ITS-NANO - Prioritising nanosafety research to develop a stakeholder driven intelligent testing strategy

Abstract

BackgroundTo assess the risk of all nanomaterials (NMs) on a case-by-case basis is challenging in terms of financial, ethical and time resources. Instead a more intelligent approach to knowledge gain and risk assessment is required.MethodsA framework of future research priorities was developed from the accorded opinion of experts covering all major stake holder groups (government, industry, academia, funders and NGOs). It recognises and stresses the major topics of physicochemical characterisation, exposure identification, hazard identification and modelling approaches as key components of the current and future risk assessment of NMs.ResultsThe framework for future research has been developed from the opinions of over 80 stakeholders, that describes the research priorities for effective development of an intelligent testing strategy (ITS) to allow risk evaluation of NMs. In this context, an ITS is a process that allows the risks of NMs to be assessed accurately, effectively and efficiently, thereby reducing the need to test NMs on a case-by-case basis.For each of the major topics of physicochemical characterisation, exposure identification, hazard identification and modelling, key-priority research areas are described via a series of stepping stones, or hexagon diagrams structured into a time perspective. Importantly, this framework is flexible, allowing individual stakeholders to identify where their own activities and expertise are positioned within the prioritisation pathway and furthermore to identify how they can effectively contribute and structure their work accordingly. In other words, the prioritisation hexagon diagrams provide a tool that individual stakeholders can adapt to meet their own particular needs and to deliver an ITS for NMs risk assessment. Such an approach would, over time, reduce the need for testing by increasing the reliability and sophistication of in silico approaches.The manuscript includes an appraisal of how this framework relates to the current risk assessment approaches and how future risk assessment could adapt to accommodate these new approaches. A full report is available in electronic format (pdf) at http://www.nano.hw.ac.uk/research-projects/itsnano.html.ConclusionITS-NANO has delivered a detailed, stakeholder driven and flexible research prioritisation (or strategy) tool, which identifies specific research needs, suggests connections between areas, and frames this in a time-perspective.

Frameworks and tools for risk assessment of manufactured nanomaterials

“…In order to focus the assessment and avoid unnecessary testing costs, careful objective prioritization and planning are needed, which should take place in the fundamental problem formulation step. RENN and ROCO (2006), Shatkin (2008), Grieger et al (2012), Hristozov et al (2012), Stone et al (2014), Bos et al (2015) Exposure-driven approach It has been recognized that the testing of the currently available and still emerging MNs in all their formulations is cost-prohibitive. This is why careful prioritization of MNs is required to optimize testing efforts.…”

“…SCCS (2012), Stone et al (2014), Bos et al (2015) Iterative and adaptive structure In the next years more empirical data will appear for RA of MNs. Thus, there is need for iterative and adaptive frameworks, allowing the rapid inclusion of new information in the decision analytical process as it becomes available.…”

“…Thus, there is need for iterative and adaptive frameworks, allowing the rapid inclusion of new information in the decision analytical process as it becomes available. RENN and ROCO (2006), SCENIHR (2007), SCENIHR (2009), Stone et al (2014), Bos et al (2015) Transparency of objectives and communication with all involved stakeholders…”

“…RENN and ROCO (2006), Hristozov et al (2012), Stone et al (2014), Bos et al (2015) Documented applications Documented applications are the best way to test a framework, confirm its functionality and understand its strengths and limitations. Grieger et al (2012), Hristozov et al (2012), Allowing for/giving directions on grouping and read-across of MNs…”

“…It could be otherwise easily misled by overconfident communication of uncertain RA results. Hristozov et al (2012), Stone et al (2014), Hristozov et al (2016) Assessment tier The assessment tier criterion distinguishes the "screening-level" from the "high-tier" tools. Stone et al (2014), Bos et al (2015) Lifecycle thinking It is important to assess the risks of MNs from a lifecycle perspective since the characteristics of some MNs are likely to change significantly during their lifetime, which would affect their hazard, exposure and risk.…”