On December 2, 2024, the United States District Court of the Northern District of California vacated the U.S. Department of Agriculture (USDA) SECURE Rule, which was finalized in 2020 as an update that enabled the Animal and Plant Health Inspection Service (APHIS) to provide regulatory guidance for gene-edited crops. The SECURE Rule was adopted after more than fifteen years of proposals, stakeholder input, and interagency discussions. More than 200 biotech crops have gone through APHIS’s Biotechnology Regulatory Service’s SECURE-defined process over the past four years. The vacatur of the rule is not retroactive, so those crops already reviewed by APHIS need not be reviewed again; however, moving forward, the process for biotech crop approval reverts to how it functioned in 2019.
Prior to 2020, biotech plants containing plant pest DNA, which include most crops created using older technologies, needed USDA permits, along with any relevant permits from the Environmental Protection Agency (EPA), even when there was little or no expected risk to plants, people, or the environment. The permitting process for these plants was extremely cumbersome and expensive, so only the largest companies working on the biggest commodities, like corn and soy, had the resources to apply. Academic researchers and small companies often left groundbreaking ideas on the shelf because the return on investment would not cover the costs associated with the pre-2020 regulatory process. Meanwhile, crops with no plant pest DNA, for example those created using gene editing whether or not they contained transgenes, were not overseen by USDA, regardless of their risk profile.
The SECURE Rule changed USDA’s approach from regulating the presence of plant pest DNA, which effectively targets the process by which the biotech crop was created, to regulating the product itself. APHIS established a process to review whether a biotech crop would pose a “plant pest risk,” which is the legislative basis for its ability to review biotech crops at all. In addition, APHIS posted a list of automatic exemptions from regulation, such as biotech crops that were indistinguishable from those created through conventional breeding. The SECURE Rule, therefore, lessened the regulatory burden for transgenic crops made with older technologies while also tightening oversight of any gene-edited crops that did not meet exemption criteria. The SECURE Rule was widely praised by academic and industry scientists for its focus on risk.
Directly after the finalization of the SECURE Rule in 2020, anti-GMO activist groups, including the Center for Food Safety, filed a lawsuit against USDA, claiming that APHIS acted “arbitrarily and capriciously” in exempting biotech plant varieties that were indistinguishable from conventionally bred versions. The groups also claimed that APHIS should have incorporated into its rule not only its plant pest risk authority but also its mandate to regulate “noxious weeds.” The Court agreed, saying that APHIS should have better explained its decisions in both respects.
What USDA chooses to do next will likely be left to the political appointees of the incoming Trump Administration. Campaign rhetoric featured open hostility towards regulations in general, so spending resources on an appeal to defend a regulation or to create a new one may not be a priority.
At this point, USDA’s simplest and least risky course of action would be to make a statement that its process for regulating GM crops will revert to its pre-SECURE Rule standard and that, therefore, gene-edited crops would, by court order, no longer be subject to regulation. This is likely not the result the Court intended – the Court seemingly believed the plaintiff’s erroneous claim that by vacating the rule, USDA would return to a process that oversees gene-edited crops; but, in fact, that was not and now is not the case. The Court’s misconception of how USDA regulated gene-edited crops before 2020 reflects poorly on the Department of Justice’s ability to communicate important information about APHIS’s role and process.
Curious if your modified plant would be regulated under the pre-SECURE Rule standard? In general, biotech plants that contain plant pest DNA, for example those made using Agrobacteria, regardless of their risk profile, will once again require APHIS permits. For more information, check out APHIS’s list of “Am I Regulated?” inquiry letters and responses from before the SECURE Rule went into effect. APHIS responses explain why gene-edited crops, regardless of whether they include transgenes or multiple edits, are not subject to regulation, though they may be subject to USDA’s Plant Protection and Quarantine (PPQ) permit and/or quarantine requirements. Biotech crops may also still be subject to regulations still in place at EPA or the Food and Drug Administration (FDA). You can learn more at USDA’s Unified Website for Biotechnology Regulation.
