Judge Orders FDA to Rethink Approval of GMO Salmon

A facility manager at AquaBounty Technologies, points out a newly hatched Atlantic salmon alevin among the first batch of bioengineered eggs in an incubation tray in Albany, Ind., Wednesday, June 19, 2019. (AP Photo/Michael Conroy)

SAN FRANCISCO (CN) — The U.S. Food and Drug Administration must rethink its approval of a plan to breed genetically altered salmon because it did not fully consider what would happen if those fish escaped into the wild, a federal judge ruled Thursday.

“It basically requires FDA to finally grapple with what scientists both inside and outside the government have been telling it for a very long time, which is that there are unacceptable risks from genetically engineered salmon,” said Earthjustice lawyer Stephen Mashuda, who represents conservation and fishing industry groups that sued the FDA.

In 2015, the FDA approved the company AquaBounty’s plans to breed its “AquAdvantage” salmon — a genetic mix of ocean pout and Pacific Chinook — at a hatchery in Rollo Bay on Prince Edward Island, then transport the eggs for growth at an Indiana farm site.

The approval spurred a lawsuit led by the Institute for Fisheries Resources, claiming the agency failed to fully assess potential consequences for the environment and endangered fish.

U.S. District Judge Vince Chhabria, a Barack Obama appointee, previously ruled that the FDA has authority to approve genetically engineered animals because the genetic material used to modify those creatures is considered a “drug” under the Food, Drug and Cosmetic Act. 

In a 16-page decision Thursday, Chhabria flatly rejected the FDA’s position that it has no duty to consider environmental impacts when reviewing applications to breed genetically modified animals.

“Even if the FDA is correct that environmental considerations writ large were not relevant to its decision, the agency is always required to consider the subset of environmental impacts that directly involve the health of animals or humans,” the judge wrote.

Mashuda considers that part of Chhabria’s ruling most significant because it will require the agency to fully assess environmental impacts for all proposals to raise genetically engineered animals in the future.

“Ensuring that FDA has the duty to look at effects on the environment from these approvals is critical,” Mashuda said.

The agency argued that it only has to ensure a drug is “safe for use.”

Noting that the law requires consideration of a drug’s “cumulative effects on man or animal,” Chhabria said it would be an absurd result if the agency only considered effects on the person or animal for whom the drug was intended.

He pitched the example of a drug designed to treat a livestock disease, for which the manufacturing process might contaminate the local water supply and kill people in a nearby community.

“Surely the FDA could deny that application to avoid killing people, even if those people are not directly administering the drug or eating the livestock,” Chhabria wrote.

In its 2015 approval, the FDA imposed several conditions on AquaBounty’s hatchery to prevent genetically engineered salmon from fleeing into the ocean. With those conditions, the agency concluded it was highly unlikely the altered fish would escape.

However, the agency did not “meaningfully analyze” what would happen if modified salmon did escape and establish themselves in the wild, the judge concluded.

“Even if this scenario was unlikely, the FDA was still required to assess the consequences of it coming to pass,” Chhabria wrote.

The judge ordered the agency to reconsider its decision and fully examine the risk of genetically altered fish escaping into the wild, where they could compete with wild salmon for food or breed with wild salmon, causing “genetic pollution.”

Chhabria also directed the agency to consider potential impacts on the endangered Gulf of Maine Atlantic salmon population, which has dwindled to around 1,200 fish according to the National Oceanic and Atmospheric Administration Fisheries.

The judge declined to vacate the FDA’s approval of genetically modified salmon breeding while reconsidering the issue, finding that would cause “disruptive consequences.”

“Revoking the approval would presumably require the current stock of salmon to be destroyed, a significant loss of property and animal life that would be wasteful given the real possibility that the FDA will be able to cure the [National Environmental Policy Act] and [Endangered Species Act] errors on remand,” Chhabria wrote.

The judge found the FDA put in place adequate conditions, such as banning the use of ocean net pens, to prevent modified salmon from escaping into the ocean.

Mashuda said he was disappointed that Chhabria chose not to vacate the FDA’s approval, but he is hopeful this will lead to more robust protections to mitigate the risks associated with breeding genetically altered salmon.

“If FDA is to look at all the risks these fish pose, it has to modify in some way its initial approval,” Mashuda said.

In a statement Thursday, AquaBounty CEO and President Sylvia Wulf said the company is disappointed with some of the judge’s conclusions but stressed that the court ruling focused on “potential environmental impacts” of genetically altered salmon breeding.

“This decision will not have an impact on our on-going operations on Prince Edward Island, Canada, to produce eggs or in the raising and selling of AquAdvantage salmon from our farm in Indiana,” Wulf said. “We are committed to working with FDA on next steps and continue to evaluate the legal decision.”

An FDA spokesperson emphasized that the court did not vacate its approval of the genetically modified salmon breeding operation.

“The FDA’s approval of the application for AquAdvantage Salmon remains in place as does the FDA’s finding of safety and effectiveness,” the spokesperson said. “The FDA is continuing to evaluate the opinion.”

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