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Biotech Salmon Faces Scrutiny At FDA Panel

Date: 21-Sep-10
Country: USA
Author: Susan Heavey

Biotech Salmon Faces Scrutiny At FDA Panel Photo: Russell Cheyne
A salmon attempts to leap rapids on the river Braan in Perthshire, Scotland September 10, 2010.
Photo: Russell Cheyne

The first genetically modified animal could move one step closer to U.S. dinner tables on Monday, when a federal advisory panel recommends whether such food -- a salmon -- is safe to eat.

Both Food and Drug Administration staff and the salmon's maker, Aqua Bounty Technologies Inc, have said the fast-growing fish appears to be the same as normal Atlantic salmon and poses little threat to the environment or diners.

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

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

Overcoming advocates' complaints and winning the panel's support is critical for Aqua Bounty, whose shares have more than tripled this year ahead the FDA's potential green light.

The company has no other approved products and is eyeing the genetic technology for use in other fish like tilapia and trout.

Aqua Bounty Chief Executive Officer Ronald Stotish told the FDA's panel of outside experts that approval could help provide the "healthy kind of diet that Americans are used to" amid threats from overfishing and increased demand. Without it, "it's hard to imagine how we'll meet the protein needs of the developing population over the next 20 to 30 years."

The small Massachusetts-based biotechnology company said it had first sought U.S. approval of the salmon in 1995. It reported a $4.8 million net loss for last year after restructuring in 2008 to preserve cash and focus on approval.

Its shares were unchanged on the London Stock Exchange ahead of the panel's recommendation.

Later on Monday, panelists will advise the FDA if there is "reasonable certainty" that the salmon is safe to eat or if there is a potential environmental threat. The agency will weigh the recommendations before making its final decision.

INCREASED RISK?

Critics, including 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 even though the company submitted its bid more than a decade ago.

Last week, various groups protested in front of the White House, urging 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."

Aqua Bounty's salmon has a gene to make it grow twice as fast as natural Atlantic salmon. The company has said it is the same in every way to wild salmon and that taste tests showed no difference.

Stotish said Aqua Bounty plans to sell the eggs to inland fish farmers. The product could eventually boost the United States' meager domestic salmon farms, he said, even though the company's first application seeks approval to grow the fish at facilities in Canada and Panama.

The United States imports more than $1 billion of Atlantic salmon a year after industrialization knocked out most wild populations in its Northeast region.

Steven Vaughn, director of the Office of New Animal Drug Evaluation at the FDA's Center for Veterinary Medicine, said it took the agency so long to bring Aqua Bounty's bid before the public because it had to grapple with how to handle the complex science.

"This has been very challenging for us as a new technology," he said.

But other genetically altered food animals, including pigs and cows, are in the works. One other engineered fish, Yorktown Technologies LP's GloFish, is already sold in the United States as a pet.

One concern is whether consumers will know when they are buying genetically modified salmon, if it is approved.

Current FDA rules only call for special labels for altered food when there is a "material difference" in the product's end result. Aqua Bounty and FDA staff both say tests show the salmon'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, of which Aqua Bounty is a member.

The FDA's panelists will offer their advice later on Monday although there will not be a formal vote. On Tuesday, the agency will take comments on public labeling issues.

(Editing by Stacey Joyce and Lisa Von Ahn)

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