Institute for Fisheries Resources v. FDA

In 2015, the Food and Drug Administration (FDA) (defendant) granted approval for a company called AquaBounty to create and farm genetically engineered salmon at two facilities, with the potential for AquaBounty’s operations to grow in the future. In deciding whether to approve AquaBounty’s initial two-facility application, the FDA considered whether engineered salmon were likely to escape from captivity and adversely affect nongenetically engineered salmon, including some endangered salmon species. The FDA concluded that the genetically engineered salmon were highly unlikely to escape but imposed conditions on the facilities that were designed to prevent the salmon from escaping. Because the FDA believed that escape was unlikely, the FDA did not fully analyze what would happen to nongenetically engineered salmon if the engineered salmon escaped, survived, and established a population in the wild. The Institute for Fisheries Resources and other advocacy and industry groups (collectively, Fisheries) (plaintiffs) brought an action against the FDA in federal district court to challenge the FDA’s approval of AquaBounty’s salmon-farming operations. Fisheries asserted, among other things, that the FDA had not adequately considered the environmental consequences of approving AquaBounty’s application. While the action was pending, AquaBounty expanded its salmon-engineering operations, and the FDA gave AquaBounty permission to operate a third salmon-farming facility based on the reasoning in the FDA’s approval of AquaBounty’s initial application. The parties cross-moved for summary judgment on Fisheries’ claims.