USDA Agricultural Marketing Service (AMS) has issued final guidance to assist regulated entities in complying with the National Bioengineered Food Disclosure 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.
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 provide guidance that regulated entities can use to ensure their validated process and testing method complies with 7 CFR 66.9(c) of the Standard.
After review of all comments received on the draft guidance, AMS: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.
- Added ISO standards for references.
AMS also provides responses to comments it received in the FAQ documents that accompany the final guidance documents. For more information visit https://www.ams.usda.gov/rules-regulations/be.