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US Agency Faulted over Plastic Chemical's Safety

Source: Reuters
29/10/2008

Washington, Oct 29 - A U.S. Food and Drug Administration advisory panel on Tuesday faulted the agency's August draft conclusion that a chemical used in many plastic products - including baby bottles - is not harmful.

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After reviewing the FDA's assessment that bisphenol A, or BPA, is safe at current exposure levels, the panel of outside experts urged the agency to consider more scientific evidence before issuing a final conclusion on the chemical's safety.

The panel cited "several significant concerns with the assessment in its current form." It said certain studies should not have been excluded from the FDA's earlier report and said research made public since August should be considered.

Most health information about BPA has come from animal studies. But a British study published in September linked BPA to health problems in humans like heart disease and diabetes.

BPA is used to make polycarbonate plastic, a clear shatter-resistant material in products ranging from baby and water bottles to sports safety equipment and medical devices.

It also is used to make durable epoxy resins used as the coating in most food and beverage cans and in dental fillings.

"FDA concludes that an adequate margin of safety exists for BPA at current levels of exposure from food contact uses, for infants and adults," the FDA said in its August draft report.

The agency said at the time its findings were based on "a full examination of data considered pivotal to the relevant exposure levels associated with food contact substances."

Consumer groups praised the advisory panel's views.

"The FDA needs to start over with a new, very different analysis of the safety of BPA, and they need to do so quickly," Diana Zuckerman, president of the National Research Center for Women & Families, said in a statement.

"They (advisory panel members) make it clear that the FDA did an inadequate job of determining if BPA levels in food containers is safe. They have agreed with the criticisms that I made about depending on inappropriate samples of infant formula, as well as other criticisms made by other independent scientists," she said.

U.S. lawmakers this month said they would look into a possible conflict of interest involving the head of the advisory panel, Martin Philbert of the University of Michigan.

A research center Philbert headed accepted a $5 million donation from a retired medical equipment maker who has said the chemical, also called BPA, is "perfectly safe," Michigan Democratic Reps. John Dingell and Bart Stupak said.



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