Following a court ruling, the USDA reverts to pre-2020 guidelines for biotechnology regulation, effective immediately.

The US Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) has reverted to its pre-2020 approach to biotechnology regulation after a court ruling found its 2020 rulemaking process deficient. The court struck down the updated program, known as the SECURE rule, which provided categorical exemptions for genetically engineered (GE) plants with modifications achievable by conventional breeding techniques. APHIS will resume issuing interstate movement permits for regulated articles and restart the “Am I Regulated?” inquiry process consistent with its prior regulatory framework. The court found APHIS’s 2020 rulemaking was “arbitrary and capricious” due to the agency’s failure to analyze potential weediness concerns and conflicting scientific evidence. The vacatur will “return the industry and GE-crop regulation to status quo ante.” Developers are advised to withdraw, revise, and resubmit pending permit applications and submit “Am I Regulated?” inquiries to determine if their GE organism meets the definition of a “regulated article.” APHIS will provide additional information on resuming the pre-2020 notification process in the coming weeks.