National Family Farm Coalition v. Vilsack

Background

The plaintiffs, including National Family Farm Coalition and Center for Food Safety, are nonprofit and public-interest groups concerned with farmers, crops, food safety, and the environment. They challenged APHIS’s 2020 final rule regulating genetically engineered plants under the Plant Protection Act. The rule focused regulation on the specific trait introduced into a plant and the trait’s potential plant-pest risks.

The rule exempted genetically engineered plants that could be created through conventional breeding techniques and plants with certain plant-trait-mechanism-of-action combinations that APHIS determined did not pose plant-pest risks. It did not add noxious weeds as a trigger for regulation under the relevant genetically engineered-plant rules. It also did not require new types of records or field-test data for certain regulatory reviews.

The plaintiffs sued under the Administrative Procedure Act, arguing that APHIS acted arbitrarily and capriciously and violated the Plant Protection Act, the 2008 Farm Bill, the Endangered Species Act, and the National Environmental Policy Act. They also challenged parts of the rule as an unconstitutional delegation of authority to private parties. Two agricultural-industry trade associations—the American Seed Trade Association and the Biotechnology Innovation Organization—intervened in the case.

Standing and Standard of Review

The court rejected the intervenors’ challenge to the plaintiffs’ standing. Evidence showed that members of the plaintiff organizations were organic or non-genetically engineered farmers who faced an increased risk of transgenic contamination and related costs if the rule remained in effect. The court concluded that those injuries were sufficiently concrete, traceable at least in part to APHIS’s deregulation decision, and likely to be reduced by vacating and remanding the rule.

The court reviewed the agency’s action under the Administrative Procedure Act’s arbitrary-and-capricious standard. Under that standard, the court examines whether the agency considered relevant factors, addressed important aspects of the problem, and provided a rational connection between the facts it found and the decision it made. The court stated that it would not substitute its judgment for APHIS’s, but would require reasoned decisionmaking supported by the administrative record.

Noxious-Weed Authority

The court rejected the plaintiffs’ argument that the Plant Protection Act required APHIS to incorporate its noxious-weed authority into the genetically engineered-plant regulations in the particular way the plaintiffs preferred. The statute gave the agency discretion over how to exercise that authority, and the plaintiffs did not identify statutory text requiring their proposed approach.

The court agreed, however, that APHIS failed to adequately explain its decision not to incorporate noxious-weed authority into the rule. Earlier agency proposals and inspector-general reports had identified limitations in the existing regulatory system, including the risk that genetically engineered plants could escape regulation when they were not created using a plant-pest vector or were not themselves classified as plant pests. The final rule did not address those previously recognized concerns and instead stated that APHIS would continue its existing practices.

The court held that APHIS’s failure to address the limitations it had previously identified was arbitrary and capricious. The agency’s statement that it had authority to choose its approach did not explain why it chose not to change the regulations.

Conventional-Breeding Exemption

The court also held that APHIS acted arbitrarily and capriciously in adopting the exemption for genetically engineered plants that could be produced through conventional breeding. APHIS relied in part on a 1989 National Research Council report stating that plants modified through classical genetic methods were manageable under accepted standards. But a 2002 National Academy of Sciences study in the administrative record rejected the assumption that all conventionally bred crops have acceptable risks and stated that those risks should not be presumed acceptable.

The final rule did not acknowledge or address that conflicting scientific evidence. Because the agency’s conclusion directly conflicted with evidence from its own experts, the court found that APHIS had not provided an adequate explanation for the exemption. The court emphasized that APHIS could reach the same or a different conclusion after considering the evidence, but it had to explain and support the decision.

Other Exemptions and Field-Test Data

The court rejected the plaintiffs’ challenge to the plant-trait-mechanism-of-action exemptions and to the rule’s decision not to require field-test data for certain genetically engineered plants. Unlike its reasoning for the conventional-breeding exemption, APHIS had acknowledged contrary scientific evidence and explained its disagreement by relying on other scientific evidence and its own experience from decades of regulatory analyses.

The court also rejected the plaintiffs’ broader argument that no exemption could be scientifically justified. APHIS was entitled to rely on its expertise and experience, and the plaintiffs did not develop an additional challenge to the exemption based on the agency’s prior “Am-I-Regulated” process.

2008 Farm Bill and Sub-Delegation Claims

The court rejected the plaintiffs’ argument that the rule violated the 2008 Farm Bill because it reduced regulatory oversight. The statute directed the Secretary of Agriculture to improve management and oversight as the Secretary considered appropriate; it did not require an increase in oversight. The court also rejected the argument that APHIS had to implement the specific proposals identified in an earlier agency report. In the court’s reading, the statute left APHIS discretion to decide what actions to take on the specified topics.

The court also granted summary judgment to the agency on the plaintiffs’ sub-delegation claim. The opinion’s conclusion contains an apparent typographical question mark after the reference to that claim, but the text states that summary judgment was granted to the agency on it.

Disposition and Remedy

Summary judgment was granted to the plaintiffs on their Plant Protection Act-based Administrative Procedure Act claim that APHIS acted arbitrarily and capriciously by failing to incorporate its noxious-weed authority into the rule and by adopting the conventional-breeding exemptions. Summary judgment was granted to the agency on the sub-delegation and 2008 Farm Bill-based Administrative Procedure Act claims.

The court vacated the final rule as of December 2, 2024, and remanded it to APHIS for further proceedings consistent with the order. The court declined to limit vacatur to only part of the rule because APHIS had not provided a developed explanation of how partial vacatur would address the noxious-weed error. The court found the agency’s errors significant and found no supported, non-speculative evidence that the disruption from vacatur outweighed those errors. Because the rule had been in effect since 2020, the court made vacatur effective on the date of the order rather than retroactively.

The parties were directed to file a joint statement by January 13, 2025, addressing the effect of the order, if any, on a related rule identifying additional genetically engineered organisms qualified for exemption. They were also directed to propose a status conference date concerning the remaining procedural challenges under the Endangered Species Act and National Environmental Policy Act.