Genetically engineered salmon still a ways off as FDA delays approval - Washington Post

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The fish, which grows twice as fast as the conventional variety, is engineered by AquaBounty, a Massachusetts-based company, but not yet allowed on the market. The company's application has been pending for more than 15 years. If the agency approves it, it would be the first time the government allows such modified animals to be marketed for people to eat.

Congressional opposition to the engineered fish is led by members of the Alaska delegation. They see the modified salmon as a threat to the state's wild salmon industry.

In June, the House adopted an amendment by Rep. Don Young, R-Alaska, to an agriculture spending bill that would prevent the FDA from spending any money on approving the fish. His amendment was approved by voice vote with no objections.

Sen. Lisa Murkowski, R-Alaska, said last week she will attempt to add the same amendment to the Senate version of the bill.

"It kind of gives me the heebie jeebies that we are messing with what Mother Nature did a pretty good job with in terms of a king salmon," Murkowski said.

While Murkowski's opposition is rooted in concern for her state's fishing industry, other senators have expressed worries about potential food safety or environmental risks. More than a dozen senators have written the FDA with concern about the approval process and food safety and environmental risks. Bills to stop the salmon have been introduced in both chambers.

Ron Stotish, the chief executive of AquaBounty, said he was optimistic when the FDA decided to hold hearings on the company's application. But a year later, he said, he is frustrated by the delay and has lost investors in his business.

"If you had asked me a year ago if we would be having this conversation, I would have said no," he said.

The FDA is still in the process of completing their review, spokesman Doug Karas said, "although we cannot predict when that will be."

Karas said the FDA is planning on releasing a review of potential environmental impacts of growing the salmon — and soliciting public comments on that review — before reaching a decision. That means a decision could be months or even years away.

In the hearings last year, FDA officials said the fish is as safe to eat as the traditional variety. But critics call the modified salmon a "frankenfish." They say they are concerned it could cause human allergies and the eventual decimation of the wild salmon population if the engineered animals escape.

AquaBounty has maintained that the fish is safe and that there are several safeguards against environmental problems. The fish would be bred female and sterile, though a very small percentage might still be able to breed. The company said potential for escape is low. The FDA backed these assertions in documents released before these hearings last year.

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. The process is common in plant foods like corn and soybeans.

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. Typical salmon produce the growth hormone only some of the time.

Stotish acknowledged that approval of AquaBounty's product is likely more difficult because they are the first. Approval of the company's application would open the door for a variety of other genetically engineered animals, including an "Enviropig" being developed in Canada that has less-polluting manure or cattle that are resistant to mad cow disease. Each would have to be individually approved by the FDA.

"Blocking us is the best way to block anything that would come behind us," Stotish said.

Copyright 2011 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

13 Sep, 2011


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