Upstream Oversight Assessment for Agrifood Nanotechnology: A Case Studies Approach

Although nanotechnology is broadly receiving attention in public and academic circles, oversight issues associated with applications for agriculture and food remain largely unexplored. Agrifood nanotechnology is at a critical stage in which informed analysis can help shape funding priorities, risk assessment, and oversight activities. This analysis is designed to help society and policymakers anticipate and prepare for challenges posed by complicated, convergent applications of agrifood nanotechnology. The goal is to identify data, risk assessment, regulatory policy, and engagement needs for overseeing these products so they can be addressed prior to market entry. Our approach, termed upstream oversight assessment (UOA), has potential as a key element of anticipatory governance. It relies on distinct case studies of proposed applications of agrifood nanotechnology to highlight areas that need study and attention. As a tool for preparation, UOA anticipates the types and features of emerging applications; their endpoints of use in society; the extent to which users, workers, ecosystems, or consumers will be exposed; the nature of the material and its safety; whether and where the technologies might fit into current regulatory system(s); the strengths and weaknesses of the system(s) in light of these novel applications; and the possible social concerns related to oversight for them.     

The Obama Administration's Regulatory Review Initiative: A 21st Century Federal Regulatory Initiative?

On January 18, 2011, President Obama signed Executive Order 13563, Improving Regulation and Regulatory Review, which instructs federal regulators to do the following: coordinate their agencies activities to simplify and harmonize rules that may be overlapping, inconsistent, or redundant; determine whether the present and future benefits of a proposed regulation justify its potential costs (including taking into account both quantitative and qualitative factors); increase participation of industry, experts, and the public (“stakeholders”) in the formal rule‐making process; encourage the use of warnings, default rules, disclosure requirements, and provisions of information to the public as an alternative to traditional “command‐and‐control” rule‐making restricting consumer choice; and mandate a government‐wide review of all existing administrative rules to remove outdated regulations. Executive Order 13563 includes a qualitative “values” provision to be considered in the required cost–benefit analysis, which can potentially counteract the alleged regulatory reform rationale of President Obama. Furthermore, in Executive Order 13563, President Obama established a deadline of May 18, 2011, for all executive branch agencies to submit their plans to streamline their rulemaking operations and repeal those “overlapping, inconsistent, or redundant” rules. These two issues, along with complementary regulatory review proposals being discussed in the U.S. Congress, are evaluated in this essay.     

Multicriteria Decision Analysis: A Comprehensive Decision Approach for Management of Contaminated Sediments

Contaminated sediments and other sites present a difficult challenge for environmental decisionmakers. They are typically slow to recover or attenuate naturally, may involve multiple regulatory agencies and stakeholder groups, and engender multiple toxicological and ecotoxicological risks. While environmental decision-making strategies over the last several decades have evolved into increasingly more sophisticated, information-intensive, and complex approaches, there remains considerable dissatisfaction among business, industry, and the public with existing management strategies. Consequently, contaminated sediments and materials are the subject of intense technology development, such as beneficial reuse or in situ treatment. However, current decision analysis approaches, such as comparative risk assessment, benefit-cost analysis, and life cycle assessment, do not offer a comprehensive approach for incorporating the varied types of information and multiple stakeholder and public views that must typically be brought to bear when new technologies are under consideration. Alternatively, multicriteria decision analysis (MCDA) offers a scientifically sound decision framework for management of contaminated materials or sites where stakeholder participation is of crucial concern and criteria such as economics, environmental impacts, safety, and risk cannot be easily condensed into simple monetary expressions. This article brings together a multidisciplinary review of existing decision-making approaches at regulatory agencies in the United States and Europe and synthesizes state-of-the-art research in MCDA methods applicable to the assessment of contaminated sediment management technologies. Additionally, it tests an MCDA approach for coupling expert judgment and stakeholder values in a hypothetical contaminated sediments management case study wherein MCDA is used as a tool for testing stakeholder responses to and improving expert assessment of innovative contaminated sediments technologies.     

An Integrated Approach to Oversight Assessment for Emerging Technologies

Analysis of oversight systems is often conducted from a single disciplinary perspective and by using a limited set of criteria for evaluation. In this article, we develop an approach that blends risk analysis, social science, public administration, legal, public policy, and ethical perspectives to develop a broad set of criteria for assessing oversight systems. Multiple methods, including historical analysis, expert elicitation, and behavioral consensus, were employed to develop multidisciplinary criteria for evaluating oversight of emerging technologies. Sixty‐six initial criteria were identified from extensive literature reviews and input from our Working Group. Criteria were placed in four categories reflecting the development, attributes, evolution, and outcomes of oversight systems. Expert elicitation, consensus methods, and multidisciplinary review of the literature were used to refine a condensed, operative set of criteria. Twenty‐eight criteria resulted spanning four categories: seven development criteria, 15 attribute criteria, five outcome criteria, and one evolution criterion. These criteria illuminate how oversight systems develop, operate, change, and affect society. We term our approach “integrated oversight assessment” and propose its use as a tool for analyzing relationships among features, outcomes, and tradeoffs of oversight systems. Comparisons among historical case studies of oversight using a consistent set of criteria should result in defensible and evidence‐supported lessons to guide the development of oversight systems for emerging technologies, such as nanotechnology.     

Improving the Regulation of Carcinogens by Expediting Cancer Potency Estimation1

The statutory language of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65; California Health and Safety Code 25249.5 et seq.) encourages rapid adoption of “no significant risk levels” (NSRLs), intakes associated with estimated cancer risks of no more than 1 in 100,000. Derivation of an NSRL for a carcinogen listed under Proposition 65 requires the development of a cancer potency value. This paper discusses the methodology for the derivation of cancer potencies using an expedited procedure, and provides potency estimates for a number of agents listed as carcinogens under Proposition 65. To derive expedited potency values, default risk assessment methods are applied to data sets selected from an extensive tabulation of animal cancer bioassays according to criteria used by regulatory agencies. A subset of these expedited values is compared to values previously developed by regulatory agencies using conventional quantitative risk assessment and found to be in good agreement. Specific regulatory activities which could be facilitated by adopting similar expedited procedures are identified.     

Revisiting NASA as a High Reliability Organization

The implementation and sustainment of High Reliability Organization (HRO) operations for large organizations, such as NASA, is problematic. Using NASA as a case study, the consistency of the intrinsic objectives of large public organizations is assessed with respect to HROs. A novel HRO model is described in terms of ten characteristic dimensions. The intrinsic public organizational objectives are found to be consistent with the HRO model only with respect to effectiveness. Additionally, NASA exhibits characteristics of a HRO only with respect to the degree of complexity and risk involved in operations.     

Genetically Modified Organisms and the U.S. Retail Food Labeling Controversy: Consumer Perceptions,Regulation, and Public Policy

In this article, we address the public issue of mandatory Genetically Modified Organism (GMO) retail food labeling in the U.S., first by reviewing the policy arguments both in support and against labeling food containing GMOs; second, by describing the existing U.S. federal regulatory system pertaining to GMO labeling, and why it does not presently require labeling of food containing GMOs; third, by reviewing and interpreting the results of studies of American consumer attitudes toward mandatory GMO retail food labeling; fourth, by evaluating, through the utilization of issue life cycle analysis in the nonmarket environment, where the issue of GMO retail food labeling stands in the national public policy process; fifth, summarizing the state of scientific evidence addressing the safety of GMO foods and the existing regulatory and public policy environment for this issue; and sixth, offering legislative and litigation strategies for the mainstream food nonmarket strategy framework to formally assess the GMO industry to protect their interests and those of American consumers not concerned with GMO food ingredients, while offering a voluntary labeling strategy for firms responding to and recognizing the “rights” of American consumers who “choose” to purchase non‐GMO food products.     

Elusive Critical Elements of Transformative Risk Assessment Practice and Interpretation: Is Alternatives Analysis the Next Step?

This article argues that “game‐changing” approaches to risk analysis must focus on “democratizing” risk analysis in the same way that information technologies have democratized access to, and production of, knowledge. This argument is motivated by the author's reading of Goble and Bier's analysis, “Risk Assessment Can Be a Game‐Changing Information Technology—But Too Often It Isn't” (Risk Analysis, 2013; 33: 1942–1951), in which living risk assessments are shown to be “game changing” in probabilistic risk analysis. In this author's opinion, Goble and Bier's article focuses on living risk assessment's potential for transforming risk analysis from the perspective of risk professionals—yet, the game‐changing nature of information technologies has typically achieved a much broader reach. Specifically, information technologies change who has access to, and who can produce, information. From this perspective, the author argues that risk assessment is not a game‐changing technology in the same way as the printing press or the Internet because transformative information technologies reduce the cost of production of, and access to, privileged knowledge bases. The author argues that risk analysis does not reduce these costs. The author applies Goble and Bier's metaphor to the chemical risk analysis context, and in doing so proposes key features that transformative risk analysis technology should possess. The author also discusses the challenges and opportunities facing risk analysis in this context. These key features include: clarity in information structure and problem representation, economical information dissemination, increased transparency to nonspecialists, democratized manufacture and transmission of knowledge, and democratic ownership, control, and interpretation of knowledge. The chemical safety decision‐making context illustrates the impact of changing the way information is produced and accessed in the risk context. Ultimately, the author concludes that although new chemical safety regulations do transform access to risk information, they do not transform the costs of producing this information—rather, they change the bearer of these costs. The need for further risk assessment transformation continues to motivate new practical and theoretical developments in risk analysis and management.     

Decisions,Science, and Values: Crafting Regulatory Alternatives Analysis

Emerging “prevention‐based” approaches to chemical regulation seek to minimize the use of toxic chemicals by mandating or directly incentivizing the adoption of viable safer alternative chemicals or processes. California and Maine are beginning to implement such programs, requiring manufacturers of consumer products containing certain chemicals of concern to identify and evaluate potential safer alternatives. In the European Union, the REACH program imposes similar obligations on manufacturers of certain substances of very high concern. Effective prevention‐based regulation requires regulatory alternatives analysis (RAA), a methodology for comparing and evaluating the regulated chemical or process and its alternatives across a range of relevant criteria. RAA has both public and private dimensions. To a significant degree, alternatives analysis is an aspect of product design; that is, the process by which private industry designs the goods it sells. Accordingly, an RAA method should reflect the attributes of well‐crafted product design tools used by businesses. But RAA adds health and environmental objectives to the mix of concerns taken into account by the product designer. Moreover, as part of a prevention‐based regulatory regime, it implicates important public values such as legitimacy, equity, public engagement, and accountability. Thus, an RAA should reflect both private standards and public values, and be evaluated against them. This article adopts that perspective, identifying an integrated set of design principles for RAA, and illustrating the application of those principles.     

Using Virtual Simulations to Assess Situational Awareness and Communication in Medical and Nursing Education: A Technical Feasibility Study

ABSTRACT

Communication and situational awareness, among other “human factors,” are critical skills needed within high-reliability organizations (HROs). HROs are challenged to develop an effective methodology for the systematic assessment of these skills. Virtual reality (VR) simulation technology offers a promising approach to meet this challenge. By utilizing a verbal coding procedure in tandem with eye-tracking metrics, we conducted a technical feasibility study to assess the impact of an interprofessional training (TeamSTEPPS®) on communication accuracy and observing responses among medical and nursing students in a virtual simulation. The results suggest that communication accuracy significantly improved as a result of TeamSTEPPS® training. These findings and changes in situational awareness among individuals are discussed.     

EPA Underestimates,Oversimplifies, Miscommunicates,and Mismanages Cancer Risks by Ignoring Human Susceptibility

If exposed to an identical concentration of a carcinogen, every human being would face a different level of risk, determined by his or her genetic, environmental, medical, and other uniquely individual characteristics. Various lines of evidence indicate that this susceptibility variable is distributed rather broadly in the human population, with perhaps a factor of 25‐ to 50‐fold between the center of this distribution and either of its tails, but cancer risk assessment at the EPA and elsewhere has always treated every (adult) human as identically susceptible. The National Academy of Sciences “Silver Book” concluded that EPA and the other agencies should fundamentally correct their mis‐computation of carcinogenic risk in two ways: (1) adjust individual risk estimates upward to provide information about the upper tail; and (2) adjust population risk estimates upward (by about sevenfold) to correct an underestimation due to a mathematical property of the interindividual distribution of human susceptibility, in which the susceptibility averaged over the entire (right‐skewed) population exceeds the median value for the typical human. In this issue of Risk Analysis, Kenneth Bogen disputes the second adjustment and endorses the first, though he also relegates the problem of underestimated individual risks to the realm of “equity concerns” that he says should have little if any bearing on risk management policy. In this article, I show why the basis for the population risk adjustment that the NAS recommended is correct—that current population cancer risk estimates, whether they are derived from animal bioassays or from human epidemiologic studies, likely provide estimates of the median with respect to human variation, which in turn must be an underestimate of the mean. If cancer risk estimates have larger “conservative” biases embedded in them, a premise I have disputed in many previous writings, such a defect would not excuse ignoring this additional bias in the direction of underestimation. I also demonstrate that sensible, legally appropriate, and ethical risk policy must not only inform the public when the tail of the individual risk distribution extends into the “high‐risk” range, but must alter benefit‐cost balancing to account for the need to try to reduce these tail risks preferentially.     

A Framework for Understanding Risk Perception,Explored from the Perspective of the Water Practitioner

Sustainable urban water systems are likely to be hybrids of centralized and decentralized infrastructure, managed as an integrated system in water‐sensitive cities. The technology for many of these systems is available. However, social and institutional barriers, which can be understood as deeply embedded risk perceptions, have impeded their implementation. Risk perceptions within the water sector are often unrecognized or unacknowledged, despite their role in risk management generally in informing value judgments and specifically in ranking risks to achieve management objectives. There has been very little examination of the role of these risk perceptions in advancing more sustainable water supply management through the adoption of alternative sources. To address this gap, this article presents a framework that can be used as a tool for understanding risk perceptions. The framework is built on the relational theory of risk and presents the range of human phenomena that might influence the perception of an “object at risk” in relation to a “risk object.” It has been synthesized from a critical review of theoretical, conceptual, and empirical studies of perception broadly and risk perception specifically, and interpreted in relation to water practitioners. For a water practitioner, the risk object might be an alternative water system, a component, a process, or a technology, and the object at risk could be public or environmental health, profitability, or professional reputation. This framework has two important functions: to allow practitioners to understand their own and others’ risk perceptions, which might differ, and to inform further empirical research.     

When Is a Risk Assessment Deficient According to an Uncertainty‐Based Risk Perspective?

The Petroleum Safety Authority Norway (PSA‐N) has recently adopted a new definition of risk: “the consequences of an activity with the associated uncertainty.” The PSA‐N has also been using “deficient risk assessment” for some time as a basis for assigning nonconformities in audit reports. This creates an opportunity to study the link between risk perspective and risk assessment quality in a regulatory context, and, in the present article, we take a hard look at the term “deficient risk assessment” both normatively and empirically. First, we perform a conceptual analysis of how a risk assessment can be deficient in light of a particular risk perspective consistent with the new PSA‐N risk definition. Then, we examine the usages of the term “deficient” in relation to risk assessments in PSA‐N audit reports and classify these into a set of categories obtained from the conceptual analysis. At an overall level, we were able to identify on what aspects of the risk assessment the PSA‐N is focusing and where deficiencies are being identified in regulatory practice. A key observation is that there is a diversity in how the agency officials approach the risk assessments in audits. Hence, we argue that improving the conceptual clarity of what the authorities characterize as “deficient” in relation to the uncertainty‐based risk perspective may contribute to the development of supervisory practices and, eventually, potentially strengthen the learning outcome of the audit reports.     

Tiered Approach to Resilience Assessment

Regulatory agencies have long adopted a three‐tier framework for risk assessment. We build on this structure to propose a tiered approach for resilience assessment that can be integrated into the existing regulatory processes. Comprehensive approaches to assessing resilience at appropriate and operational scales, reconciling analytical complexity as needed with stakeholder needs and resources available, and ultimately creating actionable recommendations to enhance resilience are still lacking. Our proposed framework consists of tiers by which analysts can select resilience assessment and decision support tools to inform associated management actions relative to the scope and urgency of the risk and the capacity of resource managers to improve system resilience. The resilience management framework proposed is not intended to supplant either risk management or the many existing efforts of resilience quantification method development, but instead provide a guide to selecting tools that are appropriate for the given analytic need. The goal of this tiered approach is to intentionally parallel the tiered approach used in regulatory contexts so that resilience assessment might be more easily and quickly integrated into existing structures and with existing policies.     

Safety Management and Public Spaces: Restoring Balance

Since 2000, the reputation of health and safety in the United Kingdom has been tarnished, so much so that it has become the subject of both a media circus and a government inquiry. This not only threatens the worthy goals of health and safety, but also impacts upon the associated tool of risk assessment itself such that "risk assessment" is increasingly seen by the public at large as a term inviting ridicule, even abuse. The main thrust of the government's examination of health and safety has been its concern that safety requirements were placing a disproportionate burden on business. However, there is another source of discontent, which is public chagrin over the impact of injury control measures upon life beyond the conventional workplace, in particular upon the public spaces that people frequent in their leisure time and on the activities they engage in there. This article provides a perspective on this second dimension of the crisis in confidence. It describes how many U.K. agencies with responsibilities for a wide portfolio of public amenities ranging from the provision of play spaces for the young to the management of publicly accessible countryside, the maintenance of urban and rural trees, the stewardship of sites of cultural heritage, and the pursuit of outdoor educational activities have responded to some conflicts posed to their services by the new safety culture. It concludes with a discussion of implications for the management of public space and for risk assessment itself.     

Comparison and Validation of Statistical Methods for Predicting Power Outage Durations in the Event of Hurricanes

This article compares statistical methods for modeling power outage durations during hurricanes and examines the predictive accuracy of these methods. Being able to make accurate predictions of power outage durations is valuable because the information can be used by utility companies to plan their restoration efforts more efficiently. This information can also help inform customers and public agencies of the expected outage times, enabling better collective response planning, and coordination of restoration efforts for other critical infrastructures that depend on electricity. In the long run, outage duration estimates for future storm scenarios may help utilities and public agencies better allocate risk management resources to balance the disruption from hurricanes with the cost of hardening power systems. We compare the out‐of‐sample predictive accuracy of five distinct statistical models for estimating power outage duration times caused by Hurricane Ivan in 2004. The methods compared include both regression models (accelerated failure time (AFT) and Cox proportional hazard models (Cox PH)) and data mining techniques (regression trees, Bayesian additive regression trees (BART), and multivariate additive regression splines). We then validate our models against two other hurricanes. Our results indicate that BART yields the best prediction accuracy and that it is possible to predict outage durations with reasonable accuracy.     

Improving Default Risk Prediction Using Bayesian Model Uncertainty Techniques

Credit risk is the potential exposure of a creditor to an obligor's failure or refusal to repay the debt in principal or interest. The potential of exposure is measured in terms of probability of default. Many models have been developed to estimate credit risk, with rating agencies dating back to the 19th century. They provide their assessment of probability of default and transition probabilities of various firms in their annual reports. Regulatory capital requirements for credit risk outlined by the Basel Committee on Banking Supervision have made it essential for banks and financial institutions to develop sophisticated models in an attempt to measure credit risk with higher accuracy. The Bayesian framework proposed in this article uses the techniques developed in physical sciences and engineering for dealing with model uncertainty and expert accuracy to obtain improved estimates of credit risk and associated uncertainties. The approach uses estimates from one or more rating agencies and incorporates their historical accuracy (past performance data) in estimating future default risk and transition probabilities. Several examples demonstrate that the proposed methodology can assess default probability with accuracy exceeding the estimations of all the individual models. Moreover, the methodology accounts for potentially significant departures from “nominal predictions” due to “upsetting events” such as the 2008 global banking crisis.     

Ex Ante and Ex Post: What Does Rod Stewart Really Know Now?1

Do we really know whether or not we have “maximized” utility, or do we just know that we are “happy” or “sad”? We argue that we can never know objectively whether or not utility has been maximized; however, people acting on a free market are sufficiently close to the decision as to be able to hazard a better guess about their opportunity costs than policy makers.