[Federal Register Volume 68, Number 232 (Wednesday, December 3, 2003)]
[Notices]
[Pages 67696-67697]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-30123]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service


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 (``the Subcommittee'') on February 17-18, 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 at 8:30 a.m.

Agenda

    The primary agenda topic is the peer review of seven draft NTP 
Technical Reports of rodent toxicology and carcinogenesis studies 
conducted by the NTP. This includes the re-review of the NTP Draft 
Technical Report on Anthraquinone (TR 494), which was 
originally reviewed in May 1999. The reports are listed in the table 
below in the tentative order of their review.
    The agenda and roster of the Subcommittee members will be available 
prior to the meeting on the NTP homepage at http://ntp-server.niehs.nih.gov/(see What's New?) and upon request to the NTP 
Executive Secretary, Dr. Barbara S. Shane (P.O. 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: [email protected]). Following the 
meeting, summary minutes will be available on the NTP web site and in 
hard copy upon request to the Executive Secretary. Plans are underway 
for making this meeting available for viewing on the Internet at 
(http://www.niehs.nih.gov/external/video.htm).
    The NTP Board of Scientific Counselors Technical Reports Review 
Subcommittee meeting is open to the public. Attendance at this meeting 
is limited only by the space available. For planning purposes, 
individuals who plan to attend are asked to register with the NTP 
Executive Secretary (see contact information above). Registration will 
also be available on-site at the meeting. 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 (see 
contact information above).

Draft Reports Available for Public Review and Comment

    Approximately seven weeks prior to the meeting, the draft reports 
will be available for public review, free of charge, through ehpOnline 
(http://ehp.niehs.nih.gov/). Printed copies of the Draft NTP Technical 
Reports can be obtained, as available, from Central Data Management 
(NIEHS, P.O. Box 12233, MD EC-03, Research Triangle Park, NC 27709, T: 
919-541-3419, F: 919-541-3687, e-mail: [email protected]).
    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 Executive Secretary (contact 
information given above) by January 30, 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 Executive Secretary on or before January 30, 2004, to enable review 
by the 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 Executive Secretary on or before January 30, 2004, to 
enable distribution to the Subcommittee and NTP staff for their review 
and consideration prior to the meeting.

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 Web site (http://ntp-server.niehs.nih.gov/, select How to Nominate Substances). 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. Study abstracts for all reports are 
available at the NTP Web site under NTP Study Information. PDF files of 
completed reports are available free-of-charge from ehpOnline under 
Publications and hard copies of published reports can be obtained 
through subscription to ehpOnline (http://ehp.niehs.nih.gov/ contact 
information: T: 919-653-2595 or 866-541-3841, e-mail: 
[email protected]).

NTP Board of Scientific Counselors

    The NTP Board of Scientific Counselors (``the Board'') is a 
technical

[[Page 67697]]

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 Technical Reports Review 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 17, 2003.
Samuel H. Wilson,
Deputy Director, National Institute of Environmental Health Sciences.

    National Toxicology Program (NTP) Technical Reports Tentatively Scheduled for Review by the NTP Board of
Scientific Counselors Technical Reports Review Subcommittee on February 17-18, 2004 at the National Institute of
                            Environmental Health Sciences, Research Triangle Park, NC
----------------------------------------------------------------------------------------------------------------
                                                                                                         Review
        Chemical/CAS No.            Report No.       Primary uses        Route and exposure levels       order
----------------------------------------------------------------------------------------------------------------
2,3,7,8-Tetrachlorodibenzo-p-    TR 521           By-product of      Two-year study by inclusion in            1
 dioxin (TCDD)/1746-01-6.                          combustion and     the diet at 3-100 ng/kg to
                                                   smelting.          female Sprague Dawley rats.
3,3',4,4',5-Pentachlorobiphenyl  TR 520           Insulating fluid.  Two-year study by inclusion in            2
 (PCB 126)/57465-28-8.                                                the diet at 10-100 ng/kg to
                                                                      female Sprague Dawley rats.
2,3,4,7,8-Pentachlorodibenzofur  TR 525           By-product of      Two-year study by inclusion in            3
 an (PeCDF)/57117-31-4.                            incineration and   the diet at 3-100 ng/kg to
                                                   combustion.        female Sprague Dawley rats.
Mixture of PCB 126, TCDD, and    TR 526           By-products of     Two-year study by inclusion in            4
 PeCDF.                                            combustion,        the diet at concentrations
                                                   smelting and       based on their toxic
                                                   incineration.      equivalency factors to female
                                                                      Sprague Dawley rats.
Malachite Green/569-64-2 and     TR 527           Dye and            Two-year study of Malachite               5
 Leucomalachite Green/129-73-7.                    antifungal agent   Green by inclusion in the diet
                                                   for fish.          to female rats (100-600 ppm)
                                                                      and to male and female mice
                                                                      (100-450 ppm). Two-year study
                                                                      of Leucomalachite Green by
                                                                      inclusion in the diet to male
                                                                      and female rats (91 to 543 ppm)
                                                                      and to female mice (100-450
                                                                      ppm).
Anthraquinone/84-65-1*.........  TR 494           Intermediate in    Two-year study by inclusion in            6
                                                   dye synthesis.     the diet to male and female
                                                                      rats (469-3,750 ppm) and to
                                                                      male and female mice (833-7,500
                                                                      ppm).
1. 1,2,3-Trichloropropane/96-18- TR 528           2. Paint and       Exposure by aquarium water to             7
 4.                                                varnish Remover.   Medaka and Guppy.
2. 2,2,3-Bis(bromomethyl)-1,3-   ...............  3. Flame
 propanediol/3296-90-0.                            retardant.
3. Nitromethane/75-52-5........  ...............  3. Fuel additive,
                                                   synthesis
                                                   intermediate and
                                                   solvent .
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* The draft NTP Technical Report on Anthraquinone was previously peer reviewed by the Subcommittee in May 1999.
  Subsequent to that peer review, the anthraquinone tested was found to contain a 0.1% contaminant. As a result,
  additional mutagenicity and metabolism studies were conducted and the findings from those studies are included
  in the revised draft report. The Subcommittee will evaluate the results from the follow-up studies, use that
  information to re-examine the carcinogenicity findings from the 2-year studies and make a recommendation on
  the carcinogenicity of anthraquinone.

[FR Doc. 03-30123 Filed 12-2-03; 8:45 am]
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