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USDA Solicits Comments on Instructions for Validation of Refining Processes for Bioengineered Food Disclosure Standard

The United States Department of Agriculture (USDA) Agricultural Marketing Service (AMS) announced today that it is soliciting comments on its draft instructions for validation of refining processes under the National Bioengineered Food Disclosure Standard rule (“the rule”). As previously covered on this blog, the rule was published on December 21, 2018, and requires entities to disclose any food that is or may be bioengineered.

Importantly, the rule’s definition of “bioengineered food” excludes foods where modified genetic material is not detectable and includes provisions for how regulated entities can use records to demonstrate that modified genetic material is not detectable, which would remove those foods from the requirement to disclose. Specifically, certain refining processes may render modified genetic material in a food undetectable, provided that the refining process is validated.

To ensure acceptable validation of refining processes, AMS has indicated that it will publish instructions to industry at https://www.ams.usda.gov/rules-regulations/be. We will continue to monitor the status of these instructions and will provide an update when they are published.

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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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