See updates below.
Jon Entine, the executive director of the Genetic Literacy Project, has an incredible story in Slate that explores whether political considerations have trumped science in the case of AquAdvantage salmon, an Atlantic salmon genetically engineered to reach its adult size twice as fast as unmodified salmon.
AquaBounty, the Massachusetts firm trying to bring the fish to market, applied for FDA approval in 1995;
twelve seventeen [[apologies for the silly math error!]] years later, it’s still awaiting a verdict. Entine suggests that the hold-up isn’t with the FDA itself, but with the White House. As he writes:
The Genetic Literacy Project (GLP), which I direct, has learned that in April, the FDA completed its draft environmental assessment (EA), the final step in its scientific evaluation. The agency confirmed that the salmon is safe to eat and poses no serious environmental hazards. The approval document had made its way through every appropriate agency in an interagency review process coordinated by the Office of Science and Technology Policy (OSTP), which oversees the president’s science policies and is empowered to enforce integrity guidelines.
But within days of the expected public release of the EA this spring, the application was frozen. The delay, sources within the government say, came after meetings with the White House, which was debating the political implications of approving the GM salmon, a move likely to infuriate a portion of its base.
Everyone who believes in sound science should be troubled by this. As Entine outlines, the FDA’s own experts, as well as many independent scientists, agree that the salmon pose virtually no risk to either humans or the environment.
If the FDA doesn’t ultimately approve the salmon–or doesn’t do so before AquaBounty runs out of funds–it will put a serious chill on biotechnological innovation in this country. In fact, in doing research for my forthcoming book on animal biotechnology, I talked to researchers like James Murray, of the University of California-Davis, who is moving his transgenic animal operation to Brazil, a country that’s been more willing to embrace GMOs. (Murray has engineered transgenic goats whose milk contains elevated levels of lysozyme, an anti-bacterial compound. He hopes that this super-charged milk could be used to prevent and treat diarrheal disease, which claims the lives of more than 2 million children every year.)
Entine also spoke with Murray, who expressed his frustration with the situation in the U.S.:
“When you don’t have a regulatory pathway forward and the government doesn’t support research in this area, what company will invest in this field?” he asked. “None. The AquaBounty situation is just confirmation of a hopelessly politicized process.”
The future of animal genetics is so dire, universities are killing off courses. “My program started off doing genetic engineering,” said Alison Van Eenennaam, a University of California–Davis animal scientist who co-authored a scathing article for Nature Biotechnology on the broken approval process. “I couldn’t get any government funding for my work in this area, so I shut the program down. Why would I train graduate students for jobs that won’t exist?”
If AquaBounty can’t make it through the regulatory and political quagmire, despite doing everything right, future entrepreneurs and scientists won’t even bother to try. And we could find ourselves losing out as other nations reap the economic, environmental, and health benefits that GMOs can bring. As Murray told me when I visited him in Davis, California last year, “We’re producing useful animals and sending them offshore.”
UPDATE (December 21, 12:30 p.m.): Jon Entine tells me that today, two days after his Slate story appeared, the FDA released its Environmental Assessment, which includes the agency’s conclusion that “approval of the AquAdvantage Salmon … will not jeopardize the continued existence of United States populations of threatened or endangered Atlantic salmon, or result in the destruction or adverse modification of their critical habitat…” You can read the full assessment on the agency’s website.