November 20, 2015


US FDA approves first GE food animal, a salmon



The US Food and Drug Administration (FDA) said Thursday it had approved for the first time a genetically engineered animal intended for food.


The approval was granted for AquAdvantage Salmon, an Atlantic salmon that reaches market size faster than non-GE farm-raised Atlantic salmon and which is raised by the Massachusetts-based aquaculture firm AquaBounty Technologies.
AquAdvantage Salmon  PHOTO FROM FDA.GOV


"The FDA has thoroughly analysed 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 Dr. Bernadette Dunham, director of the FDA's Center for Veterinary Medicine.


Ronald Stotish, AquaBounty Technologies CEO, welcomed the FDA approval, saying in a statement that 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".


The FDA, which regulates GE animals under the new animal drug provisions of the Federal Food, Drug and Cosmetic Act, said that AquAdvantage Salmon meets the requirements 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 producer's claim about faster growth.


Safe and nutritious


In addition, the FDA determined that food from AquAdvantage Salmon is as safe to eat and as nutritious as 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 approval, however, does not allow AquAdvantage Salmon to be bred or raised in US territory, but only in two specific facilities in Canada and Panama which are land-based, contained hatchery tanks.


In a news released posted on its website, the FDA said it had 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".


The FDA said that even in the highly unlikely event of an escape, the GE salmons would be unable to interbreed or establish populations in the wild as they are reproductively sterile.


The FDA moreover said it would maintain regulatory oversight over the production of the GE fish and the facilities, as well as conduct inspections to "confirm that adequate physical containment measures remain in place".


It added that the Canadian and Panamanian governments would also be conducting inspections of the facilities.-Rick Alberto

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