New Study Claims FDA Review of GM Salmon Is Incomplete

The process used by the Food and Drug Administration (FDA) to review genetically modified (GM) salmon presents “an incomplete picture” of the risks and benefits of what could be the first GM animal food approved for human consumption, according to a recent Duke University study.

The FDA’S preliminary conclusions, announced in September, found that the GM salmon were as safe to eat as any other salmon. A comment period on whether the FDA can require GM salmon to be labeled as GM expired on Monday, putting the agency one step closer to a final decision.

The Duke Study, published in the latest issue of Science magazine, echoes the concerns of anti-GM activists, who argue in public hearings that the FDA has not considered enough data on the potential health and environmental consequences of farming GM salmon.

“Instead of focusing on the safety of a food taken one portion at a time, or whether it was produced through genetic modifications or through classic breeding, a more useful approach would be to evaluate whether society is better off overall with the new product on the market than without it,” said Jonathan B. Wiener, one of the study’s co-authors.

Members of Congress have also expressed concern about the review process, and last week, senators from Alaska introduced legislation that would ban GM salmon if the FDA approves the fish.

The salmon have DNA from other organisms that cause the fish to grow faster and larger. The FDA is specifically reviewing the DNA, which is considered a “new animal drug.” Duke environmental economics professor Martin Smith said the review process has ignored broad effects that large, fast-growing salmon could have on the environment and society, like how cheaper salmon might lower prices and increase consumption.

“These market impacts could dwarf any small differences in nutritional content,” Smith said.

Smith said the review process has only compared the nutritional value of GM salmon to regular salmon and screened for known toxins and allergens.

Smith and his team argue a full review would consider broader definitions of environmental safety and public health. The FDA should also make a fuller assessment of potential economic and environmental impacts, such as the amount of pollution created by salmon farms and the increased harvesting of the wild fish used to feed farmed salmon.

FDA spokesperson Siobhan DeLancey said the FDA did not receive a copy of the Duke study and the review process is still under way.

Smith and his team also argued the FDA should have put more thought into the potential threat GM salmon could pose to native salmon if the fish escaped into the wild.

Last week, watchdog group Food and Water Watch released internal documents from the Department of the Interior to Truthout showing that federal wildlife officials are concerned about the GM salmon proposal and the FDA’s failure to consult the Fish and Wildlife Service about the potential for the salmon to escape and threaten endangered populations in the wild.

“The approval of genetically modified salmon will set an important precedent for other transgenic animals intended for human consumption,” Smith said in a statement. “It’s essential that FDA establishes an approval process that assesses the full portfolio of impacts to ensure that such decisions serve society’s best interests.”

AquaBounty Technologies, the company that spent a decade developing the GM salmon, has proposed to breed the fish in inland tanks in Canada and then grow them in Panama.

Some activists are concerned that a decision on the salmon is imminent, but DeLancey said the agency is still reviewing comments from the industry and the public.

The FDA also has to decide whether to prepare a Finding of No Significant Impact or an Environmental Impact Statement, a preliminary decision that would be subject to a 30-day comment period.