National Toxicology Program

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.

Attachment

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