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Release by FDA, USDA, and EPA of New Joint Website on Biotechnology Regulation

The U.S. Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), and the Environmental Protection Agency (EPA) launched a Unified Website for Biotechnology Regulation on January 9, 2020.  According to the FDA News Release, this new website is part of President Donald J. Trump’s Executive Order on Modernizing the Regulatory Framework for Agricultural Biotechnology Products (“EO”) and its release was timed in recognition of January 2020 as National Biotechnology Month.

FDA currently has jurisdiction over the safety of most foods for humans and animals, including those produced using biotechnology; the safety and effectiveness of intentional genomic alterations in animals produced using biotechnology; and the safety and effectiveness of human and animal drugs and the safety, purity, and potency of human biologics, including drugs and human biologics from plants and animals produced using biotechnology.  We have reported on previous FDA and USDA responses pledging that ongoing biotechnology efforts at each Agency would continue in support of the EO for modernizing the regulatory framework for agricultural biotechnology products, and on FDA’s holding firm against claims of “undue regulation” and a call released by the pork industry soon after the release of the EO for shifting regulatory oversight of genetically engineered (GE) animals to USDA.

The new joint biotechnology website does not alter the existing federal review process for biotechnology products.  It seems that the website will serve mainly as a useful repository of links to background documents and the biotechnology programs at each agency.  The website also contains responses to a long list of “Frequently Asked Questions” and has a “Contact Us” feature that will allow users to submit additional questions to the three agencies.

© 2020 Keller and Heckman LLPNational Law Review, Volume X, Number 13

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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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