National Bioengineered Food Disclosure Standard; Guidance on Validation of a Refining Process and Selecting a Testing Method, 40867 [2020-14643]

Download as PDF 40867 Rules and Regulations Federal Register Vol. 85, No. 131 Wednesday, July 8, 2020 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. DEPARTMENT OF AGRICULTURE 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. 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 trevor.findley@usda.gov. SUPPLEMENTARY INFORMATION: SUMMARY: jbell on DSKJLSW7X2PROD with RULES 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 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 VerDate Sep<11>2014 15:59 Jul 07, 2020 Jkt 250001 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 § 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, 2020. PO 00000 Frm 00001 Fmt 4700 Sfmt 4700 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/nationalbioengineered-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] BILLING CODE P DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 930 [Doc. No. AMS–SC–19–0100; SC–20–930–1 FR] Tart Cherries Grown in the States of Michigan, et al.; Free and Restricted Percentages for the 2019–20 Crop Year Agricultural Marketing Service, USDA. ACTION: Final rule. AGENCY: This rule implements a recommendation from the Cherry Industry Administrative Board (Board) to establish free and restricted percentages for the 2019–20 crop year pursuant to the marketing order for tart cherries grown in the states of Michigan, New York, Pennsylvania, Oregon, Utah, Washington, and Wisconsin. This action establishes the proportion of tart cherries from the 2019–20 crop that may be handled in commercial outlets. This action should stabilize marketing conditions by adjusting supply to meet market demand and help improve grower returns. Also, a correction is made to section 930.151 to reflect the correct desirable carry-out inventory not SUMMARY: E:\FR\FM\08JYR1.SGM 08JYR1

Agencies

[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]]



DEPARTMENT OF AGRICULTURE

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].

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 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, 
2020.
    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]
BILLING CODE P