[Federal Register Volume 85, Number 131 (Wednesday, July 8, 2020)]
[Rules and Regulations]
[Page 40867]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-14643]

Rules and Regulations
                                                Federal Register

This section of the FEDERAL REGISTER contains regulatory documents 
having general applicability and legal effect, most of which are keyed 
to and codified in the Code of Federal Regulations, which is published 
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents. 


Federal Register / Vol. 85, No. 131 / Wednesday, July 8, 2020 / Rules 
and Regulations

[[Page 40867]]


Agricultural Marketing Service

7 CFR Part 66

[Document No. AMS-FTPP-19-0104]

National Bioengineered Food Disclosure Standard; Guidance on 
Validation of a Refining Process and Selecting a Testing Method

ACTION: Notification of guidance.


SUMMARY: The Agricultural Marketing Service (AMS) of the Department of 
Agriculture (USDA) posts final guidance to validate a refining process 
and selects a testing method as it pertains to the National 
Bioengineered Food Disclosure Standard (Standard).

DATES: The guidance documents are available and effective July 7, 2020.

ADDRESSES: The final guidance and accompanying question and answer 
documents can be found at https://www.ams.usda.gov/rules-regulations/be.

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 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, among other 
things, (1) the requirements to validate that a refining process 
renders modified genetic material in a food undetectable and (2) 
standards of performance for detectability testing.
    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 Part 66.
    In the preamble to the final regulations, USDA indicated that it 
would provide instructions to the industry to explain how they can 
ensure (1) acceptable validation of refining processes in accordance 
with AMS standards and (2) acceptable testing methodology used to 
satisfy that a food does not contain detectable modified genetic 
material (83 FR 65843).
    On December 17, 2019, AMS published a document in the Federal 
Register announcing the publication of a draft Instruction to Ensure 
Acceptable Validation of Refining Processes (84 FR 68816), with a 
comment period that closed on January 16, 2020. On January 23, 2020, in 
response to multiple requests for an extension of the comment period, 
AMS extended the comment period another 15 days (85 FR 3860). The new 
comment period closed on February 7, 2020.
    On February 3, 2020, AMS published a document in the Federal 
Register announcing publication of Draft Instructions on Testing 
Methods (85 FR 5927), with a comment period that closed on March 4, 
    This document announces the publication of the final guidance to 
validate a refining process and to select an acceptable testing method. 
In addition to these two guidance documents, AMS is publishing two 
corresponding question and answer documents that respond to a number of 
questions and comments it received during the public comment periods. 
These four documents are available on the AMS bioengineered food 
disclosure website at https://www.ams.usda.gov/rules-regulations/be. 
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.

Bruce Summers,
Administrator, Agricultural Marketing Service.
[FR Doc. 2020-14643 Filed 7-7-20; 8:45 am]