E5-7617. National Toxicology Program (NTP); Center for the Evaluation of Risks to Human Reproduction (CERHR); Plans for Future Expert Panel Evaluations of Bisphenol A and Hydroxyurea; Request for Comments and Nominations of Scientists Qualified To ...

AGENCY:

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

ACTION:

Request for comments, nominations of scientific experts.

SUMMARY:

The CERHR plans to convene two expert panels to evaluate the scientific evidence regarding the potential reproductive and developmental toxicities of bisphenol A and hydroxyurea. Each expert panel will consist of approximately 12 scientists, selected for their expertise in various aspects of reproductive and developmental toxicology and other relevant areas of science. The CERHR invites the submission of public comments on these chemicals and the nomination of scientists to serve on the expert panels for their evaluation (see SUPPLEMENTARY INFORMATION below). These meetings are tentatively scheduled for late 2006, although the exact dates and locations have not yet been established. As plans are finalized, they will be announced in the Federal Register and posted on the NTP Web site (http://ntp-server.niehs.nih.gov). CERHR expert panel meetings are open to the public with time scheduled for oral public comment.

DATES:

Comments received by February 6, 2006 will be made available to the CERHR staff and the expert panels and posted on the CERHR Web site. Nominations of scientists received by February 6, 2006 will be considered for these panels and for inclusion in the CERHR Expert Registry.

ADDRESSES:

Correspondence should be sent to Dr. Michael D. Shelby, CERHR Director, NIEHS, P.O. Box 12233, MD EC-32, Research Triangle Park, NC 27709 (mail), [phone] (telephone), [phone] (fax), or [e-mail] (e-mail). Courier address: CERHR, 79 T.W. Alexander Drive, Building 4401, Room 103, Research Triangle Park, NC 27709.

SUPPLEMENTARY INFORMATION:

Evaluation of Bisphenol A

Bisphenol A (CAS RN: 80-05-7) 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; the 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 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.

Evaluation of Hydroxyurea

Hydroxyurea (CAS RN: 127-07-1) is used in the treatment of cancer, sickle cell disease, and thalassemia. It is the only treatment for sickle cell disease used in children aside from blood transfusion. Hydroxyurea may be used in the treatment of children and adults with sickle cell disease for an extended period of time or for repeated cycles of therapy. Treatment with hydroxyurea may be associated with cytotoxic and myelosuppressive effects and hydroxyurea is mutagenic. This drug is used to treat sickle cell disease only if there is an indication of significant disease complications. CERHR selected this chemical for evaluation because of (1) increasing use in the treatment of sickle cell disease in children and adults, (2) knowledge that it inhibits DNA synthesis and is cytotoxic, and (3) published evidence of reproductive and developmental toxicity in rodents and humans.

Request for Comments

CERHR invites the public and other interested parties to submit information and comments on bisphenol A and hydroxyurea including toxicology information from completed and ongoing studies, information on planned studies, and information about current production levels, human exposure, use patterns, and environmental occurrence.

Request for the Nomination of Scientists for Expert Panels

CERHR invites nominations of qualified scientists to serve on the individual expert panels for (1) bisphenol A and (2) hydroxyurea. Panelists are primarily drawn from the CERHR Expert Registry and/or the nomination of other scientists who meet the criteria for listing in that registry which include: formal academic training and experience in a relevant scientific field, publications in peer-reviewed journals, membership in relevant professional societies, and certification by an appropriate scientific board or other entities. Expert panel members are subject to applicable guidelines for conflict of interest in accordance with Federal Advisory Committee Act (5 U.S.C. Appendix 2).

All panel members serve as individual experts and not as representatives of their employers or other organizations. Scientists on the expert panel will be selected to represent a wide range of expertise including, but not limited to, developmental toxicology, reproductive toxicology, epidemiology, general toxicology, pharmacokinetics, exposure assessment, and biostatistics. Nominations should include contact information and a current curriculum vitae (if possible) and be forwarded to the CERHR at the address given above.

Background Information on the CERHR

The NTP established CERHR in June 1998 [Federal Register, December 14, 1998 (Volume 63, Number 239, page 68782)]. CERHR is a publicly accessible resource for information about adverse reproductive and developmental health effects associated with environmental and/or occupational exposures. Expert panels conduct scientific evaluations of environmental chemicals, drugs, physical agents, or mixtures selected by CERHR in public forums.

CERHR invites the nomination of substances for expert panel evaluation 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. Shelby (see ADDRESSES above). CERHR selects substances 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. The formal evaluation process was published in the Federal Register on July 16, 2001 (Volume 66, Number 136, pages 37047-37048) and is available on the CERHR Web site under “About CERHR” or in printed copy from the CERHR.

Dated: December 13, 2005.

David A. Schwartz,

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