December 21, 2012

FDA: No Environmental Impact of Genetically Engineered Salmon

The FDA has released a draft environmental assessment (EA) for the proposed introduction of genetically engineered salmon as a food product (AquaBounty Technologies AquAdvantage salmon). 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. The fish are to be only sterile females (although not 100%; the FDA notes that "proposed conditions of use specify that a minimum of 95% of the AquAdvantage Salmon eggs sold for commercial production use would be triploid (sterile)"). The production plans submitted to the FDA include the preparation of the GE fish eggs in Canada, and the actual production of the fish in Panama. Thus, neither process will occur in the U.S. The introduction of the new gene to the salmon triggers an FDA review of the genetic addition as a new animal drug application (NADA) (Federal Food, Drug & Cosmetic Act, 21 USC § 321 et seq.). The NADA review, conducted by the Center for Veterinary Medicine, must consider both food safety and environmental consequences of the proposed product; the 2010 FDA assessment concluded that food from these salmon “is as safe as food from conventional salmon, and there is a reasonable certainty of no harm from consumption of food” from these fish. The new EA prepared by the FDA pursuant to National Environmental Policy Act (NEPA) procedures – and its finding of no significant impact (FONSI) – means that the FDA will not be preparing an environmental impact statement for the introduction of the fish.

Food safety advocates have criticized the FDA’s record of assessments to date, and have called on the legislators to ban the production of the fish. The Alaska Congressional delegation is already on the record opposing the introduction of the GE salmon (see here). In addition, current FDA policy will not require the GE salmon to be labeled. The retail sale of fish requires at least country of origin labeling; the sale of food products in fish markets or restaurants does not carry any such labeling. What remains unsettled (and may further antagonized with this recent report) is whether efforts by food safety advocates to transfer GE fish into the more “conventional” category of food additive review processes will succeed; whether labeling could be required (the experience with other GE foods to date would suggest not); and even whether the environmental assessment to date is adequate (critics say no: not all fish were tested in the native conditions of production; reproductively-capable fish are present and could escape). More broadly, can a veterinary-based product review supply adequate oversight for the introduction of a genetically engineered food into the market? Does the review process for GE salmon establish a paradigm for other GE animal or fish products? The most direct response might come from Congressional action which singles out the GE salmon for targeted legislative regulation or prohibition (see here). The Alaska delegation has already responded, with Sen. Mark Begich (D-AK) sharply critical of the EA report, and calling for the public to provide comments to the FDA.

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