Federal Register: December 3, 2003 (Volume 68, Number 232)
DOCID: FR Doc 03-30123
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
NOTICE: NOTICES
ACTION: Meetings:
SUBJECT CATEGORY:
National Toxicology Program (NTP) Board of Scientific Counselors Technical Reports Review Subcommittee Meeting; Review of Draft NTP Technical Reports
DOCUMENT SUMMARY:
Pursuant to Public Law 92463, notice is hereby given of the next meeting of the NTP Board of Scientific Counselors Technical Reports Review Subcommittee (``the Subcommittee'') on February 1718, 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 rereview of the NTP Draft
Technical Report on Anthraquinone (TR
The agenda and roster of the Subcommittee members will be available
prior to the meeting on the NTP homepage at http://ntpserver.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 A301, Research Triangle Park, NC 27709, T: 9195414253; F: 9195410295; email: shane@niehs.nih.gov). 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 onsite 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 EC03, Research Triangle Park, NC 27709, T: 9195413419, F: 9195413687, email: CDM@niehs.nih.gov).
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 onsite. If registering onsite 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 email) 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://ntpserver.niehs.nih.gov/ , select How to Nominate Substances). The results
of shortterm rodent toxicology studies are published in the NTP
Toxicity Report series. Longerterm 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 freeofcharge 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: 9196532595 or 8665413841, email: ehponline@ehp.niehs.nih.gov). 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 1718, 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
2,3,7,8Tetrachlorodibenzop TR 521 Byproduct of Twoyear study by inclusion in 1
dioxin (TCDD)/1746016. combustion and the diet at 3100 ng/kg to
smelting. female Sprague Dawley rats.
3,3',4,4',5Pentachlorobiphenyl TR 520 Insulating fluid. Twoyear study by inclusion in 2
(PCB 126)/57465288. the diet at 10100 ng/kg to
female Sprague Dawley rats.
2,3,4,7,8Pentachlorodibenzofur TR 525 Byproduct of Twoyear study by inclusion in 3
an (PeCDF)/57117314. incineration and the diet at 3100 ng/kg to
combustion. female Sprague Dawley rats.
Mixture of PCB 126, TCDD, and TR 526 Byproducts of Twoyear 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/569642 and TR 527 Dye and Twoyear study of Malachite 5
Leucomalachite Green/129737. antifungal agent Green by inclusion in the diet
for fish. to female rats (100600 ppm)
and to male and female mice
(100450 ppm). Twoyear study
of Leucomalachite Green by
inclusion in the diet to male
and female rats (91 to 543 ppm)
and to female mice (100450
ppm).
Anthraquinone/84651*......... TR 494 Intermediate in Twoyear study by inclusion in 6
dye synthesis. the diet to male and female
rats (4693,750 ppm) and to
male and female mice (8337,500
ppm).
1. 1,2,3Trichloropropane/9618 TR 528 2. Paint and Exposure by aquarium water to 7
4. varnish Remover. Medaka and Guppy. 2. 2,2,3Bis(bromomethyl)1,3 ............... 3. Flame
propanediol/3296900. retardant.
3. Nitromethane/75525........ ............... 3. Fuel additive,
synthesis
intermediate and
solvent .
* 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 followup studies, use that
information to reexamine the carcinogenicity findings from the 2year studies and make a recommendation on the carcinogenicity of anthraquinone.
[FR Doc. 0330123 Filed 12203; 8:45 am]
BILLING CODE 414001P
SUMMARY:
Scientific Counselors Board,
DOCUMENT BODY 2:
Pursuant to Public Law 92463, notice is hereby given of the next meeting of the NTP Board of Scientific Counselors Technical Reports Review Subcommittee (``the Subcommittee'') on February 1718, 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 rereview of the NTP Draft
Technical Report on Anthraquinone (TR
The agenda and roster of the Subcommittee members will be available
prior to the meeting on the NTP homepage at http://ntpserver.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 A301, Research Triangle Park, NC 27709, T: 9195414253; F: 9195410295; email: shane@niehs.nih.gov). 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 onsite 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 EC03, Research Triangle Park, NC 27709, T: 9195413419, F: 9195413687, email: CDM@niehs.nih.gov).
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 onsite. If registering onsite 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 email) 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://ntpserver.niehs.nih.gov/ , select How to Nominate Substances). The results
of shortterm rodent toxicology studies are published in the NTP
Toxicity Report series. Longerterm 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 freeofcharge 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: 9196532595 or 8665413841, email: ehponline@ehp.niehs.nih.gov). 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 1718, 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
2,3,7,8Tetrachlorodibenzop TR 521 Byproduct of Twoyear study by inclusion in 1
dioxin (TCDD)/1746016. combustion and the diet at 3100 ng/kg to
smelting. female Sprague Dawley rats.
3,3',4,4',5Pentachlorobiphenyl TR 520 Insulating fluid. Twoyear study by inclusion in 2
(PCB 126)/57465288. the diet at 10100 ng/kg to
female Sprague Dawley rats.
2,3,4,7,8Pentachlorodibenzofur TR 525 Byproduct of Twoyear study by inclusion in 3
an (PeCDF)/57117314. incineration and the diet at 3100 ng/kg to
combustion. female Sprague Dawley rats.
Mixture of PCB 126, TCDD, and TR 526 Byproducts of Twoyear 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/569642 and TR 527 Dye and Twoyear study of Malachite 5
Leucomalachite Green/129737. antifungal agent Green by inclusion in the diet
for fish. to female rats (100600 ppm)
and to male and female mice
(100450 ppm). Twoyear study
of Leucomalachite Green by
inclusion in the diet to male
and female rats (91 to 543 ppm)
and to female mice (100450
ppm).
Anthraquinone/84651*......... TR 494 Intermediate in Twoyear study by inclusion in 6
dye synthesis. the diet to male and female
rats (4693,750 ppm) and to
male and female mice (8337,500
ppm).
1. 1,2,3Trichloropropane/9618 TR 528 2. Paint and Exposure by aquarium water to 7
4. varnish Remover. Medaka and Guppy. 2. 2,2,3Bis(bromomethyl)1,3 ............... 3. Flame
propanediol/3296900. retardant.
3. Nitromethane/75525........ ............... 3. Fuel additive,
synthesis
intermediate and
solvent .
* 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 followup studies, use that
information to reexamine the carcinogenicity findings from the 2year studies and make a recommendation on the carcinogenicity of anthraquinone.
[FR Doc. 0330123 Filed 12203; 8:45 am]
BILLING CODE 414001P