AquaBounty's genetically altered salmon adds a growth hormone from a Chinook salmon and a gene from an eel like fish, the ocean pout, causing the salmon to grow more quickly, and is the first submission for approval for sale of genetically engineered animals for food in the United States. It is assumed that the approval by the FDA will open the floodgates to a large number of genetically engineered animals being produced for use as food or medicines.
AquaBounty also is currently developing a genetically engineered trout and a genetically engineered tilapia.
Companies in the U.S. and other countries are working to develop other genetically engineered fish as well as cows and pigs. The FDA has received an outpouring of negative response from politicians, the scientific community and the public, concerned about possible FDA approval of the AquaBounty genetically engineered salmon and the genetic engineering of animals for food and medicine generally.
Senator Begich, along with ten members of the Senate, and Congressmen Peter DeFazio (D-OR), Dennis Kucinich (D-OH) and Mike Thompson (D-CA), along with 29 members of the House of Representatives, sent separate letters to the FDA asking them to halt the approval, and to address the serious problems with the FDA's approval process. Over 300 environmental and public health groups signed letters to the FDA opposing the approval.
The FDA requested input from the National Academies of Science about possible science based concerns about the genetic engineering of animals. The National Academies of Science stated in their response, that in many of the genetically engineered animals, "the genetic engineering often resulted in unplanned anatomical, physiological or behavior abnormalities."
The FDA's 2008 document regarding the commercial approval of genetically engineered animals, the "Guidance of Regulation of Genetically Engineered Animals", resulted in almost 29,000 public comments in response. The FDA noted that of these comments, "the vast majority opposed the genetic engineering of animals."
Another issue that has been raised is the FDA's classification of the genetically engineered salmon, and all other genetically engineered animals as a drug rather than a food product, although they are being sold as food products. This classification serves to bypass the regulatory requirement that forms the base for the FDA's oversight of animals that will be used for food to monitor the animal's health in order to assure the health of the U.S. food supply.
The allowance of the genetic engineering of animals, which is more likely to harm the animal's health and their suitability as a food source was one of the concerns that the FDA noted was raised in their public as well as scientific responses regarding the genetic engineering of animals. In addition, there are concerns that genetically engineered animals may cause allergic reactions in sensitive people.
Calling them "Frankenfish", Senator Begich likened the genetically engineered salmon to a "monster that threatens our wild stocks and their habitat, our food safety and economic harm to Alaska wild salmon fisherman." The risk of the genetically engineered salmon threatening the native Atlantic salmon population is one of the greatest concerns about the approval of the genetically engineered salmon.
AquaBounty stated in their application for approval to the FDA that they will use two containment methods to assure that the Alaska wild salmon population would not be at risk; sterilizing the genetically engineered salmon eggs that will be produced on Prince Edward Island in Canada, and physical containment where the fish will be grown in Panama.
AquaBounty has stated that they would be complying with the regulatory guidelines of each country where they are involved. Although the Canadian government must be notified before any genetically engineered animals can be imported or commercially manufactured in Canada and an assessment done to assure that they are not a threat to the environment, Leo Broderick, vice chair of the Council of Canadians, as part of a larger coalition of public action groups in Prince Edward Island, said that neither AquaBounty nor Environment Canada have responded to requests as to whether an environmental risk assessment is being done. The group has asked Prince Edward Island Premier, Robert Ghiz, to press Environment Canada for more transparency.
Even if the containment methods were being implemented fully, there are concerns about the effectiveness of both means of containment. The sterilization means of containment that AquaBounty will be using, Triploidy chromosomal sterilization, is less than 100% effective. The FDA is required to consult with the U.S. Fish and Wildlife Service (FWS) in order to decide whether the approval would pose a danger to wild Atlantic salmon. In FSW documents made public in a Freedom of Information Act request, by the organization, Food and Water Watch, government officials expressed doubts that the containment methods will keep the genetically engineered salmon from threatening wild Atlantic salmon. They also raised other concerns about the genetic engineering of the salmon in general. The internal FSW documents questioned the FDA's ability to decide about the threats to the native Atlantic salmon population, saying that the process presented a situation, "where FDA, whose jurisdiction is not focused on natural resources is entrusted with the authority to approve an application which poses such a threat to the country's natural resources." In a letter summing up it's recommendations to the FDA, the FSW, noted that there were "several unknowns and uncertainties regarding possible genetic, ecological and environmental effects of AquaAdvantage salmon that must be elucidated before an environmental risk assessment can be thoroughly evaluated and approved." Which, said the FSW, "suggests that the approval of AquaBounty Technologies' request for commercial rearing of AquaAdvantage was premature."