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9th Report on Carcinogens - Review of Substances for Listing/Delisting
[Federal Register: October 2, 1997 (Volume 62, Number 191)]
[Notices]
[Page 51674-51675]
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 or Delisting from the 9th Report on Carcinogens
Pursuant to Public Law 92-463, notice is hereby given of the next meeting of the NTP Board of Scientific Counselors' Report on Carcinogens Subcommittee to be held on October 30 & 31, 1997, 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. both days and is open to the public. The agenda are the peer review of substances nominated for listing in or delisting from the 9th Report on Carcinogens (formerly the Biennial Report on Carcinogens), and provision of an opportunity for public input.
Background
Over the past three years, there was an extensive public and
Federal interagency review of the process for the preparation
of the Report on Carcinogens (RC) to broaden input to
its preparation, broaden the scope of scientific review, and provide
review of the criteria used for inclusion in or removal of substances
from the Report. As a result, the criteria were revised and approved
in September 1996 by the Secretary, Department of Health and Human
Services. The major change in the RC which occurred as a result
of the criteria revision was to include consideration of all relevant
information, including mechanistic data, in the decision to list
substances in or delist substances from future volumes. To broaden
the scope of scientific review, a new standing subcommittee of
the NTP Board of Scientific Counselors was established. A November
1996 meeting of the Report on Carcinogens (RC) Subcommittee was
the first where public review of nominations took place, and using
the revised criteria. Thus, the current review process for review
of petitions considered by the NTP for listing in or delisting
from the Report begins with initial scientific review by the NIEHS/NTP
Report on Carcinogens Review Committee (RG1). The RG1 makes a
formal recommendation for those petitions determined to contain
sufficient information for listing or delisting in the Report.
The second scientific review is done by the NTP Executive Committee's
Working Group for the Report on Carcinogens (RG2). RG2 is comprised
of representatives of the Federal health research and regulatory
agencies on the NTP Executive Committee. Following external scientific
peer review by the RC Subcommittee in public session and solicitation
of public comments through announcements in the Federal Register
and other media, the independent recommendations of the three
review groups and all public comments are presented to the NTP
Executive Committee for review and comment. The Director, NTP,
receives the four independent recommendations and makes the final
decision to submit the Report to the Secretary for review and
approval.
Agenda
Tentatively scheduled to be peer reviewed on October 30 &
31, are 14 agents, substances, mixtures or exposure circumstances
listed alphabetically, along with supporting information in the
attached table. The table lists the nominations in the tentative
order of their presentation and review, and gives their primary
uses or exposures and the category for which they were originally
nominated. Background summary documents on each of the substances
will be provided to reviewers around October 1, and will be available
to the public at that time as well. Background documents include
1) a summary of the background data and information used to evaluate
the nomination, and 2) the recommendation for: listing as "known
to be a human carcinogen" or as "reasonably anticipated
to be a human carcinogen"; the upgrading of a current listing;
or the removal from the Report. Copies of draft background documents
can be obtained, as available, from: the Executive Secretary,
Dr. Larry G. Hart, P.O. Box 12233, Research Triangle Park, NC
27709 (telephone 919/541-3971; FAX 919/541-0295; email hart@
niehs.nih.gov.
Public Input Encouraged
The entire meeting is open to the public and time will be
provided for public comment on each of the substances being reviewed.
In order to facilitate planning for the meeting, persons wanting
to make a formal presentation regarding a particular nominated
substance must notify the Executive Secretary by telephone, by
FAX, by mail, or by email no later than October 23, 1997, and
provide a written copy in advance of the meeting. Written statements
should supplement and may expand on the oral presentation, or
may be submitted in lieu of an oral presentation, and should be
received by October 27 so copies can be made for distribution
to Subcommittee members and staff and made available for the public
Oral presentations should be limited to no more than five
minutes. Should the requests for time exceed the likely available
time, the time may have to be limited to three minutes and presenters
will be contacted.
The program would welcome receiving carcinogenesis information from completed, ongoing, or planned studies by others, 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, Report on Carcinogens, MD EC-14, P.O. Box 12233, Research Triangle Park, NC 27709 (919/541-4096; FAX 919/541-2242).
The Executive Secretary, Dr. Larry G. Hart, at the address given above, will furnish agenda and a roster of Subcommittee members prior to the meeting. Summary minutes subsequent to the meeting will be available upon request.
Dated: September 23, 1997
____________________________________________
Samuel H. Wilson, M.D.
Deputy Director, National Toxicology Program
Agents, Substances, Mixtures or Exposure Circumstances
Tentatively Scheduled for Review at the Meeting of the
NTP Board of Scientific Counselors' Report on Carcinogens Subcommittee
October 30 & 31, 1997
CAS NUMBER |
EXPOSURES |
NOMINATED FOR1 |
|
DYES METABOLIZED TO BENZIDINE (BENZIDINE DYES AS A CLASS) | Benzidine-based dyes are used primarily for dyeing textiles, paper and leather products. More than 250 benzidine-based dyes have been reported by the Society of Dyers and Colorists. | Listing as Known to be a Human Carcinogen in the 9th Report | |
1,3-BUTADIENE/
106-99-0 | Used primarily as a chemical intermediate and polymer component in the manufacture of synthetic rubber | Upgrading current listing to Known to be a Human Carcinogen in the 9th Report | |
CADMIUM and
CADMIUM COMPOUNDS/ 7440-43-9 | Used in batteries, coating and plating, plastic and synthetic products and in alloys. | Upgrading current listing to Known to be a Human Carcinogen in the 9th Report | |
CHLOROPRENE/
126-99-8 | Used as a monomer for neoprene elastomers, industrial rubber products, and as a component of adhesives in food packaging. | Listing as Reasonably Anticipated to be a Human Carcinogen in the 9th Report | |
PHENOLPHTHALEIN/
77-09-8 | Used as a laboratory reagent and acid-base indicator and as a cathartic drug in over-the-counter laxative preparations. | Listing as Reasonably Anticipated to be a Human Carcinogen in the 9th Report | |
SACCHARIN/
218-44-9 | Used primarily as a nonnutritive sweetening agent. | Removal from the Report on Carcinogens | |
SMOKELESS TOBACCO | Oral use of smokeless tobacco products. | Listing as Known to be a Human Carcinogen in the 9th Report | |
STRONG INORGANIC ACID MISTS CONTAINING SULFURIC ACID | 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. | Listing as Known to be a Human Carcinogen in the 9th Report | |
TAMOXIFEN/
10540-29-1 | Used as an anti-estrogen drug and in the palliative treatment of breast cancer. | Listing as Known to be a Human Carcinogen in the 9th Report | |
2,3,7,8- TETRACHLORODIBENZO-P- DIOXIN (TCDD)/
1746-01-6 | Not used commercially, used only as a research chemical. Potential exposure from municipal incinerators, dump sites and contaminated soil. | Upgrading current listing to Known to be a Human Carcinogen in the 9th Report | |
TETRAFLUOROETHYLENE/
116-14-3 | Used in the production of polytetrafluoroethylene (Teflon) and other polymers. Has also been used as a propellant for food product aerosols. | Listing as Reasonably Anticipated to be a Human Carcinogen in the 9th Report | |
TOBACCO SMOKING | Inhalation of tobacco smoke | Listing as Known to be a Human Carcinogen in the 9th Report | |
TRICHLOROETHYLENE/
79-01-6 | Used as an industrial solvent for vapor 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. | Listing as Reasonably Anticipated to be a Human Carcinogen in the 9th Report | |
UV RADIATION | Solar and artificial sources of ultraviolet radiation | Listing as Known to be a Human Carcinogen in the 9th Report |
Carcinogens.
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