• by Thom Forbes  @tforbes, November 20, 2015

The Food and Drug Administration yesterday said the fast-growing, genetically engineered salmon produced by AquaBounty Technologies are safe for humans to eat and need not be labeled in any way when they hit the marketplace. Consumer and environmental groups who have argued, among other concerns, that the genetically modified fish might escape their tanks and breed with wild salmon, are expected to file a lawsuit seeking to overturn the ruling. 

“The FDA has thoroughly analyzed and evaluated the data and information submitted by AquaBounty Technologies regarding AquAdvantage salmon and determined that they have met the regulatory requirements for approval, including that food from the fish is safe to eat,” Bernadette Dunham, D.V.M., Ph.D., director of the FDA’s Center for Veterinary Medicine, said in a statement announcing the decision.

AquAdvantage “is an Atlantic salmon that contains a growth hormone from a Chinook salmon and has been given a gene from the ocean pout, an eel-like fish,” reports Brady Dennis in the Washington Post. “The result is a fish that is large enough for consumption in about a year and a half, rather than the typical three years.”

The fish would be bred in two facilities — one in Canada and the other in Panama — and the ruling makes it clear that “no other facilities or locations, in the United States or elsewhere, are authorized for breeding or raising AquAdvantage salmon that are intended for marketing as food to U.S. consumers.” The agency  determined that “multiple and redundant measures [are] being taken to contain the fish and prevent their escape and establishment in the environment.”

Also, AquaBounty says its fish are “all female and sterile, making it impossible for them to breed among themselves and with other salmon.”

Because the FDA review did not find a material difference — such as a different nutritional profile — between the GE salmon and its non-GE counterpart, it cannot require that the food be labeled as a GE product. Instead, the FDA has issued “two guidance documents that explain how food companies that want to voluntarily label their products can provide this information to consumers.”

But marketers need to avoid any terminology that “suggests or implies that a food product or ingredient is safer, more nutritious, or otherwise has different attributes than other comparable foods because the food was not genetically engineered,” according to the FDA.

Because of consumers’ confusion over what the acronym GMO means, the FDA “encourages” manufacturers to use terms such as “not bioengineered,” “not genetically engineered,” and “not genetically modified through the use of modern biotechnology.” 

“We are deeply disappointed with the FDA's decision to approve the AquaAdvantage salmon,” Michael Hansen, senior scientist with Consumers Union, said in a statement reported by NPR’s Dan Charles. “And it's even more concerning that the FDA chose not to require any form of labeling, making it extremely difficult for consumers to know if the salmon is GE or not.”

Massachusetts-based AquaBounty, which is majority-owned by the synthetic-biology firm Intrexon, first approached the FDA about approving the GE salmon in the 1990s, Andrew Pollack reports for the New York Times. The agency “made its initial determination that the fish would be safe to eat and for the environment more than five years ago,” but AquaBounty CEO Ronald Stotish tells Pollack that it “had no indication that approval was imminent.” 

“Stotish declined to say what the plans were for bringing the fish to market, other than that the salmon would not be in stores immediately because it would take about two years for even these fast-growing salmon to reach market size,” Pollack writes. Plus, production capacity is minuscule at present.

Then there are the looming legal and PR battles.

The Center for Food Safety — “in coordination with other colleague plaintiffs”  — plans to sue the FDA to block its approval of the sale and consumption of AquaAdvantage salmon. Its statement claims the FDA’s action “neglects the concerns of more than 300 environmental, consumer, health and animal welfare organizations, salmon and fishing groups and associations, food companies, chefs and restaurants.”

“This unfortunate, historic decision disregards the vast majority of consumers, many independent scientists, numerous members of Congress and salmon growers around the world, who have voiced strong opposition,” says Food & Water Watch executive director Wenonah Hauter in a statement. Urging President Obama to “overturn the approval,” Hauter says the organization “will be examining all options to stop” the fish from reaching the marketplace. 

Seaweed-roots organizations, and their constituencies, will have a say, too.

“Moms buy 85% of the food. If we don't buy it they can't sell it, regardless of the corrupt lawmaking,” says Zen Honeycutt, founder of an anti-GMO and pesticides advocacy group called Moms Across America, Liz Szabo reports in USA Today.