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GMO salmon having to negotiate political upstream to the market
 
By KEVIN WALKER
Michigan Correspondent

WASHINGTON, D.C. — After the better part of 20 years, AquaBounty Technologies’ genetically modified (GMO) salmon may be on the cusp of getting the federal government’s green light for commercial production.

The salmon, which has genetic material from Chinook salmon as well as ocean pout, grows through the winter, unlike ordinary ocean salmon. As such, it reaches maturity much faster than ordinary salmon. But getting approval for the breed of fish, called AquAdvantage by the Massachusetts-based company, has been anything but fast – and according to a recent editorial, the Obama administration has been accused of playing politics with the new technology.

Recently somebody leaked a portion of the U.S. Food and Drug Administration’s (FDA) draft environmental assessment (EA) for AquAdvantage to the Genetic Literacy Project (GLT) and the group said it simultaneously learned the draft EA had been ready for publication in the Federal Register last April.

The head of the GLT, Jon Entwine, wrote about the controversy in a recent issue of Slate magazine. In his piece, Entwine suggests the Obama White House wanted to avoid something as politically controversial as news that a GMO animal might come onto the market, in an election year.

A few days after the editorial appeared in print, the FDA published the draft EA as a Notice in the Federal Register, albeit in redacted form. The EA has a comment period of 60 days. A call to the person in charge of the Notice at the FDA was unreturned as of press time.
Although the non-redacted version of the EA, published on the GLT’s website, contains comments that plainly state the FDA has no problem with the product, even the redacted version says as much.
“Assessment of the potential risks to the environment from AquAdvantage Salmon involves consideration of the likelihood and consequences of the fish escaping, becoming established in the environment and spreading to other areas,” the government’s published version of the EA states. It was published on Dec. 26, 2012.

“If the likelihood of these events, which are analogous to exposure in the traditional risk-assessment paradigm, is zero or close to zero, it is reasonable to conclude that the consequences of these events, which are analogous to the effects, are not of concern. In other words, if there is no exposure, there is no risk.”

It goes on to state a “strong management operations plan” ensures containment measures designed to keep the eggs or fish from escaping will be effective. The fish will be raised initially at a facility in Canada. According to the summary, the area outside that facility would not be hospitable to developing fish.

At some stage the growing fish would be transported to a facility in Panama. Also according to the draft EA, the warm waters surrounding the Panama facility would not be suitable to the creature’s survival were any to escape. In addition, the AquAdvantage has been developed to grow sterile females only.
“We are delighted that the Environmental Assessment is to be published for comment, which brings us a major step closer to approval,” said AquaBounty’s CEO Ron Stotish in a statement Dec. 24. “The revival of the science-based review process is encouraging and we look forward to a successful conclusion based on the merit of the product.”

But the statement also said the government hasn’t told the company what its timeline or process will be going forward. The company received the license to develop the technology as a commercial product in 1996.

Environmental groups are unhappy with the progress AquAdvantage has made of late, calling the salmon “Frankenfish.” Friends of the Earth, for example, is hoping the government will require the company to do an environmental impact statement, a development which could add two more years to the regulatory process.
“The FDA is nearing its final approval of GE salmon despite the fact that poll after poll shows that the public doesn’t want to eat genetically engineered fish or other animals,” the group said in a statement Jan. 10.
1/16/2013