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1998 Nominations - Report on Carcinogens

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[Federal Register February 3, 1998 (Volume 63, Number 22)]
[Notices]
[Page 5565 - 5567]


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 (DHHS). Section 301(b)(4) of the Public Health Service Act, as amended, provides that the Secretary, (DHHS), shall publish a report which contains a list of all substances (1) which either are known to be human carcinogen or may reasonably anticipated to be a human carcinogen, 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, changing the current listing from reasonably anticipated to be a human carcinogen to known to be a human carcinogen 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 EC-14, 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 11 substances, mixtures and exposure circumstances in 1998, for either listing in or delisting (removing) from, or changing the current listing from reasonably anticipated to be a human carcinogen to the known to be a 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 11 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 on Carcinogens 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.

Dated: 1/26/98

__________________________
Kenneth Olden, Ph.D.
Director,
National Toxicology Program

[Billing Code 4140-01-P]


Summary for
Agents, Substances, Mixtures or Exposure Circumstances
to be Reviewed in 1998, 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

Alcoholic Beverages

Consumption of alcoholic beverages

Listing in the 9th Report

Boot and Shoe
Manufacture and Repair

Workers in the boot and shoe manufacture and repair industry

Listing in the 9th Report

Diesel Particulates

Diesel engine exhaust

Listing in the 9th Report

Environmental
Tobacco Smoke

"Passive" inhalation of tobacco smoke from environmental sources

Listing in the 9th Report

Ethyl Acrylate/
140-88-5

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

Delisting from the Report on Carcinogens

Ethylene Oxide/
75-21-8

Industrial chemical used as an intermediate in the manufacture of other chemicals; e.g., ethylene glycol and is widely used in the health care industry as a sterilant.

Change current listing to the Known to be a Human Carcinogen category

Isoprene/
78-79-5

The monomeric unit of natural rubber and naturally occurring terpenes and steroids and widely used in the production of isoprene-butadiene copolymers.

Listing in the 9th Report

Methyl-t-Butyl Ether/
1634-04-4

Used as an additive in unleaded gasoline in amounts up to 11%.

Listing in the 9th Report

Nickel and Nickel Compounds /
7440-02-0

Many industrial and commercial applications.

Change current listing to the Known to be a Human Carcinogen category

Nickel Refining

Workers in the nickel refining industry

Listing in the 9th Report

Silica, Crystalline/
7631-86-9

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

Change current listing to the Known to be a Human Carcinogen category