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Government agencies have endeavored, with limited success, to improve the methodological consistency of regulatory benefit–cost analysis (BCA). This paper recommends that an independent cohort of economists, policy analysts and legal scholars take on that task. Independently established “best practices” would have four positive effects: (1) they would render BCAs more regular in form and format and, thus, more readily assessable and replicable by social scientists; (2) improved consistency might marginally reduce political opposition to BCA as a policy tool; (3) politically-motivated, inter-agency methodological disputes might be avoided; and (4) an independent set of “best practices” would provide a sound, independent basis for judicial review of agency BCAs.

Federal regulatory agencies are created by Congress to mitigate particular social problems, such as pollution (the Environmental Protection Agency), discrimination (the Equal Employment Opportunity Commission), and anticompetitive conduct (the Federal Trade Commission). These agencies have the delegated authority to issue Rules and Regulations that have the force of law within their respective domains, constrained by the oversight of the President and Congress, and by litigation through the Courts. Many view the extent of such oversight as inefficiently lax, with the result that “missionary” bureaucracies successfully overregulate and inefficiently extend the span of their authority. After describing these concerns, I develop a model of agency bias that extends my earlier work with Canice Prendergast and Topel (1993, 1996) to a regulatory framework. In the model, activist bureaucrats who seek greater regulation are attracted to an agency's mission. Their biases are constrained by the courts, where agency rules and regulations can be challenged, and by oversight from other branches of government. In equilibrium, agencies gain from the exercise of bias even though all parties know it occurs and seek to mitigate its costs. The public sector is overregulated on average. Overregulation is largest when the social problem is least harmful, and when oversight of agency actions is weak. Stronger oversight would reduce the distortionary effect of agency biases. More precise legislative language would provide clearer guidance to the court system, which would reduce deference to biased agency opinions in the formation of regulations.

Many European-level networks and regulatory constellations in different sectors (e.g., energy, telecommunications) without clear anchorage into the European Union (EU) institutional landscape have been subject to increasing efforts by the EU institutions to tie them closer to the EU. They are serving increasingly as platforms for preparing EU policy or for implementing EU decisions, which may result in closer institutional bonds with the EU. This chapter aims at examining the differences and similarities between the process towards more EU-integration in two different domains (i.e., telecommunications and patents) and regulatory constellations (i.e., supranational and intergovernmental).

The chapter analyzes the evolution in the European telecommunication sector and the European Patent System and juxtaposes this analysis with the literature on institutionalization, Europeanization of regulatory network-organizations, and multilevel governance (MLG). It focuses on the role of the European Commission and the interaction with the national regulatory agencies (NRAs) and networks within the institutional framework.

Irrespective of the particular regime (intergovernmental/supranational) in a certain domain or sector, a common trend of closer coordination and integration prompted by the Commission is taking place, which triggers a certain resistance by the national bodies regulating that domain. As long as a specific competence is considered instrumental in the creation of the single market, the Commission has strong incentives to strengthen its influence in this field, even if those competences have been regulated through an independent intergovernmental regime.

The dynamic described in this chapter allows us to reflect upon the MLG conception as developed by Marks and Hooghe (2004), which distinguish between two types of MLG. Type I MLG refers to different levels of governments, more specifically to the spread of power along different governmental levels and the interactions between them. Type II MLG refers to jurisdictions that are both task-specific and based on membership that can intersect with each other. They respond to particular problems in specific policy fields (Marks & Hooghe, 2004). Our analysis shows that the increase in coordination and integration are the outcome of both MLG Type II processes (coordination between two issue-specific bodies) and of MLG Type I processes (tensions between two governmental levels). Furthermore, the negotiation dynamics regarding this increased coordination and integration reveal that the tensions typical of MLG Type I took place as a consequence of the increased coordination between Type II bodies. Put differently, multi-level coordination and integration mechanisms in the EU can be seen as both Type I and Type II processes. They combine features of both categories and reveal that their Type I and Type II features are interdependent.

The analysis in this chapter shows a need for further strengthening the MLG Type I and II conceptual framework by balancing the analytical distinction between the two types with developments about how Type I and Type II are often entangled and intertwined with each other rather than separated realities.

The chapter describes and compares the dynamics in the European telecommunications sector and the European patent system with interesting observations for NRAs and the European Commission with respect to coordination and integration.

The original nature of the current chapter relates to the two selected areas and the addition to the literature on MLG.

First, with respect to the areas investigated the dynamics of the European telecommunications sector have been analyzed also by other authors, but the European patent system is an area which is relatively unexplored in terms of governance research. The combination of the two sectors with a detailed analysis of similarities and differences is highly original and generates interesting lessons with respect to coordination and integration in supranational and intergovernmental regimes.

Second, Marks and Hooghe (2004) distinguish between the two types of MLG as if they are two different constructs that are not related to each other. Our cases and argument cover both types of MLG and show the interconnection between the dynamics taking place in the two types of MLG.

This chapter focuses on the regulatory scheme used by the United States Food and Drug Administration (FDA) to approve medical products for commercial use in this country. After providing a brief introduction of the role of the FDA and the scope of the products regulated by the agency, the chapter outlines the common characteristics of premarket controls for drugs, medical devices, and biological products, including how clinical trials of these medical products are conducted with humans as part of the premarket approval process. The chapter then provides a detailed examination of the particular regulatory scheme for each product category. The chapter concludes with an analysis of how FDA regulates emerging medical technologies, such as cellular and tissue-engineered products. FDA regulates a variety of products intended to diagnose, cure, mitigate, treat, or prevent diseases or conditions under a legal scheme established in the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act and regulations promulgated by FDA. How a product is classified (drug, device, or biologic) forecasts the regulatory approval pathway that must be followed to bring the product to market. This chapter provides education and direction regarding regulatory requirements that must be met to market medical products in the United States.

Purpose – This chapter compares the stability of the U.S. Dual Banking system's two bank groups, national and state banks, in light of the current financial crisis. The goal of the chapter is to answer three distinct questions: first, is there a difference in the (balance sheet) fragility between the two groups and, second, to what extent has the balance sheet fragility of both groups changed after the escalation of the financial crisis beginning in August 2007? Building on that, the third question asks to whether or not the respective regulatory agencies of both bank groups are responsible for these changes in balance sheet fragility in light of the financial crisis.

Methodology – To answer these questions the chapter uses U.S. Call Report data containing full quarterly balance sheets and P&Ls of all U.S. commercial banks over the period 2005–2008. Anecdotal evidence as well as univariate and multivariate difference-in-difference methodology focusing on the immediate pre-crisis period Q1/2005–Q3/2007 and the crisis period Q3/2007–Q4/2008 are applied.

Results – Highly significant and robust results show that, ceteris paribus, national banks reduced their potential balance sheet fragility after the escalation of the crisis in August 2007 by reducing lending and liquidity creation stronger than state banks. Anecdotal evidence supports the empirical findings. Although both FDIC and OCC did not anticipate the adverse effects of the crisis, the OCC publicly showed an earlier reaction to liquidity-related problems than the FDIC.

Originality – The chapter is the first of its kind to analyze bank fragility around the escalation of the financial crisis and the role of the regulatory agencies. The chapter holds especially interesting policy implications in the light of the current discussion about the future regulation of the banking markets.

Purpose – This paper seeks to contribute to the debate on the role of corporate governance in developing, emerging and transition economies by focusing on the nature and practice of corporate governance in listed companies in Nigeria – a country which has experienced both economic growth and political turbulence over the past three decades and which too has experienced significant corporate failures in particular in the banking and insurance sectors. It does this against a contextual background which discusses issues of ethnicity, gender and power relationships and their relevance to governance in Nigeria.

Methodology – Archival and documentary analysis supported and underpinned by semi-structured interviews with 20 stakeholders in governance processes in Nigeria.

Findings – The analysis of the interviews highlighted the general support of the interviewees for corporate governance procedures and practices in Nigeria to continue to develop in line with those in more developed economies. However, concerns were expressed as to the inadequacies of aspects of the Nigerian governance regulatory infrastructure, in particular in relation to mechanisms for implementation and enforcement within a framework where there was limited confidence that either voluntary adherence to codes of good practice or market-driven regulation and control would be effective.

Contrary to the researchers’ expectations, the majority of the interviewees articulated the perspective that ethnicity, gender and power relationships were not of significance in the determination of the actuality of practice. However, a minority did identify these considerations to be of key importance, albeit frequently not overtly acknowledged or portrayed as such by parties associated with governance practices.

Research limitation(s) – The interviewees were drawn from a cross section of stakeholders from the business, government, regulatory and academic environment in Nigeria but the exigencies of conducting interview research in Nigeria and the difficulties of obtaining agreement from, and access to, interviewees meant that the potential for self-selection bias has to be considered when evaluating the study findings.

Practical Implication(s) – The research paper provides a platform for policy formulation on corporate governance in Nigeria.

Originality and value of paper – The paper builds on a number of previous studies of governance in Nigeria (for example, Oyejide & Soyibo, 2001; Yakasai, 2001; Ahunwan, 2002; Okike, 2007) in particular by means of the use of semi-structured interviews to provide a rich field of insight into the actuality of practice.

Traditionally, individual states have shared responsibility for regulating the US insurance industry. The Dodd–Frank Act changes this by tasking the Federal Reserve with regulating the systemic risks that particularly large insurance organizations might pose and assigning the regulation of swap-based substitutes for insurance and reinsurance products to the SEC and CFTC. This paper argues that prudential regulation of large insurance firms and weaknesses in federal swaps regulation could reduce the effectiveness of state-based systems in protecting policyholders and taxpayers from nonperformance in the insurance industry. Swap-based substitutes for traditional insurance and reinsurance contracts offer protection sellers a way to transfer responsibility for guarding against nonperformance into potentially less-effective hands. The CFTC and SEC lack the focus, expertise, experience, and resources to adequately manage the ways that swap transactions can affect US taxpayers’ equity position in global safety nets, while regulators at the Fed refuse to recognize that conscientiously monitoring accounting capital at financial holding companies will not adequately protect taxpayers and policyholders until and unless it is accompanied by severe penalties for managers that willfully hide their firm’s exposure to destructive tail risks.

This paper utilizes controversies over the role of a set of insecticides in mass honey bee die-offs in two different national contexts – France and the United States – in order to understand the science-state nexus in a comparative manner. On the one hand, the French government in 1999 and 2004 suspended the commercial use of the insecticidal products that beekeepers suspected of causing the honey bee declines. On the other hand, the US government has to date refused to heed beekeepers’ calls to limit the usage of the very same set of insecticides. We examine why the governments of France and the United States came to contrasting conclusions regarding broadly similar technoscientific issues. The divergent outcomes, we argue, are not simply the result of predetermined differences in the two states’ regulatory paradigms (with France being “precautionary,” and the United States adhering to a “sound science” approach), but are underpinned by divergent forms of beekeepers’ resistance. The paper further sheds light on non-state actors’ use of science and state to contest state (in)action by analyzing how historically influenced differences in state structures, the relational dynamics of beekeepers’ and farmers’ organizations, and the epistemic cultures of honey bee knowledge production, shaped different forms of resistance and influence in France and the United States.

This chapter considers and highlights a different approach to dealing with the white-collar and/or corporate offender that departs from the more commonly used punitive approach utilized by the American criminal justice system. Currently, terms of incarceration for individual offenders and the use of hefty fines and strict regulations against organizational defendants are commonly used draconian punishments. Therefore, this article is designed to remind readers of another viable approach to dealing with white-collar and/or corporate crime, one which utilizes a compliance or cooperative strategy of social control; that is the use of a system of restorative justice.