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FDA BPA assessment says bisphenol-a safe in food-contact products for infants, humans
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May 2018

Peer-Review and BPA Studies -- Two Thumbs Up For CLARITY

May 2018

Before going to a restaurant or a new movie, most people check reviews from sources they trust. Why? Because restaurant and movie critics' job is to find and report on the best food and entertainment, to help others avoid a bad experience.

Something similar happens in science with the peer review process: scientific experts critically evaluate the work of other researchers, to help ensure the quality and credibility of scientific results. If a scientific study hasn't undergone peer review, how do you know you can trust its results?

A good example of how this works is the recent peer review of the CLARITY Core Study. CLARITY was conducted by senior scientists with FDA's National Center for Toxicological Research to resolve any remaining uncertainties about the safety of Bisphenol-A (BPA). The size and scope of the study, which involved lifetime exposure of laboratory animals to BPA, are unprecedented (i.e., large and wide). CLARITY results were released in February 2018, in the form of a Draft Report from the U.S. National Toxicology Program (NTP), which provided funding for the study as part of the CLARITY-BPA program (Consortium Linking Academic and Regulatory Insights on BPA Toxicity).

Overall, the results indicate that Bisphenol-A has very little potential to cause health effects, even when people are exposed to it throughout their lives. As stated in the conclusion of the Draft Report, "BPA produced minimal effects that were distinguishable from background."

To test the quality of the study and the credibility of that conclusion, NTP organized a peer review by a panel of six independent scientific experts. The scientists were selected because they had expertise relevant to the CLARITY Core Study but did not have any conflicts related to previous research on BPA.

The experts received the full Draft Report, along with all comments submitted by the public since the Draft Report was released in February 2018. After a two-month period of deliberation, the peer review panel met in a public forum on April 26, 2018 to discuss the findings of their review and to hear from any outside participants who wished to comment.

At that meeting, the peer review panel first received presentations from the FDA scientists who conducted the study, and then had the opportunity to ask clarifying questions. In general the peer review panel was supportive of the design and conduct of the CLARITY study and the statistical methodology used to analyze the results.

The peer review panel then critically evaluated the key conclusions included in the Draft Report and offered thoughtful recommendations to improve and strengthen the conclusions. Those recommendations will be carefully considered by FDA and NTP senior scientists and incorporated, as appropriate, into a Final Report that is expected to be released by August 2018. In parallel, the study will be published in the scientific literature in late 2018.

It's expected that the CLARITY study results will be used by government bodies worldwide in future evaluations of the safety of BPA. That process has already been initiated by FDA. In a statement released in conjunction with the report, Dr. Stephen Ostroff, Deputy Commissioner for Foods and Veterinary Medicine at the U.S. Food and Drug Administration (FDA) noted: "our initial review supports our determination that currently authorized uses of BPA continue to be safe for consumers."



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