National Toxicology Program; Call for Public Comments; Chemicals Proposed for the Eighth Biennial Report on Carcinogens

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service

National Toxicology Program; Call for Public Comments; Chemicals

Proposed for the Eighth Biennial Report on Carcinogens

Background

The National Toxicology Program (NTP) announces its intent to list

additional substances in the Eighth Biennial Report on Carcinogens

(BRC). This Report 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 new entries for the Eighth BRC have undergone 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 met in an open, public

meeting that included a public comment session. All data relevant to

the criteria for inclusion of candidate agents, substances or mixtures

in the BRC have been evaluated by the three scientific review

committees.

In the Eighth BRC, the NTP is adding 14 agents, substances or

mixtures to the existing list, one of which is listed as a known human

carcinogen. The 13 remaining agents, substances or mixtures are being

added as reasonably anticipated to be human carcinogens. In addition,

thiotepa, which is currently listed in previous Reports on Carcinogens

as reasonably anticipated to be a human carcinogen is moved to the

known human carcinogen list. These agents, substances or mixtures are

provided in the following table with their Chemical Abstracts Services

(CAS) Registry numbers and listing. The Eighth BRC also contains an

appendix which is a reference to certain ``Manufacturing Processes,

Occupations and Exposure Circumstances'' that have not yet been

formally reviewed by the NTP for BRC listing but have been classified

by IARC as sources which are known to be carcinogenic to humans because

of the associated increased incidences of cancer in workers in these

settings. While not formally listed in the 8th BRC, in the interest of

public health and for completeness, these occupational exposures have

been referenced in an appendix to the Report with the corresponding

IARC citation given.

Comments concerning the addition of these substances in the Eighth

BRC will be accepted for a period of 30 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, National Toxicology

Program, Biennial Report on Carcinogens, MD WC-05, P.O. Box 12233,

Research Triangle Park, NC 27709, fax number: (919)-541-2242, email:

J[email protected].

Attachment.

Dated: April 18, 1997.

Kenneth Olden,

Director, National Institute of Environmental Health Sciences.

Summary for Agents, Substances or Mixtures to be Listed in the Eighth

Biennial Report on Carcinogens

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Chemical/CAS number Primary uses To be listed as

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AZACITIDINE/320-67-2.......... Used as a cytostatic Reasonably

agent in the Anticipated to

treatment of acute be a Human

leukemia Carcinogen.

p-CHLORO-o-TOLUIDINE and its Used to produce azo Reasonably

HCl salt/95-69-2. dyes for cotton, silk Anticipated to

acetate and nylon and be a Human

as intermediate in Carcinogen.

production of Pigment

Red 7 and Pigment

Yellow 49. Also an

impurity in and a

metabolite of the

pesticide

chlordimeform

CHLOROZOTOCIN/54749-90-5...... Used as a cytostatic Reasonably

agent in the Anticipated to

treatment of cancers be a Human

of the stomach, large Carcinogen.

intestine pancreas

and lung; melanoma;

and multiple myeloma

CYCLOSPORIN/59865-13-3........ Used as an Known to be a

immunosuppressive Human

agent in the Carcinogen.

prevention and

treatment of graft-vs-

host reactions in

bone marrow

transplantation and

for the prevention of

rejection of kidney,

heart, and liver

transplants

DANTHRON/(1,8- Used as a laxative and Reasonably

Dihydroxyanthraquinone) 117- as an intermediate in Anticipated to

10-2. the manufacture of be a Human

dyes Carcinogen.

1,6-DINITROPYRENE/42397-64-8.. Not used commercially, Reasonably

detected in ambient Anticipated to

atmospheric samples be a Human

and as a constituent Carcinogen.

of diesel exhaust

1,8-DINITROPYRENE/42397-65-9.. Not used commercially, Reasonably

detected in ambient Anticipated to

atmospheric samples be a Human

and as a constituent Carcinogen.

of diesel exhaust

DISPERSE BLUE 1/(1,4,5,8- Used as an Reasonably

Tetraaminoanthraquinone) 2475- anthraquinone based Anticipated to

45-8. dyestuff in hair be a Human

color formulations Carcinogen.

and in coloring

fabrics and plastics

FURAN/100-00-9................ Used as an Reasonably

intermediate in the Anticipated to

synthesis and be a Human

production of other Carcinogen.

organic compounds

o-NITROANISOLE/91-23-6........ Used as a precursor in Reasonably

the synthesis of o- Anticipated to

anisidine which is be a Human

used in the Carcinogen.

manufacture of over

100 azo dyes

6-NITROCHRYSENE/7495-02-8..... Not used commercially, Reasonably

detected in ambient Anticipated to

atmospheric samples be a Human

Carcinogen.

1-NITROPYRENE/5522-43-0....... Not used commercially, Reasonably

detected in ambient Anticipated to

atmospheric samples be a Human

and as a constituent Carcinogen.

of diesel and

gasoline engine

exhaust

4-NITROPYRENE/57835-92-4...... Not used commercially, Reasonably

detected in ambient Anticipated to

atmospheric samples be a Human

Carcinogen.

[[Page 23470]]

THIOTEPA/52-24-4.............. Used as a cytostatic Known to be a

agent in the Human

treatment of Carcinogen.

lymphomas and a

variety of solid

tumors, such as

breast and ovary. It

has also been used at

high doses in

combination

chemotherapy with

cyclophosphamide in

patients with

refractory

malignancies treated

with autologous bone

transplantation

1,2,3-TRICHLOROPROPANE/96-18-4 Used as a polymer Reasonably

crosslinking agent, Anticipated to

paint and varnish be a Human

remover, solvent and Carcinogen.

degreasing agent..

It has been found as

an impurity in

certain nematicides

and soil fumigants

and has been detected

in drinking and

ground water in

various parts of the

United States

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[FR Doc. 97-11136 Filed 4-29-97; 8:45 am]

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