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US approves GE salmon facility

Atlantic Salmon Biotechnology Regulations +4 more

AquaBounty has been granted approval to raise its genetically engineered AquAdvantage strain of salmon at a facility in Indiana.

The US Food and Drug Administration (FDA) approved a supplemental New Animal Drug Application (NADA) submitted by AquaBounty Technologies to grow the fish at a land-based contained facility near Albany.

AquaBounty's AquaAdvantage salmon contains a growth-regulating gene from a Chinook salmon as well as a promoter from an ocean pout, theoretically enabling it to grow from egg to market size in only 16-18 months

The facility, which the Massachusetts-based bioengineering company bought in 2017, has the capacity to grow over 1000 tonnes of salmon per year. However, there are still further regulatory loopholes to overcome before the unit can be stocked with GE salmon eggs.

In 2015, the FDA approved a NADA related to the AquAdvantage Salmon, but this approval specified that only AquaBounty’s facility on Prince Edward Island, Canada, where the salmon eggs are produced, and the company’s grow-out facility in Panama, where fish hatch from the eggs and grow to maturity, could be used for producing AquAdvantage salmon. The FDA’s new approval applies to a specific set of conditions and requirements and does not authorize the production or grow-out of AquAdvantage salmon in any other domestic or international facilities. And an FDA Import Alert continues to remain in effect, meaning that AquaBounty cannot currently import AquAdvantage salmon, including its eggs or any food from the salmon, into the US.

Despite this, AquaBounty CEO Ron Stotish stated: “This is another milestone in our journey to bring our healthy and sustainable salmon to consumers. We are very pleased the FDA has continued their rigorous science-based review process and approved our application on its merits. Our Albany facility is within a few hours' drive of major markets in Indianapolis, Chicago, Detroit, Cleveland, Columbus, Louisville, and St Louis, providing us with tremendous opportunity for growth. We still have work to do before we can start production, but we take great pride in this latest accomplishment.”

Shannon Henry, Delaware County Commissioner, added: “We are extremely excited that a cutting-edge aquaculture company like AquaBounty chose Delaware County to grow their operation. The jobs being created at this facility and large capital investment is welcomed news. We will continue to support their efforts.”