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This article is from the In-Depth Report Chemistry for a New Era

Perilous Plastics?: FDA Joins Other U.S. Health Agencies in Chorus of Concern about BPA

The Food and Drug Administration and other federal health agencies now share a growing concern about bisphenol A--and are undertaking more research
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Discard scratched baby bottles and sippy cups. Do not put hot liquids into plastic containers for infants. Most importantly, breast-feed infants if at all possible.

These are among the recommendations released Friday by the U.S. Department of Health and Human Services in response to growing concerns over bisphenol A (BPA), an ingredient found in many common plastics used in consumer packaging and containers, including infant formula can liners.

The U.S. Food and Drug Administration "is not saying that it's unsafe to use a baby bottle with BPA," Josh Sharfstein, FDA principal deputy commissioner explained in a conference call with reporters. But "we are recommending certain ways of feeding babies to minimize exposure to BPA."

That's because studies in animals and humans have shown that BPA could potentially be linked to behavioral changes, obesity, diabetes, reproductive disorders, some cancers, asthma, cardiovascular disease and health effects that may pass from one generation to the next, according to Linda Birnbaum, director of the National Institute of Environmental Health Sciences. "There is a growing body of evidence that suggests BPA may be a concern," she adds.

The National Toxicology Program, which Birnbaum also heads, found BPA of some concern for "development of toxicity in fetuses, infants and children—with effects on the brain, behavior and the prostate gland," warning in a 2008 report that "the possibility that bisphenol A may alter human development cannot be dismissed." That is a concern the FDA now shares, overturning an August 2008 draft assessment that declared BPA completely safe. "Our safety assessment of BPA is ongoing," says Margaret Hamburg, FDA commissioner. "We will conduct studies on the safety of BPA over the next 18 to 24 months, which are intended to answer key questions and clarify uncertainties."

Reproductive biologist Fred vom Saal at the University of Missouri–Columbia, who has studied BPA for more than a decade, hailed the decision as a "monumental change. This means in the future we can expect more than just one or two flawed industry studies to be the foundation of risk assessments at the FDA."

The FDA is also evaluating whether it might assert speedier regulatory control of the plastic ingredient "so the agency can move quickly if and as appropriate in light of new findings," Hamburg adds.

Already, countries such as Canada and states including Minnesota, Pennsylvania and Washington have banned or are considering banning BPA in baby bottles. Many major manufacturers claim to have removed BPA from their products, as well. But, as the FDA admitted today, there is no regulatory requirement to report on the chemical as it is considered safe under existing law. "There's about eight [billion] to nine billion pounds of this being put into products every year and FDA doesn't know where they are," vom Saal notes.

The FDA is partnering with companies to develop alternatives to BPA for these specific uses. "Particularly a priority is infant formula in cans, but there are also efforts for other types of products," Sharfstein says. "I'm not able to go into a lot of detail on what those products are." The Japanese have not allowed BPA in any surface can lining since 1999.

It remains unclear exactly what health effects BPA might have on adults, including pregnant women, although studies have shown risks for breast and prostate cancer, obesity and cardiovascular disease, among others. "We have now substantial direct evidence from human studies of risk to adult humans," vom Saal says. "We've always known how strong the risk was for fetuses."

And it is also known that BPA passes from containers to food. "We know that trace amounts of BPA can be found in these containers," says William Coll, deputy secretary for the U.S. Department of Health and Human Services. But "BPA has not been proven to harm either children or adults."

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