Adam M. Finkel

Perceiving Others' Perceptions of Risk Still a Task for Sisyphus

The recent literature providing insights from neuroscience and evolutionary biology into how individuals perceive risky choice situations represents a “second wave” of findings that recapitulates as well as challenges the risk perception research begun in the 1980s, which relied on psychometric survey research. Gleaning insights from the first wave of research that could improve the communication and control of environmental risks has yielded disappointing results. This is a result, in part, of the eagerness of scholars and pundits to posit a chasm between the “rational” and “objective” perceptions of experts, on the one hand, and a lay public that is seen as lurching between “paranoia and neglect” and as insensitive to the magnitude of risks. Interpretations of the psychometric research have suffered from inattention to uncertainty and interindividual variability in risk, to expert biases, and to important aspects of risky choice that were not explored in the first wave of research. Initial signs indicate that neuroscience and evolutionary biology research may fall prey to similar misinterpretations. This article summarizes some of the most intriguing findings of the “second wave” of risk perception research and advances four themes that may help make the new findings less divisive and more useful for improving risk communication and risk management. Continued research into risk perception should perhaps be embedded in a more general theory of public choice in the face of uncertain and variable costs and benefits and with a respect for distributive justice as an important goal in risk management.

'Solution-Focused Risk Assessment' - A Proposal for the Fusion of Environmental Analysis and Action

Rethinking risk assessment as a method for helping to solve environmental problems, rather than (merely) understanding environmental hazards, may provide three major classes of benefits over the status quo. First, it can help break the endless cycle of analysis: when the goal is to know enough to decide, rather than to know everything, natural stopping points emerge. Secondly, it can lead to more true decisions about how to achieve risk reduction, rather than mere pronouncements about how much risk reduction would be optimal. As much as agencies rightly value performance-oriented interventions, setting a permissible exposure limit or a national ambient air quality standard is often more a conclusion about what level of risk would be acceptable than any kind of guarantee that such a level will be achieved, let alone a decision about which actual behaviors will change and how. Third, it can promote expansive thought about optimal decisions, ones that resolve multiple risks simultaneously, avoid needless and tragic risk-risk tradeoffs, and involve affected stakeholders in debating what should be done. Arguably, the longer the disembodied analysis of risk information is allowed to proceed before solutions are proposed and evaluated, the more likely it is that the “problem” will be defined in a way that constrains the free-wheeling discussion of solutions, to the detriment of human health, the environment, and the economy. Therefore, I propose a new “solution-focused risk assessment” paradigm, in which the tentative arraying of control decisions would precede and guide the assessment of exposures, potencies, and risks.

Import Safety: Regulatory Governance in the Global Economy

Preface PART I: PERSPECTIVES ON THE PROBLEM 1. Consumer Protection in an Era of Globalization -Cary Coglianese, Adam M. Finkel, and David Zaring 2. The Other China Trade Deficit: Export Safety Problems and Responses -Jacques deLisle 3. Parochialism About the Safety of Imports -Jonathan Baron PART II: INTERNATIONAL TRADE INSTITUTIONS 4. Import Safety Regulation and International Trade -Tracey Epps and Michael J. Trebilcock 5. The Politics of Food Safety in the Age of Global Trade: The Codex Alimentarius Commission in the SPS Agreement of the WTO -Tim Buthe 6. Import Safety Rules and Generic Drug Markets -Kevin Outterson PART III: TOWARD SMARTER REGULATION 7. Forecasting Consumer Safety Violations and Violators -Richard Berk 8. Risk-Based Regulation for Import Safety -Lorna Zach and Vicki Bier 9. Solving the Problem of Scale: The European Approach to Import Safety and Security Concerns -Alberto Alemanno PART IV: LEVERAGING THE PRIVATE SECTOR 10. Importers as Regulators: Product Safety in a Globalized World -Kenneth A. Bamberger and Andrew T. Guzman 11. Bonded Import Safety Warranties -Tom Baker 12. Private Import Safety Regulation and Transnational New Governance -Errol Meidinger PART V: THE WAY FORWARD 13. Delegated Governance: Consumer Safety in the Global Marketplace -David Zaring and Cary Coglianese List of Contributors Index Acknowledgments

Improving Risk Assessment: Research Opportunities in Dose Response Modeling to Improve Risk Assessment

Substantial improvements in dose response modeling for risk assessment may result from recent and continuing advances in biological research, biochemical techniques, biostatistical/mathematical methods and computational power. This report provides a ranked set of recommendations for proposed research to advance the state of the art in dose response modeling. The report is the result of a meeting of invited workgroup participants charged with identifying five areas of research in dose response modeling that could be incorporated in a national agenda to improve risk assessment methods. Leading topics of emphasis are interindividual variability, injury risk assessment modeling, and procedures to incorporate distributional methods and mechanistic considerations into now-standard methods of deriving a reference dose (RfD), reference concentration (RfC), minimum risk level (MRL) or similar dose-response parameter estimates.

Protecting the Cancer Susceptibility Curve

I was dismayed, but not surprised, to read Charles Schmidt’s excellent article on the importance of considering human variation in susceptibility when regulating environmental health hazards, and to find the word and concept “cancer” mentioned not even once (Schmidt 2013). After all, for 30 years the U.S. Environmental Protection Agency (EPA) has agonized over whether a factor of 3 versus 10 (or less, or more) is adequate to protect the millions of humans who are more susceptible to non-cancer disease processes than the average person, but all the while making no similar effort to account for the substantial and perhaps greater variation in how individuals respond to carcinogenic stimuli. We estimate carcinogenic potency by fitting a dose–response function to tumor incidence data from groups of 50 inbred rodents—or from somewhat larger groups of working-age people—and simply pronounce the group potency estimate relevant for hundreds of millions of outbred humans, who among them exhibit every conceivable genetic polymorphism, co-exposure, psychological stress factor, and disease status that is deliberately engineered out of the laboratory or attenuated in the epidemiological raw material. When we conclude summarily that an allowable exposure would yield a precise point estimate of, for example, no more than 1-in-10,000 excess cancer risk, we know that many individuals will instead face a risk of 1-in-1,000, or even higher. However, we hide that knowledge from potentially affected persons and provide no interindividual adjustment on the cancer side of environmental health as we do for other types of adverse health effects. Two successive committees of the National Academy of Sciences have urged the U.S. EPA to abandon the fiction that its cancer risk estimates are “plausible upper bounds,” either of individual risk or of population risk [National Research Council (NRC) 1994, 2009]. (I was a member of both of these large consensus committees.) The more recent report (NRC 2009) went further and also recommended that the agencies “immediately” adjust their individual risk estimates for carcinogens upward by a factor of between 10- and 50-fold, based on evidence that at least 5% of humans are at least this susceptible compared with the average person, and that they adjust the corresponding population risk estimates (body counts) upward by a factor of roughly 7-fold. [For a mathematical derivation of how ignoring variability leads to underestimation of the population mean, see pp. 168–169 of NRC (2009).] The U.S. EPA’s instinct has instead been to offer post hoc rationalizations for ignoring variation in cancer susceptibility; none holds up to scrutiny. For the first decade after Science and Judgment in Risk Assessment (NRC 1994), the U.S. EPA’s various draft cancer guidelines contained this explanation: The EPA has considered [the NAS recommendation] but decided not to adopt a quantitative default factor for human differences in susceptibility [to cancer] when a linear extrapolation is used. In general, the EPA believes that the linear extrapolation is sufficiently conservative to protect public health. (U.S. EPA 1996) Obviously, linear extrapolation is not conservative at all if it is actually the correct model for the substance at issue; even if the U.S. EPA does overestimate a dose–response slope, it is unlikely that it does so by a compensating amount sufficient to cause the “two wrongs to equal one right” (Hattis and Goble 1996). When the U.S. EPA finalized the cancer guidelines in 2005, it garbled the logic further, claiming that linear extrapolation is thought to be public-health protective at low doses for the range of human variation … although it may not completely be so if pre-existing disease or genetic constitution place a percentage of the population at greater risk from exposure to carcinogens. (U.S. EPA 2005) It is unclear who “thinks” this, or why, but the entire and unarguable point is that “pre-existing disease and genetic constitution” absolutely do—not “if”—place some individuals at greater risk (Svensson et al. 2006). More recently, the U.S. EPA has simply begun asserting that its procedures have evolved to consider human variation in cancer risk (see question 6 in U.S. EPA 2011), but these amount to one trivial adjustment and one empty promise. In particular, the upward potency adjustment for children (10-fold for the first 2 years of life, 3-fold for the next 14 years) amounts to only a factor of 1.7 over the life span, which provides scant protection for susceptible adults exposed throughout life, and no additional protection for adults whose exposures begin or increase after 16 years of age. In addition, the U.S. EPA may incorporate chemical-specific data on susceptibility when they exist, but this formulation is the opposite of the sensible default the NAS has twice called for, because it treats human variation as nonexistent until proven otherwise. Having thus been awarded a strong disincentive, the regulated community or academic researchers are not likely to rush to perform the research needed to overturn this untenable but chemical-friendly default. Why might the U.S. EPA and its stakeholders be spending so much effort refining allometric scaling procedures, dialing back the estimation of exposure to the maximally exposed individual, and positing sophisticated nonlinear modes of action, while continuing to make the unscientific assertion that we are all equally susceptible to carcinogenesis? I observe that the first three improvements tend to result in lower estimated risk and less environmental protection, whereas shining a light on human variation in cancer susceptibility would tend to have the opposite effect on risk estimates. We should be advancing sound science along all fronts, not only the areas that support one type of policy preference.

A “solution-focused” comparative risk assessment of conventional and synthetic biology approaches to control mosquitoes carrying the dengue fever virus

Emerging technologies often pose various uncertain health risks that cause policymakers to hesitate to allow resultant products and processes to enter the market—but they also may offer large benefits, including the potential to greatly reduce some of the very risks currently most greatly affecting public health and the environment. Synthetic biology serves as one such emerging technology that, despite its potential benefits to various fields, gives policymakers pause until the human and environmental health risks posed by genetically engineered organisms are better characterized and assessed. Given various limitations of our current paradigm for making risk management decisions, some of which are caused by limitations of conventional methods of quantitative risk assessment (QRA), a modified approach to emerging technology characterization and assessment might be a needed step change. This paper demonstrates how one such approach—“solution-focused risk assessment” (Finkel, Hum Ecol Risk Assess 17(4):754–787, 2011)—can help evaluate synthetic biology products against conventional competitors. Specifically, this paper conducts a SFRA for Oxitec’s engineered Aedes aegypti mosquito, which serves as a synthetic biology option for dengue virus vector control.

Taking the reins: how regulatory decision-makers can stop being hijacked by uncertainty

Several decades after the mechanics of quantitative uncertainty analysis (QUA) for risk assessment and regulatory cost analysis were developed and refined, QUA still rarely reaches the minds of decision-makers. The most common justification for this situation is that “decision-makers want a number, not a set of statistical distributions.” This may be an accurate assessment of their druthers, but one obvious though perhaps impractical retort is to say that if decision-makers insist on misleading point estimates, then we need new and better decision-makers. This article offers a way out of this dilemma. Decision-makers do not have to understand (or even receive) all the information contained in a complete QUA, but they do have to drive the QUA. They need to instruct analysts how to approach the phenomena they analyze (parameter uncertainty, model uncertainty, interindividual variability, offsetting and second-order effects, and the monetary value of future uncertainty reductions), they need to insist that uncertainties in cost be treated a priori as exactly as important as uncertainties in risk, and—even more importantly—they need to instruct analysts which estimator(s) to seek, report, and explain. Here we offer 10 detailed principles to guide decision-makers into a new relationship with risk and cost analysts—10 observations about how “eyes wide open” point estimates can vastly outperform point estimates handed to the decision-maker without context, justification, or honesty about the value judgments they impose upon the decision. A decision-maker who explains “I chose Option A because its benefits of 2.345 exceed its costs of 1.234” can be replaced by a dollar-store calculator. We need decision-makers who can say “I chose Option A because the spectrum of benefits it likely offers, to these citizens, considering the range of costs it likely imposes, makes it a superior choice to any other.” QUA, performed carefully and following clear policy instructions, can empower decision-makers to earn their influential roles.

Distributional Consequences of Public Policies: An Example from the Management of Urban Vehicular Travel

This paper uses a spatially disaggregated computable general equilibrium model of a large US metropolitan area to compare two kinds of policies, “Live Near Your Work” and taxation of vehicular travel, that have been proposed to help further the aims of “smart growth.” Ordinarily, policy comparisons of this sort focus on the net benefits of the two policies; that is, the total monetized net welfare gains or losses to all citizens. While the aggregate net benefits are certainly important, in this analysis we also disaggregate these benefits along two important dimensions: income and location within the metropolitan area. The resulting identification of gainers and losers with these policies, though undoubtedly important to matters such as fairness and political feasibility, are rarely made. We find that these distributional effects are quite sensitive to the details of policy design.

A quantitative risk assessment for chronic traumatic encephalopathy (CTE) in football: How public health science evaluates evidence

ABSTRACT How should science and policy interpret the recent finding that 110 of 111 former National Football League (NFL) players had brain pathology known as chronic traumatic encephalopathy (CTE) at autopsy? Some physicians view this (and related epidemiologic and mechanistic evidence) skeptically, emphasizing that the association between repeated head trauma (RHT) and CTE may be artifactual, that this “incidence” is biased by self-selection of players with cognitive or emotional symptoms, and that even if RHT causes CTE, the lesions themselves may be inconsequential. Public health scientists look at this emerging evidence quite differently; in particular, they tend not to fall prey to certain illogical arguments justifying inaction. We present a quantitative risk assessment showing that even accounting for the non-representativeness of the 110 cases, the risk of CTE in the NFL workforce amply meets both parts of the test for “a significant risk of material impairment of health” that would permit the U.S. Occupational Safety and Health Administration to intervene to reduce RHT exposure. We further conclude that according to available evidence, CTE is a public health problem, and that lawyers and physicians need to understand that this conclusion is based on standards of evidence at least as long-standing and robust as their own.

A Healthy Public Cannot Abide Unhealthy And Unsafe Workplaces

The article focuses on public health aspects behind workplace safety and industrial hygiene. It comments on how the U.S. Occupational Safety and Health Administration (OSHA) has been underfunded, understaffed, and lacks authority to impose meaningful fines for noncompliance with basic workplace safety requirements. It suggests the administration of U.S. President Donald Trump is undermining employee health and safety which will harm public health and the U.S. economy.