Risk Assessment of Virus in Drinking Water

The reevaluation of drinking water treatment practices in a desire to minimize the formation of disinfection byproducts while assuring minimum levels of public health protection against infectious organisms has caused it to become necessary to consider the problem of estimation of risks posed from exposure to low levels of microorganisms, such as virus or protozoans, found in treated drinking water. This paper outlines a methodology based on risk assessment principles to approach the problem. The methodology is validated by comparison with results obtained in a prospective epidemiological study. It is feasible to produce both point and interval estimates of infection, illness and perhaps mortality by this methodology. Areas of uncertainty which require future data are indicated.     

The 1991 Cholera Epidemic in Peru: Not a Case of Precaution Gone Awry

The precautionary principle calls on decisionmakers to take preventive action in light of evidence indicating that there is a potential for harm to public health and the environment, even though the nature and magnitude of harm are not fully understood scientifically. Critics of the precautionary principle frequently argue that unbridled application of the principle leads to unintended damage to health and ecosystems (risk tradeoffs) and that precautious decision making leaves us vulnerable to "false-positive" risks that divert resources away from "real risks." The 1991 cholera epidemic in Peru is often cited as an example of these pitfalls of the precautionary principle. It has been mistakenly argued that application of the precautionary principle caused decisionmakers to stop chlorinating the water supply due to the risks of disinfection byproducts (DBPs), resulting in the epidemic. Through analyses of investigations conducted in the cities of Iquitos and Trujillo, Peru, literature review, and interviews with leading Peruvian infectious disease researchers, we determined that the epidemic was caused by a much more complex set of circumstances, including poor sanitation conditions, poor separation of water and waste streams, and inadequate water treatment and distribution systems. The evidence indicates that no decision was made to stop chlorinating on the basis of DBP concerns and that concerns raised about DBPs masked more important factors limiting expansion of chlorination. In fact, outside of Peru's capital Lima, chlorination of drinking water supplies at the time of the epidemic was limited at best. We conclude that the Peruvian cholera epidemic was not caused by a failure of precaution but rather by an inadequate public health infrastructure unable to control a known risk: that of microbial contamination of water supplies.     

The Possibility for "Natural" Generation of Chlorinated Organic Compounds

There is continuing concern for the exposure of persons to various chlorinated organics via the environment, for example, chlorinated disinfection byproducts in drinking water.⁽¹⁾ Some of these may be carcinogenic,⁽²⁾ although the evidence is far from strong.⁽³⁾ There is an accumulating body of evidence that one of the normal human immunological responses to foreign agents is the generation of hypochlorous acid. This evidence will be summarized. The possibility that this HOCl generated in vivo could result in the formation of organo-chlorine compounds does not appear to have been seriously considered. Based on best available information, the amount of such byproduct formation will be estimated.     

Risk Assessment for Invasive Species

Although estimates vary, there is a broad agreement that invasive species impose major costs on the U.S. economy, as well as posing risks to nonmarket environmental goods and services and to public health. The domestic effort to manage risks associated with invasive species is coordinated by the National Invasive Species Council (NISC), which is charged with developing a science-based process to evaluate risks associated with the introduction and spread of invasive species. Various international agreements have also elevated invasive species issues onto the international policy agenda. The World Trade Organization (WTO) Sanitary and Phytosanitary (SPS) Agreement establishes rights and obligations to adhere to the discipline of scientific risk assessment to ensure that SPS measures are applied only to the extent required to protect human, animal, and plant health, and do not constitute arbitrary or unjustifiable technical barriers to trade. Currently, however, the field of risk assessment for invasive species is in its infancy. Therefore, there is a pressing need to formulate scientifically sound methods and approaches in this emerging field, while acknowledging that the demand for situation-specific empirical evidence is likely to persistently outstrip supply. To begin addressing this need, the Society for Risk Analysis Ecological Risk Assessment Specialty Group and the Ecological Society of America Theoretical Ecology Section convened a joint workshop to provide independent scientific input into the formulation of methods and processes for risk assessment of invasive species to ensure that the analytic processes used domestically and internationally will be firmly rooted in sound scientific principles.     

Chronic Health Risks from Aggregate Exposures to Ionizing Radiation and Chemicals: Scientific Basis for an Assessment Framework

Very little quantitative analysis is currently available on the cumulative effects of exposure to multiple hazardous agents that have either similar or different mechanisms of action. Over the past several years, efforts have been made to develop the methodologies for risk assessment of chemical mixtures, but mixed exposures to two or more dissimilar agents such as radiation and one or more chemical agents have not yet been addressed in any substantive way. This article reviews the current understanding of the health risks arising from mixed exposures to ionizing radiation and specific chemicals. Specifically discussed is how mixed radiation/chemical exposures, when evaluated in aggregation, were linked to chronic health endpoints such as cancer and intermediate health outcomes such as chromosomal aberrations. Also considered is the extent to which the current practices are consistent with the scientific understanding of the health risks associated with mixed-agent exposures. From this the discussion moves to the research needs for assessing the cumulative health risks from aggregate exposures to ionizing radiation and chemicals. The evaluation indicates that essentially no guidance has been provided for conducting risk assessment for two agents with different mechanisms of action (i.e., energy deposition from ionizing radiation versus DNA interactions with chemicals) but similar biological endpoints (i.e., chromosomal aberrations, mutations, and cancer). The literature review also reveals the problems caused by the absence of both the basic science and an appropriate evaluation framework for the combined effects of mixed-agent exposures. This makes it difficult to determine whether there is truly no interaction or somehow the interaction is masked by the scale of effect observation or inappropriate dose-response assumptions.     

Perception of Risks From Electromagnetic Fields: A Psychometric Evaluation of a Risk-Communication Approach

Potential health risks from exposure to power-frequency electromagnetic fields (EMF) have become an issue of significant public concern. This study evaluates a brochure designed to communicate EMF health risks from a scientific perspective. The study utilized a pretest-posttest design in which respondents judged various sources of EMF (and other) health and safety risks, both before reading the brochure and after. Respondents assessed risks on dimensions similar to those utilized in previous studies of risk perception. In addition, detailed ratings were made that probed respondents' beliefs about the possible causal effects of EMF exposure. The findings suggest that naive beliefs about the potential of EMF exposure to cause harm were highly influenced by specific content elements of the brochure. The implications for using risk-communication approaches based on communicating scientific uncertainty are discussed.     

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.     

Analytical Paradigms: The Epistemological Distances between Scientists, Policy Makers, and the Public

The effective use of evidence and its resultant knowledge is increasingly recognized as critical in risk analysis. This, in turn, has led to a growing concern over issues of epistemology in risk communication, and, in particular, interest in how knowledge is constructed and employed by the key players in risk--scientists, policy makers, and the public. This article uses a critical theoretical approach to explore how evidence is recognized and validated, and how limits are placed on knowledge by scientists, policy makers, and the public. It brings together developments in the sociology of science, policy and policy development, public understandings of science, and risk communication and analysis to explicate the differing forms of rationality employed by each group. The work concludes that each group employs different, although equally legitimate, forms of rationality when evaluating evidence and generating knowledge around risky environment and health issues. Scientists, policy makers, and the public employ scientific, political, and social rationality, respectively. These differing forms of rationality reflect underlying epistemological distances from which can develop considerable misunderstandings and misinterpretations.     

The Contrast Between Risk Assessment and Rules of Evidence in the Context of International Trade Disputes: Can the U.S. Experience Inform the Process?

Risk assessment provides a formalized process to evaluate human, animal, and ecological responses associated with exposure to environmental agents. The purpose of risk assessment is to answer two related questions.

• ? How likely is an (adverse) event to occur?
• ? If it does, how severe will the impact be?

In the United States, the science of risk assessment has evolved out of the necessity to make public health decisions in the face of scientific uncertainty. Its basic propositions have been established over the past three decades and its applications have impacted virtually every aspect of public health and environmental protection in many countries, including the United States. More recently, the World Trade Organization's (WTO) dispute‐settlement process has provided additional incentive for the reliance on risk assessments internationally through the requirement that member countries be able to provide scientific justification, based on a risk assessment, for public health and environmental regulatory measures that are challenged. The purpose of this article is to review the history of risk assessment in the United States, emphasizing the development of both its scientific and policy aspects, as one example of the development of institutional capacity for risk assessment. This article discusses the importance of the social, political, and economic contexts of risk assessment and risk management in shaping the approaches taken while highlighting the reality that the analytic or risk assessment part of the decision‐making process, in the absence of scientific data, can be completed only by inserting inferences, or policy judgments, which may differ among countries. This article recognizes these differences, and the consequent difference between risk assessment that incorporates public health protective assumptions and the rules of evidence that seek to answer questions of causality, and discusses implications for the WTO dispute‐settlement process. It further explores the value of country‐specific risk assessment guidelines to facilitate consistency within a country along with the appropriateness and feasibility of international risk assessment guidelines.     

Food Risks on the Web: Analysis of the 2017 Fipronil Alert in the Italian Online Information Sources

In the summer of 2017, several European Union Member States were involved in a food alert caused by the presence of fipronil pesticide residues in chicken eggs. The food alert became a major news and received wide coverage both in the mass media and on the Internet. This article describes a study that analyzed how the Italian online information sources represented the fipronil alert, using web monitoring techniques and both manual and automatic content analysis methods. The results indicate that the alert was amplified because general news media could represent the alert within the frame of a political scandal, and because different social actors exploited the case. However, online information sources correctly communicated that the risks for consumers were low, reporting mainly what was officially communicated by the Italian health authorities. The study provides empirical evidence on how the online information sources represent food risks and food alerts and offers useful indications for health authorities in charge of the public communication of food risks.     

In Search of Perfect Foresight? Policy Bias,Management of Unknowns,and What Has Changed in Science Policy Since the Tohoku Disaster

The failure to foresee the catastrophic earthquakes, tsunamis, and nuclear accident of 2011 has been perceived by many in Japan as a fundamental shortcoming of modern disaster risk science. Hampered by a variety of cognitive and institutional biases, the conventional disaster risk management planning based on the “known risks” led to the cascading failures of the interlinked disaster risk management (DRM) apparatus. This realization led to a major rethinking in the use of science for policy and the incorporations of lessons learned in the country's new DRM policy. This study reviews publicly available documents on expert committee discussions and scientific articles to identify what continuities and changes have been made in the use of scientific knowledge in Japanese risk management. In general, the prior influence of cognitive bias (e.g., overreliance on documented hazard risks) has been largely recognized, and increased attention is now being paid to the incorporation of less documented but known risks. This has led to upward adjustments in estimated damages from future risks and recognition of the need for further strengthening of DRM policy. At the same time, there remains significant continuity in the way scientific knowledge is perceived to provide sufficient and justifiable grounds for the development and implementation of DRM policy. The emphasis on “evidence‐based policy” in earthquake and tsunami risk reduction measures continues, despite the critical reflections of a group of scientists who advocate for a major rethinking of the country's science‐policy institution respecting the limitations of the current state science.     

An Empirical Model of Perceived Mortality Risks for Selected U.S. Arsenic Hot Spots

Researchers have long recognized that subjective perceptions of risk are better predictors of choices over risky outcomes than science‐based or experts’ assessments of risk. More recent work suggests that uncertainty about risks also plays a role in predicting choices and behavior. In this article, we develop and estimate a formal model for an individual's perceived health risks associated with arsenic contamination of his or her drinking water. The modeling approach treats risk as a random variable, with an estimable probability distribution whose variance reflects uncertainty. The model we estimate uses data collected from a survey given to a sample of people living in arsenic‐prone areas in the United States. The findings from this article support the fact that scientific information is essential to explaining the mortality rate perceived by the individuals, but uncertainty about the probability remains significant.     

Risk Governance for Mobile Phones,Power Lines,and Other EMF Technologies

Power‐frequency electric and magnetic fields (EMFs) have been present in industrialized countries since the late 19th century and a considerable amount of knowledge has been accumulated as to potential health effects. The mainstream scientific view is that even if there is a risk, it is unlikely to be of major public‐health significance. EMFs from cellular communications and other radio‐frequency technologies have increased rapidly in the last decade. This technology is constantly changing, which makes continued research both more urgent and more challenging. While there are no persuasive data suggesting a health risk, research and particularly exposure assessment is still immature. The principal risk‐governance issue with power frequencies is how to respond to weak and uncertain scientific evidence that nonetheless causes public concern. For radio‐frequency electromagnetic fields, the issue is how to respond to large potential consequences and large public concern where only limited scientific evidence exists. We survey these issues and identify deficits in risk governance. Deficits in problem framing include both overstatement and understatement of the scientific evidence and of the consequences of taking protective measures, limited ability to detect early warnings of risk, and attempted reassurance that has sometimes been counterproductive. Other deficits relate to the limited public involvement mechanisms, and flaws in the identification and evaluation of tradeoffs in the selection of appropriate management strategies. We conclude that risk management of EMFs has certainly not been perfect, but for power frequencies it has evolved and now displays many successful features. Lessons from the power‐frequency experience can benefit risk governance of the radio‐frequency EMFs and other emerging technologies.     

The Effects of Exposure to "Synthetic" Chemicals on Human Health: A Review

This article examines how scientists use human, animal, and bacterial evidence to develop policy recommendations about the health consequences of human exposure to modern chemicals. Human evidence is limited because many epidemiological studies are contaminated with selection effects or unobserved heterogeneity. Changes in the aggregate incidence of morbidity (such as cancer) in the population over time are not a substitute for the lack of good individual-level data because incidence data are contaminated by the medicalization of cancer. Animal tests are also problematic because the expense of conducting experiments leads researchers to use only enough animals to allow detection of large differences in cancer incidence between controls and experimental animals that can only arise if the exposure doses are large. Predictions about the cancer incidence that would result in humans at much lower exposure levels, thus, require statistical inferences that implicitly make choices between false positive and false negative inference errors. Policy recommendations about carcinogens, therefore, are as much the product of value choices as "scientific" knowledge.     

Roles of Vegetable Surface Properties and Sanitizer Type on Annual Disease Burden of Rotavirus Illness by Consumption of Rotavirus-Contaminated Fresh Vegetables: A Quantitative Microbial Risk Assessment

Enteric viruses are often detected in water used for crop irrigation. One concern is foodborne viral disease via the consumption of fresh produce irrigated with virus-contaminated water. Although the food industry routinely uses chemical sanitizers to disinfect post-harvest fresh produce, it remains unknown how sanitizer and fresh produce properties affect the risk of viral illness through fresh produce consumption. A quantitative microbial risk assessment model was conducted to estimate (i) the health risks associated with consumption of rotavirus (RV)-contaminated fresh produce with different surface properties (endive and kale) and (ii) how risks changed when using peracetic acid (PAA) or a surfactant-based sanitizer. The modeling results showed that the annual disease burden depended on the combination of sanitizer and vegetable type when vegetables were irrigated with RV-contaminated water. Global sensitivity analyses revealed that the most influential factors in the disease burden were RV concentration in irrigation water and postharvest disinfection efficacy. A postharvest disinfection efficacy of higher than 99% (2-log₁₀) was needed to decrease the disease burden below the World Health Organization (WHO) threshold, even in scenarios with low RV concentrations in irrigation water (i.e., river water). All scenarios tested here with at least 99.9% (3-log₁₀) disinfection efficacy had a disease burden lower than the WHO threshold, except for the endive treated with PAA. The disinfection efficacy for the endive treated with PAA was only about 80%, leading to a disease burden 100 times higher than the WHO threshold. These findings should be considered and incorporated into future models for estimating foodborne viral illness risks.     

Integrated Uncertainty Analysis for Ambient Pollutant Health Risk Assessment: A Case Study of Ozone Mortality Risk

The U.S. Environmental Protection Agency (EPA) uses health risk assessment to help inform its decisions in setting national ambient air quality standards (NAAQS). EPA's standard approach is to make epidemiologically‐based risk estimates based on a single statistical model selected from the scientific literature, called the “core” model. The uncertainty presented for “core” risk estimates reflects only the statistical uncertainty associated with that one model's concentration‐response function parameter estimate(s). However, epidemiologically‐based risk estimates are also subject to “model uncertainty,” which is a lack of knowledge about which of many plausible model specifications and data sets best reflects the true relationship between health and ambient pollutant concentrations. In 2002, a National Academies of Sciences (NAS) committee recommended that model uncertainty be integrated into EPA's standard risk analysis approach. This article discusses how model uncertainty can be taken into account with an integrated uncertainty analysis (IUA) of health risk estimates. It provides an illustrative numerical example based on risk of premature death from respiratory mortality due to long‐term exposures to ambient ozone, which is a health risk considered in the 2015 ozone NAAQS decision. This example demonstrates that use of IUA to quantitatively incorporate key model uncertainties into risk estimates produces a substantially altered understanding of the potential public health gain of a NAAQS policy decision, and that IUA can also produce more helpful insights to guide that decision, such as evidence of decreasing incremental health gains from progressive tightening of a NAAQS.     

Policy Against Science: The Case of Environmental Tobacco Smoke

The grounds for official policy claims that environmental tobacco smoke is a major health risk remain speculative. In scientific terms, the evidence is compatible with either a slight increase or a decrease of risks, but is impotent to certify either conclusion. Official advocacy of unproven hypotheses presented as valid scientific conclusions raises serious ethical questions, and threatens the credibility of risk assessment as a legitimate policy instrument.     

Expert Scientific Judgment and Cancer Risk Assessment: A Pilot Study of Pharmacokinetic Data

When high-dose tumor data are extrapolated to low doses, it is typically assumed that the dose of a carcinogen delivered to target cells is proportional to the dose administered to test animals, even at exposure levels below the experimental range. Since pharmacokinetic data are becoming available that in some cases question the validity of this assumption, risk assessors must decide whether to maintain the standard assumption. A pilot study of formaldehyde is reported that was undertaken to demonstrate how expert scientific judgment can help guide a controversial risk assessment where pharmacokinetic data are considered inconclusive. Eight experts on pharmacokinetic data were selected by a formal procedure, and each was interviewed personally using a structured interview protocol. The results suggest that expert scientific opinion is polarized in this case, a situation that risk assessors can respond to with a range of risk characterizations considered biologically plausible by the experts. Convergence of expert opinion is likely in this case of several specific research strategies ar executed in a competent fashion. Elicitation of expert scientific judgment is a promising vehicle for evaluating the quality of pharmacokinetic data, expressing uncertainty in risk assessment, and fashioning a research agenda that offers possible forging of scientific consensus.     

To Sample or Not to Sample? An Analysis of the Need for Salmonella Sampling of Smaller Poultry Processors

Within the European Union (EU), microbiological criteria (MC) sampling for Salmonella in poultry was introduced in 2005. In particular, processors had to meet a target of fewer than seven positive samples out of 50. However, processors producing small amounts of poultry meat did not have to sample if national authorities determined this was an acceptable risk. The U.K. Food Standards Agency (FSA) thus has a sampling regime based on throughput that allows smaller processors not to sample. In 2011, the limit of 7/50 was reduced to 5/50. Given the current uncertainty regarding U.K. trade relations with the EU, the U.K. FSA decided to conduct a new risk assessment of the risks of Salmonella produced by smaller processors, to determine whether sampling was now necessary. Current evidence suggests that an MC sampling regime in smaller slaughterhouses is not warranted from a national public health perspective. Because of the insensitivities of the MC sampling scheme, the introduction of MC sampling into smaller slaughterhouses would only be necessary if the suspected carcass prevalence was 15% or more. While our analysis is prone to uncertainty, we estimated that the carcass prevalence in smaller processors is below this. Thus, we recommended that the current sampling framework, allowing smaller processors not to sample, was still applicable.     

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.