Altered salmon spurs debate

WASHINGTON

Fish or frankenfish?

A Massachusetts company wants to market a genetically engineered version of Atlantic salmon, and regulators are weighing the request. If approval is given, it would be the first time the government allowed such modified animals to join the foods that go onto the nation’s dinner tables.

The salmon, which grows twice as fast as the conventional fish, appears to be safe, an advisory committee told the Food and Drug Administration yesterday. But members raised several concerns about the data, saying many of the sample sizes were too small and it is not certain how healthy the fish will be many years from now. Some said there wasn’t enough data to be certain the fish won’t cause food allergies.

It is still unclear whether the public will have an appetite for the fish if it is approved. Genetic engineering is already widely used for crops, but the government until now has not considered allowing the consumption of modified animals. Although the potential benefits — and profits — are huge, many people have qualms about manipulating the genetic code of other living creatures.

The hearing will continue today, when the agency will hear public comments on labeling the fish. It is possible that if the modified salmon is approved, consumers would not even know they were eating it. Current FDA regulations require modified foods to 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 the Atlantic salmon.

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

Approval would open the door for a variety of other genetically engineered animals, including a pig that is being developed in Canada or cattle that are resistant to mad cow disease. Each would have to be individually approved by the FDA.

“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, the company that created the salmon, 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 — or GE — animals are not clones, which the FDA has already said are safe to eat. Clones are copies of an animal. In GE animals, the DNA has been altered to produce a desirable characteristic.

In the case of the salmon, AquaBounty has added a growth hormone from a Chinook salmon that allows the fish to produce growth hormone all year long. The engineers were able to keep the hormone active by using another gene from an eel-like fish called an ocean pout that acts like an on switch for the hormone, according to the company. Conventional salmon produce the growth hormone only some of the time.

In documents released ahead of the hearing, the FDA said there were no biologically relevant differences between the engineered salmon and conventional salmon, and there is a reasonable certainty of no harm from its consumption. FDA scientists said yesterday there are very few differences between the modified and conventional fish.

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

Because the altered fish has never been eaten before, 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. They would grow fast and consume more food to the detriment of the conventional wild salmon, the critics fear.

The FDA tried to allay both of those concerns yesterday, saying the fish shouldn’t cause any allergies not already found in conventional salmon and that there is little chance they could escape. But the advisory panel, which was formed to give input to the agency and did not hold a final vote, cast some doubts on whether there was enough evidence to say those things for sure.

Critics speaking at the meeting said they were concerned about the unintended consequences of approval, arguing the FDA is relying on too little data.

Wenonah Hauter, the director of the advocacy group Food & Water Watch, said 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.

“With all due respect, we don’t believe a veterinary advisory committee is the appropriate place to discuss these food-safety issues,” Hauter told the panel.

AquaBounty CEO Ron Stotish countered his product has come under more scrutiny than most food.

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