Is the White House Interfering With a Scientific Review?

An AquAdvantage? salmon

Barrett & MacKay Photo/Courtesy AquaBounty Technologies.

As president, Barack Obama promised 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 issued a science integrity memorandum in 2009 pledging, ?Political officials should not suppress or alter scientific or technological findings and conclusions.?

Except, it appears, when it comes to the fate of the first transgenic animal to be considered for federal approval?a genetically modified (GM) salmon developed by AquaBounty Technologies of Massachusetts. The so-called AquAdvantage salmon 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 effects 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. And 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.

As recently as last week, a spokeswoman for the Food and Drug Administration told me, ?The application is still under review.? But that?s not the whole story.

The Genetic Literacy Project (GLP), which I direct, has learned that in April, the FDA completed its draft environmental assessment (EA), the final step in its scientific evaluation. The agency confirmed that the salmon is safe to eat and poses no serious environmental hazards. The approval document had made its way through every appropriate agency in an interagency 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 this spring, 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 portion of its base.

The GLP has been leaked a confidential copy of the 159-page assessment, dated April 19, 2012, which had been circulated and approved?a summary of which we have been given permission to publish. It states that the Center for Veterinary Medicine, which has regulatory responsibility within the FDA, reached a ?no effect? determination under the Endangered Species Act. That 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. If the process had been followed, genetically modified salmon could have been on dinner tables by next year.

When asked about the holdup, FDA spokeswoman Siobhan DeLancey said, ?I recommend you talk to the OMB or the White House. That?s all I?m willing to say.?

If, as FDA sources confirm, the scientific review is complete, the refusal to publish the draft EA in the Federal Register directly contradicts not only the president?s directives, but also regulatory mandates ensuring the integrity of science at the Department of Health and Human Services, which oversees the FDA, and OSTP, which is under the executive branch.

?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.?

AquaBounty?s fish is an Atlantic salmon with two added genetic elements: a Chinook salmon growth hormone gene and an on-off switch from the ocean pout, another edible fish. The modifications make the salmon grow through the winter, unlike conventional salmon. Only females are produced for consumption, and they are rendered sterile.

Americans consume 650 million pounds of salmon each year, with more than 530 million pounds of that imported. If allowed into the marketplace, the AquAdvantage salmon, as it is called, could lead to lower salmon prices and an increase in consumption of salmon, a heart-healthy food.

GM crops and animals are regulated under the 1986 Coordinated Framework. But while plants have a clear path to approval under guidance in place by 1992, animals must travel through regulatory no-man?s land. The FDA has approved only one product, an anticoagulant derived from the milk of transgenic goats.

AquaBounty initiated its application to commercialize in 1995. By 2004, it had assembled its ?data package,? but its path to approval was never entirely clear. Finally in 2008, the Bush administration decided that transgenic animals intended for the dinner table would be regulated as animal drugs by the FDA?s Center for Veterinary Medicine.

Source: http://feeds.slate.com/click.phdo?i=a8821b015b4a02d77ae7fb1d27e3c2e9

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