On Thursday, April 26, the Food and Drug Administration approved AquaBounty Technologies’ genetically modified salmon for production and grow-out at a facility in Albany, Ind.
"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,” said AquaBounty CEO Ron Stotish.
The last remaining hurdle for the company to import its genetically modified eggs for grow-out and sale in the U.S. marketplace is FDA and Department of Agriculture guidelines for labeling the GM salmon.
The FDA approved AquAdvantage salmon for sale in the United States in November 2015 in seven short words: “We approve your original animal drug application.”
Uproar over the approval of the nation’s first genetically modified animal for human consumption led to scrutiny of the FDA approval process.
The FDA stated itself that the approval of GM salmon depended on data provided exclusively by the company seeking approval, as per federal guidelines.
“The data in the application are provided by the company, because the burden of proof is on the sponsor, or company, to demonstrate safety and to validate the claim that is being made. As part of the review process, whenever the FDA had additional questions, the sponsor provided additional data or information.”
With the approval rubber-stamped, the seafood industry scrambled to find a way to protect the markets for wild and even farmed salmon. Producers of non-GM salmon worried that consumers would avoid salmon altogether knowing genetically modified salmon could be sold without a GMO label.
In 2016, Alaska Sen. Lisa Murkowski led a fight to require labeling for all genetically engineered salmon sold in the U.S. market. That provision was included in the 2016 Omnibus Appropriations Act and states that “the FDA may not allow the introduction or delivery for introduction into interstate commerce any food that contains GE salmon, until final labeling guidelines for informing consumers of such content are published.”
Subsequently, Congress passed the National Bioengineered Food Disclosure Law, which requires the U.S. Department of Agriculture to develop regulations for labeling food derived from bioengineered sources.
Because those labeling guidelines have yet to be established, AquaBounty cannot import AquAdvantage salmon — including its eggs or any food products from the salmon — into the United States. The facility approval, however, paves the way for GM salmon to be produced and sold stateside once labeling requirements are in place.
"With the facility now approved, commercial production of AquAdvantage Salmon awaits only official labeling guideline by the FDA," AquaBounty Technologies announced in a press release.
