[Federal Register Volume 67, Number 160 (Monday, August 19, 2002)]
[Notices]
[Pages 53807-53810]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-20921]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service


National Toxicology Program; Notice of a 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 
on September 17-18, 2002, at the Radisson Governors Inn, 1-40 at Davis 
Drive, Exit 280, Research Triangle Park, North Carolina.
    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 meeting being held on September 17-18, 2002, is open to the 
public from 8:30 a.m. to adjournment each day with attendance limited 
only by the space available. Persons needing special assistance should 
contact the NTP Executive Secretary (contact information below). A 
draft agenda with tentative schedule is provided below. Primary agenda 
topics include: (1) A draft format for the NTP brief that will be part 
of the NTP-CERHR Monograph prepared on each chemical reviewed by the 
NTP Center for the Evaluation of Risks to Human Reproduction (CERHR); 
(2) a discussion of the proposed NTP

[[Page 53808]]

strategy for using genetically altered animals in carcinogen 
identification, (3) an overview of the NIEHS National Center for 
Toxicogenomics and its links with the NTP, and (4) recommendations of 
the NTP Interagency Committee for Chemical Evaluation and Coordination 
(ICCEC) for substances nominated to the NTP for study. There will also 
be an update about current NTP testing initiatives, the NTP Board of 
Scientific Counselors Technical Reports Review Subcommittee meeting on 
the September 5-6, 2002, and the status of the 10th and 11th Editions 
of the Report on Carcinogens. The Board will review a concept proposal 
for the continued use of a contract mechanism to investigate potential 
genetic toxicity 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.

NTP-CERHR Monograph

    The NTP Center for the Evaluation of Risks to Human Reproduction 
(CERHR) serves as an environmental health resource to the public and to 
regulatory and health agencies for scientifically based, uniform 
assessments of the potential for adverse effects on reproduction and 
development caused by agents to which humans are exposed. Additional 
information about the CERHR is available at http://cerhr.niehs.nih.gov.
    As a final step in its evaluation of a chemical, the CERHR will 
prepare an NTP-CERHR Monograph. The monograph will include an NTP 
brief, the expert panel's report on the chemical, and all public 
comments received on the expert panel report. The NTP brief provides 
the NTP's interpretation of the potential for exposure to the chemical 
to adversely affect reproduction and/or development in humans. NTP-
CERHR monographs will be made publicly available.
    As a prototype for the NTP-CERHR Monograph, the CERHR has available 
the draft NTP-CERHR Monograph on Di-n-butyl Phthalate (DBP) and will 
request comment from the Board on the proposed format for the NTP 
brief. The CERHR is interested in obtaining input about the brief's 
layout and presentation of information, it clarity, and its utility for 
the public. The draft monograph is available on the NTP-CERHR Web site 
(http://cerhr.niehs.nih.gov) or by contacting the NTP Executive 
Secretary.

NTP Draft Strategy for Using Genetically Altered Animals in Carcinogen 
Identification

    The NTP has developed a proposed draft strategy for the routine use 
of genetically altered animals in carcinogen identification. The NTP is 
seeking broad external input on this strategy and will present it to 
the Board for review and comment. This meeting also provides an 
opportunity for the public to offer comment to the Board and NTP staff 
on the proposed draft strategy. The draft strategy is available on the 
NTP Web site (http://ntp-server.niehs.nih.gov, see What's New, Meeting 
of the NTP Board of Scientific Counselors) or by contacting the NTP 
Executive Secretary (contact information below).

Toxicogenomics

    With the advent of novel molecular technologies, the NTP is moving 
into the arena of toxicogenomics, a new scientific field that examines 
how the entire genome is involved in biological responses of organisms 
exposed to environmental toxicants. Toxicogenomics studies the effect 
of toxicants on gene activity and specific proteins produced by genes 
in response to those toxicants.
    In an effort toward centralizing activities in toxicogenomics, the 
NIEHS/NIH established the National Center for Toxicogenomics (NCT) in 
September 2000. The NCT's mission is to coordinate a nationwide 
research effort for the development of a toxicogenomics knowledge base. 
Additional information about the NCT is available on the NIEHS Web site 
at  http://www.niehs.nih.gov/nct or by contacting the NTP Executive 
Secretary (contact information below). The NTP will describe some of 
its current efforts to incorporate toxicogenomics into its testing 
strategies through interactions with the NCT.

NTP Testing Program

Overview of Current Initiatives
    The NTP seeks to maintain a balanced research and testing program 
that provides data addressing a wide variety of issues of importance to 
public health. Currently the NTP is focusing on several areas that have 
received inadequate attention in the past: for example, photoactive 
chemicals, contaminants of finished drinking water, endocrine-
disrupting agents, and certain occupational exposures. The NTP is 
addressing potential safety issues associated with herbal medicines, 
radiofrequency radiation emissions from cellular telephones, hexavalent 
chromium, and DNA-based therapies. In general, these initiatives are 
broad-based and include the investigation of various health-related 
endpoints. Additional information about some current initiatives is 
available in the NTP Booklet, Current Directions and Evolving 
Strategies, available on the NTP Web site (http://ntp-server.niehs.nih.gov, select Publications).
ICCEC Recommendations for Substances Nominated for Future NTP Studies
    Information about substances nominated to the NTP for toxicology 
and carcinogenesis studies and the ICCEC's recommendations was 
published in the Federal Register on June 12, 2002 (Vol. 67, No. 113, 
p. 40329-33). This notice is available on the Web (http://ntp-server.niehs.nih.gov/htdocs/Liason/ICCECFinal02JuneFR.html) along with 
supporting documents for each nomination (http://ntp-server.niehs.nih.gov/htdocs/liason/BkgrSum02June.html) or by contacting 
the NTP Executive Secretary (contact information below). This meeting 
provides an additional opportunity for the public to provide comment on 
these nominations and study recommendations to the Board and NTP staff. 
Comments submitted to the NTP in response to the June 2002 Federal 
Register notice are under consideration and do not need to be 
resubmitted or readdressed.
    Substances recommended for study:
     Abrasive blasting agents--5 different industrial materials 
used as alternatives to sand.
     5-Amino-o-cresol--permanent hair dye ingredient.
     tert-Butyl hydroperoxide--high production volume 
industrial catalyst.
     Chloramine-T and p-Toluenesulfonamide--active ingredient 
and metabolite of therapeutant used in aquaculture to control bacterial 
infections.
     Cobalt metal dust--important industrial material linked to 
lung problems in workers.
     Ephedrine alkaloid dietary supplements--widely used in 
herbal dietary supplements with numerous reports of adverse effects.
     Ethanone, 1-(1,2,3,4,5,6,7,8-octahydro-2,3,8,8-
tetramethyl-2-naphthalenyl)-(Iso-E-Super)--high-production-volume 
fragrance material.
     Hexafluorosilicic acid and Sodium hexafluorosilicate--
primary agents used to fluoridate public drinking water system.
     Ketamine hydrochloride--approved anesthetic drug that 
causes brain lesions in developing rats.
     Mercury, ((o-carboxyphenyl)thio)ethyl-, sodium salt 
(Thimerosal)--organomercuryl-based

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preservative used in vaccines and other biological products.
     Nitrogen trifluoride--cleaning and etching agent in the 
semiconductor industry.
     Sodium metasilicate--industrial cleaning agent.
     Turpentine--high-production-volume industrial solvent and 
raw material.
     Welding fumes--variable composition mixture responsible 
for respiratory and other adverse effects in exposed workers.
    Nominations for which no studies are recommended at this time:
     Hexachloro-1,3-butadiene--industrial by-product and 
persistent environmental contaminant.
     Infrasound--low frequency acoustic energy present at low 
levels in community and occupational settings.
     Magnesium oxide--high-production-volume chemical with 
numerous industrial uses.
     Methylolurea--starting material for and impurity in urea-
formaldehyde resins.
     4-Methylquinoline--environmental pollutant structurally 
related to the rodent carcinogen quinoline.

Public Comment Encouraged

    Public input at this meeting is invited and time is set aside for 
the presentation of public comments on any agenda topic. At least 7 
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-
541-0530; and e-mail: ([email protected]) by September 10, 2002. 
Persons registering to make oral comments are asked, if possible, to 
provide a copy of their statement to the Executive Secretary by 
September 10th, 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 September 10th to enable review by the Board 
and NTP staff prior to the meeting. Persons submitting written comments 
should include their name, affiliation, mailing address, phone, fax, e-
mail, and sponsoring organization (if any) with the document.

Registration

    The NTP Board of Scientific Counselors meeting is open to the 
public. Attendance at this meeting is limited only by the space 
available. Due to changes in security policies at the NIEHS, 
individuals who plan to attend are asked to register with the NTP 
Executive Secretary (see contact information above). The names of those 
registered will be given to the NIEHS Security Office in order to gain 
access to the campus. Persons attending who have not pre-registered may 
be asked to provide pertinent information about the meeting, i.e., 
title or host of meeting before gaining access to the campus. All 
visitors (whether or not you are pre-registered) will need to be 
prepared to show 2 forms of identification (ID), i.e., driver's license 
and one of the following: company ID, government ID, or university ID. 
Also, those planning to attend who need special assistance are asked to 
notify the NTP Executive Secretary in advance of the meeting (see 
contact information above).

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 email [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 twice annually for the Board and its two subcommittees 
(the Report on Carcinogens Subcommittee and the Technical Reports 
Review Subcommittee).

    Dated: August 12, 2002.
Samuel Wilson,
Deputy Director, National Toxicology Program.

Preliminary Agenda--National Toxicology Program (NTP) Board of 
Scientific Counselors, September 17-18, 2002

Radisson Governors Inn, 1-40 at Davis Drive, Exit 280, Research 
Triangle Park, North Carolina

September 17, 2002

8:30 a.m. Welcome and Opening Comments

NTP Update
NTP-CERHR Monograph: Format of Draft NTP Brief
     Public Comments
NTP Draft Strategy for Using Genetically Altered Animals in 
Carcinogen Identification
     Evaluation of Transgenic Models for Use in Carcinogen 
Identification
     NTP Draft Strategy
     Agency Comments
     Public Comments

11:30 a.m.--Lunch

1 p.m. --NTP Draft Strategy (continued)

Toxicogenomics
     Overview of the National Center for Toxicogenomics 
(NCT)
     Links between the NCT and NTP
     Public Comments

5 p.m.--Adjourn

September 18, 2002

8:30 a.m.--Welcome and Introductions

NTP Testing Program
     Overview of Current Initiatives
     Testing Recommendations from the Interagency Committee 
for Chemical Evaluation
     Public Comments
Concept Review
Update on the NTP Technical Reports Review Subcommittee Meeting
Update on the Report on Carcinogens
Public Comments

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Noon--Adjourn

[FR Doc. 02-20921 Filed 8-16-02; 8:45 am]
BILLING CODE 4140-01-P