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FDA NEWS RELEASE

FOR IMMEDIATE RELEASE
June 6, 2008

Media Inquiries:
Michael Herndon, 301-827-9182
Consumer Inquiries:
888-INFO-FDA


FDA's Chief Scientist Asks Science Board Subcommittee to Review Research on Bisphenol-A

As part of an ongoing effort, a subcommittee of the FDA's Science Board will hold a public meeting on the safety of bisphenol-A (BPA) in plastics, review an Agency Task Force report on the topic, and deliver its findings to the Board's annual meeting this fall.

Frank M. Torti, M.D., M.P.H., the FDA's principal deputy commissioner and chief scientist, this week asked Science Board Chairwoman Barbara J. McNeil, M.D., Ph.D., head of Health Care Policy at Harvard Medical School, to establish a subcommittee to assess BPA, a substance used in some plastic baby bottles, food containers, and water bottles.

In April 2008, the FDA formed an agency-wide BPA Task Force to facilitate review of current research and new information on BPA. "The FDA Task Force is assembling an inventory of FDA-regulated products that contain BPA and we are exploring what is known about the safety of this substance in those products," said Torti.

Following this review, the Task Force will make recommendations to Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D.

The FDA has been reviewing emerging literature on BPA on a continuous basis for years and its Center for Food Safety and Applied Nutrition initiated a formal reexamination of the safety of BPA in early 2007. In April 2008, the National Toxicology Program (NTP) of the National Institutes of Health published a Draft Brief indicating that some studies in animals suggest that BPA may raise concerns for developmental effects in humans. The NTP is collecting public comments on the draft and has scheduled a June 11 peer review meeting for its Draft Brief.

In the Draft Brief, NTP stated that, based on animal studies, it had "some concern" for neural and behavioral effects in fetuses, infants, and children at current human exposures, and also had "some concern" for exposure in these populations based on effects in the prostate gland, mammary gland, and an earlier age for puberty in females.

In addition to the NTP's Draft Brief on BPA, the FDA Task Force is reviewing available information on BPA in numerous other risk assessment documents from scientific and regulatory bodies worldwide.

For more information visit www.fda.gov

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