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Experts Entreat FDA to Consider all Evidence on BPA
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Endocrine Insider An expert subcommittee has been charged with reviewing the US Food and Drug Administration's (FDA) recently released Draft Assessment of Bisphenol-A (BPA) for Use in Food Contact Applications. As part of its process, the BPA Subcommittee of the Science Board held a public meeting during which it heard from FDA officials, representatives of the National Toxicology Program, a member of the Chapel Hill Expert Panel on BPA, and interested members of the public. FDA officials described the process by which they reached their conclusion that BPA is safe for use in food contact containers, including baby formula containers, while the NTP representatives explained their position of having some concern about the effects of BPA on fetuses, infants, and young children. The Chapel Hill Expert Panel supported the NTP's position. The majority of public witnesses represented medical or public health advocacy groups and called on the FDA to reexamine its position and to ban the use of BPA in baby formula and baby food containers, if not in all food containers. FDA's narrow consideration of the literature was called into question. In its deliberations, FDA depended heavily on the findings in two large studies, excluding many smaller academic studies that showed adverse health effects of BPA exposure because they were designed to answer very specific questions and did not examine endpoints accepted by the FDA as established toxicological endpoints. Epidemiological evidence of adverse health effects of BPA is largely lacking. However, the Subcommittee heard from David Melzer, MB, PhD, corresponding author of a study comparing presence of disease with urine BPA levels in1455 adults aged 18-74 who participated in the National Health and Nutrition Examination Survey (NHANES) 2003-2004. The study was published in the Journal of the American Medical Association on September 16. The analysis showed a positive correlation between BPA levels and the presence of both cardiovascular disease and diabetes. Participants who reported a diagnosis of either CVD or diabetes had higher urine levels of BPA than those who did not report a diagnosis of these diseases. Dr. Melzer was careful to state that the results do not indicate a causal relationship between BPA and disease and that the findings need to be replicated. Society member and BPA expert Fred vom Saal, PhD, sat on an expert panel assembled by the Subcommittee to address specific questions. When asked by the Subcommittee whether it has been shown unequivocally that BPA exposure leads to disease in humans, no member of the panel stated that such evidence exists. However, Dr. vom Saal asserted that the finding of increased levels of BPA among people with diabetes is consistent with mechanistic studies in animals showing that BPA exposure increases insulin, glucose levels, and insulin insensitivity. The Subcommittee will consider all testimony in its evaluation of the FDA's draft assessment. The regulation of BPA is only one piece of the complex issue of regulation of endocrine disrupting chemicals, a process in which the consideration of endocrine research is critical. Additional information about the meeting may be found by clicking on "Science Board to the Food and Drug Administration" on the website accessed through the link below. |
