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FDA hears concerns over approving genetically modified salmon

"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.

laytonl@washpost.com


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