Uncertainty factors in risk assessment

This advisory report is concerned with scientific developments that are important in relation to the use of so-called ‘uncertainty factors’ for the determination of health-based recommended exposure limits and for toxicological risk assessment. Such factors are used to make allowance for differences between laboratory animal species and humans, for inter-personal sensitivity variations and for shortcomings in the research data.

The report covers various scientific disciplines and methodologies. Toxicological insight into substance kinetics and dynamics is increasing all the time: the absorption, dispersion, metabolism and excretion of substances are increasingly well understood, as are the mechanisms by which substances can be toxic to organisms that are exposed to them. Various molecular analysis techniques, cell culture techniques and computer modelling methods are proving valuable in this context. In more and more cases, such methodologies make it possible to specify the qualitative and quantitative differences between laboratory animals and humans.

Committee

• Dr. R.A. Woutersen, Toxicologist/pathologist, TNO Quality of Life, Zeist; Professor Extraordinary of Translational Toxicology, Wageningen University and Research Center, chairman
• Professor R. Bal, Scientific sociologist, Professor of Health Care Administration and Policy, Erasmus MC, Rotterdam
• Dr. W.F.J.P.M ten Berge, oxicologist, former employee of DSM, Heerlen
• Dr. B.J. Blaauboer, Toxicologist, Professor of Alternatives for Animal Experiments in Toxicological Risk Assessment, Institute for Risk Assessment Sciences, University of Utrecht
• Ir. P.M.J. Bos, Toxicologist, National Institute of Public Health and the Environment, Bilthoven
• Professor V.J. Feron, meritus Professor of Biological Toxicology, University of Utrecht
• Dr. W.R.F.Notten, Toxicologist/health scientist, Director of the Institute of Health Care Policy and Management; Erasmus MC, Rotterdam
• Dr. ir. M.N. Pieters, isk analyst, Public Health Sector Director, National Institute of Public Health and the Environment, Bilthoven
• Dr. G.M.H. Swaen, Epidemiologist, Dow Chemicals Benelux, Terneuzen
• Professor A.L.M. Verbeek, Professor of Clinical Epidemiology, St Radboud University Medical Centre, Nijmegen
• Dr. J.A. van Zorge, Formerly of the Ministry of Housing, Spatial Planning and the Environment, The Hague, adviser
• E.J. Schoten, Health Council, The Hague, secretary