February 15, 2013


 Agency says GE salmon unlikely to harm U.S. environment

Posted Jan. 30, 2013  
A Massachusetts-based company’s salmon, genetically engineered to grow more quickly than wild salmon, are unlikely to escape and damage environments in the U.S., federal officials said in two reports provided in December 2012.

The documents published by the Food and Drug Administration indicate the agency did not consider how the salmon could affect the environment in Canada, where AquaBounty Technologies would produce its salmon eggs, or Panama, where the salmon would be grown to market size, other than as needed to identify any potential effects on U.S. environments. The assessment does note that the sal­mon, known as AquAdvantage salmon, would be effectively sterile and grown in land-based, freshwater culture facilities, not in the ocean net pens or cages used to farm other fish.

The agency is accepting comments on the documents through Feb. 25. The two documents include a draft environmental assessment and a preliminary “Finding of No Significant Impact.”

AquaBounty claims that its triploid female Atlantic salmon grow to market size in half the time of conventional Atlantic salmon. The company uses an rDNA construct that contains gene-coding sequences from ocean pout and Chinook salmon.

The FDA is evaluating the rDNA construct as a new animal drug because of its effects on the fish, and the environmental assessment is part of that evaluation.

The FDA noted in its draft environmental assessment that, if the agency denied AquaBounty’s drug application, the company could still produce and sell the salmon outside the U.S., making the effects on the U.S. environment “highly uncertain.”

“Because production of AquAdvantage Salmon would be possible at any number of locations worldwide, under different containment conditions, and potentially within areas where native Atlantic salmon are present, there are too many variables and unknowns to perform a comprehensive assessment and make any predictions with respect to potential environmental impacts on the United States,” the assessment states.

The documents and instructions on providing comments are available under docket number FDA-2011-N-0899 at www.regulations.gov.