"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 salmon bear labelling indicating that it is bioengineered", Gottlieb said in a statement.
More than three years after the FDA approved, for the first time, a genetically engineered animal as safe to eat, the government opened the door for AquaBounty Technologies to grow and sell its GE salmon in the U.S. The salmon have been modified with DNA from other species of fish to allow them to grow roughly twice as fast as regular salmon.
Congress said rules on how genetically modified food is labeled had to be implemented first. The move, announced on Friday (March 8), will allow AquaBounty to import AquAdvantage salmon eggs from its research and development center in Canada, grow them in the U.S., and then sell them as food labeled "bioengineered", although the company is likely to face further challenges before it can do so.
Congress in 2016 directed the FDA not to allow food into the US that contained genetically engineered salmon until the agency implemented superior labeling guidelines for informing people that certain foods contained the altered salmon.
In the announcement Friday, the FDA said Congress mandated that the U.S. Department of Agriculture set standards for disclosing whether a food is bioengineered, and the FDA no longer had the authority to issue labeling guidance on the topic. 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. Aquabounty chief Sylvia Wulf told the AP she expected certification for an IN growing facility IN "weeks" and could receive eggs soon afterward, but it would take about 18 months for the salmon to reach their target weight.
In late 2015, just after FDA approval of the GE salmon, activists said they had commitments from 10 US grocery chains not to sell the salmon.
George Kimbrell, legal director for the Center for Food Safety, which is one of the groups suing the FDA, told The Associated Press that AquaBounty's own tests have shown it's not 100 percent certain its salmon would be sterile and that concerns about it getting in the enivornment would grow if the company's operations were to expand. Wulf said she doesn't expect the pending lawsuit to affect the company's USA plans.