In an article published on February 26, 2018 by the magazine Newsweek, science writer Kate Sheridan reported on the draft CLARITY-BPA core study draft report that was released on February 23, 2018 (FPF reported). The CLARITY-BPA research program investigates the potential chronic toxicity of bisphenol A (BPA, CAS 80-05-7) and has two components: 1) A government study (i.e., ‘core study’) conducted by the U.S. Food and Drug Administration’s (FDA) National Center for Toxicological Research (NCTR) and authored by the U.S. National Toxicology Program (NTP), and 2) academic studies carried out by academic researchers. The draft report released last week only covers the results from the NCTR study and has not yet been subject to peer-review.

Based on the NTP draft report, the FDA released a statement saying that the agency “continues to conclude that BPA is safe for the currently authorized uses in food containers and packaging” (FPF reported). Academic scientist Gail Prins from the University of Illinois, who investigated possible links between BPA exposure and prostate cancer in the scope of CLARITY-BPA, expressed disappointment with FDA’s statement. She said that NCTR’s results “are valid, but they are not complete.” Prins explained that the tests conducted by NCTR are “very basic” and that the academic studies will use “more advanced techniques” allowing to determine health effects at low doses.

The Endocrine Society, a professional organization for scientists and physicians dealing with hormone conditions, also released a statement regarding FDA’s assertion of BPA’s safety. The Society is equally disappointed, calling FDA’s conclusions “premature.” Laura N. Vandenberg from the University of Massachusetts Amherst, U.S., and member of the Endocrine Society, highlighted that “the endpoints studied here do not encompass the full effects of endocrine-disrupting chemicals, especially because the whole point of this study was to compare the NCTR’s endpoints with more sensitive effects evaluated by endocrinologists.” She further noted that “the NCTR’s data does not provide assurance of BPA’s safety,” because “they found certain BPA doses are linked to a higher rate of mammary gland tumors, which is concerning.” The Endocrine Society advised policymakers and regulators to “reserve judgment until the [final] full report is released.”

Read more

Kate Sheridan (February 26, 2018). “Is BPA safe? FDA touts new study showing ‘minimal’ effects, but experts are wary.Newsweek

Endocrine Society (February 26, 2018). “Endocrine Society experts express concern with FDA statement on BPA safety.

Chemical Watch (March 1, 2018). “Academics urge caution in interpreting CLARITY-BPA results.

Joseph James Whitworth (March 2, 2018). “BPA still safe determination is ‘premature’ — Endocrine Society.Beverage Daily

Frederick vom Saal, Jodi A. Flaws, Ana Soto, and Gail S. Prins (March 5, 2018). “Commentary: FDA statement on BPA’s safety is premature.Environmental Health News


NTP (February 2018). “Draft NTP research report on the CLARITY-BPA core study: A perinatal and chronic extended-dose-range study of bisphenol A in rats.” NTP Research Report 9 (9):1-249. (pdf)