The Food and Drug Administration (FDA) has released a briefing packet in advance of public meetings to discuss a new animal drug application for genetically engineered (GE) salmon. Produced by AquaBounty Technologies, Inc. (ABT), the AquAdvantage salmon contains genes from Chinook and ocean pout that accelerate maturation. Additional details about the September 19-21, 2010, meetings appear in Issue 362 of this Update.
According to the FDA briefing packet, “[T]here are no material differences in food from ABT salmon and other Atlantic salmon.” The assessment therefore concludes that “triploid ABT salmon is… as safe as food from conventional salmon,” although it recommends further allergenicity studies for diploid salmon because the ones provided were of “low quality.” In addition, an environmental impact statement (EIS) has found that the fish “are not expected to have a significant impact on the quality of the human environment.” As the EIS summary notes, the probability of AquAdvantage salmon escaping either the egg production or grow-out facility “is extremely small” due to physical containment barriers and inhospitable waters.
If approved by FDA, ABT could reportedly bring AquAdvantage salmon to market within two to three years. The company’s application, however, has already met opposition from a coalition of consumer groups that have launched a campaign challenging the FDA assessment. “While some materials released today relate to the transfer of the genes and DNA construct, and the chemistry of small samples of the flesh of the GE fish were compared to that of other farmed salmon, no data from long-term clinical feeding trials were required,” stated the Center for Food Safety in a September 3, 2010, press release that echoed U.S. Representative Dennis Kucinich’s (D-Ohio) call for an extended public comment period. See The New York Times, September 3, 2010.