The U.S. Department of Agriculture (USDA) Agricultural Marketing Service (AMS) has issued final guidance to assist regulated entities in complying with the National Bioengineered Food Disclosure Standard (the Standard), including: Guidance to Ensure Acceptable Validation of a Refining Process, Guidance on Testing Methods and two frequently asked question (FAQ) documents pertaining to each final guidance document. A notice announcing the availability of the final guidance will be published soon in the Federal Register. The documents can be found on the AMS website at https://www.ams.usda.gov/rules-regulations/be/validation-process.
Both guidance documents and their respective FAQ documents can be used by regulated entities to establish protocols for complying with the Standard by the mandatory compliance date of January 1, 2022.
In the final rule establishing the Standard, AMS indicated it would provide instructions to validate a refining process as well as instructions regarding acceptable testing methodology used to satisfy that a food does not contain detectable modified genetic material. The final documents published today provide guidance that regulated entities can use to (1) ensure their validated process complies with 7 CFR 66.9(b) of the Standard and (2) ensure they select a testing method in compliance with 7 CFR 66.9(c) of the Standard.
Prior to publishing these final documents, AMS published notices in the Federal Register requesting comments on draft guidance to Validate a Refining Process and draft guidance on Testing Methods for the National Bioengineered Food Disclosure Standard, on December 17, 2019 and January 31, 2020, respectively. After careful review of all comments, AMS removed references to the Hazard Analysis Critical Control Point to clarify that the Standard is solely for marketing and not related to food safety, specified end-product testing options, clarified fit-for-purpose methods and added ISO standards for references. AMS is providing responses to comments it received in the FAQ documents that accompany the final guidance documents.
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