Categorizing Mistaken False Positives in Regulation of Human and Environmental Health

One of the concerns often voiced by critics of the precautionary principle is that a widespread regulatory application of the principle will lead to a large number of false positives (i.e., over-regulation of minor risks and regulation of nonexisting risks). The present article proposes a general definition of a regulatory false positive, and seeks to identify case studies that can be considered authentic regulatory false positives. Through a comprehensive review of the science policy literature for proclaimed false positives and interviews with authorities on regulation and the precautionary principle we identified 88 cases. Following a detailed analysis of these cases, we found that few of the cases mentioned in the literature can be considered to be authentic false positives. As a result, we have developed a number of different categories for these cases of "mistaken false positives," including: real risks, "The jury is still out," nonregulated proclaimed risks, "Too narrow a definition of risk," and risk-risk tradeoffs. These categories are defined and examples are presented in order to illustrate their key characteristics. On the basis of our analysis, we were able to identify only four cases that could be defined as regulatory false positives in the light of today's knowledge and recognized uncertainty: the Southern Corn Leaf Blight, the Swine Flu, Saccharin, and Food Irradiation in relation to consumer health. We conclude that concerns about false positives do not represent a reasonable argument against future application of the precautionary principle.     

Regulatory False Positives: True,False, or Uncertain?

Hansen et al. (2007) recently assessed the historical performance of the precautionary principle in 88 specific cases, concluding that "applying our definition of a regulatory false positive, we were able to identify only four cases that fit the definition of a false positive." Empirically evaluating how prone the precautionary principle is to classify nonproblems as problems ("false positives") is an excellent idea. Yet, Hansen et al.'s implementation of this idea applies a diverse set of questionable criteria to label many highly uncertain risks as "real" even when no real or potential harm has actually been demonstrated. Examples include treating each of the following as reasons to categorize risks as "real": considering that a company's actions contaminated its own product; lack of a known exposure threshold for health effects; occurrence of a threat; treating deliberately conservative (upper-bound) regulatory assumptions as if they were true values; treating assumed exposures of children to contaminated soils (by ingestion) as evidence that feared dioxin risks are real; and treating claimed (sometimes ambiguous) epidemiological associations as if they were known to be true causal relations. Such criteria can classify even nonexistent and unknown risks as "real," providing an alternative possible explanation for why the authors failed to find more false positives, even if they exist.     

Trade-offs and the precautionary principle: A lexicographic utility approach

The precautionary principle is often argued to be irrational because it cannot adequately explain how resources should be distributed across multiple possible catastrophes or between catastrophic and noncatastrophic risks. We address this problem of trade-offs by extending a recently proposed formal interpretation of the precautionary principle (PP) within a lexical utility framework and using it to prove results about which distribution of resources maximizes lexical utility when several catastrophic risks exist, given different assumptions. We also explain how our lexical utility interpretation of PP can recommend balanced distributions of resources between disaster prevention and other concerns.     

Multi‐Case Review of the Application of the Precautionary Principle in European Union Law and Case Law

The precautionary principle was formulated to provide a basis for political action to protect the environment from potentially severe or irreversible harm in circumstances of scientific uncertainty that prevent a full risk or cost‐benefit analysis. It underpins environmental law in the European Union and has been extended to include public health and consumer safety. The aim of this study was to examine how the precautionary principle has been interpreted and subsequently applied in practice, whether these applications were consistent, and whether they followed the guidance from the Commission. A review of the literature was used to develop a framework for analysis, based on three attributes: severity of potential harm, standard of evidence (or degree of uncertainty), and nature of the regulatory action. This was used to examine 15 pieces of legislation or judicial decisions. The decision whether or not to apply the precautionary principle appears to be poorly defined, with ambiguities inherent in determining what level of uncertainty and significance of hazard justifies invoking it. The cases reviewed suggest that the Commission's guidance was not followed consistently in forming legislation, although judicial decisions tended to be more consistent and to follow the guidance by requiring plausible evidence of potential hazard in order to invoke precaution.     

Cell Phones and Health Concerns: Impact of Knowledge and Voluntary Precautionary Recommendations

The article explores how voluntary precautionary recommendations for cell phone usage influence people's health concerns and behavior. An experimental study using a sample of Swiss citizens (N= 408) was conducted. Three different versions of a newly developed booklet, which focused on common misconceptions in regard to mobile communication, and an existing booklet were tested. The experimental design addressed questions of the potential effects of knowledge, precautionary recommendations, and sender identity on health concerns and transfer of the proposed recommendations. Participants’ perceptions were measured three times: immediately before and after reading the booklet, and two weeks later. The reading of the booklets increased participants’ knowledge considerably and led to perceptual changes. In regard to cell phones, health concerns increased after the reading and stayed at a higher level even after two weeks. The negative perception of base stations, in contrast, tended to decrease. Neither the identity of the sender nor the omission of precautionary recommendations had significant effects on health concerns. Provision of specific recommendations enhanced readers’ behavioral changes. Confrontation with information per se, and not precautionary recommendations, influenced the public's health concerns. These changes should not prevent the provision of precautionary recommendations because, in the face of scientific uncertainty, these are the only means through which to enable users to make informed decisions.     

Application of the Precautionary Principle by Senior Policy Officials: Results of a Canadian Survey

Though use of the controversial precautionary principle in risk management has increasingly been recommended as a guide for the construction of public policy in Canada and elsewhere, there are few data available characterizing its use in risk management by senior public policymakers. Using established survey methodology we sought to investigate the perceptions and terms of application of the precautionary principle in this important subset of individuals. A total of 240 surveys were sent out to seven departments or agencies in the Canadian government. The overall survey response rate was 26.6%, and our findings need to be interpreted in the context of possible responder bias. Of respondents, the overwhelming majority perceived the precautionary principle and the management of risk as complementary, and endorsed a role for the precautionary principle as a general guideline for all risk management decisions. However, 25% of respondents responded that the lack of clarity of the definition of the principle was a limitation to its effective use. The majority of respondents viewed their own level of understanding of the precautionary principle as moderate. Risk managers appeared to favor an interpretation of the precautionary principle that was based on the seriousness and irreversibility of the threat of damage, and did not endorse as strongly the need for cost effectiveness in the measures taken as a precaution against such threats. In contrast with its perceived role as a general guideline, the application of the precautionary principle by respondents was highly variable, with >60% of respondents reporting using the precautionary principle in one-quarter or less of all risk management decisions. Several factors influenced whether the precautionary principle was applied with the perceived seriousness of the threat being considered the most influential factor. The overwhelming majority of risk managers felt that "preponderance of evidence" was the level of evidence required for precautionary action to be instituted against a serious negative event. Overall, the majority of respondents viewed the precautionary principle as having a significant and positive impact on risk management decisions. Importantly, respondents endorsed a net result of more good than harm to society when the precautionary principle was applied to the management of risk.     

Precautionary Regulation in Europe and the United States: A Quantitative Comparison

Much attention has been addressed to the question of whether Europe or the United States adopts a more precautionary stance to the regulation of potential environmental, health, and safety risks. Some commentators suggest that Europe is more risk-averse and precautionary, whereas the United States is seen as more risk-taking and optimistic about the prospects for new technology. Others suggest that the United States is more precautionary because its regulatory process is more legalistic and adversarial, while Europe is more lax and corporatist in its regulations. The flip-flop hypothesis claims that the United States was more precautionary than Europe in the 1970s and early 1980s, and that Europe has become more precautionary since then. We examine the levels and trends in regulation of environmental, health, and safety risks since 1970. Unlike previous research, which has studied only a small set of prominent cases selected nonrandomly, we develop a comprehensive list of almost 3,000 risks and code the relative stringency of regulation in Europe and the United States for each of 100 risks randomly selected from that list for each year from 1970 through 2004. Our results suggest that: (a) averaging over risks, there is no significant difference in relative precaution over the period, (b) weakly consistent with the flip-flop hypothesis, there is some evidence of a modest shift toward greater relative precaution of European regulation since about 1990, although (c) there is a diversity of trends across risks, of which the most common is no change in relative precaution (including cases where Europe and the United States are equally precautionary and where Europe or the United States has been consistently more precautionary). The overall finding is of a mixed and diverse pattern of relative transatlantic precaution over the period.     

Anticipating or Accommodating to Public Concern? Risk Amplification and the Politics of Precaution Reexamined

Regulatory use of the precautionary principle (PP) tends to be broadly characterized either as a responsible approach for safeguarding against health and environmental risks in the face of scientific uncertainties, or as “state mismanagement” driven by undue political bias and public anxiety. However, the “anticipatory” basis upon which governments variably draw a political warrant for adopting precautionary measures often remains ambiguous. Particularly, questions arise concerning whether the PP is employed preemptively by political elites from the “top down,” or follows from more conventional democratic pressures exerted by citizens and other stakeholders from the “bottom up.” This article elucidates the role and impact of citizen involvement in the precautionary politics shaping policy discourse surrounding the U.K. government's “precautionary approach” to mobile telecommunications technology and health. A case study is presented that critically reexamines the basis upon which U.K. government action has been portrayed as an instance of anticipatory policy making. Findings demonstrate that the use of the PP should not be interpreted in the preemptive terms communicated by U.K. government officials alone, but also in relation to the wider social context of risk amplification and images of public concern formed adaptively in antagonistic precautionary discourse between citizens, politicians, industry, and the media, which surrounded cycles of government policy making. The article discusses the sociocultural conditions and political dynamics underpinning public influence on government anticipation and responsiveness exemplified in this case, and concludes with research and policy implications for how society subsequently comes to terms with the emergence and precautionary governance of new technologies under conflict.     

A Robust Approach for Mitigating Risks in Cyber Supply Chains

In recent years, there have been growing concerns regarding risks in federal information technology (IT) supply chains in the United States that protect cyber infrastructure. A critical need faced by decisionmakers is to prioritize investment in security mitigations to maximally reduce risks in IT supply chains. We extend existing stochastic expected budgeted maximum multiple coverage models that identify “good” solutions on average that may be unacceptable in certain circumstances. We propose three alternative models that consider different robustness methods that hedge against worst‐case risks, including models that maximize the worst‐case coverage, minimize the worst‐case regret, and maximize the average coverage in the $(1?\alpha )$ worst cases (conditional value at risk). We illustrate the solutions to the robust methods with a case study and discuss the insights their solutions provide into mitigation selection compared to an expected‐value maximizer. Our study provides valuable tools and insights for decisionmakers with different risk attitudes to manage cybersecurity risks under uncertainty.     

The Precautionary Principle and/or Risk Assessment in World Trade Organization Decisions: A Possible Role for Risk Perception

Risk analysis has been recognized and validated in World Trade Organization (WTO) decision processes. In recent years the precautionary principle has been proposed as an additional or alternative approach to standard risk assessment. The precautionary principle has also been advocated by some who see it as part of postmodern democracy in which more power is given to the public on health and safety matters relative to the judgments of technocrats. A more cynical view is that the precautionary principle is particularly championed by the European Community as a means to erect trade barriers. The WTO ruling against the European Community's trade barrier against beef from hormone-treated cattle seemed to support the use of risk assessment and appeared to reject the argument that the precautionary principle was a legitimate basis for trade barriers. However, a more recent WTO decision on asbestos contains language suggesting that the precautionary principle, in the form of taking into account public perception, may be acceptable as a basis for a trade barrier. This decision, if followed in future WTO trade disputes, such as for genetically modified foods, raises many issues central to the field of risk analysis. It is too early to tell whether the precautionary principle will become accepted in WTO decisions, either as a supplement or a substitute for standard risk assessment. But it would undermine the value of the precautionary principle if this principle were misused to justify unwarranted trade barriers.     

Regional Risk Assessment for Point Source Pollution Based on a Water Quality Model of the Taipu River,China

Point source pollution is one of the main threats to regional environmental health. Based on a water quality model, a methodology to assess the regional risk of point source pollution is proposed. The assessment procedure includes five parts: (1) identifying risk source units and estimating source emissions using Monte Carlo algorithms; (2) observing hydrological and water quality data of the assessed area, and evaluating the selected water quality model; (3) screening out the assessment endpoints and analyzing receptor vulnerability with the Choquet fuzzy integral algorithm; (4) using the water quality model introduced in the second step to predict pollutant concentrations for various source emission scenarios and analyzing hazards of risk sources; and finally, (5) using the source hazard values and receptor vulnerability scores to estimate overall regional risk. The proposed method, based on the Water Quality Analysis Simulation Program (WASP), was applied in the region of the Taipu River, which is in the Taihu Basin, China. Results of source hazard and receptor vulnerability analysis allowed us to describe aquatic ecological, human health, and socioeconomic risks individually, and also integrated risks in the Taipu region, from a series of risk curves. Risk contributions of sources to receptors were ranked, and the spatial distribution of risk levels was presented. By changing the input conditions, we were able to estimate risks for a range of scenarios. Thus, the proposed procedure may also be used by decisionmakers for long‐term dynamic risk prediction.     

Risk Management and the Precautionary Principle: A Fuzzy Logic Model

The aim of this article is to illustrate a procedure for applying the precautionary principle within a strategy for reducing the possibility of underestimating the effective risk caused by a phenomenon, product, or process, and of adopting insufficient risk reduction measures or overlooking their need. We start by simply defining risk as the product between the numerical expression of the adverse consequences of an event and the likelihood of its occurrence or the likelihood that such consequences will occur. Uncertainty in likelihood estimates and several key concepts inherent to the precautionary principle, such as sufficient certainty, prevention, and desired level of protection, are represented as fuzzy sets. The strategy described may be viewed as a simplified example of a precautionary decision process that has been chiefly conceived as a theoretical contribution to the debate concerning the precautionary principle, the quantification of its application, and the formal approach to such problems.     

Uncertain Risk Assessment and Management: Case Studies of the Application of the Precautionary Principle in Portugal

This study intends to clarify how the precautionary principle (PP) has been interpreted and applied by the courts in Portugal in the analysis of conflicts associated with uncertain and serious potential risks to human health and the environment. It also aims to contribute to the debate of when and how to apply precautionary measures. To this end, recent court cases in the areas of waste incineration, high-voltage power lines, as well as dam and wind farm construction were considered. The degree of consistency in the courts’ decisions and their reasons in the different judicial bodies was analyzed with the support of a theoretical framework based on three attributes: the level of seriousness of potential hazards, level of evidence required, and the severity of precautionary actions taken. Different positions among courts were observed, with contradictory arguments in the same case or in similar cases. A greater propensity for favorable decisions in the acceptance of restraining orders was verified in the courts of lower instances, where human health could be threatened. However, the decisions of the Supreme Administrative Court, which were always unfavorable to the restraining orders, seem to reflect the priority given to national economic and political interests over local or regional environmental interests. They may also reflect the Supreme Court's reluctancy to apply the PP in the absence of a firm legally binding PP in national legislation. To address this situation, more explicit legal requirements and criteria for the analysis of uncertain risks and the weighting of interests by area of activity are needed.     

When Precaution Creates Misunderstandings: The Unintended Effects of Precautionary Information on Perceived Risks,the EMF Case

In the past decade, growing public concern about novel technologies with uncertain potential long‐term impacts on the environment and human health has moved risk policies toward a more precautionary approach. Focusing on mobile telephony, the effects of precautionary information on risk perception were analyzed. A pooled multinational experimental study based on a 5 × 2 × 2 factorial design was conducted in nine countries. The first factor refers to whether or not information on different types of precautionary measures was present, the second factor to the framing of the precautionary information, and the third factor to the order in which cell phones and base stations were rated by the study participants. The data analysis on the country level indicates different effects. The main hypothesis that informing about precautionary measures results in increased risk perceptions found only partial support in the data. The effects are weaker, both in terms of the effect size and the frequency of significant effects, across the various precautionary information formats used in the experiment. Nevertheless, our findings do not support the assumption that informing people about implemented precautionary measures will decrease public concerns.     

Understanding the Risk of an Avian Flu Pandemic: Rational Waiting or Precautionary Failure?

The precautionary principle (PP) has been proposed as the proper guide for the decision-making criteria to be adopted in the face of the new catastrophic risks that have arisen in the last decades. This article puts forward a workable definition of the PP based on the so-called alpha-maximin expected utility approach, applying it to the possible outbreak of the avian flu disease among humans. Moreover, it shows how the shortage and/or lack of effective drugs against the infection of the virus A(H5N1) among humans can be considered a precautionary failure.     

On the Treatment of Uncertainty and Variability in Making Decisions About Risk

Much attention has been paid to the treatment of dependence and to the characterization of uncertainty and variability (including the issue of dependence among inputs) in performing risk assessments to avoid misleading results. However, with relatively little progress in communicating about the effects and implications of dependence, the effort involved in performing relatively sophisticated risk analyses (e.g., two‐dimensional Monte Carlo analyses that separate variability from uncertainty) may be largely wasted, if the implications of those analyses are not clearly understood by decisionmakers. This article emphasizes that epistemic uncertainty can introduce dependence among related risks (e.g., risks to different individuals, or at different facilities), and illustrates the potential importance of such dependence in the context of two important types of decisions—evaluations of risk acceptability for a single technology, and comparisons of the risks for two or more technologies. We also present some preliminary ideas on how to communicate the effects of dependence to decisionmakers in a clear and easily comprehensible manner, and suggest future research directions in this area.     

The Precautionary Principle Is Incoherent

This article argues that no version of the precautionary principle can be reasonably applied to decisions that may lead to fatal outcomes. In support of this strong claim, a number of desiderata are proposed, which reasonable rules for rational decision making ought to satisfy. Thereafter, two impossibility theorems are proved, showing that no version of the precautionary principle can satisfy the proposed desiderata. These theorems are directly applicable to recent discussions of the precautionary principle in medicine, biotechnology, environmental management, and related fields. The impossibility theorems do not imply, however, that the precautionary principle is of no relevance at all in policy discussions. Even if it is not a reasonable rule for rational decision making, it is possible to interpret the precautionary principle in other ways, e.g., as an argumentative tool or as an epistemic principle favoring a reversed burden of proof.     

How Business Interests and Government Inaction Led to the Humidifier Disinfectant Disaster in South Korea: Implications for Better Risk Governance

Humidifier sterilizers were regarded as innovative and health-promoting products; they were widespread in South Korea until 2011. However, hospitals reported mysterious deaths, and a legal investigation in April 2016 found that hundreds of people have died due to use of the sterilizing disinfectant. This article takes up that topic, discussing the government's role in dealing with the risk regarding the humidifier disinfectant. We pay particular attention to the unequal nature of the uncertainty produced by the distorted socioeconomic structure. Through in-depth interviews with key informants and an examination of relevant documents from the government, civic groups, and newspapers, we find that the government had increasingly acknowledged the risk, yet their inaction failed to stop the high number of casualties, and they have only recently responded proactively. The uncertainty of the risk was unevenly distributed between companies, the government, experts, and citizens. We argue that the proactive and transparent role of the government with the precautionary principle could fix the unequal structure of knowledge production and preserve public health.     

Characterizing Environmental Harm: Developments in an Approach to Strategic Risk Assessment and Risk Management

Environmental policymakers and regulators are often in the position of having to prioritize their actions across a diverse range of environmental pressures to secure environmental protection and improvements. Information on environmental issues to inform this type of strategic analysis can be disparate; it may be too voluminous or even absent. Data on a range of issues are rarely presented in a common format that allows easy analysis and comparison. Nevertheless, judgments are required on the significance of various environmental pressures and on the inherent uncertainties to inform strategic assessments such as “state of the environment” reports. How can decisionmakers go about this type of strategic and comparative risk analysis? In an attempt to provide practical tools for the analysis of environmental risks at a strategic level, the Environment Agency of England and Wales has conducted a program of developmental research on strategic risk assessment since 1996. The tools developed under this program use the concept of “environmental harm” as a common metric, viewed from technical, social, and economic perspectives, to analyze impacts from a range of environmental pressures. Critical to an informed debate on the relative importance of these perspectives is an understanding and analysis of the various characteristics of harm (spatial and temporal extent, reversibility, latency, etc.) and of the social response to actual or potential environmental harm from a range of hazards. Recent developments in our approach, described herein, allow a presentation of the analysis in a structured fashion so as to better inform risk‐management decisions.     

Risk Management for Development—Assessing Obstacles and Prioritizing Action

Throughout the process of economic and social development, decisionmakers from the household to the state level are confronted with a multitude of risks: from health and employment risks, to financial and political crises, as well as environmental damages and from the local to global level. The World Bank's 2014 World Development Report (WDR) provides an in‐depth analysis of how the management of such risks can be improved. In particular, it argues that a proactive and integrated approach to risk management can create opportunities for fighting poverty and achieving prosperity—but also acknowledges substantial obstacles to its implementation in practice. This article presents and discusses these obstacles with respect to their causes, consequences, interlinkages, and solutions. In particular, these include obstacles to individual risk management, the obstacles that are beyond the control of individuals and thus require collective action, and, finally, the obstacles that affect the ability of governments and public authorities to manage risks. From these obstacles, this article derives a policy roadmap for the development of risk management strategies that are designed not only around the risk they have to cope with, but also around the practical obstacles to policy implementation.