Assumptions
in Dose-Response Assessment
TERA has received an
investigator-initiated grant from NIEHS and U.S. EPA/Office of
Research and Development to write a white paper on research that
has impacted the default assumptions used in dose-response
assessment. The project Director is Hugh Spitzer, a visiting
scientist with TERA, and the Co-Director is Dr. James
Wilson of Resources for the Future.
Scientists and risk
assessment practitioners were interviewed to
determine:
- how the use of default
assumptions has changed over time;
- ongoing research that
will impact dose-response assumptions; and
- ongoing efforts to
harmonize practices used by North American, Asian, and
European regulatory agencies.
Based on the information
collected, the authors, in consultation with an advisory
committee, will identify issues for workshops on default
assumptions.
Listed below are some of the questions
asked of risk assessors.
- Have dose-response
assumptions used to characterize the risk associated with
cancerous or non-cancerous responses changed or been
modified based on new scientific information in the last
ten or so years? Can you cite examples of changes?
- Has the use of
physiologically-based pharmacokinetics and dynamics had a
significant impact on the uncertainties associated with
low dose extrapolation? Can you cite examples?
- What laboratory
research is being conducted on generic or chemical
specific issues that impact dose-response extrapolation?
- What model development
is being conducted to improve low-dose extrapolation?
What are the plans to test and validate the models?
- How would you rank the
importance of improving dose-response estimates compared
to
other risk assessment issues?
2300 Montana Avenue, Suite 409,
Cincinnati OH 45211
Phone: 513-542-7475
Fax: 513-542-7487
Email: TERA@TERA.org
Last updated: 12/03/2010