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USDA Posts FAQ regarding BE Labeling and Promises Future Guidance

  • The U.S. Department of Agriculture’s Agricultural Marketing Service (AMS) has issued an FAQ for manufacturers concerning its bioengineered (BE) food labeling rule (formally known as the National Bioengineered Food Disclosure Standard (NBFDS)).  The final rule was issued in December 2018 and does not come into effect for several years, but questions are being raised by industry regarding its obligations under the rule.

  • For example, BE labeling is not required if you are processing food using a “validated refining process” or when the food is tested to confirm that genetically modified material is not present.  However, there is little information in the regulations as to what constitutes a validated refining process and what testing would be acceptable to demonstrate that genetically modified material is present or absent in a food.  The FAQ itself is not very helpful in answering these questions; for example, it states, “AMS does not specify which tests must be used, but we provide standards of performance regarding detectability testing methodology.”  That said, it does state that the agency will be providing industry with future guidance on these issues.

  • The FAQ addresses questions ranging from record keeping to how to determine whether BE material is present as a result of inadvertent contamination, which largely tracks information previously provided in the 63-page preamble to the final rule and the regulations themselves.  We have a summary of the NBFDS available here.

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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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