[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]
BILLING CODE 4140-01-P