Troubling Emails Reveal Federal Scientists Fear FDA Approval of Genetically Engineered Salmon

Washington, DC – After submitting a Freedom of Information Act request, the consumer advocacy group Food & Water Watch received numerous recent internal documents and emails from the U.S. Department of Interior’s Fish & Wildlife Service (FWS) exposing startling concerns with AquaBounty salmon – a controversial genetically engineered (GE) fish the FDA may soon approve as the first GE food animal for human consumption.

The documents reveal that, as late as last month, the FDA had not adequately fulfilled a requirement under the Endangered Species Act to consult with both FWS and another federal agency, the National Marine Fisheries Service (NMFS), to determine whether approval of AquaBounty’s salmon might impact wild, endangered Atlantic salmon.

“Nice work Greg,” Denise Hawkins, PhD, FWS Regional Geneticist wrote to a coworker in September. “Especially pointing out that there is no data to support the claims of low survival in the event of escape, which I agree with you all is a big concern.  I also agree…that using triploid fish [which AquaBounty claim have undergone a sterilization process] is not foolproof.  Maybe they [the FDA] should watch Jurassic Park.”

Despite AquaBounty’s claim to produce only sterile salmon, the company admitted that up to 5 percent of their GE salmon eggs could be fertile, prompting the FDA to label the company’s claims “potentially misleading”.

According to FWS internal emails, contrary to AquaBounty’s claims that GE salmon would be grown in closed systems (and therefore unable to escape), FWS employees received news of a proposal to grow the fish in a facility that would discharge into the ocean off the coast of Maine. It appears that the proposal, discussed with FWS employees last month, is from Joe McGonigle, former vice president of Aquabounty (as of February 2008).

“No matter what precautions you take, fish escape and once they do, there is no closing that door. So, that being said, I think it is very bad precedent to set,” said one FWS program supervisor.

At least 30 House members and 13 senators have expressed concern with the FDA’s review process, with many calling for the outright prohibition of GE salmon. Despite the outcry, the FDA is closing a public comment period on Nov. 22 and could approve the product as soon as Nov. 23.

In the documents, high-ranking FWS employees, including Jeff Adams, a branch chief, complain of the FDA’s failure to consult with FWS as required by law.

“The proposal [to approve AquaBounty salmon] also presents a situation where FDA, whose jurisdiction is not focused on natural resources, is entrusted with the authority to approve an application which poses such a threat to the country’s natural resources,” Adams said.

Regarding the FDA’s level of consultation with FWS, one assistant regional director was quoted as saying, “It’s a little hazy to me how we are supposed to be engaged.”

“Hazy to me, too,” replied Gary Frazer, FWS Assistant Director for Endangered Species.

The FDA is required by law (under the National Environmental Policy Act) to conduct an environmental impact statement for any regulatory action that could negatively affect the human environment. The agency has not done so yet.

A large part of AquaBounty’s success hinges on GE salmon. The company has invested $50 million in the product, while posting zero sales and almost five million dollars in net losses in 2009.

The FDA has allowed the company to conduct three of the four studies on whether the product is safe for human consumption. AquaBounty’s scientists have been criticized widely for using only six GE salmon to determine the potential for allergies.