By Mary Clare Jalonick, Associated Press
WASHINGTON—Genetically engineered salmon that grows twice as fast as the conventional fish appears to be safe, an advisory committee told the Food and Drug Administration Monday. But they argued that more testing may be needed before it is served on the nation's dinner tables.
If the FDA approves the sale of the salmon, it will be the first time the government allows such modified animals to be marketed for human consumption. The panel was convened by the agency to look at the science of the fish and make recommendations on its safety and environmental impact.
Ron Stotish, chief executive of the Massachusetts company that created the salmon, AquaBounty, said at Monday's hearing that his company's fish product is safe and environmentally sustainable.
FDA officials have largely agreed with him, saying that the salmon, which grows twice as fast as its conventional "sisters," is as safe to eat as the traditional variety. But they have not yet decided whether to approve the request, saying there is no timeline for a decision.
Critics call the modified salmon a "frankenfish" that could cause allergies in humans and the eventual decimation of the wild salmon population. Representatives from consumer, environmental and food safety groups asked the agency to decline the company's application to market the fish, saying it is untested.
Most members of the advisory committee agreed with the FDA that the company has presented some compelling evidence that the fish is safe. 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 Tuesday, 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 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 Monday there are very few differences between the modified and conventional fish.