On June 16, 2025, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) issued a final rule making technical amendments to the Code of Federal Regulations (C.F.R.) to conform the C.F.R. to the U.S. District Court for the Northern District of California’s vacatur of USDA’s May 2020 final rule for organisms developed using genetic engineering. 90 Fed. Reg. 25123. The rule was effective June 16, 2025.
As reported in our May 18, 2020, memorandum, the final Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient (SECURE) rule amended the regulations regarding the movement (importation, interstate movement, and environmental release) of certain genetically engineered organisms in response to advances in genetic engineering and APHIS’ understanding of the plant pest risk posed by genetically engineered organisms, thereby reducing the regulatory burden for developers of organisms that are unlikely to pose plant pest risks. Conservation and farm groups filed suit under the Administrative Procedure Act (APA), claiming that, in promulgating the final rule, USDA failed to heed procedural requirements under the Endangered Species Act (ESA) and the National Environmental Policy Act (NEPA). Plaintiffs also alleged that the final rule failed to implement directives set forth in the 2008 Farm Bill and that the rule violated the Plant Protection Act (PPA). In addition, plaintiffs stated that portions of the final rule relating to the exemptions unconstitutionally delegated statutory authority to private parties without Congress’s express authorization.
The court granted summary judgment to plaintiffs on the PPA-based APA claim that it was arbitrary and capricious for APHIS not to incorporate its noxious-weed authority in the final rule and to implement the conventional-breeding exemptions. The court granted summary judgment to USDA on plaintiffs’ sub-delegation claim and 2008 Farm Bill-based APA claim. The court vacated the final rule and remanded it to APHIS for reconsideration consistent with the court’s order.
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