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Federal Register: NTP BSC Meeting - Review of Substances for 8th BRC
[Notices]
[Page 55165-55166]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
National Toxicology Program (NTP) Board of Scientific Counselors'
Meeting; Review of Substances for Listing in the 8th Biennial Report on
Carcinogens
Background
The Director, NTP, initiated a public review in 1994 of the process
for preparation of the Biennial Report on Carcinogens (BRC)
to broaden input to its preparation, broaden the scope of
scientific review associated with the Report, and provide review
of the criteria used for inclusion of substances in the BRC. As
a result of an extensive public as well as Federal interagency
review, the criteria were revised with the revised criteria recently
approved by the Secretary, Department of Health and Human Services,
(Federal Register Vol. 61,
No. 188, 50499-50500).
The major change in the BRC which will occur as a result of the
criteria revision will be to include consideration of all relevant
information, including mechanistic data, in the decision to list
substances in or delist substances from future volumes of the
BRC. To broaden the scope of scientific review, a new standing
subcommittee of the NTP Board of Scientific Counselors was established
and held an organizational and informational meeting on May 8,
1996. The Biennial Report on Carcinogens (BRC) Subcommittee will
meet once or twice a year, in public session, to review nominations
for listing and/or delisting substances and to receive public
comments. A November 18 and 19, 1996, meeting will be the first
where review of nominations takes place. Finally, to broaden input
to preparation of the BRC, the NTP will use a number of mechanisms
to communicate to the public the revised criteria and the process
for listing and delisting substances in the BRC, and to solicit
nominations for listing or delisting. Announcements will be published
in the Federal Register and appropriate publications such
as the NIEHS journal, Environmental Health Perspectives,
and various trade publications and journals. Direct mailings from
the NTP Liaison Office will target persons and organizations who
have requested to be on a mailing list for NTP information and
specifically for information regarding the BRC. A list of new
petitions for listing or delisting, soliciting public comment,
will be disseminated through the same media.
November 18-19 Meeting
Pursuant to Public Law 92-463, notice is hereby given of the next
meeting of the NTP Board of Scientific Counselors' Biennial Report
on Carcinogens Subcommittee to be held in the Conference Center,
Building 101, South Campus, National Institute of Environmental
Health Sciences (NIEHS), 111 Alexander Drive, Research Triangle
Park, North Carolina. The meeting will begin at 8:30 a.m. and
is open to the public. The agenda topic is the peer review of
substances nominated for listing in the 8th Biennial Report
on Carcinogens. Also under review will be revisions to the
Introduction to the 8th BRC and changes to the structure of the
report. These include a.) the addition of a table of substances
considered, but rejected for inclusion in the BRC as known or
reasonably anticipated human carcinogens and b.) the addition
of a table of substances nominated but not yet reviewed for listing
in a subsequent Report. There will also be a review of the reference
in the draft 8th BRC Introduction to certain manufacturing processes
and occupations which the International Agency for Research on
Cancer (IARC) has determined are associated with increased incidences
of cancer in workers in these settings but which do not qualify
for formal review for BRC listing because no specific agent ,
substance or mixture has been identified with the exposures involved.
This will include a discussion of the appropriateness of having
this reference in the BRC and, if so, should it remain in the
Introduction or be listed separately in an appendix in the Report.
Tentatively scheduled to be peer reviewed on November 18-19 are
15 substances, listed alphabetically, along with supporting information
in the attached table. The order
of review is given in the far
right column of the table. Copies of the draft introduction for
the 8th BRC, or copies of a draft summary document which
contains the background data and information used to evaluate
the nomination for listing a substance may be obtained, as available,
from: Dr. C. W. Jameson, Biennial Report on Carcinogens, MD WC-05,
P.O. Box 12233, Research Triangle Park, NC 27709 (919/541-4096;
FAX 919/541-2242).
Public Comment
Persons wanting to make a formal presentation concerning proposed
changes to the BRC or regarding a particular nominated substance
must notify the Executive Secretary, Dr. Larry G. Hart, by telephone,
by FAX, or by mail (see contact information below) no later
than November 13, 1996. A written copy of comments is requested
in advance of the meeting so that copies can be distributed to
all Subcommittee members and staff and made available at the meeting.
Written statements should supplement and may expand upon the oral
presentation. Oral presentations must be limited to no more
than five minutes. In lieu of an oral presentation, written
statements may be submitted. These should be received by the Executive
Secretary by November 13
The program would welcome receiving carcinogenesis information
from completed, ongoing, or planned studies, as well as current
production data, human exposure information, and use patterns
for any of the substances listed in this announcement. Please
contact Dr. C. W. Jameson at the address given above.
Upon request the Executive Secretary, Dr. Larry G. Hart, P.O.
Box 12233, Research Triangle Park, North Carolina 27709 (telephone
919/541-3971; FAX 919/541-0295), will furnish an agenda and a
roster of Subcommittee members prior to the meeting. Summary minutes
subsequent to the meeting will be available upon request.
Dated: October 16, 1996
Kenneth Olden, Ph. D., Director
National Toxicology Program
[FR Doc 96-27325 Filed 10-23-96; 8:45 am,]
Billing Code 4140-01-M
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