[Federal Register Volume 66, Number 205 (Tuesday, October 23, 2001)]
[Notices]
[Pages 53626-53628]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-26621]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service


National Toxicology Program; Availability of Expert Panel Reports 
National Toxicology Program (NTP), National Institute of Environmental 
Health Sciences (NIEHS), Center for the Evaluation of Risks to Human 
Reproduction (CERHR), announces:

    (1) Availability of the Draft Expert Panel Reports on 1-
Bromopropane and 2-Bromopropane--Public comments are solicited on these 
draft reports and the deadline for written comments is November 23, 
2001.
    (2) Bromopropane Expert Panel Meeting scheduled for December 5-7, 
2001--The meeting is open to the public and will be held at the Hilton 
Washington-Dulles Airport Hotel, Herndon, VA.

Background

    The NTP and the NIEHS established the NTP CERHR [Federal Register, 
December 14, 1998 (Volume 63, Number 239, page 68782)] in June 1998. 
The purpose of the Center is to provide scientifically-based, uniform 
assessments of the potential for adverse effects on reproduction and 
development caused by agents to which humans may be exposed. Expert 
panels conduct scientific evaluations of agents selected by the Center 
in public forums. Additional details about CERHR are provided below 
(see Additional Information about CERHR evaluations).
    The agents currently under evaluation are 1-bromopropane (CASRN: 
106-94-5) and 2-bromopropane (CASRN: 75-26-3). 1-Bromopropane is used 
as a cleaning solvent; as a solvent vehicle in spray adhesives; as a 
solvent for fats, waxes, or resins; and as an intermediate in the 
synthesis of other compounds. 2-Bromopropane is used in the synthesis 
of pharmaceuticals, dyes, and other compounds and is present as a 
contaminant in 1-bromopropane. Bromopropanes are being considered as 
replacement chemicals for ozone-depleting chemicals such as 
hydrochlorofluorocarbons and chlorinated solvents. The scientific 
database on these chemicals includes studies on neurotoxicity, 
reproductive toxicity, and occupational exposures. 2-

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Bromopropane is reported to be a reproductive toxicant in humans.

Draft Expert Panel Reports on 1-Bromopropane and 2-Bromopropane 
Available

    The Draft Expert Panel Report is composed of 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
    Sections 1-4 will be available to the public by October 10, 2001. 
Copies 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 T.W. Alexander Drive, Building 4401, Room 
103, P.O. Box 12233, MD EC-32, Research Triangle Park, NC 27709, Phone: 
(919) 541-3455; Fax: (919)316-4511; [email protected]).

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 1-bromopropane and 2-bromopropane. 
Comments can be submitted in hard copy or electronic format and must be 
received by the Center by November 23, 2001. These comments will be 
distributed to CERHR staff and the Bromopropane Expert Panel for 
consideration in revising the draft report and in preparing for the 
Bromopropane Expert Panel Meeting (see below). 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, phone, fax, e-mail, and 
sponsoring organization, if any).

Expert Panel Will Review 1-Bromopropane and 2-Bromopropane

    An expert panel (the Panel) of independent scientists selected for 
their scientific expertise in reproductive and developmental toxicology 
and other relevant areas of science are conducting this review. The 
roster of experts follows:

Bromopropane Expert Panel (Name and Affiliation)

Kim Boekelheide, MD, PhD [Chair]  Brown University, Providence, RI
Cynthia F. Bearer, MD, PhD  Case Western Reserve, Cleveland, OH
Sally Perreault Darney, PhD  U.S. EPA, Research Triangle Park, NC
George P. Daston, PhD  Procter & Gamble Co., Cincinnati, OH
Raymond M. David, PhD  Eastman Kodak Company, Rochester, NY
Ulrike Luderer, MD, PhD  University of California-Irvine, Irvine, CA
Andrew F. Olshan, PhD  University of North Carolina, Chapel Hill, NC
Wayne T. Sanderson, PhD, CIH  NIOSH, Cincinnati, OH
Calvin C. Willhite, PhD  DTSC, State of California, Berkeley, CA
Susan Woskie, PhD  University of Massachusetts-Lowell, Lowell, MA

Public Meeting of the Bromopropane Expert Panel

    This meeting is open to the public and attendance is limited only 
by the availability of space. The meeting will take place on December 
5-7, 2001, in the Solarium of the Hilton Washington-Dulles Airport 
Hotel, 13869 Park Center Road, Herndon, VA 20171, Phone (703) 478-2900, 
Fax (703) 478-9286.

Preliminary Meeting Agenda

    The meeting begins each day at 8:30 a.m. It is anticipated that 
each day there will be a lunch break from 12-1 p.m. and the meeting 
will adjourn between 5 and 6 p.m. .

December 5, 2001 (8:30 a.m.)

Opening comments
Public comment session
     The Panel will receive comments from the public (up to 
seven minutes per speaker; details are given below).

Review of Sections 1-4 of the Draft Expert Panel Report on 1-
Bromopropane and 2-Bromopropane

Discussion of Section 5.0 Summary, Conclusions, and Critical Data Needs

December 6, 2001 (8:30 a.m.)

Discussion of Section 5.0 Summary, Conclusions, and Critical Data Needs
    Preparation of draft summaries and conclusion statements

December 7, 2001 (8:30 a.m.)

Presentation, discussion of, and agreement on summaries and conclusions
Closing comments

Oral Public Comments Can Be Presented at the Expert Panel Meeting

    Time is set aside on December 5 for the presentation of oral public 
comments at the Bromopropane Expert Panel Meeting. To facilitate 
planning of this meeting, those persons wishing to make oral public 
comments are asked to contact the CERHR Director by November 26 [Dr. 
Michael Shelby, NIEHS, 79 T.W. Alexander Drive, Building 4401, Room 
103, P.O. Box 12233, MD EC-32, Research Triangle Park, NC 27709, Phone: 
(919) 541-3455; Fax (919) 316-4511; [email protected]]. Seven 
minutes will be available for each speaker (one speaker per 
organization). When registering to comment orally, please provide your 
name, affiliation, mailing address, phone, fax, e-mail and sponsoring 
organization (if any). If possible, also send a copy of the statement 
or talking points to CERHR by November 26. This information will be 
provided to the expert panel, to assist the panel 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 December 5 (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 November 26. This 
statement will be distributed to CERHR staff and the Bromopropane 
Expert Panel and noted in the meeting record.

Post-Meeting Public Comments

    Following the Bromopropane Expert Panel Meeting and completion of 
the Expert Panel Report, public comment will be solicited. This 
solicitation will be announced in a future Federal Register notice.
    For other questions about the Draft Report on 1-Bromopropane and 2-
Bromopropane or the Bromopropane Expert Panel Meeting, contact the 
CERHR Director [contact information provided above].

Additional Information About CERHR Evaluations

    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 the Center Director (contact information provided above). 
The Center 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 is 
outlined in the Federal Register notice July 16, 2001 (Volume 66, 
Number 136, pages 37047-37048) and on the CERHR web site

[[Page 53628]]

under ``About CERHR''. Briefly, the Center establishes an expert panel 
to review and evaluate the scientific evidence on the selected 
chemical(s), to receive public comments, and to prepare a report on the 
chemical(s). This draft expert panel report is made publicly available 
for comment, both through the CERHR web site and upon request from 
CERHR, and an expert panel meeting is held to discuss and evaluate the 
draft report. Following the expert panel meeting and completion of the 
expert panel report, public comment is solicited again. After this 
public comment period ends, the NTP staff prepares a NTP center report 
on the evaluated chemical(s) that integrates background information on 
the chemical(s), findings of the expert panel, and a discussion of any 
additional, recent studies. The NTP center report includes all public 
comments received on the expert panel report. The final NTP center 
report is made publicly available and distributed to interested 
stakeholders and to appropriate regulatory, health, and research 
agencies.

    Dated: October 3, 2001.
Samuel H. Wilson,
Deputy Director, National Institute of Environmental Health Sciences.
[FR Doc. 01-26621 Filed 10-22-01; 8:45 am]
BILLING CODE 4140-01-P