National Toxicology Program

[Federal Register: October 2, 1997 (Volume 62, Number 191)]
[Notices]
[Page 51674-51675]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Toxicology Program

National Toxicology Program (NTP) Board of Scientific Counselors' Meeting; Review of Substances for Listing in or Delisting from the 9th Report on Carcinogens

Pursuant to Public Law 92-463, notice is hereby given of the next meeting of the NTP Board of Scientific Counselors' Report on Carcinogens Subcommittee to be held on October 30 & 31, 1997, 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 are the peer review of substances nominated for listing in or delisting from the 9th Report on Carcinogens (formerly the Biennial Report on Carcinogens), and provision of an opportunity for public input.

Background
Over the past three years, there was an extensive public and Federal interagency review of the process for the preparation of the Report on Carcinogens (RC) to broaden input to its preparation, broaden the scope of scientific review, and provide review of the criteria used for inclusion in or removal of substances from the Report. As a result, the criteria were revised and approved in September 1996 by the Secretary, Department of Health and Human Services. The major change in the RC 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 substances in or delist substances from future volumes. To broaden the scope of scientific review, a new standing subcommittee of the NTP Board of Scientific Counselors was established. A November 1996 meeting of the Report on Carcinogens (RC) Subcommittee was the first where public review of nominations took place, and using the revised criteria. Thus, the current review process for review of petitions considered by the NTP for listing in or delisting from the Report begins with initial scientific review by the NIEHS/NTP Report on Carcinogens Review Committee (RG1). The RG1 makes a formal recommendation for those petitions determined to contain sufficient information for listing or delisting in the Report. The second scientific review 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 NTP Executive Committee. Following external scientific peer review by the RC Subcommittee in public session and solicitation of public comments through announcements in the Federal Register and other media, the independent recommendations of the three 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 the final decision to submit the Report to the Secretary for review and approval.

Agenda
Tentatively scheduled to be peer reviewed on October 30 & 31, are 14 agents, substances, mixtures or exposure circumstances listed alphabetically, along with supporting information in the attached table. The table lists the nominations in the tentative order of their presentation and review, and gives their primary uses or exposures and the category for which they were originally nominated. Background summary documents on each of the substances will be provided to reviewers around October 1, and will be available to the public at that time as well. Background documents include 1) a summary of the background data and information used to evaluate the nomination, and 2) the recommendation for: listing as "known to be a human carcinogen" or as "reasonably anticipated to be a human carcinogen"; the upgrading of a current listing; or the removal from the Report. Copies of draft background documents can be obtained, as available, from: the 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.

Public Input Encouraged
The entire meeting is open to the public and time will be provided for public comment on each of the substances being reviewed. In order to facilitate planning for the meeting, persons wanting to make a formal presentation regarding a particular nominated substance must notify the Executive Secretary by telephone, by FAX, by mail, or by email no later than October 23, 1997, and provide a written copy 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 October 27 so copies can be made for distribution to Subcommittee members and staff and made available for the public Oral presentations should be limited to no more than five minutes. Should the requests for time exceed the likely available time, the time may have to be limited to three minutes and presenters will be contacted.

The program would welcome receiving carcinogenesis information from completed, ongoing, or planned studies by others, 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, Report on Carcinogens, MD EC-14, P.O. Box 12233, Research Triangle Park, NC 27709 (919/541-4096; FAX 919/541-2242).

The Executive Secretary, Dr. Larry G. Hart, at the address given above, will furnish agenda and a roster of Subcommittee members prior to the meeting. Summary minutes subsequent to the meeting will be available upon request.

Attachment

Dated: September 23, 1997

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

Attachment

[Billing Code 4140-01-P]