September 3, 2010 / 3:01 PM / 9 years ago

Biotech salmon safe for eating: FDA

WASHINGTON (Reuters) - A biotechnology company’s genetically engineered salmon are as safe to eat as other Atlantic salmon, U.S. regulators said as they weighed approval of the first DNA-altered animal for Americans’ dinner plates.

The AquAdvantage salmon, developed by Aqua Bounty Technologies Inc, are genetically modified to grow twice as fast as conventional Atlantic salmon. Environmental and food-safety critics plan to fight against approval.

The success of the salmon is crucial to Aqua Bounty, a small company that has staked its future on the technology. The company’s shares rose 26 percent on Friday after the positive comments from U.S. regulators.

The Food and Drug Administration has set a three-day public meeting starting September 19 on the DNA-altered fish, which could lead the way for biotech trout and tilapia.

In a preliminary analysis prepared for the meeting, FDA staff said the altered salmon were “as safe to eat as food from other Atlantic salmon.” The agency said it saw “no biologically relevant differences” in vitamins, minerals or fatty acids.

FDA experts also said the fish were “highly unlikely” to cause significant harm to the environment.

The chances of the altered salmon escaping from production or growing facilities and reproducing, a worry of critics, are “extremely small” thanks in part to multiple containment measures, the FDA staff said. The bio-engineered fish are “effectively sterile,” they said, and the company plans to sell only female eggs.

Massachusetts-based Aqua Bounty says the technology could boost the nation’s fish sector and reduce pressure on the environment from overfishing.

But consumer advocates and food safety experts worry splicing and dicing fish genes may have the opposite effect, leading to more industrial farming and potential escapes into the wild. Side effects from eating the fish also are unknown, with little data to show it is safe, they say.

“The FDA is basically just assuming these fish are okay to eat,” said Jaydee Hanson, a policy analyst for the nonprofit Center for Food Safety.

He said the company’s testing was “one of the smallest samples of fisheries research that I’ve seen,” For example, samples from just six fish were analyzed for possible allergic reactions, he said.

The company should have studied many more fish and run clinical trials to test health effects in people, said Hanson, who plans to testify against approval at the public meeting.

Aqua Bounty Chief Executive Ronald Stotish had a different view, calling the salmon “one of the best-documented fish in the history of fish.” The salmon look the same as conventional ones and taste “great,” he added.

At the three-day meeting, the agency will seek input from a panel of outside advisers before making a final decision in the following weeks or months.

The panel will hear from FDA staff, company officials and public speakers on the first two days before providing its opinion. On the third day, the FDA will take public input on whether the bio-engineered salmon should be labeled differently than conventional salmon.

The FDA reviewers recommended post-approval monitoring for any physical or behavior irregularities to check if the fish grow and behave in a similar way in a commercial setting.

Aqua Bounty originally filed for U.S. approval of the salmon in 1995. In 2009, it saw a $4.8 million net loss after restructuring in 2008 to preserve cash and focus on completing the FDA’s approval process.

Shares of Aqua Bounty closed up 26 percent in London.

Reporting by Lisa Richwine, editing by Gerald E. McCormick, Leslie Gevirtz and Carol Bishopric

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