On November 19th, the FDA approved genetically engineered salmon as safe for humans and animals to consume, making it the first genetically modified animal to receive such approval.  The decision is a historic one, as the FDA is the first agency to approve a genetically modified animal as safe for consumption.

The genetically modified salmon, produced by AquaBounty Technologies (AquaBounty), can grow to market size faster than unmodified, farm-raised salmon. AquaBounty genetically modifies the salmon by inserting a new gene into fertilized salmon eggs.  The inserted gene increases the production of a fish growth hormone, resulting in a type of salmon that can grow twice as quickly as unmodified, farm-raised salmon.

AquaBounty created the genetically engineered salmon, known as AquAdvantage salmon, 25 years ago and has been seeking approval to sell the fish to consumers ever since. Five years ago, the FDA concluded that AquAdvantage salmon would not harm the environment and was safe to eat; however, the FDA did not approve the fish for human or animal consumption until this week.

The FDA also announced that the AquAdvantage salmon does not have to be labeled at the point of sale as genetically altered. The director of the FDA’s Center for Food Safety and Applied Nutrition, Susan Mayne, explained that the FDA can only require mandatory labeling of genetically engineered food if the agency discovers a “material difference” when comparing the genetically modified product with its traditionally produced counterparts.  Because the FDA did not find any material differences between AquAdvantage salmon and farm-raised salmon, labeling disclosing that AquAdvantage salmon is genetically engineered will not be required.

Despite the approval, some limitations for AquaBounty’s production of the genetically modified salmon remain. FDA is requiring that AquaBounty raise the genetically engineered fish in tanks on land at two approved sites – one in Canada and one in Panama.  In addition, AquAdvantage salmon will be sterile, so that should the fish escape into the ocean, they will not be able to reproduce with wild salmon.

Food safety and environmental groups have indicated they intend to contest FDA’s approval action. In one case, the Center for Food Safety announced today that it plans to sue the FDA to block the approval of AquAdvantage salmon.