FDA panel to consider GMO salmon

The first genetically modified animal could move one step closer to the U.S. market on Monday, when a federal advisory panel makes its recommendation on whether such food - a salmon - is safe for consumers to eat.

Both Food and Drug Administration staff and the salmon’s maker, Aqua Bounty Technologies Inc, have said the faster growing fish appears to be the same as normal Atlantic salmon and poses no threat to the environment or diners.

But consumer advocates, environmentalists and others have protested the move. They say there is not enough data to show that eating it does not cause side effects such as allergic reactions or that accidental escape will not harm other fish.

On Monday, an FDA panel of medical experts will advise the FDA on whether there is “reasonable certainty” that the engineered salmon is safe to eat or if there is a potential environmental threat. The agency will weigh the recommendations before making its final decision later.

If approved, Aqua Bounty’s salmon would be the first, genetically altered animal for consumption in the United States. The FDA has already allowed modified animals as pets or to help produce biologic medicines. Genetically engineered vegetables like corn have been on the market for years.

Overcoming advocates’ complaints and winning the panel’s support is also critical for Aqua Bounty, which has seen its shares more than triple this year ahead the FDA’s potential green light.

Critics, which include groups like Consumers Union, the Center for Food Safety and Food & Water Watch, say Aqua Bounty has not done sufficient studies to prove its fish is safe. They also criticize the FDA for allowing just 14 days for the public to review the data despite the fact that the company submitted its bid more than a decade ago.

Last week, various groups protested in front of the White House in a bid to urge President Barack Obama to postpone the public meeting or block the potential approval.

Consumers Union “is particularly concerned that this salmon may pose an increased risk of severe, even life-threatening allergic reactions to sensitive individuals,” it said in a statement. It added that fish are already a major allergen and that “this salmon could make the problem worse.”

The product is key for the small Massachusetts-based biotechnology company, which has no other approved products and is eyeing the genetic technology for use in other fish like tilapia and trout.

Aqua Bounty Chief Executive Ronald Stotish has said the company’s AquaAdvantage salmon is the same “in every measurable way” to natural Atlantic salmon and that taste tests have shown no differences.

Stotish argues allowing the fish, which would be sold as eggs to inland fish farmers, could boost the nation’s meager domestic salmon farms. The United States imports more than $1 billon a year of Atlantic salmon after industrialization knocked out most wild populations in the U.S. Northeast.

Approval could also pave the way for other genetically altered food animals in the works, like pigs and cows.

One major area of concern is, if the salmon is approved, whether consumers will know when they are buying it.

Current FDA rules only call for special labels for altered food when there is a “material difference” in the product’s end result. The company and FDA staff both say tests show the fish’s composition appears similar to normal fish.

Special package labeling to note AquaAdvantage salmon is altered, “just causes confusion for the consumers,” said David Edwards, head of animal biotechnology for the Biotechnology Industry Organization, which includes Aqua Bounty as a member.

On Monday, the FDA’s panelists will hear from the company, FDA staff and the public before making its recommendation. On Tuesday, the FDA will take comments on public labeling issues.

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By Susan Heavey
WASHINGTON (Reuters)