9 February 2005 Source: http://www.access.gpo.gov/su_docs/aces/fr-cont.html ----------------------------------------------------------------------- [Federal Register: February 8, 2005 (Volume 70, Number 25)] [Notices] [Page 6721-6723] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr08fe05-123] ----------------------------------------------------------------------- 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: 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 . 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 ------------------------------------------------------------------------ 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. ------------------------------------------------------------------------ [[Page 6723]] [FR Doc. 05-2393 Filed 2-7-05; 8:45 am] BILLING CODE 4140-01-U