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Proposed Chemicals for 8th Biennial Report on Carcinogens - Call for Comments
[Federal Register: April 30, 1997 (Volume 62, Number 83)]
[Notices]
[Page 23469-23470]
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: Jameson@niehs.nih.gov.
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
------------------------------------------------------------------------
Chemical/CAS number Primary uses To be listed as
------------------------------------------------------------------------
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.
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]BILLING CODE 4140-01-M
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