The U.S. Food and Drug Administration (FDA) announced Thursday, Nov. 19, 2015, that it has approved for the first time a genetically engineered (GE) animal intended for food. That animal is the AquAdvantage Salmon, which was developed about 25 years ago by AquaBounty Technologies Inc. of Maynard, MA, to grow larger and faster, year-round, and on less food, than conventionally farmed Atlantic salmon. FDA said it had based the decision “on sound science and a comprehensive review” and had concluded that consumption of the GE salmon poses no threat to human safety or the environment.â¤-image30163955“The FDA has thoroughly analyzed and evaluated the data and information submitted by AquaBounty Technologies regarding AquAdvantage Salmon and determined that they have met the regulatory requirements for approval, including that food from the fish is safe to eat,” said Bernadette Dunham, D.V.M., Ph.D., director of FDA’s Center for Veterinary Medicine. 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. “AquAdvantage Salmon is a game-changer that brings healthy and nutritious food to consumers in an environmentally responsible manner without damaging the ocean and other marine habitats. Using land-based aquaculture systems, this rich source of protein and other nutrients can be farmed close to major consumer markets in a more sustainable manner,” said Ronald Stotish, Ph.D., AquaBounty’s CEO. acceptance of GE food animals is viewed as uncertain at best, and some national and regional retail outlets, such as Kroger, Safeway, H-E-B, Giant Eagle, Marsh, Hy-Vee, Meijer, Trader Joe’s, Target, Aldi and Whole Foods, have already announced that they will not carry the AquAdvantage Salmon regardless of regulatory approvals. However, Costco, one of the largest seafood retailers in the country, is expected to carry the GE salmon despite protesters who petitioned the Issaquah, WA-based company this past summer not to do so. (Editor’s note: Costco announced Nov. 20 that it does not currently have plans to sell genetically modified (GM) salmon. The company’s brief statement reads, “Although the FDA has approved the sale of GM salmon, Costco has not sold and does not intend to sell GM salmon at this time.” And Red Lobster, a national restaurant chain with 705 locations, recently told a Dallas newspaper that it would not be selling GM salmon anytime soon.)

Reaction to FDA’s decision Thursday was swift and critical. Several consumer groups rejected approval of the so-called “frankenfish” and vowed to organize boycotts, while independent fishermen predicted it could put some of them out of business.

“I think it’s a horrible idea,” Spencer Anderson, a commercial fisherman based in Seattle, told a local TV station. Meanwhile, the Center for Food Safety announced Thursday that it, along with other plaintiffs, plan to sue FDA over the GE salmon decision because the agency has not done its job to protect the public. “The review process by FDA was inadequate, failed to fully examine the likely impacts of the salmon’s introduction, and lacked a comprehensive analysis. This decision sets a dangerous precedent, lowering the standards of safety in this country. CFS will hold FDA to their obligations to the American people,” said Andrew Kimbrell, the group’s executive director. Food & Water Watch (FWW) stated that the group would ask President Obama and Congress to overturn FDA’s decision. “Food & Water Watch will be examining all options to stop this controversial and unnecessary GMO fish from reaching the marketplace. We urge President Obama to overturn FDA’s approval and stop GMO salmon from reaching consumers’ dinner plates,” said FWW Executive Director Wenonah Hauter. FDA also announced Thursday that it was issuing two draft guidance documents for manufacturers who wish to voluntarily label products containing ingredients from both GE and non-GE sources. One contains guidance to industry on labeling foods derived from Atlantic salmon and one is for labeling foods derived from GE plants. “We recognize that some consumers are interested in knowing whether food ingredients are derived from GE sources,” said Susan Mayne, Ph.D., director of the FDA’s Center for Food Safety and Applied Nutrition. “The FDA is issuing two guidance documents that explain how food companies that want to voluntarily label their products can provide this information to consumers.” The agency is accepting public comment for 60 days starting on Nov. 23 via instructions in the Federal Register on Draft Guidance for Industry: Voluntary Labeling Indicating Whether Food Has or Has Not Been Derived from Genetically Engineered Atlantic Salmon. Comments may be submitted here.

(To sign up for a free subscription to Food Safety News, click here.)