In the September issue of the peer-reviewed scientific journal Reproductive Toxicology, U.S. government and academia scientists report about a novel research program for assessing chemical hazard (Schug et al. 2013). The Consortium Linking Academic and Regulatory Insights on BPA Toxicity (CLARITY-BPA) is an initial proof-of-concept collaboration using the chemical bisphenol A (BPA). One of its aims is to explore how cutting-edge academic scientific research can be employed in chemical risk assessment, and how regulators can support academic study design to ensure research data can be used in regulatory decision making. As such, CLARITY-BPA may be a new model for informing chemical risk assessment of controversial substances.
The program draws from other successful examples of translational research, where basic biological researchers collaborate with clinical practitioners in so called “bench to bedside” projects. The benefits, according to Schug et al., are for public health but also for the participating scientists, as academics can work from real-world observations when developing their research, and regulators are able to build on the fruits of emerging basic science.
CLARITY-BPA is centered around a two-year good laboratory practice (GLP) guideline study of BPA in Sprague-Dawley rats, with 12 non-governmental, academic research labs participating to investigate further, non-guideline endpoints. In addition, the study includes several positive controls and covers a very wide BPA dose range (2,5 to 250,000 µg/kg bodyweight/day). Animals are dosed orally by gavage, and additional sources of BPA or other estrogens, for example through the diet, are strictly controlled. The issue of BPA metabolism is also specifically addressed in the study, to help shed light on a current controversial issue regarding BPA (the FPF reported).
First results of the CLARITY-BPA study are expected in early 2015. It can be assumed that this study’s results will serve to inform the U.S. Food and Drug Administration’s (FDA) risk assessment of BPA, and changes to the current status quo are possible. The study is funded by the National Institutes of Environmental Health Sciences (NIEHS) under the National Institutes of Health (NIH), with participation from FDA.
Schug, T. T., et al. (2013). “A new approach to synergize academic and guideline-compliant research: The CLARITY-BPA research program.” Reproductive Toxicology 40 (September 2013): 35-40.
Free BPA detected in human serum samples. FPF news, June 10, 2013