This task has been built to guarantee that SOPs associated with the ACEnano toolbox of methods deliver outputs tailored to the needs of key descriptors for hazard and risk assessment (e.g. describe surface coating and coating degradation under realistic exposure scenarios; describe particle size distribution in polydisperse samples on a particle per particle basis suitable for regulation). Therefore, output guidelines related to key descriptors for hazard and risk assessment will be developed, along with guidance on the domains of applicability of the methods, to be applied within the respective WP and utilised in WP3 in the training activities. This task will deliver D5.3.
Developing and even established nanometrology techniques require data treatment that can often be quite involved, and requiring user-intervention. Choosing a dissolved/NM cut-off value during spICP-MS data treatment is an example. This kind of expert involvement is best minimized to arrive at consistent, verifiable measurands that are intercomparable with each other and with similar measurands to be used in modelling and for longer term integration goals, such as standardization of particular techniques into an integrated testing strategy. Such activities require development of optimal, objective data treatment techniques for several nanometrology techniques, used within ACENano and other NSC projects, which will also form an important part of the standardization efforts and user guidance.
Benchmarking will feed directly into the development of the decision tree approach, which will guide end users through the sequence of methods to be used to obtain the required key descriptors for a given purpose. Development of the decision tree will be done as follows: i. Initial consultation with industry and regulatory stakeholders on required uses of the decision tree/characterisation suite in relation to regulatory hazard and risk assessment needs. ii. Following each round of method benchmarking, derived applicability domains will be used to re–assess and refine the first round decision tree workflows for each desired use. iii. The process of ii. will be repeated through the project lifetime in order to progressively refine the characterisation suite and decision tree workflows in line with stakeholder use requirements.
The developing “virtual toolbox” platform in ACEnano will need to be aligned with the needs and views of regulators and industry, to facilitate incorporation of the ACEnano virtual toolbox and approaches into regulatory processes. A regulatory workshop and teleconferences with regulators and industry will therefore be facilitated, to (i) assess their future needs and map these to the ACEnano workflows; (ii) present the proposed workflow of the ACEnano tiered approach with regulators, and to discuss how the decision trees regarding method selection can be aligned with regulatory needs and be incorporated into existing and evolving regulatory frameworks and technical guidance documents.
In order to ensure a comparable performance of labs and to guarantee reliable method output data obtained from WP1-4 will be utilized and critically evaluated. Therefore, output guidelines related to key descriptors and risk assessment will be developed by WP5 and applied within the respective WPs. Based on the knowledge developed within the project, ACEnano will establish a proficiency testing scheme providing guidelines on parameters for comparable testing and data acquisition for risk assessment in Europe. Guidance for the appropriate and efficient use of ACENano’s toolbox of methods for development of the materials characterisation section of regulatory dossiers for risk assessment will be developed.
The aim of this deliverable is to describe activities to ensure harmonisation of key in-house SOPs in WP1-4 via conducting and evaluating inter-laboratory comparisons according to international evaluation standards. Therefore, specific support during the design (definition of measurands, calibrations and traceability of measurements) and data evaluation of the inter laboratory comparisons will be provided. A default approach for ILCs will be developed and the application throughout the project wherever feasible will be ensured. This common approach will harmonise the validation of the various methods in work packages 1-4. Potential method candidates for inter laboratory validation will be determined at Month 12 based on Go/NoGo decisions made in WPs 1-3.
Benchmarking of the ACEnano approved techniques/methods (Tier 1 and those coming from WPs 1 and 2) will be an essential step to developing the analytical toolbox, building regulatory acceptance of the methods and their resulting outputs (Task 3.2. In the context of methodology and toolbox development in ACEnano, the goal of benchmarking is to establish ‘best practice’ for as many of the studied techniques/methodologies as possible, to maximise uptake of the toolbox as ‘best practice’ for NM analysis for fate and risk assessment by both regulators and industry.
The project’s website (tentative: www.acenano.eu) will be the backbone of the communication efforts of ACEnano, and will be set up as early in the life of the project as practical, in a basic form, and will be expanded as appropriate. This deliverable will confirm its launch and features.
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