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Special salmon closer to approval

May open door to more biotech food

By Andrew Pollack
New York Times / June 27, 2010

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NEW YORK — The Food and Drug Administration is seriously considering whether to approve the first genetically engineered animal that people would eat — salmon that can grow at twice the normal rate.

The developer of the salmon has been trying to get approval for a decade. But the company now seems to have submitted most or all of the data the FDA needs to analyze whether the salmon are safe to eat, nutritionally equivalent to other salmon, and safe for the environment, according to government and biotechnology industry officials. A public meeting to discuss the salmon may be held as early as this fall.

Some consumer and environmental groups are likely to raise objections. Even within the FDA, there has been a debate about whether the salmon should be labeled as genetically engineered — something that is not required of genetically engineered crops.

The salmon’s approval would help open a path for companies and academic scientists developing other genetically engineered animals, like cattle resistant to mad cow disease or pigs that could supply healthier bacon. Next in line behind the salmon for possible approval would probably be the “enviropig,’’ developed at a Canadian university, which has less phosphorus pollution in its manure.

The salmon was developed by a company called AquaBounty Technologies and would be raised in fish farms. It is an Atlantic salmon that contains a growth hormone gene from a chinook salmon as well as a genetic on switch from the ocean pout, a distant relative of the salmon.

Normally, salmon do not make growth hormone in cold weather. But the pout’s on switch keeps production of the hormone going year round. The result is salmon that can grow to market size in 16 to 18 months instead of three years, though the company says the modified salmon will not end up any bigger than a conventional fish.

“You don’t get salmon the size of the Hindenburg,’’ said Ronald L. Stotish, the chief executive of AquaBounty. “You can get to those target weights in a shorter time.’’

AquaBounty, which is based in Waltham and publicly traded in London, said earlier this month that the FDA had signed off on five of the seven sets of data required to demonstrate that the fish is safe for consumption and for the environment. It said it demonstrated, for instance, that the inserted gene did not change through multiple generations and that the genetic engineering did not harm the animals.

“Perhaps in the next few months, we expect to see a final approval,’’ Stotish said.

He said it would take two or three years after approval for the salmon to reach supermarkets.

The FDA confirmed it was reviewing the salmon but, because of confidentiality rules, would not comment further.

Under a policy announced in 2008, the FDA is regulating genetically engineered animals as if they were veterinary drugs and using the rules for those drugs. And applications for approval of new drugs must be kept confidential by the agency.

Critics say the drug evaluation process does not allow full assessment of the possible environmental impacts of genetically altered animals and also blocks public input.

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