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Volume XII, Number 231

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FDA Webinar on Genome-Edited Animals for Food Use

On June 27, 2022, FDA’s Center for Veterinary Medicine (CVM) announced that it had published a pre-recorded animal biotechnology case study webinar. The webinar addresses the agency’s risk-based review process for intentional genomic alterations (IGAs) in animals that may pose a low risk.

As previously reported, on March 7, 2022, FDA announced its first low-risk determination for the marketing of products from genome-edited beef cattle and their offspring, following a safety review. CVM’s webinar uses this evaluation as a case study to provide insight into how the agency reached its determination that the IGA did not raise any safety concerns.

By way of background, IGAs in animals are changes to an animal’s genomic DNA that are produced using modern molecular technologies, such as random or targeted DNA sequence changes. The intended uses for IGAs in animals include applications in human health (e.g., reducing allergenicity), improved animal health (e.g., disease resistance), and enhanced production of food quality (e.g., feed efficiency).  FDA’s draft guidance notes that FDA will exercise enforcement discretion where it determines that alterations present a low risk of harm.

CVM will accept feedback and questions regarding the webinar at [email protected]. Additional resources on IGAs can be found here.

 

© 2022 Keller and Heckman LLPNational Law Review, Volume XII, Number 182
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About this Author

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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