E8-20297. National Toxicology Program (NTP) Center for the Evaluation of Risks to Human Reproduction (CERHR) Announces the Availability of the NTP-CERHR Monograph on Bisphenol A

AGENCY:

National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH).

ACTION:

Availability of the NTP-CERHR Monograph on Bisphenol A.

SUMMARY:

In December 2005, the CERHR announced its intention to conduct an evaluation of the potential for bisphenol A to cause adverse effects on reproduction and development in humans (Federal Register: December 21, 2005: Vol. 70, No. 244, page 75827). The final results of this evaluation are now available in the NTP-CERHR Monograph on Bisphenol A that includes the (1) NTP Brief on Bisphenol A and (2) CERHR Expert Panel Report on the Reproductive and Developmental Toxicity of Bisphenol A. The NTP Brief provides the public, as well as government health, regulatory, and research agencies, with the NTP's conclusions regarding the potential for bisphenol A to adversely affect human reproductive health or children's development. The NTP Brief is based on information about bisphenol A provided in the expert panel report, public comments, comments from peer reviewers of the draft NTP Brief, and additional scientific information available since the expert panel meeting.

DATES:

The NTP-CERHR Monograph on Bisphenol A will be available on September 3, 2008.

ADDRESSES:

The NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Bisphenol A is now available electronically on the CERHR Web site (http://cerhr.niehs.nih.gov see “Now Available”) or on CD or in printed text from the CERHR by contacting Dr. Michael D. Shelby, CERHR Director, NIEHS, P.O. Box 12233, MC EC-32, Research Triangle Park, NC 27709 (mail), 919-316-4511 (fax), or [e-mail] (e-mail). Courier address: CERHR, 79 T.W. Alexander Drive, Building 4401, Room 103, Research Triangle Park, NC 27709. Additional information related to the evaluation of bisphenol A, including the peer review report for the NTP Brief and all public comments received during the course of the evaluation, are available on the CERHR Web site (see Bisphenol A under “CERHR Reports & Monographs” or directly at http://cerhr.niehs.nih.gov/​chemicals/​bisphenol/​bisphenol-eval.html.)

SUPPLEMENTARY INFORMATION:

Background Information on Bisphenol A

Bisphenol A (CAS RN: 80-05-7) is a high production volume chemical used primarily in the production of polycarbonate plastics and epoxy resins. Polycarbonate plastics are used in some food and drink containers; the resins are used as lacquers to coat metal products such as food cans, bottle tops, and water supply pipes. To a lesser extent bisphenol A is used in the production of polyester resins, polysulfone resins, polyacrylate resins, and flame retardants. In addition, bisphenol A is used in the processing of polyvinyl chloride plastic. Some polymers used in dental sealants and composites may contribute to bisphenol A exposures. The primary source of exposure to bisphenol A for most people is assumed to occur through the diet. The highest estimated daily intakes of bisphenol A in the general population occur in infants and children. CERHR selected bisphenol A for evaluation because of (1) widespread human exposure, (2) public concern for possible health effects, (3) high production volume, and (4) evidence of reproductive and developmental toxicity in laboratory animal studies.

Background Information on the CERHR

The NTP established CERHR in 1998 (Federal Register: December 14, 1998: Vol. 63, No. 239, page 68782). CERHR is a publicly accessible resource for information about adverse reproductive and/or developmental health effects associated with exposure to environmental and/or occupational exposures. CERHR follows a formal process for the evaluation of selected chemicals that includes opportunities for public input.

CERHR invites the nomination of agents for review or scientists for its expert registry. Information about CERHR and the nomination process can be obtained from its homepage (http://cerhr.niehs.nih.gov) or by contacting Dr. Michael Shelby, CERHR Director (see ADDRESSES). CERHR selects chemicals for evaluation based upon several factors including production volume, potential for human exposure from use and occurrence in the environment, extent of public concern, and extent of data from reproductive and developmental toxicity studies. Expert panels conduct scientific evaluations of agents selected by CERHR in public forums. Following these evaluations, CERHR prepares the NTP-CERHR monograph on the agent evaluated. The monograph is transmitted to appropriate federal and state agencies and made available to the public.

Dated: August 20, 2008.

Samuel H. Wilson,

Acting Director, National Institute of Environmental Health Sciences and National Toxicology Program.