January 15, 2010
In a shift of position, the Food and Drug Administration is expressing concerns about possible health risks from bisphenol-A, or BPA, a widely used component of plastic bottles and food packaging that it declared safe in 2008.
The agency said Friday that it had “some concern about the potential effects of BPA on the brain, behavior and prostate gland of fetuses, infants and children,” and would join other federal health agencies in studying the chemical in both animals and humans.
The action is another example of the drug agency under the Obama administration becoming far more aggressive in taking hard looks at what it sees as threats to public health. In recent months, the agency has stepped up its oversight of food safety and has promised to tighten approval standards for medical devices.
Concerns about BPA are based on studies that have found harmful effects in animals, and on the recognition that the chemical seeps into food and baby formula, and that nearly everyone is exposed to it, starting in the womb.
But health officials said there was no proof that BPA was dangerous to humans.
“If we thought it was unsafe, we would be taking strong regulatory action,” said Dr. Joshua Sharfstein, the principal deputy commissioner of the drug agency, at a news briefing.
Nonetheless, health officials suggested a number of things people could do to limit their exposure to BPA, like throwing away scratched or worn bottles or cups made with BPA (it can leak from the scratches), not putting very hot liquids into cups or bottles with BPA and checking the labels on containers to make sure they are microwave safe. The drug agency also recommended that mothers breastfeed their infants for at least 12 months; liquid formula contains traces of BPA.
BPA has been used since the 1960s to make hard plastic bottles, sippy cups for toddlers and the linings of food and beverage cans, including the cans used to hold infant formula and soda. Until recently, it was used in baby bottles, but major manufacturers are now making bottles without it. Plastic items containing BPA are generally marked with a 7 on the bottom for recycling purposes.
The chemical can leach into food, and a study of more than 2,000 people found that more than 90 percent of them had BPA in their urine. Traces have also been found in breast milk, the blood of pregnant women and umbilical cord blood.
Reports of potential health effects have made BPA notorious, especially among parents, and led to widespread shunning of products thought to contain the chemical. Canada, Chicago and Suffolk County, N.Y., have banned BPA from children’s products.
The government will spend $30 million on BPA research in humans and animals, to take place over 18 to 24 months, health officials said at a news briefing on Friday.
Dr. Linda Birnbaum, director of the National Institute of Environmental Health Sciences, said the research would involve potential effects on behavior, obesity, diabetes, reproductive disorders, cancer, asthma, heart disease and effects that could be carried from one generation to the next.
Activists on both sides of the passionately debated issue said they were disappointed in the government’s action. The American Chemical Council, which represents companies that make and use BPA, issued a statement saying BPA was safe, praising the health agencies as confirming that there was no proof of harm to people by it, but also saying, “We are disappointed that some of the recommendations are likely to worry consumers and are not well founded.”
Diana Zuckerman, president of the National Research Center for Women and Families, said the F.D.A. had not gone far enough, because its recommendations put the responsibility on families and not on companies making products containing BPA. In addition, Ms. Zuckerman said, the focus on safety should not be limited to children, because studies have linked the chemicals to heart and liver disease and other problems in adults.
Government evaluations of BPA have had a contentious history. The drug agency wrote a draft report calling it safe in 2008. But shortly after that, the National Toxicology Program, part of the National Institutes of Health, said BPA was cause for “some concern,” citing the same issues that the drug agency is now agreeing to: potential effects on the brain, behavior and prostate in fetuses, infants and children.
Then the drug agency asked an independent panel of scientific advisers to review its draft report, and the panel gave it a scathing review. It accused the F.D.A. of ignoring important evidence and giving consumers a false sense of security about the chemical. The drug agency promised to reconsider BPA, and the announcement on Friday fulfilled that pledge.
“We are for the first time saying we believe there is some concern about the substance’s safety, and we’ve closed the gap between N.I.H. and F.D.A.,” Dr. Sharfstein of the F.D.A. said in an interview.
Dr. Sharfstein said the drug agency had become more receptive to new techniques of studying the safety of chemicals. Old methods involved giving test animals large doses and looking for clear evidence of effects like illness, tumors or organ damage. Newer methods involve studying small doses — similar to human exposures — and looking for more subtle effects, like changes in behavior or biochemistry. Results can be harder to interpret and may demand more study.
Dr. Sharfstein said the drug agency was also re-evaluating the way it regulates BPA. The substance is now classified as a food additive, a category that requires a cumbersome and time-consuming process to make regulatory changes. Dr. Sharfstein said he hoped its status could be changed to “food contact substance,” which would give the F.D.A. more regulatory power and let it act more quickly if it needed to do so.
Gardiner Harris contributed reporting from Washington.
Correction: January 17, 2010
An earlier version of this article included a photo of Nalgene water bottles, which no longer contain bisphenol-A.
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