National Toxicology Program (NTP) Board of Scientific Counselors' Meeting; Review of Nominations for Listing in the 11th 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 (“the NTP RoC Subcommittee”) to be held on November 19 & 20, 2002, at the Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814. On November 19, registration will begin at 9 a.m. and the meeting will begin at 9:30 a.m. On November 20, 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 10 nominations for possible listing in the 11th 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 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, mixtures 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 listings from the RoC. The current criteria for listing in or delisting from the report is available on the Internet at the following website: http://ntp-server.niehs.nih.gov/NewHomeRoc/ListingCriteria.html,, or can be obtained in hard copy by contacting Dr. Jameson at the address listed below. 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 (RG2) is comprised of representatives from the Federal health research and regulatory agencies that are members of the NTP Executive Committee. The third step is external public peer review by the NTP RoC Subcommittee. Following completion of these reviews 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 substances or exposure circumstances in the RoC. The Secretary has final review and approval for the 11th RoC.

Agenda

The meeting of the NTP RoC Subcommittee is scheduled for November 19 & 20, 2002. Tentatively scheduled to be peer reviewed are 10 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 a summary of the scientific data and information being used to evaluate the nomination. A copy of the draft background summary document for each of these nominations is available electronically through the NTP's homepage at http://ntp-server.niehs.nih.gov/ (select Report on Carcinogens) or can be obtained on CD or in hard copy, as available, from: Dr. C.W. Jameson, Report on Carcinogens, NIEHS, MD EC-14, 79 Alexander Drive, Building 4401, Room 3118, P.O. Box 12233, Research Triangle Park, NC 27709 (919/541-4096; FAX 919/541-0144; email jameson@niehs.nih.gov).

Previous announcements in the Federal Register (July 24, 2001: Volume 66, Number 142, Pages 38430-38432 and March 28, 2002: Volume 67, Number 60, Page 14957) called for public comments on the nominations to be reviewed for possible listing in the 11th RoC. These announcements identified a total of 17 nominations. This review by the NTP RoC Subcommittee is for the first set of 10 nominations identified in those Federal Register announcements that have completed review by the RG1 and the RG2. The remaining 7 nominations for the 11th RoC will be reviewed by the NTP RoC Subcommittee in 2003. The date and details about that meeting will be published in a future Federal Register notice.

Solicitation of Public Comment

The NTP RoC Subcommittee meeting is open to the public, and time will be provided for oral 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, A3-01, Research Triangle Park, NC 27709 (telephone 919/541-3971; FAX 919/541-0295; email wolfe@niehs.nih.gov) no later than November 4, 2002. Each organization is allowed one time slot for an oral presentation per nomination. Persons registering to make comments are asked to provide, if possible, a written copy of their statement by November 4th so copies can be made and distributed to NTP RoC Subcommittee members 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 7 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 November 4th 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. Time allowed for presentation by on-site registrants may be less then that for preregistered speakers and will be determined by the number who have registered at the meeting. 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 NTP RoC Subcommittee members and supplement the record. All comments received in response to this Federal Register notice will be posted on the NTP RoC web site.

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 November 4, 2002 for distribution to the NTP RoC Subcommittee. Written comments received after November 4th will not be considered by NTP RoC Subcommittee members in their reviews.

Solicitation of Additional Information

The NTP would welcome receiving information from completed 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 NTP RoC Subcommittee members will be available prior to the meeting on the NTP homepage at http://ntp-server.niehs.nih.gov/ and upon request from Dr. Wolfe. Following the meeting, summary minutes will also be available on the NTP web site ( http://ntp-server.niehs.nih.gov , select Meetings) and upon request from Dr. Wolfe.