Multiple risk assessment frameworks and checklists were proposed defining the individual steps and points of decision taking to collect the relevant data including physicochemical characterisation, exposure scenarios, uptake routes, biokinetics and hazard and structure the needed steps and alternatives to be able to assess risk and propose mitigation measures. This case will review and document these and develop concepts to provide interoperable tools supporting them. This case is ongoing.
Although the number of tools and models for ENM RA is growing, their use by industrial organisations and regulatory agencies is not mainstream yet. Lack of sufficient data to support all steps required for RA is certainly one reason. Another missing element was identified as RA best practices and integrated user-friendly workflows that can guide users through the RA tools and provide navigational support on how to combine and link the different tools and approaches in order to arrive at reliable and well-validated RA and decisions. NanoCommons as well as multiple other projects aim to address both issues. This demonstration case is designed to document these efforts and the current status of RA processes in real-world settings and evaluate the existing approaches already integrated into the NanoCommons infrastructure but also currently developed in the partnering projects with respect to what part of the process they cover and to which readiness level. This will then be translated into a short- and long-term roadmap for the development of guidelines, pipelines and workflows that addresses identified gaps and to automate the whole process of RA, including quality standards for generating and sharing data, provision of access to high quality data and running the models inside the NanoCommons Infrastructure.
From this background it becomes clear that this demonstration case is very similar in its nature to the grouping/read-across demonstration case described above. Therefore, the aims, tasks and expected outcomes will be described to parallel the ones above or even just reference to the description provided above.
Nanomaterial risk assessment frameworks and checklists will be used similar to the ECHA RAAF described above to classify the existing tools. This classification will also be used during the onboarding efforts to bring the tools from different projects together into a common infrastructure and to structure additional informations including a clear description of the method in QMRF or MODA format if possible in the service catalogue and the training solutions.
Besides this documentation, interoperability between the tools coming from the different projects and platforms will be evaluated again using example nanomaterials like TiO2, Ag or CNTs.
The tasks for onboarding, documentation, workflow generation and evaluation are the same as for the grouping/read-across case and can be accessed there.
Also the expected outcomes resemble the one from the grouping/read-across case and are a joint paper as well as well-documented and customisable tools and workflows. However, evaluation of industry readiness and acceptance in regulatory context will be an even stronger focus as in the other demonstration case due to the increased complexity.