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Annual Report for Fiscal Year 2018

Annual Report for Fiscal Year 2018

NTP Releases Findings from Two CLARITY-BPA Study Components

NIEHS and the U.S. Food and Drug Administration (FDA) convened the Consortium Linking Academic and Regulatory Insights on BPA Toxicity (CLARITY-BPA) to study the range of potential health effects from exposure to bisphenol A (BPA) in rats and provide data that can be used for regulatory decisions.

CLARITY-BPA united standard research practices used by regulators, called federal guideline studies, with innovative research conducted at universities through grants from NIEHS. One purpose of CLARITY-BPA was to assess whether these federal guideline studies are sensitive enough to detect health effects from low-dose, endocrine-disrupting chemicals.

CLARITY-BPA has two complementary components:

  1. Core Study: A two-year guideline-compliant study of potential BPA toxicity in rats conducted by FDA’s National Center for Toxicological Research (NCTR) with guidance from a CLARITY-BPA steering committee. This portion of the project examined health endpoints typical of so-called guideline studies, such as animal weights, tissue changes, and developmental outcomes.
  2. Grantee Studies: Studies conducted by 14 university researchers that tested a range of additional endpoints, including genetic effects, cardiovascular disease, obesity, and behavior. These studies used control animals, BPA-exposed animals, and BPA-exposed tissues from animals handled identically to those in the core study, ensuring that animals used in both parts of the study were raised in the same conditions and exposed to the same doses of BPA.

NTP released for public comment a draft report of the core study on February 23, 2018. It was reviewed by a panel of external scientific experts at NIEHS on April 26, 2018, which agreed with NTP conclusions that there were minimal toxic effects of BPA exposure in rats for the range of doses studied in the core report. The panel, however, recommended revisions to several specific interpretations of the study findings, which were considered by NTP and FDA staff when they finalized the core study report.

On September 28, 2018, the CLARITY-BPA program released the final report from the CLARITY-BPA core study and the data sets from the CLARITY-BPA grantee studies.

A final integrated report from this collaboration between NIEHS, NTP, FDA, and academic researchers is expected in 2019.

4 metal food cans

BPA is a chemical produced in large quantities and is primarily used in the production of polycarbonate plastics, including water bottles and epoxy resins. BPA is also used in some dental sealants and composites.