Together with 24 partners the objective of the European caLIBRAte project is to establish a state-of-the-art versatile Risk Governance framework for assessment and management of human and environmental risks of MN and MN-enabled products. The framework will be a web-based “system-of-systems” linking different models and methods for:

1. Screening of apparent and perceived risks and trends in nanotechnology,
2. Control banding, qualitative and fully integrated predictive quantitative risk assessment operational at different information levels
3. Safety-by-design and multi-criteria decision support methods
4. Risk surveillance, -management and -guidance documents.

The risk management framework will support assessments of emerging and existing MN and MN-enabled products following the recent ISO31000 risk governance framework, as well as safety in innovation by matching models to the principle innovation steps in the “Cooper Stage-Gate®” product innovation model. Furthermore, control banding tools and quantitative models will be subject to sensitivity analysis and performance testing followed by a revision as needed. After revision the models will again be analyzed by sensitivity testing, calibration, performance tested to establish the uncertainties. After calibration, the models will be part of the framework, which will be demonstrated by case studies. Stakeholders will be involved for defining the user requirements of the framework and will receive training in the framework at the end.

Empa’s role

Lead of the work package 3 “Environmental risk assessment models”

• Compile and match the integrated risk assessment methods into a safe innovation approach along the Cooper stage-gate model®.
• Select tools that meet criteria for stakeholder and user profiles, time and resource costs, data availability and risk assessment and certainty requirements relevant for each of these stages
• Models fitting the criteria at the different Cooper stage-gates will be improved 

Publications

Wigger, H.; Wohlleben, W.; Nowack, B. (2018) Redefining environmental nanomaterial flows: Consequences of the regulatory nanomaterial definition on the results of environmental exposure models. Environ. Sci. Nano5: 1372-1385. pdf

Wigger, H.; Nowack, B. (2019) Material-specific properties applied to an environmental risk assessment of engineered nanomaterials – implications on grouping and read-across concepts. Nanotoxicology 13: 623-643. pdf

Nørgaard Sørensen, S.; Baun, A.; Burkard, M.; Dal Maso, M.; Foss Hansen, S.; Harrison, S.; Hjorth, R.; Lofts, S.; Matzke, M.; Nowack, B.; Peijnenburg, W.; Poikkimäki, M.; Quik, J.; Schirmer, K.; Verschoor, A.; Wigger H.; Spurgeon, D. (2019) Environmental risk assessment of nanomaterials: Assessing available models against stakeholder requirements for different stages of product innovation. Environ. Sci. Nano 6: 505–518. pdf

Cai, Y.; Wigger, H.; Nowack, B. (2019) Identifying ecotoxicological descriptors to enable predictive hazard assessments of nanomaterials in a meta-analysis of ecotoxicological data. NanoImpact 15: 100180. pdf

Wigger, H.; Kawecki, D.; Nowack, B.; Adam, V. (2020) Systematic consideration of parameter uncertainty and variability in probabilistic species sensitivity distributions. Integrated Environmental Assessment and Management 16: 211–222. pdf

Sørensen, S.N.; Wigger, H.; Nowack, B.; Zabeo, A.; Hristozov, D.; Semenzin, E.; Spurgeon, D.J.; Baun, A. (2020) Comparison of species sensitivity distribution modeling approaches for environmental risk assessment of nanomaterials – a case study for silver and titanium dioxide representative materials. Aquat. Toxicology 225:105543. pdf