The US Food and Drug Administration approved AquAdvantage Salmon as the first genetically modified food from animals, the agency said November 19 in a statement.
The agency also issued guidance for manufacturers who choose to voluntarily label their products as containing ingredients from GMO sources.
The FDA regulates genetically engineered animals under new provisions of the Federal Food, Drug, and Cosmetic Act, because the modified DNA introduced into the animal qualifies it as a drug.
The decision comes after almost two decades of efforts to win approval for the salmon.
“The FDA has thoroughly analyzed and evaluated the data and information submitted by AquaBounty Technologies regarding AquAdvantage Salmon and determined that they have met the regulatory requirements for approval, including that food from the fish is safe to eat,” Bernadette Dunham, director of the FDA’s Center for Veterinary Medicine, said in a statement.
In order to be approved, the GM salmon had to meet several requirements:
- It had to be safe to eat
- The modified DNA had to be safe for the fish
- The fish had to live up to the claims of faster growth
- The fish had to be as safe and as nutritious as non-GM Atlantic salmon, with no “biologically relevant differences” in nutrition compared to farm-raised Atlantic salmon
The GM salmon cannot be raised in the US. It can only be raised in contained hatchery tanks on land in two facilities in Canada and Panama. The FDA completed an environmental assessment to show that the salmon would not significantly impact the “human environment” in the US.
To ensure the fish don’t escape, they must be contained using multiple physical barriers, including plumbing that filters out eggs and fish. Even if the fish did escape, they are sterile, so they could not breed in the wild, according to the FDA.
Together with the Canadian and Panamanian governments, the FDA will oversee the facilities where the salmon are being raised and conduct regular inspections.
“I view the announcement of the FDA to approve the AquaBounty [genetically engineered] salmon for production in land based system as a huge win-win for the environment, consumers, and the process,” William Muir, a professor of Genetics at Purdue University, told the Genetic Expert News Service. “The scientific review is clear, there is no credible evidence that these fish are a risk to either human health or the environment.”
According to the Federal Food, Drug, and Cosmetic Act, the FDA can only require foods to be labeled as GMO if there is a material difference between the GM product and its non-GM counterpart. The FDA found no such difference between the AquAdvantage salmon and unmodified salmon.
But given consumers’ interest in knowing what’s in their food, the FDA issued two sets of guidelines for manufacturers who wish to voluntarily label foods with genetically modified ingredients. These include a draft guide for labeling foods derived from Atlantic salmon, and a final guide on foods derived from GM plants.