04-26885. National Toxicology Program

The National Toxicology Program (NTP) Center for the evaluation of risks to Human Reproduction (CERHR) announces plans for future evaluation of styrene; requests public comments on this chemical; and solicits the nominations of scientists qualified to serve on an expert panel.

SUMMARY:

The CERHR plans to convene an expert panel to evaluate the scientific evidence regarding the potential reproductive and/or developmental toxicity associated with exposure to styrene. The expert panel will consist of approximately 8-12 scientists, selected for their scientific expertise in various aspects of reproductive and developmental toxicology and other relevant areas of science. The CERHR invites the submission of public comments on styrene and the nomination of scientists to serve on the expert panel for its evaluation (see below). This meeting is tentatively scheduled for 2005 although the exact date and location are not yet established. As plans are finalized, they will be announced in the Federal Register and posted on the CERHR Web site (http://cerhr.niehs.nih.gov). CERHR expert panel meetings are open to the public with time scheduled for oral public comment.

Evaluation of Styrene

Styrene (ethenylbenzene; CAS RN: 100-42-5) is a high production volume chemical used in the production of polystyrene resins and as a co-polymer with acrylonitrile and 1,3 butadiene. Styrene is found in items such as foam cups, dental fillings, matrices for ion exchange filters, construction materials, and boats. It is also used in protective coatings, reinforced glass fiber, agricultural products, and as a food additive. The public can be exposed to styrene through ingesting food or drink that has been in contact with styrene polymers or through inhalation of polluted air and cigarette smoke. CERHR selected styrene for expert panel evaluation because of: (1) Public concern about styrene exposure and (2) recently available exposure studies.

Request for Public Comment on Styrene

The CERHR invites input from the public and other interested parties on styrene 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. Information and comments should be forwarded to the CERHR at P.O. Box 12233, National Institute of Environmental Health Sciences, MD EC-32, Research Triangle Park, NC 27709 (mail), [phone] (phone), [phone] (fax), or [e-mail] (e-mail). Information and comments received by 45 days from the publication date of this notice will be made available to the CERHR staff and the expert panel for consideration in the evaluation and posted on the CERHR Web site.

Request for the Nomination of Scientists for the Expert Panel

The CERHR invites nominations of qualified scientists to serve on the expert panel. 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, certification by an appropriate scientific board or other entities, and participation in similar committee activities. Expert panel members are required to sign a conflict of interest form in accordance with Federal Advisory Committee Act Guidelines (5 U.S.C. Appendix 2).

All panel members serve as individual experts in their specific areas of expertise 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 received by 45 days from the publication date of this notice will be considered for this panel and for inclusion in the CERHR Expert Registry. Nominations should include contact information and current curriculum vitae (if possible) and be forwarded to the CERHR at the address given above.

Background Information About the CERHR

The NTP established the CERHR in June 1998 (Federal Register, December 14, 1998: Volume 63, Number 239, page 68782). The 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 the CERHR in public forums.

Information about CERHR and its process for nominating agents for review or scientists for its expert registry can be obtained from its Web site (http://cerhr.niehs.nih.gov) or by contacting Dr. Michael Shelby, CERHR Director (contact information provided above). The CERHR selects chemicals for evaluation based upon several factors, including production volume, extent of human exposure, public concern, and extent of the database on reproductive or 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 (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: November 29, 2004.

Samuel H. Wilson,

Deputy Director, National Institute of Environmental Health Sciences.