[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