- On December 2, 2024, the United States District Court for the Northern District of California vacated and remanded the Animal and Plant Health Inspection Service’s (APHIS or the Agency) final rule on regulating the movement of certain genetically engineered organisms (GE organisms). This ruling primarily affects GE plants but also includes other organisms that meet the definition of a plant pest, in the case of National Family Farm Coalition v. Vilsack.
- As we’ve previously blogged, the U.S. Department of Agriculture’s (USDA) APHIS, after nearly 15 years of multiple rulemaking proposals, published a Final Rule in 2020 for Part 340 of the Code of Federal Regulations (CFR). This rule regulates the “Movement of Certain Genetically Engineered Organisms” that may pose a plant pest risk under the authority of the Plant Protection Act of 2000. The act authorizes the Secretary of Agriculture, who has delegated authority to APHIS, to regulate plant pests and noxious weeds.
- Historically, APHIS regulated GE plants as “plant pests” if they were developed by inserting genes using plant pests as the vector, which covered most GE plants for many years. However, modern techniques enable genetic modifications without using plant pests, meaning GE plants may no longer fall under the scope of Part 340 as “plant pests.”
- In 2004, APHIS published a notice of intent to open public comment and begin an environmental impact study of potential changes to Section 340 to include the scope of the noxious-weed authority to regulate GE plants that may pose risks. In 2007, the Agency published a report titled “Lessons Learned and Revisions under Consideration for APHIS Biotechnology Framework.” Following this, the 2008 Farm Bill directed the USDA to update its regulations for GE organisms by addressing each issue the Agency identified in its 2007 report, leading to a new proposed rule.
- In the 2008 proposed rule, APHIS proposed incorporating its noxious-weed authority under the PPA (21 C.F.R. Part 360) into its Part 340 regulations. This change would allow APHIS to evaluate any noxious weed risks associated with GE plants. However, this proposed rule was withdrawn after extensive public comments were submitted.
- In 2017, similar to the 2008 rule, APHIS proposed another rule aiming to address the issues from the 2007 report about GE organisms, by again proposing to use its noxious-weed authority to assess GE plants. In the proposed rule, the Agency stated that the “current regulatory structure, which entails evaluating such plants solely for plant pest risk, is not sufficient to properly identify all risks that these plants present to other plants and plant products.” This rule was also withdrawn after extensive comments were submitted.
- Then, following another proposed rule published in 2019, APHIS issued its final rule in 2020, “Movement of Certain Genetically Engineered Organisms,” shifting the focus from the method used to create GE organisms to the traits of the GE organisms themselves. The 2020 rule exempts certain GE plants that could have been developed through conventional breeding and those unlikely to pose a plant pest risk, among other risk-based regulatory streamlining provisions. Furthermore, in the final rule, the Agency reversed its position and decided not to incorporate noxious-weed authority into Part 340 despite the 2008 and 2017 proposed rules.
- In National Family Farm Coalition v. Vilsack, the plaintiffs argued that the 2020 rule reduced federal oversight of GE plants without proper explanation. The Court found that APHIS had reversed its position from the administrative record on incorporating noxious-weed authority into its Part 340 regulations without explanation. Despite the Agency’s previous concerns documented in the administrative record related to the regulations’ insufficiency of only evaluating plant pest risk, the Court noted that “the final rule does not address a single one of these issues.” Thus, the Court deemed this change arbitrary and capricious in violation of the Administrative Procedure Act (APA), which requires agencies to provide a rationale when changing their policy positions.
- We note that the Court undertook a Loper analysis and found that APHIS had not exceeded its statutory authority in promulgating the regulation – rather, the regulation was vacated under the APA under a standard arbitrary and capricious analysis.
- Following the court ruling, APHIS is reverting to the pre-May 2020 regulatory framework by re-establishing pathways for authorizing regulated activities, commercializing products, and providing compliance oversight. APHIS will also restart the “Am I Regulated” process, allowing stakeholders to inquire if their GE organisms meet the definition of a regulated article. APHIS will resume issuing permits under the 2019 framework and will provide further guidance on the notification process in the coming weeks.
© 2025 Keller and Heckman LLP
National Law Review, Volume XV, Number 3