Foundational Issues in Risk Assessment and Risk Management

This is a perspective article on foundational issues in risk assessment and management. The aim is to discuss the needs, obstacles, and challenges for the establishment of a renewed, strong scientific foundation for risk assessment and risk management suited for the current and future technological challenges. The focus is on (i) reviewing and discussing the present situation and (ii) identifying how to best proceed in the future, to develop the risk discipline in the directions needed. The article provides some reflections on the interpretation and understanding of the concept of “foundations of risk assessment and risk management” and the challenges therein. One main recommendation is that different arenas and moments for discussion are needed to specifically address foundational issues in a way that embraces the many disciplinary communities involved (from social scientists to engineers, from behavioral scientists to statisticians, from health physicists to lawyers, etc.). One such opportunity is sought in the constitution of a novel specialty group of the Society of Risk Analysis.     

On How to Deal with Deep Uncertainties in a Risk Assessment and Management Context

Recently, several authors have presented interesting contributions on how to meet deep or severe uncertainties in a risk analysis setting. In this article, we provide some reflections on some of the foundational pillars that this work is based on, including the meaning of concepts such as deep uncertainty, known probabilities, and correct models, the aim being to contribute to a strengthening of the scientific platform of the work, as well as providing new insights on how to best implement management policies meeting these uncertainties. We also provide perspectives on the boundaries and limitations of analytical approaches for supporting decision making in cases of deep uncertainties. A main conclusion of the article is that deep uncertainties call for managerial review and judgment that sees beyond the analytical frameworks studied in risk assessment and risk management contexts, including those now often suggested to be used, such as robust optimization techniques. This managerial review and judgment should be seen as a basic element of the risk management.     

Some Considerations on the Definition of Risk Based on Concepts of Systems Theory and Probability

The concept of risk has been applied in many modern science and technology fields. Despite its successes in many applicative fields, there is still not a well‐established vision and universally accepted definition of the principles and fundamental concepts of the risk assessment discipline. As emphasized recently, the risk fields suffer from a lack of clarity on their scientific bases that can define, in a unique theoretical framework, the general concepts in the different areas of application. The aim of this article is to make suggestions for another perspective of risk definition that could be applied and, in a certain sense, generalize some of the previously known definitions (at least in the fields of technical and scientific applications). By drawing on my experience of risk assessment in different applicative situations (particularly in the risk estimation for major industrial accidents, and in the health and ecological risk assessment for contaminated sites), I would like to revise some general and foundational concepts of risk analysis in as consistent a manner as possible from the axiomatic/deductive point of view. My proposal is based on the fundamental concepts of the systems theory and of the probability. In this way, I try to frame, in a single, broad, and general theoretical context some fundamental concepts and principles applicable in many different fields of risk assessment. I hope that this article will contribute to the revitalization and stimulation of useful discussions and new insights into the key issues and theoretical foundations of risk assessment disciplines.     

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.     

The Role of Quantitative Risk Assessments for Characterizing Risk and Uncertainty and Delineating Appropriate Risk Management Options, with Special Emphasis on Terrorism Risk

The purpose of this article is to discuss the role of quantitative risk assessments for characterizing risk and uncertainty and delineating appropriate risk management options. Our main concern is situations (risk problems) with large potential consequences, large uncertainties, and/or ambiguities (related to the relevance, meaning, and implications of the decision basis; or related to the values to be protected and the priorities to be made), in particular terrorism risk. We look into the scientific basis of the quantitative risk assessments and the boundaries of the assessments in such a context. Based on a risk perspective that defines risk as uncertainty about and severity of the consequences (or outcomes) of an activity with respect to something that humans value we advocate a broad risk assessment approach characterizing uncertainties beyond probabilities and expected values. Key features of this approach are qualitative uncertainty assessment and scenario building instruments.     

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.     

Risk Governance for Mobile Phones,Power Lines,and Other EMF Technologies

Power‐frequency electric and magnetic fields (EMFs) have been present in industrialized countries since the late 19th century and a considerable amount of knowledge has been accumulated as to potential health effects. The mainstream scientific view is that even if there is a risk, it is unlikely to be of major public‐health significance. EMFs from cellular communications and other radio‐frequency technologies have increased rapidly in the last decade. This technology is constantly changing, which makes continued research both more urgent and more challenging. While there are no persuasive data suggesting a health risk, research and particularly exposure assessment is still immature. The principal risk‐governance issue with power frequencies is how to respond to weak and uncertain scientific evidence that nonetheless causes public concern. For radio‐frequency electromagnetic fields, the issue is how to respond to large potential consequences and large public concern where only limited scientific evidence exists. We survey these issues and identify deficits in risk governance. Deficits in problem framing include both overstatement and understatement of the scientific evidence and of the consequences of taking protective measures, limited ability to detect early warnings of risk, and attempted reassurance that has sometimes been counterproductive. Other deficits relate to the limited public involvement mechanisms, and flaws in the identification and evaluation of tradeoffs in the selection of appropriate management strategies. We conclude that risk management of EMFs has certainly not been perfect, but for power frequencies it has evolved and now displays many successful features. Lessons from the power‐frequency experience can benefit risk governance of the radio‐frequency EMFs and other emerging technologies.     

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.     

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.     

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.     

Is Risk Analysis Scientific?

This article discusses to what extent risk analysis is scientific in view of a set of commonly used definitions and criteria. We consider scientific knowledge to be characterized by its subject matter, its success in developing the best available knowledge in its fields of study, and the epistemic norms and values that guide scientific investigations. We proceed to assess the field of risk analysis according to these criteria. For this purpose, we use a model for risk analysis in which science is used as a base for decision making on risks, which covers the five elements evidence, knowledge base, broad risk evaluation, managerial review and judgment, and the decision; and that relates these elements to the domains experts and decisionmakers, and to the domains fact‐based or value‐based. We conclude that risk analysis is a scientific field of study, when understood as consisting primarily of (i) knowledge about risk‐related phenomena, processes, events, etc., and (ii) concepts, theories, frameworks, approaches, principles, methods and models to understand, assess, characterize, communicate, and manage risk, in general and for specific applications (the instrumental part).     

Risk and Systems Theory

The last few decades have seen increasingly widespread use of risk assessment and management techniques as aids in making complex decisions. However, despite the progress that has been made in risk science, there still remain numerous examples of risk-based decisions and conclusions that have caused great controversy. In particular, there is a great deal of debate surrounding risk assessment: the role of values and ethics and other extra-scientific factors, the efficacy of quantitative versus qualitative analysis, and the role of uncertainty and incomplete information. Many of the epistemological and methodological issues confronting risk assessment have been explored in general systems theory, where techniques exist to manage such issues. However, the use of systems theory and systems analysis tools is still not widespread in risk management. This article builds on the Alachlor risk assessment case study of Brunk, Haworth, and Lee to present a systems-based view of the risk assessment process. The details of the case study are reviewed and the authors' original conclusions regarding the effects of extra-scientific factors on risk assessment are discussed. Concepts from systems theory are introduced to provide a mechanism with which to illustrate these extra-scientific effects The role of a systems study within a risk assessment is explained, resulting in an improved view of the problem formulation process The consequences regarding the definition of risk and its role in decision making are then explored.     

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.     

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.     

The Contrast Between Risk Assessment and Rules of Evidence in the Context of International Trade Disputes: Can the U.S. Experience Inform the Process?

Risk assessment provides a formalized process to evaluate human, animal, and ecological responses associated with exposure to environmental agents. The purpose of risk assessment is to answer two related questions.

• ? How likely is an (adverse) event to occur?
• ? If it does, how severe will the impact be?

In the United States, the science of risk assessment has evolved out of the necessity to make public health decisions in the face of scientific uncertainty. Its basic propositions have been established over the past three decades and its applications have impacted virtually every aspect of public health and environmental protection in many countries, including the United States. More recently, the World Trade Organization's (WTO) dispute‐settlement process has provided additional incentive for the reliance on risk assessments internationally through the requirement that member countries be able to provide scientific justification, based on a risk assessment, for public health and environmental regulatory measures that are challenged. The purpose of this article is to review the history of risk assessment in the United States, emphasizing the development of both its scientific and policy aspects, as one example of the development of institutional capacity for risk assessment. This article discusses the importance of the social, political, and economic contexts of risk assessment and risk management in shaping the approaches taken while highlighting the reality that the analytic or risk assessment part of the decision‐making process, in the absence of scientific data, can be completed only by inserting inferences, or policy judgments, which may differ among countries. This article recognizes these differences, and the consequent difference between risk assessment that incorporates public health protective assumptions and the rules of evidence that seek to answer questions of causality, and discusses implications for the WTO dispute‐settlement process. It further explores the value of country‐specific risk assessment guidelines to facilitate consistency within a country along with the appropriateness and feasibility of international risk assessment guidelines.     

Is Epidemiology the Key to Cumulative Risk Assessment?

Although cumulative risk assessment by definition evaluates the joint effects of chemical and nonchemical stressors, studies to date have not considered both dimensions, in part because toxicological studies cannot capture many stressors of interest. Epidemiology can potentially include all relevant stressors, but developing and extracting the necessary information is challenging given some of the inherent limitations of epidemiology. In this article, I propose a conceptual framework within which epidemiological studies could be evaluated for their inclusion into cumulative risk assessment, including a problem formulation/planning and scoping step that focuses on stressors meaningful for risk management decisions, extension of the chemical mixtures framework to include nonchemical stressors, and formal consideration of vulnerability characteristics of the population. In the long term, broadening the applicability and informativeness of cumulative risk assessment will require enhanced communication and collaboration between epidemiologists and risk assessors, in which the structure of social and environmental epidemiological analyses may be informed in part by the needs of cumulative risk assessment.     

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.     

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.     

Building a Human Health Risk Assessment Ontology (RsO): A Proposed Framework

Over the last decade the health and environmental research communities have made significant progress in collecting and improving access to genomic, toxicology, exposure, health, and disease data useful to health risk assessment. One of the barriers to applying these growing volumes of information in fields such as risk assessment is the lack of informatics tools to organize, curate, and evaluate thousands of journal publications and hundreds of databases to provide new insights on relationships among exposure, hazard, and disease burden. Many fields are developing ontologies as a way of organizing and analyzing large amounts of complex information from multiple scientific disciplines. Ontologies include a vocabulary of terms and concepts with defined logical relationships to each other. Building from the recently published exposure ontology and other relevant health and environmental ontologies, this article proposes an ontology for health risk assessment (RsO) that provides a structural framework for organizing risk assessment information and methods. The RsO is anchored by eight major concepts that were either identified by exploratory curations of the risk literature or the exposure‐ontology working group as key for describing the risk assessment domain. These concepts are: (1) stressor, (2) receptor, (3) outcome, (4) exposure event, (5) dose‐response approach, (6) dose‐response metric, (7) uncertainty, and (8) measure of risk. We illustrate the utility of these concepts for the RsO with example curations of published risk assessments for ionizing radiation, arsenic in drinking water, and persistent pollutants in salmon.