In an article published on November 12, 2019, Environmental Health News, a publication of the U.S non-profit organization Environmental Health Sciences, announced the results of its own investigation into the way the CLARITY-BPA study of bisphenol A’s (BPA, CAS 80-05-7) effects has been planned, executed, and interpreted by the U.S. Food and Drug Administration (FDA) (FPF reported). The investigation reveals a “regulatory push to discredit independent evidence of harm while favoring pro-industry science despite significant shortcomings.” Information received during interviews or found in the emails obtained via the Freedom of Information Act demonstrates that FDA continues to use “decades-old study methods that fail to detect effects known to be associated with BPA exposure” along with “biased data interpretation methods.” Further, there is evidence that FDA employees have put up a conscious “effort to ignore evidence of harm,” and that there was a “sharp disagreement between the FDA regulators and health officials at the National Institutes of Health on the safety of BPA and what messages are relayed to the public.”
The investigation’s results are documented in four parts, accompanied by a “comic on chemicals & controversy.”
Part 1 explains how the “American industry, aided by federal regulators, is conducting a large-scale, consequential experiment with our hormones and the developing brains and reproductive systems of our children.” In particular, FDA is accused of “willful blindness,” as supported by several of the EHN’s findings, including: “insistence by the FDA on a study design that limited CLARITY-BPA robustness to reveal health effects,” along with a “potential BPA contamination of the control animals, which may have further masked true differences in health effects” between control and BPA-treated animals, as well as the use of inappropriate statistical approaches and outdated study design. Further, the FDA’s press release that accompanied the premature publication of the draft Core Study report (FPF reported) is accused of having “downplayed the health effects that did emerge in the data” (FPF reported). Lastly, EHN points out that there are “hints of potential industry influence, such as the FDA’s reliance on industry-funded studies.”
Part 2 of the investigation focuses on the inconsistencies in the FDA’s approach to the treatment of negative and positive findings of the CLARITY-BPA study. For example, a study by Laura Vandenberg, published on November 6, 2019, in the peer-reviewed journal Endocrinology, discusses “the use and misuse of historical controls in regulatory toxicology” and concludes that “near excessive reliance on ‘guideline’ studies can result in scientifically invalid conclusions.”
Part 3 sheds light on the outdated testing approaches that are still being used by the FDA to assess BPA and other endocrine disrupting chemicals. In addition, it touches on the problems and uncertainties in exposure estimation. Patricia Hunt of Washington State University says that BPA exposure levels are “woefully underestimated,” because “all of our regulatory decisions have been based on assumptions about metabolism and levels of human exposure that are questionable.”
Part 4 discusses what can be done “to rid our store shelves of BPA and its equally hazardous cousins.” This final part of the investigation presents, for example, the efforts to develop alternative coating materials that lack significant endocrine activity (FPF reported). Given the unprecedented scale of potential consequences of the current “massive experiment” of human exposure to BPA and other endocrine disrupting chemicals, Terrence Collins of Carnegie Mellon University calls for “a global movement with regard to endocrine disruptors that parallels the one for climate change.”
Read more
EHN (November 12, 2019). “Exposed: How willful blindness keeps BPA on shelves and contaminating our bodies.”
Lynne Peeples (November 12, 2019). “Exposed: A scientific stalemate leaves our hormones and health at risk.” Environmental Health News
Lynne Peeples (November 13, 2019). “Exposed: On the edge of research honesty.” Environmental Health News
Lynne Peeples (November 14, 2019). “Exposed: Deciphering the real message about BPA.” Environmental Health News
Lynne Peeples (November 12, 2019). “Exposed: Toward a BPA-free future.” Environmental Health News
Brian Bienkowski and Andrew Towl (November 12, 2019). “Clouded in clarity: A comic on chemicals & controversy.” Environmental Health News
Emma Davies (January 16, 2020). “Latest BPA-CLARITY academic study confirms low-dose effects.” Chemical Watch
References
Vandenberg, L., et al. (2019). “The use and misuse of historical controls in regulatory toxicology: Lessons form the CLARITY-BPA study.” Endocrinology (published November 6, 2019)
Prins, G. S., et al. (2018). “CLARITY-BPA academic laboratory studies identify consistent low-dose Bisphenol A effects on multiple organ systems.” Basic & Clinical Pharmacology & Toxicology 125: 14-31.
vom Saal, F. S. (2019). “Flaws in design, execution and interpretation limit CLARITY-BPA’s value for risk assessments of bisphenol A.” Basic & Clinical Pharmacology & Toxicology 125: 32-43.
Lynn Peeples (February 18, 2019). “FDA under scrutiny: Policymakers, advocates push for stronger science, regulation of the chemical BPA.” Environmental Health News
