Assessing Potential Human Health Hazards and Benefits from Subtherapeutic Antibiotics in the United States: Tetracyclines as a Case Study

Many scientists, activists, regulators, and politicians have expressed urgent concern that using antibiotics in food animals selects for resistant strains of bacteria that harm human health and bring nearer a “postantibiotic era” of multidrug resistant “super‐bugs.” Proposed political solutions, such as the Preservation of Antibiotics for Medical Treatment Act (PAMTA), would ban entire classes of subtherapeutic antibiotics (STAs) now used for disease prevention and growth promotion in food animals. The proposed bans are not driven by formal quantitative risk assessment (QRA), but by a perceived need for immediate action to prevent potential catastrophe. Similar fears led to STA phase‐outs in Europe a decade ago. However, QRA and empirical data indicate that continued use of STAs in the United States has not harmed human health, and bans in Europe have not helped human health. The fears motivating PAMTA contrast with QRA estimates of vanishingly small risks. As a case study, examining specific tetracycline uses and resistance patterns suggests that there is no significant human health hazard from continued use of tetracycline in food animals. Simple hypothetical calculations suggest an unobservably small risk (between 0 and 1.75E‐11 excess lifetime risk of a tetracycline‐resistant infection), based on the long history of tetracycline use in the United States without resistance‐related treatment failures. QRAs for other STA uses in food animals also find that human health risks are vanishingly small. Whether such QRA calculations will guide risk management policy for animal antibiotics in the United States remains to be seen.     

Perceived Risks of Conventional and Organic Produce: Pesticides, Pathogens, and Natural Toxins

Public risk perceptions and demand for safer food are important factors shaping agricultural production practices in the United States. Despite documented food safety concerns, little attempt has been made to elicit consumers' subjective risk judgments for a range of food safety hazards or to identify factors most predictive of perceived food safety risks. In this study, over 700 conventional and organic fresh produce buyers in the Boston area were surveyed for their perceived food safety risks. Survey results showed that consumers perceived relatively high risks associated with the consumption and production of conventionally grown produce compared with other public health hazards. For example, conventional and organic food buyers estimated the median annual fatality rate due to pesticide residues on conventionally grown food to be about 50 per million and 200 per million, respectively, which is similar in magnitude to the annual mortality risk from motor vehicle accidents in the United States. Over 90% of survey respondents also perceived a reduction in pesticide residue risk associated with substituting organically grown produce for conventionally grown produce, and nearly 50% perceived a risk reduction due to natural toxins and microbial pathogens. Multiple regression analyses indicate that only a few factors are consistently predictive of higher risk perceptions, including feelings of distrust toward regulatory agencies and the safety of the food supply. A variety of factors were found to be significant predictors of specific categories of food hazards, suggesting that consumers may view food safety risks as dissimilar from one another. Based on study findings, it is recommended that future agricultural policies and risk communication efforts utilize a comparative risk approach that targets a range of food safety hazards.     

A Cross‐Cultural Study of Perceived Benefit Versus Risk as Mediators in the Trust‐Acceptance Relationship

Several recent studies have identified the significant role social trust in regulatory organizations plays in the public acceptance of various technologies and activities. In a cross‐cultural investigation, the current work explores empirically the relationship between social trust in management authorities and the degree of public acceptability of hazards for individuals residing in either developed or emerging Latin American economies using confirmatory rather than exploratory techniques. Undergraduates in Mexico, Brazil, and Chile and the United States and Spain assessed trust in regulatory authorities, public acceptance, personal knowledge, and the risks and benefits for 23 activities and technological hazards. Four findings were encountered. (i) In Latin American nations trust in regulatory entities was strongly and significantly (directly as well as indirectly) linked with the public's acceptance of any activity or technology. In developed countries trust and acceptability are essentially linked indirectly (through perceived risk and perceived benefit). (ii) Lack of knowledge strengthened the magnitude and statistical significance of the trust‐acceptability relationship in both developed and developing countries. (iii) For high levels of claimed knowledge, the impact on the trust‐acceptability relationship varied depending upon the origin of the sample. (iv) Confirmatory analysis revealed the relative importance of perceived benefit over perceived risk in meditating the trust‐acceptability causal chain.     

Unconventional Gas Development in the USA: Exploring the Risk Perception Issues

Unconventional gas development (UGD) is growing rapidly in the United States. Drawing on insights from risk perception and risk governance theories and recent public opinion surveys, we find that UGD is an emerging technology that is likely to be perceived as risky, even though objective risk assessments suggest that risks are low and controllable through best risk management practices. Perceived risk varies significantly depending on the state and locality but perceptions of risk appear to be increasing as the technology is used more widely in the United States and as organized opponents of the technology intensify their efforts. Risk perceptions are attenuated somewhat because of the perceived benefits of UGD and compensation schemes for individuals and communities. The types of triggering events necessary for large‐scale social amplification and stigmatization have not yet occurred but awareness of UGD is growing and organized opposition has been sufficient to cause prohibitions of UGD in some U.S. states and localities. Additional directions for social science research on public reactions to UGD are recommended.     

The Future of Nuclear Power: Value Orientations and Risk Perception

Since the turn of the 21st century, there has been a revival of interest in nuclear power. Two decades ago, the expansion of nuclear power in the United States was halted by widespread public opposition as well as rising costs and less than projected increases in demand for electricity. Can the renewed enthusiasm for nuclear power overcome its history of public resistance that has persisted for decades? We propose that attitudes toward nuclear power are a function of perceived risk, and that both attitudes and risk perceptions are a function of values, beliefs, and trust in the institutions that influence nuclear policy. Applying structural equation models to data from a U.S. national survey, we find that increased trust in the nuclear governance institutions reduces perceived risk of nuclear power and together higher trust and lower risk perceptions predict positive attitudes toward nuclear power. Trust in environmental institutions and perceived risks from global environmental problems do not predict attitudes toward nuclear power. Values do predict attitudes: individuals with traditional values have greater support for, while those with altruistic values have greater opposition to, nuclear power. Nuclear attitudes do not vary by gender, age, education, income, or political orientation, though nonwhites are more supportive than whites. These findings are consistent with, and provide an explanation for, a long series of public opinion polls showing public ambivalence toward nuclear power that persists even in the face of renewed interest for nuclear power in policy circles.     

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.     

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

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

Expert and Public Perception of Risk from Biotechnology

Risk perceptions of a series of biotechnology applications were examined in a public (nonexpert) sample and an expert sample. Compared with the experts, the public perceived all biotechnology applications as more risky. Both groups perceived food-related applications to be riskier than medical applications. Compared with the public, experts perceived both food and medical applications as less harmful and more useful. Experts also judged the risks posed from medical biotechnology applications as more familiar and acknowledged by people and science. Lay estimates of the risk of food applications were predicted by potential harm, potential benefits, science knowledge, and familiarity; experts' estimates were predicted only by harm and benefits. Lay estimates of the risk of medical applications were predicted by potential harm; experts' estimates were predicted by potential benefits, number and type of people exposed, and science knowledge. We discuss the implications of the results for risk communication about and management of different types of biotechnologies.     

How Solid Is the Dutch (and the British) National Risk Assessment? Overview and Decision‐Theoretic Evaluation

Internationally, national risk assessment (NRA) is rapidly gaining government sympathy as a science‐based approach toward prioritizing the management of national hazards and threats, with the Netherlands and the United Kingdom in leading positions since 2007. NRAs are proliferating in Europe; they are also conducted in Australia, Canada, New Zealand, and the United States, while regional RAs now exist for over 100 Dutch or British provinces or counties. Focused on the Dutch NRA (DNRA) and supported by specific examples, summaries and evaluations are given of its (1) scenario development, (2) impact assessment, (3) likelihood estimation, (4) risk diagram, and (5) capability analysis. Despite the DNRA's thorough elaboration, apparent weaknesses are lack of stakeholder involvement, possibility of false‐positive risk scenarios, rigid multicriteria impact evaluation, hybrid methods for likelihood estimation, half‐hearted use of a “probability × effect” definition of risk, forced comparison of divergent risk scenarios, and unclear decision rules for risk acceptance and safety enhancement. Such weaknesses are not unique for the DNRA. In line with a somewhat reserved encouragement by the OECD (Studies in Risk Management. Innovation in Country Risk Management. Paris: OECD, 2009), the scientific solidity of NRA results so far is questioned, and several improvements are suggested. One critical point is that expert‐driven NRAs may preempt political judgments and decisions by national security authorities. External review and validation of major NRA components is recommended for strengthening overall results as a reliable basis for national and/or regional safety policies. Meanwhile, a broader, more transactional concept of risk may lead to better national and regional risk assessments.     

Altruism During Ebola: Risk Perception,Issue Salience,Cultural Cognition,and Information Processing

A nationally representative sample of 1,046 U.S. adults was randomly assigned to two experimental conditions that triggered different degrees of risk perception related to the Ebola outbreak. In the high‐risk condition, issue salience and deliberate processing increased individuals’ altruistic behavioral intention. In contrast, cultural cognition worldview and negative emotions such as sadness and anger were significantly related to altruistic behavioral intention regardless of the experimental conditions. These findings suggest that affective responses diverge from cognitive processes in influencing risk‐related decisions. Practically, as the United States continues to send experts to the affected countries in West Africa, results from this study suggest meaningful pathways to improve risk communication intended to encourage more altruistic and pro‐social behaviors.     

Trust in Risk Regulation: Cause or Consequence of the Acceptability of GM Food?

Although there is ample empirical evidence that trust in risk regulation is strongly related to the perception and acceptability of risk, it is less clear what the direction of this relationship is. This article explores the nature of the relationship, using three separate data sets on perceptions of genetically modified (GM) food among the British public. The article has two discrete but closely interrelated objectives. First, it compares two models of trust. More specifically, it investigates whether trust is the cause (causal chain account) or the consequence (associationist view) of the acceptability of GM food. Second, this study explores whether the affect heuristic can be applied to a wider number of risk-relevant concepts than just perceived risk and benefit. The results suggest that, rather than a determinant, trust is an expression or indicator of the acceptability of GM food. In addition, and as predicted, "affect" accounts for a large portion of the variance between perceived risk, perceived benefit, trust in risk regulation, and acceptability. Overall, the results support the associationist view that specific risk judgments are driven by more general evaluative judgments The implications of these results for risk communication and policy are discussed.     

How The Europeans Got a Head Start on Policies to Promote Global Corporate Responsibility

This article considers the debate over public policies to promote global corporate responsibility in the United States and in Europe. The debate and the response of policymakers is compared along with an explanation of how Europeans are developing a policy response encouraging corporate social responsibility. Finally, recommendations are made for U.S. policymakers based on encouraging ethical behavior around the world.     

Understanding Public Perceptions of Benefits and Risks of Childhood Vaccinations in the United States

In the face of a growing public health concern accompanying the reemerging threat of preventable diseases, this research seeks mainly to explain variations in the perceived benefits and risks of vaccinations among the general public in the United States. As Mary Douglas and Aaron Wildavsky's grid‐group cultural theory of risk perception claims, the analytical results based upon original data from a nationwide Internet survey of 1,213 American adults conducted in 2010 suggest that individuals’ cultural predispositions contribute to the formation of their perceptions pertaining to vaccine benefits and risks at both societal and individual levels, in conjunction with other factors suggested by previous risk perception literature, such as perceived prevalence of diseases, trust, knowledge level, and demographic characteristics. Those with a strong hierarch orientation tend to envision greater benefits and lesser risks and conceive of a relatively high ratio of benefit to risk when compared to other cultural types. By contrast, those with a strong fatalist tendency are inclined to emphasize risks and downplay benefits while conceiving of a low vaccination benefit‐risk ratio. Situated between hierarchs and fatalists, strong egalitarians are prone to perceive greater benefits, smaller risks, and a more positive benefit‐risk ratio than strong individualists.     

A Look at State‐Level Risk Assessment in the United States: Making Decisions in the Absence of Federal Risk Values

State environmental agencies in the United States are charged with making risk management decisions that protect public health and the environment while managing limited technical, financial, and human resources. Meanwhile, the federal risk assessment community that provides risk assessment guidance to state agencies is challenged by the rapid growth of the global chemical inventory. When chemical toxicity profiles are unavailable on the U.S. Environmental Protection Agency's Integrated Risk Information System or other federal resources, each state agency must act independently to identify and select appropriate chemical risk values for application in human health risk assessment. This practice can lead to broad interstate variation in the toxicity values selected for any one chemical. Within this context, this article describes the decision‐making process and resources used by the federal government and individual U.S. states. The risk management of trichloroethylene (TCE) in the United States is presented as a case study to demonstrate the need for a collaborative approach among U.S. states toward identification and selection of chemical risk values while awaiting federal risk values to be set. The regulatory experience with TCE is contrasted with collaborative risk science models, such as the European Union's efforts in risk assessment harmonization. Finally, we introduce State Environmental Agency Risk Collaboration for Harmonization, a free online interactive tool designed to help to create a collaborative network among state agencies to provide a vehicle for efficiently sharing information and resources, and for the advancement of harmonization in risk values used among U.S. states when federal guidance is unavailable.     

Global Maize Trade and Food Security: Implications from a Social Network Model

In this study, we developed a social network model of the global trade of maize: one of the most important food, feed, and industrial crops worldwide, and critical to food security. We used this model to analyze patterns of maize trade among nations, and to determine where vulnerabilities in food security might arise if maize availability was decreased due to factors such as diversion to nonfood uses, climatic factors, or plant diseases. Using data on imports and exports from the U.N. Commodity Trade Statistics Database for each year from 2000 to 2009 inclusive, we summarized statistics on volumes of maize trade between pairs of nations for 217 nations. There is evidence of market segregation among clusters of nations; with three prominent clusters representing Europe, Brazil and Argentina, and the United States. The United States is by far the largest exporter of maize worldwide, whereas Japan and the Republic of Korea are the largest maize importers. In particular, the star‐shaped cluster of the network that represents U.S. maize trade to other nations indicates the potential for food security risks because of the lack of trade these other nations conduct with other maize exporters. If a scenario arose in which U.S. maize could not be exported in as large quantities, maize supplies in many nations could be jeopardized. We discuss this in the context of recent maize ethanol production and its attendant impacts on food prices elsewhere worldwide.     

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.     

The Changing Character of Regulation: A Comparison of Europe and the United States

European and U.S. regulatory policies have changed considerably over the past 30 years. In Europe, since the mid-1980s, consumer and environmental regulation has become more politically salient and regulations have by and large become stricter. On the other hand, in the United States consumer and environmental issues have become less salient and contentious, and regulations have not become (comparatively) stricter. This apparent "flip-flop" of regulatory systems has not been analyzed in much detail to date. This perspective is an attempt to analyze some examples in which it has occurred and identifies one possible cause--namely, credibility.     

THE POLITICAL COLOR OF FISCAL RESPONSIBILITY

We propose a dynamic general equilibrium model that yields testable implications about the fiscal policy run by governments of different political color. Successive generations of voters choose taxation, expenditure, and government debt through repeated elections. Voters are heterogeneous by age and by the intensity of their preferences for public good provision. The political equilibrium switches stochastically between left‐ (pro‐public goods) and right‐leaning (pro‐private consumption) governments. A shift to the left (right) is associated with a fall (increase) in government debt, an increase (fall) in taxation, and an increase (fall) in government expenditures. However, left‐leaning governments engage in more debt accumulation during recessions. These predictions are shown to be consistent with the time‐series evidence for the United States in the postwar period, and also with the evidence for a panel of OECD countries. (JEL: D72, E62, H41, H62, H63)     

Is Risk‐Based Regulation Feasible? The Case of Polybrominated Diphenyl Ethers (PBDEs)

The polybrominated diphenyl ethers (PBDEs) are a class of brominated flame retardants used extensively in an array of textiles and plastics. Initially viewed as inert and nontoxic, in recent years an emerging body of science has cast doubt on this perception. Consequently, the compounds have drawn sustained government, media, and lobby group focus in the United States and Europe, yet have taken contrasting trajectories in different risk regulation regimes. We present a longitudinal analysis of these pathways, examining the actions of legislatures, executives, courts, scientists, and pressure groups. We show that the emergence and resolution of PBDEs as a risk issue was strongly shaped by path dependency, political entrainment (inter‐institutional conflict unrelated to PBDEs), and partisan lawmaking. This raises the question of whether risk‐based principles are capable of being the foundation on which managing the potential for harm can be based—even when that harm is associated with specific objects like flame‐retardant chemicals. We conclude by reflecting on the difficult normative issues that are raised.     

A Comparison of Organic and Conventional Fresh Produce Buyers in the Boston Area

Food safety concerns and the demand for organically grown produce have increased significantly in the United States over the last decade. Key differences in lifestyle characteristics, food safety attitudes and beliefs, perceived food safety risks, and valuation of health risk reductions between organic and conventional food buyers remain largely unknown, however. To better characterize how buyers of organic fresh produce differ from their conventional counterparts, over 700 food shoppers were sampled from ten major retail stores in the Boston area. Survey results show that self-reported organic buyers are more likely than conventional buyers to engage in a variety of health-promoting and environmentally friendly behaviors. Organic buyers are less trusting of federal food safety agencies than are conventional buyers, and perceive greater benefits associated with organically grown produce than do their conventional counterparts. Further, organic buyers have significantly higher risk perceptions than do conventional buyers for food safety hazards associated with conventionally grown produce. Compared to conventional buyers, organic produce buyers also perceive significant risk reductions associated with switching to organically grown produce and are willing to pay a higher price to reduce perceived food safety risks. Few sociodemographic differences between buyer types were observed, possibly due to how organic and conventional food stores were matched. Survey findings highlight the need for greater public education about a range of food safety issues and farming practices to ensure that consumers are making informed decisions in the marketplace.