[Federal Register Volume 69, Number 34 (Friday, February 20, 2004)]
[Notices]
[Pages 7977-7978]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-3711]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
National Toxicology Program (NTP) Center for the Evaluation of
Risks to Human Reproduction (CERHR) Announcement of Availability of the
Draft Expert Panel Report on Acrylamide; Announcement of Expert Panel
Meeting on Acrylamide; Request for Public Comments
SUMMARY: The NTP CERHR announces:
(1) availability of sections 1-4 of the draft expert panel report
on acrylamide on March 15, 2004, and solicits written public comments
on the report by April 29, 2004.
(2) the acrylamide expert panel meeting May 17-19, 2004, at the
Holiday Inn Old Town Select, Alexandria, Virginia and invites the
public to present oral comments at this meeting.
Questions ublic comments should be directed to Dr. Michael Shelby,
CERHR Director (contact information below).
Draft Expert Panel Report on Acrylamide Available
The CERHR announces the availability of the draft expert panel
report on acrylamide (CAS RN 79-06-1). Acrylamide is used in the
production of polyacrylamide, which is used in water treatment, pulp
and paper production, mineral processing, and scientific research.
Polyacrylamide is used in the synthesis of dyes, adhesives, contact
lenses, soil conditioners, cosmetics and skin creams, food packaging
materials, and permanent press fabrics. In scientific research, it is
used in molecular biology procedures such as electrophoresis.
Acrylamide is a neurotoxicant and in animal studies has been shown to
be a carcinogen, germ cell mutagen, and reproductive toxicant. The
CERHR selected acrylamide for expert panel evaluation because of recent
public concern for human exposures through its presence in some starchy
foods cooked at high temperatures. In addition, recent data are
available on human exposure, bioavailability, and reproductive
toxicity.
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)
Sections 1-4 will be available to the public on March 15, 2004, and
can be obtained electronically on the CERHR Web site (http://cerhr.niehs.nih.gov) or in hard copy or compact disk by contacting Dr.
Michael Shelby, Director CERHR [NIEHS, 79 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;
[email protected]].
Request for Written Comments on Draft Expert Panel Report
The CERHR invites written public comments on sections 1-4 of the
draft expert panel report on acrylamide. Comments can be submitted in
hard copy or electronic format and must be received by the CERHR by
April 29, 2004. These comments will be distributed to the expert panel
and CERHR staff for consideration in revising the draft report and in
preparing for the expert panel meeting. They will be posted on the
CERHR web site 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 May 17-19, 2004, at the
Holiday Inn Old Town Select 480 King Street Alexandria, VA 22314
(telephone: 703-549-6080, facsimile: 703-684-6508). The CERHR has asked
the expert panel to review the scientific evidence regarding the
potential reproductive and/or developmental toxicity associated with
exposure to acrylamide. The expert panel will review and revise the
draft expert panel report and reach conclusions regarding whether
exposure to acrylamide 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 May 17 and 18, 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 May 19; 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 report, the CERHR will post the report
on its web site and solicit public comment through a Federal Register
notice.
Preliminary Meeting Agenda
Meeting begins at 8:30 a.m. each day.
Lunch break anticipated from noon-1 p.m.
May 17, 2004
Opening remarks
Oral public comments (7 minutes per speaker; one representative per
group, see below)
Review of sections 1-4 of the draft expert panel report on acrylamide
Discussion of Section 5.0 Summary, Conclusions, and Critical Data Needs
May 18, 2004
Discussion of Section 5.0 Summary, Conclusions, and Critical Data Needs
[[Page 7978]]
Preparation of draft summaries and conclusion statements
May 19, 2004
Presentation, discussion of, and agreement on summaries and conclusions
Closing comments
Oral Public Comments Welcome at Expert Panel Meeting
Time is set aside on May 17, 2004, 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 May 10 (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,
email and sponsoring organization (if any). If possible, also send a
copy of the statement or talking points to Dr. Shelby by May 10. 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 May 17, 2004 (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.
Acrylamide Expert Panel
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.
Expert Panel Members and Affiliation
Jeanne M. Manson Ph.D., M.S.C.E., Chairperson, The Children's Hospital
of Philadelphia, Philadelphia, PA
Michael Brabec, Ph.D., Eastern Michigan University, Ypsilanti, MI
Judy Buelke-Sam, M.A. , Toxicology Services, Greenfield, IN
Gary P. Carlson, Ph.D., Purdue University, West Lafayette, IN
Robert E. Chapin, Ph.D., Pfizer Inc., Groton, CT
John B. Favor, Ph.D., GSF--National Research Center for Environment and
Health, Neuherberg, Germany
Lawrence J. Fischer, Ph.D., Michigan State University, East Lansing, MI
Dale Hattis, Ph.D., Clark University, Worcester, MA
Peter J. Lees, Ph.D., The Johns Hopkins University, Baltimore, MD
Sally Perreault-Darney, Ph.D., US Environmental Protection Agency,
Research Triangle Park, NC
Joe C. Rutledge, MD, Children's Hospital and Regional Medical Center,
Seattle, WA
Thomas J. Smith, Ph.D., C.I.H., Harvard School of Public Health,
Boston, MA
Raymond R. Tice, Ph.D., Integrated Laboratory Systems, Inc., Research
Triangle Park, NC
Peter K. Working, Ph.D., Cell Genesys, Inc., South San Francisco, CA
Background Information About 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 (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 (Volume 66,
Number 136, pages 37047-37048) and is available on the CERHR website
under ``About CERHR'' or in printed copy from the CERHR.
Dated: February 11, 2004.
Samuel H. Wilson,
Deputy Director, National Institute of Environmental Health Sciences.
[FR Doc. 04-3711 Filed 2-19-04; 8:45 am]
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