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.     

Variations in Concepts of "Susceptibility" in Risk Assessment

The Food Quality Protection Act and the 1996 amendments to the Safe Drinking Water Act are two of the most recent examples of legislation calling for protection of susceptible subpopulations. As regulatory deadlines draw nearer, controversies in scientific and policy arenas increase about incorporating susceptibility in risk assessment. The previously accepted working definition of "susceptibility" has already been called into question. Part of the controversy results from different disciplines conceiving of susceptibility in different ways. Understanding the conceptual differences embodied within definitions can provide a basis on which a revised working definition may be developed across disciplines. The purposes of this article are to describe the varying definitions of susceptibility, discuss the differing concepts incorporated in the definitions, and recommend ways in which susceptibility may be defined and framed to meet current risk assessment needs. The present analysis of definitions from the fields of ecology, biology, engineering, medicine, epidemiology, and toxicology revealed different emphases that relate to the underlying perspectives and methods of each field. It is likely that susceptibility will need to be formally defined for public policy purposes, but until that time, the use of more informal communication and decision-making processes is suggested to develop and utilize a new working consensus on the definition of susceptibility.     

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).     

Why Do Countries Regulate Environmental Health Risks Differently? A Theoretical Perspective

Why do countries regulate, or prefer to regulate, environmental health risks such as radiofrequency electromagnetic fields and endocrine disruptors differently? A wide variety of theories, models, and frameworks can be used to help answer this question, though the resulting answer will strongly depend on the theoretical perspective that is applied. In this theoretical review, we will explore eight conceptual frameworks, from different areas of science, which will offer eight different potential explanations as to why international differences occur in environmental health risk management. We are particularly interested in frameworks that could shed light on the role of scientific expertise within risk management processes. The frameworks included in this review are the Risk Assessment Paradigm, research into the roles of experts as policy advisors, the Psychometric Paradigm, the Cultural Theory of Risk, participatory approaches to risk assessment and risk management, the Advocacy Coalition Framework, the Social Amplification of Risk Framework, and Hofstede's Model of National Cultures. We drew from our knowledge and experiences regarding a diverse set of academic disciplines to pragmatically assemble a multidisciplinary set of frameworks. From the ideas and concepts offered by the eight frameworks, we derive pertinent questions to be used in further empirical work and we present an overarching framework to depict the various links that could be drawn between the frameworks.     

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.     

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.     

An Evaluation of the Treatment of Risk and Uncertainties in the IPCC Reports on Climate Change

Few global threats rival global climate change in scale and potential consequence. The principal international authority assessing climate risk is the Intergovernmental Panel on Climate Change (IPCC). Through repeated assessments the IPCC has devoted considerable effort and interdisciplinary competence to articulating a common characterization of climate risk and uncertainties. We have reviewed the assessment and its foundation for the Fifth Assessment Reports published in 2013 and 2014, in particular the guidance note for lead authors of the fifth IPCC assessment report on consistent treatment of uncertainties. Our analysis shows that the work carried out by the ICPP is short of providing a theoretically and conceptually convincing foundation on the treatment of risk and uncertainties. The main reasons for our assessment are: (i) the concept of risk is given a too narrow definition (a function of consequences and probability/likelihood); and (ii) the reports lack precision in delineating their concepts and methods. The goal of this article is to contribute to improving the handling of uncertainty and risk in future IPCC studies, thereby obtaining a more theoretically substantiated characterization as well as enhanced scientific quality for risk analysis in this area. Several suggestions for how to improve the risk and uncertainty treatment are provided.     

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.     

Engaging Expert Peers in the Development of Risk Assessments

The participation of external technical experts in the development of risk assessment documents and methodologies has expanded and evolved in recent years. Many government agencies and authoritative organizations have experts peer review important works to evaluate the scientific and technical defensibility and judge the strength of the assumptions and conclusions (OMB, 2004; IPCS, 2005; IARC, 2006; Health Canada, 2007; U.S. EPA, 2006). Expert advice has been solicited in other forms of peer involvement, including peer consultation in, for example, the U.S. EPA's Voluntary Children's Chemical Evaluation Program (VCCEP). This article discusses how the principles and practices of peer review can be extended to other types of peer involvement activities (i.e., peer input and peer consultation) to develop high-quality risk assessment work products. A comprehensive process for incorporating peer input, peer consultation, and peer review into risk assessment science is outlined. Four key principles for peer involvement-independence, inclusion of appropriate experts, transparency, and a robust scientific process-are discussed. Recent examples of peer involvement in the development of Health Canada's Priority Substances and Domestic Substance List (DSL) programs under the Canadian Environmental Protection Act (CEPA) serve to highlight the concepts.     

Exploring the Conceptual Foundation of Continuity Management in the Context of Societal Safety

Public and private actors with critical roles for ensuring societal safety need to work proactively to reduce risks and vulnerabilities. Traditionally, risk management activities have often been performed in order to ensure continuous functioning of key societal services. Recently, however, business continuity management (BCM), and its analytical subcomponent business impact assessment (BIA), has been introduced and used more extensively by both the private and public sector in order to increase the robustness and resilience of critical infrastructures and societal functions and services. BCM was originally developed in the business sector but has received a broader use during the last decade. Yet, BCM/BIA has gained limited attention in the scientific literature—especially when it comes to clarifying and developing its conceptual basis. First, this article examines and discusses the conceptual foundation of BCM concepts, including practical challenges of applying the concepts. Based on recent conceptual developments from the field of risk management, a developed conceptualization is suggested. Second, the article discusses challenges that arise when applying BCM in the societal safety area and provides some recommendations aiming to improve the clarity and quality of applications. Third, the article provides suggestions of how to integrate the overlapping approaches of BIA and risk assessment in order to improve efficiency and effectiveness of proactive, analytic processes. We hope that the article can stimulate a critical discussion about the key concepts of BCM, their wider use in societal safety, and their connection to other concepts and activities such as risk assessment.     

A Risk Assessment Framework for Assessing Metallic Nanomaterials of Environmental Concern: Aquatic Exposure and Behavior

Nanomaterials are finding application in many different environmentally relevant products and processes due to enhanced catalytic, antimicrobial, and oxidative properties of materials at this scale. As the market share of nano‐functionalized products increases, so too does the potential for environmental exposure and contamination. This study presents some exposure ranking methods that consider potential metallic nanomaterial surface water exposure and fate, due to nano‐functionalized products, through a number of exposure pathways. These methods take into account the limited and disparate data currently available for metallic nanomaterials and apply variability and uncertainty principles, together with qualitative risk assessment principles, to develop a scientific ranking. Three exposure scenarios with three different nanomaterials were considered to demonstrate these assessment methods: photo‐catalytic exterior paint (nano‐scale TiO₂), antimicrobial food packaging (nano‐scale Ag), and particulate‐reducing diesel fuel additives (nano‐scale CeO₂). Data and hypotheses from literature relating to metallic nanomaterial aquatic behavior (including the behavior of materials that may relate to nanomaterials in aquatic environments, e.g., metals, pesticides, surfactants) were used together with commercial nanomaterial characteristics and Irish natural aquatic environment characteristics to rank the potential concentrations, transport, and persistence behaviors within subjective categories. These methods, and the applied scenarios, reveal where data critical to estimating exposure and risk are lacking. As research into the behavior of metallic nanomaterials in different environments emerges, the influence of material and environmental characteristics on nanomaterial behavior within these exposure‐ and risk‐ranking methods may be redefined on a quantitative basis.     

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.     

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.     

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.     

Expressing Economic Risk—Review and Presentation of a Unifying Approach

Risk related to economic values is treated by many disciplines, including safety and production engineering, business, and project management. Within each of these and across these disciplines different nomenclature and principles are adopted for describing and communicating risk. The situation is rather confusing. In this article, we review various approaches and concepts that are used to express risk. We present and discuss a unifying approach for dealing with economic risk, with uncertainty being the key risk concept. The approach represents a rethinking on how to implement the Bayesian paradigm in practice to support decision making.     

A critical review on supply chain risk – Definition,measure and modeling

Economic systems are increasingly prone to complexity and uncertainty. Therefore, making well-informed decisions requires risk analysis, control and mitigation. In some areas such as finance, insurance, crisis management and health care, the importance of considering risk is largely acknowledged and well-elaborated, yet rather heterogeneous concepts and approaches for risk management have been developed. The increased frequency and the severe consequences of past supply chain disruptions have resulted in an increasing interest in risk. This development has led to the adoption of the risk concepts, terminologies and methods from related fields. In this paper, existing approaches for quantitative supply chain risk management are reviewed by setting the focus on the definition of supply chain risk and related concepts.     

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.     

Risk Science Contributions: Three Illustrating Examples

This article aims to demonstrate that risk science is important for society, industry and all of us. Rather few people today, including scientists and managers, are familiar with what this science is about—its foundation and main features—and how it is used to gain knowledge and improve communication and decision making in real-life situations. The article seeks to meet this challenge, by presenting three examples, showing how risk science works to gain new generic, fundamental knowledge on risk concepts, principles, and methods, as well as supporting the practical tackling of actual risk problems.     

How to Design Rating Schemes of Risk Matrices: A Sequential Updating Approach

Risk matrices have been widely used as a risk evaluation tool in many fields due to their simplicity and intuitive nature. Designing a rating scheme, i.e., determining the number of ratings used in a risk matrix and assigning different ratings to different cells, is an essential part of risk matrix construction. However, most of the related literature has focused on applying a risk matrix to various fields, instead of researching how to design risk matrices. Based on the analysis of several current rules, we propose a new approach, namely, the sequential updating approach (SUA), to design the rating scheme of a risk matrix in a reliable way. In this article, we propose three principles and a rating algorithm based on these principles. The three principles, namely, adjusted weak consistency, consistent internality, and continuous screening, characterize a good rating scheme. The resulting rating scheme has been proven to be unique. A global rating algorithm is then proposed to create the design that satisfies the three principles. We then explore the performance of the SUA. An illustrative application is first given to explain the feasibility of our approach. The sensitivity analysis shows that our method captures a resolution‐reliability tradeoff for decisionmakers in choosing an appropriate rating scheme for a risk matrix. Finally, we compare the designs based on the SUA and Cox's axioms, highlighting the advantages of the SUA.     

An Emerging New Risk Analysis Science: Foundations and Implications

To solve real‐life problems—such as those related to technology, health, security, or climate change—and make suitable decisions, risk is nearly always a main issue. Different types of sciences are often supporting the work, for example, statistics, natural sciences, and social sciences. Risk analysis approaches and methods are also commonly used, but risk analysis is not broadly accepted as a science in itself. A key problem is the lack of explanatory power and large uncertainties when assessing risk. This article presents an emerging new risk analysis science based on novel ideas and theories on risk analysis developed in recent years by the risk analysis community. It builds on a fundamental change in thinking, from the search for accurate predictions and risk estimates, to knowledge generation related to concepts, theories, frameworks, approaches, principles, methods, and models to understand, assess, characterize, communicate, and (in a broad sense) manage risk. Examples are used to illustrate the importance of this distinct/separate risk analysis science for solving risk problems, supporting science in general and other disciplines in particular.