The SCRA hosted a webinar to discuss the new APHIS Biotechnology Regulations announced in May 2020. The webinar took place 17 September 2020.
Bernadette Juarez, APHIS Deputy Administrator, Biotechnology Regulatory Services, USDA
Subray Hegde, Director, Biotechnology Risk Analysis Programs, APHIS BRS, USDA APHIS
On May 14, 2020, USDA APHIS announced the availability of the Final Rule for its biotechnology regulations 7 CFR part 340. The SECURE rule, which stands for Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient, 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’ SECURE 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 SECURE 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 SECURE 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 regulation, 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.
For more information please visit the USDA-APHIS website.