[Federal Register Volume 70, Number 45 (Wednesday, March 9, 2005)]
[Notices]
[Pages 11680-11682]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-4567]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


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

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

ACTION: Announcement of a meeting and request for comment.

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SUMMARY: The CERHR announces the availability of the draft expert panel 
report for styrene on March 18, 2005, from the CERHR Web site (http://cerhr.niehs.nih.gov) 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.

DATES: 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.

ADDRESSES: The expert panel meeting for styrene will be held at the 
Holiday

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Inn 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 [email protected] (e-mail). Courier address: 
CERHR, 79 T.W. Alexander Drive, Building 4401, Room 103, Research 
Triangle Park, NC 27709.

FOR FURTHER INFORMATION CONTACT: Dr. Michael D. Shelby, CERHR Director, 
(919) 541-3455, [email protected].

SUPPLEMENTARY INFORMATION:

Background

    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 (http://cerhr.niehs.nih.gov) 
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.
[FR Doc. 05-4567 Filed 3-8-05; 8:45 am]
BILLING CODE 4140-01-P