On February 23, 2018, the FDA National Center for Toxicological Research (NCTR) released a draft report on the chronic toxicity of BPA in rats. NCTR found few significant effects of BPA. In the press release reporting these findings, FDA announced that “initial review [of the study findings] supports our determination that currently authorized uses of BPA continue to be safe for consumers.” The NCTR study will undergo external peer review April 26, 2018 during a meeting at National Toxicology Program (NTP) offices in Research Triangle Park, North Carolina.
The study evaluated chronic and early life exposure to BPA in rats. Endpoints evaluated include growth; weight; hematology; and tumor development in the liver, kidney, thyroid, parathyroid, uterine, ovary, prostate, and mammary gland. Overall, the study found “minimal effects” in the BPA-dosed rats. NCTR did report that the study found an increase in mammary gland tumors at 2.5 µg BPA/kg/bw/day dose group. The findings note that the incidence rate in this group was only marginally higher than historical rates for the strain of rats used for the study.
The study is part of a collaborative effort called the Consortium Linking Academic and Regulatory Insights on BPA Toxicity (CLARITY-BPA), which was established by the FDA and the National Institute of Environmental Health Sciences of the National Institutes of Health after a 2008 NTP report raised concerns about developmental effects in rodents exposed to relatively low doses of BPA. In addition to the NCTR study, the effort involves studies of various health endpoints, conducted at academic institutions, using offspring of rodents derived from the core study.
More information on the NTP meeting is available here. The NTP website also provides information on submitting public comments on the draft report.