[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]
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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
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Primary uses or
Agent, substance or mixture exposures Action
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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.
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[FR Doc. 01-13485 Filed 5-29-01; 8:45 am]
BILLING CODE 4140-01-P