NOTIFICATION

Addendum

The following communication, dated 15 July 2020, is being circulated at the request of the delegation of the United States of America.

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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).

The guidance documents are available and effective 7 July 2020.

Detectability Testing: The regulations implementing the National Bioengineered Food Disclosure Standard (the Standard) identify the requirements for detecting modified genetic material at 7 CFR 66.9. In the final rule (notified as _G/TBT/N/USA/1364/Add.2), AMS indicated it would provide industry stakeholders further instructions regarding:

(1) acceptable testing methodology used to satisfy that a food does not contain detectable modified genetic material and;

(2) validating a refining process. Instructions and Frequently Asked Questions (FAQs) can be found at the links below.

·        Guidance on Testing Methods (pdf)

·        FAQs on Testing Methods (pdf)

·        Guidance on Validation (pdf)

·        FAQs on Refining Process Validation (pdf)

https://www.govinfo.gov/content/pkg/FR-2020-07-08/html/2020-14643.htm

https://www.govinfo.gov/content/pkg/FR-2020-07-08/pdf/2020-14643.pdf

https://members.wto.org/crnattachments/2020/TBT/USA/20_4215_00_e.pdf