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 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: [email protected].

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.

Attachment:

Kenneth Olden,

Director, National Toxicology Program.

Summary for Substances, Mixtures or Exposure Circumstances

Nominated for Consideration of Listing in or Delisting From the

Ninth Report on Carcinogens

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Substance or exposure circumstance/CAS

No. Primary uses or exposures To be reviewed for

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BENZIDINE-BASED DYES AS A CLASS......... Benzidine-based dyes are used primarily Listing in the 9th Report.

for dyeing textiles, paper and leather

products. More than 250 benzidine-based

dyes have been reported by the Society of

Dyers and Colorists.

1,3-BUTADIENE/106-99-0.................. Used primarily as a chemical intermediate Change current listing to

and polymer component in the manufacture the Known to be a Human

of synthetic rubber. Carcinogen category.

CADMIUM and CADMIUM COMPOUNDS/7440-43-9. Used in batteries, coating and plating, Change current listing to

plastic and synthetic products and in the Known to be a Human

alloys. Carcinogen category.

CHLOROPRENE/126-99-8.................... Used as a monomer for neoprene elastomers, Listing in the 9th Report.

industrial rubber products, and as a

component of adhesives in food packaging.

[[Page 37273]]

PHENOLPHTHALEIN/77-09-8................. Used as a laboratory reagent and acid-base Listing in the 9th Report.

indicator and as a cathartic drug in over-

the-counter laxative preparations.

SACCHARIN/218-44-9...................... Used primarily as a nonnutritive Delisting from the Report

sweetening agent. 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 Listing in the 9th Report.

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.

TAMOXIFEN/10540-29-1.................... Used as an anti-estrogen drug and in the

palliative treatment of.

2,3,7,8-TETRACHLORODIBENZO-............ breast cancer............................. Listing in the 9th Report.

P-DIOXIN (TCDD)/1746-01-6............... Not used commercially, used only as a Change current listing to

research chemical. the Known to be a Human

Carcinogen category.

TETRAFLUOROETHYLENE/116-14-3............ Used in the production of Listing in the 9th Report.

polytetrafluoroethylene (Teflon) and

other polymers. Has also been used as a

propellant for food product aerosols.

TOBACCO SMOKE........................... Inhalation of tobacco smoke............... Listing in the 9th Report.

TRICHLOROETHYLENE/79-01-6............... Used as an industrial solvent for vapor Listing in the 9th Report.

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.

UV RADIATION............................ Solar and artificial sources of Listing in the 9th Report.

ultraviolet radiation.

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[FR Doc. 97-18141 Filed 7-10-97; 8:45 am]

BILLING CODE 4140-01-P