[Federal Register Volume 61, Number 207 (Thursday, October 24, 1996)]
[Notices]
[Pages 55165-55166]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-27325]
[[Page 55165]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
National Toxicology Program; National Toxicology Program (NTP)
Board of Scientific Counselors' Meeting; Review of Substances for
Listing in the 8th Biennial Report on Carcinogens
Background
The Director, NTP, initiated a public review in 1994 of the process
for preparation of the Biennial Report on Carcinogens (BRC) to broaden
input to its preparation, broaden the scope of scientific review
associated with the Report, and provide review of the criteria used for
inclusion of substances in the BRC. As a result of an extensive public
as well as Federal interagency review, the criteria were revised with
the revised criteria recently approved by the Secretary, Department of
Health and Human Services, (Federal Register Vol. 61, No. 188, 50499-
50500). The major change in the BRC which will occur as a result of the
criteria revision will be to include consideration of all relevant
information, including mechanistic data, in the decision to list
substances in or delist substances from future volumes of the BRC. To
broaden the scope of scientific review, a new standing subcommittee of
the NTP Board of Scientific Counselors was established and held an
organizational and informational meeting on May 8, 1996. The Biennial
Report on Carcinogens (BRC) Subcommittee will meet once or twice a
year, in public session, to review nominations for listing and/or
delisting substances and to receive public comments. A November 18 and
19, 1996, meeting will be the first where review of nominations takes
place. Finally, to broaden input to preparation of the BRC, the NTP
will use a number of mechanisms to communicate to the public the
revised criteria and the process for listing and delisting substances
in the BRC, and to solicit nominations for listing or delisting.
Announcements will be published in the Federal Register and appropriate
publications such as the NIEHS journal, Environmental Health
Perspectives, and various trade publications and journals. Direct
mailings from the NTP Liaison Office will target persons and
organizations who have requested to be on a mailing list for NTP
information and specifically for information regarding the BRC. A list
of new petitions for listing or delisting, soliciting public comment,
will be disseminated through the same media.
November 18-19 Meeting
Pursuant to Public Law 92-463, notice is hereby given of the next
meeting of the NTP Board of Scientific Counselors' Biennial Report on
Carcinogens Subcommittee to be held in the Conference Center, Building
101, South Campus, National Institute of Environmental Health Sciences
(NIEHS), 111 Alexander Drive, Research Triangle Park, North Carolina.
The meeting will begin at 8:30 a.m. and is open to the public. The
agenda topic is the peer review of substances nominated for listing in
the 8th Biennial Report on Carcinogens. Also under review will be
revisions to the Introduction to the 8th BRC and changes to the
structure of the report. These include a.) the addition of a table of
substances considered, but rejected for inclusion in the BRC as known
or reasonably anticipated human carcinogens and b.) the addition of a
table of substances nominated but not yet reviewed for listing in a
subsequent Report. There will also be a review of the reference in the
draft 8th BRC Introduction to certain manufacturing processes and
occupations which the International Agency for Research on Cancer
(IARC) has determined are associated with increased incidences of
cancer in workers in these settings but which do not qualify for formal
review for BRC listing because no specific agent, substance or mixture
has been identified with the exposures involved. This will include a
discussion of the appropriateness of having this reference in the BRC
and, if so, should it remain in the Introduction or be listed
separately in an appendix in the Report.
Tentatively scheduled to be peer reviewed on November 18-19 are 15
substances, listed alphabetically, along with supporting information in
the attached table. The order of review is given in the far right
column of the table. Copies of the draft introduction for the 8th BRC,
or copies of a draft summary document which contains the background
data and information used to evaluate the nomination for listing a
substance may be obtained, as available, from: Dr. C. W. Jameson,
Biennial Report on Carcinogens, MD WC-05, P.O. Box 12233, Research
Triangle Park, NC 27709 (919/541-4096; FAX 919/541-2242).
Public Comment
Persons wanting to make a formal presentation concerning proposed
changes to the BRC or regarding a particular nominated substance must
notify the Executive Secretary, Dr. Larry G. Hart, by telephone, by
FAX, or by mail (see contact information below) no later than November
13, 1996. A written copy of comments is requested in advance of the
meeting so that copies can be distributed to all Subcommittee members
and staff and made available at the meeting. Written statements should
supplement and may expand upon the oral presentation. Oral
presentations must be limited to no more than five minutes. In lieu of
an oral presentation, written statements may be submitted. These should
be received by the Executive Secretary by November 13.
The program would welcome receiving carcinogenesis information from
completed, ongoing, or planned studies, as well as current production
data, human exposure information, and use patterns for any of the
substances listed in this announcement. Please contact Dr. C. W.
Jameson at the address given above.
Upon request the Executive Secretary, Dr. Larry G. Hart, P.O. Box
12233, Research Triangle Park, North Carolina 27709 (telephone 919/541-
3971; FAX 919/541-0295), will furnish an agenda and a roster of
Subcommittee members prior to the meeting. Summary minutes subsequent
to the meeting will be available upon request.
Attachment
Dated: October 16, 1996.
Kenneth Olden,
Director, National Toxicology Program.
Summary Data for Substances Tentatively Scheduled for Review at the Meeting of the NTP Board of Scientific
Counselors' Biennial Report on Carcinogens Subcommittee, November 18-19, 1996
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Azacitidine......................... CAS Number 320-67-2.......................... Review order: 3.
Primary Uses........................ Used as a cytostatic agent in the treatment
of acute leukemia.
Nominated as........................ Reasonably Anticipated to be a Human
Carcinogen.
p-Chloro-o-Toluidine and its HCl CAS Number 95-69-2........................... Review order: 4.
salt.
Primary Uses........................ Used to produce azo dyes for cotton, silk
acetate and nylon and as intermediate in
production of Pigment Red 7 and Pigment
Yellow 49. Also an impurity in and a
metabolite of the pesticide chlordimeform.
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Nominated as........................ Reasonably Anticipated to be a Human
Carcinogen.
Chlorozotocin....................... CAS Number 54749-90-5........................ Review order: 5.
Primary Uses........................ Used as a cytostatic agent in the treatment
of cancers of the stomach, large intestine
pancreas and lung; melanoma; and multiple
myeloma.
Nominated as........................ Reasonably Anticipated to be a Human
Carcinogen.
Cyclosporin......................... CAS Number 59865-13-3........................ Review order: 1.
Primary Uses........................ Used as an immunosuppressive agent in the
prevention and treatment of graft-vs-host
reactions in bone marrow transplantation and
for the prevention of rejection of kidney,
heart, and liver transplants.
Nominated as........................ Known to be a Human Carcinogen...............
Danthron (1,8- CAS Number 117-10-2.......................... Review order: 12.
Dihydroxyanthraquinone).
Primary Uses........................ Used as a laxative and as an intermediate in
the manufacture of dyes.
Nominated as........................ Reasonably Anticipated to be a Human
Carcinogen.
1,6-Dinitropyrene................... CAS Number 42397-64-8........................ Review order: 9.
Primary Uses........................ Not used commercially, detected in ambient
atmospheric samples and as a constituent of
diesel exhaust.
Nominated as........................ Reasonably Anticipated to be a Human
Carcinogen.
1,8-Dinitropyrene................... CAS Number 42397-65-9........................ Review order: 10.
Primary Uses........................ Not used commercially, detected in ambient
atmospheric samples and as a constituent of
diesel exhaust.
Nominated as........................ Reasonably Anticipated to be a Human
Carcinogen.
Disperse Blue 1 (1,4,5,8- CAS Number 2475-45-8......................... Review order: 13.
Tetraaminoanthraquinone).
Primary Uses........................ Used as an anthraquinone based dyestuff in
hair color formulations and in coloring
fabrics and plastics.
Nominated as........................ Reasonably Anticipated to be a Human
Carcinogen.
Furan............................... CAS Number 100-00-9.......................... Review order: 6.
Primary Uses........................ Used as an intermediate in the synthesis and
production of other organic compounds..
Nominated as........................ Reasonably Anticipated to be a Human
Carcinogen.
o-Nitroanisole...................... CAS Number 91-23-6........................... Review order: 14.
Primary Uses........................ Used as a precursor in the synthesis of o-
anisidine which is used in the manufacture
of over 100 azo dyes.
Nominated as........................ Reasonably Anticipated to be a Human
Carcinogen.
6-Nitrochrysene..................... CAS Number 7495-02-8......................... Review order: 11.
Primary Uses........................ Not used commercially, detected in ambient
atmospheric samples.
Nominated as........................ Reasonably Anticipated to be a Human
Carcinogen.
1-Nitropyrene....................... CAS Number 5522-43-0......................... Review order: 7.
Primary Uses........................ Not used commercially, detected in ambient
atmospheric samples and as a constituent of
diesel and gasoline engine exhaust.
Nominated as........................ Reasonably Anticipated to be a Human
Carcinogen.
4-Nitropyrene....................... CAS Number 57835-92-4........................ Review order: 8.
Primary Uses........................ Not used commercially, detected in ambient
atmospheric samples.
Nominated as........................ Reasonably Anticipated to be a Human
Carcinogen.
Thiotepa............................ CAS Number 52-24-4........................... Review order: 2.
Primary Uses........................ Used as a cytostatic agent in the treatment
of 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.
Nominated as........................ Known to be a Human Carcinogen...............
1,2,3-Trichloropropane.............. CAS Number 96-18-4........................... Review order: 15.
Primary Uses........................ Used as a polymer crosslinking agent, paint
and varnish remover, solvent and 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.
Nominated as........................ Reasonably Anticipated to be a Human
Carcinogen.
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[FR Doc. 96-27325 Filed 10-23-96; 8:45 am]
BILLING CODE 4140-01-M