Science Advisors Chide FDA on Plastics Chemical

FDA's panel of independent science advisors charged with reviewing the agency's work on bisphenol-A, a chemical commonly found in hard plastics and the lining of food cans, criticized FDA's current policy on the substance. The panel has "significant concerns" with the draft scientific assessment FDA released in August.

In FDA's draft assessment, the agency identified "margins of safety" for both infants and adults and contended, at levels most humans are exposed to, the margins are adequate. But the science panel's report says the available evidence "provides a sufficient scientific basis to conclude that the Margins of Safety defined by FDA as 'adequate' are, in fact, inadequate."

The panel criticized the agency's selection of studies on which it based its assessment, saying FDA excluded many studies suitable for determining the health effects of exposure to bisphenol-A. The report says FDA's list of the studies it used "creates a false sense of security about the information that is used in the assessment, however, as it overlooks a wide range of potentially-serious findings."

Last week, a Milwaukee Journal Sentinel investigation turned up evidence showing FDA used studies funded by the plastics industry lobby and some studies that are decades old.

The panel's stinging rebuke of FDA's risk assessment will quiet charges that the panel chair, Martin Philbert, has unacceptable ties to an anti-regulatory activist, Charles Gelman, who believes bisphenol-A is perfectly safe. The tone of the report and the panel's recommendation that FDA look at more studies finding bisphenol-A poses a risk vindicate Philbert who claims he was aware of Gelman's views but would not be swayed by them.

FDA continues to bury its head in the sand. In a press release responding to the panel's report, FDA says, "Consumers should know that, based on all available evidence, the present consensus among regulatory agencies in the United States, Canada, Europe, and Japan is that current levels of exposure to BPA through food packaging do not pose an immediate health risk to the general population, including infants and babies."

Nearly every study on bisphenol-A raises concerns. A recent study published in the Journal of the American Medical Association concludes human adults with high levels of bisphenol-A in their urine are at greater risk of heart disease and diabetes. The National Toxicology Program — which, like FDA, is an arm of the U.S. Department of Health and Human Services — "has some concern for effects on the brain, behavior, and prostate gland in fetuses, infants, and children at current human exposures."

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