The FDA had concluded the GE salmon was safe in 2015.
FDA stated, in a press release, that it believes that the Congressional mandate was satisfied when the U.S. Department of Agriculture (USDA) issued the final rule implementing the National Bioengineered Food Disclosure Standard (for more information on the final rule, see our December 20, 2018 blog).
FDA Commissioner Scott Gottlieb stressed that the genetic changes had been deemed safe for the animal, safe to eat and wouldn't have a "significant" impact on the environment.
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. However, U.S Congress passed a law in 2016 mandating the formation of labelling guidelines informing customers that the fish was genetically modified-standards that weren't finalised until late past year. However, as of now, only a limited number of the genetically modified salmons are available in Canadian markets.
The FDA may be using the USDA's final labeling rule to justify lifting the import alert, but this move could backfire if sufficient numbers of consumers become aware that AquAdvantage Salmon is genetically engineered.
"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". AquaBounty figured out a way to use a growth hormone-regulating gene from Pacific Chinook salmon, along with a promoter gene from ocean pout, an eel-like marine animal, in order to grow genetically modified Atlantic salmon year-round instead of only during the spring and summer. "We think a remedy in our case would stop sale of the fish before they're allowed to be sold", he adds.
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"Approximately 350,000 tons of Atlantic salmon are consumed in the United States with more than 95% of it imported".
"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.
Now passed, the salmon eggs come from a company facility in Prince Edward Island, Canada.
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. Wulf said she doesn't expect the pending lawsuit to affect the company's US plans.
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.
In a statement to FOX Business, AquaBounty said if all goes well, it plans to have its first harvest by the Fall of 2020.