On September 13, 2018, the U.S. Food and Drug Administration (FDA) will hold a webinar on the CLARITY-BPA core study conducted by FDA and the U.S. National Toxicology Program (NTP). The CLARITY-BPA program was launched in 2013 to elucidate the differences between guideline studies and academic research on low-dose effects of bisphenol A (BPA, CAS 80-05-7) (FPF reported). In February 2018, the draft report on the CLARITY-BPA core study (i.e., guideline studies) was published (FPF reported).
FDA’s research pharmacologist K. Barry Delclos will present i) the purpose of the CLARITY-BPA program, ii) the results of “BPA pharmacokinetic studies and how these are combined with human exposure data in physiologically based pharmacokinetic models to predict internal exposures to BPA in humans exposed through food contact materials,” and iii) the results of “BPA rat toxicology studies conducted over a broad dose range and how all of these data can contribute to assessing BPA safety in humans.” The FDA noted that results of its core study “indicated that BPA produced adverse effects at high doses, but not at the low end of the dose range tested, consistent with its activity as a weak estrogen.”
FDA (2018). “FDA unveils its research findings on BPA.”