[Federal Register Volume 70, Number 25 (Tuesday, February 8, 2005)]
[Notices]
[Pages 6721-6723]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-2393]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service


The National Toxicology Program (NTP) Announces the Availability 
of the Report on Carcinogens, Eleventh Edition

    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 free-of-charge 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), MD-EC-03, 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; 919-541-3419 (phone), 
919-541-3687 (fax), e-mail: [email protected].

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 non-government 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, Head--Report on Carcinogens, National 
Toxicology Program, National Institute of Environmental Health 
Sciences, MD EC-14, P.O. Box 12233, Research Triangle Park, NC 27709; 
phone: (919) 541-4096, fax: (919) 541-0144, e-mail: 
[email protected].
    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, MD-A3, 
P.O. Box 12233, Research Triangle Park, NC 27709; phone: (919) 541-
0530, fax: (919) 541-0295, e-mail: [email protected].

    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
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                                 Primary uses or
         Nominations                exposures              Action
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1-Amino-2,4-                  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
                               surface-active
                               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 RNA-enveloped      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) 2-Amino-3,4-
     dimethylimidazo[4,5-
     f]quinoline (MeIQ)
    (2) 2-Amino-3,8-
     dimethylimidazo[4,5-
     f]quinoxaline (MeIQx)
    (3) 2-Amino-1-methyl-6-
     phenylimidazo[4,5-
     b]pyridine (PhIP)
Human Papillomaviruses, Some  Small, non-enveloped  Listed as known to
 Genital-Mucosal 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 lead-acid      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.
X-Radiation 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.
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[FR Doc. 05-2393 Filed 2-7-05; 8:45 am]
BILLING CODE 4140-01-U