Federal regulators on Thursday approved a genetically engineered salmon as fit for consumption, clearing the way for the first genetically altered animal to reach American supermarkets and dinner tables.
Food and Drug Administration reviewers made their initial determination that the fish would be safe to eat and for the environment more than five years ago, an unusually long period between preliminary and final approval.
The salmon has been fiercely opposed by consumer and environmental groups, which have argued that the safety studies were inadequate and that wild salmon populations might be affected if the genetically engineered fish were to escape into the oceans and rivers.
The AquAdvantage salmon, as it is known, is an Atlantic salmon that has been genetically modified so that it grows to market size faster than a conventional farmed salmon. It was developed by AquaBounty Technologies, which is now majority-owned by the Intrexon Corporation.
“The FDA has thoroughly analyzed and evaluated the data and information submitted by AquaBounty regarding the 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 agency’s Center for Veterinary Medicine, said in a statement.
It was not clear how soon the salmon will reach supermarkets. It is expected to take the company some time, perhaps years, to raise enough of the fish.
And consumer opposition could be strong. A number of supermarkets have already said, in response to environmentalists, that they have no plans to sell the salmon.
“This unfortunate, historic decision disregards the vast majority of consumers, many independent scientists, numerous members of Congress and salmon growers around the world, who have voiced strong opposition,” Wenonah Hauter, executive director of the group Food and Water Watch, said in a statement.
It was also not immediately clear whether the salmon would be labeled so that consumers would know its origins. The agency indicated that labeling would not be mandatory, a decision that is consistent with its position on foods made from genetically engineered crops, which is that genetic engineering in and of itself does not necessarily make a material change in the food.
But on Thursday, the FDA issued two documents providing guidance to companies on how to voluntarily label their foods to indicate whether it was made using genetic engineering. One is a draft guidance aimed at the salmon, and the other is final guidance for genetically modified crops.
The fish are supposed to be raised indoor to lessen the chances that they will escape into the wild. AquaBounty says this will also be less stressful on the environment and could eventually allow the fish to be raised in the United States, rather than being imported, as most farmed Atlantic salmon is.
“Using land-based aquaculture systems, this rich source of protein and other nutrients can be farmed close to major consumer markets in a more sustainable manner,” Ronald L. Stotish, chief executive of AquaBounty, said in a statement on Thursday.
For now, however, the fish are being raised in Panama, from eggs produced in Prince Edward Island, Canada. Approval to breed or raise the salmon elsewhere, for marketing to Americans, would require separate approvals.
Environmentalists in Canada have sued the government to halt production of the eggs. A hearing in that case was held this week.
The approval could help other efforts to develop genetically modified animals. Scientists and biotechnology industry executives have complained that the long, unexplained delay in approving the salmon was a deterrent to the field. Several other attempts to develop genetically engineered animals for consumption, like a pig whose manure would be less polluting, have fallen by the wayside.
Now, however, there has been a surge of interest in developing new genetically altered farm animals and pets because new techniques, including one known as Crispr-Cas9, allow scientists to edit animal genomes rather than add genes from other species. That has made it far easier to create altered animals.
Scientists in China, for instance, recently created goats with more muscle and longer hair. Researchers in Scotland used gene editing to create pigs resistant to African swine fever. It is not clear yet whether animals created this way would even fall under FDA regulation.
The AquAdvantage salmon contains a growth hormone gene from the chinook salmon and a genetic switch from the ocean pout, an eel-like creature, that keeps the transplanted gene continuously active, whereas the salmon’s own growth hormone gene is active only parts of the year. The company has said the fish could grow to market weight in as little as half the time of a conventionally farmed salmon.
Opponents of the fish say that if the bigger fish were to escape, they could outcompete wild salmon for food or mates. Other scientists have dismissed these concerns. The FDA said on Thursday that there were multiple physical barriers in the Canada and Panama facilities to prevent this. The salmon are also made sterile to prevent reproduction in the event they do escape. However, the sterilization technique is not foolproof.
AquaBounty first applied for approval of the salmon in the 1990s, but it took years to determine what data would be needed and how the salmon would be regulated. In 2010, the FDA tentatively concluded the fish would be safe for people and the environment. In September of that year, an advisory committee found some fault with the FDA’s analysis but did not in general challenge the overall conclusions. Then in December 2012, the FDA released a draft environmental assessment that also concluded that salmon would pose little risk to the environment.
The FDA regulates genetically engineered animals as veterinary drugs, using the argument that the gene inserted into the animal meets the definition of a drug.
The New York Times