Federal Register: November 6, 2003 (Volume 68, Number 215)
DOCID: FR Doc 03-27892
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
NOTICE: NOTICES
ACTION: National Toxicology Program:
SUBJECT CATEGORY:
National Toxicology Program; Call for Public Comments on Seven Nominations Proposed for Listing in the Report on Carcinogens, Eleventh Edition
DOCUMENT SUMMARY:
Summary
The National Toxicology Program (NTP) solicits final public comments on the nominations reviewed in 2003 for listing in the Report on Carcinogens, Eleventh Edition. Comments will be accepted for 60 days from the publication date of this announcement and should be directed to Dr. C. W. Jameson (contact information below).
Background
The Report on Carcinogens (``the Report'') (previously known as the Annual Report on Carcinogens) is a Congressionally mandated listing of known human carcinogens and reasonably anticipated human carcinogens, and its preparation is delegated to the NTP by the Secretary, Department of Health and Human Services (DHHS). Section 301 (b) (4) of the Public Health Service Act, as amended, provides that the Secretary, DHHS, shall publish a biennial report which contains a list of all substances (1) which either are known to be human carcinogens or may reasonably be anticipated to be human carcinogens; and (2) to which a significant number of persons residing in the United States (US) are exposed. The law also states that the reports should provide available information on the nature of exposures, the estimated number of persons exposed and the extent to which the implementation of Federal regulations decreases the risk to public health from exposure to these chemicals.
In 2003, seven nominations were reviewed by three scientific
committees, two Federal and one nongovernment, for listing in the
Eleventh Report. This review included public comment and review. The
three scientific review committees evaluated all available data
relevant to the criteria for inclusion of candidate nominations in the
Report. The seven nominations along with their Chemical Abstract Services (CAS) Registry numbers (where available) and the
recommendations from the three scientific peer reviews are provided in
the table below. The NTP will review the recommendations from each of
the review committees and consider all public comments received
throughout the review process. Based upon this information, the NTP
Director will make a recommendation to the Secretary, DHHS, regarding
the listing of each nominated substance in the Eleventh Report.
The criteria used in the review process and a detailed description
of the review procedures, including the steps in the current formal
review process, can be obtained from the NTP Web site at http://ntpserver.niehs.nih.gov/ (choose Report on Carcinogens) or by contacting
Dr. C. W. Jameson (contact information below). Background documents on
the nominations are also available on the NTP Report on Carcinogens Web
site in PDFformat and in hard copy or on CD upon request from Dr. Jameson.
Public Comment Requested
The NTP solicits final public comments on the seven nominations
reviewed in 2003 for listing in the Eleventh Report. The public is
invited to submit comments that supplement any previously submitted
comments or to provide comments for the first time on any nomination.
Comments will be accepted for 60 days from the publication date of this
announcement and should be directed to Dr. C. W. Jameson (National
Toxicology Program, Report on Carcinogens, MD EC14, P.O. Box 12233,
Research Triangle Park, NC 27709; phone: (919) 5414096, fax: (919) 5410144, email: jameson@niehs.nih.gov). Individuals submitting public
comments are asked to include relevant contact information (name,
affiliation (if any), address, telephone, fax, email, and sponsoring organization (if any)).
Dated: October 28, 2003.
Kenneth Olden,
Director, National Toxicology Program.
[[Page 62826]]
Summary of RG1, \1\ RG \2\ and NTP Board Subcommittee \3\ Recommendations for the Nominations Reviewed in 2003
for Listing in the Report on Carcinogens, 11th Edition
NTP board
Nomination/CAS number Primary uses or RG1 action RG2 action subcommittee
exposures action
Diazoaminobenzene (DAAB)/13635 DAAB is used as an Motion to list Motion to list Motion to list
6. intermediate in DAAB as DAAB as DAAB as
the production of reasonably reasonably reasonably
dyes and to anticipated to be anticipated to be anticipated to be
promote adhesion a human a human a human
of natural rubber carcinogen passed carcinogen passed carcinogen passed
to steel. by unanimous vote by majority vote by majority vote
(5/0). (8/1). Negative (6/4) with 1
vote cast because abstention.
member felt there Negative votes: 3
was not members felt
sufficient nominations did
evidence for DAAB not meet criteria
to list in the for listing and 1
Report on member felt that
Carcinogens.. because DAAB is
metabolized to
benzene, it
should be listed
as known to be a
human carcinogen.
Abstentionmembe
r felt if DAAB is
metabolized to
benzene, it
should be listed
as known to be a
human carcinogen;
however, not
convinced
chemical is
metabolized to
benzene in
humans.
Hepatitis B Virus (HBV)......... HBV is a small DNA Motion to list HBV Motion to list HBV Motion to list HBV
enveloped virus as known to be a as known to be a as known to be a
that along with human carcinogen human carcinogen human carcinogen
Hepatitis C Virus passed by passed by passed by
causes most unanimous vote (4/ unanimous vote (8/ unanimous vote
parentally 0). 0). (12/0). transmitted viral
hepatitis.
Hepatitis C Virus (HCV)......... HCV is an RNA Motion to list HCV Motion to list HCV Motion to list HCV
enveloped virus as known to be a as known to be a as known to be a
that along with human carcinogen human carcinogen human carcinogen
Hepatitis B Virus passed by passed by passed by
causes most unanimous vote (7/ unanimous vote (8/ unanimous vote
parenterally 0). 0). (12/0). transmitted viral
hepatitis.
Human Papillomaviruses (HPVs), HPVs are small, Motion to list Motion to list Motion to list
GenitalMucosal Types. nonenveloped HPVs as known to HPVs as known to HPVs as known to
viruses that be a human be a human be a human
infect genital carcinogen passed carcinogen passed carcinogen passed
skin, and genital by unanimous vote by unanimous vote by unanimous vote
and nongenital (7/0). (8/0). (12/0). mucosa. HPV
infections are
common throughout
the world.
Lead and Lead Compounds......... Major use of metal Motion to list Motion to list Motion to list
is in making lead Lead and Lead Lead and Lead Lead and Lead
acid storage Compounds as Compounds as Compounds as
batteries. Other known to be human reasonably reasonably
common uses carcinogens anticipated to be anticipated to be
include passed by human carcinogens human carcinogens
ammunition and unanimous vote (8/ passed by passed by
cable covering. 0). majority vote (4/ majority vote (11/
Lead compounds 3). Negative 0).
are used in votes cast
paint, glass, because members
ceramics, fuel felt that human
additives, and data were
some traditional sufficient to
cosmetics. list lead and
lead compounds as
known to be human
carcinogens.
Neutrons........................ Exposure to Motion to list Motion to list Motion to list
neutrons normally Neutrons as known Neutrons as known Neutrons as known
occurs from a to be a human to be a human to be a human
mixed irradiation carcinogen passed carcinogen passed carcinogen passed
field in which by unanimous vote by unanimous vote by unanimous vote
neutrons are a (7/0). (8/0). (11/0). minor component.
The exceptions
are exposure of
patients to
neutron
radiotherapy
beams and
exposures of
aircraft
passengers and
crew.
[[Page 62827]]
XRadiation and Gamma ([gamma]) Exposure to these Motion to list X Motion to list X Motion to list X
Radiation. forms of ionizing Radiation and Radiation and Radiation and
radiation comes [gamma]Radiation [gamma]Radiation [gamma]Radiation
from a variety of as known to be as known to be as known to be
natural human carcinogens human carcinogens human carcinogens
(environmental passed by passed by passed by
exposure) and unanimous vote (7/ unanimous vote (8/ unanimous vote
anthropogenic 0). 0). (11/0). sources,
including
exposure for
military,
medical, and
occupational
purposes.
\1\ The NIEHS Review Committee for the Report on Carcinogens (RG1).
\2\ The NTP Executive Committee* Interagency Working Group for the Report on Carcinogens (RG2).
*Agencies from the NTP Executive Committee represented on RG2 include: Agency for Toxic Substances and Disease
Registry (ATSDR), Consumer Product Safety Commission (CPSC), Environmental Protection Agency (EPA), National
Center for Environmental Health of the Centers for Disease Control and Prevention (NCEH/CDC), National Center
for Toxicological Research of the Food and Drug Administration (NCTR/FDA), National Institute for Occupational
Safety and Health/CDC (NIOSH/CDC), Occupational Safety and Health Administration (OSHA), National Cancer
Institute of the National Institutes of Health (NCI/NIH), and National Institute of Environmental Health Sciences/NIH (NIEHS/NIH).
\3\ The NTP Board of Scientific Counselors Report on Carcinogens Subcommittee (a standing subcommittee of the
NTP Board of Scientific Counselors that serves as an external peer review group). [FR Doc. 0327892 Filed 11503; 8:45 am]
BILLING CODE 414001P
SUMMARY:
Carcinogens Report, Eleventh Edition—; Agents, substances, mixtures, and exposure circumstances for listing or delisting,
DOCUMENT BODY 2:
Summary
The National Toxicology Program (NTP) solicits final public comments on the nominations reviewed in 2003 for listing in the Report on Carcinogens, Eleventh Edition. Comments will be accepted for 60 days from the publication date of this announcement and should be directed to Dr. C. W. Jameson (contact information below).
Background
The Report on Carcinogens (``the Report'') (previously known as the Annual Report on Carcinogens) is a Congressionally mandated listing of known human carcinogens and reasonably anticipated human carcinogens, and its preparation is delegated to the NTP by the Secretary, Department of Health and Human Services (DHHS). Section 301 (b) (4) of the Public Health Service Act, as amended, provides that the Secretary, DHHS, shall publish a biennial report which contains a list of all substances (1) which either are known to be human carcinogens or may reasonably be anticipated to be human carcinogens; and (2) to which a significant number of persons residing in the United States (US) are exposed. The law also states that the reports should provide available information on the nature of exposures, the estimated number of persons exposed and the extent to which the implementation of Federal regulations decreases the risk to public health from exposure to these chemicals.
In 2003, seven nominations were reviewed by three scientific
committees, two Federal and one nongovernment, for listing in the
Eleventh Report. This review included public comment and review. The
three scientific review committees evaluated all available data
relevant to the criteria for inclusion of candidate nominations in the
Report. The seven nominations along with their Chemical Abstract Services (CAS) Registry numbers (where available) and the
recommendations from the three scientific peer reviews are provided in
the table below. The NTP will review the recommendations from each of
the review committees and consider all public comments received
throughout the review process. Based upon this information, the NTP
Director will make a recommendation to the Secretary, DHHS, regarding
the listing of each nominated substance in the Eleventh Report.
The criteria used in the review process and a detailed description
of the review procedures, including the steps in the current formal
review process, can be obtained from the NTP Web site at http://ntpserver.niehs.nih.gov/ (choose Report on Carcinogens) or by contacting
Dr. C. W. Jameson (contact information below). Background documents on
the nominations are also available on the NTP Report on Carcinogens Web
site in PDFformat and in hard copy or on CD upon request from Dr. Jameson.
Public Comment Requested
The NTP solicits final public comments on the seven nominations
reviewed in 2003 for listing in the Eleventh Report. The public is
invited to submit comments that supplement any previously submitted
comments or to provide comments for the first time on any nomination.
Comments will be accepted for 60 days from the publication date of this
announcement and should be directed to Dr. C. W. Jameson (National
Toxicology Program, Report on Carcinogens, MD EC14, P.O. Box 12233,
Research Triangle Park, NC 27709; phone: (919) 5414096, fax: (919) 5410144, email: jameson@niehs.nih.gov). Individuals submitting public
comments are asked to include relevant contact information (name,
affiliation (if any), address, telephone, fax, email, and sponsoring organization (if any)).
Dated: October 28, 2003.
Kenneth Olden,
Director, National Toxicology Program.
[[Page 62826]]
Summary of RG1, \1\ RG \2\ and NTP Board Subcommittee \3\ Recommendations for the Nominations Reviewed in 2003
for Listing in the Report on Carcinogens, 11th Edition
NTP board
Nomination/CAS number Primary uses or RG1 action RG2 action subcommittee
exposures action
Diazoaminobenzene (DAAB)/13635 DAAB is used as an Motion to list Motion to list Motion to list
6. intermediate in DAAB as DAAB as DAAB as
the production of reasonably reasonably reasonably
dyes and to anticipated to be anticipated to be anticipated to be
promote adhesion a human a human a human
of natural rubber carcinogen passed carcinogen passed carcinogen passed
to steel. by unanimous vote by majority vote by majority vote
(5/0). (8/1). Negative (6/4) with 1
vote cast because abstention.
member felt there Negative votes: 3
was not members felt
sufficient nominations did
evidence for DAAB not meet criteria
to list in the for listing and 1
Report on member felt that
Carcinogens.. because DAAB is
metabolized to
benzene, it
should be listed
as known to be a
human carcinogen.
Abstentionmembe
r felt if DAAB is
metabolized to
benzene, it
should be listed
as known to be a
human carcinogen;
however, not
convinced
chemical is
metabolized to
benzene in
humans.
Hepatitis B Virus (HBV)......... HBV is a small DNA Motion to list HBV Motion to list HBV Motion to list HBV
enveloped virus as known to be a as known to be a as known to be a
that along with human carcinogen human carcinogen human carcinogen
Hepatitis C Virus passed by passed by passed by
causes most unanimous vote (4/ unanimous vote (8/ unanimous vote
parentally 0). 0). (12/0). transmitted viral
hepatitis.
Hepatitis C Virus (HCV)......... HCV is an RNA Motion to list HCV Motion to list HCV Motion to list HCV
enveloped virus as known to be a as known to be a as known to be a
that along with human carcinogen human carcinogen human carcinogen
Hepatitis B Virus passed by passed by passed by
causes most unanimous vote (7/ unanimous vote (8/ unanimous vote
parenterally 0). 0). (12/0). transmitted viral
hepatitis.
Human Papillomaviruses (HPVs), HPVs are small, Motion to list Motion to list Motion to list
GenitalMucosal Types. nonenveloped HPVs as known to HPVs as known to HPVs as known to
viruses that be a human be a human be a human
infect genital carcinogen passed carcinogen passed carcinogen passed
skin, and genital by unanimous vote by unanimous vote by unanimous vote
and nongenital (7/0). (8/0). (12/0). mucosa. HPV
infections are
common throughout
the world.
Lead and Lead Compounds......... Major use of metal Motion to list Motion to list Motion to list
is in making lead Lead and Lead Lead and Lead Lead and Lead
acid storage Compounds as Compounds as Compounds as
batteries. Other known to be human reasonably reasonably
common uses carcinogens anticipated to be anticipated to be
include passed by human carcinogens human carcinogens
ammunition and unanimous vote (8/ passed by passed by
cable covering. 0). majority vote (4/ majority vote (11/
Lead compounds 3). Negative 0).
are used in votes cast
paint, glass, because members
ceramics, fuel felt that human
additives, and data were
some traditional sufficient to
cosmetics. list lead and
lead compounds as
known to be human
carcinogens.
Neutrons........................ Exposure to Motion to list Motion to list Motion to list
neutrons normally Neutrons as known Neutrons as known Neutrons as known
occurs from a to be a human to be a human to be a human
mixed irradiation carcinogen passed carcinogen passed carcinogen passed
field in which by unanimous vote by unanimous vote by unanimous vote
neutrons are a (7/0). (8/0). (11/0). minor component.
The exceptions
are exposure of
patients to
neutron
radiotherapy
beams and
exposures of
aircraft
passengers and
crew.
[[Page 62827]]
XRadiation and Gamma ([gamma]) Exposure to these Motion to list X Motion to list X Motion to list X
Radiation. forms of ionizing Radiation and Radiation and Radiation and
radiation comes [gamma]Radiation [gamma]Radiation [gamma]Radiation
from a variety of as known to be as known to be as known to be
natural human carcinogens human carcinogens human carcinogens
(environmental passed by passed by passed by
exposure) and unanimous vote (7/ unanimous vote (8/ unanimous vote
anthropogenic 0). 0). (11/0). sources,
including
exposure for
military,
medical, and
occupational
purposes.
\1\ The NIEHS Review Committee for the Report on Carcinogens (RG1).
\2\ The NTP Executive Committee* Interagency Working Group for the Report on Carcinogens (RG2).
*Agencies from the NTP Executive Committee represented on RG2 include: Agency for Toxic Substances and Disease
Registry (ATSDR), Consumer Product Safety Commission (CPSC), Environmental Protection Agency (EPA), National
Center for Environmental Health of the Centers for Disease Control and Prevention (NCEH/CDC), National Center
for Toxicological Research of the Food and Drug Administration (NCTR/FDA), National Institute for Occupational
Safety and Health/CDC (NIOSH/CDC), Occupational Safety and Health Administration (OSHA), National Cancer
Institute of the National Institutes of Health (NCI/NIH), and National Institute of Environmental Health Sciences/NIH (NIEHS/NIH).
\3\ The NTP Board of Scientific Counselors Report on Carcinogens Subcommittee (a standing subcommittee of the
NTP Board of Scientific Counselors that serves as an external peer review group). [FR Doc. 0327892 Filed 11503; 8:45 am]
BILLING CODE 414001P