A 21st century roadmap for human health risk assessment

Abstract

The Health and Environmental Sciences Institute (HESI)-coordinated Risk Assessment in the 21st Century (RISK21) project was initiated to develop a scientific, transparent, and efficient approach to the evolving world of human health risk assessment, and involved over 120 participants from 12 countries, 15 government institutions, 20 universities, 2 non-governmental organizations, and 12 corporations. This paper provides a brief overview of the tiered RISK21 framework called the roadmap and risk visualization matrix, and articulates the core principles derived by RISK21 participants that guided its development. Subsequent papers describe the roadmap and matrix in greater detail. RISK21 principles include focusing on problem formulation, utilizing existing information, starting with exposure assessment (rather than toxicity), and using a tiered process for data development. Bringing estimates of exposure and toxicity together on a two-dimensional matrix provides a clear rendition of human safety and risk. The value of the roadmap is its capacity to chronicle the stepwise acquisition of scientific information and display it in a clear and concise fashion. Furthermore, the tiered approach and transparent display of information will contribute to greater efficiencies by calling for data only as needed (enough precision to make a decision), thus conserving animals and other resources.

Percent changes in mesenteric blood T-lymphocyte subsets in gilts induced by low-dose zearalenone-deoxynivalenol mycotoxin

“…Problem ten należy rozwiązy-wać sytuacyjnie, dobierając odpowiedni tryb działania (35) w wielu płaszczyznach (26). Jednym ze sposobów takiego działania jest dobór odpowiedniego modelu badawczego wykorzystującego świnie jako gatunek najbardziej wrażliwy na obecność mikotoksyn.…”

Problem formulation for risk assessment of combined exposures to chemicals and other stressors in humans

“…RISK21 has developed a conceptual framework that is a PF-based, exposure-driven paradigm that takes maximum advantage of existing information and aids in identifying when additional data are needed to make a decision. The overarching principles of the RISK21 approach are introduced by Pastoor et al (2014) and explained in detail in Embry et al (2014).…”

“…The hypotheses of risk are thus tested with the data on exposures and effects. These hypotheses can range from simple comparisons of deterministic values for exposures and effects via a quotient (with uncertainty factors) to full probabilistic analysis as discussed in Pastoor et al (2014).…”

US Environmental Protection Agency's framework for human health risk assessment to inform decision making

“…It is important that planning for the risk assessment include consideration of the decisions that the assessment is being conducted to inform. International Life Sciences Institute's (ILSIs) RISK21 project addresses problem formulation, utilising existing information, and initiation of the risk assessment process focused on exposure rather than toxicity (Pastoor et al, 2014).…”

“…EPAs efforts to advance risk assessment practice have been in parallel with many other efforts including those of the World Health Organization/International Programme on Chemical Safety, the International Life Sciences Institute and the Alliance for Risk Assessment (Pastoor et al, 2014;Dourson et al, 2013;Munns et al, 2003;Birnbaum et al, 2001).…”