GM crops and animals are regulated under the 1986 Coordinated Framework. But while plants have a clear path to approval under guidance in place by 1992, animals must travel through regulatory no-man’s land. The FDA has approved only one product, an anticoagulant derived from the milk of transgenic goats.
AquaBounty initiated its application to commercialize in 1995. By 2004, it had assembled its “data package,” but its path to approval was never entirely clear. Finally in 2008, the Bush administration decided that transgenic animals intended for the dinner table would be regulated as animal drugs by the FDA’s Center for Veterinary Medicine.
Anticipating environmental concerns, AquaBounty developed the salmon at a secure indoor facility in Prince Edward Island, Canada. A second facility was established in the mountains of Panama to evaluate whether the fish perform well under standard commercial conditions.
As part of its evaluation, the FDA inspected both facilities, determining the fish would be securely contained with multiple redundant systems that would prevent the salmon from escaping into the wild—one of the main concerns for people opposed to GMOs. The FDA concluded that even a catastrophic event at the Panamanian facility would not pose a threat. Lengthy expanses of warm, muddy water outside the facility would serve as a graveyard to any escaped cold-water fish. If some somehow made it to the ocean, they would die in the warm currents thousands of miles from their spawning grounds in the frigid waters of the North Atlantic.
There is no chance, independent scientists say, that released salmon would win a Darwinian war in open waters with wild salmon—the so-called Trojan gene effect. GMO opponents cite a 1999 study concluding that modified fish that grow extra large would have a competitive advantage, threatening extinction of conventional varieties. But AquaBounty engineered the salmon so it grows no larger than conventional fish. A co-author of that study, Bill Muir of Purdue University, who developed the risk assessment model for transgenic fish for the Department of Agriculture, studied the AquaBounty salmon and determined it has no fitness advantage—and now endorses it.
After years of reviews, in September 2010, the FDA released a long-awaited comprehensive guidance analysis that found the salmon environmentally benign and safe for human consumption. The agency concluded the AquAdvantage salmon is comparable to the traditional variety in every measurable way.
To underscore its commitment to transparency, the FDA’s CVM convened a science advisory panel, which held public hearings a few weeks later. The scientists, including representatives from organizations skeptical of GMOs, unanimously reaffirmed the food safety report: AquaBounty salmon was materially identical to conventional salmon and posed no apparent environmental hazards.
The final step in the process—a “no effect” finding required under the Endangered Species Act—was expected within weeks, which would lead to its publication in the Federal Register and public hearings. Echoing one headline—“FDA to Approve GM Salmon Despite Strong Opposition”—everyone from the New York Times to anti-GMO activist groups was reporting that AquaBounty appeared to be on its way to producing the fish eggs that other companies could purchase to raise the quick-growing salmon.
Nothing has been released by the FDA since.
Friends of the Earth, Greenpeace, Union of Concerned Scientists, and other anti-GMO groups sent a letter to FDA Commissioner Margaret Hamburg demanding further review of whether wild salmon could face a competitive survival risk. AquaBounty’s response noted the FDA’s expert panel had already rejected those speculations.
Congressional politics then flared up. Forty members of Congress, most from the Pacific Northwest—whose salmon competes with Atlantic salmon—sent a letter to the FDA citing a supposed lack of transparency in the process. Whether because of the suddenly hostile political climate or renewed lobbying by opponents, the formal environmental assessment, which reporters had been told might be released any day, was never made public.
When rumors that approval was near surfaced again, in June 2011, a dozen members of the House, in a voice vote, approved a budget amendment prohibiting the FDA from approving the AquaBounty salmon. “Frankenfish is uncertain and unnecessary,” said the bill’s sponsor, Rep. Don Young, R-Alaska. “Should it receive approval as an animal drug, it clears the path to introduce it into the food supply; my amendment cuts them off before they can get that far.” The Senate did not immediately take up the bill.
Critics cited the snail-like pace of approval as evidence that the AquaBounty application was in trouble. “If the FDA was so assured of the scientific merits of this application, they would have approved it by now,” said Colin O’Neil of the Center for Food Safety. “The mere fact that it has taken this long tells me that jury is still out.”
In fact, by summer 2011, by all reports, the FDA had yet again reaffirmed its finding that the salmon was ready for approval. The draft environmental assessment was prepared and circulated under an interagency review process coordinated by the president’s Office of Science and Technology Policy. The two other agencies responsible for assessing the application under the Endangered Species Act, Fish and Wildlife, and the National Marine Fisheries Service, signed off on the “no effect” determination.