December 21, 2012

White House Reverses Itself, Lifts Political Block on FDA Approval of GM Salmon

From: Forbes

Jon Entine

Way paved for approval of first genetically modified animal for human consumption; Genetic Literacy Project investigation uncovers Executive Office violations of science integrity guidelines, raising legal, ethical concerns.  

The Food and Drug Administration today released an electronic version of its Environmental Assessment for a genetically modified (GM) salmon developed by AquaBounty Technologies of Massachusetts—effectively giving its preliminary seal of approval on the first transgenic animal to be considered for federal approval.

According to sources within FDA, the EA had been approved by the all the relevant agencies on April 19, 2012, but had been blocked for release on orders from inside the executive branch—which has raised both legal and ethical issues of political interference with science and the independent work of federal agencies.

The decision by the White House to rescind its order to block the FDA from releasing the EA came Wednesday within hours after the publication of an investigative report by the Genetic Literacy Project (GLP) last Wednesday.

“There was no place for the White House to hide anymore,” said one FDA insider.

The EA was posted this morning. It has gone to the printer and is expected to be officially published in the Federal Register next Wednesday. That paves the way for a public review period, which could last 30 to 90 days. The FDA will then evaluate the public comments and consider a second review period. Unless some dramatically new information would emerge from the public responses, the FDA would issue it’s formal approval some time in 2013. The GM salmon could be on dinner table by 2014.

Genetic Literacy Project Investigation

The GLP had been leaked a confidential copy of the April 159-page assessment, which had been circulated and approved earlier this spring—a summary of which the GLP had been given permission to publish. It stated that the Center for Veterinary Medicine, which has regulatory responsibility within the FDA, had reached a “no effect” determination under the Endangered Species Act. The FDA had previously determined the salmon was safe to eat and materially identical to conventional salmon Those determinations should have led to the publication of the EA in the Federal Register, paving the way for a public review period, which would have lasted 30 to 90 days.

Instead, the White House ordered the document held—in violation of numerous federal guidelines and statutes. Administration officials reversed their position, sources say, within hours after a publication of the investigatory report in the online magazine Slate last Wednesday.

The revelations came as an embarrassment to the administration, say sources. As president, Barack Obama had pledged to change “the posture of our federal government from being one of the most anti-science administrations in American history to one that embraces science and technology.”

To publicly guarantee that, the White House had issued a science integrity memorandum in 2009 pledging, “Political officials should not suppress or alter scientific or technological findings and conclusions.”

Except, when it came to the fate of the so-called AquAdvantage salmon produced by AquaBounty. It is a fish that has been modified to grow to market size in about half the usual time. It’s raised in contained structures that eliminate many of the environmental impacts that make farmed salmon unpopular with some environmentalists, including the generation of excess waste and the potential to spread disease or escape and compete with wild salmon.

The bioengineered salmon has been winding its way through a labyrinthine approval process for 17 years; it’s been in regulatory purgatory for more than two years since the Food and Drug Administration held public hearings—and promised a final determination within weeks.

The Genetic Literacy Project (GLP), which I direct, had learned that the EA had made its way through every appropriate agency in an inter-agency review process coordinated by the Office of Science and Technology Policy (OSTP), which oversees the president’s science policies and is empowered to enforce integrity guidelines.

But within days of the expected public release of the EA on April 19, 2012, the application was frozen. 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 large portion of its base.

As recently as last week, Siobahn DeLancey, a spokeswoman for the Food and Drug Administration told me, “The application is still under review.” But that was not accurate. When asked about the hold-up, DeLancey said, “I recommend you talk to the OMB [Office of Management and Budget] or the White House. That’s all I’m willing to say.”

The OMB, which sometimes reviews regulations, referred me back to the FDA. The White House refused to comment, and has made no comment about its reversal and decision to lift its political ban.

“This shouldn’t be happening,” said Gregory Jaffe, director of biotechnology at the Center for Science in the Public Interest. Although cautious about biotechnology, Jaffe participated in a scientific review panel that unanimously endorsed the FDA’s findings that the salmon was safe. “AquaBounty deserves regulatory due process,” he added. “We need science-based decisions made in a timely fashion. The public deserves this, and there are questions whether that is what’s going on in this case.”

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