National Toxicology Program

[Federal Register: May 7, 2001 (Volume 66, Number 88)]
[Notices]
[Pages 23037-23039]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

PUBLIC HEALTH SERVICE

National Toxicology Program

Meeting of the NTP Board of Scientific Counselors

Pursuant to Public Law 92-463, notice is hereby given of a meeting of the National Toxicology Program (NTP) Board of Scientific Counselors, U.S. Public Health Service, in Rooms A & B of the Rodbell Auditorium, Rall Building, South Campus, National Institute of Environmental Health Sciences (NIEHS), 111 T.W. Alexander Drive, Research Triangle Park, North Carolina on May 25, 2001.

The NTP Board of Scientific Counselors (the Board) is composed of scientists from the public and private sector and provides primary scientific oversight to the NTP.

Agenda

The May 25^th meeting is open to the public from 8:30 a.m. to adjournment with attendance limited only by the space available. A draft agenda with tentative schedule is provided below. Primary agenda topics include: 1) review and discussion of draft guidelines for the NTP Center for the Evaluation of Risks to Human Reproduction's (CERHR) expert panels, 2) the NTP Interagency Committee for Chemical Evaluation and Coordination's (ICCEC) testing recommendations for substances nominated for future NTP studies, 3) the NTP's tentative study plans for hexavalent chromium, and 4) presentations about chemical disposition and toxicokinetic studies of substances by the NTP and use of this data in pharmacokinetic modeling. There will also be updates on activities of the Board's Report on Carcinogens and Technical Reports Review Subcommittees. The Board will review a concept proposal for the continued use of a contract mechanism to investigate the mechanisms of toxicity, absorption, tissue distribution, metabolism and clearance of substances under study by the NTP. Time is allotted during the meeting for the public to present comments to the Board and NTP staff on agenda topics.

CERHR Draft Guidelines for Expert Panels

The Draft Guidelines are posted on the CERHR website (http://cerhr.niehs.nih.gov) or can be obtained in hard copy from the Executive Secretary (see below). Written public comments are being solicited on the Draft Guidelines (see the Federal Register notice posted on the NTP website: http://ntp.niehs.nih.gov/ntp, under Announcements or contact the Executive Secretary). Persons wishing to provide oral comments to the Board and/or NTP staff may register to do so as instructed below. However, if the public submits written comments in response to the Federal Register notice noted above, they are under consideration and do not need to be resubmitted or readdressed.

ICCEC Testing Recommendations for Substances Nominated for Future NTP Studies

Information about substances nominated to the NTP for toxicology and carcinogenesis studies and the ICCEC's testing recommendations are provided in the Federal Register notice dated December 4, 2000 (Vol. 65, No. 233, pages 75727-75730). The Federal Register notice and supporting documents for each nomination are available on the NTP website at /index.cfm?objectid=06F4DE1D-9952-BCFB-F0FDC83E3CDA5BBF or may be obtained by contacting the Executive Secretary. Substances under consideration are listed below.

Substances recommended for testing: Aluminum complexes found in drinking water (Aluminum fluoride and Aluminum citrate), Bilberry fruit extract, Black cohosh, Blue-Green algae (dietary supplement), Cefuroxime, Clarithromycin, D&C Red No. 27 and D&C Red No. 28, N,N-Dimethyl-p-toluidine, Lemon Oil and Lime Oil, Local anesthetics that metabolize to 2,6-xylidine or o-toluidine (Bupivacaine and Prilocaine), Microcystin-LR, Organotins occurring in drinking water (Monomethyltin trichloride, Dimethyltin dichloride, Monobutyltin trichloride, and Dibutyltin dichloride), All-trans-retinyl palmitate, S-Adenosylmethionine, and Senna.

Substances for which a testing recommendation is deferred pending receipt and consideration of additional information

: 1,3-Dichloropropane, 2,2-Dichloropropane, and 1,1-Dichloropropene; Hydergine; and Yohimbe bark extract and Yohimbine.

 

Hexavalent Chromium

A study of the carcinogenic potential of hexavalent chromium administered in drinking water (CAS number 18540-29-9) was nominated to the NTP by the California Congressional delegation, the California Environmental Protection Agency, and the California Health and Human Services Agency. Although hexavalent chromium is an established human lung carcinogen in certain occupational settings, presumably as a result of inhalation exposure, there is uncertainty regarding long-term consequences of exposure to hexavalent chromium compounds in the water supply. Toxicological data on the chronic toxicity and carcinogenicity of hexavalent chromium after oral exposure are largely inadequate to establish or characterize the hazard. The NTP will present to the Board tentative study plans for its review and comment. This meeting also provides an opportunity for the public to offer comment to the Board and NTP staff on any issues to be considered in the design of the NTP rodent study on the carcinogenic potential of hexavalent chromium administered in drinking water. Persons may register to provide oral comments or submit written comments as instructed below. A primary source of background material on hexavalent chromium is a document prepared by the California Environmental Protection Agency's (EPA) Office of Environmental Health Hazard Assessment entitled "Public Health Goal for Chromium in Drinking Water" and is available on the California EPA's website http://calepa.ca.gov/.

Public Comment Encouraged

Public input at the meeting is invited and time is set aside for the presentation of public comments on any agenda topic. At least seven minutes will be allotted to each speaker, and if time permits, may be extended to 10 minutes. Persons registering to make oral comments are asked to provide their name, affiliation, mailing address, phone, fax, e-mail, and sponsoring organization (if any). Each organization is allowed one time slot per agenda topic. To facilitate planning for the meeting, persons interested in providing formal oral comments are asked to notify Dr. Mary Wolfe, NTP Board Executive Secretary, NIEHS, P.O. Box 12233, MD A3-07, Research Triangle Park, NC 27709 (telephone 919-541-3971, fax 919-541-0295, and e-mail wolfe@niehs.nih.gov). Persons registering to make oral comments are asked, if possible, to provide a copy of their statement to the Executive Secretary by May 16, to enable review by the Board and NTP staff prior to the meeting. Written statements can supplement and may expand the oral presentation. Individuals will also be able to register to give oral public comments on-site at the meeting. However, if registering on-site and reading from written text, please bring 25 copies of the statement for distribution to the Board and NTP staff and to supplement the record.

Persons may also submit written comments in lieu of making oral comments. Written comments should be sent to the Executive Secretary and must be received by May 16, to enable review by the Board and NTP staff prior to the meeting as well as to supplement the record. Persons submitting written comments should include their name, affiliation, mailing address, phone, fax, e-mail, and sponsoring organization (if any) in the document.

Additional Information about Meeting

Prior to the meeting, a copy of the agenda and a roster of the Board's members will be available on the NTP website at http://ntp.niehs.nih.gov/ntp and upon request to the Executive Secretary (contact information provided above). Following the meeting, summary minutes will be prepared and available through the NTP website and upon request to Central Data Management, NIEHS, P.O. Box 12233, MD E1-02, Research Triangle Park, NC 27709; telephone 919-541-3419; fax 919-541-3687; and e-mail CDM@niehs.nih.gov.

NTP Board of Scientific Counselors

The Board is a technical advisory body comprised of scientists from the public and private sectors who provide primary scientific oversight to the overall Program and to the NTP Center for the Evaluation of Risks to Human Reproduction. 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 purposes of determining and advising on the scientific merit of its activities and their overall scientific quality. Its members are selected from recognized authorities knowledgeable in fields such as toxicology, pharmacology, pathology, biochemistry, epidemiology, risk assessment, carcinogenesis, mutagenesis, molecular biology, behavioral and neurotoxicology, immunotoxicology, reproductive toxicology or teratology, and biostatistics. The NTP strives for equitable geographic distribution and minority and female representation on the Board. Its members are invited to serve overlapping terms of up to four years and meetings are held once or twice annually for the Board and its two subcommittees (the Report on Carcinogens Subcommittee and the Technical Reports Review Subcommittee).

Dated: April 19, 2001

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

[Billing Code 4140-01-P]

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Preliminary Agenda National Toxicology Program (NTP) Board of Scientific Counselors May 25, 2001 National Institute of Environmental Health Sciences Rall Building, South Campus Rodbell Conference Auditorium, Rooms A & B Research Triangle Park, North Carolina
8:30 a.m.	Welcome and Opening Comments NTP Update Presentation on NTP Chemical Disposition and Toxicokinetic Studies Presentation on Pharmacokinetic Modeling of Compounds Studied by the NTP Concept Review (ACTION) NTP CERHR ¿ Draft Guidelines for Expert Panels and Public Comments
12:15 p.m.	Lunch
1:15 p.m.	ICCEC Testing Recommendations for Future NTP Studies and Public Comments Hexavalent Chromium and Public Comments NTP Board Subcommittee Reviews - Updates Report on Carcinogens Technical Reports Public Comments
4-4:30 p.m.	Adjourn

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