USDA and FDA Issue Proposals to Regulate Genome Edited Plants, Animals, and Microorganisms
Today, January 19, 2017, FDA and USDA published a flurry of new policy documents related to the agencies’ regulation of plants, animals, and microorganisms produced using new breeding methods, like gene editing.
In response to advances in genetic engineering, USDA’s Animal and Plant Health Inspection Service issued a proposed rule, "Importation, Interstate Movement, and Environmental Release of Certain Genetically Engineered Organisms,” updating its regulation of genetically engineered organisms that may pose plant pest or noxious weed risks. APHIS will be accepting comments on the proposed rule through May 19.
Simultaneously, FDA’s Center for Veterinary Medicine released three documents describing its approach to regulating certain new products, including:
- Revised draft guidance titled, “Regulation of Intentionally Altered Genomic DNA in Animals;”
- Draft guidance titled, “Regulation of Mosquito-Related Products;” and
- A Federal Register notice requesting comments and scientific evidence on a wide variety of issues related to genome editing in new plant varieties used for human and animal food.
These new proposals are part of the larger effort, initiated in 2015 by the White House Office of Science and Technology Policy, to clarify the roles of the agencies with primary responsibility for regulating products of biotechnology, and follow the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology, issued by OSTP earlier this month.
Arent Fox is currently reviewing the proposed regulation and guidance documents, and will continue to actively monitor developments related to the regulation of products of new breeding techniques. If you would like more information on this or related matters, please contact Karen Carr, Stan Abramson, Donald McLean, Emily M. Leongini, or the Arent Fox attorney who regularly handles your matters.