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September 20, 2010 

Science Group Questions FDA Process for Regulating Genetically Engineered Salmon; Cautions That FDA Regs For New Salmon Will Set Precedent For Other Transgenic Animals

WASHINGTON (September 20, 2010) – The Union of Concerned Scientists (UCS) today questioned the Food and Drug Administration’s (FDA) process for determining the fate of a new genetically engineered salmon. If the agency ultimately approves the salmon for market, it would be the first genetically engineered animal intended for human consumption.

“The approval process for this genetically engineered salmon will set an important precedent that will be difficult to reverse,” said Margaret Mellon, a UCS senior scientist and director of the organization’s Food and Environment Program. “If we do not implement a comprehensive and adequate procedure to oversee genetically modified foods now, we could put human health and the environment at risk.”

The FDA’s Veterinary Medicine Advisory Committee held a two-day public meeting yesterday and today to review the engineered salmon’s safety and environmental risk data. Tomorrow, the FDA will hold a hearing on how the fish and products made from it should be labeled for consumers. Once the agency considers public comments and the advisory committee’s recommendations, it is expected to decide whether to allow the salmon on the market, and whether to require labels telling consumers it is genetically engineered.

Mellon said the FDA is inappropriately using the drug laws in the Federal Food, Drug and Cosmetic Act (FFDCA) to regulate the genetically engineered fish. The laws were written decades ago to oversee the pharmaceutical industry, she pointed out, not to regulate animals.

Mellon, a lawyer with a doctorate in molecular biology, said FFDCA drug laws have two major deficiencies. First, they do not require the FDA to convene scientific advisory committees as part of the approval process for genetically engineered animals. Second, they do not have any provisions requiring environmental protection. A number of experts have concluded that AquaBounty’s salmon could threaten aquatic environments.

She also questioned the Veterinary Medicine Advisory Committee’s ability to handle this sensitive issue. It is the only committee the FDA will consult on this matter.

“Yes, this committee is sometimes asked to consider scientific, political and environmental risks as part of the approval process under the drug laws – as we are seeing with genetically engineered fish,” Mellon explained. “But it is largely made up of veterinarians who do not have the necessary expertise to evaluate the risks genetically engineered fish may pose to consumers or the environment.”

Given the potential for setting a precedent for approving genetically engineered animals, Mellon said the FDA should bring together such agencies as the National Marine Fisheries Service, the Fish and Wildlife Service, the National Oceanic and Atmospheric Administration, along with top ecologists, food safety experts, and consumer and retail representatives, to work together to evaluate the environmental implications of approving the genetically engineered fish.

She also criticized the FDA public comment process, which she said is vague and confusing.

“While we welcome the FDA’s call for public comment, we are uncertain as to how these comments will be used,” she said. “There will be no comment period on scientific and policy issues after today’s advisory committee meeting and the FDA has not said whether it will respond to public comments in writing. Transparency is essential. This approval process will establish a foundation for how our country manages genetically modified foods.”

Finally, UCS wants to ensure that the genetically engineered fish will be properly labeled. The FDA currently plans to use the labeling policy for genetically engineered plants. Those labels do not inform consumers whether or not a product is genetically engineered. If the FDA applies this policy, consumers likewise will not know whether the farmed salmon they buy is genetically engineered.  “Consumers deserve this information so they can make their own choice about what they want to eat and serve to their families,” said Mellon.


The Union of Concerned Scientists puts rigorous, independent science to work to solve our planet's most pressing problems. Joining with citizens across the country, we combine technical analysis and effective advocacy to create innovative, practical solutions for a healthy, safe, and sustainable future.

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