TY - JOUR
T1 - Environmental risk assessment of chemicals and nanomaterials — The best foundation for regulatory decision-making?
AU - Syberg, Kristian
AU - Hansen, Steffen Foss
PY - 2016
Y1 - 2016
N2 - Environmental risk assessment (ERA) is often considered as the most transparent, objective and reliable decision-making tool for informing the risk management of chemicals and nanomaterials. ERAs are based on the assumption that it is possible to provide accurate estimates of hazard and exposure and, subsequently, to quantify risk. In this paper we argue that since the quantification of risk is dominated by uncertainties, ERAs do not provide a transparent or an objective foundation for decision-making and they should therefore not be considered as a “holy grail” for informing risk management.Webuild this thesis on the analysis of two case studies (of nonylphenol and nanomaterials) as well as a historical analysis in which we address the scientific Foundation for ERAs. The analyses show that ERAs do not properly address all aspects of actual risk, such as the mixture effect and the environmentally realistic risk fromnanomaterials. Uncertainties have been recognised for decades, and assessment factors are used to compensate for the lack of realism in ERAs. The assessment factors' values were pragmatically determined, thus lowering the scientific accuracy of the ERAs. Furthermore, the default choice of standard assay for assessing a hazard might not always be the most biologically relevant, so we therefore argue that an ERA should be viewed as a pragmatic decision-making tool among several, and it should not have a special status for informing risk management. In relation to other relevant decision-making tools we discuss the use of chemical alternative assessments (CAAs) and the precautionary principle.
AB - Environmental risk assessment (ERA) is often considered as the most transparent, objective and reliable decision-making tool for informing the risk management of chemicals and nanomaterials. ERAs are based on the assumption that it is possible to provide accurate estimates of hazard and exposure and, subsequently, to quantify risk. In this paper we argue that since the quantification of risk is dominated by uncertainties, ERAs do not provide a transparent or an objective foundation for decision-making and they should therefore not be considered as a “holy grail” for informing risk management.Webuild this thesis on the analysis of two case studies (of nonylphenol and nanomaterials) as well as a historical analysis in which we address the scientific Foundation for ERAs. The analyses show that ERAs do not properly address all aspects of actual risk, such as the mixture effect and the environmentally realistic risk fromnanomaterials. Uncertainties have been recognised for decades, and assessment factors are used to compensate for the lack of realism in ERAs. The assessment factors' values were pragmatically determined, thus lowering the scientific accuracy of the ERAs. Furthermore, the default choice of standard assay for assessing a hazard might not always be the most biologically relevant, so we therefore argue that an ERA should be viewed as a pragmatic decision-making tool among several, and it should not have a special status for informing risk management. In relation to other relevant decision-making tools we discuss the use of chemical alternative assessments (CAAs) and the precautionary principle.
U2 - 10.1016/j.scitotenv.2015.09.112
DO - 10.1016/j.scitotenv.2015.09.112
M3 - Journal article
C2 - 26433335
SN - 0048-9697
VL - 541
SP - 784
EP - 794
JO - Science of the Total Environment
JF - Science of the Total Environment
ER -