A short summary followed by the Highlights of the report in nine questions.
SHORT SUMMARY The salmon evaluated by the FDA is a genetically modified (“engineered” or also “transgenic”) Atlantic salmon to be produced and grown under specified conditions. This fish, named AquAdvantage Salmon, is a triploid (effectively sterile) female fish containing a rDNA construct designed to exhibit a rapid-growth phenotype that allows it to reach smolt size (or approximately 100 g) faster than non-genetically modified farmed salmon. The objective of the project is to meet increasing demand for fish protein in light of declining stocks and diminishing capture of wild fish.
FDA has made the preliminary determination, based on the evidence collected and evaluated, that it is reasonable to believe that approval of the AquAdvantage Salmon NADA will not have any significant impacts on the quality of the human environment of the United States, and on the populations of endangered Atlantic salmon when produced and grown under the conditions of use for the proposed action.
The US-FDA regulates animals containing rDNA constructs under the new animal drug provisions of the FD&C Act, must meet environmental review requirements under the National Environmental Policy Act (NEPA) and FDA’s regulations.
The FDA’s Center for Veterinary Medicine (CVM) has evaluated both the direct and indirect food safety impacts of AquAdvantage Salmon and any potential impacts of the rDNA insertion on target animal safety. CVM has also thoroughly evaluated the potential environmental impacts of approving an NADA for AquAdvantage Salmon.
The potential hazards and harms to the environment include the hypothesis that the transgenic salmon would escape the conditions of confinement but, as the transgenic salmon would be produced and grown-out in secure facilities that have been verified and validated by FDA, the possibility that transgenic fish could escape from containment, survive and reproduce is extremely remote. In addition, because populations produced will be triploid (effectively sterile), all-female animals, the possibility of their reproducing in the wild is likewise extremely remote. FDA, has also considered that approval of the AquAdvantage Salmon will not jeopardize the continued existence of United States populations of threatened or endangered Atlantic salmon.
The potential effects on the local environments of Canada and Panama have not been considered and evaluated in this draft assessement because the US NEPA does not require an analysis of environmental effects in foreign sovereign countries, except if there would be significant effects on the environment of the United States.
With respect to food safety, FDA has concluded that food from AquAdvantage Salmon is as safe as food from conventional Atlantic salmon, and that there is a reasonable certainty of no harm from consumption of food from triploid AquAdvantage Salmon.
1. What is the genetically modified (“engineered” or also transgenic) salmon which is evaluated by the FDA?
The development of a genetically modified salmon is the end result of advances in genetic engineering within the past 30+ years. Recombinant DNA technology was first used to produce genetically modified (engineered or transgenic) animals in 1973. Although initial interest centered primarily on mammals, by the late-1990s, genetically modified (or engineered – GE) carp, trout, loach, tilapia, catfish, and salmon had been produced.
AquaBounty Technologies, Inc. (ABT or the sponsor) has provided data and information in support of a New Animal Drug Application (NADA) for a genetically modified Atlantic salmon1 to be produced and grown under specified conditions. This fish, named AquAdvantage Salmon, is designed to exhibit a rapid-growth phenotype that allows it to reach smolt size (or approximately 100 g) faster than non-genetically modified farmed salmon.
The AquAdvantage Salmon founder animal was generated in 1989 by micro-injecting a recombinant deoxyribonucleic acid (rDNA) construct, composed of a element from an ocean pout antifreeze protein gene and a protein-coding sequence from a chinook salmon growth hormone gene into the fertilized eggs of wild Atlantic salmon. Continue reading