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Reps challenge FDA's position on bisphenol-A

On April 8, Reps. John Dingell, D-Mich., and Bart Stupak, D-Mich., issued a letter to U.S. Food and Drug Administration commissioner Andrew von Eschenbach, questioning the FDA's position on the safety of the chemical bisphenol-A, or BPA, "particularly in products intended for use by infants and children." The congressmen pointed out that FDA's position on BPA safety is based on only two studies, both funded by the American Plastics Council, only one of which was peer-reviewed.

BPA is an epoxy used in manufacturing the plastic lining of canned goods, and is necessary to prevent spoilage. It is also used in the manufacture of polycarbonate baby bottles and reusable water bottles. Studies show that 95 percent of adults show traces of BPA in their systems. Since the chemical passes through the body within 24 hours, this suggests that almost everyone is exposed to BPA on a daily basis.

The plastics industry has argued strongly for the safety of BPA. The American Chemistry Council, based in Arlington, Va., said in a February press release that "release of bisphenol A from polycarbonate bottles under real-life conditions of use is far below conservative science-based safety standards". The industry has launched a Web site,, to combat BPA's recent bad press.

The issue of BPA in canned baby formula was first made public 10 years ago by the Environmental Working Group, a nonprofit research organization based in Washington, D.C.

"In the last 10 years, there has been a huge change in our understanding of what endochrine-disrupting chemicals can do in terms of brain development," said Sonya Lunder, senior analyst for Environmental Working Group. "Ten years ago, FDA's response was that the most an infant could take in was 11 micrograms a day, which is well below FDA's established threshold for risk. But the issue now is new low dose studies that suggest that even very low doses may have an effect during infancy."

Reps. Dingell and Stupak have specifically asked FDA why the agency based its findings on only two industry-funded studies, when numerous studies on BPA toxicity exist, and have threatened to subpoena FDA if it doesn't provide information on its decision-making process.

"This is really a test case for the idea of endochrine disruption and the effects of low dose at the wrong time," Lunder said. "There's a burgeoning body of literature on chromosomal changes, effects on age of puberty, and brain and behavioral changes [as a result of exposure], and the formula issue underscores the issue, because our most sensitive group is potentially exposed to the highest levels of this chemicals."

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