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FDA Handling of BPA to Be Discussed at Public Meeting

Sep 12, 2008 | Parker Waichman LLP

Despite overwhelming evidence to the contrary, the U.S. Food and Drug Administration (FDA) appears to be ignoring the dangers of Bisphenol A—BPA—a ubiquitous, toxic chemical used in many, many consumer products and linked to a wide variety of health concerns.  Critics plan to accuse the FDA at a public meeting Tuesday of ignoring scientific warnings about BPA’s health risks.

Last month, the FDA announced that BPA is safe at current levels found in food products; however, parents, lawmakers, and scientists say the report contradicts another government study citing concerns that low BPA levels may lead to developmental health problems.  The FDA based its findings on two reports conducted by the chemical industry, which along with the agencies that regulate BPA use—FDA and the Environmental Protection Agency (EPA)—deemed BPA safe.  Hundreds of non-industry studies reveal BPA may be associated with health problems such as Type-2 diabetes, prostate cancer, genital defects in males, early onset puberty in females, and behavioral problems.  First synthesized in 1891, BPA is used to make plastics hard; its global market is estimated in the billions of dollars, and the Centers for Disease Control and Prevention (CDC) report BPA is in the urine of the vast majority of Americans.

"What the hell is the FDA doing ignoring the world's leading experts on the subject?"  asked Frederick vom Saal, a professor of reproductive biology and neurobiology at the University of Missouri-Columbia, who authored one of the first studies in 1997 linking low BPA doses to prostate cancer.  At FDA invitation, vom Saal and other scientists will speak Tuesday.  Vom Saal says the FDA has been ignoring, for five years, science showing BPA affects on human health.  "This is the kind of thing you would think would scare the heck out of anybody in the public health community," vom Saal said.

Vom Saal was part of a group of over 30 scientists invited by the National Institutes of Health (NIH) last year to review worldwide BPA studies and concluded BPA exposure at current levels presents a clear risk to human health.  The FDA is "aware" of the report, according to its own documentation; however, it says it relied instead on the industry-sponsored studies because those included raw data allowing it to form its own conclusions.  The FDA's reliance on the industry studies has resulted in attack from the public health community and a powerful Congressional committee that has been investigating the FDA’s handling of a variety of issues.

The FDA is relying on the industry studies because they follow what are known as Good Laboratory Practices or GLP, which require extensive documentation and are not typically used by independent researchers because of high costs.  Critics say the industry studies are using antiquated testing methods not sensitive to capturing BPA’s effects.  "The type of studies they're doing aren't enough," said Jerry Heindel, scientific program administrator at the National Institute of Environmental Health Services, a governmental organization that helps promote BPA research. "There are all kinds of things they're not measuring.  So what you're left with is not much."  Heindel said he wants the FDA to focus on non-GLP studies, such as those funded by the NIH.  Vom Saal added that industry studies test higher BPA doses, which mask BPA’s effect.  Unlike typical chemicals, such a lead, high BPA doses can actually shut down the body's response system and do not appear in test results, vom Saal said.

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