National Bioengineered Food Disclosure Standard; Validation of Refining Processes

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 []
[FR Doc No: 2019-26911]
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.
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 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
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].
    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 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
    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]