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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 2 - caLIBRAte (Performance testing, calibration and implementation of a next generation system-of-systems Risk Governance Framework for nanomaterials)

Teaser

Summary

Currently, there is a high drive towards development of manufactured nanomaterials (MN) and nano-products. However, industrial users and the public appear not to readily accept such products due to uncertainty in regards to their potential human and environmental risks. This is a.o. due to fact that existing exposure limits are generally not valid for MN and that accepted regulatory risk assessment methods are either not suited or not validated for MN and nano-products. Many other factors can influence the risk perception of stakeholders and need to be understood.

The overall objective in the caLIBRAte project is to establish a â€œsystem-of-systemsâ€ (SoS) nano-risk governance framework. The framework will be introduced into a web-based Nano-Risk Governance Portal, linking tested and calibrated tools for: 1) horizon scanning for screening of relevant news and trends; 2) control banding, qualitative and predictive quantitative risk assessment; 3) risk management and decision support; as well as data-ressources, guidances for risk surveillance, and â€“management, and downstream risk communication. The framework will be constructed considering the Emerging Risk Management Framework and the ISO31000 risk governance framework aligned with the Cooper Stage-GateÂ® idea to launch product innovation model. Stakeholders consultation will play an important role. Implementation will be made through training of industrial stakeholders, service providers and authorities at the end of the project.

Work performed

Stakeholdersâ€™ risk perception, needs, priorities, expectations and recommendations for the risk governance were identified through several different approaches (surveys, workshops, qualitative interviews etc.) and an overall analysis has been made. The results from stakeholder interaction showed a clear convergence in the nano-risk perception among all the stakeholders.

Tools and models for horizon scanning, human and environmental control banding, risk assessment and management have been collated and analyzed in regards to their applicability and aligning to the stakeholdersâ€™ needs, data accessibility and competences. A limited number of tools has been recommended for further testing and to become part of the Nano-Risk Governance Portal. A new Nano-Risk Radar tool has also been developed that enables web-based horizon scanning of and monitoring emerging trends and news on selected web-resources.

Analysis of possible tool improvements which could be achieved by inclusion of numerous new approach methodologies (NAMs) has been completed, but will only to a limited extend be included in existing caLIBRAte tools using e.g., data from in vitro high-throughput screening for hazard ranking. Environmental risk assessment models were improved by use of improved mass-flow data and coupling of aerosol dispersion modelling with environmental concentration estimations are being developed.
An eNanoMapper â€“ caLIBRAte database has been established with data from several previous EU-funded projects and data produced by caLIBRAte. A data analysis showed that existing data are relatively incomplete and a need to close important data gaps in the future. In particular there is only a very limited set of NMs where existing data provide information on in vivo toxicological effects on end-points relevant for risk assessment.

A study on the role of specific surface area with and without porosity in silica and with and without presence of CuO and coating was performed to provide input for potential further hazard model development. A comprehensive review on in vivo toxicological data on 13 different NMs is completed to ensure hazard data for testing the hazard models in human risk assessment tools.
More than 139 nano-specific exposure case studies were inventoried and assessed regarding data gaps showing that approximately 70 exposure measurement case studies are sufficiently detailed to be used for performance testing. Three new value-chain case study exposure measurements have also been completed by caLIBRAte or in collaboration for demonstration of the governance tools. One of these case studies is comprehensive exposure and mass-flow measurement campaign in a paint factory. Additional four high-quality value-chain case studies have been inventoried from previous and parallel ongoing projects.

Twenty-two tools were analyzed in detail in regards to their input and output parameters and sensitivity. Tools recommended for inclusion in the Nano-Risk Governance Portal were subject to user testing. Feed-back on user-friendliness were used to recommend improvements. Performance testing is ongoing and has currently resulted in rejection of one tool due to inadequate performance.

Final results

Highlights: Identification of stakeholder needs in regards to nano-specific risk assessment tools, decision support, and guidance along the stage-gate innovation funnel and the risk governance framework; evaluation of existing nanospecific control banding and risk assessment tools and their alignment with stakeholder criteria; identification of stakeholders risk perception and main concerns in regards to NM and NM-enabled products; establishment of a database on NM physicochemical properties and toxicity and data collations on value-chain case studies with occupational exposure measurement data for tool testing and use; development of new toxicological data and further understanding on the role of specific surface area and combinations of low and high toxicity materials in higher generation coated NMs, sensitivity analysis for numerous human and environmental risk assessment and management tools; ongoing performance testing against case study data; development and further refinement of a nano-risk radar tool for horizon scanning and web-monitoring; and establishment of a conceptual nano-risk governance framework and initiated development of a web-based Nano-Risk Governance Portal.

Expected key impacts at the end of the caLIBRAte project are:
1) A demonstrated framework for nano-risk governance of MN and MN-enabled products entering the market based on â€œvalidatedâ€ tools.
2) Accessible up-to-date data libraries or linked databases.
3) Relevant knowledge, needs and risk perception profiles of key stakeholder groups to support especially industries in their decisions during product development and awareness for risk communication.
4) A stepping stone for forthcoming developments in the area of innovation risk-governance and improved confidence in the risk communication between stakeholders.

In regards to socio-economic impact, the caLIBRATe project will raise awareness of NM risk assessment and management tools and potential benefits of implementing nano-risk innovation governance. Hereunder, that nano-risk innovation governance can ensure sustainable use of NM; improve innovation capacity and reducing time to market resulting in growth. Increased awareness is also achieved through the project dissemination activities covering both general and targeted stakeholder information, in addition to scientific presentations and publications.