Biotechnology Regulatory Services
On Dec. 2, 2024, the United States District Court for the Northern District of California, vacated the U.S. Department of Agriculture (USDA) final rule (7 CFR part 340) issued in May 2020 for organisms developed using genetic engineering. Regulatory Status Review responses, Confirmation Request responses, and active permits that USDA issued prior to Dec. 2, 2024, remain valid. APHIS is determining next steps and will provide additional guidance to stakeholders.
Biotechnology Regulatory Services helps American agriculture stay at the forefront of science and innovation. From row crops that better tolerate environmental stresses to vegetable and oil crops that produce healthier foods, people develop new products every day using genetic engineering. We work alongside other Federal agencies to make sure these products are safe for U.S. agriculture and the environment.
Priorities
We regulate the importation, interstate movement, or environmental release of certain organisms developed using genetic engineering that may pose a plant pest risk. Learn more about permitting requirements and our regulatory process.
Developers have the option of requesting a permit, a regulatory status review, or both of a plant developed using genetic engineering that has not been previously evaluated and determined to be nonregulated.
BRS reinstated the Am I Regulated process. Developers may submit an Am I Regulated inquiry to learn whether their modified organism is regulated under 7 CFR 340 (2019) before applying for an authorization (permit or notification).
Please note that the regulations enabling the Exemptions and Confirmations process were vacated on December 2, 2024, by a court order. Responses to confirmation requests issued before December 2, 2024, remain valid.
We have a comprehensive system to help ensure that biotechnology organizations are maintaining compliance with APHIS’ biotechnology regulations.
