Evidential requirements for the regulatory hazard and risk assessment of respiratory sensitisers: methyl methacrylate as an example.

This review addresses the need for a framework to increase the consistency, objectivity and transparency in the regulatory assessment of respiratory sensitisers and associated uncertainties. Principal issues are considered and illustrated through a case study (with methyl methacrylate). In the absence of test methods validated for regulatory use, formal documentation of the weight-of-evidence for hazard classification both at the level of integration of individual studies within lines of evidence and across a broad range of data streams was agreed to be critical for such a framework. An integrated approach is proposed to include not only occupational studies and clinical evidence for the regulatory assessment of respiratory sensitisers, but also information on structure and physical and chemical factors, predictive approaches such as structure activity analysis and in vitro and in vivo mechanistic and toxicokinetic findings. A weight-of-evidence protocol, incorporating integration of these sources of data based on predefined considerations, would contribute to transparency and consistency in the outcome of the assessment. In those cases where a decision may need to be taken on the basis of occupational findings alone, conclusions should be based on transparent weighting of relevant data on the observed prevalence of occupational asthma in various studies taking into account all relevant information including the range and nature of workplace exposures to the substance of interest, co-exposure to other chemicals and study quality.

Is the EU chemicals strategy for sustainability a green deal?

A fully integrated Chemicals Strategy for Sustainability (CSS) in respect of chemicals is crucial and must include: • An objective evaluation of the present situation including impacts of 'chemicals of concern' throughout their life cycle, that incorporates sustainability issues. • A framework that facilitates innovation of chemistry-based approaches to tackle each of the key sustainability issues. The EU CSS only addresses adverse impacts and mainly focusses on one aspect of risk assessment, the hazard to humans from individual industrial chemicals. The proposal removes consideration of the nature and amount of exposure, which is a critical determinant of risk. It can be presumed that this is solely to simplify, and hence speed up, regulatory decisions thereby enabling more chemicals to be assessed. The linkage of this proposed approach to address any of the major sustainability issues, such as environmental pollutants is obscure. For example, the well-recognised environmental problems caused by polymers such as plastics are not considered. The proposed change in the assessment methodology lacks any scientific justification and fails to address the sustainability issues the EU and the rest of the world are facing. The authors critically discuss a comprehensive innovative evaluation methodology for the impact of chemicals.

Framework for developing an exposure science curriculum as part of the European Exposure Science Strategy 2020-2030.

BACKGROUND: Evaluating and managing exposures to chemical, physical and biological stressors, which frequently interplay with psychological stressors as well as social and behavioural aspects, is crucial for protecting human and environmental health and transitioning towards a sustainable future. Advances in our understanding of exposure rely on input from well-trained exposure scientists. However, no education programmes in Europe are currently explicitly dedicated to cover the broader range of exposure science approaches, applications, stressors and receptors. OBJECTIVE: To address this challenge, a curriculum is needed that yields credible, well-defined career pathways in exposure science. METHODS: Needs and conditions for advancing exposure science education in Europe were identified. As a starting point for a way forward, harmonised learning outcomes for exposure science were defined at each level of the European Qualifications Framework. The course programme coordinators were recruited for three varying courses, with respect to the course level and the proportion of the curriculum dedicated to exposure science. These courses were assessed via our systematic course review procedure. Finally, strategic objectives and actions are proposed to build exposure science education programmes. RESULTS: The ISES Europe 'Education, Training and Communication' expert working group developed a framework for creating a viable exposure science curriculum. Harmonised learning outcomes were structured under eight learning levels, categorised by knowledge, skills and competence. Illustrative case studies demonstrated how education providers integrated these learning outcomes for their educational context and aligned the overall exposure science curriculum. CONCLUSIONS: The international recognition and adoption of exposure science education will enable advances in addressing global exposure science challenges for various stressors, from behavioural aspects from individual to population scale, and effective communication between exposure scientists and relevant stakeholders and policy makers, as part of the European Exposure Science Strategy 2020-2030.