[Federal Register Volume 65, Number 81 (Wednesday, April 26, 2000)]
[Notices]
[Pages 24495-24497]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-10414]


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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 the Rodbell Auditorium, 
Building 101, South Campus, National Institute of Environmental Health 
Sciences (NIEHS), 111 T.W. Alexander Drive, Research Triangle Park, 
North Carolina, on May 24, 2000.
    The NTP Board of Scientific Counselors is composed of scientists 
from the public and private sector. The Board provides primary 
scientific oversight to the NTP.

Agenda

    The meeting is open to the public from 8:30 a.m. to adjournment 
with attendance limited only by space available. A draft agenda with a 
tentative schedule is provided below. There are three primary agenda 
topics: (1) An update on the NTP Center for the Evaluation of Risks to 
Human Reproduction (CERHR) including a discussion of its progress, the 
phthalates review, and its procedures for nomination, selection and 
review of chemicals; (2) presentations about current initiatives for 
NTP toxicology studies; and (3) recommendations of substances by the 
Interagency Committee for future NTP studies. Also in the afternoon, 
there will be reports on activities of the Report on Carcinogens and 
Technical Reports Review Subcommittees. The Board will review a concept 
proposal for the continued use of a contract mechanism to perform NTP 
toxicology and carcinogenesis studies.
    Information about the CERHR including the chemicals currently under 
consideration for Expert Panel evaluation and the evaluation process 
are described in a Federal Register notice [March 20, 2000, Volume 65, 
Number 54, pages 14997-14998]. The opportunity for submission of 
written public comments on those candidate chemicals is provided 
through May 4, 2000. A copy of this notice is available on-line at the 
NTP web site (http://ntp-server.niehs.nih.gov) and CERHR web site 
(http://cerhr.niehs.nih.gov) or by contacting the Executive Secretary 
(address given below). The chemicals under consideration include: 1-
Bromopropane, 2-Bromopropane, Dimethyl Methyl Phosphonate, Ethylene 
glycol, Glycol ethers, Glyphosate, Methanol, Nicotine, Phenol, 
Thimerosal, and Toluene. This meeting provides an additional 
opportunity for the public to present any comments to the NTP Board of 
Scientific Counselors and NTP staff. However, if written comments were 
submitted in response to the March 20th Federal Register announcement 
they are being considered and do not need to be resubmitted or 
readdressed.
    The NTP has a broad mandate to provide toxicological 
characterization for chemicals and agents of public health concern and 
strives to balance the selection of agents for study. Current NTP 
initiatives include water disinfection by-products, DNA-based products, 
herbal/dietary supplements, phototoxicology studies and occupational 
exposures and mixtures.
    Information about substances nominated to the NTP for toxicology 
studies and recommendations for testing by the NTP Interagency 
Committee for Chemical Evaluation and Coordination (ICCEC) are provided 
in the Federal Register notice dated March 2, 2000 (Volume 65, Number 
42, Pages 11329-11331). The opportunity for submission of written 
public comments on those candidate chemicals is provided through April 
30, 2000. Substances currently under consideration include: Substances 
recommended for testing: 1-Bromopropane and 2-Bromopropane, Chitosan, 
DNA-based products, Juglone, Potassium ferricyanide, and Radio 
frequency radiation emissions of wireless communication devices; 
Substances for which no testing is recommended at this time: Cafestol 
and Plumbagin; Substances for which a testing recommendation is 
deferred pending receipt and consideration of additional information: 
Ethylenebis(tetrabromo-phthalimide), Terpinolene, Tetrabromophthalic 
anhydride, and Texanol benzyl phthalate. Testing recommendations from 
the ICCEC are given in the referenced Federal Register notice. This 
meeting provides an additional opportunity for the public to comment to 
the NTP Board and staff. However, if written comments were submitted in 
response to the March 2nd Federal Register announcement, they are under 
consideration and do not need to be resubmitted or readdressed.

Public Comment Encouraged

    Public input at the meeting is welcome and time is set aside in the 
agenda for presentation of public comments on any agenda topic. Seven 
minutes are allotted for each formal oral presentation. To facilitate 
planning for the meeting, persons interested in providing formal 
written or oral comments are asked to notify the Executive Secretary, 
Dr. Mary S. Wolfe, NIEHS, P.O. Box 12233 MD A3-07, Research Triangle 
Park, NC 27709 (telephone 919/541-3971, fax 919/541-0295, and email 
<a href="/cdn-cgi/l/email-protection#e691898a8083a6888f838e95c8888f8ec8818990"><span class="__cf_email__" data-cfemail="6e190102080b2e00070b061d4000070640090118">[email protected]</span></a>). Written comments submitted for consideration by 
the Board and NTP staff prior to the meeting must be received by May 
15, 2000. Persons wishing to register to make a formal presentation 
during a public comment period are asked to notify the Executive 
Secretary preferably no later than May 22, 2000, and, if possible, to 
provide a copy of the statement in advance of the meeting for 
distribution to the Board and NTP staff. 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 to the meeting for distribution to the 
Board and NTP staff and to supplement the record. Persons registering 
to make oral comments or submitting written comments are asked to 
provide their name, affiliation, mailing address, phone, fax, e-mail, 
and sponsoring organization (if any).

Additional Information About Meeting

    Prior to the meeting, a copy of the agenda and a roster of the 
Board members will be available from the Executive Secretary. Following 
the meeting, summary minutes will be prepared and available 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 <a href="/cdn-cgi/l/email-protection#3d7e79707d535458554e13535455135a524b"><span class="__cf_email__" data-cfemail="2b686f666b45424e435805454243054c445d">[email protected]</span></a>.


[[Page 24496]]


    Dated: April 19, 2000.
Samuel H. Wilson,
Deputy Director, National Institute for Environmental Health Sciences.

Draft Agenda; National Toxicology Program (NTP) Board of Scientific 
Counselors

May 24, 2000

Rodbell Auditorium, Building 101, South Campus, National Institute of 
Environmental Health Sciences (NIEHS), Research Triangle Park, North 
Carolina
8:30 a.m.--Welcome
8:50 a.m.--NTP Update
9:00 a.m.--NTP Center for the Evaluation of Risks to Human Reproduction 
(CERHR)
    <bullet> Role of CERHR in meeting the goals of the NTP
    <bullet> Response to last years Board Review of CERHR
9:30 a.m.--CERHR Processes and Criteria
    <bullet> Nomination and selection of agents for review
    <bullet> Evaluation of selected agents
    <bullet> Communication with public
10:00 a.m.--Break
10:15 a.m.--Public Comments
10:30 a.m.--Board Discussion
11:00 a.m.--Perspectives on the Process (e.g. Phthalates Review)
    <bullet> Expert Panel
    <bullet> Regulatory Agencies
    <bullet> NTP Board of Scientific Counselors
    <bullet> Public Comments
Noon--Lunch
1:00 p.m.--Current Trends in NTP Toxicology Testing
    <bullet> Water disinfection by-products
    <bullet> DNA-based products
    <bullet> Herbals/dietary supplements
2:15 p.m.--Break
2:30 p.m.--Current Trends in NTP Toxicology Testing (continued)
    <bullet> Phototoxicology studies and the NTP Center
    <bullet> Occupational chemicals and mixtures
3:20 p.m.--Concept Review
    <bullet> Board Discussion and ACTION
3:50 p.m.--Testing Recommendations from the Interagency Committee for 
Chemical Evaluation and Coordination
    <bullet> Public Comments
    <bullet> Board Discussion
4:35 p.m.--NTP Board Subcommittee Reviews--Updates
    <bullet> Report on Carcinogens
    <bullet> Technical Reports
    <bullet> Board Discussion
5:20 p.m.--Adjourn

Substances Nominated to the NTP for Study and Testing 
Recommendations Made by the ICCEC on December 13, 1999

                                  Table 1.--Substances Recommended for Testing
----------------------------------------------------------------------------------------------------------------
                                                                                        Study rationale; other
        Substance [CAS No.]                Nominated by        ICCEC recommendations          information
----------------------------------------------------------------------------------------------------------------
1-Bromopropane [106-94-5] and 2-     OSHA                      1-Bromopropane.......  Reported increasing
 Bromopropane [75-26-3].             NIOSH                     --Carcinogenicity....   production and use in
                                                               --Reproductive and      many industrial
                                                                developmental          applications as an
                                                                toxicity.              alternative to ozone
                                                               --Toxicokinetics.....   depleting substances;
                                                               --Mechanistic studies   available data from
                                                               --Neurotoxicity......   limited repeat dose
                                                               --Genotoxicity.......   studies indicate toxicity
                                                               --Exposure studies in   to multiple organ
                                                                workers.               systems.
                                                                                      2-Bromopropane is a
                                                                                       contaminant in reagent
                                                                                       grade.
                                                                                      1-Bromopropane with known
                                                                                       reproductive toxicity.
                                     ........................  2-Bromopropane.......
                                                               --Subchronic toxicity
Chitosan [9012-76-4]...............  NCI                       --Mechanistic studies  Significant human exposure
                                                                to evaluate vitamin    through use as a dietary
                                                                E and mineral          supplement and other
                                                                depletion.             commercial applications;
                                                                                       potential for toxicity
                                                                                       from interference with
                                                                                       dietary fat absorption.
DNA-based products.................  FDA                       --Establish joint      Rapidly growing market for
                                                                NIEHS/FDA program to   DNA-based therapeutic
                                                                evaluate long-term     agents and a lack of
                                                                toxicity in            adequate mechanisms and
                                                                anticipation of        methodologies for
                                                                regulatory needs.      evaluating safety.
Juglone [481-39-0].................  NCI                       --Mechanistic studies  Potential human exposure
                                                               --Metabolism studies.   resulting from use of
                                                               --Mouse lymphoma        walnut-based products as
                                                                assay.                 dietary supplements and
                                                               --Mammalian             natural dyes and stains;
                                                                mutagenicity.          suspicion of
                                                               --Carcinogenicity       carcinogenicity based on
                                                                testing pending        quinone structure.
                                                                results of
                                                                preliminary studies.
Potassium ferricyanide [13746-66-2]  NCI                       --Genotoxicity.......  Potential consumer and
                                                               --Subchronic toxicity   worker exposure resulting
                                                                                       from use in photographic
                                                                                       processing; suspicion of
                                                                                       toxicity based on
                                                                                       potential for redox
                                                                                       cycling; inadequate
                                                                                       toxicity information
                                                                                       available.
Radio frequency radiation emissions  FDA                       --Establish            Widespread consumer and
 of wireless communication devices.                             interagency program    worker exposure;
                                                                to design studies      available data is
                                                                assessing cancer and   inadequate to properly
                                                                non-cancer health      assess safety.
                                                                effects to fulfill
                                                                regulatory needs.
----------------------------------------------------------------------------------------------------------------


[[Page 24497]]


                      Table 2.--Substances for Which No Testing Is Recommended at This Time
----------------------------------------------------------------------------------------------------------------
        Substance [CAS No.]                Nominated by            Nominated for       Rationale for not testing
----------------------------------------------------------------------------------------------------------------
Cafestol [469-83-0] and Kahweol      Private individual......  --Toxicity and         Anti-carcinogenic effects
 [6894-43-5].                                                   carcinogenicity        demonstrated in animal
                                                                testing.               studies; limited data
                                                                                       indicate low potential
                                                                                       for toxicity; other
                                                                                       natural products with
                                                                                       higher potential for
                                                                                       toxicity and human
                                                                                       exposure exist; ongoing
                                                                                       research efforts as
                                                                                       opposed to new testing
                                                                                       may provide basis for
                                                                                       determining relevance of
                                                                                       metabolic modulatory
                                                                                       effects to chronic
                                                                                       toxicity.
Plumbagin [481-42-5]...............  NCI.....................  --Mechanistic studies  Structurally similar to
                                                               --Metabolism studies.   Juglone which is selected
                                                               --Mouse lymphoma        for study; low magnitude
                                                                assay.                 and/or prevalence of
                                                               --Mammalian             human exposure; adequate
                                                                mutagenicity.          evidence of acute and
                                                               --Carcinogenicity....   reproductive toxicity.
----------------------------------------------------------------------------------------------------------------


    Table 3.--Substances for Which a Testing Recommendation is Deferred Pending Receipt and Consideration of
                                             Additional Information
----------------------------------------------------------------------------------------------------------------
                                                                                        Additional information
        Substance [CAS No.]                Nominated by            Nominated for                needed
----------------------------------------------------------------------------------------------------------------
Ethylenebis(tetrabromo-phthalimide)  NIEHS                     --Toxicity and         Ongoing and planned
 [32588-76-4].                                                  carcinogenicity        industry testing efforts;
                                                                testing.               better characterization
                                                                                       of uses and potential
                                                                                       human exposures.
Terpinolene [586-62-9].............  NIEHS                     --Toxicity and         Ongoing and planned
                                                                carcinogenicity        industry testing efforts;
                                                                testing.               better characterization
                                                                                       of uses and potential
                                                                                       human exposures; study
                                                                                       results for structurally
                                                                                       related compounds.
Tetrabromophthalic anhydride [632-   NIEHS                     --Toxicity and         Ongoing and planned
 79-1].                                                         carcinogenicity        industry testing efforts;
                                                                testing.               better characterization
                                                                                       of uses and potential
                                                                                       human exposures.
Texanol benzyl phthalate [16883-83-  NIEHS                     --Toxicity and         Ongoing and planned
 3] or [32333-99-6].                                            carcinogenicity        industry testing efforts;
                                                                testing.               better characterization
                                                                                       of uses and potential
                                                                                       human exposures.
----------------------------------------------------------------------------------------------------------------

[FR Doc. 00-10414 Filed 4-25-00; 8:45 am]
BILLING CODE 4140-01-P


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