Am I Regulated?
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.
The Plant Protection Act (PPA) authorizes the Animal and Plant Health Inspection Service (APHIS) to protect plant health in the United States. Under that authority, APHIS Biotechnology Regulatory Services (BRS) provides the regulatory oversight of certain genetically modified organisms to protect plant health, by regulating the introduction—importation, interstate movement, and environmental release—of those modified organisms that may pose a pest risk to plants under the regulations at 7 CFR part 340. The definition of a regulated article is found at 7 CFR § 340.1.
If your modified organism meets the definition of a regulated article and you plan to import it, move it interstate or release it into the environment, you will need to apply for an authorization (permit or notification) before proceeding with the activity.
If you are unsure whether your modified organism meets the definition of a regulated article as described in 7 CFR part 340 (2019), prior to proceeding with an introduction, you may submit an Am I Regulated inquiry to learn whether your modified organism is regulated before applying for an authorization.