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

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

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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 be 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 on 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) 541-5096, fax: (919) 541-2242, email:

[email protected].

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: January 26, 1998.

Kenneth Olden,

Director, National Toxicology Program.

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

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Substance or exposure circumstance/

CAS Number Primary uses or exposures To be reviewed for

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Alcoholic Beverages................ Consumption of alcoholic beverages............. Listing in the 9th Report.

Boot and Shoe Manufacture and Workers in the boot and shoe manufacture and Listing in the 9th Report.

Repair. repair industry.

Diesel Particulates................ Diesel engine exhaust.......................... Listing in the 9th Report.

Environmental Tobacco Smoke........ ``Passive'' inhalation of tobacco smoke from Listing in the 9th Report.

environmental sources.

Ethyl Acrylate/140-88-5............ Monomer used to produce polymers and copolymers Delisting from the Report

for use in latex paints, textiles, etc. on Carcinogens.

Ethylene Oxide/75-2-8.............. Industrial chemical used as an intermediate in Change current listing to

the manufacture of other chemicals; e.g., the Known to be a Human

ethylene glycol and is widely used in the Carcinogen category.

health care industry as a sterilant.

Isoprene/78-79-5................... The monomeric unit of natural rubber and Listing in the 9th Report.

naturally occurring terpenes and steroids and

widely used in the production of isoprene-

butadiene copolymers.

Methyl-t-Butyl Ether/1634-04-4..... Used as an additive in unleaded gasoline in Listing in the 9th Report.

amounts up to 11%.

Nickel and Nickel Compounds/7440-02- Many industrial and commercial applications.... Change current listing to

0. 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 Change current listing to

other minerals, stone cutting, production of the Known to be a Human

glass and ceramics and in occupations such as Carcinogen category.

sandblasting, polishing and grinding.

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[FR Doc. 98-2563 Filed 2-2-98; 8:45 am]

BILLING CODE 4140-01-M