AquaBounty Chief Executive Officer Ronald L. Stotish. (Photo: Stock File)
FDA approves GM salmon for human consumption
Friday, November 20, 2015, 23:50 (GMT + 9)
US Food and Drug Administration (FDA) scientists have concluded that genetically modified (GM) salmon is safe to eat by humans and and determined that genetic engineering is safe for the fish and that GM salmon meets the sponsor’s claim about faster growth.
These researchers reached this conclusion after rigorously evaluating extensive data submitted by the GM salmon manufacturer, AquaBounty Technologies, and other peer-reviewed data, to assess whether AquAdvantage salmon met the criteria for approval established by law.
According to FDA the data demonstrated that the inserted genes remained stable over several generations of fish and that there would not be a significant impact on the environment of the United States, since the multiple containment measures the company will use in the land-based facilities in Panama and Canada make it extremely unlikely that the fish could escape and establish themselves in the wild.
Such precautionary measures include, among other things, 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.
On welcoming the approval of the new animal drug application by the FDA, AquaBounty Chief Executive Officer Ronald L. Stotish 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."
Among the conditions set by the FDA en its approval, it determined that 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 this salmon to be bred or raised in the United States.
The FDA ensured it will maintain regulatory oversight over the production and facilities, and will conduct inspections to confirm that adequate physical containment measures remain in place. Besides, the Canadian and Panamanian governments will also be conducting inspections of the facilities.
To meet its responsibility as to labeling and because the FDA recognizes some consumers are interested in knowing whether food ingredients are derived from GE sources, the agency is issuing two guidance documents that explain how food companies that want to voluntarily label their products can provide this information to consumers.
These two guidance documents, which provide recommended actions for manufacturers who may wish to voluntarily label their products with information about whether the foods contain ingredients from GE sources, include a draft guidance on voluntary labeling indicating whether food has or has not been derived from GE Atlantic salmon, and a final guidance on voluntary labeling indicating whether food has or has not been derived from GE plants.
The agency is accepting public comment on the draft of these guidelines for the industry for 60 days starting on 23 November.
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