Federal Register: February 8, 2005 (Volume 70, Number 25)
DOCID: FR Doc 05-2393
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
NOTICE: NOTICES
ACTION: National Toxicology Program:
SUBJECT CATEGORY:
The National Toxicology Program (NTP) Announces the Availability of the Report on Carcinogens, Eleventh Edition
DOCUMENT SUMMARY:
The Department of Health and Human Services released the Report on Carcinogens, Eleventh Edition to the public on January 31, 2005. The report is available freeofcharge on the Internet from the NTP Web site at: http://ntp.niehs.nih.gov. Printed copies of the Report on Carcinogens, Eleventh Edition can be obtained by contacting: Central Data Management (CDM), MDEC03, National Institute of Environmental Health Sciences, P.O. Box 12233, 79 T.W. Alexander Dr., Building 4401, Suite 100, Research Triangle Park, NC 27709 USA; 9195413419 (phone), 9195413687 (fax), email: cdm@niehs.nih.gov. Background
The Report on Carcinogens (RoC) (previously known as the Annual Report on Carcinogens) is a Congressionally mandated listing of known human carcinogens and reasonably anticipated human carcinogens whose 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 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.
The RoC is an informational, scientific, and public health document that identifies and discusses agents, substances, mixtures, or exposure circumstances that may pose a carcinogenic hazard to human health. It serves as a meaningful and useful compilation of data on the (1) carcinogenicity, genotoxicity, and biologic mechanisms of the listed substances in humans and/or animals, (2) the potential for exposure to these substances, and (3) the regulations promulgated by Federal agencies to limit exposures. The report does not present quantitative assessments of carcinogenic risk, an assessment that defines the conditions under which the hazard may be unacceptable. Listing of substances in the report, therefore, does not establish that such substances present carcinogenic risks to individuals in their daily lives. Such formal risk assessments are the purview of the appropriate federal, state, and local health regulatory and research agencies. New Listings to the RoC, Eleventh Edition
The RoC, Eleventh Edition, contains 246 entries, 17 of which have not appeared in earlier RoCs. The table below summarizes the actions taken for the substances or exposure circumstances reviewed for possible listing in the RoC, Eleventh Edition.
The review of the new entries to the RoC, Eleventh Edition followed
a formal process that included many phases of scientific peer review
and multiple opportunities for public comment. The process included
three scientific peer reviews: two separate, internal reviews conducted
by scientists within the federal government and an external review in a
public forum conducted by both nongovernment and government
scientists. The three scientific review committees evaluated all
available data relevant to the criteria for inclusion of candidate
nominations in the report. The criteria used to evaluate the
nominations and a description of the review procedures used are
available on the NTP Web site at http://ntp.niehs.nih.gov/ or by
contacting: Dr. C. W. Jameson, HeadReport on Carcinogens, National
Toxicology Program, National Institute of Environmental Health
Sciences, MD EC14, P.O. Box 12233, Research Triangle Park, NC 27709; phone: (919) 5414096, fax: (919) 5410144, email:
jameson@niehs.nih.gov.
Questions or comments concerning the RoC, Eleventh Edition should be directed to: Dr. Mary Wolfe, NTP Liaison and Scientific Review Office, National Institute of Environmental Health Sciences, MDA3, P.O. Box 12233, Research Triangle Park, NC 27709; phone: (919) 541 0530, fax: (919) 5410295, email: wolfe@niehs.nih.gov.
Dated: January 31, 2005.
Kenneth Olden,
Director, National Toxicology Program.
[[Page 6722]]
Summary of Actions for Agents, Substances, Mixtures or Exposure
Circumstances Reviewed for Listing in the Eleventh Edition of the Report on Carcinogens
Primary uses or
Nominations exposures Action
1Amino2,4 An anthraquinone Listed as reasonably
dibromoanthraquinone. derived vat dye anticipated to be a
that is used in the human carcinogen. textile industry.
Cobalt Sulfate.............. Used in Listed as reasonably
electroplating and anticipated to be a
electrochemical human carcinogen. industries. It is
also used as a
coloring agent for
ceramics and as a
drying agent in
inks, paints,
varnishes and
linoleum, and has
been added to
animal feed as a
mineral supplement.
Diazoaminobenzene........... Used as an Listed as reasonably
intermediate in the anticipated to be a
production of dyes human carcinogen. and to promote
adhesion of natural
rubber to steel.
Diethanolamine.............. Used in the Not listed. preparation of
surfactants used in
liquid laundry,
dishwashing
detergents,
cosmetics,
shampoos, and hair
conditioners; as a
surfaceactive
agent and corrosion
inhibitor in
metalworking
fluids; and as a
dispersant in
agricultural
chemical
formulations.
Hepatitis B Virus........... A small DNA Listed as known to
enveloped virus be a human
that, along with carcinogen. Hepatitis C Virus,
causes most
parenterally
transmitted viral
hepatitis.
Hepatitis C Virus........... An RNAenveloped Listed as known to
virus that, along be a human
with Hepatitis B carcinogen. Virus, causes most
parenterally
transmitted viral
hepatitis.
Selected Heterocyclic Amines Heterocyclic amines Listed as reasonably
(three): that are formed anticipated to be
during grilling or human carcinogens. cooking at high
temperature and are
found in cooked
meat and fish.
(1) 2Amino3,4
dimethylimidazo[4,5
f]quinoline (MeIQ)
(2) 2Amino3,8
dimethylimidazo[4,5
f]quinoxaline (MeIQx)
(3) 2Amino1methyl6
phenylimidazo[4,5
b]pyridine (PhIP)
Human Papillomaviruses, Some Small, nonenveloped Listed as known to
GenitalMucosal Types. viruses that infect be human
genital skin, and carcinogens. genital and non
genital mucosa. HPV
infections are
common throughout
the world.
Lead and Lead Compounds..... Major use is in Listed as reasonably
making leadacid anticipated to be
storage batteries. human carcinogens. Other common uses
include ammunition
and cable covering.
Lead compounds are
used in paint,
glass, ceramics,
fuel additives, and
some traditional
cosmetics.
Naphthalene................. Used as an Listed as reasonably
intermediate in the anticipated to be a
synthesis of many human carcinogen. industrial
chemicals, and has
been used as an
ingredient in some
moth repellants and
toilet bowl
deodorants.
Neutrons.................... Exposures normally Listed as known to
occur from a mixed be human
irradiation field carcinogens. in which neutrons
are a minor
component. The
exceptions are
exposure of
patients to neutron
radiotherapy beams
and exposures of
aircraft passengers
and crew.
Nitrobenzene................ Used mainly in the Listed as reasonably
production of anticipated to be a
aniline, itself a human carcinogen. major chemical
intermediate in the
production of dyes.
Nitromethane................ Used in specialized Listed as reasonably
fuels, in anticipated to be a
explosives, and in human carcinogen. the synthesis of
nitromethane
derivatives,
pharmaceuticals,
agricultural soil
fumigants, and
industrial
antimicrobials.
4,4'Thiodianiline.......... Used as an Listed as reasonably
intermediate of anticipated to be a
several diazo dyes. human carcinogen.
XRadiation and Gamma Exposure to these Listed as known to
([gamma])Radiation. forms of ionizing be human
radiation comes carcinogens. from a variety of
natural
(environmental
exposure) and
anthropogenic
sources, including
exposure for
military, medical,
and occupational
purposes.
[[Page 6723]]
[FR Doc. 052393 Filed 2705; 8:45 am]
BILLING CODE 414001U
SUMMARY:
Carcinogens Report, Eleventh Edition—; Agents, substances, mixtures, and exposure circumstances for listing or delisting,
DOCUMENT BODY 2:
The Department of Health and Human Services released the Report on Carcinogens, Eleventh Edition to the public on January 31, 2005. The report is available freeofcharge on the Internet from the NTP Web site at: http://ntp.niehs.nih.gov. Printed copies of the Report on Carcinogens, Eleventh Edition can be obtained by contacting: Central Data Management (CDM), MDEC03, National Institute of Environmental Health Sciences, P.O. Box 12233, 79 T.W. Alexander Dr., Building 4401, Suite 100, Research Triangle Park, NC 27709 USA; 9195413419 (phone), 9195413687 (fax), email: cdm@niehs.nih.gov. Background
The Report on Carcinogens (RoC) (previously known as the Annual Report on Carcinogens) is a Congressionally mandated listing of known human carcinogens and reasonably anticipated human carcinogens whose 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 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.
The RoC is an informational, scientific, and public health document that identifies and discusses agents, substances, mixtures, or exposure circumstances that may pose a carcinogenic hazard to human health. It serves as a meaningful and useful compilation of data on the (1) carcinogenicity, genotoxicity, and biologic mechanisms of the listed substances in humans and/or animals, (2) the potential for exposure to these substances, and (3) the regulations promulgated by Federal agencies to limit exposures. The report does not present quantitative assessments of carcinogenic risk, an assessment that defines the conditions under which the hazard may be unacceptable. Listing of substances in the report, therefore, does not establish that such substances present carcinogenic risks to individuals in their daily lives. Such formal risk assessments are the purview of the appropriate federal, state, and local health regulatory and research agencies. New Listings to the RoC, Eleventh Edition
The RoC, Eleventh Edition, contains 246 entries, 17 of which have not appeared in earlier RoCs. The table below summarizes the actions taken for the substances or exposure circumstances reviewed for possible listing in the RoC, Eleventh Edition.
The review of the new entries to the RoC, Eleventh Edition followed
a formal process that included many phases of scientific peer review
and multiple opportunities for public comment. The process included
three scientific peer reviews: two separate, internal reviews conducted
by scientists within the federal government and an external review in a
public forum conducted by both nongovernment and government
scientists. The three scientific review committees evaluated all
available data relevant to the criteria for inclusion of candidate
nominations in the report. The criteria used to evaluate the
nominations and a description of the review procedures used are
available on the NTP Web site at http://ntp.niehs.nih.gov/ or by
contacting: Dr. C. W. Jameson, HeadReport on Carcinogens, National
Toxicology Program, National Institute of Environmental Health
Sciences, MD EC14, P.O. Box 12233, Research Triangle Park, NC 27709; phone: (919) 5414096, fax: (919) 5410144, email:
jameson@niehs.nih.gov.
Questions or comments concerning the RoC, Eleventh Edition should be directed to: Dr. Mary Wolfe, NTP Liaison and Scientific Review Office, National Institute of Environmental Health Sciences, MDA3, P.O. Box 12233, Research Triangle Park, NC 27709; phone: (919) 541 0530, fax: (919) 5410295, email: wolfe@niehs.nih.gov.
Dated: January 31, 2005.
Kenneth Olden,
Director, National Toxicology Program.
[[Page 6722]]
Summary of Actions for Agents, Substances, Mixtures or Exposure
Circumstances Reviewed for Listing in the Eleventh Edition of the Report on Carcinogens
Primary uses or
Nominations exposures Action
1Amino2,4 An anthraquinone Listed as reasonably
dibromoanthraquinone. derived vat dye anticipated to be a
that is used in the human carcinogen. textile industry.
Cobalt Sulfate.............. Used in Listed as reasonably
electroplating and anticipated to be a
electrochemical human carcinogen. industries. It is
also used as a
coloring agent for
ceramics and as a
drying agent in
inks, paints,
varnishes and
linoleum, and has
been added to
animal feed as a
mineral supplement.
Diazoaminobenzene........... Used as an Listed as reasonably
intermediate in the anticipated to be a
production of dyes human carcinogen. and to promote
adhesion of natural
rubber to steel.
Diethanolamine.............. Used in the Not listed. preparation of
surfactants used in
liquid laundry,
dishwashing
detergents,
cosmetics,
shampoos, and hair
conditioners; as a
surfaceactive
agent and corrosion
inhibitor in
metalworking
fluids; and as a
dispersant in
agricultural
chemical
formulations.
Hepatitis B Virus........... A small DNA Listed as known to
enveloped virus be a human
that, along with carcinogen. Hepatitis C Virus,
causes most
parenterally
transmitted viral
hepatitis.
Hepatitis C Virus........... An RNAenveloped Listed as known to
virus that, along be a human
with Hepatitis B carcinogen. Virus, causes most
parenterally
transmitted viral
hepatitis.
Selected Heterocyclic Amines Heterocyclic amines Listed as reasonably
(three): that are formed anticipated to be
during grilling or human carcinogens. cooking at high
temperature and are
found in cooked
meat and fish.
(1) 2Amino3,4
dimethylimidazo[4,5
f]quinoline (MeIQ)
(2) 2Amino3,8
dimethylimidazo[4,5
f]quinoxaline (MeIQx)
(3) 2Amino1methyl6
phenylimidazo[4,5
b]pyridine (PhIP)
Human Papillomaviruses, Some Small, nonenveloped Listed as known to
GenitalMucosal Types. viruses that infect be human
genital skin, and carcinogens. genital and non
genital mucosa. HPV
infections are
common throughout
the world.
Lead and Lead Compounds..... Major use is in Listed as reasonably
making leadacid anticipated to be
storage batteries. human carcinogens. Other common uses
include ammunition
and cable covering.
Lead compounds are
used in paint,
glass, ceramics,
fuel additives, and
some traditional
cosmetics.
Naphthalene................. Used as an Listed as reasonably
intermediate in the anticipated to be a
synthesis of many human carcinogen. industrial
chemicals, and has
been used as an
ingredient in some
moth repellants and
toilet bowl
deodorants.
Neutrons.................... Exposures normally Listed as known to
occur from a mixed be human
irradiation field carcinogens. in which neutrons
are a minor
component. The
exceptions are
exposure of
patients to neutron
radiotherapy beams
and exposures of
aircraft passengers
and crew.
Nitrobenzene................ Used mainly in the Listed as reasonably
production of anticipated to be a
aniline, itself a human carcinogen. major chemical
intermediate in the
production of dyes.
Nitromethane................ Used in specialized Listed as reasonably
fuels, in anticipated to be a
explosives, and in human carcinogen. the synthesis of
nitromethane
derivatives,
pharmaceuticals,
agricultural soil
fumigants, and
industrial
antimicrobials.
4,4'Thiodianiline.......... Used as an Listed as reasonably
intermediate of anticipated to be a
several diazo dyes. human carcinogen.
XRadiation and Gamma Exposure to these Listed as known to
([gamma])Radiation. forms of ionizing be human
radiation comes carcinogens. from a variety of
natural
(environmental
exposure) and
anthropogenic
sources, including
exposure for
military, medical,
and occupational
purposes.
[[Page 6723]]
[FR Doc. 052393 Filed 2705; 8:45 am]
BILLING CODE 414001U