Nanotechnology,Risk, and Oversight: Learning Lessons from Related Emerging Technologies

Emerging technologies are defined by their novelty and thus are accompanied by significant uncertainty in determining appropriate ways to manage risks associated with them. Yet, there is a body of prior knowledge about risk management and oversight policy for other technologies that have already permeated society. Here, we describe two ways in which prospective oversight policy analysis for emerging technologies can draw upon these past experiences. One involves comparing specific products that have already been marketed to similar products of the emerging technology (cognate‐product approach). The other treats the emerging technology as a body of products and methods and relates it to another technological field that has already emerged and penetrated markets (whole‐technology approach). In this article, we describe our work using these approaches to inform risk and oversight policy for nanotechnology and its products. We draw parallels between biotechnology and nanotechnology as whole fields of development and also between genetically engineered organisms in the food supply and agricultural products of nanotechnology. Through these comparisons, we find that both approaches to historical learning have value and present lessons that could be applied to nanotechnology.     

An Integrated Approach to Oversight Assessment for Emerging Technologies

Analysis of oversight systems is often conducted from a single disciplinary perspective and by using a limited set of criteria for evaluation. In this article, we develop an approach that blends risk analysis, social science, public administration, legal, public policy, and ethical perspectives to develop a broad set of criteria for assessing oversight systems. Multiple methods, including historical analysis, expert elicitation, and behavioral consensus, were employed to develop multidisciplinary criteria for evaluating oversight of emerging technologies. Sixty‐six initial criteria were identified from extensive literature reviews and input from our Working Group. Criteria were placed in four categories reflecting the development, attributes, evolution, and outcomes of oversight systems. Expert elicitation, consensus methods, and multidisciplinary review of the literature were used to refine a condensed, operative set of criteria. Twenty‐eight criteria resulted spanning four categories: seven development criteria, 15 attribute criteria, five outcome criteria, and one evolution criterion. These criteria illuminate how oversight systems develop, operate, change, and affect society. We term our approach “integrated oversight assessment” and propose its use as a tool for analyzing relationships among features, outcomes, and tradeoffs of oversight systems. Comparisons among historical case studies of oversight using a consistent set of criteria should result in defensible and evidence‐supported lessons to guide the development of oversight systems for emerging technologies, such as nanotechnology.     

The Role of Analysis on the 17 Most Political Acres on the Face of the Earth

Benefit‐cost and risk analyses associated with agency rule making are required by presidential order and are reviewed by the Office of Management and Budget's (OMB) Office of Information and Regulatory Affairs (OIRA). This White House oversight of agency regulatory analysis means that OIRA's work, though primarily analytic, competes daily with the intense political pressures that characterize all work in the White House. Even in the face of the demands of politics, analysis is respected and utilized. A balance between politics and analysis is maintained in several ways. Several structural characteristics of the White House help protect analysis, such as a strong complement of offices whose role is primarily analytic (for example, the Council of Economic Advisors, the Office of Science and Technology Policy, and OMB). OIRA's ability to successfully coordinate its regulatory review with White House officials ensures that it serves as an agent for presidential regulatory policy at the same time it champions higher quality benefit‐cost and risk analysis. This role as intermediary between analytic and political judgment also results from OIRA's expertise in such analysis and its reputation for the discretion necessary to maintain the trust of the president's upper level staff.     

Rethinking Risk Assessment for Public Utility Safety Regulation

To aid in their safety oversight of large‐scale, potentially dangerous energy and water infrastructure and transportation systems, public utility regulatory agencies increasingly seek to use formal risk assessment models. Yet some of the approaches to risk assessment used by utilities and their regulators may be less useful for this purpose than is supposed. These approaches often do not reflect the current state of the art in risk assessment strategy and methodology. This essay explores why utilities and regulatory agencies might embrace risk assessment techniques that do not sufficiently assess organizational and managerial factors as drivers of risk, nor that adequately represent important uncertainties surrounding risk calculations. Further, it describes why, in the special legal, political, and administrative world of the typical public utility regulator, strategies to identify and mitigate formally specified risks might actually diverge from the regulatory promotion of “safety.” Some improvements are suggested that can be made in risk assessment approaches to support more fully the safety oversight objectives of public regulatory agencies, with examples from “high‐reliability organizations” (HROs) that have successfully merged the management of safety with the management of risk. Finally, given the limitations of their current risk assessments and the lessons from HROs, four specific assurances are suggested that regulatory agencies should seek for themselves and the public as objectives in their safety oversight of public utilities.     

The Essential Elements of a Risk Governance Framework for Current and Future Nanotechnologies

Societies worldwide are investing considerable resources into the safe development and use of nanomaterials. Although each of these protective efforts is crucial for governing the risks of nanomaterials, they are insufficient in isolation. What is missing is a more integrative governance approach that goes beyond legislation. Development of this approach must be evidence based and involve key stakeholders to ensure acceptance by end users. The challenge is to develop a framework that coordinates the variety of actors involved in nanotechnology and civil society to facilitate consideration of the complex issues that occur in this rapidly evolving research and development area. Here, we propose three sets of essential elements required to generate an effective risk governance framework for nanomaterials. (1) Advanced tools to facilitate risk‐based decision making, including an assessment of the needs of users regarding risk assessment, mitigation, and transfer. (2) An integrated model of predicted human behavior and decision making concerning nanomaterial risks. (3) Legal and other (nano‐specific and general) regulatory requirements to ensure compliance and to stimulate proactive approaches to safety. The implementation of such an approach should facilitate and motivate good practice for the various stakeholders to allow the safe and sustainable future development of nanotechnology.     

When Evolution Works Against the Future: Disgust's Contributions to the Acceptance of New Food Technologies

New food technologies have a high potential to transform the current resource‐consuming food system to a more efficient and sustainable one, but public acceptance of new food technologies is rather low. Such an avoidance might be maintained by a deeply preserved risk avoidance system called disgust. In an online survey, participants (N = 313) received information about a variety of new food technology applications (i.e., genetically modified meat/fish, edible nanotechnology coating film, nanotechnology food box, artificial meat/milk, and a synthetic food additive). Every new food technology application was rated according to the respondent's willingness to eat (WTE) it (i.e., acceptance), risk, benefit, and disgust perceptions. Furthermore, food disgust sensitivity was measured using the Food Disgust Scale. Overall, the WTE both gene‐technology applications and meat coated with an edible nanotechnology film were low and disgust responses toward all three applications were high. In full mediation models, food disgust sensitivity predicted the disgust response toward each new food technology application, which in turn influenced WTE them. Effects of disgust responses on the WTE a synthetic food additive were highest for and lowest for the edible nanotechnology coating film compared to the other technologies. Results indicate that direct disgust responses influence acceptance and risk and benefit perceptions of new food technologies. Beyond the discussion of this study, implications for future research and strategies to increase acceptance of new food technologies are discussed.     

Risk‐Informed Regulation and Safety Management of Nuclear Power Plants—On the Prevention of Severe Accidents

There are four operating nuclear power plant (NPP) units in Finland. The Teollisuuden Voima (TVO) power company has two 840 MWe BWR units supplied by Asea‐Atom at the Olkiluoto site. The Fortum corporation (formerly IVO) has two 500 MWe VVER 440/213 units at the Loviisa site. In addition, a 1600 MWe European Pressurized Water Reactor supplied by AREVA NP (formerly the Framatome ANP—Siemens AG Consortium) is under construction at the Olkiluoto site. Recently, the Finnish Parliament ratified the government Decision in Principle that the utilities' applications to build two new NPP units are in line with the total good of the society. The Finnish utilities, Fenno power company, and TVO company are in progress of qualifying the type of the new nuclear builds. In Finland, risk‐informed applications are formally integrated in the regulatory process of NPPs that are already in the early design phase and these are to run through the construction and operation phases all through the entire plant service time. A plant‐specific full‐scope probabilistic risk assessment (PRA) is required for each NPP. PRAs shall cover internal events, area events (fires, floods), and external events such as harsh weather conditions and seismic events in all operating modes. Special attention is devoted to the use of various risk‐informed PRA applications in the licensing of Olkiluoto 3 NPP.     

Development of a Preliminary Framework for Informing the Risk Analysis and Risk Management of Nanoparticles

Decisions are often made even when there is uncertainty about the possible outcomes. However, methods for making decisions with uncertainty in the problem framework are scarce. Presently, safety assessment for a product containing engineered nano-scale particles is a very poorly structured problem. Many fields of study may inform the safety assessment of such particles (e.g., ultrafines, aerosols, debris from medical devices), but engineered nano-scale particles may present such unique properties that extrapolating from other types of studies may introduce, and not resolve, uncertainty. Some screening-level health effects studies conducted specifically on engineered nano-scale materials have been published and many more are underway. However, it is clear that the extent of research needed to fully and confidently understand the potential for health or environmental risk from engineered nano-scale particles may take years or even decades to complete. In spite of the great uncertainty, there is existing research and experience among researchers that can help to provide a taxonomy of particle properties, perhaps indicating a relative likelihood of risk, in order to prioritize nanoparticle risk research. To help structure this problem, a framework was developed from expert interviews of nanotechnology researchers. The analysis organizes the information as a system based on the risk assessment framework, in order to support the decision about safety. In the long term, this framework is designed to incorporate research results as they are generated, and therefore serve as a tool for estimating the potential for human health and environmental risk.     

Laypeople''s and Experts'' Perception of Nanotechnology Hazards

Public perception of nanotechnology may influence the realization of technological advances. Laypeople's (N=375) and experts' (N=46) perception of 20 different nanotechnology applications and three nonnanotechnology applications were examined. The psychometric paradigm was utilized and applications were described in short scenarios. Results showed that laypeople and experts assessed asbestos as much more risky than nanotechnology applications. Analyses of aggregated data suggested that perceived dreadfulness of applications and trust in governmental agencies are important factors in determining perceived risks. Similar results were observed for experts and laypeople, but the latter perceived greater risks than the former. Analyses of individual data showed that trust, perceived benefits, and general attitudes toward technology influenced the perceived risk of laypeople. In the expert sample, confidence in governmental agencies was an important predictor of risks associated with nanotechnology applications. Results suggest that public concerns about nanotechnology would diminish if measures were taken to enhance laypeople's trust in governmental agencies.     

Foresight Study on the Risk Governance of New Technologies: The Case of Nanotechnology

Technology‐led innovation represents an important driver of European economic and industrial competitiveness and offers solutions to societal challenges. In order to facilitate responsible innovation and public acceptance, a need exists to identify and implement oversight approaches focused on the effective risk governance of emerging technologies. This article describes a foresight study on the governance of new technologies, using nanotechnology as a case example. Following a mapping of the governance landscape, four plausible foresight scenarios were developed, capturing critical uncertainties for nanotechnology governance. Key governance elements were then stress tested within these scenarios to see how well they might perform in a range of possible futures and to inform identification of the strengths, weaknesses, opportunities, and threats for nanotechnology governance in Europe. Based on the study outcomes, recommendations are proposed regarding the development of governance associated with the responsible development of new technologies.     

Safe-by-Design: Stakeholders’ Perceptions and Expectations of How to Deal with Uncertain Risks of Emerging Biotechnologies in the Netherlands

Advanced gene editing techniques such as Clustered Regularly Interspaced Short Palindromic Repeat (CRISPR)/Cas have increased the pace of developments in the field of industrial biotechnology. Such techniques imply new possibilities when working with living organisms, possibly leading to uncertain risks. In the Netherlands, current policy fails to address these uncertain risks because risk classification is determined process-wise (i.e., genetically modified organism [GMO] and non-GMO), there is a strong focus on quantifiable risks, and the linearity within current governance (science–policy–society) hinders iterative communication between stakeholders, leaving limited room to anticipate uncertainties at an early stage of development. A suggested concept to overcome these shortcomings is the Safe-by-Design (SbD) approach, which, theoretically, allows stakeholders to iteratively incorporate safety measures throughout a technology's development process, creating a dynamic environment for the anticipation of uncertain risks. Although this concept originates from chemical engineering and is already widely applied in nanotechnology, for the field of biotechnology, there is no agreed upon definition yet. To explore the possibilities of SbD for future governance of biotechnology, we should gain insight in how various stakeholders perceive notions of risk, safety, and inherent safety, and what this implies for the applicability of SbD for risk governance concerning industrial biotechnology. Our empirical research reveals three main themes: (1) diverging expectations with regard to safety and risks, and to establish an acceptable level of risk; (2) different applications of SbD and inherent safety, namely, product- and process-wise; and (3) unclarity in allocating responsibilities to stakeholders in the development process of a biotechnology and within society.     

A longitudinal study of newspaper and wire service coverage of nanotechnology risks

This study reviewed coverage of nanotechnology risks in 20 U.S. and 9 U.K. newspapers and 2 wire services from 2000 to 2009. It focused on information that citizens could come across in daily newspaper reading that could highlight the salience of these issues and alert readers to potential risks. Few articles about nanotechnology health, environmental, and societal risks were found in these publications during this period, averaging only 36.7 per year for both countries. The coverage emphasized three main narratives over time: runaway technology, science-based studies, and regulation. Health risks were covered most frequently, followed by environmental and societal risk issues. Regulation coverage was not as frequent but increased over time. The majority of the coverage focused on news events and 10 events drew modest media attention. Scientific uncertainty discussions appeared in about half of the articles, and scientists and engineers were the dominant information sources in both countries. Some significant differences between U.S. and U.K. coverage were found: U.K. coverage emphasized more societal concerns, while U.S. coverage paid more attention to environmental risks. Because the volume of coverage was not extensive and was counterbalanced by many more articles extolling nanotechnology's benefits, it is questionable whether this coverage alerted readers about potential nanotechnology risks. Coupled with citizens' minimal knowledge about nanotechnology, this type of coverage could create public distrust of nanotechnology applications should a dangerous risk event occur.     

Risk Characterization for Nanotechnology

Nanotechnology is a broad term that encompasses materials, structures, or processes that utilize engineered nanomaterials, which can be defined as materials intentionally designed to have one or more dimensions between 1 and 100 nm. Historically, risk characterization has been viewed as the final phase of a risk assessment process that integrates hazard identification, dose‐response assessment, and exposure assessment. The novelty and diversity of materials, structures, and tools that are covered by above‐defined “nanotechnology” raise substantial methodological issues and pose significant challenges for each of these phases of risk assessment. These issues and challenges culminate in the risk characterization phase of the risk assessment process, and this article discusses several of these key issues and approaches to developing risk characterization results and their implications for risk management decision making that are specific to nanotechnology.     

我国金融机构的系统重要性评估:基于多元极值理论

2008年全球金融危机以后,金融机构的"大而不能倒"问题以及由此引发的系统性风险备受关注。本文基于多元EVT和Copula函数,建立了系统重要性的多角度评估指标体系,并对我国公开上市的26家金融机构的系统重要性做了一个综合评估。实证研究结果表明:(1)我国银行业在金融体系中占有主导地位,且银行业同质性较高,易诱发系统性风险;(2)规模不是系统重要性的唯一考量因素,其他因素也会对系统重要性产生显著影响,部分股份制商业银行和城商行也应被列为金融监管的重点关注对象。     

A Look at State‐Level Risk Assessment in the United States: Making Decisions in the Absence of Federal Risk Values

State environmental agencies in the United States are charged with making risk management decisions that protect public health and the environment while managing limited technical, financial, and human resources. Meanwhile, the federal risk assessment community that provides risk assessment guidance to state agencies is challenged by the rapid growth of the global chemical inventory. When chemical toxicity profiles are unavailable on the U.S. Environmental Protection Agency's Integrated Risk Information System or other federal resources, each state agency must act independently to identify and select appropriate chemical risk values for application in human health risk assessment. This practice can lead to broad interstate variation in the toxicity values selected for any one chemical. Within this context, this article describes the decision‐making process and resources used by the federal government and individual U.S. states. The risk management of trichloroethylene (TCE) in the United States is presented as a case study to demonstrate the need for a collaborative approach among U.S. states toward identification and selection of chemical risk values while awaiting federal risk values to be set. The regulatory experience with TCE is contrasted with collaborative risk science models, such as the European Union's efforts in risk assessment harmonization. Finally, we introduce State Environmental Agency Risk Collaboration for Harmonization, a free online interactive tool designed to help to create a collaborative network among state agencies to provide a vehicle for efficiently sharing information and resources, and for the advancement of harmonization in risk values used among U.S. states when federal guidance is unavailable.     

Nanotechnology Risk Communication Past and Prologue

Nanotechnologies operate at atomic, molecular, and macromolecular scales, at scales where matter behaves differently than at larger scales and quantum effects can dominate. Nanotechnologies have captured the imagination of science fiction writers as science, engineering, and industry have leapt to the challenge of harnessing them. Applications are proliferating. In contrast, despite recent progress the regulatory landscape is not yet coherent, and public awareness of nanotechnology remains low. This has led risk researchers and critics of current nanotechnology risk communication efforts to call for proactive strategies that do more than address facts, that include and go beyond the public participation stipulated by some government acts. A redoubling of nanotechnology risk communication efforts could enable consumer choice and informed public discourse about regulation and public investments in science and safety.     

How Probabilistic Risk Assessment Can Mislead Terrorism Risk Analysts

Traditional probabilistic risk assessment (PRA), of the type originally developed for engineered systems, is still proposed for terrorism risk analysis. We show that such PRA applications are unjustified in general. The capacity of terrorists to seek and use information and to actively research different attack options before deciding what to do raises unique features of terrorism risk assessment that are not adequately addressed by conventional PRA for natural and engineered systems—in part because decisions based on such PRA estimates do not adequately hedge against the different probabilities that attackers may eventually act upon. These probabilities may differ from the defender's (even if the defender's experts are thoroughly trained, well calibrated, unbiased probability assessors) because they may be conditioned on different information. We illustrate the fundamental differences between PRA and terrorism risk analysis, and suggest use of robust decision analysis for risk management when attackers may know more about some attack options than we do.     

Quantal Risk Assessment Database: A Database for Exploring Patterns in Quantal Dose‐Response Data in Risk Assessment and its Application to Develop Priors for Bayesian Dose‐Response Analysis

Quantitative risk assessments for physical, chemical, biological, occupational, or environmental agents rely on scientific studies to support their conclusions. These studies often include relatively few observations, and, as a result, models used to characterize the risk may include large amounts of uncertainty. The motivation, development, and assessment of new methods for risk assessment is facilitated by the availability of a set of experimental studies that span a range of dose‐response patterns that are observed in practice. We describe construction of such a historical database focusing on quantal data in chemical risk assessment, and we employ this database to develop priors in Bayesian analyses. The database is assembled from a variety of existing toxicological data sources and contains 733 separate quantal dose‐response data sets. As an illustration of the database's use, prior distributions for individual model parameters in Bayesian dose‐response analysis are constructed. Results indicate that including prior information based on curated historical data in quantitative risk assessments may help stabilize eventual point estimates, producing dose‐response functions that are more stable and precisely estimated. These in turn produce potency estimates that share the same benefit. We are confident that quantitative risk analysts will find many other applications and issues to explore using this database.