Nanotechnology and the need for risk governance

After identifying the main characteristics and prospects of nanotechnology as an emerging technology, the paper presents the general risks associated with nanotechnology applications and the deficits of the risk governance process today, concluding with recommendations to governments, industry, international organizations and other stakeholders. The International Risk Governance Council (IRGC) has identified a governance gap between the requirements pertaining to the nano- rather than the micro-/macro- technologies. The novel attributes of nanotechnology demand different routes for risk-benefit assessment and risk management, and at present, nanotechnology innovation proceeds ahead of the policy and regulatory environment. In the shorter term, the governance gap is significant for those passive nanostructures that are currently in production and have high exposure rates; and is especially significant for the several ‘active’ nanoscale structures and nanosystems that we can expect to be on the market in the near future. Active nanoscale structures and nanosystems have the potential to affect not only human health and the environment but also aspects of social lifestyle, human identity and cultural values. The main recommendations of the report deal with selected higher risk nanotechnology applications, short- and long-term issues, and global models for nanotechnology governance.     

Towards a nanorisk appraisal framework

The article discusses, in the context of nanotechnology, whether current concepts of chemical risk assessment can be used to assess nanorisk. Nanorisk can be defined from the narrow (eco)toxicological perspective to the broader sense to include societal/cultural impacts or even to the fundamental philosophical level, i.e. questioning societies need for the technology. We outline here the limitations of chemical risk assessment and other recent proposed risk governance paradigms in relation to nanotechnology and nanomaterials, including its inability to include societal risks (ownership, privacy, security, nanodivide,¹ convergence of nano-, bio-, etc.) and metaphysical risk (including the lay persons perspective on the risks of nanotechnology). Finally, we outline the fundamental principles and criteria that an alternative comprehensive framework should be based on.     

Multi-criteria decision analysis and environmental risk assessment for nanomaterials

Nanotechnology is a broad and complex discipline that holds great promise for innovations that can benefit mankind. Yet, one must not overlook the wide array of factors involved in managing nanomaterial development, ranging from the technical specifications of the material to possible adverse effects in humans. Other opportunities to evaluate benefits and risks are inherent in environmental health and safety (EHS) issues related to nanotechnology. However, there is currently no structured approach for making justifiable and transparent decisions with explicit trade-offs between the many factors that need to be taken into account. While many possible decision-making approaches exist, we believe that multi-criteria decision analysis (MCDA) is a powerful and scientifically sound decision analytical framework for nanomaterial risk assessment and management. This paper combines state-of-the-art research in MCDA methods applicable to nanotechnology with a hypothetical case study for nanomaterial management. The example shows how MCDA application can balance societal benefits against unintended side effects and risks, and how it can also bring together multiple lines of evidence to estimate the likely toxicity and risk of nanomaterials given limited information on physical and chemical properties. The essential contribution of MCDA is to link this performance information with decision criteria and weightings elicited from scientists and managers, allowing visualization and quantification of the trade-offs involved in the decision-making process.     

A risk forecasting process for nanostructured materials, and nanomanufacturing

Nanomaterials exhibit novel properties that enable new applications ranging from molecular electronics to energy production. Proactive consideration of the potential impacts on human health and the environment resulting from nanomaterial production and use requires methods for forecasting risk associated with of these novel materials. However, the potential variety of nanomaterials is virtually infinite and a case-by-case analysis of the risks these materials may pose is not possible. The challenge of forecasting risk for a broad number of materials is further complicated by large degrees of uncertainty concerning production amounts, the characteristics and uses of these materials, exposure pathways, and a scarcity of data concerning the relationship between nanomaterial characteristics and their effects on organisms and ecosystems. A traditional risk assessment on nanomaterials is therefore not possible at this time. In its place, an evolving process is needed for analyzing the risks associated with emerging nanomaterials-related industries.In this communication, we propose that such a process should include the following six key features: (1) the ability to generate forecasts and associated levels of uncertainty for questions of immediate concern; (2) a consideration of all pertinent sources of nanomaterials; (3) an inclusive consideration of the impacts of activities stemming from nanomaterial use and production that extends beyond the boundaries of toxicology and include full life cycle impacts; (4) the ability to adapt and update risk forecasts as new information becomes available; (5) feedback to improve information gathering; and (6) feedback to improve nanomaterial design. Feature #6 implies that the potential risks of nanomaterials must ultimately be determined as a function of fundamental, quantifiable properties of nanomaterials, so that when these properties are observed in a new material, they can be recognized as indicators of risk. Thus, the required risk assessment process for nanomaterials addresses needs that span from urgent, short-term questions dealing with nanomaterials currently in commerce, to longer-term issues that will require basic research and advances in theory. In the following sections we outline issues surrounding each of these six features and discuss.     

Is adaptation or transformation needed? Active nanomaterials and risk analysis

Nanotechnology has been a key area of funding and policy for the United States and globally for the past two decades. Since nanotechnology research and development became a focus and nanoproducts began to permeate the market, scholars and scientists have been concerned about how to assess the risks that they may pose to human health and the environment. The newest generation of nanomaterials includes biomolecules that can respond to and influence their environments, and there is a need to explore whether and how existing risk-analysis frameworks are challenged by such novelty. To fill this niche, we used a modified approach of upstream oversight assessment (UOA), a subset of anticipatory governance. We first selected case studies of “active nanomaterials,” that are early in research and development and designed for use in multiple sectors, and then considered them under several, key risk-analysis frameworks. We found two ways in which the cases challenge the frameworks. The first category relates to how to assess risk under a narrow framing of the term (direct health and environmental harm), and the second involves the definition of what constitutes a “risk” worthy of assessment and consideration in decision making. In light of these challenges, we propose some changes for risk analysis in the face of active nanostructures in order to improve risk governance.     

Evaluating the Control Banding Nanotool: a qualitative risk assessment method for controlling nanoparticle exposures

Control banding (CB) strategies offer simplified processes for controlling worker exposures in the absence of firm toxicological and exposure information. The nanotechnology industry is an excellent candidate for applying such strategies with overwhelming uncertainties of work-related health risks posed by nanomaterials. A recent survey shows that a majority of nanomaterial producers are not performing a basic risk assessment of their product in use. The CB Nanotool, used internationally, was developed to conduct qualitative risk assessments to control nanoparticle exposures. Nanotoxicology experts have requested standardization of toxicological parameters to ensure better utility and consistency of research. Such standardization would fit well in the CB Nanotool’s severity and probability risk matrix, therefore enhancing the protection of nanotechnology industry workers. This article further evaluates the CB Nanotool for structure, weighting of risk factors, and utility for exposure mitigation, and suggests improvements for the CB Nanotool and the research needed to bolster its effectiveness.     

Nanotoxicology and nanomedicine: making development decisions in an evolving governance environment

The fields of nanomedicine, risk analysis, and decision science have evolved considerably in the past decade, providing developers of nano-enabled therapies and diagnostic tools with more complete information than ever before and shifting a fundamental requisite of the nanomedical community from the need for more information about nanomaterials to the need for a streamlined method of integrating the abundance of nano-specific information into higher-certainty product design decisions. The crucial question facing nanomedicine developers that must select the optimal nanotechnology in a given situation has shifted from “how do we estimate nanomaterial risk in the absence of good risk data?” to “how can we derive a holistic characterization of the risks and benefits that a given nanomaterial may pose within a specific nanomedical application?” Many decision support frameworks have been proposed to assist with this inquiry; however, those based in multicriteria decision analysis have proven to be most adaptive in the rapidly evolving field of nanomedicine—from the early stages of the field when conditions of significant uncertainty and incomplete information dominated, to today when nanotoxicology and nano-environmental health and safety information is abundant but foundational paradigms such as chemical risk assessment, risk governance, life cycle assessment, safety-by-design, and stakeholder engagement are undergoing substantial reformation in an effort to address the needs of emerging technologies. In this paper, we reflect upon 10 years of developments in nanomedical engineering and demonstrate how the rich knowledgebase of nano-focused toxicological and risk assessment information developed over the last decade enhances the capability of multicriteria decision analysis approaches and underscores the need to continue the transition from traditional risk assessment towards risk-based decision-making and alternatives-based governance for emerging technologies.     

Toward responsible development and effective risk management of nano-enabled products in the U.S. construction industry

The global construction sector is experiencing major improvements to building materials used in large quantities through commercial applications of nanotechnology. Nano-enabled construction products hold great promise for energy efficiency and resource conservation, but risk assessments lag as new products emerge. This paper presents results from an inventory, survey, and exposure assessment conducted by the authors and explores these findings in the broader context of evolving research trends and responsible development of nanotechnology. An inventory of 458 reportedly nano-enabled construction products provided insight into product availability, potential exposures, and deficiencies in risk communication that are barriers to adoption of proactive safety measures. Seasoned construction trainers surveyed were largely unaware of the availability of nano-enabled construction products. Exposure assessment demonstrated the effectiveness of ventilation to reduce exposures during mechanical abrasion of photocatalytic tiles containing titanium dioxide (TiO₂). Dissociated particles of TiO₂ just above the nanoscale (138 nm) were detected in the debris collected during cutting of the tiles, but measurements were below recommended exposure limits for TiO₂. Exposure assessments remain scarce, and toxicological understanding primarily pertains to unincorporated nanomaterials; less is known about the occupational risks of nano-enabled construction products across their life cycle. Further research is needed to characterize and quantify exposure to debris released from nanocomposite materials for realistic risk assessment, and to ascertain how nanocomposite matrices, fillers, and degradation forces interact to affect release dynamics. Improving risk communication strategies and implementing safe work practices will cultivate responsible development of nanotechnology in construction, as will multidisciplinary research efforts.     

Emerging methods and tools for environmental risk assessment, decision-making, and policy for nanomaterials: summary of NATO Advanced Research Workshop

Nanomaterials and their associated technologies hold promising opportunities for the development of new materials and applications in a wide variety of disciplines, including medicine, environmental remediation, waste treatment, and energy conservation. However, current information regarding the environmental effects and health risks associated with nanomaterials is limited and sometimes contradictory. This article summarizes the conclusions of a 2008 NATO workshop designed to evaluate the wide-scale implications (e.g., benefits, risks, and costs) of the use of nanomaterials on human health and the environment. A unique feature of this workshop was its interdisciplinary nature and focus on the practical needs of policy decision makers. Workshop presentations and discussion panels were structured along four main themes: technology and benefits, human health risk, environmental risk, and policy implications. Four corresponding working groups (WGs) were formed to develop detailed summaries of the state-of-the-science in their respective areas and to discuss emerging gaps and research needs. The WGs identified gaps between the rapid advances in the types and applications of nanomaterials and the slower pace of human health and environmental risk science, along with strategies to reduce the uncertainties associated with calculating these risks.     

Risk-based classification system of nanomaterials

Various stakeholders are increasingly interested in the potential toxicity and other risks associated with nanomaterials throughout the different stages of a product’s life cycle (e.g., development, production, use, disposal). Risk assessment methods and tools developed and applied to chemical and biological materials may not be readily adaptable for nanomaterials because of the current uncertainty in identifying the relevant physico-chemical and biological properties that adequately describe the materials. Such uncertainty is further driven by the substantial variations in the properties of the original material due to variable manufacturing processes employed in nanomaterial production. To guide scientists and engineers in nanomaterial research and application as well as to promote the safe handling and use of these materials, we propose a decision support system for classifying nanomaterials into different risk categories. The classification system is based on a set of performance metrics that measure both the toxicity and physico-chemical characteristics of the original materials, as well as the expected environmental impacts through the product life cycle. Stochastic multicriteria acceptability analysis (SMAA-TRI), a formal decision analysis method, was used as the foundation for this task. This method allowed us to cluster various nanomaterials in different ecological risk categories based on our current knowledge of nanomaterial physico-chemical characteristics, variation in produced material, and best professional judgments. SMAA-TRI uses Monte Carlo simulations to explore all feasible values for weights, criteria measurements, and other model parameters to assess the robustness of nanomaterial grouping for risk management purposes.     

Characterization of exposure to silver nanoparticles in a manufacturing facility

An assessment of the extent of exposure to nanomaterials in the workplace will be helpful in improving the occupational safety of workers. It is essential that the exposure data in the workplace are concerned with risk management to evaluate and reduce worker exposure. In a manufacturing facility dealing with nanomaterials, some exposure data for gas-phase reactions are available, but much less information is available regarding liquid-phase reactions. Although the potential for inhaling nanomaterials in a liquid-phase process is less than that for gas-phase, the risks of exposure during wet-chemistry processes are not negligible. In this study, we monitored and analyzed the exposure characteristics of silver nanoparticles during a liquid-phase process in a commercial production facility. Based on the measured exposure data, the source of Ag nanoparticles emitted during the production processes was indentified and a mechanism for the growth of Ag nanoparticle released is proposed. The data reported in this study could be used to establish occupational safety guidelines in the nanotechnology workplace, especially in a liquid-phase production facility.     

Taking stock of the occupational safety and health challenges of nanotechnology: 2000–2015

Engineered nanomaterials significantly entered commerce at the beginning of the 21st century. Concerns about serious potential health effects of nanomaterials were widespread. Now, approximately 15 years later, it is worthwhile to take stock of research and efforts to protect nanomaterial workers from potential risks of adverse health effects. This article provides and examines timelines for major functional areas (toxicology, metrology, exposure assessment, engineering controls and personal protective equipment, risk assessment, risk management, medical surveillance, and epidemiology) to identify significant contributions to worker safety and health. The occupational safety and health field has responded effectively to identify gaps in knowledge and practice, but further research is warranted and is described. There is now a greater, if imperfect, understanding of the mechanisms underlying nanoparticle toxicology, hazards to workers, and appropriate controls for nanomaterials, but unified analytical standards and exposure characterization methods are still lacking. The development of control-banding and similar strategies has compensated for incomplete data on exposure and risk, but it is unknown how widely such approaches are being adopted. Although the importance of epidemiologic studies and medical surveillance is recognized, implementation has been slowed by logistical issues. Responsible development of nanotechnology requires protection of workers at all stages of the technological life cycle. In each of the functional areas assessed, progress has been made, but more is required.     

Redefining risk research priorities for nanomaterials

Chemical-based risk assessment underpins the current approach to responsible development of nanomaterials (NM). It is now recognised, however, that this process may take decades, leaving decision makers with little support in the near term. Despite this, current and near future research efforts are largely directed at establishing (eco)toxicological and exposure data for NM, and comparatively little research has been undertaken on tools or approaches that may facilitate near-term decisions, some of which we briefly outline in this analysis. We propose a reprioritisation of NM risk research efforts to redress this imbalance, including the development of more adaptive risk governance frameworks, alternative/complementary tools to risk assessment, and health and environment surveillance.     

Comparing nanoparticle risk perceptions to other known EHS risks

Over the last decade social scientific researchers have examined how the public perceives risks associated with nanotechnology. The body of literature that has emerged has been methodologically diverse. The findings have confirmed that some publics perceive nanotechnology as riskier than others, experts feel nanotechnology is less risky than the public does, and despite risks the public is optimistic about nanotechnology development. However, the extant literature on nanotechnology and risk suffers from sometimes widely divergent findings and has failed to provide a detailed picture of how the public actually feels about nanotechnology risks when compared to other risks. This study addresses the deficiencies in the literature by providing a comparative approach to gauging nanotechnology risks. The findings show that the public does not fear nanotechnology compared to other risks. Out of 24 risks presented to the participants, nanotechnology ranked 19th in terms of overall risk and 20th in terms of “high risk.”     

National nanotechnology partnership to protect workers

Nanotechnology is predicted to improve many aspects of human life. By 2015, it is estimated to represent $3.1 trillion in manufactured goods. Data is emerging that exposure to nanomaterials may pose a health risk to workers. If the economic promise of nanotechnology is to be achieved, ways need to be found to protect nanotechnology workers now. The Occupational Safety and Health Act of 1970 (OSHAct) gave the responsibility to protect workers to the Occupational Safety and Health Administration (OSHA) and the National Institute for Occupational Safety and Health (NIOSH) through research, standards adoption, and standards enforcement. Since 1980, adopting new occupational health standards has grown more complex. The increased complexity has greatly slowed efforts to adopt protective standards for toxic agents that are well-known to pose significant risks. The likelihood of rapidly adopting standards to protect workers from nanomaterials, whose risks are just emerging, seems even more unlikely. Use of the OSHAct’s general duty clause to protect workers also seems uncertain at this time. In the interim, a national partnership led by NIOSH involving nanotech manufacturers and downstream users, workers, academic researchers, safety, and health practitioners is proposed. A National Nanotechnology Partnership would generate knowledge about the nature and the extent of worker risk, utilize that knowledge to develop risk control strategies to protect nanotechnology workers now, and provide an evidence base for NIOSH recommendations to OSHA for a nanotechnology program standard at a future date.     

How can nanobiotechnology oversight advance science and industry: examples from environmental,health, and safety studies of nanoparticles (nano-EHS)

Nanotechnology has great potential to transform science and industry in the fields of energy, material, environment, and medicine. At the same time, more concerns are being raised about the occupational health and safety of nanomaterials in the workplace and the implications of nanotechnology on the environment and living systems. Studies on environmental, health, and safety (EHS) issues of nanomaterials have a strong influence on public acceptance of nanotechnology and, eventually, affect its sustainability. Oversight and regulation by government agencies and non-governmental organizations (NGOs) play significant roles in ensuring responsible and environmentally friendly development of nanotechnology. The EHS studies of nanomaterials can provide data and information to help the development of regulations and guidelines. We present research results on three aspects of EHS studies: physico-chemical characterization and measurement of nanomaterials; emission, exposure, and toxicity of nanomaterials; and control and abatement of nanomaterial releases using filtration technology. Measurement of nanoparticle agglomerates using a newly developed instrument, the Universal NanoParticle Analyzer (UNPA), is discussed. Exposure measurement results for silicon nanoparticles in a pilot scale production plant are presented, as well as exposure measurement and toxicity study of carbon nanotubes (CNTs). Filtration studies of nanoparticle agglomerates are also presented as an example of emission control methods.     

Future Perspectives Towards the Use of Nanomaterials for Smart Food Packaging and Quality Control

In this Progress Report some recent trends and future perspectives towards the use of nanomaterials for smart food packaging and quality control of food are given. The examples and discussion are meant to illustrate the potential use of nanotechnology for food sustainability rather than to review the state of the art of nanomaterials in this area, which although expected to have a groundbreaking impact on food sustainability is still on an early stage.     

Nanotechnology for sustainability: what does nanotechnology offer to address complex sustainability problems?

Nanotechnology is widely associated with the promise of positively contributing to sustainability. However, this view often focuses on end-of-pipe applications, for instance, for water purification or energy efficiency, and relies on a narrow concept of sustainability. Approaching sustainability problems and solution options from a comprehensive and systemic perspective instead may yield quite different conclusions about the contribution of nanotechnology to sustainability. This study conceptualizes sustainability problems as complex constellations with several potential intervention points and amenable to different solution options. The study presents results from interdisciplinary workshops and literature reviews that appraise the contribution of the selected nanotechnologies to mitigate such problems. The study focuses exemplarily on the urban context to make the appraisals tangible and relevant. The solution potential of nanotechnology is explored not only for well-known urban sustainability problems such as water contamination and energy use but also for less obvious ones such as childhood obesity. Results indicate not only potentials but also limitations of nanotechnology??s contribution to sustainability and can inform anticipatory governance of nanotechnology in general, and in the urban context in particular.     

Horses for courses: risk information and decision making in the regulation of nanomaterials

Despite the widespread commercial use of nanomaterials, regulators currently have a limited ability to characterize and manage risks. There is a paucity of data available on the current production and use of nanomaterials and extreme scientific uncertainty on most aspects of the risk assessment “causal chain.” Regulatory decisions will need to be made in the near-term in the absence formal quantitative risk assessments. The article draws on examples from three different regulatory contexts—baseline data monitoring efforts of the U.S. Environmental Protection Agency and California Department of Toxic Substances Control, prioritization of risk information in the context of environmental releases, and mitigation of occupational risks—to argue for the use of decision-analytic tools in lieu of formal risk assessment to help regulatory bodies. We advocate a “horses for courses” approach whereby existing analytical tools (such as risk ranking, multi-criteria decision analysis, and “control banding” approaches) might be adapted to regulators’ goals in particular decision contexts. While efforts to build new and modify existing tools are underway, they need greater support from funding and regulatory agencies because innovative approaches are needed for the “extreme” uncertainty problems that nanomaterials pose.