RASTECH Magazine

Industry update News Regulations Technology
U.S. judge voices concern over FDA’s approval of AquaBounty’s GMO salmon


September 1, 2020
By Nestor Arellano


Topics
AquaBounty’s AquAdvantage salmon, the first genetically engineered seafood, has been granted regulatory approvals for commercial production in the U.S. and Canada.

A United States federal judge has questioned the Food and Drug Administration’s (FDA) 2015 decision to greenlight AquaBounty Technologies’ application to create and sell genetically engineered salmon.

During a hearing last week, U.S. District Judge Vincent Chhabria expressed concerns that the FDA may have moved too quickly in approving the  Massachusetts-based  biotech company’s application.

The judge’s comment comes at a time when AquaBounty is preparing for the company’s first commercial harvest of its genetically engineered salmon from its recirculating aquaculture system (RAS) facility in Indiana. The company hopes to follow that up with the first harvest of its AquAdvantage salmon at its Prince Edward Island, Canada, facility in the first quarter of 2021. In early August, AquaBounty also announced it has initiated plans to locate a suitable site for its next American RAS facility.

Advertisment

It was the FDA ruling, made five years ago, which prompted the Centre for Food Safety, an anti-genetically modified organism (GMO) group, and other environmental and fishing industry organizations to file a lawsuit against the FDA.

“I’m not saying it opens the floodgates or sets the standards, but perhaps it pushes us in a direction and future agency action will likely be informed by this agency action,” Chhabria was quoted as saying by CourthouseNews.com. “Shouldn’t the FDA in this case have considered the fact that this was the first such facility and future decisions would be building on this facility?”

Marissa Piropato, a justice department attorney representing the FDA, said that Chhabria was in effect asking the FDA to speculate on what AquaBounty’s future plans were.

AquaBounty developed its AquAdvantage branded salmon. To create the fish, a growth hormone regulating gene from a Chinook salmon and a promoter from an ocean pout was added to the Atlantic salmon’s genes.

This enables the AquAdvantage salmon to grow year-round instead of only during the spring and summer. The fish is able to grow to market size in 16 to 18 months while regular salmon takes up to three years.

For more on this story, click here.