Bisphenol A (BPA) poses "some concern" to infants and young children, the Food and Drug Administration said today in a shift that opens the door to further research and could lead to regulations.

The agency previously said the chemical was safe at current exposure levels. But after reviewing the scientific literature on the industrial chemical used in polycarbonate plastic and can linings, FDA said there is enough information to raise some concerns about the health effects of BPA, although more research is needed.

The agency will conduct several studies over the next 18 to 24 months to clarify some of the uncertainties surrounding the chemical, FDA Commissioner Margaret Hamburg told reporters today.

"BPA has not been proven to harm either children or adults, but the data deserves a much closer look because children are being exposed in early stages of development," said William Corr, deputy secretary at the Health and Human Services Department. "We need more research to understand the health effects."

The announcement puts FDA in line with a 2008 report by the National Toxicology Program that found some concern about BPA's possible effects on the development of the prostate and brain and behavioral damages to fetuses, infants and children.

FDA previously had released a draft assessment of the NTP report, finding that small amounts of BPA leaching from food containers do not threaten children or adults. That assessment had relied solely on standardized toxicity tests commonly used in regulatory decisionmaking -- a move that drew stinging criticism from FDA's outside expert panel and others.

The agency is now looking at some of the newer studies, including low-dose and other peer-reviewed studies used by NTP as it determines whether stronger regulatory action is needed.

FDA's decision to include newer studies using new scientific approaches that focus on different endpoints also marks a shift in federal regulatory policy, said Jane Houlihan, senior vice president for research at the Environmental Working Group.

"That signals that the agency is moving into the 21st century," Houlihan said. "BPA is the first chemical that signals the agency now appears to be willing to look at the full body of science including low dose studies."

FDA is not recommending that consumers stop buying products containing BPA but has recommended several steps aimed at reducing children's exposure to the chemical while it reviews additional data. These include encouraging industry efforts to replace BPA in baby bottles and infant formula and develop alternatives, and discarding used or scratched baby bottles or containers that could allow the chemical to leach.

"A growing body of evidence suggests BPA may be concern, and I agree we need more research -- we know young children are especially vulnerable," said Linda Birnbaum, director of the National Institute of Environmental Health Sciences, which has pledged $30 million in grants to study BPA. "We're working with other agencies to learn as much as we can as fast as we can."

The two-year animal and human studies will focus on developmental exposure or adult chronic exposures to low doses of BPA. Researchers will examine behavior; obesity; diabetes; reproductive disorders; development of prostate, breast and uterine cancer; asthma; cardiovascular diseases; and transgenerational effects.

Reaction

Environmental groups largely applauded the announcement but said they wished the agency had gone further to restrict the chemical's use.

"Overall we're pleased with the announcement, and we think it's the beginning of the end of bisphenol A in baby products," Houlihan said. "FDA was tentative in some of their answers. ... [W]e think BPA should be banned from products as soon as possible, but overall the announcement was a pretty dramatic reversal from the previous assessment."

Sarah Janssen, a staff scientist with the Natural Resources Defense Council, was more blunt: "While this announcement is an improvement from their previous conclusion that BPA was safe in our food supply -- it is too little, too late," Janssen wrote on a blog. "They have finally caught up to another federal agency's scientific report that was finalized over a year ago."

The American Chemistry Council said it agrees more research is needed but that the weight of scientific evidence today supports the chemical's safety.

"While ACC recognizes that HHS and FDA are attempting to address public confusion about BPA, we are disappointed that some of the recommendations are likely to worry consumers and are not well-founded," the council said in a statement.