Responding to Agency Avoidance of OIRA

Concerns have recently been raised that US federal agencies may sometimes avoid regulatory review by the White House Office of Information and Regulatory Affairs (OIRA). In this article, we assess the seriousness of such potential avoidance, and we recommend a framework for evaluating potential responses. After summarizing the system of presidential regulatory oversight through OIRA review, we analyze the incentives for agencies to cooperate with or avoid OIRA. We identify a wider array of agency avoidance tactics than has past scholarship, and a wider array of corresponding response options available to OIRA, the President, Congress, and the courts. We argue that, because the relationship between agencies and OIRA involves ongoing repeat player interactions, some of these avoidance tactics are less likely to occur (or to succeed) than has previously been alleged, and others are more likely; the difference depends significantly on how easy it is for OIRA to detect avoidance, and for OIRA, the courts, and others to respond. Further, we note that in this repeat player relationship, responses to agency avoidance tactics may induce further strategic moves and countermoves. Thus we further argue that the optimal response may not always be to try to eliminate the avoidance behavior; some avoidance may be worth tolerating where the benefits of trying to reduce agency avoidance would not justify the costs of response options and countermoves. We therefore conclude that responses to agency avoidance should be evaluated in a way similar to what OIRA asks of agencies evaluating proposed regulations: by weighing the pros and cons of alternative response options (including no action)

EXPLORING THE USE OF HUMAN RELIABILITY AND ACCIDENT INVESTIGATION METHODS TO INFLUENCE DESIGN REQUIREMENTS FOR NAVAL SYSTEMS

This thesis explores whether established methods from human reliability analysis and accident investigation can be applied early in system development to identify the design vulnerabilities that increase risk of system failure. Human reliability analyses evaluate performance shaping factors to quantify the likelihood of human failure before an accident occurs. Mishap investigations performed after an accident identify both human contributions to the system's failure and recommendations to avoid human failures in the future. This thesis proposes a method to evaluate system resiliency to variations in human performance and estimate the likelihood of human error. This method begins with functional analysis and failure mode analysis for a system concept, and then proposes two questionnaires based on human reliability and accident investigation criteria. This method is intended for the requirements development phase before system requirements are finalized and system design prototypes are completed. A demonstration of this method evaluates the human role using the electronic chart display and information system. Results from the demonstration reveal the two dominant factors that increase human error probability. The thesis concludes with an examination of the method's performance and results in support of validation of the method. Follow-on work is proposed to conduct a human subjects experiment for further validation and verification of the method.Civilian, Department of the NavyApproved for public release. distribution is unlimite

Risk Equity: A New Proposal

What does distributive justice require of risk regulators? Various executive orders enjoin health and safety regulators to take account of “distributive impacts,” “equity,” or “environmental justice,” and many scholars endorse these requirements. But concrete methodologies for evaluating the equity effects of risk regulation policies remain undeveloped. The contrast with cost-benefit analysis--now a very well developed set of techniques --is stark. Equity analysis by governmental agencies that regulate health and safety risks, at least in the United States, lacks rigor and structure. This Article proposes a rigorous framework for risk-equity analysis, which I term “probabilistic population profile analysis” (PPPA). PPPA is both novel, yet firmly grounded in the social-welfare-function tradition in welfare economics. The PPPA framework conceptualizes both the status quo, and possible policies, as probability distributions across population profiles -- where each population profile is, in turn, a concatenation of lifetime health-longevity-income histories, one for each member of the population. A utility function transforms each such profile into a utility vector. An equity-regarding social welfare function (SWF) is then specified. Policy analysts can employ the equity-regarding SWF both (1) to determine how policies compare purely as a matter of equality; and (2) to determine how they compare all-things-considered, considering both equality and overall welfare. The proposal may seem utopian, but is not. Scholars in the field of optimal tax policy already use SWFs to evaluate policies. Characterizing policies as distributions across population health-longevity-income profiles builds on existing risk assessment and general-equilibrium-modeling techniques. Utility functions can be specified through survey research and, in the interim, by building on standard functional forms. Plausible normative axioms considerably narrow the possible forms of the SWF, and survey research or thought experiments narrow the field further. Part I of the Article describes and criticizes existing approaches to risk equity that have been proposed in the scholarly literature: the environmental justice conception of risk equity; “individual risk” approaches; QALY-based equity analysis; incidence analysis; inclusive equality measurement; and cost-benefit analysis with distributive weights. Part II describes and defends PPPA. PPPA has many virtues. It recognizes that well-being is multidimensional, a function of both income and health/longevity; furnishes a metric for inequality; provides a framework for making tradeoffs between equality and overall well-being; and understands that distributive justice includes (but is not limited to) inequalities between high and low-status social groups

GLOBAL REGULATORY ASPECTS OF WOUND CARE AND BURN DRESSINGS

Objective: The objective of the study was to present an overview of regulatory requirements for wound and burn care dressings.Methods: A total of 80 research and review articles including regulatory guidelines to control the marketing of wound and burn care dressings recommended by international regulatory agencies were reviewed.Results: A wide range of dressings, as a new target of the healing process, have been developed due to continued growth and innovations in the field. Ideal dressings should be safe and achieve healing at a reasonable cost with minimum inconvenience to patients. It is mandatory that manufacture and sale of such dressings are approved by the relevant health authority of each country. This article provides manufacturers with an overview regarding regulatory approval procedures for marketing such dressings in different countries and addresses the gaps and challenges in the existing guidelines aimed at maintaining product quality. It provides a comparative analysis of the differences in regulatory requirements and highlights that ongoing discussions and appropriate actions are required to support the continuous development of these dressings. Most countries have their own regulatory guidelines, and the approval processes differ according to the country. Quality parameters concerning the type of material, pore size, sterilization methods, shape and size, and labeling are not discussed in guidelines; therefore, innovators and manufacturers are facing tough challenges to showcase their products in the market, and this further leads to either lack of market availability or high cost of such dressings.Conclusion: Development of common quality guidelines is essential for market availability of low-cost, high-quality dressings