Federal Register: October 23, 2001 (Volume 66, Number 205)
DOCID: FR Doc 01-26621
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
NOTICE: NOTICES
ACTION: Reports and guidance documents; availability, etc.:
SUBJECT CATEGORY:
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:
DOCUMENT SUMMARY:
(1) Availability of the Draft Expert Panel Reports on 1
Bromopropane and 2BromopropanePublic 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 57,
2001The meeting is open to the public and will be held at the Hilton WashingtonDulles 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 scientificallybased, 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 1bromopropane (CASRN:
106945) and 2bromopropane (CASRN: 75263). 1Bromopropane 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. 2Bromopropane is used in the synthesis
of pharmaceuticals, dyes, and other compounds and is present as a
contaminant in 1bromopropane. Bromopropanes are being considered as
replacement chemicals for ozonedepleting chemicals such as
hydrochlorofluorocarbons and chlorinated solvents. The scientific
database on these chemicals includes studies on neurotoxicity, reproductive toxicity, and occupational exposures. 2
[[Page 53627]]
Bromopropane is reported to be a reproductive toxicant in humans.
Draft Expert Panel Reports on 1Bromopropane and 2Bromopropane 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 14 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 EC32, Research Triangle Park, NC 27709, Phone: (919) 5413455; Fax: (919)3164511; shelby@niehs.nih.gov). Request for Written Comments on Draft Expert Panel Reports
The CERHR invites written public comments on Sections 14 of the Draft Expert Panel Reports on 1bromopropane and 2bromopropane. 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, email, and sponsoring organization, if any).
Expert Panel Will Review 1Bromopropane and 2Bromopropane
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 CaliforniaIrvine, 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 MassachusettsLowell, 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 57, 2001, in the Solarium of the Hilton WashingtonDulles Airport Hotel, 13869 Park Center Road, Herndon, VA 20171, Phone (703) 4782900, Fax (703) 4789286.
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 121 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
Review of Sections 14 of the Draft Expert Panel Report on 1 Bromopropane and 2Bromopropane
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 EC32, Research Triangle Park, NC 27709, Phone: (919) 5413455; Fax (919) 3164511; shelby@niehs.nih.gov]. 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, email 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 (7:308:30 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.
PostMeeting 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 1Bromopropane 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, multistep 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 3704737048) 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. 0126621 Filed 102201; 8:45 am]
BILLING CODE 414001P
SUMMARY:
National Toxicology Program—; 1-Bromopropane and 2-bromopropane; Expert Panel Reports,
DOCUMENT BODY 2:
(1) Availability of the Draft Expert Panel Reports on 1
Bromopropane and 2BromopropanePublic 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 57,
2001The meeting is open to the public and will be held at the Hilton WashingtonDulles 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 scientificallybased, 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 1bromopropane (CASRN:
106945) and 2bromopropane (CASRN: 75263). 1Bromopropane 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. 2Bromopropane is used in the synthesis
of pharmaceuticals, dyes, and other compounds and is present as a
contaminant in 1bromopropane. Bromopropanes are being considered as
replacement chemicals for ozonedepleting chemicals such as
hydrochlorofluorocarbons and chlorinated solvents. The scientific
database on these chemicals includes studies on neurotoxicity, reproductive toxicity, and occupational exposures. 2
[[Page 53627]]
Bromopropane is reported to be a reproductive toxicant in humans.
Draft Expert Panel Reports on 1Bromopropane and 2Bromopropane 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 14 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 EC32, Research Triangle Park, NC 27709, Phone: (919) 5413455; Fax: (919)3164511; shelby@niehs.nih.gov). Request for Written Comments on Draft Expert Panel Reports
The CERHR invites written public comments on Sections 14 of the Draft Expert Panel Reports on 1bromopropane and 2bromopropane. 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, email, and sponsoring organization, if any).
Expert Panel Will Review 1Bromopropane and 2Bromopropane
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 CaliforniaIrvine, 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 MassachusettsLowell, 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 57, 2001, in the Solarium of the Hilton WashingtonDulles Airport Hotel, 13869 Park Center Road, Herndon, VA 20171, Phone (703) 4782900, Fax (703) 4789286.
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 121 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
Review of Sections 14 of the Draft Expert Panel Report on 1 Bromopropane and 2Bromopropane
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 EC32, Research Triangle Park, NC 27709, Phone: (919) 5413455; Fax (919) 3164511; shelby@niehs.nih.gov]. 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, email 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 (7:308:30 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.
PostMeeting 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 1Bromopropane 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, multistep 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 3704737048) 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. 0126621 Filed 102201; 8:45 am]
BILLING CODE 414001P