[Federal Register Volume 68, Number 153 (Friday, August 8, 2003)]
[Notices]
[Pages 47346-47348]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-20299]


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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 Nominations for 
Listing in the 11th Edition of the 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 (``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.

Agenda

    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 http://ntp-server.niehs.nih.gov/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 [email protected]).
    The agenda and a roster of NTP RoC Subcommittee members will be 
available prior to the meeting on the NTP homepage at http://ntp-server.niehs.nih.gov/ or upon request from Dr. Wolfe. Following the 
meeting, summary minutes will also be available electronically at 
http://ntp-server.niehs.nih.gov/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

[[Page 47347]]

Carcinogens (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 http://ntp-server.niehs.nih.gov/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 [email protected]) 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.

Background

    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: http://ntp-server.niehs.nih.gov/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.

    Dated: July 30, 2003.
Samuel H. Wilson,
Deputy Director, National Institute of Environmental Health Sciences.

      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]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                               Tentative
    Nomination to be reviewed/CAS number                  Primary uses or exposures                           To be reviewed for                review
                                                                                                                                                 order
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Diazoaminobenzene (DAAB)/136-35-6..........  DAAB is used as an intermediate in the production   Listing in the 11th RoC....................           6
                                              of dyes, and as a complexing agent, polymer
                                              additive and to promote adhesion of natural
                                              rubber to steel.
Hepatitis B Virus (HBV)....................  HBV is a small DNA-enveloped virus that along with  Listing in the 11th RoC....................           4
                                              Hepatitis C Virus causes most parenterally
                                              transmitted viral hepatitis.
Hepatitis C Virus (HCV)....................  HCV is an RNA-enveloped virus that along with       Listing in the 11th RoC....................           5
                                              Hepatitis B Virus causes most parenterally
                                              transmitted viral hepatitis.

[[Page 47348]]

 
Human Papillomaviruses (HPVs), Genital-      HPVs are small, non-enveloped viruses that infect   Listing in the 11th RoC....................           3
 Mucosal Types.                               oral and genital mucosa. HPV infections are
                                              common throughout the world.
Lead and Lead Compounds....................  Major use of metal is in making lead-acid storage   Listing in the 11th RoC....................           2
                                              batteries. Other common uses include ammunition
                                              and cable covering. Lead compounds are used in
                                              paint, glass, ceramics, fuel additives, and some
                                              traditional cosmetics.
Neutrons...................................  Exposure to neutrons normally occurs from a mixed   Listing in the 11th RoC....................         * 1
                                              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 crew.
X-Radiation and GAMMA Radiation............  Exposure to these forms of ionizing radiation       Listing in the 11th RoC....................       ** 1
                                              comes from a variety of natural (environmental
                                              exposure) and anthropogenic sources, including
                                              exposure for military, medical, and occupational
                                              purposes.
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* Note--will be reviewed together with X-Radiation and GAMMA Radiation nomination.
** Note--will be reviewed together with Neutrons nomination.

[FR Doc. 03-20299 Filed 8-7-03; 8:45 am]
BILLING CODE 4140-01-U