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November 20, 2017

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USDA Publishes Proposed Rule to Revamp Its Biotechnology Regulations

  • For decades, the United States government has regulated genetically modified organisms (GMOs) under a regulatory framework called the “Coordinated Framework for the Regulation of Biotechnology” (Coordinated Framework).  The Coordinated Framework explains the different roles played by the three major agencies involved in the regulation of GMOs:

    • The Food and Drug Administration (FDA) regulates GMOs under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and ensures the safety and proper labeling of GMO-derived foods and feed.

    • The Environmental Protection Agency (EPA) regulates plant-incorporated protectants (PIPs) — a type of pesticide that is bioengineered into crops — under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and sets tolerance limits or exemptions from tolerance for pesticide residues on or in food and animal feed.  EPA also regulates certain biological control organisms under the Toxic Control Substances Act (TSCA).

    • The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) regulates GMOs under the Plant Pest Act.  APHIS reviews GM crops to determine whether they meet the definition of a “plant pest” and may pose risks to domestic agriculture.

  • On January 19, 2017, APHIS published proposed revisions to its biotechnology regulations (82 FR 7008).  The proposed rule seeks to update the regulations in a number of areas, all within the Agency’s current statutory authority under the Plant Protection Act.

  • In particular, APHIS is proposing a regulatory program in which it first assesses GE organisms to determine if they pose plant pest or noxious weed risks. If APHIS concludes that a GE organism does not pose a plant pest or noxious weed risk, then APHIS would not require a permit for the importation, interstate movement, and environmental release (outdoor use) of the GE organism. If, on the other hand, the Agency determines based on risk analysis that controls on movement are needed, APHIS would require a permit and work with the regulated entity to establish appropriate permit conditions to manage identified risks to allow safe movement (i.e., import, interstate movement, or environmental release (regulated controlled outdoor use such as in field trials)).

  • In crafting the proposed rule, APHIS considered comments received during public scoping and comment periods related to withdrawal of its 2008 proposed rule, as well as comments relative to a March 2016 notice of intent to conduct a programmatic environmental impact statement, recommendations made in two Office of the Inspector General audits, recent advances in biotechnology, provisions in the 2008 Farm Bill, and the Agency’s accumulated experience in implementing the current regulations. Should the rule proposed on January 19, 2017 ultimately become law, this would be the first comprehensive revision of the regulations since they were established in 1987.

  • APHIS will be accepting public comments through May 19, 2017.  Once the public comment period closes, APHIS will then determine how or whether to finalize the proposed rule based on its evaluation of public comments to the proposed revisions.

© 2017 Keller and Heckman LLP

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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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