National Bioengineered Food Disclosure Standard; Draft Instructions on Testing Methods

• Published date: 03 February 2020
• Citation: 85 FR 5927
• Record Number: 2020-01906
• Section: Notices
• Court: Agricultural Marketing Service

Federal Register, Volume 85 Issue 22 (Monday, February 3, 2020)

[Federal Register Volume 85, Number 22 (Monday, February 3, 2020)]
                [Notices]
                [Pages 5927-5928]
                From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
                [FR Doc No: 2020-01906]
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                DEPARTMENT OF AGRICULTURE
                Agricultural Marketing Service
                [Document No. AMS-FTPP-19-0112]
                National Bioengineered Food Disclosure Standard; Draft
                Instructions on Testing Methods
                ACTION: Notice and 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 on testing methods as it pertains to the National
                Bioengineered Food Disclosure Standard (Standard).
                DATES: Comments are due by March 4, 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
                [[Page 5928]]
                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 the standards of
                performance for detectability testing. Paragraph (c) of 7 CFR 66.9
                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 that it
                would provide instructions regarding acceptable testing methodology
                used to satisfy that a food does not contain detectable modified
                genetic material. 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 previously provided an opportunity to comment on draft
                instructions to validate a refining process. At this time, we are only
                seeking feedback on the instructions on testing methods 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: January 28, 2020.
                Bruce Summers,
                Administrator, Agricultural Marketing Service.
                [FR Doc. 2020-01906 Filed 1-31-20; 8:45 am]
                 BILLING CODE 3410-02-P