The FDA Just Got Slapped with a Lawsuit for Approving Genetically-Engineered Salmon

By Claire Bernish

Controversy over genetically-engineered salmon intensified Thursday, as a “broad coalition of environmental, consumer, and commercial and recreational fishing organizations” filed a lawsuit against the FDA over safety and environmental concerns surrounding its approval of the fish.

Food & Water Watch, Center for Food Safety, and the Center for Biological Diversity are joined by a number of other organizations in the lawsuit coalition, which issued a statement on the litigation:

In approving the GE salmon, FDA determined it would not require labeling of the GE fish to let consumers know what they are buying, which led Congress to call for labeling in the 2016 omnibus spending bill. FDA’s also ignored comments from nearly 2 million people opposed to the approval because the agency failed to analyze and prevent the risks to wild salmon and the environment, as well as fishing communities, including the risk that GE salmon could escape and threaten endangered wild salmon stocks.

The suit was filed in the U.S. District Court for Northern District of California.

Created by AquaBounty Technologies, Inc., the engineered salmon actually contain DNA from three fish species: Arctic Ocean eelpout, Atlantic salmon, and Pacific king salmon. Telling of the groups’ concerns about the Food and Drug Administration’s approval, the suit challenges the agency’s authority to make such a decision — which it did by regulating GE salmon under the 1938 Federal Food, Drug, and Cosmetic Act as “animal drugs.”

According to the statement:

Those provisions were meant to ensure the safety of veterinary drugs administered to treat disease in livestock and were not intended to address entirely new GE animals that can pass along their altered genes to the next generation. The approval of the GE salmon opens the door to other genetically engineered fish and shellfish, as well as chickens, cows, sheep, goats, rabbits and pigs that are reportedly in development.

Another aspect of the lawsuit concerns the FDA’s failure to sufficiently examine the potential environmental impacts caused by the genetically-engineered salmon. AquaBounty salmon eggs would be produced in Prince Edward Island, Canada, raised to market-size and then filleted and processed in Panama, and then distributed for sale around the world. Because the proposed salmon only included its being raised abroad, the FDA didn’t perform an assessment of its impacts on the environment in the U.S. But AquaBounty already publicly announced its intent to ultimately bring the entire process inside the country.

“When GE salmon escape or are accidentally released into the environment,” the statement says, “the new species could threaten wild populations by mating with endangered salmon species, outcompeting them for scarce resources and habitat, and/or introducing new diseases.”

Coalition member groups are asking for the FDA’s approval of the genetically-engineered salmon to be reversed, found unlawful, and a determination the agency does not have the authority to make such approvals for GE animals.

“FDA’s decision is as unlawful as it is irresponsible,” said senior attorney for Center for Food Safety and plaintiffs’ co-counsel, George Kimbrell. “This case is about protecting our fisheries and ocean ecosystems from the foreseeable harms from the first-ever GE fish, harms FDA refused to even consider, let alone prevent. But it’s also about the future of our food: FDA should not, and cannot, responsibly regulate this GE animal, nor any future GE animals, by treating them as drugs under a 1938 law.”

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