Ecological Risk Assessment Framework for Low-Altitude Aircraft Overflights: II. Estimating Effects on Wildlife

An ecological risk assessment framework for aircraft overflights has been developed, with special emphasis on military applications. This article presents the analysis of effects and risk characterization phases; the problem formulation and exposure analysis phases are presented in a companion article. The framework addresses the effects of sound, visual stressors, and collision on the abundance and production of wildlife populations. Profiles of effects, including thresholds, are highlighted for two groups of endpoint species: ungulates (hoofed mammals) and pinnipeds (seals, sea lions, walruses). Several factors complicate the analysis of effects for aircraft overflights. Studies of the effects of aircraft overflights previously have not been associated with a quantitative assessment framework; therefore no consistent relations between exposure and population-level response have been developed. Information on behavioral effects of overflights by military aircraft (or component stressors) on most wildlife species is sparse. Moreover, models that relate behavioral changes to abundance or reproduction, and those that relate behavioral or hearing effects thresholds from one population to another are generally not available. The aggregation of sound frequencies, durations, and the view of the aircraft into the single exposure metric of slant distance is not always the best predictor of effects, but effects associated with more specific exposure metrics (e.g., narrow sound spectra) may not be easily determined or added. The weight of evidence and uncertainty analyses of the risk characterization for overflights are also discussed in this article.     

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.     

A Bayesian Approach to Integrated Ecological and Human Health Risk Assessment for the South River,Virginia Mercury‐Contaminated Site

We conducted a regional‐scale integrated ecological and human health risk assessment by applying the relative risk model with Bayesian networks (BN‐RRM) to a case study of the South River, Virginia mercury‐contaminated site. Risk to four ecological services of the South River (human health, water quality, recreation, and the recreational fishery) was evaluated using a multiple stressor–multiple endpoint approach. These four ecological services were selected as endpoints based on stakeholder feedback and prioritized management goals for the river. The BN‐RRM approach allowed for the calculation of relative risk to 14 biotic, human health, recreation, and water quality endpoints from chemical and ecological stressors in five risk regions of the South River. Results indicated that water quality and the recreational fishery were the ecological services at highest risk in the South River. Human health risk for users of the South River was low relative to the risk to other endpoints. Risk to recreation in the South River was moderate with little spatial variability among the five risk regions. Sensitivity and uncertainty analysis identified stressors and other parameters that influence risk for each endpoint in each risk region. This research demonstrates a probabilistic approach to integrated ecological and human health risk assessment that considers the effects of chemical and ecological stressors across the landscape.     

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.     

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.     

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.     

Aligning Chemical Assessment Tools Across the Hazard-Risk Continuum

With the growing number and diversity of hazard and risk assessment algorithms, models, databases, and frameworks for chemicals and their applications, risk assessors and managers are challenged to select the appropriate tool for a given need or decision. Some decisions require relatively simple tools to evaluate chemical hazards (e.g., toxicity), such as labeling for safe occupational handling and transport of chemicals. Others require assessment tools that provide relative comparisons among chemical properties, such as selecting the optimum chemical for a particular use among a group of candidates. Still other needs warrant full risk characterization, coupling both hazard and exposure considerations. Examples of these include new chemical evaluations for commercialization, evaluations of existing chemicals for novel uses, and assessments of the adequacy of risk management provisions. Even well-validated tools can be inappropriately applied, with consequences as severe as misguided chemical management, compromised credibility of the tool and its developers and users, and squandered resources. This article describes seven discrete categories of tools based on their information content, function, and the type of outputs produced. It proposes a systematic framework to assist users in selecting hazard and risk assessment tools for given applications. This analysis illustrates the importance of careful selection of assessment tools to achieve responsible chemical assessment communication and sound risk management.     

Where Deer Roam: Chronic Yet Acute Site Exposures Preclude Ecological Risk Assessment

Global positioning system (GPS) technology has made possible the detailed tracking of the spatial movements of wildlife. Using GPS tracking collars placed on female white‐tailed deer (Odocoileus virginianus) over a protracted period, we illustrate that this species is spatially irrelevant for consideration in ecological risk assessments (ERAs) for commonly assessed contaminated sites. Specifically, deer movements do not allow for a sufficiency of chemical exposures to occur such that toxicological endpoints would be triggered. Deer are spatially irrelevant not only because their home ranges and overall utilized areas dwarf prototypical hazardous waste sites. They are also inappropriate for assessment because they only minimally contact reasonably sized preferred locations, this while demonstrating a confounding high degree of site affinity for them. Our spatial movements analysis suggests that deer introduce the ERA novelty of a species displaying elements of both chronic and acute site exposure. We further suggest that other large commonly assessed high‐profile mammals could also be found to be spatially irrelevant for ERAs were they to submit to the GPS tracking and subsequent data analysis we performed for the deer. Recognizing that certain receptors need not be considered in ERAs can help to simplify the ERA process.     

Generic Assessment Endpoints Are Needed for Ecological Risk Assessment

This article presents arguments for the development of generic assessment endpoints for ecological risk assessment. Generic assessment endpoints would be ecological entities and attributes that are assumed to be worthy of protection in most contexts. The existence of generic assessment endpoints would neither create a requirement that they be used in every assessment nor preclude the use of other assessment endpoints. They would simply be a starting point in the process of identifying the assessment endpoints for a particular assessment. They are needed to meet legal mandates, to provide a floor for environmental degradation, to provide some consistency in environmental regulation, as exemplars for site- or project-specific assessment endpoints, to allow development of methods and models, to give risk managers the courage to act, for screening and site-independent assessments, to support environmental monitoring, to facilitate communication, and to avoid paralysis by analysis. Generic assessment endpoints should include not only a list of entities and attributes, but also explanations of each endpoint, guidance on their use and interpretation, and measures and models that could be used to estimate them.     

Characterizing Risk for Cumulative Risk Assessments

In assessing environmental health risks, the risk characterization step synthesizes information gathered in evaluating exposures to stressors together with dose–response relationships, characteristics of the exposed population, and external environmental conditions. This article summarizes key steps of a cumulative risk assessment (CRA) followed by a discussion of considerations for characterizing cumulative risks. Cumulative risk characterizations differ considerably from single chemical‐ or single source‐based risk characterization. CRAs typically focus on a specific population instead of a pollutant or pollutant source and should include an evaluation of all relevant sources contributing to the exposures in the population and other factors that influence dose–response relationships. Second, CRAs may include influential environmental and population‐specific conditions, involving multiple chemical and nonchemical stressors. Third, a CRA could examine multiple health effects, reflecting joint toxicity and the potential for toxicological interactions. Fourth, the complexities often necessitate simplifying methods, including judgment‐based and semi‐quantitative indices that collapse disparate data into numerical scores. Fifth, because of the higher dimensionality and potentially large number of interactions, information needed to quantify risk is typically incomplete, necessitating an uncertainty analysis. Three approaches that could be used for characterizing risks in a CRA are presented: the multiroute hazard index, stressor grouping by exposure and toxicity, and indices for screening multiple factors and conditions. Other key roles of the risk characterization in CRAs are also described, mainly the translational aspect of including a characterization summary for lay readers (in addition to the technical analysis), and placing the results in the context of the likely risk‐based decisions.     

A Conceptual Framework to Assess the Risks of Human Disease Following Exposure to Pathogens

Currently, risk assessments of the potential human health effects associated with exposure to pathogens are utilizing the conceptual framework that was developed to assess risks associated with chemical exposures. However, the applicability of the chemical framework is problematic due to many issues that are unique to assessing risks associated with pathogens. These include, but are not limited to, an assessment of pathogen/host interactions, consideration of secondary spread, consideration of short- and long-term immunity, and an assessment of conditions that allow the microorganism to propagate. To address this concern, a working group was convened to develop a conceptual framework to assess the risks of human disease associated with exposure to pathogenic microorganisms. The framework that was developed consists of three phases: problem formulation, analysis (which includes characterization of exposure and human health effects), and risk characterization. The framework emphasizes the dynamic and iterative nature of the risk assessment process, and allows wide latitude for planning and conducting risk assessments in diverse situations, each based on the common principles discussed in the framework.     

Quantitative Risk Assessment of the New York State Operated West Valley Radioactive Waste Disposal Area

This article is based on a quantitative risk assessment (QRA) that was performed on a radioactive waste disposal area within the Western New York Nuclear Service Center in western New York State. The QRA results were instrumental in the decision by the New York State Energy Research and Development Authority to support a strategy of in‐place management of the disposal area for another decade. The QRA methodology adopted for this first of a kind application was a scenario‐based approach in the framework of the triplet definition of risk (scenarios, likelihoods, consequences). The measure of risk is the frequency of occurrence of different levels of radiation dose to humans at prescribed locations. The risk from each scenario is determined by (1) the frequency of disruptive events or natural processes that cause a release of radioactive materials from the disposal area; (2) the physical form, quantity, and radionuclide content of the material that is released during each scenario; (3) distribution, dilution, and deposition of the released materials throughout the environment surrounding the disposal area; and (4) public exposure to the distributed material and the accumulated radiation dose from that exposure. The risks of the individual scenarios are assembled into a representation of the risk from the disposal area. In addition to quantifying the total risk to the public, the analysis ranks the importance of each contributing scenario, which facilitates taking corrective actions and implementing effective risk management. Perhaps most importantly, quantification of the uncertainties is an intrinsic part of the risk results. This approach to safety analysis has demonstrated many advantages of applying QRA principles to assessing the risk of facilities involving hazardous materials.     

An ecological risk assessment for chlorpyrifos in an agriculturally dominated tributary of the San Joaquin River.

Single-species toxicity testing of ambient water samples and national-scale probabilistic risk assessment have implicated the organophosphorous (OP) insecticide chlorpyrifos (O, O-diethyl O-(3,5,6-trichloro-2-pyridyl)-phosphorothioate) as a potential chemical stressor of aquatic organisms residing in the lower San Joaquin River basin. This site-specific aquatic ecological risk assessment was conducted to determine the probability of adverse effects occurring from exposure to chlorpyrifos in an agriculturally dominated tributary of the San Joaquin River and to assess the ecological significance of such effects. Assessment endpoints were fish population persistence and invertebrate community productivity. Daily chemical measurements collected over a period of one year were analyzed temporally for frequency, duration, and spacing between events for acute and chronic exposure episodes. Effects thresholds for fish and freshwater lotic invertebrates were determined from single-species laboratory toxicity tests. Potential risk was characterized by the degree of overlap of distributions of exposure events and effects, with consideration given to additive toxicity of other OP insecticides, recovery periods, and duration of chronic exposure (> or = 21 d). Ecological significance was determined by analysis of fish assemblage dietary and reproductive habits in relation to the surrogate invertebrate taxa judged at risk. Results of analysis indicated no direct effects on fish, and indirect effects on fish through elimination of invertebrate food items were considered unlikely. Biological survey information will be necessary to address uncertainty in this risk conclusion, especially as it relates to the benthic invertebrate community. Results of this site-specific risk analysis suggest that fish population persistence and invertebrate community productivity were not adversely affected by measured chlorpyrifos residues during a year-long monitoring period.     

Subsea Release of Oil from a Riser: An Ecological Risk Assessment

This study illustrates a newly developed methodology, as a part of the U.S. EPA ecological risk assessment (ERA) framework, to predict exposure concentrations in a marine environment due to underwater release of oil and gas. It combines the hydrodynamics of underwater blowout, weathering algorithms, and multimedia fate and transport to measure the exposure concentration. Naphthalene and methane are used as surrogate compounds for oil and gas, respectively. Uncertainties are accounted for in multimedia input parameters in the analysis. The 95th percentile of the exposure concentration (EC_95%) is taken as the representative exposure concentration for the risk estimation. A bootstrapping method is utilized to characterize EC_95% and associated uncertainty. The toxicity data of 19 species available in the literature are used to calculate the 5th percentile of the predicted no observed effect concentration (PNEC_5%) by employing the bootstrapping method. The risk is characterized by transforming the risk quotient (RQ), which is the ratio of EC_95% to PNEC_5%, into a cumulative risk distribution. This article describes a probabilistic basis for the ERA, which is essential from risk management and decision‐making viewpoints. Two case studies of underwater oil and gas mixture release, and oil release with no gaseous mixture are used to show the systematic implementation of the methodology, elements of ERA, and the probabilistic method in assessing and characterizing the risk.     

Use of Multicriteria Decision Analysis to Support Weight of Evidence Evaluation

Weight of evidence (WOE) methods are key components of ecological and human health risk assessments. Most WOE applications rely on the qualitative integration of diverse lines of evidence (LOE) representing impact on ecological receptors and humans. Recent calls for transparency in assessments and justifiability of management decisions are pushing the community to consider quantitative methods for integrated risk assessment and management. This article compares and contrasts the type of information required for application of individual WOE techniques and the outcomes that they provide in ecological risk assessment and proposes a multicriteria decision analysis (MCDA) framework for integrating individual LOE in support of management decisions. The use of quantitative WOE techniques is illustrated for a hypothetical but realistic case study of selecting remedial alternatives at a contaminated aquatic site. Use of formal MCDA does not necessarily eliminate biases and judgment calls necessary for selecting remedial alternatives, but allows for transparent evaluation and fusion of individual LOE. It also provides justifiable methods for selecting remedial alternatives consistent with stakeholder and decision‐maker values.     

Multicriteria Decision Analysis: A Comprehensive Decision Approach for Management of Contaminated Sediments

Contaminated sediments and other sites present a difficult challenge for environmental decisionmakers. They are typically slow to recover or attenuate naturally, may involve multiple regulatory agencies and stakeholder groups, and engender multiple toxicological and ecotoxicological risks. While environmental decision-making strategies over the last several decades have evolved into increasingly more sophisticated, information-intensive, and complex approaches, there remains considerable dissatisfaction among business, industry, and the public with existing management strategies. Consequently, contaminated sediments and materials are the subject of intense technology development, such as beneficial reuse or in situ treatment. However, current decision analysis approaches, such as comparative risk assessment, benefit-cost analysis, and life cycle assessment, do not offer a comprehensive approach for incorporating the varied types of information and multiple stakeholder and public views that must typically be brought to bear when new technologies are under consideration. Alternatively, multicriteria decision analysis (MCDA) offers a scientifically sound decision framework for management of contaminated materials or sites where stakeholder participation is of crucial concern and criteria such as economics, environmental impacts, safety, and risk cannot be easily condensed into simple monetary expressions. This article brings together a multidisciplinary review of existing decision-making approaches at regulatory agencies in the United States and Europe and synthesizes state-of-the-art research in MCDA methods applicable to the assessment of contaminated sediment management technologies. Additionally, it tests an MCDA approach for coupling expert judgment and stakeholder values in a hypothetical contaminated sediments management case study wherein MCDA is used as a tool for testing stakeholder responses to and improving expert assessment of innovative contaminated sediments technologies.     

What to Do at Low Doses: A Bounding Approach for Economic Analysis

To quantify the health benefits of environmental policies, economists generally require estimates of the reduced probability of illness or death. For policies that reduce exposure to carcinogenic substances, these estimates traditionally have been obtained through the linear extrapolation of experimental dose-response data to low-exposure scenarios as described in the U.S. Environmental Protection Agency's Guidelines for Carcinogen Risk Assessment (1986). In response to evolving scientific knowledge, EPA proposed revisions to the guidelines in 1996. Under the proposed revisions, dose-response relationships would not be estimated for carcinogens thought to exhibit nonlinear modes of action. Such a change in cancer-risk assessment methods and outputs will likely have serious consequences for how benefit-cost analyses of policies aimed at reducing cancer risks are conducted. Any tendency for reduced quantification of effects in environmental risk assessments, such as those contemplated in the revisions to EPA's cancer-risk assessment guidelines, impedes the ability of economic analysts to respond to increasing calls for benefit-cost analysis. This article examines the implications for benefit-cost analysis of carcinogenic exposures of the proposed changes to the 1986 Guidelines and proposes an approach for bounding dose-response relationships when no biologically based models are available. In spite of the more limited quantitative information provided in a carcinogen risk assessment under the proposed revisions to the guidelines, we argue that reasonable bounds on dose-response relationships can be estimated for low-level exposures to nonlinear carcinogens. This approach yields estimates of reduced illness for use in a benefit-cost analysis while incorporating evidence of nonlinearities in the dose-response relationship. As an illustration, the bounding approach is applied to the case of chloroform exposure.     

Characterizing the Risk of Infection from Mycobacterium tuberculosis in Commercial Passenger Aircraft Using Quantitative Microbial Risk Assessment

Quantitative microbial risk assessment was used to predict the likelihood and spatial organization of Mycobacterium tuberculosis ( Mtb ) transmission in a commercial aircraft. Passenger exposure was predicted via a multizone Markov model in four scenarios: seated or moving infectious passengers and with or without filtration of recirculated cabin air. The traditional exponential ( k  = 1) and a new exponential ( k  = 0.0218) dose-response function were used to compute infection risk. Emission variability was included by Monte Carlo simulation. Infection risks were higher nearer and aft of the source; steady state airborne concentration levels were not attained. Expected incidence was low to moderate, with the central 95% ranging from 10⁻⁶ to 10⁻¹ per 169 passengers in the four scenarios. Emission rates used were low compared to measurements from active TB patients in wards, thus a "superspreader" emitting 44 quanta/h could produce 6.2 cases or more under these scenarios. Use of respiratory protection by the infectious source and/or susceptible passengers reduced infection incidence up to one order of magnitude.     

Life cycle impact assessment: a challenge for risk analysts.

Modern technology, together with an advanced economy, can provide a good or service in myriad ways, giving us choices on what to produce and how to produce it. To make those choices more intelligently, society needs to know not only the market price of each alternative, but the associated health and environmental consequences. A fair comparison requires evaluating the consequences across the whole "life cycle"--from the extraction of raw materials and processing to manufacture/construction, use, and end-of-life--of each alternative. Focusing on only one stage (e.g., manufacture) of the life cycle is often misleading. Unfortunately, analysts and researchers still have only rudimentary tools to quantify the materials and energy inputs and the resulting damage to health and the environment. Life cycle assessment (LCA) provides an overall framework for identifying and evaluating these implications. Since the 1960s, considerable progress has been made in developing methods for LCA, especially in characterizing, qualitatively and quantitatively, environmental discharges. However, few of these analyses have attempted to assess the quantitative impact on the environment and health of material inputs and environmental discharges Risk analysis and LCA are connected closely. While risk analysis has characterized and quantified the health risks of exposure to a toxicant, the policy implications have not been clear. Inferring that an occupational or public health exposure carries a nontrivial risk is only the first step in formulating a policy response. A broader framework, including LCA, is needed to see which response is likely to lower the risk without creating high risks elsewhere. Even more important, LCA has floundered at the stage of translating an inventory of environmental discharges into estimates of impact on health and the environment. Without the impact analysis, policymakers must revert to some simple rule, such as that all discharges, regardless of which chemical, which medium, and where they are discharged, are equally toxic. Thus, risk analysts should seek LCA guidance in translating a risk analysis into policy conclusions or even advice to those at risk. LCA needs the help of RA to go beyond simplistic assumptions about the implications of a discharge inventory. We demonstrate the need and rationale for LCA, present a brief history of LCA, present examples of the application of this tool, note the limitations of LCA models, and present several methods for incorporating risk assessment into LCA. However, we warn the reader not to expect too much. A comprehensive comparison of the health and environmental implications of alternatives is beyond the state of the art. LCA is currently not able to provide risk analysts with detailed information on the chemical form and location of the environmental discharges that would allow detailed estimation of the risks to individuals due to toxicants. For example, a challenge for risk analysts is to estimate health and other risks where the location and chemical speciation are not characterized precisely. Providing valuable information to decisionmakers requires advances in both LCA and risk analysis. These two disciplines should be closely linked, since each has much to contribute to the other.     

A Quantitative Microbial Risk Assessment Model for Legionnaires'' Disease: Animal Model Selection and Dose-Response Modeling

Legionnaires' disease (LD), first reported in 1976, is an atypical pneumonia caused by bacteria of the genus Legionella, and most frequently by L. pneumophila (Lp). Subsequent research on exposure to the organism employed various animal models, and with quantitative microbial risk assessment (QMRA) techniques, the animal model data may provide insights on human dose-response for LD. This article focuses on the rationale for selection of the guinea pig model, comparison of the dose-response model results, comparison of projected low-dose responses for guinea pigs, and risk estimates for humans. Based on both in vivo and in vitro comparisons, the guinea pig (Cavia porcellus) dose-response data were selected for modeling human risk. We completed dose-response modeling for the beta-Poisson (approximate and exact), exponential, probit, logistic, and Weibull models for Lp inhalation, mortality, and infection (end point elevated body temperature) in guinea pigs. For mechanistic reasons, including low-dose exposure probability, further work on human risk estimates for LD employed the exponential and beta-Poisson models. With an exposure of 10 colony-forming units (CFU) (retained dose), the QMRA model predicted a mild infection risk of 0.4 (as evaluated by seroprevalence) and a clinical severity LD case (e.g., hospitalization and supportive care) risk of 0.0009. The calculated rates based on estimated human exposures for outbreaks used for the QMRA model validation are within an order of magnitude of the reported LD rates. These validation results suggest the LD QMRA animal model selection, dose-response modeling, and extension to human risk projections were appropriate.