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FDA considers sale of altered salmon as food

Concerns cited over Mass. firm’s product

By Mary Clare Jalonick
Associated Press / September 21, 2010

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WASHINGTON — Federal food regulators opened hearings yesterday to consider whether to approve, for the first time, a genetically engineered animal for the dinner tables of Americans.

The Food and Drug Administration is holding two days of hearings on a request to market genetically modified salmon. Ron Stotish, chief executive of AquaBounty, the Massachusetts company that made the request, said at the meeting that his company’s fish product is safe and environmentally sustainable.

Critics, however, call the modified salmon “Frankenfish’’ that could cause allergies in humans and eventually decimate the wild salmon population. An FDA advisory committee is reviewing the science of the genetically engineered fish this week and hearing such criticisms as the agency ponders approval.

The FDA has already said that the salmon, which grow twice as fast as conventional ones, are as safe to eat as the traditional variety.

Whether the American public will have an appetite for it is another matter. Genetic engineering is already widely used for crops, but until now the government has not considered allowing the consumption of modified animals. Although the potential benefits — and profits — are huge, many individuals have qualms about manipulating the genetic code of other living creatures.

Part of the two-day hearing will focus on labeling of the fish. It is possible that if the modified salmon is approved, consumers would not even know they were eating a genetically engineered product. Current FDA regulations require that modified foods be labeled as such only if the food is substantially different from the conventional version, and the agency has said that the modified salmon is essentially the same as Atlantic salmon.

Approval of the salmon would open the door for a variety of other genetically engineered animals, including an environmentally friendly pig that is being developed in Canada or cattle that are resistant to mad cow disease.

“For future applications out there, the sky’s the limit,’’ said David Edwards of the Biotechnology Industry Association. “If you can imagine it, scientists can try to do it.’’

AquaBounty, based in Waltham, says it would be the first in the world to market genetically engineered fish. The company submitted its first application for FDA approval in 1995, but the agency did not decide until two years ago to consider applications for genetically engineered animals — a move seen as a breakthrough by the biotechnology industry.

Genetically engineered animals are not clones, which the FDA has already said are safe to eat. Clones are copies of an animal. With genetic engineering, the animal’s DNA has been altered to produce a desirable characteristic.

In documents released ahead of the hearing, the FDA said there are no biologically relevant differences between AquaBounty’s engineered salmon and conventional salmon, and there is a reasonable certainty of no harm from its consumption.

Critics have two main concerns: the safety of the food to humans, and the salmon’s effect on the environment.

Because altered fish has never been eaten, they say, it could include dangerous allergens, especially because seafood is highly allergenic. They also worry that the fish will escape and intermingle with the wild salmon population, which is already endangered. The modified salmon would grow faster and consume more food, to the detriment of the conventional wild salmon, the critics fear.

A wide range of environmental, food safety, and consumer groups have argued that more public studies are needed and that the FDA process is inadequate because it allows the company to keep some proprietary information private. Modified foods are regulated under the same process used for animal drugs.

“It is outrageous to keep this vital information secret,’’ said Wenonah Hauter, director of the advocacy group Food & Water Watch. “Consumers have a right to know what FDA is trying to allow into our food supply.’’

AquaBounty’s Stotish countered that the company has more than addressed critics’ concerns.

“This is perhaps the most studied fish in history,’’ Stotish said. “Environmentally, this is a very sustainable technology.’’

The company has several safeguards in place to allay concerns. All the fish would be bred female and sterile, though a small percentage may be able to breed. They would be bred in confined pools where the potential for escape would be very low.

If approved, the fish could be in grocery stores in two years, the company estimates.

Growth spurt
The Waltham-based company AquaBounty has added to conventional salmon a growth hormone from Chinook salmon that allows the fish to produce the growth hormone all year long. Conventional salmon produce the hormone only some of the time. AquaBounty engineers were able to keep the hormone active by using a gene from an eellike fish called an ocean pout that acts like an “on’’ switch for the hormone.

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