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A 21st Century Roadmap for Human Health Risk Assessment
Pastoor, T., A. Bachman, D. Bell, S. Cohen, M. Dellarco, I. Dewhurst, J. Doe, N. Doerrer, M. Embry, R. Hines, A. Moretto, R. Phillips, J. Rowlands, J. Tanir, D. Wolf, AND A. Boobis. A 21st Century Roadmap for Human Health Risk Assessment. CRITICAL REVIEWS IN TOXICOLOGY. CRC Press LLC, Boca Raton, FL, 44:1-5, (2014).
For decades human health risk assessment has depended primarily on animal testing to predict adverse effects in humans, but that paradigm has come under question because of calls for more accurate information, less use of animals, and more efficient use of resources. Moreover, the disproportionate use of hazard information has overshadowed the important role of exposure science in determinations of human safety. In addition, major risk assessments lack the clarity and transparency that hinder an understanding of the analysis and communication of key safety messages. To help answer these challenges, the HESI-managed RISK21 project was initiated to develop a scientific, transparent, and efficient approach to the evolving world of human health risk assessment. RISK21 involved over 120 participants from 12 countries, 15 government institutions, 20 universities, 2 non-governmental organizations, and 12 corporations. RISK21 developed a tiered approach that is problem formulation-based, makes maximum use of prior knowledge, and is led by exposure science to produce a highly transparent and flexible visualization of and approach to assessing human safety and risk. The general principles underlying the RISK21 approach as well as an overview of the RISK21 Roadmap are presented here. This paper will be followed by a series of publications that will articulate the details that comprise this systematic approach.
The purpose of this manuscript is to provide an overview of the ILSI/HESI Risk21 project and the proposed framework for conducting risk assessment using data anticipated from a Tox21-type approach.
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
ASSOCIATE DIRECTOR FOR HEALTH