[Federal Register Volume 64, Number 223 (Friday, November 19, 1999)]
[Notices]
[Pages 63326-63327]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-30198]



[[Page 63326]]

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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 or Delisting From the 10th Report on Carcinogens

    Pursuant to Pub. L. 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 January 20 & 21, 2000, at 
the Crystal City Marriott, 1999 Jefferson Davis Highway, Arlington, VA 
22202. On January 20, registration will begin at 9 a.m. and the meeting 
will begin at 9:30 a.m. On January 21, 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 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 (RoC) is a public information document prepared for the US 
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, 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 substances 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 is comprised of representatives from the 
Federal health research and regulatory agencies that are members of the 
NTP Executive Committee. Following external public review by the NTP 
Board RoC Subcommittee 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 Report.

Agenda

    The meeting of the NTP RoC Subcommitee is scheduled for January 20 
& 21, 2000. Tentatively scheduled to be peer reviewed are nine 
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 (1) A summary of the scientific data and 
information used to evaluate the nomination, (2) a recommendation for 
listing either as ``known to be a human carcinogen'' or as ``reasonably 
anticipated to be a human carcinogen,'' or (3) the upgrading or 
delisting of a current listing in the RoC. Copies of a draft background 
summary document for each of these nominations are available on the NTP 
web homepage at http://ntp-server.niehs.nih.gov/ 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 3127, P.O. Box 12233, Research Triangle Park, NC 27709 (919/541-
4096; FAX 919/541-2242; email [email protected]).
    The April 2, 1999 Federal Register Announcement (Volume 64, Number 
63, Page 15983-15984) calling for public comments on the nominations to 
be reviewed in 1999 for listing in or delisting (removing) from the 
10th RoC, indicated that UV Radiation (separate consideration of three 
segments of the wavelength spectrum: UVA (315-400 nm), UVB (280-315 
nm), and UVC (100-280 nm)) and Toluene Diisocyanate (CAS Number 26471-
62-5) would be among the nominations to be reviewed. The initial review 
of the UV Radiation nomination by NTP staff found an extensive 
published database for this nomination and there was insufficient time 
to prepare adequately a comprehensive summary background document for 
its review in 1999. Therefore, the nomination of UV Radiation (separate 
consideration of three segments of the wavelength spectrum: UVA (315-
400 nm), UVB (280-315 nm), and UVC (100-280 nm)) was deferred for 
review until later in 2000.
    Toluene Diisocyanate (TDI) was nominated by the Diisocyanates Panel 
of the Chemical Manufacturers Association for review and delisting from 
the RoC. As outlined in the published listing/delisting procedures for 
the RoC, the RG1 reviewed the nomination and data provided by the 
Diisocyanates Panel. Based on its review of the available information 
concerning the carcinogenicity of TDI, the RG1 determined that there is 
no new, relevant data to support the delisting of TDI from the RoC. RG1 
recommended that the nomination to delist TDI from the RoC not proceed 
any further through the review process. Therefore, TDI is not on the 
agenda for review at the January 20-21 RoC Subcommittee meeting. The 
Diisocyanates Panel was notified of this action and invited to resubmit 
the nomination to delist TDI from the RoC providing additional 
justification and relevant new data to support the nomination. The RG2, 
NTP Board of Scientific Counselors RoC Subcommittee, and the NTP 
Executive Committee were notified of this action.

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 
[email protected]) no later than January 7, 2000. Persons registering 
to make comments are asked to provide, if possible, a written copy of 
their statement by January 7th so copies can be made and distributed to

[[Page 63327]]

Subcommittee 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 January 7th 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. 
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 Subommittee 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 
January 7th for distribution to the Subcommittee. Written comments 
received after January 7th will not be considered by Subcommittee 
members in their reviews.
    The NTP would welcome receiving information from completed, 
ongoing, or planned 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: November 10, 1999.
Samuel H. Wilson,
Deputy Director, NIEHS and NTP.

   Summary Data for Nominations Tentatively Scheduled for Review at the Meeting of the NTP Board of Scientific
                       Counselors' Report on Carcinogens Subcommittee January 20-21, 2000
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                                                                                                      Tentative
    Nomination to be reviewed/CAS No.      Primary uses or  exposures       To be reviewed for      review order
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Beryllium and Beryllium Compounds/7440-   Fiber optics and cellular    Possible updating of                   3
 41-7.                                     network communications       current listing of
                                           systems, aerospace,          beryllium and certain
                                           defense and other industry   beryllium compounds to a
                                           applications.                known human carcinogen.
2,2-bis-(bromomethyl) -1,3-propanediol/   Used as a fire retardant in  Listing in the 10th Report.            2
 3296-90-9.                                unsaturated polyester
                                           resins, in molded
                                           products, and in rigid
                                           polyurethane foam.
2,3-Dibromo-1-Propanol/96-13-9..........  Used as a flame retardant,   Listing in the 10th Report.            1
                                           as an intermediate in the
                                           preparation of the flame
                                           retardant tris(2,3-
                                           dibromopropyl) phosphate,
                                           and as an intermediate in
                                           the manufacture of
                                           pesticides and
                                           pharmaceutical
                                           preparations.
Dyes Metabolized to Dimethoxybenzidine    Dyes widely used for         Listing in the 10th Report.            4
 (Dimethoxybenzidine Dyes as a Class).     leather, paper, plastics,
                                           rubber, and textile
                                           industries.
Dyes Metabolized to Dimethylbenzidine     Dyes widely used for         Listing in the 10th Report.            5
 (Dimethylbenzidine Dyes as a Class).      leather, paper, plastics,
                                           rubber, and textile
                                           industries.
IQ (2-Amino-3-methylimidazo[4,5-          Found in cooked meat and     Listing in the 10th Report.            6
 f]quinoline)/76180-96-6.                  fish.
Styrene-7,8-oxide/96-09-3...............  Used mainly in the           Listing in the 10th Report.            7
                                           preparation of fragrances
                                           and in some epoxy resin
                                           formulations.
Vinyl Bromide/593-60-2..................  Used commercially since      Listing in the 10th Report.            8
                                           1968, primarily in the
                                           manufacture of flame
                                           retardant synthetic fibers.
Vinyl Fluoride/75-02-5..................  Used commercially since the  Listing in the 10th Report.            9
                                           1960s, in the production
                                           of polyvinylfluoride,
                                           which is used for plastics.
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[FR Doc. 99-30198 Filed 11-18-99; 8:45 am]
BILLING CODE 4140-01-P