FDA acts on biotech salmon

FDA acts on biotech salmon

- Assessment goes to public comment. - Company and industry say final decision could take months. - Critics claim studies were inadequ

THE Food & Drug Administration has issued its draft environmental assessment of AquaBounty Technologies' genetically engineered salmon, concluding that the salmon would have "no significant impact" on the environment.

The assessment, released Dec. 21, will be open for public comment for 60 days, after which FDA will develop its final assessment.

FDA noted that it isn't possible to say when a final decision may be made, but Biotechnology Industry Organization and company officials said the final assessment could take weeks or even months.

AquaBounty, headquartered in Maynard, Mass., has been seeking approval for its biotech salmon for more than a decade.

The company's AquaAdvantage salmon is an Atlantic salmon that contains a growth hormone gene from the Chinook salmon and a "genetic switch" from the ocean pout, according to AquaBounty.

That switch keeps the growth hormone gene constantly turned on, allowing the fish to reach market weight in 18 months instead of the three years required for wild salmon, the company said.

Eggs would be produced at a facility in Prince Edward Island in Canada and shipped to Panama, where they would be hatched and grown in inland tanks that would have multiple barriers to prevent escape.

FDA initially determined in 2010 that the salmon are safe to eat, a determination that was supported by an expert panel.

The salmon would be the first genetically engineered animal to enter the food supply.

However, a number of consumer and environmental groups criticized FDA's findings, including the Center for Food Safety and Consumers Union, the advocacy and policy arm of Consumer Reports, which dismissed the findings outright.

Critics claimed that samplings to determine the safety of eating the fish were insufficient and said a more thorough environmental impact statement should be conducted.

FDA's 158-page report is available at www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/GeneticEngineering/GeneticallyEngineeredAnimals/ucm280853.htm.

Volume:84 Issue:54

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