Analysis of different preferences for the EU's regulatory options forendocrine disruptor identification criteria using argumentation theory

What criteria are most suitable to identify endocrine disrupting substances (EDSs) for regulatory purposes in the EU? The results of the European Commission's public consultation, as part of the process to establish identification criteria for EDSs, show that different regulatory options are supported. Some respondents prefer an option including hazard characterization considerations, whereas others prefer an option that avoids these considerations and introduces several hazard-identification based weight-of-evidence categories. In this study, the argumentation underlying the different preferences for identification criteria are analyzed and compared using pragma-dialectical argumentation theory (PDAT). All responses of non-anonymous, national governments that submitted a response in English (n = 17) were included. Responses of other stakeholder organizations were included if a Google News search returned an opinionated presence in the media on the subject (n = 9). Five topical themes and 21 underlying issues were identified. The themes are 1) mechanistic understanding of EDSs, 2) regulatory considerations related to the identification of EDSs, 3) consistency with existing regulatory frameworks, and 4) evaluations of specific issues related to a category approach and 5) related to including potency. We argue that two overarching (implicit) ‘advocacy coalitions’ can be discerned, that adopted contrasting positions towards the identified themes and issues. Among these ‘coalitions’, there appears to be consensus about the necessity of having ‘science-based’ criteria, though different perspectives exist as to what the most accurate mechanistic understanding of EDSs entails. To move the discussion forward, we argue that a societal dialogue would be beneficial, where EDS science and regulation are discussed as interrelated themes

Evaluating uncertainties in an integrated approach for chemical risk assessment under REACH: more certain decisions?

This thesis concentrates on uncertainty and variability in the risk assessment methodology for industrial chemicals as applied within the current regulatory framework for industrial chemicals in Europe, REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals). The methodological approaches discussed address the risk assessment for both humans and the environment. The aim of this thesis is to investigate in what way the scientific process of risk assessment can improve decision-making knowing that uncertainties are inherently linked to risk assessment. An important element of this decision-making is consideration of precautionary measures in the event of reasonable grounds for concern of a potential risk that cannot, or not in time, be determined with sufficient certainty. The investigation is built on two frameworks: the IPCS/WHO framework for Integrated Risk Assessment (IRA) and the framework for Uncertainty Management of Walker et al. (2003). The framework of Integrated Risk Assessment was developed to improve the quality and efficiency of the assessment of risks of adverse effects on human health and the environment from chemicals, physical factors, and other environmental stressors and to provide more complete and coherent inputs to the decision making process. The underlying idea is that both the scientific discussion and the regulatory responses can benefit from a more integrated, interdisciplinary approach leading to sharing of information, decreased uncertainties and fully informed decisions. The Uncertainty Management framework closely parallels the stages in the Integrated Risk Assessment scheme and is considered very useful for highlighting different types of uncertainty in risk assessment. The main, general conclusion of this thesis is that both the process and the methodology of risk assessment as a decision-support tool under REACH can be improved. The process can be improved by the introduction of an IRA framework with a strong uncertainty management component (IRA+). The methodology can be improved by a tiered approach for uncertainty analysis, starting with simple deterministic approaches and, if necessary, classification and prioritisation of uncertainties and probabilistic approaches. Qualitative and quantitative tools for uncertainty assessment were shown to be available. If process and methodology follow the direction shown, decision-support will be more transparent, will lead to less communication problems and will improve the trust between various parties involved. Decisions which fully take into account the uncertainties in the assessments performed, including the influence of divergent opinions and assumptions of experts and stakeholders, will be better informed and will lead to transparent decisions which can be communicated in a clear way

Probabilistic risk characterization: an example with di(2-ethylhexyl) phtalate

While probabilistic methods gain attention in hazard characterization and are increasingly used in exposure assessment, full use of the available probabilistic information in risk characterization is still uncommon. Usually, after probabilistic hazard characterization and/or exposure assessment, percentiles from the obtained distributions are used as point estimates in risk characterization. In this way, all information on variability and uncertainty is lost, while these aspects are crucial in any risk assessment. In this paper, we present a method to integrate the entire distributions from probabilistic hazard characterization and exposure assessment into one risk characterization plot. This method is illustrated using di(2-ethylhexyl) phthalate as an example. The final result of this probabilistic risk assessment is summarized in a single plot, containing two pieces of information: the confidence we may have in concluding there is no risk, and the fraction of the population this conclusion applies to. This information leads to a better informed conclusion on the risk of a substance, and may be very useful to define the necessary measures for risk reduction

Evaluation of EU Risk Assessments Existing Chemicals (EC Regulation 793/93).

Abstract not availableJRC.I-Institute for Health and Consumer Protection (Ispra