[Federal Register: December 9, 2002 (Volume 67, Number 236)]
[Notices]
[Page 72965-72967]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09de02-93]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
The National Toxicology Program (NTP) Center for the Evaluation
of Risks to Human Reproduction (CERHR): Availability of Draft Expert
Panel Reports on Ethylene Glycol and Propylene Glycol, Request for
Public Comment, and Expert Panel Meeting Planned
Summary: The NTP CERHR announces:
1. The availability of the draft expert panel reports on ethylene
glycol and propylene glycol and solicits written public comments on the
reports January 23, 2003.
2. An expert panel meeting on February 11-13, 2003, at the Holiday
Inn Old Town Select, Alexandria, Virginia and invites the public to
present oral comments at this meeting.
Questions about the draft expert panel reports, submission of
public comments, and the expert panel meeting should be directed to Dr.
Michael Shelby, CERHR director (contact information below).
Draft Expert Panel Reports on Ethylene Glycol and Propylene Glycol
Available
The CERHR announces the availability of draft expert panel reports
on ethylene glycol (CASRN 107-21-1) and propylene glycol (CASRN 57-55-
6). Most ethylene glycol is used as a chemical intermediate in the
production of polyester compounds. There is widespread public exposure
to ethylene glycol due to its use as automotive antifreeze and as a de-
icer for aircraft. The toxicology database on ethylene glycol includes
recent mechanistic data and occupational exposure information.
Propylene glycol, similar in structure to ethylene glycol, is used as
an antifreeze and de-icing solution and in various paints and coatings.
Propylene glycol is approved for use in foods, drugs, and cosmetics.
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 written at
expert panel meeting)
Sections 1-4 will be available to the public by December 4, 2003,
and can be obtained electronically on the CERHR web site (http://cerhr.niehs.nih.gov
) or in hard copy by contacting Dr. Michael Shelby,
Director CERHR (NIEHS, 79
[[Page 72966]]
T.W. Alexander Drive, Building 4401, Room 103, P.O. Box 12233, MD EC-
32, Research Triangle Park, NC 27709, telephone: (919) 541-3455;
facsimile: (919) 316-4511; shelby@niehs.nih.gov).
Request for Written Comments on Draft Expert Panel Reports
The CERHR invites written public comments on sections 1-4 of the
draft expert panel reports on ethylene glycol and propylene glycol.
Comments can be submitted in hard copy or electronic format and must be
received by the CERHR by January 23, 2003. These comments will be
distributed to the expert panel and CERHR staff for consideration in
revising the draft reports and in preparing for the expert panel
meeting. They will be posted on the CERHR website prior to the expert
panel meeting. These comments should be sent to Dr. Michael Shelby at
the address provided 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).
Expert Panel Meeting Planned
The CERHR will hold an expert panel meeting February 11-13, 2002,
at the Holiday Inn Old Town Select, 480 King Street, Alexandria, VA
22314 (telephone: 703-549-6080, facsimile: 684-6508). The CERHR will
ask the expert panel to review the scientific evidence regarding the
potential reproductive and/or developmental toxicity associated with
exposure to ethylene glycol and to propylene glycol. The expert panel
will review and revise the draft expert panel reports and reach
conclusions regarding whether exposure to ethylene glycol or propylene
glycol is a hazard to human development or reproduction. The expert
panel will also identify data gaps and research needs.
This meeting is open to the public and attendance is limited only
by the available meeting room space. The meeting will begin at 8:30
a.m. each day. On February 11 and 12 it is anticipated that a lunch
break will occur from noon-1 p.m. and that the meeting will adjourn 5-6
p.m. The meeting is expected to adjourn by noon on February 13;
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. Following the expert panel
meeting and completion of the expert panel reports, the CERHR will post
the reports on its website and solicit public comment through a Federal
Register notice.
Preliminary Meeting Agenda
February 11, 2003
Opening remarks (8:30 a.m.).
Oral public comments (7 min per speaker; one representative per
group, see below).
Review of sections 1-4 of the draft expert panel reports on
ethylene glycol and propylene glycol.
Discussion of section 5.0 summary, conclusions, and critical data
needs.
February 12, 2002
Discussion of section 5.0 summary, conclusions, and critical data
needs (8:30 a.m.).
Preparation of draft summaries and conclusion statements.
February 13, 2003
Presentation, discussion of, and agreement on summaries and
conclusions (8:30 a.m.).
Closing comments.
Oral Public Comments Welcome at Expert Panel Meeting
Time is set-aside on February 11, 2003, for the presentation of
oral public comments at the expert panel meeting. To facilitate
planning, those persons wishing to make oral public comments are asked
to contact Dr. Shelby by January 31, 2003 (contact information provided
above). 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
February 3, 2003. This information 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 February 11, 2003 (7:30-8:30
a.m.). Those persons registering at the meeting are asked to bring 20
copies of their statement or talking points.
In lieu of making an oral presentation at the meeting, the public
is invited to submit a written statement to CERHR by February 3, 2003.
This statement will be distributed to CERHR staff and the expert panel,
noted in the meeting record, and posted on the CERHR website.
Ethylene Glycol and Propylene Expert Panel
The CERHR will convene an expert panel of independent scientists
whose members were selected for their scientific expertise in
reproductive and/or developmental toxicology and other areas of science
relevant for this review.
Expert Panel Members and Affiliation
Elaine Faustman, PhD, DABT Chair)--University of Washington, Seattle,
WA
Cynthia F. Bearer, MD, PhD--Rainbow Babies & Children's Hospital,
Cleveland, OH
John M. DeSesso, PhD--Mitretek Systems, Falls Church, VA
Bruce A. Fowler, PhD-- Agency for Toxic Substances Diseases Registry,
Atlanta, GA
Gary L. Ginsberg, PhD--Connecticut Department of Public Health,
Hartford, CT
Deborah K. Hansen, PhD--National Center for Toxicological Research,
Jefferson, AR
Cynthia J. Hines, MS--National Institute for Occupational Safety and
Health, Cincinnati, OH
Ronald N. Hines, PhD--Medical College of Wisconsin, Milwaukee, WI
Ken Portier, PhD--University of Florida, Gainesville, FL
Karl K. Rozman, PhD--University of Kansas Medical Center, Kansas City,
KS
John A. Thomas, PhD--University of Texas, San Antonio, TX
Background Information About the CERHR
The NTP established the NTP CERHR in June 1998 (63 FR 68782,
December 14, 1998). 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 (contact information provided 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 notice July 16, 2001 (66 FR 37047-48)
and is available on the CERHR website under ``About CERHR'' or in
printed copy from the CERHR.
[[Page 72967]]
Dated: November 18, 2002.
Samuel H. Wilson,
Deputy Director, National Institute of Environmental Health Sciences.
[FR Doc. 02-30960 Filed 12-6-02; 8:45 am]
BILLING CODE 4140-01-P