"After an exhaustive and rigorous scientific review, FDA [Food and Drug Administration] has arrived at the decision that AquAdvantage salmon is as safe to eat as any non-genetically engineered (GE) Atlantic salmon, and also as nutritious," the FDA report stated.
The FDA scientists evaluated data submitted by the manufacturer, AquaBounty Technologies, and other peer-reviewed data, to assess whether AquAdvantage salmon met the criteria for approval established by law; namely safety and effectiveness, the press released stated.
According to the FDA, the data demonstrated that the inserted genes remained stable over several generations of fish, that food from the GE salmon is sage to eat by humans and animals, that the genetic engineering is safe for the fish, and the salmon meets the sponsor's claim about faster growth.
The FDA also looked at the environmental impacts of approving this application and found that the approval would not have a significant impact on the environment of the United States. This is because 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.
Consumers may want to know whether their food or other ingredients in their food comes from genetically engineered sources. The law does not require that food containing ingredients derived from these salmon be labeled as GE, but the FDA recognizes that many consumers are interested in this information, as well as manufacturers who may want to make the distinction, the FDA said.
The FDA is releasing two guidance documents detailing the agency's current thinking on labeling—a draft guidance for labeling food derived from Atlantic salmon that has or has not been genetically engineered (UCM469802) and a final guidance for labeling that has or has not been derived from GE plants (UCM059098)—to help those who wish to make the distinction on the labeling of their food products.
"Both guidance documents explain FDA's best thinking on how to make it easy for consumers to know whether a food was produced using genetic engineering or not," said Felicia Billingslea, B.S., M.S., director of FDA's Division of Food Labeling and Standards.
The public is invited to provide comments on this draft guidance, and can learn more about how a food is produced by contacting the manufacturer, Billingslea said. The comment period began Monday, November 23, 2015.
For more information, visit www.fda.gov.
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