Bounding Poorly Characterized Risks: A Lung Cancer Example

For diseases with more than one risk factor, the sum of probabilistic estimates of the number of cases caused by each individual factor may exceed the total number of cases observed, especially when uncertainties about exposure and dose response for some risk factors are high. In this study, we outline a method of bounding the fraction of lung cancer fatalities not due to specific well-studied causes. Such information serves as a "reality check" for estimates of the impacts of the minor risk factors, and, as such, complements the traditional risk analysis. With lung cancer as our example, we allocate portions of the observed lung cancer mortality to known causes (such as smoking, residential radon, and asbestos fibers) and describe the uncertainty surrounding those estimates. The interactions among the risk factors are also quantified, to the extent possible. We then infer an upper bound on the residual mortality due to "other" causes, using a consistency constraint on the total number of deaths, the maximum uncertainty principle, and the mathematics originally developed of imprecise probabilities.     

Significance of Exposure Assessment to Analysis of Cancer Risk from Inorganic Arsenic in Drinking Water in Taiwan

The primary source of evidence that inorganic arsenic in drinking water is associated with increased mortality from cancer at internal sites (bladder, liver, lung, and other organs) is a large ecologic study conducted in regions of Southwest Taiwan endemic to Blackfoot disease. The dose-response patterns for lung, liver, and bladder cancers display a nonlinear dose-response relationship with arsenic exposure. The data do not appear suitable, however, for the more refined task of dose-response assessment, particularly for inference of risk at the low arsenic concentrations found in some U.S. water supplies. The problem lies in variable arsenic concentrations between the wells within a village, largely due to a mix of shallow wells and deep artesian wells, and in having only one well test for 24 (40%) of the 60 villages. The current analysis identifies 14 villages where the exposure appears most questionable, based on criteria described in the text. The exposure values were then changed for seven of the villages, from the median well test being used as a default to some other point in the village's range of well tests that would contribute to smoothing the appearance of a dose-response curve. The remaining seven villages, six of which had only one well test, were deleted as outliers. The resultant dose-response patterns showed no evidence of excess risk below arsenic concentrations of 0.1 mg/l. Of course, that outcome is dependent on manipulation of the data, as described. Inclusion of the seven deleted villages would make estimates of risk much higher at low doses. In those seven villages, the cancer mortality rates are significantly high for their exposure levels, suggesting that their exposure values may be too low or that other etiological factors need to be taken into account.     

The Risk of MTBE Relative to Other VOCs in Public Drinking Water in California

Ongoing publicity about methyl tertiary butyl ether (MTBE) suggests that this chemical is of greater concern than other contaminants commonly found in drinking water. The purpose of this article is to evaluate the available MTBE data in context with other volatile organic compounds (VOCs) that are detected in public drinking water sources in California. We find that of the 28 VOCs with a primary maximum contaminant level (MCL) in California, 21 were found in 50 or more drinking water sources from 1985 to 2002. Over the last 10 years, the most frequently detected VOCs were chloroform, tetrachloroethylene (PCE), and trichloroethylene (TCE), which were found in about 9-15% of all sampled drinking water sources. These same chemicals were found to have the highest mean detected concentrations over the last 5 years, ranging from 13 to 15 microg/L. Many VOCs were also found to routinely exceed state and federal drinking water standards, including benzene and carbon tetrachloride. By comparison, MTBE was found in approximately 1% of sampled drinking water sources for most years, and of those drinking water sources found to contain MTBE from 1998 to 2002, over 90% had detected concentrations below California's primary MCL of 13 microg/L. Relative to the other VOCs evaluated, MTBE has the lowest estimated California cancer potency value, and was found to pose one of the least cancer risks from household exposures to contaminated drinking water. These findings suggest that MTBE poses an insignificant threat to public drinking water supplies and public health in California, particularly when compared to other common drinking water contaminants.     

Application of a QMRA Framework to Inform Selection of Drinking Water Interventions in the Developing Context

The aim of this study was to develop a modified quantitative microbial risk assessment (QMRA) framework that could be applied as a decision support tool to choose between alternative drinking water interventions in the developing context. The impact of different household water treatment (HWT) interventions on the overall incidence of diarrheal disease and disability adjusted life years (DALYs) was estimated, without relying on source water pathogen concentration as the starting point for the analysis. A framework was developed and a software tool constructed and then implemented for an illustrative case study for Nepal based on published scientific data. Coagulation combined with free chlorine disinfection provided the greatest estimated health gains in the short term; however, when long‐term compliance was incorporated into the calculations, the preferred intervention was porous ceramic filtration. The model demonstrates how the QMRA framework can be used to integrate evidence from different studies to inform management decisions, and in particular to prioritize the next best intervention with respect to estimated reduction in diarrheal incidence. This study only considered HWT interventions; it is recognized that a systematic consideration of sanitation, recreation, and drinking water pathways is important for effective management of waterborne transmission of pathogens, and the approach could be expanded to consider the broader water‐related context.     

Considering the Risk of Infection by Cryptosporidium via Consumption of Municipally Treated Drinking Water from a Surface Water Source in a Southwestern Ontario Community

Through the use of case‐control analyses and quantitative microbial risk assessment (QMRA), relative risks of transmission of cryptosporidiosis have been evaluated (recreational water exposure vs. drinking water consumption) for a Canadian community with higher than national rates of cryptosporidiosis. A QMRA was developed to assess the risk of Cryptosporidium infection through the consumption of municipally treated drinking water. Simulations were based on site‐specific surface water contamination levels and drinking water treatment log₁₀ reduction capacity for Cryptosporidium. Results suggested that the risk of Cryptosporidium infection via drinking water in the study community, assuming routine operation of the water treatment plant, was negligible (6 infections per 10¹³ persons per day—5th percentile: 2 infections per 10¹⁵ persons per day; 95th percentile: 3 infections per 10¹² persons per day). The risk is essentially nonexistent during optimized, routine treatment operations. The study community achieves between 7 and 9 log₁₀Cryptosporidium oocyst reduction through routine water treatment processes. Although these results do not preclude the need for constant vigilance by both water treatment and public health professionals in this community, they suggest that the cause of higher rates of cryptosporidiosis are more likely due to recreational water contact, or perhaps direct animal contact. QMRA can be successfully applied at the community level to identify data gaps, rank relative public health risks, and forecast future risk scenarios. It is most useful when performed in a collaborative way with local stakeholders, from beginning to end of the risk analysis paradigm.     

Treating and Drinking Well Water in the Presence of Health Risks from Arsenic Contamination: Results from a U.S. Hot Spot

The Safe Drinking Water Act of 1974 regulates water quality in public drinking water supply systems but does not pertain to private domestic wells, often found in rural areas throughout the country. The recent decision to tighten the drinking water standard for arsenic from 50 parts per billion (ppb) to 10 ppb may therefore affect some households in rural communities, but may not directly reduce health risks for those on private wells. The article reports results from a survey conducted in a U.S. arsenic hot spot, the rural area of Churchill County, Nevada. This area has elevated levels of arsenic in groundwater. We find that a significant proportion of households on private wells are consuming drinking water with arsenic levels that pose a health risk. The decision to treat tap water for those on private wells in this area is modeled, and the predicted probability of treatment is used to help explain drinking water consumption. This probability represents behaviors relating to the household's perception of risk.     

Reducing Drinking Water Supply Chemical Contamination: Risks from Underground Storage Tanks

Drinking water supplies are at risk of contamination from a variety of physical, chemical, and biological sources. Ranked among these threats are hazardous material releases from leaking or improperly managed underground storage tanks located at municipal, commercial, and industrial facilities. To reduce human health and environmental risks associated with the subsurface storage of hazardous materials, government agencies have taken a variety of legislative and regulatory actions—which date back more than 25 years and include the establishment of rigorous equipment/technology/operational requirements and facility‐by‐facility inspection and enforcement programs. Given a history of more than 470,000 underground storage tank releases nationwide, the U.S. Environmental Protection Agency continues to report that 7,300 new leaks were found in federal fiscal year 2008, while nearly 103,000 old leaks remain to be cleaned up. In this article, we report on an alternate evidence‐based intervention approach for reducing potential releases from the storage of petroleum products (gasoline, diesel, kerosene, heating/fuel oil, and waste oil) in underground tanks at commercial facilities located in Rhode Island. The objective of this study was to evaluate whether a new regulatory model can be used as a cost‐effective alternative to traditional facility‐by‐facility inspection and enforcement programs for underground storage tanks. We conclude that the alternative model, using an emphasis on technical assistance tools, can produce measurable improvements in compliance performance, is a cost‐effective adjunct to traditional facility‐by‐facility inspection and enforcement programs, and has the potential to allow regulatory agencies to decrease their frequency of inspections among low risk facilities without sacrificing compliance performance or increasing public health risks.     

An Upper‐Bound Assessment of the Benefits of Reducing Perchlorate in Drinking Water

The Environmental Protection Agency plans to issue new federal regulations to limit drinking water concentrations of perchlorate, which occurs naturally and results from the combustion of rocket fuel. This article presents an upper‐bound estimate of the potential benefits of alternative maximum contaminant levels for perchlorate in drinking water. The results suggest that the economic benefits of reducing perchlorate concentrations in drinking water are likely to be low, i.e., under $2.9 million per year nationally, for several reasons. First, the prevalence of detectable perchlorate in public drinking water systems is low. Second, the population especially sensitive to effects of perchlorate, pregnant women who are moderately iodide deficient, represents a minority of all pregnant women. Third, and perhaps most importantly, reducing exposure to perchlorate in drinking water is a relatively ineffective way of increasing iodide uptake, a crucial step linking perchlorate to health effects of concern.     

Health Risks and Air Pollution — Error Analysis for a Cross-Sectional Mortality Study

An attempt is made to analyze in quantitative terms the uncertainties in multiple regression estimates of the effects of air pollution on death rates. A range of factors--statistical fluctuations in numbers of deaths, differences in local age distribution, differences in smoking habits, errors in estimated pollution levels, migration, and variability of the characterization of socioeconomic effects--are assessed as potential sources of error. Both the precision and the robustness of the regression calculation are shown to be poor. Examples and illustrative calculations are given based on a study of U. K. death rates around the 1971 Census.     

A Comparative Cancer Risk Evaluation of MTBE and Other Compounds (Including Naturally Occurring Compounds) in Drinking Water in New Hampshire

Methyl tert-butyl ether (MTBE) was added to gasoline in New Hampshire (NH) between 1995 and 2006 to comply with the oxygenate requirements of the 1990 Amendments to the Clean Air Act. Leaking tanks and spills released MTBE into groundwater, and as a result, MTBE has been detected in drinking water in NH. We conducted a comparative cancer risk assessment and a margin-of-safety (MOS) analysis for several constituents, including MTBE, detected in NH drinking water. Using standard risk assessment methods, we calculated cancer risks from exposure to 12 detected volatile organic compounds (VOCs), including MTBE, and to four naturally occurring compounds (i.e., arsenic, radium-226, radium-228, and radon-222) detected in NH public water supplies. We evaluated exposures to a hypothetical resident ingesting the water, dermally contacting the water while showering, and inhaling compounds volatilizing from water in the home. We then compared risk estimates for MTBE to those of the other 15 compounds. From our analysis, we concluded that the high-end cancer risk from exposure to MTBE in drinking water is lower than the risks from all the other VOCs evaluated and several thousand times lower than the risks from exposure to naturally occurring constituents, including arsenic, radium, and radon. We also conducted an MOS analysis in which we compared toxicological points of departure to the NH maximum contaminant level (MCL) of 13 µg/L. All of the MOSs were greater than or equal to 160,000, indicating a large margin of safety and demonstrating the health-protectiveness of the NH MCL for MTBE.     

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.     

A Monte Carlo Analysis of Health Risks from PCB-Contaminated Mineral Oil Transformer Fires

The objective of this study is the estimation of health hazards due to the inhalation of combustion products from accidental mineral oil transformer fires. Calculations of production, dispersion, and subsequent human intake of polychlorinated dibenzofurans (PCDFs) provide us with exposure estimates. PCDFs are believed to be the principal toxic products of the pyrolysis of polychlorinated biphenyls (PCBs) sometimes found as contaminants in transformer mineral oil. Cancer burdens and birth defect hazard indices are estimated from population data and exposure statistics. Monte Carlo-derived variational factors emphasize the statistics of uncertainty in the estimates of risk parameters. Community health issues are addressed and risks are found to be insignificant.     

Communication About Micropollutants in Drinking Water: Effects of the Presentation and Psychological Processes

This study investigates how people change their risk perception, trust, and behavior as a consequence of being informed about the occurrence of micropollutants in drinking water. Micropollutants are substances present in extremely low concentrations that might be dangerous in higher concentrations. Data were gathered in the city of Zurich, Switzerland in 2013 using a questionnaire in which the information on micropollutants was presented differently to 12 experimental groups. Data of the key constructs were gathered before and after this information, so that causal effects could be quantified by regression analyses. Affective reactions to the information turned out to be the critical mediator of changes in risk perception (operationalized as the perceived change of quality due to pollution), which is an important determinant of changes in behavior and trust. Also, direct effects of affective reactions on behavior and trust were observed. Trust before appraising risks reduces negative affective reactions; however, it also reduces perceived quality (i.e., increases risk perception) and trust after risks are appraised. The different forms of information mainly influenced the participants’ affective reactions, but they also influenced perceived quality. The presentation with the least negative effects was a comparison of the intake of the substance by water with intake by food. The experimental design with repeated measurement that considers trust as a determinant and consequence of risk perception uncovered positive and negative effects of trust before appraising risks on changes of risk perception and trust due to appraising risks.     

A Framework for Estimating the Adverse Health Effects of Contamination Events in Water Distribution Systems and its Application

Intentional or accidental releases of contaminants into a water distribution system (WDS) have the potential to cause significant adverse health effects among individuals consuming water from the system. A flexible analysis framework is presented here for estimating the magnitude of such potential effects and is applied using network models for 12 actual WDSs of varying sizes. Upper bounds are developed for the magnitude of adverse effects of contamination events in WDSs and evaluated using results from the 12 systems. These bounds can be applied in cases in which little system‐specific information is available. The combination of a detailed, network‐specific approach and a bounding approach allows consequence assessments to be performed for systems for which varying amounts of information are available and addresses important needs of individual utilities as well as regional or national assessments. The approach used in the analysis framework allows contaminant injections at any or all network nodes and uses models that (1) account for contaminant transport in the systems, including contaminant decay, and (2) provide estimates of ingested contaminant doses for the exposed population. The approach can be easily modified as better transport or exposure models become available. The methods presented here provide the ability to quantify or bound potential adverse effects of contamination events for a wide variety of possible contaminants and WDSs, including systems without a network model.     

Quantitative Assessment of Human MRSA Risks from Swine

The public health community, news media, and members of the general public have expressed significant concern that methicillin‐resistant Staphylococcus aureus (MRSA) transmitted from pigs to humans may harm human health. Studies of the prevalence and dynamics of swine‐associated (ST398) MRSA have sampled MRSA at discrete points in the presumed causative chain leading from swine to human patients, including sampling bacteria from live pigs, retail meats, farm workers, and hospital patients. Nonzero prevalence is generally interpreted as indicating a potential human health hazard from MRSA infections, but quantitative assessments of resulting risks are not usually provided. This article integrates available data from several sources to construct a conservative (plausible upper bound) probability estimate for the actual human health harm (MRSA infections and fatalities) arising from ST398‐MRSA from pigs. The model provides plausible upper bounds of approximately one excess human infection per year among all U.S. pig farm workers, and one human infection per 31 years among the remaining total population of the United States. These results assume the possibility of transmission events not yet observed, so additional data collection may reduce these estimates further.     

Review and Evaluation of the J100-10 Risk and Resilience Management Standard for Water and Wastewater Systems

Risk analysis standards are often employed to protect critical infrastructures, which are vital to a nation's security, economy, and safety of its citizens. We present an analysis framework for evaluating such standards and apply it to the J100-10 risk analysis standard for water and wastewater systems. In doing so, we identify gaps between practices recommended in the standard and the state of the art. While individual processes found within infrastructure risk analysis standards have been evaluated in the past, we present a foundational review and focus specifically on water systems. By highlighting both the conceptual shortcomings and practical limitations, we aim to prioritize the shortcomings needed to be addressed. Key findings from this study include (1) risk definitions fail to address notions of uncertainty, (2) the sole use of “worst reasonable case” assumptions can lead to mischaracterizations of risk, (3) analysis of risk and resilience at the threat-asset resolution ignores dependencies within the system, and (4) stakeholder values need to be assessed when balancing the tradeoffs between risk reduction and resilience enhancement.     

Managing Potential Health Risks from Electric Powerlines: A Decision Analysis Caught in Controversy

Over the past 20 years, several epidemiological studies have found an association between exposure to electromagnetic fields (EMFs) and health effects, including childhood leukemia and adult brain cancer. However, experts strongly disagree about whether this association is causal and, if so, how strong it is. In this article, we examine several alternatives to reduce EMFs from sources of the California power grid, including undergrounding distribution and transmission lines and reconfiguring or rephasing lines. The alternatives were evaluated in terms of the potential health risk reduction, cost, impacts on service reliability, property values, and many other consequences. Because of the uncertainty about an EMF-health link, the main effort was to determine the sensitivity of the decisions to the probability and seriousness of an EMF hazard. User-friendly computer models were developed to allow stakeholders to change the model assumptions and parameters to analyze the impacts of their own assumptions and estimates on the decision. The analysis clearly demonstrated that only four of the many concerns raised by the stakeholders could make a difference in the decision: health risks, costs, service reliability, and property values. Whether undergrounding, moderate alternatives for EMF reduction, or no change was the best decision depended on a few key factors, including the probability that EMF exposure is a hazard, the severity of this hazard, how the EMF reduction measures are financed, and the impacts on property values. While the analysis did not resolve the EMF issues, it showed that even in the most controversial settings, a little analysis goes a long way to clarifying the issues and to focus the debate.     

Analysis of Exogenous Components of Mortality Risks

A new technique for deriving exogenous components of mortality risks from national vital statistics has been developed. Each observed death rate D_ij (where i corresponds to calendar time (year or interval of years) and j denotes the number of corresponding age group) was represented as D_ij=A_j+B_iC_j, and unknown quantities A_j, B_i, and C_j were estimated by a special procedure using the least-squares principle. The coefficients of variation do not exceed 10%. It is shown that the term A_j can be interpreted as the endogenous and the second term B_iC_j as the exogenous components of the death rate. The aggregate of endogenous components A_j can be described by a regression function, corresponding to the Gompertz-Makeham law, A(τ) =γ+β· eατ, where γ, β, and α are constants, τ is age, AττAττA_j, and τ_j, is the value of age τ in jth age group. The coefficients of variation for such a representation does not exceed 4%. An analysis of exogenous risk levels in the Moscow and Russian populations during 1980–1995 shows that since 1992 all components of exogenous risk in the Moscow population had been increasing up to 1994. The greatest contribution to the total level of exogenous risk was lethal diseases, and their death rate was 387 deaths per 100,000 persons in 1994, i.e., 61.9% of all deaths. The dynamics of exogenous mortality risk change during 1990–1994 in the Moscow population and in the Russian population without Moscow had been identical: the risk had been increasing, and its value in the Russian population had been higher than that in the Moscow population.     

A Framework for Assessing Uncertainty Associated with Human Health Risks from MSW Landfill Leachate Contamination

Landfilling is a cost‐effective method, which makes it a widely used practice around the world, especially in developing countries. However, because of the improper management of landfills, high leachate leakage can have adverse impacts on soils, plants, groundwater, aquatic organisms, and, subsequently, human health. A comprehensive survey of the literature finds that the probabilistic quantification of uncertainty based on estimations of the human health risks due to landfill leachate contamination has rarely been reported. Hence, in the present study, the uncertainty about the human health risks from municipal solid waste landfill leachate contamination to children and adults was quantified to investigate its long‐term risks by using a Monte Carlo simulation framework for selected heavy metals. The Turbhe sanitary landfill of Navi Mumbai, India, which was commissioned in the recent past, was selected to understand the fate and transport of heavy metals in leachate. A large residential area is located near the site, which makes the risk assessment problem both crucial and challenging. In this article, an integral approach in the form of a framework has been proposed to quantify the uncertainty that is intrinsic to human health risk estimation. A set of nonparametric cubic splines was fitted to identify the nonlinear seasonal trend in leachate quality parameters. LandSim 2.5, a landfill simulator, was used to simulate the landfill activities for various time slices, and further uncertainty in noncarcinogenic human health risk was estimated using a Monte Carlo simulation followed by univariate and multivariate sensitivity analyses.     

A Perspective: Risk Analysis as a Tool for Reducing the Risks of Terrorism

The destruction by terrorists of the twin towers of the World Trade Center and major damage wrought to the Pentagon on September 11, 2001, followed closely by the bioterrorist anthrax attacks via the mails raised the question of whether risk analysis might have a place in defending the United States against terrorist attacks. After first reviewing the multifaceted nature of terrorism and the reasons it is likely to become endemic in world society in the long term, just as other areas of crime are endemic, this article surveys several fields of risk analysis, finding possible short- and long-term uses of risk analysis. The areas chiefly considered are: risk communication and chemical, biological, and technological risk analysis. Broad policy and other uses are also considered. The author finds that risk analysis has already played some role, perhaps informally, but he sees the possibility for a much larger, formal one, a role that is centrally important for the present and future of the United States and the world.