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(s’ouvre dans une nouvelle fenêtre)) 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.
