Institute for Fisheries Resources v. United States Food and Drug Administration

A district court granted in part and denied in part advocacy and industry groups' motion for summary judgment in a challenge to FDA's decision to allow a company to create and farm genetically engineered salmon. The groups argued that FDA violated NEPA by failing to take a sufficiently "hard look" at the environmental consequences of its decision and by failing to prepare an EIS. The court found the agency failed to adequately explain in its EA why the potential impacts of producing and growing engineered salmon would be insignificant. The groups next argued FDA violated the ESA by failing to properly consult with FWS and NMFS on its decision. The court found that the agency determined the engineered salmon would have "no effect" on wild salmon while the EA was under active consideration and five years before the NEPA process was completed, suggesting "that the agency may have failed to grasp the practical relationship between the [ESA's and NEPA's] requirements." The groups also argued that FDA violated the Food, Drug, and Cosmetic Act, but the court found the agency took measures that prevented the engineered salmon from mixing with wild salmon and thus that its safety determination was not arbitrary or capricious. It therefore granted in part and denied in part the groups' motion for summary judgment, and remanded to FDA to reconsider its EA.