[Federal Register Volume 65, Number 201 (Tuesday, October 17, 2000)]
[Notices]
[Pages 61352-61354]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-26586]


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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 10th 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 (RoC) Subcommittee to be held on December 13, 14, and 15, 
2000, at the Wyndham City Center, 1143 New Hampshire Ave., Washington, 
DC 20037. On December 13, registration will begin at 9 a.m. and the 
meeting will begin at 9:30 a.m. On December 14 and 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, Executive Secretary, prior to the meeting (contact 
information given below). The agenda covers the peer review of agents, 
substances, mixtures, or exposure circumstances nominated for listing 
in the 10th Report on Carcinogens, and includes an opportunity for 
public input.

Background

    The Department of Health and Human Services (DHHS) Report on 
Carcinogens

[[Page 61353]]

(RoC) 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 peer 
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 were 
approved by the Secretary, DHHS, in September 1996. The major change in 
the RoC, 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 in or delist from future 
editions. 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 is external public 
peer review by the NTP Board of Scientific Counselors (BSC) RoC 
Subcommittee. Following completions of these reviews and solicitation 
of public comments through announcements in the Federal Register and 
other media, the independent recommendations of the three scientific 
peer 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 chemicals or exposure circumstances in the RoC. 
The Secretary has final review and approval for the Tenth Report.

Agenda

    The meeting of the NTP RoC Subcommittee is scheduled for December 
13, 14 and 15, 2000. Tentatively scheduled to be peer reviewed are 
eight nominated chemicals or exposure circumstances. These nominations 
are listed alphabetically in the attached table, along with supporting 
information and a tentative order of presentation and review. 
Background summary documents for each of the nominations are available 
to the public and include a summary of the scientific data and 
information used to evaluate the nomination. A copy of the draft 
background summary document for each of these nominations is available 
electronically on the NTP web homepage at <a href="http://ntp_server.niehs.nih.gov/">http://ntp_server.niehs.nih.gov/</a> and the Environmental Health Information Service 
website at http://ehis.niehs.nih.gov/ or can be obtained in hard copy, 
as available, from: Dr. C.W. Jameson, Report on Carcinogens, NIEHS, MD 
EC-14, 79 Alexander Drive, Building 4401, Room 3118, P.O. Box 12233, 
Research Triangle Park, NC 27709 (919/541-4096; FAX 919/541-2242; email 
<a href="/cdn-cgi/l/email-protection#afc5cec2cadcc0c1efc1c6cac7dc81c1c6c781c8c0d9"><span class="__cf_email__" data-cfemail="462c272b2335292806282f232e3568282f2e68212930">[email protected]</span></a>).
    The April 5, 2000 Federal Register Announcement (Volume 65, Number 
66, Page 17889-17891) calling for public comments on the nominations to 
be reviewed in 2000 for listing in the 10th RoC, indicated that Human 
Papillomaviruses and Lead and Lead Compounds would be among the 
nominations to be reviewed. The initial review of these two nominations 
by NTP staff found an extensive published database for each nomination 
and there was insufficient time to prepare adequately a comprehensive 
summary background document on each for review in 2000. Therefore, the 
nominations of Human Papillomaviruses and Lead and Lead Compounds are 
deferred for review until 2001.
    Solar Radiation and Exposure to Sunlamps and Sunbeds was nominated 
by a private individual for review and delisting from the RoC. In 
addition the Suntanning Association for Education also nominated 
Exposure to Sunlamps and Sunbeds for review and delisting from the RoC. 
As outlined in the published listing/delisting procedures for the RoC, 
the RG1 reviewed these nominations and the data provided by the 
nominators. Based on its review of the available information concerning 
the carcinogenicity of Solar Radiation and Exposure to Sunlamps and 
Sunbeds, the RG1 determined that no new information was provided by the 
nominators that was not already considered during the listing procedure 
and recommended that, due to the lack of any significant new data to 
support this delisting, the nomination to delist should not proceed any 
further through the review process. Therefore, the delisting of Solar 
Radiation and Exposure to Sunlamps and Sunbeds is not on the agenda for 
review at the December 13th-15th RoC Subcommittee meeting. The 
nominators have been notified of this action and invited to resubmit 
the nomination to delist Solar Radiation and Exposure to Sunlamps and 
Sunbeds from the RoC providing additional justification and relevant 
new data to support the nomination.

Solicitation of Public Comment

    The NTP Board of Scientific Counselors RoC Subcommittee meeting is 
open to the public, and time will be provided for public comment on 
each of the nominations under review. In order to facilitate planning 
for the meeting, persons requesting time for an oral presentation 
regarding a particular 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; email 
<a href="/cdn-cgi/l/email-protection#afd8c0c3c9caefc1c6cac7dc81c1c6c781c8c0d9"><span class="__cf_email__" data-cfemail="14637b787271547a7d717c673a7a7d7c3a737b62">[email protected]</span></a>) no later than December 1, 2000. Persons 
registering to make comments are asked to provide, if possible, a 
written copy of their statement by December 1st so copies can be made 
and distributed to 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 seven minutes will be allotted to each 
speaker, and if time permits, can be extended to 10 minutes. 
Individuals who register to make oral presentations by December 1st 
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 then that for preregistered speakers 
and will be determined by the number who register at the meeting. 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 Chair and Subcommittee members and 
supplement the record.
    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 
December 1st for distribution to the Subcommittee. Written comments 
received after December 1st will not be considered by Subcommittee 
members in their reviews.

[[Page 61354]]

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 agenda and a roster of Subcommittee members will be available 
prior to the meeting on the NTP web homepage at http://
ntp__server.niehs.nih.gov/ and upon request from Dr. Wolfe. Summary 
minutes from the previous meeting are available on the NTP web homepage 
and upon request from Dr. Wolfe.

    Dated: October 6, 2000.
Kenneth Olden,
Director, National Toxicology Program.

   Summary Data for Nominations Tentatively Scheduled for Review at the Meeting of the NTP Board of Scientific
                   Counselors' Report on Carcinogens Subcommittee December 13, 14, & 15, 2000
----------------------------------------------------------------------------------------------------------------
                                                                                                      Tentative
  Nomination to be reviewed/ CAS number     Primary uses or exposures        To be reviewed for         review
                                                                                                        order
----------------------------------------------------------------------------------------------------------------
Broad Spectrum UV Radiation and UVA, UVB   Solar and artificial         Listing in the 10th Report.            1
 and UVC.                                   sources of ultraviolet
                                            radiation.
Chloramphenicol/(56-75-7)................  Used widely as an            Listing in the 10th Report.            6
                                            antibiotic since the 1950s.
Estrogens, Steroidal.....................  Estrogens are widely used    Listing in the 10th Report.            5
                                            in post-menopausal therapy
                                            and in oral contraceptives
                                            for women.
Metallic Nickel & Nickel Alloys..........  Widely used in commercial    Listing in the 10th Report.            4
                                            applications for over 100
                                            years.
Methyleugenol/(93-15-2)..................  Flavoring agent used in      Listing in the 10th Report.            3
                                            jellies, baked goods,
                                            nonalcoholic beverages,
                                            chewing gum, candy, and
                                            ice cream. Also used as a
                                            fragrance for many
                                            perfumes, lotions,
                                            detergents and soaps.
Talc/(14807-96-6) (Asbestiform and (Non-   Asbestiform talc (i.e. talc  Listing in the 10th Report.            7
 Asbestiform).                              containing asbestiform
                                            (fibers) occurs in various
                                            geological settings around
                                            the world. Occupational
                                            exposure occurs during
                                            mining, milling and
                                            processing. Non-
                                            asbestiform talc (i.e.
                                            talc not containing
                                            asbestiform fibers) occurs
                                            in various geological
                                            settings around the world.
                                            Occupational exposure
                                            occurs during mining,
                                            milling and processing.
                                            Exposure to general
                                            population occurs through
                                            use of products such as
                                            cosmetics.
Trichloroethylene (TCE)/(79-01-6)........  Trichloroethylene is widely  Upgrade to Known...........            2
                                            used as a solvent with 80-
                                            90% used worldwide for
                                            degreasing metals.
Wood Dust................................  It is estimated that at      Listing in the 10th Report.            8
                                            least two million people
                                            are routinely exposed
                                            occupationally to wood
                                            dust worldwide. Non-
                                            occupational exposure also
                                            occurs. The highest
                                            exposures have generally
                                            been reported in wood
                                            furniture and cabinet
                                            manufacture, especially
                                            during machine sanding and
                                            similar operations.
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[FR Doc. 00-26586 Filed 10-16-00; 8:45 am]
BILLING CODE 4140-01-P


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