The draft NTP Research Report presenting Core Study results will undergo peer review by an external expert panel on April 26, 2018. The draft report and additional details are available on the meeting and study data webpages.
In order to study the full range of potential health effects from exposure to Bisphenol A (BPA) and to provide data that can be used for regulatory decisions, NIEHS, NTP, and the U.S. Food and Drug Administration (FDA) developed a research program called Consortium Linking Academic and Regulatory Insights on BPA Toxicity (CLARITY-BPA).
CLARITY-BPA aims to create a mutually beneficial partnership that unites standard research practices used by regulators with innovative studies conducted at universities.
CLARITY-BPA has two components:
- Core Study: A two-year guideline-compliant study of potential BPA toxicity in rats, which was conducted according to federal regulatory and statutory guidelines for toxicity testing.
- Grantee Studies: Studies conducted by university researchers but testing a broader range of health endpoints, including genetic impacts, cardiovascular disease, obesity, and behavior. The Grantee Studies used animals raised in the same conditions and exposed to the same doses of BPA as the Core Study.
These two components combined to produce a robust study design. One key strength was identical BPA exposure conditions for both components of the study, which were provided at the same facility in the FDA’s National Center for Toxicological Research (NCTR). A second strength was that grantees received blinded Core Study samples, meaning they did not know whether samples had been dosed with BPA or how much, to minimize the potential for bias.
Final CLARITY-BPA conclusions, expected from NTP in 2019 as shown in the timeline, will be drawn from the integration of the Core Study and Grantee Studies.
The CLARITY-BPA program was overseen by a steering committee with members from NTP, NIEHS, NCTR, and researchers from the grantee institutions. In addition, an external scientific panel of three scientists provided overall programmatic guidance and offered advice in the management and technical performance of the research.