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Why the delay in release of FDA documents on gene-modified salmon?

December 26, 2012|By Rosie Mestel
  • Genetically modified AquAdvantage salmon, back, reaches maturity faster than regular Atlantic salmon.
Genetically modified AquAdvantage salmon, back, reaches maturity faster… (AquaBounty Technologies…)

The Food and Drug Administration released long-awaited documents Dec. 21 on genetically modified salmon: an assessment of the fish’s potential environmental effects and a preliminary “finding of no significant impact” of the fish on the environment. This brings AquAdvantage salmon -- Atlantic salmon that has been modified with a growth hormone gene from chinook salmon so that it reaches maturity faster -- a significant step closer to FDA approval.  

Astute readers will notice that the recently released documents are dated May 4. So why were they just released Dec. 21 -- seven months later?

In a Dec. 21 email, a spokesperson for the FDA explained it this way: “Yes there was a delay. As you are aware, we’ve been working on this for a while, and it was an oversight in our [quality control] process. We are working to address it now.”

The report did get passed around a variety of government agencies, and that does take time. But an investigation by Jon Entine published Dec. 19 by Slate.com and the nonprofit Genetic Literacy Project reported that all internal regulatory hurdles had been passed back in April but that the White House put a hold on release of the documents.

“Within days of the expected public release of the EA [environmental assessment] this spring, the application was frozen,” wrote Entine, who is the Genetic Literacy Project's executive director. “The delay, sources within the government say, came after meetings with the White House, which was debating the political implications of approving the GM salmon, a move likely to infuriate a portion of its base.”

Should AquAdvantage salmon be approved, it would be the first genetically engineered animal for food consumption to reach that milestone. It has been a long road for the fish. The transgenic salmon was first created in 1989. AquaBounty Technologies, its makers, applied for FDA approval 17 years ago. And since 2010, the salmon has been in “regulatory purgatory,” as Entine’s article put it, waiting for a decision from the FDA that was expected within weeks.

Read the entire article for an overview of the history of the salmon and the repeated roadblocks placed in its path. Both those who are opposed to approval of the fish and those who believe it is safe have criticized the way events have unfolded.

And, Entine wrote, “A question remains whether the White House or FDA could face legal challenges for intervening in a scientific evaluation process that is supposed to be insulated from politics. The Federal Food, Drug & Cosmetic Act [under which genetically modified animals are regulated] requires that the Health and Human Services secretary approve the AquaBounty application within six months after compliance with Section 512 [of the act]. The company holds letters from earlier this year from the FDA advising that every major component of its application has been successfully addressed.”

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