December 24, 2012
Genetically Engineered Fish Receives Environmental Approval From FDA
redOrbit Staff & Wire Reports - Your Universe Online
Federal regulators have moved one step closer to allowing the first genetically engineered animal to enter the world's food supply, ruling that a salmon that grows twice as quickly as normal is not likely to harm the environment.The Food and Drug Administration (FDA) issued a declaration on Friday stating the modified AquAdvantage fish, which was developed by Massachusetts-based AquaBounty Technologies would have "no significant impact" on nature, and that it would be "as safe as food from conventional Atlantic salmon," Andrew Pollack of the New York Times said.
According to Associated Press (AP), environmental assessment comes after a "contentious, years long debate" amongst federal officials. The FDA reportedly said more than two years ago the salmon appeared to be safe for consumption, but they had failed to act further since then.
The delay led to some speculation amongst AquaBounty executives that action on their application was being delayed due to opposition from groups opposing genetically modified food, the AP said. Experts believe Friday's approval could be the last hurdle before the transgenic fish receives FDA approval, which would make it the first genetically altered animal approved for consumption anywhere in the world.
AquaBounty Chief Executive Ronald Stotish told Pollack the company was "encouraged" by the declaration, but added "not so foolish as to be wildly enthusiastic" the product's chances for approval were now all but guaranteed. Even if AquAdvantage is approved, it is unlikely it will bring an end the debates over the safety of genetically modified food animals.
"Critics call the modified salmon a 'frankenfish.' They worry that it could cause human allergies and the eventual decimation of the natural salmon population if it escapes and breeds in the wild," the AP said. "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 the potential for escape is low. The FDA backed these assertions in documents released in 2010."
As Jon Entine of Forbes explains, it is expected to be officially published in the Federal Register on Wednesday, which will begin a 60-day public review period. After that, the FDA will evaluate public comments and consider a possible second review period.
Barring "some dramatically new information" during the review period or periods, the modified salmon should be formally approved sometime in 2013 and could be available for sale by the following year, he says.
"The AquAdvantage salmon has an added growth hormone from the Pacific Chinook salmon that allows the fish to produce growth hormone all year long," the AP said. "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 Atlantic salmon produce the growth hormone for only part of the year."