpart.
In the proposed rule, paragraph (c) of this section provided that
LAAF-accreditation endures as long as the laboratory maintains
compliance with all requirements of this subpart, unless the laboratory
relinquishes its LAAF-accreditation, FDA disqualifies the laboratory
from the program, or the recognized accreditation body withdraws the
laboratory's LAAF-accreditation.
On our own initiative, we specified the relevant paragraph in the
cross-reference to Sec. 1.1142 and made other conforming and minor
editorial changes. Conforming terminology changes include adding the
phrase, ``reduced in scope,'' and the term, ``disqualified'' to the
list of ways LAAF-accreditation may end, in paragraph (c). Whereas in
the proposed rule, the words, ``withdrawn'' and ``revoked'' included
``in part'' withdrawal or reduction, in the final rule we use the word,
``reduce,'' to mean that some (but not all) methods are removed from
the scope of LAAF-accreditation and we use ``disqualify'' to refer to
the action FDA takes with respect to a LAAF-accredited laboratory.
Additionally, we have revised the section to remove reference to
``modification of scope,'' instead referring to extension of scope in
the final rule. We also revised the section title accordingly to read,
``How does a laboratory apply for LAAF-accreditation or extend its
scope of LAAF-accreditation?'' Comments regarding this section are
discussed below.
(Comment 99) We received a few comments on this section; they
concern paragraph (c). Comments state that as proposed, LAAF-
accreditation would continue indefinitely, and accreditation bodies may
approach this policy differently. Some accreditation bodies take a
proactive approach and prompt laboratories to begin the renewal
accreditation process for ISO/IEC 17025:2017 well in advance of
expiration.
(Response 99) We acknowledge that accreditation bodies vary in
their approaches to the duration and renewal of ISO/IEC 17025:2017
accreditation. Nevertheless, we are comfortable with the policy that
LAAF-accreditation for a particular method endures indefinitely for a
variety of reasons including that ISO/IEC 17011:2017 section 7.9.1
prescribes that ISO/IEC 17025:2017 accreditation may be for a maximum
of 5 years (Ref. 2); Sec. 1.1120(e) of this subpart requires
recognized accreditation bodies to conduct an onsite assessment of a
sample of the laboratory's scope every 2 years; and we have included
various quality assurance requirements in this subpart such as the
requirement in Sec. 1.1138(a)(2) for a successful proficiency test at
least every 12 months for each method to which a laboratory is LAAF-
accredited.
3. What must a LAAF-accredited laboratory do to voluntarily relinquish
its LAAF-accreditation (Sec. 1.1140)?
This topic appeared in Sec. 1.1163 in the proposed rule. We
proposed to title this section, ``What if a laboratory wants to
voluntary relinquish its accreditation?'' For precision and in keeping
with the terminology changes described above at Response 10, the title
has been reworded to read, ``What must a LAAF-accredited laboratory do
to voluntarily relinquish its LAAF-accreditation?''.
In the proposed rule, paragraph (a) of this section provided that a
LAAF-accredited laboratory must notify FDA and its recognized
accreditation body at least 60 days before relinquishing its LAAF-
accreditation either in whole or in part. We proposed that the notice
must include the date on which the relinquishment will occur, and if
the laboratory is relinquishing its LAAF-accreditation in whole,
certain information on a records custodian.
In the proposed rule, paragraph (b) stated that FDA will provide
notice of the relinquishment on the public registry described in Sec.
1.1109.
On our own initiative, we made a few changes to this section.
First, we removed the language requiring the notice of relinquishment
to be electronic and in English; requirements for submitting
information to FDA under this subpart are now addressed in Sec.
1.1110. We also removed mention of the fact that the relinquishing
laboratory must make its records available to FDA as required by Sec.
1.1153 because it was superfluous. We also made minor editorial changes
and specified ``calendar'' days in paragraph (a).
We received no comments solely related to this section and made no
further changes to it.
[[Page 68789]]
4. What is the effect on a LAAF-accredited laboratory if its recognized
accreditation body is no longer recognized by FDA (Sec. 1.1141)?
This topic appeared in Sec. 1.1164 in the proposed rule. We
proposed to title this section, ``What is the effect on accredited
laboratories if their accreditation body voluntarily or involuntarily
loses its recognition?'' We rephrased the title for efficiency and in
keeping with the terminology changes described above at Response 10 so
that it now reads, ``What is the effect on a LAAF-accredited laboratory
if its recognized accreditation body is no longer recognized by FDA?''.
In the proposed rule, paragraph (a)(1) of this section explained
the actions a LAAF-accredited laboratory must take if its recognized
accreditation body departs the program. Within 30 days of FDA issuing a
notice informing the LAAF-accredited laboratory of the recognized
accreditation body's departure, the laboratory must submit to FDA its
most recent internal audit (see Sec. 1.1154(a)(5) of the final rule),
documentation showing compliance with the conflict of interest
requirements in Sec. 1.1147, and documentation of the most recent
proficiency test for each method to which the laboratory is LAAF-
accredited (see proposed Sec. 1.1148(a), (b)). Proposed paragraph
(a)(2) stated that within 1 year of receiving FDA's notice informing
the laboratory of its accreditation body's departure from the program,
the laboratory must become LAAF-accredited by a recognized
accreditation body.
In the proposed rule, paragraph (b) provided that the laboratory
need not comply with paragraph (a) if, within 15 days of receiving
FDA's notice informing the laboratory of its accreditation body's
departure from the program, the laboratory initiates relinquishment of
its LAAF-accreditation in whole (see proposed Sec. 1.1163, final rule
Sec. 1.1140) with the relinquishment to occur within no more than 90
days.
In addition to changes made in response to comments discussed
below, we made several changes to this section on our own initiative in
the final rule. We restructured the section to change proposed
paragraph (a) to a chapeau introducing paragraphs (a) and (b) of the
final rule and reordered the language of the chapeau to match the order
in which the notifications are listed in the final rule. On our own
initiative we replaced the phrase, ``30 days after FDA issues the
notice to the accredited laboratory'' with, ``30 calendar days after
receiving the notice,'' because these notices do not always come from
FDA and it is clearer to specify ``calendar'' days here and in
paragraph (b) of this section. In the case of a recognized
accreditation body that chooses to allow its recognition to expire or
voluntarily relinquishes its recognition, Sec. 1.1116(b) requires the
recognized accreditation body to notify the laboratories it has LAAF-
accredited. We also updated cross-references to the sections requiring
notice to the LAAF-accredited laboratories. In addition, we corrected
the reference to the section addressing a recognized accreditation body
allowing expiration of, or voluntarily relinquishing, its recognition.
Comments regarding this section are discussed below.
(Comment 100) Comments state that the 15-day timeframe proposed in
Sec. 1.1164(b), during which time a LAAF-accredited laboratory
``orphaned'' by its recognized accreditation body may inform FDA that
the laboratory intends to relinquish its LAAF-accreditation, instead of
taking the actions required by paragraph (a), is inconsistent with the
timeframes established in the section on relinquishment (see Sec.
1.1140 of the final rule). Section 1.1140 of the final rule states that
a LAAF-accredited laboratory that chooses to voluntarily relinquish its
LAAF-accreditation must provide at least 60 calendar days advance
notice of the intention to relinquish. Comments indicate that the 15-
day timeframe in proposed Sec. 1.1164(b) seems irrelevant because a
laboratory could decide to depart the program on the 25th day after
receiving FDA's notice and still comply with the timeframes established
in Sec. 1.1140.
(Response 100) We agree with these aspects of the comments and so
have revised the introduction of this section to provide that the LAAF-
accredited laboratory has 30 calendar days to either provide to FDA the
required documentation (i.e., its most recent internal audit (see Sec.
1.1154(a)(5)), documentation showing compliance with the conflict of
interest requirements in Sec. 1.1147, and documentation of the most
recent proficiency test for each method to which the laboratory is
LAAF-accredited (see Sec. 1.1138(a)) or inform FDA of its intent to
relinquish under Sec. 1.1140(a).
5. How does a laboratory request reinstatement of LAAF-accreditation
(Sec. 1.1142)?
This topic appeared in Sec. 1.1165 in the proposed rule. In the
proposed rule, paragraph (a) of this section provided that a laboratory
that had any portion of its LAAF-accreditation withdrawn by the
recognized accreditation body or was disqualified by FDA for any
portion of its LAAF-accreditation, may seek reinstatement by submitting
a new application for LAAF-accreditation. We also proposed that the
laboratory take additional actions: Notify FDA of certain information
prior to submitting the application to the recognized accreditation
body and demonstrate to the recognized accreditation body to which the
laboratory is newly applying that the grounds for the withdrawal or
disqualification have been resolved and the laboratory has implemented
measures to prevent recurrence.
In the proposed rule, paragraph (b) of this section stated that a
LAAF-accredited laboratory that voluntarily relinquished any portion of
its LAAF-accreditation may seek reaccreditation by submitting a new
application to a recognized accreditation body.
We revised the section and section title to reflect updated
terminology and made other conforming and minor editorial changes
within the section. In this section and throughout the final rule, we
removed ``legal'' as a modifier for certain names required to be
submitted (for example, names of the laboratory and recognized
accreditation body in this section and the analyst names in other
sections) as the distinction was unnecessary and inconsistently used in
the proposed rule. We also removed ``valid'' as a modifier for contact
information in Sec. 1.1142(a)(1) as it was also unnecessary. We
received no comments solely related to this section.
I. Comments Regarding Requirements for LAAF-Accredited Laboratories
Table 10--Changes to Sections Regarding Requirements for LAAF-Accredited
Laboratories
------------------------------------------------------------------------
Final rule Proposed rule Notes
------------------------------------------------------------------------
Requirements for LAAF-Accredited Requirements for Revised to reflect
Laboratories. Accredited new terminology.
Laboratories.
[[Page 68790]]
N/A............................. Sec. 1.1146 What Merged contents of
are the general proposed section
requirements for with Sec.
accredited 1.1138.
laboratories to
remain
accredited?
Sec. 1.1147 What are the Sec. 1.1147 What Revised to reflect
impartiality and conflict of impartiality and new terminology
interest requirements for a conflict of and to improve
LAAF-accredited laboratory? interest clarity.
requirements must
accredited
laboratories
meet?
N/A............................. Sec. 1.1148 What Removed this
quality assurance section and
requirements must relocated content
accredited to Sec. 1.1138.
laboratories
meet?
Sec. 1.1149 What oversight Sec. 1.1149 What Section title
standards apply to sampling? oversight remains the same.
standards apply
to sampling?
Sec. 1.1150 What are the Sec. 1.1150 What Revised to reflect
requirements for analysis of requirements new terminology
samples by a LAAF-accredited apply to analysis and to improve
laboratory? of samples by an clarity.
accredited
laboratory?
Sec. 1.1151 What requirements Sec. 1.1151 What Revised to reflect
apply to the methods of requirements new terminology.
analysis a LAAF-accredited apply to the
laboratory uses to conduct food methods of
testing under this subpart? analysis an
accredited
laboratory uses
to conduct food
testing under
this subpart?
Sec. 1.1152 What Sec. 1.1152 What Revised to reflect
notifications, results, notifications, new terminology
reports, and studies must a results, and and include
LAAF-accredited laboratory reports must ``studies''.
submit to FDA? accredited
laboratories
submit to FDA?
Sec. 1.1153 What are the New section....... Created new stand-
requirements for submitting alone section for
abridged analytical reports? the portions of
Sec. 1.1152
related to
abridged reports.
Sec. 1.1154 What other records Sec. 1.1153 What Relocated records
requirements must a LAAF- other records section and
accredited laboratory meet? requirements must revised to
an accredited reflect new
laboratory meet? terminology.
------------------------------------------------------------------------
1. What are the impartiality and conflict of interest requirements for
a LAAF-accredited laboratory (Sec. 1.1147)?
In the proposed rule, Sec. 1.1147(a) required LAAF-accredited
laboratories to generally prohibit employees, contractors, and agents
involved in food testing and related activities from accepting any
money or other item of value from the owner or consignee of the food
that is being, or will be, tested by the laboratory. Proposed paragraph
(b) excepted from the general prohibition the payment of fees for
testing services; reimbursement of direct costs associated with the
testing; and for laboratories owned by the owner or consignee, payment
of salary. Proposed paragraph (c) required that payment by the owner or
consignee for the testing service, and any direct reimbursement related
to the testing, must be independent of the test outcome.
On our own initiative we revised paragraph (b)(1). In the proposed
rule, paragraph (b)(1) excepted, ``payment of fees for food testing
services.'' In the final rule, it excepts, ``[p]ayment of fees for food
testing under this subpart and related services,'' because owners and
consignees may pay a LAAF-accredited laboratory for services incidental
to testing, such as to collect a sample or for shipping and handling
costs.
We have revised the text of this section to update terminology and
to make other conforming and editorial changes. We also revised the
section title to read, ``What are the impartiality and conflict of
interest requirements for a LAAF-accredited laboratory?'' We discuss
additional changes to the section made in response to comments below.
(Comment 101) We proposed to allow laboratories owned by the owner
or consignee (``in-house'' laboratories) to become LAAF-accredited. We
received several comments regarding this proposed policy.
Some comments express support for the proposed policy. These
comments state that the LAAF-accreditation process and other
requirements in the proposed rule would protect against potential
conflicts of interest. Some of these comments express the view that
although in-house laboratories should be permitted to become LAAF-
accredited, they should not be required to do so.
Some comments oppose the proposed policy. Some of these comments
contend in-house laboratories cannot be free from conflicts of
interest. Some comments contend that this conflict of interest may
place public health at risk since owners or consignees testing their
food would have a vested interest in the outcome of the food testing;
some comments cite a widely-publicized foodborne illness outbreak and
state that the risk of our proposed policy is the recurrence of such
situations. Some comments also seem to argue that in-house laboratories
do not, or inherently cannot, satisfy the conflict of interest
provisions in ISO/IEC 17025:2017. These comments may have been
attempting to address our statement in the proposed rule that we were
unaware of any information indicating that laboratories owned by owners
or consignees are less able to become LAAF-accredited than independent
laboratories.
Some comments opposing the proposed policy argue that the statute
precludes in-house laboratories from conducting at least import-related
testing under the LAAF program. These comments disagree with FDA's
interpretation of ``on behalf of'' in 422(b)(1)(B) of the FD&C Act.
These comments argue that when Congress used such language it was
clearly Congress's intent to prohibit in-house laboratories from
testing their own products under that 422(b)(1)(B) of the FD&C Act.
In the proposed rule, we said that reading the statute such that
in-house laboratories would be ineligible for import-related testing
under this program could raise potential concerns under U.S.
international trade obligations. (see 84 FR 59452 at 59461 through
59462). We tentatively concluded that such a reading would not comport
with section 404 of FSMA, which states that nothing in the FD&C Act
shall be construed in a manner inconsistent with the agreement
establishing the WTO or any other treaty or international agreement to
which the United States is a party. Some comments that oppose the
proposed policy disagree with our proposed reasoning, and state that
there is insufficient evidence that treaties or international
agreements apply in this instance or that they are sufficient to
[[Page 68791]]
justify, according to these comments, risking public health by allowing
in-house laboratories to be eligible for LAAF-accreditation.
(Response 101) After considering the comments and reviewing the
statute, we are retaining the proposed policy such that in-house
laboratories may become LAAF-accredited to conduct any of the testing
described in Sec. 1.1107 as long as those laboratories meet all the
laboratory requirements of this subpart.
We acknowledge that opportunities may exist for owners and
consignees to exert undue influence over an in-house laboratory; owners
and consignees generally do not have the same amount of power and
control over an independent or third-party laboratory. However, as we
discussed in the proposed rule, ISO/IEC 17025:2017 contains several
requirements relevant to conflict of interest and impartiality (see 84
FR 59452 at 59478). For example, ISO/IEC 17025:2017 section 4.1
requires the laboratory to conduct its activities impartially and to be
structured and managed so as to safeguard impartiality, to not allow
commercial, financial, or other pressures to compromise its
impartiality, and, if a risk to impartiality is identified, the
laboratory must be able to demonstrate how the laboratory eliminates or
minimizes the risk (Ref. 3). We are aware that in-house laboratories
are accredited to ISO/IEC 17025:2017, indicating that accreditation
bodies have found sufficient safeguards in place to allow such
laboratories to be impartial. We have no basis to question those
accreditation body determinations.
To further protect the integrity of the testing conducted under
this subpart, Sec. 1.1147 imposes on laboratories impartiality and
conflict of interest requirements that supplement those contained in
ISO/IEC 17025:2017. With limited exceptions, we require laboratory
employees, contractors, and agents not to accepts gifts or other items
of value from owners or consignees whose food is tested by the
laboratory. We also require that the owners' or consignees' payment to
the laboratory be independent of the testing outcome. This final rule
also contains oversight provisions which allow accreditation bodies to
assess, and FDA to review, the performance of, laboratories. Recognized
accreditation bodies and FDA both have the authority and the
responsibility to exercise their oversight to help ensure that
laboratories comply with the requirements of this subpart including the
requirements of Sec. 1.1147.
Some comments point to a widely publicized foodborne illness
outbreak case as an example of the risk presented by in-house
laboratories. In that case, several executives and employees were
convicted and sentenced for Federal crimes related to selling peanut
butter products that the defendants knew had tested positive for
Salmonella. Among other misdeeds, the defendants fabricated test
results. That is, the testing accurately indicated that the product
contained Salmonella but the owners produced fraudulent test
certificates stating the opposite. In addition, the firm did not use an
in-house laboratory; rather, it sent its product to two different
independent laboratories for analysis. Accordingly, the facts of that
case have no direct bearing on the integrity of in-house laboratories.
Furthermore, section 422(b)(2) of the FD&C Act, implemented by Sec.
1.1152(b) of this final rule, requires laboratories to send the results
of all tests covered by this subpart directly to FDA, thus protecting
against the opportunity for owners or consignees to fabricate test
results of independent or third-party laboratories.
We disagree that the statute precludes in-house laboratories from
conducting any or all testing covered by this subpart. Section
422(b)(1) of the FD&C Act contains two paragraphs. Paragraph (A) states
that certain testing ``by or on behalf of an owner or consignee'' must
be conducted by a LAAF-accredited laboratory; this paragraph describes
specific followup testing required by existing FDA regulations and
testing ``as the Secretary deems appropriate,'' in both cases to
address an identified or suspected food safety problem. Paragraph (B)
states that certain testing, ``on behalf of an owner or consignee''
must be conducted by a LAAF-accredited laboratory; paragraph (B)
describes testing in support of admission of detained imported food.
First, section 422 of the FD&C Act explicitly contemplates the
participation of in-house laboratories when it states that ``food
testing shall be conducted . . . by or on behalf of an owner or
consignee'' (section 422(b)(1)(A)). As we discussed in the proposed
rule, section 422(b)(1)(B) of the FD&C Act is silent with respect to
testing conducted on imports by owners or consignees. Under one
possible interpretation, the absence of ``by or'' in paragraph (B)
would mean that only independent laboratories may be accredited to
conduct food testing on detained imports (84 FR 59452 at 59461 through
59462).\13\ Under this interpretation, laboratories owned by owners or
consignees would be prohibited from conducting such import-related food
testing, but laboratories owned by owners or consignees would be
eligible to conduct food testing under section 422(b)(1)(A) of the FD&C
Act. That would raise the prospect that section 422(b)(1) would not
apply equally to domestic and foreign goods (section 422(b)(1)(A) of
the FD&C Act would generally apply to domestic owners or consignees and
potentially foreign owners or consignees). Such a difference in
treatment could raise potential concerns under U.S. international trade
obligations. In this regard, we note that section 404 of FSMA provides
that nothing in the FD&C Act shall be construed in a manner
inconsistent with the agreement establishing the WTO or any other
treaty or international agreement to which the United States is a
party.
---------------------------------------------------------------------------
\13\ Under another possible interpretation of section 422(b)(1),
the phrase, ``on behalf of'' may be read as sufficiently broad to
encompass in-house laboratories (i.e., an in-house laboratory
conducts testing on behalf of the entity that owns the laboratory).
In that case, the absence of ``by or'' is inconsequential, and we
would again reach the conclusion that allowing in-house laboratories
to conduct any testing under this subpart is consistent with the
statute.
---------------------------------------------------------------------------
In considering section 422(b)(1)(B) of the FD&C Act and section 404
of FSMA together, we finalize the proposed conclusion that it is
reasonable to interpret section 422(b)(1)(B) of the FD&C Act to allow
laboratories owned by owners or consignees to conduct food testing that
falls under section 422(b)(1)(B) of the FD&C Act, provided that such
laboratories meet the accreditation requirements proposed.
We understand some comments to question whether treaties or
international agreements are relevant to the food testing circumstances
covered by this subpart. Other comments appear to question whether the
existence of such treaties or international agreements justifies
permitting in-house laboratories to participate despite the purported
public health risks posed by such participation. It is undisputed that
the United States is a party to the WTO, and two WTO agreements are
relevant to FDA's regulatory authorities: (1) The Agreement on the
Application of Sanitary and Phytosanitary Measures and (2) the
Agreement on Technical Barriers to Trade. More significantly, however,
we believe we have addressed the fundamental issue at the heart of the
opposing comments, i.e., the concern that allowing in-house
laboratories (whether foreign or domestic) to become LAAF-accredited
jeopardizes public health because in-house laboratories have such a
vested interest in vouching
[[Page 68792]]
for their products that their test results are inherently suspect.
Above, we have explained our view that robust requirements in ISO/IEC
17025:2017 and in the final rule address conflict of interest and
impartiality such that in-house laboratories may qualify to become
LAAF-accredited. We also have explained our view that the statute
appropriately may be read to permit participation by such laboratories.
We therefore conclude that owners or consignees may become LAAF-
accredited as long as they satisfy all the relevant requirements of
this subpart.
Finally, to clarify, no laboratory is required to participate in
this program; it is entirely voluntary for both accreditation bodies
and laboratories.
(Comment 102) Some comments agree with the requirement in Sec.
1.1147(c) that payment for laboratory services must be independent of
the testing result; these comments indicate that it is routine
commercial practice to require payment in advance of testing to prevent
non-payment for violative samples.
(Response 102) We appreciate comments concurring with the proposed
provision and are pleased that it is common practice for laboratories
to require payment prior to conducting the test. On our own initiative
and because the section discusses impartiality and conflict of interest
requirements for a LAAF-accredited laboratory, we have clarified in
Sec. 1.1147(c) of the final rule that the LAAF-accredited laboratory
must require the owner's or consignee's payment to be independent of
the outcome of the test results.
2. What are the quality assurance requirements for LAAF-accredited
laboratories (Sec. 1.1148)?
Proposed Sec. 1.1148 concerned the quality assurance requirements
beyond those in ISO/IEC 17025:2017 for LAAF-accredited laboratories.
Paragraph (a) described the annual proficiency test requirement and
provided for the opportunity to use a comparison program if an annual
proficiency test for the method was not available or was otherwise
impracticable. Paragraph (b) provided that LAAF-accredited laboratories
ensure procedures for monitoring the validity of the results of testing
conducted under this subpart include the use of reference materials or
quality control samples with each batch of samples it tests under this
subpart.
On our own initiative, we determined that the requirements in
proposed Sec. 1.1148 are more appropriately categorized as eligibility
requirements for LAAF-accredited laboratories. As such, these
provisions are in Sec. 1.1138 of the final rule.
3. What oversight standards apply to sampling (Sec. 1.1149)?
In the proposed rule, Sec. 1.1149(a) required a LAAF-accredited
laboratory to develop (if the laboratory collected the sample) or
obtain (if the laboratory was not the entity responsible for collecting
the sample) certain documents related to sampling, prior to analyzing
the sample. Proposed paragraph (b) provided that if the sampling
documentation requirements were not met, we might consider the test to
be invalid.
Proposed paragraph (a)(1) required documentation of the sampler's
qualifications by training and experience. We proposed that such
qualification documentation need only be obtained the first time an
individual collects a sample, unless the qualifications had changed
significantly. Proposed paragraph (a)(2) required a written sampling
plan that identified the sampler and listed factors the sampler would
control to ensure sample validity. Proposed paragraph (a)(3) required a
written sample collection report to include at least the following five
elements: The product code or, if collecting an environmental sample,
the location and a description of the environment; the date of
sampling; the size, identity, and quantity of the sample; documentation
of the sample collection procedures and any sample preparation
techniques; and documentation of the chain of custody and measures
taken to secure the validity of the subsequent test, including
controlling for the representational nature of the sample. On our own
initiative, we added, ``lot number'' to the information required in a
sample collection report. This information is consistent with the other
types of information required in a sample collection report and will
provide us with better visibility into how the sample was collected, as
well as additional information to allow us to trace the sample back to
its origin.
In terms of the requirement that the sample collection report
include a product code, for domestic products we mean the product code
assigned by the manufacturer, packager, or labeler, as applicable. In
the import context, a product code is a string of letters and numbers
that represent certain information such as which industry produced the
item. For more information on product codes for imports, see https://www.fda.gov/industry/import-program-resources/product-codes-and-product-code-builder#whatcode. On our own initiative, we moved the
provisions addressing the advance notice of sampling from proposed
Sec. 1.1152(i) to a new paragraph (c) in Sec. 1.1149 of the final
rule. In the proposed rule, these provisions required that in certain
circumstances FDA may require a LAAF-accredited laboratory to request
and obtain from a sampler advance notice of sampling. We proposed that
we may require advance notice of sampling if we determine that sampling
may materially differ from the sampling documented in the associated
sampling plan or sample collection report, or, if we determine that the
sampling may otherwise have been improper.
When we require advance notice of sampling, either the LAAF-
accredited laboratory must submit, or it must require the sampler to
submit, the notice to FDA 48 hours before each of that sampler's next
10 LAAF program sampling collections. We proposed that the notice must
contain:
A unique identification code for the advance notice of
sampling;
The name of the accredited laboratory that will conduct
analysis of the sample;
The name and street address of the sampler that will
conduct the sampling;
A primary contact (name and phone number) for the sampler;
The reason(s) why the food product or environment will be
sampled;
The location of the food product or environment that will
be sampled, including sufficient information to identify the food
product or environment to be sampled;
As applicable, the U.S. Customs and Border Protection
entry and line number(s) and the FDA product code(s) of the food; and
The date and approximate time the sampling will begin.
We also proposed that FDA may, as appropriate, specify the type of
food product or environment that requires advance notice of sampling.
We proposed that we might specify an amount of time other than 48 hours
advance notice is required, between 24 hours and 7 business days. We
proposed that we might require a number of sampling occasions other
than 10, between 1 and 20. Finally, we proposed that we might notify
the LAAF-accredited laboratory that additional advance notice is not
required.
As discussed previously in Response 22, we added the term,
``sampling firm'' in Sec. 1.1102 and defined it to mean an entity that
provides sampling services. We have updated the references to sampler
in Sec. 1.1149 to more accurately distinguish between requirements for
the sampler and the sampling firm.
[[Page 68793]]
On our own initiative, for clarity, we added the phrase, ``at
least'' before ``48 hours.'' We clarify in Sec. 1.1149(c)(2)(i) that
FDA may, as appropriate, specify that the requirement regarding the
advance notice of sampling applies to samples collected by a particular
sampler. We also deleted the word, ``code,'' after, ``identification,''
because it was unnecessary and inconsistent with other uses of
``identification'' in this subpart. We also clarify in the final rule
that ``the FDA product code(s) of the food'' contained in proposed
Sec. 1.1152(i)(3)(vii) must include the product code of the food
product (if product is being sampled) or the location and a description
of the environment (if environment is being sampled). See Sec.
1.1149(c)(3)(viii) of the final rule. Finally, we made terminology,
conforming, and minor editorial changes to this section. We discuss
changes made in response to comments below.
(Comment 103) Some comments ask FDA to clarify what constitutes an
acceptable sampling plan. Some comments state that our sampling
requirements are different for different types of commodity and test,
that FDA commonly rejects results due to sampling variations, and that
we should publish all FDA Laboratory Information Bulletin methods and
refer to them in import alerts as applicable. Some comments recommend
that we align sampling requirements under this subpart with certain
existing documents that describe a scientific approach to creating or
assessing sampling protocol: The AAFCO/Association of Public Health
Laboratories/Association of Food and Drug Officials documents
``GOODSamples'' (Ref. 19) and ``GOOD Test Portions'' (Ref. 20).
(Response 103) As we discussed in the proposed rule, proper
sampling procedures are essential to meaningful test results and it is
therefore important that this subpart address the training and
procedures of samplers. After careful consideration of the comments, we
have decided that the most appropriate way to support those goals at
the present time is through the oversight provisions in this section,
rather than by requiring ISO/IEC 17025:2017-accreditation of samplers.
Accordingly, we are not establishing model standards for sampling in
this subpart. For more information on our decision not to require the
accreditation of samplers, see (Response 98.
Regarding comments' suggestion that FDA publish all Laboratory
Information Bulletin methods, we note that although we have published
some (see https://www.fda.gov/science-research/field-science-and-laboratories/laboratory-information-bulletins), Laboratory Information
Bulletins typically do not include sampling collection information.
However, there are a variety of other publicly available FDA resources
concerning sampling. Generally applicable sampling procedures and
methods are described in the FDA Food Compliance Programs (https://www.fda.gov/food/compliance-enforcement-food/food-compliance-programs)
and the sampling chapter of the IOM, Ch. 4. The IOM section 4.3.7.2
addresses random sampling. A random representative sample should
reflect the average composition of the entire lot to ensure that
analytical results are meaningful. This is particularly imperative when
potential foodborne adulterants that pose a public health risk are not
homogeneous in the product.
FDA also provides more specific information on sampling in certain
circumstances.
Some import alerts contain more customized information on sampling
(see https://www.fda.gov/science-research/field-science-and-laboratories/private-laboratory-testing). Sampling for the testing of
bottled drinking water, shell eggs, and sprouts required under Sec.
1.1107(a)(1) is impacted by the product-specific regulations and/or may
be informed by product-specific guidance. See e.g., Sec. Sec. 118.7
(addresses shell egg sampling); 129.35(a)(3)(ii) (addresses bottled
drinking water sampling); and ``Compliance with and Recommendations for
Implementation of the Standards for the Growing, Harvesting, Packing,
and Holding of Produce for Human Consumption for Sprout Operations:
Draft Guidance for Industry,'' available at https://www.fda.gov/media/102430/download (addresses product and environmental sampling for
sprouts). When finalized, this guidance will represent FDA's current
thinking on this issue.
FDA appreciates the suggestion that we consult reputable industry
sampling guidance documents. We note that the ``GOODSamples'' and
``GOOD Test Portions'' documents were generally written for use by
State and local regulatory laboratories and not for private laboratory
use. Nevertheless, we are aware of these documents and agree they are
helpful resources.
(Comment 104) Some comments disagree with, or request additional
clarification about, certain provisions within Sec. 1.1149. Some
comments express concern that requirements in Sec. 1.1149(a) for
documentation before analyzing the sample will lead to delays in
testing and obtaining results, and some comments express concern that
the delay could interfere with the sample's integrity. Some of those
comments suggest that instead, FDA should have a mechanism in place to
approve the sampling method or plan prior to sample collection.
A few comments ask FDA to clarify how a laboratory is to evaluate
the effectiveness of a sampling plan. Comments also request that FDA
clarify what would constitute a ``significant change'' in a sampler's
qualifications and how a laboratory would learn about such a change.
Some comments contend that FDA should not collect all the proposed
sampling documentation in Sec. 1.1149(a) in every instance, and argue
that the documentation need not be collected if the sample is collected
at a domestic food facility, because such entities are subject to
preventive controls regulations and we could allow the preventive
controls qualified individual to attest to the sufficiency of the
sampler's qualifications and the sampling procedures.
Other comments suggest the documentation in Sec. 1.1149(a) should
be submitted to the laboratory's recognized accreditation body. Some
comments express the view that recognized accreditation bodies are
noticeably absent from the sample document collection process and this
could be rectified by either requiring that samplers be accredited or
by establishing clear substantive sampling requirements against which
recognized accreditation bodies could assess sampling documents.
(Response 104) The submission to FDA of the sampler's
qualifications, the sampling plan, and the sampling collection report
will allow the Agency to exercise oversight over the sampling that
occurs under this subpart. We acknowledge that the proposed rule could
have been clearer on this point, but there is no requirement that the
sampling documents be submitted to or approved by FDA prior to the
LAAF-accredited laboratory conducting the test. Nor does the LAAF-
accredited laboratory need to evaluate the documents or do anything
with them prior to conducting the test; the laboratory need only submit
the documents to FDA with the analytical report, after the testing is
complete (see Sec. 1.1152(c)). As long as the LAAF-accredited
laboratory possesses the documents, it can proceed to conduct the test,
and we presume that in most instances the documents will either be
developed by the laboratory (if it collected the sample) or delivered
with the sample (if another entity collected
[[Page 68794]]
the sample). Either way, once the LAAF-accredited laboratory possesses
the sample we expect it will usually also possess the documentation
required under Sec. 1.1149(a). Relatedly, at the present time the
Agency does not perceive a need to require or create a pathway for
routine preapproval of the sample method or plan prior to sampling.
After considering the comments, we are removing from the final rule
the requirement that the LAAF-accredited laboratory obtain
documentation of an individual sampler's qualifications more than once
if that person's qualifications have ``significantly changed.'' We no
longer view the information as necessary and agree that often the LAAF-
accredited laboratory would be unaware of it. We have also clarified
that a LAAF-accredited laboratory may refer to the previously submitted
qualifications if the LAAF-accredited laboratory has previously
submitted them to FDA under Sec. 1.1152(c). We do not expect many
samples collected under this program to come from food facilities
subject to the preventive controls regulations and so decline the
invitation to create an exception to Sec. 1.1149(a) for such
establishments. We discourage samplers and LAAF-accredited laboratories
from submitting to us an individual's social security number, or other
unnecessary personally identifiable information.
For the reasons discussed above at Response 98, we have decided not
to require the accreditation of samplers at the present time, and we
also do not perceive a reviewing role for the recognized accreditation
bodies with regard to the documents required under Sec. 1.1149(a). As
noted above, submission of those documents to FDA is the mechanism
whereby we may exercise oversight of the sampling that occurs under
this subpart.
(Comment 105) Some comments express concern with the proposed
provisions on advance notice of sampling. Comments ask for
clarification regarding how these requirements might work in the
context of the directed food laboratory order and the other testing
conducted under this subpart. Comments also indicate that delays
associated with this requirement could lead to significant losses for
entities, particularly regarding perishable foods. A few comments
suggest that requiring advance notice of sampling may not be
appropriate when resolving a food safety issue that needs rapid testing
and that it is commercially and logistically impractical to regularly
specify an exact date and approximate time of sampling.
(Response 105) FDA has concluded it is reasonable for public health
reasons to require advance notice of sampling when the Agency suspects
a sampler previously has failed to follow proper protocols. Again,
utilizing appropriate sampling techniques is essential to generating a
representative sample, which is in turn essential to producing a
meaningful test result. FDA generally will require the advance notice
of sampling to be submitted to us at least 48 hours prior to collection
of the sample(s) to allow us time to determine whether to observe the
sampling or to take an audit sample and assign appropriate personnel to
the task. However, under Sec. 1.1149(c)(2)(iii), we may require an
amount of time other than 48 hours, perhaps as little as 24. In
tailoring the requirements to a particular situation, we would consider
a variety of factors including product shelf life.
It is possible that we could require advance notice of sampling in
connection with any test required to be conducted by a LAAF-accredited
laboratory, including a directed food laboratory order. As the
circumstances in which we might require advance notice of sampling vary
widely, it is impossible to predict or generalize regarding how these
requirements will be implemented, e.g., depending on the provision of
Sec. 1.1107 under which the testing falls. However, FDA will take into
consideration such factors as the type of product, its shelf life,
timing requirements of the test method, public health context for the
testing, etc., and will use the options under Sec. 1.1149(c)(2) to
customize the requirements accordingly.
(Comment 106) Some comments recommend that FDA clarify how we will
notify a LAAF-accredited laboratory that a sampler must provide advance
notice of sampling under Sec. 1.1149(c) (proposed Sec. 1.1152(i)),
and how we will track the subsequent 10 samples from that sampler. Some
comments suggest that we share with owners or consignees the pending
requirement for advance notice of sampling. Some comments emphasize the
logistical and operational challenges of several entities coordinating
around the collection of a sample. With regard to the requirements in
Sec. 1.1149(c)(3)(iii) (proposed Sec. 1.1152(i)(3)(iii)) that the
advance notice include the sampler's name and street address, some
comments seek clarification as to why we would require the sampler's
street address. Some comments recommend that we clarify that the
requirement is for a business name and address for the sampling entity,
and not an individual's name and address. In addition, these comments
suggest we clarify that the primary contact required by Sec.
1.1149(c)(3)(iv) (proposed Sec. 1.1152(i)(3)(iv)) should be the
individual managing the sampling operation.
(Response 106) First, we note that under Sec. 1.1149(c), the LAAF-
accredited laboratory is not simply communicating a requirement to the
sampler. Instead, the LAAF-accredited laboratory is the entity required
either to obtain the advance notice of sampling from the sampler and
submit it to FDA itself, or to require the sampler to submit the notice
directly to FDA.
In terms of our communications with LAAF-accredited laboratories
regarding Sec. 1.1149(c), such communications may occur by email but
regardless, will be tailored to the circumstances. Further, we may use
a variety of methods to track subsequent collections by a sampler
identified under Sec. 1.1149(c); one method will be to review the
documents we receive under Sec. 1.1149(a).
Regarding the suggestion that we inform owners and consignees when
we will require advance notice of sampling from a particular sampler,
we have revised the codified text to state that we may, as appropriate,
notify the owner or consignee that advance notice of sampling applies
to food testing conducted on its behalf. Such notification is
consistent with current FDA practice in the context of reviewing
import-related private laboratory analytical packages (PLAPs), which we
have been doing for years. If FDA identifies a deficiency in a PLAP, we
routinely inform the owner or consignee the basis for FDA's concern
(i.e., we would inform the owner or consignee if we identified a
sampling problem that may have impacted the test result).
FDA has experience auditing samplers and we acknowledge that it can
be a logistical challenge. Nevertheless, when we have cause for concern
with a particular sampler, especially given the public health context
in which testing under this subpart occurs, it is reasonable to require
advance notice of sampling.
Finally, after considering the comments regarding the sampler's
name and address required by Sec. 1.1149(c)(3)(iii) and the primary
contact required by Sec. 1.1149(c)(3)(iv), we note that we have
revised this section to incorporate the new term, ``sampling firm''
(see Sec. 1.1102). We have revised these sections to refer instead to
the sampling firm information in the final rule.
Our general purpose in requiring a sampling entity's address in an
advance
[[Page 68795]]
notice of sampling is to clearly identify the commercial operation
responsible for conducting the sampling. Again, we would only require
an individual sampler's name and street address if that person has been
contracted to provide sampling services for testing conducted under
this subpart. If an individual has assumed responsibility for that
task, then we have an interest in ensuring that we can properly
identify that individual and a street address helps us to do so. We
again emphasize that all the tests required to be conducted by a LAAF-
accredited laboratory occur in the context of heightened public health
concern. Although we are not requiring the accreditation of samplers,
we nevertheless require that any individuals collecting samples under
this subpart be properly qualified. Owners and consignees risk having
us reject test results if the sample that was analyzed, was collected
using improper sampling methods or procedures. If we have cause to
believe that past sampling conducted by an individual has, for example,
materially differed from the sampling described in the sample
collection report, this may constitute a reasonable need to clearly
identify that individual and may also provide a reasonable basis on
which to audit that person's future sampling activities.
4. What are the requirements for analysis of samples by a LAAF-
accredited laboratory (Sec. 1.1150)?
Proposed Sec. 1.1150 concerned requirements for analysis of
samples by a LAAF-accredited laboratory. Paragraph (a) required
analysis to be conducted on the sample received from the sampler or a
representative sample of the sample received from the sampler.
Paragraph (b) provided requirements for the analyst conducting the
analysis: (1) To be qualified by appropriate education, training or
experience; (2) to have appropriately demonstrated their ability to
perform the method properly in the specific context of the food testing
to be conducted; and (3) be in compliance with the conflict of interest
requirements in this subpart. Paragraph (c) required that the method
used to conduct food testing meet the requirements of Sec. 1.1151.
Paragraph (d) stated that the LAAF-accredited laboratory must document
testing information and test results to account for all the information
that is required to be included in a full analytical report. We note
that this requirement concerns all testing under this subpart,
regardless of whether the LAAF-accredited laboratory submits full or
abridged analytical reports (see Sec. Sec. 1.1152 and 1.1153 of the
final rule).
We have made revisions to the section to update terminology and
cross-references to reflect the reorganization of the final rule. We
revised the section title to read, ``What are the requirements for
analysis of samples by a LAAF-accredited laboratory?'' and made minor
editorial changes to the section. We received no comments specific to
this section and made no further changes.
5. What requirements apply to the methods of analysis a LAAF-accredited
laboratory uses to conduct food testing under this subpart (Sec.
1.1151)?
Proposed Sec. 1.1151 concerned requirements for methods of
analysis a LAAF-accredited laboratory uses to conduct food testing
under this subpart. Paragraph (a) required that analysis conducted
under this subpart must be conducted using a method of analysis that is
fit for purpose, within the laboratory's scope of LAAF-accreditation,
and has been appropriately validated and verified for use in such food
testing. In paragraph (b), we stated that if a method is prescribed by
the FD&C Act or implementing regulations for the testing under Sec.
1.1107(a)(1), or by the directed food laboratory order for the testing
under Sec. 1.1107(a)(2), then that method must be used to conduct food
testing under this subpart. Paragraph (c) stated that a LAAF-accredited
laboratory must validate methods and record the information. Paragraph
(d) stated that before a LAAF-accredited laboratory conducts food
testing under this subpart using a method for a specific intended use
for which the method has been validated, but for which the laboratory
has not previously applied the method under this subpart, the LAAF-
accredited laboratory must have verified it can properly perform the
method for the specific intended use. Further, a LAAF-accredited
laboratory performing verification of a method under this subpart must
record the method that is the subject of the verification, the intended
purpose of the analysis, the results of the verification, the procedure
used for the verification, supporting analytical data, and whether the
accredited laboratory is able to properly perform the method. Paragraph
(e) provided that a LAAF-accredited laboratory may submit a request to
FDA to use a method outside its scope of LAAF-accreditation. FDA may
approve the request if: (1) A new method has been developed and
validated, but no reasonably available laboratory has been accredited
to perform the method and (2) use of the method is necessary to
prevent, control, or mitigate a food emergency or foodborne illness
outbreak.
We made several revisions to this section on our own initiative to
improve clarity and readability of the section. We also have updated
terminology and revised cross-references throughout the section,
including the section title. Comments regarding this section are
discussed below.
(Comment 107) Some comments ask FDA to identify the criteria that
will be used to assess whether a method is ``fit for purpose'' in Sec.
1.1151(a)(1). Other comments request that FDA provide a list of
validated methods deemed fit for purpose. These comments state that
since there may be more than one method that could be classified as
such, there may be inconsistent test results from use of different
methodologies.
In the proposed rule, we referenced a page on our website that
lists methods currently being used for food and feed safety programs:
https://www.fda.gov/food/science-research-food/laboratory-methods-food
(84 FR 59452 at 59481). Some comments argue that this website is often
outdated or incomplete, and that FDA should publish a complete list and
reference it in import alerts. Other comments urge FDA to specify
methods in import alerts. These comments state that some import alerts
cover perishable food items such as produce, and it would be impossible
to validate a new method quickly enough to test such perishable goods.
(Response 107) As a preliminary matter, we describe some key terms.
Validation is meant to demonstrate that a method is suitable for the
intended purpose, and verification is meant to show that the laboratory
can properly apply the method for a specific intended use, and meet the
performance criteria of the method for the matrix and analyte being
tested. When we say a method is ``fit for purpose,'' we mean that it
may only be applied for the food testing to which it is intended to
apply, for the purpose for which it is validated, and that the method
performance is suitable for the intended use--specifically with respect
to the limit of detection or probability of detection, specificity,
reproducibility, and accuracy. Due to the broad range of testing under
this subpart, it is not possible for us to provide a more specific set
of criteria for determining whether a method is fit for purpose. (See
also, section 7.2.1.4 of ISO/IEC 17025:2017 (Ref. 3).)
Standard methods must be verified and non-standard methods or a
standard method applied outside its original scope (for example,
applied in a different food matrix) must be validated.
[[Page 68796]]
If a LAAF-accredited laboratory wishes to use a method that is already
validated, the laboratory must verify that the laboratory is able to
run the method and achieve an acceptable detection limit. If a method
validation was not performed on a particular food category (i.e.,
validation performed on dairy but the new matrix is fruit or
vegetables) then the laboratory will need to perform a ``matrix
extension'' either through a single laboratory validation or an
independent validation study. We will review laboratory analytical
reports to determine whether the food matrix tested fits into a
validated matrix, and if not, the laboratory will need to perform a
matrix extension. (For additional discussion of matrix extensions, see
Response 108.) FDA guidelines for validations can be found at: https://www.fda.gov/science-research/field-science-and-laboratories/method-validation-guidelines. LAAF-accredited laboratories may use these
guidelines in performing validation studies, or they may use other
established and recognized protocols, such as those published by AOAC.
We request that a LAAF-accredited laboratory cite the protocol used
when submitting a validation.
Regarding the request that FDA provide a list of validated methods
deemed fit for purpose, we decline to provide a list or to include
specific methods in import alerts. It is simply not practical for FDA
to try and provide an exhaustive list of all methods that may be
appropriate in food testing circumstances. The website provided above
(and in the proposed rule) is one example of a potential resource for
methods of analysis; we endeavor to keep it current. Also, a method
prescribed for use in a compliance program is considered to have
already been validated. (See https://www.fda.gov/food/compliance-enforcement-food/food-compliance-programs and https://www.fda.gov/animal-veterinary/compliance-enforcement/cvm-compliance-programs.)
However, laboratories are not required to use these methods.
Regarding specifying methods in import alerts, in most cases it not
necessary to limit testing to a single specific method where there are
multiple acceptable methods of analysis. Further, we do not agree with
the comments expressing concern that use of different methodologies may
produce inconsistent results; validated methods that are fit for
purpose and conducted properly by a laboratory should yield consistent
results. Indeed, that concept lies at the base of all validation
studies; if the new method works properly, the result should be
consistent with the result produced using the standard method.
Finally, we agree that validating a new method takes time. It is
anticipated that products under import alert will already have
appropriate methods available. For import alerts concerning time-
sensitive products, we expect that owners and consignees will refer to
the online registry described in Sec. 1.1109 (once it is up and
running) to locate a LAAF-accredited laboratory that is able to conduct
the desired test promptly.
(Comment 108) Many comments agree with the requirements in proposed
Sec. 1.1151(a)(3) and (4) that methods used under this rule must be
appropriately validated or verified. However, some comments state that
it would be very onerous for a laboratory to validate every single
potential food matrix. Some of these comments discuss the example in
the preamble to the proposed rule regarding chloramphenicol in shrimp
(see 84 FR 59452 at 59480) and assert that this example conflicts with
FDA validation guidance and use of the AOAC Food Matrix Triangle to
group like foods into one validation. Other comments request that we
clarify when a matrix extension or further validation would be
necessary, especially if other validated methods are available.
(Response 108) Appropriate method validation and verification, as
just discussed in Response 107, is critical to data acceptability.
Although tools such as the AOAC Food Triangle are commonly used to
group like foods, there are sometimes limits to this approach as
provided in the example of the chloramphenicol analysis that performs
differently for fish and shrimp which are similar matrices within the
same food group. Though it is generally assumed that the more closely
related a new food matrix is to a previously validated matrix from the
same food group for the detection of a defined analyte, the greater the
probability that the method will perform similarly with the new matrix,
the method must nonetheless be verified for all new matrices. This is
to ensure that the new matrix will neither produce high false positive
rates (e.g., matrix is free from cross reactive substances) nor high
false negative rates (e.g., matrix is free of inhibitory substances).
As we agree that it would be onerous for a laboratory to validate every
single potential food matrix, an acceptable approach for a matrix
verification within the same food group as the validated matrices is
the use of spiked samples and blank matrix (if available) as described
in the ``matrix extension'' sections of the validation guidance
documents provided at: https://www.fda.gov/science-research/field-science-and-laboratories/method-validation-guidelines. Note that
matrices falling within food groups not previously validated cannot use
this approach and will require validation.
Some comments asking about our requirements for verification and
validation studies reference the portion of the PRIA in which we
estimated the cost of requiring LAAF-accredited laboratories to submit
additional verification studies to be between 1 percent and 5 percent
of the costs for verification and validation activities required to
maintain ISO/IEC 17025:2017 accreditation. To the extent that such
comments are questioning why we would estimate between 1 percent and 5
percent of the costs for verification and validation studies over and
above verification and validation costs required to maintain
accreditation to ISO/IEC 17025:2017, we note that the additional costs
acknowledge the possibility of differing requirements for matrix
extensions between this subpart and ISO/IEC 17025:2017 on a case-by-
case basis.
Finally, we agree that in most cases it is not necessary to limit
testing to a single specific method where there are multiple acceptable
methods of analysis.
(Comment 109) A few comments state that proposed Sec. 1.1108(b)
provided that the directed food laboratory order would specify, among
other things, ``the manner of the food testing, such as the methods
that must be used'' whereas proposed Sec. 1.1151(b)(2) stated that
``if the [directed food laboratory] order prescribes a test method,
that is the only appropriate method. . . .'' These comments explain
that, read in conjunction, these proposed sections indicate that FDA
may not specify a method in the directed food laboratory order and may
allow a LAAF-accredited laboratory to use an appropriate method within
its scope of LAAF-accreditation.
(Response 109) As discussed above in Response 54, in a directed
food laboratory order, we would specify the method to the owner or
consignee and, in some circumstances, may provide flexibility to use
equivalent methods, so that an owner or consignee may have access to a
greater number of LAAF-accredited laboratories that could conduct the
testing. If a directed food laboratory order allows for flexibility to
use equivalent methods, a LAAF-accredited laboratory could use an
appropriate method within its scope of LAAF-accreditation which meets
the requirements of this section.
(Comment 110) Proposed Sec. 1.1151(e) implemented the waiver
provision of
[[Page 68797]]
section 422(b)(3) of the FD&C Act and stated that a LAAF-accredited
laboratory could submit a written request to FDA requesting permission
to use a method outside its scope of LAAF-accreditation. The proposed
rule went on to state that FDA may approve the request if two
conditions were met: (1) A new method had been developed and validated
but no reasonably available laboratory had been accredited to perform
the method and (2) the use of the new method is necessary to prevent,
control, or mitigate a food emergency or foodborne illness outbreak.
Some comments agree that FDA should decide whether to allow a LAAF-
accredited laboratory to use a method outside its scope; they state,
however, that the recognized accreditation body is not involved in the
decision and should be notified. Other comments urge FDA to clearly
define ``reasonably available'' to avoid improper use of this exception
and an unfair barrier to competition among laboratories if, for
example, one LAAF-accredited laboratory is not reasonably available due
to a longer turnaround time than another.
(Response 110) We appreciate the supportive comments. Given the
narrow circumstances in which the statute contemplates FDA waiving the
requirements of this subpart (e.g., new method and either a food
emergency or a foodborne illness outbreak), we disagree that a
definition of ``reasonably available,'' is necessary to avoid our abuse
of this provision. Further, we hesitate to limit our authority to rely
on this subpart in the context of either an outbreak or an emergency.
We expect that in most circumstances, we would notify a recognized
accreditation body if we authorize a laboratory it has LAAF-accredited
to use a method outside the scope of the laboratory's LAAF-
accreditation. However, because food emergencies and outbreaks may
necessitate fast action, we decline to add to the final rule a
commitment that we will notify the recognized accreditation body in
every situation.
6. What notifications, results, reports, and studies must a LAAF-
accredited laboratory submit to FDA (Sec. 1.1152)?
Proposed Sec. 1.1152 concerned the notifications, results, and
reports a LAAF-accredited laboratory must submit to FDA. Note that in
the final rule we devote a separate section to abridged analytical
reports (Sec. 1.1153), and so the content from proposed Sec.
1.1152(d), (e), and (f) is now located in Sec. 1.1153 of the final
rule. In the final rule we also relocated the contents of Sec.
1.1152(i), on advance notice of sampling, to Sec. 1.1149.
In the proposed rule, paragraph (a) of Sec. 1.1152 stated general
requirements such as that all LAAF-accredited laboratory notifications,
results, reports, and studies must display a unique identification
(e.g., an alphanumeric identifier unique to each analytical report, to
clarify which pages comprise the report), and that the LAAF-accredited
laboratory must submit corrected versions if the LAAF-accredited
laboratory becomes aware that the originals were in some way
inaccurate.
Briefly, in proposed paragraph (b) we stated that test results must
generally be submitted by the LAAF-accredited laboratory directly to
FDA via a destination we will specify on the website described in Sec.
1.1109. Also briefly, in paragraph (c) we listed the documentation
required to be submitted to FDA with each test result: All sampling
documentation required by Sec. 1.1149, a full analytical report unless
permitted to submit an abridged analytical report, validation or
verification information required by Sec. 1.1151 unless submitted to
the recognized accreditation body under proposed Sec. 1.1138, and a
signed certification from the laboratory's management that the
submissions are true, accurate, and include the results of all the
tests conducted under this subpart. Note that in the final rule, we
moved the requirement for submission of justification and authorization
for deviating from or modifying the method of analysis to paragraph
(c). In the proposed rule, that requirement was stated once for
abridged analytical reports (Sec. 1.1152(f)(2)) and also referenced
for full analytical reports (Sec. 1.1152(g)(1)); for efficiency and
clarity it is now stated once in Sec. 1.1152(c).
Proposed paragraph (g) listed the required contents of a full
analytical report, such as documentation of references to the test
method used, identification and qualifications of the analyst(s),
calculations, and identification of any software used. Proposed
paragraph (h) stated that if the LAAF-accredited laboratory used a
method not published in a reputable standard or that is otherwise not
publicly or readily available, the LAAF-accredited laboratory must
submit documentation of the method to FDA upon request. Proposed
paragraph (j) required LAAF-accredited laboratories to immediately
(within 48 hours) notify FDA and the recognized accreditation body of
any changes that affect LAAF-accreditation. Proposed paragraph (k)
provided that if FDA does not receive all the information required in
Sec. 1.1152, we may consider the related testing to be invalid.
On our own initiative, we made several revisions to this section in
the final rule. We revised the title of the section to include
``studies'' to more accurately reflect the contents of the section. We
revised paragraph (a) to remove the requirement here for notifications,
results, and reports to be submitted electronically and in English; the
requirement remains and is now in Sec. 1.1110 of the final rule. We
have also revised the list of general requirements for all
notifications, results, reports, and studies required to be submitted
to FDA in paragraph (a)(1) to improve clarity and readability. We
revised paragraph (b) to clarify that a LAAF-accredited laboratory must
identify on the test results the name and street address of the owner
or consignee for which the testing was conducted and, as appropriate,
the U.S. Customs and Border Protection entry number and line number(s).
The entry and line numbers link import-related tests with related
product shipments; they are inapplicable in the domestic context.
Although ISO/IEC 17025:2017 provides that test reports include the name
and contact information for the customer, FDA needs the level of detail
we have specified in the final rule so that we may precisely identify
the entity and/or article of food to which the test results relate. We
have also revised the section to reflect revised terminology, to update
cross-references, to improve the clarity and readability of the
section, and to make minor editorial changes. We discuss additional
changes made in response to comments below.
(Comment 111) Some comments recommend that FDA establish uniform
analytical data requirements by adopting international accreditation
standards and appropriate national scientific technical standards as
the main basis for qualifying laboratories and sampling organizations
to sample and submit analytical data to FDA.
(Response 111) We agree with the aspects of these comments stating
that it can be beneficial to rely on international standards in the
right circumstances. Accordingly, we are relying on the international
voluntary consensus standards ISO/IEC 17025:2017 and ISO/IEC 17011:2017
as the foundational requirements for laboratories and accreditation
bodies, respectively, under this subpart. Further, we agree with the
aspects of comments stating that the LAAF program will benefit from
uniform requirements for test records and the data, analysis, and
information supporting the test result. However, we
[[Page 68798]]
do not agree that such requirements in a voluntary consensus standard
or national scientific technical standard alone would meet the unique
needs of the LAAF program. Accordingly, we have established in
Sec. Sec. 1.1152, 1.1153, and 1.1154 the notifications, results,
records, and reports that a LAAF-accredited laboratory must create,
maintain, and submit under this subpart.
For our discussion regarding the decision not to require ISO/IEC
17025:2017 accreditation of samplers, see Response 98.
(Comment 112) Some comments express the mistaken impression that
results from tests conducted under this subpart will be made publicly
available.
(Response 112) Information on the recognized accreditation bodies
and LAAF-accredited laboratories participating in the LAAF program will
be made available via the online registry described in Sec. 1.1109.
However, test results will not be made public. All the testing
conducted under this subpart is initiated by an owner, such as a food
producer or a consignee, such as an importer of food. The owner or
consignee contracts with a LAAF-accredited laboratory to conduct a food
test. Due to the public heath significance of the test, various
provisions of the FD&C Act grant FDA the authority to require the test
results and associated records and reports to be submitted to us, but
these documents contain confidential business information. FDA will
treat such information in accordance with the requirements of
applicable information disclosure laws, such as FOIA and its
implementing regulations.
(Comment 113) Some comments recommend clarifications to proposed
Sec. 1.1152(b). As proposed, section 1.1152(b)(1) stated that, ``the
results of any and all tests conducted by an accredited laboratory
under this subpart must be submitted directly to FDA''; some comments
contend that this provision could be misinterpreted to mean that all
testing from a LAAF-accredited laboratory must be submitted to FDA.
These comments recommend that this section be revised to clearly state
that LAAF-accredited laboratories only need to send test results to FDA
if the testing is conducted under this subpart.
Other comments urge FDA to address when LAAF-accredited
laboratories should send test results to the owner or consignee of the
product, e.g., at the same time as the results are submitted to FDA.
Comments state that given the importance of the results, owners and
consignees need this information to make informed decisions about the
products to protect public health.
(Response 113) Proposed Sec. 1.1152(b)(1) was intended to apply
only to the results of tests required to be conducted by LAAF-
accredited laboratories under this subpart. We have revised the
provision as follows: ``The LAAF-accredited laboratory must submit the
results of all testing required to be conducted under this subpart
directly to FDA via the location specified by the website described in
Sec. 1.1109, unless another location is specified by FDA regarding
testing conducted under Sec. 1.1107(a)(2) or (a)(3).'' See Sec.
1.1152(b)(1) of the final rule.
We decline to address the timing of when a LAAF-accredited
laboratory sends results to the owner or consignee. Section 422(b)(2)
of the FD&C Act states that testing results under this subpart shall be
sent directly to FDA. Nothing in section 422 of the FD&C Act addresses
sharing test results with an owner or consignee. Therefore, we decline
to regulate or opine on this matter. In short, the issue of when the
LAAF-accredited laboratory shares test results with the food owner or
consignee is strictly a matter of negotiation between those two
parties. We note that nothing in the final rule would prohibit the
LAAF-accredited laboratory from sending the results of testing required
to be conducted under this subpart to the owner or consignee at the
same time results are sent to FDA in accordance with this subpart.
(Comment 114) Regarding the testing described in Sec. 1.1107(a)(1)
(explicit followup testing requirements in existing FDA regulations),
some comments express concern that requiring such tests to be conducted
by LAAF-accredited laboratories may delay products moving into
commerce. We understand these comments to reason that the use of
different methods by different laboratories may result in confusion and
therefore delay the release of product being held pending the test
results. These comments recommend that FDA specify testing requirements
and timelines for each product subject to testing under Sec.
1.1107(a)(1). These comments also request that we provide owners and
consignees with guidance on any product hold requirements during
testing.
(Response 114) Section 1.1107(a)(1) requires that certain followup
tests required by existing product-specific FDA regulations be
conducted by a LAAF-accredited laboratory. There are three commodities
for which existing FDA regulations require followup testing that is
covered under this subpart: Sprouts, shell eggs, and bottled drinking
water. Producers of these three commodities have been required to
conduct the particular followup tests referenced in Sec. 1.1107(a)(1)
for years; under this final rule, the new requirement is for producers
to have the tests conducted by a LAAF-accredited laboratory.
There is no reason to suspect that LAAF-accredited laboratories
will be slower than other laboratories, nor is there any reason to
suspect that test results from LAAF-accredited laboratories will be
more confusing than results from other laboratories. In fact, we
anticipate less confusion with results from LAAF-accredited
laboratories because such laboratories must meet the standards we are
establishing in this rule. For example, all LAAF-accredited
laboratories will be ISO/IEC 17025:2017-accredited and will participate
in the proficiency test and other quality assurance activities required
under this subpart.
Further, wide variation in test methods is less probable in the
context of testing under Sec. 1.1107(a)(1). Existing sprouts, shell
eggs, and bottled drinking water regulations and guidances address the
test methods for the tests referenced in Sec. 1.1107(a)(1) (see
Sec. Sec. 129.35(a)(3)(ii) (bottled drinking water), 118.8 (shell
eggs), 112.152 (sprouts)).
For the foregoing reasons, there is no need for us to further
specify testing requirements and timelines for these products, nor is
additional guidance on these specific test requirements necessary as a
result of this rulemaking.
(Comment 115) Some comments disagree with proposed Sec. 1.1152(h),
which stated that LAAF-accredited laboratories that use non-standard
methods that are not publicly available in a reputable international or
national standard must submit documentation of the method to FDA upon
request and caution that laboratories may be hesitant to provide
proprietary method information to the FDA. Others question whether we
should allow use of non-standard methods for testing under this subpart
at all, arguing that results generated for regulatory purposes should
be transparent to the regulated industry and the public.
Other comments agree with the requirement to submit documentation
of a non-standard method in proposed Sec. 1.1152(h) but believe the
information would be redundant since it would be included on the
certificate of analysis. Comments also contend that FDA does not have a
mechanism for reviewing the requested information on non-standard
methods.
[[Page 68799]]
(Response 115) First, we note that this provision appears in Sec.
1.1152(e) in the final rule.
We decline to prohibit use of non-standard methods in the LAAF
program. First, given the breadth of food testing covered by this rule,
it is not practical to rely solely on standard methods. Moreover, test
methods, test results, and analytical reports submitted to FDA under
this program will not be made publicly available regardless of whether
a standard method was applied; accordingly we do not believe use of
non-standard methods is problematic. Therefore, LAAF-accredited
laboratories can use any validated and verified method within the scope
of their LAAF-accreditation. LAAF-accredited laboratories are not
limited to using methods FDA has developed or uses; they can use any
properly validated and verified method as long as the method achieves
the same performance specifications as the FDA method. Any standard or
FDA official methods need verification to ensure that the LAAF-
accredited laboratory is capable of performing the analysis, and all
non-standard and laboratory-developed methods need method validation.
If a standard method has been modified significantly, it requires
revalidation. We acknowledge the concerns regarding submitting
proprietary information method information to FDA and will protect such
information.
We disagree that the information FDA would request under Sec.
1.1152(e) is redundant. The certificate of analysis includes a
reference to the method used; for published or standard methods, FDA
can use the reference to determine the technology and methods used
without requesting additional information. Section 1.1152(e) will allow
FDA to request documentation of a non-standard method and will ensure
that we have access to the same type of information on which to base
our review as we would for published or standard methods.
We also disagree that FDA does not have a mechanism for reviewing
requested information on non-standard methods. For decades, FDA field
scientists have been assessing the scientific credibility, reliability,
and validity of each analytical testing result, and the analytical
methods used to obtain these results, as part of reviewing the PLAPs
submitted to FDA (see ORA Laboratory Manual Volume II, ORA-LAB.5.4.5
``Methods, Method Verification and Validation'' (Ref. 21)).
(Comment 116) Comments suggest that it is unnecessary and
burdensome for FDA to request that the qualifications of the laboratory
analyst be submitted as part of a full analytical report in proposed
Sec. 1.1152(g)(12), as the recognized accreditation body would have
already reviewed and vetted the analyst as part of their accreditation
process. A few comments question how FDA will use the analyst
information requested in the full analytical report. Other comments
state that personal analyst information is not needed if individual
proficiency testing worksheets are collected. Several comments seek
clarification on how FDA intends to use such information and how FDA
will protect individual analyst information from disclosure.
(Response 116) Under final Sec. 1.1152(d)(12), we are requiring
that certain information on the qualification of individual analysts be
submitted to FDA the first time that analyst conducts testing under
this subpart and to account for any significant changes (e.g., new
competencies gained). Briefly, we require the analyst's curriculum
vitae, training records for the methods that the analyst is qualified
to perform, and any other documentation of the analyst's ability to
perform the method properly (see Sec. 1.1150(b)). Note that in the
final rule we are not requiring individual proficiency test worksheets
as part of the full analytical report; for that discussion see Response
93, and we have clarified that analyst training information is limited
to the applicable methods (we are not requiring submission of all an
analyst's training records).
Analyst-specific information is essential to our review of the
LAAF-accredited laboratory's performance; it allows us to verify the
technical competence of the individual conducting the test. Further,
while recognized accreditation bodies assess LAAF-accredited
laboratories every 2 years (see Sec. 1.1120), there may be significant
analyst turnover and changes in responsibilities in the interim. We
note that analyst-specific information is not required for abridged
analytical reports (see Sec. 1.1153(c) of the final rule).
We have been routinely collecting information on individual
analysts as part of the PLAPs submitted to support admission of an
article of imported food and removal from import alert. FDA is
critically aware of protecting individual personally identifiable
information, and FDA information technology systems have safeguards in
place to ensure this information remains confidential. Having said
that, we discourage LAAF-accredited laboratories from submitting to us
an individual analyst's social security number or any other unnecessary
personally identifiable information.
(Comment 117) Several comments express concern with FDA collecting
and reviewing test results and analytical reports. Some comments state
concern with the resources required for the Agency to review test
results and analytical reports and the mechanisms to ensure consistent
review across FDA.
(Response 117) FDA has been collecting and reviewing the private
laboratory test results and analytical packages used to support
admission of an article of imported food and removal from import alert
for decades. To implement the LAAF program described in section 422 of
the FD&C Act, FDA will collect and review additional test results and
analytical packages as well (e.g., shell egg testing) (see Sec.
1.1107). This program is designed to further protect the U.S. food
supply and FDA is committed to implementing this program and realizing
the public health benefits associated with the improved confidence in
these test results. See the FRIA (Ref. 4) for additional discussion of
the estimated costs (and cost savings) to FDA associated with this
rule.
For discussion of how we ensure consistent review of analytical
reports, please see Response 132.
(Comment 118) Some comments ask whether the justification for any
modification to or deviation from the method of analysis and the
recognized accreditation body's authorization therefore should be
submitted as an extra document or as part of a full or abridged
analytical report.
(Response 118) ISO/IEC 17025:2017 requires the laboratory to
justify and authorize any method deviation or modification (e.g.,
sections 5.6.b and 5.6.c require personnel to have the authority and
resources to identify and prevent or minimize deviations; section
7.2.1.7 requires deviations to be technically justified and authorized)
(Ref. 3). Final Sec. 1.1152(c)(5) requires the LAAF-accredited
laboratory to submit documentation of any such justification and
authorization to FDA as part of the documentation required to be
submitted with test results. Regarding the method of submission, the
justification and authorization should be a distinct document, clearly
marked, within the analytical report.
Again, note that in the final rule this requirement appears at
Sec. 1.1152(c)(5), which is the provision detailing information
required with every analytical report (whether full or abridged); in
the proposed rule the requirement was repeated in the separate lists of
what is required in a full and what is required in an abridged
analytical report.
[[Page 68800]]
(Comment 119) Some comments state that the reporting requirements
under Sec. 1.1152 should be modified, suggesting that they are
duplicative, onerous, and can create unnecessary delays and increases
in both laboratory administrative time and FDA review. Under the
proposed rule, laboratories would be required to be accredited by
recognized accreditation bodies that are full members of the ILAC (see
Sec. 1.1113); some comments state this means that FDA should require
less documentation under Sec. 1.1152. Some comments state that testing
procedures within the scope of LAAF-accreditation are assessed by
auditors and that certificates of analysis of test medium and equipment
calibration are reviewed before LAAF-accreditation is granted. Further,
comments question the need for the analyst name and signature for each
analytical step. Comments overall question the added value of
collecting what they view as a large amount of information.
Some comments express concern over the burden of submitting the
full analytical reports as required under proposed Sec. 1.1152(g). To
decrease this burden, the comments recommend that FDA reduce the level
of detail in each report since ISO/IEC 17025:2017 already includes
periodic audits by the accreditation body for many of these analytical
report requirements, such as proficiency testing and verification and
validation studies required by proposed Sec. 1.1152(c). The comments
also suggest that the frequency of reporting to FDA could be adjusted
and reduced based on risk.
A few comments also suggest that an official certificate of
analysis from a laboratory accredited by a recognized accreditation
body and submission of an analytical report meeting the requirements of
ISO/IEC 17025:2017 should be sufficient to serve as the full analytical
report required in proposed Sec. 1.1152(g).
Some comments express the belief that certain documents listed
below should not be required to be submitted to FDA with each test
result under proposed Sec. 1.1152:
All sampling plans and sample collection reports related
to food testing conducted and written documentation of the sampler's
qualifications (proposed Sec. 1.1152(c)(1) and (2));
Certification from one or more members of the accredited
laboratory's management certifying that test results, notifications,
reports and studies are true and accurate (proposed Sec.
1.1152(c)(7));
Documentation of references for the method or methods of
analysis used (proposed Sec. 1.1152(g)(2));
Identification of the analyst(s) who conducted each
analytical step, validation step, and verification step, including
analyst(s) legal name and signature (proposed Sec. 1.1152(g)(3));
Calculations (proposed Sec. 1.1152(g)(4));
References, in color, of chromatograms, charts, graphs,
observations, photographs of thin layer chromatographic plates, and
spectra (proposed Sec. 1.1152(g)(5));
Copy of the label from any immediate container sampled and
any additional labeling needed to evaluate the product (proposed Sec.
1.1152(g)(7));
All original compilations of raw data secured in the
course of analysis, including discarded, unused, or reworked data, with
the justification for discarding or reworking such data, corresponding
supporting data, and quality control results all identified with unique
sample identification (proposed Sec. 1.1152(g)(8));
Any other relevant additional supporting information,
storage location of analyzed samples, and appropriate attachments such
as instrument printouts, computer generated charts and data sheets,
photocopies or original labels for the product analyzed (proposed Sec.
1.1152(g)(9));
Curriculum vitae of testing analysts, training records for
analyst(s), including dates of training, name of trainer; any other
documentation of the analyst(s)' ability to perform the method properly
in the context of the food testing (proposed Sec. 1.1152(g)(12);
``Documents related to the accredited laboratory's grant''
(proposed Sec. 1.1153(a)(1)).
A few comments support the submission of the remaining items in
proposed Sec. 1.1152(a), (c), and (g), with the exception of the
modifiers ``all'' and ``any'' throughout Sec. 1.1152 since comments
contend the language is unclear and may put participating laboratories
at unreasonable risk.
(Response 119) After considering the comments, FDA is making
limited changes to the required contents of a full analytical report.
We note that documents related to the LAAF-accredited laboratory's
grant of LAAF-accreditation are not required to be submitted as part of
an analytical report. Next, we note that we have removed the individual
proficiency test worksheet requirement from among the documents to be
submitted as part of a full analytical report. Also, we have clarified
in the final rule that analyst training information is only for the
applicable methods, not all training records. We also added a
parenthetical clarification after ``quality control results,'' which
states, ``including the expected result and whether it is acceptable.''
Note that we have added corresponding text to the required contents of
an abridged analytical report; see our discussion of Sec. 1.1153
below.
According to some comments, FDA is asking for too much information
in a full analytical report or is asking for LAAF-accredited
laboratories to prepare and maintain too much information or
documentation for each test. The reason we disagree with both
contentions is based on our mission of protecting the public health
from adulterated food products; namely, in order for FDA to responsibly
carry out its duties with regard to the food testing described in Sec.
1.1107, we need to be able to assess the scientific credibility,
reliability, and validity of each test result. When a LAAF-accredited
laboratory submits a full analytical report, we are able to conduct a
meaningful scientific review of the LAAF-accredited laboratory's work.
When a laboratory submits an abridged analytical report, we must be
able to promptly access the information that would facilitate our
substantive scientific review; hence, we require its creation and
maintenance under this subpart (see Sec. 1.1150(d)).
To the extent that we are allowing for the submission of abridged
analytical reports under this subpart, we are allowing laboratories
that have been LAAF-accredited by a recognized accreditation body to
submit less documentation under this rule than we have routinely
accepted for import-related PLAPs. We do not agree with comments
arguing that because a recognized accreditation body reviews some
laboratory documentation during its biennial assessment, we should
decline to review documentation related to individual test results; the
purpose of an assessment by a recognized accreditation body is entirely
different than the purpose of our review of analytical reports and
naturally the scope and depth of the two activities will reflect those
differences.
With regard to the particular documents the comments suggest we
should not require:
The information related to the sampling plan, sample
collection, and sampler qualifications are required since the
accreditation of sampling is not required under this rule; therefore,
FDA uses this documentation to ensure that sampling was performed
correctly.
The certification of results is a requirement of ISO/IEC
17025:2017 section 6.2.6.c (``authorization'');
[[Page 68801]]
however since this is not one of the required reporting elements in
ISO/IEC 17025:2017 section 7.8, it is specified as a required document
in this rule to ensure that FDA receives the information (Ref. 3).
Where standard methods have not been referenced on a
report, it is critical for FDA to be able to determine the test method
used and therefore we require that the reference method is listed in
order to make that determination.
Identification of analysts performing specific steps are a
requirement for an audit trail in laboratory records.
The calculations are needed for the review of data to
ensure that no errors affecting the reported results occurred due to
math errors.
The compilation of all raw data along with the
chromatograms, charts, graphs, observations, photographs of thin layer
chromatographic plates, and spectra and other attachments such as
instrument printouts, computer generated charts and data sheets
requested are records that are required by ISO/IEC 17025:2017 to be
retained as technical records and should be readily accessible by the
laboratories. This information provides the necessary evidence to
support the analytical conclusion of the test results. Note that, as
long as a record of the processed data file is submitted, we do not
consider instrument data files maintained on the instrument computer as
originally obtained to be ``raw data'' and so do not require their
submission (or their maintenance under Sec. 1.1154(a)(3)).
The requirement for the label from any immediate container
sampled and any additional labeling needed to evaluate the product as
well as photocopies or original labels for the product analyzed are
important components for any analysis in making a determination on the
acceptability of the specific product tested in relationship to the
test result obtained.
The storage location of the sample is important to assure
that samples were stored in a manner which protected the integrity of
the sample prior to and during analysis so that test results were not
adversely impacted.
Curriculum vitae, training records, and other records of
analyst competence are discussed in Response 116.
Finally, while FDA agrees that use of the words, ``any'' (e.g.,
``any other relevant supporting information'') and ``all'' (``all
original compilations of raw data'') is broad, we have retained their
use in this section of the final rule because it is not possible to
generate a full list of the potential information or data that might be
needed to review the testing data due to the broad scope of analysis
covered by this rule. The intent is for the LAAF-accredited laboratory
to submit any records needed for a thorough technical review of the
testing data.
(Comment 120) A few comments ask for FDA to define ``individual
proficiency testing worksheets'' in proposed Sec. 1.1152(g)(12)(iv)
and to clarify whether each analyst who submits test results must have
participated in proficiency testing each year on the method used.
(Response 120) As discussed in Response 92, the requirement that a
LAAF-accredited laboratory must meet the proficiency test requirements
on an annual basis for each method within the scope of LAAF-
accreditation is on a per laboratory basis. Also, we have revised the
final rule to delete from the full analytical package the relevant
proficiency test worksheets. The recognized accreditation bodies will
be reviewing proficiency testing results and any related corrective
actions under Sec. 1.1138(a)(2)(iii) of the final rule.
(Comment 121) A few comments recommend that FDA modify the language
requiring a copy of the container label to be submitted to FDA as part
of a full analytical report under Sec. 1.1152(g)(7) of the proposed
rule to include the qualifier, ``if available,'' as foods taken from
bulk containers may not have a label.
(Response 121) We appreciate this suggestion and have revised the
final rule to include ``if available'' (see Sec. 1.1152(d)(7)).
(Comment 122) A few comments request clarification of what is
required to be submitted to the recognized accreditation body or FDA as
part of analytical method verification or validation studies in
proposed Sec. 1.1152 (c)(4) through (6). These comments recommend
that, at a minimum, accuracy, precision, recovery, detection limits and
in-matrix studies be included.
(Response 122) Note that under the final rule, all validation and
verification studies required by Sec. 1.1151(c) and (d) are required
to be submitted to FDA (see Sec. 1.1152(c)(3) and (4)). In the
proposed rule, we proposed to require that some validation and
verification studies be submitted to the recognized accreditation body;
specifically, those validation and verification studies that were
necessary for the recognized accreditation body to assess competence to
the method for purposes of granting LAAF-accreditation. However, we
believe it better clarifies the role of FDA as distinct from the role
of the recognized accreditation body if we do not share the
responsibility of reviewing those studies. When FDA reviews validation
and verification studies, it is for the purpose of determining whether
such a study, such as a matrix extension, demonstrates laboratory
performance sufficient to support the particular analytical report
under review. In contrast, recognized accreditation bodies review
validation and verification studies for the purpose of assessing
whether to award accreditation. Therefore, upon further consideration,
in light of the comments, and in keeping with our role as reviewer of
the performance of LAAF-accredited laboratories, we have determined it
to be appropriate for all such studies to be submitted to FDA as a
component of an analytical report.
Note that because of the differences in types of testing (chemical,
biological, or physical) and the purpose of the testing, it is not
practical to provide a single concise list of elements needed in a
specific validation or verification study. In terms of clarifying what
a LAAF-accredited laboratory needs to submit to FDA as part of a
validation or verification study, we direct interested parties to the
existing FDA Food Program's guidelines on performing validation and
verification studies located at the following web link: https://www.fda.gov/science-research/field-science-and-laboratories/method-validation-guidelines. Laboratories may use these guidelines in
performing validation studies or they may use other established and
recognized protocols such as AOAC. Please identify the protocol that is
being used when submitting a validation.
7. What are the requirements for submitting abridged analytical reports
(Sec. 1.1153)?
Proposed Sec. 1.1153 covered records requirements for LAAF-
accredited laboratories; we have relocated those provisions to Sec.
1.1154 in the final rule. Section 1.1153 in the final rule addresses
abridged analytical reports and is comprised of provisions that
appeared in Sec. 1.1152(d) through (f) in the proposed rule.
In the proposed rule, an abridged analytical report was comprised
of most of the information required in a report by ISO/IEC 17025:2017
and the justification and documented authorization for any modification
to or deviation from the method used. Note that in the proposed rule,
the justification and authorization information was also required as
part of a full analytical report. On our own initiative and for
efficiency and clarity, we moved this requirement to
[[Page 68802]]
Sec. 1.1152(c), which is the provision describing documentation
required to be submitted with test results (whether full or abridged
analytical reports).
Additionally, in the final rule we have added a component to the
abridged analytical report contents: Quality control results (including
the expected result and whether it is acceptable). The addition of
quality control results to the abridged analytical report will provide
FDA with important contextual information for the certificate of
analysis and may reduce our need to request other documentation or a
full analytical report pursuant to Sec. 1.1153(d). Finally, in Sec.
1.1153(e) of the final rule, we reiterate that we may consider the
testing to be invalid if the LAAF-accredited laboratory fails to submit
all required testing-related documentation. This appeared in Sec.
1.1152(k) of the proposed rule and applied to all analytical reports;
it appears in Sec. 1.1152(g) of the final rule as it applies to full
analytical reports and all other information required to be submitted
to FDA under Sec. 1.1152.
Briefly, in the proposed rule a LAAF-accredited laboratory would
have gained permission to submit abridged analytical reports after
submitting 10 successful consecutive full analytical reports to FDA. Of
the full analytical reports, at least one would have needed to be from
each of the major food testing discipline for which the laboratory
sought permission. LAAF-accredited laboratories that failed to submit
10 successful consecutive analytical reports would be required to wait
a minimum of 2 years before again attempting to submit the 10
successful consecutive analytical reports. Similarly, if an abridged
analytical report contained material substantive shortcomings or
repeated administrative deficiencies, that laboratory would be required
to wait a minimum of 2 years before reapplying for permission to submit
abridged analytical reports. Comments regarding the abridged analytical
report provisions of the proposed rule are discussed below.
(Comment 123) Many comments support allowing laboratories to submit
shorter and simpler abridged analytical reports to FDA after meeting
certain requirements, as outlined in proposed Sec. 1.1152(d). These
comments suggest that FDA may be able to more quickly review abridged
analytical reports. A few comments request clarification on whether the
requirements for abridged analytical reports apply to governmental
accredited laboratories and if not, whether FDA would consider
developing a similar process for them. Some comments state that the
opportunity to submit abridged analytical reports should apply to all
accredited laboratories, public and private.
A few comments contend that the ability to submit abridged
analytical reports to FDA is of limited benefit because LAAF-accredited
laboratories would have to submit a full analytical report to FDA
within 48 hours if requested, as proposed under Sec. 1.1152(e)(1).
Some comments also recommend that the timeframe for providing FDA with
the full analytical report should be at least 72 hours, as 48 hours is
not enough time to compile the large amount of information needed for a
full analytical report.
Other comments mention that the circumstances necessitating the
exceptions described in the preamble to the proposed rule, (``. . .
[for] the purposes of auditing abridged analytical reports and
otherwise protecting the public health and the integrity of this food
testing program . . . .'' (84 FR 59452 at 59484)) are vague and request
that FDA clarify the standard it will use in requesting full analytical
reports.
(Response 123) We appreciate the support for the proposal to allow
the submission of abridged analytical reports and we agree that this
approach may promote certain efficiencies for LAAF-accredited
laboratories and FDA.
As a threshold matter, the final rule requirements regarding
abridged analytical reports apply to all LAAF-accredited laboratories
conducting food testing under this subpart. Government laboratories may
apply to a recognized accreditation body to become LAAF-accredited to
conduct food testing under this subpart and may request permission to
submit abridged analytical reports as described in Sec. 1.1153.
Regarding the 48-hour timeframe in which laboratories permitted to
submit abridged analytical reports may need to produce and submit to
FDA a full analytical report, we are making two changes in response to
comments. First, we are changing the timeframe in which a LAAF-
accredited laboratory would need to submit a full analytical report
pursuant to the exception from 48 to 72 hours to provide additional
time to prepare documents for submission to FDA. Second, we are
clarifying that we may request one or more additional documents up to a
full analytical report under the exception. This will enable the Agency
to tailor the request to the specific circumstances and likewise will
reduce the burden on LAAF-accredited laboratories under this exception.
With those changes, we are maintaining the exception as it remains
an important tool by which we may audit abridged analytical reports and
otherwise protect public health and LAAF program integrity (see
discussion at 84 FR 59452 at 59484). Under this exception and as stated
in the preamble to the proposed rule, we may request additional
documentation or a full report under this exception at our discretion,
which may be based on the underlying public health risk of the analyte,
if we have a question about something in the abridged analytical
report, something in the abridged analytical report appears to be
amiss, or on a random basis to spot-check LAAF-accredited laboratory
performance. We estimated making these requests for no more than 10
percent of abridged analytical reports submitted, but at least once per
year (see 84 FR 59452 at 59484).
Finally, we note that the analytical steps should not change when
producing an abridged analytical report, only the amount of information
submitted to FDA (see Sec. 1.1150(d)).
(Comment 124) Several comments state that FDA should simplify the
process for granting permission to submit abridged analytical reports
as it is overly burdensome on both LAAF-accredited laboratories and FDA
and diverts resources away from protecting public health. These
comments recommend that FDA consider as few as one or two full
analytical reports per major food testing discipline. These comments
contend that the proposed process, requiring 10 full reports, would
give larger LAAF-accredited laboratories an advantage and that these
larger laboratories are better able to absorb the increased cost of
full analytical reports without the need to pass the higher cost on to
the owner or consignee.
Many comments argue that the proposed disqualification periods from
submitting abridged analytical reports or even the failure to gain
permission would be detrimental to LAAF-accredited laboratories and
overly punitive. These comments state that corrective action to address
deficiencies would be more appropriate and would afford the LAAF-
accredited laboratory due process. Some comments recommend that FDA
issue a warning letter to LAAF-accredited laboratories with material
substantive shortcomings so that corrective action could be taken in
response. Comments state further that FDA should meet with the LAAF-
accredited laboratory and recognized accreditation body or allow for an
appeals process prior to taking further action to use probation or
disqualification especially since this could be based on minor repeated
[[Page 68803]]
administrative deficiencies yet would result in a long disqualification
period.
Comments also request additional details regarding ``material
substantive shortcomings'' and ``administrative deficiencies'' and
argue that interpretation of these terms, if not clearly defined, could
be inconsistently applied when reviewing abridged analytical reports.
Further, comments express concerns that, as proposed, repeated
administrative deficiencies could become a material substantive
shortcoming and lead to disqualification, which would have a large
financial impact on LAAF-accredited laboratories. These comments urge
FDA to consider what public health benefit, if any, would accrue from
focusing on administrative deficiencies and the resulting burden on
LAAF-accredited laboratories.
Some comments indicate that permission to submit abridged reports
represents a direct relationship between FDA and LAAF-accredited
laboratories where the recognized accreditation body is not involved.
Other comments contend that the LAAF-accreditation process should be
considered evidence of a laboratory's ability to submit full analytical
reports and ultimately reduce or eliminate the number of full
analytical reports required to be submitted to gain permission from FDA
to submit abridged analytical reports.
(Response 124) We agree with comments regarding the need to
simplify the proposed process for seeking permission to submit abridged
analytical reports and the need to revisit the consequences of
deficiencies in abridged analytical reports. We have made significant
changes to both aspects of the abridged analytical report process in
the final rule. In simplifying the process, we decline the
recommendation to rely on recognized accreditation bodies to evaluate a
LAAF-accredited laboratory's ability to submit abridged analytical
reports. We agree that recognized accreditation bodies will play a
crucial role with respect to LAAF-accrediting laboratories and
continuing oversight of the laboratories they LAAF-accredit; however,
FDA's role is to review the performance of those laboratories and in
particular, to do so by reviewing analytical reports. Moreover, we
maintain that FDA's experience with LAAF-accredited laboratories' full
analytical reports and the Agency's confidence in reliance on such
analytical reports to make regulatory decisions are imperative factors
in the decision to grant permission to submit abridged analytical
reports. Therefore, although we have revised the processes related to
abridged analytical reports, it remains FDA, rather than the recognized
accreditation bodies, that will have the authority to grant permission
to submit abridged reports.
In terms of gaining permission to submit reports, on request of the
LAAF-accredited laboratory, FDA will review the last five full
analytical reports for a major food testing discipline (biological,
chemical, and physical) to determine whether the LAAF-accredited
laboratory will be granted permission to submit abridged analytical
reports for that major food testing discipline. In reviewing the last
five analytical reports, FDA will check that the reports contain no
shortcomings that call into question the validity of the test result or
repeated administrative errors. Additionally, FDA will confirm that the
LAAF-accredited laboratory requesting permission is not on suspension
or probation for any method within the major food testing discipline
for which the laboratory is requesting permission and that the
laboratory has successfully implemented any required corrective action
(see Sec. Sec. 1.1121 and 1.1161). FDA will notify the LAAF-accredited
laboratory if permission has been granted or denied.
The revised process for requesting permission should reduce the
burden for both FDA and LAAF-accredited laboratories and will still
ensure that there is requisite experience with full analytical reports
for each major food testing discipline for which permission to submit
abridged analytical reports is sought. We recognize that the proposed
process of submitting 10 full analytical reports and granting
permission for the major food testing disciplines included in those 10
reports could result in a grant of permission for a major food testing
discipline based on as few as 1 full analytical report if it was
included among a group of 9 other full analytical reports for another
major food testing discipline. Changing the process to review five full
analytical reports per major food testing discipline provides for more
equal oversight of, and experience with, full analytical reports,
reduces the potential competitive advantage of larger laboratories, and
reduces the overall barrier to permission. It also alleviates the need
for a separate process for adding a major food testing discipline as
proposed (see Sec. 1.1152(d)(3) of the proposed rule). Finally, in
response to comments and on our own initiative, we have revised and
simplified the oversight process for abridged analytical reports to
leverage existing program oversight tools, including corrective action,
described in Sec. 1.1161 as opposed to relying on the separate process
proposed. Thus, we have removed disqualification periods specific to
issues with submitting abridged analytical reports (see proposed Sec.
1.1152(d)(2) and (d)(4) through (6)). Section 1.1153(b) of the final
rule describes the process by which FDA will review and communicate
issues with abridged analytical reports and when FDA may require
corrective action, probation, or may revoke permission to submit
abridged analytical reports. We believe the revised process will be
fairer and more transparent for LAAF-accredited laboratories and easier
for FDA to implement.
In response to concerns that a LAAF-accredited laboratory's failure
to gain permission to submit abridged analytical reports will
negatively impact the laboratory, we note that, as discussed above in
Response 57, permission to submit abridged analytical reports will not
be included on the public registry described in Sec. 1.1109.
We decline the request to define the terms, ``material substantive
shortcomings'' and ``repeated administrative deficiencies''; however,
we have made the following modifications which we believe will address
the underlying concerns: We revised the final rule to specify that
substantive shortcomings are those that call into question the validity
of the results and clarified the section to refer to repeated
administrative errors. In addition, we have specified that FDA will
notify the LAAF-accredited laboratory of any deficiencies as described
in Sec. 1.1153(b)(2).
8. What other records requirements must a LAAF-accredited laboratory
meet (Sec. 1.1154)?
The other records requirements for a LAAF-accredited laboratory
appeared in Sec. 1.1153 of the proposed rule but appear in Sec.
1.1154 of the final rule. In paragraph (a) we proposed that LAAF-
accredited laboratories be required to maintain electronically for 5
years, records created and received under this subpart, such as
documents relating to the grant of LAAF-accreditation and documentation
of testing conducted under this subpart. In paragraph (b) we proposed
that within 30 days of the receipt of proficiency testing results, the
LAAF-accredited laboratory submit the results to the recognized
accreditation body and, if the laboratory failed the test, to FDA.
Proposed paragraph (c) stated that a LAAF-accredited laboratory must
make records available for FDA inspection and copying upon written
request, and addressed related details.
[[Page 68804]]
Proposed paragraph (d) stated that a LAAF-accredited laboratory must
ensure that significant amendments to records can be tracked to
previous and original versions, and addressed related details.
We have revised the section to update terminology and cross-
references and to make other minor editorial changes to improve the
clarity and readability of the section. We also have made several
conforming changes to reflect changes elsewhere in the final rule: We
have revised paragraph (a)(1) to specify proficiency test and
comparison program records; this information was previously required by
proposed Sec. 1.1153(b)(1). Accordingly, paragraph (b) has been
removed and the requirement to submit proficiency test results to the
recognized accreditation body has been incorporated in Sec.
1.1138(a)(2)(iii). We removed reference to the English language and
English translation requirement and electronic submission as this is
now included in Sec. 1.1110 of the final rule. Additionally, we
removed the word, ``electronically,'' from paragraph (a) to allow
flexibility around how LAAF-accredited laboratories maintain records
and to align with the same revision for recognized accreditation bodies
in Sec. 1.1124(a). We revised paragraph (a)(3) so that it now says,
``associated correspondence between the LAAF-accredited laboratory . .
. and the owner or consignee'' rather than, ``associated correspondence
by the LAAF-accredited laboratory . . . with the owner or consignee;''
to clarify that correspondence to the laboratory related to food
testing under this subpart is among the records the laboratory must
maintain. Finally, we clarify in Sec. 1.1154(a)(2) that the
documentation of food testing that a LAAF-accredited laboratory
conducted under this subpart must account for all information required
by Sec. 1.1152(d) of the final rule. This addition better clarifies
the contents of the cross-reference to Sec. 1.1150(d) in the proposed
and final rule. We discuss additional changes made in response to
comments below.
(Comment 125) Some comments agree that the requirement to maintain
records for 5 years is reasonable and agree with the 10-business day
record submission requirement in proposed Sec. 1.1153(c).
A few comments request that FDA clarify that food testing records
required in proposed Sec. 1.1153(a)(2) are limited to records related
to testing covered by this subpart and would not apply to routine
testing that is performed outside the scope of the rule. Some comments
request clarification as to why all requests for food testing from an
owner or consignee are necessary as stated in proposed Sec.
1.1153(a)(4).
(Response 125) We appreciate the supportive comments and agree that
records a LAAF-accredited laboratory must maintain under this rule
(proposed Sec. 1.1153, final rule Sec. 1.1154) are only those related
to food testing covered by this subpart. Per the request from comments,
we clarify in the final rule that LAAF-accredited laboratories maintain
all requests for food testing from an owner or consignee that would be
conducted under this subpart. These records would help FDA ascertain
compliance with the requirement to submit all test results to FDA
(under Sec. 1.1152(b)).
J. Comments Regarding FDA Oversight of LAAF-Accredited Laboratories
Table 11--Changes to Sections Regarding FDA Oversight of LAAF-Accredited
Laboratories
------------------------------------------------------------------------
Final rule Proposed rule Notes
------------------------------------------------------------------------
FDA Oversight of LAAF-Accredited Procedures for Revised to reflect
Laboratories. Accreditation of new terminology
Laboratories. and
reorganization of
the final rule.
Sec. 1.1159 How will FDA Sec. 1.1159 How Revised to reflect
oversee LAAF-accredited will FDA oversee new terminology.
laboratories? accredited
laboratories?
Sec. 1.1160 How will FDA Sec. 1.1160 How Minor editorial
review test results and will FDA review change.
analytical reports? submitted test
results and
analytical
reports?
Sec. 1.1161 When will FDA Sec. 1.1161 When Revised to reflect
require corrective action, put will FDA put an new terminology
a LAAF-accredited laboratory on accredited and revised
probation, or disqualify a LAAF- laboratory on contents of the
accredited laboratory from probation or section.
submitting analytical reports? revoke the
accreditation of
a laboratory?
Sec. 1.1162 What are the Sec. 1.1162 What Revised to reflect
consequences if FDA puts a LAAF- are the new terminology.
accredited laboratory on consequences if
probation or disqualifies a FDA puts an
LAAF-accredited laboratory? accredited
laboratory on
probation or
revokes the
accreditation of
a laboratory?
------------------------------------------------------------------------
1. How will FDA oversee LAAF-accredited laboratories (Sec. 1.1159)?
This section of the proposed rule described three broad mechanisms
FDA might employ to oversee LAAF-accredited laboratories. First, in
proposed paragraph (a) we stated that we ``may assess accredited
laboratories at any time to determine whether . . . there are
deficiencies . . . that, if not corrected, would warrant . . .
revocation of its accreditation.''
In proposed paragraph (b), we listed various records and
information that we may review in evaluating the performance of a LAAF-
accredited laboratory, such as records the laboratory is required to
maintain under this subpart. Proposed paragraph (c) stated that we may
conduct an onsite ``assessment'' of the LAAF-accredited laboratory.
Proposed paragraph (d) stated that we will report our observations and
findings to the recognized accreditation body.
As discussed above at Response 10, FDA has revised terminology
throughout this rule to clarify that our role with regard to LAAF-
accredited laboratories is not to ``assess'' them but is to review
their performance, primarily by reviewing analytical reports and test
results. In final Sec. 1.1159 we revised the language accordingly, to
more clearly communicate our role. This section now consistently refers
to FDA reviewing the performance of a LAAF-accredited laboratory and
explicitly includes analytical reports and test results submitted to
FDA among the things we may review in Sec. 1.1159(b)(5).
We have also revised paragraph (c) of the final rule to explicitly
state that certain FDA review activities may be conducted remotely if
it will not aid in the review to conduct them onsite. For example,
records reviews or auditing filth plates are common review activities
that may be conducted remotely. The ability to conduct remote reviews
of LAAF-accredited laboratory performance under this subpart will
provide a more efficient, cost-effective, and less intrusive option for
reviews. This may also allow for continued
[[Page 68805]]
oversight of LAAF-accredited laboratories when onsite visits are
otherwise impracticable.
We also made other conforming and minor editorial changes to this
section and section title, including deletion of the phrase, ``of food
subject to food testing under this subpart'' in proposed Sec.
1.1159(b)(5) because the phrase is included in the definition of owner
or consignee in Sec. 1.1102 and therefore need not be repeated; see
Sec. 1.1159(b)(6) if the final rule. Comments regarding this section
are discussed below.
(Comment 126) A few comments state that FDA onsite reviews under
Sec. 1.1159(c) should be limited to work performed under this subpart
and should not extend to other work conducted by the LAAF-accredited
laboratory, even work related to other FDA regulations (e.g., testing
under part 117). These comments further contend that when FDA conducts
onsite reviews, we may not examine privileged or proprietary records or
laboratory practices not directly related to this subpart.
(Response 126) We agree that an onsite review of a LAAF-accredited
laboratory and any review activities conducted remotely would be
limited to work performed under this subpart. We have revised Sec.
1.1159(c) to further clarify that FDA's onsite review is limited to a
LAAF-accredited laboratory's performance under this subpart. As such,
it would not include review of privileged or proprietary records or
laboratory practices outside the scope of this final rule.
(Comment 127) Some comments encourage FDA to communicate with the
recognized accreditation body if during the course of our review of a
LAAF-accredited laboratory we obtain information causing us to place
the LAAF-accredited laboratory on probation or disqualify the LAAF-
accredited laboratory from conducting food testing under this subpart.
The recognized accreditation body could then perform an assessment of
its own related to the laboratory's ISO/IEC 17025:2017 accreditation
and LAAF-accreditation status.
(Response 127) Section 1.1159(d) of the final rule states that
``FDA may report any observations and deficiencies identified during
its review of LAAF-accredited laboratory performance under this subpart
to the recognized accreditation body.'' This would include information
that causes us to place the LAAF-accredited laboratory or disqualify
the laboratory from conducting testing under this subpart.
(Comment 128) Some comments express concern that the proposed rule
did not communicate more detailed information about the processes
around FDA review of LAAF-accredited laboratories. These comments ask
what the impact would be if FDA found a deficiency in the course of its
review; for example, whether FDA would invalidate past test results
and, if so, how far back in time the invalidation would extend.
(Response 128) The impact of any deficiency identified in the
course of an FDA review of a LAAF-accredited laboratory's performance
under this subpart would depend on the deficiency found. Section 1.1160
describes what would happen if FDA finds a deficiency in an analytical
report. As described in Sec. 1.1161(a) of the final rule, FDA may
require corrective action to address any deficiencies identified. In
the case of certain serious deficiencies such as those described in
Sec. 1.1161(c) of the final rule, FDA may disqualify a LAAF-accredited
laboratory from submitting analytical reports for one or more methods
within the scope of LAAF-accreditation. The consequences of probation
or disqualification are described in Sec. 1.1162 of the final rule.
Paragraph (c) states in relevant part that FDA may refuse to consider
specific food testing results if the basis for disqualification of the
laboratory indicates that the specific food testing conducted by the
laboratory may not be reliable.
2. How will FDA review test results and analytical reports (Sec.
1.1160)?
Proposed Sec. 1.1160(a) through (c) described how FDA would
proceed if it finds deficiencies in any test result, analytical report,
related documents (e.g., related to sampling), or the associated
analysis indicates that any aspect of the testing under this subpart is
not being conducted in compliance with the requirements of this
subpart. In paragraph (a), we proposed that we may consider the
analysis to be invalid and/or will notify the LAAF-accredited
laboratory and may also notify the owner or consignee, of the
deficiency. The LAAF-accredited laboratory would be required to respond
to FDA within 30 days. Proposed paragraph (b) stated that we may report
our determination of a deficiency to the recognized accreditation body.
Proposed paragraph (c) stated that if the deficiency demonstrates a
material substantive shortcoming in the related food testing, or
demonstrates repeated administrative deficiencies, we may also consider
disallowing the LAAF-accredited laboratory from submitting abridged
analytical reports, or other actions under this subpart. Proposed
paragraph (d) noted that nothing in this subpart limits FDA's ability
to review and act upon information received about food testing.
We revised this section to incorporate updated terminology, to make
conforming changes, and to improve clarity and readability. We discuss
additional changes made in response to comments below.
(Comment 129) Some comments indicate that proposed Sec. 1.1160(b)
did not state that recognized accreditation bodies ``will'' be informed
when FDA finds a deficiency as a result of reviewing a LAAF-accredited
laboratory's test results, analytical reports, related documents, or
the associated analysis; instead we used the word, ``may.'' These
comments urge FDA to inform the recognized accreditation body of
findings of deficiency. Other comments appear to encourage us to notify
the recognized accreditation body when we learn of a possible
deficiency, before we reach a conclusion that a deficiency has
occurred. Comments generally urge FDA to have transparent communication
with recognized accreditation bodies regarding the LAAF-accredited
laboratories.
(Response 129) We agree that communication between the FDA and the
recognized accreditation bodies will be beneficial for this program. At
the same time, we do not want to overwhelm a recognized accreditation
body with details concerning analytical reports that are unlikely to be
relevant to their oversight of a LAAF-accredited laboratory. To that
end, final Sec. 1.1160(b) provides FDA with discretion regarding which
observations and deficiencies we will report to a recognized
accreditation body. We anticipate deciding on a case-by-case basis
which deficiencies are significant enough to warrant notifying a
recognized accreditation body. By way of two examples, while a
deficiency such as failure to run quality control samples as required
in Sec. 1.1138(a)(3), that would call into question the validity of
the test result, likely would be reported to the recognized
accreditation body, a deficiency that does not call into question the
validity of the test, such as FDA requesting a missing document,
generally would not require notification of the recognized
accreditation body. Relatedly, we have clarified in Sec. 1.1160(a)
that we may require that a laboratory correct the test result,
analytical report, related documents, or the associated analysis. Such
correction would not require additional corrective action; however, FDA
may require corrective action for certain deficiencies.
[[Page 68806]]
(Comment 130) Some comments request that in the event that FDA
identifies a deficiency in an analytical report, FDA not notify the
owner or consignee if the deficiency can be immediately resolved and
human health is not directly affected.
(Response 130) The potential circumstances surrounding FDA
identification of a deficiency in a test result, analytical report, or
related documents are numerous and varied. It would be imprudent for us
to try to categorize deficiencies and establish different notification
requirements for the various categories. Instead, we will approach each
instance of deficiency under Sec. 1.1160(a) on a case-by-case basis,
in terms of determining whether it is appropriate to inform the owner
or consignee. We do take the point of the comment, though, and agree
that owners or consignees need not always be informed when FDA
identifies a deficiency in a test result, analytical report, or related
documents. Accordingly, we are retaining the conditional language of
the proposed rule in Sec. 1.1160(a) of the final rule by stating that
FDA ``may'' report such deficiencies to the owner or consignee.
(Comment 131) Some comments state that FDA should expedite review
of analytical reports and test results from all LAAF-accredited
laboratories. These comments contend that this will benefit both
importers and their customers and will result in more efficient use of
FDA resources during review.
(Response 131) We acknowledge these comments and intend to review
analytical reports in a timely fashion.
(Comment 132) Some comments express the concern that FDA's review
of analytical reports submitted in relation to testing to support
removal from import alert has been inconsistent, both between FDA
regions and within single facilities. Comments contend that over time
FDA has required increasing amounts of information. Comments express
frustration that it has been difficult to gain clarity from FDA
regarding what our standards are for the documents comprising a full
analytical report. Comments recommend that FDA develop a document that
clearly communicates to FDA staff as well as laboratories submitting
reports, our requirements for each component of a full analytical
report; comments assert this should be done before holding laboratories
accountable for failure to satisfy such requirements.
Other comments express frustration regarding working with FDA to
resolve issues identified in analytical reports submitted in relation
to testing to support removal from import alert. These comments assert
that such resolution requires the participation of more than one office
within FDA's Office of Regulatory Affairs. In the view of these
comments, the cumbersome FDA resolution process results in delayed
admissibility decisions.
Other comments request that we clarify how we will ensure that
analytical reports are reviewed by qualified FDA personnel.
(Response 132) The review of the laboratory analytical reports and
test results is a very structured process. Reviewers complete technical
reviews using the Laboratory Manual Volume III Section 7--Private
Laboratory Guidance, corresponding import alerts, and other appropriate
guidance documents ensuring that the technical reviews are consistent
across reviewers and that testimony submitted contains all pertinent
elements needed for the specified analysis to assure FDA that the
scientific data is credible, reliable, and valid. Reviewing personnel
are highly qualified and have gone through extensive training to
perform these reviews. The use of technical lead review panels further
aids in preventing inconsistencies and in standardizing the review
process by insuring a uniform, systematic, and effective approach to
package review across the FDA. The periodic auditing of the technical
review process in accordance with FDA's quality system and Laboratory
Manual Volume III Section 7--Private Laboratory Guidance (https://www.fda.gov/media/73540/download) provides another layer of consistency
to the process. Average turnaround time for a review is generally 2
days including the technical lead review assignments. The required
elements for full and abridged analytical reports, along with the
documents required to be submitted with test results, are set forth in
this final rule. This process is designed to mitigate inconsistencies.
Finally, it is true that more than one FDA office may have a role
to play when we work with laboratories to resolve questions regarding
an analytical report. We endeavor to work efficiently across the
involved FDA offices to resolve such issues and communicate the
resolution to impacted internal and external entities.
3. When will FDA require corrective action, put a LAAF-accredited
laboratory on probation, or disqualify a LAAF-accredited laboratory
from submitting analytical reports (Sec. 1.1161)?
Proposed Sec. 1.1161 described the grounds necessary for FDA to
place a LAAF-accredited laboratory on probation or disqualify it from
the program and the processes for taking such action. In paragraph (a)
we stated that we may disqualify a laboratory in whole or in part for
good cause and when the recognized accreditation body fails to withdraw
LAAF-accreditation. We stated that the reasons may include demonstrated
bias or lack of objectivity in testing, performance that calls into
question the validity or reliability of testing, or other failure to
substantially comply with this subpart.
In proposed paragraph (b) we described the grounds for probation as
deficiencies that are less serious and more limited than those
identified in paragraph (a), when it is reasonably likely that the
LAAF-accredited laboratory will be able to correct them within a
specified period of time. We stated that under such circumstances we
would temporarily place the laboratory on probation and request
appropriate corrective action. In proposed paragraph (c) we clarified
that we may disqualify a LAAF-accredited laboratory in part (for just
some methods).
In proposed paragraph (d) we stated that a LAAF-accredited
laboratory's probationary status would last either until the deficiency
is corrected or FDA determines that disqualification is warranted. In
proposed paragraph (e) we described the notice of disqualification that
we would provide to a LAAF-accredited laboratory. In proposed paragraph
(f) we described the notice of probation that we would provide to a
LAAF-accredited laboratory. In proposed paragraph (g) we stated that if
we place a LAAF-accredited laboratory on probation and determine that
the laboratory is not implementing appropriate corrective actions we
may disqualify the laboratory in whole or in part. In proposed
paragraph (h) we stated that probationary status and disqualification
will be noted on the public registry described in Sec. 1.1109.
We revised the section to incorporate updated terminology and to
specify that probation can be method-specific, to be consistent with
disqualification which is also method-specific (see Sec. 1.1161(b) of
the final rule). We also revised the section title to more accurately
reflect the section contents of the final rule (``When will FDA require
corrective action, put a LAAF-accredited laboratory on probation, or
disqualify a LAAF-accredited laboratory from submitting analytical
reports?'') We discuss additional changes made in response to comments
below.
(Comment 133) Some comments disagree with the processes we proposed
in Sec. 1.1161 regarding how FDA would follow up with a LAAF-
accredited laboratory if we identify a
[[Page 68807]]
concern with the laboratory's performance. Some comments disagree with
the ordering of our actions because in the proposed rule, we described
first notifying a LAAF-accredited laboratory that we were placing it on
probation, and then allowing an opportunity for the laboratory to
correct. Some comments assert that such a process is not consistent
with processes in the conformity assessment arena.
Several comments state that under the proposed rule, probationary
status would be publicly noted on the online registry; several comments
argue that sharing that status publicly could impede the LAAF-
accredited laboratory's business. Comments contend that professional
courtesy and due process should dictate that the Agency provide notice
before imposing any status changes or restrictions on a LAAF-accredited
laboratory. These comments argue it would be unfair of FDA to imply on
the public registry that the laboratory's performance had been
unacceptable without first allowing the laboratory an opportunity to
take corrective action.
Several comments recommend that, instead, FDA should notify the
LAAF-accredited laboratory of our concern and provide an opportunity
for the laboratory to correct, before the Agency imposes any status
changes. In particular some comments recommend that, if FDA has a
concern with the LAAF-accredited laboratory's performance, FDA should
utilize the laboratory complaint process (required by ISO/IEC
17025:2017 section 7.9 (Ref. 3)). In the view of these comments, if
FDA's concern has not yet been adequately addressed via the LAAF-
accredited laboratory's complaint process, then the matter should be
raised to the recognized accreditation body. For example, some comments
suggest that if FDA is not satisfied with a LAAF-accredited
laboratory's corrective action, then there should be a meeting between
FDA, the LAAF-accredited laboratory, and the recognized accreditation
body to try and resolve the issue, before FDA proceeds to probation or
disqualification. Some comments suggest that, after FDA places a LAAF-
accredited laboratory on probation, the laboratory be afforded an
additional opportunity to remedy the deficiency.
Some comments maintain that LAAF-accredited laboratories should
have an opportunity to defend against a potentially ``hypercritical
review'' that raises only minor problems or mistakes that do not impact
the test results. These comments further contend that such problems or
mistakes should not impact the laboratory's LAAF-accreditation status.
Finally, comments encourage FDA to establish a single process for
following up on concerns with the performance of a LAAF-accredited
laboratory, and that process should lead only to potential probation or
disqualification. In this view, potential or actual deficiencies in the
performance of a LAAF-accredited laboratory should not impact the
laboratory's eligibility to submit abridged analytical reports.
(Response 133) After considering the comments, we agree that a
LAAF-accredited laboratory should be afforded the opportunity to take
corrective action on FDA notification of a deficiency prior to being
placed on probation by FDA. Thus, we have revised Sec. 1.1161 of the
final rule to reflect this position. Specifically, Sec. 1.1161(a)
describes a corrective action process which relies on the complaint and
corrective action processes required by ISO/IEC 17025:2017 sections 7.9
and 8.7, respectively. As stated in Sec. 1.1161(b) of the final rule,
FDA will only proceed to probation if ``FDA determines that a LAAF-
accredited laboratory has not effectively implemented corrective action
or otherwise fails to address deficiencies identified.'' Similarly, FDA
will only proceed to disqualify a laboratory from the LAAF program if
we determine that ``a LAAF-accredited laboratory on probation [failed]
to effectively implement correction action or otherwise address
identified deficiencies.'' Id. at (c)(2). Thus, a LAAF-accredited
laboratory will have at least two opportunities to respond to FDA
regarding an identified deficiency before FDA disqualifies the
laboratory from submitting analytical reports under the LAAF program.
Some comments suggest that if the initial complaint and corrective
action process fails to satisfy FDA, FDA should involve the recognized
accreditation body. FDA agrees and accordingly, final Sec.
1.1161(b)(1) provides that FDA will notify both the LAAF-accredited
laboratory and its recognized accreditation body if we have grounds for
probation. It is possible that a meeting between the FDA, the
recognized accreditation body, and the LAAF-accredited laboratory may
be beneficial at that stage, but as deficiency circumstances will vary
greatly, we will consider that option on a case-by-case basis.
We accept the point made in some comments that minor deficiencies
should not result in probationary status, and agree that a small number
of administrative errors would not form the basis for FDA to require
corrective action. However, in the case of submissions from a LAAF-
accredited laboratory that evidence a pattern of inattention with
regard to any requirements, it may not be unreasonable for FDA to grow
concerned that the laboratory may also be failing to observe other,
more substantive, details.
Finally, after considering the comments we agree that it will be
clearer and more efficient to forego a separate set of disciplinary
actions regarding permission for a LAAF-accredited laboratory to submit
abridged analytical reports. Accordingly, final Sec. 1.1161 describes
the single path of actions that FDA can pursue against a LAAF-
accredited laboratory. For more information on permission to submit
abridged analytical reports, see above discussion of Sec. 1.1153 at
Response 124.
(Comment 134) Several comments express concern with FDA's proposed
use of the words, ``probation'' and ``revoke'' in Sec. 1.1161. Some
comments advise that FDA should better distinguish between actions the
FDA may take against a LAAF-accredited laboratory under this subpart,
and the actions an accreditation body might take against a laboratory
with regard to that laboratory's ISO/IEC 17025:2017 accreditation. Some
comments suggest that, because FDA lacks authority to impact a
laboratory's ISO/IEC 17025:2017 accreditation, we should clarify that
if we place a LAAF-accredited laboratory on probation, the impact of
our action is limited to this subpart, and not the laboratory's ISO/IEC
17025:2017 accreditation.
(Response 134) We agree that FDA authority under this subpart does
not directly impact or relate to the laboratory's ISO/IEC 17025:2017
accreditation. We have made changes throughout the final rule to
clarify that actions taken under this subpart against LAAF-accredited
laboratories by recognized accreditation bodies are limited to
impacting a laboratory's LAAF-accreditation and actions taken by FDA
are limited to impacting the laboratory's ability to conduct the tests
described in Sec. 1.1107. Additionally, we have revised the language
used in Sec. 1.1161 to better distinguish FDA and recognized
accreditation body actions under this subpart. For example, we use the
terms, ``reduce the scope'' and ``withdraw'' to describe the actions a
recognized accreditation body may take with respect to LAAF-
accreditation and we use the word, ``disqualify'' to describe the
action FDA may take with regard to a laboratory's eligibility to
conduct the testing described in Sec. 1.1107. For a full discussion of
[[Page 68808]]
terminology revisions in the final rule, see Response 10, above.
(Comment 135) A few comments request clarification of exactly when
a LAAF-accredited laboratory would be placed on probation. We
understand these comments to be expressing confusion over what
``probation'' means in this context, because it is not a familiar
concept in the realm of conformity assessment (e.g., neither ISO/IEC
17011:2017 or ISO/IEC 17025:2017 contemplate probation).
(Response 135) We first note that in light of the comments, FDA
changed several terms in the final rule. We are now using separate
terms for actions taken by FDA and recognized accreditation bodies with
regard to LAAF-accredited laboratories, to better delineate the roles
of FDA and the recognized accreditation bodies under this subpart. In
the final rule, FDA may place a LAAF-accredited laboratory on
``probation'' but the recognized accreditation body ``suspends'' a
laboratory's LAAF-accreditation.
Also in light of the comments, we substantively revised the grounds
for probation of a LAAF-accredited laboratory. In the proposed rule,
probation was reserved for less serious laboratory deficiencies than
the deficiencies that might lead to FDA disqualification of the LAAF-
accredited laboratory. In the final rule, FDA will use a single path
for all laboratory deficiencies and that single path will typically
involve at least a three-step process: Corrective action, then
probation if the corrective action is not effective, followed by
disqualification if additional actions taken during probation are
ineffective. Thus, final Sec. 1.1161(b) provides that probation may
occur when ``FDA determines that a LAAF-accredited laboratory has not
effectively implemented corrective action or otherwise fails to address
deficiencies identified.'' Note, however, that we reserve the option to
disqualify a LAAF-accredited laboratory without prior corrective action
or probation in certain egregious cases described in Sec. 1.1161(c)(1)
of the final rule.
4. What are the consequences if FDA puts a LAAF-accredited laboratory
on probation or disqualifies a LAAF-accredited laboratory (Sec.
1.1162)?
Proposed Sec. 1.1162 describes the consequences of FDA placing a
LAAF-accredited laboratory on probation or disqualifying the laboratory
from submitting analytical reports under the program. Proposed
paragraph (a) stated that the disqualified laboratory is immediately
ineligible to conduct testing under this subpart either in part or in
whole, depending on the extent of the disqualification, and a
laboratory on probation may continue to conduct testing under this
subpart.
Proposed paragraph (b) stated that FDA may refuse to consider
testing conducted prior to disqualification if the basis for the
disqualification indicates that the specific food testing previously
conducted may not be reliable. Proposed paragraph (c) provided that a
disqualified laboratory must notify FDA of a records custodian within
10 days. Proposed paragraph (d) stated that a laboratory on probation
or that has been disqualified must notify any owners or consignees for
whom it is conducting testing under this subpart, that it is on
probation or has been disqualified.
We have updated this section of the final rule to incorporate
updated terminology and to make other conforming changes to denote that
probation and disqualification by FDA can be on a method-specific
basis. On our own initiative, we relocated the requirement that the
laboratory notification regarding the records custodian be submitted to
FDA electronically and in English in Sec. 1.1162(c) of the proposed
rule to Sec. 1.1110 in the final rule. We also made minor editorial
changes to improve clarity and readability of the section. We received
no comments solely related to this section.
K. Comments Regarding Requesting FDA Reconsideration or Regulatory
Hearings of FDA Decisions Under This Subpart
Table 12--Changes Regarding Requesting FDA Reconsideration or Regulatory
Hearings of FDA Decisions Under This Subpart
------------------------------------------------------------------------
Final rule Proposed rule Notes
------------------------------------------------------------------------
Requesting FDA Reconsideration Requesting FDA Revised to reflect
or Regulatory Hearings of FDA Reconsideration, the contents of
Decisions Under This Subpart. FDA Internal the sections
Review, or included.
Regulatory
Hearings of FDA
Decisions Under
This Subpart.
Sec. 1.1171 How does an Sec. 1.1171 How No changes to the
accreditation body request does an section title.
reconsideration by FDA of a accreditation
decision to deny its body request
application for recognition, reconsideration
renewal, or reinstatement? by FDA of a
decision to deny
its application
for recognition,
renewal, or
reinstatement?
Sec. 1.1173 How does an Sec. 1.1173 How Revised to reflect
accreditation body or does an new terminology.
laboratory request a regulatory accreditation
hearing on FDA's decision to body or
revoke the accreditation body's laboratory
recognition or disqualify a request a
LAAF-accredited laboratory? regulatory
hearing on FDA's
decision to
revoke the
recognized
accreditation
body's
recognition or
revoke the
accredited
laboratory's
accreditation?
Sec. 1.1174 How does an owner Sec. 1.1174 How Revised to reflect
or consignee request a does an owner or new terminology.
regulatory hearing on a consignee request
directed food laboratory order? a regulatory
hearing on a food
testing order?
------------------------------------------------------------------------
(Comment 136) Some comments suggest that regulatory hearings be
held for decisions relating to FDA acceptance of test reports (full or
abridged) from LAAF-accredited laboratories.
(Response 136) We decline to expand the availability of regulatory
hearings to this situation. The mere acceptance of test reports from
LAAF-accredited laboratories does not constitute regulatory action for
which a hearing under part 16 is available or would be warranted. To
the extent comments suggest a regulatory hearing should be available
regarding whether a LAAF-accredited laboratory has met the criteria
specified in Sec. 1.1153 and thus may submit abridged analytical
reports, as discussed in Response 124, we have revised the final rule
based on the comments received to facilitate a more streamlined process
for obtaining FDA permission to submit abridged analytical reports. In
addition, under the final rule, if FDA identifies a deficiency in an
abridged analytical report, such deficiencies are handled the same way
[[Page 68809]]
we would handle a deficiency in a full analytical report. Under Sec.
1.1161 of the final rule, that means the laboratory generally has an
opportunity to pursue corrective action before experiencing any
negative consequences such as probation and loss of permission to
submit abridged analytical reports. In our view, this process will be
more productive and efficient than holding regulatory hearings in each
case. Further, as discussed above in Response 57, permission to submit
abridged analytical reports will not be included on the public registry
described in Sec. 1.1109. This decision mitigates any potential
negative impact on a LAAF-accredited laboratory and obviates the need
for a formal regulatory hearing.
1. How does an accreditation body request reconsideration by FDA of a
decision to deny its application for recognition, renewal, or
reinstatement (Sec. 1.1171)?
Proposed Sec. 1.1171 described the processes for an accreditation
body to request that FDA reconsider its decision to deny an application
either for recognition, renewal, or reinstatement. In paragraph (a), we
proposed that an accreditation body must submit a reconsideration
request within 10 business days after FDA issues the denial. In
paragraph (b), we proposed that the reconsideration request must be
signed and submitted in English, electronically, and in compliance with
whatever procedures are described in the denial notice. In paragraph
(c), we proposed that after reviewing and evaluating the
reconsideration request, FDA would notify the accreditation body of our
decision.
On our own initiative, we relocated the requirement that the
reconsideration request be submitted to FDA electronically and in
English in Sec. 1.1171(b) of the proposed rule to Sec. 1.1110 in the
final rule. Additionally, we clarify in Sec. 1.1171(b) that the
request must include any supporting information. Comments regarding
this section are discussed below.
(Comment 137) Some comments suggest that prior to denying an
accreditation body's application for recognition, renewal, or
reinstatement, FDA should provide the reason for the proposed denial
and allow the accreditation body the opportunity to address FDA's
concerns.
(Response 137) Procedures outlined in other sections of this final
rule provide the notice and opportunity requested by these comments.
With regard to an application for recognition or renewal, Sec.
1.1115(a) provides that FDA will notify the applicant of any
insufficiencies. FDA views the accreditation body application process
as iterative; as stated in 1.1115(a), we will notify the applicant of
any insufficiencies and provide an opportunity for the accreditation
body to complete the application, before we evaluate it under Sec.
1.1115(b).
With regard to reinstatement, under Sec. 1.1117 an accreditation
body seeks recognition by submitting a new application. The new
application would be processed as described under Sec. 1.1115. Note
that an accreditation body that has had its recognition revoked by FDA
is also required to submit evidence that the ground(s) for revocation
have been resolved; for more information see the discussion of Sec.
1.1117(a), above.
2. How does an accreditation body or laboratory request a regulatory
hearing on FDA's decision to revoke the accreditation body's
recognition or disqualify a LAAF-accredited laboratory (Sec. 1.1173)?
Proposed Sec. 1.1173 described the processes for a regulatory
hearing concerning a decision by the Agency to revoke an accreditation
body's recognition or disqualify a laboratory from the LAAF program.
In paragraph (a) we proposed that an entity must submit a request
for a regulatory hearing within 10 business days after FDA issued a
revocation of recognition or disqualification. We proposed that the
hearing would be conducted under part 16 and that the revocation or
disqualification notice would contain all necessary elements to
constitute the notice of an opportunity for hearing under part 16 of
this chapter. In brief, in paragraph (b) we proposed that the hearing
request must be written and respond to the bases for FDA's
determinations described in the notice.
Proposed paragraph (c) stated that the submission of a request for
a hearing will not operate to delay or stay FDA's decision to revoke or
disqualify, unless FDA determines that delay or a stay is in the public
interest. Proposed paragraph (d) stated that the presiding officer
would be designated after the hearing request is submitted to FDA and
proposed paragraph (e) stated that the presiding officer may deny the
hearing request under Sec. 16.26(a). Proposed paragraph (f) addressed
the conduct of the hearing.
In the proposed rule, we used the word, ``revocation'' in this
section, to refer to FDA removing a laboratory from the program. We
received comments expressing concern with that terminology and have
revised our phrasing in light of such concerns, as discussed above at
Response 10. On our own initiative, we relocated the requirement that
the reconsideration request be submitted to FDA electronically and in
English in Sec. 1.1173(b) of the proposed rule to Sec. 1.1110 in the
final rule. We received no other comments solely related to this
section and so have only made minor editorial and conforming changes
(e.g., FDA may ``disqualify'' a laboratory rather than ``revoke the
laboratory's accreditation'') to the section, including the section
title.
3. How does an owner or consignee request a regulatory hearing on a
directed food laboratory order (Sec. 1.1174)?
Proposed Sec. 1.1174 described the processes for a regulatory
hearing concerning a directed food laboratory order. In paragraph (a)
we proposed that an owner or consignee must submit a request for a
regulatory hearing within 24 hours. We proposed that the hearing would
be conducted under part 16 and that the directed food laboratory order
would contain all necessary elements to constitute the notice of an
opportunity for hearing under part 16 of this chapter.
In brief, in paragraph (b) we proposed that the hearing request
must be written and respond to the bases for FDA's determinations
described in the directed food laboratory order. Proposed paragraph (c)
stated that the presiding officer would be designated after the hearing
request is submitted to FDA and proposed paragraph (d) stated that the
presiding officer may deny the hearing request under Sec. 16.26(a).
Proposed paragraph (e) addressed the conduct of the hearing.
On our own initiative, we relocated the requirement that the
reconsideration request be submitted to FDA electronically and in
English in Sec. 1.1174(b) of the proposed rule to Sec. 1.1110 in the
final rule. We also revised the section to incorporate updated
terminology and made minor editorial changes to improve the clarity and
readability of the section. We discuss changes made in response to
comments below.
(Comment 138) Several comments disagree with the proposed hearing
process for a directed food laboratory order because they contend it
would not afford sufficient due process protections to owners or
consignees. Specifically, comments raise concerns that the hearing
process under part 16 is discretionary and that an owner or consignee
must request a hearing by filing an appeal within 24 hours. These
comments state that the hearing should be guaranteed if requested.
Further,
[[Page 68810]]
these comments argue that 24 hours is not enough time to request the
hearing upon receipt of a directed food laboratory order, and that this
timeframe is also not warranted from a public health standpoint.
Instead, comments recommend more time, up to 10 days, as a reasonable
timeframe in which to review the directed food laboratory order and
prepare the request. Comments state the hearing should provide the
opportunity to determine the appropriate scope of the directed food
laboratory order and the ability to lift or vacate the directed food
laboratory order. Comments suggest that the hearing process used for
the facility registration suspension and mandatory recalls would be
more appropriate.
(Response 138) After considering the comments, we agree that 24
hours may not be sufficient time to request a regulatory hearing on a
directed food laboratory order. Part 16 of this chapter, which provides
for regulatory hearings before the FDA, provides not less than 3
working days after receipt of the notice to request a hearing (see
Sec. 16.22(b)). We have therefore revised Sec. 1.1174(a) to state
that the hearing request under this subpart must be submitted within 3
business days, to align with the intent of part 16 of this chapter. We
decline the request to establish a 10-day deadline because we consider
the 3 business days applicable in other part 16 contexts to be
sufficient in the directed food laboratory order context as well.
We also decline to adopt the hearing processes for facility
registration suspension and mandatory recalls. The statute guarantees
the opportunity for a hearing on the suspension of a food facility
registration ``to be held as soon as possible, but not later than two
business days after the issuance of the order . . .'' unless FDA and
the registrant agree otherwise (section 415(b)(2) of the FD&C Act).
Similarly, the statute guarantees the opportunity for an informal
hearing regarding a mandatory recall order ``to be held as soon as
possible, but not later than 2 days after the issuance of the order . .
. . '' (section 423(c) of the FD&C Act). In contrast, section 422 of
the FD&C Act does not provide for a guaranteed hearing process.
Therefore we believe the discretionary hearing process proposed, which
incorporates existing procedures in 21 CFR part 16, is appropriate with
respect to directed food laboratory orders. Under Sec. 16.26(a), a
hearing request may be denied, in whole or in part, if ``no genuine and
substantial issue of fact has been raised by the material submitted.''
With regard to the comments' contention that the hearing should
provide the opportunity to determine the appropriate scope of the
directed food laboratory order and the ability to lift or vacate the
directed food laboratory order, we believe this is inherent in the
procedure specified in Sec. 16.60, which permits the presentation of
any oral or written information relevant to the hearing, and which
grants the presiding officer power to take any actions necessary or
appropriate to conduct a fair, expeditious, and impartial hearing.
L. Comments Regarding Electronic Records and Public Disclosure
Requirements
1. Are electronic records created under this subpart subject to the
electronic records requirements of part 11 of this chapter (Sec.
1.1199)?
In Sec. 1.1199 of the proposed rule, we proposed to exempt from
the requirements of part 11 (21 CFR part 11) those records that meet
the definition of electronic records in Sec. 11.3(b)(6) and were
established or maintained to satisfy the requirements of this subpart.
(Comment 139) Comments on this aspect of the proposed rule voice
support for the proposed exemption. Comments contend that requiring
such records to comply with the requirements in 21 CFR part 11 would be
unnecessarily burdensome.
(Response 139) We appreciate support for this section and have
finalized it without change.
2. Are the records obtained by FDA under this subpart subject to public
disclosure (Sec. 1.1200)?
Proposed Sec. 1.1200 stated that records obtained by FDA under
this subpart are subject to the disclosure requirements under 21 CFR
part 20. We received no comments on this section and have finalized the
section without change.
M. Comments on Conforming and Technical Amendments and FDA Response
The proposed rule contained several conforming and technical
amendments.
We proposed revising the requirements for certain analyses under
the Accredited Third-Party Certification Program. Specifically, we
proposed to revise Sec. 1.651(b)(3) to require use of a laboratory
that is accredited in accordance with ISO/IEC 17025:2017 to perform
certain analyses for a regulatory audit. We also proposed to update the
cross-reference in paragraph (c)(2) of the same section.
We received no comments on these proposed changes. Thus, we have
finalized these changes as proposed, with one minor exception. In final
Sec. 1.651(c)(2), we changed, ``Federal Food, Drug, and Cosmetic
Act,'' to ``FD&C Act'' to be consistent with references to the statute
in the regulations for the Accredited Third-Party Certification Program
in part 1, subpart M.
We proposed to amend Sec. 11.1 regarding the scope of the
electronic records and electronic signatures regulations to add
paragraph (p) which states that part 11 does not apply to records
required to be established or maintained by part 1, subpart R of this
chapter (i.e., the LAAF regulations). However, records that satisfy the
requirements of subpart R of part 1 of this chapter (i.e., the LAAF
regulations), but that are also required under other applicable
statutory provisions or regulations, remain subject to part 11.
We received no comments regarding this conforming amendment. Thus,
we have finalized these changes as proposed.
We proposed conforming amendments to revise FDA's regulatory
hearing regulations at Sec. 16.1(b)(2) to include Sec. Sec. 1.1173
and 1.1174 in the list of regulations covered by this part. We received
no comments directly related to these conforming amendments. On our own
initiative, we changed, ``revocation of accreditation'' to
``disqualification,'' consistent with the terminology changes discussed
in Response 10, and ``food testing order'' to ``directed food
laboratory order,'' consistent with the change in terminology discussed
in the definitions section (Sec. 1.1102). In relation to the directed
food laboratory order, we also replaced the reference to Sec.
1.1107(a)(2) with a reference to Sec. 1.1108, consistent with the
reference we are providing in the definition of directed food
laboratory order (see Sec. 1.1102).
We proposed revising the bottled drinking water regulations in 21
CFR 129.35 to state that, ``the analysis of the five samples from the
same sampling site that originally tested positive for E. coli, as
required by paragraph (a)(3) of this section, must be conducted under
part 1, subpart R of this chapter.'' We received a few comments on that
proposal and are finalizing the revision without change; see comment
and Response 87.
VI. Effective Date
This final rule will be effective 60 days after publication in the
Federal Register. For information on implementation of the final rule,
see the discussion under that subheading in section V.B. of this
preamble.
[[Page 68811]]
VII. Economic Analysis of Impacts
We have examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct us to assess all costs
and benefits of available regulatory alternatives and, when regulation
is necessary, to select regulatory approaches that maximize net
benefits (including potential economic, environmental, public health
and safety, and other advantages; distributive impacts; and equity). We
believe that this final rule is not a significant regulatory action as
defined by Executive Order 12866.
The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because the per-entity one-time costs of the rule may exceed
one percent of revenues for accreditation bodies that choose to
participate in the LAAF program, we find that the final rule will have
a significant economic impact on a substantial number of small
entities.
The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $158 million, using the most current (2020) Implicit
Price Deflator for the Gross Domestic Product. This final rule would
not result in an expenditure in any year that meets or exceeds this
amount.
We have developed a comprehensive Economic Analysis of Impacts that
assesses the impacts of this rule. In table 13 we provide the
Regulatory Information Service Center and Office of Information and
Regulatory Affairs Consolidated Information System accounting
information.
Table 13--Summary of Benefits, Costs and Distributional Effects of Final Rule \1\
----------------------------------------------------------------------------------------------------------------
Units
Primary Low High ----------------------------
Category estimate estimate estimate Year Discount Period Notes
dollars rate (%) covered
----------------------------------------------------------------------------------------------------------------
Benefits:
Annualized Monetized $9.1 $6.6 $12.5 2020 7 10 Cost savings and
$millions/year. years avoided QALD
losses.
9.1 6.6 12.5 2020 3 10 Cost savings and
years avoided QALD
losses.
Annualized Quantified........ ........ ........ ........ ....... 7 ....... ...................
........ ........ ........ ....... 3 ....... ...................
------------------------------------------------------------------------------
,nQualitative................ Reduced risk of food-related
illness from improved test
performance for covered
tests. Cost savings from
clarifying reporting
requirements and from
allowing abridged analytical
reports.
Reduced risk of food-related
illness from unsafe food
manufacturing practices.
----------------------------------------------------------------------------------------------------------------
Costs:
Annualized Monetized 7.9 5.8 9.6 2020 7 10
$millions/year. 7.9 5.9 9.7 2020 3 years
10
years
Annualized Quantified........ ........ ........ ........ ....... 7 ...................
3
Qualitative.................. ........ ........ ........ ....... ........ ...................
----------------------------------------------------------------------------------------------------------------
Transfers
Federal Annualized Monetized ........ ........ ........ ....... 7 ...................
$millions/year. 3
------------------------------------------------------------------------------
From/To...................... From:
To: ....... ........ ....... ...................
------------------------------------------------------------------------------
Other........................ ........ ........ ........ ....... 7 ...................
------------------------------------------------------------------------------
Annualized Monetized ........ ........ ........ ....... 3 ...................
$millions/year.
From/To...................... From:
To:
----------------------------------------------------------------------------------------------------------------
Effects:
State, Local or Tribal Government: None.....................................................................
Small Business: Potential impacts on laboratories currently not accredited to ISO/IEC 17025 that would
participate in the LAAF program described by this rule.
Wages: None.................................................................................................
Growth: None................................................................................................
----------------------------------------------------------------------------------------------------------------
\1\ The lower bound equals the 5th percentile and the upper bound equals the 95th percentile.
[[Page 68812]]
The full analysis of economic impacts is available in the docket
for this final rule (Ref. 4) and at https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.
VIII. Analysis of Environmental Impact
We previously considered the environmental effects of this rule, as
stated in the proposed rule (84 FR 59452 at 59496). We stated that we
had determined, under 21 CFR 25.30(h), that this action ``is of a type
that does not individually or cumulatively have a significant effect on
the human environment'' such that neither an environmental assessment
nor an environmental impact statement is required. We have not received
any new information or comments that would affect our previous
determination (Ref. 22).
IX. Paperwork Reduction Act of 1995
This final rule contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The title,
description, and respondent description of the information collection
provisions are shown in the following paragraphs with an estimate of
the annual reporting and recordkeeping burden. Included in the estimate
is the time for reviewing instructions, searching existing data
sources, gathering and maintaining the data needed, and completing and
reviewing each collection of information.
Title: Laboratory Accreditation for Analyses of Foods; OMB Control
Number 0910-0898.
Description: As mandated by section 422 of the FD&C Act, we are
establishing a program for the testing of food by accredited
laboratories (LAAF program); establishing the standards and procedures
for recognizing accredited laboratories and for recognized
accreditation bodies that LAAF-accredit laboratories; establishing a
publicly available registry of recognized accreditation bodies and
LAAF-accredited laboratories; and establishing procedures for reporting
any changes affecting the recognition of such accreditation bodies or
LAAF-accreditation of such laboratories.
Description of Respondents: Respondents to the collection of
information are accreditation bodies seeking recognition from FDA,
recognized accreditation bodies, laboratories seeking LAAF-
accreditation from recognized accreditation bodies, and LAAF-accredited
laboratories.
We estimate the burden of the information collection as follows:
Table 14--Estimated Annual Reporting Burden
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Part 1, Subpart R Citation; Number of responses per Total annual per response (in Total hours
Activity respondents respondent responses hours)
----------------------------------------------------------------------------------------------------------------
Sec. Sec. 1.1113 and 4 1 4 20.............. 80
1.1114; Accreditation bodies
(ABs) application for
recognition (one-time
submission).
Sec. Sec. 1.1113 and 4 1 4 3.6............. 14.4
1.1114; ABs--application for
renewal of recognition.
Sec. 1.1116(a) and (b); ABs-- 0 3 0 3............... 0
notices of intent to
relinquish, records custodian.
Sec. 1.1123; ABs--reports, 4 42 168 1.75............ 294
notifications, and
documentation requirements.
Sec. Sec. 1.1138 and 170 1 170 20.............. 3,400
1.1139; laboratories--
submission of application for
LAAF-accreditation (one-time
submission).
Sec. 1.1140(a); 2 3 6 1............... 6
laboratories--notices of
intent to relinquish, records
custodian.
Sec. Sec. 1.1149(a) and 170 25 4,250 1.75............ 7,437.5
1.1152(c)(1), (2);
laboratories--submission of
sampling plan, sample
collection report, and
sampler qualifications.
Sec. Sec. 1.1152(d) and 170 10 1,700 2............... 3,400
1.1153(a); laboratories--
qualification to submit
abridged analytical reports
(one-time submission).
Sec. 1.1153; laboratories-- 170 25 4,250 1.16............ 4,930
abridged analytical reports
submissions.
Sec. 1.1152(c)(3), (4), and 9 1 9 .25 (15 minutes) 2.25
(5); laboratories--validation
and verification studies
submissions.
Sec. 1.1149(c); 170 1 170 1.5............. 255
laboratories--advance notice
of sampling submissions.
Sec. 1.1152(f); 170 1.5 255 .25 (15 minutes) 63.75
laboratories--immediate
notification.
Sec. Sec. 1.1142; 1.1171; 1 1 1 1............... 1
1.1173; and 1.1174--requests
in response to FDA action.
---------------------------------------------------------------------------------
Total..................... .............. .............. .............. ................ 19,883.9
----------------------------------------------------------------------------------------------------------------
Reporting Burden: Consistent with estimates in our FRIA (see
section II.F, Costs of this Rule (Ref. 4)), we estimate a total of 174
respondents. We estimate that 5 to 80 accreditation bodies could apply
for FDA recognition under this final rule and assume that 4
accreditation bodies will apply for FDA recognition. We estimate 170
laboratories will participate in the program. The reporting burden
includes a burden of 20,640 hours associated with one-time submissions.
In this analysis, we annualize the one-time submission burden using a
3-year
[[Page 68813]]
period horizon and zero percent discount rate, for an annualized one-
time reporting burden of 6,880 hours. Cumulatively, this results in a
total annual reporting burden of 19,883.9 hours, as reflected in table
14.
Section 1.1114 requires an accreditation body seeking initial
recognition to submit an application to FDA demonstrating it meets the
eligibility requirements described in Sec. 1.1113 of the final rule.
The burden to prepare and submit an application is an initial burden
and, once realized, would apply only to respondents new to the program.
We estimate this process would take one analyst between 40 and 80 hours
to compile all the relevant information, prepare for an assessment,
complete the initial application process, and submit the application.
For this analysis we assume a middle value of 60 hours. Also for this
analysis, we use a 3-year period horizon and zero percent discount rate
to convert the one-time submission burden to an annualized figure
(i.e., 60 hours / by 3 = 20 hours). Annually this results in 80 hours
of burden for initial applications submitted by 4 accreditation bodies
(4 applications x 20 hours per application), as reflected in row 1.
Section 1.1114 requires a recognized accreditation body to apply
for renewal of recognition at least every 5 years. We believe renewal
would take less time than an initial application because much of the
information will have already been compiled and therefore assume
between 20 and 40 hours. For this analysis we use a middle value and
calculate that each recognized accreditation body will spend 30 hours
every 5 years to complete and submit an application for renewal of its
recognition. This results in 6 hours per year (30 hours / 5 years) for
each accreditation body. Because we use a 3-year period horizon and
zero percent discount rate for this analysis, we annualize that figure
to three-fifths or 3.6. We multiply this figure by 4 accreditation
bodies for a total of 14.4 hours annually for the submission of renewal
of applications (4 applications x 3.6 hours per application), as
reflected in row 2.
Section 1.1116 requires that if a recognized accreditation body
voluntarily chooses to relinquish or not renew its recognition, it must
notify FDA and the laboratories it LAAF-accredits of its intention to
depart the program at least 60 days ahead of the departure. The
recognized accreditation body must also provide FDA with the name and
contact information of the custodian who will maintain and make
available to FDA requisite program records. We estimate a 1 percent
voluntary departure rate, which equates to the departure of 0.04
recognized accreditation body annually. We estimate it would take a
recognized accreditation body one hour for each of the three required
notices. Accordingly, with rounding, the estimate for the burden
associated with Sec. 1.1116 is zero (0.04 recognized accreditation
body x 3 notices = .12 annual responses, which rounds to 0; 0 annual
response x 3 hours = 0 total hours), as reflected in row 3.
Section 1.1123 requires a recognized accreditation body to submit
certain reports, notifications, and documentation to FDA, including
significant changes affecting its accreditation program or the
accreditation status of laboratories it LAAF-accredits, and to ensure
FDA has access to these and other records. We estimate recognized
accreditation bodies would incur a burden of 3.5 hours per month, or 42
hours per year, complying with the reporting requirements of Sec.
1.1123 and the recordkeeping requirements of Sec. 1.1124. For this
analysis, we identify recordkeeping and reporting burdens separately
and assume 21 of the 42 hours (i.e., 1.75 hours per month) would be
spent meeting the reporting requirements of Sec. 1.1123. Annually,
this results in 294 hours (4 recognized accreditation bodies x 42
responses per accreditation body x 1.75 hours per response), as
reflected in row 4.
Section 1.1139 requires a laboratory seeking LAAF-accreditation to
submit an application to a recognized accreditation body, demonstrating
that it meets the eligibility requirements specified in Sec. 1.1138.
We estimate 170 laboratories will apply and assume it would take one
analyst an average of 60 hours to compile all the relevant information;
however we regard the burden as a one-time burden and therefore have
annualized it by 3 years (20 hours annually). This results in an annual
reporting burden for initial applications by 170 laboratories being
3,400 hours (170 applications x 20 hours per application), as reflected
in row 5.
Section 1.1140 provides that if a laboratory voluntarily chooses to
relinquish or not renew its LAAF-accreditation, it must notify FDA and
its recognized accreditation body of its intention to do so at least 60
days ahead of the departure. If the laboratory is voluntarily
relinquishing or not renewing all methods within its scope, it must
also provide FDA with the name and contact information of the custodian
who will maintain and make available to FDA requisite program records.
We estimate a 1 percent program departure rate, which equates to the
departure of 1.70 LAAF-accredited laboratories each year, which we
round to 2. We estimate it would take a laboratory one hour for each of
the three required notices. Accordingly, we estimate a burden of 6
hours per year under Sec. 1.1140 (2 laboratories x 3 notices = 6
annual responses; 6 annual responses x 1 hour = 6 total hours), as
reflected in row 6.
Section 1.1152(a) through (e) requires a LAAF-accredited laboratory
to submit results of testing required to be conducted under the LAAF
program and include supporting documentation. As discussed in our
supporting statement, only a percentage of that testing would be
defined as information collection under the PRA. For this analysis we
assume a mean figure of 4,065 test result and supporting documentation
submissions (4,065.2 rounded to the nearest integer) as the basis for
factoring a corresponding information collection burden. This figure is
derived using lower and upper bound estimates of submissions we expect
under the rule. To allow for adjustment and potential increase we have
added 50 submissions for a total of 4,115.
Section 1.1152(c)(1) requires a LAAF-accredited laboratory to
submit a sample collection plan and sample collection report (the
contents of which are described in Sec. 1.1149(a)) with each test
result. Under Sec. 1.1152(c)(2), a LAAF-accredited laboratory must
include documentation of the sampler's qualifications the first time
the sampler collects a sample. We assume that it would take 30 minutes
to 1 hour to compile a sampling plan, 30 minutes to 1 hour to compile a
sample collection report, and an average of 10 to 20 minutes to obtain
the sampling plan, sample collection report, and sampler's
qualifications. Using a middle value of 1.5 hours to generate the
sampling plan and the sample collection report, and a middle value of
15 minutes (.25 hours) to obtain those two documents and documentation
of the sampler's qualifications, we calculate a total time per test
result of 1.75 hours (1.5 + .25). When multiplied together the total
reporting burden for the submission of sampling plans, sample
collection reports, and sampler qualification requirements (170
accredited laboratories x 25 sampling plans and sample collection
reports x 1.75 hours) is 7,437.5 hours, as reflected in row 7.
Section 1.1153(a) allows a LAAF-accredited laboratory to qualify to
submit abridged analytical reports in lieu of full analytical reports.
We expect
[[Page 68814]]
this will be a one-time burden, but we may revisit this assumption in
the future based on actual rates of revocation of permission to submit
abridged analytical reports. We assume that each LAAF-accredited
laboratory would submit 10 consecutive full analytical reports (for the
middle value of 2 major food testing disciplines per laboratory) to
qualify to submit abridged analytical reports. We also assume that a
LAAF-accredited laboratory will spend 4 to 8 hours to compile and
submit a full analytical report, and we use the middle value of 6 hours
for this analysis. For initial or one-time burdens we use a 3-year
period horizon and zero percent discount rate to convert the one-time
burden to an annualized figure (2 hours). When multiplied together,
this results in a total reporting burden for the LAAF-accredited
laboratories to qualify to submit abridged analytical reports of 3,400
hours (170 laboratories x 10 full analytical reports each x 2 hours per
analytical report), as reflected in row 8.
Once a LAAF-accredited laboratory qualifies to submit abridged
analytical reports, we assume it will submit abridged analytical
reports to us thereafter. We may revisit this assumption in the future
based on actual rates of revocation of permission to submit abridged
analytical reports. We estimate the burden to compile and submit an
abridged analytical report to be between 25 percent and 33 percent of
the burden of compiling and submitting a full analytical report, and we
use a middle value of 29 percent here. Thus, using these figures we
calculate it would take a LAAF-accredited laboratory 1.16 hours to
compile and submit an abridged analytical report (29 percent x 4
hours). This results in an annual total reporting burden for the 170
LAAF-accredited laboratories to compile and submit abridged analytical
reports of approximately 4,930 hours (170 laboratories x 25 abridged
analytical reports x 1.16 hours per abridged analytical report), as
reflected in row 9.
The final rule also requires a LAAF-accredited laboratory to submit
verification and validation studies to FDA as part of an analytical
report. The ISO/IEC 17025:2017 standard requires the use of validated
and verified methods for food testing. However, the final rule requires
additional verification studies over and above the requirements of ISO/
IEC 17025:2017. Additional studies may include information to verify
that a method previously validated for a specific food item is also
valid for a different food item, in what is called a ``matrix
extension.'' We estimate that the additional time burden of requiring a
LAAF-accredited laboratory to submit verification studies such as
matrix extensions under this final rule to be a middle value of
approximately 3 percent of the time burden incurred by laboratories to
maintain accreditation to ISO/IEC 17025:2017 (the FRIA estimates a
range of 1 percent to 5 percent). In the FRIA we also note that
internal FDA experts suggest that between 5 percent and 30 percent of
import food testing results require verification studies such as matrix
extensions. We use a middle value of 17.5 percent for this analysis.
Regarding validation requirements, we assume that methods used to
test shell eggs, sprouts, and bottled drinking water are either already
validated or that the costs of doing so would be included in the costs
to maintain ISO/IEC 17025:2017 accreditation. Consequently, we assume
that shell eggs, sprouts, and bottled drinking water producers would
incur no burden from this requirement beyond the burden of the final
rule's requirement to meet the validation requirements of ISO/IEC
17025:2017.
We estimate the time required to perform a matrix extension is a
middle value of 34 hours (the FRIA estimates a range of 22 to 46
hours). We do not distinguish between the burden of reporting the study
and the burden of conducting the study. We assume 25 percent of the 34
hours (8.5 hours) is attributable to the associated reporting burden.
Because we estimate that the additional time burden of requiring
laboratories to submit verification studies such as matrix extensions
under this final rule would be approximately 3 percent of the time
burden incurred by laboratories to maintain accreditation to ISO/IEC
17025:2017, we multiply 8.5 hours by 3 percent to get the additional
reporting burden of .255 hours (15.3 minutes, which we round to 15
minutes, which is .25 hours) per study imposed by the verification
study submission requirements of the final rule. To estimate the number
of test results that would require matrix extensions, we multiply the
number of import testing results that would be submitted to us under
this rule annually that are subject to PRA requirements (50) by the
share of test results submitted to us for import food testing that
require matrix extensions (17.5 percent), for a total of 8.75 matrix
extensions per year. This equates to an average of .3241 matrix
extensions per LAAF-accredited laboratory conducting food testing for
imports (8.75 / 27). Because the number of respondents and the annual
responses per respondent in a PRA analysis must be whole numbers, we
instead estimate that nine LAAF-accredited laboratories (27 x .3241,
rounded to 9 from 8.75) will submit one full verification study to FDA
annually. Therefore, the annual reporting burden of requiring the
submission of validation and verification studies under this final rule
is 2.25 hours (9 accredited laboratories x 1 verification studies x .25
hours per study), as reflected in row 10.
Under section 1.1149(c), FDA may require under certain
circumstances, that a LAAF-accredited laboratory submit an advance
notice of sampling to FDA before each of the next several occasions
that the sampler will a collect a sample that the LAAF-accredited
laboratory will analyze under the LAAF program. We assume that it would
take a laboratory analyst between 1 and 2 hours to compile and submit
the required information, and we assume that between one percent and
five percent of all test results submitted annually under the LAAF
program will be subject to the advance notice of sampling requirement.
For this analysis we assume middle values of 1.5 hours and three
percent, respectively. Thus, we estimate that 123.45 test results
(4,115 x 3%) will require submission of advance notice of sampling
under the final rule. For this analysis we assume that each of the
estimated 170 LAAF-accredited laboratories will be required to submit
three advance notices sampling annually under the final rule (123.45 /
170 = 0.74; rounded to 1). Thus, the annual reporting burden on LAAF-
accredited laboratories for the advance notice of sampling requirement
would be 255 hours (170 laboratories x 1 advance notices of sampling x
1.5 hours), as reflected in row 11.
Section 1.1152(f) requires a LAAF-accredited laboratory to notify
FDA and the recognized accreditation body of any changes that affect
the laboratory's LAAF-accreditation. Note, however, that a LAAF-
accredited laboratory is not required to notify FDA of changes that the
recognized accreditation body must provide to FDA under Sec.
1.1123(d). As a conservative estimate, we assume that each LAAF-
accredited laboratory will have some change requiring notification of
its recognized accreditation body, and for half of those changes the
LAAF-accredited laboratory will also need to notify FDA. We estimate it
will take a LAAF-accredited laboratory 15 minutes per notification.
Thus, we estimate the burden associated with Sec. 1.1152(f) would be
63.75 hours (170 accredited laboratories x 1.5 notifications x 0.25
hours per notification), as reflected in row 12.
[[Page 68815]]
Sections 1.1142, 1.1171, 1.1173, and 1.1174 provide for requests to
FDA. Specifically, Sec. 1.1142 provides for requests for reinstatement
of LAAF accreditation; Sec. 1.1171 provides for requests for
reconsideration of denials; and Sec. Sec. 1.1173 and 1.1174 provide
for requests for hearings. Because this is a new collection, we
estimate a cumulative total of 1 respondent and 1 burden hour, as
reflected in row 13.
Table 15--Estimated Annual Recordkeeping Burden
----------------------------------------------------------------------------------------------------------------
Average burden
21 CFR part 1, subpart R; Number of Number of Total annual per
activity recordkeepers records per records recordkeeping Total hours
recordkeeper (in hours)
----------------------------------------------------------------------------------------------------------------
Sec. 1.1113; recordkeeping 4 1 4 1 4
associated with ISO/IEC
17011:2017.....................
Sec. 1.1124; ABs--additional 4 1 4 21 84
recordkeeping requirements.....
Sec. 1.1138; laboratories-- 9 1 9 91.06 819.54
becoming accredited to ISO/IEC
17025:2017 (one-time)..........
Sec. 1.1138; laboratories-- 170 1 170 889.53 151,220.10
maintaining ISO/IEC 17025:2017
accreditation..................
Sec. 1.1154; laboratories-- 170 1 170 12 2,040
additional recordkeeping
requirements...................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 154,167.64
----------------------------------------------------------------------------------------------------------------
Recordkeeping Burden: We estimate the annual recordkeeping
requirements associated with the final rule to be 154,167.64 hours, as
reflected in table 15.
Section 1.1113 requires a recognized accreditation body to meet the
requirements of ISO/IEC 17011:2017. While ISO/IEC 17011:2017 includes
recordkeeping requirements, as noted above we anticipate that all 4 of
the accreditation bodies that we estimate will apply to become
recognized currently adhere to ISO/IEC 17011:2017. We therefore regard
these activities as usual and customary; however, we include a place
holder of one response and one burden hour for each respondent, as
reflected in row 1.
Section 1.1124 requires maintenance of certain records in addition
to those required by ISO/IEC 17011:2017. We estimate that a recognized
accreditation body will incur a burden of 12 hours per year to comply
with both the recordkeeping requirements of Sec. 1.1124 and the
reporting requirements of Sec. 1.1123. For this analysis, we identify
the recordkeeping and reporting burdens separately, assuming 21 of
those 42 annual hours would be spent complying with the recordkeeping
requirements of Sec. 1.1124. Thus, the annual recordkeeping burden for
the 4 recognized accreditation bodies to meet the additional
recordkeeping requirements of Sec. 1.1124 would be 84 hours, as
reflected in row 2.
Section 1.1138 requires a laboratory to be ISO/IEC 17025:2017-
accredited, including meeting its recordkeeping requirements, to become
LAAF-accredited under the rule. We estimate that 7 to 10 laboratories
not currently accredited to ISO/IEC 17025:2017 would become so
accredited to participate in the LAAF program. For this estimate, we
assume the middle value of 8.5 laboratories, which we round up to 9,
would become ISO/IEC 17025-accredited to participate in the LAAF
program. The burden to become ISO/IEC 17025:2017-accredited is an
initial burden and, once realized, would apply only to respondents
becoming accredited to ISO/IEC 17025:2017 to participate in the LAAF
program. We estimate that it would take a mean of 91.06 hours for the
associated recordkeeping activities. In this analysis, we annualize
this recordkeeping burden using a 3-year period horizon and zero
percent discount rate, for an annualized recordkeeping burden of 819.54
hours, as reflected in row 3.
Section 1.1138 requires a LAAF-accredited laboratory to maintain
conformance with ISO/IEC 17025:2017, including its recordkeeping
requirements. As discussed in the proposed rule, we estimate a mean of
889.53 hours for this recordkeeping. This results in an annual burden
of 151,220.10 hours, as reflected in row 4.
Section 1.1154 requires maintenance of certain records in addition
to those required by ISO/IEC 17025:2017. We estimate that a LAAF-
accredited laboratory will incur a burden of about 1 hour per month (12
hours per year) to comply with the recordkeeping requirements in Sec.
1.1154. This results in an annual burden of 2,040 hours, as reflected
in row 5.
The information collection provisions in this final rule have been
submitted to OMB for review as required by section 3507(d) of the
Paperwork Reduction Act of 1995.
Before the effective date of this final rule, FDA will publish a
notice in the Federal Register announcing OMB's decision to approve,
modify, or disapprove the information collection provisions in this
final rule. An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid OMB control number.
X. Federalism
We have analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. We have determined that the rule
does not contain policies that have substantial direct effects on the
States, on the relationship between the National Government and the
States, or on the distribution of power and responsibilities among the
various levels of government. Accordingly, we conclude that the rule
does not contain policies that have federalism implications as defined
in the Executive Order and, consequently, a federalism summary impact
statement is not required.
XI. Consultation and Coordination With Indian Tribal Governments
We have analyzed this rule in accordance with the principles set
forth in Executive Order 13175. We have determined that the rule does
not contain policies that have substantial direct effects on one or
more Indian Tribes, on the relationship between the Federal Government
and Indian Tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian Tribes. Accordingly, we
conclude that the rule
[[Page 68816]]
does not contain policies that have tribal implications as defined in
the Executive Order and, consequently, a tribal summary impact
statement is not required.
XII. References
The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (see ADDRESSES) and are available for
viewing by interested persons between 9 a.m. and 4 p.m., Monday through
Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public
display at https://www.regulations.gov because they have copyright
restriction. Some may be available at the website address, if listed.
References without asterisks are available for viewing only at the
Dockets Management Staff. FDA has verified the website addresses, as of
the date this document publishes in the Federal Register, but websites
are subject to change over time.
* Ref. 1. Congressional Hearing, ``The Safety of Food Imports:
Fraud & Deception in the Food Import Process; Hearings Before the
Senate Committee on Governmental Affairs, Permanent Subcommittee on
Investigations.'' September 10, 1998. https://www.gpo.gov/fdsys/pkg/CHRG-105shrg51562/pdf/CHRG-105shrg51562.pdf. Accessed November 4,
2021.
Ref. 2. ISO/IEC 17011:2017(E), ``Conformity Assessment--
Requirements for Accreditation Bodies Accrediting Conformity
Assessment Bodies.'' ISO/IEC. November 2017. Copies are available
from the International Organization for Standardization, Chemin de
Blandonnet 8, 1214 Vernier, Geneva, Switzerland, or on the internet
at https://www.iso.org/standard/67198.html, or may be examined at
the Dockets Management Staff (Ref. Docket No. FDA-2019-N-3325 and/or
RIN 0910-AH31).
Ref. 3. ISO/IEC 17025:2017(E), ``General Requirements for the
Competence of Testing and Calibration Laboratories.'' ISO/IEC.
November 2017. Copies are available from the International
Organization for Standardization, Chemin de Blandonnet 8, 1214
Vernier, Geneva, Switzerland, or on the internet at https://www.iso.org/standard/66912.html, or may be examined at the Dockets
Management Staff (Ref. Docket No. FDA-2019-N-3325 and/or RIN 0910-
AH31).
* Ref. 4. FDA. LAAF: Final Regulatory Impact Analysis, Final
Regulatory Flexibility Analysis, Unfunded Mandates Reform Act
Analysis, 2021. https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.
* Ref. 5. Partnership for Food Protection, ``Human and Animal
Food Testing Laboratories Best Practices Manual,'' December 2018,
available at https://www.pfp-ifss.org/ifss-resources/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018/. Accessed November 4, 2021.
* Ref. 6. Association for Public Health Laboratories, ``Best
Practices for Submission of Actionable Human and Animal Food Testing
Data Generated in State and Local Laboratories,'' January 2019,
available at https://www.aphl.org/aboutAPHL/publications/Documents/FS-2019Jan-Best-Practices-Human-Animal-Food-Data.pdf. Accessed
November 4, 2021.
* Ref. 7. The Cambridge Dictionary, https://dictionary.cambridge.org/us/dictionary/english/assess. Accessed
November 4, 2021.
* Ref. 8. ``OMB Circular A-119: Federal Participation in the
Development and Use of Voluntary Consensus Standards and in
Conformity Assessment Activities.'' Office of Management and Budget.
January 2016. https://www.nist.gov/system/files/revised_circular_a-119_as_of_01-22-2016.pdf. Accessed November 4, 2021.
* Ref. 9. National Institute of Standards and Technology Special
Publication 2000-02, ``Conformity Assessment Considerations for
Federal Agencies,'' September 2018. https://doi.org/10.6028/NIST.SP.2000-02. Accessed November 4, 2021.
* Ref. 10. Codex Alimentarius Commission, ``General Guidelines
on Sampling,'' CAC/GL-50-2004. http://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXG%2B50-2004%252FCXG_050e.pdf. Accessed November
4, 2021.
* Ref. 11. FDA, ``Control of Listeria monocytogenes in Ready-To-
Eat Foods: Guidance for Industry,'' Draft Guidance, January 2017.
https://www.fda.gov/media/102633/download. Accessed November 4,
2021.
* Ref. 12. FDA, ``Outbreak Investigation of Scombrotoxin Fish
Poisoning: Yellowfin/Ahi Tuna (November 2019).'' https://
www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-
scombrotoxin-fish-poisoning-yellowfinahi-tuna-november-
2019#:~:text=%2C%20WV%20(1)-
,What%20is%20Scombrotoxin%20Fish%20Poisoning%3F,eating%20mishandled%2
0and%20decomposed%20fish. Accessed November 4, 2021.
Ref. 13. AOAC International, ``Guidelines for Laboratories
Performing Microbiological and Chemical Analyses of Food, Dietary
Supplements, and Pharmaceuticals, An Aid to Interpretation of ISO/
IEC 17025:2017.'' August 2018. Copies are available from AOAC
International, 2275 Research Blvd., Ste. 300, Rockville, MD 20850-
3250, USA, or on the internet at https://www.aoac.org/aoac-accreditation-guidelines-for-laboratories-alacc/, or may be examined
at the Dockets Management Staff (Ref. Docket No. FDA-2019-N-3325
and/or RIN 0910-AH31).
Ref. 14. Association of American Feed Control Officials, ``2014
Quality Assurance/Quality Control Guidelines for Feed Laboratories,
2014.'' Copies are available from Association of American Feed
Control Officials, 1800 South Oak St., Suite 100, Champaign, IL
61820 or on the internet at https://www.aafco.org/Publications/QA-QC-Guidelines-for-Feed-Laboratories, or may be examined at the
Dockets Management Staff (Ref. Docket No. FDA-2019-N-3325 and/or RIN
0910-AH31).
* Ref. 15. FDA Memorandum, ``Assessment of DWPE Sampling and
Analysis Data to Determine what Portion of Sampling and Analysis of
Food under DWPE is Conducted by Accredited Entities.'' Toni Morales
and Tyler Scandalios, FDA. November 20, 2018.
Ref. 16. ISO/IEC 17043:2010, ``Conformity Assessment--General
Requirements for Proficiency Testing.'' ISO/IEC. February 2010.
Copies are available from the International Organization for
Standardization, Chemin de Blandonnet 8, 1214 Vernier, Geneva,
Switzerland, or on the internet at https://www.iso.org/standard/29366.html, or may be examined at the Dockets Management Staff (Ref.
Docket No. FDA-2019-N-3325 and/or RIN 0910-AH31).
* Ref. 17. FDA, Investigations Operations Manual, 2021. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/investigations-operations-manual. Accessed November 4, 2021.
* Ref. 18. University of Georgia Extension, Bulletin 1306,
``Biosecurity Basics for Poultry Growers,'' March 2020. https://secure.caes.uga.edu/extension/publications/files/pdf/B%201306_6.PDF.
Accessed November 4, 2021.
* Ref. 19. Association of American Food Control Officials,
``GOODSamples: Guidance On Obtaining Defensible Samples,'' October
2015. https://www.aafco.org/Portals/0/SiteContent/Publications/GOODSamples.pdf. Accessed November 4, 2021.
* Ref. 20. Association of American Food Control Officials,
``GOOD Test Portions: Guidance On Obtaining Defensible Test
Portions,'' June 2018. http://www.aafco.org/Publications/GOODTestPortions. Accessed November 4, 2021.
* Ref. 21. FDA, ``Methods, Method Verification and Validation,''
ORA Laboratory Manual, Vol. II, Section 2, document number ORA-
LAB.5.4.5. June 30, 2020. https://www.fda.gov/media/73920/download.
Accessed November 4, 2021.
* Ref. 22. FDA Memorandum, ``Categorical Exclusion--Final Rule
Laboratory Accreditation for Analyses of Foods [Docket No. FDA-2019-
N-3325].'' Mariellen Pfeil, FDA. July 21, 2021.
List of Subjects
21 CFR Part 1
Cosmetics, Drugs, Exports, Food labeling, Imports, Incorporation by
reference, Labeling, Reporting and recordkeeping requirements.
21 CFR Part 11
Computer technology, Reporting and recordkeeping requirements.
21 CFR Part 16
Administrative practice and procedure.
21 CFR Part 129
Beverages, Bottled water, Food packaging, Reporting and
recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act, and
under
[[Page 68817]]
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
1, 11, 16, and 129 are amended as follows:
PART 1--GENERAL ENFORCEMENT REGULATIONS
0
1. The authority citation for part 1 continues to read as follows:
Authority: 15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C.
1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 343, 350c,
350d, 350e, 350j, 350k, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2,
362, 371, 373, 374, 379j-31, 381, 382, 384a, 384b, 384d, 387, 387a,
387c, 393; 42 U.S.C. 216, 241, 243, 262, 264, 271; Pub. L. 107-188,
116 Stat. 594, 668-69; Pub. L. 111-353, 124 Stat. 3885, 3889.
0
2. In Sec. 1.651, revise paragraphs (b)(3) and (c)(2) to read as
follows:
Sec. 1.651 How must an accredited third-party certification body
conduct a food safety audit of an eligible entity?
* * * * *
(b) * * *
(3) When, for a regulatory audit, sampling and analysis is
conducted, the accredited third-party certification body must use a
laboratory that is accredited in accordance with ISO/IEC 17025:2017 to
perform the analysis.
* * * * *
(c) * * *
(2) The audit must include records review prior to the onsite
examination; an onsite examination of the facility, its process(es),
and the food that results from such process(es); and where appropriate
or when required by FDA, environmental or product sampling and
analysis. When, for a regulatory audit, sampling and analysis is
conducted, the accredited third-party certification body must use a
laboratory that is accredited in accordance with paragraph (b)(3) of
this section to conduct the analysis. The audit may include any other
activities necessary to determine compliance with applicable food
safety requirements of the FD&C Act and FDA regulations, and, for
consultative audits, also includes conformance with applicable industry
standards and practices.
* * * * *
0
3. Add subpart R, consisting of Sec. Sec. 1.1101 through 1.1201, to
read as follows:
Subpart R--Laboratory Accreditation for Analyses of Foods
General Provisions
Sec.
1.1101 What documents are incorporated by reference in this subpart?
1.1102 What definitions apply to this subpart?
1.1103 Who is subject to this subpart?
General Requirements
1.1107 When must food testing be conducted under this subpart?
1.1108 When and how will FDA issue a directed food laboratory order?
1.1109 How will FDA make information about recognized accreditation
bodies and LAAF-accredited laboratories available to the public?
1.1110 What are the general requirements for submitting information
to FDA under this subpart?
FDA Recognition of Accreditation Bodies
1.1113 What are the eligibility requirements for a recognized
accreditation body?
1.1114 How does an accreditation body apply to FDA for recognition
or renewal of recognition?
1.1115 How will FDA evaluate applications for recognition and
renewal of recognition?
1.1116 What must a recognized accreditation body do to voluntarily
relinquish or not renew its recognition?
1.1117 How may an accreditation body request reinstatement of
recognition?
Requirements for Recognized Accreditation Bodies
1.1119 What are the conflict of interest requirements for a
recognized accreditation body?
1.1120 How must a recognized accreditation body assess laboratories
seeking LAAF-accreditation and oversee LAAF-accredited laboratories?
1.1121 When must a recognized accreditation body require corrective
action, suspend a LAAF-accredited laboratory, or reduce the scope of
or withdraw the LAAF-accreditation of a laboratory?
1.1122 What procedures must a recognized accreditation body provide
for appeals of decisions to suspend, reduce the scope of, withdraw,
or deny LAAF-accreditation?
1.1123 What reports, notifications, and documentation must a
recognized accreditation body submit to FDA?
1.1124 What are the records requirement for a recognized
accreditation body?
1.1125 What are the internal audit requirements for a recognized
accreditation body?
FDA Oversight of Recognized Accreditation Bodies
1.1130 How will FDA oversee recognized accreditation bodies?
1.1131 When will FDA require corrective action, put a recognized
accreditation body on probation, or revoke the recognition of an
accreditation body?
LAAF-Accreditation of Laboratories
1.1138 What are the eligibility requirements for a LAAF-accredited
laboratory?
1.1139 How does a laboratory apply for LAAF-accreditation or extend
its scope of LAAF-accreditation?
1.1140 What must a LAAF-accredited laboratory do to voluntarily
relinquish its LAAF-accreditation?
1.1141 What is the effect on a LAAF-accredited laboratory if its
recognized accreditation body is no longer recognized by FDA?
1.1142 How does a laboratory request reinstatement of LAAF-
accreditation?
Requirements for LAAF-Accredited Laboratories
1.1147 What are the impartiality and conflict of interest
requirements for a LAAF-accredited laboratory?
1.1149 What oversight standards apply to sampling?
1.1150 What are the requirements for analysis of samples by a LAAF-
accredited laboratory?
1.1151 What requirements apply to the methods of analysis a LAAF-
accredited laboratory uses to conduct food testing under this
subpart?
1.1152 What notifications, results, reports, and studies must a
LAAF-accredited laboratory submit to FDA?
1.1153 What are the requirements for submitting abridged analytical
reports?
1.1154 What other records requirements must a LAAF-accredited
laboratory meet?
FDA Oversight of LAAF-Accredited Laboratories
1.1159 How will FDA oversee LAAF-accredited laboratories?
1.1160 How will FDA review test results and analytical reports?
1.1161 When will FDA require corrective action, put a LAAF-
accredited laboratory on probation, or disqualify a LAAF-accredited
laboratory from submitting analytical reports?
1.1162 What are the consequences if FDA puts a LAAF-accredited
laboratory on probation or disqualifies a LAAF-accredited
laboratory?
Requesting FDA Reconsideration or Regulatory Hearings of FDA
Decisions Under This Subpart
1.1171 How does an accreditation body request reconsideration by FDA
of a decision to deny its application for recognition, renewal, or
reinstatement?
1.1173 How does an accreditation body or laboratory request a
regulatory hearing on FDA'sdecision to revoke the accreditation
body's recognition or disqualify a LAAF-accredited laboratory?
1.1174 How does an owner or consignee request a regulatory hearing
on a directed food laboratory order?
Electronic Records and Public Disclosure Requirements
1.1199 Are electronic records created under this subpart subject to
the electronic records requirements of part 11 of this chapter?
1.1200 Are the records obtained by FDA under this subpart subject to
public disclosure?
[[Page 68818]]
Subpart R--Laboratory Accreditation for Analyses of Foods
General Provisions
Sec. 1.1101 What documents are incorporated by reference in this
subpart
(a) Certain material is incorporated by reference into this subpart
with the approval of the Director of the Federal Register under 5
U.S.C. 552(a) and 1 CFR part 51. All approved material is available for
inspection at the Food and Drug Administration's Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500,
and is available from the source listed elsewhere in this section. It
is also available for inspection at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, email [email protected] or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.
(b) International Organization for Standardization (ISO), Chemin de
Blandonnet 8, CP 401, 1214 Vernier, Geneva, Switzerland; Telephone 41
22 749 01 11, https://www.iso.org/home.html.
(1) ISO/IEC 17011:2017(E), Conformity assessment--Requirements for
accreditation bodies accrediting conformity assessment bodies, Second
edition, November 2017, IBR approved for Sec. Sec. 1.1113(a) and (c),
1.1114(b), 1.1120(c), 1.1131(a).
(2) ISO/IEC 17025:2017(E), General requirements for the competence
of testing and calibration laboratories, Third edition, November 2017,
IBR approved for Sec. Sec. 1.1120(c), 1.1121(a), 1.1138(a), 1.1139(b)
and (c), 1.1141(a), 1.1152(a) and (d), 1.1153(c), and 1.1161(a).
Sec. 1.1102 What definitions apply to this subpart?
The definitions of terms in section 201 of the Federal Food, Drug,
and Cosmetic Act apply to such terms when used in this subpart, unless
otherwise specified. For the purposes of this subpart, the following
definitions also apply:
Analyst means an individual who analyzes samples.
Corrective action means an action taken by an accreditation body or
laboratory to investigate and eliminate the cause of a deficiency so
that it does not recur.
Directed food laboratory order means an order issued by FDA under
Sec. 1.1108 requiring food testing to be conducted under this subpart
by or on behalf of an owner or consignee.
Food has the meaning given in section 201(f) of the Federal Food,
Drug, and Cosmetic Act, except that food does not include pesticides
(as defined in 7 U.S.C. 136(u)).
Food testing and testing of food means the analysis of food product
samples or environmental samples.
Laboratory accreditation for analyses of foods (LAAF)-accreditation
means a determination by a recognized accreditation body that a
laboratory meets the applicable requirements of this subpart to conduct
food testing under this subpart using one or more methods of analysis.
LAAF-accredited laboratory means a laboratory that a recognized
accreditation body has determined meets the applicable requirements of
this subpart and has been LAAF-accredited to conduct food testing under
this subpart using one or more methods of analysis.
Owner or consignee means any person with an ownership or
consignment interest in the food product or environment that is the
subject of food testing conducted under Sec. 1.1107(a).
Recognition means a determination by FDA that an accreditation body
meets the applicable requirements of this subpart and is authorized to
LAAF-accredit laboratories under this subpart.
Recognized accreditation body means an accreditation body that FDA
has determined meets the applicable requirements of this subpart and is
authorized to LAAF-accredit laboratories under this subpart.
Representative sample means a sample that accurately, to a
statistically acceptable degree, represents the characteristics and
qualities of the food product or environment from which the sample was
collected.
Sampler means an individual who collects samples.
Sampling firm means an entity that provides sampling services.
Scope of LAAF-accreditation refers to the methods of analysis for
which the laboratory is LAAF-accredited.
Street address means the full physical address, including the
country. For purposes of this rule, a post office box number alone is
insufficient; however, a post office box number may be provided in
addition to the street address.
Sec. 1.1103 Who is subject to this subpart?
(a) Accreditation bodies. An accreditation body is subject to this
subpart if it has been or is seeking to be recognized by FDA to LAAF-
accredit laboratories to conduct food testing under this subpart.
(b) Laboratories. A laboratory is subject to this subpart if it has
been or is seeking to be LAAF-accredited by a recognized accreditation
body to conduct food testing under this subpart.
(c) Owners and consignees. An owner or consignee is subject to this
subpart if it is required to use a LAAF-accredited laboratory to
conduct food testing under this subpart.
General Requirements
Sec. 1.1107 When must food testing be conducted under this subpart?
(a) Food testing must be conducted under this subpart whenever such
testing is conducted by or on behalf of an owner or consignee:
(1) In response to explicit testing requirements that address an
identified or suspected food safety problem, which are contained in the
following provisions:
(i) Sprouts. Section 112.146(a), (c), and (d) of this chapter;
(ii) Shell eggs. Sections 118.4(a)(2)(iii), 118.5(a)(2)(ii) and
(b)(2)(ii), and 118.6(a)(2) and (e) of this chapter; and
(iii) Bottled drinking water. Section 129.35(a)(3)(i) of this
chapter (for the requirement to test five samples from the same
sampling site that originally tested positive for Escherichia coli);
(2) As required by FDA in a directed food laboratory order issued
under Sec. 1.1108;
(3) To address an identified or suspected food safety problem and
presented to FDA as part of evidence for a hearing under section 423(c)
of the Federal Food, Drug, and Cosmetic Act prior to the issuance of a
mandatory food recall order, as part of a corrective action plan under
section 415(b)(3)(A) of the Federal Food, Drug, and Cosmetic Act
submitted after an order suspending the registration of a food
facility, or as part of evidence submitted for an appeal of an
administrative detention order under section 304(h)(4)(A) of the
Federal Food, Drug, and Cosmetic Act.
(4) In support of admission of an article of food under section
801(a) of the Federal Food, Drug, and Cosmetic Act; and
(5) To support removal from an import alert through successful
consecutive testing.
(b) When food testing is conducted under paragraph (a) of this
section, analysis of samples must be conducted by a laboratory that is
LAAF-accredited for the appropriate analytical method by a recognized
accreditation body under this subpart.
(c) Food testing conducted on articles of food offered for import
into the United States under section 801(a) of the Federal Food, Drug,
and Cosmetic
[[Page 68819]]
Act pursuant to paragraph (a)(4) or (a)(5) of this section may only be
conducted after the articles offered for import have arrived in the
United States unless the owner or consignee has written approval from
FDA that a sample taken prior to arrival is or would be a
representative sample of the article offered for import into the United
States.
Sec. 1.1108 When and how will FDA issue a directed food laboratory
order?
(a) FDA may require the owner or consignee to conduct food testing,
or to have food testing conducted on their behalf, under this subpart
to address an identified or suspected food safety problem, as FDA deems
appropriate.
(b) The directed food laboratory order will specify the food
product or environment to be tested; whether the food testing may be
conducted using a LAAF-accredited laboratory that is owned, operated,
or controlled by the owner or consignee; the timeframe in which the
food testing must be conducted; and the manner of the food testing,
such as the methods that must be used.
(c) The directed food laboratory order will contain all the
elements required by Sec. 16.22(a) of this chapter and will thereby
constitute the notice of an opportunity for hearing under part 16 of
this chapter. An affected owner or consignee may request a regulatory
hearing on a directed food laboratory order pursuant to Sec. 1.1174.
Sec. 1.1109 How will FDA make information about recognized
accreditation bodies and LAAF-accredited laboratories available to the
public?
FDA will place on its website a publicly available registry listing
of:
(a) Recognized accreditation bodies, including for each: the name,
contact information, and duration of recognition of the recognized
accreditation body;
(b) Accreditation bodies that have a change in recognition,
including for each: the name of the accreditation body, the specific
change in recognition (i.e., probation, revocation of recognition,
denial of renewal of recognition, relinquishment of recognition, or
expiration of recognition) and the effective date of the change;
(c) LAAF-accredited laboratories, including for each: the name,
contact information, and scope of LAAF-accreditation, and the name and
contact information of the recognized accreditation body that has LAAF-
accredited the laboratory; and
(d) Laboratories that have a change in LAAF-accreditation,
including for each: the name of the laboratory, the specific change in
LAAF-accreditation (i.e., suspension, reduction of scope, or withdrawal
of LAAF-accreditation by the recognized accreditation body, probation
or disqualification by FDA, or relinquishment of LAAF-accreditation),
and the effective date of the change.
Sec. 1.1110 What are the general requirements for submitting
information to FDA under this subpart?
(a) All applications, reports, notifications, and records submitted
to FDA under this subpart must be submitted electronically and in
English unless otherwise specified. If FDA requests inspection or
submission of records that are maintained in any language other than
English, the recognized accreditation body or LAAF-accredited
laboratory must provide an English translation within a reasonable
time.
(b) A program applicant must provide any translation and
interpretation services needed by FDA during the processing of the
application, including during any onsite assessments of the applicant
by FDA.
FDA Recognition of Accreditation Bodies
Sec. 1.1113 What are the eligibility requirements for a recognized
accreditation body?
A recognized accreditation body or an accreditation body seeking
recognition must meet all of the following requirements:
(a) Demonstrates compliance with ISO/IEC 17011:2017(E)
(incorporated by reference, see Sec. 1.1101).
(b) Demonstrates that it is a full member of the International
Laboratory Accreditation Cooperative (ILAC).
(c) Demonstrates that it is a signatory to the ILAC Mutual
Recognition Arrangement (MRA) that has demonstrated competence to ISO/
IEC 17011:2017(E) with a scope of ``Testing: ISO/IEC 17025.''
(d) Will comply with all additional requirements for recognized
accreditation bodies under this subpart while recognized.
Sec. 1.1114 How does an accreditation body apply to FDA for
recognition or renewal of recognition?
(a) Application for recognition or renewal of recognition. An
accreditation body seeking initial recognition or renewal of
recognition must submit an application to FDA demonstrating that it
meets the eligibility requirements in Sec. 1.1113.
(b) Documentation of conformance with requirements. The
accreditation body must submit documentation of conformance with ISO/
IEC 17011:2017(E) (incorporated by reference, see Sec. 1.1101) and
separate documentation of ILAC membership and ILAC MRA signatory status
demonstrating competence to ISO/IEC 17011:2017(E) with a scope of
``Testing: ISO/IEC 17025,'' in meeting the requirements of Sec.
1.1113(a) through (c). The accreditation body also must submit
documentation of its compliance with Sec. 1.1113(d).
(c) Signature. An application for recognition or renewal of
recognition must be signed in the manner designated by FDA by an
individual authorized to act on behalf of the applicant for purposes of
seeking recognition or renewal of recognition.
Sec. 1.1115 How will FDA evaluate applications for recognition and
renewal of recognition?
(a) Review of application for recognition or renewal of
recognition. FDA will review an accreditation body's application for
recognition or renewal of recognition for completeness and notify the
applicant of any insufficiencies. FDA generally will review
accreditation body applications for recognition or renewal of
recognition in the order in which completed applications are received;
however, FDA may prioritize the review of specific applications to meet
program needs.
(b) Evaluation of application for recognition or renewal of
recognition. FDA will evaluate a complete application for recognition
or renewal of recognition to determine whether the applicant meets the
requirements for recognition. Such evaluation may include an onsite
evaluation of the accreditation body. If FDA does not reach a final
decision on an application for renewal of recognition before an
accreditation body's recognition expires, FDA may extend the existing
term of recognition for a specified period of time or until FDA reaches
a final decision on the application for renewal of recognition.
(c) Grant of recognition. FDA will notify the applicant that its
application for recognition or renewal of recognition has been approved
and will include any conditions associated with the recognition.
(d) Duration of recognition. FDA may grant recognition of an
accreditation body for a period not to exceed 5 years from the date of
recognition, except under the circumstances described in paragraph (b)
of this section.
(e) Denial of application for recognition or renewal of
recognition. FDA will notify the applicant that its
[[Page 68820]]
application for recognition or renewal of recognition has been denied
and will state the basis for such denial and describe the procedures
for requesting reconsideration of the application under Sec. 1.1171.
(f) Notice of records custodian after denial of an application for
renewal of recognition. Within 10 business days of the date of FDA's
issuance of a denial of an application for renewal of recognition, the
applicant must provide the name and contact information of the
custodian who will maintain required records and make them available to
FDA under Sec. 1.1124. The contact information must include an email
address for the records custodian and the street address where the
records required under Sec. 1.1124 will be located.
(g) FDA notice to LAAF-accredited laboratories. FDA will promptly
notify all laboratories LAAF-accredited by the accreditation body whose
application for renewal of recognition was denied, informing them of
such denial.
(h) Public notice of denial of an application for renewal of
recognition of an accreditation body. FDA will provide public notice on
the website described in Sec. 1.1109 of the issuance of a denial of an
application for renewal of recognition and will include the date of the
issuance of such denial.
Sec. 1.1116 What must a recognized accreditation body do to
voluntarily relinquish or not renew its recognition?
(a) Notice to FDA of intent to relinquish or not to renew
recognition. At least 60 calendar days before voluntarily relinquishing
its recognition or before allowing its recognition to expire without
seeking renewal, a recognized accreditation body must notify FDA of its
intention to leave the program, specifying the date on which the
relinquishment or expiration will occur. The recognized accreditation
body must provide the name and contact information of the custodian who
will maintain and make available to FDA the records required by Sec.
1.1124 after the date of relinquishment or the date recognition
expires, as applicable. The contact information must include an email
address for the records custodian and the street address where the
records required under Sec. 1.1124 will be located.
(b) Notice to LAAF-accredited laboratories of intent to relinquish
or not to renew recognition. At least 60 calendar days before
voluntarily relinquishing its recognition or before allowing its
recognition to expire without seeking renewal, a recognized
accreditation body must notify the laboratories it LAAF accredits of
its intention to leave the program, specifying the date on which
relinquishment or expiration will occur.
(c) Public notice of voluntary relinquishment or expiration of
recognition. FDA will provide notice on the website described in Sec.
1.1109 of the voluntary relinquishment or expiration of recognition of
an accreditation body.
Sec. 1.1117 How may an accreditation body request reinstatement of
recognition?
(a) Application following revocation of recognition. An
accreditation body that has had its recognition revoked by FDA (as
described in Sec. 1.1131) may seek reinstatement by submitting a new
application for recognition under Sec. 1.1114. The accreditation body
must also submit evidence to FDA with its application to demonstrate
that the issues resulting in revocation of recognition have been
resolved, including evidence addressing the cause or condition of the
grounds for revocation of recognition. The evidence also must identify
measures that have been implemented to help ensure that such cause or
condition is unlikely to recur.
(b) Application following relinquishment or expiration of
recognition. An accreditation body that previously relinquished its
recognition or allowed its recognition to expire (as described in Sec.
1.1116) may seek reinstatement by submitting a new application for
recognition under Sec. 1.1114.
Requirements for Recognized Accreditation Bodies
Sec. 1.1119 What are the conflict of interest requirements for a
recognized accreditation body?
(a) In addition to meeting the impartiality and conflict of
interest requirements of Sec. 1.1113(a), a recognized accreditation
body must:
(1) Ensure that the recognized accreditation body (and its
officers, employees, or other agents involved in LAAF-accreditation
activities) does not own or have a financial interest in, manage, or
otherwise control any laboratory (or any affiliate, parent, or
subsidiary) it LAAF-accredits, subject to the exceptions in paragraphs
(c) and (d) of this section; and
(2) Prohibit, subject to the exceptions in paragraph (e) of this
section, officers, employees, or other agents involved in LAAF-
accreditation activities of the recognized accreditation body from
accepting any money, gift, gratuity, or other item of value from any
laboratory the recognized accreditation body LAAF-accredits or assesses
for LAAF-accreditation.
(b) The financial interests of any children younger than 18 years
of age or a spouse of a recognized accreditation body's officers,
employees, and other agents involved in LAAF-accreditation activities
are considered the financial interests of such officers, employees, and
other agents involved in LAAF-accreditation activities.
(c) An accreditation body (and its officers, employees, or other
agents involved in LAAF-accreditation activities) may have an interest
in a publicly traded or publicly available investment fund (e.g., a
mutual fund), or a widely held pension or similar fund if the
accreditation body (and its officers, employees, or other agents
involved in LAAF-accreditation activities) neither exercises control
nor has the ability to exercise control over the financial interests
held in the fund.
(d) A recognized accreditation body's agent that is a contract
assessor will be permitted to own or have a financial interest in,
manage, or otherwise control a LAAF-accredited laboratory if all of the
following circumstances apply:
(1) The contract assessor's primary occupation is owning or having
a financial interest in, managing, or otherwise controlling a LAAF-
accredited laboratory;
(2) The assessor contracts with the recognized accreditation body
to provide assessment services on an intermittent or part-time basis;
(3) The contract assessor does not assess the LAAF-accredited
laboratory that the assessor owns or has a financial interest in,
manages, or otherwise controls; and
(4) The contract assessor and the recognized accreditation body
inform any laboratory that the contract assessor may assess or reassess
for LAAF-accreditation that the contract assessor owns or has a
financial interest in, manages, or otherwise controls a LAAF-accredited
laboratory. The laboratory seeking LAAF-accreditation assessment or
reassessment must acknowledge that the contract assessor owns or has a
financial interest in, manages, or otherwise controls a LAAF-accredited
laboratory and be provided the option to be assessed by a different
representative of the recognized accreditation body.
(e) The prohibited items of value specified in paragraph (a)(2) of
this section do not include:
(1) Money representing payment of fees for LAAF-accreditation
services or reimbursement of direct costs associated with an onsite
assessment or reassessment of the laboratory; or
(2) Meal of de minimis value provided during the course of an
assessment or reassessment and on the premises where
[[Page 68821]]
the assessment or reassessment is conducted, if necessary for the
efficient conduct of the assessment or reassessment.
Sec. 1.1120 How must a recognized accreditation body assess
laboratories seeking LAAF-accreditation and oversee LAAF-accredited
laboratories?
(a) A recognized accreditation body must conduct an initial
assessment of a laboratory seeking LAAF-accreditation in accordance
with the requirements of this subpart, to determine whether the
laboratory meets the requirements of Sec. 1.1138.
(b) Subject to the exception in paragraph (c) of this section, the
initial assessment must be conducted onsite, although certain
assessment activities may be conducted remotely if it will not aid the
assessment to conduct them onsite.
(c) If, within the previous 2 years, the recognized accreditation
body conducted an onsite assessment of the laboratory in accordance
with ISO/IEC 17011:2017(E) (incorporated by reference, see Sec.
1.1101) to assess whether the laboratory meets the requirements of ISO/
IEC 17025:2017(E) (incorporated by reference, see Sec. 1.1101), then
the initial assessment under this section:
(1) May be conducted remotely, and
(2) Need only address whether the laboratory meets the requirements
of Sec. 1.1138(a)(2) and (3) and (b).
(d) A recognized accreditation body must oversee the performance of
a laboratory it LAAF-accredits in accordance with the requirements of
Sec. 1.1113(a), except as otherwise provided by this subpart, to
determine whether the LAAF-accredited laboratory continues to meet the
applicable requirements of this subpart.
(e) A recognized accreditation body must conduct a reassessment of
a LAAF-accredited laboratory in accordance with this subpart at least
every 2 years. Such reassessment must be conducted onsite, although
certain reassessment activities may be conducted remotely if it will
not aid in the reassessment to conduct the activities onsite.
(f) If the recognized accreditation body conducted the initial
assessment of the LAAF-accredited laboratory remotely in accordance
with paragraph (c) of this section, the recognized accreditation body
must conduct its first reassessment of the LAAF-accredited laboratory
no later than 2 years after the recognized accreditation body last
conducted an onsite assessment of the laboratory.
(g) The reassessment at the end of the LAAF-accredited laboratory's
ISO/IEC 17025:2017-accreditation cycle, which the recognized
accreditation body must conduct in accordance with this subpart, must
be conducted onsite, although certain reassessment activities may be
conducted remotely if it will not aid the reassessment to conduct them
onsite.
(h) Any assessments or reassessments conducted by a recognized
accreditation body in addition to the assessments or reassessments
referred to in paragraphs (a), (e), and (g) of this section may be
conducted remotely if it will not aid the assessment or reassessment to
conduct it onsite.
Sec. 1.1121 When must a recognized accreditation body require
corrective action, suspend a LAAF-accredited laboratory, or reduce the
scope of or withdraw the LAAF-accreditation of a laboratory?
(a) Corrective action. A recognized accreditation body may require
corrective action using the procedures described by ISO/IEC
17025:2017(E) (incorporated by reference, see Sec. 1.1101) section 8.7
to address any deficiencies identified while assessing and overseeing a
LAAF-accredited laboratory.
(1) The recognized accreditation body must notify the LAAF-
accredited laboratory of all deficiencies requiring corrective action
and will either specify a deadline to implement corrective action or
will require the LAAF-accredited laboratory to submit a corrective
action plan and timeframe for implementation to the recognized
accreditation body for approval.
(2) The LAAF-accredited laboratory must implement appropriate
corrective action under ISO/IEC 17025:2017(E) section 8.7, and submit
the results of the corrective action to the recognized accreditation
body.
(3) The recognized accreditation body will review the corrective
action and will notify the LAAF-accredited laboratory whether the
corrective action is acceptable.
(b) Suspension. If a recognized accreditation body determines that
a laboratory it LAAF-accredits has not effectively implemented
corrective action or otherwise fails to address deficiencies
identified, the recognized accreditation body may temporarily suspend
the LAAF-accredited laboratory for one or more LAAF-accredited methods,
and require corrective action under paragraph (a) of this section.
(1) The recognized accreditation body must notify the LAAF-
accredited laboratory of the grounds for the suspension, the LAAF-
accredited methods subject to the suspension, and all deficiencies that
must be addressed via the process described in paragraph (a) of this
section.
(2) The recognized accreditation body must notify FDA of the
suspension under this section in accordance with the requirements of
Sec. 1.1123(d)(5). FDA will provide notice of the LAAF-accredited
laboratory's suspension on the website described in Sec. 1.1109.
(3) The recognized accreditation body will review the corrective
action required under paragraph (b) of this section and will notify the
LAAF-accredited laboratory whether the corrective action is acceptable.
(4) A LAAF-accredited laboratory shall remain suspended until it
demonstrates to the recognized accreditation body's satisfaction that
the LAAF-accredited laboratory has successfully implemented appropriate
corrective action.
(5) If the recognized accreditation body determines that a LAAF-
accredited laboratory on suspension has failed to implement appropriate
corrective action or otherwise fails to address deficiencies
identified, the recognized accreditation body may reduce the scope of
or withdraw the LAAF-accreditation of the laboratory under paragraph
(c) of this section.
(c) Reduction of scope or withdrawal of LAAF-accreditation. A
recognized accreditation body must reduce the scope of or withdraw the
LAAF-accreditation of a laboratory it LAAF-accredits when the
laboratory substantially fails to comply with this subpart. When only
certain methods within the laboratory's scope of LAAF-accreditation are
affected by the noncompliance, the recognized accreditation body may
reduce the scope of the laboratory's LAAF-accreditation for only those
affected methods. If all methods are affected, the recognized
accreditation body must withdraw the laboratory's LAAF-accreditation.
(d) Procedures for reduction of scope or withdrawal of LAAF-
accreditation. (1) The recognized accreditation body must notify the
laboratory of any reduction of scope or withdrawal of LAAF-
accreditation, including:
(i) The grounds for the reduction of scope or withdrawal of LAAF-
accreditation;
(ii) The method(s) to which the reduction of scope applies;
(iii) The procedures for appealing the reduction of scope or
withdrawal of LAAF-accreditation as described in Sec. 1.1122; and
(iv) The date the reduction of scope or withdrawal of LAAF-
accreditation is effective.
[[Page 68822]]
(2) The recognized accreditation body must notify FDA of the
reduction of scope or withdrawal of LAAF-accreditation under this
section in accordance with the requirements in Sec. 1.1123(d)(4). FDA
will provide notice of the reduction of scope or withdrawal of the
laboratory's LAAF-accreditation on the website described in Sec.
1.1109.
(e) Records request associated with suspension, reduction of scope,
or withdrawal of LAAF-accreditation. To assist the recognized
accreditation body in determining whether a suspension, reduction of
scope, or withdrawal of LAAF-accreditation is warranted under this
section, the recognized accreditation body may require the submission
of records that the LAAF-accredited laboratory is required to maintain
under Sec. 1.1154.
(f) Consequences of suspension, reduction of scope, or withdrawal
of LAAF-accreditation. (1) A LAAF-accredited laboratory may not conduct
food testing under this subpart using suspended methods.
(2) If the recognized accreditation body withdraws the laboratory's
LAAF-accreditation, the laboratory is immediately ineligible to conduct
any food testing under this subpart. If the recognized accreditation
body reduces the laboratory's scope of LAAF-accreditation, the
laboratory is immediately ineligible to use the methods to which the
reduction of scope applies to conduct food testing under this subpart.
Sec. 1.1122 What procedures must a recognized accreditation body
provide for appeals of decisions to suspend, reduce the scope of,
withdraw, or deny LAAF-accreditation?
A recognized accreditation body must consider a laboratory's appeal
regarding a decision to suspend, reduce the scope of, withdraw, or deny
LAAF-accreditation in accordance with the requirements of Sec.
1.1113(a). Appeals must be reviewed and decided by a competent
person(s) free from bias or prejudice who has not participated in the
LAAF-accreditation decision and is not the subordinate of a person who
participated in the LAAF-accreditation decision. For the purposes of
appeals, the competent person(s) may be external to the recognized
accreditation body.
Sec. 1.1123 What reports, notifications, and documentation must a
recognized accreditation body submit to FDA?
(a) General requirements. All reports and notifications required by
this section must include:
(1) The name, street address, telephone number, and email address
of the recognized accreditation body associated with the report or
notification, and the name of an appropriate point of contact for the
recognized accreditation body, and
(2) If the report or notification concerns a LAAF-accredited
laboratory, the name, street address, telephone number, and email
address of the LAAF-accredited laboratory, and the name of an
appropriate point of contact for the LAAF-accredited laboratory.
(b) Internal audit reports. A recognized accreditation body must
submit to FDA a report of the results of the internal audit conducted
pursuant to Sec. 1.1125 within 45 calendar days of completing the
audit. The audit report must include:
(1) A description of the internal audit conducted;
(2) A description of any identified deficiencies;
(3) A description of any corrective action taken or planned,
including the timeline for such corrective action; and
(4) A statement disclosing the extent to which the internal audit
was conducted by personnel different from those who perform the
activity or activities that were audited.
(c) Changes affecting recognition. A recognized accreditation body
must notify FDA within 48 hours when the recognized accreditation body
is aware of a change that would affect the recognition of such
accreditation body, and the notification must include:
(1) A description of the change, and
(2) If the change is one made by the recognized accreditation body,
an explanation of the purpose of the change.
(d) Changes in LAAF-accreditation. A recognized accreditation body
must notify FDA and submit a certificate reflecting the scope of
accreditation within 48 hours when any of the following occur:
(1) The recognized accreditation body grants or extends LAAF-
accreditation of a laboratory, and the notification must include:
(i) The scope of LAAF-accreditation requested by the laboratory,
(ii) The scope of LAAF-accreditation granted, and
(iii) The effective date of the grant or extension;
(2) The recognized accreditation body denies LAAF-accreditation of
a laboratory, and the notification must include:
(i) The scope of LAAF-accreditation requested by the laboratory,
(ii) The scope of LAAF-accreditation denied, and
(iii) The grounds for the denial;
(3) The recognized accreditation body receives notice that a
laboratory it LAAF-accredits intends to relinquish its LAAF-
accreditation and the laboratory has not provided notice to FDA 60
calendar days prior to relinquishment as required under Sec. 1.1140.
The recognized accreditation body's notification must include:
(i) The scope of LAAF-accreditation to which the relinquishment
applies, as applicable, and
(ii) The effective date of the relinquishment;
(4) The recognized accreditation body reduces the scope of or
withdraws the LAAF-accreditation of a laboratory, and the notification
must include:
(i) The scope of LAAF-accreditation to which the reduction applies,
(ii) The grounds for the reduction of scope or withdrawal, and
(iii) The effective date of the reduction of scope or withdrawal;
(5) The recognized accreditation body suspends or lifts the
suspension of a LAAF-accredited laboratory, and the notification must
include:
(i) The scope of LAAF-accreditation to which the suspension
applies,
(ii) The grounds for the suspension or for lifting the suspension,
and
(iii) The effective date of the suspension or date the suspension
is lifted.
(e) Laboratory fraud. A recognized accreditation body must notify
FDA within 48 hours if the recognized accreditation body knows that a
laboratory it LAAF-accredits has committed fraud or submitted material
false statements to FDA, and the notification must include:
(1) A description of the basis for the recognized accreditation
body's knowledge of the fraud or material false statements,
(2) A description of the fraud or material false statements, and
(3) The action(s) taken by the recognized accreditation body with
respect to such LAAF-accredited laboratory.
Sec. 1.1124 What are the records requirements for a recognized
accreditation body?
(a) In addition to meeting the requirements of Sec. 1.1113(a)
related to records, a recognized accreditation body must maintain, for
5 years after the date of creation of the records, records created
while it is recognized demonstrating its compliance with this subpart,
including records relating to:
(1) Applications for LAAF-accreditation;
(2) Assessments, reassessments, and decisions to grant, extend the
scope of, renew, deny, reduce the scope of, or withdraw LAAF-
accreditation or to
[[Page 68823]]
suspend or lift the suspension of a LAAF-accredited laboratory;
(3) Appeals of suspensions, denials, reductions of scope of, and
withdrawals of LAAF-accreditation, final decisions on such appeals, and
the bases for such final decisions;
(4) Its oversight of laboratories it has LAAF-accredited;
(5) Its oversight of its own performance, including all records
related to internal audits, complaints, and corrective actions;
(6) Any reports or notifications required to be submitted to FDA
under Sec. 1.1123, including any supporting information;
(7) Records of fee payments and reimbursement of direct costs; and
(8) Any documents demonstrating compliance with the requirements
for assessment activities by contract assessors with certain financial
interests described in Sec. 1.1119(d).
(b) A recognized accreditation body must make the records it is
required to maintain by paragraph (a) of this section available for
inspection and copying or for electronic submission upon written
request of an authorized officer or employee of FDA. If FDA requests
records for inspection and copying, the recognized accreditation body
must make such records promptly available at the physical location of
the recognized accreditation body or at another reasonably accessible
location. If FDA requests electronic submission, the records must be
submitted within 10 business days of the request.
(c) A recognized accreditation body must not prevent or interfere
with FDA's access to the records the LAAF-accredited laboratories it
LAAF-accredits are required to maintain under Sec. 1.1154.
Sec. 1.1125 What are the internal audit requirements for a recognized
accreditation body?
As part of the internal audit a recognized accreditation body is
required to conduct pursuant to Sec. 1.1113(a), the recognized
accreditation body must audit its compliance with the requirements of
Sec. 1.1113(d).
FDA Oversight of Recognized of Accreditation Bodies
Sec. 1.1130 How will FDA oversee recognized accreditation bodies?
(a) FDA will evaluate each recognized accreditation body to
determine its compliance with the applicable requirements of this
subpart no later than:
(1) Year 4 of a 5-year recognition period; or
(2) The midpoint of a recognition period less than 5 years.
(b) An FDA evaluation of a recognized accreditation body may
include review of records, an onsite evaluation of the accreditation
body, and onsite reviews of one or more LAAF-accredited laboratories
the recognized accreditation body LAAF-accredits, with or without the
recognized accreditation body present. Certain evaluation activities
may be conducted remotely if it will not aid in the evaluation to
conduct them onsite.
(c) FDA may conduct additional evaluations of a recognized
accreditation body at any time to determine whether the recognized
accreditation body complies with the applicable requirements of this
subpart.
Sec. 1.1131 When will FDA require corrective action, put a recognized
accreditation body on probation, or revoke the recognition of an
accreditation body?
(a) Corrective action. FDA may require corrective action to address
any deficiencies identified while evaluating a recognized accreditation
body under this subpart.
(1) FDA will notify the recognized accreditation body of all
deficiencies requiring corrective action and will either specify a
deadline to implement corrective action or will require the recognized
accreditation body to submit a corrective action plan and timeframe for
implementation to FDA for approval.
(2) The recognized accreditation body must handle FDA's
notification as a complaint under ISO/IEC 17011:2017(E) (incorporated
by reference, see Sec. 1.1101) section 7.12, implement appropriate
corrective action under ISO/IEC 17011:2017 section 9.5, and submit both
the results of the complaint investigation and subsequent corrective
action to FDA.
(3) FDA will review the corrective action and will notify the
recognized accreditation body whether the corrective action is
acceptable.
(b) Probation. If FDA determines that a recognized accreditation
body has not effectively implemented corrective action or otherwise
fails to address deficiencies identified, FDA may put the recognized
accreditation body on probation and require corrective action under
paragraph (a) of this section.
(1) FDA will notify the recognized accreditation body of the
grounds for the probation and all deficiencies requiring corrective
action via the process described in paragraph (a) of this section.
(2) FDA will notify all laboratories LAAF-accredited by the
recognized accreditation body that the recognized accreditation body is
on probation and will provide notice of the probation on the website
described in Sec. 1.1109.
(3) FDA will review the corrective action and will notify the
recognized accreditation body whether the corrective action is
acceptable.
(4) A recognized accreditation body shall remain on probation until
the recognized accreditation body demonstrates to FDA's satisfaction
that it has successfully implemented appropriate corrective action.
(5) If FDA determines that a recognized accreditation body on
probation has failed to implement appropriate corrective action or
otherwise fails to address deficiencies identified, FDA may revoke
recognition of the recognized accreditation body under paragraph (c) of
this section.
(c) Revocation of recognition. FDA will revoke the recognition of
an accreditation body if it fails to meet the requirements of this
subpart, if FDA determines the accreditation body has committed fraud
or submitted material false statements to FDA, or if FDA determines
that a recognized accreditation body on probation has failed to
implement appropriate corrective action or otherwise fails to address
deficiencies identified.
(d) Revocation of recognition procedures. (1) FDA will issue a
notice of revocation of recognition to the recognized accreditation
body that will include the grounds for revocation, the date on which
revocation is effective, the procedures for requesting a regulatory
hearing on the revocation under Sec. 1.1173, and the procedures for
requesting reinstatement of recognition under Sec. 1.1117.
(2) FDA will notify all laboratories LAAF-accredited by the
recognized accreditation body that recognition has been revoked and
will provide notice of the revocation of recognition of an
accreditation body on the website described in Sec. 1.1109.
(3) Within 10 business days of the date of issuance of revocation,
the accreditation body must provide the name and contact information of
the custodian who will maintain records and make them available to FDA
as required by Sec. 1.1124. The contact information must include an
email address for the records custodian and the street address where
the records required by Sec. 1.1124 will be located.
(e) Effect of probation or revocation of recognition on the
accreditation body. (1) A recognized accreditation body that is put on
probation by FDA must continue to oversee laboratories that it has
LAAF-accredited under this subpart
[[Page 68824]]
and may continue to LAAF-accredit laboratories under Sec. 1.1120.
(2) An accreditation body that has had its recognition revoked by
FDA may not LAAF-accredit laboratories under this subpart or continue
to oversee the laboratories it has previously LAAF-accredited while the
accreditation body is not recognized.
LAAF-Accreditation of Laboratories
Sec. 1.1138 What are the eligibility requirements for a LAAF-
accredited laboratory?
(a) A laboratory that is LAAF-accredited or seeking LAAF-
accreditation must demonstrate it is capable of conducting each method
of food testing for which it is or will be LAAF-accredited by meeting
all of the following requirements:
(1) For each method, the laboratory is accredited by a recognized
accreditation body to ISO/IEC 17025:2017(E) (incorporated by reference,
see Sec. 1.1101).
(2)(i) Except as provided in paragraph (a)(2)(ii) of this section,
the laboratory has successfully passed a proficiency test provided by a
competent proficiency testing organization within the last 12 months
for each method within the scope of LAAF-accreditation.
(ii) If the laboratory determines there is no proficiency testing
program available or practicable for a method, it may use a comparison
program. A laboratory must request approval from the recognized
accreditation body regarding the determination prior to using a
comparison program in lieu of an annual proficiency test. The
laboratory is required to demonstrate competency through participation
in the comparison program.
(iii) A laboratory must submit all proficiency test and comparison
program results, regardless of outcome, to the recognized accreditation
body within 30 calendar days of receipt.
(3) The laboratory ensures that its procedures for monitoring the
validity of the results of testing it conducts under this subpart
include the use of reference materials or quality control samples with
each batch of samples it tests under this subpart.
(b) Will comply with all additional requirements for LAAF-
accredited laboratories under this subpart while LAAF-accredited.
Sec. 1.1139 How does a laboratory apply for LAAF-accreditation or
extend its scope of LAAF-accreditation?
(a) Application for LAAF-accreditation. A laboratory seeking LAAF-
accreditation or extension of its scope of LAAF-accreditation must
submit its application for LAAF-accreditation to a recognized
accreditation body identified on the website described in Sec. 1.1109.
The recognized accreditation body will review and assess the
application in accordance with the requirements of this subpart. If the
laboratory seeking LAAF-accreditation had its LAAF-accreditation
withdrawn or one or more methods within its scope of LAAF-accreditation
reduced by a recognized accreditation body or has been previously
disqualified by FDA, the laboratory must meet the additional
requirements specified by Sec. 1.1142(a).
(b) Documentation of conformance with ISO/IEC 17025:2017(E). The
laboratory may use documentation of conformance with ISO/IEC
17025:2017(E) (incorporated by reference, see Sec. 1.1101), as
applicable and supplemented as necessary, in meeting the applicable
requirements of this subpart.
(c) Duration of accreditation. If a LAAF-accredited laboratory
maintains compliance with all requirements of this subpart, including
accreditation to ISO/IEC 17025:2017(E), the laboratory's LAAF-
accreditation will not end until reduced in scope, withdrawn,
relinquished, or the laboratory is disqualified, under this subpart.
Sec. 1.1140 What must a LAAF-accredited laboratory do to voluntarily
relinquish its LAAF-accreditation?
(a) Notice to FDA and the recognized accreditation body of intent
to relinquish. A LAAF-accredited laboratory must notify FDA and its
recognized accreditation body at least 60 calendar days before
voluntarily relinquishing LAAF-accreditation or any method within the
scope of LAAF-accreditation. The notice must include the date on which
relinquishment will occur. If the laboratory will relinquish all
methods within its scope of LAAF-accreditation, the notification must
also include the name and contact information of the custodian who will
maintain the records required by Sec. 1.1154 after the date of
relinquishment. The contact information for the records custodian must
include an email address and the street address where the records
required by Sec. 1.1154 will be located.
(b) Public notice of voluntary relinquishment of accreditation. FDA
will provide notice on the website described in Sec. 1.1109 of the
voluntary relinquishment of LAAF-accreditation of a laboratory.
Sec. 1.1141 What is the effect on a LAAF-accredited laboratory if its
recognized accreditation body is no longer recognized by FDA?
If a recognized accreditation body has its application for renewal
of recognition denied, relinquishes its recognition or allows its
recognition to expire, or has its recognition revoked, any laboratory
LAAF-accredited by the accreditation body must take either the actions
in paragraph (a) of this section or the action in paragraph (b) of this
section no later than 30 calendar days after receiving the notice to
the LAAF-accredited laboratory required under Sec. 1.1115(g), Sec.
1.1116(b), or Sec. 1.1131(d)(2):
(a)(1) The LAAF-accredited laboratory must submit to FDA
documentation of the LAAF-accredited laboratory's most recent internal
audit, required under Sec. 1.1154(a)(5), documentation showing
compliance with the conflict of interest requirements in Sec. 1.1147,
and documentation of the most recent proficiency test or comparison
program result for each test method within the laboratory's scope of
LAAF-accreditation, to show compliance with Sec. 1.1138(a)(2); and
(2) The laboratory must become LAAF-accredited by another
recognized accreditation body before the laboratory's ISO/IEC
17025:2017(E) (incorporated by reference, see Sec. 1.1101)
accreditation lapses or not later than 1 year after the LAAF-accredited
laboratory receives the applicable notice under Sec. 1.1115(g), Sec.
1.1116(b), or Sec. 1.1131(d)(2), whichever is sooner.
(b) The LAAF-accredited laboratory initiates relinquishment of its
LAAF-accreditation under Sec. 1.1140, with the relinquishment to occur
within 90 calendar days.
Sec. 1.1142 How does a laboratory request reinstatement of LAAF-
accreditation?
(a) Application following reduction of scope or withdrawal of LAAF-
accreditation by a recognized accreditation body or disqualification by
FDA. A laboratory that has had any methods within its scope of LAAF-
accreditation reduced or has had its LAAF-accreditation withdrawn by a
recognized accreditation body or that has been disqualified by FDA may
seek reinstatement of LAAF-accreditation by submitting a new
application for LAAF-accreditation to a recognized accreditation body
under Sec. 1.1139. The laboratory must also:
(1) Notify FDA prior to submitting a new application for LAAF-
accreditation to the recognized accreditation body, including in the
notification the name of the laboratory, contact information for
[[Page 68825]]
the laboratory, the name of the recognized accreditation body to which
the laboratory will be submitting the application, and the date that
the laboratory expects to submit the new application for LAAF-
accreditation; and
(2) Demonstrate, to the satisfaction of the recognized
accreditation body to which it is submitting the new application, that
the grounds for the reduction of scope or withdrawal of LAAF-
accreditation or disqualification have been resolved and that the
laboratory has implemented measures to prevent such grounds from
recurring.
(b) Application following voluntary relinquishment of LAAF-
accreditation. A laboratory that voluntarily relinquished any methods
within the scope of its LAAF-accreditation pursuant to Sec. 1.1140,
may seek reaccreditation by submitting a new application for LAAF-
accreditation to a recognized accreditation body under Sec. 1.1139.
Requirements for LAAF-Accredited Laboratories
Sec. 1.1147 What are the impartiality and conflict of interest
requirements for a LAAF-accredited laboratory?
(a) In addition to the impartiality and conflict of interest
requirements in Sec. 1.1138(a)(1), a LAAF-accredited laboratory must,
subject to the exceptions in paragraph (b) of this section, prohibit
the LAAF-accredited laboratory's employees, contractors, and agents
involved in food testing under this subpart and related activities from
accepting any money, gift, gratuity, or other item of value from the
owner or consignee of the food that is being tested or will be tested
by the LAAF-accredited laboratory.
(b) The prohibited items of value in paragraph (a) of this section
do not include:
(1) Payment of fees for food testing under this subpart and related
services;
(2) Reimbursement of direct costs associated with the food testing
by the LAAF-accredited laboratory; and
(3) With respect to a LAAF-accredited laboratory that is owned by
the owner or consignee of the food that is or will be tested, payment
of the officer's, employee's, contractor's, or agent's compensation in
the normal course of business.
(c) The LAAF-accredited laboratory must require the owner's or
consignee's payment to the LAAF-accredited laboratory of fees for food
testing services and reimbursement of direct costs associated with food
testing to be independent of the outcome of the test results.
Sec. 1.1149 What oversight standards apply to sampling?
(a) Documents. Before analyzing a sample, the LAAF-accredited
laboratory must develop (if it collected the sample) or obtain (if
another firm collected the sample) the following information to be
submitted with test results (see Sec. 1.1152(c)):
(1) Written documentation of the sampler's applicable
qualifications by training and experience. A LAAF-accredited laboratory
only needs to develop or obtain documentation of a sampler's
qualifications the first time that sampler collects a sample for the
LAAF-accredited laboratory under this subpart. If a LAAF-accredited
laboratory has previously submitted the sampler's qualifications to FDA
under Sec. 1.1152(c), the LAAF-accredited laboratory may refer to its
previously submitted qualifications.
(2) The written sampling plan used to conduct the sampling. The
written sampling plan must identify the sampler and sampling firm and
must list factors that will be controlled to ensure the sampling does
not impact the validity of the subsequent analytical testing, including
controlling for the representational nature of the sample; and
(3) A written sample collection report for each sample collected.
The written sample collection report must include:
(i) The product code of the food product (if product is being
sampled) or the location and a description of the environment (if
environment is being sampled);
(ii) The date of the sampling;
(iii) The lot number, size, identity, and quantity of the sample;
(iv) Documentation of sample collection procedures and any sample
preparation techniques; and
(v) Documentation of the chain of custody of the sample and of
measures taken to ensure the validity of the subsequent analytical
testing, including controlling for the representational nature of the
sample.
(b) Potential consequences. If any of the requirements in paragraph
(a) of this section is not met, FDA may consider the analysis of the
sample to be invalid.
(c) Advance notice of sampling. (1) If FDA determines that sampling
conducted may materially differ from the sampling documented in the
associated sampling plan or sample collection report, or if FDA
determines that the sampling otherwise may have been improper, FDA may
require the LAAF-accredited laboratory that analyzed the associated
sample, and other LAAF-accredited laboratories that have analyzed
samples previously collected by the sampling firm, to obtain from the
sampling firm, and submit, or require the sampling firm to submit, an
advance notice of sampling. The advance notice of sampling must be
submitted to FDA at least 48 hours before each of the next 10 occasions
that the sampling firm will collect a sample that the LAAF-accredited
laboratory will analyze under this subpart.
(2) FDA may, as appropriate:
(i) Specify that the requirement applies to samples collected by a
particular sampler;
(ii) Specify the type of food product or environment that requires
advance notice of sampling under this subpart;
(iii) Determine that an amount of time other than 48 hours in
advance is required, from a minimum of 24 hours up to 7 business days
in advance;
(iv) Determine that a number of occasions other than 10 is
required, from a minimum of 1 occasion to a maximum of 20 occasions;
(v) Notify affected LAAF-accredited laboratories that submission of
additional notices of sampling are not required; and
(vi) Notify the owner or consignee that the advance notice applies
to sampling for food testing being conducted on their behalf.
(3) The advance notice of sampling must contain:
(i) A unique identification for the advance notice of sampling;
(ii) The name of the LAAF-accredited laboratory that will conduct
analysis of the sample;
(iii) The name and street address of the sampling firm that will
conduct the sampling;
(iv) A primary contact (name and phone number) for the sampling
firm;
(v) The reason why the food product or environment will be sampled;
(vi) The location of the food product or environment that will be
sampled, including sufficient information to identify the food product
or environment to be sampled;
(vii) As applicable, the U.S. Customs and Border Protection entry
and line number;
(viii) The product code of the food product (if product is being
sampled) or the location and a description of the environment (if
environment is being sampled); and
(ix) The date and approximate time the sampling will begin.
Sec. 1.1150 What are the requirements for analysis of samples by a
LAAF-accredited laboratory?
In addition to the sample analysis requirements of Sec. 1.1138(a):
(a) The analysis must be conducted on either the sample received
from the
[[Page 68826]]
sampling firm or, if appropriate, on a representative sample of the
sample received from the sampling firm.
(b) The analyst must:
(1) Be qualified by appropriate education, training, and/or
experience to conduct the analysis;
(2) Have appropriately demonstrated their ability to perform the
method properly in the specific context of the food testing to be
conducted; and
(3) Be in compliance with the conflict of interest requirements of
Sec. Sec. 1.1138(a) and 1.1147.
(c) The method used to conduct the food testing must meet the
requirements of Sec. 1.1151.
(d) The LAAF-accredited laboratory must document the testing
information and test results to the extent necessary to account for all
information that is required to be included in a full analytical report
(see Sec. 1.1152(d)).
Sec. 1.1151 What requirements apply to the methods of analysis a
LAAF-accredited laboratory uses to conduct food testing under this
subpart?
In addition to the requirements of Sec. 1.1138(a), a LAAF-
accredited laboratory must meet the following requirements:
(a) The method of analysis used to conduct food testing under this
subpart must be:
(1) Fit for purpose;
(2) Within the laboratory's scope of LAAF-accreditation;
(3) Appropriately validated for use in such food testing, in
accordance with paragraph (c) of this section; and
(4) Appropriately verified by the LAAF-accredited laboratory for
use in such food testing, in accordance with paragraph (d) of this
section.
(b) Food testing must be conducted using the specified method:
(1) Under Sec. 1.1107(a)(1), if the Federal Food, Drug, and
Cosmetic Act or implementing regulations prescribe a test method.
(2) Under Sec. 1.1107(a)(2), if the directed food laboratory order
prescribes a test method.
(c)(1) A LAAF-accredited laboratory must validate methods in
accordance with the requirements of Sec. 1.1138(a).
(2) A LAAF-accredited laboratory performing validation of a method
under this subpart must record the information required by Sec.
1.1138(a) and the supporting analytical data.
(d)(1) Before a LAAF-accredited laboratory conducts food testing
under this subpart using a method for a specific intended use for which
the method has been validated, but for which the LAAF-accredited
laboratory has not previously applied the method under this subpart,
the LAAF-accredited laboratory must have verified it can properly
perform the method for the specific intended use.
(2) A LAAF-accredited laboratory performing verification of a
method under this subpart must record the method that is the subject of
the verification, the intended purpose of the analysis, the results of
the verification, the procedure used for the verification, supporting
analytical data, and whether the LAAF-accredited laboratory is able to
properly perform the method.
(e) A LAAF-accredited laboratory may submit a written request to
FDA requesting permission to use a method outside of its scope of LAAF-
accreditation for food testing. FDA may approve the request if both
following conditions are satisfied:
(1) A new method or methodology has been developed and validated
but no reasonably available laboratory has been LAAF-accredited to
perform such method or methodology, and
(2) The use of such method is necessary to prevent, control, or
mitigate a food emergency or foodborne illness outbreak.
Sec. 1.1152 What notifications, results, reports, and studies must a
LAAF-accredited laboratory submit to FDA?
(a) General requirements. (1) All notifications, results, reports,
and studies required to be submitted to FDA by a LAAF-accredited
laboratory under this subpart must:
(i) Include the name and street address of the LAAF-accredited
laboratory;
(ii) Identify a point of contact for the LAAF-accredited
laboratory, including email and telephone number, whom FDA may contact
with questions or comments;
(iii) Display an identification unique to the test results, report,
notification, or study; and
(iv) Be true, accurate, unambiguous, and objective.
(2) The LAAF-accredited laboratory that conducts the analysis of
the sample under this subpart is responsible for the submission of all
notifications, results, reports, and studies to FDA as required by this
section.
(3) If the LAAF-accredited laboratory becomes aware that any aspect
of the submitted material is inaccurate, the LAAF-accredited laboratory
must immediately inform FDA and submit a corrected version. Such
corrections must meet the requirements for amendments to reports
specified by ISO/IEC 17025:2017(E) (incorporated by reference, see
Sec. 1.1101) section 7.8.8.
(4) Any opinions and interpretations in any notification, result,
report, or study submitted to FDA under this subpart must meet the
requirements in ISO/IEC 17025:2017(E) section 7.8.7 and any statements
of conformity to a specification or standard in any notification,
result, report, or study submitted to FDA under this subpart must meet
the requirements of ISO/IEC 17025:2017(E) section 7.8.6.
(b) Test results. (1) The LAAF-accredited laboratory must submit
the results of all testing required to be conducted under this subpart
directly to FDA via the location specified by the website described in
Sec. 1.1109, unless another location is specified by FDA regarding
testing conducted under Sec. 1.1107(a)(2) or (3).
(2) The test results must be clear and identify:
(i) The name and street address of the owner or consignee for which
the testing was conducted,
(ii) As appropriate, the U.S. Customs and Border Protection entry
and line number(s), and
(iii) The associated notifications, reports, and studies required
to be submitted with the test results under this subpart.
(c) Documentation required to be submitted with test results. The
following documentation must be included with each full analytical
report (see paragraph (d) of this section) and each abridged analytical
report (see Sec. 1.1153) submitted to FDA under this subpart:
(1) All sampling plans and sample collection reports related to the
food testing conducted as developed or obtained by the LAAF-accredited
laboratory in accordance with Sec. 1.1149;
(2) Written documentation of the sampler's qualifications or an
indication that the sampler's qualifications have been submitted
previously, in accordance with Sec. 1.1149(a)(1);
(3) For any validation studies required by Sec. 1.1151(c)(1), the
documentation required by Sec. 1.1151(c)(2);
(4) For any verification studies required by Sec. 1.1151(d)(1),
the documentation required by Sec. 1.1151(d)(2);
(5) The justification for any modification to or deviation from the
method(s) of analysis used and documentation of the LAAF-accredited
laboratory's authorization for the modification or deviation; and
(6) A certification from one or more members of the LAAF-accredited
laboratory's management certifying that the test results,
notifications, reports, and studies are true and accurate; and that the
documentation includes the results of all tests conducted under this
subpart. The certification must include
[[Page 68827]]
the name, title, and signature of any certifiers.
(d) Full analytical report contents. In addition to the
documentation required to be submitted with all test results (see
paragraph (c) of this section), a full analytical report must include:
(1) All information described by ISO/IEC 17025:2017(E) sections
7.8.2.1(a) through (p) and 7.8.3.1(a) through (d);
(2) Documentation of references for the method of analysis used;
(3) Name and signature of the analyst who conducted each analytical
step, including any applicable validation and verification steps, and
the date each step was performed;
(4) Calculations, presented in a legible and logical manner;
(5) As applicable, references to chromatograms, charts, graphs,
observations, photographs of thin layer chromatographic plates, and
spectra. References must be in color when appropriate and presented in
a clear order;
(6) Identification of the source and purity of reference standards
used, and, as applicable: Certified reference materials, certified
reference cultures traceable to a nationally or internationally
recognized type culture collection (including concentration, units,
preparation, and storage conditions), and reference standard
preparation information (including who prepared the reference standard,
date of preparation, expiration date, chemical balance, and solvent
used);
(7) A copy of the label from any immediate container sampled, if
available, and any additional labeling needed to evaluate the product;
(8) All original compilations of raw data secured in the course of
the analysis, including discarded, unused, or re-worked data, with the
justification for discarding or re-working such data, corresponding
supporting data, and quality control results (including the expected
result and whether it is acceptable), all identified with unique sample
identification, date, and time, associated with the test;
(9) Any other relevant additional supporting information such as
the storage location of analyzed samples, appropriate attachments such
as instrument printouts, computer generated charts and data sheets, and
photocopies or original labels for the product analyzed;
(10) Identification of any software used;
(11) Any certificate of analysis for standards and software; and
(12) The following information about the qualifications of each
analyst involved in the analysis conducted under this subpart, if the
LAAF-accredited laboratory has not previously submitted documentation
of the analyst's qualifications to FDA or the analyst's qualifications
have significantly changed since the LAAF-accredited laboratory last
submitted documentation of the analyst's qualifications to FDA:
(i) The analyst's curriculum vitae;
(ii) Training records for the applicable methods that the analyst
is qualified to perform, including the dates of such training and the
name of the trainer or training provider; and
(iii) Any other documentation of the analyst's ability to perform
the method properly in the context of the food testing to be conducted,
pursuant to Sec. 1.1150(b).
(e) Additional information about non-standard methods. If the LAAF-
accredited laboratory conducts the analysis using a method that is not
published in a reputable international or national standard or that is
otherwise not publicly and readily available, upon request by FDA the
LAAF-accredited laboratory must submit documentation of the method to
FDA.
(f) Immediate notification of significant changes. The LAAF-
accredited laboratory must notify FDA and the recognized accreditation
body that LAAF-accredited the laboratory of changes that affect the
LAAF-accreditation of the laboratory within 48 hours, including a
detailed description of such changes, and an explanation of how such
changes affect the LAAF-accreditation of the laboratory. LAAF-
accredited laboratories are not required to notify FDA of changes that
a recognized accreditation body must provide to FDA under Sec.
1.1123(d).
(g) Consequence of omission. If FDA does not receive all
information required to be submitted to FDA under this section, FDA may
consider the related food testing to be invalid.
Sec. 1.1153 What are the requirements for submitting abridged
analytical reports?
(a) Requesting permission. A LAAF-accredited laboratory may request
permission to submit abridged analytical reports for each major food
testing discipline: Biological, chemical, and physical.
(1) FDA will grant permission to submit abridged analytical reports
for a single major food testing discipline if all of the following
conditions are met:
(i) The LAAF-accredited laboratory is not on suspension or
probation for any method within the major food testing discipline that
is the subject of its request (see Sec. 1.1121(b) or Sec. 1.1161(b));
(ii) The LAAF-accredited laboratory has successfully implemented
any required corrective action under Sec. 1.1121(a) or Sec.
1.1161(a); and
(iii) The last five full analytical reports for the major food
testing discipline contain no shortcomings that call into question the
validity of the test results or repeated administrative errors.
(2) FDA will notify the LAAF-accredited laboratory if permission is
granted or denied.
(b) FDA review of abridged analytical reports. (1) FDA will review
all abridged analytical reports submitted.
(2) FDA will notify the LAAF-accredited laboratory if FDA
identifies a shortcoming that calls into question the validity of the
test results or repeated administrative errors, will require corrective
action under Sec. 1.1161(a), and may revoke permission to submit
abridged analytical reports for the specific major food testing
discipline.
(3) If FDA identifies a shortcoming that calls into question the
validity of the test results or repeated administrative errors in
abridged analytical reports from a LAAF-accredited laboratory that has
previously had its permission to submit abridged analytical reports
revoked for any major food testing discipline, FDA may put the LAAF-
accredited laboratory on probation for one or more methods under Sec.
1.1161(b). Under Sec. 1.1162(a), a laboratory on probation for one or
more methods may not submit abridged analytical reports for the major
food testing disciplines of which the probationary methods are a part.
(4) A LAAF-accredited laboratory that has had permission to submit
abridged analytical reports revoked for one or more major food testing
disciplines may request permission to submit abridged analytical
reports as described in paragraph (a) of this section for each major
food testing discipline.
(c) Contents of abridged analytical reports. In addition to the
documentation required to be submitted with all test results (see Sec.
1.1152(c)), an abridged analytical report must include:
(1) All information described by ISO/IEC 17025:2017(E)
(incorporated by reference, see Sec. 1.1101) sections 7.8.2.1(a)
through (p) and 7.8.3.1(a) through (d); and
(2) Quality control results (including the expected result and
whether it is acceptable).
(d) Exceptions. FDA may require additional documentation or a full
analytical report from a LAAF-accredited laboratory permitted to submit
abridged analytical reports in the following circumstances:
[[Page 68828]]
(1) FDA may require a full analytical report related to an FDA
investigation or FDA enforcement proceeding.
(2) Occasionally, for the purposes of auditing abridged analytical
reports and otherwise protecting the public health and the integrity of
this food testing program, FDA will require additional documentation or
a full analytical report within 72 hours of FDA's request.
(e) Consequence of omission. If FDA does not receive all
information required to be submitted to FDA under paragraph (c) of this
section, FDA may consider the related food testing to be invalid.
Sec. 1.1154 What other records requirements must a LAAF-accredited
laboratory meet?
(a) In addition to the records requirements of Sec. 1.1138(a), a
LAAF-accredited laboratory must maintain, for 5 years after the date of
creation, records created and received while it is LAAF-accredited that
relate to compliance with this subpart, including:
(1) Documents related to the LAAF-accredited laboratory's grant of
LAAF-accreditation (and, if applicable, extensions and reductions of
scope of LAAF-accreditation) from its recognized accreditation body,
including all required proficiency test and comparison program records
for each method within the scope of LAAF-accreditation under Sec.
1.1138(a)(2);
(2) Documentation of food testing the LAAF-accredited laboratory
conducted under this subpart sufficient to account for all information
required by Sec. 1.1152(d), in accordance with Sec. 1.1150(d);
(3) All documents that the LAAF-accredited laboratory was required
to submit to FDA under Sec. Sec. 1.1152 and 1.1153, and associated
correspondence between the LAAF-accredited laboratory (and its
officers, employees, and other agents) and the owner or consignee (and
its officers, employees, and other agents) regarding food testing under
this subpart;
(4) All requests for food testing from an owner or consignee that
would be conducted under this subpart;
(5) Documentation of any internal investigations, internal audits,
and corrective action taken to address any problems or deficiencies
related to activities under this subpart;
(6) All documentation related to suspension, probation, reduction
of scope, or withdrawal of LAAF-accreditation, or laboratory
disqualification under this subpart; and
(7) Documentation of changes to its management system or food
testing activities that may affect its compliance with this subpart.
(b) Make the records required by paragraph (a) of this section
available for inspection and copying or for electronic submission upon
written request of an authorized officer or employee of FDA. If FDA
requests records for inspection and copying, the laboratory must make
such records promptly available at the physical location of the
laboratory or at another reasonably accessible location. If the
authorized officer or employee of FDA requests electronic submission,
the records must be submitted within 10 business days of the request.
(c) Ensure that significant amendments to records described by this
section can be tracked to previous and original versions. If such a
significant amendment is made, both the original document and amended
document must be maintained by the LAAF-accredited laboratory during
the time period for which the amended document must be maintained under
this subpart. The laboratory must also document the date of amendment,
the personnel responsible for the amendment, and a conspicuous
indication on the original document stating that the document has been
altered and that a more recent version of the document exists.
FDA Oversight of LAAF-Accredited Laboratories
Sec. 1.1159 How will FDA oversee LAAF-accredited laboratories?
(a) FDA may review the performance of LAAF-accredited laboratories
at any time to determine whether the LAAF-accredited laboratory
continues to comply with the applicable requirements of this subpart
and whether there are deficiencies in the performance of the LAAF-
accredited laboratory that, if not corrected, would warrant corrective
action, probation, or disqualification under Sec. 1.1161.
(b) In evaluating the performance of a LAAF-accredited laboratory,
FDA may review any of the following:
(1) Records the LAAF-accredited laboratory is required to maintain
under this subpart;
(2) Records the recognized accreditation body that LAAF-accredited
the laboratory is required to maintain under this subpart;
(3) Information obtained by FDA during a review of the LAAF-
accredited laboratory conducted pursuant to paragraph (c) of this
section;
(4) Information obtained by FDA during an evaluation of the
recognized accreditation body that LAAF-accredits the laboratory;
(5) Analytical reports and test results submitted to FDA; and
(6) Any other information obtained by FDA, including during FDA's
inspections or investigations of one or more owners or consignees.
(c) FDA may conduct an onsite review of a LAAF-accredited
laboratory at any reasonable time, with or without a recognized
accreditation body (or its officers, employees, and other agents)
present, to review the performance of a LAAF-accredited laboratory
under this subpart. Certain review activities may be conducted remotely
if it will not aid in the review to conduct them onsite.
(d) FDA may report any observations and deficiencies identified
during its review of LAAF-accredited laboratory performance under this
subpart to the recognized accreditation body.
Sec. 1.1160 How will FDA review test results and analytical reports?
(a) If FDA finds that any test result, analytical report, related
documents, or the associated analysis contains deficiencies or
otherwise indicates that any aspect of the food testing is not being
conducted in compliance with this subpart, FDA will notify the LAAF-
accredited laboratory that submitted the analytical report of any
deficiency and may:
(1) Require the laboratory to correct the test result, analytical
report, related documents, or the associated analysis;
(2) Revoke permission to submit abridged reports for that major
food testing discipline under Sec. 1.1153(b);
(3) Require a corrective action under Sec. 1.1161(a);
(4) Consider the analysis to be invalid; and/or
(5) Notify the owner or consignee of the deficiency.
(b) FDA may report any deficiencies identified during its review of
any test results, reports, and related documents under this subpart to
the recognized accreditation body that LAAF-accredits the laboratory.
(c) Nothing in this subpart shall be construed to limit the ability
of FDA to review and act on information received about food testing,
including determining the sufficiency of such information and testing.
Sec. 1.1161 When will FDA require corrective action, put a LAAF-
accredited laboratory on probation, or disqualify a LAAF-accredited
laboratory from submitting analytical reports?
(a) Corrective action. FDA may require corrective action to address
any deficiencies identified while reviewing a LAAF-accredited
laboratory's performance under this subpart.
(1) FDA will notify the LAAF-accredited laboratory of all
deficiencies requiring corrective action and will
[[Page 68829]]
either specify a deadline to implement corrective action or will
require the LAAF-accredited laboratory to submit a corrective action
plan and timeframe for implementation to FDA for approval.
(2) The LAAF-accredited laboratory must handle FDA's notification
as a complaint under ISO/IEC 17025:2017(E) (incorporated by reference,
see Sec. 1.1101) section 7.9, implement appropriate corrective action
under ISO/IEC 17025:2017(E) section 8.7, and submit both the results of
the complaint investigation and subsequent corrective action to FDA.
(3) FDA will review the corrective action and will notify the LAAF-
accredited laboratory whether the corrective action is acceptable.
(b) Probation. If FDA determines that a LAAF-accredited laboratory
has not effectively implemented corrective action or otherwise fails to
address deficiencies identified, FDA may put the LAAF-accredited
laboratory on probation for one or more methods and require corrective
action under paragraph (a) of this section.
(1) FDA will notify the LAAF-accredited laboratory and its
recognized accreditation body of the grounds for the probation, the
method(s) covered by the probation, and all deficiencies requiring
corrective action via the process described in paragraph (a) of this
section.
(2) FDA will provide notice of a LAAF-accredited laboratory's
probation on the website described in Sec. 1.1109.
(3) FDA will review the corrective action and will notify the LAAF-
accredited laboratory and its recognized accreditation body whether the
corrective action is acceptable.
(4) A LAAF-accredited laboratory will remain on probation until the
LAAF-accredited laboratory demonstrates to FDA's satisfaction that it
has successfully implemented appropriate corrective action.
(5) If FDA determines that a LAAF-accredited laboratory on
probation has failed to implement appropriate corrective action or
otherwise fails to address deficiencies identified, FDA may disqualify
the LAAF-accredited laboratory under paragraph (c) of this section.
(c) Disqualification. FDA may disqualify a LAAF-accredited
laboratory from submitting analytical reports under this subpart for
one or more methods for good cause, which may include any of the
following reasons:
(1) Deliberate falsification of analytical reports, testing
results, or other records submitted to FDA.
(2) Failure of a LAAF-accredited laboratory on probation to
effectively implement corrective action or otherwise address identified
deficiencies.
(3) Other failure to substantially comply with this subpart where
the laboratory's recognized accreditation body has not reduced the
scope of or withdrawn LAAF-accreditation of the laboratory.
(d) Disqualification procedures. (1) FDA will issue a notice of
disqualification to a LAAF-accredited laboratory and its recognized
accreditation body, which will include:
(i) The grounds for disqualification;
(ii) The method or methods to which the disqualification applies;
(iii) The date the disqualification will be effective;
(iv) The procedures for requesting a regulatory hearing on the
disqualification under Sec. 1.1173; and
(v) The procedures for requesting reinstatement after
disqualification under Sec. 1.1142.
(2) FDA will provide notice of a LAAF-accredited laboratory's
disqualification on the website described in Sec. 1.1109.
Sec. 1.1162 What are the consequences if FDA puts a LAAF-accredited
laboratory on probation or disqualifies a LAAF-accredited laboratory?
(a) A LAAF-accredited laboratory that FDA has put on probation for
one or more methods is permitted to continue to conduct food testing
under this subpart; however, a LAAF-accredited laboratory that is on
probation for one or more methods is not permitted to submit abridged
analytical reports for the major food testing discipline of which the
probationary methods are part.
(b) If FDA disqualifies a LAAF-accredited laboratory for all
methods within its scope of LAAF-accreditation, the laboratory is
immediately ineligible to conduct food testing under this subpart. If
FDA disqualifies a LAAF-accredited laboratory for specific methods
within the scope of LAAF-accreditation, the laboratory is immediately
ineligible to use the methods for which the laboratory has been
disqualified to conduct food testing under this subpart.
(c) With respect to food testing conducted by the laboratory prior
to its disqualification, FDA may refuse to consider results and
associated reports of food testing conducted under this subpart if the
basis for the disqualification of the laboratory indicates that the
specific food testing conducted by the laboratory may not be reliable.
(d) Within 10 business days of the date of issuance of
disqualification, the laboratory must provide the name and email
address of the custodian who will maintain and make available to FDA
the records required by Sec. 1.1154, and the street address where the
records will be located.
(e) Within 10 business days of the date of issuance of a notice of
probation or disqualification, the laboratory must notify any owners or
consignees for which it is conducting food testing using methods for
which it is being placed on probation or disqualified under this
subpart, that it is on probation or has been disqualified.
Requesting FDA Reconsideration or Regulatory Hearings of FDA Decisions
Under This Subpart
Sec. 1.1171 How does an accreditation body request reconsideration by
FDA of a decision to deny its application for recognition, renewal, or
reinstatement?
(a) Timing of request. An accreditation body may seek
reconsideration of FDA's decision to deny its application for
recognition or renewal of recognition under Sec. 1.1114, or
reinstatement of recognition under Sec. 1.1117, no later than 10
business days after the date of the issuance of such denial.
(b) Submission of request. The request to reconsider an application
under paragraph (a) of this section must be signed by the accreditation
body, as appropriate, or by an individual authorized to act on its
behalf. The accreditation body must submit the request, together with
any supporting information, to FDA in accordance with the procedures
described in the notice of denial.
(c) Notification of FDA's decision. After completing its review and
evaluation of the request for reconsideration and any supporting
information submitted pursuant to paragraph (b) of this section, FDA
will notify the accreditation body of its decision to grant or deny
recognition upon reconsideration.
[[Page 68830]]
Sec. 1.1173 How does an accreditation body or laboratory request a
regulatory hearing on FDA's decision to revoke the accreditation body's
recognition or disqualify a LAAF-accredited laboratory?
(a) Request for hearing. No later than 10 business days after the
date FDA issued a revocation of recognition of an accreditation body
pursuant to Sec. 1.1131 or disqualification of a LAAF-accredited
laboratory under Sec. 1.1161, the accreditation body, laboratory, or
an individual authorized to act on the accreditation body's or
laboratory's behalf, may submit a request for a regulatory hearing,
conducted pursuant to part 16 of this chapter, on the revocation or
disqualification. The notice of revocation issued under Sec. 1.1131 or
notice of disqualification issued under Sec. 1.1161, as applicable,
will contain all the elements required by Sec. 16.22(a) of this
chapter and will thereby constitute the notice of an opportunity for
hearing under part 16 of this chapter.
(b) Submission of request for regulatory hearing. The request for a
regulatory hearing under this subpart must be submitted with a written
appeal that responds to the bases for the FDA decision described in the
written notice of revocation or disqualification, together with any
supporting information. The request, appeal, and supporting information
must be submitted to FDA in accordance with the procedures described in
the notice of revocation or disqualification.
(c) Effect of submitting a request for a regulatory hearing on an
FDA decision. The submission of a request for a regulatory hearing
under this subpart will not operate to delay or stay the effect of a
decision by FDA to revoke the recognition of an accreditation body or
disqualify the LAAF-accredited laboratory unless FDA determines that
delay or a stay is in the public interest.
(d) Presiding officer. The presiding officer for a regulatory
hearing under this subpart will be designated after a request for a
regulatory hearing is submitted to FDA.
(e) Denial of a request for regulatory hearing. The presiding
officer may deny a request for regulatory hearing under this subpart
pursuant to Sec. 16.26(a) of this chapter when no genuine or
substantial issue of fact has been raised.
(f) Conduct of regulatory hearing. (1) If the presiding officer
grants a request for a regulatory hearing, the hearing will be held
within 10 business days after the date the request was filed or, if
applicable, within a timeframe agreed upon in writing by the
accreditation body or laboratory, and the presiding officer and FDA.
(2) The presiding officer must conduct the hearing in accordance
with part 16 of this chapter, except that, pursuant to Sec. 16.5(b) of
this chapter, the procedures for a regulatory hearing apply only to the
extent that such procedures are supplementary and do not conflict with
the procedures specified for regulatory hearings under this subpart.
Accordingly, the following requirements of part 16 of this chapter are
inapplicable to regulatory hearings conducted under this subpart: The
requirements of Sec. 16.22 (Initiation of regulatory hearing); Sec.
16.24(e) (timing) and (f) (contents of notice); Sec. 16.40
(Commissioner); Sec. 16.60(a) (public process); Sec. 16.95(b)
(administrative decision and record for decision); and Sec. 16.119
(Reconsideration and stay of action).
(3) A decision by the presiding officer to affirm the revocation of
recognition or laboratory disqualification is considered a final agency
action under 5 U.S.C. 702.
Sec. 1.1174 How does an owner or consignee request a regulatory
hearing on a directed food laboratory order?
(a) Request for hearing. No later than 3 business days after FDA
has issued the directed food laboratory order, an owner or consignee
may submit a request for a regulatory hearing, conducted pursuant to
part 16 of this chapter, on the directed food laboratory order. The
directed food laboratory order will contain all of the elements
required by Sec. 16.22 of this chapter and will thereby constitute the
notice of an opportunity for hearing under part 16 of this chapter.
(b) Submission of request for regulatory hearing. The request for a
regulatory hearing must be submitted with a written appeal that
responds to the bases, as appropriate, for FDA's determinations
described in the directed food laboratory order, together with any
supporting information. The request, appeal, and supporting information
must be submitted in accordance with the procedures described in the
directed food laboratory order.
(c) Presiding officer. The presiding officer for a regulatory
hearing under this subpart will be designated after a request for a
regulatory hearing is submitted to FDA.
(d) Denial of a request for regulatory hearing. The presiding
officer may deny a request for regulatory hearing under this subpart
pursuant to Sec. 16.26(a) of this chapter.
(e) Conduct of regulatory hearing. (1) If the presiding officer
grants a request for a regulatory hearing, such hearing will be held
within 2 business days after the date the request was filed or, if
applicable, within a timeframe agreed upon in writing by the requestor
and the presiding officer and FDA.
(2) The presiding officer may require that a hearing conducted
under this subpart be completed within 1 business day, as appropriate.
(3) The presiding officer must conduct the hearing in accordance
with part 16 of this chapter, except that, pursuant to Sec. 16.5(b) of
this chapter, the procedures for a regulatory hearing described in part
16 of this chapter apply only to the extent that such procedures are
supplementary and not in conflict with the procedures specified for the
conduct of regulatory hearings under this subpart. Accordingly, the
following requirements of part 16 of this chapter are inapplicable to
regulatory hearings conducted under this subpart: Sec. 16.22
(Initiation of regulatory hearing); Sec. 16.24(e) (timing) and (f)
(contents of notice); Sec. 16.40 (Commissioner); Sec. 16.60(a)
(public process); Sec. 16.95(b) (administrative decision and record
for decision); and Sec. 16.119 (Reconsideration and stay of action).
(4) A decision by the presiding officer to affirm the directed food
laboratory order is considered a final agency action under 5 U.S.C.
702.
Electronic Records and Public Disclosure Requirements
Sec. 1.1199 Are electronic records created under this subpart subject
to the electronic records requirements of part 11 of this chapter?
Records that are established or maintained to satisfy the
requirements of this subpart and that meet the definition of electronic
records in Sec. 11.3(b)(6) of this chapter are exempt from the
requirements of part 11 of this chapter. Records that satisfy the
requirements of this subpart, but that also are required under other
applicable statutory provisions or regulations, remain subject to part
11 of this chapter.
Sec. 1.1200 Are the records obtained by FDA under this subpart
subject to public disclosure?
Records obtained by FDA under this subpart are subject to the
disclosure requirements under part 20 of this chapter.
PART 11--ELECTRONIC RECORDS; ELECTRONIC SIGNATURES
0
4. The authority citation for part 11 continues to read as follows:
Authority: 21 U.S.C. 321-393; 42 U.S.C. 262.
0
5. In Sec. 11.1, add paragraph (p) to read as follows:
[[Page 68831]]
Sec. 11.1 Scope.
* * * * *
(p) This part does not apply to records required to be established
or maintained by subpart R of part 1 of this chapter. Records that
satisfy the requirements of subpart R of part 1 of this chapter, but
that also are required under other applicable statutory provisions or
regulations, remain subject to this part.
PART 16--REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION
0
6. The authority citation for part 16 continues to read as follows:
Authority: 15 U.S.C. 1451-1461; 21 U.S.C.141-149, 321-394, 467f,
679, 821, 1034, 28 U.S.C. 2112; 42 U.S.C. 201-262, 263b, 364.
0
7. In Sec. 16.1, add entries for Sec. Sec. 1.1173 and 1.1174 in
numerical order to paragraph (b)(2) to read as follows:
Sec. 16.1 Scope.
* * * * *
(b) * * *
(2) * * *
Sec. 1.1173, relating to the revocation of recognition of an
accreditation body, and the disqualification of a laboratory, with
respect to food testing conducted under part 1, subpart R of this
chapter.
Sec. 1.1174, relating to the issuance of a directed food
laboratory order by FDA pursuant to Sec. 1.1108.
* * * * *
PART 129--PROCESSING AND BOTTLING OF BOTTLED DRINKING WATER
0
8. The authority citation for part 129 is revised to read as follows:
Authority: 21 U.S.C. 342, 348, 350k, 371, 374, 42 U.S.C. 264.
0
9. Amend Sec. 129.35 by revising paragraph (a)(3)(iii) to read as
follows:
Sec. 129.35 Sanitary facilities.
* * * * *
(a) * * *
(3) * * *
(iii) Analysis of the sample may be performed for the plant by
competent commercial laboratories (e.g., Environmental Protection
Agency (EPA) and State-certified laboratories), except that the
analysis of the five samples from the same sampling site that
originally tested positive for E. coli, as required by paragraph (a)(3)
of this section, must be conducted under part 1, subpart R of this
chapter.
* * * * *
Dated: November 15, 2021.
Janet Woodcock,
Acting Commissioner of Food and Drugs.
[FR Doc. 2021-25716 Filed 12-1-21; 11:15 am]
BILLING CODE 4164-01-P