On September 12-13, 2018, two webinars were held on the results of the CLARITY-BPA program (FPF reported). The first webinar was hosted by the Carnegie Mellon University, U.S., and focused on the academic research within CLARITY-BPA (FPF reported), while the second webinar was held by the U.S. Food and Drug Administration (FDA) who presented the results of the CLARITY-BPA guideline studies (FPF reported).
In an article published on September 13, 2018, by news provider Environmental Health News (EHN), journalist Lynne Peeples summarized the contradictory outcomes of the two webinars. According to K. Barry Delclos, an FDA research pharmacologist, the data from the guideline studies showed health effects in rodents after exposure to high doses of bisphenol A (BPA, CAS 80-05-7) but not at low doses. Therefore, “regulatory agencies currently conclude that BPA does not pose risk at estimated dietary exposure levels,” Delclos stated. There were some effects detected at low BPA-doses in the guideline studies, but due to a “lack of a dose-response” and no “clear pattern of consistent responses,” the effects’ biological significance was questioned.
Scientific experts on BPA, some of them involved in CLARITY-BPA, discussed the results of the academic studies. Health effects were found at doses 20 times lower than the current U.S. regulatory tolerable daily intake for BPA. Notably, 50% of the significant effects were found only at low-dose exposures and not at high doses. “This contrasts with what the FDA is claiming that there are only high-dose effects and there are not low-dose effects,” stated Gail Prins, a CLARITY-BPA researcher at the University of Illinois at Chicago, U.S..
The final FDA report on the guideline studies is expected by the end of September, 2018; the draft report was published in February 2018 (FPF reported). A collective report, combining the results of the guideline studies and the academic research, is yet to be written and finalized. “The power of the CLARITY-BPA study is in the combined data,” highlighted Patricia Hunt, a reproductive biologist at Washington State University, U.S., who was not involved in CLARITY-BPA.
Lynne Peeples (September 13, 2018). “Despite findings that tiny amounts of BPA impact health, FDA sticks to its message.” EHN
Institute for Green Science (2018). “Webinar: CLARITY-BPA: Achieving clarity on low dose effects of bisphenol A.”
FDA (September 13, 2018). “Bisphenol A: Toxicology and pharmacokinetic data to inform on-going safety assessments.”
Emma Davies (September 20, 2018). “Academics clash with FDA over CLARITY-BPA results.“