Periodic Reporting for period 3 - caLIBRAte (Performance testing, calibration and implementation of a next generation system-of-systems Risk Governance Framework for nanomaterials)
Berichtszeitraum: 2019-05-01 bis 2019-10-31
The market uptake of MN and MN-enabled products by industrial users and the public remains limited due to uncertainties about their potential human and environmental risks and lack of adequate and validated risk assessment methods for MN and MN-products. Several qualitative and quantitative human and environmental nano-risk assessment and management tools exist, but none have been tested and calibrated. A next generation nano-risk governance framework is needed to keep pace with nanotechnology innovation. Nano-risk governance tools needs to be validated and aligned with user capacities. Use of validated tools is expected to improve trust in the nano-risk assessment approach and associated nano-risk communication.
The key objective of the caLIBRAte project was to establish a web-based “Systems-of-Systems” nano-risk governance framework supported by tools for: 1) horizon scanning; 2) control banding, qualitative and predictive quantitative risk assessment; 3) risk management and decision support; as well as data-resources, guidance for risk surveillance, –management, and downstream risk communication.
The work resulted in establishment of a nano-risk innovation governance framework based on a Cooper-like stage-gate idea-to-launch innovation model, which is supported by an emering nano-risk assessment and management framework. The established framework includes considerations of Safety-by-Design, green chemistry and the STOP (Substitution, Technological, Operational, Personal protection) principles.
The framework was implemented in a one-stop-shop nano-risk governance portal (www.nanoriskgov-portal.org). This portal also provide key nano-risk information, guidance, data, and direct library access to selected and thoroughly assessed nano-risk governance tools. The tool suite include a new nano-risk radar and an app for monitoring of workplace nano-safety observations.
The nano-risk governance portal, framework, tools and guidance were established based on a strong scientific foundation including: results from extensive stakeholder consultation, creation of carefully assessed test data sets based on existing and new hazard and exposure measurements, and thorough tool analysis and testing. Availability of high-quality data fit for tool testing remains to be an issue for future attention.
The key objective of the caLIBRAte project was to establish a web-based “Systems-of-Systems” nano-risk governance framework supported by tools for: 1) horizon scanning; 2) control banding, qualitative and predictive quantitative risk assessment; 3) risk management and decision support; as well as data-resources, guidance for risk surveillance, –management, and downstream risk communication.
The work resulted in establishment of a nano-risk innovation governance framework based on a Cooper-like stage-gate idea-to-launch innovation model, which is supported by an emering nano-risk assessment and management framework. The established framework includes considerations of Safety-by-Design, green chemistry and the STOP (Substitution, Technological, Operational, Personal protection) principles.
The framework was implemented in a one-stop-shop nano-risk governance portal (www.nanoriskgov-portal.org). This portal also provide key nano-risk information, guidance, data, and direct library access to selected and thoroughly assessed nano-risk governance tools. The tool suite include a new nano-risk radar and an app for monitoring of workplace nano-safety observations.
The nano-risk governance portal, framework, tools and guidance were established based on a strong scientific foundation including: results from extensive stakeholder consultation, creation of carefully assessed test data sets based on existing and new hazard and exposure measurements, and thorough tool analysis and testing. Availability of high-quality data fit for tool testing remains to be an issue for future attention.
The scientific and technical work was conducted in 4 topics:
1) Stakeholder consultation.
Stakeholders’ knowledge, risk perception, needs, and recommendations for the risk governance framework were identified through surveys, workshops, interviews etc. In total more than 3200 stakeholders participated in the different consultations. A convergence was observed in the stakeholders’ nano-risk perception. Greatest concerns were about worker safety and personal contact products. Research laboratories and industrial companies need valid information that is more accessible, guidance, and useful tools to assess and manage nano-risks.
2) Models and tools
From a large number of existing models and tools for horizon scanning, human and environmental risk assessment and management, 22 tools were selected to comply best with stakeholder criteria. Only 10 of the tools (consumer, worker, environment, decision support tools) were accepted after performance testing. A new Nano-Risk Radar tool was developed for horizon scanning and monitoring using trusted web-sites. A nano-safety observer app was established for workplace safety monitoring. New approach methodologies (NAMs) were identified for further development of risk-governance tool. Some NAMs were already included in tools during the project.
3) Test data
An eNanoMapper – caLIBRAte database was established. Analysis of existing data showed a lack of toxicological data adequate for tool testing and important data gaps. Hence, suitable in vivo toxicological data and associated characterization data were gathered from scientific literature to derive material-specific limit values . Extensive work was also completed to gather existing value-chain case study data with exposure measurements for testing exposure assessment models. Most case-studies also had incomplete information for tool testing. Key data gaps for both characterization and release data were filled to the extent possible.
To expand the test data set, 3 life-cycle case-studies on occupational exposure and release were completed as part of the project. Eco-toxicological, in vitro, in vivo studies were completed on 8 materials produced in caLIBRAte to investigate the role of specific surface area and CuO doping of silica with and without porosity. High-throughput in vitro studies were conducted on 17 case-study materials.
In total, more than 70 exposure measurements were suitable for testing the simplest inhalation exposure assessment models. Adequate toxicological data was found for 29 materials for testing human hazard models. Extensive data set were available on TiO2 and silver to demonstrate the use of environmental risk assessment models.
4) Framework development and implementation
Based on results from stakeholder consultation, a Nano-Risk Governance Portal (http://nanoriskgov-portal.org) was established as a one-stop-shop to gain or access trustworthy information on nanomaterials, risk, guidance and access to validated tools.
A nano-risk innovation governance framework was developed combining a modified Stage-Gate Innovation funnel approach supported by an emerging risk management and assessment framework based on requirements in e.g. ISO21505, ISO31000, and CWA 16649, and scientific literature. The framework includes considerations of Safety-by-Design, green chemistry, and the adherence to the occupational STOP principle. The framework was implemented as a web-based Nano-Risk Innovation Governance project portfolio management tool to guide innovators towards pre-risk assessment and safety by design.
The nano-risk governance portal is intended a living source to be further developed over time.
1) Stakeholder consultation.
Stakeholders’ knowledge, risk perception, needs, and recommendations for the risk governance framework were identified through surveys, workshops, interviews etc. In total more than 3200 stakeholders participated in the different consultations. A convergence was observed in the stakeholders’ nano-risk perception. Greatest concerns were about worker safety and personal contact products. Research laboratories and industrial companies need valid information that is more accessible, guidance, and useful tools to assess and manage nano-risks.
2) Models and tools
From a large number of existing models and tools for horizon scanning, human and environmental risk assessment and management, 22 tools were selected to comply best with stakeholder criteria. Only 10 of the tools (consumer, worker, environment, decision support tools) were accepted after performance testing. A new Nano-Risk Radar tool was developed for horizon scanning and monitoring using trusted web-sites. A nano-safety observer app was established for workplace safety monitoring. New approach methodologies (NAMs) were identified for further development of risk-governance tool. Some NAMs were already included in tools during the project.
3) Test data
An eNanoMapper – caLIBRAte database was established. Analysis of existing data showed a lack of toxicological data adequate for tool testing and important data gaps. Hence, suitable in vivo toxicological data and associated characterization data were gathered from scientific literature to derive material-specific limit values . Extensive work was also completed to gather existing value-chain case study data with exposure measurements for testing exposure assessment models. Most case-studies also had incomplete information for tool testing. Key data gaps for both characterization and release data were filled to the extent possible.
To expand the test data set, 3 life-cycle case-studies on occupational exposure and release were completed as part of the project. Eco-toxicological, in vitro, in vivo studies were completed on 8 materials produced in caLIBRAte to investigate the role of specific surface area and CuO doping of silica with and without porosity. High-throughput in vitro studies were conducted on 17 case-study materials.
In total, more than 70 exposure measurements were suitable for testing the simplest inhalation exposure assessment models. Adequate toxicological data was found for 29 materials for testing human hazard models. Extensive data set were available on TiO2 and silver to demonstrate the use of environmental risk assessment models.
4) Framework development and implementation
Based on results from stakeholder consultation, a Nano-Risk Governance Portal (http://nanoriskgov-portal.org) was established as a one-stop-shop to gain or access trustworthy information on nanomaterials, risk, guidance and access to validated tools.
A nano-risk innovation governance framework was developed combining a modified Stage-Gate Innovation funnel approach supported by an emerging risk management and assessment framework based on requirements in e.g. ISO21505, ISO31000, and CWA 16649, and scientific literature. The framework includes considerations of Safety-by-Design, green chemistry, and the adherence to the occupational STOP principle. The framework was implemented as a web-based Nano-Risk Innovation Governance project portfolio management tool to guide innovators towards pre-risk assessment and safety by design.
The nano-risk governance portal is intended a living source to be further developed over time.
The caLIBRAte project has progressed considerably beyond state-of-the-art in all four research and development areas of the project.
All expected impacts were delivered:
1) A framework for the risk governance of nanomaterials entering the market by developing tools for risk appraisal, risk transfer and guidance for risk communication.
2) Demonstration in specific industrial settings or industrial sectors of the feasibility of the developed approaches and tools through worked examples as case studies and pilots with outcomes as guidance, good practices and tools for risk management and risk communication
3) Leveraging and building on current knowledge related to hazard mapping, exposure and control banding and risk prioritization as well on inter/national and company level risk governance and risk dialogue efforts with key stakeholders including regulators and insurers.
4) Improving innovation capacity and reducing time to market
The effect of impact item 4 depends on whether users apply the tools and the framework and how recent regulatory changes, such as the requirement to register MN in REACH by January 2020 and global demands, affects the nanotechnology area in the coming years.
Importantly, caLIBRAte is the first project to validate specific nano-risk assessment and management tools; an important achievement on its own.
All expected impacts were delivered:
1) A framework for the risk governance of nanomaterials entering the market by developing tools for risk appraisal, risk transfer and guidance for risk communication.
2) Demonstration in specific industrial settings or industrial sectors of the feasibility of the developed approaches and tools through worked examples as case studies and pilots with outcomes as guidance, good practices and tools for risk management and risk communication
3) Leveraging and building on current knowledge related to hazard mapping, exposure and control banding and risk prioritization as well on inter/national and company level risk governance and risk dialogue efforts with key stakeholders including regulators and insurers.
4) Improving innovation capacity and reducing time to market
The effect of impact item 4 depends on whether users apply the tools and the framework and how recent regulatory changes, such as the requirement to register MN in REACH by January 2020 and global demands, affects the nanotechnology area in the coming years.
Importantly, caLIBRAte is the first project to validate specific nano-risk assessment and management tools; an important achievement on its own.