Agency will continue to study and review chemical’s effects
by Helena Bottemiller | Mar 31, 2012
The U.S. Food and Drug Administration on Friday denied a petition seeking to ban bisphenol-A, commonly known as BPA, from food and beverage packaging, but the agency said it continues to support research examining the safety of the chemical.
BPA has been used for decades in a broad range of food and beverage containers, including sippy cups, cans and baby bottles. Though standardized toxicology tests have indicated that the chemical is safe, a growing body of research looking at subtle effects at low levels of exposure to the endocrine disruptor has led the Natonal Toxicology Program at the National Institutes of Health and FDA to conclude that they have “some concern” about the potential effects “on the brain, behavior, and prostate gland in fetuses, infants and young children.”
FDA said that while it was denying a petition by the Natural Resources Defense Council (NRDC) to ban BPA, on the basis that it did not provide sufficient scientific evidence, the agency is continuing to study the issue with the National Institute of Environmental Health Sciences.
“I cannot stress enough that this is not a final safety determination on BPA,” said FDA spokesman Douglas Karas. “This is a decision on the NRDC petition. The FDA denied the NRDC petition because it did not have the scientific data needed for the FDA to change current regulations, which allows the use of BPA in food packaging.”
NRDC scientist Sara Janssen expressed disappointment in the agency’s decision: “BPA is a toxic chemical that has no place in our food supply. We believe FDA made the wrong call,” she said. “The agency has failed to protect our health and safety - in the face of scientific studies that continue to raise disturbing questions about the long-term effects of BPA exposures, especially in fetuses, babies and young children.”
FDA and NIEHS are in the middle of a $30 million research initiative attempting to shed light on BPA safety. The agency said it was working on finishing another updated safety review based on the new studies. So far, FDA’s research has found that human infants’ exposure to BPA is between 84 and 92 percent less than previously estimated and that the level of BPA from food that could be passed on by pregnant rodents to their unborn offspring is “so low it could not be measured.”
“Researchers fed pregnant rodents 100 to 1,000 times more BPA than people are exposed to through food, and could not detect the active form of BPA in the fetus eight hours after the mother’s exposure,” said FDA in a brief overview of the latest research. “People of all ages process and rid their bodies of BPA faster than the rodents used as test animals do.”
The FDA had until Saturday to respond to a petition filed by NRDC, according to a court order issued in December 2011. The group petitioned FDA three years ago, requesting that BPA be prohibited in food packaging. The NRDC cited human health concerns, and eventually filed suit to force the agency to respond.
Jeff Stier, director of the Risk Analysis Division at the National Center for Public Policy Research, a conservative think tank, said he believes FDA did the right thing by denying the petition.
“The risk-averse FDA would not have left a product on the market if it were dangerous, as NRDC has been claiming,” said Stier in a statement. “At this point, this issue should be laid to rest. The federal government has spent tens of millions of dollars investing in research on BPA, already one of the most well-studied chemicals on earth, and the FDA has squandered its limited resources on multiple safety assessments, including the one litigated by NRDC.”
The packaging industry response was divided along unsurprising lines.
The North American Metal Packaging Alliance (NAMPA), which represents canned food makers, welcomed the news, while the glass industry expressed disappointment.
NAMPA said that FDA’s decision reiterated that BPA, “at current levels of exposure, is safe for use in food contact applications for people of all ages, including infants and children.”
Lynn Bragg, president of the Glass Packing Institute, pointed out that glass is the only widely used packaging designated “generally recognized as safe, or GRAS, and can help consumers reduce their toxic health concerns.”
In its letter to NRDC, FDA said it appreciated the group’s concern about BPA and added that it takes that concern seriously.
“FDA has determined, as a matter of science and regulatory policy, that the best course of action at this time is to continue our review and study of emerging data on BPA,” read the letter. “FDA is performing, monitoring, and reviewing new studies and data as they become available, and depending on the results, any of these studies or data could influence FDA’s assessment and future regulatory decisions about BPA.”
Many companies, including the Campbell Soup Company, have already discontinued or begun phasing out the use of BPA in their packaging and products.