Federal Register: August 8, 2003 (Volume 68, Number 153)
DOCID: FR Doc 03-20299
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
NOTICE: NOTICES
ACTION: Meetings:
SUBJECT CATEGORY:
National Toxicology Program; National Toxicology Program (NTP) Board of Scientific Counselors Meeting; Review of Nominations for Listing in the 11th Edition of the Report on Carcinogens
DOCUMENT SUMMARY:
Pursuant to Public Law 92463, notice is hereby given of the next meeting of the NTP Board of Scientific Counselors Report on Carcinogens Subcommittee (``the NTP RoC Subcommittee'') to be held on October 14 15, 2003, at the Marriott at Metro Center, 775 12th Street, NW., Washington, DC 20005. On October 14, registration will begin at 9 a.m. and the meeting will begin at 9:30 a.m. On October 15, the meeting will begin at 8:30 a.m. Preregistration is not required; however, persons requesting time to make oral public comments are asked to notify Dr. Mary S. Wolfe, NTP Executive Secretary, prior to the meeting (contact information given below). The agenda covers the peer review of seven nominations for possible listing in the 11th Edition of the Report on Carcinogens (``the 11th RoC''), and includes an opportunity for public input.
Agenda
The meeting of the NTP RoC Subcommittee is scheduled for October
1415, 2003 and is open to the public with attendance limited to only
the available space. Tentatively scheduled for peer review are seven
nominations for possible listing in the 11th RoC. These nominations are
listed alphabetically in the attached table, along with supporting
information and a tentative order of presentation and review.
Background documents for each of the nominations have been made
available previously to the public on the web and include a summary of
the scientific data and information being used to evaluate the
nomination. A copy of the background document for each of these
nominations is available electronically through the NTP's RoC web site
for the 11th RoC at http://ntpserver.niehs.nih.gov/Newhomeroc/11RoCBkgrnd.html (select Nominations Under Review in 2003) or can be
obtained on CD or in hard copy, as available, from: Dr. C.W. Jameson,
Report on Carcinogens, NIEHS, MD EC14, 79 T.W. Alexander Drive,
Building 4401, Room 3118, P.O. Box 12233, Research Triangle Park, NC
27709 (919/5414096; FAX 919/5412242; email jameson@niehs.nih.gov).
The agenda and a roster of NTP RoC Subcommittee members will be
available prior to the meeting on the NTP homepage at http://ntpserver.niehs.nih.gov/ or upon request from Dr. Wolfe. Following the
meeting, summary minutes will also be available electronically at
http://ntpserver.niehs.nih.gov/NewHomeRoc/mtgs.html and in hardcopy upon request from Dr. Wolfe.
A total of 17 nominations are under consideration for the 11th RoC.
Previous notices in the Federal Register (July 24, 2001: Volume 66,
Number 142, Pages 3843038432 and March 28, 2002: Volume 67, Number 60,
Page 14957) announced the nominations to be reviewed for possible
listing in the 11th RoC. This review by the NTP RoC Subcommittee is for
the second set of seven nominations identified in those Federal
Register announcements that have completed review by the NIEHS Review Committee for the Report on
[[Page 47347]]
Carcinogens (RG1) and the NTP Executive Committee Interagency Working
Group for the Report on Carcinogens (RG2). The RoC Subcommittee
reviewed the first 10 nominations to the 11th RoC at a public meeting
on November 1920, 2002, in Washington, DC. Summary minutes of that
meeting are available electronically at http://ntpserver.niehs.nih.gov/NewHomeRoc/mtgs.html or in hardcopy upon request
to the Executive Secretary (contact information below).
Solicitation of Public Comment
This meeting of the NTP RoC Subcommittee is open to the public, and time will be provided for oral public comment on each of the nominations under review. In order to facilitate planning, persons requesting time for an oral presentation on a nomination should notify the Executive Secretary, (Dr. Mary S. Wolfe, P.O. Box 12233, A307, Research Triangle Park, NC 27709; telephone 919/5413971; FAX 919/541 0295; email wolfe@niehs.nih.gov) no later than September 29, 2003. Each organization is allowed one time slot for an oral presentation per nomination. Persons registering to make comments are asked to provide, if possible, a written copy of their statement by September 29 so copies can be made and distributed to NTP RoC Subcommittee members for their timely review prior to the meeting. Written statements can supplement and expand the oral presentation, and each speaker is asked to provide his/her name, affiliation, mailing address, phone, fax, e mail and supporting organization (if any). At least 7 minutes will be allotted to each speaker, and if time permits, may be extended to 10 minutes. Individuals who register to make oral presentations by September 29 will be notified about the time available for their presentation at least one week prior to the meeting. Registration for making public comments will also be available onsite. Time allowed for presentation by onsite registrants may be less than that for preregistered speakers and will be determined by the number of speakers who register at the meeting to give comments. If registering onsite to speak and reading oral comments from printed copy, the speaker is asked to bring 25 copies of the text. These copies will be distributed to the NTP RoC Subcommittee members and supplement the record. All comments received in response to this Federal Register notice will be posted on the NTP RoC web site.
Written comments, in lieu of making oral comments, are welcome. All comments must include name, affiliation, mailing address, phone, fax, email and sponsoring organization (if any) and should be received by September 29, 2003, for distribution to the NTP RoC Subcommittee. Written comments received after September 29 will not be considered by NTP RoC Subcommittee members in their reviews.
Solicitation of Additional Information
The NTP would welcome receiving information from completed human or experimental animal cancer studies or studies of mechanism of cancer formation, as well as current production data, human exposure information, and use patterns for any of the nominations listed in this announcement. Organizations or individuals that wish to provide information should contact Dr. C.W. Jameson at the address given above. Background
The Department of Health and Human Services (DHHS) Report on
Carcinogens is a public information document prepared for the U.S.
Congress by the National Toxicology Program (NTP) in response to
Section 301(b)(4) of the Public Health Service Act, as amended. The
intent of the document is to provide a listing of those agents,
substances, mixtures or exposure circumstances that are either
``known'' or ``reasonably anticipated'' to cause cancer in humans and
to which a significant number of people in the United States are
exposed. The process for preparation of the RoC has three levels of
scientific review. Central to the evaluations of the review groups is
the use of criteria for inclusion in or removal of listings from the
report. The current criteria for listing in or delisting from the
Report is available on the Web at the following web site: http://ntpserver.niehs.nih.gov/NewHomeRoc/ListingCriteria.html , or can be
obtained in hard copy by contacting Dr. C.W. Jameson at the address
listed above. The review process for listing in or delisting from the
RoC begins with initial scientific review by the National Institute of
Environmental Health Sciences (NIEHS)/NTP Report on Carcinogens Review
Committee (RG1), which is comprised of NIEHS/NTP staff scientists. The
second scientific review group (RG2) is comprised of representatives
from the Federal health research and regulatory agencies that are
members of the NTP Executive Committee. The third step is external
scientific review at a public meeting by the NTP RoC Subcommittee.
Following completion of these reviews and solicitation of public
comments through announcements in the Federal Register and other media,
the independent recommendations of the three scientific review groups
and all public comments are presented to the NTP Executive Committee
for review and comment. All recommendations and public comments are
submitted to the Director, NTP, who reviews them and makes a final
recommendation to the Secretary, DHHS, concerning the listing or
delisting of substances or exposure circumstances in the RoC. The
Secretary has final review and approval authority for the 11th RoC.
Dated: July 30, 2003.
Samuel H. Wilson,
Deputy Director, National Institute of Environmental Health Sciences.
Summary Data for Nominations Tentatively Scheduled for Review at the Meeting of the NTP Board of Scientific Counselors Report on Carcinogens
Subcommittee
[October 1415, 2003]
Tentative
Nomination to be reviewed/CAS number Primary uses or exposures To be reviewed for review
order
Diazoaminobenzene (DAAB)/136356.......... DAAB is used as an intermediate in the production Listing in the 11th RoC.................... 6
of dyes, and as a complexing agent, polymer
additive and to promote adhesion of natural
rubber to steel.
Hepatitis B Virus (HBV).................... HBV is a small DNAenveloped virus that along with Listing in the 11th RoC.................... 4
Hepatitis C Virus causes most parenterally
transmitted viral hepatitis.
Hepatitis C Virus (HCV).................... HCV is an RNAenveloped virus that along with Listing in the 11th RoC.................... 5
Hepatitis B Virus causes most parenterally
transmitted viral hepatitis. [[Page 47348]]
Human Papillomaviruses (HPVs), Genital HPVs are small, nonenveloped viruses that infect Listing in the 11th RoC.................... 3
Mucosal Types. oral and genital mucosa. HPV infections are
common throughout the world.
Lead and Lead Compounds.................... Major use of metal is in making leadacid storage Listing in the 11th RoC.................... 2
batteries. Other common uses include ammunition
and cable covering. Lead compounds are used in
paint, glass, ceramics, fuel additives, and some
traditional cosmetics.
Neutrons................................... Exposure to neutrons normally occurs from a mixed Listing in the 11th RoC.................... * 1
irradiation field in which neutrons are a minor
component. The exceptions are exposure of
patients to neutron radiotherapy beams and
exposures of aircraft passengers and crew.
XRadiation and GAMMA Radiation............ Exposure to these forms of ionizing radiation Listing in the 11th RoC.................... ** 1
comes from a variety of natural (environmental
exposure) and anthropogenic sources, including
exposure for military, medical, and occupational purposes.
* Notewill be reviewed together with XRadiation and GAMMA Radiation nomination. ** Notewill be reviewed together with Neutrons nomination.
[FR Doc. 0320299 Filed 8703; 8:45 am]
BILLING CODE 414001U
SUMMARY:
National Toxicology Program—; Scientific Counselors Board,
DOCUMENT BODY 2:
Pursuant to Public Law 92463, notice is hereby given of the next meeting of the NTP Board of Scientific Counselors Report on Carcinogens Subcommittee (``the NTP RoC Subcommittee'') to be held on October 14 15, 2003, at the Marriott at Metro Center, 775 12th Street, NW., Washington, DC 20005. On October 14, registration will begin at 9 a.m. and the meeting will begin at 9:30 a.m. On October 15, the meeting will begin at 8:30 a.m. Preregistration is not required; however, persons requesting time to make oral public comments are asked to notify Dr. Mary S. Wolfe, NTP Executive Secretary, prior to the meeting (contact information given below). The agenda covers the peer review of seven nominations for possible listing in the 11th Edition of the Report on Carcinogens (``the 11th RoC''), and includes an opportunity for public input.
Agenda
The meeting of the NTP RoC Subcommittee is scheduled for October
1415, 2003 and is open to the public with attendance limited to only
the available space. Tentatively scheduled for peer review are seven
nominations for possible listing in the 11th RoC. These nominations are
listed alphabetically in the attached table, along with supporting
information and a tentative order of presentation and review.
Background documents for each of the nominations have been made
available previously to the public on the web and include a summary of
the scientific data and information being used to evaluate the
nomination. A copy of the background document for each of these
nominations is available electronically through the NTP's RoC web site
for the 11th RoC at http://ntpserver.niehs.nih.gov/Newhomeroc/11RoCBkgrnd.html (select Nominations Under Review in 2003) or can be
obtained on CD or in hard copy, as available, from: Dr. C.W. Jameson,
Report on Carcinogens, NIEHS, MD EC14, 79 T.W. Alexander Drive,
Building 4401, Room 3118, P.O. Box 12233, Research Triangle Park, NC
27709 (919/5414096; FAX 919/5412242; email jameson@niehs.nih.gov).
The agenda and a roster of NTP RoC Subcommittee members will be
available prior to the meeting on the NTP homepage at http://ntpserver.niehs.nih.gov/ or upon request from Dr. Wolfe. Following the
meeting, summary minutes will also be available electronically at
http://ntpserver.niehs.nih.gov/NewHomeRoc/mtgs.html and in hardcopy upon request from Dr. Wolfe.
A total of 17 nominations are under consideration for the 11th RoC.
Previous notices in the Federal Register (July 24, 2001: Volume 66,
Number 142, Pages 3843038432 and March 28, 2002: Volume 67, Number 60,
Page 14957) announced the nominations to be reviewed for possible
listing in the 11th RoC. This review by the NTP RoC Subcommittee is for
the second set of seven nominations identified in those Federal
Register announcements that have completed review by the NIEHS Review Committee for the Report on
[[Page 47347]]
Carcinogens (RG1) and the NTP Executive Committee Interagency Working
Group for the Report on Carcinogens (RG2). The RoC Subcommittee
reviewed the first 10 nominations to the 11th RoC at a public meeting
on November 1920, 2002, in Washington, DC. Summary minutes of that
meeting are available electronically at http://ntpserver.niehs.nih.gov/NewHomeRoc/mtgs.html or in hardcopy upon request
to the Executive Secretary (contact information below).
Solicitation of Public Comment
This meeting of the NTP RoC Subcommittee is open to the public, and time will be provided for oral public comment on each of the nominations under review. In order to facilitate planning, persons requesting time for an oral presentation on a nomination should notify the Executive Secretary, (Dr. Mary S. Wolfe, P.O. Box 12233, A307, Research Triangle Park, NC 27709; telephone 919/5413971; FAX 919/541 0295; email wolfe@niehs.nih.gov) no later than September 29, 2003. Each organization is allowed one time slot for an oral presentation per nomination. Persons registering to make comments are asked to provide, if possible, a written copy of their statement by September 29 so copies can be made and distributed to NTP RoC Subcommittee members for their timely review prior to the meeting. Written statements can supplement and expand the oral presentation, and each speaker is asked to provide his/her name, affiliation, mailing address, phone, fax, e mail and supporting organization (if any). At least 7 minutes will be allotted to each speaker, and if time permits, may be extended to 10 minutes. Individuals who register to make oral presentations by September 29 will be notified about the time available for their presentation at least one week prior to the meeting. Registration for making public comments will also be available onsite. Time allowed for presentation by onsite registrants may be less than that for preregistered speakers and will be determined by the number of speakers who register at the meeting to give comments. If registering onsite to speak and reading oral comments from printed copy, the speaker is asked to bring 25 copies of the text. These copies will be distributed to the NTP RoC Subcommittee members and supplement the record. All comments received in response to this Federal Register notice will be posted on the NTP RoC web site.
Written comments, in lieu of making oral comments, are welcome. All comments must include name, affiliation, mailing address, phone, fax, email and sponsoring organization (if any) and should be received by September 29, 2003, for distribution to the NTP RoC Subcommittee. Written comments received after September 29 will not be considered by NTP RoC Subcommittee members in their reviews.
Solicitation of Additional Information
The NTP would welcome receiving information from completed human or experimental animal cancer studies or studies of mechanism of cancer formation, as well as current production data, human exposure information, and use patterns for any of the nominations listed in this announcement. Organizations or individuals that wish to provide information should contact Dr. C.W. Jameson at the address given above. Background
The Department of Health and Human Services (DHHS) Report on
Carcinogens is a public information document prepared for the U.S.
Congress by the National Toxicology Program (NTP) in response to
Section 301(b)(4) of the Public Health Service Act, as amended. The
intent of the document is to provide a listing of those agents,
substances, mixtures or exposure circumstances that are either
``known'' or ``reasonably anticipated'' to cause cancer in humans and
to which a significant number of people in the United States are
exposed. The process for preparation of the RoC has three levels of
scientific review. Central to the evaluations of the review groups is
the use of criteria for inclusion in or removal of listings from the
report. The current criteria for listing in or delisting from the
Report is available on the Web at the following web site: http://ntpserver.niehs.nih.gov/NewHomeRoc/ListingCriteria.html , or can be
obtained in hard copy by contacting Dr. C.W. Jameson at the address
listed above. The review process for listing in or delisting from the
RoC begins with initial scientific review by the National Institute of
Environmental Health Sciences (NIEHS)/NTP Report on Carcinogens Review
Committee (RG1), which is comprised of NIEHS/NTP staff scientists. The
second scientific review group (RG2) is comprised of representatives
from the Federal health research and regulatory agencies that are
members of the NTP Executive Committee. The third step is external
scientific review at a public meeting by the NTP RoC Subcommittee.
Following completion of these reviews and solicitation of public
comments through announcements in the Federal Register and other media,
the independent recommendations of the three scientific review groups
and all public comments are presented to the NTP Executive Committee
for review and comment. All recommendations and public comments are
submitted to the Director, NTP, who reviews them and makes a final
recommendation to the Secretary, DHHS, concerning the listing or
delisting of substances or exposure circumstances in the RoC. The
Secretary has final review and approval authority for the 11th RoC.
Dated: July 30, 2003.
Samuel H. Wilson,
Deputy Director, National Institute of Environmental Health Sciences.
Summary Data for Nominations Tentatively Scheduled for Review at the Meeting of the NTP Board of Scientific Counselors Report on Carcinogens
Subcommittee
[October 1415, 2003]
Tentative
Nomination to be reviewed/CAS number Primary uses or exposures To be reviewed for review
order
Diazoaminobenzene (DAAB)/136356.......... DAAB is used as an intermediate in the production Listing in the 11th RoC.................... 6
of dyes, and as a complexing agent, polymer
additive and to promote adhesion of natural
rubber to steel.
Hepatitis B Virus (HBV).................... HBV is a small DNAenveloped virus that along with Listing in the 11th RoC.................... 4
Hepatitis C Virus causes most parenterally
transmitted viral hepatitis.
Hepatitis C Virus (HCV).................... HCV is an RNAenveloped virus that along with Listing in the 11th RoC.................... 5
Hepatitis B Virus causes most parenterally
transmitted viral hepatitis. [[Page 47348]]
Human Papillomaviruses (HPVs), Genital HPVs are small, nonenveloped viruses that infect Listing in the 11th RoC.................... 3
Mucosal Types. oral and genital mucosa. HPV infections are
common throughout the world.
Lead and Lead Compounds.................... Major use of metal is in making leadacid storage Listing in the 11th RoC.................... 2
batteries. Other common uses include ammunition
and cable covering. Lead compounds are used in
paint, glass, ceramics, fuel additives, and some
traditional cosmetics.
Neutrons................................... Exposure to neutrons normally occurs from a mixed Listing in the 11th RoC.................... * 1
irradiation field in which neutrons are a minor
component. The exceptions are exposure of
patients to neutron radiotherapy beams and
exposures of aircraft passengers and crew.
XRadiation and GAMMA Radiation............ Exposure to these forms of ionizing radiation Listing in the 11th RoC.................... ** 1
comes from a variety of natural (environmental
exposure) and anthropogenic sources, including
exposure for military, medical, and occupational purposes.
* Notewill be reviewed together with XRadiation and GAMMA Radiation nomination. ** Notewill be reviewed together with Neutrons nomination.
[FR Doc. 0320299 Filed 8703; 8:45 am]
BILLING CODE 414001U