Exposure Assessment Framework development and road-testing
Lead: Alison Crossley, University of Oxford
The overall objective of WP1 is to ensure the project delivers a fit-for-purpose exposure assessment framework in a form that allows industry to assess the full breadth of nano-enabled product types and uses in an efficient manner in accordance with regulatory requirements.
Industry case studies are developed and catalogued which profile production, use and disposal of ENMs (current uses and near-market developments), to cover all potential environmental compartments and to confirm that the framework design is fit for purpose (in consultation also with FP7 FutureNanoNeeds).
The outputs generated by the framework are scoped initially by consideration of existing case study data and consultation with industry partners and the project Advisory Board. Links between what level of data enables what level of model output are considered. Limitations, constraints and additional required inputs are identified early in the project. These are subsequently addressed by further studies in the project.
The Exposure Assessment Framework is gradually tailored to the requirements of all stakeholders, including regulators, by direct and continuous stakeholder engagement and dialogue with industry partners and end users during the lifetime of the project, thus ensuring the widest possible involvement among stakeholders.
The industry partners owning case studies provide product and knowledge on the fabrication specifications and processes, use profiles, market details and disposal options for a ‘pathway analysis’ (deliverable D1.2) along and beyond the product value chain. This establishes the potential release points to the environment and potential pathways through the environment following disposal/release. Gap analysis is used to identify the most urgent analytical/technical/modelling developments required to maximise the value of each case study. The case studies are used to inform the development of experimental protocols and modelling tools allowing prioritization of experimental, analytical and modelling developments in WP2-9.
Finally, the catalogue of case studies covering industry breadth and potential environmental impact is used to evaluate and validate the models developed and used within the Exposure Assessment Framework with all elements being consolidated into a comprehensive, robust system providing clear guidance. Examples for utilisation will be included for regulators/industry (i.e. framework use for conducting ENM hazard and fate assessment, including fully worked case studies); scientists (e.g. incorporation of nano-enabling algorithms into other multimedia models), and testing laboratories and consultants (e.g. models and protocols application for ENM characterisation).