The FDA published its draft environmental assessment on Boxing Day — one of the final steps in what has been a 17-year regulatory process.
It's a major step, said Ron Stotish, CEO of AquaBounty Technologies, the Massachusetts-based company that produces the GM salmon eggs at its AquaBounty Farms facility in Prince Edward Island and rears the fish at a fish farm in Panama.
"The revival of the science-based review process is encouraging and we look forward to a successful conclusion based on the merit of the product," Stotish, who was not immediately available for comment, said in a statement.
The U.S. agency notes in its 145-page report and an accompanying document that it has assessed the environmental impact of the salmon in the United States, not in Canada or Panama.
"FDA has carefully considered the potential environmental impacts of the proposed action and at this time has made a preliminary determination that this action would not have significant effect on the quality of the human environment in the United States," the agency said.
The AquAdvantage salmon, developed at Memorial University and the University of Toronto, consists of an Atlantic salmon egg that includes genes from Chinook salmon and an eel-like fish called the ocean pout.
The genetically engineered salmon grow twice as fast as conventional fish, reducing the rearing period to about 18 months from three years.
Critics fear the "frankenfish" could escape their onshore fish farms and affect wild populations.
"Genetic modification is really sort of untested, and over and over again it seems to be unnecessary in order to either meet food needs or solve environmental problems," said Jay Ritchlin, western region director for the David Suzuki Foundation.
"I think that the risks involved in genetic modification for food — especially when you're using cross-species modification — are enough that it's not worth doing when they don't actually solve the problems we need to solve."
Opponents have allies in Washington. Lawmakers from Alaska have unanimously opposed FDA approval for the GM salmon.
"The notion that consuming frankenfish is safe for the public and our oceans is a joke," Sen. Mark Begich said in a statement after the FDA announced the decision.
"I will fight tooth and nail with my Alaska colleagues to make sure consumers have a clear choice when it comes to wild and sustainable versus lab-grown science projects."
The FDA said the facilities in P.E.I. and Panama have been verified and validated by the agency, and the possibility that GE fish could escape and reproduce "is extremely remote."
While the first genetically modified plant crop was approved by the FDA in 1994, GM animals for human food consumption are highly controversial.
The FDA is accepting public comment on the draft environmental assessment until Feb. 25, before proceeding to a final decision.
"At this point, it is not possible to predict a timeline for when these decisions will be made," agency spokeswoman Morgan Liscinsky said Friday in an email.
It is not within the federal agency's mandate to weigh the ethics or policy around biotech foods, and the FDA has already found that the AquAdvantage salmon are safe to eat.
The agency does not examine ethical or policy issues around products up for approval.
"Basically all the boxes are ticked. It doesn't mean the broader consumer controversy is solved but as far as they're concerned that's not their mandate," said Alain Goubau, author of a research paper on the issue published by Harvard Law.
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