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FDA Approves AquAdvantage® Salmon

More than 20 years since AquaBounty first sought approval, the company's salmon, the first genetically modified food animal, has gained approval.

November 19, 2015

The U.S. Food and Drug Administration (FDA) today approved a New Animal Drug Application for the production, sale, and consumption of AquaBounty's AquAdvantage® Salmon, an Atlantic salmon that has been genetically enhanced to reach market size in less time than conventional farmed Atlantic salmon.

“The FDA has thoroughly analyzed and evaluated the data and information submitted by AquaBounty Technologies regarding AquAdvantage Salmon and determined that they have met the regulatory requirements for approval, including that food from the fish is safe to eat,” said Bernadette Dunham, D.V.M., Ph.D., director of the FDA’s Center for Veterinary Medicine.

Based on a comprehensive analysis of the scientific evidence, the FDA determined that AquAdvantage Salmon meets the statutory requirements for safety and effectiveness under the Federal Food, Drug, and Cosmetic Act. Among the requirements the sponsor had to meet are that food from the fish is safe to eat; the rDNA construct (the piece of DNA that makes the salmon grow faster) is safe for the fish itself; and the AquAdvantage Salmon meets the sponsor’s claim about faster growth. In addition, the FDA determined that food from AquAdvantage Salmon is as safe to eat and as nutritious as food from other non-GE Atlantic salmon and that there are no biologically relevant differences in the nutritional profile of AquAdvantage Salmon compared to that of other farm-raised Atlantic salmon.

The AquAdvantage Salmon may be raised only in land-based, contained hatchery tanks in two specific facilities in Canada and Panama. The approval does not allow AquAdvantage Salmon to be bred or raised in the United States. In fact, under this approval, no other facilities or locations, in the United States or elsewhere, are authorized for breeding or raising AquAdvantage Salmon that are intended for marketing as food to U.S. consumers. As required by the National Environmental Policy Act, the FDA completed an environmental assessment to determine whether approval of the application would result in significant effects on the quality of the human environment in the United States. The FDA has determined that the approval of the AquAdvantage Salmon application would not have a significant environmental impact because of the multiple and redundant measures being taken to contain the fish and prevent their escape and establishment in the environment.

These measures include a series of multiple and redundant levels of physical barriers placed in the tanks and in the plumbing that carries water out of the facilities to prevent the escape of eggs and fish. Finally, the AquAdvantage Salmon are reproductively sterile so that even in the highly unlikely event of an escape, they would be unable to interbreed or establish populations in the wild.

The FDA will maintain regulatory oversight over the production and facilities, and will conduct inspections to confirm that adequate physical containment measures remain in place. In addition, the Canadian and Panamanian governments will also be conducting inspections of the facilities.

The FDA held a Veterinary Medicine Advisory Committee meeting on the sufficiency of the scientific review and a hearing to gather opinions on labeling of food from AquAdvantage Salmon. The agency received and reviewed comments from these two meetings. In addition, the agency released a draft environmental assessment and preliminary finding of no significant impact for public comment; these comments were also reviewed prior to the agency’s final decision.

Ronald L. Stotish, Ph.D., Chief Executive Officer of AquaBounty, commented, “AquAdvantage Salmon is a game-changer that brings healthy and nutritious food to consumers in an environmentally responsible manner without damaging the ocean and other marine habitats. Using land-based aquaculture systems, this rich source of protein and other nutrients can be farmed close to major consumer markets in a more sustainable manner.”

The U.S. currently imports over 90% of all the seafood, and more specifically over 95% of the Atlantic salmon, it consumes. AquAdvantage Salmon will offer the opportunity for an economically viable domestic aquaculture industry while providing consumers a fresh and delicious product.

Through greater efficiency and localized production, AquaBounty’s AquAdvantage Salmon increases productivity while reducing costs and the environmental impacts associated with current salmon farming operations. Land-based aquaculture systems can provide a continuous supply of fresh, safe, traceable, and sustainable AquAdvantage Salmon to communities across the U.S. and do it with a reduced carbon footprint. Importantly, it offers an alternative approach to fish farming that does not exploit the oceans.

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