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A Framework for "Fit for Purpose" Dose Response Assessment
Meek, M., M. Bolger, J. Bus, J. Christopher, R. Conolly, R. Lewis, G. Paolini, R. Schoney, L. Haber, A. Rosenstein, AND M. Dourson. A Framework for "Fit for Purpose" Dose Response Assessment. REGULATORY TOXICOLOGY AND PHARMACOLOGY. Elsevier Science Ltd, New York, NY, 66(2):234-240, (2013).
The NRC report Science and Decisions: Advancing Risk Assessment made several recommendations to improve chemical risk assessment, with a focus on in-depth chronic dose-response assessments conducted by the U.S. Environmental Protection Agency. The recommendations addressed two broad elements: improving technical analysis and utility for decision making. To advance the discussions in the NRC report, three multi-stakeholder workshops organized by the Alliance for Risk Assessment considered available and evolving risk assessment methodologies through the development and application of case studies. A key workshop product was a framework to guide risk assessors and managers to various dose-response assessment methods relevant to a range of decision context: ranging from priority setting to full assessment, as illustrated by case studies. The framework is designed for use in a variety of settings at the problem formulation stage, to aid in selecting appropriate methodology(s), based on the objective of the assessment and other factors such as time and resource constraints. The framework includes a variety of methods, particularly for areas flagged specifically by the NRC committee for consideration - e.g., :msceptible sub-populations, population variability and background. Organization and communication about methodologies for incorporating increasingly biologically informed and chemical specific knowledge into dose- response analysis is critical in evolving fit-for-purpose assessment to address relevant problem formulations.
As the framework described in the manuscript is refined and hopefully widely accepted we can expect to see an increase in risk assessments that use relevant data to the maximum extent possible, and which to a large extent incorporate the approach espoused by the Silver Book. It is to be hoped that risk assessors within EPA would be interested in this effort and would consider how the ARA framework might [nfluence their own activities.
Record Details:Record Type: DOCUMENT (JOURNAL/PEER REVIEWED JOURNAL)
Organization:U.S. ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF RESEARCH AND DEVELOPMENT
NATIONAL HEALTH AND ENVIRONMENTAL EFFECTS RESEARCH LAB
INTEGRATED SYSTEMS TOXICOLOGY DIVISION
SYSTEMS BIOLOGY BRANCH