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Volume X, Number 221

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August 06, 2020

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USDA Publishes Final BE Guidance Documents On Validation and Detectability Testing

The USDA’s Agricultural Marketing Service (AMS) issued final guidance to assist regulated entities in complying with the National Bioengineered Food Disclosure Standard (NBFDS). By the mandatory compliance date of January 1, 2022, regulated entities will need to disclose whether food offered for retail sale is bioengineered (BE) or contains BE ingredients. The final guidance discusses two possible ways entities can show their products do not contain BE material and thus avoid disclosure: (1) verifying that the food has been subjected to a refinement process validated to make the modified genetic material in the food undetectable (7 CFR 66.9(b)), and (2) utilizing acceptable testing methods to confirm the absence of modified genetic material (7 CFR 66.9(c)).

The Guidance to Ensure Acceptable Validation of a Refining Processoutlines eight general steps: (1) identify raw materials, ingredients, and product-contact materials; (2) define characteristics and intended use of end product; (3) define the sequence and interaction of all processing steps used to arrive at the end product; (4) identify key step(s) in the refinement process that may influence the end product’s characteristics and its ability to meet specified requirements; (5) assemble relevant validation information that demonstrates the refinement process operates as intended to meet specified requirements (end product characteristics), conducting studies as needed; (6) continually verify the refinement process is operating as validated; (7) revalidate the refinement process, as applicable, if significant changes are made to the process; and (8) maintain record(s) of the validation and ongoing verification.

As our readers may recall, we previously covered the draft instructions for acceptable testing methods to confirm the absence of detectable modified genetic material. The final Guidance on Testing Methods is largely similar, and addresses five main topics: (1) general considerations in selecting a test method; (2) DNA-based methods; (3) emerging technologies and other methods; (4) general considerations in selecting a laboratory; and (5) recordkeeping requirements.

© 2020 Keller and Heckman LLPNational Law Review, Volume X, Number 190

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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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