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Studies Raise Concern about Low-Dose BPA Effects; FDA Draft Assessment Fails to Consider Same Studies
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Endocrine Insider
On September 3, the Center for Evaluation of Risks to Human Reproduction (CERHR) released its Monograph on Bisphenol A, including a National Toxicology Program (NTP) Brief and the final report of an Expert Panel convened to review the available literature on BPA. In its Brief, the NTP agrees with the report of the Expert Panel in its moderate concern for effects of environmental exposure to BPA on the brain and behavior in fetuses, infants, and children. Based on recent research that was not available at the time of the Expert Panel report, the NTP also expresses some concern about the effects of such exposures on the prostate in the same populations. Human exposure to BPA seems to be increasing; the Brief cites the CDC NHANES reports that show median levels in human urine doubled between the 1988-1994 study and the 2003-2004 study. The greatest concern about health effects is in the very young, not only because infants and children are at risk for the highest exposures, but also because fetuses, infants, and children are thought to metabolize BPA for elimination less effectively than adults. The full Monograph is available at: http://cerhr.niehs.nih.gov/chemicals/bisphenol/bisphenol.pdf The U.S. Food and Drug Administration (FDA) has stated that it will consider the Monograph in its role as a regulatory agency. However, the Agency recently released its draft Assessment of Bisphenol A for Use in Food Contact Applications in which it concludes that current levels of exposure from food-contact uses are safe. Notably, the FDA does not consider in its draft assessment the low-dose studies upon which the NTP bases some of its concerns, even though low-dose studies include doses that are well within the range of environmental exposure. To view the FDA draft assessment, please click here. The NTP was established in 1978 to address emerging questions about potential health hazards resulting from the presence of chemicals in the environment. It is a joint venture of the National Institutes of Health, the Centers for Disease Control and Prevention, and the FDA. CERHR was established by the NTP in 1998 to be a resource to the public and to health agencies. The central role of CERHR is to conduct reviews of the scientific literature and evaluate the potential for risk from exposure to specified chemicals. Both the NTP and FDA have called for more research on the health effects of BPA. |
