FDA lifts import alert on GE salmon

The US Food and Drug Administration (FDA) has deactivated a 2016 import alert that prevented genetically engineered (GE) AquAdvantage Salmon from entering the US following 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 FDA had concluded the GE salmon was safe in 2015. However, in 2016, US Congress directed it not to allow any food that contained GE salmon to be sold until it had  issued final labelling guidelines for informing consumers of the GE salmon content in food. The FDA complied with this requirement, which is why an import alert was issued in 2016. Final labelling guidelines were implemented by the United States Department of Agriculture (USDA) at the end of 2018, at which point the alert could be lifted. 

The deactivation of the import alert means that AquAdvantage Salmon eggs can now be imported to the company’s contained grow-out facility in Indiana to be raised into salmon for food. Says the FDA, “As was determined during the FDA’s 2015 review, 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.”

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 US environment and published its final Environmental Assessment and Finding of No Significant Impact in November 2015. Based on the multiple forms of physical and biological environmental containment measures proposed by the company in its application, the FDA found that an approval of AquAdvantage Salmon’s application would not cause a significant environmental impact.