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

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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: 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 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: 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, MD-A3, P.O. Box 12233, Research Triangle Park, NC 27709; phone: (919) 541-0530, fax: (919) 541-0295, e-mail: wolfe@niehs.nih.gov.

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Dated: January 31, 2005.

Kenneth Olden,

Director, National Toxicology Program.

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Summary of Actions for Agents, Substances, Mixtures or Exposure Circumstances Reviewed for Listing in the Eleventh Edition of the Report on Carcinogens

NominationsPrimary uses or exposuresAction
1-Amino-2,4-dibromoanthraquinoneAn anthraquinone-derived vat dye that is used in the textile industryListed as reasonably anticipated to be a human carcinogen.
Cobalt SulfateUsed in electroplating and electrochemical 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 supplementListed as reasonably anticipated to be a human carcinogen.
DiazoaminobenzeneUsed as an intermediate in the production of dyes and to promote adhesion of natural rubber to steelListed as reasonably anticipated to be a human carcinogen.
DiethanolamineUsed in the 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 formulationsNot listed.
Hepatitis B VirusA small DNA-enveloped virus that, along with Hepatitis C Virus, causes most parenterally transmitted viral hepatitisListed as known to be a human carcinogen.
Hepatitis C VirusAn RNA-enveloped virus that, along with Hepatitis B Virus, causes most parenterally transmitted viral hepatitisListed as known to be a human carcinogen.
Selected Heterocyclic Amines (three):Heterocyclic amines that are formed during grilling or cooking at high temperature and are found in cooked meat and fishListed as reasonably anticipated to be human carcinogens.
(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 Genital-Mucosal TypesSmall, non-enveloped viruses that infect genital skin, and genital and non-genital mucosa. HPV infections are common throughout the worldListed as known to be human carcinogens.
Lead and Lead CompoundsMajor use is in making lead-acid storage batteries. Other common uses include ammunition and cable covering. Lead compounds are used in paint, glass, ceramics, fuel additives, and some traditional cosmeticsListed as reasonably anticipated to be human carcinogens.
NaphthaleneUsed as an intermediate in the synthesis of many industrial chemicals, and has been used as an ingredient in some moth repellants and toilet bowl deodorantsListed as reasonably anticipated to be a human carcinogen.
NeutronsExposures normally occur from a mixed 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 crewListed as known to be human carcinogens.
NitrobenzeneUsed mainly in the production of aniline, itself a major chemical intermediate in the production of dyesListed as reasonably anticipated to be a human carcinogen.
NitromethaneUsed in specialized fuels, in explosives, and in the synthesis of nitromethane derivatives, pharmaceuticals, agricultural soil fumigants, and industrial antimicrobialsListed as reasonably anticipated to be a human carcinogen.
4,4'-ThiodianilineUsed as an intermediate of several diazo dyesListed as reasonably anticipated to be a human carcinogen.
X-Radiation and Gamma (γ)-RadiationExposure to these forms of ionizing radiation comes from a variety of natural (environmental exposure) and anthropogenic sources, including exposure for military, medical, and occupational purposesListed as known to be human carcinogens.
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[FR Doc. 05-2393 Filed 2-7-05; 8:45 am]

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