November 30, 2015

FDA Approves Genetically Engineered Salmon for Market; No Labeling Required

The FDA has issued an approval for the marketing of genetically engineered (GE) Atlantic salmon, capping a long regulatory review (see here). The product, AquaAdvantage, made by Aqua Bounty, Inc., has been under agency review for years. This Atlantic salmon has been genetically engineered to add the growth hormone gene from the Chinook salmon, which causes the fish to reach market weight in about half the time. The FDA regulates GE animals under the new animal drug provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) because recombinant DNA introduced into an animal is treated as a drug. From the FDA statement
Based on a comprehensive analysis of the scientific evidence, the FDA determined that AquAdvantage Salmon meets the statutory requirements for safety and effectiveness under the Federal Food, Drug, and Cosmetic Act. Among the requirements the sponsor had to meet are 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 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.

The 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 AquAdvantage Salmon to be bred or raised in the United States. In fact, under this approval, no other facilities or locations, in the United States or elsewhere, are authorized for breeding or raising AquAdvantage Salmon that are intended for marketing as food to U.S. consumers. As required by the National Environmental Policy Act, the FDA completed an environmental assessment to determine whether approval of the application would result in significant effects on the quality of the human environment in the United States. The FDA has 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 agency will not require the GE salmon to be labeled:
Based on our assessments of food derived from the AquAdvantage Salmon, we have determined that the term “Atlantic salmon” is the appropriate common or usual name for such food within the meaning of section 403(i) of the FD&C Act because AquAdvantage Salmon meets FDA’s regulatory standard for Atlantic salmon (Ref. 10) and the composition and basic nature of food from AquAdvantage Salmon does not significantly differ from its non-GE counterpart—non-GE farm-raised Atlantic salmon. In addition, we have determined that food derived from AquAdvantage Salmon is as safe and nutritious as food from other farm-raised Atlantic salmon. For these reasons, we have concluded that there is no material difference between food derived from AquAdvantage Salmon and food derived from other non-GE, farm-raised Atlantic salmon that is required to be disclosed in the labeling of food derived from AquAdvantage Salmon under the relevant provisions of the FD&C Act, as explained above. See 21 U.S.C. 321(n) & 343(a).
Senator Lisa Murkowski (R-AK) has been an outspoken opponent of FDA approval of the GE salmon (in line with general statewide opposition), and has been attempting to pass legislation requiring the labeling of the GE salmon if the agency approval cannot be overturned:
The FDA has said there will be draft guidance on voluntary labeling indicating whether food has or has not been derived from GE Atlantic salmon. So, basically, if you want to put a label on that says this is a fake fish, a fake salmon, you can go ahead, but you don't have to. It is only voluntary. That is not good enough for this mom. That is not good enough for most who care about what their families are eating. So we are going to continue to press for mandatory labeling if the FDA is going to approve--wrongheadedly, in my mind--this genetically engineered fake fish for human consumption. They darn well better agree that labeling will be required because I am not going to eat it. 
Public sentiment against approval of the GE salmon was well-registered with the FDA; over 1.5 million public comments were posted against agency approval; the agency decision not to require labeling has generated more opposition and the FDA's safety evaluation has been challenged as cursory. The marketplace could well determine whether GE salmon actually becomes part of the American food supply; many retailers and restaurants are on record stating that they will not sell the product. Upcoming developments to watch will be the ongoing pressure to require labeling (as well as the Senate prospects for the federal anti-GE labeling bill discussed here earlier). Furthermore, the fate of future GE seafood products (about 35, by one count) that come before the FDA remains uncertain. Lastly, a lawsuit has been filed in Canada opposing the AquaBounty production of the GE salmon eggs in Canada as a potential environmental threat to wild salmon stocks.

No comments: