[Federal Register Volume 84, Number 213 (Monday, November 4, 2019)]
[Proposed Rules]
[Pages 59452-59516]
[FR Doc No: 2019-23870]

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:<PHONE_NUMBER>, or email to
<EMAIL_ADDRESS>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_ADDRESS>    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,<PHONE_NUMBER>,
email<EMAIL_ADDRESS>
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

    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

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

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),

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

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

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

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

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

G. Incorporation by Reference

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

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

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

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

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

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

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

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

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

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

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

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

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

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