03-30123. 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: [e-mail]). 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: [e-mail]).

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: [e-mail]).

NTP Board of Scientific Counselors

The NTP Board of Scientific Counselors (“the Board”) is a technical 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

Chemical/CAS No.	Report No.	Primary uses	Route and exposure levels	Review order
2,3,7,8-Tetrachlorodibenzo-p-dioxin (TCDD)/1746-01-6	TR 521	By-product of combustion and smelting	Two-year study by inclusion in the diet at 3-100 ng/kg to female Sprague Dawley rats	1
3,3′,4,4′,5-Pentachlorobiphenyl (PCB 126)/57465-28-8	TR 520	Insulating fluid	Two-year study by inclusion in the diet at 10-100 ng/kg to female Sprague Dawley rats	2
2,3,4,7,8-Pentachlorodibenzofuran (PeCDF)/57117-31-4	TR 525	By-product of incineration and combustion	Two-year study by inclusion in the diet at 3-100 ng/kg to female Sprague Dawley rats	3
Mixture of PCB 126, TCDD, and PeCDF	TR 526	By-products of combustion, smelting and incineration	Two-year study by inclusion in the diet at concentrations based on their toxic equivalency factors to female Sprague Dawley rats	4
Malachite Green/569-64-2 and Leucomalachite Green/129-73-7	TR 527	Dye and antifungal agent for fish	Two-year study of Malachite Green by inclusion in the diet 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)	5
Anthraquinone/84-65-1*	TR 494	Intermediate in dye synthesis	Two-year study by inclusion in the diet to male and female rats (469-3,750 ppm) and to male and female mice (833-7,500 ppm)	6
1. 1,2,3-Trichloropropane/96-18-4	TR 528	2. Paint and varnish Remover	Exposure by aquarium water to Medaka and Guppy	7
2. 2,2,3-Bis(bromomethyl)-1,3-propanediol/3296-90-0		3. Flame retardant
3. Nitromethane/75-52-5		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 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.