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- FDA Considers Application For Genetically ... - Covington & Burling
Get FDA Considers Application For Genetically ... - Covington & Burling
S AquAdvantage salmon. This is the first time FDA is considering an application for a genetically engineered ( GE ) animal intended for use as a food. FDA regulates GE animals differently than it regulates GE plants. While GE plants for food use are reviewed informally under the generally recognized as safe rubric, the DNA of a genetically-modified animal is treated as a new animal drug requiring affirmative approval by FDA s Center for Veterinary Medicine (CVM). FDA conduct.
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Cvm FAQ
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2017 Update to the Coordinated Framework A sequel to the 1986 CF and the 1992 Update to the CF, it clarifies the current roles and responsibilities of the primary agencies involved in the regulation of biotechnology products. It describes the types of biotechnology product areas regulated by EPA, FDA and USDA.
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The Coordinated Framework for Regulation of Biotechnology, proposed in 1984 by the White House Office of Science and Technology Policy and finalized in 1986, spells out the basic federal policy for regulating the development and introduction of products derived from biotechnology.
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The U.S. Coordinated Framework for Biotechnology Products outlines a comprehensive Federal regulatory policy for ensuring the safety of biotechnology products.
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On June 26, 1986, the White House Office of Science and Technology Policy (OSTP) issued the Coordinated Framework for the Regulation of Biotechnology (the 1986 Coordinated Framework), which outlined a comprehensive Federal regulatory policy for ensuring the safety of biotechnology products.
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The USDA oversees over meat, poultry, and egg products. However, the majority of the food supply (80% or more) is regulated by FDA. FDA is responsible for dairy, seafood, produce, packaged foods, bottled water, and whole eggs.
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The FDA regulates plant and animal biotechnology products in coordination with the U.S. Department of Agriculture (USDA) and U.S. Environmental Protection Agency (EPA), consistent with the U.S. Coordinated Framework for the Regulation of Biotechnology.
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