National Toxicology Program

National Toxicology Program

9th Report on Carcinogens - Review of Substances for Listing/Delisting

[Federal Register: October 2, 1997 (Volume 62, Number 191)]
[Page 51674-51675]


Public Health Service

National Toxicology Program

National Toxicology Program (NTP) Board of Scientific Counselors'Meeting; Review of Substances for Listing in or Delisting fromthe 9th Report on Carcinogens

Pursuant to Public Law 92-463, notice is hereby given of the nextmeeting of the NTP Board of Scientific Counselors' Report on CarcinogensSubcommittee to be held on October 30 & 31, 1997, in the ConferenceCenter, Building 101, South Campus, National Institute of EnvironmentalHealth Sciences (NIEHS), 111 Alexander Drive, Research TrianglePark, North Carolina. The meeting will begin at 8:30 a.m. bothdays and is open to the public. The agenda are the peer reviewof substances nominated for listing in or delisting from the 9thReport on Carcinogens (formerly the Biennial Reporton Carcinogens), and provision of an opportunity for publicinput.

Over the past three years, there was an extensive public andFederal interagency review of the process for the preparationof the Report on Carcinogens (RC) to broaden input toits preparation, broaden the scope of scientific review, and providereview of the criteria used for inclusion in or removal of substancesfrom the Report. As a result, the criteria were revised and approvedin September 1996 by the Secretary, Department of Health and HumanServices. The major change in the RC which occurred as a resultof the criteria revision was to include consideration of all relevantinformation, including mechanistic data, in the decision to listsubstances in or delist substances from future volumes. To broadenthe scope of scientific review, a new standing subcommittee ofthe NTP Board of Scientific Counselors was established. A November1996 meeting of the Report on Carcinogens (RC) Subcommittee wasthe first where public review of nominations took place, and usingthe revised criteria. Thus, the current review process for reviewof petitions considered by the NTP for listing in or delistingfrom the Report begins with initial scientific review by the NIEHS/NTPReport on Carcinogens Review Committee (RG1). The RG1 makes aformal recommendation for those petitions determined to containsufficient information for listing or delisting in the Report. The second scientific review is done by the NTP Executive Committee'sWorking Group for the Report on Carcinogens (RG2). RG2 is comprisedof representatives of the Federal health research and regulatoryagencies on the NTP Executive Committee. Following external scientificpeer review by the RC Subcommittee in public session and solicitationof public comments through announcements in the Federal Register and other media, the independent recommendations of the threereview groups and all public comments are presented to the NTPExecutive Committee for review and comment. The Director, NTP,receives the four independent recommendations and makes the finaldecision to submit the Report to the Secretary for review andapproval.

Tentatively scheduled to be peer reviewed on October 30 &31, are 14 agents, substances, mixtures or exposure circumstanceslisted alphabetically, along with supporting information in theattached table. The table lists the nominations in the tentativeorder of their presentation and review, and gives their primaryuses or exposures and the category for which they were originallynominated. Background summary documents on each of the substanceswill be provided to reviewers around October 1, and will be availableto the public at that time as well. Background documents include1) a summary of the background data and information used to evaluatethe nomination, and 2) the recommendation for: listing as "knownto be a human carcinogen" or as "reasonably anticipatedto be a human carcinogen"; the upgrading of a current listing; or the removal from the Report. Copies of draft background documentscan be obtained, as available, from: the Executive Secretary,Dr. Larry G. Hart, P.O. Box 12233, Research Triangle Park, NC27709 (telephone 919/541-3971; FAX 919/541-0295; email

Public Input Encouraged
The entire meeting is open to the public and time will beprovided for public comment on each of the substances being reviewed. In order to facilitate planning for the meeting, persons wantingto make a formal presentation regarding a particular nominatedsubstance must notify the Executive Secretary by telephone, byFAX, by mail, or by email no later than October 23, 1997, andprovide a written copy in advance of the meeting. Written statementsshould supplement and may expand on the oral presentation, ormay be submitted in lieu of an oral presentation, and should bereceived by October 27 so copies can be made for distributionto Subcommittee members and staff and made available for the public Oral presentations should be limited to no more than fiveminutes. Should the requests for time exceed the likely availabletime, the time may have to be limited to three minutes and presenterswill be contacted.

The program would welcome receiving carcinogenesis informationfrom completed, ongoing, or planned studies by others, as wellas current production data, human exposure information, and usepatterns 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 givenabove, will furnish agenda and a roster of Subcommittee membersprior to the meeting. Summary minutes subsequent to the meetingwill be available upon request.


Dated: September 23, 1997

Samuel H. Wilson, M.D.
Deputy Director, National Toxicology Program



Summary Data for
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


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
Used primarily as a chemical intermediate and polymer component in the manufacture of synthetic rubberUpgrading current listing to Known to be a Human Carcinogen in the 9th Report
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
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
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
Used primarily as a nonnutritive sweetening agent.Removal from the Report on Carcinogens
SMOKELESS TOBACCOOral use of smokeless tobacco products.Listing as Known to be a Human Carcinogen in the 9th Report
STRONG INORGANIC ACID MISTS CONTAINING SULFURIC ACIDUsed 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
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
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
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 SMOKINGInhalation of tobacco smokeListing as Known to be a Human Carcinogen in the 9th Report
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 RADIATIONSolar and artificial sources of ultraviolet radiationListing as Known to be a Human Carcinogen in the 9th Report
1Nominationdoes not necessarily reflect the final recommendation of the twoNTP Scientific Review Committees for the Report on


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The NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.