[Federal Register Volume 84, Number 213 (Monday, November 4, 2019)]
[Proposed Rules]
[Pages 59452-59516]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23870]
[[Page 59451]]
Vol. 84
Monday,
No. 213
November 4, 2019
Part II
Department of Health and Human Services
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Food and Drug Administration
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21 CFR Parts 1, 11, 16, et al.
Laboratory Accreditation for Analyses of Foods; Proposed Rule
Federal Register / Vol. 84 , No. 213 / Monday, November 4, 2019 /
Proposed Rules
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 1, 11, 16, and 129
[Docket No. FDA-2019-N-3325]
RIN 0910-AH31
Laboratory Accreditation for Analyses of Foods
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
proposing to amend its regulations to establish a program for the
testing of food in certain circumstances by accredited laboratories, as
required under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Establishing such a program will help FDA improve the safety of the
U.S. food supply and protect U.S. consumers by helping ensure that
certain food testing of importance to public health is conducted
subject to appropriate oversight and in accordance with appropriate
model standards, and produces reliable and valid test results.
DATES: Submit either electronic or written comments on the proposed
rule by March 3, 2020. Submit comments on information collection issues
under the Paperwork Reduction Act of 1995 by March 3, 2020 (see the
``Paperwork Reduction Act of 1995'' section of this document).
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before March 3, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of March 3, 2020. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions.'')
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2019-N-3325 for Laboratory Accreditation for Analyses of Foods.
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at Dockets Management Staff between 9 a.m. and
4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
Submit comments on information collection issues under the
Paperwork Reduction Act of 1995 to the Office of Management and Budget
(OMB) in the following ways:
Fax to the Office of Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or email to
[email protected]. All comments should be identified with the
title, ``Laboratory Accreditation for Analyses of Foods.''
FOR FURTHER INFORMATION CONTACT: Timothy McGrath, Staff Director, Food
and Feed Laboratory Operations, Office of Regulatory Affairs, Food and
Drug Administration, 12420 Parklawn Dr., Rm. 3142, Rockville, MD 20857,
301-796-6591, email: [email protected].
With regard to the information collection: Domini Bean, Office of
Operations, Food and Drug Administration, Three White Flint North,
10A63, 11601 Landsdown Street, North Bethesda, MD 20852, 301-796-5733,
email: [email protected].
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Executive Summary
A. Purpose and Coverage of the Proposed Rule
B. Summary of the Major Provisions of the Proposed Rule
C. Legal Authority
D. Costs and Benefits
II. Table of Abbreviations/Commonly Used Acronyms in This Document
III. Background
A. FDA Food Safety Food Modernization Act
B. Food Testing Under FSMA
[[Page 59453]]
C. Import-Related Food Testing and Detention Without Physical
Examination (DWPE) Procedures
D. Testing of Imported Food by Private Laboratories
E. Current Industry Practices Relating to Accreditation Bodies,
Accreditation of Laboratories, and Food Testing
F. U.S. Government Policies on Consensus Standards
G. Incorporation by Reference
IV. FSMA Public Meetings, Comments Related to Other FSMA
Rulemakings, and Stakeholder Input
V. Legal Authority
VI. Description of the Proposed Rule
A. Proposed General Provisions (Proposed Sec. Sec. 1.1102
Through 1.1103)
B. Proposed Provisions About General Requirements of This Rule
(Proposed Sec. Sec. 1.1107 Through 1.1109)
C. Proposed Provisions About Recognition of Accreditation Bodies
(Proposed Sec. Sec. 1.1113)
D. Proposed Provisions About Requirements for Recognized
Accreditation Bodies (Proposed Sec. Sec. 1.1118 Through 1.1125)
E. Proposed Provisions About Procedures for Recognition of
Accreditation Bodies (Proposed Sec. Sec. 1.1128 Through 1.1133)
F. Proposed Provisions About Accreditation of Laboratories
(Proposed Sec. Sec. 1.1138)
G. Proposed Provisions About Requirements for Accredited
Laboratories (Proposed Sec. Sec. 1.1146 Through 1.1153)
H. Proposed Provisions About Procedures for Accreditation of
Laboratories (Proposed Sec. Sec. 1.1158 Through 1.1165)
I. Proposed Provisions About Requesting FDA Reconsideration, FDA
Internal Review, or Regulatory Hearings of FDA Decisions Under This
Rule (Proposed Sec. Sec. 1.1171 Through 1.1174)
J. Proposed Provisions About Electronic Records and Public
Disclosure Requirements Under This Rule (Proposed Sec. Sec. 1.1199
Through 1.1200)
K. Proposed Revisions to 21 CFR Part 1, Subpart M
L. Proposed Revisions to 21 CFR Part 11
M. Proposed Revisions to 21 CFR Part 16
N. Proposed Revisions to 21 CFR Part 129
VII. Proposed Effective Date and Implementation Steps
VIII. Preliminary Economic Analysis of Impacts
Summary of Costs and Benefits
IX. Analysis of Environmental Impact
X. Paperwork Reduction Act of 1995
XI. Federalism
XII. References
I. Executive Summary
A. Purpose and Coverage of the Proposed Rule
This proposed rule, if finalized, would establish a new program for
food testing by accredited laboratories. The FDA Food Safety
Modernization Act (FSMA) (Pub. L. 111-353), section 202(a), added
section 422 to the FD&C Act (21 U.S.C. 350k), which requires us to
establish this program.
You would be subject to this rule, if finalized, if you are a
recognized accreditation body, an entity seeking to be a recognized
accreditation body, an accredited laboratory, or an entity seeking to
be an accredited laboratory, for purposes of food testing as specified
in this proposed rule. You would also be subject to this rule if you
are an owner or consignee required to use an accredited laboratory to
conduct food testing as specified in this proposed rule. Although
participation in this program is voluntary for laboratories,
laboratories would only be able to conduct testing described in
proposed Sec. 1.1107 if they are accredited under this proposed
program.
Under this proposed rule FDA would recognize accreditation bodies
that would accredit laboratories to conduct food testing. The program
structure is portrayed in the following diagram:
[GRAPHIC] [TIFF OMITTED] TP04NO19.000
This proposed program for the testing of food by accredited
laboratories would establish the oversight, uniformity, and standards
necessary to help ensure that the results of certain food testing of
importance to public health are reliable and accurate, and, in turn,
establishment of the program would substantially improve our capability
to protect U.S. consumers from unsafe food.
B. Summary of the Major Provisions of the Proposed Rule
The proposed rule contains model standards that laboratories must
meet in order to be and stay accredited. The proposed rule, if
finalized, would establish a publicly available list of accreditation
bodies and laboratories that have been recognized or accredited under
this program. Results of food testing conducted by laboratories under
the program would be required to be sent directly to FDA. Laboratories
accredited under this program would be required to submit to FDA some
analytical reports, but for certain laboratories less documentation
would
[[Page 59454]]
be required than we currently expect as part of a private laboratory
analytic package.
This proposal contains eligibility requirements for accreditation
bodies to qualify for recognition and requirements that accreditation
bodies must meet once recognized, such as requirements related
competency and conflict of interest safeguards. The proposed rule also
contains eligibility requirements for laboratories to qualify for
accreditation by a recognized accreditation body and requirements that
laboratories must meet once accredited, such as requirements related to
conflicts of interest, analysis, and records. These requirements will
help ensure the effectiveness of the recognized accreditation bodies
and accredited laboratories under this program. This proposal also
contains procedures we would follow to recognize accreditation bodies
under this program and procedures for accreditation bodies to follow to
accredit laboratories under this program. This proposed rule also
contains regulatory procedures and requirements relating to our
monitoring and oversight of recognized accreditation bodies and
accredited laboratories.
This proposed rule would apply when food testing is conducted in
certain circumstances. ``Food testing'' and ``testing of food'' would
include the analysis of human or animal food. ``Food testing'' and
``testing of food'' would also include testing of the food growing or
manufacturing environment (i.e., ``environmental testing'').
We seek comments on all aspects of this proposed rule.
C. Legal Authority
Section 422(a)(1)(A) the FD&C Act, which was added by section
202(a) of FSMA, directs us to establish a program for the testing of
food by accredited laboratories. Therefore, section 422 of the FD&C Act
provides FDA with authority for these proposed requirements, which
outline what would be required of participants in the program for the
testing of food by accredited laboratories. FDA also derives authority
for these proposed requirements from section 701(a) of the FD&C Act (21
U.S.C. 371(a)), which authorizes FDA to issue regulations for the
efficient enforcement of the FD&C Act.
D. Costs and Benefits
The costs of the proposed rule, if finalized, would be incurred
primarily by participating accreditation bodies, participating labs,
shell-egg producers, sprouts producers, bottled water manufacturers,
and owners and consignees of human and animal food offered for import
covered by the proposed rule. We would incur costs to establish and
maintain the program for recognizing accreditation bodies hoping to
participate in our program, assessing participating accreditation
bodies and participating labs, and for reviewing associated documents
and reports. The present value of the cost of the proposed rule, if
finalized, would range from $34 million to $78 million when discounted
by 7 percent over 10 years. When discounted by 3 percent over 10 years
the present value of the cost would range from $39 million to $92
million.
The proposed rule, if finalized, would generate some quantified and
unquantified benefits. Quantified benefits include cost-savings from
the proposed clarifications of the process for compiling, submitting
and reviewing analytical reports for human and animal food offered for
import covered under the proposed rule, and a reduced burden from the
proposed abbreviated reporting requirements. In addition, there would
be savings from fewer false positive test results. We anticipate a
reduction in the number of foodborne illnesses from fewer false
negative test results for human and animal food offered for import
covered under the proposed rule and for shell eggs, sprouts, bottled
water, and other food subject to specific testing requirements covered
under the proposed rule. Unquantified benefits could include fewer
illnesses from deterring unsafe manufacturing practices by all entities
affected by the proposed rule. The present value of the quantified
benefits of the proposed rule, if finalized, would range from $26
million to $81 million when discounted by 7 percent over 10 years. When
discounted by 3 percent over 10 years the present value of the
quantified benefits would range from $32 million to $98 million.
II. Table of Abbreviations and Acronyms Commonly Used in This Document
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Abbreviation/ acronym What it means
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ANSI............................. American National Standards
Institute.
BAM.............................. Bacteriological Analytical Manual.
CFR.............................. Code of Federal Regulations.
CPSC............................. Consumer Product Safety Commission.
DWPE............................. Detention Without Physical
Examination.
EO............................... Executive Order.
E. coli.......................... Escherichia coli.
FDA.............................. United States Food and Drug
Administration.
FD&C Act......................... Federal Food, Drug, and Cosmetic Act.
FR............................... Federal Register.
FSMA............................. FDA Food Safety Modernization Act.
FSVP............................. Foreign Supplier Verification
Programs.
GAO.............................. Government Accountability Office.
HHS.............................. Health and Human Services.
IBR.............................. Incorporation by Reference.
IEC.............................. International Electrotechnical
Commission.
ILAC............................. International Laboratory
Accreditation Cooperation.
ISO.............................. International Organization for
Standardization.
MRA.............................. Mutual Recognition Arrangement.
NIST............................. National Institute of Standards and
Technology.
NTTAA............................ National Technology Transfer and
Advancement Act of 1995.
OMB.............................. Office of Management and Budget.
ORA.............................. Office of Regulatory Affairs.
PLAP............................. Private Laboratory Analytical
Package.
PRA.............................. Paperwork Reduction Act.
PRIA............................. Preliminary Regulatory Impact
Analysis.
IEC.............................. International Electrotechnical
Commission.
U.S.C............................ United States Code.
WTO.............................. World Trade Organization.
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III. Background
A. FDA Food Safety Modernization Act
On January 4, 2011, President Obama signed FSMA into law. FSMA is
intended to allow FDA to better protect public health by helping ensure
the safety and security of the U.S. food supply and enables us to focus
more on preventing food safety problems rather than primarily reacting
to them once they surface. FSMA also provides us with new enforcement
authorities designed to achieve higher rates of compliance with risk-
based, prevention-oriented safety standards and to better respond to
and contain problems when they do occur. In addition, FSMA gives us
important new tools to better ensure the safety of imported foods and
encourages partnerships with State, local, tribal, and territorial
authorities. In implementing FSMA, we prioritized the development of
seven foundational rules that provide the framework for risk-based
preventive controls and enhance our ability to oversee their
implementation by industry for both domestic and imported food. We have
finalized these foundational rules and begun their implementation while
also developing additional programs required by FSMA, including a
program for food testing by accredited laboratories, as proposed in
this document.
B. Food Testing Under FSMA
FSMA recognized that food testing could perform different roles in
supporting a modern food safety system. For example, section 418(f)(4)
of the
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FD&C Act (21 U.S.C. 350g) provides for the use of environmental and
product testing programs as part of required verification that
preventive controls are effectively and significantly minimizing or
preventing the occurrence of identified hazards (food testing under
such requirements may be conducted for biological, chemical, physical,
radiological hazards, or, most commonly, microbiological hazards).
Section 805(c)(4) of the FD&C Act (21 U.S.C. 384a) states that
verification activities under a foreign supplier verification program
may include periodically testing and sampling shipments. Under these
provisions, food testing is used to verify that control measures,
including those related to suppliers, are controlling the identified
hazards. In implementing these provisions in the regulations for
preventive controls for human food and foreign supplier verification
programs, we attempted to provide flexibility by specifying that they
apply as appropriate to the facility, the food, and the nature of the
preventive control and its role in the facility's food safety system.
21 CFR 117.165(a); accord 21 CFR 507.49(a) (parallel provision in the
regulation for preventive controls for animal food); 21 CFR
1.506(d)(1)(ii)(B) (including sampling and testing of a food among
other appropriate supplier verification activities).
FSMA, in establishing section 422 of the FD&C Act, also underscores
that food testing can play a role in detecting and responding to food
safety problems. Section 422(b)(1) of the FD&C Act requires that food
be tested by accredited laboratories in four circumstances:
In response to a specific testing requirement under the
FD&C Act or implementing regulations, when applied to address an
identified or suspected food safety problem;
As required by the Secretary of Health and Human Services
(HHS), as the Secretary deems appropriate, to address an identified or
suspected food safety problem;
In support of admission of an article of food under
section 801(a) of the FD&C Act (21 U.S.C. 381(a)); and
Under an import alert through successful consecutive
tests.
With one exception, section 422(b)(2) of the FD&C Act requires the
results of food testing conducted under section 422(b)(1) to be sent
directly to FDA, thereby allowing FDA to review the test results.
In food manufacturing or processing facilities, followup or
corrective action testing is often conducted as part of corrective
actions when an environmental pathogen or indicator organism (i.e., an
organism that indicates conditions in which an environmental pathogen
may be present) is found during environmental monitoring. See current
good manufacturing practice and hazard analysis and risk-based
preventive controls for human food proposed rule, 78 FR 3646 at 3816,
January 16, 2013. Corrective action testing may also occur in response
to the results of product testing, although testing cannot ensure the
absence of a hazard. Id. at 3819. The accredited laboratory testing
requirement in this proposed rule would not apply to all corrective
action testing, but would apply to food testing conducted under
specific testing requirements in the FD&C Act and implementing
regulations that ``address an identified or suspected food safety
problem'', and in food testing orders that we would issue ``to address
an identified or suspected food safety problem.'' As discussed in
section VI.B.1, we have tentatively determined that an ``identified
food safety problem'' could be present where a specific article of food
violates a provision of the FD&C Act that relates to food safety and a
``suspected food safety problem'' could be present where there is
reasonable suspicion that a specific article of food violates a
provision of the FD&C Act that relates to food safety or where there is
particularized suspicion of a food safety problem that does not
necessarily render food violative. An example of a specific testing
requirement in our FD&C Act regulations that would ``address an
identified or suspected food safety problem'' and be subject to section
422(b)(1)(A)(i) of the FD&C Act is a requirement for bottled water
producers to test, after corrective measures have been applied, 5
samples collected over a 24-hour period from the same site that
previously tested positive for Escherichia coli (E.coli). See Sec.
129.35(a)(3)(i) (21 CFR 129.35(a)(3)(i)). In this example, the presence
of E. coli in the tested source water would constitute an ``identified
or suspected food safety problem'' because its presence in the source
water is not considered water of a safe quality as is required for
bottled drinking water by Sec. 129.35(a)(1).
C. Import-Related Food Testing and Detention Without Physical
Examination (DWPE) Procedure
Section 422(b)(1)(B) of the FD&C Act requires accredited laboratory
food testing where testing of food is conducted as part of testimony
for the purposes of section 801(a) of the FD&C Act. Under section
801(a)(3) of the FD&C Act, we may refuse admission of an imported food
into the United States if the food is, or appears to be, adulterated or
misbranded. Pending our decision to refuse admission, section 801(a) of
the FD&C Act allows the owner or consignee of the imported article of
food to introduce evidence regarding the admissibility of the food. See
also 21 CFR 1.94(a). Owners and consignees often hire private
laboratories to test the food product and submit the results of the
testing, along with associated analysis and data, to us to show that
the imported food complies with the FD&C Act. If we determine that the
food testing results are valid and that they demonstrate the detained
food product does not violate the FD&C Act, we will release the food
from detention and allow it to proceed into the United States.
The DWPE procedure allows us to detain a product without physically
examining it at the time of entry. We use the DWPE procedure when there
exists a history of the importation of violative products, or products
that may appear violative, or when other information indicates that
future entries may appear violative. Import alerts inform FDA field
staff and the public that we have enough evidence to allow for DWPE of
products that appear to be in violation of FDA laws and regulations.
Depending on the reason for DWPE, owners and consignees may hire
private laboratories to test a food product in an attempt to overcome
the appearance of the violation and release the food from detention.\1\
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\1\ In both the domestic and import arenas, the owner or
consignee of a food may accept that a food product is violative and
offer to recondition the food to make it nonviolative (e.g., by
subjecting an adulterated food to a treatment that cures the
adulteration), divert human food for use as animal food, and/or
recondition the food to make the food not subject to our enforcement
authorities (e.g., by processing the food in a manner that makes it
into a type of product we do not regulate). After food has been
reconditioned and/or identified for diversion to animal food, the
owner or consignee of the food (who we also refer to herein as the
``importer'' in the import context) may have food testing conducted
on the product to demonstrate to us that the product is safe for the
intended use.
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D. Testing of Imported Food by Private Laboratories
As the volume of food offered for import to the United States
increased in recent decades, our use of the DWPE procedure also
increased, as did concomitant food testing by private laboratories on
behalf of importers. From January 1, 2016, through December 31, 2017,
we received food testing submissions, known as private laboratory
analytical packages (PLAPs),
[[Page 59456]]
from approximately 100 different private laboratories. See FDA
Memorandum, ``Assessment of DWPE Sampling and Analysis Data to
Determine What Portion of Sampling and Analysis of Food under DWPE is
Conducted by Accredited Entities'' (Ref. 1). Historically, we relied on
Agency procedural documents and communications from FDA offices that
review PLAPs to encourage private laboratories to meet certain
standards for testing and sampling. We previously have observed that
our recommended procedures for private laboratories were ``not
sufficiently specific,'' which may have contributed to a lack of
consistency in standards for testing and sampling across FDA districts
(requirements pertaining to sampling services and private laboratories
used in connection with imported food proposed rule, 69 FR 23460 at
23468, April 29, 2004). In addition, the lack of regulatory
requirements for PLAP content has sometimes complicated our scientific
review of PLAP submissions from private laboratories.
Concerns also have periodically arisen regarding importers'
manipulation or substitution of the samples a private laboratory tests,
and practices such as ``testing into compliance,'' in which multiple
samples from a shipment are tested, but only those results that would
allow the shipment to enter the United States are submitted to us. See,
e.g., ``The Safety of Food Imports: Fraud & Deception in the Food
Import Process; Hearings Before the Senate Committee on Governmental
Affairs, Permanent Subcommittee on Investigations,'' September 10, 1998
(statement of ``Former Customs Broker'') (Ref. 2, pages 26-35 and 137-
140).
In attempts to address these issues, FDA and others have taken
several actions to improve coordination between FDA and private
laboratories and improve the safety of food imports. This section
describes several of these activities up to and including the enactment
of FSMA section 202(a).
In 1996 we held several public meetings across the country to
discuss how FDA might improve its policies and procedures relating to
the use of private laboratories to test food offered for import. (61 FR
29416, June 10, 1996). These public meetings resulted in an action plan
which suggested, among other things, that we establish consistent and
objective standards for the format and content of food testing results
and analytical information that private laboratories submit to us, that
we require independent sampling of such food prior to the food's
analysis by a private laboratory, and that we require the laboratory to
send the results of all such food testing directly to us (see
discussion of the plan in the 2004 proposed rule, 69 FR 23460, at
23460, April 29, 2004).
In 2003, we added a section on ``Private Laboratory Guidance'' to
FDA's Office of Regulatory Affairs (ORA) Laboratory Manual (ORA
Laboratory Manual) (Ref. 3). This document updated procedures for
reviewing PLAPs (which contain sampling collection reports, testing
results, and associated analytical information) submitted to us as
testimony relevant to the admissibility, destruction, or reconditioning
of FDA-regulated articles offered for import.
Recognizing a need for oversight over sampling services and private
laboratories testing of imported food on behalf of importers, in the
Federal Register of April 29, 2004, we proposed a rule on
``Requirements Pertaining to Sampling Services and Private Laboratories
Used in Connection With Imported Food'' (the 2004 proposed rule). We
designed the 2004 proposed rule with the goals of deterring the
importation of unsafe food, establishing uniformity in the practices of
samplers and laboratories testing imported food for FDA regulatory
purposes, and improving the reliability and scientific validity of the
food testing analytical information that FDA uses to make food import
admissibility decisions. The proposed rule would have required, among
other requirements, that samples of food to be tested be properly
identified, collected, and maintained; that laboratories conducting
food testing use validated or recognized analytical methods; and that
laboratories conducting food testing submit the analytical results of
the food testing directly to FDA. Id.
The 2004 proposed rule would not have required laboratories
conducting food testing to be accredited because we determined that
doing so would have been premature. Id. at 23464. We did, however, in
the preamble to the 2004 proposed rule strongly encourage laboratories
conducting such food testing to become accredited. Id. Most comments on
the accreditation issue contended that accreditation to International
Organization for Standardization/International Electrotechnical
Commission (ISO/IEC) 17025:2005, ``General Requirements for the
Competence of Testing and Calibration Laboratories'' (Ref. 4), would
substantially enhance the effectiveness of the rule. We withdrew the
2004 proposed rule on August 5, 2005 (see 70 FR 64553 at 64590, October
31, 2005).\2\
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\2\ See https://www.govinfo.gov/content/pkg/GPO-UA-2005-10-31/pdf/GPO-UA-2005-10-31-8.pdf.
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In November 2007, an Interagency Working Group on Import Safety,
made up of representatives from 12 federal departments and agencies,
presented an Action Plan for Import Safety to President Bush containing
recommendations and action steps to further improve the safety of
imports entering the United States (Ref. 5). One of these action steps
was that we issue guidance setting ``standards for the sampling and
testing of imported products, including the use of accredited
laboratories submitting data to FDA to assist in evaluating whether an
appearance of a violation may be resolved.''
On January 29, 2008, the Government Accountability Office (GAO)
recommended, in testimony to the Subcommittee on Oversight and
Investigations of the House Committee on Energy and Commerce, that we
consider accrediting private laboratories to test seafood. See GAO,
``Federal Oversight of Food Safety: FDA's Food Protection Plan Proposes
Positive First Steps, but Capacity to Carry Them Out Is Critical,''
GAO-08-435T (Ref. 6), at page 7). This recommendation, which GAO had
originally made in 2004, was intended to help us leverage outside
resources and provide greater assurance about the quality of the
laboratories importers use for seafood products subject to DWPE. See
GAO, ``Food Safety: FDA's Imported Seafood Safety Program Shows Some
Progress, but Further Improvements are Needed,'' GAO-04-246 (Ref. 7),
at page 6.
On January 16, 2009, under the Action Plan for Import Safety, we
issued a draft guidance document entitled ``Guidance for Industry:
Submission of Laboratory Packages by Accredited Laboratories'' (the
2009 draft guidance) (Ref. 8), in which we recommended a voluntary
accreditation program for laboratories conducting testing to support
the admissibility of articles offered for import of all product types
that FDA regulates. (See 74 FR 3056, January 16, 2009).
We acknowledged in the 2009 draft guidance that the landscape of
laboratory accreditation had changed since we published the 2004
proposed rule, including a general trend toward laboratory
accreditation and wider industry adoption of the ISO/IEC 17025
standard, as well as accreditation of FDA's own laboratories to the
ISO/IEC 17025 standard. The 2009 draft guidance also noted that
rigorous
[[Page 59457]]
accreditation standards provide FDA and industry with greater
confidence that laboratories receiving accreditation have sufficient
technical capability, trained personnel, and quality management systems
to perform the specific testing methods for which they are accredited.
We further noted in the 2009 draft guidance that laboratory
accreditation bodies' continuing oversight over accredited laboratories
would enhance the Agency's confidence in the accredited laboratories'
analyses and results. To encourage laboratories to voluntarily seek
accreditation, the 2009 draft guidance recommended that laboratories
that became accredited would be permitted to submit ``abbreviated''
laboratory packages to FDA in lieu of full PLAPs. Under the 2009 draft
guidance, abbreviated laboratory packages consisted of documents
identifying the entry from the importer of record, a summary of
analysis, and affirmation from the laboratory director regarding the
accuracy of the sampling and analysis. Full PLAPs, in turn, include the
details of the analyses performed, including underlying raw data and
supporting materials such as sample collection reports, validation and
verification studies, analyst training records, etc.
The 2009 draft guidance further recommended that accreditation
bodies that accredit laboratories conducting import admissibility
testing on FDA-regulated products should operate in accordance with
ISO/IEC 17011:2004 ``General Requirements for Accreditation Bodies
Accrediting Conformity Assessment Bodies'', as this would help ensure
the competency of the accreditation bodies. The 2009 draft guidance
additionally recommended that accreditation bodies should be
signatories to the International Laboratory Accreditation Cooperation
(ILAC) Mutual Recognition Arrangement (MRA), by which they would agree
to maintain conformity with the current version of ISO/IEC 17011 and
ensure that all laboratories they accredit comply with appropriate
laboratory standards. The 2009 draft guidance also recommended that
accreditation bodies accredit laboratories for specific testing
methodologies used to generate test results submitted to FDA, and that
they do so by assessing laboratories' conformance to ISO/IEC
17025:2005.\3\ The 2009 draft guidance noted ``widespread agreement,''
including by our own laboratories, that ISO/IEC 17025 was the most
internationally recognized and accepted standard for testing
laboratories.
---------------------------------------------------------------------------
\3\ FDA also recommended that laboratories incorporate in their
implementation of ISO/IEC 17025 the factors established in the AOAC
International's ``Guidelines for Laboratories Performing
Microbiological and Chemical Analyses of Food, Dietary Supplements,
and Pharmaceuticals, and Aid to Interpretation of ISO/IEC
17025:2005'' (Ref. 9).
---------------------------------------------------------------------------
On the issue of sampling, the 2009 draft guidance recommended that
accreditation bodies review laboratories' sampling procedures to ensure
the integrity, accuracy, and representative quality of samples,
including samples collected by laboratories themselves and samples
collected by sampling services under contract to the laboratory. The
2009 draft guidance further recommended that importers provide us with
advance notice that they intend to use a particular accredited
laboratory and that an abridged laboratory package would be submitted
under the guidance, and that accredited laboratories conducting the
analysis directly submit to us the results of all testing on the
articles at issue.
Almost all comments we received in response to the 2009 draft
guidance supported our recommendation for laboratory accreditation. The
2009 draft guidance was never finalized and was withdrawn in May 2015
(see 80 FR 26059, May 6, 2015). However, we considered both the 2004
proposed rule and the 2009 draft guidance and the comments we received
in response to both documents, in developing this proposal.
E. Current Industry Practices Relating to Accreditation Bodies,
Accreditation of Laboratories, and Food Testing
FDA has not had a policy of weighing food testing results
differently depending on whether the laboratory that conducted the food
testing is accredited, and therefore we generally do not track the
accreditation status of private laboratories that conduct food testing
in either the domestic or import arenas. However, we are able to make
some reasonable inferences and conclusions regarding the laboratories
that have conducted testing related to imports, with the data we do
have.
With regards to the testing of imported foods, our analysis of the
data in our internal systems (Ref. 1) indicates that just over one
hundred different private laboratories submitted (although in some
cases the laboratory would submit the results and supporting
information to the importer, who would then submit them to us) analyses
and results to us between January 1, 2016, and December 31, 2017, of
food offered for import that we had detained. Ten of those laboratories
submitted approximately 84 percent of the analyses. By examining
publicly available records from accreditation bodies regarding the
accreditation status of those laboratories, we concluded that all 10 of
those laboratories are accredited to ISO/IEC 17025. This indicates that
the large majority of import-related food testing results that we
receive come from laboratories that are accredited to ISO/IEC 17025. We
found no laboratories conducting analyses in support of food offered
for import that we had detained that were accredited to any standard
other than ISO/IEC 17025. We also found that all of the accredited
laboratories that submitted import-related food testing results were
accredited by accreditation bodies that are full members of ILAC and
signatories to the ILAC MRA, which requires signatories to have been
peer evaluated in accordance with ISO/IEC 17011 to demonstrate
competence. ILAC MRA signatories must maintain conformance with ISO/IEC
17011 (see, e.g., IAF/ILAC ``Multi-Lateral Mutual Recognition
Arrangements (Arrangements): Requirements and Procedures for Evaluation
of a Single Accreditation Body'' (Ref. 10, p. 8)).
F. U.S. Government Policies on Consensus Standards
Implementation of section 422 of the FD&C Act occurs against the
backdrop of broader U.S. federal policies on consensus standards under
the National Technology Transfer and Advancement Act of 1995 (NTTAA)
(Pub. L. 104-113).
The NTTAA, together with the Office of Management and Budget (OMB)
Circular A-119, ``Federal Participation in the Development and Use of
Voluntary Consensus Standards and in Conformity Assessment Activities''
(most recently revised on January 27, 2016) (Ref. 11), directs federal
agencies to use voluntary consensus standards in their procurement and
regulatory activities in lieu of government-unique standards, except
where inconsistent with law or otherwise impractical. OMB Circular A-
119 states that the use of voluntary consensus standards, whenever
practicable and appropriate, is intended to: (1) Eliminate the cost to
government of developing its own standards and decrease the cost of
goods procured and the burden of complying with Agency regulation, (2)
provide incentives and opportunities to establish standards that serve
national needs, encouraging long-term growth for U.S. enterprises and
promoting efficiency, economic competition, and trade, and (3) further
the reliance upon private sector expertise to supply the
[[Page 59458]]
Federal government with cost-efficient goods and services.
Additionally, as directed by OMB in Circular A-119 (Ref. 11), the
National Institute of Standards and Technology issued policy guidance
on Federal conformity assessment activities \4\ (Federal conformity
assessment guidance), published in the Federal Register of August 10,
2000 (65 FR 48894), and codified at 15 CFR part 287. The guidance
recommends that, as appropriate, Federal Agencies use relevant guides
or standards for conformity assessment practices from domestic and
international standardizing bodies (e.g., the ISO, the IEC, and the
Codex Alimentarius Commission).\5\ The guidance also notes that each
agency retains the responsibility, and authority, to select the
conformity assessment activities and procedures (i.e., guides and
standards) that will best meet its legislative mandates and
programmatic objectives.
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\4\ The Federal conformity assessment guidance defines
conformity assessment activities, in part, as ``any activity
concerned with determining directly or indirectly that requirements
are fulfilled'' (see 15 CFR 287.2).
\5\ The Codex Alimentarius Commission, established by Food and
Agriculture Organization of the United Nations and the World Health
Organization (WHO) in 1963 develops harmonized international food
standards, guidelines, and codes of practice to protect the health
of the consumers and ensure fair trade practices in the food trade.
The Commission also promotes coordination of all food standards work
undertaken by international governmental and non-governmental
organizations.
---------------------------------------------------------------------------
Further, section 422(a)(6) of the FD&C Act requires us to ``consult
existing standards for guidance'' in the course of developing model
standards that a laboratory must meet to be accredited by a recognized
accreditation body for a specified sampling or analytical testing
methodology.
In developing this proposed rule, two relevant voluntary consensus
standards stood out as containing globally-recognized and widely-used
requirements relevant to the program for food testing by accredited
laboratories: ISO/IEC 17011:2017, ``Conformity Assessment--Requirements
for Accreditation Bodies Accrediting Conformity Assessment Bodies''
(ISO/IEC 17011:2017) (Ref. 12), for accreditation bodies that would be
recognized under the program, and ISO/IEC 17025:2017, ``General
Requirements for the Competence of Testing and Calibration
Laboratories'' (ISO/IEC 17025:2017) (Ref. 13), for laboratories that
would be accredited under the program.
Although we are proposing to require accreditation bodies to meet
ISO/IEC 17011:2017 entirely, we are proposing to not require accredited
laboratories to meet certain aspects of ISO/IEC 17025:2017 that would
be inconsistent with section 422 of the FD&C Act or would be
impractical for use in our program. We are also proposing to require
accredited laboratories to meet certain requirements in addition to
ISO/IEC 17025:2017. For further discussion on this issue, please see
sections VI.C and VI.D (regarding the proposed requirements under this
program for accreditation bodies) and sections VI.F and VI.G (regarding
the proposed requirements under this program for laboratories). For
information on accessing these consensus standards, please see section
III.G.
We invite public comment on whether the voluntary consensus
standards we cite are the appropriate standards upon which to base this
rulemaking.
G. Incorporation by Reference
We are proposing to incorporate the following consensus standards
by reference, with the approval of the Director of the Federal Register
in accordance with 5 U.S.C. 553(a) and 1 CFR part 51:
ISO/IEC 17011:2017, ``Conformity Assessment--Requirements
for Accreditation Bodies Accrediting Conformity Assessment Bodies,''
Second edition, November 2017 (Ref. 12), and
ISO/IEC 17025:2017, ``General Requirements for the
Competence of Testing and Calibration Laboratories,'' Third edition,
November 2017 (Ref. 13).
For an overview of ISO/IEC 17011:2017, please see section VI.C. of the
preamble. For an overview of ISO/IEC 17025:2017, please see section
VI.F of the preamble.
The consensus standards proposed to be incorporated by reference
are available to the public in four different ways: (1) Generally, the
most convenient way for interested parties to view these consensus
standards is via the special link created by the American National
Standards Institute (ANSI), which is a private non-profit organization
that supports the U.S. voluntary standards and conformity assessment
system. ISO/IEC 17011:2017 and ISO/IEC 17025:2017 are available to view
through the following link free of charge: https://www.surveymonkey.com/r/KFJMZ67. Please note that you must have certain
software on your computer (available free of charge through following
the process on this website) and complete a registration form (when
prompted by the process on this website) to view these consensus
standards via the website facilitated by ANSI. Alternatively,
interested parties may: (2) Examine these standards at Dockets
Management Staff at FDA at the locations listed in proposed Sec. Sec.
1.1113(b) and 1.1138(a)(2), (3) purchase copies of these standards from
ISO or from IEC, or (4) purchase copies of these standards from any
other source from which the user is assured that the copy to be
received is an accurate and current version of the standard.
IV. FSMA Public Meetings, Comments Related to Other FSMA Rulemakings,
and Stakeholder Input
Since the enactment of FSMA, we have reached out to stakeholders in
the food industry, the international community, standards
organizations, accreditation and certification bodies, consumer groups,
government agencies, and other interested parties to gain input and
perspective on how to best implement FSMA. Such interested parties have
also provided comments to us at their own initiative and requested
meetings with us at their own initiative to discuss our implementation
of FSMA. The input and perspectives we gained through these comments
and meetings helped shape this proposed rule.
Since the enactment of FSMA, we have also received several comments
from interested parties specifically regarding our implementation of
section 422 of the FD&C Act. We received many such comments in response
to our solicitation of comments regarding our implementation of other
aspects of FSMA, for example, with regards to the accreditation of
third-party auditors (see section 808 of the FD&C Act, added by FSMA
section 307), hazard analysis and risk-based preventative controls (see
section 418 of the FD&C Act, added by FSMA section 103), and standards
for produce safety (see section 805 of the FD&C Act, added by FSMA
section 105). The most common issue discussed in those comments related
to what scenarios should require food testing to be conducted by
accredited laboratories under section 422(b)(1) of the FD&C Act. Other
issues discussed in such comments include the circumstances under which
we should allow variance from the requirement to submit to FDA the
results of all tests conducted under this proposed program. There were
also a small number of comments regarding the implementation of section
422 of the FD&C Act submitted to the docket established to help FDA
identify existing ways of achieving meaningful burden reduction while
still allowing us to achieve our public health mission and fulfill our
statutory obligations. To the extent practicable, we tried to consider
all comments in drafting this
[[Page 59459]]
proposed rule. However, to ensure that we consider your comment in the
context of this rulemaking, you should resubmit in response to this
proposed rule any comment(s) you previously submitted regarding our
implementation of section 422 of the FD&C Act.
Since the enactment of FSMA, we have also met with several
stakeholders, some of who requested meetings with FDA to discuss their
current programs and to share their views and recommendations for our
implementation of section 422 of the FD&C Act, and others whom we
contacted in order to learn from their relevant experience and subject
matter expertise. Topics for our meetings with these stakeholders
included the general structure and function of the program, the
standards to which accreditation bodies, sampling services, and
laboratories should adhere in order to be recognized or accredited
under this proposed program, and how sampling services should be
addressed in the program. We discuss issues relevant to this rulemaking
that were covered during these meetings in Section VI, Description of
the Proposed Rule of this NPRM.
In this proposed rule we have intended to draft a practical,
flexible, and effective approach to the program for the testing of
foods by accredited laboratories. We seek comments on all aspects of
this proposal, including comments about any potential impacts of this
proposed rule.
V. Legal Authority
We are issuing this proposed rule under the FD&C Act and FSMA. As
noted, section 202(a) of FSMA, ``Laboratory Accreditation for Analyses
of Foods'', amends the FD&C Act to create a new provision, section 422,
under the same name. Section 422 of the FD&C Act directs us to
establish a program for the testing of food by accredited laboratories
and provides several requirements for the program.
Additionally, section 701(a) of the FD&C Act gives FDA the
authority to publish regulations for the efficient enforcement of the
FD&C Act. The requirements discussed in this proposed rule would allow
FDA to efficiently enforce section 422 of the FD&C Act. Thus, our legal
authority for this proposed rule is derived primarily from section 422
and section 701(a) of the FD&C Act. Further, we also note that this
rule is consistent with section 404 of FSMA (21 U.S.C. 2252), which
states that nothing in FSMA should be construed in a manner that is
inconsistent with the agreement establishing the World Trade
Organization (WTO) or any other treaty or international agreement to
which the United States is a party.
VI. Description of the Proposed Rule
In section 422 of the FD&C Act Congress directs us to establish a
program for the testing of food by accredited laboratories. We are
proposing to add new subpart R, ``Accreditation of Laboratories to
Conduct Food Testing,'' to part 1 (21 CFR part 1) (``General
Enforcement Regulations'') and amend our regulations in parts 11
(``Electronic Records; Electronic Signatures''), and 16 (``Regulatory
Hearing before the Food and Drug Administration'') (21 CFR parts 11 and
16) to establish and implement a program for food testing by accredited
laboratories, as required by section 422 of the FD&C Act. We are also
proposing to amend part 129 (21 CFR part 129) (``Processing and
Bottling of Bottled Drinking Water'') to ensure that the requirements
in part 129 are consistent with the requirements of section 422 of the
FD&C Act. We are also proposing to revise certain testing provisions in
part 1, Subpart M (``Accreditation of Third-Party Certification Bodies
to Conduct Food Safety Audits and to Issue Certifications''), in the
interest of consistency with this proposed rule and in response to
additional information we have gathered, in developing this proposed
rule, about the number and capacity of laboratories accredited under
ISO/IEC 17025 to conduct food testing.
We also note that in November 2017, ISO/IEC released new versions
of ISO/IEC 17011 and ISO/IEC 17025. ISO/IEC 17011 and ISO/IEC 17025
were last revised in 2004 and 2005, respectively. The new versions of
ISO/IEC 17011 and 17025--ISO/IEC 17011:2017 and 17025:2017--do not
represent fundamental changes to the previous versions of ISO/IEC 17011
and ISO/IEC 17025. Rather, the new versions of ISO/IEC 17011 and ISO/
IEC 17025 have been technically revised to more accurately reflect
current best practices of accreditation bodies and of testing and
calibration laboratories.
A. Proposed General Provisions (Proposed Sec. Sec. 1.1102 Through
1.1103)
1. What definitions apply to this subpart? (Proposed Sec. 1.1102)
We propose to define several terms used in this rule (see proposed
Sec. 1.1102). Where possible, we propose to rely on existing statutory
and regulatory definitions. Proposed Sec. 1.1102 states that
definitions and interpretations contained in section 201 of the FD&C
Act (21 U.S.C. 321) will apply to this rule, except as those terms are
otherwise defined in this section. We also note here that grammatical
variations of the terms defined in proposed Sec. 1.1102 have the same
meaning as the defined term, modified as grammatically appropriate. For
example, the term to ``accredit,'' although not specifically defined by
proposed section Sec. 1.1102, would mean to bestow accreditation, in
accordance with how the term ``accreditation'' would be defined by this
rule.
Where necessary to provide clarity to this rule, we have developed
some additional definitions that align with existing law and
regulations, as well as with current practices of the international
community, accreditation bodies, food testing laboratories, and the
food industry. We seek comments on these proposed definitions,
including with respect to whether any of the proposed definitions are
unnecessary and with respect to whether any additional terms we use in
this proposed rule should be defined.
We propose to define ``accreditation'' to mean a determination by a
recognized accreditation body that a laboratory meets the applicable
requirements of this program to conduct food testing under this program
using one or more methods of analysis. In developing the definition of
accreditation, we considered the use of the term accreditation in
section 422 of the FD&C Act. Specifically, section 422(a)(6) of the
FD&C Act directs us to develop model standards that a laboratory shall
meet to be accredited by a recognized accreditation body for a
specified sampling or analytical testing methodology and section
422(b)(1) of the FD&C Act provides that food testing under this program
may only be conducted by laboratories that have been accredited for the
appropriate sampling or analytical testing methodology or methodologies
by a recognized accreditation body. These provisions indicate that
accreditation under section 422 of the FD&C Act requires a
determination by a recognized accreditation body that a laboratory
meets our model standards for a specified analytical testing
methodology. We also considered the meaning of accreditation in
international standards on accreditation, including ISO/IEC 17011:2017
(Ref. 12), which defines accreditation as an attestation ``conveying
formal demonstration'' of a conformity assessment body's competence to
carry out specific conformity assessment tasks. In the context of the
proposed
[[Page 59460]]
rule, recognized accreditation bodies would accredit laboratories that
they determine meet the applicable requirements of the rule.
The term accreditation as it is used in the proposed rule, refers
only to a recognized accreditation body's determination that a
laboratory meets the applicable requirements of this program and does
not refer to any accreditation outside of this program. For example,
although conformance to certain aspects of ISO/IEC 17025:2017 is a
prerequisite to becoming accredited by a recognized accreditation body
under this proposed rule, the term accreditation, as used in this
proposed rule, does not refer to accreditation to ISO/IEC 17025 or to
any other standard.
We propose to define ``accredited laboratory'' to mean a laboratory
that a recognized accreditation body has determined meets the
applicable requirements of this program and has been accredited to
conduct food testing using one or more methods of analysis under this
program.
We propose to define ``analyst'' to mean an individual who analyzes
samples. The term refers to a single individual and does not refer to
any other type of entity that is treated as a person for certain legal
purposes.
Proposed Sec. 1.1102 would define ``food,'' as having the meaning
given in section 201(f) of the FD&C Act, except that it would not
include pesticides as defined in 7 U.S.C. 136(u), consistent with the
definition of food used in the FSMA Foreign Supplier Verification
Programs for Importers of Food for Humans and Animals (FSVP) (part 1,
Subpart L) and Accreditation of Third-Party Certification Bodies To
Conduct Food Safety Audits and To Issue Certifications (accredited
third-party certification) (part 1, Subpart M) regulations. We have
tentatively determined there is no significant reason to define food
differently in this proposal. We have not identified a need for food
testing under this program to address pesticides as articles of food.
We propose to define ``food testing'' and ``testing of food'' to
mean the analysis of food product samples or environmental samples. The
terms food testing in sections 422(b)(1) and 422(d) of the FD&C Act,
and testing of food in section 422(a)(1)(A) of the FD&C Act, are not
defined in the statute. We see two possible ways to interpret and apply
these terms. As noted, the FD&C Act has a definition of food at section
201(f), and it therefore may be a reasonable assumption that food
testing means only the testing of food as food is defined under section
201(f). Under this approach, food testing would mean only product
testing (where product testing includes testing of any food product,
including raw materials or other ingredients, in-process foods, or
finished products).
The alternative interpretation, which we propose, would interpret
food testing to include product testing as well as environmental
testing (e.g., testing from the growing, harvesting, manufacturing,
processing, packing, or holding environment). We have tentatively
concluded that the meaning of food testing, a term that appears only in
section 422 of the FD&C Act, is ambiguous and may be interpreted to
encompass both product testing and testing that is related to food,
that is, environmental testing. Food testing is distinct from ``product
testing,'' used in section 418(f)(4) of the FD&C Act, and
``environmental testing programs'' and ``environmental monitoring
programs,'' which are used in sections 418(f)(4) and 418(o)(3)(C) of
the FD&C Act, respectively. We note that section 202(a) of FSMA is
located in title II of FSMA, which is entitled improving capacity to
detect and respond to food safety problems, and section 422(b)(1)(A) of
the FD&C Act requires accredited laboratory performance of food testing
to address an identified or suspected food safety problem. Given the
role of environmental testing in determining both the source of
contamination and in determining whether such contamination has been
eliminated, interpreting food testing to exclude environmental testing
would not cover an important method to detect and respond to identified
and suspected food safety problems. Additionally, if food testing does
not include environmental testing, our laboratory accreditation program
would be unable to accredit laboratories to perform environmental
testing or to issue model laboratory standards for environmental
testing even though the food testing industry performs both food
product tests and environmental tests. We invite comment on this
interpretation.
We propose to define ``food testing order'' to mean an order issued
by FDA under Sec. 1.1108 of this subpart requiring food testing to be
conducted under this program by or on behalf of an owner or consignee.
We are proposing specific requirements related to food testing orders
in Sec. Sec. 1.1107, 1.1108, and 1.1174 of this proposed rule.
We propose to define ``owner or consignee'' as any person with an
ownership or consignment interest in: The food product or environment
that is the subject of food testing conducted under Sec. 1.1107(a)(1);
the food product or environment that is the subject of the order issued
under Sec. 1.1107(a)(2); the food product or environment that is the
subject of food testing conducted under Sec. 1.1107(a)(3); the article
of food for which food testing is being conducted under Sec.
1.1107(a)(4); or the food subject to an import alert for which food
testing is conducted under Sec. 1.1107(a)(5). Anyone meeting this
definition of owner or consignee would be required to use an accredited
laboratory to conduct food testing as specified in this proposed rule.
We propose to define ``recognition'' to mean a determination by FDA
that an accreditation body meets the applicable requirements of the
program and is authorized to accredit laboratories under the program.
This definition aligns with the use of the term recognition and
``recognized'' in section 422 of the FD&C Act, which uses these terms
to describe the status we will accord to an accreditation body that we
have determined meets certain requirements and may therefore accredit
laboratories to conduct food testing under this program.
We propose to define ``recognized accreditation body'' to mean an
accreditation body that FDA has determined meets the applicable
requirements of the program and is authorized to accredit laboratories
under the program. As previously discussed, this definition aligns with
the use of the term recognition and recognized in section 422 of the
FD&C Act, which uses these terms to describe the status we will accord
to an accreditation body that we have determined meets certain
requirements and may therefore accredit laboratories to conduct food
testing under this program. This proposed definition of recognized
accreditation body follows from our proposed definitions of recognition
and accreditation body.
We propose to define ``representative sample'' to mean ``a sample
that accurately, to a scientifically acceptable degree, represents the
characteristics and qualities of the food product or environment the
sample was collected from.'' If food testing is required to be
conducted on a specific food product or environment under this rule,
and the sample that is collected from that food or environment is not
representative of the food or environment at issue, then analysis of
the sample would not produce information that is meaningful. We propose
to use the qualifier ``to a scientifically acceptable degree'' because
we acknowledge there are practical limits to how accurately a sample
can represent the characteristics and qualities of the food product or
environment from which it was
[[Page 59461]]
collected. Furthermore, what constitutes a representative sample in the
context of a certain food product or environment may be a scientific
determination that depends on the environment, food matrix, and analyte
at issue, among other potential factors. FDA's Investigations
Operations Manual, Chapter 4--Sampling, includes some considerations
which may inform the identification and collection of a representative
sample (https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/investigations-operations-manual).
Depending on the food testing to be conducted, it may be
appropriate to analyze a single sample that is representative of the
food product or environment from which it was collected, to analyze a
composite of multiple samples collected from the food product or
environment from which it was collected, and/or to analyze a
representative sample, taken in the laboratory, of the original
representative sample.
We propose to define ``sampler'' as an individual or individuals
who perform sampling. The term sampler would refer to single
individuals and would not refer to any other type of entity that is
treated as a person for certain legal purposes.
We propose to define ``scope of accreditation'' as referring to the
methods of analysis for which the accredited laboratory is accredited.
We also propose to clarify that references in this rule to
accreditation ``in-whole'' refers to all methods in the accredited
laboratory's scope of accreditation and accreditation ``in-part''
refers to only certain methods in the accredited laboratory's scope of
accreditation. We note that section 7.8 of ISO/IEC 17011:2017 (Ref. 12)
requires accreditation bodies to provide information to the
laboratories they accredit that identifies their scope of
accreditation.
2. Who is subject to this subpart? (Proposed Sec. 1.1103)
The proposed rule would apply to recognized accreditation bodies,
entities seeking to become recognized accreditation bodies, accredited
laboratories, entities seeking to become accredited laboratories, and
owners and consignees who are required to use accredited laboratories
for the food testing under this program. Although participation by
accreditation bodies and laboratories in this program is voluntary,
only accreditation bodies recognized by us under this program would be
able to accredit laboratories to conduct food testing under this
program, and only laboratories accredited by an accreditation body
recognized by us under this program would be able to conduct food
testing under this program. However, if finalized, it will not be
voluntary for owners and consignees to conduct food testing conducted
as described in proposed Sec. 1.1107(a).
B. Proposed Provisions About General Requirements of This Rule
(Proposed Sec. Sec. 1.1107 Through 1.1109)
We have proposed various provisions outlining the general
requirements of the food testing program, including when food testing
would have to be conducted under this rule, when and how we would issue
food testing orders, and how we would make information about recognized
accreditation bodies and accredited laboratories available to the
public.
1. Under what circumstances must food testing be conducted under this
subpart by an accredited laboratory? (Proposed Sec. 1.1107)
Proposed Sec. 1.1107 would require that food testing must be
conducted under this rule whenever food testing is conducted by or on
behalf of an owner or consignee in any of the following five
circumstances: (1) In response to explicit testing requirements (in the
FD&C Act or implementing regulations) that address an identified or
suspected food safety problem (we elaborate on these explicit
corrective action testing requirements below, but, in short, they are
located at 21 CFR 112.146(a), (c) and (d), 118.4(a)(2)(iii),
118.5(a)(2)(ii), 118.5(b)(2)(ii), 118.6(a)(2), 118.6(e), and
129.35(a)(3)(i) (regarding the requirement to test five samples from
the same sampling site that originally tested positive for E. coli));
(2) as required by FDA in a food testing order (issued under Sec.
1.1108 of this rule); (3) to address an identified or suspected food
safety problem and presented to FDA as part of evidence for a hearing
under section 423(c) of the FD&C Act (21 U.S.C. 350l) prior to the
issuance of a mandatory food recall order, as part of a corrective
action plan under section 415(b)(3)(A) of the FD&C Act (21 U.S.C. 350d)
submitted after an order suspending the registration of a food
facility, or as part evidence submitted for an appeal of an
administrative detention order under section 304 (h)(4)(A) of the FD&C
Act (21 U.S.C. 334(h)(4)(A)); (4) in support of admission of an article
of food under section 801(a) of the FD&C Act; and (5) to support
removal from an import alert through successful consecutive testing.
a. Ownership of laboratories that may conduct food testing.
We note that section 422(b)(1)(A) of the FD&C Act provides that
food testing must be conducted under this proposed program whenever
food testing is conducted ``by or on behalf'' of an owner or consignee,
while section 422(b)(1)(B) of the FD&C Act provides that food testing
must be conducted under this rule whenever such testing is conducted on
behalf of an owner or consignee in support of admission of an imported
article of food and to support removal from an import alert through
successful consecutive testing. We tentatively conclude that the ``by
or on behalf'' language of section 422(b)(1)(A) of the FD&C Act means
that both laboratories owned by owners or consignees and independent,
or third-party laboratories, that conduct food testing ``on behalf of''
owners and consignees, must be accredited under this proposed program
in order to conduct food testing under section 422(b)(1)(A) of the FD&C
Act. Similarly, the ``on behalf of'' language of section 422(b)(1)(B)
of the FD&C Act requires independent laboratories to be accredited
under this proposed program in order to conduct food testing ``on
behalf'' of owners and consignees under section 422(b)(1)(B) of the
FD&C Act.
Section 422(b)(1)(B) of the FD&C Act is silent with respect to
testing conducted on imports by owners or consignees. Under one
possible interpretation, the absence of ``by or'' in this provision
would mean that only independent laboratories may be accredited to
conduct food testing of imports under section 422(b)(1)(B) of the FD&C
Act. Under this interpretation, laboratories owned by owners or
consignees would be prohibited from conducting such import-related food
testing. Otherwise, such ``in-house'' laboratories would be able to
conduct import-related food testing without being accredited through
our proposed program, which seems to be contrary to the intent of this
program.
Under this interpretation, laboratories owned by owners or
consignees would be eligible to conduct food testing under section
422(b)(1)(A) of the FD&C Act but not section 422(b)(1)(B), thereby
raising the prospect that section 422(b)(1) would not apply equally to
domestic and foreign goods (section 422(b)(1)(A) of the FD&C Act would
generally apply to domestic owners or consignees and potentially
foreign owners or consignees). Such a difference in treatment could
raise potential concerns under U.S. international trade obligations. In
this regard, we note that section 404 of FSMA provides that
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nothing in the FD&C Act shall be construed in a manner inconsistent
with the agreement establishing the WTO or any other treaty or
international agreement to which the United States is a party.
In considering section 422(b)(1)(B) of the FD&C Act and section 404
of FSMA together, and to avoid any inconsistency with treaties or
international agreements to which the United States is a party, we
tentatively conclude that it is reasonable to interpret section
422(b)(1)(B) of the FD&C Act to allow laboratories owned by owners or
consignees to conduct food testing that falls under section
422(b)(1)(B) of the FD&C Act, provided that such laboratories meet the
accreditation requirements proposed. In addition, we are not aware of
information indicating that laboratories owned by owners or consignees
of foreign foods are less able to become accredited under this proposed
program or to conduct food testing under section 422(b)(1)(B) of the
FD&C Act than independent laboratories.
b. Considerations in interpreting ``identified or suspected food
safety problem'' in section 422(b)(1)(A) of the FD&C Act.
Section 422(b)(1)(A)(i) and (ii) of the FD&C Act both require, in
relevant part, that food testing must be conducted by a laboratory
accredited under the food testing program that would be established by
this proposed rule, if finalized, when applied to address an identified
or suspected food safety problem. Because the circumstances that may
constitute a food safety problem are highly fact dependent, we are not
proposing an exhaustive list of circumstances that would constitute an
``identified or suspected food safety problem.'' Instead, in proposed
Sec. 1.1107(a)(1), we are proposing to codify the circumstances in
existing FD&C Act regulations that address an identified or suspected
food safety problem and thus trigger the requirement to use an
accredited laboratory under this program. We also discuss as part of
this rulemaking additional examples of identified or suspected food
safety problems to explain the circumstances in which we tentatively
conclude would allow for the issuance of food testing orders under
proposed Sec. 1.1107(a)(2). In proposed Sec. 1.1107(a)(3) we are
proposing to require the use of an accredited laboratory in additional
circumstances where FDA determines it is appropriate to address an
identified or suspected food safety problem.
The statute does not define the terms ``identified or suspected
food safety problem'' or ``food safety problem'' and the term ``food
safety problem'' is not used elsewhere in the FD&C Act. However, the
section titles of FSMA indicate that ``food safety problems'' are the
problems that FSMA is intended to address: Title I of FSMA is entitled
``Improving Capacity to Prevent Food Safety Problems,'' while Title II
is entitled ``Improving Capacity to Detect and Respond to Food Safety
Problems.'' In the preamble to the preventive controls for human food
proposed rule, we noted that food safety problems may be associated
with biological, chemical, physical, or radiological hazards (78 FR
3646 at 3667). (We subsequently categorized radiological hazards as a
subset of chemical hazards, see 80 FR 55908 at 55950, September 17,
2015).
In considering the circumstances that could constitute an
identified or suspected food safety problem, we note that Congress did
not require the presence of specific health risks, as in the reasonable
probability of serious adverse health consequences or death to humans
or animals standard, as a prerequisite to requiring the use of an
accredited laboratory under section 422(b)(1)(A) of the FD&C Act. In
the preventive controls for human food rule, we indicated that an
``unanticipated food safety problem'' could occur where a preventive
control is not properly implemented, including circumstances where a
pathogen or appropriate indicator organism is present in a ready-to-eat
product detected through product testing, or an environmental pathogen
or appropriate indicator organism is detected through environmental
monitoring, or where a preventive control is found to be ineffective.
See 21 CFR 117.150(b)(1)(i) and (ii) and 117.150(a)(1)(i) and (ii).
Depending on the circumstances, we tentatively conclude that a positive
indicator organism test would not necessarily constitute even a
``suspected'' food safety problem. For example, because Listeria spp.
will occasionally be found in a food production environment, our
current thinking is that, depending on certain factors, a single
positive Listeria spp. on a food-contact surface in a facility would
not necessarily constitute a suspected food safety problem. We
tentatively conclude that an ``identified food safety problem'' could
be present when a specific article of food violates a provision of the
FD&C Act that relates to food safety, such as certain violations of
section 402 of the FD&C Act (21 U.S.C. 342).
Section 422(b)(1)(A) of the FD&C Act does not limit the factors
that can generate suspicion of a food safety problem, and we believe a
variety of circumstances could generate such suspicion depending on the
circumstances, including the presence of Listeria monocytogenes on a
food-contact surface; the presence of multiple positives for Listeria
spp. on a food-contact surface; and potential contamination events. We
are proposing that the element of suspicion in a ``suspected food
safety problem'' typically be particularized, that is, have a basis in
fact about a particular article or articles of food (e.g., a lot or
batch) or food production environment (e.g., a specific facility), as
opposed to being satisfied by the common or usual characteristics of a
food (e.g., whether a food is considered ``high-risk'' because of its
inherent characteristics, such as pH or water activity) or the manner
in which such food is typically produced. Under this proposal,
suspicion that a specific article of food violates a provision of the
FD&C Act or implementing regulations related to food safety would
constitute a suspected food safety problem.
For these reasons, we tentatively conclude that the routine product
testing and environmental monitoring requirements at Sec.
117.165(a)(2) and (3), respectively, are not conducted to address a
suspected (or identified) food safety problem, because this testing is
conducted to verify the implementation and effectiveness of preventive
controls and not because a food safety problem is suspected or
identified. See 80 FR 55908 at 56062.
Although we are not proposing an exhaustive list of identified or
suspected food safety problems, in proposed Sec. 1.1107(a)(1), (a)(2),
or (a)(3), we are proposing to codify testing requirements in Sec.
1.1107(a)(1) and (a)(3) that address an identified or suspected food
safety problem, which provides examples of circumstances that would
constitute an identified or suspected food safety problem.
c. Proposed Sec. 1.1107(a)(1) and section 422(b)(1)(A)(i) of the
FD&C Act.
Because section 422(b)(1)(A)(i) of the FD&C Act applies to
``specific'' testing requirements, we propose to interpret section
422(b)(1)(A)(i) to apply only to provisions of the FD&C Act or its
implementing regulations that explicitly require food testing.
We have identified nine explicit testing requirements in our
regulations that we tentatively conclude address an identified or
suspected food safety problem. Each of these explicit testing
requirements is required as followup, or corrective action, testing
after a routine test is positive for a pathogen or indicator organism.
Five of these testing requirements are in our regulations on
production, storage, and transportation
[[Page 59463]]
of shell eggs (specifically, the testing requirements of Sec. Sec.
118.4(a)(2)(iii), 118.5(a)(2)(ii), 118.5(b)(2)(ii), 118.6(a)(2), and
118.6(e)), three are in our standards for the growing, harvesting,
packing, and holding of sprouts (specifically, the testing requirements
of Sec. 112.146(a), (c), and (d)), and one is in our regulations on
the processing and bottling of bottled drinking water (specifically,
one of the testing requirements of Sec. 129.35(a)(3)(i)). More
specifically, testing would have to be conducted under this program
under proposed Sec. 1.1107(a)(1), if finalized, under the following
circumstances:
With respect to production, storage, transportation of shell eggs:
Section 118.4(a)(2)(iii) requires that if the
environmental test required in paragraph (a)(2)(i) of Sec. 118.4 is
positive, you must begin egg testing, as specified in Sec. 118.6,
within 2 weeks of the start of egg laying.
Section 118.5(a)(2)(ii) requires that if the environmental
test at 40 to 45 weeks is positive, then you must begin egg testing
(described in Sec. 118.6), unless you divert eggs to treatment as
defined in Sec. 118.3 for the life of the flock in that poultry house.
Results of egg testing must be obtained within 10 calendar days of
receiving notification of the positive environmental test.
Section 118.5(b)(2)(ii) requires that if the environmental
test at 4 to 6 weeks after the end of a molting process is positive,
then you must begin egg testing (described in Sec. 118.6), unless you
divert eggs to treatment as defined in Sec. 118.3 for the life of the
flock in that poultry house. Results of egg testing, when conducted,
must be available within 10 calendar days of receiving notification of
the positive environmental test.
Section 118.6(a)(2) requires that if you have an SE-
positive environmental test at any time during the life of a flock, you
must divert eggs to treatment (defined in Sec. 118.3) for the life of
the flock in that positive poultry house or conduct egg testing as
specified in paragraphs (b) through (e) of this section.
Section 118.6(e) requires that if you have a positive egg
test in a flock and divert eggs from that flock and later meet the
negative test result requirements described in paragraph (c) of this
section and return to table egg production, you must conduct one egg
test per month on that flock, using sampling and methodology in
Sec. Sec. 118.7 and 118.8, for the life of the flock.
With respect to our standards for the growing, harvesting, packing,
and holding of sprouts:
Section 112.146 requires that, if you detect Listeria
species or L. monocytogenes in the growing, harvesting, packing, or
holding environment you must conduct additional testing of surfaces and
areas surrounding the areas where Listeria species or L. monocytogenes
was detected to evaluate the extent of the problem, including the
potential for Listeria species or L. monocytogenes to have become
established in a niche; conduct additional sampling and testing to
determine whether the Listeria species or L. monocytogenes has been
eliminated; and conduct finished product testing when appropriate.
With respect to the processing and bottling of bottled drinking
water:
Section 129.35(a)(3)(i) requires that a source previously
found to contain E. coli will be considered negative for E. coli after
five samples collected over a 24-hour period from the same sampling
site that originally tested positive for E. coli are tested and found
to be E. coli negative.
Many explicit testing requirements in our regulations are not
subject to section 422(b)(1)(A)(i) of the FD&C Act because they require
routine or verification testing, as opposed to testing to address an
identified or suspect food safety problem. For example, none of the
various testing requirements in our infant formula regulations at 21
CFR part 106 would require the use of an accredited laboratory under
this program because they are routine testing requirements for each
production aggregate of infant formula manufactured.
Section 422(b)(1)(A)(ii) of the FD&C Act requires, in pertinent
part, that food testing must be conducted under this proposed rule
whenever food testing is conducted by or on behalf of an owner or
consignee as required by the Secretary of HHS, as the Secretary deems
appropriate, to address an identified or suspected food safety problem.
As such, we are interpreting section 422(b)(1)(A)(ii) of the FD&C Act
to give FDA the authority to specify additional circumstances where
food testing will be required to be conducted under this program,
provided that the food testing is conducted to address an identified or
suspected food safety problem. Unlike our authority under section
422(b)(1)(A)(i) of the FD&C Act, which gives us the authority to
require food testing to be conducted under this program in response to
``specific testing requirements,'' we are interpreting section
422(b)(1)(A)(ii) to give us authority to require testing to be
conducted under this program in the absence of an existing explicit
requirement to conduct testing under the FD&C Act or its implementing
regulations. Therefore, we are proposing in Sec. 1.1107(a)(2) to
require that food testing be conducted under this rule whenever food
testing is conducted by or on behalf of an owner or consignee as
required by FDA in a food testing order. We explain food testing orders
in more detail in section VI.B.2 where we discuss proposed Sec. 1.1108
(which addresses the question of when and how FDA will issue a food
testing order).
Proposed Sec. 1.1107(a)(3) would require that food testing be
conducted under this program when food testing is conducted to address
an identified or suspected food safety problem and presented to FDA as
part of evidence for an informal hearing before a mandatory recall
order under section 423(c) of the FD&C Act, as part of a corrective
action plan under section 415(b)(3)(A) of the FD&C Act submitted after
an order suspending the registration of a food facility, or as part of
evidence submitted for an appeal of an administrative detention order
under section 304(h)(4)(A) of the FD&C Act. Although these three
enforcement authorities do not require food testing, if owners and
consignees elect to conduct food testing in response to proceedings
under these authorities, and such food testing addresses an identified
or suspected food safety problem, this proposal would require such food
testing to be conducted by a laboratory accredited under this proposed
program.
This proposed requirement is authorized under section
422(b)(1)(A)(ii) of the FD&C Act, which states that testing must be
conducted under the accredited laboratory program whenever such testing
is conducted as required by the Secretary of HHS, as the Secretary
deems appropriate, to address an identified or suspected food safety
problem. As explained previously in the discussion of food testing
orders under proposed section Sec. 1.1107(a)(2), we are interpreting
section 422(b)(1)(A)(ii) of the FD&C Act to give FDA the authority to
specify additional circumstances where food testing will be required to
be conducted under this program in the absence of an explicit
requirement to conduct food testing under the FD&C Act or its
implementing regulations, provided that the food testing is conducted
to address an identified or suspected food safety problem. As such, we
are proposing in Sec. 1.1107(a)(3) to require owners or consignees to
conduct food testing under this program whenever they elect to conduct
food testing under the circumstances specified in Sec. 1.1107(a)(3).
We tentatively conclude that it is
[[Page 59464]]
appropriate to require food testing related to these important public
health enforcement authorities to be conducted under this program
because all three of those circumstances could involve situations where
food testing might be conducted to address an identified or suspected
food safety problem.
Specifically, FDA's mandatory food recall authority gives us the
authority to order a responsible party to recall an article of food
where we determine that there is a reasonable probability that the
article of food (other than infant formula) is adulterated under
section 402 of the FD&C Act or misbranded under section 403(w) of the
FD&C Act (21 U.S.C. 343(w)) and there is a reasonable probability that
the use of or exposure to such article will cause serious adverse
health consequences or death to humans or animals. Before such an order
is issued, FDA must provide the responsible party with an opportunity
to request an informal hearing. Under the provision proposed here, if
the results of food testing intended to address an identified or
suspected food safety problem are submitted as evidence for the
hearing, such tests must be conducted by a laboratory accredited under
this program.
Section 415(b)(1) of the FD&C Act provides that if the Secretary of
HHS determines that food manufactured, processed, packed, received, or
held by a facility registered under section 415 of the FD&C Act has a
reasonable probability of causing serious adverse health consequences
or death to humans or animals, the Secretary may by order suspend the
registration of a facility that: (1) Created, caused, or was otherwise
responsible for such reasonable probability or (2) packed, received, or
held such food. Section 415(b)(3)(A) of the FD&C Act provides that if,
after providing opportunity for an informal hearing, the Secretary of
HHS determines that the suspension of registration remains necessary,
the Secretary shall require the registrant to submit a corrective
action plan to demonstrate how the registrant plans to correct the
conditions found by the Secretary. We are proposing in Sec.
1.1107(a)(3), that if any such corrective action plan includes food
testing to address an identified or suspected food safety problem, such
food testing must be conducted by a laboratory accredited under this
program.
Under section 304(h) of the FD&C Act, FDA can order administrative
detention of food if there is reason to believe that an article of food
is adulterated or misbranded. If FDA issues an order to
administratively detain food, FDA will provide an opportunity to appeal
the detention as specified under section 304(h)(4)(A) of the FD&C Act.
We are proposing that if the results of testing intended to address an
identified or suspected food safety problem are submitted to appeal the
detention, such tests must be conducted by a laboratory accredited
under this program. See proposed Sec. 1.1107(a)(3).
Use of a laboratory accredited under this program in the context of
these three enforcement authorities will increase our confidence in the
food testing conducted in response to identified or suspected food
safety problems of great significance to public health. By requiring
that food testing be conducted in a manner in which we have added
confidence, we will be in a better position to make appropriate
decisions that protect public health.
Section 422(b)(1)(B)(i) of the FD&C Act requires, in pertinent
part, that food testing must be conducted under the food testing
program that would be established by this proposed rule, if finalized,
whenever food testing is conducted on behalf of an owner or consignee
in support of admission of an article of food under section 801(a) of
the FD&C Act (i.e., food that is imported or offered for import into
the United States). We are proposing this requirement in Sec.
1.1107(a)(4) of this proposed rule.
As explained in section III.C., under section 801(a)(3) of the FD&C
Act, we may refuse admission of an article of food imported or offered
for import into the United States if the food is, or appears to be,
adulterated or misbranded. Pending our decision to refuse admission,
section 801(a) of the FD&C Act allows the owner or consignee of the
imported article of food to introduce testimonial evidence regarding
the admissibility of the food. Under Sec. 1.94(a), such testimony must
be confined to matters relevant to the admissibility or destruction of
the article of food and may be introduced orally or in writing.
Owners and consignees often hire private laboratories to test the
food and submit to us the results of the testing, along with associated
analysis and data, as testimony to establish that the imported food
complies with the FD&C Act. Currently, if we determine that the
sampling methods and testing results are valid and that they
demonstrate the detained food product does not appear to violate the
FD&C Act, we will release the food from detention and allow it to
proceed into the United States. Again, if this rule is finalized, an
owner or consignee whose entry has been detained under 801(a) of the
FD&C Act would need to use a lab accredited under this program in order
to use the test results as testimonial evidence supporting admission.
We note that to the extent that a question exists as to whether
section 422(b)(1)(B)(i) of the FD&C Act applies to food testing to
demonstrate compliance with section 805 of the FD&C Act for purposes of
supporting admission of an article of food under section 801(a)(3) of
the FD&C Act, we tentatively conclude that it does not apply. FSMA
amended the FD&C Act to add section 805 to require persons who import
food into the United States to perform risk-based foreign supplier
verification activities for the purpose of verifying that imported food
meets applicable U.S. safety requirements (the FSVP regulation,
codified in Sec. Sec. 1.500 through 1.514, specifies the foods and
importers to which the FSVP regulation applies and establishes
requirements related to supplier verification). An article of food is
subject to refusal of admission under section 801(a)(3) of the FD&C Act
if it appears that the importer of the food ``is in violation of such
section 805,'' that is, fails to comply with the FSVP regulations with
respect to that food. See also Sec. 1.514(a). Significantly, this
provision in section 801(a)(3) of the FD&C Act relates to the
compliance status of the importer, and not the food. Consequently, the
relevant inquiry for purposes of this provision of section 801(a)(3) of
the FD&C Act is whether an importer has followed FSVP requirements. By
contrast, section 422(b)(1)(B)(i) of the FD&C Act relates directly to
the compliance status of articles of food.
Given the different focus of the FSVP provision in section
801(a)(3) of the FD&C Act from the focus of section 422(b)(1)(B)(i) of
the FD&C Act, we tentatively conclude that it is reasonable to not
apply section 422(b)(1)(B)(i) of the FD&C Act to food testing related
to FSVP. That is, we tentatively conclude that it is reasonable to not
require accredited laboratory to conduct food testing under this
program for purposes of the FSVP rule.
Section 422(b)(1)(B)(ii) of the FD&C Act requires that food testing
must be conducted under the food testing program that would be
established by this proposed rule, if finalized, whenever food testing
is conducted on behalf of an owner or consignee to support the removal
of food from an import alert through successful consecutive testing. We
are proposing this food testing requirement in Sec. 1.1107(a)(5) of
this proposed rule.
An import alert conveys evidence that FDA can use to detain,
without first
[[Page 59465]]
physically examining, incoming products that appear to violate the FD&C
Act. The alert communicates that the Agency has enough evidence or
other information to refuse admission of future shipments of an
imported article, without first physically examining (sampling) the
shipments. Put another way, the import alert indicates that there is
enough evidence to detain the product without physical examination.
There are a variety of factors that could lead FDA to place a product,
manufacturer, shipper, grower, geographical area, and/or country on
import alert. For example, questions could have been raised in an
inspection of the manufacturing site, concerns might be raised by a
recall, or there could be a history of problems and no signs that
appropriate actions were taken to remedy the cause. In order for FDA to
consider removing a product and/or firm from import alert, FDA must
have evidence that the conditions that gave rise to the appearance of a
violation have been resolved and the Agency has confidence that future
entries will be in compliance with FDA laws and regulations. Often,
individual import alerts include specific information regarding removal
from DWPE. At the present time, many import alerts indicate that it
would be helpful for responsible entities to present to FDA evidence of
at least five shipments to the United States that have been found to
not be violation.
In contrast to section 422(b)(1)(B)(i) of the FD&C Act, which
applies exclusively to specific articles of food that are imported or
offered for import into the United States, section 422(b)(1)(B)(ii) of
the FD&C Act applies to food generally. As such, we tentatively
conclude that section 422(b)(1)(B)(ii) of the FD&C Act applies whenever
successful consecutive testing supports the removal of food from an
import alert, including testing on specific articles of food that are
imported or offered for import into the United States and less common
situations where food testing is conducted on food that is not being
imported or offered for import into the United States. For example,
section 422(b)(1)(B)(ii) of the FD&C Act would also apply if the
results from successful consecutive testing of environmental swabs or
of food that is being imported or offered for import in a foreign
country are presented as evidence demonstrating that a manufacturer
should be removed from an import alert. At present, most successful
consecutive testing conducted for food under an import alert is
conducted on specific articles of food that are imported or offered for
import into the United States--and thus fall under both sections
422(b)(1)(B)(i) and (ii) of the FD&C Act (and proposed Sec. Sec.
1.1107(a)(4) and (a)(5)). However, we assume that Congress intended
section 422(b)(1)(B)(ii) of the FD&C Act to have an independent
meaning. (Norman J. Singer & J.D. Shambie Singer, 1A Sutherland
Statutory Construction Sec. 21:1 (7th ed. 2018) which states that
``[c]ourts should construe a statute, if possible, so no term is
rendered superfluous or meaningless.'') Therefore, we interpret section
422(b)(1)(B)(ii) of the FD&C Act to apply in part to food testing not
covered by section 422(b)(1)(B)(i) of the FD&C Act, including
successful consecutive testing for food under import alert that is not
conducted on specific articles of food that are imported or offered for
import into the United States.
Finally, we note that we are not, as part of this rulemaking,
defining the number of successful consecutive tests that would be
required or recommended to support removal from import alert. Instead,
this proposed rule would require that if you use successful consecutive
testing as a means to support removal of food from an import alert,
then such testing must be conducted under this program. (For procedural
information on removal from DWPE, see section 9-8 of FDA's Regulatory
Procedures Manual at https://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/default.htm.)
In accordance with section 422(b)(1) of the FD&C Act, proposed
Sec. 1.1107(b) would require that whenever food testing is required to
be conducted in accordance with this program, as described in proposed
Sec. 1.1107(a), analysis of the collected samples must be conducted by
accredited laboratories that are accredited for the appropriate
analytical method or methods by a recognized accreditation body.
Proposed Sec. 1.1107(c) would require, with one exception, that
such food testing may only be conducted on samples taken after the
articles of food have arrived in the United States. As part of our
import admissibility process, this policy allows us to verify that the
requirements of Sec. 1.94(a) are met--i.e., that the testimony is
relevant to admissibility in that the article(s) of food that is
sampled and tested is the same article(s) of food being offered for
import into the United States. Importantly, this policy would also help
to ensure that the tested sample(s) accurately represents the condition
of the article when presented for admission, thereby ensuring the
evidence presented by the owner or consignee is representative of the
article(s) offered for import. Proper and valid analysis of a sample is
not relevant testimony about admissibility if the analyzed sample is
not representative of the article of food imported or offered for
import into the United States. Based on best available science and
grounded in years of experience, we know that the process of getting a
food item from where it was produced abroad to a U.S. port of entry is
such that change in the item or analyte may occur. For example,
bacteria may grow in the time it takes to transport an article of food
from the point of export to the United States, or a new contaminant may
be intentionally or inadvertently introduced in transit. Accordingly,
when specific articles of food are imported or offered for import into
the United States, our general policy would be that the sample must be
taken after arrival.
We are also proposing, however, an exception to that sampling
policy for circumstances in which we determine that a sample taken
prior to arrival is representative of the article of food offered for
import into the United States and thereby satisfies those evidentiary
requirements. We would make such a determination on a case-by-case
basis, based on clear evidence that the product sampled and analyzed is
actually the product offered for import. We would communicate our
determination in writing to the owner/consignee. We invite comment on
this proposed exception and whether, in addition to applying the
exception on a case-by-case basis, we could extend the exception to
apply to a set of defined circumstances. We invite comment on whether
there are specific circumstances under which we could make a
determination that could be applied broadly, say to a particular
commodity or analyte generally, that sampling taken prior to export is
representative of the article(s) offered for import? If so, what are
those circumstances, and what evidence would give us assurance that
sampling of all such articles prior to export would be representative
of all articles arriving in the United States?
As discussed above, we are proposing to interpret section
422(b)(1)(B)(ii) of the FD&C Act such that testing conducted under
paragraph (ii) (under an import alert that requires successful
consecutive tests) would encompass both testing of specific articles of
food imported or offered for import and other testing related to an
import alert. For import alerts where food product testing
[[Page 59466]]
is generally sufficient evidence to overcome the appearance of the
violation(s), although at present it is standard practice for a
responsible entity seeking to have a food product removed from import
alert to submit evidence of at least five non-violative shipments, it
is possible that in some circumstances other testing could constitute
relevant evidence. Examples of other, potentially relevant, testing
might be environmental swabbing of a production facility, or food
testing unconnected to a shipment of food offered for import into the
United States. Our proposed sampling policy in Sec. 1.1107(c) would
not apply to testing under an import alert that is unrelated to
articles of food offered for import, because in circumstances unrelated
to shipments, transit and timing issues would not present likely
barriers to the relevance of the testing evidence.
2. When and how will FDA issue a food testing order? (Proposed Sec.
1.1108)
Proposed Sec. 1.1108 would, if finalized, establish our procedure
for issuing food testing orders. Specifically, proposed Sec. 1.1108(a)
provides that we may require an owner or consignee of an article of
food to conduct food testing, or to have food testing conducted on
their behalf, under this program, to address an identified or suspected
food safety problem related to the article of food. As described
previously, our authority for proposed Sec. 1.1108 comes from section
422(b)(1)(A)(ii) of the FD&C Act, which provides that food testing must
be conducted under the food testing program described in section 422 of
the FD&C Act, whenever such testing is conducted by or on behalf of an
owner or consignee, as required by FDA, as FDA deems appropriate, to
address an identified or suspected food safety problem.
Proposed Sec. 1.1108(b) elaborates that the food testing order
will specify the food product or environment to be tested; whether the
food testing may be conducted using an accredited laboratory that is
owned, operated, or controlled by the owner or consignee; the timeframe
in which the food testing must be conducted; and the manner of the food
testing, such as the methods that must be used. We tentatively conclude
that the language in section 422(b)(1)(A)(ii) of the FD&C Act stating
that food testing must be conducted as required by FDA and as FDA deems
appropriate grants FDA discretion to specify the terms and conditions
of a food testing order to address an identified or suspected food
safety problem.
Proposed Sec. 1.1108(c) provides that food testing orders would
contain all of the elements required by 21 CFR 16.22(a) and would
thereby constitute notice of an opportunity for a regulatory hearing
under 21 CFR part 16. Proposed Sec. 1.1108 further provides that an
affected owner or consignee would be able to request a regulatory
hearing on a food testing order under proposed Sec. 1.1174.
3. How will FDA make information about recognized accreditation bodies
and accredited laboratories available to the public? (Proposed Sec.
1.1109)
Proposed Sec. 1.1109 provides that (except as provided by proposed
Sec. 1.1109(b), which we discuss below) we would place on our website
a list, which would be readily accessible to the public, of recognized
accreditation bodies and accredited laboratories in the food testing
program. We would establish and display this list in accordance with
section 422(a)(1)(B) of the FD&C Act, which requires us to establish a
publicly available registry of accreditation bodies recognized by FDA
and laboratories accredited by a recognized accreditation body,
including the name of, contact information for, and other information
deemed appropriate by the FDA about such bodies and laboratories.
The proposed list would include the name of and contact information
for each recognized accreditation body and accredited laboratory in our
program. We propose that it is also appropriate for the list to
include, for each recognized accreditation body, the duration of the
recognized accreditation body's recognition, and, for each accredited
laboratory, the scope of accreditation, as well as the name and contact
information of the recognized accreditation body that accredited the
accredited laboratory. We also propose that the list include the
recognition status of each accreditation body that has been recognized
(i.e., whether the accreditation body's recognition is active, or
whether it has been put on probation or revoked by FDA, relinquished by
the accreditation body, or allowed to expire by the accreditation
body), the date of any such change in recognition status, the
accreditation status of each laboratory that has been accredited (i.e.,
whether the laboratory's accreditation is active, or whether the
laboratory's accreditation is withdrawn or revoked or it has been put
on probation by a recognized accreditation body or FDA (including
whether by FDA or by a recognized accreditation body), or the
laboratory has relinquished its accreditation (in-whole or in-part)),
and the date of any such change in accreditation status.
We believe this additional information beyond the name and contact
information of recognized accreditation bodies and accredited
laboratories would be appropriate to include in the list because it
would make the list more useful and increase transparency. For example,
if we did not include information about whether an accreditation body
had its recognition revoked by FDA, and we instead simply deleted the
accreditation body from the list, there could be ambiguity with respect
to whether the deletion was for cause or whether the accreditation body
voluntarily relinquished its recognition. We believe that users of the
list would find the distinction between those two alternatives to be
important. In addition, if a laboratory voluntarily relinquished its
accreditation in-part, it might want the list to make clear that the
reduction in its scope of accreditation was a voluntary action.
Proposed Sec. 1.1109(b) reiterates section 422(a)(4) of the FD&C
Act, which grants us the authority to, when in the interest of national
security, determine in coordination with the Secretary of Homeland
Security the time, manner, and form in which the list described in
proposed Sec. 1.1109(a) is made publicly available. In the absence of
a determination to the contrary under proposed Sec. 1.1109(b), the
list would remain publicly and readily available at all times on our
website and display all information specified by proposed Sec.
1.1109(a).
C. Proposed Provisions About Recognition of Accreditation Bodies
(Proposed Sec. 1.1113)
Section 422(a)(2) of the FD&C Act requires that FDA provide for the
recognition of laboratory accreditation bodies that meet the criteria
established by FDA for accreditation of laboratories to conduct food
testing. Accordingly, this proposed rule proposes certain criteria that
accreditation bodies must meet to become recognized by FDA to accredit
laboratories under this program.
1. What requirements must an accreditation body meet to be recognized
by FDA? (Proposed Sec. 1.1113)
Proposed Sec. 1.1113 would require that, to become recognized by
FDA, an accreditation body seeking recognition by FDA must: (a) Be a
full member of ILAC and a signatory to the ILAC MRA that has
demonstrated competence to ISO/IEC 17011:2017; (b) demonstrate it meets
the requirements of ISO/IEC 17011:2017 (Ref. 12); (c) demonstrate
[[Page 59467]]
that it possesses sufficient scientific/technical expertise to be able
to substantively assess certain work of the laboratories it accredits;
and (d) demonstrate it is capable of complying with this rule's
proposed requirements for recognized accreditation bodies.
ILAC was established to create an international arrangement between
member accreditation bodies to develop and harmonize laboratory and
inspection body accreditation practices. Currently more than 90
accreditation bodies are signatories to the ILAC MRA. To become an ILAC
MRA signatory, an accreditation body must commit itself to maintaining
conformity with the current version of ISO/IEC 17011 and to ensuring
that all laboratories it accredits comply with appropriate laboratory
standards. Under this proposed rule, accreditation bodies would be
required to meet ISO/IEC 17011:2017, which is incorporated by
reference. Therefore, we are proposing that in order to be recognized
as an accreditation body, an accreditation body must be a signatory to
the ILAC MRA that has demonstrated competence to ISO/IEC 17011:2017. If
at some point in the future ISO/IEC 17011:2017 is updated, FDA would
consider whether to amend the codified consistent with that update,
allowing an adequate transition period.
Requiring recognized accreditation bodies to be signatories to the
ILAC MRA that have demonstrated competence to ISO/IEC 17011:2017 and to
be members in good standing of ILAC would also be consistent with our
withdrawn 2009 draft guidance, in which we recommended that accredited
laboratories be ILAC MRA signatories. We also considered the rationale
stated by the Consumer Product Safety Commission (CPSC) in its 2013
rule, ``Requirements Pertaining to Third Party Conformity Assessment
Bodies'' (78 FR 15836, March 12, 2013), for requiring accreditation
bodies to be signatories to the ILAC MRA. In particular, we agree with
CPSC that requiring accreditation bodies to be signatories to the ILAC
MRA that have demonstrated competence to ISO/IEC 17011, and not
accepting any other arrangement, would: (1) Keep the accreditation
program as simple as possible for use by interested parties (in our
case, owners and consignees, accreditation bodies, and laboratories);
(2) avoid any perceived notions of barriers to fair trade practices;
establish a program that is manageable within Agency resources; and (3)
maintain consistency in the procedures used by the recognized
accreditation bodies (see 78 FR 15836 at 15857).
Proposed Sec. 1.1113(b) would require that, to become recognized
by FDA, an accreditation body seeking recognition by FDA must
demonstrate that it meets the requirements of ISO/IEC 17011:2017. ISO/
IEC 17011:2017 specifies the general requirements for accreditation
bodies assessing and accrediting conformity assessment bodies
(``conformity assessment bodies'' are organizations providing testing,
inspection, management system certification, personnel certification,
or product certification). ISO/IEC 17011 is widely accepted, both
domestically and internationally, and its incorporation by reference
should allow us to utilize a framework that is familiar to
accreditation bodies and the food industry.
Proposed paragraph (c) would require that to be recognized under
this program, an accreditation body must possess certain scientific/
technical expertise. Because the food testing that occurs under this
program is important to public health, the laboratories conducting
these food tests must be able to properly and accurately apply a
particular test method, in an appropriate circumstance. Thus, it is
vital that test methods be validated \6\ and verified as necessary (see
Sec. 1.1151(a)), and that laboratories demonstrate their capability by
participating in comparison programs such as proficiency testing (see
Sec. 1.1138(a)(1)(ii)). Under this proposed rule, we would be relying
on recognized accreditation bodies to substantively review some
validation and verification studies, as well as accredited
laboratories' proposed alternatives to proficiency tests, as part of
their consideration of whether laboratories are competent to conduct
the test methods for which they are seeking accreditation (see Sec.
1.1138(a)(1)). Thus, we would expect recognized accreditation bodies to
serve a function that accreditation bodies have not traditionally
performed.
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\6\ The terms validate, validation, verify, and verification are
used in this proposed rule in the specific context of conducting
food testing. Other rules we have issued, particularly some rules we
have issued pursuant to FSMA, use one or more of these terms in
other contexts. The terms validate, validation, verify, and
verification, as used in contexts other than the context of
conducting food testing, may have different meanings than they do in
the context of this proposed rule.
---------------------------------------------------------------------------
Accordingly, to be recognized in this program, we expect an
accreditation body to be able to substantively review validation
studies; to have the scientific knowledge to meaningfully assess
whether a study indicates that a proposed test method detected the
identified hazard (or analyte) with sufficient accuracy and precision.
We would expect recognized accreditation bodies to assess verification
studies to determine whether the test method at issue may be properly
applied to a particular food/analyte combination (e.g., strawberries/
salmonella). We would also expect recognized accreditation bodies to be
able to assess an accredited laboratory's determination under proposed
Sec. 1.1148(a)(2) that no proficiency testing program is available or
practicable for a particular method, and to be able to assess whether a
proposed alternative to a proficiency test would adequately demonstrate
the laboratory's competence to conduct a test method. In these ways, we
would expect accreditation bodies to possess and apply substantive
scientific/technical knowledge. We acknowledge that for most if not all
accreditation bodies, obtaining such scientific knowledge will require
either hiring qualified in-house staff or contracting with assessors
with the necessary experience and expertise. We have accounted for that
cost in our proposed regulatory impact analysis.
Again, this function of a recognized accreditation body is
important to the public health, and we plan to robustly monitor this
aspect of their performance. To that point, we intend to communicate
our expectations for the assessment of validation and verification
studies, and alternatives to proficiency tests, to the recognized
accreditation bodies. We may consider issuing guidance on this topic,
making ourselves available for technical assistance such as via regular
roundtable meetings/conference calls with recognized accreditation
bodies, and we welcome suggestions of other measures we could employ to
support the recognized accreditation bodies in this function. We also
welcome comments on this proposed provision.
Proposed Sec. 1.1113(d) provides that an accreditation body
seeking recognition must demonstrate it is capable of complying with
this subpart's requirements for recognized accreditation bodies, which
refers in part to requirements that are specific to this program and
not contained in ISO/IEC 17011:2017. These requirements are primarily
specified by proposed Sec. Sec. 1.1119 through 1.1125. For example,
those proposed requirements specify that before we will recognize an
accreditation body, it must demonstrate to us that it has policies,
standard operating procedures, and other appropriate programs and
measures in place to meet the proposed impartiality and conflict of
interest requirements of proposed Sec. 1.1119 and to make appeals
[[Page 59468]]
procedures publicly available in accordance with proposed Sec. 1.1121.
Another example of how paragraphs (b) and (d) of proposed Sec.
1.1113 interact involves certain recordkeeping requirements of ISO/IEC
17011:2017 and additional recordkeeping requirements for recognized
accreditation bodies under this proposed rule. ISO/IEC 17011:2017 (Ref.
12) section 9.4.2 requires accreditation bodies to have in place
procedures by which records are retained for whatever period of time
comports with the accreditation bodies' contractual duties, and
proposed Sec. 1.1124 would require that recognized accreditation
bodies electronically maintain, for 5 years after the date of creation
of the records, records created while they are recognized. Accordingly,
under proposed Sec. 1.1113(b) and (d) and Sec. 1.1124, an
accreditation body seeking recognition would have to demonstrate the
capability to implement records procedures to retain records for a
period consistent with its contractual and legal obligations, which
would include an obligation under proposed Sec. 1.1124 to maintain
certain records, for at least 5 years after the date of creation of the
records, created while the accreditation body is recognized.
We discuss the documentation needed to meet the requirements of
proposed Sec. 1.1113(a)-(d) where we discuss proposed Sec. 1.1128,
below.
We invite comment on proposed Sec. 1.1113's requirements for an
accreditation body to become recognized under this program. If comments
opposing these proposed requirements are submitted, we request comment
on what alternative requirements or qualifications an accreditation
body should have to be eligible for recognition to accredit
laboratories under this program.
D. Proposed Provisions About Requirements for Recognized Accreditation
Bodies (Proposed Sec. Sec. 1.1118 Through 1.1125)
Section 422 of the FD&C Act provides that food testing under this
program may only be conducted by laboratories accredited by
accreditation bodies that we have recognized. Section 422(a)(2) of the
FD&C Act directs us to establish the criteria for recognition of
accreditation bodies and section 422(a)(7)(B) directs us to promptly
revoke the recognition of any accreditation body found not to be in
compliance with the requirements of section 422 of the FD&C Act.
Accordingly, this proposed rule would establish certain criteria and
obligations that recognized accreditation bodies must continue to meet
to remain recognized. We have proposed these general requirements for
recognized accreditation bodies to remain recognized at Sec. Sec.
1.1118 through 1.1125, and we discuss these requirements below.
1. What are the general requirements for recognized accreditation
bodies to remain recognized? (Proposed Sec. 1.1118)
For recognized accreditation bodies to remain recognized, proposed
Sec. 1.1118 would require them to continue to: (a) Be a full member of
the ILAC and a signatory to the ILAC MRA that has demonstrated
competence to ISO/IEC 17011:2017; (b) meet, with respect to activities
under this subpart, the requirements of ISO/IEC 17011:2017, which would
be incorporated by reference under this rule; (c) demonstrate that it
possesses sufficient scientific/technical expertise to be able to
substantively assess certain work of the laboratories it accredits; and
(d) comply with the proposed requirements for recognized accreditation
bodies. The additional requirements referenced by proposed Sec.
1.1118(d) are primarily specified by proposed Sec. Sec. 1.1119 through
1.1125. See our discussion at section VI.C, above, for more information
about these proposed criteria.
2. What requirements apply to how a recognized accreditation body must
protect against conflicts of interest? (Proposed Sec. 1.1119)
We believe that protecting against conflicts of interest among
participants in this program is critical to the integrity of this
proposed program. We are proposing that recognized accreditation bodies
take certain steps to safeguard against conflicts of interest in
addition to meeting the impartiality requirements of ISO/IEC
17011:2017. Under proposed Sec. 1.1119(a)(1), a recognized
accreditation body would need to ensure that it, and its officers,
employees, or other agents involved in accreditation activities, does
not own or have a financial interest in, manage, or otherwise control
any laboratory (or any affiliate, parent, or subsidiary) it accredits.
Section 4.4.11 of ISO/IEC 17011:2017 (Ref. 12) prohibits an
accreditation body from offering or providing any food testing services
(and from offering or providing any other services that may affect its
impartiality). However, we have tentatively concluded that it is also
important to prevent a recognized accreditation body from having a
financial interest in, managing, or otherwise controlling any
laboratory (or any affiliate, parent, or subsidiary) that it accredits,
and to explicitly extend that prohibition to officers, employees, and
other agents of the recognized accreditation body, in order to protect
against conflicts of interest. To ensure the effectiveness of proposed
Sec. 1.1119(a)(1), we also have tentatively concluded that it is
important to extend the conflict of interest safeguards in this
provision to subsidiaries, affiliates, and parent organizations of the
laboratory. We seek comments with regards to whether proposed Sec.
1.1119(a)(1) would impose an undue burden on any existing financial,
managerial, or control interest that accreditation bodies may currently
have in food testing laboratories and/or whether there are other
measures that could prevent such an interest from creating a conflict
of interest.
Under proposed Sec. 1.1119(a)(2), a recognized accreditation body
would be required to prohibit officers, employees, or other agents
involved in accreditation activities of the recognized accreditation
body from accepting any money, gift, gratuity, or other item of value
from any laboratory that they accredit or that are seeking their
accreditation that conducts food testing. We seek comment on whether
this proposal is sufficient to protect against conflicts of interest
related to money, gifts, gratuity, and other items of value.
Proposed Sec. 1.1119(b) provides that the prohibited money, gift,
gratuity, or other item of value described by proposed Sec.
1.1119(a)(2) does not include payment of fees for accreditation
services, reimbursement of direct costs associated with an onsite
assessment or reassessment of the laboratory, and onsite lunch, of a de
minimis value, provided during the course of an assessment or
reassessment, if necessary to facilitate the efficient conduct of the
assessment.
Under proposed Sec. 1.1119(c), the financial interests of spouses
and children younger than 18 years of age would be imputed to a
recognized accreditation body's officers, employees, and other agents
involved in its accreditation activities. We have included a similar
imputation provision in other regulations, including the FSMA
accredited third-party certification regulation. See 21 CFR 1.657(c))
and 21 CFR 516.141(g). We believe this provision would help ensure the
integrity of the food testing program.
We seek comment on proposed Sec. 1.1119 and whether there are any
other potential conflicts interest for recognized accreditation bodies
that should be addressed in this proposed program. For any comment
recommending that we address other types of conflicts, we request
[[Page 59469]]
recommended measures to address such conflicts, and any references or
documents that are available to support the recommendation.
3. How must a recognized accreditation body evaluate laboratories
seeking accreditation and oversee the performance of laboratories it
accredits? (Proposed Sec. 1.1120)
We anticipate that many laboratories that seek accreditation in our
proposed program already will be accredited to ISO/IEC 17025:2017 by an
accreditation body to which we have granted recognition. To provide
flexibility to such participants, we are proposing laboratory
assessment requirements for our program that build upon, and could be
combined with, the existing assessments of laboratories that
accreditation bodies conduct under ISO/IEC 17011:2017 during an
accreditation cycle. For example, if an accreditation body has
conducted an onsite assessment of an ISO/IEC 17025:2017 accredited
laboratory in the past 2 years, proposed Sec. 1.1120(c) would
potentially allow the initial assessment for accreditation to our
program to be conducted remotely, and to only address whether the
laboratory meets the unique requirements of our program that are not
required by ISO/IEC 17025:2017 (see proposed Sec. 1.1138(a)(1) and
(c)). If such an onsite assessment has not been conducted in the past 2
years, an accreditation body's initial assessment of a laboratory for
accreditation in our program would be required to be conducted onsite
and would be required to address whether the laboratory meets all the
requirements of our program, including the requirements of ISO/IEC
17025:2017 specified in proposed Sec. 1.1138(a)(2) and (b).
Where the initial assessment for accreditation to our program is
conducted remotely under proposed Sec. 1.1120(c), proposed Sec.
1.1120(e) and (f) would require the recognized accreditation body to
conduct its first assessment of the sample of the scope of
accreditation of the accredited laboratory onsite, and no later than 2
years after the accreditation body last conducted an onsite assessment
of the laboratory, in accordance with ISO/IEC 17011:2017. These
proposed requirements are intended to ensure that recognized
accreditation bodies conduct onsite assessments of accredited
laboratories in our program at least every 2 years. We regard periodic
onsite assessments as necessary to effectively evaluating a laboratory.
In addition, proposed Sec. 1.1120(g) would require that the
reassessment of an accredited laboratory (see ISO/IEC 17011:2017 (Ref.
12, at section 7.9.4)) at the end of the laboratory's accreditation
cycle be conducted onsite.
However, when conducting an ``onsite'' assessment, if conducting a
particular assessment activity onsite will not aid in the assessment of
a laboratory, proposed Sec. 1.1120(b), (e), and (g), would allow such
activities to be conducted remotely. Our intent is that this exception
would allow assessment activities such as document review or followup
inquiries to a laboratory after an onsite visit to be conducted
remotely. Proposed Sec. 1.1120(h) would allow any assessments
conducted by a recognized accreditation body other than the assessments
referred to in Sec. 1.1120(a), (e), and (g)--that is, the initial
assessment, sample of the scope of accreditation, and reassessment--to
be conducted entirely remotely if it will not aid the assessment to
conduct them onsite.
4. What appeal procedures must a recognized accreditation body provide
for appeals of decisions to not grant accreditation? (Proposed Sec.
1.1121)
Proposed Sec. 1.1121 provides that a laboratory may appeal a
decision by the recognized accreditation body to not grant the
accreditation (in-whole or in-part) that the laboratory sought, and the
recognized accreditation body must consider the appeal, in accordance
with the requirements of Sec. 1.1118(b). We are proposing this
provision because ISO/IEC 17011:2017 does not explicitly state what
actions by the accreditation body a laboratory may appeal.
Proposed Sec. 1.1121 would require recognized accreditation bodies
to establish and implement certain written procedures for addressing
appeals from laboratories challenging a recognized accreditation body's
decision to not grant the accreditation (in-whole or in-part) that the
laboratory sought. Specifically, proposed Sec. 1.1121 provides that,
in addition to meeting the requirements of Sec. 1.1118(b) related to
appeals, the recognized accreditation body must establish and implement
written procedures to make the appeals procedures publicly available,
and use a competent person(s), who may or may not be external to the
recognized accreditation body, is free from bias or prejudice and has
not participated in the accreditation decision, and is not the
subordinate of a person who participated in the accreditation decision,
to review and decide appeals. We have tentatively concluded that the
requirements of proposed Sec. 1.1121 are important supplemental
requirements to ISO/IEC 17011:2017 (Ref. 12) section 7.13 that would
provide additional protections to laboratories and help ensure
transparency of the program. We seek comments on these proposed
requirements, including with respect to whether these proposed
requirements would significantly differ from the current appeals
practices of accreditation bodies.
5. When must a recognized accreditation body withdraw or reduce the
scope of the accreditation of a laboratory, and when may a recognized
accreditation body put an accredited laboratory on probation? (Proposed
Sec. 1.1122)
Proposed Sec. 1.1122(a) would require recognized accreditation
bodies to withdraw the accreditation of a laboratory it accredits when
the accredited laboratory substantially fails to comply with this rule.
Although section 7.11 of ISO/IEC 17011:2017 (Ref. 12) specifies certain
circumstances that would require the accreditation body to initiate the
process for withdrawing the accreditation of the laboratory--including
fraudulent behavior--it does not articulate a general standard for when
accreditation bodies should initiate the process for withdrawing
accreditation.
Although we are proposing that withdrawal of accreditation be
initiated by a ``substantial'' failure to comply with this subpart--and
not by minor or de minimis violations--we note that the failure or
refusal by the accredited laboratory to take appropriate corrective
action (as it is required to do under ISO/IEC 17025:2017 (Ref. 13) at
section 8.7) to prevent subsequent minor violations may rise to the
level of substantial failure to comply with this rule. For example, if
on a single occasion an accredited laboratory fails to provide FDA with
documentation of the sampler's qualifications as required by Sec.
1.1152(c)(2), that in and of itself would not generally be considered a
substantial violation. However, frequent and recurring failure by a
laboratory to submit all required components of a full analytical
report, even when each instance constitutes a minor violation, combined
with a failure or refusal by the accredited laboratory to take
appropriate corrective action to prevent such mistakes from recurring,
may in certain circumstances be grounds for withdrawal of
accreditation.
Proposed Sec. 1.1122(b) provides that a recognized accreditation
body may put an accredited laboratory it accredits on probation if the
recognized accreditation body determines that the laboratory
demonstrates deficiencies in performing
[[Page 59470]]
its functions under this program that are less serious than would
justify withdrawal of the accredited laboratory's accreditation (in-
whole or in-part) under proposed Sec. 1.1122(a), and it is reasonably
likely that the accredited laboratory will be able to correct such
deficiencies within a reasonable specified period of time. Our intent
is that probation would allow recognized accreditation bodies to work
with laboratories they accredit to bring such laboratories into
compliance with the program without having to resort to withdrawing
accreditation.
As noted, this proposed rule refers to reduction of an accredited
laboratory's scope of accreditation by a recognized accreditation body
as withdrawal of accreditation in-part. Proposed Sec. 1.1122(c)
clarifies that when there are grounds for withdrawal of accreditation,
but the deficiencies affect only certain analytical methods within the
accredited laboratory's scope of accreditation, the recognized
accreditation body may withdraw the accredited laboratory's scope of
accreditation for only those affected analytical methods. This
provision is meant to facilitate limited withdrawal of accreditation
when warranted.
Under proposed Sec. 1.1122(d) a recognized accreditation body may
require from a laboratory that it accredits the submission of records
that the accredited laboratory would be required to maintain under
proposed Sec. 1.1153, in order to assist the recognized accreditation
body in determining whether a withdrawal of accreditation (in-whole or
in-part) or probation is warranted.
Proposed Sec. 1.1122(e) describes the process a recognized
accreditation body must follow when withdrawing the accreditation of an
accredited laboratory under this program. Under proposed Sec.
1.1122(e), the recognized accreditation body must notify the laboratory
of the withdrawal of the laboratory's accreditation, and the
notification must specify whether the withdrawal of accreditation is
in-whole or in-part, and if it is in-part, to which testing methods it
applies. The notification must also describe the grounds on which the
accreditation was withdrawn and state the procedures for appealing the
withdrawal.
Proposed Sec. 1.1122(f) provides that the recognized accreditation
body would have to: (1) Notify the laboratory of its probationary
status; (2) describe the grounds for the probation; (3) identify all
deficiencies that the laboratory must correct for the recognized
accreditation body to lift the probation; and (4) either inform the
laboratory that it has a specific timeframe to take particular
corrective actions with respect to the identified deficiencies or
require the laboratory to submit a plan to the recognized accreditation
body for approval that identifies the appropriate corrective actions
the laboratory will take to resolve the identified deficiencies and
that identifies appropriate timeframes for resolution. Our intent is
that while probation is in effect, the recognized accreditation body
will work with the accredited laboratory to bring it into compliance
with the requirements of the program.
Proposed Sec. 1.1122(g) describes the consequences of withdrawal
of accreditation (in-whole or in-part) or probation. If a recognized
accreditation body withdraws the accreditation of a laboratory in-
whole, the laboratory would be immediately ineligible to conduct food
testing under this rule. If the recognized accreditation body withdraws
the accreditation of a laboratory in-part, the laboratory would be
immediately ineligible to conduct food testing under this rule with
respect to only the specific methods for which accreditation was
withdrawn. An accredited laboratory's substantial failure to comply
with this rule would undermine the integrity and validity of this
proposed program and of the laboratory's affected food testing
conducted under this proposed rule. Withdrawal of the laboratory's
accreditation would ensure that the laboratory does not continue to
conduct the affected food testing under this rule. This consequence is
in accordance with the requirement in section 422(b)(1) of the FD&C Act
that food testing under section 422 may only be conducted by
laboratories that are accredited by recognized accreditation bodies for
the methods of analysis appropriate for such food testing. An
accredited laboratory that is put on probation by an accreditation body
under this proposed rule would be permitted to continue to conduct food
testing under this subpart, because it would still be accredited under
this program. However, an accredited laboratory that is put on
probation under this proposed rule would not be able to submit abridged
analytical reports under Sec. 1.1152(d).
Proposed Sec. 1.1122(h) discusses requirements related to how the
recognized accreditation body must handle appeals of withdrawals of
accreditation (in-whole or in-part). Under proposed Sec. 1.1122(h), a
laboratory may appeal a decision by the recognized accreditation body
to withdraw the accreditation (in-whole or in-part) of the laboratory,
and the recognized accreditation body must consider the appeal in
accordance with the requirements of ISO/IEC 17011:2017 (Ref. 12)
(specifically, ISO/IEC 17011:2017 at section 7.13). In addition to
meeting the requirements of ISO/IEC 17011:2017 related to appeals, the
recognized accreditation body must establish and implement written
procedures to make the appeals procedures publicly available; and to
use a competent person(s), who may or may not be external to the
recognized accreditation body, who is free from bias or prejudice and
has not participated in the withdrawal decision, and is not the
subordinate of a person who participated in the withdrawal decision, to
review and decide appeals.
6. What reports and notifications must a recognized accreditation body
submit to FDA? (Proposed Sec. 1.1123)
Proposed Sec. 1.1123 would require recognized accreditation bodies
to submit to FDA reports of their internal audits and notices of
matters affecting their recognition and the accreditation status of
laboratories they accredit, among other notices.
In proposed Sec. 1.1123 and other provisions in this proposed
rule, we are proposing that information submitted to FDA be submitted
electronically and in English. Electronic submission of information
will help ensure we have ready access to information needed for
monitoring and oversight of the program and promote the overall
efficiency of the program. We have also tentatively concluded that
requiring electronic submission would not be significantly burdensome
for the accreditation bodies and laboratories in this program. FDA
plans to establish an electronic portal for this program and recognized
accreditation bodies would be able to submit all required notification
and reports through that portal.
Proposed Sec. 1.1123(a) would require all reports and
notifications submitted to FDA under this proposed section to include
contact information for the accreditation body associated with the
report or notification and, if applicable, contact information for the
laboratory associated with the report or notification. Proposed Sec.
1.1123(b) would require recognized accreditation bodies to submit to
FDA electronically, in English, a report of the results of the internal
audit required by section 9.7 of ISO/IEC 17011:2017 (Ref. 12) and the
results of the audit of its compliance with the requirements of Sec.
1.1118(c) and (d), which would be required by proposed Sec. 1.1125, no
later than 45 days after completing the internal audit. Proposed Sec.
1.1123(b) further provides that the report of the recognized
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accreditation body's internal audit must include a description of the
internal audit conducted; a description of any identified deficiencies;
a description of any corrective actions taken and any corrective action
the recognized accreditation body will take, including the timeline for
such corrective actions; and a statement disclosing the extent to which
the internal audit was conducted by personnel different from those who
perform the activity or activities that were audited. The report does
not have to be the same report used internally by the recognized
accreditation body, but must be comprehensive enough to demonstrate
whether the accreditation body is complying with the requirements of
ISO/IEC 17011:2017 and the requirements of Sec. 1.1118(c) and (d).
Such reports would provide us with important information about the
extent to which the recognized accreditation body is monitoring its own
performance under this program, any deficiencies the recognized
accreditation body discovered about its activities, and any corrective
actions implemented to address such deficiencies.
Because recognized accreditation bodies must conduct such internal
audits under ISO/IEC 17011:2017 and to maintain their ILAC membership,
proposed Sec. 1.1123(b) would not require the recognized accreditation
body to engage in duplicative internal audits. We also believe that
providing 45 days for the recognized accreditation body to compile and
submit this report is a reasonable amount of time that strikes a
balance between our interest in reviewing information that is important
to our oversight of the program and providing the recognized
accreditation body sufficient time to initiate any appropriate
corrective actions and develop a meaningful internal audit report. If
the internal audit results in the recognized accreditation body
discovering information that must be submitted to FDA immediately under
proposed Sec. 1.1123(c), we expect the recognized accreditation body
to submit that particular information to us immediately, within 48
hours, in accordance with proposed Sec. 1.1123(c).
Section 422(a)(1)(C) of the FD&C Act requires, as a condition of
recognition, that recognized accreditation bodies report to us any
changes that would affect the recognition of such recognition body. To
implement this provision, proposed Sec. 1.1123(c)(1) would require the
recognized accreditation body to notify us immediately of any changes
it is aware of that would affect its recognition, including a
description of the change, and, if the change is one made by the
recognized accreditation body, an explanation for the purpose of the
change. Proposed Sec. 1.1123(c)(1) would cover changes in the name or
operations of a recognized accreditation body, such as the purchase of
a recognized accreditation body by a company, as well as changes that
would cause the recognized accreditation body to no longer meet the
requirements of this proposed program, including if the recognized
accreditation body ceases membership in ILAC or is no longer a
signatory of the ILAC MRA demonstrating competence to ISO/IEC
17011:2017. A change that prevents or undermines the accreditation
body's compliance with this proposed program may result in revocation
of recognition under proposed Sec. 1.1131. We would encourage
recognized accreditation bodies to contact us if there are
uncertainties about whether a change should be reported under proposed
Sec. 1.1123(c)(1).
Proposed Sec. 1.1123(c)(2) through (6) would require recognized
accreditation bodies to immediately notify us, within 48 hours, of
certain information related to the accreditation status of laboratories
they accredit or that have sought their accreditation. Immediate notice
is essential so that we can take timely action to update the public
website described by proposed Sec. 1.1109; accept food testing results
from newly accredited laboratories; refuse to accept food testing
results from laboratories that are no longer accredited for the food
testing at issue; and take any other actions as appropriate based on
such information.
Proposed Sec. 1.1123(c)(2) and (3) would require recognized
accreditation bodies to submit information to us about their grants and
denials of accreditation (in-whole or in-part) of laboratories. If a
recognized accreditation body received a request for accreditation
(which includes a request from a laboratory to add testing methods to
its scope of accreditation) from a laboratory, and the recognized
accreditation body granted accreditation for certain testing methods in
the laboratory's request but denied accreditation for other testing
methods in the laboratory's request, proposed Sec. 1.1123 would only
require that a recognized accreditation body provide us with a single
notification encompassing this information, as long as the notification
includes all of the information that would be required under proposed
Sec. 1.1123(c)(2) and (3).
Proposed Sec. 1.1123(c)(2) and (3) would require the notification
to include the scope of accreditation requested by the laboratory, the
scope of accreditation granted and/or denied, and the ground for such
denial, and the date of such grant. This information would be useful
for our program oversight. For example, it would allow us to monitor
accreditation activities, including situations where a laboratory
appears to be successively applying for, and being denied,
accreditation from different recognized accreditation bodies without
changing its practices or application to remedy the basis or bases for
the previous denial(s).
Proposed Sec. 1.1123(c)(4) would require a recognized
accreditation body to notify us immediately if it receives notice that
an accredited laboratory it accredits intends to relinquish its
accreditation (in-whole or in-part). Proposed Sec. 1.1123(c)(4) would
also require such notification to include the scope of accreditation to
which the relinquishment applies, and the effective date of the
relinquishment.
Proposed Sec. 1.1123(c)(5) would require a recognized
accreditation body to notify us immediately when it withdraws (in-whole
or in-part) its accreditation of a laboratory. Proposed Sec.
1.1123(c)(5) would also require such notification to include the scope
of accreditation to which the withdrawal applies, and the grounds for
the withdrawal.
Proposed Sec. 1.1123(c)(6) would require a recognized
accreditation body to notify us immediately when it puts an accredited
laboratory on probation. Proposed Sec. 1.1123(c)(6) would also require
such notification to include the grounds for the probation, and any
date by which the recognized accreditation body has determined the
accredited laboratory must take appropriate corrective action.
Having information on the reason(s) for probation or withdrawal of
accreditation, and whether such withdrawal is in-whole or in-part, is
important to us because it may affect whether and how we conduct any
followup actions with regards to the laboratory in question or how we
review food testing results from the laboratory in the future.
Proposed Sec. 1.1123(c)(7) would require recognized accreditation
bodies to notify us immediately when the recognized accreditation body
knows that an accredited laboratory it accredits has committed fraud or
submitted material false statements to FDA. We note that we would also
typically expect the recognized accreditation body to initiate its
process to withdraw accreditation of the laboratory in this
circumstance (in accordance with ISO/IEC 17011:2017 (Ref. 12) section
7.11.2). Proposed Sec. 1.1123(c)(7) would require the notification to
include a description
[[Page 59472]]
of the basis for the accreditation body's knowledge of the fraud or
material false statements, a description of the alleged fraud or
material false statements, and the actions taken by the accreditation
body with respect to such laboratory. Recognized accreditation bodies
may be in a better position than us in many cases to determine whether
an accredited laboratory has committed fraud or submitted material
false statements to the FDA, due to recognized accreditation bodies'
role in monitoring the laboratories they accredit. Furthermore,
although proposed Sec. 1.1152(j) would require accredited laboratories
to immediately notify us of any changes that would affect an accredited
laboratory's compliance with the program requirements or that would
otherwise affect the laboratory's accreditation, an accredited
laboratory that has committed fraud or submitted material false
statements to us may be unlikely to notify us that it did so.
7. What records requirements must a recognized accreditation body meet?
(Proposed Sec. 1.1124)
This proposed rule identifies specific types of records a
recognized accreditation body would be required to control and maintain
to document compliance with applicable requirements. The recognized
accreditation body also would be required to provide FDA access to such
records.
Proposed Sec. 1.1124(a) provides that, in addition to meeting the
records requirements of ISO/IEC 17011:2017 (as required by proposed
Sec. 1.1118(b)), an accreditation body that has been recognized must
electronically maintain records demonstrating its compliance with the
program, created while it is recognized, for 5 years after the date of
creation of the record. The requirements of Sec. 1.1124 would apply to
accreditation bodies that have been recognized even if they later are
no longer recognized. We are proposing this requirement because
maintenance of such records could be vital to our management of this
program.
We are not proposing to require records subject to this proposed
section to be maintained in English. In accordance with our position on
this issue in the accredited third-party certification final rule, we
are proposing to allow recognized accreditation bodies to maintain and
submit records in languages other than English, provided that they
electronically submit an English translation within a reasonable time
thereafter. We decline to set a specific timeframe for submission of
the translation because the circumstances surrounding each request will
differ (e.g., varying number of documents/pages). Further, we are
proposing under Sec. 1.1124(b) to require that if FDA requests records
electronically, the records must be submitted no later than 10 business
days after the date of the request, with the exception that records
covered by the immediate notification provision in Sec. 1.1123(c)
would be required to be submitted within 48 hours. By allowing records
to be submitted in a language other than English, we think that it will
not be unduly burdensome for recognized accreditation bodies to provide
most requested records electronically within 10 days.
We have tentatively concluded that the records maintenance and
access requirements in proposed Sec. 1.1124 are necessary for us to
adequately monitor recognized accreditation bodies, as we are directed
to do by section 422(a)(7) of the FD&C Act. For example, access to such
records could facilitate our determination of whether revocation of the
accreditation body's recognition is warranted.
Proposed Sec. 1.1124(c) further clarifies that recognized
accreditation bodies must not prevent or interfere with FDA's access to
the records accredited laboratories it accredits are required to
maintain under proposed Sec. 1.1153. When FDA requests, under proposed
Sec. 1.1153 or proposed Sec. 1.1159, that a laboratory submit or
provide FDA access to records the laboratory would be required to
maintain under proposed Sec. 1.1146(b) or proposed Sec. 1.1153, we
expect that the recognized accreditation body that accredits the
laboratory would not interfere with our access to such records.
Maintaining freedom of access to such records is important to
facilitate FDA's ability to provide general oversight of the food
testing program, with respect to both recognized accreditation bodies
and accredited laboratories.
8. What internal audit requirements must a recognized accreditation
body meet? (Proposed Sec. 1.1125)
Proposed Sec. 1.1125 would require a recognized accreditation body
to audit its compliance with the requirements under Sec. 1.1118(c) and
(d) as part of the internal audit that a recognized accreditation body
conducts under Sec. 1.1118(b). Requiring recognized accreditation
bodies to monitor their conformance to the requirements that are
specific to this program, as well as to the requirements of ISO/IEC
17011:2017, would ensure that accreditation bodies' internal audits
cover all the requirements of this program. As discussed, proposed
Sec. 1.1123(b)(1) would require the results of this audit to be
submitted to us.
E. Proposed Provisions About Procedures for Recognition of
Accreditation Bodies (Proposed Sec. Sec. 1.1128 Through 1.1133)
In these sections we propose how an accreditation body may apply
for recognition under this rule, propose procedures for recognition,
probation, revocation, and relinquishment of recognition of
accreditation bodies, and propose how FDA would oversee recognized
accreditation bodies.
1. How does an accreditation body apply to FDA for recognition or
renewal of recognition? (Proposed Sec. 1.1128)
This proposed rule would establish procedures for accreditation
bodies to follow when applying to FDA for recognition or renewal of
recognition. Proposed Sec. 1.1128(a) would provide that an
accreditation body seeking recognition must submit an application to
FDA demonstrating that it meets the eligibility requirements of
proposed Sec. 1.1113, which describes the proposed requirements for
accreditation bodies to become recognized to accredit laboratories to
conduct food testing under this program.
Similarly, proposed Sec. 1.1128(b) would require an accreditation
body seeking renewal of its recognition to submit a renewal application
to us demonstrating that it continues to meet the requirements of this
program.
Proposed Sec. 1.1128(c) clarifies that accreditation bodies
applying for recognition or renewal of recognition must submit
documentation of conformance with ISO/IEC 17011:2017, and documentation
of ILAC MRA signatory status demonstrating competence to ISO/IEC
17011:2017, in meeting the requirements of proposed Sec. 1.1113(a) and
(b) or proposed Sec. 1.1118(a) and (b), as applicable. Although we
recognize that documentation of ILAC MRA signatory status under this
program represents a determination that an accreditation body has
demonstrated competence to ISO/IEC 17011:2017, proposed Sec. 1.1128(c)
would require independent documentation that an accreditation body
demonstrates competence to ISO/IEC 17011:2017 to provide us additional
assurance that an accreditation body meets the specific requirements of
the standard. Independent documentation of ISO/IEC 17011:2017
competence could include the report of a peer evaluation by a regional
cooperation group or ILAC conducted as part of the
[[Page 59473]]
ILAC MRA application and evaluation process. An accreditation body
applying for recognition or renewal of recognition also would be
required to submit documentation demonstrating it meets the
requirements for accreditation bodies that are specific to this program
under proposed Sec. 1.1113(c) and (d) or proposed Sec. 1.1118(c) and
(d), as applicable. We would expect documentation of proposed Sec.
1.1113(c) and (d) to come in the form of documents such as standard
operating procedures, records procedures, the resumes of the scientific
and technical staff or contractors who review validation and
verification studies, and examples of contracts the accreditation body
uses in its activities, while documentation of proposed Sec. 1.1118(c)
and (d) would consist of documents created during the accreditation
body's term of recognition, such as the internal audit required under
proposed Sec. 1.1125. We request comments on what additional documents
would demonstrate that an accreditation body meets the requirements of
proposed Sec. 1.1113(c) and (d) and proposed Sec. 1.1118(c) and (d).
Where the application for recognition or renewal of recognition
does not sufficiently demonstrate that the accreditation body meets the
requirements for recognition by FDA, it may be necessary for FDA to
review additional documentation to determine whether the accreditation
body meets the recognition requirements of the program, and FDA also
may, as is noted by proposed Sec. 1.1129(b), request and conduct an
onsite assessment of the applicant if necessary. Such additional
documentation may include the accreditation body's reviews,
assessments, and investigations of laboratories; results of the
accreditation body's self-monitoring and internal audits; documents and
other information regarding the accreditation body's authority,
qualifications (including the expertise and training of its employees
that assess laboratories that conduct food testing), resources, quality
assurance program, and recordkeeping, reporting, notification, and
monitoring procedures. For applications for renewal of recognition, FDA
may also review documents and other information of one or more of the
laboratories that are accredited by the recognized accreditation body.
Applications for recognition and renewal are subject to certain
requirements for the form and manner of submission. Under paragraphs
(d) and (e) of proposed Sec. 1.1128 the accreditation body must submit
to FDA a signed application (signed by the applicant or by an
individual authorized to act on behalf of the applicant for purposes of
seeking recognition or renewal of recognition), accompanied by any
supporting documents, electronically and in English. We also propose to
require an applicant to provide any translation or interpretation
services we need to process the application. This may include providing
translators or interpreters for FDA staff conducting onsite assessments
of the applicant. We invite comment on our proposal to require
submissions in English and to require translation or interpretation
services as necessary.
2. How will FDA review applications for recognition and applications
for renewal of recognition? (Proposed Sec. 1.1129)
Under proposed Sec. 1.1129(a), FDA would review an accreditation
body's recognition or renewal application for completeness and would
notify the applicant of any deficiencies. We are proposing to review
applications on a first-in, first-out basis according to the date the
accreditation body submits the completed application. However, we may
prioritize the review of specific applications based on program needs.
To encourage applicants to supply any missing information promptly, we
will not place an application in the queue for review until it is
complete. Allowing incomplete applications in the queue might hold up
applications that are ready for review, but were submitted later in
time.
Under proposed Sec. 1.1129(b), FDA would evaluate applications to
determine whether the applicant meets the requirements for recognition
or renewal of recognition. The evaluation may include an onsite
assessment of the accreditation body. For renewal applications, if FDA
does not reach a final decision before an accreditation body's
recognition terminates by expiration, FDA may extend the terms of
recognition for a specified period of time or until FDA reaches a final
decision on the renewal application. Proposed Sec. 1.1129(b) further
provides that FDA would notify the applicant, in writing, regarding
whether the application has been approved or denied, and that we may
make such notification electronically.
Under proposed Sec. 1.1129(c), we would notify applicants of our
decision to approve the application for recognition or renewal through
issuance of recognition that would list any conditions associated with
the recognition, including the duration of recognition.
Proposed Sec. 1.1129(d) would allow us to grant recognition to an
accreditation body for up to 5 years at a time (except if FDA needs to
extend the term of recognition while it makes a renewal determination,
as described at proposed Sec. 1.1129(b)), although we will determine
the length of recognition on a case-by-case basis. We are proposing the
5-year upper limit in accordance with section 422(a)(7) of the FD&C
Act, which requires us to (in pertinent part), periodically, and in no
case less than once every 5 years, reevaluate accreditation bodies
recognized under this program to assess whether they meet the criteria
for recognition. We do not necessarily expect to grant every
recognition at the maximum 5-year duration. We believe that shorter
terms of recognition may potentially be appropriate in the initial
years of the food testing program or for any accreditation bodies with
fewer years of experience accrediting laboratories to conduct food
testing. When we proposed the same duration for recognition of
accreditation bodies for the accredited third-party certification
regulation, we received support for the proposal and for the
flexibility to determine the length of recognition on a case-by-case
basis, although we also did receive some comments expressing concern
that we did not propose a fixed duration of recognition (80 FR 74570 at
74601). As we noted in the accredited third-party certification final
rule, where appropriate, we would grant recognition for the maximum
duration of 5 years. Id. However, we also recognize it may be
appropriate for the duration of recognition to vary depending on a
number of factors, such as accreditation body experience and, for
example, whether the accreditation body has had problems meeting the
recognition requirements in the past.
Under proposed Sec. 1.1129(e), if we deny a recognition or renewal
application, we would notify the applicant, through an issuance of a
notification of denial of recognition or denial of renewal application,
that the accreditation body's recognition or renewal application has
been denied. The notification of denial of recognition or denial of
renewal application would state the basis for the denial and describe
the procedures for requesting reconsideration of the application under
Sec. 1.1171.
Proposed Sec. 1.1129(f) provides that an applicant whose
application for renewal or recognition was denied by FDA must notify
FDA electronically, in English, within 10 business days of the date of
issuance of a denial of a renewal application, of the name and contact
information of the custodian who will maintain the records it is
required to
[[Page 59474]]
maintain under proposed Sec. 1.1124(a) and to make them available to
FDA as required by proposed Sec. 1.1124(b). Proposed Sec. 1.1129(f)
would also require that the contact information for the custodian must
include, at a minimum, an email address and the street address where
the records required by proposed Sec. 1.1124 will be located. As noted
previously, under proposed Sec. 1.1124 accreditation bodies that have
been recognized must electronically maintain, for at least 5 years
after the date of creation of the records, records subject to proposed
Sec. 1.1124 that were created during the term of recognition.
Under proposed Sec. 1.1129(g), FDA would promptly issue a notice
of the denial of the application for renewal of recognition of the
accreditation body to all laboratories accredited by the accreditation
body whose application for renewal of recognition was denied.
Under proposed Sec. 1.1129(h), FDA would provide public notice on
the website described in proposed Sec. 1.1109 of the issuance of a
denial of a renewal application and include the date of the issuance of
the denial of a renewal application. This is the same approach we took
in the accredited third-party certification regulation with respect to
denials of renewal applications. See 21 CFR 1.631(h). We believe
notification of denial of renewal would be important information to
make easily available to interested parties and the public.
3. How will FDA oversee recognized accreditation bodies? (Proposed
Sec. 1.1130)
As noted above, section 422(a)(7)(A) of the FD&C Act requires us to
periodically, and in no case less than once every 5 years, reevaluate
recognized accreditation bodies. Section 422(a)(7)(B) of the FD&C Act
requires us to promptly revoke the recognition of a recognized
accreditation body for failure to meet the requirements of section 422
of the FD&C Act.
As we discuss above, proposed Sec. 1.1129(d) provides that we may
grant recognition of an accreditation body for a period not to exceed 5
years from the date of recognition. Proposed Sec. 1.1130(a) provides
that we will assess each recognized accreditation body to determine its
compliance with the applicable requirements of this proposed rule by no
later than 4 years after the date of recognition for a 5-year
recognition period, or by no later than the midterm point for a
recognition period of less than 5 years. Accordingly, we propose to
assess recognized accreditation bodies at least once during their
period of recognition, in addition to any assessment we may have
conducted during our review of an application for recognition and in
addition to any assessment we may conduct during a review of an
application for renewal of recognition. Proposed Sec. 1.1130(a)
provides that our assessment of a recognized accreditation body may
include review of records, an onsite assessment of the accreditation
body, and onsite assessments of accredited laboratories the recognized
accreditation body accredits, with or without the recognized
accreditation body present (we would conduct such onsite assessments
under proposed Sec. 1.1159).
Proposed Sec. 1.1130(b) provides that we may conduct additional
assessments of a recognized accreditation body, at any time, to
determine the recognized accreditation body's compliance with the
applicable requirements of the program. We may or may not notify the
recognized accreditation body that we will be conducting such an
assessment, which may be onsite.
Our assessments of recognized accreditation bodies under proposed
Sec. 1.1130 may be as brief or as extensive as is warranted and may
include our review of an accreditation body's accreditations,
assessments, and investigations of laboratories; results of an
accreditation body's internal audits; documents and other information
accreditation bodies are required maintain under Sec. Sec. 1.1118 and
1.1124 regarding the accreditation body's authority, qualifications,
resources, quality assurance program, and recordkeeping, reporting,
notification, and monitoring procedures.
4. When will FDA revoke the recognition of an accreditation body or put
a recognized accreditation body on probation? (Proposed Sec. 1.1131)
This proposed rule would establish the criteria and procedures for
revocation of recognition of an accreditation body. Section
422(a)(7)(B) of the FD&C Act requires us to promptly revoke the
recognition of any accreditation body found not to be in compliance
with the requirements of section 422 of the FD&C Act. Accordingly, if a
recognized accreditation body ceases to meet the criteria for
recognition we establish under section 422 of the FD&C Act, we must
revoke the recognized accreditation body's recognition.
Under proposed Sec. 1.1131(a), we would revoke the recognition of
an accreditation body if it fails to meet the requirements of this
program, or where FDA determines the accreditation body has committed
fraud or submitted material false statements to FDA.
Examples of what would qualify as a failure by a recognized
accreditation body to meet the requirements of this program would
include:
Refusing to allow FDA to access records as required by
proposed Sec. 1.1124, to allow FDA to conduct an onsite assessment
under proposed Sec. 1.1130, or to allow FDA to otherwise conduct an
assessment under proposed Sec. 1.1130. Denial of access and ability to
perform our oversight functions would prevent us from meeting our
statutory responsibilities under section 422 of the FD&C Act to
periodically reevaluate accreditation bodies and to promptly revoke the
recognition of an accreditation body found not to be in compliance with
section 422 of the FD&C Act.
Demonstrating bias or lack of objectivity when conducting
activities under this rule would violate the impartiality requirements
of ISO/IEC 17011:2017, which recognized accreditation bodies must meet
in accordance with Sec. 1.1118(b).
Failing to take timely and appropriate corrective action
in accordance with ISO/IEC 17011:2017 (Ref. 12) section 9.5 (which
proposed Sec. 1.1118(b) of this rule would require the recognized
accreditation body to comply with) after the recognized accreditation
body identifies, or should have identified, that the recognized
accreditation body is not operating in conformance with one or more
requirements of this proposed rule.
Fraud or the submission of material false statements by recognized
accreditation bodies would undermine our ability to implement the
program and would undermine the program's integrity and credibility. We
request comment on whether this section should also allow for FDA to
revoke a recognized accreditation body's recognition for ``other good
cause.'' If you submit a comment in favor of adding such a provision,
we request the comment provide one or more examples of what would
constitute such other good cause (and yet would not otherwise support
revocation under the proposed Sec. 1.1131(a)).
Proposed Sec. 1.1131(b)(1) provides that, when we revoke an
accreditation body's recognition we would notify the accreditation body
that its recognition has been revoked through the issuance of a
revocation stating the grounds for revocation, the procedures for
requesting a regulatory hearing on the revocation under proposed Sec.
1.1173, and the procedures for requesting reinstatement of recognition
under proposed Sec. 1.1133.
[[Page 59475]]
Proposed Sec. 1.1131(b)(2) would require the accreditation body
to, within 10 business days of the date of issuance of revocation,
notify us electronically, in English, of the name of the custodian who
will maintain records and make them available to FDA as required by
proposed Sec. 1.1124. Proposed Sec. 1.1131(b)(2) further provides
that the contact information for the custodian must include, at a
minimum, an email address and the street address where the records will
be located. As we have discussed previously, the accreditation body's
responsibility under this proposed rule to maintain certain records
created while it was recognized does not end when the accreditation
body is no longer recognized.
Proposed Sec. 1.1131(c) provides that if we determine that a
recognized accreditation body has demonstrated deficiencies in
performing its functions under this proposed rule that are less serious
and more limited than those identified in proposed Sec. 1.1131(a), and
it is reasonably likely that the accreditation body will be able to
correct such deficiencies within a reasonable period of time, we may
temporarily put the recognized accreditation body on probation, rather
than revoke its recognition, and request that the accreditation body
take appropriate corrective actions. We expect that the probationary
status of a recognized accreditation body would allow us to work with
the recognized accreditation body to bring it into compliance with the
requirements of the program without having to resort to the more
permanent remedy of revoking recognition.
Proposed Sec. 1.1131(d) provides that the probationary status of
the recognized accreditation body would remain in effect until the
recognized accreditation body demonstrates to our satisfaction that it
has successfully addressed the deficiencies specified by FDA within the
time period identified by FDA. Proposed Sec. 1.1131(d) also provides
that, alternatively, the probationary period would end if we determine
that revocation of recognition is warranted. We would likely determine
that revocation of recognition is appropriate if the accreditation body
fails or refuses to take appropriate corrective actions, or otherwise
does not comply with the conditions specified by the notification of
probation within the timeframe specified, or if appropriate, an
otherwise reasonable timeframe.
Proposed Sec. 1.1131(e) provides that if we put the recognized
accreditation body on probation, we would formally notify the
accreditation body of its probation. The notification would describe
the grounds for the probation, identify all deficiencies that must be
corrected for us to lift the probation, would identify a specified
period of time to take certain corrective actions to address the
deficiencies specified by us.
Proposed Sec. 1.1131(f) would provide that an accreditation body
that has had its recognition revoked may not accredit laboratories
under this program or continue to oversee the laboratories it has
previously accredited. This provision would also clarify that a
recognized accreditation body that has been put on probation by FDA is
expected to continue to oversee laboratories that it has accredited
under this subpart and is permitted to continue to accredit
laboratories under Sec. 1.1120 of this subpart. We would normally
anticipate that such an accreditation body would continue to fulfill
its responsibilities under this program during the probationary period.
Note that FDA may conduct additional oversight of recognized
accreditation bodies that are on probation, to help ensure quality and
competency on the part of that particular accreditation body (and by
extension for the integrity of the overall program).
Proposed Sec. 1.1131(g) provides that FDA would issue a notice of
the probation or revocation of recognition to all laboratories
accredited by the accreditation body whose recognition was revoked or
who was put on probation. In proposed Sec. 1.1164, we address the
effects on accredited laboratories of the revocation of the recognition
of their accreditation bodies.
Proposed Sec. 1.1131(h) clarifies that we would also provide
notice on the website described in proposed Sec. 1.1109, in accordance
with proposed Sec. 1.1109, of our issuance of probation or revocation
of recognition of the accreditation body. This is consistent with the
provisions of proposed Sec. 1.1109.
We solicit comments on our tentative conclusions regarding possible
grounds for probation and revocation of recognition, and with respect
to the procedures and requirements we have proposed here related to
revocation and probation of recognition.
5. What must a recognized accreditation body do if it wants to
voluntarily relinquish its recognition or does not want to renew its
recognition? (Proposed Sec. 1.1132)
Proposed Sec. 1.1132 requires a recognized accreditation body that
voluntarily relinquishes its recognition before the recognition period
terminates by expiration to follow certain procedures. Relinquishment
on the initiative of the accreditation body is distinct from revocation
of recognition under proposed Sec. 1.1131 and is a mechanism provided
to recognition bodies in the accredited third-party certification
regulation and under FDA's mammography program. See 21 CFR 1.635 and 21
CFR 900.3(e). We are proposing certain procedural requirements, similar
to those in the mammography and third-party accreditation programs,
which accreditation bodies would be required to follow in relinquishing
recognition or when a recognized accreditation body intends to allow
its recognition to expire without seeking renewal. We believe these
procedures are necessary to ensure an orderly transition for
laboratories accredited by an accreditation body that is relinquishing
its recognition or allowing it to expire and for us to make necessary
adjustments in the program based on that relinquishment or expiration.
Proposed Sec. 1.1132(a) describes the procedures that a recognized
accreditation body would need to follow when it intends to relinquish
its recognition or when it wishes to allow its recognition to expire
without seeking renewal. In order to voluntarily relinquish its
recognition or allow it to expire, a recognized accreditation body
would need to notify FDA electronically and in English at least 60 days
before voluntarily relinquishing its recognition or allowing its
recognition to expire.
Proposed Sec. 1.1132(a) would also require the recognized
accreditation body to provide the name and contact information of the
custodian who will maintain the records required under proposed Sec.
1.1124 after the date of relinquishment or the date its recognition
expires, as applicable, and make such records available to FDA as
required by proposed Sec. 1.1124. The contact information for the
custodian must include, at a minimum, an email address and the street
address where the records required by proposed Sec. 1.1124 will be
located.
Under proposed Sec. 1.1132(b), we would require the accreditation
body to notify the laboratories it had accredited that the
accreditation body intends to relinquish its recognition or to allow
its recognition to expire, specifying the date on which relinquishment
or expiration will occur, and at least 60 days in advance.
Proposed Sec. 1.1132(c) states that we would provide notice on the
website described in proposed Sec. 1.1109 of the voluntary
relinquishment or expiration of recognition of an accreditation body.
This provision is consistent with the provisions of proposed Sec.
1.1109, which
[[Page 59476]]
would establish what information we would display on the website
described by Sec. 1.1109.
6. How does an accreditation body request reinstatement of recognition?
(Proposed Sec. 1.1133)
This proposed section describes the procedures that an
accreditation body would have to follow when seeking reinstatement of
its recognition. The procedures the accreditation body would be
required to follow would differ depending on whether we revoked the
accreditation body's recognition or the accreditation body voluntarily
relinquished its recognition or allowed its recognition to expire.
Under proposed Sec. 1.1133(a), an accreditation body that has had
its recognition revoked may seek reinstatement of recognition by
submitting a new application for recognition under proposed Sec.
1.1128. The accreditation body must also submit evidence to us that the
grounds for revocation have been resolved, including evidence
addressing the cause(s) or condition(s) that were the basis for
revocation, and it must identify measures it implemented to help ensure
that such cause(s) or condition(s) are unlikely to recur.
Under proposed Sec. 1.1133(b), an accreditation body that
previously relinquished its recognition or allowed its recognition to
expire may seek recognition by submitting a new application for
recognition under proposed Sec. 1.1128.
F. Proposed Provisions About Accreditation of Laboratories (Proposed
Sec. 1.1138)
This proposed rule would establish the requirements for a
laboratory seeking accreditation by a recognized accreditation body to
test food in this program. Section 422(a)(2) and (a)(5) of the FD&C Act
mention independent private laboratories, laboratories run and operated
by Federal agencies, States, localities, and foreign laboratories, as
examples of laboratories that recognized accreditation bodies may
accredit under this program, so long as they meet accreditation
requirements for our program. We expect a variety of these types of
laboratories would apply to this program. With regard to States in
particular, it is our understanding that State and public university
laboratories currently conduct a significant portion of the shell egg
testing which would be covered by this proposed rule. We therefore
believe some state laboratories would apply.
Section 422 of the FD&C Act contains requirements for laboratories
to be accredited, including that they have a demonstrated capability to
conduct one or more sampling and analytical testing methodologies for
food (section 422(a)(2)) and that they meet model laboratory standards
that FDA is required to develop (section 422(a)(6)).
Section 422(a)(6) of the FD&C Act further requires that the model
laboratory standards include methods to ensure that: (1) Appropriate
analytical procedures (including rapid analytical procedures), and
commercially available techniques are followed and reports of analyses
are certified as true and accurate (section 422(a)(6)(A)(i)); (2)
internal quality systems are established and maintained (section
422(a)(6)(A)(ii)); (3) procedures exist to evaluate and respond
promptly to complaints regarding analyses and other activities for
which the laboratory is accredited (section 422(a)(6)(A)(iii)); and (4)
individuals who conduct the analyses are qualified by training and
experience to do so (section 422(a)(6)(A)(iv)). Section 422(a)(6)(B) of
the FD&C Act also authorizes us to include in the model laboratory
standards any other criteria we determine are appropriate.
Section 422(a)(6) of the FD&C Act directs us to consult existing
standards for guidance in developing the model laboratory standards for
use in qualifying laboratories for accreditation. As discussed, we have
consulted, and propose to incorporate by reference, ISO/IEC 17025:2017.
The model laboratory standards we are proposing consist of ISO/IEC
17025:2017, which laboratories would be required to meet (except for a
few provisions, as we discuss in more detail below) to become
accredited in accordance with proposed Sec. 1.1138(a)(2), and our
additional proposed requirements in Sec. Sec. 1.1146 through 1.1158.
For example, ISO/IEC 17025:2017 (Ref. 13) section 7.9 requires
accredited laboratories to establish a process for evaluating and
responding to complaints, which we tentatively conclude would fulfill
the model laboratory standard requirement of section 422(a)(6)(A)(iii)
of the FD&C Act.
We carefully considered whether to include a sampling accreditation
requirement in the proposed rule. Proper sampling procedures are
essential in order for analytical testing results to convey meaningful
information about the food product or environment at issue.
Accreditation for sampling could increase confidence in the training
and procedures of samplers and potentially help ensure the collection
of representative samples.
According to our analysis (Ref. 1) of the applicable data stored in
our internal systems, from January 1, 2016, to December 31, 2017,
approximately 63 percent of sampling conducted for analysis in support
of admission of food offered for import that we had detained without
physical examination was conducted by five entities accredited for
sampling under ISO/IEC 17025. Approximately 37 percent of such sampling
conducted during that time was conducted by more than 300 entities not
accredited for sampling under any standard.
It is our understanding that whereas under the 2005 version of ISO/
IEC 17025 only laboratories are eligible for accreditation, starting
with the 2017 version of ISO/IEC 17025, entities that do not conduct
any analyses (i.e., an entity that solely collects samples) may be
considered for accreditation for sampling under ISO/IEC 17025. It is
also our understanding that it will take some time to develop and
implement this new policy. Some of the larger laboratory accreditation
bodies in the United States indicated that demand for accrediting
entities that only conduct sampling is still relatively small, and thus
far, these accreditation bodies have not performed accreditation
assessments of such entities. (See Meeting Minutes, ``Sampling
Accreditation Discussion with A[ccreditation] B[odie]s,'' November 13,
2017 (Ref. 14).) As the ISO/IEC 17025 revision is still relatively new,
FDA is not able to adequately assess the accreditation of entities that
only conduct sampling at this time.
Given these considerations, we are not proposing requirements for
the accreditation of sampling in this proposed rule. However, we
strongly encourage all samplers to consider accreditation, and we may
reassess our position after accreditation bodies have gained experience
with accrediting entities that only conduct sampling. We will watch
developments in this area with interest, and would be willing to
consider expanding the proposed program to include accreditation of
laboratories and sampling services to perform sampling in the future.
While we are not proposing requirements for accreditation of
samplers, we invite comment on the matter. More specifically, what is
the current capacity of accredited sampling entities, both laboratories
and sampling services (i.e., entities that only perform sampling)? Are
there attributes unique to sampling that present challenges in terms of
the continued development of this field? What existing standards (e.g.,
[[Page 59477]]
ISO/IEC 17025, ISO 9001, ISO/IEC 17020) would be best to use as a basis
for developing a more comprehensive and focused consensus sampling
standard? What are the critical detailed requirements that should be
included in a consensus sampling standard to ensure food safety? What
standards are currently employed to assess samplers, are they
effective, and in what ways are they insufficient?
We note that because we are not proposing accreditation for
sampling under this proposed rule, we would not expect laboratories
seeking to become accredited under this program to demonstrate the
capability to conduct sampling methods under this program if finalized.
If we were to propose to require accreditation for sampling under the
authority of section 422 of the FD&C Act in the future, at that time we
would likely propose that entities seeking to become accredited for
sampling would have to demonstrate the capability to conduct one or
more methods of sampling for food testing.
What requirements must a laboratory meet to become accredited by a
recognized accreditation body? (Proposed Sec. 1.1138)
Proposed Sec. 1.1138 states the requirements a laboratory must
meet to be accredited by a recognized accreditation body to conduct
food testing under this program.
Section 422(a)(2) of the FD&C Act requires, in pertinent part, that
this program provide for the accreditation of laboratories with a
demonstrated capability to conduct one or more analytical testing
methodologies for food and section 422(b)(1) of the FD&C Act requires,
in pertinent part, that food testing under this program be conducted by
laboratories that have been accredited for the appropriate analytical
testing methodology. We have considered these two provisions and
propose to interpret section 422(b)(1) as requiring laboratories to be
accredited on a method-specific basis, and to interpret section
422(a)(2) of the FD&C Act to mean that a laboratory may become
accredited even if it seeks to be accredited for a single method.
Accordingly, proposed Sec. 1.1138(a)(1) would require that a
laboratory seeking to be accredited must demonstrate that it is capable
of conducting each method of food testing for which it seeks to be
accredited. The laboratory would have to do so by meeting the
requirements described under proposed Sec. 1.1138(a)(1)(i) and (ii).
Proposed Sec. 1.1138(a)(1)(i) and (ii) clarify how an accredited
laboratory must demonstrate it is capable of conducting each method for
which it seeks to be accredited. Proposed Sec. 1.1138(a)(1)(i)
provides that a laboratory must do so by submitting information related
to validation or verification studies.
Validation studies are required in certain circumstances by ISO/IEC
17025:2017 (Ref. 13) section 7.2, which we have already incorporated by
reference, but which we would explicitly require in proposed Sec.
1.1151(c)(1). For example, a validation study would be required when a
laboratory seeks to be accredited for a non-standard method or for a
standard method it will use outside the method's intended application.
Validation is meant to demonstrate that a method is suitable for the
intended purpose.
Method verification is meant to verify that the laboratory can
properly apply the method for a specific intended use, specifically
with respect to the limit of detection or probability of detection. We
would require verification studies in proposed Sec. 1.1151(d)(1), and
proposed Sec. 1.1151(d)(2) would require an accredited laboratory to
record certain information related to a verification study (e.g., the
results of the verification, supporting analytical data) (we discuss
proposed Sec. 1.1151(d)(1) and (2) in more detail in section VI.G.7).
Under this program, a laboratory may demonstrate that it is capable of
conducting a particular method by submitting to the recognized
accreditation body the verification study information required in
proposed Sec. 1.1151(d)(2).
To be clear, under this program a laboratory may fulfill the
requirements of proposed Sec. 1.1138(a)(1)(i) by submitting to the
recognized accreditation body either validation study information or
verification study information.
Proposed Sec. 1.1138(a)(1)(ii) provides that the laboratory must
also, in order to demonstrate it is capable of conducting a method of
food testing for which it seeks to be accredited, pass, or have passed
within the past year, a proficiency test for the method(s), subject to
the exception that if the laboratory determines there is no proficiency
testing program available that addresses the method, or that
proficiency testing for the method is otherwise impracticable, the
accredited laboratory may instead subject, or have subjected in the
past year, the method to an appropriate comparison program. This
proposed requirement and exception reflect a similar requirement and
exception in AOAC International's Guidelines for Laboratories
Performing Microbiological and Chemical Analyses of Food, Dietary
Supplements, and Pharmaceuticals, An Aid to Interpretation of ISO/IEC
17025:2005 (April 2015 revision) (AOAC 17025 Guidelines) (Ref. 9) at
section 5.9.1. Proposed Sec. 1.1138(a)(1)(ii) further provides that
the laboratory's determination there is no proficiency testing program
available that addresses the method must be reviewed, and approved or
denied (as appropriate), by the recognized accreditation body from
which the laboratory is seeking accreditation. For more information
about the exception in proposed Sec. 1.1138(a)(1)(ii), please see our
discussion of proposed Sec. 1.1148(a)(2) below at section VI.G.3.
Under proposed Sec. 1.1138(a)(2) a laboratory seeking
accreditation under this program must demonstrate it meets (or, with
respect to activities the laboratory may only conduct once accredited,
is capable of meeting) the requirements of ISO/IEC 17025:2017. ISO/IEC
17025:2017 sets general standards for the competence of testing
laboratories, including general management requirements such as
impartiality and quality assurance. There are, however, a few
provisions in ISO/IEC 17025:2017 that we propose to exclude from our
requirements, as reflected in proposed Sec. 1.1138(b). Section 7.3 of
ISO/IEC 17025:2017 (Ref. 13), which addresses sampling, would be
excluded because, as discussed previously, we are not proposing
accreditation of sampling (see the introduction to section VI.F for
additional discussion of this issue). We also are not proposing to
require laboratories to meet ISO/IEC 17025:2017 section 7.8, which
describes requirements for reporting test results to customers, to
avoid potential conflicts with proposed Sec. 1.1152, which contains
requirements for the food testing results and supporting documentation
that are necessary for us to assess the validity of food testing
conducted under this program. We are also proposing in Sec. 1.1138(b)
that laboratories seeking accreditation are not required to meet, or
demonstrate that they are capable of meeting, requirements of ISO/IEC
17025:2017 that relate to the relationship between the laboratory and
its customers, to the extent that such provisions establish obligations
that conflict with the requirements of this rule. For example, ISO/IEC
17025:2017 section 7.1.1(d) would require the laboratory to ensure that
the methods it uses are capable of meeting the customers' requirements,
ISO/IEC 17025:2017 section 7.2.1.4 indicates that the laboratory's
customer may choose
[[Page 59478]]
the method of analysis to be used for food testing, and ISO/IEC
17025:2017 section 7.2.1.7 would restrict the laboratory from deviating
from a method if the customer does not accept the deviation. As such,
requiring accredited laboratories to meet all of the customer
requirement provisions of ISO/IEC 17025:2017 could create potential
conflicts with the requirements of section 422 of the FD&C Act.
Proposed Sec. 1.1138(c) would require laboratories seeking
accreditation to demonstrate they are capable of meeting and operating
in conformance with all of this subpart's requirements for accredited
laboratories. For example, under proposed Sec. Sec. 1.1152 and 1.1153
laboratories would have to meet certain requirements specific to this
program relating to reporting, notifications, and records, and under
proposed Sec. 1.1148 laboratories would have to meet certain quality
assurance requirements specific to this program and beyond the
requirements in ISO/IEC 17025:2017. A laboratory would have to
demonstrate that it has implemented written procedures to meet those
requirements of this proposed rule so that it will be able to comply
with such requirements once it is accredited.
G. Proposed Requirements for Accredited Laboratories (Proposed
Sec. Sec. 1.1146 Through 1.1153)
Proposed Sec. Sec. 1.1146 through 1.1153 would establish certain
model laboratory standards that accredited laboratories must meet to
remain accredited. In accordance with section 422(a)(6)(A) of the FD&C
Act, these model laboratory standards would help ensure that
appropriate analytical procedures and commercially available techniques
are followed and reports of analyses are certified as true and
accurate; internal quality systems are established and maintained;
procedures exist to evaluate and respond promptly to complaints
regarding analyses for which the laboratory is accredited; and
individuals who conduct analyses are qualified by training and
experience to do so. In accordance with section 422(a)(6)(B) of the
FD&C Act, we have also proposed additional requirements that
laboratories would have to meet to remain accredited, such as certain
requirements relating to methods of analysis, notifications and
submissions to FDA, and recordkeeping.
1. What are the general requirements for accredited laboratories to
remain accredited? (Proposed Sec. 1.1146)
Proposed Sec. 1.1146 provides that for an accredited laboratory to
remain accredited, the accredited laboratory must be capable of
conducting each method of analysis for the testing of food for which it
is accredited, continue to conform to the applicable provisions of ISO/
IEC 17025:2017, and fulfill the additional requirements of this
subpart. For a discussion of why we believe these ISO/IEC 17205:2017
requirements are important for laboratories to meet to be accredited
under this proposed rule, please see our previous discussion of
proposed Sec. 1.1138 in section VI.F.1.
2. What impartiality and conflict of interest requirements must
accredited laboratories meet? (Proposed Sec. 1.1147)
Proposed Sec. 1.1147 would require accredited laboratories to meet
certain requirements related to impartiality and conflicts of interest
in addition to those impartiality and conflict of interest requirements
of ISO/IEC 17025:2017 they would have to meet in accordance with
proposed Sec. 1.1146(b).
ISO/IEC 17025:2017 contains several requirements related to
impartiality and conflicts of interest that accredited laboratories
would have to meet under proposed Sec. 1.1146(b). For example, ISO/IEC
17025:2017 (Ref. 13) section 4.1 requires the laboratory to conduct its
activities impartially and to be structured and managed so as to
safeguard impartiality, to not allow commercial, financial, or other
pressures to compromise its impartiality, and that, if a risk to
impartiality is identified, the laboratory must be able to demonstrate
how the laboratory eliminates or minimizes the risk.
However, we have tentatively determined that additional
requirements related to impartiality and conflicts of interest are
appropriate in the context of this rule. With certain exceptions,
proposed Sec. 1.1147(a) would prohibit the accredited laboratory's
officers, employees, contractors, and agents involved in food testing
and related activities from accepting any money, gift, gratuity, or
other item of value from the owner or consignee of the food that is
being tested or will be tested by the accredited laboratory. Proposed
Sec. 1.1147(b)(1) and (2) provide the caveats that the prohibited
items of value specified in proposed Sec. 1.1147(a) do not include
payment of fees for food testing services or reimbursement of direct
costs associated with the food testing by the accredited laboratory.
With respect to accredited laboratories that are owned by the owner or
consignee of the food that is tested or to be tested, proposed Sec.
1.1147(b)(3) provides that the prohibited items of value specified in
proposed Sec. 1.1147(a) also do not include the officer's, employee's,
contractor's, or agent's compensation in the normal course of business.
Proposed Sec. 1.1147(c) would require the owner or consignee's
payment to the accredited laboratory for food testing services and/or
reimbursement of direct costs associated with food testing to be
independent of whether the test results indicate the tested food is or
appears to be violative. It is crucial that the accredited laboratory
be able to conduct its testing without fear of receiving reduced
payment or no payment from the owner or consignee if the food testing
results are violative. We seek comment with respect to whether there
are more effective provisions that might achieve the aim of impartial
food testing.
3. What quality assurance requirements must accredited laboratories
meet? (Proposed Sec. 1.1148)
Proposed Sec. 1.1148 would establish quality assurance
requirements accredited laboratories must meet for proficiency testing
and the use of reference materials and quality control samples, in
addition to the ISO/IEC 17025:2017 quality assurance requirements
accredited laboratories would need to meet under proposed Sec.
1.1146(b). Specifically, under proposed Sec. 1.1146(b), accredited
laboratories would have to develop, maintain, and implement a
complaints program (see ISO/IEC 17025:2017 (Ref. 13) section 7.9), a
program to control nonconforming testing work (see ISO/IEC 17025:2017
section 7.10), a program to continually improve (see ISO/IEC 17025:2017
section 8.6), a corrective action program (see ISO/IEC 17025:2017
section 8.7), an internal audit program (see ISO/IEC 17025:2017 section
8.8), a management review program (see ISO/IEC 17025:2017 section 8.9),
and policies for ensuring the validity of test results (see ISO/IEC
17025:2017 section 7.7).
As described by ISO/IEC 17025:2017, proficiency testing evaluates
laboratory performance against established criteria. ISO/IEC 17025:2017
(Ref. 13) section 7.7.2 provides that accredited laboratories must
participate in proficiency testing and/or interlaboratory comparison
programs other than proficiency testing. ISO/IEC 17011:2017 (which
applies to accreditation bodies), indicates that the accreditation
body's review of proficiency test results may help it assess
laboratories, but ISO/IEC 17011:2017 does not require accreditation
bodies to require the laboratories they accredit to participate in a
proficiency testing program (ISO/
[[Page 59479]]
IEC 17011:2017 (Ref. 12) at section 3.24 n.1). Although both ISO/IEC
standards address proficiency testing, we are proposing more specific
proficiency testing requirements in this document to support the
regular evaluation of the performance of accredited laboratories in
this program.
Proposed Sec. 1.1148(a)(1) would require accredited laboratories
to participate in a proficiency testing program or programs, provided
by a competent proficiency testing organization, and ensure that
proficiency testing is conducted at least once per year for each method
within the accredited laboratory's scope of accreditation (subject to
an exception in proposed Sec. 1.1148(a)(2), which we discuss below).
In developing proposed Sec. 1.1148(a), we considered how various
existing standards address the frequency and coverage of laboratory
proficiency testing. Some accreditation bodies that accredit food
testing laboratories require laboratories they accredit to conduct
proficiency testing on their entire scope of accreditation over a four-
year accreditation period and participate in at least one proficiency
testing activity per year. (See, e.g., ``R103--General Requirements:
Proficiency Testing for ISO/IEC Laboratories,'' American Association
for Laboratory Accreditation (Ref. 15), at p. 6; and ``Accreditation
Requirements: ISO/IEC 17025 Testing Laboratories (Non-Forensics),''
ANSI/ASQ National Accreditation Board (Ref. 16), at pp. 4-5). We note
that if only one proficiency testing activity takes place each year,
the bulk of proficiency testing for a laboratory's scope of
accreditation could occur at one time during the laboratory's
accreditation period. We tentatively conclude that requiring yearly
proficiency testing for each method on a laboratory's scope of
accreditation would encourage more periodic proficiency testing
throughout the accreditation period. This element of proposed Sec.
1.1148(a) is based on the AOAC 17025 Guidelines (Ref. 9) at section
5.9.1, which provides that laboratories participate in at least one
proficiency test annually for each ``test, type of test/method, and/or
technique on the scope of accreditation''. Periodic proficiency testing
throughout the four-year accreditation period should also help the
accredited laboratory manage its other ongoing quality assurance
activities (e.g., its control of nonconforming testing work under ISO/
IEC 17025:2017 (Ref. 13) section 7.10 and its program to continually
improve under ISO/IEC 17025:2017 section 8.6). We seek comments on our
proposed requirements for the frequency of proficiency testing.
We are proposing to require in Sec. 1.1148(a)(1) that the
proficiency test provider be ``competent.'' We note that ISO/IEC
17043:2010, ``Conformity Assessment--General Requirements for
Proficiency Testing'' (Ref. 17) provides specific standards for
proficiency test providers. We are requesting comment on whether, and
if so, under what circumstances, we should require accredited
laboratories to only use proficiency test providers accredited to ISO/
IEC 17043 for proficiency testing under this proposed rule.
Proposed Sec. 1.1148(a)(2) describes an exception to the proposed
proficiency testing requirement. Proposed Sec. 1.1148(a)(2) states
that if the accredited laboratory determines there is no proficiency
testing program available that addresses a particular method of
analysis in the accredited laboratory's scope of accreditation, or that
participating in a proficiency testing program for the particular
method is otherwise impracticable, the accredited laboratory may
subject that method to an appropriate comparison program. The
laboratory's determination must be reviewed, and approved or denied (as
appropriate), by the recognized accreditation body that accredits the
laboratory. The AOAC 17025 Guidelines (Ref. 9) at section 5.9.1 provide
a helpful list of examples of such alternative comparison programs.
Proposed Sec. 1.1148(b) would require accredited laboratories to
ensure their procedures for monitoring the validity of the results of
testing it conducts under this program include the use of reference
materials or quality control samples with each batch of samples it
tests under this program. This requirement reflects a similar
requirement in the AOAC 17025 Guidelines (Ref. 9), at section 5.9.1.
ISO/IEC 17025:2017 (Ref. 13) section 7.7, which accredited laboratories
must comply with under proposed Sec. 1.1146(b), requires that
laboratories' procedures for monitoring the validity of their results
``include, where appropriate'' use of reference materials or quality
control materials. We tentatively agree with the AOAC 17025 Guidelines
that it is always appropriate to use of reference materials or quality
control samples when conducting food testing. Therefore, to encourage
clarity and consistency with respect to the use of reference materials
and quality control samples under this program, we have proposed to
adopt the AOAC 17025 Guidelines' position on this issue.
4. What oversight standards apply to sampling? (Proposed Sec. 1.1149)
Because we are not proposing accreditation for sampling, we are not
proposing model standards for sampling. However, whether a sample is
collected and maintained properly is integral to whether analysis of
that sample will produce information that is of regulatory
significance. For example, if the analyzed sample(s) is not
representative of the food product or environment at issue, the
analysis of the sample(s) will not result in information that is
meaningful with respect to the food product or environment at issue.
Accordingly, we are proposing provisions that would allow us to
exercise oversight over the sampling conducted as part of this program.
Proposed Sec. 1.1149 would require the accredited laboratory to
develop or obtain (depending on whether the accredited laboratory or a
different entity collected the sample) and submit to FDA certain
information about the sampler and sampling before the accredited
laboratory analyzes the collected sample.
Specifically, proposed Sec. 1.1149(a) would require that, before
the accredited laboratory analyzes the sample, it must either develop
(if it collected the sample) or obtain (if another entity collected the
sample) the following documentation:
Written documentation of the sampler's applicable
qualifications by training and experience. If the accredited laboratory
collects the sample, the accredited laboratory would need to develop
such documentation the first time the individual collects a sample
under this subpart. If another entity collects the sample, the
accredited laboratory would need to obtain such documentation the first
time it receives a sample collected under this subpart from that
sampler. The accredited laboratory must also develop or obtain such
documentation if the accredited laboratory learns that the sampler's
qualifications have significantly changed since the accredited
laboratory last developed or obtained documentation of the sampler's
qualifications.
A written sampling plan used to conduct the sampling. The
written sampling plan must identify the sampler and must list factors
that will be controlled to ensure the sampling does not impact the
validity of the subsequent analytical testing, including controlling
for the representational nature of the sample. This information would
help us determine whether the sampling conducted would result in a
[[Page 59480]]
sample that is representative of the food product or environment in
question. Identification of the sampler would allow us to determine
whether we have the sampler's qualifications on file already and/or
whether their qualifications may now be significantly different.
A written sample collection report for each sample
collected. The written sample collection report must, at a minimum,
include:
[cir] The product code of the food product sampled (if product is
being sampled) or the location of and a description of the environment
(if environment is being sampled). This information would help us
determine whether the correct lot or lots were sampled and whether the
sample is otherwise representative of the food product or environment
in question.
[cir] The date(s) of the sampling. This information would help us,
in part, identify whether certain lots were sampled and help us review
the chain of custody of the sample. For example, if the sample was
collected a significant amount of time before the analysis, we may
evaluate whether the documented chain of custody procedures for the
sample would have preserved the sample's integrity.
[cir] The size, identity, and quantity of the sample(s). This
information would help us determine whether the sample is
representative of the food product or environment in question.
[cir] Documentation of sample collection procedures and any sample
preparation techniques. This information would help us determine
whether the sampling resulted in a sample that is representative of the
food product or environment at issue.
[cir] Documentation of the chain of custody of the sample(s), and
of measures taken, to not impact the validity of the subsequent
analytical testing, including controlling for the representational
nature of the sample(s). This information would help us determine
whether the sample received by the laboratory is the sample that was
collected from the product or environment at issue and whether the
integrity of the collected sample was compromised between collection of
the sample and its analysis. Documentation of the chain of custody
should account for the continuous custody of the sample and indicate
any gaps in the chain of custody. Documentation of measures taken to
not impact the validity of the subsequent analytical testing, including
controlling for the representational nature of the sample(s), might
include, for example, documentation of the use of tamper-evident
containers, use of secure storage spaces, and any refrigeration or
freezing of the sample. The documentation should indicate at what point
in the chain of custody such measures were taken.
Proposed Sec. 1.1149(b) clarifies that we may consider the
analysis of a sample to be invalid if the requirements of Sec.
1.1149(a) are not met.
5. What requirements apply to analysis of samples by an accredited
laboratory? (Proposed Sec. 1.1150)
Proposed Sec. 1.1150 would establish standards that laboratory
analysis conducted under this proposed rule would need to meet,
procedures the analysis would need to follow, and other requirements
such as the qualifications of the individuals who perform the analysis.
Proposed Sec. 1.1150 explicitly states that accredited laboratories
must meet the requirements of this section in addition meeting to the
requirements in ISO/IEC 17025:2017 relating to analysis that an
accredited laboratory is required to meet under Sec. 1.1146(b).
Proposed Sec. 1.1150(a) would require the analysis to be conducted
on either the sample(s) received, or, if appropriate for the analysis,
on a representative sample of the sample(s) received. Because the
sample(s) received may consist of too much material to analyze in its
entirety, a laboratory will often take a subsample(s) from the
sample(s) received. The laboratory must ensure that it follows
appropriate procedures so that the subsample(s) they analyze are
representative of the lot. For example, in some circumstances it may be
appropriate to homogenize the sample(s) by grinding, sieving, blending,
or mixing the original sample(s) and taking a subsample(s) from the
resulting mixture.
Proposed Sec. 1.1150(b) would require that the analyst(s) that
conducts the analysis be qualified by appropriate education, training,
and/or experience to conduct the analysis; to have appropriately
demonstrated their ability to conduct the method properly in the
specific context of the food testing to be conducted; and to be in
compliance with the conflict of interest requirements of proposed Sec.
1.1146(b) (i.e., the applicable sections of ISO/IEC 17025:2017) and
proposed Sec. 1.1147. Of note, under proposed Sec. 1.1152(g)(12)
(which we discuss in more detail at section VI.G.8), the laboratory
must provide certain information about the analyst's or analysts'
qualifications to us at our request.
Proposed Sec. 1.1150(c) clarifies that the method used to conduct
the food testing must meet the requirements of proposed Sec. 1.1151
(requirements for methods of analysis, which we discuss at section
VI.G.7).
Proposed Sec. 1.1150(d) requires that the accredited laboratory
document the testing information and test results to the extent
necessary to account for all information that is required to be
included in a full analytical report. Please see our discussion of
proposed Sec. 1.1152(g) for more information about what information
full analytical reports must contain.
5. What requirements apply to the methods of analysis an accredited
laboratory uses to conduct food testing under this subpart? (Proposed
Sec. 1.1151)
Food testing subject to section 422(b)(1) of the FD&C Act must be
conducted by accredited laboratories that have been accredited for the
appropriate analytical testing methodology or methodologies.'' Proposed
Sec. 1.1151 would establish certain requirements with regard to
methods of analysis, which would apply in addition to the requirements
in ISO/IEC 17025:2017 (Ref. 13) section 7.2 relating to selection,
validation, and verification of methods (under proposed Sec.
1.1146(b)).
Proposed Sec. 1.1151(a) would require that analysis under this
program be conducted using a method(s) of analysis that: (1) Is fit for
purpose, (2) is within the accredited laboratory's scope of
accreditation, (3) has been appropriately validated for use in such
food testing, in accordance with Sec. 1.1146(b) (i.e., the applicable
ISO/IEC 17025:2017 provisions) and paragraph (c) of Sec. 1.1151, and
(4) has been appropriately verified by the accredited laboratory for
use in such food testing, in accordance with paragraph (d) of Sec.
1.1151.
As we noted above, proposed Sec. 1.1151(a)(1) would state that all
methods of analysis used in food testing under this rule would have to
be fit for purpose, in that they may only be applied for the food
testing to which they are intended to apply and for the purpose for
which they are validated. For example, if a method of analysis was
developed and validated only for determining the presence and level of
chloramphenicol in shrimp, the method may only be used to determine the
presence and level of chloramphenicol in shrimp. The concept of fit for
purpose is related to the concept of validation, in that successful
validation of a method for a purpose for which the method had not yet
been validated would typically demonstrate that the method is in fact
fit for that purpose. For example, if the method that has
[[Page 59481]]
been validated only for determining the presence and level of
chloramphenicol in shrimp is subsequently validated for determining the
presence and level of chloramphenicol in fish, the method could then be
applied as fit for the purpose of determining the presence and level of
chloramphenicol in fish.
Proposed Sec. 1.1151(a)(2) would require that the method used be
included within the accredited laboratory's scope of accreditation.
This requirement flows from section 422(a)(6) of the FD&C Act, which
requires laboratories to be accredited for the specified testing
methods they use for food testing in this program. Note that while some
of the food testing that would be covered by this program is static
(e.g., the testing of shell eggs described in Sec. 118.4(a)(2)(i))
other testing scenarios covered by this program are dynamic and will
change with different circumstances (e.g., testing to support removal
from Import Alert). Therefore, we are not proposing a defined inventory
of possible scopes; rather, under this program laboratories would be
able to become accredited for a variety of food analytical methods,
such as methods listed in the Bacteriological Analytical Manual (BAM)
of procedures preferred by FDA for the detection of pathogens and
microbial toxins in food (see https://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm2006949.htm).
Proposed Sec. 1.1151(a)(3) and (4), respectively, would require
that the method must have been appropriately validated for use in the
food testing to be conducted and have been appropriately verified by
the accredited laboratory for use in such food testing. We have issued
procedures for our laboratories on these issues (e.g., ``Methods,
Method Verification and Validation,'' ORA Laboratory Manual Vol. II
Section 2, document number 5.4.5 (Ref. 18) and ``Guidelines for the
Validation of Chemical Methods for the FDA FVM Program, 2nd Edition''
(Ref. 19)), and we note that many food testing laboratories currently
adhere to voluntary consensus standards and procedures issued by
organizations, such as ISO and AOAC International, that address how to
ensure analytical methods used by the laboratory are fit for purpose
and appropriately validated and verified. Depending on the needs of the
program as it develops, in the future we may issue guidance on this
topic. Note that FDA maintains a website listing of all the FDA
regulatory methods currently being used for food and feed safety
programs, including links to other online manuals/compendia of methods
(at https://www.fda.gov/food/science-research-food/laboratory-methods-food). On that web page we also provide links to the method
development, validation, and implementation guidelines of FDA's Office
of Food Policy and Response, and a list of methods currently undergoing
validation.
Proposed Sec. 1.1151(b) provides that with respect to food testing
conducted under proposed Sec. 1.1107(a)(1), the method or methods of
analysis (if any) prescribed by the applicable testing requirement in
the FD&C Act or implementing regulations are the only appropriate
methods for the food testing to be conducted; and with respect to food
testing conducted under proposed Sec. 1.1107(a)(2), the method or
methods of analysis (if any) prescribed by the food testing order are
the only appropriate methods for the food testing to be conducted. In
such cases, the statute, regulation, or food testing order would
dictate the appropriate method for the food testing.
Proposed Sec. 1151.1(c)(1) would make explicit for this program
the validation requirement in ISO/IEC 17025:2017 (Ref. 13) section
7.2.2, which accredited laboratories must follow in accordance with
proposed Sec. 1.1146(b). As stated in ISO/IEC 17025:2017 section
7.2.2, accredited laboratories would be required to validate ``non-
standard methods, laboratory-developed methods and standard methods
used outside their intended scope or otherwise modified.''
Proposed Sec. 1.1151(c)(2) would require an accredited laboratory
validating a method under this subpart to record all the information
required by ISO/IEC 17025:2017 (Ref. 13) section 7.2.2.4 as well as the
supporting analytical data. In the context of validation studies,
supporting analytical data may include information about the detection
limit, selectivity of method, linearity, limit of repeatability and/or
reproducibility (accuracy and precision), robustness against external
influences and/or cross sensitivity against interference from the
matrix of sample. We have tentatively determined that this information
is necessary for us to assess the validation and determine whether it
demonstrates that the accredited laboratory can properly apply the
method for the specific intended use.
Proposed Sec. 1.1151(d)(1) provides that before an accredited
laboratory conducts food testing under this program using a method for
a specific intended use for which the method has been validated, but
for which the laboratory has not previously applied the method under
this program, the accredited laboratory must have verified it can
properly perform the method for the specific intended use. We propose
to make this requirement explicit for this program; and believe it is
consistent with ISO/IEC 17025:2017 (Ref. 13) section 7.2.1 (which
accredited laboratories must follow in accordance with proposed Sec.
1.1146(b)), which requires that accredited laboratories verify a method
before they introduce the method.
Proposed Sec. 1.1151(d)(2) would require that an accredited
laboratory performing verification of a method under this subpart must
record: The method that is the subject of the verification, the
intended purpose of the analysis, the results of the verification, the
procedure used for the verification, supporting analytical data, and
whether the accredited laboratory is able to properly perform the
method. We have tentatively determined that this information is
necessary for us to determine whether the verification is valid.
Section 422(b)(3) of the FD&C Act provides that FDA may waive
requirements of section 422(b) if a new methodology or methodologies
have been developed and validated but a laboratory has not yet been
accredited to perform such methodology or methodologies; and the use of
such methodology or methodologies are necessary to prevent, control, or
mitigate a food emergency or foodborne illness outbreak. In accordance
with this statutory provision, proposed Sec. 1.1151(e) provides that
an accredited laboratory may submit a written request to FDA requesting
FDA's permission to use a method or methods outside of its scope of
accreditation for food testing. FDA may approve the request if both of
the following conditions are satisfied: (1) A new methodology or
methodologies have been developed and validated but no reasonably
available laboratory has been accredited to perform such methodology or
methodologies and (2) the use of such method or methods is necessary to
prevent, control, or mitigate a food emergency or foodborne illness
outbreak. We propose to interpret section 422(b)(3)(A) of the FD&C Act
to allow waiver of section 422(b)'s requirements when no ``reasonably
available'' laboratory has been accredited to perform such a
methodology. If an accredited laboratory exists but is not reasonably
available (e.g., due to geographic location, capacity constraints, or
other factors), such a laboratory would not be able to address the
emergent circumstances in which section 422(b)(3) applies. Therefore,
if no ``reasonably available'' laboratory has been accredited to
[[Page 59482]]
perform the methodology in question, we believe section 422(b)(3)(A) of
the FD&C Act may be interpreted to permit waiver of section 422(b)'s
requirements. We have tentatively determined that any laboratory that
conducts food testing under the exception of section 422(b)(3) of the
FD&C Act must be accredited for at least one method under this program,
because such accreditation would ensure that all of the requirements
for this program apply to the laboratory and would ensure an important
level of general competence and reliability.
7. What notifications, results, and reports must accredited
laboratories submit to FDA? (Proposed Sec. 1.1152)
Proposed Sec. 1.1152 would require that accredited laboratories
submit test results, sampling reports, analytical reports, validation
and verification studies, and certain other notifications to FDA about
food testing they conduct under this program. Proposed Sec. 1.1152
would also establish requirements for such submissions, including
requirements about what information the submissions must contain. Under
section 422(b)(2) of the FD&C Act, the results of food testing
conducted under this program must be submitted directly to FDA. To
facilitate our meaningful review of such test results, it is critical
that we receive supporting information necessary for us to understand
the test results and to assess the validity of the underlying testing
conducted in that instance. Section 422 of the FD&C Act acknowledges
that other information may be sent to FDA under this program,
specifically requiring that the model standards we establish under this
program must ensure that reports of analyses, which laboratories
currently routinely submit to us as testimony in the circumstances
described by section 422(b)(1)(B) of the FD&C Act, are certified as
true and accurate (see section 422(a)(6) of the FD&C Act).
Proposed Sec. 1.1152(a) through (c) address what information
(e.g., test results, sample collection reports, and analytical reports)
about the food testing conducted under this program must be submitted
to FDA. We have proposed in Sec. 1.1152(d) that accredited
laboratories that meet certain requirements may submit abridged
analytical reports in lieu of full analytical reports, subject to
certain exceptions in proposed Sec. 1.1152(e). Proposed Sec.
1.1152(f) would establish what information must be in an abridged
analytical report, and proposed Sec. 1.1152(g) would establish what
information must be in a full analytical report. Proposed Sec.
1.1152(h) would require an accredited laboratory using a non-standard
method to provide FDA with documentation of the method. By
``documentation'' we mean the method standard operating procedure, or
some other document that describes the steps within the method.
Proposed Sec. 1.1152(i) would establish requirements for the
submission of advance notices of sampling to FDA. Proposed Sec.
1.1152(j) would establish requirements for notifications to FDA of
significant changes affecting the accreditation of the accredited
laboratory. Proposed Sec. 1.1152(k) would state if FDA does not
receive all information required under this section we may consider the
related testing to be invalid.
Proposed Sec. 1.1152(a) would require all documentation submitted
to us by accredited laboratories under the subpart, which includes test
results, sampling reports, analytical reports, validation and
verification studies, and certain notifications, to be submitted to us
electronically and in English, and to contain certain generally
applicable information. More specifically, proposed Sec.
1.1152(a)(1)(i) would require all such notifications, results, reports,
and studies submitted to us to include the legal name and street
address of the accredited laboratory submitting the information, and
would require the documents to identify an appropriate point-of-contact
for the accredited laboratory who FDA may contact with questions or
comments regarding the notification, result, report, or study, and to
include the email address and telephone number of the point of contact.
Identification of the accredited laboratory submitting the report would
help us identify which accredited laboratory is responsible for the
submissions. The identification of a point-of-contact for the
accredited laboratory, and the email address and telephone number of
the point-of-contact, would help us efficiently conduct any followup
communications, as appropriate, with the accredited laboratory that
submitted the information. Proposed Sec. 1.1152(a)(1) would also
require all documents submitted to FDA under this section to display an
identification unique to each test result, report, notification, or
study. Of note, proposed Sec. 1.1152(b)(3) would require the test
results to cross reference the unique identifiers of all associated
reports, notifications, and studies. These requirements are intended to
help us quickly identify which submissions are related to each other as
we receive them. This provision also reflects a similar provision in
ISO/IEC 17025:2017 (Ref. 13) at section 7.8.2, ``Common requirements
for reports.'' The last general requirement for submissions, per
proposed Sec. 1.1152(a)(iii), is that each submission must be true,
accurate, unambiguous, and objective. This requirement would implement
the requirement underlying section 422(a)(6)(A)(i) of the FD&C Act that
the model standards established by this program for accredited
laboratories must ensure that ``reports of analyses are certified as
true and accurate,'' and help ensure that accredited laboratories
submissions clearly and correctly communicate the information the
submission is based on and is intended to communicate. We have
tentatively concluded that it is appropriate to establish such a
requirement for all submissions under this program to FDA from
accredited laboratories.
Proposed Sec. 1.1152(a)(2) would clarify that the accredited
laboratory that conducts the analysis of the sample under this program
is responsible for the submission of all related notifications,
results, reports, and studies to FDA as required by this section.
Proposed Sec. 1.1152(a)(3) provides that if the accredited
laboratory that is responsible for the submission becomes aware that
any aspect of the submission is inaccurate, the accredited laboratory
or sampling service must immediately inform FDA and submit a corrected
version. Proposed Sec. 1.1152(a)(3) further provides that such
corrections to the notification, result, report, or study must meet the
requirements for amendments to reports specified by ISO/IEC 17025:2017
(Ref. 13) section 7.8.8 (incorporated by reference, see Sec.
1.1138(a)(2)). This requirement is important so that we may easily
determine when and how a submission has been amended and to which prior
submissions the amended submission relates.
Proposed Sec. 1.1152(a)(4) would require that any opinions and
interpretations in any notification, result, report, or study submitted
to FDA must meet the requirements in ISO/IEC 17025:2017 (Ref. 13)
section 7.8.7 (which is incorporated by reference, see proposed Sec.
1.1138(a)(2)), and any statements of conformity to a specification or
standard in any notification, result, report, or study submitted to FDA
under this subpart must meet the requirements of ISO/IEC 17025:2017
section 7.8.6 (incorporated by reference, see proposed Sec.
1.1138(a)(2)). We have tentatively determined that ISO/IEC 17025:2017
section 7.8.7 provides rules that will be effective at ensuring that
opinions and interpretations in submissions to FDA are appropriate and
clearly identified. Similarly, we have tentatively determined that ISO/
IEC 17025:2017
[[Page 59483]]
section 7.8.6 provides rules that will be effective at ensuring that
statements of conformity in submissions to FDA under this section are
accompanied by appropriate disclosures.
Proposed Sec. 1.1152(b) would establish requirements for
submission of test results to FDA. In accordance with section 422(b)(2)
of the FD&C Act, proposed Sec. 1.1152(b)(1) provides that the results
of all tests conducted under this subpart must be directly submitted to
FDA. Proposed Sec. 1.1152(b)(2) specifies that the accredited
laboratory that conducted the analysis must submit the results of the
food testing to FDA via the website described by Sec. 1.1109, unless
FDA has directed a different method of submission in connection with
the testing conducted under Sec. 1.1107(a)(2) or (3).
Proposed Sec. 1.1152(b)(3) would require the test results
submitted to FDA under this section to be clear, and identify the
unique identification of the associated notifications, reports, and
studies. These requirements would help us ensure that we can
efficiently review the test results and associated submissions as one
package.
Proposed Sec. 1.1152(c) would require certain documentation to be
submitted with the test results. Specifically, we would require
submission to FDA of the following documentation with each test
results:
All sampling plans and sample collection reports related
to the food testing conducted, as obtained or developed by the
accredited laboratory in accordance with proposed Sec. 1.1149.
Written documentation of the sampler's qualifications, if
proposed Sec. 1.1149(a)(1) requires the accredited laboratory to
obtain or develop such documentation.
The analytical report or reports documenting the analysis
related to the food testing. The analytical reports would have to be
either abridged or full, depending on whether the accredited laboratory
is permitted under proposed Sec. 1.1152(d) to submit abridged
analytical reports to FDA. For more information about our proposed
requirements for abridged and full analytical reports, see our
discussion of proposed Sec. 1.1152(d) through (g) below.
For any validation studies required by proposed Sec.
1.1151(c)(1), any documentation required by proposed Sec.
1.1151(c)(2), except when the circumstances of proposed Sec.
1.1152(c)(6) (which we discussed in connection with Sec.
1.1138(a)(1)(a), previously) apply with respect to the validation
study.
For any verification studies required by Sec.
1.151(d)(1), the documentation required by Sec. 1.1151(d)(2), except
when the circumstances of proposed Sec. 1.1152(c)(6) (which we
discussed in connection with Sec. 1.1138(a)(1)(A), previously) apply
with respect to the verification study.
Proposed Sec. 1.1152(c)(6) would establish an important
exception to the above two validation and verification study
documentation requirements. Proposed Sec. 1.1152(c)(6) provides that
we would not require the accredited laboratory to submit the validation
or verification study to FDA if the accredited laboratory submitted the
validation or verification study to its recognized accreditation body
as required by proposed Sec. 1.1138(a)(1) (which addresses certain
requirements a laboratory must meet to become accredited by a
recognized accreditation body). We have tentatively determined that it
is not appropriate under this program for us to duplicate, on a routine
basis, the accreditation efforts of accredited laboratory's recognized
accreditation body. If the accredited laboratory submitted the
validation or verification study to its accreditation body as required
by Sec. 1.1138(a)(1), the accreditation body must instead submit to
FDA, in lieu of the validation or verification study, a statement that
the validation or verification study has been submitted to its
recognized accreditation body in accordance with Sec. 1.1138(a)(1),
and the accredited laboratory must identify the method, analyte, and
matrix that were the subject of the validation or verification study.
This information would provide us with sufficient information to
determine whether the accredited laboratory's invocation of this
exception is appropriate. As discussed in relation to proposed Sec.
1.1113(c), we expect recognized accreditation bodies to substantively
review the validation and verification studies they receive from
laboratories participating in this program.
A certification from one or more members of the accredited
laboratory's management certifying that the test results,
notifications, reports, and studies are true and accurate, and that the
documentation includes the results of all tests conducted under this
subpart. The certification must specify the name, title, and signature
of the certifier or certifiers. The certification that reports are true
and accurate is required by section 422(a)(6)(A)(i) of the FD&C Act,
but we propose to require the certification to also extend to the test
results and related submissions. We propose to include a certification
that the laboratory has submitted all tests conducted under this
subpart not only because direct submission of test results to FDA is a
statutory directive, but because it is vital to the integrity of this
program. We expect this certification to help ensure that appropriate
laboratory personnel have confirmed the accuracy of the statement.
Note that we do not intend for this certification to mean that the
laboratory is attesting that the tested product satisfies regulatory
requirements as it is FDA's purview (and not the laboratory's) to
determine whether the product meets our regulatory standards. Although
the word ``certification'' has such meaning in conformity assessment
terminology, we intend a different meaning here. We are using the word,
``certification'' to mean that the management of the laboratory
acknowledges that the test was conducted and vouches that the test was
conducted properly according to laboratory defined procedures, that the
report is true and accurate, and that the report represents all the
testing conducted by that laboratory of that particular product for
this program.
We propose in Sec. 1.1152(d) that accredited laboratories that
meet certain requirements may submit abridged analytical reports under
this program in lieu of full analytical reports. We would require full
analytical reports to document, in full and step-by-step, the analysis
conducted by the accredited laboratory, so that we can engage in a
meaningful indepth scientific review of the analysis to determine
whether, in that instance, the analysis was valid. For example, we
propose in Sec. 1.1152(g) that a full analytical report must include
all original compilations of raw data, identify and describe negative
and positive quality controls, and include all calculations, among
other documentation. Abridged analytical reports, in contrast to full
analytical reports, would only need to include certain more limited
information describing the analysis.
We view the standards we are creating in this program as relatively
rigorous. Accreditation to ISO/IEC 17025:2017, along with the quality
assurance, conflict of interest, and other additional requirements
contained in this proposed rule, enhance our confidence in the
laboratories that participate. In addition, the recognized
accreditation bodies will serve an ongoing role monitoring the
laboratories they have accredited under this program, helping ensure
that the required standards are maintained and serving as an additional
observer of the laboratories. For those reasons, and contingent on a
positive experience with the accredited laboratories' initial
[[Page 59484]]
reports, we would have adequate assurance in the validity of the test
results to permit abridged analytical reports, and we tentatively
conclude that such abridged analytical reports will provide an adequate
basis for FDA to make regulatory decisions.
In addition, we believe that allowing the submission of abridged
analytical reports under this food testing program may provide
advantages to FDA and the public. We should be able to review abridged
analytical reports more quickly than we review full analytical reports,
and this may enable us to decide more quickly whether a food safety
problem has been addressed and whether to admit an article of food into
the United States. This may further allow us to allocate our own
laboratory and field resources more efficiently. Furthermore, not
requiring accredited laboratories to compile and submit a full
analytical report every time they conduct food testing under this
program may reduce some of the paperwork and administrative costs of
food testing conducted under this program.
At the same time, we note that this laboratory accreditation
program would not guarantee that testing by participating laboratories
will be valid in every instance. Indeed, a single false negative test
result submitted to us under this program could lead us to admit
violative food into the United States, or to incorrectly determine that
a food safety problem has been adequately addressed, thus potentially
harming U.S. consumers. Accordingly, we do not propose to automatically
or always allow all accredited laboratories to submit abridged
analytical reports under this program. Instead, we have proposed that
only accredited laboratories that have fulfilled certain conditions may
submit abridged analytical reports to us under this program, and that
in certain circumstances we may require such accredited laboratories to
submit full analytical reports.
Proposed Sec. 1.1152(e)(1) provides that FDA will occasionally
require an accredited laboratory permitted to submit abridged
analytical reports to submit to FDA, within 48 hours of the request,
the full version of the analytical report. Such a policy will serve the
purposes of auditing abridged analytical reports and otherwise
protecting the public health and the integrity of this food testing
program. By ``occasionally,'' we tentatively conclude that we would not
invoke the exception for more than approximately 10 percent of the
abridged analytical reports that any given accredited laboratory
submits to us per year. We would invoke this exception at our
discretion, sometimes on a random basis and sometimes based on risk.
With regard to risk, we may be more likely to invoke this requirement
where the analysis conducted is for an analyte that presents a
relatively high risk to public health (e.g., Clostridium botulinum). We
may also invoke the exception where something in the abridged
laboratory report appears to be amiss (e.g., the method used does not
appear to be appropriate). However, we may also invoke the exception on
a random basis and in relatively low-risk situations to ensure
consistent laboratory performance across the program. At a minimum, we
expect to invoke this exception to require each accredited laboratory
permitted to submit abridged analytical reports to us to submit at
least one full analytical report to us per year. We also note that this
provision (along with proposed Sec. 1.1150(d)) would effectively
require that accredited laboratories permitted to submit abridged
analytical reports to us must still consistently document their
analyses internally to such a degree that the accredited laboratory
would be able to complete and submit a full analytical report for the
analysis to FDA within forty-eight hours of when FDA requests the full
analytical report.
We have proposed an additional exception, in proposed Sec.
1.1152(e)(2), to accredited laboratories' ability to submit abridged
analytical reports to us under this program. Proposed Sec.
1.1152(e)(2) provides that FDA may require an accredited laboratory
that is permitted to submit abridged analytical reports to submit full
analytical reports to FDA under this program if such analytical reports
relate to an FDA investigation or FDA enforcement proceeding. We may
invoke this exception, for example, in the case of a food testing order
involving a potentially high risk to public health, or as part of
evidence for a hearing under section 423(c) of the FD&C Act, in which
case we would have determined that not only does a suspected or
identified food safety problem exist but that there is also reasonable
probability that the use of or exposure to an article of food will
cause serious adverse health consequences or death to humans or
animals.
Proposed Sec. 1.1152(d)(1) describes the criteria for an
accredited laboratory seeking initial permission to submit abridged
analytical reports. Accredited laboratories that are not currently
disqualified from submitting abridged analytical reports (see our
discussion about disqualification under proposed Sec. 1.1152(d)(6) and
(7)) and that are not on probation would become permitted to submit
abridged analytical reports to FDA under this program on an ongoing
basis after FDA has given notice that all four of the following
conditions are fulfilled: (1) The accredited laboratory submits 10
consecutive full analytical reports to FDA under this program, (2) the
consecutive full analytical reports include at least one full
analytical report relating to each major food testing discipline
represented by the methods in the accredited laboratory's scope of
accreditation for which it seeks to submit abridged analytical reports,
(3) none of the consecutive full analytical reports demonstrate any
material substantive shortcoming in the food testing, and (4) the
consecutive full analytical reports submitted by the accredited
laboratory do not contain repeated administrative deficiencies.
Accordingly, when laboratories become accredited under the program they
must first submit full laboratory analytical reports under Sec.
1.1152(g), along with the test results and the other documentation
required under proposed Sec. 1.1152(c), which FDA will assess to
determine whether the four conditions are fulfilled. FDA will track
whether the accredited laboratory has fulfilled the four conditions.
As we state above, we are proposing to require that the 10
consecutive full analytical reports includes least one full analytical
report relating to each major food testing discipline represented by
the methods in the accredited laboratory's scope of accreditation for
which the accredited laboratory seeks to submit abridged analytical
reports. Three examples of the ``major food testing disciplines''
relevant in this context are microbiology, chemistry, and physical
(filth).
Proposed Sec. 1.1152(d)(2) addresses the impact of an accredited
laboratory's failure to initially satisfy the four criteria of Sec.
1.1152(d)(1). Under proposed Sec. 1.1152(d)(2)(i), if any analytical
report submitted by the accredited laboratory to FDA under this program
demonstrates a material substantive shortcoming in the food testing,
the accredited laboratory would become disqualified from submitting
abridged analytical reports, in accordance with proposed Sec.
1.1152(d)(6)(i). If the 10 full analytical reports submitted by an
accredited laboratory are substantively satisfactory but suffer from
repeated administrative deficiencies, the accredited laboratory would
have another chance to submit consecutive full analytical reports that
fulfill the criteria in Sec. 1.1152(d)(1)(i) through (iv). Repeated
administrative deficiencies during the second set of 10 full analytical
reports would result in
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disqualification in accordance with proposed Sec. 1.1152(d)(6)(i).
We propose that a single material substantive shortcoming in the
food testing in any of the initial 10 full analytical reports would
disqualify an accredited lab, for the period described in Sec.
1.1152(d)(6). We would consider a material substantive shortcoming in
the food testing to be incompetence or dishonesty resulting in an
invalid test result. FDA will be relying on the food testing conducted
under this program to make regulatory decisions, which will impact
public health. It is critical that the testing be valid. We have a duty
to monitor the testing conducted by an accredited laboratory that
submits a full analytical report containing a material substantive
shortcoming, so it is appropriate that such a laboratory be
disqualified from the privilege of submitting abridged analytical
reports (see Sec. 1.1152(d)(6)). Note also that under proposed Sec.
1.1160(a) and (b), if we find a material substantive shortcoming in the
food testing, we may consider the analysis to be invalid, and will
notify the accredited laboratory, and potentially its recognized
accreditation body and the owner or consignee of the food, of the
deficiency. For further information on proposed Sec. 1.1160, see
section VI.I.3. Note also that under proposed Sec. 1.1146(b), the
accredited laboratory would have to treat the feedback as a complaint,
in accordance with sections 3.2 and 7.9 of ISO/IEC 17025:2017 (Ref.
13).
Proposed Sec. 1.1152(d)(3) discusses the criteria that
laboratories, already submitting abridged analytical reports, must meet
in order to begin submitting abridged analytical reports for additional
disciplines. Specifically, proposed Sec. 1.1152(d)(3) allows
accredited laboratories, not on probation and already permitted to
submit abridged analytical reports for at least one major food testing
discipline, to submit to abridged analytical reports relating to
additional major food testing discipline(s), after FDA has given notice
that the following conditions are fulfilled: (1) The accredited
laboratory submits to FDA at least one full analytical report for each
additional major food testing discipline for which the accredited
laboratory seeks to submit abridged analytical reports; (2) there is no
material substantive shortcoming in the full analytical report(s) for
the additional major food testing discipline(s); and (3) the full
analytical reports for the additional major food testing discipline(s)
do not contain repeated administrative deficiencies.
Proposed Sec. 1.1152(d)(4) addresses the impact of an accredited
laboratory's failure to initially satisfy the three criteria of Sec.
1.1152(d)(3). Under proposed Sec. 1.1152(d)(4)(i), if any analytical
report submitted by the accredited laboratory to FDA under this program
demonstrates a material substantive shortcoming in the food testing,
the accredited laboratory would become disqualified from submitting
abridged analytical reports for the food testing discipline that was
represented in the analytical report containing the material
substantive shortcoming, in accordance with proposed Sec.
1.1152(d)(6)(ii). If any full analytical reports relating to a food
testing discipline submitted by an accredited laboratory are
substantively satisfactory but suffer from repeated administrative
deficiencies, the accredited laboratory would have another chance to
submit a full analytical report for that food testing discipline that
fulfills the criteria in Sec. 1.1152(d)(3)(i) through (iii). Repeated
administrative deficiencies in the second full analytical report would
result in disqualification in accordance with proposed Sec.
1.1152(d)(6)(ii).
Proposed Sec. 1.1152(d)(5) provides that if an accredited
laboratory, permitted to submit abridged analytical reports for a
particular discipline, submits one or more test results, notifications,
reports, and/or studies that demonstrate a single material substantive
shortcoming in testing or repeated significant administrative
deficiencies, the accredited laboratory would be disqualified for that
discipline. The period of disqualification should be governed by Sec.
1.1152(d)6)(ii) if the accredited laboratory is permitted to submit
abridged analytical reports for other disciplines, and with Sec.
1.1152(d)(6)(i) if not.
For accredited laboratories that currently do not have permission
to submit any abridged analytical reports for any disciplines, proposed
Sec. 1.1152(d)(6)(i) states that the period of disqualification is
either 2 years or until the accredited laboratory submits 20 more
satisfactory full analytical reports to FDA under this program,
whichever period is longer. During this period of disqualification the
accredited laboratory would be ineligible to submit, and to request
permission to submit, abridged analytical reports under this program.
It is important that this period of disqualification be of sufficient
length to establish a meaningful consequence for accredited
laboratories that are seeking permission to submit abridged analytical
reports but who demonstrate a single material substantive shortcoming
in testing or repeated significant administrative deficiencies. We also
propose that shortcomings during the disqualification period under
Sec. 1.1152(d)(6)(i) would extend the disqualification. Such a policy
would help ensure that disqualified laboratories have every incentive
to maintain excellent performance during the disqualification period.
We propose that any material substantive shortcoming in testing would
extend the disqualification period by 6 months, and repeated
administrative deficiencies would extend the disqualification period by
2 months.
For an accredited laboratory that currently is permitted to submit
abridged analytical reports for at least one food testing discipline
and is subject to disqualification for at least one additional food
testing discipline, proposed Sec. 1.1152(d)(6)(ii) states that the
period of disqualification is either 2 years or until the accredited
laboratory submits two or more satisfactory full analytical reports to
FDA under this program, whichever period is longer. During this period
of disqualification, the accredited laboratory would be ineligible to
submit, and to request permission to submit, abridged analytical
reports for the testing discipline(s) that is subject to the
disqualification period. We also propose that shortcomings during the
disqualification period under Sec. 1.1152(d)(6)(ii) would extend the
disqualification. Such a policy would help ensure that disqualified
laboratories have every incentive to maintain excellent performance
during the disqualification period. We propose that any material
substantive shortcoming in testing would extend the disqualification
period by 6 months, and repeated administrative deficiencies would
extend the disqualification period by 2 months.
While the policy in proposed Sec. 1.1152(d)(1) for becoming
permitted to submit abridged analytical reports to FDA under this
program would apply to newly accredited laboratories that have never
been disqualified under proposed Sec. 1152(d)(1), the policy and
procedures would be somewhat different for accredited laboratories that
have been disqualified. Proposed Sec. 1.1152(d)(7) provides that an
accredited laboratory that has fulfilled the criteria under Sec.
1.1152(d)(6), as applicable, and is not on probation, may submit a
request (via a portal we would establish on our website) to FDA to
submit abridged analytical reports under Sec. 1.1152(d)(1) or (3), as
applicable. After FDA receives the request, FDA will consider
permitting the accredited laboratory to
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fulfill the conditions of proposed Sec. 1.1152(d)(1) or (3), as
applicable. If FDA grants permission, and once the conditions described
by proposed Sec. 1.1152(d)(1) and (3), as applicable, are fulfilled,
FDA will provide notice that the accredited laboratory is permitted to
submit to FDA on an ongoing basis abridged analytical reports relating
to the discipline(s) for which the conditions are fulfilled.
As we have noted above, if an accredited laboratory submits one or
more test results, notifications, reports, and/or studies that
demonstrate a single material substantive shortcoming in testing or
repeated significant administrative deficiencies we may also take other
appropriate action under this proposed rule, including notifying the
accredited laboratory's recognized accreditation body (in accordance
with proposed Sec. 1.1160) and/or, in more egregious cases, even
putting an accredited laboratory on probation or revoking the
accredited laboratory's accreditation, if appropriate under proposed
Sec. 1.1161.
We request comment on all aspects of our proposed approach to
allowing accredited laboratories to submit abridged analytical reports
to FDA, including with respect to the practicality and potential
consequences of the approach.
Abridged analytical reports, in contrast to full analytical
reports, would have to include only certain limited information
describing the analysis. Proposed Sec. 1.1152(f) provides that
abridged analytical reports must contain:
All information described by ISO/IEC 17025:2017 (Ref. 13)
sections 7.8.2.1(a) through (p) and 7.8.3.1(a) through (d).
The justification for any modification or deviation to the
method(s) of analysis used, and documentation of the accredited
laboratory's authorization for the modification or deviation. Although
ISO/IEC 17025:2017 (Ref. 13) section 7.8.2.1 requires disclosure of
additions to, deviations, or exclusions from the method, we have
tentatively determined that abridged analytical reports should also
include the justification and authorization for any modification or
deviation to the method. This proposed requirement should help us
understand whether the method, although modified, is within the
accredited laboratory's scope of accreditation, and otherwise help us
determine whether we should require submission of the full analytical
report version of the abridged analytical report.
Although the information in abridged analytical reports are not
sufficient to allow us to engage in a meaningful indepth scientific
review of the analysis, and ISO/IEC 17025:2017 section 7.8 appears to
relate more to reports laboratories submit to their customers rather
than reports laboratories submit to regulatory authorities, we have
tentatively determined that the information in abridged analytical
reports, as proposed by Sec. 1.1152(f), would be sufficient
information for us to make other meaningful decisions related to the
analysis, such as whether the method used is appropriate or whether
certain risks are present that warrant the submission of the full
analytical report. We request comments on what other information
should, or should not be, in an abridged analytical report.
Proposed Sec. 1.1152(g) establishes what information full
analytical reports submitted under this program must contain. We
developed the proposed requirements for what information full
analytical reports must contain based on what information we have found
is necessary for us to assess the validity of the analyses that private
laboratories currently conduct in support of admission of an article of
food under section 801(a) of the FD&C Act and to support removal from
an import alert through successful consecutive testing. We have
tentatively determined that the information we propose full analytical
reports must contain is necessary for us to engage in a meaningful
indepth scientific review of the analysis to determine that the
analysis is valid. Proposed Sec. 1.1152(g) would require full
analytical reports to include the following information:
All information that must be included in an abridged
analytical report. As noted previously, this information consists
primarily of administrative items and limited substantive information
about the analysis performed. It also includes the justification for
any modification or deviation to the method(s) of analysis used and
documentation of the accredited laboratory's authorization for the
modification or deviation.
Documentation of references for the method or methods of
analysis used. Here we simply mean that the package must include the
name (e.g., ``Concentration, Extraction, and Detection of Norovirus and
Hepatitis A Virus in Molluscan Shellfish'') and source (e.g., AOAC, FDA
BAM) of the method used.
Identification of the analyst or analysts who conducted
each analytical step, validation step (if applicable), and verification
step (if applicable), including the analyst's or analysts' legal name
and signature, and the date each analytical step, validation step (if
applicable), and verification step (if applicable) was performed. This
information is important because, in accordance with section
422(a)(6)(A)(iv) of the FD&C Act and proposed Sec. 1.1150(b), the
analysts must be appropriately qualified.
Calculations presented in a legible and logical manner. We
may need to verify the calculations to verify whether the results of
the testing are valid.
As applicable, references to chromatograms, charts,
graphs, observations, photographs of thin layer chromatographic plates,
and spectra. References must be in color when appropriate and made in a
clear order. These items represent objective evidence and raw data
supporting the test results. We may need to review such information to
understand and verify the validity of the results of the testing.
Identification of the source and purity of reference
standards used, and, as applicable: Certified reference materials,
certified reference cultures traceable to a nationally or
internationally recognized type culture collection, including
concentration, units preparation, and storage conditions, and reference
standard preparation information, including who prepared, date of
preparation, expiration date, chemical balance, and solvent used.
A copy of the label from any immediate container sampled
and any additional labeling needed to evaluate the product. Many
products are shipped in a variety of different forms, container
quantities, and may have varying packaging or labels. The label would
likely include important information about the form, unit quantity, or
packaging of the food, which we may use to verify that the laboratory
analyzed the samples using an appropriate method. The label and
labeling would provide additional information which may be helpful to
the analysis and our review, such as the ingredient list of the food.
For example, if the ingredient list indicates that the food contains an
ingredient, additive, or pesticide at a violative level, we may subject
to higher scrutiny test results that indicate the food is free from the
ingredient, additive, or pesticide or that indicate the food contains
the ingredient, additive, or pesticide at a lower level than the
ingredient list indicates.
All original compilations of raw data secured in the
course of the analysis, including discarded, unused,
[[Page 59487]]
or reworked data with the justification for discarding or reworking
such data, corresponding supporting data, and quality control results
all identified with unique sample identification, date and time,
associated with the test. This information is important for us to
understand and to verify the validity of the test results. Furthermore,
requiring submission of discarded, unused, or reworked data, along with
a justification for discarding, not using, or reworking such data,
should discourage testing into compliance.
Any other relevant additional supporting information such
as the storage location of analyzed samples, appropriate attachments
such as instrument printouts, computer generated charts and data
sheets, and photocopies or original labels for the product analyzed.
Identification of any software used, including any
certificate or certificates of analysis for standards and software
used. This information helps us understand the associated test results
and verify that the standards used are valid and that the software used
is functioning properly.
The following information about the qualifications of the
analyst or analysts who were involved in the analysis conducted under
this program, if the accredited laboratory has not previously submitted
documentation of the analyst's qualifications to FDA or the analyst's
qualifications have significantly changed since the accredited
laboratory last submitted documentation of the analyst's qualifications
to FDA:
[cir] The analyst's curriculum vitae;
[cir] Training records with regards to methods that the analyst is
qualified to perform, including the dates of such training and the name
of the trainer or training provider;
[cir] Any other documentation of analyst's ability to perform the
method properly in the specific context of the food testing to be
conducted, under Sec. 1.1150(b) (e.g., a certificate of completion of
a relevant training and/or documentation that the analyst was the
investigator for the relevant validation or verification study); and
[cir] Individual proficiency test worksheets relevant to the
analysis being performed.
We invite comment on our proposed requirements for what information
full analytical reports must contain. If commenters believe we are
proposing to require too much information to be included in full
analytical reports, please specifically address in your comments which
requirements of Sec. 1.1152(g) we should delete or revise, and why
that piece of information is not necessary for us to engage in a
meaningful indepth scientific review of the analysis to determine
whether the analysis is valid. For commenters who believe we have not
proposed sufficient information to be included in full analytical
reports, please specify what additional information we should require
and why it is critical to our assessment of the analysis and test
results.
Proposed Sec. 1.1152(h) would require that if the accredited
laboratory conducts the analysis using a method that is not published
in a reputable international or national standard or that is otherwise
not publicly and readily available, upon request by FDA the accredited
laboratory must submit documentation of the method to FDA. If the
method used has been published in a reputable international or national
standard (e.g., in the Official Methods of Analysis of AOAC
International) or the method is otherwise publicly available (readily
available, so that a reasonable analyst would be able to easily find
the method), we would be able to look up the method ourselves. However,
if the method is not published in a reputable international or national
standard or otherwise readily publicly available, the accredited
laboratory would need to share information about the method with us, if
requested, as we may have no other way to access the information. For
example, in the case of a method developed by the laboratory, the
laboratory would need to submit to us sufficient information about the
method for us to understand how the method is applied, such as the
method standard operating procedure, or some other document that
describes the steps within the method. Such information would be in
addition to the validation or verification information that would be
required under proposed Sec. 1.1152(c)(4), (5), or (6).
Proposed Sec. 1.1152(i) addresses advance notice of sampling. We
are proposing to require advance notice of sampling in certain
circumstances as an additional technique to exercise oversight over
sampling conducted for food testing in this program. Under proposed
Sec. 1.1152(i)(1), if we determine that the sampling conducted by a
sampler may materially differ from the sampling documented in the
associated sampling plan or sample collection report, or if we
determine that the sampling may have been otherwise improper, we may
require the accredited laboratory that analyzed the associated
sample(s), and other accredited laboratories under this program that
have analyzed samples collected by the sampler previously, to request
and receive from the sampler, and submit or require the sampler to
submit, an advance notice of sampling to the destination specified by
the laboratory accreditation program website portal 48 hours before
each of the 10 occasions that the sampler will collect a sample that
the accredited laboratory will analyze under this program. As we
discuss below, we also propose at Sec. 1.1152(i)(2)(ii) and (iii) to
be able to specify certain timeframes other than 48 hours and to
specify a number other than 10 occasions.
We intend advance notice of sampling to encourage the use of
sampling techniques that will allow for a meaningful analysis, by
facilitating our observation of sampling and collection of audit
samples before we receive the test results with the accompanying sample
collection report. Audit samples are samples we collect from the lot or
environment at issue, which we then analyze, and compare our test
results with the test results of the accredited laboratory. We believe
it is reasonable to generally require the notice of sampling to be
submitted to us 48 hours prior to collection of the sample(s) to allow
us time to determine whether to observe the sampling and/or take an
audit sample, and assign appropriate personnel to the task. Note that
we may take audit samples (as we currently do) even if we have not
required advance notice of sampling.
Proposed Sec. 1.1152(i)(2) elaborates that we may, as appropriate
(based on the relevant circumstances): Specify the type of food product
or environment that requires advance notice of sampling under this
section; determine that an amount of time other than 48 hours in
advance is required, to a minimum of 24 hours and up to 7 business days
in advance; determine that a number of occasions other than 10 are
required, to a minimum of one occasion and up to a maximum of 20
occasions; and notify affected accredited laboratories that submission
of additional notices of sampling are not required. We would typically
notify affected accredited laboratories that submission of additional
notices of sampling are not required after we have observed and/or
audit an amount of sampling conducted by the sampler sufficient for us
to determine whether the sampler appears to be conducting sampling
properly.
Proposed Sec. 1.1152(i)(3) would require that the advance notice
of sampling include the following information:
A unique identification code for the notice of sampling.
This would help us identify, review, and record the notification
efficiently and would help
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us identify associated submissions. The test results would reference
the identification numbers of each associated submission.
The name of the accredited laboratory that will conduct
analysis of the sample. This would allow us to, for example, followup
with the accredited laboratory that will conduct the analysis, if
appropriate, before or during the accredited laboratory's analysis of
the samples.
The name and street address of the sampler that will
conduct the sampling. This information will help us organize our review
of notices of sampling as they are submitted to us.
A primary contact (name and phone number) for the sampler.
This information would be necessary if we need to contact the sampler.
For example, we may need to contact the sampler if we choose to observe
or audit the sampling, but the food product or environment at issue is
not at the location specified on the notice of sampling.
The reason(s) why the food product or environment will be
sampled. We would want to know, for example, if the sample to be
collected will be analyzed by an accredited laboratory with regards to
a particular import alert. We expect this information to help us
determine whether to observe or audit the sampling.
The location of the food product or environment that will
be sampled, including sufficient information to identify the food
product or environment to be sampled. This would help us locate the
food product or environment in the case we would want to observe the
sampling or take an audit sample.
As applicable, the U.S. Customs and Border Protection
entry and line number(s) and the product code(s) of the food. This
would help us identify the food product at issue if we choose to
observe or audit the sampling. In the import context, we would want to
know the FDA product code. In the domestic context, the U.S. Customs
and Border Protection entry and line number(s) would be inapplicable,
and we would instead want to know the product code assigned by the
manufacturer, packager, labeler, as applicable. In the context of
environmental sampling, both items are inapplicable.
The date and approximate time the sampling will begin. The
date must be correct and we would expect the estimated time to be as
close to the actual time of the sampling as reasonably possible.
Proposed Sec. 1.1152(j) provides that when any changes occur that
affect the accreditation of the accredited laboratory, the accredited
laboratory must immediately send FDA, within 48 hours, and the
accreditation body that accredited it notice of such changes, a
detailed description of such changes, and an explanation of how such
changes affect the accreditation of the accredited laboratory. This
provision would cover changes in the name or operations of an
accredited laboratory, such as the purchase of an accredited laboratory
by a company, as well as changes that would cause the accredited
laboratory to no longer meet the requirements of this program. We have
proposed this requirement in accordance with section 422(a)(1)(C) of
the FD&C Act, which requires that, in pertinent part, as a condition of
accreditation, as appropriate, accredited laboratories must report to
FDA any changes that would affect the accreditation of the laboratory.
Proposed Sec. 1.1152(j) would not require accredited laboratories to
notify us of changes covered by proposed Sec. 1.1123(c), which
requires recognized accreditation bodies to immediately notify us of
certain information related to the accreditation status of laboratories
they accredit or that have sought their accreditation (e.g., certain
changes initiated by the recognized accreditation body, and findings of
fraud).
Proposed Sec. 1.1152(k) provides that if FDA does not receive all
information required to be submitted to FDA by proposed Sec. 1.1152(a)
through (j), FDA may consider the related food testing to be invalid.
For example, if we do not receive a validation study when its
submission to FDA is required, we would not be able to determine
whether the method is appropriate for the intended use; if we do not
receive a full analytical report when we require its submission, we
would be unable to conduct the necessary indepth scientific review of
the analysis to determine whether, in that instance, the analysis was
valid; and if we do not receive all the required information about the
sampling, we would not be able to determine whether the sample that was
analyzed was representative of the food product or environment at
issue.
8. What other records requirements must an accredited laboratory meet?
(Proposed Sec. 1.1153)
This proposed rule would establish requirements for accredited
laboratories to establish, control, and retain records relating to
their food testing activities under this program. In addition to
meeting the ISO/IEC 17025:2017 records requirements (in accordance with
proposed Sec. 1.1146(b)), accredited laboratories would have to meet
the additional records requirements of this proposed section.
Proposed Sec. 1.1153(a) would require laboratories that have been
accredited to maintain electronically, for 5 years after the date of
creation, certain records created and received during their period of
accreditation that relate to compliance with this proposed rule. Even
if no longer accredited, laboratories that used to be accredited would
have an obligation under this proposed rule to maintain records created
and received during their period of accreditation. Proposed Sec.
1.1153(a) elaborates that these records include: (1) Documents related
to the accredited laboratory's grant (and, if applicable, extensions)
of accreditation from its accreditation body; (2) documentation of food
testing the accredited laboratory conducted under this program, in
accordance with proposed Sec. 1.1150(d); (3) all documents that the
accredited laboratory was required to submit to FDA under Sec. 1.1152,
and associated correspondence by the accredited laboratory (and its
officers, employees, and other agents) with the owner or consignee (and
its officer, employees, and other agents) of the tested food product or
environment; (4) all requests for food testing from an owner or
consignee that would be conducted under this proposed rule; (5)
documentation of any internal investigations, internal audits, and
corrective actions taken to address any problems or deficiencies
related to activities under this proposed rule; (6) documentation
related to probation or withdrawal from accreditation under this
program; and (7) documentation of changes to its management system or
food testing activities that may affect its compliance with this
proposed rule. We believe it appropriate to require maintenance of
these records for purposes of this proposed rule.
Proposed Sec. 1.1153(b) provides that within 30 days of the
receipt of proficiency testing results by the accredited laboratory,
the accredited laboratory must submit the proficiency testing results
to the recognized accreditation body that accredits the accredited
laboratory, and, if the accredited laboratory failed the proficiency
test, also to FDA, via the destination specified by the website
described by Sec. 1.1109. During our conversations with certain
laboratories and accreditation bodies, we received feedback that this
proposed rule would benefit from a requirement that proficiency testing
results be submitted to the recognized accreditation body that
accredits the laboratory. See
[[Page 59489]]
``Record of Outreach Sessions on FDA Proposed Rules, Conference call
between the FSMA Lab Accreditation Workgroup and the Food Laboratory
Alliance, July 21, 2015'' (Ref. 20), and attached meeting minutes. Our
understanding is that there is currently no such requirement, and
accredited laboratories may decline to submit proficiency test results
to their accreditation body. Proficiency test results would provide
accreditation bodies with valuable information about the food testing
capabilities and proficiencies of the accredited laboratories they
accredit. Furthermore, because proficiency testing providers are
typically uninterested third parties, there is little risk that
submitting the proficiency test results to the accreditation body and
potentially FDA would affect the conduct of the proficiency testing. We
also believe we may find proficiency testing results helpful as well,
particularly if the proficiency testing was unsuccessful and related to
food testing results submitted to us under proposed Sec. 1.1152.
Proposed Sec. 1.1153(c) provides that laboratories that have been
accredited must make these records available for inspection and copying
upon written request of an authorized officer or employee of FDA. The
authorized officer or employee of FDA may request that the laboratory
submit such records to FDA electronically or that the laboratory make
such records promptly available at the physical location of the
laboratory or at another reasonably accessible location. If the
authorized officer or employee of FDA requests the records be submitted
electronically, the records must be submitted electronically not later
than 10 business days after the date of the request. However, records
related to the immediate notification requirements in Sec. 1.1152(j)
must be submitted within 48 hours. If the authorized FDA officer or
employee requests records that are maintained in a language other than
English, the laboratory must electronically submit an English
translation of the records to FDA within a reasonable time. We are not
proposing that the records themselves be maintained in English, as we
believe such an approach would be unduly burdensome, particularly for
foreign laboratories.
Proposed Sec. 1.1153(d) would require laboratories that have been
accredited to ensure that significant amendments to records described
by proposed Sec. 1.1153(a) and (b) can be tracked to previous and
original versions. Proposed Sec. 1.1153(d) further provides that if
such a significant amendment is made, both the original document and
amended document must be maintained by the laboratory that has been
accredited during the time period that the amended document must be
maintained. Further, the laboratory must also document the date of
amendment, the personnel responsible for the amendment, and a
conspicuous indication on the original document stating that the
document has been altered and a more recent version of the document
exists. This provision is based on ISO/IEC 17025:2017 (Ref. 13) at
section 7.5.2. However, section 7.5.2 of ISO/IEC 17025:2017 applies to
``technical records,'' while proposed Sec. 1.1153 applies to a wider
category of records.
We acknowledge that the requirements of proposed Sec. 1.1153 may
require revisions to contracts and perhaps other documents establishing
the scope of a laboratory's authority with respect to granting records
access. We nonetheless have tentatively concluded that the records
maintenance and access requirements in proposed Sec. 1.1153 are
necessary for us to maintain an appropriate degree of oversight over
accredited laboratories (in accordance with proposed Sec. 1.1159) and
for recognized accreditation bodies to monitor and assess laboratories
they accredit.
H. Proposed Provisions About Procedures for Accreditation of
Laboratories (Proposed Sec. Sec. 1.1158 Through 1.1165)
This proposed rule would establish procedures for laboratories to
apply for accreditation or relinquish accreditation, and for our
oversight of accredited laboratories, including procedures for our
review of test results and supporting information, and for probation
and revocation of the accreditation of laboratories.
1. How does a laboratory apply for accreditation or modification of its
scope of accreditation by a recognized accreditation body? (Proposed
Sec. 1.1158)
Proposed Sec. 1.1158 explains how laboratories must apply for
accreditation; reinstatement of accreditation or modification of their
scope of accreditation; addresses the duration of accreditation; and
describes the effects of a denial of an application for accreditation.
Section 422 of the FD&C Act establishes a structure whereby FDA
recognizes accreditation bodies, who, in turn, accredit laboratories
that meet the applicable requirements of the program. As we indicate in
proposed Sec. 1.1109, we will maintain a list of recognized
accreditation bodies, who may perform accreditation, along with the
contact information of these recognized accreditation bodies, so that
laboratories would be able to use our website as a resource to find a
recognized accreditation body that can assess whether the laboratory is
eligible for accreditation.
Proposed Sec. 1.1158(a) provides that a laboratory seeking
accreditation must submit its application for accreditation to a
recognized accreditation body identified on the website described in
proposed Sec. 1.1109. Proposed Sec. 1.1158(a) further provides that
the recognized accreditation body will review and assess the
application in accordance with the applicable requirements of this
program. Proposed Sec. 1.1158(a) also provides that if the laboratory
seeking accreditation had its accreditation (in-whole or in-part)
withdrawn by a recognized accreditation body, or revoked by FDA the
previous time it was accredited under this program, the laboratory must
meet the additional requirements specified by proposed Sec. 1.1165
(which addresses the question of how a laboratory requests
reinstatement of accreditation).
Proposed Sec. 1.1158(b) clarifies that a laboratory may use
documentation of conformance with ISO/IEC 17025:2017, as applicable and
supplemented as necessary, in meeting the applicable requirements of
this program. For example, if a laboratory is already accredited to
ISO/IEC 17025:2017 by a recognized accreditation body, the recognized
accreditation body could accept this accreditation as evidence that the
laboratory meets the requirements of ISO/IEC 17025:2017 the laboratory
must meet under proposed Sec. 1.1138 to become accredited under this
proposed rule.
Proposed Sec. 1.1158(c) clarifies that an accredited laboratory's
accreditation continues until withdrawn, revoked, or relinquished under
this program. It is our understanding that the current practice by
accreditation bodies and laboratories is that the laboratory's intent
to remain accredited is generally assumed, and the accreditation body
continues to accredit the laboratory and conduct assessments and
reassessments under that understanding. We seek comment with regards to
whether this is correct.
2. How will FDA oversee accredited laboratories? (Proposed Sec.
1.1159)
Proposed Sec. 1.1159 would establish certain requirements related
to our oversight of accredited laboratories. Although the recognized
accreditation
[[Page 59490]]
bodies have primary oversight responsibility over accredited
laboratories, we would also exercise some ability to oversee accredited
laboratories, via requesting records and, if appropriate, conducting
onsite assessments. We note that in contrast to recognized
accreditation bodies, under section 422(b)(2) of the FD&C Act, FDA will
routinely receive the results of food testing conducted under section
422(b)(1), along with supporting information, which will provide us
with information on accredited laboratories' compliance with this
program.
Proposed Sec. 1.1159(a) provides that we may assess accredited
laboratories at any time to determine whether they continue to comply
with the applicable requirements of the program and whether there are
any deficiencies in the performance of the accredited laboratory that,
if not corrected, would warrant probation or revocation of its
accreditation.
Proposed Sec. 1.1159(b) clarifies that, in the course of our
evaluation of the performance of an accredited laboratory, we may
review any of the following: Records the accredited laboratory would be
required to maintain under this proposed rule; records the recognized
accreditation body that accredited the accredited laboratory is
required to maintain under this proposed rule; information we obtain
during an onsite assessment of the accredited laboratory (conducted
under proposed Sec. 1.1159(c)); information we obtain during our
assessment of the recognized accreditation body that accredited the
laboratory; and any other information we obtain, including during FDA's
inspections or investigations of one or more owners or consignees of
food subject to food testing under this proposed rule.
Proposed Sec. 1.1159(c) provides that our assessment may include
our own onsite assessment of the accredited laboratory at any
reasonable time, with or without a recognized accreditation body (or
its officers, employees, and other agents) present, to assess an
accredited laboratory. We would exercise this authority as appropriate
to followup on potential problems that come to our attention, for which
referral to a recognized accreditation body may be inefficient or
otherwise inappropriate, and to otherwise verify compliance with the
program. Proposed Sec. 1.1159(d) clarifies that we will also report
any of our observations and findings of our assessment to the
accredited laboratory's recognized accreditation body.
We seek comments regarding this proposed section and how
accreditation bodies and FDA should share oversight of accredited
laboratories under this proposed program.
3. How will FDA review submitted test results and analytical reports?
(Proposed Sec. 1.1160)
Proposed Sec. 1.1160(a) clarifies that if we find that any test
results, analytical report, related documents (for example, the
sampling plan, verification studies, and validation studies) or the
associated analysis, contains deficiencies or otherwise indicates that
any aspect of the food testing is not being conducted in compliance
with the program, FDA may consider the analysis to be invalid. We will
notify the accredited laboratory that appears to be responsible for the
deficiency, and we may also notify the owner or consignee of the food
of the deficiency. When we notify the accredited laboratory that
appears to be responsible for the deficiency, our notice would be
considered a complaint that would be treated in accordance with the
laboratory's established procedures for complaints under section 7.9 of
ISO/IEC 17025:2017 (Ref. 13). When we notify the laboratory of the
deficiency, the laboratory must respond, in writing, to us regarding
the deficiency within 30 days or an agreed-upon timeframe, including a
statement with respect to how the accredited laboratory intends to
address the deficiency, and/or a statement describing the extent to
which the laboratory has addressed the deficiency.
Proposed Sec. 1.1160(b) clarifies that we may also report any of
our determinations of deficiencies resulting from our review of any
test results, reports, and related documents under this rule to the
recognized accreditation body that accredits the accredited laboratory.
Proposed Sec. 1.1160(c) clarifies that if the deficiency in the
test result, analytical report, and/or the associated analysis
demonstrates a material substantive shortcoming in the related food
testing or demonstrates repeated administrative deficiencies, FDA will
also consider whether disqualification from being eligible for
permission to submit abridged analytical reports under proposed Sec.
1.1152(d), and/or other action under this program, is appropriate.
Proposed Sec. 1.1160(d) reiterates the language of section 422(d)
of the FD&C Act, stating that nothing in this rule shall be construed
to limit our ability to review and act upon information from food
testing, including determining the sufficiency of such information and
testing. For example, we would typically consider analysis of a non-
representative sample to be invalid.
4. When will FDA put an accredited laboratory on probation or revoke
the accreditation of a laboratory? (Proposed Sec. 1.1161)
This proposed rule would establish the conditions under which we
could put an accredited laboratory on probation or revoke a
laboratory's accreditation to conduct food testing under this proposed
program. Under this proposal, we could put an accredited laboratory on
probation or revoke accreditation only in limited circumstances,
including where the recognized accreditation body that accredits the
accredited laboratory does not withdraw accreditation itself.
Proposed Sec. 1.1161(a) provides that we may revoke the
accreditation (in whole or in part) of an accredited laboratory program
for good cause, which may include any of the following reasons: (1)
Demonstrated bias or lack of objectivity when conducting food testing
under this subpart where the laboratory's recognized accreditation body
fails to withdraw accreditation of the laboratory; (2) performance that
calls into question the validity or reliability of its food testing
under this subpart where the laboratory's recognized accreditation body
fails to withdraw accreditation of the laboratory; or (3) other failure
to substantially comply with this rule where the laboratory's
recognized accreditation body fails to withdraw accreditation of the
laboratory.
Proposed Sec. 1.1161(b) provides that if we determine that an
accredited laboratory has demonstrated deficiencies in performing its
functions that are less serious and more limited than would warrant
revocation of accreditation, and it is reasonably likely that the
accredited laboratory will be able to correct such deficiencies within
a specified period of time, we may temporarily put the laboratory on
probation and request that the laboratory take appropriate corrective
actions.
Proposed Sec. 1.1161(c) further clarifies that when there are
grounds for revocation of accreditation, but the deficiencies are
associated with or affect only certain methods within the accredited
laboratory's scope of accreditation, we may revoke the accredited
laboratory's accreditation only for those affected methods.
Proposed Sec. 1.1161(d) clarifies that our probation of a
laboratory's accreditation shall remain in effect until the laboratory
demonstrates to our satisfaction that the laboratory has
[[Page 59491]]
successfully implemented appropriate corrective actions, or until we
determine that revocation of accreditation is warranted.
If we determine that revocation is warranted, under proposed Sec.
1.1161(e) we would notify the laboratory and its recognized
accreditation body of the revocation of its accreditation through the
issuance of a revocation notice. The revocation notice would state the
grounds for revocation; whether the revocation of accreditation is in-
whole or in-part, and if it is in-part, to which methods it applies;
state the procedures for requesting a regulatory hearing on the
revocation under proposed Sec. 1.1173; and state the procedures for
requesting reinstatement of accreditation under proposed Sec. 1.1165.
Similarly, if we determine that probation of an accredited
laboratory is warranted, under proposed Sec. 1.1161(f) we would notify
the laboratory and its recognized accreditation body of the probation,
describe the grounds for the probation, and specify other key details,
including all deficiencies that must be corrected for FDA to lift the
probation. Furthermore, the probation notice would either inform the
laboratory that the laboratory has a specified time period to take
corrective actions specified by FDA; or request that the laboratory
submit a corrective action plan to FDA for FDA's approval that
identifies the corrective actions it will take to address deficiencies
identified in the notice and identify timeframes for completion.
Proposed Sec. 1.1161(g) provides that we may revoke (in-whole or
in-part) the accreditation of the laboratory that has been put on
probation if we determine that the laboratory is not implementing
appropriate corrective actions.
Proposed Sec. 1.1161(h) reiterates the provision of proposed Sec.
1.1109 that we will provide notice on the website described in proposed
Sec. 1.1109 of our probation or revocation of the laboratory's
accreditation.
5. What are the consequences if FDA puts an accredited laboratory on
probation or revokes the accreditation of a laboratory? (Proposed Sec.
1.1162)
Under proposed Sec. 1.1162(a), if we revoke the accreditation in
whole of a laboratory, the laboratory would be immediately ineligible
to conduct food testing under this rule. Proposed Sec. 1.1162(a)
further provides that if we revoke the accreditation of laboratory in-
part, the laboratory is immediately ineligible to use the methods that
are subject to the revocation to conduct food testing under this
subpart. An accredited laboratory that is put on probation by FDA would
be permitted to continue to conduct food testing under this proposed
program.
Proposed Sec. 1.1162(b) further provides that, with respect to
food testing conducted by the laboratory prior to our revocation of
accreditation, we may refuse to consider specific food testing results
and associated reports of food testing conducted under this program by
the accredited laboratory if the basis for our revocation of
accreditation of the laboratory indicates that the specific food
testing conducted by the laboratory may not be reliable.
Proposed Sec. 1.1162(c) would require that within 10 business days
of the date of issuance of the revocation of accreditation, the
laboratory must notify us electronically, in English, of the name of
the custodian who will maintain the records required by proposed Sec.
1.1153, and the contact information for the custodian, which must
include an email address, and the street address where the records will
be located.
Proposed Sec. 1.1162(d) would require that within 10 business days
of the date of issuance of the probation or revocation the laboratory
notify any owners or consignees for whom it is conducting food testing
under this proposed rule that it is on probation or its accreditation
has been revoked.
6. What if a laboratory wants to voluntarily relinquish its
accreditation? (Proposed Sec. 1.1163)
This proposed rule would offer accredited laboratories a mechanism
for voluntarily relinquishing their accreditation. We are proposing
certain procedural requirements, similar to those in the accredited
third-party certification regulation, that accredited laboratories must
follow to relinquish their accreditation. We believe these procedures
are necessary to ensure an orderly accreditation relinquishment process
and so that we may exercise appropriate oversight and timely update the
website described by proposed Sec. 1.1109.
Proposed Sec. 1.1163(a) would require accredited laboratories to
notify us electronically, in English, and notify their recognized
accreditation body, at least 60 days before voluntarily relinquishing
its accreditation in whole or in part. The notice would need to include
the date on which relinquishment will occur. If the relinquishment is
of the laboratory's accreditation in-whole, the notification must also
include the name and contact information of the custodian who will
maintain the records required under proposed Sec. 1.1153 after the
date of relinquishment or the date accreditation expires, as
applicable, and make them available to FDA as required by proposed
Sec. 1.1153. The contact information for the custodian must include,
at a minimum, an email address and the street address where the records
required by proposed Sec. 1.1153 will be located.
For food testing that is subject to proposed Sec. 1.1107(a), we
would consider food testing conducted by a laboratory that is not
accredited at the time of the food testing to be invalid. This position
is in accordance with section 422(b)(1) of the FD&C Act, which requires
such food testing to be conducted only by accredited laboratories.
Proposed Sec. 1.1163(b) reiterates that we will provide notice on
the website described in Sec. 1.1109 of the voluntary relinquishment
of accreditation of the laboratory.
7. What is the effect on accredited laboratories if their accreditation
body voluntarily or involuntarily loses its recognition? (Proposed
Sec. 1.1164)
Section 422(a)(7)(B) of the FD&C Act provides that we must promptly
revoke the recognition of any accreditation body found not to be in
compliance with the requirements of section 422 of the FD&C Act,
specifying, as appropriate, any terms and conditions necessary for
laboratories accredited by such body to continue to perform food
testing under this proposed program. We would establish those terms and
conditions in Sec. 1.1164 of this proposed rule. Accordingly, proposed
Sec. 1.1164(a) provides that when an accreditation body has its
recognition revoked, relinquishes its recognition, allows its
recognition to expire, or has its application for renewal of
recognition denied, a laboratory accredited by the accreditation body
must take the following actions (subject to an exception in paragraph
(b), which we discuss below): (1) No later than 30 days after FDA
issues the notice to the laboratory under proposed Sec. 1.1129, Sec.
1.1130, or Sec. 1.1131 that its accreditation body is no longer
recognized, the laboratory submits to FDA documentation of the
accredited laboratory's most recent internal audit, which all
accredited laboratories would be required to maintain under proposed
Sec. 1.1153(a)(5), documentation showing compliance with the conflict
of interest requirements in proposed Sec. 1.1147, and documentation of
the most recent proficiency test for each test method for which the
laboratory is accredited under this subpart, to show compliance with
proposed Sec. 1.1138(a)(1)(ii); and (2) no
[[Page 59492]]
later than 1 year after FDA issues the applicable notice under proposed
Sec. 1.1129, Sec. 1.1130, or Sec. 1.1131 to the laboratory, the
laboratory becomes accredited by a recognized accreditation body.
Our review of accredited laboratories' quality assurance records in
accordance with proposed Sec. 1.1164(a)(1) would allow us to ensure
that the accredited laboratory is in compliance with this rule while it
transitions. We believe a period of one year, in accordance with
proposed Sec. 1.1164(a)(2), gives the laboratory sufficient time to
find a recognized accreditation body and complete its accreditation
process while limiting the time the laboratory conducts food testing
without the oversight of a recognized accreditation body. We may be
more proactive in our oversight of such accredited laboratories during
the period they are not subject to the oversight of a recognized
accreditation body.
Proposed Sec. 1.1164(b) would establish an exception to the above-
described requirements. Under proposed Sec. 1.1164(b), the accredited
laboratory may choose to relinquish its accreditation in lieu of
meeting the requirements of proposed Sec. 1.1164(a). In such case, the
accredited laboratory would have to initiate relinquishment of its
accreditation in-whole under proposed Sec. 1.1163 not later than 15
days after FDA issues the applicable notice to the accredited
laboratory under proposed Sec. 1.1129, Sec. 1.1130, or Sec. 1.1131,
and the relinquishment would need to occur within 90 days. Of note,
proposed Sec. 1.1163(a) would typically require an accredited
laboratory to submit the relinquishment notice to its recognized
accreditation body and to FDA.
However, for a relinquishment initiated in accordance with proposed
Sec. 1.1164(b), the accredited laboratory would submit the
relinquishment notice under proposed Sec. 1.1163(a) to FDA only, as
the accredited laboratory would have no recognized accreditation body
at the time.
Generally, if the accredited laboratory does not meet the
requirements of either proposed Sec. 1.1164(a) or (b), the accredited
laboratory would no longer be in substantial compliance with this
proposed rule and its accreditation would generally be subject to
revocation under proposed Sec. 1.1161.
8. How does a laboratory request reinstatement of accreditation?
(Proposed Sec. 1.1165)
Proposed Sec. 1.1165 describes how a laboratory may obtain
reinstatement of its accreditation if we revoked its accreditation, if
a recognized accreditation body withdrew its accreditation, or if the
laboratory voluntarily relinquished its accreditation.
Proposed Sec. 1.1165(a) addresses how a laboratory may obtain
reaccreditation if its accreditation was withdrawn (in whole or in
part) by a recognized accreditation body or revoked (in-whole or in-
part) by FDA. The laboratory may seek reaccreditation by submitting a
new application for accreditation (in-whole or in-part, as applicable)
under proposed Sec. 1.1158 to a recognized accreditation body.
Proposed Sec. 1.1165(a) further provides that the laboratory must
also: (1) Notify us, before it submits the new application for
accreditation to the recognized accreditation body, that the laboratory
will be submitting a new application for accreditation to the
recognized accreditation body, including in the notification the legal
name of the laboratory, valid contact information for the laboratory,
the legal name of the recognized accreditation body the laboratory will
be submitting the application to, and the date that the laboratory
expects to submit the new application for accreditation; and (2)
demonstrate, to the satisfaction of the recognized accreditation body
it is submitting the new application to, that the grounds for the
withdrawal of accreditation have been resolved and that the laboratory
has implemented measures to prevent such grounds from recurring. If the
laboratory's accreditation had been withdrawn by a recognized
accreditation body, the requirement to notify us would allow us to
check whether the laboratory had been recently denied reaccreditation
by a different recognized accreditation body, which could possibly
indicate whether the laboratory is successively seeking approval of
accreditation without changing its practices. Alternatively, if we
revoked the laboratory's accreditation, we may want to contact the
recognized accreditation body to which the laboratory is applying, to,
for example, explain to the accreditation body why we found it
necessary to revoke the laboratory's accreditation.
Proposed Sec. 1.1165(b) addresses how a laboratory may obtain
reaccreditation after it voluntarily relinquishes its accreditation. A
laboratory that voluntarily relinquished its accreditation may seek
reinstatement of accreditation by submitting a new application for
accreditation under proposed Sec. 1.1158 to a recognized accreditation
body.
I. Proposed Provisions About Requesting FDA Reconsideration, FDA
Internal Review, or Regulatory Hearings of FDA Decisions Under This
Rule (Proposed Sec. Sec. 1.1171 Through 1.1174)
This proposed rule would establish requirements and procedures an
accreditation body would have to follow to request that we reconsider
our decision to deny its application for recognition, to request we
internally review our decision to deny its request to reconsider its
application for recognition, and to request a regulatory hearing on our
decision to take adverse action with respect to its recognition. This
proposed rule would also establish requirements and procedures a
laboratory would have to follow to request a regulatory hearing on our
decision to take an adverse action with respect to the laboratory's
accreditation. Further, this proposed rule would establish requirements
and procedures owners and consignees would have to follow to request a
regulatory hearing on a food testing order. Finally, this proposed rule
would establish procedures for the conduct of such reconsiderations,
internal reviews, and regulatory hearings.
1. How does an accreditation body request reconsideration by FDA of
a decision to deny its application for recognition, renewal, or
reinstatement? (Proposed Sec. 1.1171)
This proposed rule would establish procedures for an accreditation
body to seek reconsideration of our denial of its application for
recognition, renewal of recognition, or reinstatement of recognition.
The procedures described by proposed Sec. 1.1171 require
submission of the request for reconsideration within 10 business days
of the issuance of such denial. The request for reconsideration must be
submitted to us electronically, in English, and in accordance with the
procedures described in the notice of denial. The request must also be
signed by the accreditation body or by an individual authorized to act
on its behalf. Within a reasonable time after we complete our review
and evaluation of the request for reconsideration and the supporting
information submitted, we would notify the requestor through the
issuance of the recognition upon reconsideration or through the
issuance of a denial of recognition upon reconsideration. We note that
should FDA issue a denial after a request for reconsideration, the
accreditation body would be able to request the review of such decision
under 21 CFR 10.75.
[[Page 59493]]
2. How does an accreditation body or laboratory request a regulatory
hearing on FDA's decision to revoke the recognized accreditation body's
recognition or revoke the accredited laboratory's accreditation?
(Proposed Sec. 1.1173)
This proposed rule explains the procedures that would be used for
challenges to our revocation of an accreditation body's recognition or
our revocation of a laboratory's accreditation.
Under proposed Sec. 1.1173(a), an accreditation body whose
recognition was revoked or a laboratory whose accreditation was revoked
(or an individual authorized to act on the accreditation body's or
laboratory's behalf) may submit a request for a regulatory hearing,
under part 16, on the revocation. The request must be submitted within
10 business days of the date of revocation. Written notices of
revocation will contain all the elements required by Sec. 16.22 and
will thereby constitute the notice of an opportunity for hearing under
part 16.
Under proposed Sec. 1.1173(b), the request for a regulatory
hearing must be submitted with a written appeal that responds to the
bases for our decision described in the written notice of revocation
together with any supporting information upon which the requestor is
relying. The request, appeal, and supporting information must be
submitted to us electronically, in English, and in accordance with the
procedures described in the notice of revocation.
Proposed Sec. 1.1173(c) makes clear that the submission of a
request for a regulatory hearing under this rule will not operate to
delay or stay the effect of our decision to revoke recognition of an
accreditation body or to revoke accreditation of a laboratory unless we
determine that delay or a stay is in the public interest.
Under proposed Sec. 1.1173(d) and (e), the presiding officer for a
regulatory hearing under this proposed rule will be designated after
the request for a regulatory hearing is submitted to us. The presiding
officer may deny a request for regulatory hearing under this proposed
rule under 21 CFR 16.26(a) when no genuine or substantial issue of fact
has been raised.
Proposed Sec. 1.1173(f) states that if a hearing request is
granted, the hearing will be held within 10 business days after the
date the request was filed or, if applicable, within a timeframe agreed
upon in writing by requestor and the presiding officer and FDA.
The presiding officer must conduct the hearing under part 16,
except that, under Sec. 16.5(b), the procedures for a regulatory
hearing described in part 16 apply only to the extent that such
procedures are supplementary and not in conflict with the procedures
specified for the conduct of regulatory hearings under this rule. The
following requirements of part 16 are inapplicable to regulatory
hearings conducted under this rule: Sec. 16.22 (Initiation of a
regulatory hearing); Sec. 16.24(e) (Timing) and (f) (Contents of
notice); Sec. 16.40 (Commissioner); Sec. 16.60(a) (public process);
Sec. 16.95(b) (Administrative decision and record for decision); and
Sec. 16.119 (Reconsideration and stay of action).
Proposed Sec. 1.1173(f)(3) clarifies that a decision by the
presiding officer to affirm the revocation of recognition or the
revocation of accreditation that served as the basis for the request
for a regulatory hearing is considered a final Agency action for
purposes of 5 U.S.C. 702.
3. How does an owner or consignee request a regulatory hearing on a
food testing order? (Proposed Sec. 1.1174)
This proposed rule explains the procedures that would be used for
challenges to our issuance of a food testing order.
Proposed Sec. 1.1174(a) provides that no later than 24 hours after
we issue the food testing order, the owner or consignee who is the
subject of the food testing order may submit a request for a regulatory
hearing, conducted under part 16, on the food testing order. The food
testing order will contain all of the elements required by Sec.
16.22(a) and will thereby constitute the notice of an opportunity for
hearing under part 16.
Proposed Sec. 1.1174(b) provides that the request for a regulatory
hearing must be submitted with a written appeal that responds to the
bases for our determinations described in the food testing order,
together with any supporting information upon which the requestor is
relying. The request, appeal, and supporting information must be
submitted in English to the address specified in such notice and in
accordance with the procedures described therein. The request, appeal,
and supporting information may be submitted electronically.
Proposed Sec. 1.1174(c) states that the presiding officer for the
regulatory hearing will be designated after a request for the
regulatory hearing is submitted to FDA. Proposed Sec. 1.1174(c) states
that the presiding officer may deny a request for regulatory hearing
under this rule under Sec. 16.26(a).
Proposed Sec. 1.1174 provides that if the presiding officer grants
a request for a regulatory hearing, the hearing will be held within 2
business days after the date the request was filed or, if applicable,
within a time frame agreed upon in writing by requestor and the
presiding officer and FDA. Furthermore, the presiding officer may
require that a hearing conducted under this proposed rule be completed
within one business day, as appropriate. We believe that it is in the
interest of both public health and the owner and consignee that
regulatory hearings on food testing orders be resolved quickly and
efficiently. As noted, however, this proposed rule would allow for
flexibility by allowing the requestor, the presiding officer, and FDA
to agree on an alternative timeframe for holding the hearing.
Proposed Sec. 1.1174(e)(3) provides that the presiding officer
must conduct the hearing in accordance with part 16, except that,
consistent with Sec. 16.5(b), the procedures for a regulatory hearing
described in part 16 apply only to the extent that such procedures are
supplementary and not in conflict with the procedures specified for the
conduct of regulatory hearings under this proposed rule. Accordingly,
the following requirements of part 16 would be inapplicable to
regulatory hearings conducted under this proposed rule: The
requirements of Sec. Sec. 16.22 (Initiation of a regulatory hearing);
16.24(e) (timing) and (f) (contents of notice); 16.26(a) (denial of
hearing); 16.40 (Commissioner); 16.42(a) (presiding officer); 16.60(a)
(public process); 16.95(b) (Administrative decision and record for
decision); and 16.120 (Reconsideration and stay of action) of this
chapter.
Proposed Sec. 1.1174 clarifies that a decision by the presiding
officer to affirm the testing order would be considered a final Agency
action under 5 U.S.C. 702.
J. Proposed Provisions About Electronic Records and Public Disclosure
Requirements Under This Rule (Proposed Sec. Sec. 1.1199 Through
1.1200)
1. Are electronic records created under this rule subject to the
electronic records requirements of part 11 of this chapter? (Proposed
Sec. 1.1199)
We are proposing to exempt from the requirements of 21 CFR part 11
records that meet the definition of electronic records in Sec.
11.3(b)(6) and are established or maintained to satisfy the
requirements of this proposed rule. We believe it would be
unnecessarily burdensome to require such records to
[[Page 59494]]
comply with the requirements in part 11. However, records that are
established or maintained to satisfy the requirements of this program
but that also are required under other applicable statutory provisions
or regulations remain subject to part 11 of this chapter. This is the
same approach we took when finalizing our rule on accredited third-
party certification.
2. Are the records obtained by FDA under this rule subject to public
disclosure? (Proposed Sec. 1.1200)
We understand that notifications, records, and reports required
under this program will often contain commercially sensitive
information. Information submitted to the Agency, including reports and
notifications submitted under proposed Sec. Sec. 1.1123 and 1.1152,
becomes an Agency record. We are proposing to clarify at proposed Sec.
1.1200 that records under this proposed rule are subject to 21 CFR part
20, which provides protections for trade secrets and confidential
commercial information from public disclosure (see, e.g., Sec. 20.61,
``Trade secrets and commercial or financial information which is
privileged or confidential''). This is the same approach we took when
finalizing our rule on accredited third-party certification.
K. Proposed Revisions to 21 CFR Part 1, Subpart M
On November 27, 2015, FDA published in the Federal Register a final
rule, ``Accreditation of Third-Party Certification Bodies to Conduct
Food Safety Audits and to Issue Certifications'' (accredited third-
party certification regulation), to implement section 808 of the FD&C
Act on accreditation of third-party certification bodies to conduct
food safety audits and to certify that eligible foreign entities
(including registered food facilities) and the human and animal food
produced by such entities meet applicable FDA food safety requirements
(80 FR 74570). The accredited third-party certification regulation,
codified at part 1, subpart M, establishes the requirements for how an
accredited third-party certification body must conduct a food safety
audit--i.e., a regulatory audit or a consultative audit that is
conducted to determine compliance with the applicable requirements of
the FD&C Act, FDA regulations, and for consultative audits, also
includes conformance with industry standards and practices.
Under the accredited third-party certification regulation, an
accredited third-party certification body must use an accredited
laboratory when sampling and analysis is conducted for a regulatory
audit (Sec. 1.651(c)(2)). Laboratories may be accredited in accordance
with ISO/IEC 17025:2005 or another laboratory accreditation standard
that provides at least a similar level of assurance in the validity and
reliability of the sampling methodologies, analytical methodologies,
and analytical results (Sec. 1.651(b)(3)). For consistency between the
accredited third-party certification regulation and this rulemaking, we
propose to revise Sec. 1.651(b)(3) to cite the current version of the
ISO/IEC laboratory accreditation standard by striking ``ISO/IEC
17025:2005'' and inserting ``ISO/IEC 17025:2017.'' This would mean that
a laboratory accredited under this proposed rule, if finalized, would
be among the laboratories that a third-party certification body could
use to perform analysis.
In addition, we propose to remove the option in Sec.
1.651(b)(3)(ii) for an accredited third-party certification body to use
a laboratory accredited under a standard other than ISO/IEC 17025 when
sampling and analysis is conducted for a regulatory audit. In
developing this proposed rule, we have gathered additional information
about the number and capacity of laboratories accredited under ISO/IEC
17025 to conduct food testing. Based on this information and in the
interest of consistency, we are proposing to remove the option in Sec.
1.651(b)(3)(ii) for an accredited third-party certification body to use
a laboratory accredited under a standard other than ISO/IEC 17025 when
sampling and analysis is conducted for a regulatory audit.
Finally, we are proposing clarifying edits to Sec. Sec.
1.651(b)(3) and 1.651(c)(2) make it clear that the requirement to use a
laboratory accredited under ISO/IEC 17025 to conduct food testing
applies only to the analysis of the sample and not the collection of
the sample itself. As discussed previously in this rule, we are not at
this time proposing requirements for the accreditation of samplers.
We solicit comment on the effect, if any, of these proposed changes
on an accredited third-party certification body's ability to meet the
requirements in Sec. Sec. 1.651(b)(3) and 1.651(c)(2) to use an
accredited laboratory when analyzing samples collected during a
regulatory audit.
L. Proposed Revisions to 21 CFR Part 11
As we discussed in section VI.K.2, we are proposing to exempt from
the requirements of part 11 records that meet the definition of
electronic records in Sec. 11.3(b)(6) and are established or
maintained to satisfy the requirements of this proposed rule.
Consistent with that provision, we are making a conforming change in
part 11 by adding a paragraph (p) to Sec. 11.1 to that effect. The new
paragraph (p) would also clarify that records that satisfy the
requirements of this program but that also are required under other
statutory provisions or regulations remain subject to part 11 to the
extent that they are not separately exempted.
M. Proposed Revisions to 21 CFR Part 16
As we discussed in section VI.J, at proposed Sec. Sec. 1.1171
through 1.1174 we have proposed to establish procedures for regulatory
hearings for certain actions we may take under this proposed rule. We
are proposing a conforming change to part 16, which describes
procedures for regulatory hearings, to add revocation of recognition of
an accreditation body, revocation of accreditation of a laboratory, and
issuance of a food testing order to the list of actions for which a
regulation hearing under part 16 may be held. The affected section is
Sec. 16.1.
N. Proposed Revisions to 21 CFR Part 129
As noted above at section VI.B.1, where we discuss proposed Sec.
1.1107, the regulations on the processing and bottling of bottled
drinking water at part 129 contain an explicit testing requirement that
addresses an identified or suspected food safety problem and that
therefore would have to be conducted by a laboratory accredited under
this proposed rule. Specifically, Sec. 129.35(a)(3)(i) contains a
requirement that a source previously found to contain E. coli will be
considered negative for E. coli after five samples collected over a 24-
hour period from the same sampling site that originally tested positive
for E. coli are tested and found to be E. coli negative. Section
129.35(a)(3)(i) contains additional routine testing requirements that
do not address an identified or suspected food safety problem and are
not subject to this proposed rule.
Section 129.35(a)(3)(iii) provides that the analysis of samples
taken under Sec. 129.35(a)(3)(i) ``may be performed for the plant by
competent commercial laboratories (e.g., Environmental Protection
Agency and State-certified laboratories).'' Section 129.35(a)(3)(iii)
has the potential to conflict with this proposed rule because section
422(b)(1)(A)(i) of the FD&C Act requires food testing conducted in
response to the explicit testing requirement that ``address[es] an
identified or suspected food safety problem'' in Sec. 129.35(a)(3)(i)
[[Page 59495]]
to be conducted by a laboratory accredited under this proposed program.
A laboratory may qualify as a ``competent commercial laboratory'' but
not be accredited under this proposed program. Accordingly, we are
proposing a conforming change to Sec. 129.35(a)(3)(iii) to clarify
that the explicit testing requirement in Sec. 129.35(a)(3)(i) that
addresses an identified or suspected food safety problem must be
conducted under this proposed program, which would require, in
pertinent part, the laboratory conducting the testing to be accredited
under this proposed program.
VII. Proposed Effective Date and Implementation Steps
The effective date is the date that provisions in the rule affect
the current Code of Federal Regulations. We propose that the effective
date of this rule would be 60 days after publication of the final rule
in the Federal Register.
FDA intends to implement this program as expeditiously as
practicable. Implementation of this laboratory accreditation program
will necessarily need to occur in a stepwise fashion. We would announce
when, after the effective date, we are prepared to accept applications
for recognition from accreditation bodies. We would announce when we
have recognized a sufficient number of accreditation bodies, at which
point laboratories could then apply to the recognized accreditation
bodies for accreditation. FDA would publish in the Federal Register, at
least 6 months in advance, notice that we have attained sufficient
laboratory capacity such that owners/consignees in the circumstances
described in proposed Sec. 1.1107 will be required to utilize
laboratories accredited under this program.
VIII. Preliminary Economic Analysis of Impacts
We have examined the impacts of the proposed rule under Executive
Order (E.O.) 12866, E.O. 13563, E.O. 13771, the Regulatory Flexibility
Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995
(Pub. L. 104-4). E.O.s 12866 and 13563 direct us to assess all costs
and benefits of available regulatory alternatives and, when regulation
is necessary, to select regulatory approaches that maximize net
benefits (including potential economic, environmental, public health
and safety, and other advantages; distributive impacts; and equity).
E.O. 13771 requires that the costs associated with significant new
regulations ``shall, to the extent permitted by law, be offset by the
elimination of existing costs associated with at least two prior
regulations.'' We believe that this proposed rule is not a significant
regulatory action as defined by E.O. 12866.
The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because a significant number of testing laboratories are
small businesses and due to initial one-time costs we find that the
proposed rule may have a significant economic impact on a substantial
number of small entities.
The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $154 million, using the most current (2018) Implicit
Price Deflator for the Gross Domestic Product. This proposed rule would
not result in an expenditure in any year that meets or exceeds this
amount.
Summary of Costs and Benefits
The proposed rule, if finalized, would require that testing of food
in certain circumstances be performed by an accredited laboratory
(participating lab) accredited to the proposed standards by a
recognized accreditation body (participating accreditation body), and
for the results to be submitted to us. The costs of the proposed rule,
if finalized, would be incurred primarily by participating
accreditation bodies, participating labs, shell-egg producers, sprouts
producers, bottled water manufacturers, and owners and consignees of
human and animal food offered for import covered by the proposed rule.
We would incur costs to establish and maintain the program for
recognizing accreditation bodies hoping to participate in our program,
assessing participating accreditation bodies and participating labs,
and for reviewing associated documents and reports. The present value
of the cost of the proposed rule, if finalized, would range from $34
million to $78 million when discounted by 7 percent over 10 years. When
discounted by 3 percent over 10 years the present value of the cost
would range from $39 million to $92 million.
The proposed rule, if finalized, would generate some quantified and
unquantified benefits. Quantified benefits include cost-savings from
the proposed clarifications of the process for compiling, submitting
and reviewing analytical reports for human and animal food offered for
import covered under the proposed rule, and a reduced burden from the
proposed abbreviated reporting requirements. In addition, there would
be savings from fewer false positive test results. We anticipate a
reduction in the number of foodborne illnesses from fewer false
negative test results for human and animal food offered for import
covered under the proposed rule and for shell eggs, sprouts, bottled
water, and other food subject to specific testing requirements covered
under the proposed rule. Unquantified benefits could include fewer
illnesses from deterring unsafe manufacturing practices by all entities
affected by the proposed rule. The present value of the quantified
benefits of the proposed rule, if finalized, would range from $26
million to $81 million when discounted by 7 percent over 10 years. When
discounted by 3 percent over 10 years the present value of the
quantified benefits would range from $32 million to $98 million. We
expect that specific test reporting requirements would result in more
accurate analytical reports and reporting.\7\
---------------------------------------------------------------------------
\7\ There are currently no reporting requirements for tests of
shell eggs, sprouts, or bottled water.
---------------------------------------------------------------------------
We have developed a comprehensive Preliminary Economic Analysis of
Impacts that assesses the impacts of the proposed rule. In table 1, we
provide the Regulatory Information Service Center and Office of
Information and Regulatory Affairs Consolidated Information System
accounting information.
[[Page 59496]]
Table 1--Summary of Benefits, Costs and Distributional Effects of Proposed Rule \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Units
---------------------------------------
Category Primary Low High Period Notes
estimate estimate estimate Year Discount covered
dollars rate (%) (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
Annualized Monetized $millions/year.... $7.56 $3.71 $11.52 2016 7 10 Cost savings.
7.56 3.71 11.52 2016 3 10 Cost savings.
Annualized Quantified.................. ........... ........... ........... ........... 7 ...........
........... ........... ........... ........... 3 ...........
------------------------------------------------------------------------------------------------------------
Qualitative............................ Reduced risk of food-related illness
from improper test reporting
practices imported human and animal
food covered under the proposed rule,
and shell eggs, sprouts and bottled
water and other tests subject to
specific testing requirements.
Reduced risk of food-related illness
from unsafe food manufacturing
practices.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs:
Annualized Monetized $millions/year.... $6.73 $4.64 $9.27 2016 7 10
6.76 4.73 9.28 2016 3 10
Annualized Quantified.................. ........... ........... ........... ........... 7 ...........
........... ........... ........... ........... 3 ...........
Qualitative............................ ........... ........... ........... ........... ........... ...........
--------------------------------------------------------------------------------------------------------------------------------------------------------
Transfers:
Federal Annualized Monetized $millions/ ........... ........... ........... ........... 7 ...........
year.
........... ........... ........... ........... 3 ...........
------------------------------------------------------------------------------
From/To................................ From:
To:
------------------------------------------------------------------------------
Other Annualized Monetized $millions/ ........... ........... ........... ........... 7 ...........
year.
........... ........... ........... ........... 3 ...........
------------------------------------------------------------------------------
From/To................................ From:
To:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects:
State, Local or Tribal Government: None.............................................................................................................
Small Business: Potential impacts on laboratories currently not accredited to ISO/IEC 17025 that would participate in the labs program described by
the proposed rule..
Wages: None.........................................................................................................................................
Growth: None........................................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The lower bound equals the 5th percentile and the upper bound equals the 95th percentile.
In line with E.O. 13771, in table 2 we estimate present and
annualized values of costs and cost savings over an infinite time
horizon.
Table 2--E.O. 13771 Summary Table
[in $ millions 2016 dollars discounted over an infinite time horizon] \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Lower bound Upper bound Lower bound Upper bound
Primary (7%) (7%) (7%) Primary (3%) (3%) (3%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Present Value of Costs.................................. $100.29 $56.49 $144.54 $216.92 $115.07 $319.32
Present Value of Cost Savings........................... 101.85 71.15 134.87 237.65 172.25 307.92
Present Value of Net Costs.............................. -1.56 -57.43 53.51 -20.73 -149.76 110.77
Annualized Costs........................................ 7.02 3.95 10.12 6.51 3.45 9.58
Annualized Cost Savings................................. 7.13 5.17 9.24 7.13 5.17 9.24
Annualized Net Costs.................................... -0.11 -3.99 3.84 -0.62 -4.49 3.32
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The lower bound equals the 5th percentile and the upper bound equals the 95th percentile.
We have developed a comprehensive Preliminary Economic Analysis of
Impacts that assesses the impacts of the proposed rule. The full
preliminary analysis of economic impacts is available in the docket for
this proposed rule (Ref. 21) and at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.
IX. Analysis of Environmental Impact
We have carefully considered the potential environmental effects of
this action. We have concluded, under 21 CFR 25.30(h), that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required (Ref. 22).
X. Paperwork Reduction Act of 1995
This proposed rule contains information collection provisions that
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520).
This analysis provides a description of these
[[Page 59497]]
provisions and an estimate of the annual reporting and recordkeeping
burden associated with the proposed rule. Included in the estimate is
the time for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and reviewing
each collection of information.
We invite comments on these topics: (1) Whether the proposed
collection of information is necessary for the proper performance of
FDA's functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Title: Laboratory Accreditation for Analyses of Foods.
Description: As mandated by section 422 of the FD&C Act, we are
establishing of a program for the testing of food by accredited
laboratories; establishing a publicly available registry of recognized
accreditation bodies and accredited laboratories; and establishing
procedures for reporting any changes affecting the recognition of such
accreditation bodies or accreditation of such laboratories.
Description of Respondents: Respondents to the collection of
information are accreditation bodies seeking recognition from FDA,
recognized accreditation bodies, laboratories seeking accreditation
from recognized accreditation bodies, and accredited laboratories. We
estimate the burden of the information collection as follows:
Reporting Burden: Consistent with figures discussed in our
Preliminary Regulatory Impact Analysis (PRIA) (see Section II.D, Number
of Entities), we estimate a total of 66 respondents. We estimate that
five to 80 accreditation bodies would apply for FDA recognition under
the rule, with a mean distribution of 17.5 accreditation bodies. For
this analysis we round up to 18. Similarly, we estimate of a mean of 48
laboratories will participate in the program, for a total of 66
respondents to the information collection. The reporting burden
includes a burden of 8,820 hours associated with one-time submissions.
In this analysis, we annualize the one-time submission burden using a
3-year period horizon and zero percent discount rate, for an annualized
one-time reporting burden of 2,940 hours. Cumulatively, this results in
a total annual reporting burden of 15,049.05 hours, as reflected in
table 3.
Table 3--Estimated Annual Reporting Burden
----------------------------------------------------------------------------------------------------------------
Average
21 CFR part 1, subpart R citation; IC Number of Number of Total burden per
activity respondents responses per annual response Total hours
respondent responses (in hours)
----------------------------------------------------------------------------------------------------------------
Sec. Sec. 1.1113/1.1128(a); Accreditation 18 1 18 20 360
bodies (ABs) application for recognition
(one-time submission)......................
Sec. 1.1123(b) and (c); ABs--general 18 12 216 * .5 108
reporting requirements.....................
Sec. 1.1128(b); ABs--application for 18 1 18 3.6 64.8
renewal of recognition.....................
Sec. Sec. 1.1138 and 1.1158; 48 1 48 20 960
laboratories--submission of application for
accreditation (one-time submission)........
Sec. 1.1152(c)(1) and (2); laboratories-- 48 88.48 4,247 1.75 7,432
Submission of sampling plan, sample
collection report, and sampler
qualifications.............................
Sec. 1.1152(d); laboratories-- 48 10 480 2 960
qualification to submit abridged analytical
reports (one-time submission)..............
Sec. 1. 1152(c)(3); laboratories--abridged 48 88.48 4,247 1.16 4,927
analytical reports submissions.............
Sec. 1.1152(c)(4) and (5); laboratories-- 9 1 9 [dagger].25 2.25
validation and verification studies
submissions................................
Sec. 1.1152(i); laboratories--advance 48 3 144 1.5 216
notice of sampling submissions.............
Sec. 1.1152(j); laboratories--immediate 48 1.5 72 .25 18
notification...............................
Sec. Sec. 1.1165; 1.1171; 1.1173; and 1 1 1 1 1
1.1174; requests in response to FDA action.
-------------------------------------------------------------------
Total................................... ........... .............. ........... ........... 15,049.05
----------------------------------------------------------------------------------------------------------------
* (30 mins.)
[dagger] (15 mins.)
Proposed Sec. 1.1128(a) would require accreditation bodies that
wish to be recognized to submit an application to FDA that demonstrates
their qualifications (those qualifications are specified by proposed
Sec. 1.1113) to accredit laboratories under this rule. We estimate
this process would take one analyst between 40 and 80 hours to compile
all the relevant information, prepare for an assessment, and complete
initial application process, and submit the application. For this
analysis we assume a middle value of 60 hours. Also for this analysis,
we use a 3-year period horizon and zero percent discount rate to
convert the one-time submission burden to an annualized figure (i.e.,
60 hours / by 3 = 20 hours). Annually this results in 360 hours of
burden for initial applications submitted by 18 accreditation bodies
(18 applications x 20 hours per application), as reflected in row 1.
Proposed Sec. 1.1123 would require a recognized accreditation body
to report information, including significant changes affecting its
accreditation program or the accreditation status of laboratories it
accredits, and ensure FDA has access to these and other records. We
estimate recognized accreditation bodies would incur a burden of 1 hour
per month, or 12 hours per year, complying with both the reporting
requirements of proposed Sec. 1.1123 and the recordkeeping
requirements of proposed Sec. 1.1124. For this analysis, we identify
recordkeeping and reporting burdens separately and assume 6 of the 12
hours (i.e., 30 minutes per month) would be spent meeting the reporting
requirements of Sec. 1.1123. Annually, this results in 108 hours (18
recognized accreditation bodies x 6 hours per year), as reflected in
row 2.
Proposed Sec. 1.1128(b) would require accreditation bodies to
apply for renewal of recognition at least every 5 years. We believe
renewal would take less time than an initial application because much
of the information will have already been compiled and therefore assume
between 20 and 40 hours. For this analysis we use a middle value and
calculate that each recognized accreditation body will spend 30 hours
every 5 years to complete and submit an application for renewal of its
[[Page 59498]]
recognition. This results in 6 hours per year (30 hours / 5 years) for
each accreditation body. Because we use a 3-year period horizon and
zero percent discount rate for this analysis, we annualize that figure
to three-fifths or 3.6. We multiply this figure by 18 accreditations
bodies for a total of 64.8 hours annually for the submission of renewal
of applications (18 applications x 3.6 hours per application), as
reflected in row 3.
Proposed Sec. 1.1158 would require a laboratory seeking
accreditation to submit an application for accreditation to a
recognized accreditation body, demonstrating that it meets the
requirements for accreditation under the proposed rule (those
requirements are specified by proposed Sec. 1.1138). We estimate 48
laboratories will apply and assume it would take one analyst an average
of 60 hours to compile all the relevant information, however we regard
the burden as a one-time burden and therefore have annualized it by 3
years (20 hours annually). This results in an annual reporting burden
for initial applications by 48 laboratories would be 960 hours (48
applications x 20 hours per application), as reflected in row 4.
Proposed Sec. 1.1152(a) through (i) would require accredited
laboratories to submit testing results of testing conducted under the
program and include supporting documentation. However, as discussed in
our supporting statement, only a percentage of that testing would be
defined as information collection under the PRA. For this analysis we
assume a mean figure of 4,197, as the basis for factoring a
corresponding information collection burden. This figure is derived
using lower and upper bound estimates of submissions we expect under
the rule. To allow for adjustment and potential increase we have added
a count of 50 submissions for a total of 4,247.
Proposed Sec. 1.1152(c)(1) would require accredited laboratories
to obtain, or develop, and submit a sample collection plan and sample
collection report (the contents of which would be prescribed by
proposed Sec. 1.1149) with each test result. Under proposed Sec.
1.1152(c)(2), laboratories would also be required to include
documentation of the sampler's qualifications the first time the
sampler collects a sample, or when the sampler's qualifications have
significantly changed. We assume that it would take 30 minutes to 1
hour to compile a sampling plan, 30 minutes to one hour to compile a
sample collection report, and an average of 10 to 20 minutes to obtain
the sampling plan, sample collection report, and sampler's credentials.
Using a middle value of 1.5 hours to generate the sampling plan and the
sample collection report, and a middle value of 15 minutes (.25 hours)
to obtain those two documents and documentation of the sampler's
qualifications, we calculate a total of time per test results of 1.75
hours (1.5 + .25). When multiplied together the total reporting burden
for the submission of sampling plans, sample collection reports, and
sampler credential requirements (48 accredited laboratories x 88.48
sampling plans and sample collection reports x 1.75 hours) is 7,432
hours, as reflected in row 5.
Proposed Sec. 1.1152(d) would allow accredited laboratories to
qualify to submit abridged analytical reports in lieu of full
analytical reports. At this time we expect this would be a one-time
burden, but we may revisit this assumption in the future based on
actual disqualification rates if the proposed rule is finalized and
implemented. We assume that each accredited laboratory would submit 10
consecutive full analytical reports to qualify to submit abbreviated
reports. We also assume accredited laboratories spend 4 to 8 hours to
compile and submit a full analytical report, and we use the middle
value of 6 hours for this analysis. For initial or one-time burdens we
use a 3-year period horizon and zero percent discount rate to convert
the one-time burden to an annualized figure (2 hours). When multiplied
together, this results in a total reporting burden for the accredited
laboratories to qualify to submit abridged analytical reports of 960
hours (48 laboratories x 10 full analytical reports each x 2 hours per
analytical report), as reflected in row 6.
After an accredited laboratory qualifies to submit abridged
analytical reports, we assume it would submit abridged analytical
reports to us thereafter. We may revisit this assumption in the future
based on actual disqualification rates if the proposed rule is
finalized and implemented. We estimate the burden to compile and submit
an abridged analytical report to be between 25 percent and 33 percent
of the burden of compiling and submitting a full analytical report, and
we use a middle value of 29 percent here. Thus, using these figures we
calculate it would take an accredited laboratory 1.74 hours to compile
and submit an abridged analytical report (29 percent x 6 hours). This
results in an annual total reporting burden for the 48 accredited
laboratories to compile and submit abridged analytical reports of
approximately 4,927 hours (48 laboratories x 88.48 abridged analytical
reports x 1.16 hours per abridged analytical report), as reflected in
row 7.
The proposed rule would also require the participating lab to
submit verification and validation studies to FDA as part of an
analytical report, or to an accreditation body as a prerequisite for
participation in the labs program. The ISO/IEC 17025 standard requires
the use of validated and verified methods for testing foods. However,
the proposed rule, if finalized, would require additional verification
studies over and above the requirements of ISO/IEC 17025. Additional
studies may include information to verify that a method previously
validated for a specific food item is also valid for a different food
item, in what is called a ``matrix extension.'' We estimate that the
additional time burden of requiring laboratories to submit verification
studies such as matrix extensions under this proposed rule to be a
middle value of approximately 3 percent of the time burden incurred by
laboratories to maintain accreditation to ISO/IEC 17025 (the PRIA
estimates a range of 1 percent to 5 percent). In the PRIA we also note
that internal FDA experts suggest that between 5 percent and 30 percent
of import food testing results require verification studies such as
matrix extensions. We use a middle value of 17.5 percent for this
analysis.
With regard to validation requirements, we assume that methods used
to test shell eggs, sprouts, and bottled water are either already
validated or the costs to doing so would be included in the costs to
maintain accreditation to the ISO/IEC 17025 standard. Consequently, we
assume that shell eggs, sprouts, and bottled water producers would
incur no burden from this requirement beyond the burden of the proposed
rule's requirements to meet the validation requirements of ISO/IEC
17025.
We estimate the time required to perform a matrix extension is a
middle value of 34 hours (the PRIA estimates a range of 22 to 46
hours). We do not distinguish between the burden of reporting the study
and the burden of conducting the study. We assume 25 percent of the 34
hours (8.5 hours) is attributable to the associated reporting burden.
Because we estimate that the additional time burden of requiring
laboratories to submit verification studies such as matrix extensions
under this proposed rule would be approximately 3 percent of the time
burden incurred by laboratories to maintain accreditation to ISO 17025,
we multiply 8.5 hours by 3 percent to get the additional reporting
burden of .255 hours (15.3 minutes, which we round to
[[Page 59499]]
15 minutes, which is .25 hours) per study imposed by the verification
study submission requirements of the proposed rule. To estimate the
number of test results that would require matrix extensions, we
multiply the number of import testing results that would be submitted
to us under this rule annually that are subject to PRA requirements
(50) by the share of test results submitted to us for import food
testing that require matrix extensions (17.5 percent), for a total of
8.75 matrix extensions per year. This equates to an average of .17708
matrix extensions per accredited laboratory (8.5 / 48). Because the
number of respondents and the annual responses per respondent in a PRA
analysis must be whole numbers, we instead estimate that nine
accredited laboratories (48 x .17708, rounded to 9 from 8.5) will
submit one full verification study to FDA annually. Therefore, the
annual reporting burden of requiring the submission of validation and
verification studies under this proposed rule is 2.25 hours (9
accredited laboratories x 1 verification studies x .25 hours per
study), as reflected in row 8.
Proposed Sec. 1.1152(i) would provide that, under certain
circumstances, FDA may require one or more accredited laboratories to
submit an advance notice of sampling to FDA before each of the next
several occasions that the sampler will a collect a sample that the
accredited laboratory will analyze under this program. We assume that
it would take a laboratory analyst between 1 and 2 hours to compile the
required information and submit the information, and we assume that
between one percent and five percent of all test results submitted
annually under this program would be subject to the notice of sampling
requirement. For this analysis we assume middle values of 1.5 hours and
three percent, respectively. Thus, we estimate that 127.41 test results
(4,247 x 3%) would require submission of advance notice of sampling
under the proposed rule. For this analysis we assume that each of the
estimated 48 accredited laboratories would be required to submit three
notices of advance sampling annually under the proposed rule (127.41 /
48 = 2.65; rounded to 3). Thus, the annual reporting burden on
accredited laboratories due to the proposed advance notice of sampling
requirement would be 216 hours (48 laboratories x 3 advance notices of
sampling x 1.5 hours), as reflected in row 9.
Proposed Sec. 1.1152(j) would require accredited laboratories to
notify FDA and the accreditation body of any changes that affect the
laboratory's accreditation. Note, however, that under Sec. 1.1123(c),
recognized accreditation bodies also have a duty to immediately notify
FDA of changes in an accredited laboratory's status. Thus, an
accredited laboratory is not required to notify FDA of changes that
fall under Sec. 1.1123(c). To be conservative we estimate that every
lab that participates will have some change about which it must notify
its accreditation body, and for half of those changes the accredited
laboratory will also need to notify FDA. We estimate it will take an
accredited laboratory 15 minutes per notification. Thus we estimate the
burden associated with Sec. 1.1152(j) would be 18 hours (48 accredited
laboratories x 1.5 notifications x 0.25 hours per notification), as
reflected in row 10.
Proposed Sec. Sec. 1.1165, 1.1171, 1.1173, and 1.1174 provide for
requests to FDA. Specifically, Sec. 1.1165 provides for requests for
reinstatement of accreditation; Sec. 1.1171 provides for requests for
reconsideration of denials; and Sec. Sec. 1.1173 and 1.1174 provide
for requests for hearings. Because this is a new collection, we are
estimating a cumulative total of 1 respondent and 1 burden hour, as
reflected in row 11, however we invite specific comment in this regard.
Upon implementation of any final rule, we will reevaluate our burden
estimate in light of overall submissions to the Agency and public
comments received.
Recordkeeping Burden: Recordkeeping requirements associated with
the proposed rule include a one-time burden of 1,366.05 hours and
annual burden of 41,912.74 hours. In this analysis, we annualize the
one-time recordkeeping burden using a 3-year period horizon and zero
percent discount rate, for an annualized one-time recordkeeping burden
of 455.35. Cumulatively, we estimate an annual recordkeeping burden
under this proposed rule of 43,278.79 hours, as reflected in table 4.
Table 4--Estimated Annual Recordkeeping Burden
----------------------------------------------------------------------------------------------------------------
Average
Proposed 21 CFR part 1, subpart R; IC Number of Number of Total burden per
activity recordkeepers records per annual recordkeeping Total hours
recordkeeper records (in hours)
----------------------------------------------------------------------------------------------------------------
Sec. Sec. 1.113 and 1.1118; 18 1 18 1 18
recordkeeping associated with ISO/IEC
17011....................................
Sec. 1.1124; ABs--additional 18 1 18 6 108
recordkeeping requirements...............
Sec. 1.1138; laboratories--becoming 5 1 5 91.06 455.35
accredited to ISO/IEC 17025 (one-time)...
Sec. 1.1146; laboratories--maintaining 48 1 48 889.53 42,697.44
ISO/IEC 17025 accreditation..............
---------------------------------------------------------------------
Total................................. ............. ............ ........... ............. 43,278.79
----------------------------------------------------------------------------------------------------------------
Proposed Sec. 1.1113 and Sec. 1.1118 would require accreditation
bodies to meet the requirements of ISO/IEC 17011 to be recognized.
While ISO/IEC 17011 includes recordkeeping requirements, as noted above
we estimate that all of the 18 accreditation bodies that would become
recognized under the proposed rule currently adhere to ISO/IEC 17011.
We therefore regard these activities as usual and customary, however we
include a place holder of one response and one burden hour for each
respondent, as reflected in row 1.
Proposed Sec. 1.1124, however, provides for the maintenance of
certain records in addition to those required by ISO/IEC 17011. We
estimate recognized accreditation bodies would incur a burden of 12
hours per year to comply with both the recordkeeping requirements of
proposed Sec. 1.1124 and the reporting requirements of proposed Sec.
1.1123. For this analysis, we identify the recordkeeping and reporting
burdens separately, assuming six of those 12 annual hours would be
spent complying with the recordkeeping requirements of proposed Sec.
1.1124. Thus, the annual recordkeeping burden for the 18 recognized
accreditation bodies to meet the additional recordkeeping requirements
of proposed Sec. 1.1124 would be 108 hours, as reflected in row 2.
Proposed Sec. 1.1138 would require laboratories to meet certain
requirements of ISO/IEC 17025, including its recordkeeping
requirements, to be accredited under the proposed rule. We estimate
that between two to eight laboratories not
[[Page 59500]]
currently accredited to ISO/IEC 17025 would become accredited. We use a
middle estimate of five laboratories and also estimate that it would
take a mean of 91.06 hours for the associated recordkeeping activities.
This results in an annualized burden of 455.35, as reflected in row 3.
Proposed Sec. 1.1146 would require laboratories to maintain
conformance with ISO/IEC 17025, including its recordkeeping
requirements. Based on available data, and as discussed in our PRIA, we
estimate a mean of 889.53 hours for this recordkeeping. This results in
an annual burden of 42,697.44 hours, as reflected in row 4.
The proposed rule also affects currently approved information
collections. Information collection provisions found in part 11 of our
regulations are currently approved under OMB Control No. 0910-0303.
Information collection provisions found in part 129 of our regulations
are currently approved under OMB Control No. 0910-0658. Although no new
information collection or no material modification is being introduced
by the proposed rule, upon implementation of any final rule we will
reevaluate our burden estimates for these collections accordingly.
Finally, information collection provisions found in part 16 of our
regulations are exempt from OMB review and approval under the PRA, as
the information collection occurs during the conduct of an official
administrative action (see 5 CFR 1320.4(a)(2)).
To ensure that comments on this information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB (see ADDRESSES). All
comments should be identified with the title of the information
collection.
In compliance with the PRA, the Agency has submitted the
information collection provisions of this proposed rule to OMB for
review. These information collection requirements will not be effective
until FDA publishes a final rule, OMB approves the information
collection requirements, and the rule goes into effect. We will publish
a notice concerning OMB approval of these requirements in the Federal
Register.
XI. Federalism
We have analyzed this proposed rule in accordance with the
principles set forth in E.O. 13132. We have determined that the
proposed rule does not contain policies that have a substantial direct
effect on the States, on the relationship between the National
Government and the States, or on the distribution of power and
responsibilities among the various levels of government. Accordingly,
we have tentatively concluded that the proposed rule does not contain
policies that have federalism implications as defined in the Executive
order and, consequently, a federalism summary impact statement is not
required.
XII. References
The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (see ADDRESSES) and are available for
viewing by interested persons between 9 a.m. and 4 p.m., Monday through
Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public
display at https://www.regulations.gov because they have copyright
restriction. Some may be available at the website address, if listed.
References without asterisks are available for viewing only at the
Dockets Management Staff. FDA has verified the website addresses, as of
the date this document publishes in the Federal Register, but websites
are subject to change over time.
* 1. FDA Memorandum, ``Assessment of DWPE Sampling and Analysis Data
to Determine what Portion of Sampling and Analysis of Food under
DWPE is Conducted by Accredited Entities.'' Toni Morales and Tyler
Scandalios, FDA. November 20, 2018.
* 2. Congressional Hearing, ``The Safety of Food Imports: Fraud &
Deception in the Food Import Process; Hearings Before the Senate
Committee on Governmental Affairs, Permanent Subcommittee on
Investigations.'' September 10, 1998. https://www.gpo.gov/fdsys/pkg/CHRG-105shrg51562/pdf/CHRG-105shrg51562.pdf. Accessed on June 17,
2019.
* 3. ``Private Laboratory Guidance,'' ORA Laboratory Manual, Vol.
III, Section 7, document number III-07. FDA. January 30, 2013.
https://www.fda.gov/media/81810/download. Accessed on June 17, 2019.
4. ``ISO/IEC 17025:2005 ``General Requirements for the Competence of
Testing and Calibration Laboratories'' (withdrawn). International
Organization for Standardization/International Electrotechnical
Commission. May 2005. Copies are available from the International
Organization for Standardization, Chemin de Blandonnet 8, 1214
Vernier, Geneva, Switzerland, or on the internet at https://www.iso.org/standard/39883.html, or may be viewed on the internet
through, https://www.surveymonkey.com/r/KFJMZ67 or may be examined
at the Dockets Management Staff (Ref. Docket No. FDA-2019-N-3325
and/or RIN 0910-AH31).
*5. ``Action Plan for Import Safety.'' Interagency Working Group on
Import Safety. November 2007. http://www.itagc.org/docs/ITAGC-2010-11-10-FDA-4.pdf. Accessed June 17, 2019.
* 6. GAO Report, ``Federal Oversight of Food Safety: FDA's Food
Protection Plan Proposes Positive First Steps, but Capacity to Carry
Them Out Is Critical (GAO-08-435T).'' Government Accountability
Office. January 29, 2008. https://www.gao.gov/assets/120/118821.pdf.
Accessed on June 17, 2019.
* 7. GAO Report, ``Food Safety: FDA's Imported Seafood Safety
Program Shows Some Progress, but Further Improvements are Needed
(GAO-04-246).'' Government Accountability Office. January 30, 2004.
https://www.gao.gov/assets/250/241327.pdf. Accessed on June 17,
2019.
* 8. FDA Draft Guidance for Industry, ``Submission of Laboratory
Packages by Accredited Laboratories'' (withdrawn). FDA. January 16,
2009.
9. ``Guidelines for Laboratories Performing Microbiological and
Chemical Analyses of Food, Dietary Supplements, and Pharmaceuticals,
An Aid to Interpretation of ISO/IEC 17025:2005.'' AOAC
International. April 2015. Copies are available from AOAC
International, 2275 Research Blvd., Ste. 300, Rockville, MD 20850-
3250, USA, or on the internet at http://www.aoac.org/aoac_prod_imis/AOAC/AOAC_Member/PUBSCF/ALACCCF/ALACC_M.aspx, or may be examined at
the Dockets Management Staff (Ref. Docket No. FDA-2019-N-3325 and/or
RIN 0910-AH31).
* 10. ``IAF/ILAC Multi-Lateral Mutual Recognition Arrangements
(Arrangements): Requirements and Procedures for Evaluation of a
Single Accreditation Body.'' International Accreditation Forum/
International Laboratory Accreditation Cooperation. January 2018.
Available at https://ilac.org/publications-and-resources/joint-ilac-iaf-series/. Accessed on June 17, 2019.
* 11. ``OMB Circular A-119: Federal Participation in the Development
and Use of Voluntary Consensus Standards and in Conformity
Assessment Activities.'' Office of Management and Budget. January
2016. https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/inforeg/inforeg/revised_circular_a-119_as_of_1_22.pdf. Accessed on
June 17, 2019.
* 12. ``ISO/IEC 17011:2017(E), ``Conformity Assessment--Requirements
for Accreditation Bodies Accrediting Conformity Assessment Bodies.''
International Organization for Standardization/International
Electrotechnical Commission. November 2017. Copies are available
from the International Organization for Standardization, Chemin de
Blandonnet 8, 1214 Vernier, Geneva, Switzerland, or on the internet
at https://www.iso.org/standard/67198.html, or may be examined at
the Dockets Management Staff (Ref. Docket No. FDA-2019-N-3325 and/or
RIN 0910-AH31).
13. ISO/IEC 17025:2017(E), ``General Requirements for the Competence
of
[[Page 59501]]
Testing and Calibration Laboratories.'' International Organization
for Standardization/International Electrotechnical Commission.
November 2017. Copies are available from the International
Organization for Standardization, Chemin de Blandonnet 8, 1214
Vernier, Geneva, Switzerland, or on the internet at https://www.iso.org/standard/66912.html, or may be examined at the Dockets
Management Staff (Ref. Docket No. FDA-2019-N-3325 and/or RIN 0910-
AH31).
* 14. Meeting Minutes, ``Sampling Accreditation Discussion with
ABs.'' FDA. November 13, 2017.
* 15. ``R103--General Requirements: Proficiency Testing for ISO/IEC
Laboratories.'' American Association for Laboratory Accreditation.
September 19, 2013. https://portal.a2la.org/requirements/R103_2013.pdf. Accessed on June 17, 2019.
*16. ``Accreditation Requirements: ISO/IEC 17025 Testing
Laboratories (Non-Forensics).'' ANSI/ASQ National Accreditation
Board. October 9, 2018. https://anab.qualtraxcloud.com/ShowDocument.aspx?ID=8160. Accessed on June 17, 2019.
17. ISO/IEC 17043:2010, ``Conformity Assessment--General
Requirements for Proficiency Testing.'' International Organization
for Standardization/International Electrotechnical Commission.
February 2010. Copies are available from the International
Organization for Standardization, Chemin de Blandonnet 8, 1214
Vernier, Geneva, Switzerland, or on the internet at https://www.iso.org/standard/29366.html, or may be examined at the Dockets
Management Staff (Ref. Docket No. FDA-2019-N-3325 and/or RIN 0910-
AH31).
* 18. ``Methods, Method Verification and Validation,'' ORA
Laboratory Manual, Vol. II, Section 2, document number ORA-
LAB.5.4.5. FDA. August 29, 2014. https://www.fda.gov/media/73920/download. Accessed on June 17, 2019.
* 19. FDA Memorandum, ``Guidelines for the Validation of Chemical
Methods for the FDA FVM Program, 2nd Edition.'' FDA Foods and
Veterinary Medicine Science and Research Steering Committee. May 19,
2015. https://www.fda.gov/media/81810/download. Accessed on June 17,
2019.
* 20. Meeting Record, ``FSMA Lab Accreditation/Food Laboratory
Alliance Meeting Record August 21, 2015.'' FDA. July 21, 2015.
* 21. FDA. Accreditation of Laboratories to Conduct Food Testing:
Preliminary Regulatory Impact Analysis, Initial Regulatory
Flexibility Analysis, Unfunded Mandates Reform Act Analysis, 2019.
https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.
* 22. FDA Memorandum. ``Proposed Rule: Amendment of 21 CFR parts 1,
11, 16, and 129 to Establish a Program for Laboratory Accreditation
for Analyses of Foods as Required by FD&C Act.'' Leah D. Proffitt,
FDA, June 14, 2019.
List of Subjects
21 CFR Part 1
Cosmetics, Drugs, Exports, Food labeling, Imports, Labeling,
Reporting and recordkeeping requirements, Incorporation by reference.
21 CFR Part 11
Computer technology, Reporting and recordkeeping requirements.
21 CFR Part 16
Administrative practice and procedure.
21 CFR Part 129
Beverages, Bottled water, Food packaging, Reporting and
recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR parts 1, 11, 16, and 129 be amended as follows:
PART 1--GENERAL ENFORCEMENT REGULATIONS
0
1. The authority citation for part 1 continues to read as follows:
Authority: 15 U.S.C. 1333, 1453, 1454, 1455; 4402; 19 U.S.C.
1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 343, 350c,
350d, 350e, 350j, 350k, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2,
362, 371, 373, 374, 381, 382, 384a, 384b, 384d, 387, 387a, 387c,
393; 42 U.S.C. 216, 241, 243, 262, 264, 271.
0
2. In Sec. [thinsp]1.651, revise paragraphs (b)(3) and (c)(2) to read
as follows:
Sec. 1.651 How must an accredited third-party certification body
conduct a food safety audit of an eligible entity?
* * * * *
(b) * * *
(3) When, for a regulatory audit, sampling and analysis is
conducted, the accredited third-party certification body must use a
laboratory that is accredited in accordance with ISO/IEC 17025:2017 to
perform the analysis.
* * * * *
(c) * * *
(2) The audit must include records review prior to the onsite
examination; an onsite examination of the facility, its process(es),
and the food that results from such process(es); and where appropriate
or when required by FDA, environmental or product sampling and
analysis. When, for a regulatory audit, sampling and analysis is
conducted, the accredited third-party certification body must use a
laboratory that is accredited in accordance with paragraph (b)(3) of
this section to conduct the analysis. The audit may include any other
activities necessary to determine compliance with applicable food
safety requirements of the Federal Food, Drug, and Cosmetic Act and FDA
regulations, and, for consultative audits, also includes conformance
with applicable industry standards and practices.
* * * * *
0
3. Add subpart R, consisting of Sec. Sec. 1.1102 through 1.1200, to
read as follows:
Subpart R--Accreditation of Laboratories to Conduct Food Testing
General Provisions
Sec.
1.1102 What definitions apply to this subpart?
1.1103 Who is subject to this subpart?
General Requirements of this Subpart
1.1107 Under what circumstances must food testing be conducted under
this subpart by an accredited laboratory?
1.1108 When and how will FDA issue a food testing order?
1.1109 How will FDA make information about recognized accreditation
bodies and accredited laboratories available to the public?
Recognition of Accreditation Bodies
1.1113 What requirements must an accreditation body meet to be
recognized by FDA?
Requirements for Recognized Accreditation Bodies
1.1118 What are the general requirements for recognized
accreditation bodies to remain recognized?
1.1119 What requirements apply to how a recognized accreditation
body must protect against conflicts of interests?
1.1120 How must a recognized accreditation body evaluate
laboratories seeking accreditation and oversee the performance of
laboratories it accredits?
1.1121 What appeal procedures must a recognized accreditation body
provide for appeals of decisions to not grant accreditation?
1.1122 When must a recognized accreditation body withdraw or reduce
the scope of the accreditation of a laboratory, and when may a
recognized accreditation body put an accredited laboratory on
probation?
1.1123 What reports and notifications must a recognized
accreditation body submit to FDA?
1.1124 What records requirements must a recognized accreditation
body meet?
1.1125 What internal audit requirements must a recognized
accreditation body meet?
Procedures for Recognition of Accreditation Bodies
1.1128 How does an accreditation body apply to FDA for recognition
or renewal of recognition?
[[Page 59502]]
1.1129 How will FDA review applications for recognition and
applications for renewal of recognition?
1.1130 How will FDA oversee recognized accreditation bodies?
1.1131 When will FDA revoke the recognition of an accreditation body
or put a recognized accreditation body on probation?
1.1132 What must a recognized accreditation body do if it wants to
voluntarily relinquish its recognition or does not want to renew its
recognition?
1.1133 How does an accreditation body request reinstatement of
recognition?
Accreditation of Laboratories
1.1138 What requirements must a laboratory meet to become accredited
by a recognized accreditation body?
Requirements for Accredited Laboratories
1.1146 What are the general requirements for accredited laboratories
to remain accredited?
1.1147 What impartiality and conflict of interest requirements must
accredited laboratories meet?
1.1148 What quality assurance requirements must accredited
laboratories meet?
1.1149 What oversight standards apply to sampling?
1.1150 What requirements apply to analysis of samples by an
accredited laboratory?
1.1151 What requirements apply to the methods of analysis an
accredited laboratory uses to conduct food testing under this
subpart?
1.1152 What notifications, results, and reports must accredited
laboratories submit to FDA?
1.1153 What other records requirements must an accredited laboratory
meet?
Procedures for Accreditation of Laboratories
1.1158 How does a laboratory apply for accreditation or modification
of its scope of accreditation by a recognized accreditation body?
1.1159 How will FDA oversee accredited laboratories?
1.1160 How will FDA review submitted test results and analytical
reports?
1.1161 When will FDA put an accredited laboratory on probation or
revoke the accreditation of a laboratory?
1.1162 What are the consequences if FDA puts an accredited
laboratory on probation or revokes the accreditation of a
laboratory?
1.1163 What if a laboratory wants to voluntarily relinquish its
accreditation?
1.1164 What is the effect on accredited laboratories if their
accreditation body voluntarily or involuntarily loses its
recognition?
1.1165 How does a laboratory request reinstatement of accreditation?
Requesting FDA Reconsideration, FDA Internal Review, or Regulatory
Hearings of FDA Decisions Under This Subpart
1.1171 How does an accreditation body request reconsideration by FDA
of a decision to deny its application for recognition, renewal, or
reinstatement?
1.1173 How does an accreditation body or laboratory request a
regulatory hearing on FDA's decision to revoke the recognized
accreditation body's recognition or revoke the accredited
laboratory's accreditation?
1.1174 How does an owner or consignee request a regulatory hearing
on a food testing order?
Electronic Records and Public Disclosure Requirements Under This
Subpart
1.1199 Are electronic records created under this subpart subject to
the electronic records requirements of part 11 of this chapter?
1.1200 Are the records obtained by FDA under this subpart subject to
public disclosure?
Subpart R--Accreditation of Laboratories To Conduct Food Testing
General Provisions
Sec. 1.1102 What definitions apply to this subpart?
The definitions of terms in section 201 of the Federal Food, Drug,
and Cosmetic Act apply to such terms when used in this subpart, unless
otherwise specified. For the purposes of this subpart, the following
definitions also apply:
Accreditation means a determination by a recognized accreditation
body that a laboratory meets the applicable requirements of this
subpart to conduct food testing under this subpart using one or more
methods of analysis.
Accredited laboratory means a laboratory that a recognized
accreditation body has determined meets the applicable requirements of
this subpart and has been accredited to conduct food testing using one
or more methods of analysis under this subpart.
Analyst means an individual who analyzes samples.
Food has the meaning given in section 201(f) of the Federal Food,
Drug, and Cosmetic Act, except that food does not include pesticides
(as defined in 7 U.S.C. 136(u)).
Food testing and testing of food means the analysis of food product
samples or environmental samples.
Food testing order means an order issued by FDA under Sec. Sec.
1.1107(a)(2) and 1.1108 requiring food testing to be conducted under
this subpart by or on behalf of an owner or consignee.
Owner or consignee means any person with an ownership or
consignment interest in:
(1) The food product or environment that is the subject of food
testing conducted under Sec. 1.1107(a)(1);
(2) Food product or environment that is the subject of the order
issued under Sec. 1.1107(a)(2);
(3) The food product or environment that is the subject of food
testing conducted under Sec. 1.1107(a)(3);
(4) The article of food for which food testing is being conducted
under Sec. 1.1107(a)(4); or
(5) The food subject to an import alert for which food testing is
conducted under Sec. 1.1107(a)(5).
Recognition means a determination by FDA that an accreditation body
meets the applicable requirements of this subpart and is authorized to
accredit laboratories under this subpart.
Recognized accreditation body means an accreditation body that FDA
has determined meets the applicable requirements of this subpart and is
authorized to accredit laboratories under this subpart.
Representative sample means a sample that accurately, to a
scientifically acceptable degree, represents the characteristics and
qualities of the food product or environment that the sample was
collected from.
Sampler means an individual or individuals who perform sampling.
Scope of accreditation refers to the methods of analysis for which
the accredited laboratory is accredited. References in this subpart to
accreditation ``in-whole'' refers to all methods in the accredited
laboratory's scope of accreditation and references to accreditation
``in-part'' refers to only certain methods in the accredited
laboratory's scope of accreditation.
Sec. 1.1103 Who is subject to this subpart?
(a) Accreditation bodies. An accreditation body is subject to this
subpart if it has been recognized by FDA, or is seeking to be
recognized by FDA, to accredit laboratories to conduct food testing
under this subpart.
(b) Laboratories. A laboratory is subject to this subpart if it has
been accredited by a recognized accreditation body, or is seeking to be
accredited by a recognized accreditation body, to conduct food testing
under this subpart.
(c) Owners and consignees. An owner or consignee is subject to this
subpart if they are required to use an accredited laboratory to conduct
food testing under this subpart.
General Requirements of This Subpart
Sec. 1.1107 Under what circumstances must food testing be conducted
under this subpart by an accredited laboratory?
(a) Food testing must be conducted under this subpart whenever such
testing is conducted by or on behalf of an owner or consignee:
(1) In response to explicit testing requirements that address an
identified
[[Page 59503]]
or suspected food safety problem, which are contained in the following
provisions:
(i) Sprouts. 21 CFR 112.146(a), (c) and (d);
(ii) Shell eggs. 21 CFR 118.4(a)(2)(iii), 118.5(a)(2)(ii) and
(b)(2)(ii), and 118.6(a)(2) and (e); and
(iii) Bottled drinking water. 21 CFR 129.35(a)(3)(i) (for the
requirement to test five samples from the same sampling site that
originally tested positive for Escherichia coli);
(2) As required by FDA in a food testing order;
(3) To address an identified or suspected food safety problem and
presented to FDA as part of evidence for a hearing under section 423(c)
of the Federal Food, Drug, and Cosmetic Act prior to the issuance of a
mandatory food recall order, as part of a corrective action plan under
section 415(b)(3)(A) of the Federal Food, Drug, and Cosmetic Act
submitted after an order suspending the registration of a food
facility, or as part evidence submitted for an appeal of an
administrative detention order under section 304(h)(4)(A) of the
Federal Food, Drug, and Cosmetic Act.
(4) In support of admission of an article of food under section
801(a) of the Federal Food, Drug, and Cosmetic Act;
(5) To support removal from an import alert through successful
consecutive testing;
(b) When food testing is conducted under paragraph (a) of this
section, analysis of samples must be conducted by accredited
laboratories that are accredited for the appropriate analytical method
or methods by a recognized accreditation body.
(c) Food testing conducted on articles of food offered for import
into the United States under section 801(a) of the Federal Food, Drug,
and Cosmetic Act pursuant to paragraph (a)(4) or (a)(5) of this section
may only be conducted after the articles offered for import have
arrived in the United States unless FDA has determined, and responded
in writing to the owner/consignee, that a sample(s) taken prior to
arrival is or would be representative sample(s) of such article(s)
offered for import into the United States.
Sec. 1.1108 When and how will FDA issue a food testing order?
(a) FDA may require the owner or consignee of an article of food to
conduct food testing, or to have food testing conducted on their
behalf, under this subpart to address an identified or suspected food
safety problem related to the article of food.
(b) The food testing order will specify the food product or
environment to be tested; whether the food testing may be conducted
using an accredited laboratory that is owned, operated, or controlled
by the owner or consignee; the timeframe in which the food testing must
be conducted; and the manner of the food testing, such as the methods
that must be used.
(c) The food testing order will contain all the elements required
by Sec. 16.22(a) of this chapter and will thereby constitute the
notice of an opportunity for hearing under part 16 of this chapter. An
affected owner or consignee may request a regulatory hearing on a food
testing order, pursuant to Sec. 1.1174 of this subpart.
Sec. 1.1109 How will FDA make information about recognized
accreditation bodies and accredited laboratories available to the
public?
(a) Except as provided by paragraph (b) of this section, FDA will
place on its website a list of:
(1) Recognized accreditation bodies, including for each recognized
accreditation body: The name, contact information, and duration of
recognition of the recognized accreditation body;
(2) Accreditation bodies that have their recognition revoked by FDA
or are put on probation, and accreditation bodies that have
relinquished their recognition or have allowed their recognition to
expire, including for each accreditation body: The name of the
accreditation body, whether FDA revoked recognition of the
accreditation body or put the recognized accreditation body on
probation, or whether the accreditation body relinquished its
recognition or allowed its recognition to expire, and the date of the
probation, revocation, relinquishment, or expiration;
(3) Laboratories accredited under this subpart, including for each
laboratory: The name, contact information, and scope of accreditation
of the accredited laboratory, and the name and contact information of
the accreditation body that accredits the accredited laboratory; and
(4) Laboratories that have been put on probation or have had their
accreditation withdrawn or revoked (in-whole or in-part) by a
recognized accreditation body or by FDA, or have relinquished their
accreditation (in-whole or in-part), including for each laboratory: The
name of the laboratory, whether a recognized accreditation body or FDA
put the laboratory on probation, or withdrew or revoked the
accreditation of the laboratory, or whether the laboratory relinquished
its accreditation, and the date of the probation, withdrawal,
revocation, or relinquishment.
(b) In the interest of national security, FDA, in coordination with
the Secretary of Homeland Security, may determine an alternate time,
manner, and form in which the list described in paragraph (a) of this
section is made publicly available.
Recognition of Accreditation Bodies
Sec. 1.1113 What requirements must an accreditation body meet to
become recognized by FDA?
To become recognized by FDA, an accreditation body seeking
recognition by FDA must:
(a) Be a full member of the International Laboratory Accreditation
Cooperative (ILAC) and a signatory to the ILAC Mutual Recognition
Arrangement (MRA) that has demonstrated competence to ISO/IEC
17011:2017;
(b) Demonstrate it complies with ISO/International Electrotechnical
Commission (IEC) 17011:2017, ``Conformity assessment--Requirements for
accreditation bodies accrediting conformity assessment bodies,'' Second
edition, November 2017. The Director of the Federal Register approves
this incorporation by reference under 5 U.S.C. 552(a) and 1 CFR part
51. The approved material is available for inspection at Dockets
Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852, 301-827-6860, and is available
from International Organization for Standardization (ISO), Chemin de
Blandonnet 8, 1214 Vernier, Geneva, Switzerland; Telephone 41 22 749 01
11, https://www.iso.org/home.html. It is also available for inspection
at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, email
[email protected] or go to www.archives.gov/federal-register/cfr/ibr-locations; and
(c) Demonstrate that it possesses sufficient scientific/technical
expertise to be able to:
(1) Review the validation and verification studies required by
Sec. 1.1138(a)(1), including reviewing the verification studies for
fitness for purpose;
(2) Assess an accredited laboratory's determination under Sec.
1.1148(a)(2) that no proficiency testing program is available or
practicable for a particular method of analysis; and
(3) Assess whether the comparison program proposed by the
accredited laboratory under Sec. 1.1148(a)(2) would provide the
recognized accreditation
[[Page 59504]]
body with the ability to monitor the quality of the laboratory's
performance to a degree comparable to a proficiency test.
(d) Demonstrate it is capable of complying with all requirements
under this subpart for recognized accreditation bodies.
Requirements for Recognized Accreditation Bodies
Sec. 1.1118 What are the general requirements for recognized
accreditation bodies to remain recognized?
To remain recognized, a recognized accreditation body must:
(a) Be a full member of the International Laboratory Accreditation
Cooperative (ILAC) and a signatory to the ILAC Mutual Recognition
Arrangement (MRA) that has demonstrated competence to ISO/IEC
17011:2017;
(b) Meet, with respect to activities under this subpart, the
requirements of ISO/IEC 17011:2017, which is incorporated by reference
(see Sec. 1.1113(b)); and
(c) Demonstrate that it possesses sufficient scientific/technical
expertise to be able to:
(1) Review the validation and verification studies required by
Sec. 1.1138(a)(1), including reviewing the verification studies for
fitness for purpose;
(2) Assess an accredited laboratory's determination under Sec.
1.1148(a)(2) that no proficiency testing program is available or
practicable for a particular method of analysis; and
(3) Assess whether the comparison program proposed by the
accredited laboratory under Sec. 1.1148(a)(2) would provide the
recognized accreditation body with the ability to monitor the quality
of the laboratory's performance to a degree comparable to a proficiency
test.
(d) Comply with all of the additional requirements under this
subpart for recognized accreditation bodies.
Sec. 1.1119 What requirements apply to how a recognized
accreditation body must protect against conflicts of interests?
(a) In addition to meeting the impartiality and conflict of
interest requirements of Sec. 1.1118(b), the recognized accreditation
body must:
(1) Ensure that the recognized accreditation body (and its
officers, employees, or other agents involved in accreditation
activities) does not own or have a financial interest in, manage, or
otherwise control any laboratory (or any affiliate, parent, or
subsidiary) it accredits; and
(2) Prohibit, subject to the exceptions in paragraph (b) of this
section, officers, employees, or other agents involved in accreditation
activities of the recognized accreditation body from accepting any
money, gift, gratuity, or other item of value from any laboratory they
accredit or that is seeking their accreditation that conducts food
testing.
(b) The prohibited items of value specified in paragraph (a)(2) of
this section do not include:
(1) Money representing payment of fees for accreditation services
or reimbursement of direct costs associated with an onsite assessment
or reassessment of the laboratory; or
(2) Lunch of de minimis value provided during the course of an
assessment or reassessment and on the premises where the assessment or
reassessment is conducted, if necessary to facilitate the efficient
conduct of the assessment or reassessment.
(c) The financial interests of the spouses and children younger
than 18 years of age of a recognized accreditation body's officers,
employees, and other agents involved in accreditation activities are
considered the financial interests of such officers, employees, and
other agents involved in accreditation activities.
Sec. 1.1120 How must a recognized accreditation body evaluate
laboratories seeking accreditation and oversee the performance of
laboratories it accredits?
(a) A recognized accreditation body must conduct an initial
assessment of a laboratory seeking accreditation in accordance with the
requirements of Sec. 1.1118(b), to determine whether the laboratory
meets the requirements of Sec. 1.1138.
(b) Subject to the exception in paragraph (c) of this section, the
initial assessment must be conducted onsite, although certain
assessment activities may be conducted remotely if it will not aid the
assessment to conduct them onsite.
(c) If, within the previous 2 years, the accreditation body
conducted an onsite assessment of the laboratory in accordance with
ISO/IEC 17011:2017 to assess whether the laboratory meets the
requirements of ISO/IEC 17025:2017, then the initial assessment under
this section:
(1) May be conducted remotely, and
(2) Need only address whether the laboratory meets the requirements
of Sec. 1.1138(a)(1) and (c).
(d) A recognized accreditation body must oversee the performance of
a laboratory it accredits in accordance with the applicable
requirements of Sec. 1.1118(b), except as otherwise provided by this
subpart, to determine whether the accredited laboratory continues to
meet the applicable requirements of this subpart.
(e) The assessment of the sample of the scope of accreditation of
the accredited laboratory, which the recognized accreditation body must
conduct at least every 2 years in accordance with Sec. 1.1118(b), must
be conducted onsite, although certain assessment activities may be
conducted remotely if it will not aid the assessment to conduct them
onsite.
(f) If the recognized accreditation body conducted the initial
assessment of the laboratory remotely in accordance with paragraph (c)
of this section, the recognized accreditation body must conduct its
first assessment of the sample of the scope of accreditation of the
accredited laboratory no later than 2 years after the recognized
accreditation body last conducted an onsite assessment of the
laboratory in accordance with ISO/IEC 17011:2017 to assess whether the
laboratory meets the requirements of ISO/IEC 17025:2017.
(g) The reassessment at the end of the accredited laboratory's
accreditation cycle, which the recognized accreditation body must
conduct in accordance with Sec. 1.1118(b), must be conducted onsite,
although certain assessment activities may be conducted remotely if it
will not aid the assessment to conduct them onsite.
(h) Any assessments conducted by a recognized accreditation body
that are in addition to the assessments referred to in paragraphs (a),
(e), and (g) of this section may be conducted remotely if it will not
aid the assessment to conduct them onsite.
Sec. 1.1121 What appeal procedures must a recognized accreditation
body provide for appeals of decisions to not grant accreditation?
A laboratory may appeal a decision by the recognized accreditation
body to not grant the accreditation (in-whole or in-part) that the
laboratory sought, and the recognized accreditation body must consider
the appeal in accordance with the requirements of Sec. 1.1118(b). In
addition to meeting the requirements of Sec. 1.1118(b) relating to
appeals, the recognized accreditation body must make the appeals
procedures publicly available. It must also establish and implement
written procedures to use a competent person(s) who may or may not be
external to the recognized accreditation body, who is free from bias or
prejudice and has not participated in the accreditation decision and is
not the subordinate of a person who participated in the accreditation
decision, to review and decide appeals.
[[Page 59505]]
Sec. 1.1122 When must a recognized accreditation body withdraw or
reduce the scope of the accreditation of a laboratory, and when may a
recognized accreditation body put an accredited laboratory on
probation?
(a) Grounds for withdrawal of accreditation. A recognized
accreditation body must withdraw the accreditation of a laboratory it
accredits when the accredited laboratory substantially fails to comply
with this subpart.
(b) Grounds for probation. If a recognized accreditation body
determines that an accredited laboratory it accredits demonstrates
deficiencies in performing its functions under this subpart that are
less serious than those identified in paragraph (a) of this section,
and it is reasonably likely that the accredited laboratory will be able
to correct such deficiencies within a specified period of time, the
recognized accreditation body may temporarily put the accredited
laboratory on probation.
(c) Withdrawal in-part. When there are grounds for withdrawal of
accreditation of an accredited laboratory that the recognized
accreditation body accredits, but the deficiencies affect only certain
methods within the accredited laboratory's scope of accreditation, the
recognized accreditation body may withdraw the accredited laboratory's
accreditation for only for those affected methods.
(d) Records request associated with withdrawal of accreditation or
probation. To assist the recognized accreditation body in determining
whether a withdrawal of accreditation (in-whole or in-part) or
probation is warranted under paragraph (a), (b), or (c) of this
section, the recognized accreditation body may require from a
laboratory that it accredits the submission of records that the
accredited laboratory is required to maintain under Sec. 1.1153.
(e) Notification of withdrawal of accreditation. The recognized
accreditation body must notify the laboratory of the withdrawal (in-
whole or in-part) of the laboratory's accreditation, and such
notification must:
(1) Specify whether the withdrawal of accreditation is in-whole or
in-part, and if it is in-part, to which method or methods it applies;
(2) Describe the grounds for withdrawal; and
(3) State the procedures for appealing the withdrawal.
(f) Notification of probation. The recognized accreditation body
must notify the laboratory of the laboratory's probation, and such
notification must:
(1) Describe the grounds for the probation;
(2) Identify all deficiencies that the laboratory must correct for
the recognized accreditation body to lift the probation; and either
(i) Inform the laboratory that it has a specific timeframe to take
particular corrective actions with respect to the deficiencies
identified by the recognized accreditation body, or
(ii) Require the laboratory to submit a plan to the recognized
accreditation body for approval that identifies the appropriate
corrective actions the laboratory will take to resolve the deficiencies
identified by the recognized accreditation body, and identify
appropriate timeframes for resolution; and
(g) Consequences of probation or withdrawal of accreditation, in-
whole or in-part. If the recognized accreditation body withdraws the
accreditation of a laboratory in-whole, the laboratory is immediately
ineligible to conduct food testing under this subpart. If the
recognized accreditation body withdraws the accreditation of a
laboratory in-part, the laboratory is immediately ineligible to conduct
food testing under this subpart with respect to only the specific
method or methods for which accreditation was withdrawn. An accredited
laboratory that is put on probation by an accreditation body is
permitted to continue to conduct food testing under this subpart.
(h) Appeals procedures. A laboratory may appeal a decision by the
recognized accreditation body to withdraw the accreditation (in-whole
or in-part) of the laboratory, and the recognized accreditation body
must consider the appeal in accordance with Sec. 1.1118(b). In
addition to meeting the requirements of Sec. 1.1118(b) related to
appeals, the recognized accreditation body must establish and implement
written procedures to:
(1) Make the appeals procedures publicly available; and
(2) Use a competent person or persons, who may or may not be
external to the recognized accreditation body, who are free from bias
or prejudice and have not participated in the withdrawal decision, and
are not the subordinate of a person who participated in the withdrawal
decision, to review and decide appeals.
Sec. 1.1123 What reports and notifications must a recognized
accreditation body submit to FDA?
(a) General requirements. All reports and notifications required by
this section to be submitted to FDA must be submitted to FDA
electronically and in English, and include:
(1) The name, street address, telephone number, and email address
of the accreditation body associated with the report or notification,
and the name of an appropriate point-of-contact for the accreditation
body, and
(2) If there is a laboratory associated with the report or
notification, the name, street address, telephone number, and email
address of the laboratory associated with the report or notification,
and the name of an appropriate point-of-contact for the laboratory.
(b) Reporting results of recognized accreditation body internal
audits. A recognized accreditation body must submit to FDA a report of
the results of the internal audit it is required to conduct pursuant to
Sec. 1.1118(b), including results of the audit of its compliance with
the requirements of Sec. 1.1118(c) and (d), conducted pursuant to
Sec. 1.1125, no later than 45 days after completing such internal
audit, and the report must include:
(1) A description of the internal audit conducted;
(2) A description of any identified deficiencies;
(3) A description of any corrective actions taken and any
corrective action the recognized accreditation body will take,
including the timeline for such corrective actions; and
(4) A statement disclosing the extent to which the internal audit
was conducted by personnel different from those who perform the
activity or activities that were audited.
(c) Immediate notification to FDA. A recognized accreditation body
must immediately, within 48 hours, notify FDA when the recognized
accreditation body:
(1) Is aware of a change that would affect the recognition of such
accreditation body, and the notification must include:
(i) A description of the change, and
(ii) If the change is one made by the recognized accreditation
body, an explanation of the purpose of the change;
(2) Grants accreditation of a laboratory, and the notification must
include:
(i) The scope of accreditation requested by the laboratory,
(ii) The scope of accreditation granted, and
(iii) The date on which accreditation was granted;
(3) Denies accreditation (in-whole or in-part) of a laboratory, and
the notification must include:
(i) The scope of accreditation requested by the laboratory,
[[Page 59506]]
(ii) The scope of accreditation denied, and
(iii) The grounds for the denial;
(4) Receives notice that an accredited laboratory it accredited
intends to relinquish its accreditation (in-whole or in-part), and the
notification must include:
(i) The scope of accreditation to which the relinquishment applies,
as applicable, and
(ii) The effective date of the relinquishment;
(5) Withdraws (in-whole or in-part) the accreditation of a
laboratory; and the notification must include:
(i) The scope of accreditation to which the withdrawal applies, and
(ii) The grounds for the withdrawal;
(6) Puts an accredited laboratory on probation, and the
notification must include:
(i) The grounds for the probation, and
(ii) Any date by which the recognized accreditation body has
determined the accredited laboratory must take appropriate corrective
action; and
(7) Knows that an accredited laboratory it accredits has committed
fraud or submitted material false statements to FDA, and the
notification must include:
(i) A description of the basis for the accreditation body's
knowledge of the fraud or material false statements,
(ii) A description of the alleged fraud or material false
statements, and
(iii) The actions taken by the recognized accreditation body with
respect to such laboratory.
Sec. 1.1124 What records requirements must a recognized
accreditation body meet?
(a) In addition to meeting the requirements of Sec. 1.1118(b)
related to records, a recognized accreditation body must maintain
electronically, for 5 years after the date of creation of the records,
records created while it is recognized demonstrating its compliance
with this subpart, including records relating to:
(1) Applications for accreditation;
(2) Assessments, reassessments, and decisions to grant, renew,
deny, withdraw, expand, or reduce the scope of an accreditation or
place an accredited laboratory on probation;
(3) Appeals of probation and denials and withdrawals of
accreditation, final decisions on such appeals, and the bases for such
final decisions;
(4) Its oversight of accredited laboratories it accredited;
(5) Its oversight of its own performance, including all records
related to internal audits, complaints, and corrective actions;
(6) Any reports or notifications required to be submitted to FDA
under Sec. 1.1123, including any supporting information; and
(7) Records of fee payments and reimbursement of direct costs.
(b) An accreditation body that has been recognized must make
records it is required to maintain under paragraph (a) of this section
available to FDA for inspection and copying promptly upon written
request by an authorized FDA officer or employee at the place of
business of the accreditation body or at a reasonably accessible
location. If the records required by paragraph (a) of this section are
requested by FDA electronically, the records must be submitted to FDA
electronically not later than 10 business days after the date of the
request. Additionally, if the requested records are maintained in a
language other than English, the accreditation body must electronically
submit an English translation within a reasonable time.
(c) A recognized accreditation body must not prevent or interfere
with FDA's access to the records the accredited laboratories it
accredits are required to maintain under Sec. 1.1153.
Sec. 1.1125 What internal audit requirements must a recognized
accreditation body meet?
As part of the internal audit a recognized accreditation body is
required to conduct pursuant to Sec. 1.1118(b), the recognized
accreditation body must audit its compliance with the requirements of
Sec. 1.1118(c) and (d).
Procedures for Recognition of Accreditation Bodies
Sec. 1.1128 How does an accreditation body apply to FDA for
recognition or renewal of recognition?
(a) Applicant for recognition. An accreditation body seeking
recognition must submit an application to FDA demonstrating that it
meets the eligibility requirements in Sec. 1.1113.
(b) Applicant for renewal of recognition. An accreditation body
seeking renewal of its recognition must submit a renewal application
demonstrating that it continues to meet the requirements of this
subpart.
(c) Documentation of conformance with requirements. The
accreditation body must submit documentation of conformance with ISO/
IEC 17011:2017 and separate documentation of ILAC MRA signatory status
demonstrating competence to ISO/IEC 17011:2017, in meeting the
requirements of Sec. 1.1113(a) and (b) or Sec. 1.1118(a) and (b), as
applicable. The accreditation body also must submit documentation of
its compliance with Sec. 1.1113(c) and (d) or Sec. 1.1118(c) and (d),
as applicable.
(d) Submission. An accreditation body must submit recognition and
renewal applications and any documents provided as part of the
application process to FDA electronically, in English. The applicant
must provide any translation and interpretation services needed by FDA
during the processing of the application, including during any onsite
assessments of the applicant by FDA.
(e) Signature. An accreditation body must sign the recognition and
renewal applications in the manner designated by FDA. Recognition and
renewal application must be signed by the applicant or by an individual
authorized to act on behalf of the applicant for purposes of seeking
recognition or renewal of recognition.
Sec. 1.1129 How will FDA review applications for recognition and
applications for renewal of recognition?
(a) Review of application for recognition or renewal of
recognition. FDA will examine an accreditation body's application for
recognition or renewal of recognition for completeness and notify the
applicant of any deficiencies. FDA will review an accreditation body's
application for recognition or renewal of recognition on a first in,
first out basis according to the date on which the completed
application was submitted; however, FDA may prioritize the review of
specific applications to meet program needs.
(b) Evaluation of application for recognition or renewal of
recognition. FDA will evaluate any submitted application for
recognition or renewal of recognition to determine whether the
applicant meets the requirements for recognition. Such evaluation may
include an onsite assessment of the accreditation body. FDA will notify
the applicant, in writing, regarding whether the application has been
approved or denied. FDA may make such notification electronically. If
FDA does not reach a final decision on a renewal application before an
accreditation body's recognition terminates by expiration, FDA may
extend the existing term of recognition for a specified period of time
or until FDA reaches a final decision on the renewal application.
(c) Issuance of recognition. FDA will notify the applicant that its
application for recognition or renewal of recognition has been approved
through issuance of recognition that will list any conditions
associated with the recognition.
(d) Duration of recognition. FDA may grant recognition of an
accreditation body for a period not to exceed 5 years
[[Page 59507]]
from the date of recognition, except under the circumstances described
in paragraph (b) of this section.
(e) Issuance of denial of application for recognition or renewal of
recognition. If FDA denies an applicant's application for recognition
or renewal of recognition, FDA will notify the applicant, through an
issuance of a notification of denial of recognition or denial of
renewal of recognition. The notification of denial of recognition or
denial of renewal of recognition will state the basis for such denial
and describe the procedures for requesting reconsideration of the
application under Sec. 1.1171.
(f) Notice of records custodian after denial of an application for
renewal of recognition. An applicant whose application for renewal of
recognition was denied by FDA must notify FDA electronically, in
English, within 10 business days of the date of issuance of a denial of
a renewal application, of the name and contact information of the
custodian who will maintain the records required by Sec. 1.1124 and
make them available to FDA as required by Sec. 1.1124. The contact
information for the custodian must include, at a minimum, an email
address and the street address where the records required by Sec.
1.1124 will be located.
(g) FDA notice to accredited laboratories. FDA will promptly issue
a notice of the denial of the application for renewal of recognition of
the accreditation body to all laboratories accredited by the
accreditation body whose application for renewal of recognition was
denied.
(h) Public notice of denial of an application for renewal of
recognition of an accreditation body. FDA will provide public notice on
the website described in Sec. 1.1109 of the issuance of a denial of a
renewal application and will include the date of the issuance of the
denial of a renewal application.
Sec. 1.1130 How will FDA oversee recognized accreditation bodies?
(a) FDA will assess each recognized accreditation body to determine
its compliance with the applicable requirements of this subpart. Such
assessment will occur by at least 4 years after the date of recognition
for a 5-year recognition period, or by no later than the mid-term point
for a recognition period of less than 5 years. An FDA assessment of a
recognized accreditation body may include review of records, an onsite
assessment of the accreditation body, and onsite assessments of one or
more accredited laboratories the recognized accreditation body
accredits, with or without the recognized accreditation body present.
(b) FDA may conduct additional assessments of a recognized
accreditation body at any time to determine the recognized
accreditation body's compliance with the applicable requirements of
this subpart.
Sec. 1.1131 When will FDA revoke the recognition of an accreditation
body or put a recognized accreditation body on probation?
(a) Grounds for revocation of recognition. FDA will revoke the
recognition of an accreditation body if it fails to meet the
requirements of this subpart, or where FDA determines the accreditation
body has committed fraud or submitted material false statements to FDA.
(b) Issuance of revocation. (1) FDA will notify the accreditation
body that its recognition has been revoked through the issuance of a
revocation that will state the grounds for revocation, the procedures
for requesting a regulatory hearing under Sec. 1.1173 on the
revocation, and the procedures for requesting reinstatement of
recognition under Sec. 1.1133.
(2) Within 10 business days of the date of issuance of revocation,
the accreditation body must notify FDA electronically, in English, of
the name of the custodian who will maintain records and make them
available to FDA as required by Sec. 1.1124. The contact information
for the custodian must provide, at a minimum, an email address and the
street address where the records will be located.
(c) Grounds for probation. If FDA determines that a recognized
accreditation body has demonstrated deficiencies in performing its
functions that are less serious and more limited than those identified
in paragraph (a) of this section, and it is reasonably likely that the
accreditation body will be able to correct such deficiencies within a
reasonable period of time, FDA may temporarily put the recognized
accreditation body on probation and request that the accreditation body
take appropriate corrective actions.
(d) Length of probation. FDA's probation of an accreditation body's
recognition shall remain in effect until the accreditation body
demonstrates to FDA's satisfaction that the accreditation body has
successfully implemented appropriate corrective actions to address the
deficiencies specified by FDA within the time period identified by FDA,
or until FDA revokes the recognition of the accreditation body.
(e) Notification of probation. FDA will notify the accreditation
body of its probation and such notification will:
(1) Describe the grounds for the probation;
(2) Identify all deficiencies that must be corrected for FDA to
lift the probation and identify a specified period of time to take
corrective actions to address the deficiencies specified by FDA.
(f) Effect of revocation of recognition or probation on the
accreditation body. (1) An accreditation body that has had its
recognition revoked by FDA may not accredit laboratories under this
subpart or continue to oversee the laboratories it has previously
accredited.
(2) A recognized accreditation body that is put on probation by FDA
will be expected to continue to oversee laboratories that it has
accredited under this subpart and is permitted to continue to accredit
laboratories under Sec. 1.1120 of this subpart.
(g) FDA notice to the accredited laboratories. FDA will issue a
notice of the probation or revocation of recognition to all
laboratories accredited by the recognized accreditation body that was
put on probation or the accreditation body whose recognition was
revoked.
(h) Public notice of probation or revocation of recognition. FDA
will provide notice on the website described in Sec. 1.1109 of the
issuance of the probation or revocation of recognition of an
accreditation body.
Sec. 1.1132 What must a recognized accreditation body do if it wants
to voluntarily relinquish its recognition or does not want to renew its
recognition?
(a) Notice to FDA of intent to relinquish or not to renew
recognition. A recognized accreditation body must notify FDA
electronically, in English, at least 60 days before voluntarily
relinquishing its recognition or before allowing its recognition to
expire without seeking renewal. The recognized accreditation body must
provide the name and contact information of the custodian who will
maintain the records required under Sec. 1.1124 after the date of
relinquishment or the date recognition expires, as applicable, and make
them available to FDA as required by Sec. 1.1124. The contact
information for the custodian must include, at a minimum, an email
address and the street address where the records required by Sec.
1.1124 will be located.
(b) Notice to accredited laboratories of intent to relinquish or
not to renew recognition. At least 60 days before voluntarily
relinquishing its recognition
[[Page 59508]]
or before allowing its recognition to expire without seeking renewal, a
recognized accreditation body must notify the laboratories it
accredited of its intention to leave the program, specifying the date
on which relinquishment or expiration will occur.
(c) Public notice of voluntary relinquishment or expiration of
recognition. FDA will provide notice on the website described in Sec.
1.1109 of the voluntary relinquishment or expiration of recognition of
an accreditation body.
Sec. 1.1133 How does an accreditation body request reinstatement of
recognition?
(a) Application following revocation of recogniion. An
accreditation body that has had its recognition revoked by FDA may seek
reinstatement by submitting a new application for recognition under
Sec. 1.1128. The accreditation body must also submit evidence to FDA
with its application that the grounds for revocation have been
resolved, including evidence addressing the cause(s) or condition(s)
that were the grounds for revocation and must identify measures that
have been implemented to help ensure that such cause(s) or condition(s)
are unlikely to recur.
(b) Application following relinquishment or expiration of
recognition. An accreditation body that previously relinquished its
recognition or allowed its recognition to expire may seek recognition
by submitting a new application for recognition under Sec. 1.1128.
Accreditation of Laboratories
Sec. 1.1138 What requirements must a laboratory meet to become
accredited by a recognized accreditation body?
(a) To become accredited by a recognized accreditation body, an
accredited laboratory must:
(1) Demonstrate it is capable of conducting each method of food
testing for which it seeks to be accredited, by:
(i) Submitting information to demonstrate appropriate verification
or validation of the method(s), including the information required by
Sec. 1.1151(c)(2) and (d)(2), and a statement by the laboratory based
on the verification or validation results of whether the laboratory is
able to properly apply the method; and
(ii) Passing, or having passed within the past year, a proficiency
test for the method, subject to the exception that if the laboratory
determines there is no proficiency testing program available that
addresses the method, or that proficiency testing for the method is
otherwise impracticable, the accredited laboratory may instead subject,
or have subjected in the past year, the method to an appropriate
comparison program. The laboratory's determination must be reviewed by,
and approved or denied (as appropriate) by, the recognized
accreditation body from which the laboratory is seeking accreditation.
(2) Except as provided in paragraph (b) of this section,
demonstrate it complies with ISO/IEC 17025:2017, ``General Requirements
for the Competence of Testing and Calibration Laboratories,'' Third
edition, November 2017. The Director of the Federal Register approves
this incorporation by reference under 5 U.S.C. 552(a) and 1 CFR part
51. The approved material is available for inspection at Dockets
Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852, 301-827-6860, and is available
from International Organization for Standardization (ISO), Chemin de
Blandonnet 8, 1214 Vernier, Geneva, Switzerland; Telephone 41 22 749 01
11, https://www.iso.org/home.html. It is also available for inspection
at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, email
[email protected] or go to www.archives.gov/federal-register/cfr/ibr-locations.
(b) For purposes of this program the laboratory is not required to
satisfy the following provisions of ISO/IEC 17025:2017:
(1) That relate to the relationship between the laboratory and its
customers, to the extent that such provisions establish obligations
that conflict with the requirements of this subpart;
(2) In section 7: 7.3; or
(3) In section 7: 7.8.
(c) Demonstrate it is capable of meeting and operating in
conformance with all of this subpart's additional requirements for
accredited laboratories.
Requirements for Accredited Laboratories
Sec. 1.1146 What are the general requirements for accredited
laboratories to remain accredited?
To remain accredited, the accredited laboratory must:
(a) Be capable of conducting the methods of analysis for the
testing of food for which it is accredited;
(b) Maintain conformance with the provisions of ISO/IEC 17025:2017,
``General Requirements for the Competence of Testing and Calibration
Laboratories,'' Third edition, November 2017. The Director of the
Federal Register approves this incorporation by reference under 5
U.S.C. 552(a) and 1 CFR part 51. The approved material is available for
inspection at Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 301-
827-6860, and is available from International Organization for
Standardization (ISO), Chemin de Blandonnet 8, 1214 Vernier, Geneva,
Switzerland; Telephone 41 22 749 01 11, https://www.iso.org/home.html.
It is also available for inspection at the National Archives and
Records Administration (NARA). For information on the availability of
this material at NARA, email [email protected] or go to
www.archives.gov/federal-register/cfr/ibr-locations. This requirement
is subject to the exceptions in Sec. 1.1138(b); and
(c) Operate in conformance with the additional requirements of this
subpart.
Sec. 1.1147 What impartiality and conflict of interest requirements
must accredited laboratories meet?
(a) In addition to the requirements relating to impartiality and
conflict of interest an accredited laboratory is required to meet under
Sec. 1.1146(b), the accredited laboratory must, subject to the
exceptions in paragraph (b) of this section, prohibit the accredited
laboratory's employees, contractors, and agents involved in food
testing and related activities from accepting any money, gift,
gratuity, or other item of value from the owner or consignee of the
food that is being tested or will be tested by the accredited
laboratory.
(b) The prohibited items of value specified in paragraph (a) of
this section do not include:
(1) Payment of fees for food testing services;
(2) Reimbursement of direct costs associated with the food testing
by the accredited laboratory; and
(3) With respect to accredited laboratories that are owned by the
owner or consignee of the food that is tested or to be tested, payment
of the officer's, employee's, contractor's, or agent's compensation in
the normal course of business.
(c) The owner or consignee's payment to the accredited laboratory
of fees for food testing services and/or reimbursement of direct costs
associated with food testing must be independent of whether the test
results indicate that food is or appears to be violative.
Sec. 1.1148 What quality assurance requirements must accredited
laboratories meet?
In addition to the requirements relating to quality assurance an
accredited laboratory is required to meet by Sec. 1.1146(b),
accredited labs must:
[[Page 59509]]
(a) Meet the following proficiency testing requirements:
(1) Accredited laboratories must participate in a proficiency
testing program or programs provided by a competent proficiency testing
organization, except as provided in paragraph (a)(2) of this section.
The accredited laboratory must ensure such proficiency testing is
conducted at least once per year for each method within the accredited
laboratory's scope of accreditation.
(2) If the accredited laboratory determines there is no proficiency
testing program available that addresses a particular method of
analysis in the accredited laboratory's scope of accreditation, or that
participating in a proficiency testing program for the particular
method of analysis is otherwise impracticable, the accredited
laboratory may subject that method of analysis to an appropriate
comparison program. The determination must be reviewed, and approved or
denied (as appropriate), by the recognized accreditation body that
accredits the accredited laboratory.
(b) Ensure its procedures for monitoring the validity of the
results of testing it conducts under this subpart include the use of
reference materials or quality control samples with each batch of
samples it tests under this subpart.
Sec. 1.1149 What oversight standards apply to sampling?
(a) Before analyzing a sample, the accredited laboratory must
develop (if it collected the sample) or obtain (if another entity
collected the sample):
(1) Written documentation of the sampler's applicable
qualifications by training and experience. An accredited laboratory
only needs to develop or obtain documentation of a sampler's
qualifications the first time that individual collects a sample under
this subpart, unless the accredited laboratory learns that the
sampler's qualifications have significantly changed since the
accredited laboratory last obtained documentation of the sampler's
qualifications;
(2) A written sampling plan used to conduct the sampling. The
written sampling plan must identify the sampler and must list factors
that will be controlled to ensure the sampling does not impact the
validity of the subsequent analytical testing, including controlling
for the representational nature of the sample; and
(3) A written sample collection report for each sample collected.
The written sample collection report must, at a minimum, include:
(i) The product code of the food product sampled (if product is
being sampled) or the location of and a description of the environment
(if environment is being sampled);
(ii) The date(s) of the sampling;
(iii) The size, identity, and quantity of the sample(s);
(iv) Documentation of sample collection procedures and any sample
preparation techniques; and
(v) Documentation of the chain of custody of the sample(s), and of
measures taken, to not impact the validity of the subsequent analytical
testing, including controlling for the representational nature of the
sample(s).
(b) If any of the requirements in paragraph (a) of this section are
not met, FDA may consider the analysis of the sample to be invalid.
Sec. 1.1150 What requirements apply to analysis of samples by an
accredited laboratory?
In addition to meeting the requirements of Sec. 1.1146(b):
(a) The analysis must be conducted on either the sample(s) received
from the sampler or, if appropriate, on a representative sample of the
sample(s) received from the sampler.
(b) The analyst(s) that conducts the analysis must:
(1) Be qualified by appropriate education, training, and/or
experience to conduct the analysis;
(2) Have appropriately demonstrated their ability to perform the
method properly in the specific context of the food testing to be
conducted; and
(3) Be in compliance with the conflict of interest requirements of
Sec. Sec. 1.1146(b) and 1.1147.
(c) The method used to conduct the food testing must meet the
requirements of Sec. 1.1151.
(d) The accredited laboratory must document the testing information
and test results to the extent necessary to account for all information
that is required to be included in a full analytical report (see Sec.
1.1152(g)).
Sec. 1.1151 What requirements apply to the methods of analysis an
accredited laboratory uses to conduct food testing under this subpart?
In addition to meeting the requirements of Sec. 1.1146(b), an
accredited laboratory must meet the following requirements:
(a) Analysis under this subpart must be conducted using a method of
analysis that:
(1) Is fit for purpose;
(2) Is within the accredited laboratory's scope of accreditation;
(3) Has been appropriately validated for use in such food testing,
in accordance with paragraph (c) of this section; and
(4) Has been appropriately verified by the accredited laboratory
for use in such food testing, in accordance with paragraph (d) of this
section.
(b) With respect to food testing conducted under:
(1) Section 1.1107(a)(1), if the Federal Food, Drug, and Cosmetic
Act or implementing regulations prescribes a test method, that is the
only appropriate method that may be conducted for such food testing;
(2) Section 1.1107(a)(2), if the food testing order prescribes a
test method, that is the only appropriate method that may be conducted
for such food testing.
(c)(1) An accredited laboratory must validate methods in accordance
with the requirements of Sec. 1.1146(b).
(2) An accredited laboratory performing validation of a method
under this subpart must record the information required by the
requirements of Sec. 1.1146(b), and the supporting analytical data.
(d)(1) Before an accredited laboratory conducts food testing under
this subpart using a method for a specific intended use for which the
method has been validated, but for which the laboratory has not
previously applied the method under this subpart, the accredited
laboratory must have verified it can properly perform the method for
the specific intended use.
(2) An accredited laboratory performing verification of a method
under this subpart must record the method that is the subject of the
verification, the intended purpose of the analysis, the results of the
verification, the procedure used for the verification, supporting
analytical data, and whether the accredited laboratory is able to
properly perform the method.
(e) An accredited laboratory may submit a written request to FDA
requesting FDA's permission to use a method or methods outside of its
scope of accreditation for food testing. FDA may approve the request if
both following conditions are satisfied:
(1) A new methodology or methodologies have been developed and
validated but no reasonably available laboratory has been accredited to
perform such methodology or methodologies, and
(2) The use of such method or methods is necessary to prevent,
control, or mitigate a food emergency or foodborne illness outbreak.
Sec. 1.1152 What notifications, results, and reports must accredited
laboratories submit to FDA?
(a) General requirements. (1) All notifications, results, reports,
and
[[Page 59510]]
studies required to be submitted to FDA by accredited laboratories
under this subpart must be submitted to FDA electronically and in
English, and:
(i) Include the legal name and street address of the accredited
laboratory, identify a point-of-contact for the accredited laboratory
that FDA may contact with questions or comments regarding the
notification, result, report, or study, and include the email address
and telephone number of the point-of-contact;
(ii) Display an identification unique to the test results, report,
notification, or study; and
(iii) Be true, accurate, unambiguous, and objective.
(2) The accredited laboratory that conducts the analysis of the
sample under this subpart is responsible for the submission of all
notifications, results, reports, and studies to FDA as required by this
section.
(3) If the accredited laboratory that is responsible for the
submission of same becomes aware that any aspect of the submitted
material is inaccurate, the accredited laboratory must immediately
inform FDA and submit a corrected version. Such corrections must meet
the requirements for amendments to reports specified by ISO/IEC
17025:2017 section 7.8.8. ISO/IEC 17025:2017, ``General Requirements
for the Competence of Testing and Calibration Laboratories,'' Third
edition, November 2017. The Director of the Federal Register approves
this incorporation by reference under 5 U.S.C. 552(a) and 1 CFR part
51. The approved material is available for inspection at Dockets
Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852, 301-827-6860, and is available
from International Organization for Standardization (ISO), Chemin de
Blandonnet 8, 1214 Vernier, Geneva, Switzerland; Telephone 41 22 749 01
11, https://www.iso.org/home.html. It is also available for inspection
at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, email
[email protected] or go to www.archives.gov/federal-register/cfr/ibr-locations.
(4) Any opinions and interpretations in any notification, result,
report, or study submitted to FDA under this subpart must meet the
requirements in ISO/IEC 17025:2017 section 7.8.7 and any statements of
conformity to a specification or standard in any notification, result,
report, or study submitted to FDA under this subpart must meet the
requirements of ISO/IEC 17025:2017 section 7.8.6.
(b) Test results. (1) The results of any and all tests conducted by
an accredited laboratory under this subpart must be submitted directly
to FDA.
(2) The accredited laboratory must submit the results of testing
conducted under this subpart directly to FDA via the destination
specified by the website described by Sec. 1.1109, unless directed to
use a different method of submission by FDA regarding testing conducted
under Sec. 1.1107(a)(2) or (3).
(3) The test results must be clear and identify the associated
notifications, reports, and studies required to be submitted with the
test results under this subpart.
(c) Documentation required to be submitted with test results. The
following documentation must be submitted to FDA with each test result
submitted to FDA under this subpart:
(1) All sampling plans and sample collection reports related to the
food testing conducted, as developed or obtained by the accredited
laboratory in accordance with Sec. 1.1149;
(2) Written documentation of the sampler's qualifications, if Sec.
1.1149(a)(1) requires the accredited laboratory to obtain such
documentation;
(3) The full analytical report required by paragraph (g) of this
section, documenting the analysis related to the food testing, except
that if the accredited laboratory is permitted in accordance with
paragraph (d) of this section to submit abridged analytical reports,
the accredited laboratory may instead submit an abridged analytical
report, which must contain the information required by paragraph (f) of
this section;
(4) For any validation studies required by Sec. 1.1151(c)(1), the
documentation required by Sec. 1.1151(c)(2), except when the
circumstances of paragraph (c)(6) of this section apply with respect to
the validation study.
(5) For any verification studies required by Sec. 1.1151(d)(1),
the documentation required by Sec. 1.1151(d)(2), except when the
circumstances of paragraph (c)(6) of this section apply with respect to
the verification study.
(6) Paragraphs (c)(4) and (5) of this section do not require the
accredited laboratory to submit the validation or verification study to
FDA if the accredited laboratory submitted the validation or
verification study to its accreditation body as required by Sec.
1.1138(a)(1)(i). If the accredited laboratory submitted the validation
or verification study to its accreditation body as required by Sec.
1.1138(a)(1)(i), the accredited laboratory must instead submit to FDA,
in lieu of the validation or verification study, a statement that the
validation or verification study has been submitted to its recognized
accreditation body in accordance with Sec. 1.1138(a)(1)(i), and the
accredited laboratory must identify the method, analyte, and matrix
that were the subject of the validation or verification study;
(7) A certification from one or more members of the accredited
laboratory's management certifying that the test results,
notifications, reports, and studies are true and accurate; and that the
documentation includes the results of all tests conducted under this
subpart. The certification must include the name, title, and signature
of the certifier(s).
(d) Permission to submit abridged analytical reports. (1)
Accredited laboratories that are not disqualified under paragraphs
(d)(6)(i) and (d)(7) of this section or on probation are permitted to
submit to FDA on an ongoing basis abridged analytical reports relating
to a specific major food testing discipline(s) that is represented in
the reports described in paragraph (d)(1)(ii) of this section, after
FDA has given notice that the following conditions are fulfilled:
(i) The accredited laboratory submits 10 consecutive full
analytical reports to FDA under this subpart;
(ii) The consecutive full analytical reports include at least one
full analytical report relating to each major food testing discipline
for which the accredited laboratory seeks to submit abridged analytical
reports;
(iii) None of the consecutive full analytical reports demonstrate
any material substantive shortcoming in the food testing; and
(iv) The consecutive full analytical reports do not contain
repeated administrative deficiencies.
(2)(i) Accredited laboratories that fail to satisfy the condition
in paragraph (d)(1)(iii) of this section are subject to the
disqualification period described in paragraph (d)(6)(i) of this
section.
(ii) Accredited laboratories that fail to satisfy the condition in
paragraph (d)(1)(iv) of this section have a second attempt to satisfy
the conditions in paragraphs (d)(1)(i) to (iv) of this section with 10
subsequent consecutive full analytic reports. If one of those
subsequent consecutive full analytical reports demonstrate any material
substantive shortcoming in the food testing, or the subsequent
consecutive full analytical reports contain repeated administrative
deficiencies, the accredited laboratory is subject to the
disqualification period described in paragraph (d)(6)(i) of this
section.
[[Page 59511]]
(3) Accredited laboratories that are not on probation and are
currently permitted to submit abridged analytical reports for at least
one major food testing discipline under this paragraph are permitted to
submit to FDA on an ongoing basis abridged analytical reports relating
to any additional major food testing disciplines that were not
represented in the reports described in paragraph (d)(1)(ii) of this
section, after FDA has given notice that the following conditions are
fulfilled:
(i) The accredited laboratory submits to FDA at least one full
analytical report for each additional major food testing discipline for
which the accredited laboratory seeks to submit abridged analytical
reports;
(ii) None of the full analytical reports for each additional major
food testing discipline demonstrate any material substantive
shortcoming in the food testing; and
(iii) None of the full analytical reports for each additional major
food testing discipline contain repeated administrative deficiencies.
(4)(i) Accredited laboratories that fail to satisfy the condition
in paragraph (d)(3)(ii) of this section for an additional major food
testing discipline(s) are subject to the disqualification period
described in paragraph (d)(6)(ii) of this section for such additional
major food testing discipline(s).
(ii) Accredited laboratories that fail to satisfy the condition in
paragraph (d)(3)(iii) of this section for an additional major food
testing discipline(s) have a second attempt to satisfy the conditions
in paragraphs (d)(3)(i) to (iii) of this section with at least one full
analytic report for each additional major food testing discipline for
which the accredited laboratory is seeking to submit abridged
analytical reports. If that subsequent full analytical report(s)
demonstrates any material substantive shortcoming in the food testing,
or the subsequent full analytical report(s) contains repeated
administrative deficiencies, the accredited laboratory is subject to
the disqualification period described in paragraph (d)(6)(ii) of this
section for the major food testing discipline that was the subject of
the full analytical report containing the shortcoming or deficiencies.
(5) If one or more test results, notifications, reports, and/or
studies relating to a specific major food testing discipline submitted
to FDA under this subpart by an accredited laboratory that is permitted
to submit abridged analytical reports for that major food testing
discipline demonstrates any material substantive shortcoming in the
related food testing or demonstrates repeated administrative
deficiencies, the accredited laboratory is disqualified to submit
abridged reports for that specific major food testing discipline in
accordance with either paragraph (d)(6)(ii) of this section (if the
accredited laboratory is permitted to submit abridged analytical
reports for another discipline) or paragraph (d)(6)(i) of this section
(if the accredited laboratory is not permitted to submit abridged
analytical reports for any another discipline).
(6)(i) The period of disqualification is either 2 years or until
the accredited laboratory submits 20 more full analytical reports to
FDA under this subpart, whichever period of time is longer, after which
time the accredited laboratory may request permission under paragraph
(d)(7) of this section to fulfill the eligibility conditions under
paragraph (d)(1) of this section.
(ii) The period of disqualification is either 2 years or until the
accredited laboratory submits two more full analytical reports to FDA
under this subpart, whichever period of time is longer, after which
time the accredited laboratory may request permission under paragraph
(d)(7) of this section to fulfill the eligibility conditions under
paragraph (d)(3) of this section.
(iii) Whenever, during the period of disqualification described
under paragraph (d)(6)(i) or (ii) of this section, a full analytical
report submitted by an accredited laboratory demonstrates any material
substantive shortcoming in the food testing, that accredited
laboratory's disqualification period is extended by 6 months.
(iv) Whenever, during the period of disqualification described
under paragraph (d)(6)(i) or (ii) of this section, the full analytical
reports submitted by an accredited laboratory contain repeated
administrative deficiencies, that accredited laboratory's
disqualification period is extended by 2 months.
(7) An accredited laboratory that has fulfilled the conditions of
paragraph (d)(6)(i) or (ii) of this section, as applicable, and that is
not on probation, may submit a request to FDA via the destination
specified by the website described by Sec. 1.1109 to attempt to
fulfill the conditions as described in paragraphs (d)(1) and (3) of
this section, as applicable. FDA will consider permitting the
accredited laboratory to again try and fulfill the conditions of
paragraph (d)(1) or (3) of this section, as applicable. If FDA grants
permission and upon fulfillment of those conditions, FDA will provide
notice that the accredited laboratory is permitted to submit to FDA on
an ongoing basis abridged analytical reports relating to the
disciplines for which the conditions are fulfilled.
(e) Exceptions to permission to submit abridged analytical reports.
(1) Occasionally, for the purposes of auditing abridged analytical
reports and otherwise protecting the public health and the integrity of
this food testing program, FDA will require that an accredited
laboratory that is permitted to submit abridged analytical reports
additionally submit to FDA the full analytical report within 48 hours
of FDA's notice.
(2) FDA may require an accredited laboratory that is permitted to
submit abridged analytical reports under this subpart to submit full
analytical reports if such analytical reports relate to an FDA
investigation or FDA enforcement proceeding.
(f) Abridged analytical report contents. Abridged analytical
reports must contain:
(1) All information described by ISO/IEC 17025:2017 sections
7.8.2.1(a) through (p) and 7.8.3.1(a) through (d). ISO/IEC 17025:2017,
``General Requirements for the Competence of Testing and Calibration
Laboratories,'' Third edition, November 2017. The Director of the
Federal Register approves this incorporation by reference under 5
U.S.C. 552(a) and 1 CFR part 51. The approved material is available for
inspection at Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 301-
827-6860, and is available from International Organization for
Standardization (ISO), Chemin de Blandonnet 8, 1214 Vernier, Geneva,
Switzerland; Telephone 41 22 749 01 11, https://www.iso.org/home.html.
It is also available for inspection at the National Archives and
Records Administration (NARA). For information on the availability of
this material at NARA, email [email protected] or go to
www.archives.gov/federal-register/cfr/ibr-locations; and
(2) The justification for any modification or deviation to the
method(s) of analysis used and documentation of the accredited
laboratory's authorization for the modification or deviation.
(g) Full analytical report contents. Full analytical reports must
contain:
(1) All information described by paragraphs (f)(1) and (2) of this
section;
(2) Documentation of references for the method or methods of
analysis used;
(3) Identification of the analyst or analysts who conducted each
analytical step, validation step (if applicable), and verification step
(if applicable),
[[Page 59512]]
including the analyst's or analysts' legal name and signature, and the
date each analytical step, validation step (if applicable), and
verification step (if applicable) was performed;
(4) Calculations, presented in a legible and logical manner;
(5) As applicable, references to chromatograms; charts; graphs;
observations; photographs of thin layer chromatographic plates; and
spectra. References must be in color when appropriate and made in a
clear order;
(6) Identification of the source and purity of reference standards
used, and, as applicable: Certified reference materials, certified
reference cultures traceable to a nationally or internationally
recognized type culture collection (including concentration, units
preparation, and storage conditions), and reference standard
preparation information (including who prepared the reference standard,
date of preparation, expiration date, chemical balance, and solvent
used);
(7) A copy of the label from any immediate container sampled and
any additional labeling needed to evaluate the product;
(8) All original compilations of raw data secured in the course of
the analysis, including discarded, unused or re-worked data, with the
justification for discarding or re-working such data, corresponding
supporting data, and quality control results all identified with unique
sample identification, date and time, associated with the test;
(9) Any other relevant additional supporting information such as
the storage location of analyzed samples, appropriate attachments such
as instrument printouts, computer generated charts and data sheets, and
photocopies or original labels for the product analyzed;
(10) Identification of any software used;
(11) Any certificate or certificates of analysis for standards and
software; and
(12) The following information about the qualifications of the
analyst or analysts who were involved in the analysis conducted under
this subpart, if the accredited laboratory has not previously submitted
documentation of the analyst's qualifications to FDA or the analyst's
qualifications have significantly changed since the accredited
laboratory last submitted documentation of the analyst's qualifications
to FDA:
(i) The analyst's curriculum vitae;
(ii) Training records with regards to methods that the analyst is
qualified to perform, including the dates of such training and the name
of the trainer or training provider;
(iii) Any other documentation of the analyst's ability to perform
the method properly in the context of the food testing to be conducted,
pursuant to Sec. 1.1150(b); and
(iv) Individual proficiency test worksheets relevant to the
analysis being performed.
(h) Additional information about non-standard methods. If the
accredited laboratory conducts the analysis using a method that is not
published in a reputable international or national standard or that is
otherwise not publicly and readily available, upon request by FDA the
accredited laboratory must submit documentation of the method to FDA.
(i) Advance notice of sampling. (1) If FDA determines that the
sampling conducted by a sampler may materially differ from the sampling
documented in the associated sampling plan or sample collection report,
or if FDA determines that the sampling may have been otherwise
improper, FDA may require the accredited laboratory that analyzed the
associated sample(s), and other accredited laboratories that have
analyzed samples collected by the sampler previously, to request and
receive from the sampler, and submit or require the sampler to submit,
an advance notice of sampling to FDA 48 hours before each of the next
10 occasions that the sampler will collect a sample that the accredited
laboratory will analyze under this subpart.
(2) FDA may, as appropriate:
(i) Specify the type of food product or environment that requires
advance notice of sampling under this subpart,
(ii) Determine that an amount of time other than 48 hours in
advance is required, to a minimum of 24 hours and up to 7 business days
in advance, and
(iii) Determine that a number of occasions other than 10 are
required, to a minimum of 1 occasion and up to a maximum of 20
occasions.
(iv) Notify affected accredited laboratories that submission of
additional notices of sampling are not required.
(3) The advance notice of sampling must contain:
(i) A unique identification code for the advance notice of
sampling;
(ii) The name of the accredited laboratory that will conduct
analysis of the sample;
(iii) The name and street address of the sampler that will conduct
the sampling;
(iv) A primary contact (name and phone number) for the sampler;
(v) The reason(s) why the food product or environment will be
sampled;
(vi) The location of the food product or environment that will be
sampled, including sufficient information to identify the food product
or environment to be sampled;
(vii) As applicable, the U.S. Customs and Border Protection entry
and line number(s) and the FDA product code(s) of the food; and
(viii) The date and approximate time the sampling will begin.
(j) Immediate notification of significant changes. When any changes
occur that affect the accreditation of the accredited laboratory, the
accredited laboratory must immediately, within 48 hours, send FDA and
the accreditation body that accredited it notice of such changes, a
detailed description of such changes, and an explanation of how such
changes affect the accreditation of the accredited laboratory.
Accredited laboratories are not required to notify FDA of changes that
recognized accreditation bodies must provide notification of under
Sec. 1.1123(c).
(k) Consequence of omission. If FDA does not receive all
information required to be submitted to FDA by paragraphs (a) through
(j) of this section, FDA may consider the related food testing to be
invalid.
Sec. 1.1153 What other records requirements must an accredited
laboratory meet?
In addition to meeting the requirements of Sec. 1.1146(b) related
to records, laboratories that have been accredited must meet the
following requirements:
(a) Maintain electronically, for 5 years after the date of
creation, records created and received while they are accredited that
relate to compliance with this subpart, including:
(1) Documents related to the accredited laboratory's grant (and, if
applicable, expansions and reductions) of accreditation from its
recognized accreditation body;
(2) Documentation of food testing the accredited laboratory
conducted under this subpart, in accordance with Sec. 1.1150(d);
(3) All documents that the accredited laboratory was required to
submit to FDA under Sec. 1.1152, and associated correspondence by the
accredited laboratory (and its officers, employees, and other agents)
with the owner or consignee (and its officer, employees, and other
agents) of the tested food product or environment;
(4) All requests for food testing from an owner or consignee that
would be conducted under this subpart;
(5) Documentation of any internal investigations, internal audits,
and corrective actions taken to address any
[[Page 59513]]
problems or deficiencies related to activities under this subpart;
(6) Any and all documentation related to probation or withdrawal
from accreditation under this subpart; and
(7) Documentation of changes to its management system or food
testing activities that may affect its compliance with this subpart.
(b) Within 30 days of the receipt of proficiency testing results,
submit the results:
(1) To the recognized accreditation body that accredits the
accredited laboratory; and
(2) If the accredited laboratory failed the proficiency test, to
FDA, via the destination specified by the website described by Sec.
1.1109.
(c) Make the records required by paragraphs (a) and (b) of this
section available for inspection and copying upon written request of an
authorized officer or employee of FDA. The authorized officer or
employee of FDA may request that the laboratory that has been
accredited submit such records to FDA electronically or that the
laboratory make such records promptly available at the physical
location of the laboratory or at another reasonably accessible
location. If the authorized officer or employee of FDA requests the
records be submitted electronically, the records must be submitted
electronically not later than 10 business days after the date of the
request, except that records related to the immediate notification
provision in Sec. 1.1152(j) must be submitted within 48 hours.
Additionally, if the authorized FDA officer or employee requests
records that are maintained in a language other than English, the
laboratory that has been accredited must electronically submit an
English translation of the records to FDA within a reasonable time.
(d) Ensure that significant amendments to records described by
paragraphs (a) and (b) of this section can be tracked to previous and
original versions. If such a significant amendment is made, both the
original document and amended document must be maintained by the
laboratory that has been accredited during the time period that the
amended document must be maintained under this subpart. The laboratory
must also document the date of amendment, the personnel responsible for
the amendment, and a conspicuous indication on the original document
stating that the document has been altered and a more recent version of
the document exists.
Procedures for Accreditation of Laboratories
Sec. 1.1158 How does a laboratory apply for accreditation or
modification of its scope of accreditation by a recognized
accreditation body?
(a) Submission of application for accreditation to a recognized
accreditation body. A laboratory seeking accreditation must submit its
application for accreditation to a recognized accreditation body
identified on the website described in Sec. 1.1109. The recognized
accreditation body will review and assess the application in accordance
with the requirements of this subpart. If the laboratory seeking
accreditation had its accreditation (in-whole or in-part) withdrawn by
a recognized accreditation body or revoked by FDA the previous time it
was accredited under this subpart, the laboratory must meet the
additional requirements specified by Sec. 1.1165.
(b) Documentation of conformance with ISO/IEC 17025:2017. The
laboratory may use documentation of conformance with ISO/IEC
17025:2017, as applicable and supplemented as necessary, in meeting the
applicable requirements of this subpart.
(c) Duration of accreditation. If an accredited laboratory
maintains compliance with all requirements of this subpart including
maintaining accreditation to ISO/IEC 17025:2017, the laboratory's
accreditation does not end until withdrawn, revoked, or relinquished
under this subpart.
Sec. 1.1159 How will FDA oversee accredited laboratories?
(a) FDA may assess accredited laboratories at any time to determine
whether the accredited laboratory continues to comply with the
applicable requirements of this subpart and whether there are
deficiencies in the performance of the accredited laboratory that, if
not corrected, would warrant probation or revocation of its
accreditation under Sec. 1.1161.
(b) In evaluating the performance of an accredited laboratory under
paragraph (a) of this section, FDA may review any of the following:
(1) Records the accredited laboratory is required to maintain under
this subpart;
(2) Records the accreditation body that accredited the accredited
laboratory is required to maintain under this subpart;
(3) Information obtained by FDA during an onsite assessment by FDA
of the accredited laboratory conducted pursuant to paragraph (c) of
this section;
(4) Information obtained by FDA during an assessment of the
recognized accreditation body that accredited the laboratory; and
(5) Any other information obtained by FDA, including during FDA's
inspections or investigations of one or more owners or consignees of
food subject to food testing under this subpart.
(c) FDA may conduct an onsite assessment of an accredited
laboratory at any reasonable time, with or without a recognized
accreditation body (or its officers, employees, and other agents)
present, to assess an accredited laboratory.
(d) FDA will report any of its observations and findings of its
assessment to the accredited laboratory's recognized accreditation
body.
Sec. 1.1160 How will FDA review submitted test results and
analytical reports?
(a) If FDA finds that any test result, analytical report, related
documents, or the associated analysis contains deficiencies or
otherwise indicates that any aspect of the food testing is not being
conducted in compliance with this subpart, FDA:
(1) May consider the analysis to be invalid; and/or
(2) Will notify the accredited laboratory that appears to be
responsible for the deficiency and may also notify the owner or
consignee of the food of the deficiency. When we notify the accredited
laboratory that appears to be responsible for the deficiency, the
accredited laboratory must respond, in writing, to FDA regarding the
deficiency within 30 days or an agreed-upon timeframe, including a
statement with respect to how the accredited laboratory intends to
address the deficiency, and/or a statement describing the extent to
which the laboratory has addressed the deficiency.
(b) FDA may report FDA's determinations of any deficiencies
resulting from its review of any test results, reports, and related
documents under this subpart to the recognized accreditation body that
accredits the accredited laboratory.
(c) If the deficiency in the test result, analytical report, and/or
associated analysis demonstrates a material substantive shortcoming in
the related food testing or demonstrates repeated administrative
deficiencies, FDA will also consider whether disqualification from
being eligible for permission to submit abridged analytic reports under
Sec. 1.1152(d), and/or other action under this subpart, is
appropriate.
(d) Nothing in this subpart shall be construed to limit the ability
of FDA to review and act upon information
[[Page 59514]]
received about food testing, including determining the sufficiency of
such information and testing.
Sec. 1.1161 When will FDA put an accredited laboratory on probation
or revoke the accreditation of a laboratory?
(a) Grounds for revocation of accreditation. FDA may revoke the
accreditation (in-whole or in-part) of an accredited laboratory to
conduct food testing under this subpart for good cause, which may
include any of the following reasons:
(1) Demonstrated bias or lack of objectivity when conducting food
testing under this subpart where the laboratory's recognized
accreditation body fails to withdraw accreditation of the laboratory.
(2) Performance that calls into question the validity or
reliability of its food testing under this subpart where the
laboratory's recognized accreditation body fails to withdraw
accreditation of the laboratory.
(3) Other failure to substantially comply with this subpart where
the laboratory's recognized accreditation body fails to withdraw
accreditation of the laboratory.
(b) Grounds for probation. If FDA determines that an accredited
laboratory has demonstrated deficiencies in performing its functions
that are less serious and more limited than those identified in
paragraph (a) of this section, and it is reasonably likely that the
accredited laboratory will be able to correct such deficiencies within
a specified period of time, FDA may temporarily put the accredited
laboratory on probation and request that the laboratory take
appropriate corrective actions.
(c) Revocation in-part. When there are grounds for revocation of
accreditation of a laboratory, but the deficiencies affect only certain
methods within the accredited laboratory's scope of accreditation, FDA
may revoke the accredited laboratory's accreditation only for those
affected methods.
(d) Length of probation. FDA's probation of a laboratory's
accreditation shall remain in effect until the laboratory demonstrates
to FDA's satisfaction that the laboratory has successfully implemented
appropriate corrective actions, or until FDA determines that revocation
of accreditation is warranted.
(e) Notice to the accredited laboratory of revocation of
accreditation. FDA will notify a laboratory and its accreditation body
of the revocation of its accreditation through issuance of a revocation
notice that will state:
(1) The grounds for revocation;
(2) Whether the revocation of accreditation is in-whole or in-part,
and if it is in-part, to which method or methods it applies;
(3) The procedures for requesting a regulatory hearing under Sec.
1.1173 on the revocation; and
(4) The procedures for requesting reinstatement of accreditation
under Sec. 1.1165.
(f) Notification of probation. FDA will notify a laboratory and its
accreditation body of the probation and such notification will:
(1) Describe the grounds for the probation; and
(2) Identify all deficiencies that must be corrected for FDA to
lift the probation; and will either:
(i) Inform the laboratory that the laboratory has a specified time
period to take corrective actions specified by FDA; or
(ii) Request that the laboratory submit a corrective action plan to
FDA for FDA's approval that identifies the corrective actions it will
take to address deficiencies identified in the notice and identify
timeframes for completion.
(g) Revocation following probation. FDA may revoke (in-whole or in-
part) the accreditation of a laboratory that has been put on probation
if FDA determines that the laboratory is not implementing appropriate
corrective actions.
(h) Public notice of probation or revocation of accreditation. FDA
will provide notice on the website described in Sec. 1.1109 of
probation or revocation of accreditation of a laboratory.
Sec. 1.1162 What are the consequences if FDA puts an accredited
laboratory on probation or revokes the accreditation of a laboratory?
(a) If FDA revokes the accreditation of a laboratory in-whole, the
laboratory is immediately ineligible to conduct food testing under this
subpart. If FDA revokes the accreditation of a laboratory in-part, the
laboratory is immediately ineligible to use the methods that are
subject to the revocation to conduct food testing under this subpart.
An accredited laboratory that is put on probation by FDA is permitted
to continue to conduct food testing under this subpart.
(b) With respect to food testing conducted by the laboratory prior
to the revocation of accreditation, FDA may refuse to consider specific
food testing results and associated reports of food testing conducted
under this subpart by the laboratory if the basis for the revocation of
accreditation of the laboratory indicates that the specific food
testing conducted by the laboratory may not be reliable.
(c) Within 10 business days of the date of issuance of revocation,
the laboratory must notify FDA electronically, in English, of the name
of the custodian who will maintain the records required by Sec.
1.1153, and provide contact information for the custodian, which will
at least include an email address, and the street address where the
records will be located.
(d) Within 10 business days of the date of issuance of probation or
revocation, the laboratory must notify any owners or consignees that it
is conducting food testing on behalf of under this subpart that it is
on probation or its accreditation has been revoked.
Sec. 1.1163 What if a laboratory wants to voluntarily relinquish its
accreditation?
(a) Notice to FDA and the recognized accreditation body of intent
to relinquish. An accredited laboratory must notify FDA electronically,
in English, and must notify its recognized accreditation body at least
60 days before voluntarily relinquishing accreditation (in-whole or in-
part). The notice must include the date on which relinquishment will
occur. If the relinquishment is of the laboratory's accreditation in-
whole, the notification must also include the name and contact
information of the custodian who will maintain the records required
under Sec. 1.1153 after the date of relinquishment, and the laboratory
must make such records available to FDA as required by Sec. 1.1153.
The contact information for the custodian must include, at a minimum,
an email address and the street address where the records required by
Sec. 1.1153 will be located.
(b) Public notice of voluntary relinquishment of accreditation. FDA
will provide notice on the website described in Sec. 1.1109 of the
voluntary relinquishment of accreditation of a laboratory.
Sec. 1.1164 What is the effect on accredited laboratories if their
accreditation body voluntarily or involuntarily loses its recognition?
(a) If an accreditation body has its recognition revoked,
relinquishes its recognition, allows its recognition to expire, or has
its application for renewal of recognition denied, the laboratory
accredited by the accreditation body must take the following actions
(subject to the exception in paragraph (b) of this section):
(1) No later than 30 days after FDA issues the notice to the
accredited laboratory under Sec. 1.1129, Sec. 1.1130, or Sec. 1.1131
that the accreditation body that accredits the laboratory has had its
[[Page 59515]]
recognition revoked, has relinquished its recognition, has allowed its
recognition to expire, or has had its application for renewal of
recognition denied, the accredited laboratory submits to FDA
documentation of the accredited laboratory's most recent internal
audit, which all accredited laboratories are required to maintain under
Sec. 1.1153(a)(5), documentation showing compliance with the conflict
of interest requirements in Sec. 1.1147, and documentation of the most
recent proficiency test for each test method for which the laboratory
is accredited under this subpart, to show compliance with Sec.
1.1138(a)(1)(ii); and
(2) No later than 1 year after FDA issues the applicable notice
under Sec. 1.1129, Sec. 1.1130, or Sec. 1.1131 to the accredited
laboratory, the laboratory becomes accredited under this subpart by a
recognized accreditation body.
(b) The accredited laboratory does not have to comply with
paragraph (a) of this section if, no later than 15 days after FDA
issues the applicable notice to the accredited laboratory under Sec.
1.1129, Sec. 1.1130, or Sec. 1.1131, the accredited laboratory
initiates relinquishment of its accreditation in-whole under Sec.
1.1163, with the relinquishment to occur within no more than 90 days.
Sec. 1.1165 How does a laboratory request reinstatement of
accreditation?
(a) Application following withdrawal of accreditation by a
recognized accreditation body or revocation of accreditation by FDA. A
laboratory that had its accreditation (in-whole or in-part) withdrawn
by a recognized accreditation body or revoked by FDA may seek
reinstatement of accreditation by submitting a new application for
accreditation (in-whole or in-part, as applicable) to a recognized
accreditation body under Sec. 1.1158, and the laboratory must also:
(1) Notify FDA, before it submits the new application for
accreditation to the recognized accreditation body, that the laboratory
will be submitting a new application for accreditation to the
recognized accreditation body, including in the notification the legal
name of the laboratory, valid contact information for the laboratory,
the legal name of the recognized accreditation body the laboratory will
be submitting the application to, and the date that the laboratory
expects to submit the new application for accreditation; and
(2) Demonstrate, to the satisfaction of the recognized
accreditation body it is submitting the new application to, that the
grounds for the withdrawal of accreditation have been resolved and that
the laboratory has implemented measures to prevent such grounds from
recurring.
(b) Application following voluntary relinquishment of
accreditation. A laboratory that voluntarily relinquished its
accreditation (in-whole or in-part), pursuant to Sec. 1.1163, may seek
reaccreditation by submitting a new application for accreditation to a
recognized accreditation body under Sec. 1.1158.
Requesting FDA Reconsideration, FDA Internal Review, or Regulatory
Hearings of FDA Decisions Under This Subpart
Sec. 1.1171 How does an accreditation body request reconsideration
by FDA of a decision to deny its application for recognition, renewal,
or reinstatement?
(a) Timing of request. An accreditation body may seek
reconsideration of FDA's decision to deny its application for
recognition, renewal of recognition, or reinstatement of recognition no
later than 10 business days after the date of the issuance of such
denial.
(b) Submission of request. The request to reconsider an application
under paragraph (a) of this section must be signed by the accreditation
body, as appropriate, or by an individual authorized to act on its
behalf. The accreditation body must submit the request to FDA
electronically, in English, and in accordance with the procedures
described in the notice of denial.
(c) Notification of FDA's decision. After completing its review and
evaluation of the request for reconsideration and any supporting
information submitted pursuant to paragraph (b) of this section, FDA
will notify the accreditation body of its decision to grant recognition
upon reconsideration or deny recognition upon reconsideration.
Sec. 1.1173 How does an accreditation body or laboratory request a
regulatory hearing on FDA's decision to revoke the recognized
accreditation body's recognition or revoke the accredited laboratory's
accreditation?
(a) Request for hearing. No later than 10 business days after the
date FDA issued a revocation of recognition of an accreditation body
pursuant to Sec. 1.1131 or revocation of accreditation of a laboratory
pursuant to Sec. 1.1161, the accreditation body, laboratory, or an
individual authorized to act on the accreditation body's or
laboratory's behalf, may submit a request for a regulatory hearing,
conducted pursuant to part 16 of this chapter, on the revocation. The
notice of revocation issued under Sec. 1.1131 or Sec. 1.1161, as
applicable, will contain all the elements required by Sec. 16.22(a) of
this chapter and will thereby constitute the notice of an opportunity
for hearing under part 16 of this chapter.
(b) Submission of request for regulatory hearing. The request for a
regulatory hearing under this subpart must be submitted with a written
appeal that responds to the bases for the FDA decision described in the
written notice of revocation, together with any supporting information
upon which the requestor is relying. The request, appeal, and
supporting information must be submitted to FDA electronically, in
English, in accordance with the procedures described in the notice of
revocation.
(c) Effect of submitting a request for a regulatory hearing on an
FDA decision. The submission of a request for a regulatory hearing
under this subpart will not operate to delay or stay the effect of a
decision by FDA to revoke recognition of an accreditation body or
revoke the accreditation of laboratory unless FDA determines that delay
or a stay is in the public interest.
(d) Presiding officer. The presiding officer for a regulatory
hearing under this subpart will be designated after a request for a
regulatory hearing is submitted to FDA.
(e) Denial of a request for regulatory hearing. The presiding
officer may deny a request for regulatory hearing under this subpart
pursuant to Sec. 16.26(a) of this chapter when no genuine or
substantial issue of fact has been raised.
(f) Conduct of regulatory hearing. (1) If the presiding officer
grants a request for a regulatory hearing, the hearing will be held
within 10 business days after the date the request was filed or, if
applicable, within a timeframe agreed upon in writing by the
accreditation body, laboratory, and the presiding officer and FDA.
(2) The presiding officer must conduct the hearing in accordance
with part 16 of this chapter, except that, pursuant to Sec. 16.5(b) of
this chapter, the procedures for a regulatory hearing apply only to the
extent that such procedures are supplementary and do not conflict with
the procedures specified for regulatory hearings under this subpart.
Accordingly, the following requirements of part 16 of this chapter are
inapplicable to regulatory hearings conducted under this subpart: The
requirements of Sec. 16.22 (Initiation of a regulatory hearing); Sec.
16.24(e) (timing) and (f) (contents of notice); Sec. 16.40
(Commissioner); Sec. 16.60(a) (public process); Sec. 16.95(b)
(administrative decision and record for decision); and
[[Page 59516]]
Sec. 16.119 (Reconsideration and stay of action).
(3) A decision by the presiding officer to affirm the revocation of
recognition or revocation of accreditation is considered a final agency
action under 5 U.S.C. 702.
Sec. 1.1174 How does an owner or consignee request a regulatory
hearing on a food testing order?
(a) Request for hearing. No later than 24 hours after the time at
which FDA issued the food testing order, an owner or consignee may
submit a request for a regulatory hearing, conducted pursuant to part
16 of this chapter, on the food testing order. The food testing order
will contain all of the elements required by Sec. 16.22 of this
chapter and will thereby constitute the notice of an opportunity for
hearing under part 16 of this chapter.
(b) Submission of request for regulatory hearing. The request for a
regulatory hearing must be submitted with a written appeal that
responds to the bases, as appropriate, for FDA's determinations
described in the food testing order, together with any supporting
information upon which the requestor is relying. The request, appeal,
and supporting information must be submitted in English to the
destination specified in such notice and in accordance with the
procedures described therein. The request, appeal, and supporting
information may be submitted electronically.
(c) Presiding officer. The presiding officer for a regulatory
hearing under this subpart will be designated after a request for a
regulatory hearing is submitted to FDA.
(d) Denial of a request for regulatory hearing. The presiding
officer may deny a request for regulatory hearing under this subpart
pursuant to Sec. 16.26(a) of this chapter.
(e) Conduct of regulatory hearing. (1) If the presiding officer
grants a request for a regulatory hearing, such hearing will be held
within 2 business days after the date the request was filed or, if
applicable, within a timeframe agreed upon in writing by the requestor
and the presiding officer and FDA.
(2) The presiding officer may require that a hearing conducted
under this subpart be completed within 1 business day, as appropriate.
(3) The presiding officer must conduct the hearing in accordance
with part 16 of this chapter, except that, pursuant to Sec. 16.5(b) of
this chapter, the procedures for a regulatory hearing described in part
16 of this chapter apply only to the extent that such procedures are
supplementary and not in conflict with the procedures specified for the
conduct of regulatory hearings under this subpart. Accordingly, the
following requirements of part 16 of this chapter are inapplicable to
regulatory hearings conducted under this subpart: Sec. 16.22
(Initiation of a regulatory hearing); Sec. 16.24(e) (timing) and (f)
(contents of notice); Sec. 16.40 (Commissioner); Sec. 16.60(a)
(public process); Sec. 16.95(b) (administrative decision and record
for decision); and Sec. 16.119 (Reconsideration and stay of action).
(4) A decision by the presiding officer to affirm the food testing
order is considered a final agency action under 5 U.S.C. 702.
Electronic Records and Public Disclosure Requirements Under This
Subpart
Sec. 1.1199 Are electronic records created under this subpart
subject to the electronic records requirements of part 11 of this
chapter?
Records that are established or maintained to satisfy the
requirements of this subpart and that meet the definition of electronic
records in Sec. 11.3(b)(6) of this chapter are exempt from the
requirements of part 11 of this chapter. Records that satisfy the
requirements of this subpart, but that also are required under other
applicable statutory provisions or regulations, remain subject to part
11 of this chapter.
Sec. 1.1200 Are the records obtained by FDA under this subpart
subject to public disclosure?
Records obtained by FDA under this subpart are subject to the
disclosure requirements under part 20 of this chapter.
PART 11--ELECTRONIC RECORDS; ELECTRONIC SIGNATURES
0
4. The authority citation for part 11 continues to read as follows:
Authority: 21 U.S.C. 321-393; 42 U.S.C. 262.
0
5. In Sec. 11.1, add paragraph (p) to read as follows:
Sec. 11.1 Scope.
* * * * *
(p) This part does not apply to records required to be established
or maintained by subpart R of part 1 of this chapter. Records that
satisfy the requirements of subpart R of part 1 of this chapter, but
that also are required under other applicable statutory provisions or
regulations, remain subject to this part.
PART 16--REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION
0
6. The authority citation for part 16 continues to read as follows:
Authority: 15 U.S.C. 1451-1461; 21 U.S.C.141-149, 321-394,
467f, 679, 821, 1034, 28 U.S.C. 2112; 42 U.S.C. 201-262, 263b, 364.
0
7. In Sec. 16.1, add the following entries in numerical order to
paragraph (b)(2) to read as follows:
Sec. 16.1 Scope.
* * * * *
(b) * * *
(2) * * *
Sec. 1.1173, relating to the revocation of recognition of an
accreditation body, and revocation of accreditation of a laboratory,
with respect to food testing conducted under part 1, subpart R of this
chapter.
Sec. 1.1174, relating to the issuance of a food testing order by
FDA pursuant to Sec. 1.1107(a)(2).
* * * * *
PART 129--PROCESSING AND BOTTLING OF BOTTLED DRINKING WATER
0
8. The authority citation for part 129 is revised to read as follows:
Authority: 21 U.S.C. 342, 348, 350k, 371, 374, 42 U.S.C. 264.
0
9. Amend Sec. 129.35 by revising paragraph (a)(3)(iii) to read as
follows:
Sec. 129.35 Sanitary facilities.
* * * * *
(a) * * *
(3) * * *
(iii) Analysis of the sample may be performed for the plant by
competent commercial laboratories (e.g., Environmental Protection
Agency (EPA) and State-certified laboratories), except that the
analysis of the five samples from the same sampling site that
originally tested positive for E. coli, as required by paragraph (a)(3)
of this section, must be conducted under part 1, subpart R of this
chapter.
* * * * *
Dated: September 30, 2019.
Norman E. Sharpless,
Acting Commissioner of Food and Drugs.
Dated: October 25, 2019.
Eric D. Hargan,
Deputy Secretary, Department of Health and Human Services.
[FR Doc. 2019-23870 Filed 11-1-19; 8:45 am]
BILLING CODE 4164-01-P