Working Together: Research- and Science-Based Regulation of BPA

Administration (FDA) work to promote and protect public health. The NIEHS a c h i e v e s t h i s m i s s i o n by conducting research, including toxicological studies, on agents of public health concern through its intramural laboratories, the National Toxicology Program (NTP), grants and contracts to research labs across the country, and inter agency agreements. The FDA, in turn, reviews and uses information from these and other studies and, where needed, performs studies of its own to develop standards to ensure that the products it regulates meet its requirements, maximizing product benefits while protecting the public from unacceptable risks. The FDA and NIEHS have a long history of working together to generate and evaluate toxicological data necessary both for setting standards and for informing important regulatory decisions. For example, collaborative research projects between the NTP (itself a collaboration involving the National Institutes of Health, FDA, and Centers for Disease Control and Prevention) and the FDA National Center for Toxicological Research (NCTR) have contributed to safety determina-tions and regulation of a number of ingredients in dietary supplements, animal feed, and cosmetics and have been important for assessing potential risks of both human and veterinary pharma ceuticals (NTP 2013). For several years, the NIEHS and FDA have been working col-laboratively to address potential health concerns about bisphenol A (BPA), a chemical used in manufacturing the packaging of some foods and beverages, in some medical devices, and in some thermal papers. In September 2008, the NTP completed a review of available research on BPA and concluded that there was " some concern for effects on the brain, behavior, and prostate gland in fetuses, infants, and children at current human exposures. " The NTP report also recognized the existence of substantial uncertainties, stating that " Overall, the current literature cannot yet be fully interpreted for biological or experimental consistency or for relevance to human health " [NTP-Center for the Evaluation of Risks to Human Reproduction (CERHR) 2008]. In 2008, the FDA, which has regulatory authority over many consumer and medical products containing BPA, issued a draft assessment of BPA (FDA 2008). In 2009, the FDA provided additional updates to the assessment and expressed its agreement with the the NTP's perspective (FDA 2013). The FDA, like the NTP, also identified substantial uncertainties both in reported BPA research findings and in their implications for human health. Both …