Just a few days before President-elect Donald Trump takes office, the Obama administration released a series of proposals to update and streamline the regulation of genetically engineered crops and animals, reported AgriPulse.
The U.S. Department of Agriculture (USDA) and the U.S. Food and Drug Administration (FDA) have published four documents related to the pre-market regulatory oversight of a variety of biology-based agricultural tools, including genetically engineered plants and plants and animals derived from certain newer precision breeding techniques, such as genome editing.
USDA’s Animal and Plant Health Inspection Service (APHIS) is proposing revisions to its biotechnology regulations (7 CFR 340). In its proposed rule, the USDA calls for regulating only certain plants that pose a plant pest or noxious weed risk, reports Politico. If made final, the rule could make it easier for crops produced with novel gene editing and other techniques to get to market, while potentially leading to greater oversight of other crops.
The U.S. Food and Drug Administration (FDA) also released:
- FDA Draft Revision to Guidance 187: The FDA’s Center for Veterinary Medicine (CVM) published a proposed document to expand the scope of its existing pre-market regulatory guidance for industry, proposing that the FDA require pre-market evaluation of genome-edited animals, effectively treating them the same as transgenic animals.
- FDA’s Plant-Focused Request for Information: The FDA’s Center for Food Safety and Applied Nutrition (CFSAN) and CVM are requesting information on whether plants created with the newer precision breeding techniques, such as genome editing, should follow the same pre-market regulatory review process at the FDA as transgenic plants currently do.
- FDA Regulation of Mosquito Products: This FDA draft guidance provides information regarding regulatory oversight of mosquito-related products; The FDA seeks to clarify circumstances under which such products are regulated by FDA as new animal drugs under the Federal Food, Drug, and Cosmetic Act and other circumstances under which such products are regulated by the Environmental Protection Agency (EPA) as pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
For more information, the FDA published a blogpost describing it actions. “FDA’s Science-based Approach to Genome Edited Products” was written by Robert M. Califf, M.D., FDA Commissioner, and Ritu Nalubola, Ph.D., Senior Policy Advisor, FDA’s Office of Policy.