Embedding Ethical Impact Assessment in Nanosafety Decision Support

Nanotechnology is a key enabling technology, which is developing fast and influences many aspects of life. Nanomaterials are already included in a broad range of products and industrial sectors. Nanosafety issues are still a matter of concern for policy makers and stakeholders, but currently, there is no platform where all stakeholders can meet and discuss these issues. A comprehensive overview of all the issues in one single dashboard presenting the output of a decision support system is also lacking. This article outlines a strategy for developing one innovative part of a modular decision support system, designed to support the work of a new Risk Governance Council (RGC) for nanomaterials which will be established through the combined efforts of the GOV4NANO, NANORIGO, and RiskGONE H2020 projects. This new module will consist of guidelines for Ethical Impact Assessment (EIA) for nanomaterials and nanoenabled products. This article offers recommendations for adapting the European Committee for Standardization (CEN) prestandard on Ethical Impact Assessment CWA (CEN Workshop Agreement) 17145-2:2017 (E), to fit into the more-encompassing decision support system for risk governance of nanomaterials within the RiskGONE project

Risk Governance of Emerging Technologies Demonstrated in Terms of its Applicability to Nanomaterials

Nanotechnologies have reached maturity and market penetration that require nano-specific changes in legislation and harmonization among legislation domains, such as the amendments to REACH for nanomaterials (NMs) which came into force in 2020. Thus, an assessment of the components and regulatory boundaries of NMs risk governance is timely, alongside related methods and tools, as part of the global efforts to optimise nanosafety and integrate it into product design processes, via Safe(r)-by-Design (SbD) concepts. This paper provides an overview of the state-of-the-art regarding risk governance of NMs and lays out the theoretical basis for the development and implementation of an effective, trustworthy and transparent risk governance framework for NMs. The proposed framework enables continuous integration of the evolving state of the science, leverages best practice from contiguous disciplines and facilitates responsive re-thinking of nanosafety governance to meet future needs. To achieve and operationalise such framework, a science-based Risk Governance Council (RGC) for NMs is being developed. The framework will provide a toolkit for independent NMs' risk governance and integrates needs and views of stakeholders. An extension of this framework to relevant advanced materials and emerging technologies is also envisaged, in view of future foundations of risk research in Europe and globally

A Multi-Criteria Decision Analysis based methodology for quantitatively scoring the reliability and relevance of ecotoxicological data

Ecotoxicological data are highly important for risk assessment processes and are used for deriving environmental quality criteria, which are enacted for assuring the good quality of waters, soils or sediments and achieving desirable environmental quality objectives. Therefore, it is of significant importance the evaluation of the reliability of available data for analysing their possible use in the aforementioned processes. The thorough analysis of currently available frameworks for the assessment of ecotoxicological data has led to the identification of significant flaws but at the same time various opportunities for improvement. In this context, a new methodology, based on Multi-Criteria Decision Analysis (MCDA) techniques, has been developed with the aim of analysing the reliability and relevance of ecotoxicological data (which are produced through laboratory biotests for individual effects), in a transparent quantitative way, through the use of expert knowledge, multiple criteria and fuzzy logic. The proposed methodology can be used for the production of weighted Species Sensitivity Weighted Distributions (SSWD), as a component of the ecological risk assessment of chemicals in aquatic systems. The MCDA aggregation methodology is described in detail and demonstrated through examples in the article and the hierarchically structured framework that is used for the evaluation and classification of ecotoxicological data is shortly discussed. The methodology is demonstrated for the aquatic compartment but it can be easily tailored to other environmental compartments (soil, air, sediments).Ecotoxicological data are highly important for risk assessment processes and are used for deriving environmental quality criteria, which are enacted for assuring the good quality of waters, soils or sediments and achieving desirable environmental quality objectives. Therefore, it is of significant importance the evaluation of the reliability of available data for analysing their possible use in the aforementioned processes. The thorough analysis of currently available frameworks for the assessment of ecotoxicological data has led to the identification of significant flaws but at the same time various opportunities for improvement. In this context, a new methodology, based on Multi-Criteria Decision Analysis (MCDA) techniques, has been developed with the aim of analysing the reliability and relevance of ecotoxicological data (which are produced through laboratory biotests for individual effects), in a transparent quantitative way, through the use of expert knowledge, multiple criteria and fuzzy logic. The proposed methodology can be used for the production of weighted Species Sensitivity Weighted Distributions (SSWD), as a component of the ecological risk assessment of chemicals in aquatic systems. The MCDA aggregation methodology is described in detail and demonstrated through examples in the article and the hierarchically structured framework that is used for the evaluation and classification of ecotoxicological data is shortly discussed. The methodology is demonstrated for the aquatic compartment but it can be easily tailored to other environmental compartments (soil, air, sediments)

NanoSolveIT Project: Driving nanoinformatics research to develop innovative and integrated tools for in silico nanosafety assessment

Nanotechnology has enabled the discovery of a multitude of novel materials exhibiting unique physicochemical (PChem) properties compared to their bulk analogues. These properties have led to a rapidly increasing range of commercial applications; this, however, may come at a cost, if an association to long-term health and environmental risks is discovered or even just perceived. Many nanomaterials (NMs) have not yet had their potential adverse biological effects fully assessed, due to costs and time constraints associated with the experimental assessment, frequently involving animals. Here, the available NM libraries are analyzed for their suitability for integration with novel nanoinformatics approaches and for the development of NM specific Integrated Approaches to Testing and Assessment (IATA) for human and environmental risk assessment, all within the NanoSolveIT cloud-platform. These established and well-characterized NM libraries (e.g. NanoMILE, NanoSolutions, NANoREG, NanoFASE, caLIBRAte, NanoTEST and the Nanomaterial Registry (>2000 NMs)) contain physicochemical characterization data as well as data for several relevant biological endpoints, assessed in part using harmonized Organisation for Economic Co-operation and Development (OECD) methods and test guidelines. Integration of such extensive NM information sources with the latest nanoinformatics methods will allow NanoSolveIT to model the relationships between NM structure (morphology), properties and their adverse effects and to predict the effects of other NMs for which less data is available. The project specifically addresses the needs of regulatory agencies and industry to effectively and rapidly evaluate the exposure, NM hazard and risk from nanomaterials and nano-enabled products, enabling implementation of computational ‘safe-by-design’ approaches to facilitate NM commercialization

A weight of evidence approach for hazard screening of engineered nanomaterials

Hazard identification is an important step in assessing nanomaterial risk and is required under multiple regulatory frameworks in the US, Europe and worldwide. Given the emerging nature of the field and complexity of nanomaterials, multiple studies on even basic material properties often result in varying data pointing in different directions when data interpretation is attempted. Weight of evidence (WOE) evaluation has been recommended for nanomaterial risk assessment, but the majority of WOE frameworks are qualitative in nature and do not satisfy the growing needs for objectivity and transparency that are necessary for regulatory decision making. This paper implements a quantitative WOE framework that utilizes multi-criteria decision analysis methodology for integrating individual studies on nanomaterial hazard resulting from physico-chemical and toxicological properties of nanomaterials. For the first time, a WOE approach explicitly integrates expert evaluation of data quality of available information. Application of the framework is illustrated for titanium dioxide nanoparticles (nano-TiO2), but the approach is designed to compare the relative hazard of several nanomaterials as well as emerging stressors in general