"However, the FDA believes this Congressional mandate has been satisfied by the USDA's issuance of final regulations implementing that law in late 2018 because the law and regulations require that human food containing GE [genetically engineered] salmon bear labeling indicating that it is bioengineered", Gottlieb said in a statement.
The salmon is the only genetically modified animal approved by the FDA to be sold as food to humans, though many other products are likely to follow in AquaAdvantage's wake.
With the ban lifted, salmon eggs from AquAdvantage, a company that genetically modifies Atlantic salmon, can be imported into the company's contained growth facility in IN to be raised into salmon for food.
In context: The U.S. has long used genetically modified (GM) plant crops in its food chains, but so far has had no GM animals on sale for human consumption.
According to the FDA, it complied with the guideline by blocking modified salmon from entering the U.S. However, after Congress enacted the National Bioengineered Food Disclosure Standard relating to food labels in December, the FDA has made a decision to deactivate the import alert.
Congress said rules on how genetically modified food is labeled had to be implemented first. But in 2016, Congress asked the agency to block the salmon from being sold while lawmakers were agreeing on labeling guidelines aimed at informing consumers about the production of engineered foods.
The move comes despite a lawsuit challenging the FDA's original approval of the fish. "This fish is safe to eat, the genetic construct added to the fish's genome is safe for the animal, and the manufacturer's claim that it reaches a growth marker important to the aquaculture industry more rapidly than its non-GE farm-raised Atlantic salmon counterpart is confirmed".
By lifting the alert, the FDA is allowing AquAdvantage Salmon eggs to be imported to a facility in IN where the eggs can be grown into fish for food.
What's more, the FDA said it analyzed the potential impact the genetically modified salmon would have on the environment and it found no "significant impact". AquaBounty says this won't be an issue for their salmon, as they are raised in tanks, are modified to be all female, and are sterile.
In a news release, AquaBounty's CEO Sylvia Wulf said the company is aiming to send the eggs to its plant in IN, where they will be hatched and grown to market size.
George Kimbrell, legal director for the Center for Food Safety, one of the groups suing the FDA, said the company's tests shows it's not 100 percent certain the fish would be sterile, and concerns about it getting in the environment would grow if the AquaBounty's operations were to expand. AquaBounty said its GE salmon would reduce US reliance on imported seafood.