Risk Governance of Nanomaterials: Review of Criteria and Tools for Risk Communication, Evaluation, and Mitigation

Abstract

Nanotechnologies have been increasingly used in industrial applications and consumer products across several sectors, including construction, transportation, energy, and healthcare. The widespread application of these technologies has raised concerns regarding their environmental, health, societal, and economic impacts. This has led to the investment of enormous resources in Europe and beyond into the development of tools to facilitate the risk assessment and management of nanomaterials, and to inform more robust risk governance process. In this context, several risk governance frameworks have been developed. In our study, we present and review those, and identify a set of criteria and tools for risk evaluation, mitigation, and communication, the implementation of which can inform better risk management decision-making by various stakeholders from e.g., industry, regulators, and the civil society. Based on our analysis, we recommend specific methods from decision science and information technologies that can improve the existing risk governance tools so that they can communicate, evaluate, and mitigate risks more transparently, taking stakeholder perspectives and expert opinion into account, and considering all relevant criteria in establishing the risk-benefit balance of these emerging technologies to enable more robust decisions about the governance of their risks.

Risk Governance of Emerging Technologies Demonstrated in Terms of its Applicability to Nanomaterials

“…For example, Hristozov et al [62] have detailed the range of different risk pre-assessment and evaluation methods available, Lombi et al [63] addressed risk governance in the agriculture-nanotechnology field, while Grieger et al [64] have detailed the bevy of tools for risk screening of NMs. Similarly, Subramanian et al [65] and Isigonis et al [66] reflected upon tools for nanotechnology risk communication and mitigation, Trump et al [67] presented six options that have been deployed to address uncertainty regarding NMs in the United States, the European Union, as well as in developing countries, while Sørensen et al [68] evaluated environmental risk assessment models for NMs, in relation to their applicability within the caLIBRAte product innovation framework for NMs risk governance.…”

“…Notable developments include the nanorisk framework, [69] the ISO 31000:2018 Risk Management Framework for new technologies, [70] the risk governance framework of IRGC for NMs with specific guidelines on governance of emerging risks, [71,72] the iNTeg-Risk project Emerging Risk Management Framework (ERMF) [73] and the frameworks developed by EU funded projects such as NanoTEST, [74] MARINA, [75] SUN, [76] NANoReg, [77] NANoReg2, [78] caLIBRAte, [79] and NanoMILE. [80] Most of these approaches contain similar elements that form the main pillars of risk governance for NMs, such as "risk pre-assessment," "risk concern/safety assessment," "risk evaluation," "risk management, and decision making," while they are complemented by continuous supporting processes such as "risk communication" and "monitoring," as identified by Isigonis et al [66] The most important characteristics of these frameworks have been analyzed in relation to their suitability for risk governance of NMs, their advantages and disadvantages, their acceptability, legal basis, and broad applicability, enabling identification of knowledge gaps that need to be filled, as summarized in Table 1.…”

“…The principal components of risk governance frameworks, such as risk pre-assessment, risk appraisal, risk evaluation, and risk management have been described extensively in various previous studies. [66,71] They are accepted by the scientific community as important steps in chemical and material assessment and are used in the most recent research regarding risk governance processes for NMs. Our study uses the pre-existing principal components as the basis of the envisioned risk governance framework and focuses on the development and incorporation of specific elements that are currently missing and are considered essential toward the establishment of science-based risk governance of NMs, as also seen in Table 1.…”

Topical Minoxidil-Loaded Nanotechnology Strategies for Alopecia

“…The development of nanotechnology-based formulations for MXD topical delivery has introduced major improvements for AGA treatment due to the distinct physicochemical features of such formulations. Nonetheless, such formulations, as nanoscale-tailored materials, should be carefully assessed regarding their safety profile [81]. Indeed, the nanosized dimension is responsible for an increase in the surface area, hence increasing the surface contact area, potentiating the interaction between the nano sized MXD carrier and the biological systems.…”

Embedding Ethical Impact Assessment in Nanosafety Decision Support

“…[ 7 ] While this is difficult enough for traditional chemicals, risk governance of nanomaterials is even more challenging, because the environmental, health, and safety risks are still not fully assessed. [ 8 ] It is not clearly defined among policy makers, stakeholders, and key actors, neither what constitutes appropriate risk governance, nor which are the boundaries of regulatory compliance and legal basis of risk governance approaches. In this context, evidence‐based (i.e., taking into account peer‐reviewed, interdisciplinary scientific data and knowledge, including risk assessment, life cycle assessment and economic, social and ethical aspects) and participative (i.e., engaging all stakeholders in decision making) risk governance of nanomaterials is hampered by three interrelated conundrums. …”