Can Sidestepping NEPA "Unleash Innovation" at USDA?

The U.S. Department of Agriculture (USDA) first started regulating genetically modified plants in 1987. In the decades to follow, new breakthroughs like CRISPR gene editing technology have made it easier for plant breeders to find and tweak traits that make plants more productive, better tasting, and more likely to survive until harvest. In addition to delivering these benefits, biotech crops have been proven safe over and over again, and, in some cases, are even indistinguishable from their conventionally bred counterparts. As the pace of biotechnology innovation accelerated over the last 40 years, USDA’s regulatory framework for crops made with biotechnologies remained largely unresponsive. Efforts to implement substantial changes were unsuccessful until 2020. Since then, a cascade of changes and reversals have created a period of regulatory whiplash.

In 2020, USDA finalized the SECURE rule which updated premarket oversight of genetically engineered organisms developed with biotechnology. The rule marked the first significant update to USDA’s agricultural biotechnology regulations in decades. While the new framework had shortcomings, it did succeed in significantly streamlining regulatory processes and reducing the burden of environmental review for some products. This lasted for 4 years until a U.S. District Court found fault with the rule, threw it out, and required USDA to revert back to the legacy regulations that were in place prior to 2020. The shift back to the legacy regulations at the start of 2025 increased the extent to which USDA was required to conduct Environmental Assessments (EA), and in some cases Environmental Impact Statements (EIS), in line with NEPA, lengthening review times specifically for petitions to deregulate new genetically modified plant varieties.

In the latest whiplash-inducing move, the White House Council on Environmental Quality under President Trump rescinded its own NEPA regulations and directed individual agencies to update their NEPA implementing procedures. In response, USDA released its revised NEPA implementing regulations, fully rescinding and rewriting those relevant to the the Animal and Plant Health Inspection Service, among others. Given these changes, and confirmed via an announcement from the agency, USDA will no longer conduct a NEPA analysis during its review of petitions seeking a determination of nonregulated status for genetically modified organisms.

This change is poised to shorten the time it takes USDA to review petitions, accelerating the rate at which improved plant varieties reach farmers, without adding environmental risk. But, simply curbing NEPA review of agricultural biotechnology will do little to alleviate regulatory burden on developers, and could even elicit prolonged legal backlash.

Sidestepping NEPA will speed up reviews

When a plant breeder submits a petition seeking nonregulated status for their product, the Animal Plant Health Inspection Service (APHIS) conducts a plant pest risk assessment (PPRA) to determine the potential for the modified plant to survive, reproduce, become a weed, or to facilitate the spread of plant diseases or pests. Historically, APHIS also conducted a NEPA analysis (EA or EIS) on factors beyond plant pest risk, to determine if the organism’s unconfined release would have a significant impact on the human environment. The PPRA and NEPA assessments were published simultaneously for public comment before a final decision was made for a modified organism’s regulatory status.

In line with the USDA’s revised NEPA implementing regulations, APHIS announced it will now complete its PPRA first. As soon as the agency completes a PPRA that determines a plant does not pose a plant pest risk, APHIS claims it will no longer have legal authority to consider or mitigate environmental impacts under the Plant Protection Act, and therefore has no obligation to conduct NEPA analysis for petitions.

The environmental community has decried the White House’s rollback of NEPA as an unprecedented weakening of bedrock environmental law. While this perspective highlights a general concern for environmental oversight, the specific impact on plant biotechnology reviews has the potential to be a net positive for the climate. Scientific bodies have repeatedly asserted that genetically engineered crops are as safe as their conventional counterparts on the market, in terms of both human health and environmental impact. At the same time, new advances in crop biotechnology offer faster, more targeted, and more effective genetic improvements that have created crops that are higher yielding (reducing deforestation driven by cropland expansion) or have increased pest resistance (reducing the volume or toxicity of pesticide applications). Gene-edited microbes can improve crop nutrient uptake and efficiency (reducing the need for fertilizers that can cause runoff-induced environmental degradation and greenhouse gas emissions from synthetic fertilizer application and production). The faster these innovations get through regulatory approval, the faster they can reach farmers and start reaping yield-boosting, input-reducing, and land-sparing benefits.

Crucially, forgoing NEPA analysis will not change the way APHIS makes regulatory determinations on petitions. Nor will releasing genetically modified organisms on farms without NEPA analysis cause environmental catastrophe. Even when the agency did complete EAs, APHIS was still only able to make decisions about petitions based on its statutory authority under the Plant Protection Act: whether there is a plant pest risk. The completion of EAs on a wider variety of impacts beyond what is included in the PPRA was only ever procedural, not a factor that could legally preclude deregulation.

Broader impacts on reviews and litigation prospects

Limiting NEPA review for agricultural biotechnology will reduce the amount of time it takes APHIS to issue regulatory decisions. Prior to 2020, it took APHIS an average of 15 months to issue decisions on petitions, and almost all of these evaluations included preparation of a NEPA analysis, most often an EA.

USDA claims this rollback of regulation will “unleash innovation.” In practice, this change does mean less work for regulators and less wait time for developers. But in comparison to the agency’s reversion to legacy regulations after the SECURE rule was vacated, the burden of review will remain much higher for most products. Beyond decreasing review wait time, reducing NEPA analysis does nothing to lessen the regulatory burden on developers. The petition submission package APHIS requires developers to submit remains exactly the same, as does the types of products that are subject to review. While the SECURE rule paved the way for small and mid-sized crop breeders to benefit from a streamlined review process for transgenic crops, that progress was largely undone by the reversion to the legacy regulations. Now it’s likely only the largest developers will be able to bear the expenses of an extensive submission package and still prolonged regulatory review. The reversion to the legacy regulations is the opposite of deregulation in practice, despite USDA’s claim that they have reduced regulation by 66%.

Despite the positive impact of USDA’s revised NEPA implementing regulations on regulatory streamlining, the abrupt move away from NEPA analysis is sure to invite new litigation. Plaintiffs could argue that deregulating a genetically engineered crop, which allows its unconfined release, is a "major Federal action significantly affecting the quality of the human environment,” for which APHIS would be required to complete an environmental analysis consistent with NEPA requirements. They could contend that APHIS' decision to entirely cease NEPA analysis for petitions is an arbitrary and capricious reversal of long-standing practice. In defense, APHIS could rely on precedent set by the Ninth Circuit’s ruling in Center for Food Safety v. Vilsack (2013) and subsequent changes to NEPA. However, it’s unclear how these arguments will fare in future legal proceedings, especially given that the Supreme Court’s decision in Loper Bright limited agency discretion to interpret statutory triggers for environmental reviews.

USDA might have traded a chance at reducing review timelines for unleashing years of uncertainty on the agricultural biotech industry. If anti-GMO activists are successful in winning lawsuits that question APHIS compliance with NEPA, USDA will once again revert to its preexisting review processes and developers will be forced to keep up with an ever evolving regulatory landscape. The Trump administration has made clear its interest in unleashing innovation and rolling back regulations that unnecessarily limit the growth of American industries. To truly ease the regulatory burdens delaying safe products of agricultural biotechnology from reaching the market, USDA will have to do more than this legally-dubious attempt to cut back on a small part of the review process. USDA must think bigger and pursue politically durable ways to overhaul and modernize what products they review in the first place.