National Toxicology Program

[Federal Register: July 11, 1997 (Volume 62, Number 133)]
[Notices]
[Page 37272-37273]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service

National Toxicology Program; Call for Public Comments; Substances, Mixtures and Exposure Circumstances Proposed for Listing in or Delisting (Removing) From the Report on Carcinogens, Ninth Edition

Background

The National Toxicology Program (NTP) announces its intent to review additional substances, mixtures and exposure circumstances for possible listing in or delisting (removing) from the Report on Carcinogens, Ninth Edition. This Report (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 (HHS). Section 301(b)(4) of the Public Health Service Act, as amended, provides that the Secretary, (HHS), shall publish a 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 review of the substances, mixtures or exposure circumstances for listing in or delisting from the Ninth Report will involve a multiphased, peer review process involving two Federal scientific review groups and one non-government, scientific peer review body (a subcommittee of the NTP Board of Scientific Counselors) which will meet in an open, public meeting that will provide for public comments. All available data relevant to the criteria for inclusion or removal of candidate agents, substances, mixtures or exposure circumstances in the Report will be evaluated by the three scientific review committees. The criteria to be used in the review process and the detailed description of the review procedures, including the steps in the formal review process, can be obtained by contacting: Dr. C. W. Jameson, National Toxicology Program, Report on Carcinogens, MD WC-05, P.O. Box 12233, Research Triangle Park, NC 27709; phone: (919) 541-4096, fax: (919) 541-2242, email: jameson@niehs.nih.gov.

Public Comment Requested

The NTP will be considering 14 substances, mixtures and exposure circumstances in 1997, for either listing or delisting (removing) from, or changing the current listing from reasonably anticipated to be a human carcinogen to the known human carcinogen category in the Ninth Report. These substances, mixtures or exposure circumstances are provided in the following table with their Chemical Abstracts Services (CAS) Registry numbers (where available) and pending review action. The NTP solicits public input on these 14 substances, mixtures and exposure circumstances and asks for relevant information anyone may have on carcinogenesis from completed, ongoing, or planned studies by others, as well as current production data, use patterns, and human exposure information for any of the substances, mixtures or exposure circumstances listed in this announcement. Comments concerning the review of these substances, mixtures or exposure circumstances for listing in or delisting from the Ninth Report will be accepted for a period of 45 days from the date of the publication of this announcement in the Federal Register. Comments or questions should be directed to Dr. C. W. Jameson at the address listed above.

Public Nominations for Delisting or Listing Encouraged

The NTP solicits and encourages the broadest participation from interested individuals or parties in nominating agents, substances, or mixtures for listing in or delisting from the ninth and future Reports on Carcinogens. Petitions should contain a rationale for listing or delisting. Appropriate background information and relevant data (e.g. Journal articles, NTP Technical Reports, IARC listings, exposure surveys, release inventories, etc.) which support a petition should be provided or referenced when possible.

A detailed description of listing/delisting procedures, including the steps in the formal review process, can be obtained by contacting Dr. Jameson at the address listed above.

Kenneth Olden,
Director, National Toxicology Program

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Summary for
Substances, Mixtures or Exposure Circumstances
Nominated for Consideration of Listing in or Delisting from
the Ninth Report on Carcinogens

SUBSTANCE OR EXPOSURE CIRCUMSTANCE/ CAS NUMBER	PRIMARY USES OR EXPOSURES	TO BE REVIEWED FOR
BENZIDINE-BASED DYES AS A CLASS	Benzidine-based dyes are used primarily for dyeing textiles, paper and leather products. More than 250 benzidine-based dyes have been reported by the Society of Dyers and Colorists.	Listing in the 9th Report
1,3-BUTADIENE/ 106-99-0	Used primarily as a chemical intermediate and polymer component in the manufacture of synthetic rubber	Change current listing to the Known to be a Human Carcinogen category
CADMIUM and CADMIUM COMPOUNDS/ 7440-43-9	Used in batteries, coating and plating, plastic and synthetic products and in alloys.	Change current listing to the Known to be a Human Carcinogen category
CHLOROPRENE/ 126-99-8	Used as a monomer for neoprene elastomers, industrial rubber products, and as a component of adhesives in food packaging.	Listing in the 9th Report
PHENOLPHTHALEIN/ 77-09-8	Used as a laboratory reagent and acid-base indicator and as a cathartic drug in over-the-counter laxative preparations.	Listing in the 9th Report
SACCHARIN/ 218-44-9	Used primarily as a nonnutritive sweetening agent.	Delisting from the Report on Carcinogens
SMOKELESS TOBACCO	Oral use of smokeless tobacco products.	Listing in the 9th Report
SULFURIC ACID MIST/ 7664-93-9	Sulfuric acid is the one of the most widely used of all industrial chemicals. Used in the manufacture of fertilizers, rayon and other fibers, pigments and colors, explosives, plastics, coal-tar products such as dyes and drugs, storage batteries, synthetic detergents, natural and synthetic rubber, pulp and paper, cellophane and catalysts. It is also used in petroleum refining, pickling iron, steel and other metals and in ore concentration.	Listing in the 9th Report
TAMOXIFEN/ 10540-29-1	Used as an anti-estrogen drug and in the palliative treatment of breast cancer.	Listing in the 9th Report
2,3,7,8- TETRACHLORODIBENZO-P-DIOXIN (TCDD)/ 1746-01-6	Not used commercially, used only as a research chemical.	Change current listing to the Known to be a Human Carcinogen category
TETRAFLUOROETHYLENE/ 116-14-3	Used in the production of polytetrafluoroethylene (Teflon) and other polymers. Has also been used as a propellant for food product aerosols.	Listing in the 9th Report
TOBACCO SMOKE	Inhalation of tobacco smoke	Listing in the 9th Report
TRICHLOROETHYLENE/ 79-01-6	Used as an industrial solvent for vapor degreasing and cold cleaning of fabricated metal parts. Has also been used as a carrier solvent for the active ingredients of insecticides and fungicides, as a solvent for waxes, fats, resins, and oils, as an anesthetic for medical and dental use, and as an extractant for spice oleoresins and for caffeine from coffee.	Listing in the 9th Report
UV RADIATION	Solar and artificial sources of ultraviolet radiation	Listing in the 9th Report

[FR Doc. 97-18141 Filed 7-10-97; 8:45 am]
BILLING CODE 4140-01-P