The US Food and Drug Administration (FDA) has released a draft amended Environmental Assessment (EA) following a 2020 court ruling to re-examine the environmental risks of allowing AquaBounty's genetically modified salmon to be grown in the United States.
The FDA approved the company’s application to produce and sell the genetically engineered salmon in the United States in 2015, marking the first time a genetically engineered animal was approved safe for human consumption.
The draft amended EA has reevaluated the potential risk to the US environment from production of the GM eggs at all AquaBounty's operating facilities on Prince Edward Island, Canada, including the Bay Fortune and Rollo Bay facilities.
AquaBounty CEO Sylvia Wulf said that like the review in 2015, the amended assessment "once again concluded there is a 'negligible likelihood' that our product would 'cause significant harms' or even 'effects on the environment of the US.'"
Specifically, the draft said there is "negligible likelihood that any eggs or fish of any life stage of ABT (AquaBounty) salmon could escape into the wild and cause effects on the environment of the US."
The agency also announced a virtual public meeting scheduled for Dec. 15 where it will be asking if there are "any potential environmental impacts on endangered Atlantic salmon or their critical habit in the United States that were not identified or evaluated" in the draft.
"We are continuing to review FDA’s amended Environmental Assessment and are confident this process will affirm the extremely low likelihood that our salmon could successfully establish a population in the wild," Wulf said.
