For the first time, the FDA has approved a genetically engineered animal as food—the AquAdvantage Salmon.
The agency said the particular genetic modification introduced into the salmon meets the definition of a drug. The fish has a growth hormone gene from a Chinook salmon and a promoter sequence from another edible fish, the ocean pout, which activates the growth hormone gene. The result is an Atlantic salmon that reaches market size much more quickly than traditional farm-raised Atlantic salmon (http://1.usa.gov/1MEDh2k).
The genetically modified salmon’s producer, AquaBounty Technologies of Maynard, Massachusetts, “met the regulatory requirements for approval, including that the food from the fish is safe to eat,” Bernadette Dunham, DVM, PhD, director of the FDA’s Center for Veterinary Medicine, said in a statement (http://1.usa.gov/1PChNZK).
Besides being safe for human consumption, the Federal Food, Drug, and Cosmetics Act requires that the genetic modification be safe for the fish and that the company’s claims of faster growth are accurate. The FDA said its comprehensive review of the scientific evidence also showed that the genetically engineered fish is as nutritious as nonmodified farm-raised Atlantic salmon.
AquAdvantage Salmon are raised in land-based hatchery tanks in Canada and Panama. The FDA approval specified that no other locations, in the United States or elsewhere, are authorized to breed or raise the genetically modified fish for US consumption. The agency said its environmental assessment showed production methods won’t cause harm because the fish and eggs are blocked from escaping the tanks. Also, they can’t interbreed or establish populations in the wild.
Because the genetically engineered salmon aren’t substantially different than conventional farm-raised Atlantic salmon, the FDA doesn’t require special labeling.