"Today, we are taking another important step by deactivating a 2016 import alert that prevented GE salmon from entering the U.S. The FDA's approval of the application related to AquaAdvantage Salmon followed a comprehensive analysis of the scientific evidence, which determined that the GE Atlantic salmon met the statutory requirements for safety and effectiveness under the Federal Food, Drug, and Cosmetic Act".
The U.S. FDA Commissioner, Scott Gottlieb stated that the changes bioengineered into the fish had been deemed both safe for the animal, for human consumption & would not impact the environment significantly as the fish are bred to be sterile & female, which theoretically eliminates the possibility of them breeding with wild salmon & contaminating natural salmon population.
"The Golden Gate Salmon Association and allied groups are now in court challenging the approval of farmed salmon carrying foreign genes that change the basic DNA of the fish", said John McManus, president, Golden Gate Salmon Association.
On Friday the FDA announced that a genetically modified type of salmon will soon be allowed to be imported and reared in the US ahead of new labelling requirements coming into force which ultimately will allow the fish to be sold to consumers.
The salmon, which has been dubbed by some as "Frankenfish", is the creation of Maynard, Massachusetts-based biotechnology company AquaBounty Technologies.
"We will immediately start the process to import AquAdvantage eggs from our hatchery in Canada to begin grow out at our in facility", said Wulf.
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Following the US Department of Agriculture's issuance of labeling guidelines on so-called bioengineered foods at the end of 2018, "the FDA believes this Congressional mandate has been satisfied", says Gottlieb in the statement. As the Washington Post noted in 2017, the fish are created to be exclusively female as well as sterile, though the process is not entirely effective, and AquaBounty's Prince Edward Island facility is surrounded by salt water, where it believes the eggs can not survive. Therefore, the FDA is deactivating the import alert that prevented food from AquAdvantage Salmon, including salmon eggs used to grow the fish, from entering the U.S. "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".
- US regulators on Friday gave the green light to salmon genetically modified to grow about twice as fast as normal.
Citing the finalization of labeling guidelines, Congress had initially directed the FDA to block the import & sales of any foods that contained the fish. An alliance of public interest, environmental and pro-fishing groups is in the midst of suing the FDA to overturn the approval on safety grounds.
Congress said rules on how genetically modified food is labeled had to be implemented first.
AquaBounty CEO Sylvia Wulf said the company expects to get a final certification for its Albany, Indiana, growing facility in the coming weeks and the salmon will take about 18 months to grow to a harvest size of 10 pounds after they arrive.