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With New Data from CLARITY Study, FDA Clearly States BPA is Safe

WASHINGTON (February 23, 2018) – The U.S. government today released its Draft Report with results from the largest study ever conducted on bisphenol A (BPA). The results of the study, which is the key part of a multi-year in-depth research program, strongly support the safety of BPA.

“The results of the CLARITY Core study once again demonstrate that BPA is safe at the very low levels to which people are typically exposed. This study is the largest study ever conducted on BPA, and the results indicate that BPA has very little potential to cause health effects even when people are exposed to it throughout their lives,” said Steven G. Hentges, Ph.D., Polycarbonate/BPA Global Group of the American Chemistry Council (ACC).

“The CLARITY Core study is the capstone of an in-depth research program conducted by scientists with the U.S. Food and Drug Administration (FDA) to answer key scientific questions and resolve uncertainties about the safety of BPA. With the results of the CLARITY Core study now available, FDA has substantially achieved its goals,” Hentges said.

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.

The Draft Report, issued by the U.S. National Toxicological Program (NTP), states the results of a 5+ year, multi-million dollar study conducted by scientists at FDA’s National Center for Toxicological Research with funding from NTP. The Draft Report will next undergo an expert peer review, which will include a public meeting of the peer-review panel on April 26. The report will then be finalized, and the results are expected to be published in the scientific literature.

Earlier studies from FDA’s research program demonstrated that BPA is rapidly eliminated from the body after exposure and is thus unlikely to cause health effects. The CLARITY Core study resoundingly confirms the absence of health effects at typical human exposure levels. In this study, laboratory animals were exposed to various doses of BPA from pregnancy, through early-life development, and continuing through their entire lifetime.

“We now look forward to updated safety conclusions from regulatory authorities worldwide who have been awaiting the study results. Based substantially on the compelling body of U.S. government research already available, government bodies around the world have clearly stated that BPA is safe as currently used in food contact materials,” Hentges said. “The results of this extensive study again confirm those earlier safety scientific assessments and validate FDA’s recent response to the question ‘ Is BPA safe?' and the agency’s one word answer: ‘Yes.’”


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