In the latest move in an ongoing case against the Food and Drug Administration (“FDA”), a collection of environmental groups moved for summary judgment on their claims that the FDA failed to comply with the National Environmental Policy Act (“NEPA”) and the Endangered Species Act (“ESA”) when it approved genetically-engineered (“GE”) salmon developed by AquaBounty Technologies, Inc. (“AquaBounty”) for commercial production. The plaintiff environmental groups first filed this case, Inst. for Fisheries Res. v. Hahn, No. 3:16-cv-01574-VC (N.D. Cal.), in 2016. Along with the environmental claims now before the court, the original case also challenged FDA’s authority to regulate the GE salmon and the agency’s decision to regulate the salmon as a drug instead of a food. The court has already resolved the challenge to FDA’s authority and its decision on how to regulate the GE salmon, concluding that unless FDA stepped in, there would be a regulatory gap that would allow companies to genetically engineer animals without oversight. Having lost on those claims, the plaintiffs are now asking the court to find in their favor on the environmental law claims.

The FDA approval of AquaBounty’s GE salmon was the first time a GE animal has been approved to be sold as food within the United States. AquaBounty’s fish is an Atlantic salmon that contains genes from a deep-water ocean eelpout and a Chinook salmon that cause it to grow to market rate in roughly half the time of a non-GE Atlantic salmon. In 2015, FDA approved AquaBounty’s GE salmon for human consumption in 2015. The agency concluded that AquaBounty’s salmon was as safe and nutritious as any conventional salmon. Although the FDA decision approved the GE salmon for commercial production, it did not permit AquaBounty to breed or raise its salmon within the United States. Instead, AquaBounty intended to continue shipping salmon eggs from its hatchery in Canada to its facility in Panama where the GE salmon would be raised to maturity in contained pens before being processed and sent back to the United States for consumption.

While AquaBounty had plans to open United States facilities in the future, because it was only using the facilities in Canada and Panama at the time it applied to FDA, the agency only conducted environmental review on those facilities when making its decision to approve the GE salmon. NEPA requires federal agencies to conduct an environmental review of any agency action that will affect the human environment. Because FDA’s approval of a GE salmon for human consumption would affect the human environment, the agency underwent a NEPA review of its decision to approve AquaBounty’s salmon. In conducting the first part of the NEPA process, the Environmental Assessment (“EA”) which either results in a finding of no significant impact (“FONSI”) or a conclusion that further environmental review is needed, FDA determined that AquaBounty’s GE salmon posed no environmental or ecological risks because the facilities in Canada and Panama would be subject to strict containment measures which would prevent the GE salmon from escaping into the wild. Because FDA concluded that AquaBounty’s GE salmon would not escape either the Canada or Panama facilities, it determined that it did not have to undergo ESA consultation with either Fish and Wildlife Service (“FWS”) or National Marine Fisheries Service (“NMFS”) because FDA’s approval of the GE salmon would have no effect on endangered wild salmon populations.

The plaintiff environmental groups challenge both of FDA’s conclusions. They allege that FDA violated both NEPA and the ESA by failing to conduct an appropriate review under either statute. First, the plaintiffs allege that FDA violated NEPA by only engaging in the less rigorous EA review instead of drafting a more thorough Environmental Impact Statement (“EIS”). Second, the plaintiffs argue that FDA violated the ESA by not engaging in consultation with either FWS or NMFS to consider potential harms to endangered wild salmon.

In making their first argument, the plaintiffs argued that FDA failed to take the “hard look” required under NEPA at the consequences of its decision to approve AquaBounty’s GE salmon for commercial consumption. In particular, the plaintiffs allege that FDA violated NEPA by failing to take a hard look at the environmental risks that could occur if any GE salmon escaped from either of AquaBounty’s facilities. According to the plaintiffs, if FDA had taken the necessary hard look at the possible risks that could occur if any GE salmon escaped into the wild, the agency would have completed an EIS instead of only drafting an EA. Additionally, the plaintiffs argue that the scope of FDA’s NEPA analysis was too narrow because it only considered the risks posed by AquaBounty’s facilities in Canada and Panama. The plaintiffs argue that because AquaBounty has always had plans to pursue opening facilities in the United States, FDA’s NEPA analysis should have considered the environmental risks posed by AquaBounty’s plans for additional facilities.

Next, the plaintiffs argued that FDA’s decision not to engage in ESA consultation because there would be no effect on any listed species was arbitrary and in violation of the law. Under the ESA, a federal agency must engage in consultation with either FWS or NMFS if an agency action “may affect” a listed species. The “may affect” standard is a low threshold to meet, any action that has any chance of affecting either a listed species or designated critical habitat will trigger the need for ESA consultation. The plaintiffs argue that the possibility that GE salmon could escape from AquaBounty’s facilities easily clears the “may affect” threshold and that FDA should have consulted with either FWS or NMFS on the risks posed to listed wild salmon species should any of AquaBounty’s salmon escape.

The plaintiffs petitioned the court for summary judgment on both their NEPA and ESA claims. In other words, the plaintiffs are arguing that there are factual disputes between themselves and the defendants and that the court can make a decision by applying the law to the case without having to conduct a full trial. Currently, the parties are waiting on FDA to reply.

Whether the court finds for the plaintiffs or for FDA, the outcome of this case will have an impact on the commercial production of GE animals going forward. Because AquaBounty’s GE salmon is the first GE animal to receive approval for commercial production by FDA, the conclusion of this case will likely set a precedent for the scope of environmental review that will be required for many future decisions surrounding GE animals in commercial production.

To read the plaintiffs’ motion for summary judgment in Inst. for Fisheries Res. v. Hahn, click here.

To read the complaint in Inst. for Fisheries Res. v. Hahn, click here.

For more FDA resources on the decision to approve GE salmon, click here.

For more National Agricultural Law Center resources on biotechnology, click here.

For more National Agricultural Law Center resources on aquaculture, click here.

For more National Agricultural Law Center resources on food safety, click here.

For more National Agricultural Law Center resources on GE salmon, click here.