03-9283. National Toxicology Program (NTP) Board of Scientific Counselors Technical Reports Review Subcommittee Meeting; Review of Draft NTP Technical Reports

Pursuant to Pub. L. 92-463, notice is hereby given of the next meeting of the NTP Board of Scientific Counselors Technical Reports Review Subcommittee on May 22, 2003 in the Rodbell Auditorium, Rall Building, South Campus, National Institute of Environmental Health Sciences (NIEHS), 111 T.W. Alexander Drive, Research Triangle Park, North Carolina. The meeting will begin at 8:30 a.m.

Agenda

The primary agenda topic is the peer review of six draft NTP Technical Reports of rodent toxicology and carcinogenesis studies conducted by the NTP. The reports are listed in the table below in the tentative order of their review. There will be a brief presentation describing the p53 (+/−) and the p16 (+/−) haploinsufficient transgenic mouse models for short-term cancer bioassays prior to the reviews of the aspartame and acesulfame potassium reports.

The agenda and roster of Subcommittee members will be available prior to the meeting on the NTP Web homepage at http://ntp-server.niehs.nih.gov and upon request to the NTP Executive Secretary, Dr. Mary S. Wolfe, PO Box 12233, 111 T.W. Alexander Dr., MD A3-01, Research Triangle Park, NC 27709, T: 919-541-0530; 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 (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. 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) (e.g., driver's license, government ID). 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 one month 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 (CDM), NIEHS, PO 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 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 May 14, 2003 and 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 May 14, 2003, 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. These copies will be distributed to the Subcommittee and NTP staff and will 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 May 14, 2003, 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 CDM at the address given above. CDM will forward the information to the appropriate NTP staff scientist.

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. Shorter-term carcinogenicity studies will appear in a new Technical Report Series being unveiled at the upcoming meeting. The studies of aspartame and acesulfame potassium will be the first two studies reported in the new series. 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: April 8, 2003.

Kenneth Olden,

Director, National Toxicology Program.

National Toxicology Program (NTP) Technical Reports Tentatively Scheduled for Review by the NTP Board of Scientific Counselors Technical Reports Review Subcommittee on May 22, 2003 at the National Institute of Environmental Health Sciences, Research Triangle Park, NC

Chemical CAS number	Report number	Primary uses	Route and exposure levels	Review order
Propylene Glycol Mono-t-butyl Ether 57018-52-7	TR 515	Solvent	Two-year study by inhalation 0, 75, 300, or 1,200 ppm in air to F344/N rats and B6C3F1 mice	1
2-Methylimidazole 693-98-1	TR 516	Chemical and pharmaceutical intermediate	Two-year study by feed 0, 300, 1,000, or 3,000 ppm to male F344/N rats 0, 1,000, 2,500 or 5,000 ppm to female F344/N rats 0, 625, 1,250, or 2,500 ppm to male and female B6C3F1 mice	2
Triethanolamine 102-71-6	TR 518	Large variety of industrial and manufacturing applications	Two-year dermal study 0, 200, 630, or 2,000 mg/kg to male B6C3F1 mice and 0, 100, 300, or 1,000 mg/kg to female B6C3F1 mice	3
Stoddard Solvent IIC 64742-88-7	TR 519	Paint and dry cleaning solvent	Two-year study by inhalation 0, 550, 1,100, or 2,200 mg/cubic meter in air to F344/N rats and B6C3F1 mice	4
Aspartame 22839-47-0	NEW 01	Artificial sweetener	Nine-month study by feed 0, 3,125, 6,250, 12,500, 25,000, or 50,000 ppm to p53 (+/−) haploinsufficient mice	5
Acesulfame Potassium 55589-62-3	NEW 02	Artificial sweetener	Nine-month study by feed 0, 0.3%, 1%, or 3% to p53 (+/−) haploinsufficient mice	6