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FDA close to approving first genetically engineered fish

The U.S. Food and Drug Administration appears to be on the verge of approving the first genetically modified animal for human eating. The AquAdvantage Salmon, created by AquaBounty Technologies, has been given a gene from the ocean pout and a growth hormone from a Chinook salmon, which allow the salmon to “reach market size twice as fast as a traditional salmon,” according to the company. The salmon is reproductively sterile, the company has said. salmon

In a briefing document, the FDA staff wrote that “food from AquAdvantage Salmon … is the same as food from other Atlantic salmon” and “is as safe to eat as food from other Atlantic salmon.”

But independent scientists, environmental organizations and consumer groups are concerned about the process of approval, product labeling and human and environmental safety risks.

According to Greg Jaffe, biotechnology director for the Center for Science in the Public Interest, the FDA uses a drug-approval process for new animal drugs, such as genetically engineered salmon. Any company producing a new animal drug must prove to the FDA that the new product is safe. The company carries out tests or hires independent organizations to conduct tests, and the company collects the data to make its argument. The FDA then evaluates the company’s data behind closed doors.

On Sept. 19 and 20, the FDA’s Center for Veterinary Medicine, which is charged with evaluating the GE salmon issue, will have a hearing to determine product safety.

“It’s good to have a procedure. It’s good to have pre-market approval. It’s good to have a high hurdle to gain approval,” said Jaffe. “But on the whole, it’s not a transparent and participatory process. Only at the 11th hour does the public get the data.”

As for product labeling, the FDA can require labeling only if there’s a “material difference” between a GE product and a non-GE product, according to Jaffe. However, the resulting label describes the difference—for example, the label might say that a GE soybean has high-oleic acid content, not that it is GE. As far as Jaffe knows, the FDA has not yet required a company to label any animal drug product as GE.

A public hearing will be held on Sept. 21 to “explain the relevant legal principles for food labeling and to solicit information and views from interested persons on the application of these principles to the labeling of food made from AquAdvantage Salmon,” according to an FDA press release.

According to the Washington Post, some consumer and environmental groups, as well as certain scientists, are concerned about whether AquAdvantage Salmon could escape fish farms and threaten the wild salmon population and whether the FDA can assess the risks to the natural world of a fish created in a laboratory.

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