[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