The FDA approved AquAdvantage® Salmon, an Atlantic salmon that has been genetically engineered (GE) to reach market size in less time than conventionally farmed Atlantic salmon. The decision marks the first gene-altered animal deemed safe and fit for dinner.

“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,” said Ronald Stotish, Ph.D., the CEO of AquaBounty Technologies, the company that developed the GE Atlantic salmon. “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 United States currently imports over 90% of all the seafood, and more specifically, over 95% of the Atlantic salmon it consumes, explained Dr. Stotish. “AquAdvantage Salmon will offer the opportunity for an economically viable domestic aquaculture industry while providing consumers a fresh and delicious product,” he added.

FDA officials reported that the agency carried out a comprehensive analysis of the scientific evidence and determined that AquAdvantage Salmon meets the statutory requirements for safety and effectiveness under the Federal Food, Drug, and Cosmetic Act. The FDA required AquaBounty, the sponsor, to meet a number of requirements. For example, the food from the fish had to be safe to eat; the recombinant DNA construct had to be safe for the fish itself; and the AquaAdvantage Salmon had to meet 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.

AquAdvantage Salmon (a female fish with three sets of chromosomes instead of two) contain a recombinant DNA construct that is composed of the growth hormone gene from Chinook salmon under the control of a promoter from another type of fish, an ocean pout. This reportedly allows the salmon to grow to market size twice as fast as non-GE farm-raised Atlantic salmon, even though it is raised on approximately 10% less food.

The FDA mandates that the fish 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. The agency also 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.

AquAdvantage Salmon also 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, said the FDA in a statement.

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