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Hallerman advises FDA on approving world’s first genetically modified animal


Eric Hallerman

Nov. 15, 2016 – When federal regulators declared the AquAdvantage salmon fit to eat last fall, it became the world’s first genetically engineered animal approved for human consumption. Professor Eric Hallerman advised the U.S. Food and Drug Administration (FDA) on the environmental issues surrounding transgenic Atlantic salmon as part of the agency’s investigation. “The FDA is respected globally,” Hallerman said. “Now that the U.S. has approved an animal for food, other countries might follow.”

The firm AquaBounty Technologies, which produces AquAdvantage salmon, asked Hallerman to lead research on the fish’s environmental impact. Hallerman had pushed for a better framework for risk assessment and management in genetic engineering since the late 1980s, and in the early 1990s helped develop the performance standards the USDA uses to evaluate the safety of aquatic genetic engineering projects.

Hallerman and his co-investigators discovered that AquAdvantage fish could potentially breed in the wild, passing down their engineered genes, so AquaBounty developed a system of redundant safeguards to confine their salmon. The company grows only sterile females and raises them in aboveground tanks in Panama. If these cold-water fish escaped, they would probably die in the warm, muddy rivers downstream from the facility, 4,000 miles from their spawning grounds along the North Atlantic.

The FDA invited Hallerman to present his findings in September 2010. “At the hearing, I was asked flat out, ‘Would you approve this?’ I said yes,” Hallerman recalled. “That recommendation sat around for five years.” The FDA finally approved the salmon grown in AquaBounty’s existing facilities in November 2015. If the company wants to expand production, it must re-apply for approval to sell fish from its new operations.

Read the full press release.

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