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

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: ehis@niehs.nih.gov. 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

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: jameson@niehs.nih.gov.

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

Agent, substance or mixture

Primary uses or exposures

Action

Alcoholic Beverage Consumption

Consumption of alcoholic beverages

Listed as a known to be human carcinogen.

1,3-Butadiene/CAS# 106-99-0

Used primarily in the manufacture of synthetic rubber

Listing upgraded to a known to be human carcinogen.

Cadmium and Cadmium Compounds/CAS# 7440-43-9

Used in batteries, coating and plating, plastics and in alloys

Listing upgraded to a known to be human carcinogen.

Chloroprene/CAS# 126-99-8

Used as a monomer for industrial rubber products, and as a component of adhesives in food packaging

Listed as a reasonably anticipated to be human carcinogen.

Diesel Exhaust Particulates

Diesel engine exhaust

Listed as a reasonably anticipated to be human carcinogen.

Dyes Metabolized To Benzidine (Benzidine Dyes As A Class)

Benzidine-based dyes are used primarily for dyeing textiles, paper and leather products

Listed as known to be human carcinogens. This action also resulted in the upgrading of the listing of Direct Black 38, Direct Blue 6 to known to be human carcinogens.

Environmental Tobacco Smoke

“Passive” inhalation of tobacco smoke from environmental sources

Listed as a known to be human carcinogen.

Ethyl Acrylate/CAS# 140-88-5

Monomer used to produce polymers for use in latex paints, textiles, etc

Removed (delisted) from the RoC.

Ethylene Oxide/CAS# 75-21-8

Industrial chemical used as a synthetic intermediate and also widely used in the health care industry as a sterilant

Listing upgraded to a known to be human carcinogen.

Isoprene/CAS# 78-79-5

Widely used in the production of isoprene-butadiene copolymers.

Listed as a reasonably anticipated to be human carcinogen.

Phenolphthalein/CAS# 77-09-8

Used as a laboratory reagent and in over-the-counter laxative preparations

Listed as reasonably anticipated to be a human carcinogen.

Saccharin/CAS# 218-44-9

Used primarily as a nonnutritive sweetening agent

Removed (delisted) from the RoC.

Silica, Crystalline (Respirable Size)/CAS# 7631-86-9

Exposure from mining of coal and other minerals, stone cutting, production of glass and ceramics and in occupations such as sandblasting, polishing and grinding

Listing upgraded to a known to be human carcinogen.

Smokeless Tobacco

Oral use of smokeless tobacco products

Listed as a known to be human carcinogen.

Strong Inorganic Acid Mists Containing Sulfuric Acid

Present in a wide variety of industries, especially the finishing of metal and fertilizer production

Listed as a known to be human carcinogen.

Tamoxifen/CAS# 10540-29-1

Used as an anti-estrogen drug and in the palliative treatment of breast cancer

Listed as a known to be human carcinogen.

2,3,7,8-Tetrachlorodibenzo-p-Dioxin (TCDD)/CAS# 1746-01-6

Found as a contaminant in the production of some pesticides and other commercial products

Listing upgraded to a known to be human carcinogen.

Tetrafluoroethylene/CAS# 116-14-3

Used in the production of polytetrafluoroethylene

Listed as a reasonably anticipated to be human carcinogen.

Tobacco Smoking

Inhalation of tobacco smoke

Listed as a known to be human carcinogen.

Trichloroethylene/CAS# 79-01-6

Used mainly as an industrial solvent for vapor degreasing and cold cleaning of fabricated metal parts

Listed as a reasonably anticipated human carcinogen.

Solar UV Radiation And Exposure To Sunlamps And Sunbeds

Solar and artificial sources of ultraviolet radiation

Listed as known to be human carcinogens.

[FR Doc. 01-13485 Filed 5-29-01; 8:45 am]

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