FDA Sued Over GM Salmon Approval


Apr. 4, 2016

Feedstuffs magazine reports:

A broad coalition of environmental, consumer and commercial and recreational fishing organizations sued the U.S. Food & Drug Administration for approving the first-ever genetically engineered (GE) food animal: an Atlantic salmon engineered to grow quickly.

The manmade salmon was created by AquaBounty Technologies Inc. with DNA from three fish: Atlantic salmon, Pacific king salmon and Arctic ocean eelpout. This marks the first time any government in the world has approved a GE animal for commercial sale and consumption.

The plaintiff coalition, jointly represented by legal counsel from the Center for Food Safety and Earthjustice, includes the Pacific Coast Federation of Fishermen's Associations, Institute for Fisheries Resources, Golden Gate Salmon Assn., Kennebec Reborn, Friends of Merrymeeting Bay, Ecology Action Centre, Food & Water Watch, Center for Biological Diversity, Friends of the Earth, Cascadia Wildlands and Center for Food Safety.

"FDA has not answered crucial questions about the environmental risks posed by these fish or what can happen when these fish escape," said Earthjustice attorney Brettny Hardy, co-counsel for the plaintiffs. "We need these answers now, and the FDA must be held to a higher standard. We are talking about the mass production of a highly migratory GE fish that could threaten some of the last remaining wild salmon on the planet. This isn't the time to skimp on analysis and simply hope for the best."

The lawsuit challenges FDA's claim that it has authority to approve and regulate GE animals as "animal drugs" under the 1938 Federal Food, Drug & Cosmetic Act. The groups claim that these 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, they said.

The lawsuit also highlights what the plaintiffs claim is FDA's failure to protect the environment and consult wildlife agencies in its review process, as required by federal law.

U.S. Atlantic salmon - and many populations of Pacific salmon - are protected by the Endangered Species Act and are in danger of extinction. The groups contend that studies have shown that there is a high risk for GE organisms to escape into the natural environment and that GE salmon can crossbreed with native fish. Transgenic contamination has become common in the GE plant context, where contamination episodes have cost U.S. farmers billions of dollars over the past decade.

"FDA's decision is as unlawful as it is irresponsible," said George Kimbrell, senior attorney for the Center for Food Safety and co-counsel for the plaintiffs. "This case is about protecting our fisheries and ocean ecosystems from the foreseeable harms of 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."