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Current Position:Home » News » Law & Regulation » International Regulations » Topic

FDA releases key impact statement on GE salmon

Zoom in font  Zoom out font Published: 2012-12-25  Authour: Christine Blank  Views: 40
Core Tip: AquaBounty, the company behind genetically modified salmon, will likely receive approval for the fish after a favorable environmental assessment from the Food and Drug Administration’s (FDA).
GM salmonAquaBounty, the company behind genetically modified salmon, will likely receive approval for the fish after a favorable environmental assessment from the Food and Drug Administration’s (FDA).

The FDA said on 21 December that the AquAdvantage fish “will not have any significant impacts on the quality of the human environment of the United States.” Importantly, the FDA also found that the genetically modified (GM) salmon is unlikely to harm populations of natural salmon, a key concern for environmental activists. This could pave the way towards final FDA approval of the first GM fish in the world.

“We are encouraged that the environmental assessment is being released, and hope the government continues the science-based regulatory process,” said Ronald Stotish, AquaBounty CEO. The approved environmental assessment will still be subject to a 60-day public comment period before the FDA rule is final.

The FDA’s environmental assessment approval comes just in the nick of time for the struggling technology firm. Earlier this month, AquaBounty said it would only have enough capital to continue operations until March 2013. As a result, the technology company agreed to a short-term bridge loan financing of USD 500,000 (EUR 379,500 ) to cover the company’s working capital requirements earlier this month.

Executives with Food & Water Watch criticized the environmental assessment approval.

“The FDA, which has been tasked with protecting consumer safety, failed to conduct the appropriate studies to determine if it is safe to eat or even if the fish can live up to AquaBounty’s claim of faster growth rates. And, by releasing an environmental assessment instead of a more thorough environmental impact statement, the FDA failed to fully consider the threat this controversial new fish could pose to wild fish populations,” said Wenonah Hauter, Food & Water Watch executive director.

Food & Water Watch is also concerned that, if AquAdvantage is improved, the FDA will not require labeling identifying that it is GM salmon. “We don’t know whether GM salmon will be labeled. If people don’t want to eat GM salmon and it is not labeled, what will that do for the demand for salmon?” said Patty Lovera, assistant director of Food & Water Watch.

However, Food & Water Watch is not the only organization to raise concerns about AquAdvantage. Over 40 members of Congress and scientists at other federal agencies, including the National Oceanic and Atmospheric Administration and the U.S. Fish & Wildlife Service, have also voiced strong opposition to GE salmon, citing the lack of scientific rigor and expertise at the FDA.

“Congress can still keep FDA from unleashing this dangerous experiment. Bipartisan legislation would ban the commercialization of this controversial fish. Food & Water Watch will be examining legal options to force FDA to do a more thorough assessment of this new GE food animal,” Hauter said.

 
 
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