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.     

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.     

The Role of the Community in the Implementation of the EPA's Rule on Risk Management Programs for Chemical Accidental Release Prevention

Regulations under the 1990 Clean Air Act Amendments (CAAA) include requirements for preventing accidental chemical releases. Section 112(r) of the CAAA, the Accidental Release Provisions, requires the U.S. Environmental Protection Agency (EPA) to develop and implement regulations for preventing accidental releases to the air of regulated substances and to minimize the consequences of releases that do occur. The regulations require regulated facilities to have in place the structural elements of a sound process safety program, and to practice, document, and communicate the elements of their program. The rule requires also that registered facilities calculate and make available worst case accidental chemical release information. The rule does not set a level of risk that a facility must achieve after it takes the required compliance steps, the level of risk a community must accept, the limit of consequences the community might suffer from a worst case chemical release, nor the specific actions a community must take in its response plan. These are issues that local communities and local officials must decide. Because the regulation involves the community in many unsettled risk issues the Wharton School initiated a project within the City Philadelphia to evaluate the proposition that productive dialogue on the implementation of the Rule and resolution of unsettled risk issues can take place in advance of a crisis occasioned by a major accidental release. This paper describes the steps taken by Wharton to bring together various stakeholders in the community to explore the implementation of the rule and the reaction of those stakeholders to be involved in such a process. It outlines some principal choices communities will have to make in order to implement 112(r) and explains some of the dilemmas associated with these choices. It describes the stakeholder-based implementation effort being undertaken in Philadelphia in the hope that others may benefit from what has been learned there.     

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.     

The Role of Environmental Accidental Risk Assessment in the Process of Granting Development Consent

Environmental impact assessment (EIA) is a procedure that must be followed for certain types of development before they are granted development consent. The procedure requires the developer to compile an environmental impact report (EIR) describing the likely significant effects of the project on the environment. A regulatory requirement in Slovenia is that an accidental risk assessment for a new installation should be a part of an EIR. The article shows how risk assessment (RA) related to accidental release of methylene diphenyl diisocyanate (MDI) or a polyvalent alcohol mixture from a new planned unit of a chemical factory in the Alpine region of Slovenia was performed in the framework of an EIA for the purpose of obtaining a construction permit. Two accidental scenarios were considered: (a) a spill of 20 m³ of MDI or polyvalent alcohol mixture into the river Soča (the river runs close to the chemical factory) and (b) a fire in the warehouse storing the raw material, where emission of toxic gases HCN, NO_x, and CO is expected during combustion of MDI. One of the most important results of this case is the agreement among the developer, the competent authority, and a consultant in the field of EIA and RA to positively conclude the licensing process despite the absence of formal (regulatory) limit values for risk. It has been approved that transparent, reasonably uncertain, and semi-quantitative environmental risk assessment is an inevitable component of an EIA, and an essential factor in informed, licensing-related decision making.     

Ecological Risk Assessment,Prediction, and Assessing Risk Predictions

Ecological risk assessment embodied in an adaptive management framework is becoming the global standard approach for formally assessing and managing the ecological risks of technology and development. Ensuring the continual improvement of ecological risk assessment approaches is partly achieved through the dissemination of not only the types of risk assessment approaches used, but also their efficacy. While there is an increasing body of literature describing the results of general comparisons between alternate risk assessment methods and models, there is a paucity of literature that post hoc assesses the performance of specific predictions based on an assessment of risk and the effectiveness of the particular model used to predict the risk. This is especially the case where risk assessments have been used to grant consent or approval for the construction of major infrastructure projects. While postconstruction environmental monitoring is increasingly commonplace, it is not common for a postconstruction assessment of the accuracy and performance of the ecological risk assessment and underpinning model to be undertaken. Without this “assessment of the assessment,” it is difficult for other practitioners to gain insight into the performance of the approach and models used and therefore, as argued here, this limits the rate of improvement of risk assessment approaches.     

Perceived Risk, Stigma, and Potential Economic Impacts of a High-Level Nuclear Waste Repository in Nevada

This study investigates the potential impacts of the proposed nuclear waste repository at Yucca Mountain, Nevada, upon tourism, retirement and job-related migration, and business development in Las Vegas and the state. Adverse impacts may be expected to result from perceptions of risk, stigmatization, and socially amplified reactions to "unfortunate events" associated with the repository (major and minor accidents, discoveries of radiation releases, evidence of mismanagement, attempts to sabotage or disrupt the facility, etc.). The conceptual underpinnings of risk perception, stigmatization, and social amplification are discussed and empirical data are presented to demonstrate how nuclear images associated with Las Vegas and the State of Nevada might trigger adverse economic effects. The possibility that intense negative imagery associated with the repository may cause significant harm to Nevada's economy can no longer be ignored by serious attempts to assess the risks and impacts of this unique facility. The behavioral processes described here appear relevant as well to the social impact assessment of any proposed facility that produces, uses, transports, or disposes of hazardous materials.     

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.     

Quantitative Risk Assessment of Rabies Entering Great Britain from North America via Cats and Dogs

Great Britain has been rabies-free since 1922, which is often considered to be in part due to the strict laws requiring that imported cats and dogs be vaccinated and quarantined for 6 months immediately on entry into the country. Except for two isolated incidents, this quarantine policy has contributed to ensuring that Great Britain has remained free of rabies. In 2000, amendments to the UK quarantine laws were made and the Pet Travel Scheme (PETS) was launched for companion animals traveling from European Union countries and rabies-free islands. Since its introduction, it has been proposed that other countries including North America should be included within the UK scheme. A quantitative risk assessment was developed to assist in the policy decision to amend the long-standing quarantine laws for dogs and cats from North America. It was determined that the risk of rabies entry is very low and is dependent on the level of compliance (i.e., legally conforming to all of the required regulations) with PETS and the number of pets imported. Assuming 100% compliance with PETS and the current level of importation of cats and dogs from North America, the annual probability of importing rabies is lower for animals traveling via PETS (7.22 x 10(-6), 95th percentile) than quarantine (1.01 x 10(-5), 95th percentile). These results, and other scientific evidence, directly informed the decision to expand the PETS scheme to North America as of December 2002.     

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.     

Risk Assessment and Alternatives Assessment: Comparing Two Methodologies

The selection and use of chemicals and materials with less hazardous profiles reflects a paradigm shift from reliance on risk minimization through exposure controls to hazard avoidance. This article introduces risk assessment and alternatives assessment frameworks in order to clarify a misconception that alternatives assessment is a less effective tool to guide decision making, discusses factors promoting the use of each framework, and also identifies how and when application of each framework is most effective. As part of an assessor's decision process to select one framework over the other, it is critical to recognize that each framework is intended to perform different functions. Although the two frameworks share a number of similarities (such as identifying hazards and assessing exposure), an alternatives assessment provides a more realistic framework with which to select environmentally preferable chemicals because of its primary reliance on assessing hazards and secondary reliance on exposure assessment. Relevant to other life cycle impacts, the hazard of a chemical is inherent, and although it may be possible to minimize exposure (and subsequently reduce risk), it is challenging to assess such exposures through a chemical's life cycle. Through increased use of alternatives assessments at the initial stage of material or product design, there will be less reliance on post facto risk‐based assessment techniques because the potential for harm is significantly reduced, if not avoided, negating the need for assessing risk in the first place.     

Risk Assessment for Carcinogens Under California''s Proposition 65

Risk assessments for carcinogens are being developed through an accelerated process in California as a part of the state's implementation of Proposition 65, the Safe Drinking Water and Toxic Enforcement Act. Estimates of carcinogenic potency made by the California Department of Health Services (CDHS) are generally similar to estimates made by the U.S. Environmental Protection Agency (EPA). The largest differences are due to EPA's use of the maximum likelihood estimate instead of CDHS' use of the upper 95% confidence bounds on potencies derived from human data and to procedures used to correct for studies of short duration or with early mortality. Numerical limits derived from these potency estimates constitute "no significant risk" levels, which govern exemption from Proposition 65's discharge prohibition and warning requirements. Under Proposition 65 regulations, lifetime cancer risks less than 10(-5) are not significant and cumulative intake is not considered. Following these regulations, numerical limits for a number of Proposition 65 carcinogens that are applicable to the control of toxic discharges are less stringent than limits under existing federal water pollution control laws. Thus, existing federal limits will become the Proposition 65 levels for discharge. Chemicals currently not covered by federal and state controls will eventually be subject to discharge limitations under Proposition 65. "No significant risk" levels (expressed in terms of daily intake of carcinogens) also trigger warning requirements under Proposition 65 that are more extensive than existing state or federal requirements. A variety of chemical exposures from multiple sources are identified that exceed Proposition 65's "no significant risk" levels.     

Forty Years of Food Safety Risk Assessment: A History and Analysis

Before the founding of the Society for Risk Analysis (SRA) in 1980, food safety in the United States had long been a concern, but there was a lack of systematic methods to assess food-related risks. In 1906, the U.S. Congress passed, and President Roosevelt signed, the Pure Food and Drug Act and the Meat Inspection Act to regulate food safety at the federal level. This Act followed the publication of multiple reports of food contamination, culminating in Upton Sinclair's novel The Jungle, which highlighted food and worker abuses in the meatpacking industry. Later in the 20th century, important developments in agricultural and food technology greatly increased food production. But chemical exposures from agricultural and other practices resulted in major amendments to federal food laws, including the Delaney Clause, aimed specifically at cancer-causing chemicals. Later in the 20th century, when quantitative risk assessment methods were given greater scientific status in a seminal National Research Council report, food safety risk assessment became more systematized. Additionally, in these last 40 years, food safety research has resulted in increased understanding of a range of health effects from foodborne chemicals, and technological developments have improved U.S. food safety from farm to fork by offering new ways to manage risks. We discuss the history of food safety and the role risk analysis has played in its evolution, starting from over a century ago, but focusing on the last 40 years. While we focus on chemical risk assessment in the U.S., we also discuss microbial risk assessment and international food safety.     

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.     

Historical Relationship Between Performance Assessment for Radioactive Waste Disposal and Other Types of Risk Assessment

This article describes the evolution of the process for assessing the hazards of a geologic disposal system for radioactive waste and, similarly, nuclear power reactors, and the relationship of this process with other assessments of risk, particularly assessments of hazards from manufactured carcinogenic chemicals during use and disposal. This perspective reviews the common history of scientific concepts for risk assessment developed until the 1950s. Computational tools and techniques developed in the late 1950s and early 1960s to analyze the reliability of nuclear weapon delivery systems were adopted in the early 1970s for probabilistic risk assessment of nuclear power reactors, a technology for which behavior was unknown. In turn, these analyses became an important foundation for performance assessment of nuclear waste disposal in the late 1970s. The evaluation of risk to human health and the environment from chemical hazards is built on methods for assessing the dose response of radionuclides in the 1950s. Despite a shared background, however, societal events, often in the form of legislation, have affected the development path for risk assessment for human health, producing dissimilarities between these risk assessments and those for nuclear facilities. An important difference is the regulator's interest in accounting for uncertainty.     

Use of Advances in Technology for Maritime Risk Assessment

The maritime industry is moving toward a "goal-setting" risk-based regime. This opens the way to safety engineers to explore and exploit flexible and advanced risk modeling and decision-making approaches in the design and operation processes. In this article, following a brief review of the current status of maritime risk assessment, a design/operation selection framework and a design/operation optimization framework are outlined. A general discussion of control engineering techniques and their application to risk modeling and decision making is given. Four novel risk modeling and decision-making approaches are then outlined with illustrative examples to demonstrate their use. Such approaches may be used as alternatives to facilitate risk modeling and decision making in situations where conventional techniques cannot be appropriately applied. Finally, recommendations on further exploitation of advances in general engineering and technology are suggested with respect to risk modeling and decision making.     

One Agency's Use of Risk Assessment and Risk Communication1

Few organizations have the courage to evaluate their own use of risk assessment (identifying hazards and estimating their probability and magnitude) and risk communication (interacting with internal and external stakeholder groups about risks). The USDA Animal and Plant Health Inspection Service (APHIS) wants to enhance its overall risk analysis process for managing a wide range of risks to animals, plants, and human health. We gathered survey data for a baseline of APHIS professionals’ understanding and use of risk assessment and risk communication. APHIS professionals spend a surprisingly large share of their time communicating about risks. They perceive that risk estimates influence decisions, but that risk estimates should have more influence. Respondents reported little opposition to APHIS risk management decisions, and little use of channels such as USDA Extension Service for disseminating risk messages. Substantial variance across responses is explained mostly by differences in the roles of the 11 work units (now 10) within the agency. Location also contributes to the variance. Demographic variables seem less important.     

Peak Exposures in Epidemiologic Studies and Cancer Risks: Considerations for Regulatory Risk Assessment

We review approaches for characterizing “peak” exposures in epidemiologic studies and methods for incorporating peak exposure metrics in dose–response assessments that contribute to risk assessment. The focus was on potential etiologic relations between environmental chemical exposures and cancer risks. We searched the epidemiologic literature on environmental chemicals classified as carcinogens in which cancer risks were described in relation to “peak” exposures. These articles were evaluated to identify some of the challenges associated with defining and describing cancer risks in relation to peak exposures. We found that definitions of peak exposure varied considerably across studies. Of nine chemical agents included in our review of peak exposure, six had epidemiologic data used by the U.S. Environmental Protection Agency (US EPA) in dose–response assessments to derive inhalation unit risk values. These were benzene, formaldehyde, styrene, trichloroethylene, acrylonitrile, and ethylene oxide. All derived unit risks relied on cumulative exposure for dose–response estimation and none, to our knowledge, considered peak exposure metrics. This is not surprising, given the historical linear no‐threshold default model (generally based on cumulative exposure) used in regulatory risk assessments. With newly proposed US EPA rule language, fuller consideration of alternative exposure and dose–response metrics will be supported. “Peak” exposure has not been consistently defined and rarely has been evaluated in epidemiologic studies of cancer risks. We recommend developing uniform definitions of “peak” exposure to facilitate fuller evaluation of dose response for environmental chemicals and cancer risks, especially where mechanistic understanding indicates that the dose response is unlikely linear and that short‐term high‐intensity exposures increase risk.     

A Heuristic Risk Assessment Technique for Birdstrike Management at Airports

Collisions between birds and aircraft (birdstrikes) have caused the loss of at least 88 aircraft and 243 lives in world civil aviation. Conservative estimates suggest that more routine damage and delays following birdstrikes cost the industry and its insurers US$1.2-1.5 billion per year. The majority of strikes happen close to airports and most countries have regulations that require airport managers to control the birdstrike risk on their property. Birdstrike prevention has, however, lagged behind other aspects of flight safety in the development and implementation of risk assessment protocols, possibly because of the inherent difficulty in quantifying the variability in the populations and behavior of the various bird species involved. This article presents a technique that uses both national and airport-specific data to evaluate risk by creating a simple probability-times-severity matrix. It uses the frequency of strikes reported for different bird species at a given airport over the preceding five years as a measure of strike probability, and the proportion of strikes with each species that result in damage to aircraft, in the national birdstrike database, as a measure of likely severity. Action thresholds for risk levels for particular bird species are then defined, above which the airport should take action to reduce the risk further. The assessment is designed for airports where the reporting and collation of birdstrike events is reasonably consistent over time and where a bird hazard management program of some sort is already in place. This risk assessment is designed to measure risk to the airport as a business rather than risk to the traveling passenger individually. It therefore takes no account of aircraft movement rate in the calculations and is aimed at minimizing the number of damaging incidents rather than concentrating on catastrophic events. Once set up at an airport, the technique is simple to implement for nonexperts, and it allows managers to focus bird control resources on the species causing the greatest risk, hence maximizing the return on investment. This protocol is now being successfully used at major airports in the United Kingdom and elsewhere in the world.