This week the United States District Court for the Northern District of California vacated the U.S. Department of Agricuture's final rule issued in May 2020 for organisms developed using genetic engineering. The court sided with the National Family Farmers Coalition and other plaintiffs, ruling that USDA's Animal & Plant Health Inspection Service (APHIS) made “significant errors” when it did not incorporate its noxious-weed authority in the final rule and implemented conventional breeding exemptions.

In his decision, U.S. District Judge James Donato writes, “For over a decade it [APHIS] believed it should incorporate its noxious-weed authority into its Part 340 regulations due to specific concerns APHIS itself identified. The final rule does the opposite without so much as a mention of the concerns identified in the prior NPRMs [Notice of Proposed Rulemaking]. This is not an error of a ‘technical nature.’ The error undergirding the conventional-breeding exemption is also substantial, for the rule ignores scientific evidence suggesting that its premise is without scientific basis.”

Since the rule took effect in 2020, at least 99 genetically engineered (GE) plants have been exempted.

The court noted in the last four years, the national agricultural economy has been rapidly developing. The GE organisms that have been introduced or moved without a permit under the final rule would have had to meet much more stringent requirements under the pre-2020 regime. That said, the court stated that the "egg has been scrambled,” and retroactive vacatur “seems an invitation to chaos.”

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Prior to 2020, APHIS assessed the plant pest risk of each plant transformation event separately, even though the inserted genetic material may have been identical or very similar to transformation events already assessed. Under the revised regulations, developers have the option of requesting a permit or a regulatory status review of a plant developed using genetic engineering that has not been previously evaluated and determined to be nonregulated.

When USDA announced the final rule four years ago, it emphasized the process would be more efficient in identifying plants that would be subject to regulation, focusing on the properties of the plant rather than on its method of production. 

APHIS contends this week’s decision to vacate “would jeopardize the agency’s regulatory work ... and require a disruptive switch back to the prior regulatory framework after years of reliance on the new one.” However, the court noted APHIS did not point to anything in the record indicating that “ostensible disruption” would outweigh the “seriousness of the rule’s flaws.”

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The final rule has now been returned to APHIS for reconsideration consistent with the court order.

APHIS stated it is determining next steps and will provide guidance to stakeholders in the coming days, including on the status of the notice, Movement of Organisms Modified or Produced Through Genetic Engineering; Notice of Additional Modifications Exempt Plans Can Contain, 89 Fed. Reg. 89569 (Nov. 13, 2024). Regulatory status review responses, confirmation request responses and active permits that USDA issued prior to Dec. 2, 2024, remain valid.