The U.S. Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) announced an abrupt reversion to its pre-2020 approach to biotechnology regulation on December 19, in the wake of a December 2 ruling by the U.S. District Court for the Northern District of California finding APHIS’s rulemaking process deficient and striking down the updated program immediately. Because of the Court’s vacatur, APHIS set aside its categorical exemptions for genetically engineered (GE) plants with modifications that are also achievable by conventional breeding techniques – a cornerstone of the 2020 updates that were put in place under the first Trump administration and are known as the SECURE rule (shorthand for the Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient rule). It will resume issuing interstate movement permits for regulated articles and restart the agency’s “Am I Regulated?” inquiry process consistent with its prior regulatory framework. Consistent with historic practice, APHIS will presumably soon begin accepting new petitions for determinations of non-regulated status, as well.

According to the Court’s ruling, APHIS’s 2020 rulemaking was “arbitrary and capricious” under the Administrative Procedure Act (APA) because the agency dismissed concerns about the potential weediness of GE plants without sound analysis, even though APHIS had consistently identified those same concerns over its nearly 15 years of prior attempts to update these regulations. In addition, the Court found the agency’s failure to analyze conflicting scientific evidence around the basis for the conventional-breeding exemption was arbitrary and capricious, as well.

Characterizing APHIS’s errors as “significant,” the Court vacated the 2020 rule as of the date of its order. However, the Court declined to apply the vacatur retroactively, mindful that at least 99 new GE plants have already been exempted under the updated program. Immediately following the Court’s decision, APHIS expressly confirmed that all Regulatory Status Review responses, Confirmation Request responses, and active permits issued before December 2, 2024, remain valid. The Court separately directed APHIS and the public interest group plaintiffs to file a joint statement by January 13, 2025, addressing what effect, if any, the ruling should have on two additional exemptions finalized by APHIS under the now-vacated rules just a few weeks ago. It also directed the parties to jointly propose a date for a status conference about the remaining aspects of the plaintiffs’ challenges under the Endangered Species Act and the National Environmental Policy Act.

When promulgating its revisions in 2020, APHIS highlighted its intent to reduce the regulatory burden for developers of organisms that are unlikely to pose plant pest risks. Citing evidence that genetically engineering a plant with a plant pest as a vector, vector agent, or donor does not result in a GE plant that presents a plant pest risk, APHIS sought to provide a “clear, predictable, and efficient” regulatory pathway for innovators to replace the “regulate first, analyze later” approach under which it had operated for the previous three decades.

Upending these aims, the Court’s ruling disrupts a regulatory process that has been relied upon for more than four years. While existing exemptions may not be impacted, developers should carefully evaluate if and how the adjustment back to pre-2020 rules and definitions may impact pending matters and future activities. According to the Court, the vacatur will “return the industry and GE-crop regulation to status quo ante.” Contending with this old-new reality, APHIS’s December 19 announcement encourages developers to withdraw, revise, and resubmit any pending permit applications to align with the criteria of the prior rules. Developers unsure if their GE organism meets the definition of a “regulated article” are further advised to submit an “Am I Regulated?” inquiry. APHIS also indicates that additional information on resuming the pre-2020 notification process will be provided in the coming weeks.