On May 14, 2020, USDA APHIS announced the availability of the Final Rule for its biotechnology regulations 7 CFR part 340. The APHIS’ revised biotechnology regulations is the first comprehensive revision of APHIS’ biotechnology regulations since they were established in 1987. The revisions enable APHIS to regulate organisms developed using genetic engineering for plant pest risk with greater precision, and reduces regulatory burden for developers of organisms that are unlikely to pose plant pest risks. Like the preexisting regulations, APHIS revised rule regulates the importation, interstate movement, and environmental release of certain organisms developed using genetic engineering that may pose a pest risk to plants. The rule revises the preexisting regulations to account for advances in genetic engineering and our understanding of the plant pest risk posed by organisms developed using genetic engineering. The revised rule represents a new approach for regulating organisms developed using genetic engineering. It establishes a clear, consistent, and risk-based regulatory framework for products developed using genetic engineering that provides regulatory relief and better focuses regulatory resources on potential areas of risk. Under the revised regulations, the biotechnology community can expect reduced regulatory burden and processes that allow us to more efficiently and effectively protect agriculture and foster technological advancement. It is APHIS’ goal to minimize regulatory burden and help you comply with the regulations. Consumers and the public can expect to see us continue to regulate organisms developed using genetic engineering in a manner that protects plant health and U.S. agriculture.

USDA’s Revised Biotechnology Regulations

ACS Fall 2021

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.