U.S. Approval of GMO Salmon May Set Precedent

There’s a new fish in town—but not everyone’s ready to make room on their plates for it.

Thursday, the U.S. Food and Drug Administration issued its first approval for a genetically engineered animal intended for human consumption. The animal is the AquAdvantage salmon, an Atlantic salmon modified to contain a growth hormone gene from Chinook salmon, turned on by a chunk of DNA from another fish called the ocean pout. These modifications let the AquAdvantage salmon reach adult size far before conventional salmon do.

Already, the FDA’s decision has been challenged by groups like the Center for Food Safety, which issued a statement Thursday that it intends to sue the FDA, and the Canadian organization Ecology Action Centre, which went to court on Tuesday to argue against Canada’s approval of the fish.

This isn’t a sudden decision, though. AquaBounty, a small biotech company based in Maynard, Massachusetts, and Fortune, Prince Edward Island, has been working on the salmon since 1989, according to its website. They went to FDA about starting to develop AquAdvantage Salmon in 1995. Their argument? The U.S. imports 90 percent of its seafood, and fishing in the wild is unsustainable in the long run. We have to find ways to feed the planet.

So why has this approval process taken so long?

The FDA considers genetic engineering in this case to be a drug for animals. So by law, they had to evaluate whether the recombinant DNA is safe for the fish, whether the fish are safe for us to eat, and whether they’re as fast-growing as advertised. They also assessed whether the fish might have any adverse effects on the environment, and whether there are any nutritional differences between AquAdvantage and conventional farm-raised Atlantic salmon.

After much deliberation and years of study, they concluded that the AquAdvantage Salmon met all of these requirements—provided the salmon remain in land-locked tanks in Canada and Panama; and they keep an all female, sterile stock of fish for food use in Panama.

Plus, because genetically engineered foods are such a hot-button issue, it’s possible that the FDA might have wanted to be extra thorough.

“This is an application that is full of various implications and policy considerations for the federal government. Some of it’s controversial in some respects or to some individuals at least,” says Joseph (Jay) Cormier, a lawyer at Hyman, Phelps, & McNamara who worked at the FDA as a scientific reviewer between 2005 and 2011. During that time, he helped develop the regulatory process for genetically engineered animals.

“So there was a lot of very deliberate thought by the government under various administrations regarding specifically how to regulate these animals and then whether approval of the animals made sense,” he says. Cormier covers the FDA’s decision in more depth at the FDA Law Blog.

This isn’t the first genetically engineered animal to be approved by the FDA, just the first one that people might eat.

In 2009, the FDA-approved ATryn, an anti-clotting therapy for people with a rare blood disorder that is produced by genetically-engineered goats in their milk. And genetically modified plants, which Cormier explains are regulated by the U.S. Department of Agriculture, have been around for some time. (For more background on GM foods we are already eating and what’s in the works, see Food: How Altered? and Can GMOs Save Chocolate?)

So will AquAdvantage’s FDA approval make it easier for genetically engineered food animals to be approved in the future?

The answer seems to be: maybe.

“I do think in the future, it shows that the process can work, there is a way through it, and that there’s a mechanism [to have] a science-led discussion with the government about these kinds of technologies,” adds Cormier. “And we can approach them from a risk-based prospective, and regulate them accordingly.”

Research groups around the world are investigating ways to tweak livestock’s genes to make them less susceptible to infectious disease. One lab is looking into ways to change a single amino acid in an immune molecule to reduce cows’ susceptibility to a respiratory disease, and the Roslin Institute at the University of Edinburgh that brought us Dolly the cloned sheep have genetically engineered chickens to prevent them from transmitting bird flu from one bird to the next.

Ricardo Carvajal, Cormier’s colleague at Hyman, Phelps & McNamara who also worked at the FDA from 2002–2007 in their office of chief counsel, says that AquAdvantage’s approval provides a template, and sets precedent.

He adds, though, “That’s not to say that if there are subsequent submissions along these lines, that they’re going to be easy—they’re not. It’s a very demanding, multilayer review—and a bioengineered animal of a different species could well raise different types of issues.” Issues like—if they make it, will people eat it?

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