## Facts

- FDA approved a new animal drug application for a genetically engineered Atlantic salmon (“AquAdvantage”) designed to reach market size in about half the time of conventional salmon.
- FDA regulated the inserted recombinant DNA construct as a “new animal drug” under the FDCA and approved production subject to containment conditions.
- The approval authorized egg production at a land-based facility in Prince Edward Island, Canada, and grow-out at a land-based facility in Panama, with resulting fish sold as food in the United States.
- Environmental, tribal, and fishing-industry organizations sued, challenging the approval under NEPA and the ESA (and also raising statutory and APA claims).
- FDA’s environmental review focused on the likelihood of escape from the approved facilities and concluded escape was highly unlikely; FDA also concluded that escaped fish were unlikely to survive or establish a wild population.
- FDA did not meaningfully analyze the environmental consequences if AquAdvantage salmon nonetheless escaped, survived, and established in the wild, including potential effects on wild and endangered salmon.
- FDA anticipated AquaBounty’s operations would likely expand to additional facilities, increasing cumulative escape risk over time; after the initial approval, FDA later permitted operation of a third facility while relying heavily on the earlier analysis.
- In earlier proceedings, the court rejected a broad challenge to FDA’s statutory authority to regulate genetically engineered animals under the FDCA; the 2020 decision addressed cross-motions for summary judgment on the remaining claims.

## Issues

1. Whether FDA’s environmental assessment and Finding of No Significant Impact complied with NEPA when FDA did not meaningfully evaluate the consequences of a low-probability but high-consequence escape-and-establishment scenario.
2. Whether FDA complied with ESA § 7 duties to ensure its action was not likely to jeopardize listed species or adversely modify critical habitat, including whether its analysis adequately addressed potential effects on endangered Atlantic salmon.
3. What remedy was appropriate if FDA’s NEPA and ESA analyses were legally deficient.

## Decision

- The court granted in part and denied in part plaintiffs’ motion for summary judgment and granted in part and denied in part defendants’ cross-motion.
- The court held FDA violated NEPA by failing to take a “hard look” at consequences if the engineered salmon escaped and established a wild population, even if FDA viewed that scenario as unlikely.
- The court held FDA violated the ESA by inadequately assessing potential effects on listed species and failing to perform analysis commensurate with the risk to endangered salmon.
- The court remanded the matter to FDA for further NEPA and ESA work but did not vacate FDA’s approval; the approval remained in effect pending reconsideration.
- The court rejected or resolved against plaintiffs various other challenges not central to the NEPA and ESA deficiencies.

## Legal Principles

- NEPA requires an agency to evaluate not only the probability of an adverse event but also the environmental consequences if a low-probability, high-consequence event occurs, when that event is within the action’s realm of concern.
- A NEPA FONSI is arbitrary and capricious if the agency fails to provide a reasoned, adequately supported analysis of potentially significant environmental effects.
- When an agency action may affect listed species, ESA § 7 requires analysis sufficient to ensure the action is not likely to jeopardize listed species or adversely modify critical habitat; an agency may not rely solely on the asserted improbability of harm while leaving consequential impact analysis undeveloped.
- Remand without vacatur is available where an agency’s analysis is legally deficient but the court determines the disruptive effects of vacatur outweigh the benefits while the agency corrects the deficiencies.

## Conclusion

The court held that FDA’s approval of genetically engineered AquAdvantage salmon was supported by an incomplete NEPA and ESA analysis because FDA did not meaningfully address the consequences of escape and establishment in the wild and related risks to endangered salmon, and it remanded to FDA for further analysis without vacating the approval.


Inst. for Fisheries Res. v. U.S. Food & Drug Admin., 499 F. Supp. 3d 657 (N.D. Cal. 2020)