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.
The main objectives of Gov4Nano are listed below, together with the outputs reached at the project end.
Although establishing a Nano Risk Governance Council (NRGC) is an appealing concept, currently it is nothing more than just a concept, an idea for which support has to be won. The NRGC will gain credibility by a participative and pro-active form of governance involving all relevant stakeholders, by stressing their needs and creating incentives to contribute and by stimulating dialogue thus overcoming any inherent barriers. To achieve this overall aim of Gov4Nano to create the NRGC, a number of specific objectives were defined and the results of the project can be measured against the achievement of these objectives.
Objective 1: To improve the FAIRness of the nano-EHS data infrastructure, eventually leading to machine-readable data
At project start
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.
Gov4Nano launched the AdvancedNano GO FAIR Implementation Network. The network has currently 28 members (from Europe but also some countries outside Europe). Its action plan foresees three categories of objectives to address the identified FAIRification challenges (i.e., increase people’s awareness, promote harmonisation of tools, and infrastructure, and involve monitoring strategies enabling refinement and further improvement of the FAIRification process), which has been described in a comment article (https://doi.org/10.5281/zenodo.7614989). In addition to this network, the FAIRness of the nano-EHS data infrastructure has been improved by Gov4Nano by 1) developing a range of user-friendly solutions in the Nanosafety Data Interface (previously known as eNanoMapper database), such as a template wizard and a data completeness scoring system (D1.3) and 2) performing four case studies, applying a harmonized data FAIRification workflow (D1.4). D1.5 describes how the work was disseminated in two conferences: the NanoWeek in Cyprus (June 2022) and the joint NMBP-13 conference at the OECD (January 2023)
Objective 2: Harmonized guidance for characterization and testing of nanomaterials
At project start
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.
Efforts in Gov4Nano have resulted in a new OECD Test Guideline on “Determination of the Volume Specific Surface Area of Manufactured Nanomaterials” and an OECD Study Report on applicability of the key event-based TG 442D for in vitro skin sensitisation testing of nanomaterials. Efforts on dissolution rate, surface chemistry and dustiness will provide valuable input for the NanoHarmony project as well as the ongoing OECD Test Guideline development on these topics. Efforts on abiotic transformation in the environment and bioaccumulation provide a solid basis for OECD development of Guidance Documents in the WNT, while results on the development of Guidance on Release Tests for Manufactured Nanomaterials were brought to the OECD WPMN.
Objective 3: To understand how risk perception on nanotechnologies is formed in (a) civil society and (b) (re-) insurance industry
At project start
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 conditions of the organisational form for Nano Risk Governance.
Based on extensive consultations with stakeholders who represent civil society and (re)-insurance industry, it was concluded that while there is an interest in risk perception from civil society, the (re)-insurance industry was disinterested in the topic, having concluded that all relevant risks are now covered so there is no problem of financial exposure in the market.
Objective 4: To develop a Nano-Risk Governance Portal (NRGP) with tools, data, and guidance
At project start
A web-based Nano Risk Governance Portal (NRGP) 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 4) The NRGP will enable assessment and guidance support to the organisational form for Nano Risk Governance. In addition to risk- governance, the NRGP 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 NRGP 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.
A joint NMBP-13 NRGP and a caLIBRAte x Gov4Nano platform. The joint NMBP-13 NRGP was developed with the objective of becoming the one-stop-shop (library) for nano-risk governance data, tools, regulatory information, and guidances. The joint NRGP does not offer any specific nano-risk governance guidance. The caLIBRAte x Gov4Nano platform offers a dynamic stage-gate nano-risk governance framework guidance supported by thoroughly tested tools, besides key educational information and comprehensive libraries on data, tools, guidance and regulations. The implemented governance framework essentially promotes Sustainable SbD and SIA. All library information can be easily sorted to make a shortlist of relevant documents. The developed sites can in each their way support an organizational form for nano-risk governance.
Link to the Nano-Risk Governance Portal
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
At project start
Develop conditions for a science based, organisational form for Nano Risk Governance, 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 organisational form for Nano Risk Governance 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 organisational form for Nano Risk Governance and thus Gov4Nano will follow an inclusive, well-balanced and carefully designed process. The creation of the organisational form for Nano Risk Governance will lead to the utilisation of risk research for nanomaterials and products, comparable to the valorisation of research for innovation.
WP5 in Gov4Nano has extensively analysed the conditions for the development of risk governance approaches for nanomaterials, exploring stakeholder needs and perspectives, and as well scientific and technical, regulatory, policy, business and societal factors. The analysis considered traditional issues related to nanomaterial development (risk assessment & management & communication) as well as novel aspects related to the implementation of safe and sustainable by design strategies. WP5 of Gov4Nano clearly identified conditions to establish an organizational form for risk governance of nanomaterials, in terms of drivers and opportunities, key themes and actions, stakeholders to engage, potential structures, value proposition and business models (Deliverable report D5.5). It has tested several of the possible modes of action of such a form and engaged with a variety of potential members and sponsors of such a structure. Following the decisions taken in the 5th amendment, such findings remained as a proof of concept of a risk governance organizational form, that could be taken up by other bodies, and have not been translated in an existing, operational organization.
Link to Governance Briefs
Objective 6: From stakeholder engagement to stakeholder involvement in the NRGC
At project start
Stakeholders are a vital copoint of the organisational form for Nano Risk Governance 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 conditions for an organisational form for Nano Risk Governance, 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 organisational form for Nano Risk Governance, which is critical for the sustainability of the organisational form for Nano Risk Governance. This will help ensure the long-term relevance and global ownership of the organisational form for Nano Risk Governance, 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.
Efforts in Gov4Nano have resulted in a strong partnership with the sister projects active in the field of disseminating and or collecting information from informed stakeholders. The stakeholder community which is represented by the stakeholder database has confirmed commitment to continuing their efforts but without any costs. This is an important resource developed by WP6 in collaboration with WP3. Throughout the project, several dialogue, engagement, dissemination and communication initiatives have been undertaken (directly in WP6 or in connection with other WPs and the sister projects), involving wide and multi-disciplinary and cross-sectoral communities of different type of stakeholders (researchers, industry, regulators, policy makers, civil society organizations) in Europe and at international level, to discuss and compare approaches for risk governance and safe and sustainable by design of nanomaterials. This helped to increase awareness, build capacity, competences on risk governance of nanomaterials and favour trust and trustworthiness amongst these communities.
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
At project start
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 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 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 to continuously evaluate not progress in risk governance cross sectors. The potential for non-European inclusion, thereby expanding the activities to a global level, will be explored.
WP7 developed a dashboard as instrument for monitoring the progress of how risk governance was actually applied in practice, and therefore fully achieved this objective.