FDA Ordered to Complete Environmental Assessment of Genetically Engineered Salmon

Federal judge rules FDA did not adequately assess the risk of harm when it approved Albany-grown AquaBounty Technologies AquAdvantage salmon in 2016.
November 10, 2020

A federal judge ruled that the U.S. Food & Drug Administration must complete an analysis of potential environmental consequences of genetically engineered salmon produced in Canada and raised in Indiana.

U.S. District Judge Vince Chhabria found that the FDA did not comply with the National Environmental Policy Act or the Endangered Species Act when it approved the application of AquaBounty Technologies’ AquAdvantage salmon in 2015, the first time any government approved a commercially genetically engineered animal as food.

Chhabria said the agency did not “adequately assess the risk of harm” from the genetically engineered salmon nor “sufficiently consider” the effect the salmon would have on endangered fish species if the salmon escaped into the wild.

The FDA must now complete an analysis on the environmental consequences were genetically engineered salmon to escape from AquaBounty facilities.

The ruling also allows AquaBounty’s facilities in Prince Edward Island, Canada and Albany, Indiana to continue to operate despite the deficiencies in the FDA’s approval.

AquaBounty's AquAdvantage salmon farm in Albany, Indiana. AquaBounty photo

AquaBounty President and CEO Sylvia Wulf told the Indiana Environmental Reporter the company was disappointed with some of the conclusions reached in the decision but remained confident in the “robust scientific studies” that resulted in the FDA’s approval.

“This case did not call into question FDA’s approval regarding the health and safety of our AquaAdvantage salmon. The focus of this decision was on the potential environmental impacts, and the judge confirmed the ‘low’ threat to the environment of our salmon,” Wulf said. “We are committed to working with FDA on next steps and continue to evaluate the legal decision.”

The coalition of environmental, consumer and commercial and recreational fishing organizations that sued the FDA over the approval said the ruling reinforced the threat the genetically engineered salmon pose to natural fish.

“Genetically engineered animals create novel risks and regulators must rigorously analyze them using sound science, not stick their head in the sand as officials did here,” said George Kimbrell, counsel for the case and legal director for the Center for Food Safety. “In reality, this engineered fish offers nothing but unstudied risks. The absolute last thing our planet needs right now is another human-created crisis like escaped genetically engineered fish running amok.”

The AquAdvantage salmon was created using the DNA from endangered Atlantic salmon, Chinook salmon and ocean pout. The modifications allow the fish to grow about twice as fast as wild salmon.

That growth rate allows AquaBounty to produce more fish for sale at a reduced time frame and cost compared to fish farms with non-engineered fish.

AquaBounty's AquAdvantage salmon was created with DNA from endangered Atlantic salmon, Chinook salmon and ocean pout.

The modified salmon’s benefits are clear, but their effect on wild salmon, should they escape, has been studied far less.

Past studies have urged biocontainment of genetically modified plants or animals, also known as transgenic organisms. Isolating them would prevent possible serious consequences that could affect or alter how native species live or reproduce, much like invasive plant and animal species.

The FDA found that there was an “extremely low likelihood” that AquAdvantage salmon could escape due to physical and biological containment measures undertaken by AquaBounty.

The 122,000-square-foot AquaBounty farm in Albany is capable of raising 1,200 metric tons of salmon each year. The company said the fish are contained in tanks with multiple redundant physical containment measures and are monitored 24 hours a day. The environment around the farm was found to be “hostile to the long-term survival, dispersal, reproduction and establishment” of the genetically engineered salmon.

The company also engineered the salmon to be female and “effectively sterile.”

Although it sounds like Steven Spielberg’s 1993 blockbuster Jurassic Park with lower stakes, the threat of genetically engineered salmon entering the wild poses a biological and cultural threat to many around the country.

Salmon are considered a “keystone” species, meaning they influence the survival or reproduction of many other animals and plants. Any change to salmon could cause ripples in the food chain.

“It’s a terrible idea to design genetically engineered ‘Frankenfish’ which, when they escape into the wild (as they inevitably will), could destroy our irreplaceable salmon runs,” wrote Mike Conroy, executive director of the Pacific Coast Federation of Fishermen’s Association, one of the groups involved in the lawsuit. “Once engineered genes are introduced into the wild salmon gene pool, it cannot be undone.”

AquaBounty argues that genetically engineered salmon could reverse negative trends in overfishing and pollution caused by traditional fish farming methods.

Wulf said genetically engineered food, like AquAdvantage salmon, will be necessary to keeping up with global food demand. The company, she said, takes its responsibilities as a technology pioneer very seriously.

“AquaBounty is excited about the future, and takes seriously the unwavering leadership that is required to offer a safe, secure and sustainable source of Atlantic Salmon that is raised right here in the U.S. heartland for U.S consumers. The future of our domestic and global food supply will depend on innovation and technology and AquaBounty remains steadfast in our commitment to leading that charge.”

It's unclear when the FDA will complete the analysis.

AquaBounty Technologies announced in October it would build a large-scale farm for its salmon in Mayfield, Kentucky beginning in 2021. The facility will be about eight times larger than the farm in Albany.

FDA Ordered to Complete Environmental Assessment of Genetically Engineered Salmon