AquaBounty cleared to export GM salmon eggs to U.S.

13 March, 2019, 03:27 | Author: Kelly Sanders
  • U.S. regulators clear path for genetically modified salmon

In late 2015, just after FDA approval of the GE salmon, activists said they had commitments from 10 USA grocery chains not to sell the salmon.

The FDA says those standards are in place, so the salmon eggs can be imported to a facility in Indiana. "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.

U.S. Food and Drug Commissioner Scott Gottlieb, M.D., announced on March 8, that the Agency was deactivating a 2016 import alert that prevented genetically engineered (GE) salmon from entering the U.S. By way of background, in 2015, FDA approved a New Animal Drug Application (NADA) related to AquAdvantage Salmon after determining that it met the statutory requirements for safety and effectiveness under the Federal Food, Drug, and Cosmetic Act.

Additionally, as part of its approval, the FDA also analysed the potential environmental impact that an approval of the AquAdvantage Salmon application would have on the U.S. environment and published its final Environmental Assessment and Finding of No Significant Impact in November 2015.

The ban on the genetic fish, however, was imposed upon a directive given to the FDA by the U.S. Congress that asked the agency to block the import & sales of any foods that contained the fish until it issued appropriate labeling guidelines that informed consumers about the GE salmon in their food.

"With Congress' enactment of the National Bioengineered Food Disclosure Standard, USDA was charged with implementing a mandatory standard for disclosing whether a food is "bioengineered" and FDA was divested of its authority over voluntary labeling to indicate the presence of GE content in human foods".


"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 company can grow the genetically engineered Atlantic salmon year-round instead of just during the spring and summer.

Now passed, the salmon eggs come from a company facility in Prince Edward Island, Canada.

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. 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. The fish is already available in limited qualities on the market in Canada, where labelling is discretionary and up to grocers, the Post added.

Wulf told AP she doesn't expect the pending lawsuit filed by a coalition of consumer, environmental and fishing groups to affect the company's US plans.

The move comes despite a pending lawsuit filed by a coalition of consumer, environmental and fishing groups that challenged the FDA's approval of the fish.

"We think a remedy in our case would stop sale of the fish before they're allowed to be sold", Kimbrell told AP.

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