FDA hears concerns over approving genetically modified salmon

By Lyndsey Layton
Washington Post Staff Writer
Monday, September 20, 2010; 8:41 PM

Environmental organizations, consumer groups and independent researchers assailed the plans of a Massachusetts company to market the first genetically modified animal as food in the United States - an Atlantic salmon - and argued at a public meeting Monday that federal regulators should deny permission.

"Science cannot prove that this new gene-spliced salmon is safe for human consumption over a long period of time," said Darrell Rogers of the Alliance for Natural Health. "This recklessly and needlessly endangers human health."

He made the comments at a meeting of a panel of experts convened by the Food and Drug Administration, which is poised to make a landmark decision that could mark a turning point in the way American food is produced.

AquaBounty, the company seeking permission to market the fish in the United States, wants to incubate genetically modified eggs in Prince Edward Island, Canada, then ship them in plastic coolers to Panama. There they would be raised in land-based tanks and eventually processed before being transported to the United States for sale.

In developing its fish, AquaBounty took an Atlantic salmon and inserted a growth hormone gene from a Chinook salmon as well as an "antifreeze" gene from the ocean pout, a large, eel-like species. The result is a genetically modified fish that can grow to market size in 18 months instead of three years, according to AquaBounty. That means farmers can speed production and increase yields, the company said.

The advisory panel did not vote on the matter, but individual members offered a range of comments - sometimes conflicting - after two days of testimony from AquaBounty, the FDA and the public.

Gregory Jaffe, a panel member who is the biotechnology director at the Center for Science in the Public Interest, said the committee did not find any fatal flaws in the application.

"In some areas, we said we need more information to do the analysis," Jaffe said. "I think the agency is going to take its time with this, but I anticipate at some point this will be approved by the FDA."

A separate panel will meet Tuesday to discuss whether the FDA should require labeling on the modified salmon. The FDA commissioner will decide both matters, but it is unclear when.

AquaBounty, which first applied to the FDA for permission to sell its fish in 1995, says the modified fish is identical to the Atlantic salmon except for the speed of its growth.

FDA scientists who reviewed the company's application agreed. "AquAdvantage salmon is Atlantic salmon," said Kathleen Jones, an FDA scientist. "AquAdvantage salmon is as safe as food from any other Atlantic salmon."

Agency scientists also agreed with AquaBounty's assertion that the modified fish would not pose a threat to the environment.

"The likelihood that these fish could escape and reproduce and establish themselves is extremely small," said Eric Silberhorn of the FDA, noting that the fish would be raised in physically contained tanks and would be sterile females, unable to mate.

Critics said the company had not proved that the fish was safe for humans or the environment.

"If you tried to publish this information in a peer-reviewed journal, it would be rejected," said Anne Kapuscinski, a professor at Dartmouth College and an international expert on the safety of genetically modified organisms.

She said that AquaBounty's application was built on "overly simplistic claims" and that the FDA had not thoroughly analyzed the impact of a modified salmon if it escaped into the ocean.

"There are always human errors or equipment failures, and you have to analyze what would happen under those circumstances," Kapuscinski said.

Ron Stotish, the chief executive of AquaBounty, said his company had spent $60 million and 10 years developing and studying the AquAdvantage salmon. "The data we supplied adequately supports our application," he said. "Any fair-minded person would find this to be fairly complete."

Several public speakers argued that the FDA's approval process is not designed to handle the complexities of genetically engineered organisms. The agency is treating the application for AquAdvantage salmon as if it were a new veterinary drug, which means that the deliberations are taking place behind closed doors and that AquaBounty can say much of the research and other supporting data it supplies to the agency is confidential.

The pending decision is being carefully tracked by biotechnology companies that have invested millions of dollars in developing other genetically modified food animals and are next in line behind AquaBounty, waiting for the FDA to act on their requests for approval. The U.S. already permits genetically modified plants, such as corn and soybean.


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