Foundational Issues in Risk Assessment and Risk Management

In spite of the maturity reached by many of the methods used in risk assessment and risk management, broad consensus has not been established on fundamental concepts and principles. The risk fields still suffer from a lack of clarity on many key scientific pillars. The purpose of this article is to point to this situation and through some illustrating examples discuss the challenges that the fields here face. Moreover, the purpose of the article is to reflect on how to improve the present situation and enhance the risk fields. We argue that the establishment of some common scientific pillars as well as a strong and continuous research focus on foundational issues are critical success factors. The article specifically addresses the role of the peer‐reviewed journals and the international standards in the fields. We hope that the article can contribute to a revitalization of the discussion of foundational issues in risk assessment and risk management.     

From Ideal to Real Risk: Philosophy of Causation Meets Risk Analysis

A question has been raised in recent years as to whether the risk field, including analysis, assessment, and management, ought to be considered a discipline on its own. As suggested by Terje Aven, unification of the risk field would require a common understanding of basic concepts, such as risk and probability; hence, more discussion is needed of what he calls “foundational issues.” In this article, we show that causation is a foundational issue of risk, and that a proper understanding of it is crucial. We propose that some old ideas about the nature of causation must be abandoned in order to overcome certain persisting challenges facing risk experts over the last decade. In particular, we discuss the challenge of including causally relevant knowledge from the local context when studying risk. Although it is uncontroversial that the receptor plays an important role for risk evaluations, we show how the implementation of receptor‐based frameworks is hindered by methodological shortcomings that can be traced back to Humean orthodoxies about causation. We argue that the first step toward the development of frameworks better suited to make realistic risk predictions is to reconceptualize causation, by examining a philosophical alternative to the Humean understanding. In this article, we show how our preferred account, causal dispositionalism, offers a different perspective in how risk is evaluated and understood.     

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.     

The NAS Risk Paradigm as a Medium for Communication

Many journalists, public interest groups and other recipients of risk assessment information are familiar with the National Academy of Sciences risk assessment paradigm. From time to time, paradigm concepts appear in news features or community group discussions on environmental issues. With knowledge of the paradigm common to scientists, journalists, and other interested parties, the paradigm is a potentially important medium for communication between risk scientists, journalists, and the public. Specifically, the paradigm offers widely-accepted organizing principles for presenting risk information, a common language for addressing a variety of issues and concepts, and a flexible analytical system that accommodates the diversity of scientific information and policy perspectives that characterize the risk assessment process. In addition, the paradigm outlines important relationships and distinctions between risk assessment and risk management. Informed and creative use of these features of the paradigm can guide and simplify interviews between journalists or community groups and their expert sources, clarify presentation of risk information, and promote collaboration between risk scientists, journalists, and others to assure complete, objective and fair comment on risk issues of interest to the public.     

Issues in Ecological Risk Assessment: The CRAM Perspective

In 1989, a Committee on Risk Assessment Methodology (CRAM) was convened by the National Research Council (NRC) to identify and investigate important scientific issues in risk assessment. One of the first issues considered by the committee was the development of a conceptual framework for ecological risk assessment, defined as "the characterization of the adverse ecological effects of environmental exposures to hazards imposed by human activities." Adverse ecological effects include all biological and nonbiological environmental changes that society perceives as undesirable. The committee's opinion was that a general framework is needed to define the relationship of ecological risk assessment to environmental management and to facilitate the development of uniform technical guidelines. The framework for human health risk assessment proposed by the NRC in 1983 was adopted as a starting point for discussion. CRAM concluded that, although ecological risk assessment and human health risk assessment differ substantially in terms of scientific disciplines and technical problems, the underlying decision process is the same for both. Therefore, CRAM recommended that the 1983 risk assessment framework be modified to accommodate both human health and ecological risk assessment. CRAM defined an integrated health/ ecological risk assessment framework consisting of the four components: Hazard Identification, Exposure Assessment, Exposure-Response Assessment, and Risk Characterization. CRAM further provided recommendations on the scope of issues to be addressed in ecological risk assessment, critical research needs, and mechanisms for providing more detailed guidance on the scientific content of ecological risk assessments.     

Addressing Climate Change as an Emerging Risk to Infrastructure Systems

The consequences that climate change could have on infrastructure systems are potentially severe but highly uncertain. This should make risk analysis a natural framework for climate adaptation in infrastructure systems. However, many aspects of climate change, such as weak background knowledge and societal controversy, make it an emerging risk where traditional approaches for risk assessment and management cannot be confidently employed. A number of research developments aimed at addressing these issues have emerged in recent years, such as the development of probabilistic climate projections, climate services, and robust decision frameworks. However, additional research is needed to improve the suitability of these methods for infrastructure planning. In this perspective, we outline some of the challenges in addressing climate change risks to infrastructure and summarize new developments aimed at meeting these challenges. We end by highlighting needs for future research, many of which could be well‐served by expertise within the risk analysis community.     

Risk Management Solutions for Climate Change–Induced Disasters

In honor of the 40th anniversary of Risk Analysis, this article suggests ways of linking risk assessment and risk perception in developing risk management strategies that have a good chance of being implemented, focusing on the problem of reducing losses from natural hazards in the face of climate change. Following a checklist for developing an implementable risk management strategy, Section 2 highlights the impact that exponential growth of CO₂ emissions is likely to have on future disaster losses as assessed by climate and social scientists. Section 3 then discusses how people perceive the risks of low-probability adverse events and the cognitive biases that lead them to underprepare for future losses. Based on this empirical evidence, Section 4 proposes a risk management strategy for reducing future losses using the principles of choice architecture to communicate the likelihood and consequences of disasters, coupled with economic incentives and well-enforced regulations.     

Whither Risk Assessment: New Challenges and Opportunities a Third of a Century After the Red Book

Six multi‐decade‐long members of SRA reflect on the 1983 Red Book in order to examine the evolving relationship between risk assessment and risk management; the diffusion of risk assessment practice to risk areas such as homeland security and transportation; the quality of chemical risk databases; challenges from other groups to elements at the core of risk assessment practice; and our collective efforts to communicate risk assessment to a diverse set of critical groups that do not understand risk, risk assessment, or many other risk‐related issues. The authors reflect on the 10 recommendations in the Red Book and present several pressing challenges for risk assessment practitioners.     

Concerns,Challenges, and Directions of Development for the Issue of Representing Uncertainty in Risk Assessment

In the analysis of the risk associated to rare events that may lead to catastrophic consequences with large uncertainty, it is questionable that the knowledge and information available for the analysis can be reflected properly by probabilities. Approaches other than purely probabilistic have been suggested, for example, using interval probabilities, possibilistic measures, or qualitative methods. In this article, we look into the problem and identify a number of issues that are foundational for its treatment. The foundational issues addressed reflect on the position that “probability is perfect” and take into open consideration the need for an extended framework for risk assessment that reflects the separation that practically exists between analyst and decisionmaker.     

Variability and Uncertainty Meet Risk Management and Risk Communication

In the past decade, the use of probabilistic risk analysis techniques to quantitatively address variability and uncertainty in risks increased in popularity as recommended by the 1994 National Research Council that wrote Science and Judgment in Risk Assessment. Under the 1996 Food Quality Protection Act, for example, the U.S. EPA supported the development of tools that produce distributions of risk demonstrating the variability and/or uncertainty in the results. This paradigm shift away from the use of point estimates creates new challenges for risk managers, who now struggle with decisions about how to use distributions in decision making. The challenges for risk communication, however, have only been minimally explored. This presentation uses the case studies of variability in the risks of dying on the ground from a crashing airplane and from the deployment of motor vehicle airbags to demonstrate how better characterization of variability and uncertainty in the risk assessment lead to better risk communication. Analogies to food safety and environmental risks are also discussed. This presentation demonstrates that probabilistic risk assessment has an impact on both risk management and risk communication, and highlights remaining research issues associated with using improved sensitivity and uncertainty analyses in risk assessment.     

On the Risk Management and Risk Governance of Petroleum Operations in the Barents Sea Area

In this article, we discuss issues of risk management and risk governance with respect to petroleum operations in the Barents Sea area. We will focus on the decision problems related to whether or not to open the Barents Sea for petroleum activities in special vulnerable areas. We will explore to what extent the International Risk Governance Council risk governance framework provides valuable insights for and assistance to the decisionmaker and other stakeholders (including the industry and NGOs). The study covers issues related to risk assessment and appraisal, risk acceptance and tolerability, the use of the precautionary principle, risk perception, stakeholder involvement, risk communication, and risk management. The overall aim of the article is to point to areas where the risk governance could have been and can be improved for these and similar decision problems.     

Nano Risk Analysis: Advancing the Science for Nanomaterials Risk Management

Scientists, activists, industry, and governments have raised concerns about health and environmental risks of nanoscale materials. The Society for Risk Analysis convened experts in September 2008 in Washington, DC to deliberate on issues relating to the unique attributes of nanoscale materials that raise novel concerns about health risks. This article reports on the overall themes and findings of the workshop, uncovering the underlying issues for each of these topics that become recurring themes. The attributes of nanoscale particles and other nanomaterials that present novel issues for risk analysis are evaluated in a risk analysis framework, identifying challenges and opportunities for risk analysts and others seeking to assess and manage the risks from emerging nanoscale materials and nanotechnologies. Workshop deliberations and recommendations for advancing the risk analysis and management of nanotechnologies are presented.     

Trust‐Level Risk Evaluation and Risk Control Guidance in the NHS East of England

In recent years, the healthcare sector has adopted the use of operational risk assessment tools to help understand the systems issues that lead to patient safety incidents. But although these problem‐focused tools have improved the ability of healthcare organizations to identify hazards, they have not translated into measurable improvements in patient safety. One possible reason for this is a lack of support for the solution‐focused process of risk control. This article describes a content analysis of the risk management strategies, policies, and procedures at all acute (i.e., hospital), mental health, and ambulance trusts (health service organizations) in the East of England area of the British National Health Service. The primary goal was to determine what organizational‐level guidance exists to support risk control practice. A secondary goal was to examine the risk evaluation guidance provided by these trusts. With regard to risk control, we found an almost complete lack of useful guidance to promote good practice. With regard to risk evaluation, the trusts relied exclusively on risk matrices. A number of weaknesses were found in the use of this tool, especially related to the guidance for scoring an event's likelihood. We make a number of recommendations to address these concerns. The guidance assessed provides insufficient support for risk control and risk evaluation. This may present a significant barrier to the success of risk management approaches in improving patient safety.     

Risk Framework for an Organizational System With Major Components

Many large organizations accomplish their various functions through interactions across their major components. Components refers to functional entities within a large complex organization, such as business sectors, academic departments, or regional divisions. The dependency between the various components can cause risk to propagate through their overall system. This article presents a risk assessment framework that integrates risk across a diverse set of components to the overall organization functions. This project addresses three major challenges: aggregating risk, estimating component interdependencies including cycles of dependencies, and propagating risk across components. The framework aggregates risk assessments through a value function for severity that is evaluated at the expected outcome of accomplishing planned goals in terms of performance, schedule, and resources. The value function, which represents risk tolerance, scales between defined points corresponding to failure and success. Different risk assessment may be aggregated together. This article presents a novel approach to establishing relationships between the various components. This article develops and compares three network risk propagation models that characterize the overall organizational risk. The U.S. Air Force has applied this risk framework to evaluate success in hypothetical future wars. The analysts employing this risk framework have informed billions of dollars of strategic investment decisions.     

A Discussion of Findings and Their Possible Implications from a Workshop on Bioterrorism Threat Assessment and Risk Management

In November 2001, the Monterey Institute of International Studies convened a workshop on bioterrorism threat assessment and risk management. Risk assessment practitioners from various disciplines, but without specialized knowledge of terrorism, were brought together with security and intelligence threat analysts to stimulate an exchange that could be useful to both communities. This article, prepared by a subset of the participants, comments on the workshop's findings and their implications and makes three recommendations, two short term (use of threat assessment methodologies and vulnerability analysis) and one long term (application of quantitative risk assessment and modeling), regarding the practical application of risk assessment methods to bioterrorism issues.     

Politics and Scientific Expertise: Scientists, Risk Perception, and Nuclear Waste Policy

To study the homogeneity and influences on scientists'perspectives of environmental risks, we have examined similarities and differences in risk perceptions, particularly regarding nuclear wastes, and policy preferences among 1011 scientists and engineers. We found significant differences ( p 0.05)in the patterns of beliefs among scientists from different fields of research. In contrast to physicists, chemists, and engineers, life scientists tend to: (a)perceive the greatest risks from nuclear energy and nuclear waste management; (b)perceive higher levels of overall environmental risk; (c)strongly oppose imposing risks on unconsenting individuals; and (d)prefer stronger requirements for environmental management. On some issues related to priorities among public problems and calls for government action, there are significant variations among life scientists or physical scientists. We also found that–independently of field of research–perceptions of risk and its correlates are significantly associated with the type of institution in which the scientist is employed. Scientists in universities or state and local governments tend to see the risks of nuclear energy and wastes as greater than scientists who work as business consultants, for federal organizations, or for private research laboratories. Significant differences also are found in priority given to environmental risks, the perceived proximity of environmental disaster, willingness to impose risks on an unconsenting population, and the necessity of accepting risks and sacrifices.     

Science and Decisions: Advancing Risk Assessment

At the request of the U.S. Environmental Protection Agency (EPA), the National Research Council (NRC) recently completed a major report, Science and Decisions: Advancing Risk Assessment, that is intended to strengthen the scientific basis, credibility, and effectiveness of risk assessment practices and subsequent risk management decisions. The report describes the challenges faced by risk assessment and the need to consider improvements in both the technical analyses of risk assessments (i.e., the development and use of scientific information to improve risk characterization) and the utility of risk assessments (i.e., making assessments more relevant and useful for risk management decisions). The report tackles a number of topics relating to improvements in the process, including the design and framing of risk assessments, uncertainty and variability characterization, selection and use of defaults, unification of cancer and noncancer dose‐response assessment, cumulative risk assessment, and the need to increase EPA's capacity to address these improvements. This article describes and summarizes the NRC report, with an eye toward its implications for risk assessment practices at EPA.     

Perspectives on Risk Management

The development of the techniques of risk assessment and management are considered, noting the early emphasis on quantitative approaches. The basic strategies available to governments for risk management—educational, economic, and regulatory—are discussed. Six specific issues are considered with reference to the Canadian experience and the lessons learned. These are: the separation of risk assessment from risk management; the uncertainties of science; the weakness of numerical comparisons; too great a trust in education; the Great White Father Syndrome; and regulatory perils. This examination shows a number of inadequacies in the application of risk management techniques. It is suggested that knowledge of the limitations of quantitative assessment in its application to decision-making together with the involvement of those affected by the risk in the decision-making processes will lead to greater success.     

A Discourse on the Incorporation of Organizational Factors into Probabilistic Risk Assessment: Key Questions and Categorical Review

This article presents a discourse on the incorporation of organizational factors into probabilistic risk assessment (PRA)/probabilistic safety assessment (PSA), a topic of debate since the 1980s that has spurred discussions among industry, regulatory agencies, and the research community. The main contributions of this article include (1) identifying the four key open questions associated with this topic; (2) framing ongoing debates by considering differing perspectives around each question; (3) offering a categorical review of existing studies on this topic to justify the selection of each question and to analyze the challenges related to each perspective; and (4) highlighting the directions of research required to reach a final resolution for each question. The four key questions are: (I) How significant is the contribution of organizational factors to accidents and incidents? (II) How critical, with respect to improving risk assessment, is the explicit incorporation of organizational factors into PRA? (III) What theoretical bases are needed for explicit incorporation of organizational factors into PRA? (IV) What methodological bases are needed for the explicit incorporation of organizational factors into PRA? Questions I and II mainly analyze PRA literature from the nuclear domain. For Questions III and IV, a broader review and categorization is conducted of those existing cross-disciplinary studies that have evaluated the effects of organizational factors on safety (not solely PRA-based) to shed more light on future research needs.     

Foundational Challenges for Advancing the Field and Discipline of Risk Analysis

Risk analysis as a field and discipline is about concepts, principles, approaches, methods, and models for understanding, assessing, communicating, managing, and governing risk. The foundation of this field and discipline has been subject to continuous discussion since its origin some 40 years ago with the establishment of the Society for Risk Analysis and the Risk Analysis journal. This article provides a perspective on critical foundational challenges that this field and discipline faces today, for risk analysis to develop and have societal impact. Topics discussed include fundamental questions important for defining the risk field, discipline, and science; the multidisciplinary and interdisciplinary features of risk analysis; the interactions and dependencies with other sciences; terminology and fundamental principles; and current developments and trends, such as the use of artificial intelligence.