National Toxicology Program

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 2 & 3, 1998, 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. both days and is open to the public. The agenda topics are the peer review of substances, mixtures, or exposure circumstances nominated for listing in or delisting from the 9th Report on Carcinogens , and the provision of the opportunity for public input.

The process for preparation of the Report on Carcinogens (RoC) has three levels of scientific peer review. Central to the evaluations of the review groups is the use of revised criteria, for inclusion in or removal of substances from the Report, which were approved by the Secretary, Department of Health and Human Services (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 volumes. To broaden the scope of scientific review and broaden input to preparation of the Report, a new standing subcommittee of the NTP Board of Scientific Counselors was established in 1996. The meeting on December 2 & 3 will be the third meeting at which the RoC Subcommittee has conducted public review of nominations. The current review process for review of petitions considered by the NTP for listing in or delisting from the RoC begins with initial scientific review by the NIEHS/NTP Report on Carcinogens Review Committee (RG1). The RG1 is comprised of NIEHS/NTP staff scientists. The second scientific review phase is done by the NTP Executive Committee’s Working Group for the Report on Carcinogens (RG2). RG2 is comprised of representatives of the Federal health research and regulatory agencies on the Executive Committee. The third level of review is the external public review by the RoC Subcommittee and includes time for public comments. 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. The Director, NTP, receives the four independent recommendations and makes NTP recommendations regarding listing or delisting to the Secretary, DHHS.

Tentatively scheduled to be peer reviewed on December 2 & 3 are 11 nominations. An alphabetical listing of the nominations with supporting information follows this announcement. The table notes the tentative order of presentation and review in the right hand column, and gives primary uses or exposures and the category for which they were originally nominated. Draft background documents on each of the nominations will be provided to Board Subcommittee reviewers around November 1. Paper copies of draft background documents can be obtained, as available, from: the Board Executive Secretary, Dr. Larry G. Hart, P.O. Box 12233, Research Triangle Park, NC 27709 (telephone 919/541-3971; FAX 919/541-0295; email hart@niehs.nih.gov.)

The entire meeting is open to the public and time will be provided for public comment on each of the nominations being reviewed. In order to facilitate planning for the meeting, persons wanting to make a formal presentation regarding a particular nomination must notify the Executive Secretary by telephone, by FAX, by mail, or by email no later than November 30, 1998, and, if possible, provide a written copy of their statement in advance of the meeting. Written statements should supplement and may expand on the oral presentation, or may be submitted in lieu of an oral presentation, and should be received by November 30 so copies can be made for distribution to Subcommittee members and staff and made available for the public. All attempts will be made to send statements received by November 24 to Subcommittee members in advance of the meeting. Oral presentations must be limited to no more than five minutes.

Upon request, the Executive Secretary, Dr. Larry G. Hart, at the address given above, will furnish the 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, 1998

_______________________
Samuel H. Wilson, M.D.
Deputy Director
National Toxicology Program

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