Court orders FDA to reassess environmental impact of GM salmon

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Federal agency must go back to the drawing board. With every new facility built, the “possibility of exposure grows,” says judge.

A federal court judge has ruled that the U.S. Food and Drug Administration did not analyse enough the impact of genetically engineered salmon if they escaped in the wild.

The ruling by U.S. District Court Judge Vince Chhabria in San Francisco is focused on AquaBounty’s genetically engineered-fast growing AquAdvantage salmon.

The biotech company is working on its first harvest of GM salmon, which are being raised in a land-based RAS facility in Albany, Indiana.

As part of the approval process, the FDA assessed the likelihood that the engineered salmon and concluded that they were highly unlikely to escape from the two facilities where the company initially planned to raise them and that even if the salmon found a way to escape they were unlikely to survive or establish themselves as a population in the wild.

But in 2016, environmental activist groups Center for Food Safety (CFS) and Earthjustice, representing a coalition of commercial fishing organisations and First Nation groups, sued the FDA. The CFS release a statement that included a copy of the court ruling.

On Thursday, the court concluded that the FDA should have developed a full understanding—and provided a full explanation of the potential environmental consequences. “The agency is ordered to go back and complete the analysis,” said Judge Chhabria.

He added that because the FDA took the risk of escape seriously and imposed conditions designed to prevent escape, the short-term threat to the environment from engineered salmon at the Prince Edward Island facility and the Indiana facility was low.

But with more sites planned, he added that: “with every new facility built, the possibility of exposure grows. Understanding the harm that could result from that exposure—and having an explanation of it on record—will only become more important”.

On Friday, after the article was published AquaBounty provided SalmonBusiness with a statement from CEO Sylvia A. Wulf.

Wulf said that the company was “disappointed with some of the conclusions reached in the judge’s decision regarding the environmental assessment conducted by the U.S. Food and Drug Administration (FDA)”.

“We remain confident in the robust scientific studies and review that resulted in the 2015 FDA approval. This case did not call into question FDA’s approval regarding the health and safety of our AquAdvantage 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. 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. We are committed to working with FDA on next steps and continue to evaluate the legal decision,” she added.