Health Risk Assessment for Planned Waste Incinerators: Getting the Right Science and the Science Right

Health risk assessment is widely advocated in the United Kingdom as the most comprehensive means of assessing the health risks posed by the emissions of a planned waste incinerator. Its main advantage over other methods of assessment, such as air quality impact assessment, is its ability to address explicitly the direct (inhalation) and indirect (ingestion and dermal contact) health risks posed by different chemicals, including those that are not thought to have a threshold below which no adverse effect will take place. This article examines the level and quality of the emissions assessments included in 61 waste incinerator environmental statements (ESs); in particular, it focuses on the quality of the exposure assessment and risk characterization stages of the health risk assessment process. The article concludes that the ES has not always provided interested stakeholders with the best available information upon which to determine the tolerability of the health risks posed by waste incinerator emissions Some recommendations are made as to how this problem might be addressed in future environmental impact assessment (EIA) processes.     

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

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

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.     

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.     

Advancing Risk‐Informed Decision Making in Managing Defense Nuclear Waste in the United States: Opportunities and Challenges for Risk Analysis

An omnibus spending bill in 2014 directed the Department of Energy to analyze how effectively Department of Energy (DOE) identifies, programs, and executes its plans to address public health and safety risks that remain as part of DOE's remaining environmental cleanup liabilities. A committee identified two dozen issues and associated recommendations for the DOE, other federal agencies, and the U.S. Congress to consider, as well as other stakeholders such as states and tribal nations. In regard to risk assessment, the committee described a risk review process that uses available data, expert experience, identifies major data gaps, permits input from key stakeholders, and creates an ordered set of risks based on what is known. Probabilistic risk assessments could be a follow‐up from these risk reviews. In regard to risk management, the states, in particular, have become major drivers of how resources are driven. States use different laws, different priorities, and challenge DOE's policies in different ways. Land use decisions vary, technology choices are different, and other notable variations are apparent. The cost differences associated with these differences are marked. The net result is that resources do not necessarily go to the most prominent human health and safety risks, as seen from the national level.     

Contaminated consignment simulation to support risk-based inspection design

Invasive nonnative plant pests can cause extensive environmental and economic damage and are very difficult to eradicate once established. Phytosanitary inspections that aim to prevent biological invasions by limiting movement of nonnative plant pests across borders are a critical component of the biosecurity continuum. Inspections can also provide valuable information about when and where plant pests are crossing national boundaries. However, only a limited portion of the massive volume of goods imported daily can be inspected, necessitating a highly targeted, risk-based strategy. Furthermore, since inspections must prioritize detection and efficiency, their outcomes generally cannot be used to make inferences about risk for cargo pathways as a whole. Phytosanitary agencies need better tools for quantifying pests going undetected and designing risk-based inspection strategies appropriate for changing operational conditions. In this research, we present PoPS (Pest or Pathogen Spread) Border, an open-source consignment inspection simulator for measuring inspection outcomes under various cargo contamination scenarios to support recommendations for inspection protocols and estimate pest slippage rates. We used the tool to estimate contamination rates of historical interception data, quantify tradeoffs in effectiveness and workload for inspection strategies, and identify vulnerabilities in sampling protocols as changes in cargo configurations and contamination occur. These use cases demonstrate how this simulation approach permits testing inspection strategies and measuring quantities that would otherwise be impossible in a field-based setting. This work represents the first steps toward a decision support tool for creating dynamic inspection protocols that respond to changes in available resources, workload, and commerce trends.     

Improving Food Safety in the Domestic Environment: The Need for a Transdisciplinary Approach

Microbial food safety has been the focus of research across various disciplines within the risk analysis community. Natural scientists involved in food microbiology and related disciplines work on the identification of health hazards, and the detection of pathogenic microorganisms. To perform risk assessment, research activities are increasingly focused on the quantification of microbial contamination of food products at various stages in the food chain, and modeling the impact of this contamination on human health. Social scientists conduct research into how consumers perceive food risks, and how best to develop effective risk communication with consumers in order to improve public health through improved food handling practices. The two approaches converge at the end of the food chain, where the activities regarding food preparation and food consumption are considered. Both natural and social sciences may benefit from input and expertise from the perspective of the alternative discipline, although, to date, the integration of social and natural sciences has been somewhat limited. This article therefore explores the potential of a transdisciplinary approach to food risk analysis in terms of delivering additional improvements to public health. Developing knowledge arising from research in both the natural and social sciences, we present a novel framework involving the integration of the two approaches that might provide the most effective way to improve the consumer health associated with food-borne illness.     

Adaptive Approaches to Biosecurity Governance

This article discusses institutional changes that may facilitate an adaptive approach to biosecurity risk management where governance is viewed as a multidisciplinary, interactive experiment acknowledging uncertainty. Using the principles of adaptive governance, evolved from institutional theory, we explore how the concepts of lateral information flows, incentive alignment, and policy experimentation might shape Australia's invasive species defense mechanisms. We suggest design principles for biosecurity policies emphasizing overlapping complementary response capabilities and the sharing of invasive species risks via a polycentric system of governance.     

Ecological Risk Assessment Framework for Low-Altitude Aircraft Overflights: I. Planning the Analysis and Estimating Exposure

An ecological risk assessment framework for low-altitude aircraft overflights was developed, with special emphasis on military applications. The problem formulation and exposure analysis phases are presented in this article; an analysis of effects and risk characterization is presented in a companion article. The intent of this article is threefold: (1) to illustrate the development of a generic framework for the ecological risk assessment of an activity, (2) to show how the U.S. Environmental Protection Agency's ecological risk assessment paradigm can be applied to an activity other than the release of a chemical, and (3) to provide guidance for the assessment of ecological risks from low-altitude aircraft overflights. The key stressor for low-altitude aircraft overflights is usually sound, although visual and physical (collision) stressors may also be significant. Susceptible and regulated wildlife populations are the major assessment endpoint entities, although plant communities may be impacted by takeoffs and landings. The exposure analysis utilizes measurements of wildlife locations, measurements of sound levels at the wildlife locations, measurements of slant distances from aircraft to wildlife, models that extrapolate sound from the source aircraft to the ground, and bird-strike probability models. Some of the challenges to conducting a risk assessment for aircraft overflights include prioritizing potential stressors and endpoints, choosing exposure metrics that relate to wildlife responses, obtaining good estimates of sound or distance, and estimating wildlife locations.     

Climate Change and Human Health: Estimating Avoidable Deaths and Disease

Human population health has always been central in the justification for sustainable development but nearly invisible in the United Nations Framework Convention on Climate Change negotiations. Current scientific evidence indicates that climate change will contribute to the global burden of disease through increases in diarrhoeal disease, vector-borne disease, and malnutrition, and the health impacts of extreme weather and climate events. A few studies have estimated future potential health impacts of climate change but often generate little policy-relevant information. Robust estimates of future health impacts rely on robust projections of future disease patterns. The application of a standardized and established methodology has been developed to quantify the impact of climate change in relation to different greenhouse gas emission scenarios. All health risk assessments are necessarily biased toward conservative best-estimates of health effects that are easily measured. Global, regional, and national risk assessments can take no account of irreversibility, or plausible low-probability events with potentially very high burdens on human health. There is no "safe limit" of climate change with respect to health impacts as health systems in some regions do not adequately cope with the current climate variability. Current scientific methods cannot identify global threshold health effects in order for policymakers to regulate a "tolerable" amount of climate change. We argue for the need for more research to reduce the potential impacts of climate change on human health, including the development of improved methods for quantitative risk assessment. The large uncertainty about the future effects of climate change on human population health should be a reason to reduce greenhouse gas emissions, and not a reason for inaction.     

Predicting the Risk of Biological Invasions Using Environmental Similarity and Transport Network Connectedness

Understanding the risk of biological invasions associated with particular transport pathways and source regions is critical for implementing effective biosecurity management. This may require both a model for physical connectedness between regions, and a measure of environmental similarity, so as to quantify the potential for a species to be transported from a given region and to survive at a destination region. We present an analysis of integrated biosecurity risk into Australia, based on flights and shipping data from each global geopolitical region, and an adaptation of the “range bagging” method to determine environmental matching between regions. Here, we describe global patterns of environmental matching and highlight those regions with many physical connections. We classify patterns of global invasion risk (high to low) into Australian states and territories. We validate our analysis by comparison with global presence data for 844 phytophagous insect pest species, and produce a list of high‐risk species not previously known to be present in Australia. We determined that, of the insect pest species used for validation, the species most likely to be present in Australia were those also present in geopolitical regions with high transport connectivity to Australia, and those regions that were geographically close, and had similar environments.     

Quantifying Potential Human Health Impacts of Animal Antibiotic Use: Enrofloxacin and Macrolides in Chickens

Use of similar or identical antibiotics in both human and veterinary medicine has come under increasing scrutiny by regulators concerned that bacteria resistant to animal antibiotics will infect people and resist treatment with similar human antibiotics, leading to excess illnesses and deaths. Scientists, regulators, and interest groups in the United States and Europe have urged bans on nontherapeutic and some therapeutic uses of animal antibiotics to protect human health. Many regulators and public health experts have also expressed dissatisfaction with the perceived limitations of quantitative risk assessment and have proposed alternative qualitative and judgmental approaches ranging from "attributable fraction" estimates to risk management recommendations based on the precautionary principle or on expert judgments about the importance of classes of compounds in human medicine. This article presents a more traditional quantitative risk assessment of the likely human health impacts of continuing versus withdrawing use of fluoroquinolones and macrolides in production of broiler chickens in the United States. An analytic framework is developed and applied to available data. It indicates that withdrawing animal antibiotics can cause far more human illness-days than it would prevent: the estimated human BENEFIT:RISK health ratio for human health impacts of continued animal antibiotic use exceeds 1,000:1 in many cases. This conclusion is driven by a hypothesized causal sequence in which withdrawing animal antibiotic use increases illnesses rates in animals, microbial loads in servings from the affected animals, and hence human health risks. This potentially important aspect of human health risk assessment for animal antibiotics has not previously been quantified.     

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.     

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

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

Nano Risk Analysis: Advancing the Science for Nanomaterials Risk Management

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

Risk‐Based Approach for Microbiological Food Safety Management in the Dairy Industry: The Case of Listeria monocytogenes in Soft Cheese Made from Pasteurized Milk

According to Codex Alimentarius Commission recommendations, management options applied at the process production level should be based on good hygiene practices, HACCP system, and new risk management metrics such as the food safety objective. To follow this last recommendation, the use of quantitative microbiological risk assessment is an appealing approach to link new risk‐based metrics to management options that may be applied by food operators. Through a specific case study, Listeria monocytogenes in soft cheese made from pasteurized milk, the objective of the present article is to practically show how quantitative risk assessment could be used to direct potential intervention strategies at different food processing steps. Based on many assumptions, the model developed estimates the risk of listeriosis at the moment of consumption taking into account the entire manufacturing process and potential sources of contamination. From pasteurization to consumption, the amplification of a primo‐contamination event of the milk, the fresh cheese or the process environment is simulated, over time, space, and between products, accounting for the impact of management options, such as hygienic operations and sampling plans. A sensitivity analysis of the model will help orientating data to be collected prioritarily for the improvement and the validation of the model. What‐if scenarios were simulated and allowed for the identification of major parameters contributing to the risk of listeriosis and the optimization of preventive and corrective measures.     

Consumer Responses to Integrated Risk‐Benefit Information Associated with the Consumption of Food

The risk analysis of the health impact of foods is increasingly focused on integrated risk‐benefit assessment, which will also need to be communicated to consumers. It therefore becomes important to understand how consumers respond to integrated risk‐benefit information. Quality‐adjusted‐life‐years (QALYs) is one measure that can be used to assess the balance between risks and benefits associated with a particular food. The effectiveness of QALYs for communicating both positive and negative health effects associated with food consumption to consumers was examined, using a 3 × 2 experiment varying information about health changes in terms of QALYs associated with the consumption of fish (n = 325). The effect of this information on consumer perceptions of the usefulness of QALYs for describing health effects, on risk and benefit perceptions, attitudes, and intentions to consume fish was examined. Results demonstrated that consumers perceived QALYs as useful for communicating health effects associated with food consumption. QALYs communicated as a net effect were preferred for food products associated with negative net effects on health, while separate communication of both risks and benefits may be preferred for food products associated with positive or zero net health effects. Information about health changes in terms of QALYs facilitated informed decision making by consumers, as indicated by the impact on risk and benefit perceptions as intended by the information. The impact of this information on actual food consumption choices merits further investigation.     

Deliberation: Integrating Analytical Results into Environmental Decisions Involving Multiple Stakeholders

The National Research Council has recommended the use of an analytic/deliberative decision making process in environmental restoration decisions that involve multiple stakeholders. This work investigates the use of the results of risk assessment and multiattribute utility analysis (the "analysis") in guiding the deliberation. These results include the ranking of proposed remedial action alternatives according to each stakeholder's preferences, as well as the identification of the major reasons for these rankings. The stakeholder preferences are over a number of performance measures that include the traditional risk assessment metrics, e.g., individual worker risk, as well as programmatic, cultural, and cost-related impacts. Based on these results, a number of proposals are prepared for consideration by the stakeholders during the deliberation. These proposals are the starting point for the formulation of actual recommendations by the group. In our case study, these recommendations included new remedial action alternatives that were created by the stakeholders after an extensive discussion of the detailed analytical results.