[Federal Register Volume 67, Number 242 (Tuesday, December 17, 2002)]
[Notices]
[Pages 77283-77285]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-31629]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service


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

    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

[[Page 77284]]

Web 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: [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 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-17[beta], 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: [email protected].
    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: 
[email protected].

    Dated: December 9, 2002.
Kenneth Olden,
Director, National Toxicology Program.

Summary for Agents, Substances, Mixtures or Exposure Circumstances Being Added to or Changing the Listing in the
                                   Tenth Edition of the Report on Carcinogens
----------------------------------------------------------------------------------------------------------------
              Nominations                       Primary uses or exposures                     Action
----------------------------------------------------------------------------------------------------------------
2-Amino-3-methylimidazo[4,5-f]           One of a series of heterocyclic amines   Listed as reasonably
 quinoline (IQ)/CAS 76180-96-6.  that is formed in food during heating    anticipated to be a human
                                          or cooking and is found in cooked        carcinogen.
                                          meats and eggs. It is also found in
                                          cigarette smoke.
Beryllium and Beryllium Compounds......  Used in fiber optics and cellular        Listing changed to known to be
                                          network communications systems,          human carcinogens.
                                          aerospace, defense and other industry
                                          applications.
2,2-bis-(Bromomethyl)-1,3-propanediol    Used as a flame retardant in             Listed as reasonably
 (Technical Grade)/CAS 3296-90-  unsaturated polyester resins, for        anticipated to be a human
 9.                                       molded products, and in the production   carcinogen.
                                          of rigid polyurethane foam.
Broad Spectrum UV Radiation and UVA      Solar and artificial sources of          Broad Spectrum UV Radiation
 Radiation, UVB Radiation and UVC         ultraviolet radiation.                   listed as known to be a human
 Radiation.                                                                        carcinogen,
                                                                                  UVA Radiation, UVB Radiation
                                                                                   and UVC Radiation each listed
                                                                                   as reasonably anticipated to
                                                                                   be a human carcinogen.
Chloramphenicol/CAS 56-75-7...  Used as an antibiotic since the 1950s    Listed as reasonably
                                          but currently has restricted use in      anticipated to be a human
                                          the United States because it causes      carcinogen.
                                          blood dyscrasia.

[[Page 77285]]

 
2,3-Dibromo-1-Propanol/CAS 96-  Used as an intermediate in the           Listed as reasonably
 13-9.                                    preparation of flame retardants and as   anticipated to be a human
                                          an intermediate in the manufacture of    carcinogen.
                                          pesticides and pharmaceuticals.
Dyes Metabolized to Dimethoxybenzidine.  Dyes used in leather, paper, plastics,   Listed as reasonably
                                          rubber, and textile industries.          anticipated to be human
                                                                                   carcinogens.
Dyes Metabolized to Dimethylbenzidine..  Dyes used in printing textiles, as       Listed as reasonably
                                          biological stains, and in color          anticipated to be human
                                          photography.                             carcinogens.
Estrogens, Steroidal...................  Comprise a group of structurally         Listed as known to be human
                                          related hormones that control sex and    carcinogens.
                                          growth characteristics and are
                                          commonly used in hormone replacement
                                          therapy (HRT) to treat symptoms of
                                          menopause and in oral contraceptives.
Methyleugenol/CAS 93-15-2.....  Occurs naturally in oils, herbs and      Listed as reasonably
                                          spices and is used in its natural or     anticipated to be a human
                                          synthetic forms as a flavoring agent,    carcinogen
                                          insect attractant, anesthetic and in
                                          sunscreens.
Nickel and Nickel Compounds............  Used in many industrial and commercial   Metallic Nickel listed as
                                          applications including alloys,           reasonably anticipated to be
                                          catalysts, batteries, pigments, and      a human carcinogen,
                                          ceramics.                               Nickel Compounds listed as
                                                                                   known to be human
                                                                                   carcinogens,
                                                                                  Nickel alloys not listed.
Styrene7,8-oxide/CAS 96-09-3..  Used mainly as an intermediate in the    Listed as reasonably
                                          production of styrene glycol and its     anticipated to be a human
                                          derivatives, in the production of        carcinogen.
                                          reinforced plastics, and as a chemical
                                          intermediate for cosmetics, surface
                                          coatings, agricultural and biological
                                          chemicals.
Trichloroethylene/CAS 79-01-6.  Used as an industrial solvent for vapor  Remains listed as reasonably
                                          degreasing and cold cleaning of          anticipated to be a human
                                          fabricated metal parts.                  carcinogen.
Vinyl Bromide/CAS 593-60-2....  Used predominantly in polymers in the    Listed as reasonably
                                          production of fabrics and fabric         anticipated to be a human
                                          blends used in sleepwear (mostly         carcinogen.
                                          children's) and home furnishings, as
                                          well as in leather, fabricated metal
                                          products and in the production of
                                          pharmaceuticals and fumigants.
Vinyl Fluoride/CAS 75-02-5....  Used mainly in the production of         Listed as reasonably
                                          polyvinyl fluoride and other             anticipated to be a human
                                          fluoropolymers that are widely used      carcinogen.
                                          because they are resistant to weather
                                          and have great strength, chemical
                                          inertness, and low permeability to air
                                          and water.
Wood Dust..............................  Created when machines or tools are used  Listed as a known to be a
                                          to cut or shape wood. High amounts of    human carcinogen.
                                          wood dust are produced in sawmills,
                                          dimension mills, furniture making
                                          industries, cabinetmaking, and
                                          carpentry.
----------------------------------------------------------------------------------------------------------------

[FR Doc. 02-31629 Filed 12-16-02; 8:45 am]
BILLING CODE 4140-01-P