The Food and Drug Administration approved yesterday a genetically engineered salmon as fit for consumption and said it would not be labeled as genetically engineered. This is the first genetically altered animal to be cleared for sale in American supermarkets.
The FDA approval caps a long struggle for AquaBounty Technologies, based in Maynard, Massachusetts, that first approached FDA about approval in the 1990s. FDA made an initial determination that the fish would be safe to eat and safe for the environment more than five years ago. FDA officials said that the process took so long because it was the first approval of its kind.
The AquAdvantage salmon, as it is called, is an Atlanta salmon that has been genetically modified so that it grows to market size faster than salmon that is not genetically engineered. The AquaAdvantage salmon can grow to market weight in 18 to 20 months as opposed to 28 to 36 months for conventionally farmed salmon.
“FDA has thoroughly analyzed and evaluated the data and information submitted by AquaBounty regarding the AguAdvantage 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.
FDA said the fish would not have to be labeled as genetically engineered, which is consistent with its stance on widely eaten foods made from genetically modified crops, such as corn and soybeans. Since there is no material differences between the genetically engineered salmon and a conventional salmon, FDA said it does not need to be labeled. FDA did issue a draft guidance as to wording that companies could use to voluntarily label the salmon as genetically engineered or to label other salmon as not genetically engineered.
FDA also said that to approve the salmon, it determined that the fish was safe to eat, that the inserted genetic elements did not harm the fish itself, and that the company had adequately proved that the salmon grew faster.
AquaBounty said their salmon would not be in stores soon because it would take about two years for even these fast-growing salmon to reach market size. The company’s production facility is in Panama and has the capacity to produce about 100 tons of fish a year, compared with the more than 200,000 tons of Atlantic Salmon imports each year. The fish, raised from eggs produced in Prince Edward Island, Canada, are raised inland in contained tanks to lessen the chance that they will escape into the wild. The salmon are also made sterile to prevent reproduction in the event they do escape, although the sterilization technique is not foolproof.
According to a regulatory filing by AquaBounty a year ago, the company said that after winning FDA approval, it would look to build a hatchery in the United States and expand the one in Canada to sell more eggs to fish farmers, who would then grow the salmon to market size.
A Vermont law requiring labeling of genetically engineered foods will take effect in July unless food industry groups succeed in getting it blocked by a court. The House of Representatives has passed a bill that would pre-empt state laws, such as the one passed in Vermont. The Grocery Manufacturers Associations and other groups have been pushing the Senate to pass a similar measure.
The Center for Food Safety, a consumer advocacy group, said it and other such organizations would file a lawsuit challenging the approval.
Some supermarkets have already said, in response to opposition, that they have no plans to sell the genetically engineered salmon.