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Implementation of Risk Governance: meeting the needs of nanotechnology

Periodic Reporting for period 1 - Gov4Nano (Implementation of Risk Governance: meeting the needs of nanotechnology)

Reporting period: 2019-01-01 to 2020-06-30

Problems and Issues: Gov4Nano is a project built on more than 10 years of research funded by Framework Programmes into health and safety aspects of nanomaterials and nanotechnology. Concepts such as Safe by Design and Safe Innovation Approach have progressed from theoretical concepts to increasingly practical steps in the design, manufacture and use of nano-enabled products, including disposal and end of life. Currently innovation policies are focussed on promoting technology development, whilst lacking a simultaneous, proportional push for appropriate risk governance that is increasingly lagging behind innovation. Innovators and manufacturers of Advanced Materials such as nano must ensure they are Green Materials (safe and sustainable). Basic knowledge can be translated into products satisfying the criteria of the Green Deal and Circular Economy when supported by regulation. Regulatory Preparedness is a key aspect of innovation. Gov4Nano will achieve this, in collaboration with two sister NBMP13 projects (RiskGONE and NANORIGO) by developing a Nano Risk Governance Council (NRGC) which brings together the elements of innovation and regulation.

Societal Relevance: Concerns about the safety of nanotechnologies on the market and the adequacy of their regulation has been negative for innovation. Addressing these issues, it is important to optimize the transfer of scientific data/knowledge into standards and regulation, and to engage civil society about potential risks from nanotechnologies. Gov4Nano will develop a framework on how to do this, ensuring best practice for risk evaluation and acceptance of nanotechnologies. Societal relevance is an integral part of the NRGC and essential for its credibility. The proposed risk governance approach will be based on existing infrastructure (regulatory agencies, organisations officially representing industry and societal stakeholders), and connect key organizations and stakeholders at EU and international level (research, industry, regulators, insurers, end-users, workers, consumers and society).

Overall Objectives: The Gov4Nano project takes up the challenge of building a functioning council which must be one of the building blocks for delivering the Green Deal. Ideally the NRGC will oversee the process of the innovation value chain as a whole. To achieve this, the following specific objectives are addressed:

• To improve the FAIRness of the nano-EHS data infrastructure, eventually leading to machine-readable data (WP1)
• Harmonized guidance for characterization and testing of nanomaterials (WP2)
• To understand how risk perception on nanotechnologies is formed in civil society and (re-) insurance industry (WP3)
• To develop a Nano Risk Governance Portal with tools, data and guidance (WP4)
• To build a NRGC to coordinate and harmonize transdisciplinary international efforts toward safe and sustainable nano-related products (WP5)
• Turn stakeholder engagement to stakeholder involvement in the NRGC (WP6)
• To monitor the progress on implementation of risk governance for nanotechnology across different regulatory sectors (i.e. chemicals, biocides, cosmetics, food, medicine) in Europe and beyond (WP7)
Work performed: All work in Gov4Nano follows a strategic concept leading to the establishment of the NRGC (Figure 1). It comprises three main elements, namely Scientific Excellence, Co-creational Excellence and Proving the Outcomes. The scientific excellence is covered mainly by WPs 1, 2 and 4. FAIRness of data (WP1) is crucial in order to provide a sound scientific basis to any evaluation or decision making process. Existing OECD Test Guidelines and Guidance Documents are in several cases not nano-specific and therefore unsuited to use for NMs. WP2 as part of the Malta Initiative is developing knowledge and data needed to improve evaluating eight TGs and making recommendations on improvements for practical application. Development of the Nano Risk Governance Portal (WP4) includes tools which will support the process of Nano-Risk Governance by Risk Assessment and Innovation Risk Management of new NMs.

WPs 3 and 6 deal with stakeholder engagement and also serve as facilitators for other WPs who need opinions and input from outside sources and experts. These WPs facilitate the involvement of different views and opinions from the very beginning of the NRGC design phase. By active participation of different Stakeholders, recognition and acceptance of the NRGC can be achieved already during its development phase.

Bringing together all the scientific elements with the organisational skills to develop the NRGC is the core of the Co-creational Excellence. A skilled process of debate and questioning, involving value proposition workshops and a force field analysis, is now coming to a close with four distinct scenarios being presented for evaluation. How the work and WPs of Gov4Nano interacts with RiskGONE and NANORIGO is shown in Figure 2.

Main Results: The inventory and input of stakeholder needs was used for the development of four possible scenarios in a co-creative manner between the NMBP-13 projects. A final choice of scenario will establish the fundamental principles of the Council (WP5) supported by monitoring processes from WP7. This is an ongoing process (Figure 3) and Gov4Nano is now in the design phase of the Council. After a cross NMBP-13 consortium evaluation of scenarios, the stakeholders in the joint NMBP-13 database have now been asked for their opinions and feedback and this will help shape the council. Research funding to support council development has been set out by the SAFERA network.
State of the Art: The date for defining the operational rules of the Council is M24, and Gov4Nano will achieve this. At M18 the process of defining the nature of the Council, its mandate, its potential members, how to ensure credibility and establish itself within existing groups and organisations is the major joint activity, involving Gov4Nano, RiskGONE and NANORIGO. There is no precursor to the NGRC, so this is the new State of the Art. Risk Governance of Nano materials will be entering new territory.

Expected results: At the end of Gov4Nano a functioning NRGC will have been established with secured funding, a mandate and clear rules of engagement in the nano community.

Potential Impact: The impact of the NRGC covers many sectors:
A transparent, self-sustaining and science-based risk governance council that will facilitate a risk governance platform and initiates meaningful dialogue between stakeholder communities.
Risk governance tools and guidance for managing potential nanotechnology risks in regard to social, environmental and economic benefits will become available. It will provide an overview on the status of tools regarding validation, verification and qualification from a regulatory perspective as regulatory acceptance of the tools is of relevance for application by industry.
Secure high quality data will be facilitated by means of a standardised curation system, that will create a reliable open data platform needed to support a Safe by Design approach in industry, as well as enabling the use as weighted evidence in the regulatory procedures.
Consistency of science based risk management approaches, through which Gov4Nano will stimulate the acceptance and reliance on consolidated knowledge and access to high quality data and promote a secure innovation climate for all involved stakeholders.