E7-23234. National Toxicology Program (NTP); Center for the Evaluation of Risks to Human Reproduction (CERHR); Announcement of the Availability of the Bisphenol A Expert Panel Report; Request for Public Comment

AGENCY:

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

ACTION:

Announcement of report availability and request for comment.

SUMMARY:

CERHR announces the availability of the final bisphenol A expert panel report on November 26, 2007, from the CERHR Web site (http://cerhr.niehs.nih.gov) or in print from CERHR (see ADDRESSES below). The expert panel report is an evaluation of the reproductive and developmental toxicity of bisphenol A conducted by an independent, 12-member expert panel composed of scientists from the public and private sectors convened by CERHR. CERHR invites the submission of public comments on this report (see SUPPLEMENTARY INFORMATION below). The expert panel met twice in public session (March 5-7, 2007 and August 6-8, 2007) to review and revise the draft expert panel report and reach conclusions regarding whether exposure to bisphenol A is a hazard to human development or reproduction. The expert panel also identified data gaps and research needs.

DATES:

The final bisphenol A expert panel report will be available for public comment on November 26, 2007. Written public comments on this report should be received by January 25, 2008.

ADDRESSES:

Comments on the expert panel report and any other correspondence should be sent to Dr. Michael D. Shelby, CERHR Director, NIEHS, P.O. Box 12233, MD EC-32, Research Triangle Park, NC 27709, fax: [phone], or e-mail: [e-mail]. Courier address: CERHR, 79 T.W. Alexander Drive, Building 4401, Room 103, Research Triangle Park, NC 27709.

SUPPLEMENTARY INFORMATION:

Background

Bisphenol A (CAS RN: 80-5-07) is a high production volume chemical used in the production of epoxy resins, polyester resins, polysulfone resins, polyacrylate resins, polycarbonate plastics, and flame retardants. Polycarbonate plastics are used in food and drink packaging; resins are used as lacquers to coat metal products such as food cans, bottle tops, and water supply pipes. Some polymers used in dental sealants and tooth coatings contain bisphenol A. Exposure to the general population can occur through direct contact to bisphenol A or by exposure to food or drink that has been in contact with a material containing bisphenol A. CERHR selected this chemical for evaluation because of (1) high production volume, (2) widespread human exposure, (3) evidence of reproductive toxicity in laboratory animal studies, and (4) public concern.

The CERHR convened an expert panel on March 5-7, 2007, and on August 6-8, 2007, to review and revise the draft and interim draft expert panel reports and reach conclusions regarding whether exposure to bisphenol A is a hazard to human development or reproduction. The expert panel also identified data gaps and research needs. CERHR solicited public comments on drafts of the expert panel report several times (FR, December 12, 2006, Vol. 71, No. 238 pp. 74534-74536; FR, April 2, 2007, Vol. 72, No. 62 pp. 15695-15696; FR, May 1, 2007, Vol. 72, No. 83 pp. 23833-23834).

Following receipt of public comments on the final bisphenol A expert panel report, CERHR staff will prepare the NTP-CERHR monograph. NTP-CERHR monographs are divided into four major sections: (1) The NTP Brief that provides the NTP's interpretation of the potential for the chemical to cause adverse reproductive and/or developmental effects in exposed humans, (2) a roster of expert panel members, (3) the final expert panel report, and (4) public comments received on that report. The NTP Brief is based on the expert panel report, public comments on that report, public and peer review comments on the draft NTP Brief, and any new, relevant information that becomes available after the expert panel meetings.

Request for Comments

CERHR invites written public comments on the bisphenol A expert panel report. Written comments should be sent to Dr. Michael Shelby (see ADDRESSES above). Persons submitting written comments are asked to include their name and contact information (affiliation, mailing address, telephone and facsimile numbers, e-mail, and sponsoring organization, if any). Any comments received will be posted on the CERHR Web site and included in the NTP CERHR monograph on this chemical. All public comments will be considered by the NTP during preparation of the NTP Brief (see “Background” above).

Background Information on CERHR

The NTP established the CERHR in June 1998 [FR, December 14, 1998 (Vol. 63, No. 239, pp. 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. Expert panels conduct scientific evaluations of agents selected by CERHR in public forums.

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 Web site (http://cerhr.niehs.nih.gov) or by contacting Dr. Shelby (see ADDRESSES above). 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.

CERHR follows a formal, multi-step process for review and evaluation of selected chemicals. A description of the evaluation process is available on the CERHR Web site under “About CERHR” or in printed copy from CERHR.

Dated: November 15, 2007.

Samuel H. Wilson,

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