[Federal Register Volume 66, Number 88 (Monday, May 7, 2001)]
[Notices]
[Pages 23037-23039]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-11391]


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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 25th 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.

[[Page 23038]]

CERHR Draft Guidelines for Expert Panels

    The Draft Guidelines are posted on the CERHR web site (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 
web site: http://ntp-server.niehs.nih.gov, 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 web 
site at http://ntp-server.niehs.nih.gov/htdocs/liason/ICCEC102700finalFR.html 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 web site 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 [email protected]). 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 web site at http://ntp-server.niehs.nih.gov and upon request to the Executive Secretary 
(contact information provided above). Following the meeting, summary 
minutes will be prepared and available through the NTP web site 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 [email protected].

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

[[Page 23039]]

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,
Deputy Director, National Institute of Environmental Health Sciences.

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 & BResearch 
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
    Public Comments
12:15 p.m.
    Lunch
1:15 p.m.
    ICCEC Testing Recommendations for Future NTP Studies
    Public Comments
    Hexavalent Chromium
    Public Comments
    NTP Board Subcommittee Reviews--Updates
     Report on Carcinogens
     Technical Reports
    Public Comments
4-4:30 p.m.
    Adjourn

[FR Doc. 01-11391 Filed 5-4-01; 8:45 am]
BILLING CODE 4140-01-P