[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
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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