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National Toxicology Program (NTP); Center for the Evaluation of Risks to Human Reproduction (CERHR); Announcement of the Styrene Expert Panel Meeting and Availability of the Draft Expert Panel Report on Styrene; Request for Public Comment on the Draft Report

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Information about this document as published in the Federal Register.

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


Announcement of a meeting and request for comment.


The CERHR announces the availability of the draft expert panel report for styrene on March 18, 2005, from the CERHR Web site ( or in printed text from the CERHR (see FOR FURTHER INFORMATION CONTACT below). The CERHR invites the submission of public comments on sections 1-4 of the draft expert panel report (see SUPPLEMENTARY INFORMATION below). The expert panel will meet on June 1-3, 2005, at the Holiday Inn Old Town Select in Alexandria, Virginia to review and revise the draft expert panel report and reach conclusions regarding whether exposure to styrene is a hazard to human development or reproduction. The expert panel will also identify data gaps and research needs. CERHR expert panel meetings are open to the public with time scheduled for oral public comment. Attendance is limited only by the available meeting room space. Following the expert panel meeting and completion of the expert panel report, the CERHR will post the report on its Web site and solicit public comment on it through a Federal Register notice.


The expert panel meeting for styrene will be held on June 1-3, 2005. Sections 1-4 of the draft expert panel report will be available for public comment on March 18, 2005. Written public comments on the draft report must be received by May 2, 2005. Time is set-aside at the expert panel meeting on June 1, 2005 for oral public comments. Individuals wishing to make oral public comments are asked to contact Dr. Michael D. Shelby, CERHR Director, by May 25, 2005, and if possible, also send a copy of the statement or talking points at that time. Persons needing special assistance in order to attend are asked to contact Dr. Shelby at least 7 business days prior to the meeting.


The expert panel meeting for styrene will be held at the Holiday Start Printed Page 11681Inn Old Town Select Alexandria, Virginia (telephone: (703) 549-6080, facsimile: (703) 684-6508). Comments on the draft expert panel report should be sent to Dr. Michael D. Shelby, CERHR Director, NIEHS, P.O. Box 12233, MD EC-32, Research Triangle Park, NC 27709 (mail), (919) 316-4511 (fax), or (e-mail). Courier address: CERHR, 79 T.W. Alexander Drive, Building 4401, Room 103, Research Triangle Park, NC 27709.

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Dr. Michael D. Shelby, CERHR Director, (919) 541-3455,

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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 by 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.

At the expert panel meeting, the expert panel will review and revise the draft expert panel report and reach conclusions regarding whether exposure to styrene is a hazard to human reproduction or development. Each draft expert panel report has the following sections:

1.0 Chemistry, Use, and Human Exposure

2.0 General Toxicological and Biological Effects

3.0 Developmental Toxicity Data

4.0 Reproductive Toxicity Data

5.0 Summary, Conclusions, and Critical Data Needs (to be prepared at expert panel meeting)

Request for Comments

The CERHR invites written public comments on sections 1-4 of the draft expert panel report on styrene. Any comments received will be posted on the CERHR Web site prior to the meeting and distributed to the expert panel and CERHR staff for their consideration in revising the draft report and preparing for the expert panel meeting. 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) and send them to Dr. Shelby (see ADDRESSES above) for receipt by May 2.

Time is set-aside on June 1, 2005, for the presentation of oral public comments at the expert panel meeting. Seven minutes will be available for each speaker (one speaker per organization). When registering to comment orally, please provide your name, affiliation, mailing address, telephone and facsimile numbers, e-mail and sponsoring organization (if any). If possible, also send a copy of the statement or talking points to Dr. Shelby by May 25. This statement will be provided to the expert panel to assist them in identifying issues for discussion and will be noted in the meeting record. Registration for presentation of oral comments will also be available at the meeting on June 1, 2005, from 7:30-8:30 a.m. Those persons registering at the meeting are asked to bring 20 copies of their statement or talking points for distribution to the expert panel and for the record.

Preliminary Agenda

The meeting begins each day at 8:30 a.m. On June 1 and 2, it is anticipated that a lunch break will occur from noon-1 p.m. and the meeting will adjourn at 5-6 p.m. The meeting is expected to adjourn by noon on June 3; however, adjournment may occur earlier or later depending upon the time needed by the expert panel to complete its work. Anticipated agenda topics for each day are listed below.

June 1, 2005

  • Opening remarks.
  • Oral public comments (7 minutes per speaker; one representative per group).
  • Review of sections 1-4 of the draft expert panel report on styrene.
  • Discussion of section 5.0 Summary, Conclusions, and Critical Data Needs.

June 2, 2005

  • Discussion of section 5.0 Summary, Conclusions, and Critical Data Needs.
  • Preparation of draft summaries and conclusion statements.

June 3, 2005

  • Presentation, discussion of, and agreement on summaries, conclusions, and data needs.
  • Closing comments.

Expert Panel Roster

The CERHR expert panel is composed of independent scientists selected for their scientific expertise in reproductive and/or developmental toxicology and other areas of science relevant for this review.

Ulrike Luderer, Ph.D., M.D., M.P.H. (Chair)—University of California, Irvine, CA

Thomas F. X. Collins, Ph.D.—U.S. Food and Drug Administration, Laurel, MD

George P. Daston, Ph.D.—The Procter & Gamble Company, Cincinnati, OH

Lawrence J. Fischer, Ph.D.—Michigan State University, East Lansing, MI

Ronald Gray, M.D., M.Sc.—The Johns Hopkins University, Baltimore, MD

Franklin E. Mirer, Ph.D., CIH—International Union, UAW, Detroit, MI

Andrew D. Olshan, Ph.D.—University of North Carolina, Chapel Hill, NC

R. Woodrow Setzer, Ph.D.—U.S. Environmental Protection Agency, Research Triangle Park, NC

Kimberly A. Treinen, Ph.D.—Schering-Plough Research Institute, Lafayette, NJ

Roel Vermeulen, Ph.D.—National Cancer Institute, Bethesda, MD

Background Information on the CERHR

The NTP established the NTP 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.

The 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 ( or by contacting Dr. Shelby (see FOR FURTHER INFORMATION CONTACT above). The CERHR selects chemicals for evaluation based upon several factors including production volume, extent of human exposure, public concern, and published evidence of reproductive or developmental toxicity.

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.

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Dated: February 28, 2005.

Samuel H. Wilson,

Deputy Director, National Institute of Environmental Health Sciences.

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[FR Doc. 05-4567 Filed 3-8-05; 8:45 am]