Photo by NOAA on Unsplash
AquaBounty Technologies’ path to the U.S. market for its genetically engineered (GE) salmon has been a long one. In 2015, the FDA approved AquaBounty’s application to create and farm its GE salmon (trade name, AquAdvantage) becoming the first GE animal approved for human consumption in the United States. AquAdvantage salmon, a DNA mix of Atlantic salmon, Pacific king salmon, and Arctic ocean eelpout, grow roughly twice as fast as unaltered, wild salmon. In its 2015 decision, the FDA declared that it had completed its risk analysis, as required by the Federal Food, Drug and Cosmetic Act (FD&C Act), and concluded that AquAdvantage salmon were safe for human consumption. In evaluating AquAdvantage salmon’s potential environmental impact, the FDA judged it “highly unlikely” that the GE salmon would escape AquaBounty’s landlocked facilities (a Canadian hatchery and an Indiana production facility for growing the imported eggs to market size fish) and, even if they did escape, deemed it unlikely that the GE salmon would survive and establish themselves in the wild. Based on these and other containment safeguards, the FDA further ruled that approval of AquaBounty’s application would not produce a significant impact on the quality of the human environment in the United States and, thus, complied with the requirements of the National Environmental Policy Act (NEPA).
Despite FDA approval in 2015, AquaBounty has faced delays in the sale of its GE salmon in the United States. In 2016, Congress directed the FDA not to allow the import of AquAdvantage salmon until regulators crafted labeling guidelines for GE animals produced for human consumption. In 2019, this import ban was deactivated after the passage of the National Bioengineered Food Disclosure Standard which required food manufacturers, importers, and certain retailers to ensure bioengineered foods were appropriately disclosed.
Now, AquaBounty faces another hurdle after a federal judge’s ruling on November 5, 2020 in the United States District Court for the Northern District of California. The ruling stems from a 2016 lawsuit against the FDA filed by fishing, environmental, and Native American groups alleging that the FDA’s 2015 environmental assessment of AquAdvantage salmon did not thoroughly assess potential consequences to the environment and endangered fish. As a remedy, the Plaintiffs requested that the FDA’s approval of AquAdvantage salmon be rescinded. In his November 2020 decision, Judge Vince Chhabria ordered the FDA back to the drawing board to do more study. The judge reasoned that an agency’s decision not to prepare a detailed environmental statement is considered arbitrary and capricious if the agency “fails to supply a convincing statement of reasons why potential effects are insignificant.” A challenge to an agency’s ruling will succeed if “substantial questions are raised” as to whether the proposal will have significant environmental consequences.
While acknowledging the FDA’s conclusion that it was highly unlikely for AquAdvantage salmon to escape into the wild, Judge Chhabria ruled that the FDA did not meaningfully analyze what might happen to unaltered, wild salmon if, in the unlikely event, that AquAdvantage salmon escaped and successfully established themselves in the wild. The judge ruled that before proceeding down a path that could lead to large-scale, commercial production of GE fish, the FDA should develop a full understanding and provide a full explanation of the potential environmental consequences.
In remanding this action to the FDA to expand its environmental assessment, Judge Chhabria, however, did not vacate the FDA’s 2015 approval of AquAdvantage salmon. Predicting that there is a real possibility that the FDA will be able to “cure” its assessment, the judge reasoned that the short-term threat to the environment at the Canadian and Indiana facilities from AquAdvantage salmon was low and permitted egg harvesting and fish production at these facilities to continue.
Importantly, the FDA has not wavered from its 2015 determination that AquAdvantage salmon is safe for human consumption. So, will there be a market for AquAdvantage salmon in the United States? To date, large national retailers, such as Walmart, Kroger, Whole Foods, and Costco, have indicated that they do not intend to carry GE salmon. That stance may change once AquaBounty’s legal challenges are resolved and if consumer demand for alternative, sustainable foods increases.