Smart discussion about toxics policy reform

Groundhog Day at FDA

Remember the 1993 film Groundhog Day? Bill Murray’s TV weatherman found himself trapped in a time warp in a turgid little town and despaired, “What would you do if you were stuck in one place and every day was exactly the same, and nothing that you did mattered?”

That locked-in-place feeling gripped us during last week’s briefing on the federal Food and Drug Administration (FDA)’s progress – or lack of same — in reconsidering bisphenol A (BPA), the synthetic sex hormone found to leach into food and drink from plastic packaging. Back in June, the new FDA had promised a resolution of the question in “weeks, not months.”

Last week, though, FDA officials said the new review would not be done until late November. Moreover, they made it clear that the review was being led by one of the same officials who had developed the earlier, controversial FDA position that BPA food contamination is harmless to people.

We at Environmental Working Group don’t like to let the sun set on backpedaling, so immediately after the FDA staff briefing, Richard Wiles, EWG senior vice president for policy, sent a letter to FDA commissioner Margaret Hamburg, asserting that “the course on which the agency seems to have embarked will do nothing to restore public confidence in FDA.”

Specifically, Wiles asked Hamburg to remove a key FDA official from the BPA reassessment — Mitchell Cheeseman, who, as deputy director of the Office of Food Additive Safety, was a principle architect of the agency’s Bush era position that BPA food contamination presents no danger to the public, even infants.

Cheeseman’s name had surfaced back in September 2007, when he told Chemical and Engineering News, “FDA absolutely still considers BPA safe for uses in food containers.”

At the time, Cheeseman was dismissing a statement by the so-called Chapel Hill group, a panel of BPA experts convened by the National Institute of Environmental Health, who had asserted that BPA at levels to which people were exposed caused laboratory animals to develop, among other things, cancer, reproductive system abnormalities, brain and neurological disorders and diabetes.

The FDA stuck to its guns throughout 2008, even as more and more research labs produced evidence of the chemical’s hazards, leading Canada to ban BPA in baby bottles. Some U.S. states and municipalities enacted partial BPA bans in the early months of 2009.

Meanwhile, the Milwaukee Journal Sentinel added texture to the saga by publishing internal FDA emails showing that Cheeseman had consulted with chemical industry lobbyists on the agency’s position but had excluded dissenting voices. At one point, the Journal Sentinel reported, Cheeseman asked an American Chemistry Council (ACC) official how to discredit a Japanese study of BPA toxicity.

Last October, the Science Board pronounced the FDA staff’s work on BPA “incomplete and unreliable.”

Harsh words. Last week, FDA officials indicated to the Science Board that they wanted to set up a fresh new BPA panel in place of the more experienced subcommittee responsible for that stinging indictment.

As far as we’re concerned, green isn’t always a good thing. So Wiles asked Hamburg to keep the battled-hardened panel to oversee the FDA staff’s work.

Bill Murray’s character extricated himself from the Groundhog Day infinity loop when he abandoned his self-absorbed malaise, devoted himself to the public good — and got the girl.

EWG’s message to FDA was similar, except for the girl part. Don’t just sit there. Do something. As Wiles put it, to salvage its reputation, FDA has to show that it “puts the health of the public before the interests of BPA manufacturers and users.”


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