The overarching aim is to develop a proof of concept of an efficient and effective risk governance process for nanotechnologies, dealing with the legacy as well as future technological developments.
Gov4Nano will work towards a resilient and adaptive form of risk governance covering the needs of a continually developing technology and addressing the needs of all involved stakeholders across all relevant disciplines, including civil society.
Objective 1: To improve the FAIRness of the nano-EHS data infrastructure, eventually leading to machine-readable data
Gov4Nano will work to improve the Findability, Accessibility, Interoperability and Reusability of databases in order to support a science-based risk governance of nanomaterials (including elucidation of the mode of action, grouping, read across, development of quantitative structure-activity relationships, Safe by Design). A first goal is the establishment of a NanoSafety Implementation Network under the European GO-FAIR initiative, in which key players agree on ways to improve the FAIRness of databases and on the stepwise implementation of these. The implementation of FAIR principles eventually aims at machine-readable data, thereby opening the potential to highly improve the efficiency of investigations.
Objective 2: Harmonized guidance for characterization and testing of nanomaterials
Expanding the state of the art knowledge and data with laboratory research to support the initiation and updating of a selected number of OECD Guidance Documents (GDs) and Test Guidelines (TGs) as part of European input in the OECD WPMN and TGP (so-called Malta Initiative). More specifically, new or refined regulatory test methods and strategies as well as relevant parameters such as accuracy, reproducibility, detection limits for these methods will be assessed and the results communicated to enable the assessment of nanomaterials in European regulations like REACH.
Objective 3: To understand how risk perception on nanotechnologies is formed in (a) civil society and (b) (re-) insurance industry
Characterising and understanding particular information needs and concerns about nanotechnology of (a) civil society, and (b) (re-)insurance industry, will help identifying indicators that influence and form public risk perception on nanotechnologies. Therefore, one objective is to identify, analyse and understand their needs when it comes to possible risks and how to deal with them. Indicators will be created and further translated into criteria that form different perceived risk levels, which will enable the monitoring of public risk perception through the project runtime. Moreover, this will allow the evaluation of the impact of stakeholder engagement activities (e.g., informative workshops, training, dialogues, etc.) on public acceptance of nanotechnologies. Specific focus will be given to dedicated training sessions as well as education and out-of-the-box thinking activities, in order to elaborate how training and education can help non-experts to build their own unbiased opinion. The aim is to raise awareness of civil society concerns while addressing the insurance issues which will ensure that the needs of (a) civil society and (b) (re-)insurance industry are appropriately addressed and included into the NRGC’s mission and activities.
Objective 4: To develop a Nano-Risk Governance Portal (NRGP) with tools, data, and guidance
A web-based NanoSafety Governance Portal (NSGP) will be developed and established, consolidating state-of-the-art and future-looking nanosafety governance tools (e.g. human and environmental risk assessment and management and SbD tools, databases, communication and knowledge transfer tools), as well as various technical and procedural guidance materials (Figure 2) The NSGP will enable assessment and guidance support to the NRGC. In addition to risk-governance, the NSGP will facilitate systematic procedures to monitor, organize, evaluate and structure (according to the Safe Innovation approach; SIA) available resources to assess and manage risks related to nanomaterials along the life cycle and the innovation chain. An essential focus is to align with and reach regulatory and industry acceptance of the NSGP and its supporting tools and functions. This will be aimed at through stakeholder dialogue in collaboration with e.g., WP3, 5 and 6. Starting points for the objective are the web-based caLIBRAte nano-risk innovation governance framework and the NanoReg2 Safe Innovation Approach tools, as well as the eNanoMapper-data infrastructure. Emerging next generation tools with high future potential are included.
Objective 5: To build a Risk Governance Council for nano (NRGC) to coordinate and harmonize transdisciplinary international efforts toward safe and sustainable nano-related products
Establishment of a science based, NRGC, coordinating efforts of the broad range of organizations dealing with risk governance issues across EU and at international level, supporting business decision making in innovation and the development of sustainable nano-products. Furthermore, the NRGC needs to meet the demand for efficient and transparent adaptive risk governance, to evolve concepts, taking into account existing approaches (such as Safe-by-Design). The consortium is fully aware of the threat experienced by some stakeholders of a not yet well described Council and thus the establishment of the Council will follow an inclusive, well-balanced and carefully designed process. The creation of the NRGC will lead to the utilisation of risk research for nanomaterials and products, comparable to the valorisation of research for innovation. The NRGC will convey the efforts and outcomes of all other activities of Gov4Nano, to lead to widely accepted options for decision-making on governance, regulatory developments, and safety research on nanotechnologies.
Objective 6: From stakeholder engagement to stakeholder involvement in the NRGC
Stakeholders are a vital copoint of the NRGC whose full engagement is vital to its sustainability. There is a need for significant investments in dialogues with stakeholders, awareness raising for the added value of their input and having an eye (and ear!) for incentives and barriers stakeholders experience or foresee. The project will include stakeholders in developing the NRGC, with WP3 bringing in civil society and insurers and WP6 focussing on industry and authorities. Gov4Nano will begin with an inventory of stakeholder goals and an analysis of their critical needs within risk governance covering both existing and new risk governance structures. A representative stakeholder community will be designed and established, and a subscription mechanism will be used to measure active involvement in the NRGC, which is critical for the sustainability of the NRGC. This will help ensure the long-term relevance and global ownership of the NRGC, based on the principles of participation, transparency and inclusiveness. It builds on trust in governance, providing “responsible communication” based on good quality information and feedback.
Objective 7: To equip the NRGC with the mechanisms and tools 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
One of the important activities in this regard is the elucidation of so-called minimum data standards. Those reflect the minimum completeness and quality of information that needs to be known about each nanomaterial or product for risk governance across sectors. These data standards form the core for FAIR databases and will become an item for the NRGC to monitor as an indicator for transdisciplinary, (cross)sectorial governance. More indicators will be developed to describe progress not only in the development and implementation of data, but also in maturity of governance tools, establishing trust, transdisciplinary collaboration, regulatory preparedness and industrial initiative beyond regulatory compliance. These indicators will be combined with appropriate methods to develop a scheme to be used by the NRGC for monitoring implementation of risk governance. Since the current monitoring methods such as Multi-criteria Decision Analysis (MCDA) will only suffice partially, the relevance of innovative approaches such as corporate social responsibility index and blockchains will be evaluated to use as cockpit tools for the NRGC to continuously evaluate not only progress in risk governance cross sectors, but also its own agility for governance initiatives. The potential for non-European inclusion, thereby expanding the activities to a global level, will be explored.