```

[Federal Register Volume 66, Number 104 (Wednesday, May 30, 2001)]
[Notices]
[Pages 29340-29342]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-13485]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service

National Toxicology Program (NTP); Availability of the Report on 
Carcinogens, Ninth Edition

Background

    The National Toxicology Program (NTP) announces the availability of 
the Report on Carcinogens, Ninth Edition.
    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 and its 
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 (US) 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 Report on Carcinogens, Ninth Edition was 
submitted to Congress on May 15, 2000.
    The new entries for the Report on Carcinogens, Ninth Edition have 
undergone a multiphased peer review. This review included two Federal 
and one non-government, scientific peer reviews and public comment and 
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 Home Page 
web site at http://ntp-server.niehs.nih.gov/ or by contacting: Dr. C. 
W. Jameson, National Toxicology Program, Report on Carcinogens, at the 
address listed below.
    The Report on Carcinogens, Ninth Edition, which was publicly 
released on May 15, 2000, contains 218 entries, 14 of which have not 
appeared in earlier Reports. This Report also reclassifies 1,3-
butadiene, cadmium and cadmium compounds, Direct Black 38, Direct Blue 
6, ethylene oxide, and silica (crystalline, respirable size) from 
reasonably anticipated to be a human carcinogen to known to be a human 
carcinogen, with corresponding revisions of the earlier entries for 
these chemicals. Two substances, saccharin and ethyl acrylate, have 
been removed from the Report on Carcinogens, Ninth Edition as a result 
of formal reviews for delisting. In addition, the NTP published an 
addendum to its Report on Carcinogens, Ninth Edition on January 19, 
2001. This addendum changes the listing of 2,3,7,8-tetrachlorodibenzo-
p-dioxin CAS No. 1746-01-6, also known as ``TCDD'' or ``Dioxin'', to a 
known to be human carcinogen, from its earlier listing as reasonably 
anticipated to be a human carcinogen. Publication of this addendum 
followed the ruling by the US Court of Appeals for the District of 
Columbia to dismiss a request for an injunction to prevent the listing 
of TCDD as a known to be human carcinogen in the Report on Carcinogens, 
Ninth Edition. The proposal to list TCDD as a known human carcinogen 
was reviewed in the same way and at the same time as the other new 
listings for the Report on Carcinogens, Ninth Edition.
    The Report on Carcinogens 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.
    Hard copies of the Report on Carcinogens, Ninth Edition can be 
obtained by contacting the NIEHS Environmental Health Information 
Service, ATTN: Order Processing, PO Box 12510, Research Triangle Park, 
NC 27709-2510, fax number (919) 541-0763, email: [email protected]. 
The Report on Carcinogens, Ninth Edition is also available on the 
internet and can be accessed from the NIEHS Environmental Health 
Information Service Home Page

[[Page 29341]]

at: http://ehis.niehs.nih.gov/ or from the NTP Home Page at: http://ntp-server.niehs.nih.gov/.
    Questions or comments concerning the Report on Carcinogens, Ninth 
Edition should be directed to: Dr. C. W. Jameson, National Toxicology 
Program, Report on Carcinogens, MD EC-14, P.O. Box 12233, Research 
Triangle Park, NC 27709; phone: (919) 541-4096, fax: (919) 541-0144, 
email: [email protected].

    Dated: April 17, 2001.
Kenneth Olden,
Director, National Toxicology Program.

  Summary for Agents, Substances or Mixtures Newly Listed, Upgraded or
          Delisted in the Report on Carcinogens, Ninth Edition
------------------------------------------------------------------------
                                    Primary uses or
   Agent, substance or mixture         exposures            Action
------------------------------------------------------------------------
Alcoholic Beverage Consumption..  Consumption of      Listed as a known
                                   alcoholic           to be human
                                   beverages.          carcinogen.
1,3-Butadiene/CAS# 106-99-0.....  Used primarily in   Listing upgraded
                                   the manufacture     to a known to be
                                   of synthetic        human carcinogen.
                                   rubber.
Cadmium and Cadmium Compounds/    Used in batteries,  Listing upgraded
 CAS# 7440-43-9.                   coating and         to a known to be
                                   plating, plastics   human carcinogen.
                                   and in alloys.
Chloroprene/CAS# 126-99-8.......  Used as a monomer   Listed as a
                                   for industrial      reasonably
                                   rubber products,    anticipated to be
                                   and as a            human carcinogen.
                                   component of
                                   adhesives in food
                                   packaging.
Diesel Exhaust Particulates.....  Diesel engine       Listed as a
                                   exhaust.            reasonably
                                                       anticipated to be
                                                       human carcinogen.
Dyes Metabolized To Benzidine     Benzidine-based     Listed as known to
 (Benzidine Dyes As A Class).      dyes are used       be human
                                   primarily for       carcinogens. This
                                   dyeing textiles,    action also
                                   paper and leather   resulted in the
                                   products.           upgrading of the
                                                       listing of Direct
                                                       Black 38, Direct
                                                       Blue 6 to known
                                                       to be human
                                                       carcinogens.
Environmental Tobacco Smoke.....  ``Passive''         Listed as a known
                                   inhalation of       to be human
                                   tobacco smoke       carcinogen.
                                   from
                                   environmental
                                   sources.
Ethyl Acrylate/CAS# 140-88-5....  Monomer used to     Removed (delisted)
                                   produce polymers    from the RoC.
                                   for use in latex
                                   paints, textiles,
                                   etc.
Ethylene Oxide/CAS# 75-21-8.....  Industrial          Listing upgraded
                                   chemical used as    to a known to be
                                   a synthetic         human carcinogen.
                                   intermediate and
                                   also widely used
                                   in the health
                                   care industry as
                                   a sterilant.
Isoprene/CAS# 78-79-5...........  Widely used in the  Listed as a
                                   production of       reasonably
                                   isoprene-           anticipated to be
                                   butadiene           human carcinogen.
                                   copolymers..
Phenolphthalein/CAS# 77-09-8....  Used as a           Listed as
                                   laboratory          reasonably
                                   reagent and in      anticipated to be
                                   over-the-counter    a human
                                   laxative            carcinogen.
                                   preparations.
Saccharin/CAS# 218-44-9.........  Used primarily as   Removed (delisted)
                                   a nonnutritive      from the RoC.
                                   sweetening agent.
Silica, Crystalline (Respirable   Exposure from       Listing upgraded
 Size)/CAS# 7631-86-9.             mining of coal      to a known to be
                                   and other           human carcinogen.
                                   minerals, stone
                                   cutting,
                                   production of
                                   glass and
                                   ceramics and in
                                   occupations such
                                   as sandblasting,
                                   polishing and
                                   grinding.
Smokeless Tobacco...............  Oral use of         Listed as a known
                                   smokeless tobacco   to be human
                                   products.           carcinogen.
Strong Inorganic Acid Mists       Present in a wide   Listed as a known
 Containing Sulfuric Acid.         variety of          to be human
                                   industries,         carcinogen.
                                   especially the
                                   finishing of
                                   metal and
                                   fertilizer
                                   production.
Tamoxifen/CAS# 10540-29-1.......  Used as an anti-    Listed as a known
                                   estrogen drug and   to be human
                                   in the palliative   carcinogen.
                                   treatment of
                                   breast cancer.
2,3,7,8-Tetrachlorodibenzo-p-     Found as a          Listing upgraded
 Dioxin (TCDD)/CAS# 1746-01-6.     contaminant in      to a known to be
                                   the production of   human carcinogen.
                                   some pesticides
                                   and other
                                   commercial
                                   products.
Tetrafluoroethylene/CAS# 116-14-  Used in the         Listed as a
 3.                                production of       reasonably
                                   polytetrafluoroet   anticipated to be
                                   hylene.             human carcinogen.
Tobacco Smoking.................  Inhalation of       Listed as a known
                                   tobacco smoke.      to be human
                                                       carcinogen.
Trichloroethylene/CAS# 79-01-6..  Used mainly as an   Listed as a
                                   industrial          reasonably
                                   solvent for vapor   anticipated human
                                   degreasing and      carcinogen.
                                   cold cleaning of
                                   fabricated metal
                                   parts.
Solar UV Radiation And Exposure   Solar and           Listed as known to
 To Sunlamps And Sunbeds.          artificial          be human
                                   sources of          carcinogens.
                                   ultraviolet
                                   radiation.
------------------------------------------------------------------------

[[Page 29342]]

[FR Doc. 01-13485 Filed 5-29-01; 8:45 am]
BILLING CODE 4140-01-P
```