Perspectives for integrating human and environmental risk assessment and synergies with socio-economic analysis

Abstract

For more than a decade, the integration of human and environmental risk assessment (RA) has become an attractive vision. At the same time, existing European regulations of chemical substances such as REACH (EC Regulation No. 1907/2006), the Plant Protection Products Regulation (EC regulation 1107/2009) and Biocide Regulation (EC Regulation 528/2012) continue to ask for sector-specific RAs, each of which have their individual information requirements regarding exposure and hazard data, and also use different methodologies for the ultimate risk quantification. In response to this difference between the vision for integration and the current scientific and regulatory practice, the present paper outlines five medium-term opportunities for integrating human and environmental RA, followed by detailed discussions of the associated major components and their state of the art. Current hazard assessment approaches are analyzed in terms of data availability and quality, and covering non-test tools, the integrated testing strategy (ITS) approach, the adverse outcome pathway (AOP) concept, methods for assessing uncertainty, and the issue of explicitly treating mixture toxicity. With respect to exposure, opportunities for integrating exposure assessment are discussed, taking into account the uncertainty, standardization and validation of exposure modeling as well as the availability of exposure data. A further focus is on ways to complement RA by a socio-economic assessment (SEA) in order to better inform about risk management options. In this way, the present analysis, developed as part of the EU FP7 project HEROIC, may contribute to paving the way for integrating, where useful and possible, human and environmental RA in a manner suitable for its coupling with SEA.

Data Quality in the Human and Environmental Health Sciences: Using Statistical Confidence Scoring to Improve QSAR/QSPR Modeling

“…Low, or poor, data quality may also affect the quality of computational models, such as Quantitative Structure-Activity Relationships (QSARs), grouping and read-across, which are relevant both for risk assessment and regulatory decisions. [2][3][4] In principle there are two general approaches to assess the quality of biological and toxicological data. The first is based on the assessment of the reported testing information alone.…”

De-Icing of aircraft: Incorporating business risks and occupational health and safety

“…To achieve this, we need: (1) to understand and formalize the functioning and dysfunction of the system under study; (2) to model the system; (3) to quantify/qualify the model; (4) to apply the model in the field and validate its results. The principal scientific challenge consists of integrating risks characterized at different levels of sophistication (Aubert and Bernard [24]), for example risks for which it is not possible to identify the events that could result (level 0), risks for which there are definable event scenarios (level 4) and finally risks for which the uncertainty can be estimated in quantitative terms (level 6). It is also necessary to materialize this integration in interdisciplinary or even inter-sectorial contexts, which poses the challenge of determining the applicability of definitions and evaluation methods to the uncertainty concept (Péry et al [25]).…”

White paper on the promotion of an integrated risk assessment concept in European regulatory frameworks for chemicals

“…In addition, the existing close interactions at ECHA between human and environmental risk assessors, and between its Scientific Committees for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC) offer further opportunities for better integration into the RA process of cost-benefits and value-relevant impacts on human health and ecosystems services to more efficiently inform about the pros and cons of possible risk management options (Péry et al, 2013). Furthermore, ECHA liaises with other EU regulatory bodies, which enables the assessment of environmental safety in a cross-sectorial manner (REACH, Art.…”

“…• Augment technical RA by including SEA and socio-behavioural considerations into the risk analysis process: SEA could be a powerful tool to check and improve the level of integration of HHRA and ERA, from the point of view of their outputs (Péry et al, 2013). Indeed, outcomes of the assessment may differ substantially depending both on the nature of the analysis and the stakeholders or users concerned.…”