03-35. National Toxicology Program, National Institute of Environmental Health Sciences, National Institutes of Health: Notice of Workshop

Summary

The National Toxicology Program (NTP) is sponsoring a workshop entitled “Genetically Modified Rodent Models for Cancer Hazard Identification: Selecting Substances for Study and Interpreting and Communicating Results' on February 21, 2003, at the Hamilton Crowne Hotel, 14th and K Street, NW., Washington, DC. Registration starts at 8 a.m. and the meeting begins at 8:30 a.m. and is open to the public with attendance limited only by the available space. Persons interested in attending are asked, if possible, to preregister with the NTP Liaison and Scientific Review Office (contact information below). As information about this workshop becomes available, it will be posted on the NTP web site (http://ntp-server.niehs.nih.gov).

Background

The NTP has invested considerable time and resources in addressing whether cancer bioassay results from studies conducted in genetically modified or “transgenic” rodent models are useful for identifying chemicals presumed to be of carcinogenic risk to humans, in order to determine whether these models might be integrated into NTP research and testing activities. After reviewing available information on the use of selected models in carcinogen identification, the NTP recognizes that important issues of experimental design and data interpretation need further attention to enable future regulatory acceptance and eventual use in human risk assessment. Therefore, to begin to address these areas the NTP is sponsoring a workshop with the following objectives:

• Solicit comment on a process for selection of appropriate nominated substances to undergo cancer hazard evaluation in genetically modified or “transgenic” models.
• Solicit comment on issues related to the proper interpretation of results of “transgenic” cancer models, the implications of these findings for public health decisions, and the most appropriate interpretive language to describe the results of such studies to the scientific/regulatory communities and the public.

Preliminary Agenda

8 a.m. Registration

8:30 a.m. Introduction and Welcome

8:45 a.m. Plenary Session

• Overview of Selected Transgenic Models
• Experience with Transgenic Models in the NTP Bioassay
• Workshop Charge
• Public Comment

10 a.m. Break

10:30 a.m. Breakout Groups

• Group 1: Solicit comment on a process for selection of appropriate nominated substances to undergo cancer hazard evaluation in genetically modified or “transgenic” models.
• Group 2: Solicit comment on issues related to the proper interpretation of results of “transgenic” cancer models, the implications of these findings for public health decisions, and the most appropriate interpretive language to describe the results of such studies to the scientific/regulatory communities and the public.

Noon Lunch (on your own)

1:00 p.m. Breakout Groups continued

2:30 p.m. Break

3:15 p.m. Plenary Session

• Breakout Group Reports
• Open Discussion

4:30 p.m. Adjourn

As additional details and materials for this workshop become available, they will be posted on the NTP web site (http://ntp-server.niehs.nih.gov) or can be obtained by contacting Ms. Diane Spencer, NTP Liaison and Scientific Review Office (T: 919-541-2759, F: 919-541-0295, [e-mail]).

Registration and Public Comment

The workshop is open to the public and interested individuals are invited to attend as observers. The number of observers will be limited only by the space available. Due to space limitations, persons interested in attending are asked to pre-register by contacting Ms. Spencer (contact information above).

The NTP invites public comment and time is set-aside during the morning session for presentation of oral comments. Persons wishing to make oral comment are asked to contact Ms. Spencer in advance of the meeting and provide contact information (name, affiliation, telephone, e-mail, and sponsoring organization, if any); however, registration for oral comments will also be accepted on-site. Observers are also welcome to participate in the open discussion in the afternoon plenary session.

The NTP also welcomes receipt of written comments. If sending written comments, please include contact information (name, affiliation, telephone, e-mail, and sponsoring organization, if any) and send to Dr. Mary S. Wolfe, NTP Executive Secretary (P.O. Box 12233, MD A3-01. 111 T.W. Alexander Drive, Research Triangle Park, NC 27709 or [e-mail]) by Friday, February 14, 2003. Any comments received will be provided to invited attendees at the meeting and made available for the public.

Samuel H. Wilson,

Deputy Director, National Institute of Environmental Health Sciences.