The objectives of this article are to: (1) investigate the current state of knowledge of the risks of engineered nanoparticles for the environment and human health, (2) estimate whether this knowledge is sufficient to facilitate their comprehensive and effective risk assessment and (3) provide recommendations on future research in the field of risk assessment of nanomaterials. In order to meet the objectives, the relevance of each of the four steps of the risk assessment methodology (i.e., hazard identification, dose-response assessment, exposure assessment and risk characterization) was evaluated in the context of the current state of knowledge of the risks of nanomaterials, limitations were identified and recommendations were given on how to overcome them
Various emerging technologies challenge existing governance processes to identify, assess, and manage risk. Though the existing risk-based paradigm has been essential for assessment of many chemical, biological, radiological, and nuclear technologies, a complementary approach may be warranted for the early-stage assessment and management challenges of high uncertainty technologies ranging from nanotechnology to synthetic biology to artificial intelligence, among many others. This paper argues for a risk governance approach that integrates quantitative experimental information alongside qualitative expert insight to characterize and balance the risks, benefits, costs, and societal implications of emerging technologies. Various articles in scholarly literature have highlighted differing points of how to address technological uncertainty, and this article builds upon such knowledge to explain how an emerging technology risk governance process should be driven by a multi-stakeholder effort, incorporate various disparate sources of information, review various endpoints and outcomes, and comparatively assess emerging technology performance against existing conventional products in a given application area. At least in the early stages of development when quantitative data for risk assessment remain incomplete or limited, such an approach can be valuable for policymakers and decision makers to evaluate the impact that such technologies may have upon human and environmental health.
The significant uncertainties associated\ud with the (eco)toxicological risks of engineered nanomaterials\ud pose challenges to the development of nanoenabled\ud products toward greatest possible societal\ud benefit. This paper argues for the use of risk governance\ud approaches to manage nanotechnology risks and\ud sustainability, and considers the links between these\ud concepts. Further, seven risk assessment and management\ud criteria relevant to risk governance are defined:\ud (a) life cycle thinking, (b) triple bottom line, (c) inclusion\ud of stakeholders, (d) risk management, (e) benefit–\ud risk assessment, (f) consideration of uncertainty, and (g) adaptive response. These criteria are used to\ud compare five well-developed nanotechnology frameworks:\ud International Risk Governance Council framework,\ud Comprehensive Environmental Assessment,\ud Streaming Life Cycle Risk Assessment, Certifiable\ud Nanospecific Risk Management and Monitoring System\ud and LICARA NanoSCAN. A Sustainable Nanotechnology\ud Decision Support System (SUNDS) is\ud proposed to better address current nanotechnology risk\ud assessment and management needs, and makes.\ud Stakeholder needs were solicited for further SUNDS\ud enhancement through a stakeholder workshop that\ud included representatives from regulatory, industry and\ud insurance sectors. Workshop participants expressed\ud the need for the wider adoption of sustainability\ud assessment methods and tools for designing greener\ud nanomaterials
Nanotechnologies have reached maturity and market penetration that require nano‐specific changes in legislation and harmonization among legislation domains, such as the amendments to REACH for nanomaterials (NMs) which came into force in 2020. Thus, an assessment of the components and regulatory boundaries of NMs risk governance is timely, alongside related methods and tools, as part of the global efforts to optimise nanosafety and integrate it into product design processes, via Safe(r)‐by‐Design (SbD) concepts. This paper provides an overview of the state‐of‐the‐art regarding risk governance of NMs and lays out the theoretical basis for the development and implementation of an effective, trustworthy and transparent risk governance framework for NMs. The proposed framework enables continuous integration of the evolving state of the science, leverages best practice from contiguous disciplines and facilitates responsive re‐thinking of nanosafety governance to meet future needs. To achieve and operationalise such framework, a science‐based Risk Governance Council (RGC) for NMs is being developed. The framework will provide a toolkit for independent NMs' risk governance and integrates needs and views of stakeholders. An extension of this framework to relevant advanced materials and emerging technologies is also envisaged, in view of future foundations of risk research in Europe and globally.
Mental modelling analysis can be a valuable tool in understanding and bridging cognitive values in multi-stakeholders' communities. It is especially true in situation of emerging risks where significant uncertainty and competing objectives could result in significant difference in stakeholder perspective on the use of new materials and technologies. This paper presents a mental modelling study performed among prospective users of an innovative decision support system for safe and sustainable development of nano-enabled products. These users included representatives of industry and regulators, as well as several insurance specialists and researchers. We present methodology and tools for comparing stakeholder views and objectives in the context of developing a decision support system
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