Development of an Evidence-Based Risk Assessment Framework

Main Article Content

Daniel Krewski
Patrick Saunders-Hastings
Robert A. Baan
Tara S. Barton-Maclaren
Patience Browne
Weihsueh A. Chiu
Maureen Gwinn
Thomas Hartung
Andrew D. Kraft
Juleen Lam
R. Jeffrey Lewis
Moez Sanaa
Rebecca L. Morgan
Greg Paoli
Lorenz Rhomberg
Andrew Rooney
Salomon Sand
Holger J. Schünemann
Kurt Straif
Kristina A. Thayer
Katya Tsaioun


Assessment of potential human health risks associated with environmental and other agents requires careful evaluation of all available and relevant evidence for the agent of interest, including both data-rich and data-poor agents. With the advent of new approach methodologies in toxicological risk assessment, guidance on integrating evidence from multiple evidence streams is needed to ensure that all available data is given due consideration in both qualitative and quantitative risk assessment. The present report summarizes the discussions among academic, government, and private sector participants from North America and Europe in an international workshop convened to explore the development of an evidence-based risk assessment framework, taking into account all available evidence in an appropriate manner in order to arrive at the best possible characterization of potential human health risks, and associated uncertainty. Although consensus among workshop participants was not a specific goal, there was general agreement on the key considerations involved in evidence-based risk assessment incorporating 21st century science into human health risk assessment. These considerations have been embodied into an overarching prototype framework for evidence integration that will be explored in more depth in a follow-up meeting.

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Krewski, D., Saunders-Hastings, P., Baan, R. A., Barton-Maclaren, T. S., Browne, P., Chiu, W. A., Gwinn, M., Hartung, T., Kraft, A. D., Lam, J., Lewis, R. J., Sanaa, M., Morgan, R. L., Paoli, G., Rhomberg, L., Rooney, A., Sand, S., Schünemann, H. J., Straif, K., Thayer, K. A. and Tsaioun, K. (2022) “Development of an Evidence-Based Risk Assessment Framework”, ALTEX - Alternatives to animal experimentation. doi: 10.14573/altex.2004041.
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