April 7, 2013

Alaska Continues Statewide Opposition to FDA Approval of Genetically Engineered Salmon

At state and federal levels, Alaska continues to display its opposition to the introduction of a genetically engineered (GE) food product - specifically, to the potential entry of GE salmon into the U.S. marketplace (see here). To date, the product, AquAdvantage salmon, made by AquaBounty Technologies (ABT) has not received market approval from the FDA. To produce the GE salmon, Atlantic salmon is engineered to contain the growth hormone gene from Pacific Chinook salmon, which causes the fish to grow in less time; the gene is placed under the control of a promoter from ocean pout, which causes elevated expression of the hormone. According to ABT, the addition of the growth hormone gene “provides the fish with the potential to grow to market size in half the time of conventional salmon.” At the end of 2012, pursuant to the National Environmental Policy Act (NEPA), the FDA released a draft Environmental Assessment (EA) in support of its Finding of No Significant Impact (FONSI) for AquAdvantage salmon. The FONSI determination, if prevailing, means that the FDA will not be required to prepare the more rigorous environmental impact statement (EIS) for GE salmon; this determination has been criticized by consumer advocates. The FDA has extended the period for public comments on the draft EA until April 26, 2013. Both state and federal legislators from Alaska have been active in opposing the introduction of the fish, voicing concerns about potential mating between the GE salmon and the native Alaska salmon, with the potential for irreversible genetic contamination of the wild-type stock. According to ABT, the selected fish would be female and sterile and could not breed with the wild salmon. But assuming less than 100% ability to properly screen and control the stocks, even a minute number of GE fish that could breed into the wild population could initiate the genetic contamination of the wild-type stock. The Alaska legislature has now passed a bipartisan resolution opposing the introduction of the GE salmon
Opposing the United States Food and Drug Administration's preliminary finding relating to genetically engineered salmon; urging further examination of genetically engineered salmon; opposing AquaBounty's petition to produce genetically engineered salmon; and proposing, if AquaBounty's petition is approved, that its product should be labeled as "genetically modified.” 
The regulatory paradigm for the review of the ABT salmon is that the added gene is reviewed as a veterinary drug: "the rDNA construct in the resulting GE animal is thus a regulated article that meets the drug definition" - hence the oversight by the FDA's Center for Veterinary Medicine (CVM). In 2010, an earlier CVM report stated that there were no significant safety or environmental issues raised by the ABT salmon. A food additive petition was filed at the FDA by food safety advocates in 2012, requesting that the addition of the growth hormone gene to the fish trigger a food additive review, bringing the GE salmon under the purview of a more conventional food safety review process. In addition, current FDA policy will not require the GE salmon to be labeled (nor any other GE food). Several supermarket chains have announced that they will not carry the GE salmon product. Just last month, Sen. Mark Begich (D-AK) succeeded in introducing an amendment to the continuing resolution passed in March (temporary budget agreement) that would establish a reserve fund for the labeling of GE fish. Begich also introduced two bills in the Senate; a prohibition on approval of GE salmon (the bill cites “escapement”) and, if GE salmon is approved, a requirement for food labeling (that would a first at the federal level). Regarding the strength of the opposition in Alaska, there is no comparable statewide cohesion to date targeting a specific GE food product. More generally, future litigation is likely to challenge both the FDA’s regulatory paradigm for GE salmon as well as the merits of the FONSI determination for the food product by the agency.

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