Laboratory Accreditation for Analyses of Foods

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.

SUMMARY:

The Food and Drug Administration (FDA, Agency, or we) is proposing to amend its regulations to establish a program for the testing of food in certain circumstances by accredited laboratories, as required under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Establishing such a program will help FDA improve the safety of the U.S. food supply and protect U.S. consumers by helping ensure that certain food testing of importance to public health is conducted subject to appropriate oversight and in accordance with appropriate model standards, and produces reliable and valid test results.

DATES:

Submit either electronic or written comments on the proposed rule by March 3, 2020. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by March 3, 2020 (see the “Paperwork Reduction Act of 1995” section of this document).

ADDRESSES:

You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before March 3, 2020. The

https://www.regulations.gov

electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of March 3, 2020. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

Electronic Submissions

Submit electronic comments in the following way:

•

Federal eRulemaking Portal: https://www.regulations.gov.

Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to

https://www.regulations.gov

will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on

https://www.regulations.gov.

• If you want to submit a comment with confidential information that you do not wish to be made available to the public submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions.”)

Written/Paper Submissions

Submit written/paper submissions as follows:

•

Mail/Hand Delivery/Courier (for written/paper submissions):

Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions:

All submissions received must include the Docket No. FDA-2019-N-3325 for Laboratory Accreditation for Analyses of Foods. Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at

https://www.regulations.gov

or at Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on

https://www.regulations.gov.

Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at:

http://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

Docket:

For access to the docket to read background documents or the electronic and written/paper comments received, go to

https://www.regulations.gov

and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

Submit comments on information collection issues under the Paperwork Reduction Act of 1995 to the Office of Management and Budget (OMB) in the following ways:

• Fax to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or email to

oira_submission@omb.eop.gov.

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:

timothy.mcgrath@fda.hhs.gov.

With regard to the information collection:

Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown Street, North Bethesda, MD 20852, 301-796-5733, email:

PRAStaff@fda.hhs.gov.

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 §§ 1.1102 Through 1.1103)

B. Proposed Provisions About General Requirements of This Rule (Proposed §§ 1.1107 Through 1.1109)

C. Proposed Provisions About Recognition of Accreditation Bodies (Proposed §§ 1.1113)

D. Proposed Provisions About Requirements for Recognized Accreditation Bodies (Proposed §§ 1.1118 Through 1.1125)

E. Proposed Provisions About Procedures for Recognition of Accreditation Bodies (Proposed §§ 1.1128 Through 1.1133)

F. Proposed Provisions About Accreditation of Laboratories (Proposed §§ 1.1138)

G. Proposed Provisions About Requirements for Accredited Laboratories (Proposed §§ 1.1146 Through 1.1153)

H. Proposed Provisions About Procedures for Accreditation of Laboratories (Proposed §§ 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 §§ 1.1171 Through 1.1174)

J. Proposed Provisions About Electronic Records and Public Disclosure Requirements Under This Rule (Proposed §§ 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 § 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:

EP04NO19.000

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

Abbreviation/

acronym

What it means

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.

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 § 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 § 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.

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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.

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).

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See

https://www.govinfo.gov/content/pkg/GPO-UA-2005-10-31/pdf/GPO-UA-2005-10-31-8.pdf.

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.

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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.

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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 §§ 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 §§ 1.1102 Through 1.1103)

1. What definitions apply to this subpart? (Proposed § 1.1102)

We propose to define several terms used in this rule (see proposed § 1.1102). Where possible, we propose to rely on existing statutory and regulatory definitions. Proposed § 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 § 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 § 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 § 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 § 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 §§ 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 § 1.1107(a)(1); the food product or environment that is the subject of the order issued under § 1.1107(a)(2); the food product or environment that is the subject of food testing conducted under § 1.1107(a)(3); the article of food for which food testing is being conducted under § 1.1107(a)(4); or the food subject to an import alert for which food testing is conducted under § 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 § 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 § 1.1107(a).

B. Proposed Provisions About General Requirements of This Rule (Proposed §§ 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 § 1.1107)

Proposed § 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 § 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 § 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 § 1.1107(a)(2). In proposed § 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 § 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 § 1.1107(a)(1), (a)(2), or (a)(3), we are proposing to codify testing requirements in § 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 § 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 §§ 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 § 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 § 129.35(a)(3)(i)). More specifically, testing would have to be conducted under this program under proposed § 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 § 118.4 is positive, you must begin egg testing, as specified in § 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 § 118.6), unless you divert eggs to treatment as defined in § 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 § 118.6), unless you divert eggs to treatment as defined in § 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 § 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 §§ 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 § 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 § 1.1108 (which addresses the question of when and how FDA will issue a food testing order).

Proposed § 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 § 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 § 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 § 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 § 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 § 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 § 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 § 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 §§ 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 § 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 § 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 §§ 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 § 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 § 1.1107(b) would require that whenever food testing is required to be conducted in accordance with this program, as described in proposed § 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 § 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 § 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 § 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 § 1.1108)

Proposed § 1.1108 would, if finalized, establish our procedure for issuing food testing orders. Specifically, proposed § 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 § 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 § 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 § 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 § 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 § 1.1174.

3. How will FDA make information about recognized accreditation bodies and accredited laboratories available to the public? (Proposed § 1.1109)

Proposed § 1.1109 provides that (except as provided by proposed § 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 § 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 § 1.1109(a) is made publicly available. In the absence of a determination to the contrary under proposed § 1.1109(b), the list would remain publicly and readily available at all times on our website and display all information specified by proposed § 1.1109(a).

C. Proposed Provisions About Recognition of Accreditation Bodies (Proposed § 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 § 1.1113)

Proposed § 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 § 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 § 1.1151(a)), and that laboratories demonstrate their capability by participating in comparison programs such as proficiency testing (see § 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 § 1.1138(a)(1)). Thus, we would expect recognized accreditation bodies to serve a function that accreditation bodies have not traditionally performed.

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 § 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 § 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 §§ 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 § 1.1119 and to make appeals

procedures publicly available in accordance with proposed § 1.1121.

Another example of how paragraphs (b) and (d) of proposed § 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 § 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 § 1.1113(b) and (d) and § 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 § 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 § 1.1113(a)-(d) where we discuss proposed § 1.1128, below.

We invite comment on proposed § 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 §§ 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 §§ 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 § 1.1118)

For recognized accreditation bodies to remain recognized, proposed § 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 § 1.1118(d) are primarily specified by proposed §§ 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 § 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 § 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 § 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 § 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 § 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 § 1.1119(b) provides that the prohibited money, gift, gratuity, or other item of value described by proposed § 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 § 1.1119(c), the financial interests of spouses and children younger than 18 years of age would be imputed to a recognized accreditation body's officers, employees, and other agents involved in its accreditation activities. We have included a similar imputation provision in other regulations, including the FSMA accredited third-party certification regulation. See 21 CFR 1.657(c)) and 21 CFR 516.141(g). We believe this provision would help ensure the integrity of the food testing program.

We seek comment on proposed § 1.1119 and whether there are any other potential conflicts interest for recognized accreditation bodies that should be addressed in this proposed program. For any comment recommending that we address other types of conflicts, we request

recommended measures to address such conflicts, and any references or documents that are available to support the recommendation.

3. How must a recognized accreditation body evaluate laboratories seeking accreditation and oversee the performance of laboratories it accredits? (Proposed § 1.1120)

We anticipate that many laboratories that seek accreditation in our proposed program already will be accredited to ISO/IEC 17025:2017 by an accreditation body to which we have granted recognition. To provide flexibility to such participants, we are proposing laboratory assessment requirements for our program that build upon, and could be combined with, the existing assessments of laboratories that accreditation bodies conduct under ISO/IEC 17011:2017 during an accreditation cycle. For example, if an accreditation body has conducted an onsite assessment of an ISO/IEC 17025:2017 accredited laboratory in the past 2 years, proposed § 1.1120(c) would potentially allow the initial assessment for accreditation to our program to be conducted remotely, and to only address whether the laboratory meets the unique requirements of our program that are not required by ISO/IEC 17025:2017 (see proposed § 1.1138(a)(1) and (c)). If such an onsite assessment has not been conducted in the past 2 years, an accreditation body's initial assessment of a laboratory for accreditation in our program would be required to be conducted onsite and would be required to address whether the laboratory meets all the requirements of our program, including the requirements of ISO/IEC 17025:2017 specified in proposed § 1.1138(a)(2) and (b).

Where the initial assessment for accreditation to our program is conducted remotely under proposed § 1.1120(c), proposed § 1.1120(e) and (f) would require the recognized accreditation body to conduct its first assessment of the sample of the scope of accreditation of the accredited laboratory onsite, and no later than 2 years after the accreditation body last conducted an onsite assessment of the laboratory, in accordance with ISO/IEC 17011:2017. These proposed requirements are intended to ensure that recognized accreditation bodies conduct onsite assessments of accredited laboratories in our program at least every 2 years. We regard periodic onsite assessments as necessary to effectively evaluating a laboratory. In addition, proposed § 1.1120(g) would require that the reassessment of an accredited laboratory (see ISO/IEC 17011:2017 (Ref. 12, at section 7.9.4)) at the end of the laboratory's accreditation cycle be conducted onsite.

However, when conducting an “onsite” assessment, if conducting a particular assessment activity onsite will not aid in the assessment of a laboratory, proposed § 1.1120(b), (e), and (g), would allow such activities to be conducted remotely. Our intent is that this exception would allow assessment activities such as document review or followup inquiries to a laboratory after an onsite visit to be conducted remotely. Proposed § 1.1120(h) would allow any assessments conducted by a recognized accreditation body other than the assessments referred to in § 1.1120(a), (e), and (g)—that is, the initial assessment, sample of the scope of accreditation, and reassessment—to be conducted entirely remotely if it will not aid the assessment to conduct them onsite.

4. What appeal procedures must a recognized accreditation body provide for appeals of decisions to not grant accreditation? (Proposed § 1.1121)

Proposed § 1.1121 provides that a laboratory may appeal a decision by the recognized accreditation body to not grant the accreditation (in-whole or in-part) that the laboratory sought, and the recognized accreditation body must consider the appeal, in accordance with the requirements of § 1.1118(b). We are proposing this provision because ISO/IEC 17011:2017 does not explicitly state what actions by the accreditation body a laboratory may appeal.

Proposed § 1.1121 would require recognized accreditation bodies to establish and implement certain written procedures for addressing appeals from laboratories challenging a recognized accreditation body's decision to not grant the accreditation (in-whole or in-part) that the laboratory sought. Specifically, proposed § 1.1121 provides that, in addition to meeting the requirements of § 1.1118(b) related to appeals, the recognized accreditation body must establish and implement written procedures to make the appeals procedures publicly available, and use a competent person(s), who may or may not be external to the recognized accreditation body, is free from bias or prejudice and has not participated in the accreditation decision, and is not the subordinate of a person who participated in the accreditation decision, to review and decide appeals. We have tentatively concluded that the requirements of proposed § 1.1121 are important supplemental requirements to ISO/IEC 17011:2017 (Ref. 12) section 7.13 that would provide additional protections to laboratories and help ensure transparency of the program. We seek comments on these proposed requirements, including with respect to whether these proposed requirements would significantly differ from the current appeals practices of accreditation bodies.

5. When must a recognized accreditation body withdraw or reduce the scope of the accreditation of a laboratory, and when may a recognized accreditation body put an accredited laboratory on probation? (Proposed § 1.1122)

Proposed § 1.1122(a) would require recognized accreditation bodies to withdraw the accreditation of a laboratory it accredits when the accredited laboratory substantially fails to comply with this rule. Although section 7.11 of ISO/IEC 17011:2017 (Ref. 12) specifies certain circumstances that would require the accreditation body to initiate the process for withdrawing the accreditation of the laboratory—including fraudulent behavior—it does not articulate a general standard for when accreditation bodies should initiate the process for withdrawing accreditation.

Although we are proposing that withdrawal of accreditation be initiated by a “substantial” failure to comply with this subpart—and not by minor or de minimis violations—we note that the failure or refusal by the accredited laboratory to take appropriate corrective action (as it is required to do under ISO/IEC 17025:2017 (Ref. 13) at section 8.7) to prevent subsequent minor violations may rise to the level of substantial failure to comply with this rule. For example, if on a single occasion an accredited laboratory fails to provide FDA with documentation of the sampler's qualifications as required by § 1.1152(c)(2), that in and of itself would not generally be considered a substantial violation. However, frequent and recurring failure by a laboratory to submit all required components of a full analytical report, even when each instance constitutes a minor violation, combined with a failure or refusal by the accredited laboratory to take appropriate corrective action to prevent such mistakes from recurring, may in certain circumstances be grounds for withdrawal of accreditation.

Proposed § 1.1122(b) provides that a recognized accreditation body may put an accredited laboratory it accredits on probation if the recognized accreditation body determines that the laboratory demonstrates deficiencies in performing

its functions under this program that are less serious than would justify withdrawal of the accredited laboratory's accreditation (in-whole or in-part) under proposed § 1.1122(a), and it is reasonably likely that the accredited laboratory will be able to correct such deficiencies within a reasonable specified period of time. Our intent is that probation would allow recognized accreditation bodies to work with laboratories they accredit to bring such laboratories into compliance with the program without having to resort to withdrawing accreditation.

As noted, this proposed rule refers to reduction of an accredited laboratory's scope of accreditation by a recognized accreditation body as withdrawal of accreditation in-part. Proposed § 1.1122(c) clarifies that when there are grounds for withdrawal of accreditation, but the deficiencies affect only certain analytical methods within the accredited laboratory's scope of accreditation, the recognized accreditation body may withdraw the accredited laboratory's scope of accreditation for only those affected analytical methods. This provision is meant to facilitate limited withdrawal of accreditation when warranted.

Under proposed § 1.1122(d) a recognized accreditation body may require from a laboratory that it accredits the submission of records that the accredited laboratory would be required to maintain under proposed § 1.1153, in order to assist the recognized accreditation body in determining whether a withdrawal of accreditation (in-whole or in-part) or probation is warranted.

Proposed § 1.1122(e) describes the process a recognized accreditation body must follow when withdrawing the accreditation of an accredited laboratory under this program. Under proposed § 1.1122(e), the recognized accreditation body must notify the laboratory of the withdrawal of the laboratory's accreditation, and the notification must specify whether the withdrawal of accreditation is in-whole or in-part, and if it is in-part, to which testing methods it applies. The notification must also describe the grounds on which the accreditation was withdrawn and state the procedures for appealing the withdrawal.

Proposed § 1.1122(f) provides that the recognized accreditation body would have to: (1) Notify the laboratory of its probationary status; (2) describe the grounds for the probation; (3) identify all deficiencies that the laboratory must correct for the recognized accreditation body to lift the probation; and (4) either inform the laboratory that it has a specific timeframe to take particular corrective actions with respect to the identified deficiencies or require the laboratory to submit a plan to the recognized accreditation body for approval that identifies the appropriate corrective actions the laboratory will take to resolve the identified deficiencies and that identifies appropriate timeframes for resolution. Our intent is that while probation is in effect, the recognized accreditation body will work with the accredited laboratory to bring it into compliance with the requirements of the program.

Proposed § 1.1122(g) describes the consequences of withdrawal of accreditation (in-whole or in-part) or probation. If a recognized accreditation body withdraws the accreditation of a laboratory in-whole, the laboratory would be immediately ineligible to conduct food testing under this rule. If the recognized accreditation body withdraws the accreditation of a laboratory in-part, the laboratory would be immediately ineligible to conduct food testing under this rule with respect to only the specific methods for which accreditation was withdrawn. An accredited laboratory's substantial failure to comply with this rule would undermine the integrity and validity of this proposed program and of the laboratory's affected food testing conducted under this proposed rule. Withdrawal of the laboratory's accreditation would ensure that the laboratory does not continue to conduct the affected food testing under this rule. This consequence is in accordance with the requirement in section 422(b)(1) of the FD&C Act that food testing under section 422 may only be conducted by laboratories that are accredited by recognized accreditation bodies for the methods of analysis appropriate for such food testing. An accredited laboratory that is put on probation by an accreditation body under this proposed rule would be permitted to continue to conduct food testing under this subpart, because it would still be accredited under this program. However, an accredited laboratory that is put on probation under this proposed rule would not be able to submit abridged analytical reports under § 1.1152(d).

Proposed § 1.1122(h) discusses requirements related to how the recognized accreditation body must handle appeals of withdrawals of accreditation (in-whole or in-part). Under proposed § 1.1122(h), a laboratory may appeal a decision by the recognized accreditation body to withdraw the accreditation (in-whole or in-part) of the laboratory, and the recognized accreditation body must consider the appeal in accordance with the requirements of ISO/IEC 17011:2017 (Ref. 12) (specifically, ISO/IEC 17011:2017 at section 7.13). In addition to meeting the requirements of ISO/IEC 17011:2017 related to appeals, the recognized accreditation body must establish and implement written procedures to make the appeals procedures publicly available; and to use a competent person(s), who may or may not be external to the recognized accreditation body, who is free from bias or prejudice and has not participated in the withdrawal decision, and is not the subordinate of a person who participated in the withdrawal decision, to review and decide appeals.

6. What reports and notifications must a recognized accreditation body submit to FDA? (Proposed § 1.1123)

Proposed § 1.1123 would require recognized accreditation bodies to submit to FDA reports of their internal audits and notices of matters affecting their recognition and the accreditation status of laboratories they accredit, among other notices.

In proposed § 1.1123 and other provisions in this proposed rule, we are proposing that information submitted to FDA be submitted electronically and in English. Electronic submission of information will help ensure we have ready access to information needed for monitoring and oversight of the program and promote the overall efficiency of the program. We have also tentatively concluded that requiring electronic submission would not be significantly burdensome for the accreditation bodies and laboratories in this program. FDA plans to establish an electronic portal for this program and recognized accreditation bodies would be able to submit all required notification and reports through that portal.

Proposed § 1.1123(a) would require all reports and notifications submitted to FDA under this proposed section to include contact information for the accreditation body associated with the report or notification and, if applicable, contact information for the laboratory associated with the report or notification. Proposed § 1.1123(b) would require recognized accreditation bodies to submit to FDA electronically, in English, a report of the results of the internal audit required by section 9.7 of ISO/IEC 17011:2017 (Ref. 12) and the results of the audit of its compliance with the requirements of § 1.1118(c) and (d), which would be required by proposed § 1.1125, no later than 45 days after completing the internal audit. Proposed § 1.1123(b) further provides that the report of the recognized

accreditation body's internal audit must include a description of the internal audit conducted; a description of any identified deficiencies; a description of any corrective actions taken and any corrective action the recognized accreditation body will take, including the timeline for such corrective actions; and a statement disclosing the extent to which the internal audit was conducted by personnel different from those who perform the activity or activities that were audited. The report does not have to be the same report used internally by the recognized accreditation body, but must be comprehensive enough to demonstrate whether the accreditation body is complying with the requirements of ISO/IEC 17011:2017 and the requirements of § 1.1118(c) and (d). Such reports would provide us with important information about the extent to which the recognized accreditation body is monitoring its own performance under this program, any deficiencies the recognized accreditation body discovered about its activities, and any corrective actions implemented to address such deficiencies.

Because recognized accreditation bodies must conduct such internal audits under ISO/IEC 17011:2017 and to maintain their ILAC membership, proposed § 1.1123(b) would not require the recognized accreditation body to engage in duplicative internal audits. We also believe that providing 45 days for the recognized accreditation body to compile and submit this report is a reasonable amount of time that strikes a balance between our interest in reviewing information that is important to our oversight of the program and providing the recognized accreditation body sufficient time to initiate any appropriate corrective actions and develop a meaningful internal audit report. If the internal audit results in the recognized accreditation body discovering information that must be submitted to FDA immediately under proposed § 1.1123(c), we expect the recognized accreditation body to submit that particular information to us immediately, within 48 hours, in accordance with proposed § 1.1123(c).

Section 422(a)(1)(C) of the FD&C Act requires, as a condition of recognition, that recognized accreditation bodies report to us any changes that would affect the recognition of such recognition body. To implement this provision, proposed § 1.1123(c)(1) would require the recognized accreditation body to notify us immediately of any changes it is aware of that would affect its recognition, including a description of the change, and, if the change is one made by the recognized accreditation body, an explanation for the purpose of the change. Proposed § 1.1123(c)(1) would cover changes in the name or operations of a recognized accreditation body, such as the purchase of a recognized accreditation body by a company, as well as changes that would cause the recognized accreditation body to no longer meet the requirements of this proposed program, including if the recognized accreditation body ceases membership in ILAC or is no longer a signatory of the ILAC MRA demonstrating competence to ISO/IEC 17011:2017. A change that prevents or undermines the accreditation body's compliance with this proposed program may result in revocation of recognition under proposed § 1.1131. We would encourage recognized accreditation bodies to contact us if there are uncertainties about whether a change should be reported under proposed § 1.1123(c)(1).

Proposed § 1.1123(c)(2) through (6) would require recognized accreditation bodies to immediately notify us, within 48 hours, of certain information related to the accreditation status of laboratories they accredit or that have sought their accreditation. Immediate notice is essential so that we can take timely action to update the public website described by proposed § 1.1109; accept food testing results from newly accredited laboratories; refuse to accept food testing results from laboratories that are no longer accredited for the food testing at issue; and take any other actions as appropriate based on such information.

Proposed § 1.1123(c)(2) and (3) would require recognized accreditation bodies to submit information to us about their grants and denials of accreditation (in-whole or in-part) of laboratories. If a recognized accreditation body received a request for accreditation (which includes a request from a laboratory to add testing methods to its scope of accreditation) from a laboratory, and the recognized accreditation body granted accreditation for certain testing methods in the laboratory's request but denied accreditation for other testing methods in the laboratory's request, proposed § 1.1123 would only require that a recognized accreditation body provide us with a single notification encompassing this information, as long as the notification includes all of the information that would be required under proposed § 1.1123(c)(2) and (3).

Proposed § 1.1123(c)(2) and (3) would require the notification to include the scope of accreditation requested by the laboratory, the scope of accreditation granted and/or denied, and the ground for such denial, and the date of such grant. This information would be useful for our program oversight. For example, it would allow us to monitor accreditation activities, including situations where a laboratory appears to be successively applying for, and being denied, accreditation from different recognized accreditation bodies without changing its practices or application to remedy the basis or bases for the previous denial(s).

Proposed § 1.1123(c)(4) would require a recognized accreditation body to notify us immediately if it receives notice that an accredited laboratory it accredits intends to relinquish its accreditation (in-whole or in-part). Proposed § 1.1123(c)(4) would also require such notification to include the scope of accreditation to which the relinquishment applies, and the effective date of the relinquishment.

Proposed § 1.1123(c)(5) would require a recognized accreditation body to notify us immediately when it withdraws (in-whole or in-part) its accreditation of a laboratory. Proposed § 1.1123(c)(5) would also require such notification to include the scope of accreditation to which the withdrawal applies, and the grounds for the withdrawal.

Proposed § 1.1123(c)(6) would require a recognized accreditation body to notify us immediately when it puts an accredited laboratory on probation. Proposed § 1.1123(c)(6) would also require such notification to include the grounds for the probation, and any date by which the recognized accreditation body has determined the accredited laboratory must take appropriate corrective action.

Having information on the reason(s) for probation or withdrawal of accreditation, and whether such withdrawal is in-whole or in-part, is important to us because it may affect whether and how we conduct any followup actions with regards to the laboratory in question or how we review food testing results from the laboratory in the future.

Proposed § 1.1123(c)(7) would require recognized accreditation bodies to notify us immediately when the recognized accreditation body knows that an accredited laboratory it accredits has committed fraud or submitted material false statements to FDA. We note that we would also typically expect the recognized accreditation body to initiate its process to withdraw accreditation of the laboratory in this circumstance (in accordance with ISO/IEC 17011:2017 (Ref. 12) section 7.11.2). Proposed § 1.1123(c)(7) would require the notification to include a description

of the basis for the accreditation body's knowledge of the fraud or material false statements, a description of the alleged fraud or material false statements, and the actions taken by the accreditation body with respect to such laboratory. Recognized accreditation bodies may be in a better position than us in many cases to determine whether an accredited laboratory has committed fraud or submitted material false statements to the FDA, due to recognized accreditation bodies' role in monitoring the laboratories they accredit. Furthermore, although proposed § 1.1152(j) would require accredited laboratories to immediately notify us of any changes that would affect an accredited laboratory's compliance with the program requirements or that would otherwise affect the laboratory's accreditation, an accredited laboratory that has committed fraud or submitted material false statements to us may be unlikely to notify us that it did so.

7. What records requirements must a recognized accreditation body meet? (Proposed § 1.1124)

This proposed rule identifies specific types of records a recognized accreditation body would be required to control and maintain to document compliance with applicable requirements. The recognized accreditation body also would be required to provide FDA access to such records.

Proposed § 1.1124(a) provides that, in addition to meeting the records requirements of ISO/IEC 17011:2017 (as required by proposed § 1.1118(b)), an accreditation body that has been recognized must electronically maintain records demonstrating its compliance with the program, created while it is recognized, for 5 years after the date of creation of the record. The requirements of § 1.1124 would apply to accreditation bodies that have been recognized even if they later are no longer recognized. We are proposing this requirement because maintenance of such records could be vital to our management of this program.

We are not proposing to require records subject to this proposed section to be maintained in English. In accordance with our position on this issue in the accredited third-party certification final rule, we are proposing to allow recognized accreditation bodies to maintain and submit records in languages other than English, provided that they electronically submit an English translation within a reasonable time thereafter. We decline to set a specific timeframe for submission of the translation because the circumstances surrounding each request will differ (

e.g.,

varying number of documents/pages). Further, we are proposing under § 1.1124(b) to require that if FDA requests records electronically, the records must be submitted no later than 10 business days after the date of the request, with the exception that records covered by the immediate notification provision in § 1.1123(c) would be required to be submitted within 48 hours. By allowing records to be submitted in a language other than English, we think that it will not be unduly burdensome for recognized accreditation bodies to provide most requested records electronically within 10 days.

We have tentatively concluded that the records maintenance and access requirements in proposed § 1.1124 are necessary for us to adequately monitor recognized accreditation bodies, as we are directed to do by section 422(a)(7) of the FD&C Act. For example, access to such records could facilitate our determination of whether revocation of the accreditation body's recognition is warranted.

Proposed § 1.1124(c) further clarifies that recognized accreditation bodies must not prevent or interfere with FDA's access to the records accredited laboratories it accredits are required to maintain under proposed § 1.1153. When FDA requests, under proposed § 1.1153 or proposed § 1.1159, that a laboratory submit or provide FDA access to records the laboratory would be required to maintain under proposed § 1.1146(b) or proposed § 1.1153, we expect that the recognized accreditation body that accredits the laboratory would not interfere with our access to such records. Maintaining freedom of access to such records is important to facilitate FDA's ability to provide general oversight of the food testing program, with respect to both recognized accreditation bodies and accredited laboratories.

8. What internal audit requirements must a recognized accreditation body meet? (Proposed § 1.1125)

Proposed § 1.1125 would require a recognized accreditation body to audit its compliance with the requirements under § 1.1118(c) and (d) as part of the internal audit that a recognized accreditation body conducts under § 1.1118(b). Requiring recognized accreditation bodies to monitor their conformance to the requirements that are specific to this program, as well as to the requirements of ISO/IEC 17011:2017, would ensure that accreditation bodies' internal audits cover all the requirements of this program. As discussed, proposed § 1.1123(b)(1) would require the results of this audit to be submitted to us.

E. Proposed Provisions About Procedures for Recognition of Accreditation Bodies (Proposed §§ 1.1128 Through 1.1133)

In these sections we propose how an accreditation body may apply for recognition under this rule, propose procedures for recognition, probation, revocation, and relinquishment of recognition of accreditation bodies, and propose how FDA would oversee recognized accreditation bodies.

1. How does an accreditation body apply to FDA for recognition or renewal of recognition? (Proposed § 1.1128)

This proposed rule would establish procedures for accreditation bodies to follow when applying to FDA for recognition or renewal of recognition. Proposed § 1.1128(a) would provide that an accreditation body seeking recognition must submit an application to FDA demonstrating that it meets the eligibility requirements of proposed § 1.1113, which describes the proposed requirements for accreditation bodies to become recognized to accredit laboratories to conduct food testing under this program.

Similarly, proposed § 1.1128(b) would require an accreditation body seeking renewal of its recognition to submit a renewal application to us demonstrating that it continues to meet the requirements of this program.

Proposed § 1.1128(c) clarifies that accreditation bodies applying for recognition or renewal of recognition must submit documentation of conformance with ISO/IEC 17011:2017, and documentation of ILAC MRA signatory status demonstrating competence to ISO/IEC 17011:2017, in meeting the requirements of proposed § 1.1113(a) and (b) or proposed § 1.1118(a) and (b), as applicable. Although we recognize that documentation of ILAC MRA signatory status under this program represents a determination that an accreditation body has demonstrated competence to ISO/IEC 17011:2017, proposed § 1.1128(c) would require independent documentation that an accreditation body demonstrates competence to ISO/IEC 17011:2017 to provide us additional assurance that an accreditation body meets the specific requirements of the standard. Independent documentation of ISO/IEC 17011:2017 competence could include the report of a peer evaluation by a regional cooperation group or ILAC conducted as part of the

ILAC MRA application and evaluation process. An accreditation body applying for recognition or renewal of recognition also would be required to submit documentation demonstrating it meets the requirements for accreditation bodies that are specific to this program under proposed § 1.1113(c) and (d) or proposed § 1.1118(c) and (d), as applicable. We would expect documentation of proposed § 1.1113(c) and (d) to come in the form of documents such as standard operating procedures, records procedures, the resumes of the scientific and technical staff or contractors who review validation and verification studies, and examples of contracts the accreditation body uses in its activities, while documentation of proposed § 1.1118(c) and (d) would consist of documents created during the accreditation body's term of recognition, such as the internal audit required under proposed § 1.1125. We request comments on what additional documents would demonstrate that an accreditation body meets the requirements of proposed § 1.1113(c) and (d) and proposed § 1.1118(c) and (d).

Where the application for recognition or renewal of recognition does not sufficiently demonstrate that the accreditation body meets the requirements for recognition by FDA, it may be necessary for FDA to review additional documentation to determine whether the accreditation body meets the recognition requirements of the program, and FDA also may, as is noted by proposed § 1.1129(b), request and conduct an onsite assessment of the applicant if necessary. Such additional documentation may include the accreditation body's reviews, assessments, and investigations of laboratories; results of the accreditation body's self-monitoring and internal audits; documents and other information regarding the accreditation body's authority, qualifications (including the expertise and training of its employees that assess laboratories that conduct food testing), resources, quality assurance program, and recordkeeping, reporting, notification, and monitoring procedures. For applications for renewal of recognition, FDA may also review documents and other information of one or more of the laboratories that are accredited by the recognized accreditation body.

Applications for recognition and renewal are subject to certain requirements for the form and manner of submission. Under paragraphs (d) and (e) of proposed § 1.1128 the accreditation body must submit to FDA a signed application (signed by the applicant or by an individual authorized to act on behalf of the applicant for purposes of seeking recognition or renewal of recognition), accompanied by any supporting documents, electronically and in English. We also propose to require an applicant to provide any translation or interpretation services we need to process the application. This may include providing translators or interpreters for FDA staff conducting onsite assessments of the applicant. We invite comment on our proposal to require submissions in English and to require translation or interpretation services as necessary.

2. How will FDA review applications for recognition and applications for renewal of recognition? (Proposed § 1.1129)

Under proposed § 1.1129(a), FDA would review an accreditation body's recognition or renewal application for completeness and would notify the applicant of any deficiencies. We are proposing to review applications on a first-in, first-out basis according to the date the accreditation body submits the completed application. However, we may prioritize the review of specific applications based on program needs. To encourage applicants to supply any missing information promptly, we will not place an application in the queue for review until it is complete. Allowing incomplete applications in the queue might hold up applications that are ready for review, but were submitted later in time.

Under proposed § 1.1129(b), FDA would evaluate applications to determine whether the applicant meets the requirements for recognition or renewal of recognition. The evaluation may include an onsite assessment of the accreditation body. For renewal applications, if FDA does not reach a final decision before an accreditation body's recognition terminates by expiration, FDA may extend the terms of recognition for a specified period of time or until FDA reaches a final decision on the renewal application. Proposed § 1.1129(b) further provides that FDA would notify the applicant, in writing, regarding whether the application has been approved or denied, and that we may make such notification electronically.

Under proposed § 1.1129(c), we would notify applicants of our decision to approve the application for recognition or renewal through issuance of recognition that would list any conditions associated with the recognition, including the duration of recognition.

Proposed § 1.1129(d) would allow us to grant recognition to an accreditation body for up to 5 years at a time (except if FDA needs to extend the term of recognition while it makes a renewal determination, as described at proposed § 1.1129(b)), although we will determine the length of recognition on a case-by-case basis. We are proposing the 5-year upper limit in accordance with section 422(a)(7) of the FD&C Act, which requires us to (in pertinent part), periodically, and in no case less than once every 5 years, reevaluate accreditation bodies recognized under this program to assess whether they meet the criteria for recognition. We do not necessarily expect to grant every recognition at the maximum 5-year duration. We believe that shorter terms of recognition may potentially be appropriate in the initial years of the food testing program or for any accreditation bodies with fewer years of experience accrediting laboratories to conduct food testing. When we proposed the same duration for recognition of accreditation bodies for the accredited third-party certification regulation, we received support for the proposal and for the flexibility to determine the length of recognition on a case-by-case basis, although we also did receive some comments expressing concern that we did not propose a fixed duration of recognition (80 FR 74570 at 74601). As we noted in the accredited third-party certification final rule, where appropriate, we would grant recognition for the maximum duration of 5 years. Id. However, we also recognize it may be appropriate for the duration of recognition to vary depending on a number of factors, such as accreditation body experience and, for example, whether the accreditation body has had problems meeting the recognition requirements in the past.

Under proposed § 1.1129(e), if we deny a recognition or renewal application, we would notify the applicant, through an issuance of a notification of denial of recognition or denial of renewal application, that the accreditation body's recognition or rene

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