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FDA’s GE Salmon Announcement Sparks Controversy

Agency announces genetically engineered salmon is safe, drawing a CFS lawsuit. Salmon will be regulated under new animal drug provisions. GE products also have labeling implications.

Agency announces genetically engineered salmon is safe, drawing a CFS lawsuit. Salmon will be regulated under new animal drug provisions. GE products also have labeling implications.
Agency announces genetically engineered salmon is safe, drawing a CFS lawsuit. Salmon will be regulated under new animal drug provisions. GE products also have labeling implications.

FDA’s Nov. 19 announcement that it had determined AquaBounty Technology’s AquAdvantage salmon is as safe to eat as non-genetically engineered salmon drew passionate responses, particularly from those opposing the fish.

The agency’s announcement also caused the Center for Food Safety (CFS) to announce plans to sue FDA to block its approval. On the CFS website, the non-profit environmental advocacy organization noted, “Consumers concerned about their personal health may not be able to avoid the fish. While 9,000 grocery stores and numerous restaurants have vowed not to sell the GE fish, [the] lack of labeling laws mean that average consumers will not have a choice.”

Among the media responses, Wired.com said, “In a first, the FDA clears genetically modified salmon for eating—it just took 20 years,” attributing the lengthy timeframe to the development of the science and the regulatory pathway. The lead paragraph in the piece referred to the salmon as “Frankenfish.”

A Washington Post story quoted Dana Perls, Food and Technology Campaigner at Friends of the Earth, as saying, “It was a flawed and irresponsible approval. It sets a very dangerous precedent, given our federal government agencies are ill-equipped to handle genetically engineered animals. I think it is a grave mistake we will come to regret.”

NYTimes.com said, “Despite the approval, it is likely to be at least two years before any of the salmon reaches supermarkets, and at first it will be in tiny amounts.” The article noted, “The approval could help other efforts to develop genetically modified animals.”

AquaBounty Technologies, Inc., with offices in Maynard, MA, and Fortune, Prince Edward Island, Canada, raises and produces the salmon. The NYTimes.com story said, “If the salmon were bred or raised elsewhere, for marketing to Americans, that would require separate approvals.”

FDA to regulate salmon as a drug

One especially interesting aspect of the agency’s announcement: “The FDA regulates GE animals under the new animal drug provisions of the Federal Food, Drug, and Cosmetic Act, because the recombinant DNA (rDNA) construct introduced into the animal meets the definition of a drug. In this case, the rDNA construct introduces a trait that makes the AquAdvantage Salmon grow faster.”

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