A long-awaited U.S. government study of the health effects of bisphenol A, a key building block of polycarbonate, seems to be giving the controversial chemical a clean bill of health in food packaging.
The Food and Drug Administration said in a statement that the Feb. 23 preliminary report supports its earlier determination that “currently authorized uses of BPA continue to be safe for consumers.”
The report was welcomed by the American Chemistry Council, which said the multi-year review by government scientists is the largest study ever on BPA.
“The results indicate that BPA has very little potential to cause health effects even when people are exposed to it throughout their lives,” said Steven Hentges, senior director of the Polycarbonate/BPA Global Group for the Washington-based ACC.
BPA has been widely examined for the past two decades, with some studies saying the chemical interferes with human endocrine systems, including at very low doses.
The study said most regulatory agencies around the world have now ruled that nonworkplace exposures to BPA “do not pose a credible risk to people” but it noted disagreement in some circles: “This conclusion is not without controversy.”
Baby bottle manufacturers in North America agreed in 2009 to no longer use BPA, responding to regulatory and public concern. Canada banned BPA in baby bottles in 2008, and the U.S. FDA in 2013 banned it in packaging for baby formula.
FDA said this new study, a multimillion dollar project, was commissioned after a 2008 National Toxicology Program review “raised some concerns” about development effects in rodents exposed to relatively low doses of BPA.
The Feb. 23 study is a draft report, and will be reviewed in a public meeting April 26 organized by the National Institute of Environmental Health Sciences in Raleigh, N.C.
The study was conducted by scientists at FDA's National Center for Toxicological Research, in collaboration with NIEHS and its parent, the National Institutes of Health. A final report is expected in 2019, incorporating additional research.
Stephen Ostroff, FDA deputy commissioner for foods and veterinary medicine, said in the statement that the study examined a range of BPA doses in rodents, from low doses simulating typical human exposure to doses that vastly exceed human exposure.
“Overall the study found ‘minimal effects' for the BPA-dosed groups of rodents,” he said.
The study found some areas that need further assessment, such as increases in mammary gland tumors at one of five doses.
But the FDA statement said the new study, part of a project called the Consortium Linking Academic and Regulatory Insights on BPA Toxicity, or CLARITY-BPA, backs up its earlier reviews of the chemical.
“Although a comprehensive review of this report... will be conducted as part of our continued assessment of BPA safety, our initial review supports our determination that currently authorized uses of BPA continue to be safe for consumers,” Ostroff said.
“The report also builds upon the already extensive data collected in FDA's 2014 assessment,” he said.
The new study includes only data from so-called “core studies” at FDA's toxicological research center done according to agency laboratory regulations, with future studies conducted at academic institutions by government grantees using offspring of rodents in the original studies.
ACC said the research effort set out to resolve uncertainties about BPA safety.
“With the results of the CLARITY Core study now available, FDA has substantially achieved its goals,” Hentges said.
He said regulatory agencies around the world have been waiting for the results of the U.S. study: “We now look forward to updated safety conclusions from regulatory authorities worldwide.”
