Institute for Fisheries Resources v. Hahn

Background

The case challenges the Food and Drug Administration’s 2015 approval of AquaBounty’s application to create and farm genetically engineered salmon called AquAdvantage. The approval allowed AquaBounty to produce eggs at a facility on Prince Edward Island in Canada and grow them into mature fish at a facility in Panama. The approval required containment measures, including landlocked facilities and a prohibition on ocean-connected net pens.

AquaBounty later shut down the Panama facility and obtained approval to use a facility in Indiana. The FDA relied on and incorporated its original approval when approving the Indiana facility. The plaintiffs challenged only the original approval, but the later approval was relevant because it relied on the original environmental analysis. AquaBounty intervened to defend the approval alongside the FDA and other government defendants.

The plaintiffs’ broader argument—that the FDA lacked authority under the Food, Drug, and Cosmetic Act to regulate genetically engineered animals—had already been resolved for the defendants in an earlier ruling. The remaining claims challenged the FDA’s particular approval decision, primarily on the ground that the agency did not adequately assess the risk that engineered salmon could escape, survive, interact with wild salmon, and establish a persistent population.

Claims and legal framework

Eight claims remained. Claims 2, 3, 4, 5, 6, and 7 arose under the National Environmental Policy Act, or NEPA, and the Administrative Procedure Act. NEPA requires an agency to consider the environmental effects of a major action. Under the Administrative Procedure Act, a court may set aside agency action that is arbitrary, capricious, an abuse of discretion, or otherwise unlawful.

Claim 2 alleged that the FDA failed to take a sufficiently serious look at the environmental consequences of approving AquAdvantage salmon. Claim 6 alleged that the agency was required to prepare a more thorough environmental impact statement instead of stopping at an environmental assessment. Claims 3, 4, 5, and 7 challenged the agency’s treatment of connected, cumulative, and interdependent actions, alternatives, and mitigation measures.

Claim 10 alleged that the FDA violated Section 7 of the Endangered Species Act by failing to consult with the National Marine Fisheries Service and the Fish and Wildlife Service before deciding that the approval would have no effect on endangered Gulf of Maine Atlantic salmon. Claim 12 alleged that the Food, Drug, and Cosmetic Act itself required the FDA to consider environmental impacts when deciding whether the genetically engineered salmon were safe for use.

NEPA claims

The FDA’s environmental assessment analyzed the likelihood of exposure, including escape, survival, interaction with wild salmon, and establishment of a persistent population. The court found that the agency carefully analyzed why each of those events was unlikely. But the assessment did not meaningfully analyze the consequences for wild salmon if the engineered salmon did establish themselves in the wild.

The court held that this omission made the FDA’s finding of no significant environmental impact inadequate. The agency’s own risk framework required analysis of both the probability of exposure and the potential harm if exposure occurred. Because the FDA left the second part unknown, it had not supplied the convincing explanation required for its finding.

The court also held that the possibility of future facilities made the missing analysis important. The FDA was not required to formally evaluate projects that had not yet been submitted, but it should have considered that future facilities could build on the initial approval and increase the possibility of exposure. On remand, the FDA must analyze the consequences of engineered salmon establishing a persistent population outside captivity. That revised analysis could lead to either a full environmental impact statement or another finding of no significant impact.

The court rejected the plaintiffs’ Claims 3, 4, 5, and 7. It found that the plaintiffs had not shown that the FDA needed to consider connected, cumulative, or interdependent actions, that prior agency actions created cumulative impacts requiring analysis, or that the assessment considered too few alternatives. The court also rejected the challenge to mitigation measures because the FDA relied on enforceable approval conditions designed to prevent escape.

Endangered Species Act claim

The court ruled for the plaintiffs on Claim 10. Because the FDA had not adequately examined whether the engineered salmon could significantly affect wild salmon under NEPA, the court concluded that the agency also could not adequately support its determination that the fish would have no effect at all on endangered Gulf of Maine Atlantic salmon.

The FDA must reconsider its no-effect determination together with the revised NEPA analysis. The court stated that the agency could also consult with the National Marine Fisheries Service and the Fish and Wildlife Service so that its ultimate conclusions are supported by those agencies’ expertise.

Food, Drug, and Cosmetic Act claim

The court rejected Claim 12. It held that the Food, Drug, and Cosmetic Act was broad enough to allow—and at least in relevant circumstances require—the FDA to consider effects on the health of humans or animals, including wild salmon. But the court concluded that the FDA’s safety determination was not arbitrary and capricious because the agency had imposed conditions intended to prevent the engineered salmon from escaping and mixing with wild salmon.

The court distinguished this conclusion from its NEPA ruling. The environmental assessment was inadequate because it failed to complete the required environmental risk analysis. That did not necessarily mean that the FDA’s separate safety analysis under the Food, Drug, and Cosmetic Act was unlawful.

Disposition and remedy

The court granted the plaintiffs’ motion for summary judgment as to Claims 2 and 6 because the FDA failed to assess the risk of harm if engineered salmon established themselves in the wild. It also granted the plaintiffs’ motion as to Claim 10 because the FDA failed to sufficiently consider whether the salmon might affect endangered wild salmon before deciding not to consult with the expert agencies.

The court granted the government’s cross-motion for summary judgment as to all other pending claims. It remanded the case to the FDA for reconsideration of the environmental assessment under NEPA and the Endangered Species Act. The court did not vacate the approval while that reconsideration occurs, reasoning that the short-term environmental risk was low because of the containment conditions and that cancelling the approval could cause significant waste if the agency could cure the errors.