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

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Information about this document as published in the Federal Register.

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The Report on Carcinogens, Tenth Edition was submitted to the Congress by the Secretary HHS and also released publicly on December 11, 2002. It is available on the Internet and can be accessed from the Environmental Health Perspectives web site at: http://www.ehponline.org or from the NTP Start Printed Page 77284Web site at: http://ntp-server.niehs.nih.gov. Hard copies of the Report on Carcinogens, Tenth Edition can also be obtained by contacting Environmental Health Perspectives, ATTN: Order Processing, 1001 Winstead Drive Suite 355, Cary, NC 27513; Telephone: 866-541-3841 or 919-653-2586; Fax (919) 678-8696; email: ehponline@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 National Toxicology Program 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, Tenth Edition

The RoC, Tenth Edition, contains 228 entries, 15 of which have not appeared in earlier RoCs. The Tenth Edition of the RoC also changes the listing of beryllium and beryllium compounds from reasonably anticipated to be human carcinogens to known to be human carcinogens, with corresponding revisions of the earlier profile for these chemicals. The Tenth Edition of the RoC lists estrogens, steroidal as known human carcinogens. This listing of steroidal estrogens supersedes the previous listing of individual estrogens in the RoC (including conjugated estrogens, estradiol-17β, estrone, ethinylestradiol, and mestranol) and applies to all chemicals of this steroid class. The profile for steroidal estrogens includes information on carcinogenicity, properties, use, production, exposure, and regulations for steroidal estrogens as a class, as well as some specific information for individual estrogens. The table below summarizes the actions taken for the substances or exposure circumstances reviewed for possible listing in or change in the listing in the RoC, Tenth Edition.

The new entries for the Report on Carcinogens, Tenth Edition, including those whose listing changed, underwent a multiphase peer review. This review included three scientific peer reviews, two consisting of scientists within the Federal government and the other consisting of an outside peer review by both government and non-government scientists. During the entire review period, there was extensive opportunity for public comment and stakeholder review. The three scientific review committees evaluated all available data relevant to the criteria for inclusion of candidate nominations in the 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://ntp-server.niehs.nih.gov/​ or by contacting: Dr. C. W. Jameson, Head—Report on Carcinogens, National Toxicology Program, MD EC-14, P.O. Box 12233, Research Triangle Park, NC 27709; phone: (919) 541-4096, fax: (919) 541-0144, email: jameson@niehs.nih.gov.

Questions or comments concerning the RoC, Tenth Edition should be directed to: Dr. Mary Wolfe, Office of Scientific Review and NTP Liaison, MDA3-01, 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: December 9, 2002.

Kenneth Olden,

Director, National Toxicology Program.

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Summary for Agents, Substances, Mixtures or Exposure Circumstances Being Added to or Changing the Listing in the Tenth Edition of the Report on Carcinogens

NominationsPrimary uses or exposuresAction
2-Amino-3-methylimidazo[4,5-f] quinoline (IQ)/CAS# 76180-96-6One of a series of heterocyclic amines that is formed in food during heating or cooking and is found in cooked meats and eggs. It is also found in cigarette smokeListed as reasonably anticipated to be a human carcinogen.
Beryllium and Beryllium CompoundsUsed in fiber optics and cellular network communications systems, aerospace, defense and other industry applicationsListing changed to known to be human carcinogens.
2,2-bis-(Bromomethyl)-1,3-propanediol (Technical Grade)/CAS# 3296-90-9Used as a flame retardant in unsaturated polyester resins, for molded products, and in the production of rigid polyurethane foamListed as reasonably anticipated to be a human carcinogen.
Broad Spectrum UV Radiation and UVA Radiation, UVB Radiation and UVC RadiationSolar and artificial sources of ultraviolet radiationBroad Spectrum UV Radiation listed as known to be a human carcinogen, UVA Radiation, UVB Radiation and UVC Radiation each listed as reasonably anticipated to be a human carcinogen.
Chloramphenicol/CAS# 56-75-7Used as an antibiotic since the 1950s but currently has restricted use in the United States because it causes blood dyscrasiaListed as reasonably anticipated to be a human carcinogen.
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2,3-Dibromo-1-Propanol/CAS# 96-13-9Used as an intermediate in the preparation of flame retardants and as an intermediate in the manufacture of pesticides and pharmaceuticalsListed as reasonably anticipated to be a human carcinogen.
Dyes Metabolized to DimethoxybenzidineDyes used in leather, paper, plastics, rubber, and textile industriesListed as reasonably anticipated to be human carcinogens.
Dyes Metabolized to DimethylbenzidineDyes used in printing textiles, as biological stains, and in color photographyListed as reasonably anticipated to be human carcinogens.
Estrogens, SteroidalComprise a group of structurally related hormones that control sex and growth characteristics and are commonly used in hormone replacement therapy (HRT) to treat symptoms of menopause and in oral contraceptivesListed as known to be human carcinogens.
Methyleugenol/CAS# 93-15-2Occurs naturally in oils, herbs and spices and is used in its natural or synthetic forms as a flavoring agent, insect attractant, anesthetic and in sunscreensListed as reasonably anticipated to be a human carcinogen
Nickel and Nickel CompoundsUsed in many industrial and commercial applications including alloys, catalysts, batteries, pigments, and ceramicsMetallic Nickel listed as reasonably anticipated to be a human carcinogen, Nickel Compounds listed as known to be human carcinogens, Nickel alloys not listed.
Styrene7,8-oxide/CAS# 96-09-3Used mainly as an intermediate in the production of styrene glycol and its derivatives, in the production of reinforced plastics, and as a chemical intermediate for cosmetics, surface coatings, agricultural and biological chemicalsListed as reasonably anticipated to be a human carcinogen.
Trichloroethylene/CAS# 79-01-6Used as an industrial solvent for vapor degreasing and cold cleaning of fabricated metal partsRemains listed as reasonably anticipated to be a human carcinogen.
Vinyl Bromide/CAS# 593-60-2Used predominantly in polymers in the production of fabrics and fabric blends used in sleepwear (mostly children's) and home furnishings, as well as in leather, fabricated metal products and in the production of pharmaceuticals and fumigantsListed as reasonably anticipated to be a human carcinogen.
Vinyl Fluoride/CAS# 75-02-5Used mainly in the production of polyvinyl fluoride and other fluoropolymers that are widely used because they are resistant to weather and have great strength, chemical inertness, and low permeability to air and waterListed as reasonably anticipated to be a human carcinogen.
Wood DustCreated when machines or tools are used to cut or shape wood. High amounts of wood dust are produced in sawmills, dimension mills, furniture making industries, cabinetmaking, and carpentryListed as a known to be a human carcinogen.
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[FR Doc. 02-31629 Filed 12-16-02; 8:45 am]

BILLING CODE 4140-01-P