National Toxicology Program

[Federal Register: November 11, 2004 (Vol. 69, No. 219)]
[Notices]
[Pages 65613-65615]

PDF version of this document

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service

National Toxicology Program

National Toxicology Program (NTP) Board of Scientific Counselors Technical Reports Review Subcommittee Meeting; Review of Draft NTP Technical Reports

Pursuant to Public Law 92-463, notice is hereby given of the next meeting of the NTP Board of Scientific Counselors Technical Reports Review Subcommittee ("TRR Subcommittee") on December 9-10, 2004, in the Rodbell Auditorium, Rall Building at the National Institute of Environmental Health Sciences, 111 T. W. Alexander Drive, Research Triangle Park, NC 27709. The meeting will begin each day at 8:30 a.m. The meeting is open to the public with attendance limited only by the space available (see "Attendance, Registration, and Remote Access" below).

AGENDA

The primary agenda topic is the peer review by the TRR Subcommittee of the findings and conclusions of seven draft NTP Technical Reports (TR) of rodent toxicology and carcinogenesis studies conducted by the NTP (see Preliminary Agenda below). There will also be a presentation on how the NTP handles contaminants in study materials and their impact on the interpretation of 2-year bioassays. In addition, at the request of the NTP Board of Scientific Counselors, the TRR Subcommittee will readdress the title of the Draft NTP Technical Report on Anthraquinone (see minutes from the NTP Board of Scientific Counselors meeting held June 29, 2004, available at http://ntp.niehs.nih.gov/ntpweb/index.cfm?objectid=720164E3-BDB7-CEBA-F338FA2626639D56. As an introduction to the reports on the studies of polychlorinated biphenyl (PCB), a short presentation will be given on the use of Toxic Equivalency Factors (TEFs). The TEF methodology was developed as a mathematical tool that ranks the dioxin-like activity of a compound relative to 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD), the most potent dioxin. This methodology has been applied to the NTP studies reported in TR 531: Mixture of 3,3',4,4',5-Pentachlorobiphenyl (PCB 126) and 2,3',4,4',5- Pentachlorobiphenyl (PCB 118), TR 529: 2,2',4,4',5,5'-Hexachlorobiphenyl (PCB 153), and TR 530: Mixture of PCB 126 and PCB 153.

A copy of the agenda, TRR Subcommittee roster, and the draft NTP Technical Reports, as available, will be posted on the NTP website (http://ntp.niehs.nih.gov/ under Latest News) and will be available upon request to the NTP Executive Secretary, Dr. Barbara S. Shane (PO Box 12233, 111 T.W. Alexander Dr., MD A3-01, Research Triangle Park, NC 27709, T: 919-541-4253; F: 919-541-0295; e-mail: shane@niehs.nih.gov). Following the meeting, summary minutes will be available on the TRR Subcommittee website (see http://ntp.niehs.nih.gov/ntpweb/index.cfm?objectid=227FC084-EB0C-7E93-9DCD6F03104F0D22) and in hard copy upon request to the NTP Executive Secretary.

DRAFT REPORTS AVAILABLE FOR PUBLIC REVIEW AND COMMENT

Approximately four weeks prior to the meeting, the draft reports will be available for public review, through the NTP web page (http://ntp.niehs.nih.gov/ under Latest News). Printed copies of the Draft NTP Technical Reports can be obtained, as available, from Central Data Management (NIEHS, PO Box 12233, MD EC-03, Research Triangle Park, NC 27709, T: 919-541-3419, F: 919-541-3687, e-mail: CDM@niehs.nih.gov).

ATTENDANCE, REGISTRATION AND REMOTE ACCESS

The meeting is open to the public with attendance limited only by the space available. Individuals who plan to attend are strongly encouraged to register with the NTP Executive Secretary by December 2, 2004 to ensure easy access to the NIEHS campus (contact information above) or online on the NTP website (http://ntp.niehs.nih.gov under Latest News). Please note that a photo ID is required to access the NIEHS campus. Persons needing special assistance, such as sign language interpretation or other reasonable accommodation in order to attend are asked to notify the NTP Executive Secretary at least seven business days in advance of the meeting. The NTP is also making plans to videocast the TRR Subcommittee meeting through the Internet at http://www.niehs.nih.gov/news/video/. The NTP cannot guarantee the technical quality of the video casting and people wishing to use this option are encouraged to test their ability to access the video cast at the above Internet address under Check your live video setup.

PUBLIC COMMENT

Comments on any of the Draft NTP Technical Reports are welcome. Time will be provided at the meeting for oral public comment on the reports. Persons requesting time for an oral presentation on a particular report are asked to notify the NTP Executive Secretary (contact information given above) by December 2, 2004, and to provide their contact information (name, affiliation, mailing address, phone, fax, e-mail), and supporting organization (if any). Persons registering to make comments are asked to provide a written copy of their statement to the NTP Executive Secretary on or before December 2, 2004, to enable review by the TRR Subcommittee and NTP staff prior to the meeting. These statements can supplement or expand an oral presentation. Each speaker will be allotted at least 7 minutes and, if time permits, up 10 minutes for presentation of oral comments. Each organization is allowed one time slot per report being reviewed. Registration for making public comments will also be available on-site. If registering on-site to speak and reading comments from printed text, the speaker is asked to provide 25 copies of the statement for distribution to the Subcommittee and NTP staff, and to supplement the record.

Written comments without an oral presentation at the meeting are also welcome. Comments should include contact information for the submitter (name, affiliation, mailing address, phone, fax, and e-mail) and supporting organization (if any). Written comments should be received by the NTP Executive Secretary on or before December 2, 2004, to enable distribution to the Subcommittee and NTP staff for their review and consideration prior to the meeting. Written comments received in response to this notice will be posted on the NTP website (http://ntp.niehs.nih.gov under Latest News).

REQUEST FOR ADDITIONAL INFORMATION

The NTP would welcome receiving toxicology and carcinogenesis information from completed, ongoing or planned studies as well as current production data, human exposure information, and use patterns for any of the chemicals listed in this announcement. Please send this information to Central Data Management at the address given above and it will be forwarded to the appropriate NTP staff.

NTP TECHNICAL AND TOXICITY REPORT SERIES

The NTP conducts toxicology and carcinogenesis studies of agents of public health concern. Any scientist, organization, or member of the public may nominate a chemical for NTP testing. Details about the nomination process are available on the NTP website (http://ntp.niehs.nih.gov under Nominations to the Testing Program). The results of short-term rodent toxicology studies are published in the NTP Toxicity Report series. Longer-term studies, generally, rodent carcinogenicity studies, are published in the NTP Technical Report series. The NTP has a new technical report series for studies conducted in genetically modified models. PDF files of completed reports are available free-of-charge at the NTP website (http://ntp.niehs.nih.gov/index.cfm?objectid=084801F0-F43F-7B74-0BE549908B5E5C1C).

NTP BOARD OF SCIENTIFIC COUNSELORS

The NTP Board of Scientific Counselors ("the Board") is a technical advisory body composed of scientists from the public and private sectors who provide primary scientific oversight and peer review to the NTP. Specifically, the Board advises the NTP on matters of scientific program content, both present and future, and conducts periodic review of the program for the purpose of determining and advising on the scientific merit of its activities and overall scientific quality. The TRR Subcommittee of the Board provides scientific peer review of the findings and conclusions of NTP Technical Reports. The Report on Carcinogens Subcommittee of the Board provides scientific peer review of nominations to the Report on Carcinogens, a Congressionally mandated listing of agents known or reasonably anticipated to be human carcinogens.

The Board's members are selected from recognized authorities knowledgeable in fields, such as toxicology, pharmacology, pathology, biochemistry, epidemiology, risk assessment, carcinogenesis, mutagenesis, molecular biology, behavioral toxicology, neurotoxicology, immunotoxicology, reproductive toxicology or teratology, and biostatistics. The NTP strives for equitable geographic distribution and for minority and female representation on the Board.

Dated: November 5, 2004

Samuel H. Wilson, M.D.
Deputy Director
National Institute of Environmental Health Sciences

[Billing Code 4140-01-P]

PRELIMINARY AGENDA

National Toxicology Program (NTP) Technical Reports (TR) Scheduled for Review by the NTP Board of Scientific Counselors Technical Reports Review Subcommittee
December 9-10, 2004
Rodbell Auditorium
National Institute of Environmental Health Sciences
111 TW Alexander Drive, Research Triangle Park, NC

1. Overview of Dioxin Toxic Equivalency Factors (TEFs)
2. TR 531: Mixture of 3,3',4,4',5-Pentachlorobiphenyl (PCB 126) and 2,3',4,4',5- Pentachlorobiphenyl (PCB 118) (CAS Nos. 57465-28-8 and 31508-00-6, respectively)
   • No longer used commercially; persistent polyhalogenated aromatic hydrocarbons present in the environment.
3. TR 529: 2,2',4,4',5,5'-Hexachlorobiphenyl (PCB 153) (CAS No. 35065-27-1)
   • No longer used commercially; persistent polyhalogenated aromatic hydrocarbon present in the environment.
4. TR 530: Mixture of PCB 126 and PCB 153 (CAS No: 57465-28-8 and 835065-27-1, respectively)
   • No longer used commercially; persistent polyhalogenated aromatic hydrocarbons present in the environment.
5. Discussion on Contaminants in NTP Study Materials: Impact on Interpretation of 2-year Bioassays
   • Discussion of the Title of Draft NTP Technical Report on Anthraquinone (TR-494)
6. TR 517: Sodium Chlorate (CAS No. 7775-09-9)
   • Oxidizing agent, precursor in the synthesis of chlorine dioxide; found as byproduct in water disinfected with chlorine dioxide
7. TR 532: Bromodichloromethane (CAS No. 75-27-4)
   • Water disinfectant by-product
8. TR 522: 3'-Azido-3'-thymidine (AZT) (CAS No. 30516-87-1) Chemotherapeutic agent for treatment of people with acquired immune deficiency syndrome (AIDS)
   • Chemotherapeutic agent for treatment of people with acquired immune deficiency syndrome (AIDS)
9. TR 533: Benzophenone (CAS No. 119-61-9)
   • Photoinitiator fragrance enhancer, ultraviolet curing agent, intermediate in the manufacture of agricultural chemicals.