FDA Approves GE Salmon, Voluntary Labeling of GE Ingredients

Salmon for human consumption would not have a significant impact on the environment.

The FDA scientists rigorously evaluated extensive 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 data demonstrated that the inserted genes remained stable over several generations of fish, that food from the GE salmon is safe 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.
In addition, FDA assessed 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. That 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.

The agency had made a preliminary finding in December 2012 that approving the AquAdvantage Salmon for human consumption would not have a significant impact on the environment if, as the company plans, it is raised in tanks away from the ocean to limit the impact on wild salmon stocks.
FDA has specified that the GE salmon only be raised in two places, one on Vancouver Island, Canada, and the other in Panama, where Aqua Bounty was fined by the government last year for reportedly not having the proper permits and for repeatedly violating regulations.
Alison Van Eenennaam, Ph.D., a specialist in animal genomics and biotechnology at the University of California, Davis, participated in FDA’s scientific review.
“Basically, nothing in the data suggested that these fish were in any way unsafe or different to the farm-raised salmon,” she said.
AquaBounty’s GE salmon contains a growth gene from the Chinook salmon, which the company says could allow its product to grow to market size in half the time of a conventional Atlantic salmon. Because it involves a recombinant DNA (rDNA) construct introduced into the animal, the GE salmon meets FDA’s definition of a drug.
The company stated Thursday that the FDA approval could mean an “economically viable domestic aquaculture industry while providing consumers a fresh and delicious product,” adding that more than 90 percent of the seafood, and more than 95 percent of the Atlantic salmon, consumed in the U.S. today is imported.

Source: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm472487.htm