title: Risk analysis under uncertainty, the precautionary principle, and the new EU chemicals strategy.
abstract: Three categories of uncertainty in relation to risk assessment are defined; uncertainty in effect, uncertainty in cause, and uncertainty in the relationship between a hypothesised cause and effect. The Precautionary Principle (PP) relates to the third type of uncertainty. Three broad descriptions of the PP are set out, uncertainty justifies action, uncertainty requires action, and uncertainty requires a reversal of the burden of proof for risk assessments. The application of the PP is controversial but what matters in practise is the precautionary action (PA) that follows. The criteria by which the PAs should be judged are detailed. This framework for risk assessment and management under uncertainty is then applied to the envisaged European system for the regulation of chemicals. A new EU regulatory system has been proposed which shifts the burden of proof concerning risk assessments from the regulator to the producer, and embodies the PP in all three of its main regulatory stages. The proposals are critically discussed in relation to three chemicals, namely, atrazine (an endocrine disrupter), cadmium (toxic and possibly carcinogenic), and hydrogen fluoride (a toxic, high-production-volume chemical). Reversing the burden of proof will speed up the regulatory process but the examples demonstrate that applying the PP appropriately, and balancing the countervailing risks and the socio-economic benefits, will continue to be a difficult task for the regulator. The paper concludes with a discussion of the role of precaution in the management of change and of the importance of trust in the effective regulation of uncertain risks.
authors.affiliation: The Group of Policy Advisers, The European Commission, BREY 10/232, B-1049, Brussels, Belgium. michael.rogers@cec.eu.int
authors.forename: Michael D
authors.initials: MD
authors.lastname: Rogers
mesh_terms: D002617:Chemical Industry / Q000331:legislation & jurisprudence; D005062:European Union; D006801:Humans; D011640:Public Policy; D018570:Risk Assessment / Q000331:legislation & jurisprudence / Q000379:methods*; D035501:Uncertainty; D015262:Xenobiotics / Q000633:toxicity*
chemical_list: D015262:Xenobiotics