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.     

Overcoming barriers to integrating economic analysis into risk assessment

Regulatory risk analysis is designed to provide decisionmakers with a clearer understanding of how policies are likely to affect risk. The systems that produce risk are biological, physical, and social and economic. As a result, risk analysis is an inherently interdisciplinary task. Yet in practice, risk analysis has been interdisciplinary in only limited ways. Risk analysis could provide more accurate assessments of risk if there were better integration of economics and other social sciences into risk assessment itself. This essay examines how discussions about risk analysis policy have influenced the roles of various disciplines in risk analysis. It explores ways in which integrated bio/physical-economic modeling could contribute to more accurate assessments of risk. It reviews examples of the kind of integrated economics-bio/physical modeling that could be used to enhance risk assessment. The essay ends with a discussion of institutional barriers to greater integration of economic modeling into risk assessment and provides suggestions on how these might be overcome.     

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.     

Trust,Emotion, Sex,Politics, and Science: Surveying the Risk-Assessment Battlefield

Risk management has become increasingly politicized and contentious. Polarized views, controversy, and conflict have become pervasive. Research has begun to provide a new perspective on this problem by demonstrating the complexity of the concept risk and the inadequacies of the traditional view of risk assessment as a purely scientific enterprise. This paper argues that danger is real, but risk is socially constructed. Risk assessment is inherently subjective and represents a blending of science and judgment with important psychological, social, cultural, and political factors. In addition, our social and democratic institutions, remarkable as they are in many respects, breed distrust in the risk arena. Whoever controls the definition of risk controls the rational solution to the problem at hand. If risk is defined one way, then one option will rise to the top as the most cost-effective or the safest or the best. If it is defined another way, perhaps incorporating qualitative characteristics and other contextual factors, one will likely get a different ordering of action solutions. Defining risk is thus an exercise in power. Scientific literacy and public education are important, but they are not central to risk controversies. The public is not irrational. Their judgments about risk are influenced by emotion and affect in a way that is both simple and sophisticated. The same holds true for scientists. Public views are also influenced by worldviews, ideologies, and values; so are scientists' views, particularly when they are working at the limits of their expertise. The limitations of risk science, the importance and difficulty of maintaining trust, and the complex, sociopolitical nature of risk point to the need for a new approach—one that focuses upon introducing more public participation into both risk assessment and risk decision making in order to make the decision process more democratic, improve the relevance and quality of technical analysis, and increase the legitimacy and public acceptance of the resulting decisions.     

Improving Health Risk Assessment as a Basis for Public Health Decisions in the 21st Century

One-fifth of the way through the 21st century, a commonality of factors with those of the last 50 years may offer the opportunity to address unfinished business and current challenges. The recommendations include: (1) Resisting the tendency to oversimplify scientific assessments by reliance on single disciplines in lieu of clear weight-of-evidence expressions, and on single quantitative point estimates of health protective values for policy decisions; (2) Improving the separation of science and judgment in risk assessment through the use of clear expressions of the range of judgments that bracket protective quantitative levels for public health protection; (3) Use of comparative risk to achieve the greatest gains in health and the environment; and (4) Where applicable, reversal of the risk assessment and risk management steps to facilitate timely and substantive improvements in public health and the environment. Lessons learned and improvements in the risk assessment process are applied to the unprecedented challenges of the 21st century such as, pandemics and climate change. The beneficial application of the risk assessment and risk management paradigm to ensure timely research with consistency and transparency of assessments is presented. Institutions with mandated stability and leadership roles at the national and international levels are essential to ensure timely interdisciplinary scientific assessment at the interface with public policy as a basis for organized policy decisions, to meet time sensitive goals, and to inform the public.     

Categorizing Mistaken False Positives in Regulation of Human and Environmental Health

One of the concerns often voiced by critics of the precautionary principle is that a widespread regulatory application of the principle will lead to a large number of false positives (i.e., over-regulation of minor risks and regulation of nonexisting risks). The present article proposes a general definition of a regulatory false positive, and seeks to identify case studies that can be considered authentic regulatory false positives. Through a comprehensive review of the science policy literature for proclaimed false positives and interviews with authorities on regulation and the precautionary principle we identified 88 cases. Following a detailed analysis of these cases, we found that few of the cases mentioned in the literature can be considered to be authentic false positives. As a result, we have developed a number of different categories for these cases of "mistaken false positives," including: real risks, "The jury is still out," nonregulated proclaimed risks, "Too narrow a definition of risk," and risk-risk tradeoffs. These categories are defined and examples are presented in order to illustrate their key characteristics. On the basis of our analysis, we were able to identify only four cases that could be defined as regulatory false positives in the light of today's knowledge and recognized uncertainty: the Southern Corn Leaf Blight, the Swine Flu, Saccharin, and Food Irradiation in relation to consumer health. We conclude that concerns about false positives do not represent a reasonable argument against future application of the precautionary principle.     

Defining Susceptibility for Microbial Risk Assessment: Results of a Workshop

An interdisciplinary workshop was convened by the George Washington University in June 2001 to discuss how to incorporate new knowledge about susceptibility to microbial pathogens into risk assessment and management strategies. Experts from government, academic, and private sector organizations discussed definitions, methods, data needs, and issues related to susceptibility in microbial risk assessment. The participants agreed that modeling approaches need to account for the highly specific nature of host-pathogen relationships, and the wide variability of infectivity, immunity, disease transmission, and outcome rates within microbial species and strains. Concerns were raised about distinguishing between exposure and dose more clearly, interpreting experimental and outbreak data correctly, and using thresholds and possibly linearity at low doses. Recommendations were made to advance microbial risk assessment by defining specific terms and concepts more precisely, designing explicit conceptual frameworks to guide development of more complex models and data collection, addressing susceptibility in all steps of the model, measuring components of immunity to characterize susceptibility, reexamining underlying assumptions, applying default methods appropriately, obtaining more mechanistic data to improve default methods, and developing more biologically relevant and continuous risk estimators. The interrelated impacts of selecting specific subpopulations and health outcomes, and of increasing model complexity and data demands, were considered in the contexts of public policy goals and resources required. The participants stated that zero risk is unattainable, so targeted and effective risk reduction and communication strategies are essential not only to raise pubic awareness about water quality but also to protect the most susceptible members of the population.     

What Should Be the Implications of Uncertainty,Variability, and Inherent “Biases”/“Conservatism” for Risk Management Decision-Making?

This paper is a challenge from a pair of lifelong technical specialists in risk assessment for the risk-management community to better define social decision criteria for risk acceptance vs. risk control in relation to the issues of variability and uncertainty. To stimulate discussion, we offer a variety of straw man proposals about where we think variability and uncertainty are likely to matter for different types of social policy considerations in the context of a few different kinds of decisions. In particular, we draw on recent presentations of uncertainty and variability data that have been offered by EPA in the context of the consideration of revised ambient air quality standards under the Clean Air Act.     

EPA Underestimates,Oversimplifies, Miscommunicates,and Mismanages Cancer Risks by Ignoring Human Susceptibility

If exposed to an identical concentration of a carcinogen, every human being would face a different level of risk, determined by his or her genetic, environmental, medical, and other uniquely individual characteristics. Various lines of evidence indicate that this susceptibility variable is distributed rather broadly in the human population, with perhaps a factor of 25‐ to 50‐fold between the center of this distribution and either of its tails, but cancer risk assessment at the EPA and elsewhere has always treated every (adult) human as identically susceptible. The National Academy of Sciences “Silver Book” concluded that EPA and the other agencies should fundamentally correct their mis‐computation of carcinogenic risk in two ways: (1) adjust individual risk estimates upward to provide information about the upper tail; and (2) adjust population risk estimates upward (by about sevenfold) to correct an underestimation due to a mathematical property of the interindividual distribution of human susceptibility, in which the susceptibility averaged over the entire (right‐skewed) population exceeds the median value for the typical human. In this issue of Risk Analysis, Kenneth Bogen disputes the second adjustment and endorses the first, though he also relegates the problem of underestimated individual risks to the realm of “equity concerns” that he says should have little if any bearing on risk management policy. In this article, I show why the basis for the population risk adjustment that the NAS recommended is correct—that current population cancer risk estimates, whether they are derived from animal bioassays or from human epidemiologic studies, likely provide estimates of the median with respect to human variation, which in turn must be an underestimate of the mean. If cancer risk estimates have larger “conservative” biases embedded in them, a premise I have disputed in many previous writings, such a defect would not excuse ignoring this additional bias in the direction of underestimation. I also demonstrate that sensible, legally appropriate, and ethical risk policy must not only inform the public when the tail of the individual risk distribution extends into the “high‐risk” range, but must alter benefit‐cost balancing to account for the need to try to reduce these tail risks preferentially.     

Plurality of Worlds, Plurality of Risks

Risk management decisions are not made only on the basis of expert risk assessment. In numerous instances, public controversy erupts, questioning the results of previous risk assessment procedures and shaping the development of risk management episodes. This article presents a case study of risk management in the context of a 1980s controversy over aerial spraying against a spruce budworm epidemic in Quebec and draws some general conclusions concerning the relationship between risk analysis and public controversies. Actors in public controversies define risks more broadly than risk assessment experts. Moreover, public controversies only partly concern issues of risk. They are first and foremost debates about social choices in which actors carry with them a multidimensional social experience of technology, trust, credibility and decision-making institutions. This experience contributes to the construction of a plurality of emergent representations of what is at stake in a controversy, referred to in this paper as "worlds of relevance." Analysis shows that in any given public controversy, there are not just two parties arguing against each other. Rather, several "worlds of relevance" can be found that link, in a variety of ways, a variety of entities not necessarily shared by all these worlds. Each "world of relevance" presents a different definition of what the issues and the stakes of the controversy are. Risks are only part of the picture, and they are embedded in "worlds of relevance" from which they take their significance. The successful management of a controversy entails the association of entities from different worlds.     

Artifactual Uncertainty in Risk Analysis

The field of comparative risk analysis of electrical energy alternatives has traditionally been plagued by highly uncertain estimates of risk rates, and consequently by conflicting judgements of relative risk. To the extent that this uncertainty arises from traditional sources–imperfect observations or actual variance in the data–it can be brought within a Bayesian statistical framework which allows policy conclusions to be formulted and tested at different levels of confidence. It is shown that there are important methodological or "artifactual" sources of uncertainty, however, that cannot be treated by statistical means; these require conceptual advances for their resolution. By identifying these sources of uncertainty in simple thought experiments and examples, it is shown in what ways the concept of attributable risk, which is the policy-maker's chief concern, must be sharpened and refined to have unambiguous meaning. The conventional "multilinear" formula for calculating risk indices is challenged as a measure of attributable risk, and directions for further research to improve the methodological foundations of comparative risk analysis are identified.     

A Disciplinary Perspective on the Epistemological Status of Risk

A unique multidisciplinary perspective on the risk literature is used to establish a fresh and provocative argument regarding the epistemological understanding and definition of risk. Building on economic conceptualizations that distinguish risk from uncertainty and argue that risk is an ordered application of knowledge to the unknown, the survey identifies each of the disciplines as having a particular knowledge approach with which they confront the unknown so as to order its randomness and convert it into a risk proposition. This epistemological approach suggests the concept of risk can act as a mirror, reflecting the preoccupations, strengths, and weaknesses of each discipline as they grapple with uncertainty. The conclusion suggests that the different disciplines can, and desirably should, act in concert toward a cumulative appreciation of risk that progresses our understanding of the concept. One way in which the article challenges risk experts to join disciplinary forces in a collaborative effort is to holistically appreciate and articulate the concept of political risk calculation.     

A clarification of the goal setting and appraisal processes in MBO

Under the guise of Management by Objectives, "goal setting" and "performance appraisal" have assumed many different shapes and purposes. To clarify the concept of MBO, this review examines the writings of leading MBO experts, extracts those elements common to their respective definitions of goal setting and performance appraisal, and joins them into a single definition of MBO.     

On the Meaning and Use of the Risk Appetite Concept

The risk appetite concept has been given considerable attention recently in enterprise risk management contexts. A number of definitions exist, most with a link to risk acceptability, but also values and goals. The usefulness of the concept is, however, disputed; some authors argue that we can in fact do better without it. In this article, we provide a thorough discussion of what the risk appetite concept is actually trying to express and how it best can be used in the relevant decision making. The main purposes of the article are (i) to argue that the risk appetite concept, suitably interpreted, has a role to play in risk management, (ii) to show that the risk appetite concept is well supported by some types of risk perspectives and not by others, and (iii) to show how the risk appetite concept is linked to other related concepts, such as risk seeking and risk acceptability. The risk perspectives studied range from expected value and probability based definitions of risk to views on risk, that are founded on uncertainties.     

Engaging with Comparative Risk Appraisals: Public Views on Policy Priorities for Environmental Risk Governance

Communicating the rationale for allocating resources to manage policy priorities and their risks is challenging. Here, we demonstrate that environmental risks have diverse attributes and locales in their effects that may drive disproportionate responses among citizens. When 2,065 survey participants deployed summary information and their own understanding to assess 12 policy‐level environmental risks singularly, their assessment differed from a prior expert assessment. However, participants provided rankings similar to those of experts when these same 12 risks were considered as a group, allowing comparison between the different risks. Following this, when individuals were shown the prior expert assessment of this portfolio, they expressed a moderate level of confidence with the combined expert analysis. These are important findings for the comprehension of policy risks that may be subject to augmentation by climate change, their representation alongside other threats within national risk assessments, and interpretations of agency for public risk management by citizens and others.     

The Use of Risk Assessment to Decide the Control Strategy for Bluetongue in Italian Ruminant Populations

The affiliation, assessment and management of risks is a traditional part of veterinary medicine. In the past, veterinary services involved in this type of activity usually assessed risks qualitatively. However, since the 1990s, quantitative methods have become increasingly important. The establishment of the World Trade Organization in 1994, and the promulgation of its Agreement on the Application of Sanitary and Phytosanitary Measures (the "SPS Agreement") led to an increased application of import risk analysis and to significant improvements in the methodology of risk analysis as applied to international trade policy for animals and animal products. However, there was very little development of risk analysis in veterinary fields other than international trade and management of health risks to consumers of animal products and little has been published on its use in the choice and definition of control or prophylaxis strategies for animal diseases. This article describes a quantitative risk assessment, which was undertaken in Italy to help choose an appropriate national response strategy following an incursion of bluetongue, an infectious disease of sheep and goats. The results obtained in this study support the use of risk analysis as a tool to assist in choosing an appropriate animal disease management strategy. The use of risk analysis in the evaluation of disease management strategies also offers advantages in international trade. It makes easier the comparison of different strategies applied in the various countries, and thus facilitates the assessment of equivalence of the guarantees provided by different strategies.     

Direct Inference, Probability, and a Conceptual Gulf in Risk Communication

Differences in the conceptual frameworks of scientists and nonscientists may create barriers to risk communication. This article examines two such conceptual problems. First, the logic of "direct inference" from group statistics to probabilities about specific individuals suggests that individuals might be acting rationally in refusing to apply to themselves the conclusions of regulatory risk assessments. Second, while regulators and risk assessment scientists often use an "objectivist" or "relative frequency" interpretation of probability statements, members of the public are more likely to adopt a "subjectivist" or "degree of confidence" interpretation when estimating their personal risks, and either misunderstand or significantly discount the relevance of risk assessment conclusions. If these analyses of inference and probability are correct, there may be a conceptual gulf at the center of risk communication that cannot be bridged by additional data about the magnitude of group risk. Suggestions are made for empirical studies that might help regulators deal with this conceptual gulf.