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National Toxicology Program; National Toxicology Program (NTP) Board of Scientific Counselors Meeting; Review of Nominations for Listing in the 11th Edition of the Report on Carcinogens

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Information about this document as published in the Federal Register.

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This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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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 (“the NTP RoC Subcommittee”) to be held on October 14-15, 2003, at the Marriott at Metro Center, 775 12th Street, NW., Washington, DC 20005. On October 14, registration will begin at 9 a.m. and the meeting will begin at 9:30 a.m. On October 15, the meeting will begin at 8:30 a.m. Pre-registration is not required; however, persons requesting time to make oral public comments are asked to notify Dr. Mary S. Wolfe, NTP Executive Secretary, prior to the meeting (contact information given below). The agenda covers the peer review of seven nominations for possible listing in the 11th Edition of the Report on Carcinogens (“the 11th RoC”), and includes an opportunity for public input.


The meeting of the NTP RoC Subcommittee is scheduled for October 14-15, 2003 and is open to the public with attendance limited to only the available space. Tentatively scheduled for peer review are seven nominations for possible listing in the 11th RoC. These nominations are listed alphabetically in the attached table, along with supporting information and a tentative order of presentation and review. Background documents for each of the nominations have been made available previously to the public on the web and include a summary of the scientific data and information being used to evaluate the nomination. A copy of the background document for each of these nominations is available electronically through the NTP's RoC web site for the 11th RoC at​Newhomeroc/​11RoCBkgrnd.html (select Nominations Under Review in 2003) or can be obtained on CD or in hard copy, as available, from: Dr. C.W. Jameson, Report on Carcinogens, NIEHS, MD EC-14, 79 T.W. Alexander Drive, Building 4401, Room 3118, P.O. Box 12233, Research Triangle Park, NC 27709 (919/541-4096; FAX 919/541-2242; email

The agenda and a roster of NTP RoC Subcommittee members will be available prior to the meeting on the NTP homepage at​ or upon request from Dr. Wolfe. Following the meeting, summary minutes will also be available electronically at​NewHomeRoc/​mtgs.html and in hardcopy upon request from Dr. Wolfe.

A total of 17 nominations are under consideration for the 11th RoC. Previous notices in the Federal Register (July 24, 2001: Volume 66, Number 142, Pages 38430-38432 and March 28, 2002: Volume 67, Number 60, Page 14957) announced the nominations to be reviewed for possible listing in the 11th RoC. This review by the NTP RoC Subcommittee is for the second set of seven nominations identified in those Federal Register announcements that have completed review by the NIEHS Review Committee for the Report on Start Printed Page 47347Carcinogens (RG1) and the NTP Executive Committee Interagency Working Group for the Report on Carcinogens (RG2). The RoC Subcommittee reviewed the first 10 nominations to the 11th RoC at a public meeting on November 19-20, 2002, in Washington, DC. Summary minutes of that meeting are available electronically at​NewHomeRoc/​mtgs.html or in hardcopy upon request to the Executive Secretary (contact information below).

Solicitation of Public Comment

This meeting of the NTP RoC Subcommittee is open to the public, and time will be provided for oral public comment on each of the nominations under review. In order to facilitate planning, persons requesting time for an oral presentation on a nomination should notify the Executive Secretary, (Dr. Mary S. Wolfe, P.O. Box 12233, A3-07, Research Triangle Park, NC 27709; telephone 919/541-3971; FAX 919/541-0295; e-mail no later than September 29, 2003. Each organization is allowed one time slot for an oral presentation per nomination. Persons registering to make comments are asked to provide, if possible, a written copy of their statement by September 29 so copies can be made and distributed to NTP RoC Subcommittee members for their timely review prior to the meeting. Written statements can supplement and expand the oral presentation, and each speaker is asked to provide his/her name, affiliation, mailing address, phone, fax, e-mail and supporting organization (if any). At least 7 minutes will be allotted to each speaker, and if time permits, may be extended to 10 minutes. Individuals who register to make oral presentations by September 29 will be notified about the time available for their presentation at least one week prior to the meeting. Registration for making public comments will also be available on-site. Time allowed for presentation by on-site registrants may be less than that for preregistered speakers and will be determined by the number of speakers who register at the meeting to give comments. If registering on-site to speak and reading oral comments from printed copy, the speaker is asked to bring 25 copies of the text. These copies will be distributed to the NTP RoC Subcommittee members and supplement the record. All comments received in response to this Federal Register notice will be posted on the NTP RoC web site.

Written comments, in lieu of making oral comments, are welcome. All comments must include name, affiliation, mailing address, phone, fax, e-mail and sponsoring organization (if any) and should be received by September 29, 2003, for distribution to the NTP RoC Subcommittee. Written comments received after September 29 will not be considered by NTP RoC Subcommittee members in their reviews.

Solicitation of Additional Information

The NTP would welcome receiving information from completed human or experimental animal cancer studies or studies of mechanism of cancer formation, as well as current production data, human exposure information, and use patterns for any of the nominations listed in this announcement. Organizations or individuals that wish to provide information should contact Dr. C.W. Jameson at the address given above.


The Department of Health and Human Services (DHHS) Report on Carcinogens is a public information document prepared for the U.S. Congress by the National Toxicology Program (NTP) in response to Section 301(b)(4) of the Public Health Service Act, as amended. The intent of the document is to provide a listing of those agents, substances, mixtures or exposure circumstances that are either “known” or “reasonably anticipated” to cause cancer in humans and to which a significant number of people in the United States are exposed. The process for preparation of the RoC has three levels of scientific review. Central to the evaluations of the review groups is the use of criteria for inclusion in or removal of listings from the report. The current criteria for listing in or delisting from the Report is available on the Web at the following web site:​NewHomeRoc/​ListingCriteria.html, or can be obtained in hard copy by contacting Dr. C.W. Jameson at the address listed above. The review process for listing in or delisting from the RoC begins with initial scientific review by the National Institute of Environmental Health Sciences (NIEHS)/NTP Report on Carcinogens Review Committee (RG1), which is comprised of NIEHS/NTP staff scientists. The second scientific review group (RG2) is comprised of representatives from the Federal health research and regulatory agencies that are members of the NTP Executive Committee. The third step is external scientific review at a public meeting by the NTP RoC Subcommittee. Following completion of these reviews and solicitation of public comments through announcements in the Federal Register and other media, the independent recommendations of the three scientific review groups and all public comments are presented to the NTP Executive Committee for review and comment. All recommendations and public comments are submitted to the Director, NTP, who reviews them and makes a final recommendation to the Secretary, DHHS, concerning the listing or delisting of substances or exposure circumstances in the RoC. The Secretary has final review and approval authority for the 11th RoC.

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Dated: July 30, 2003.

Samuel H. Wilson,

Deputy Director, National Institute of Environmental Health Sciences.

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Summary Data for Nominations Tentatively Scheduled for Review at the Meeting of the NTP Board of Scientific Counselors Report on Carcinogens Subcommittee

[October 14-15, 2003]

Nomination to be reviewed/CAS numberPrimary uses or exposuresTo be reviewed forTentative review order
Diazoaminobenzene (DAAB)/136-35-6DAAB is used as an intermediate in the production of dyes, and as a complexing agent, polymer additive and to promote adhesion of natural rubber to steelListing in the 11th RoC6
Hepatitis B Virus (HBV)HBV is a small DNA-enveloped virus that along with Hepatitis C Virus causes most parenterally transmitted viral hepatitisListing in the 11th RoC4
Hepatitis C Virus (HCV)HCV is an RNA-enveloped virus that along with Hepatitis B Virus causes most parenterally transmitted viral hepatitisListing in the 11th RoC5
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Human Papillomaviruses (HPVs), Genital-Mucosal TypesHPVs are small, non-enveloped viruses that infect oral and genital mucosa. HPV infections are common throughout the worldListing in the 11th RoC3
Lead and Lead CompoundsMajor use of metal is in making lead-acid storage batteries. Other common uses include ammunition and cable covering. Lead compounds are used in paint, glass, ceramics, fuel additives, and some traditional cosmeticsListing in the 11th RoC2
NeutronsExposure to neutrons normally occurs from a mixed irradiation field in which neutrons are a minor component. The exceptions are exposure of patients to neutron radiotherapy beams and exposures of aircraft passengers and crewListing in the 11th RoC* 1
X-Radiation and GAMMA RadiationExposure to these forms of ionizing radiation comes from a variety of natural (environmental exposure) and anthropogenic sources, including exposure for military, medical, and occupational purposesListing in the 11th RoC** 1
* Note—will be reviewed together with X-Radiation and GAMMA Radiation nomination.
** Note—will be reviewed together with Neutrons nomination.
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[FR Doc. 03-20299 Filed 8-7-03; 8:45 am]