Update on the Regulatory Journey of the AquAdvantage Genetically-Engineered Salmon

Although the first transgenic or genetically engineered (GE) animals were developed almost 30 years ago, no GE animals have yet been commercialized for food production. An application to allow a fast-growing GE (AquAdvantage) salmon to enter the food supply was presented at a Food and Drug Administration (FDA) public advisory committee meeting in September 2010. The FDA concluded that AquAdvantage salmon were as safe to eat as food from conventional Atlantic salmon, and that they were not expected to have a significant environmental impact when reared with the multiple physical, biological, and geographic/geophysical containment measures detailed in the application. Unfortunately for the sponsor this public meeting was used an opportunity for opponents of GE animals to cherry pick data from the application and formulate menacing sound bites about cancer risks, allergens, and Trojan horses. There would appear to be little benefit to society if attempts to increase public participation in the regulatory process are used as an opportunity to vilify technology. Further, in 2011 the U.S. House of Representatives passed a budget amendment “to prohibit the use of FDA funds to approve any application for approval of genetically engineered salmon”. The protracted evaluation of the AquAdvantage salmon and political intervention in the FDA’s science-based review process have essentially halted commercial and public investment in the development of GE animals for food applications in the United States. This outcome has broad implications for the competitiveness of U.S. agriculture and the future geographic location of GE animal research, development, and production.