By ANDREW POLLACK New York Times
Government regulators moved a big step closer on Friday to allowing the first genetically engineered animal ? a fast-growing salmon ? to enter the nation?s food supply.
The Food and Drug Administration said it had concluded that the salmon would have ?no significant impact? on the environment. The agency also said the salmon was ?as safe as food from conventional Atlantic salmon.? While the agency?s draft environmental assessment will be open to public comment for 60 days, it seems likely that the salmon will be approved, though that could still be months away.
The environmental assessment is dated May 4. It is unclear why it took until now for it to be released, but supporters of the salmon say they believe it is because the Obama administration was afraid of an unfavorable consumer reaction before the election in November.
Environmental and consumer groups quickly criticized the federal agency?s conclusions.
?The G.E. salmon has no socially redeeming value,? Andrew Kimbrell, executive director of the Center for Food Safety, a Washington advocacy group opposed to farm biotechnology, said in a statement. ?It?s bad for the consumer, bad for the salmon industry and bad for the environment. F.D.A.?s decision is premature and misguided.?
But the decision was long in coming. AquaBounty Technologies, the company that developed the salmon, has been trying to win approval for more than a decade.
?We?re encouraged by this,? Ronald Stotish, the chief executive of AquaBounty, said on Friday. However, he added, ?We?re not so foolish as to be wildly enthusiastic? that Friday?s action will definitely lead to approval. Among other things, some members of Congress have tried to block the agency from approving the fish.
The AquAdvantage salmon, as it is called, is an Atlantic salmon that contains a growth hormone gene from the Chinook salmon and a genetic switch from the ocean pout, an eel-like creature. The switch keeps the gene on so that the salmon produces growth hormone year round, rather than only during warm weather. The fish reach market weight in about 18 months instead of three years.
The F.D.A. tentatively concluded in September 2010 that the salmon would be safe to eat and for the environment. A committee of outside advisers, while finding some shortcomings in the analysis, did not contradict those conclusions in general.
The agency then embarked on a more detailed environmental analysis that has now come to the same conclusions.
The main concern addressed was whether the genetically engineered salmon could escape and establish themselves in the wild, with detrimental environmental consequences. The larger salmon, for instance, could conceivably outcompete wild Atlantic salmon for food or mates.
The agency said the chance this would happen was ?extremely remote.? It said the salmon would be raised in inland tanks with multiple barriers to escape. Even if some fish did escape, the nearby bodies of water would be too hot or salty for their survival. And reproduction would be unlikely because the fish would be sterilized, though the sterilization technique is not foolproof.
The agency also said that approval of the salmon would have no effect on endangered species, including wild Atlantic salmon. The National Marine Fisheries Service and the Fish and Wildlife Service did not disagree.
AquaBounty produces its eggs at a facility in Prince Edward Island, Canada. The eggs are shipped to the highlands of Panama, where the fish are grown to market weight.
The federal agency said that other facilities for growing the salmon would require separate approvals. It also noted that it did not assess how the salmon would affect the environment in Panama and Canada, only in the United States.
Opponents said that the agency should do a more complete environmental impact statement. They also said that not enough samples were studied to conclude that the fish would be safe to eat.
Scientists and companies working on animal biotechnology had complained that the failure to approve the salmon was discouraging investment in the industry.
An article in Slate earlier this week said the White House had been delaying release of the environmental assessment for political reasons, violating the Obama administration?s pledge to make decisions based on science. The environmental assessment was released soon afterward.
An agency spokesman declined to comment on the delay. He said it was not possible to predict when a final decision on the salmon would be made.
The F.D.A. is likely to take weeks or months to analyze the comments it receives. Even if it then affirms the conclusions released Friday, that would be a decision that a bigger environmental impact statement is not needed. The agency would still have to take a separate step to approve the salmon for introduction into the food supply, although it is thought there are no other important issues outstanding.
Mr. Stotish of AquaBounty said that if the approval came early next year, some salmon could reach American dinner plates late next year. But quantities would be limited by the small capacity in Panama. AquaBounty hopes to sell eggs to other fish farms that would grow larger quantities of salmon, but that is likely to take a few more years.
AquaBounty has argued that the faster growth of its fish makes it feasible to rear them in inland tanks rather than ocean pens, reducing the environmental impact. ?That allows us not to disturb the oceans whatsoever,? said Elliot Entis, the founder of AquaBounty.
Mr. Entis, who no longer works for the company, has formed a new company to rear the salmon in the United States.
AquaBounty, which is based in Maynard, Mass., nearly ran out of money waiting for the salmon to be approved.
Kakha Bendukidze, an investor from the nation of Georgia who owned nearly half the company?s stock, sold his holdings in October to Intrexon, an American company. Intrexon, which is offering to buy the rest of AquaBounty, is providing it with a $500,000 loan.
Intrexon is working on synthetic biology, which is sort of a souped-up form of genetic engineering. It is not clear yet how it plans to apply that technology to AquaBounty?s fish.