National Bioengineered Food Disclosure Standard; Validation of Refining Processes

Published date17 December 2019
Citation84 FR 68816
Record Number2019-26911
SectionProposed rules
CourtAgricultural Marketing Service
Federal Register, Volume 84 Issue 242 (Tuesday, December 17, 2019)
[Federal Register Volume 84, Number 242 (Tuesday, December 17, 2019)]
                [Proposed Rules]
                [Pages 68816-68817]
                From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
                [FR Doc No: 2019-26911]
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                DEPARTMENT OF AGRICULTURE
                Agricultural Marketing Service
                7 CFR Part 66
                [Document No. AMS-FTPP-19-0104]
                National Bioengineered Food Disclosure Standard; Validation of
                Refining Processes
                ACTION: Request for comments.
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                SUMMARY: The Agricultural Marketing Service (AMS) of the Department of
                Agriculture (USDA) is soliciting comments and feedback on draft
                instructions for validation of refining processes as it pertains to the
                National Bioengineered Food Disclosure Standard (Standard).
                DATES: Comments are due by January 16, 2020.
                ADDRESSES: We invite you to submit written comments via the internet at
                http://www.regulations.gov. All comments should refer to the date and
                page number of this issue of the Federal Register. All comments
                submitted in response to this notice, including the identity of
                individuals or entities submitting comments, will be made available to
                the public on the internet via http://www.regulations.gov.
                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 65843). 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 the requirements
                for validating that a
                [[Page 68817]]
                refining process renders modified genetic material in a food
                undetectable. 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 this part.
                 In the preamble to the final regulations, USDA indicated it would
                provide instructions to the industry to explain how they can ensure
                acceptable validation of refining processes in accordance with AMS
                standards (83 FR 65843). A draft of those instructions is now available
                on the AMS bioengineered food disclosure website at https://www.ams.usda.gov/rules-regulations/be. With this notice, AMS is seeking
                comments on these draft instructions. USDA will provide further
                instructions on testing method selection at a later date. At this time,
                we are only seeking feedback on the validation instructions referenced
                in this notice. Any comments not directly related to these draft
                instructions will not be considered.
                 After reviewing the comments on these draft instructions, AMS will
                publish final instructions on its website. The final instructions will
                be maintained and available on the AMS website. 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.
                 Dated: December 10, 2019.
                Bruce Summers,
                Administrator, Agricultural Marketing Service.
                [FR Doc. 2019-26911 Filed 12-16-19; 8:45 am]
                 BILLING CODE 3410-02-P
                

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