The Food and Drug Administration must evaluate the risks posed if genetically engineered salmon escape into the wild, a federal judge said in a case involving FDA’s 2015 approval of AquaBounty’s plans to create and farm GE Atlantic salmon.
FDA’s analysis, contained in an environmental assessment prepared under the National Environmental Policy Act (NEPA), “essentially stopped without assessing the possibility of harm to the natural salmon species in the unlikely event of [GE] salmon establishing themselves in the wild,” U.S. District Judge Vince Chhabria said in a ruling issued Thursday.
Chhabria also found that FDA violated the Endangered Species Act (ESA) by not adequately looking at the potential impacts on listed fish species.
The judge declined to shut down operations at the Indiana facility where AquaBounty is currently raising fish and making “continued progress towards the first-ever commercial scale harvest of AquAdvantage salmon,” AquaBounty CEO Sylvia Wulf said Wednesday in releasing the company’s third-quarter results.
Chhabria said that “revoking the [FDA’s] 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 NEPA and ESA errors on remand.”
In a statement, Wulf said while the company was "disappointed with some of the conclusions reached in the judge’s decision, ... we remain confident in the robust scientific studies and review that resulted in the 2015 FDA approval." She added that "this case did not call into question FDA’s approval regarding the health and safety of our AquAdvantage salmon." Instead, "the focus of this decision was on the potential environmental impacts, and the judge confirmed the 'low' threat to the environment of our salmon."
The decision "will not have an impact on our ongoing 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. AquaBounty intervened on the side of the FDA in the case.
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“The absolute last thing our planet needs right now is another human-created crisis like escaped genetically engineered fish running amok," said George Kimbrell, legal director at the Center for Food Safety and counsel in the case. CFS and Earthjustice represent plaintiffs including the Institute for Fisheries Resources and Pacific Coast Federation of Fishermen's Associations.
“FDA’s error in failing to completely analyze the risks to wild salmon in the event that engineered salmon escape and establish a population base is important in light of the significant possibility that more engineered salmon will be produced and farmed at additional facilities in the future,” the judge said.
“But 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, for that matter, the Indiana facility) is low,” he said.
AquaBounty produces eggs at a facility on Prince Edward Island.
The company says it is "raising its disease-free, antibiotic-free salmon in land-based recirculating aquaculture systems, offering a reduced carbon footprint and no risk of pollution of marine ecosystems as compared to traditional sea-cage farming."
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This story was updated to include comments from AquaBounty.
