In an article published on September 10, 2018, by news provider Environmental Health News (EHN), Jerry Heindel, founder of the Program on Endocrine Disruption Strategies at Commonweal, U.S., commented on the CLARITY-BPA program that aims to integrate regulatory guideline studies and independent academic research on bisphenol A (BPA, CAS 80-05-7) (FPF reported). Heindel was Scientific Program Administrator in the Extramural Division at the U.S. National Institute of Environmental Health Sciences (NIEHS) and managed grants on endocrine disruption to university-based scientists.
The CLARITY-BPA program is now coming to a close as all the studies have been conducted and the participants are writing up their results. However, Heindel is concerned that the main goal of CLARITY-BPA, namely to merge the results of both guideline and academic studies, might not be met. He worries that the U.S. Food and Drug Administration (FDA), who is in charge of the guideline studies within CLARITY-BPA, “is short circuiting the process” as the agency “appears to be rushing to judgement” without fully integrating both parts of the program (FPF reported). The FDA “risks wasting U.S. taxpayer dollars and doesn’t get us any closer to understanding the hazards of BPA,” Heindel stated. “I’ve seen enough of the data to be confident that there are low dose impacts of BPA in both the guideline studies and the academic research,” he further asserted. Thus, “[a] rush to judgement of the hazard of BPA by the FDA and other regulatory agencies worldwide based on the report from the guidelines study alone would negate the intent and goal of the CLARITY-BPA study,” he pointed out.
On September 12, 2018, the Carnegie Mellon University, U.S., will hold a webinar on the academic studies within CLARITY-BPA (FPF reported). The day after, the FDA will hold a webinar on the guideline studies (FPF reported). The European Food Safety Authority (EFSA) will hold its annual conference on September 18-20, 2018 (FPF reported), where the FDA and NIEHS will give presentations on CLARITY-BPA (September 20). According to the EFSA conference website, a livestream will be made available.
Jerry Heindel (September 10, 2018). “Jerry Heindel: Is the FDA short-circuiting a large effort to understand BPA risk?” EHN
Jerry Heindel (September 10, 2018). “The CLARITY Study: Integration of apples and oranges.” EHN