This means AquaBounty Technologies can legally bring its GMO AquAdvantage Salmon eggs into the US from Canada and grow the fish for food at the company's contained facility in Indiana.
"Additionally, as part of its approval, the FDA also analyzed the potential environmental impact that an approval of the AquAdvantage Salmon application would have on the USA environment and published its final Environmental Assessment and Finding of No Significant Impact in November 2015". AquaAdvantage Salmon contains intentional genomic alterations (IGAs) and is genetically engineered to reach market size more rapidly than its non-GE, farm-raised Atlantic salmon counterpart.
"Instead of opening the market to high-cost, risky technology like GMO salmon - particularly in this time of weakened government oversight - we need to reinvest in protecting our wild rivers and wild fish", said Rose Marcario, CEO of the clothing company Patagonia. "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." he claimed.
"With the deactivation of the import alert, AquAdvantage Salmon eggs can now be imported to the company's contained grow-out facility in IN to be raised into salmon for food".
The administration finally lifted the import alert after the Congress brought into effect its latest National Bioengineered Food Disclosure Standard, which the agency believes meets the labeling requirements. The FDA, after years of review, had deemed food from the AquaAdvantage Salmon safe to eat in 2015 and said there is no biological difference between these salmon and nongenetically engineered salmon.
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She said the salmon already has been sold in limited quantities in Canada, where it doesn't have to be labeled as genetically modified.
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.
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. The FDA also studied the environmental impact of the genetically engineered fish and found that it "would not cause a significant impact on the US environment".
"We are delighted that FDA has lifted the import alert, which will allow AquaBounty to begin producing and marketing AquAdvantage Salmon in the United States", said Sylvia Wulf, Chief Executive Officer of AquaBounty.
While the salmon are bred to be sterile females, AquaBounty's own research suggests that it would be hard to guarantee all salmon are indeed sterile, he tells the AP, and there are concerns about the engineered fish breeding with wild salmon. Wulf said she doesn't expect the pending lawsuit to affect the company's USA plans.
In a statement to FOX Business, AquaBounty said if all goes well, it plans to have its first harvest by the Fall of 2020.