National Bioengineered Food Disclosure Standard; Guidance on Validation of a Refining Process and Selecting a Testing Method

Published date08 July 2020
Citation85 FR 40867
Record Number2020-14643
SectionRules and Regulations
CourtAgricultural Marketing Service
Federal Register, Volume 85 Issue 131 (Wednesday, July 8, 2020)
[Federal Register Volume 85, Number 131 (Wednesday, July 8, 2020)]
                [Rules and Regulations]
                [Page 40867]
                From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
                [FR Doc No: 2020-14643]
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                Rules and Regulations
                 Federal Register
                ________________________________________________________________________
                This section of the FEDERAL REGISTER contains regulatory documents
                having general applicability and legal effect, most of which are keyed
                to and codified in the Code of Federal Regulations, which is published
                under 50 titles pursuant to 44 U.S.C. 1510.
                The Code of Federal Regulations is sold by the Superintendent of Documents.
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                Federal Register / Vol. 85, No. 131 / Wednesday, July 8, 2020 / Rules
                and Regulations
                [[Page 40867]]
                DEPARTMENT OF AGRICULTURE
                Agricultural Marketing Service
                7 CFR Part 66
                [Document No. AMS-FTPP-19-0104]
                National Bioengineered Food Disclosure Standard; Guidance on
                Validation of a Refining Process and Selecting a Testing Method
                ACTION: Notification of guidance.
                -----------------------------------------------------------------------
                SUMMARY: The Agricultural Marketing Service (AMS) of the Department of
                Agriculture (USDA) posts final guidance to validate a refining process
                and selects a testing method as it pertains to the National
                Bioengineered Food Disclosure Standard (Standard).
                DATES: The guidance documents are available and effective July 7, 2020.
                ADDRESSES: The final guidance and accompanying question and answer
                documents can be found at https://www.ams.usda.gov/rules-regulations/be.
                FOR FURTHER INFORMATION CONTACT: Trevor Findley, Deputy Director, Food
                Disclosure and Labeling Division, Fair Trade Practices Program,
                Agricultural Marketing Service, U.S. Department of Agriculture,
                telephone (202) 690-3460, email [email protected].
                SUPPLEMENTARY INFORMATION:
                Background
                 On July 29, 2016, Public Law 114-216 amended the Agricultural
                Marketing Act of 1946 (7 U.S.C. 1621 et seq.) (amended Act) to require
                USDA to establish a national, mandatory standard for disclosing any
                food that is or may be bioengineered. In accordance with the amended
                Act, USDA published final regulations to implement the Standard on
                December 21, 2018 (83 FR 65814). The regulations became effective on
                February 19, 2019, with a mandatory compliance date of January 1, 2022.
                 Foods that do not contain detectable modified genetic material are
                not bioengineered foods and do not require disclosure under the
                Standard. Under the definition of bioengineered food at 7 CFR 66.1,
                food does not contain modified genetic material if the genetic material
                is not detectable pursuant to Sec. 66.9. The recordkeeping
                requirements for detectability at 7 CFR 66.9 specify, among other
                things, (1) the requirements to validate that a refining process
                renders modified genetic material in a food undetectable and (2)
                standards of performance for detectability testing.
                 A refining process is validated through analytical testing that
                meets the standards described in paragraph (c) of 7 CFR 66.9. Paragraph
                (c) requires that analytical testing meet the following standard: (1)
                Laboratory quality assurance must ensure the validity and reliability
                of test results; (2) analytical method selection, validation, and
                verification must ensure that the testing method used is appropriate
                (fit for purpose) and that the laboratory can successfully perform the
                testing; (3) the demonstration of testing validity must ensure
                consistent accurate analytical performance; and (4) method performance
                specifications must ensure analytical tests are sufficiently sensitive
                for the purposes of the detectability requirements of Part 66.
                 In the preamble to the final regulations, USDA indicated that it
                would provide instructions to the industry to explain how they can
                ensure (1) acceptable validation of refining processes in accordance
                with AMS standards and (2) acceptable testing methodology used to
                satisfy that a food does not contain detectable modified genetic
                material (83 FR 65843).
                 On December 17, 2019, AMS published a document in the Federal
                Register announcing the publication of a draft Instruction to Ensure
                Acceptable Validation of Refining Processes (84 FR 68816), with a
                comment period that closed on January 16, 2020. On January 23, 2020, in
                response to multiple requests for an extension of the comment period,
                AMS extended the comment period another 15 days (85 FR 3860). The new
                comment period closed on February 7, 2020.
                 On February 3, 2020, AMS published a document in the Federal
                Register announcing publication of Draft Instructions on Testing
                Methods (85 FR 5927), with a comment period that closed on March 4,
                2020.
                 This document announces the publication of the final guidance to
                validate a refining process and to select an acceptable testing method.
                In addition to these two guidance documents, AMS is publishing two
                corresponding question and answer documents that respond to a number of
                questions and comments it received during the public comment periods.
                These four documents are available on the AMS bioengineered food
                disclosure website at https://www.ams.usda.gov/rules-regulations/be.
                These final instructions pertain to the requirements of the existing
                regulations, which can be found at https://www.federalregister.gov/documents/2018/12/21/2018-27283/national-bioengineered-food-disclosure-standard.
                 Authority: 7 U.S.C. 1639.
                Bruce Summers,
                Administrator, Agricultural Marketing Service.
                [FR Doc. 2020-14643 Filed 7-7-20; 8:45 am]
                BILLING CODE P
                

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