Regulatory beneficiaries and informal agency policymaking

Administrative agencies frequently use guidance documents to set policy broadly and prospectively in areas ranging from Department of Education Title IX enforcement to Food and Drug Administration regulation of direct-to- consumer pharmaceutical advertising. In form, these guidances often closely resemble the policies agencies issue in ordinary notice-and-comment rulemaking. However, guidances are generally developed with little public participation and are often immune from judicial review. Nonetheless, guidances can prompt significant changes in behavior from those the agencies regulate. A number of commentators have guardedly defended the current state of affairs. Though guidances lack some important procedural safeguards, they can help agencies supervise low-level employees and supply valuable information to regulated entities regarding how an agency will implement a program. Thus far, however, the debate has largely ignored the distinct and substantial interests of regulatory beneficiaries--those who expect to benefit from government regulation of others. Regulatory beneficiaries include, among others, pharmaceutical consumers, environmental users, and workers seeking safe workplaces. When agencies make policy informally, regulatory beneficiaries suffer distinctive losses to their ability to participate in the agency's decision and to invoke judicial review. This Article argues that considering the interests of regulatory beneficiaries strengthens the case for procedural reform. The Article then assesses some possible solutions.     

Dimensions of Enforcement Style: Factoring in Regulatory Autonomy and Capacity

This article explores how the concept of enforcement style can be adapted to be more analytically useful in the study of regulatory behavior and its effects in developing countries. In its first part, the article sets forth a dimensional conception of enforcement style and suggests two new dimensions to incorporate the variations in the autonomy and capacity of regulatory agencies that are so significant in developing countries. In its second part, the article uses this analytical framework to compare the enforcement styles of state environmental agencies in two Brazilian states, São Paulo and Pará.     

中国政府监管机构构建中的缺失与前瞻性思考──兼议政府监管领域"大部门体制"的改革方向

中国目前虽然成立了一些冠以"监管"或"监督管理"之名的机构,但与现代意义上的监管机构还有相当大的差距。中国政府监管机构的设立应坚持"立法先行"的原则,避免"三定方案"带给监管机构的尴尬境地;中国政府监管机构不宜采用美国的独立管制委员会模式或以英国为代表的公法人模式,现阶段比较现实和稳妥的做法是在国家行政体制框架内设置行政机构类型的监管机构,最好采用隶属于国务院的监管机构模式,并通过法律机制保障其独立性;面对产业汇流的趋势,在经济性监管领域,应设立综合性的监管机构。     

To What Extent Do Third Parties Influence Business Compliance?

Regulatory scholars have increasingly observed that it is not only public regulatory agencies and official enforcement action that motivate and enforce businesses' compliance with the law; in many situations, certain third parties may have greater capacity and power to motivate and enforce compliance with the law than do official regulatory agencies. This paper examines the extent to which businesses' worries about, and perceptions of pressure from, various third parties influence their internal compliance management activities and moral commitment in relation to complying with the objectives of competition and consumer protection law. Using data from a survey of 999 large Australian businesses, we find that businesses worry a lot about the reactions of a range of third parties including customers, shareholders, employees, and business partners to non-compliance. We find little evidence that these worries have much impact on what businesses actually do. However, perceptions of risk of complaints do influence what they do.     

The Response of Business to Social Regulation in England and Wales: An Enforcement Perspective*

This paper considers business adaptation to legal regulation from an enforcement perspective. It is argued that regulatory agencies and business have a reflexive relationship in which there is a continual process of adaptation and readaptation by one party and then the other. This reflexivity and its implications are discussed with reference to socio-legal research into the regulation of occupational health and safety and environmental pollution in England and Wales.     

Revisiting the Role of Negotiation and Trivialization in Environmental Law Enforcement

Using an empirical assessment of the use of enforcement undertakings by the Environment Agency and the engagement of the courts with the recently enacted sentencing guidelines for environmental offences, this article argues that the enforcement of environmental law is undergoing significant change. This change manifests itself in an increased reliance on written negotiated agreements in the form of enforcement undertakings by the Enivironment Agency and the willingness of the courts to hand down significant fines in cases against certain types of polluters. These new dynamics suggest that negotiation continues to play an important role in the enforcement of environmental law, albeit in a contractualized form. The application of the sentencing guidelines conversely suggests that environmental offences are no longer trivialized by the courts. Taken together, these emerging dynamics not only create specific incentives between agencies and offenders but also call into question established understandings and perceptions of regulatory enforcement.     

Market-Oriented Regulation of Environmental Problems in the Netherlands

Two functioning regulatory tax programs in The Netherlands indicate certain conditions under which such frequently-advocated but infrequently-adopted regulatory strategies can be successfully implemented. A flat fee on oxygen-demanding substances in industrial effluents, introduced in 1970, has been very successful, stimulating a 90% reduction in pollution and a search for cost-effective abatement measures. However, a recently-enacted law aimed at agricultural pollution, using a combination of direct controls and taxes on polluting inputs, has led to resistance and is not likely to be very successful. Based on these programs, regulatory taxes seem more likely to be politically and technically feasible when (a) emissions can be monitored economically; (b) the relation between emissions and environmental harm is relatively uniform and predictable; (c) implementing agencies have the technical competence and strong political and economic incentives to monitor and tax strictly; (d) the regulatory taxes apply uniformly to all sources of pollution; (e) economic efficiency is strongly valued in environmental policymaking.     

我国法律援助机构设置中存在的主要问题及对策建议

目前,我国法律援助机构设置中存在的主要问题是法律援助机构性质不统一、职能不统一以及在同一层次上法律援助机构和法律援助管理机构并行.本文针对这些问题提出了解决思路和办法,认为名称应为法律援助机构、政府性质、单一系统模式即可.     

Editor's Introduction: Understanding Regulatory Enforcement

This issue of Law & Policy adds to the growing body of empirical case studies of decision-making and enforcement in regulatory agencies. Summarizing that research, regulatory enforcement styles can be described in terms of two dimensions, one concerning the ways in which regulatory violations are defined and punished, the other concerning outcomes, described in policy-evaluative terms. In explaining variation in enforcement style, existing studies point to three sets of factors: characteristics of the regulatory "legal design"; features of agencies' "task environment"; and the regulatory "political environment." Weighting the relative importance of these factors, however, is difficult because of the number and fluidity of variables and the adaptiveness of regulatory agencies.     

An Enforcement Taxonomy of Regulatory Agencies

A variety of multivariate techniques were used to develop a taxonomy of regulatory agencies from the first comprehensive study of the disparate enforcement strategies employed by business regulatory agencies in one country. Seven types of agencies were identified: Conciliators, Benign Big Guns, Diagnostic Inspectorates, Detached Token Enforcers, Detached Modest Enforcers, Token Enforcers and Modest Enforcers. Agencies were distinguished primarily according to their orientation to enforcement versus persuasion, according to their commitment to detached (or arms length) command and control regulation versus cooperative fostering of self-regulation, and according to their attachment to universalistic rulebook regulation versus particularistic regulation. Nevertheless, it is not unreasonable to view regulatory agencies as lying on a single continuum from particularistic non-enforcers who engage in cooperative fostering of self-regulation to rulebook enforcers whose policy is detached command and control. This approximates the suggestions of Hawkins and Reiss for distinguishing regulatory agencies according to a "sanctioning/deterrence" versus "compliance" dimension. The predominant regulatory style in Australia, however, is distant from both poles, being a perfunctory regulatory approach which is neither distinctively diagnostic and educative nor litigiously "going by the book"; rather it amounts to "going through the motions". The typology also partially conforms to Black's categorisation of social control as penal, therapeutic, conciliatory and compensatory.     

Medicare program; criteria and procedures for extending coverage to certain devices and related services--HCFA. Final rule with comment period

This final rule establishes in regulations that certain devices with an investigational device exemption (IDE) approved by the Food and Drug Administration (FDA) and certain services related to those devices may be covered under Medicare. Specifically, it sets forth the process by which the FDA will assist HCFA in identifying non-experimental investigational devices that are potentially covered under Medicare. This rule responds to the mandate that Federal agencies streamline their regulatory processes to make them less burdensome and more customer-focused. It is intended to provide Medicare beneficiaries with greater access to advances in medical technology and encourage clinical researchers to conduct high quality studies of newer technologies.     

CORPORATE SELF‐POLICING AND THE ENVIRONMENT*

The U.S. Environmental Protection Agency's Self‐Policing Policy (more commonly referred to as the Audit Policy) waives or reduces penalties when regulated entities voluntarily discover, disclose, and correct environmental violations. This study draws upon a rational choice model of corporate crime to determine if traditional regulatory efforts such as inspections and enforcement actions are associated with the odds of disclosing an environmental violation under the Audit Policy. A case control design is used to compare companies that self‐police to companies that do not self‐police. The event group consists of all 551 companies that disclosed at least one environmental violation under the Audit Policy between October 1, 1998 and September 30, 2000. The control group consists of a simple random sample of 551 companies that did not use the Audit Policy but were discovered to have violated at least one environmental law during the same time period as the event group. There is no evidence that inspections and enforcement increase Audit Policy use. However, the results do suggest, first, that the Audit Policy is more likely to be used by large companies than by small companies and, second, that it is likely to be used for reporting violations as opposed to more serious emissions or permit violations. In terms of public policy these findings suggest that regulatory agencies such as the EPA can do relatively little to increase the self‐policing of environmental violations.     

VOLUNTARY COMPLIANCE AND REGULATORY ENFORCEMENT

Enforcement strategies that encourage "voluntary compliance" can improve regulatory efficiency by reducing unnecessary enforcement and compliance costs associated with legal confrontation between firms and agencies. This article analyzes the enforcement dilemma that causes confrontation and describes a "Tit for Tat" strategy capable of increasing socially beneficial cooperation. The strategy requires agencies to be reasonable toward cooperative firms, vengeful toward cheaters, unrelenting in pursuit of chronic evaders, but conciliatory toward repentant firms. Reforms in this neglected and poorly understood part of the regulatory process could yield considerable social benefits.     

Hydraulic Fracturing in North Carolina: How It Came to Be,and What It Means for Our State

This article details the process of legalizing hydraulic fracturing in North Carolina, which began with a request by the North Carolina Congress for a study of implementation strategies and geologic concerns from the state's environmental agencies. Steadily afterwards several pieces of legislation were introduced to create a regulatory scheme to encompass the issuing of drilling permits, regulating operations, and protecting surrounding groundwater. This article illustrates the legislative history, highlighting key components. Lastly, two recent studies regarding groundwater safety around hydraulic fracturing sites are explored in order to gain a brief understanding of the scientific consensus of the process.     

Delegation of Regulatory Powers in a Mixed Polity

It is a common place of academic and political discourse that the EC/EU, being neither a parliamentary democracy nor a separation‐of‐powers system, must be a sui generis polity. Tocqueville reminds us that the pool of original and historically tested constitutional models is fairly limited. But however limited, it contains more than the two systems of rule found among today's democratic nation states. During the three centuries preceding the rise of monarchical absolutism in Europe, the prevalent constitutional arrangement was ‘mixed government’—a system characterised by the presence in the legislature of the territorial rulers and of the ‘estates’ representing the main social and political interests in the polity. This paper argues that this model is applicable to the EC, as shown by the isomorphism of the central tenets of the mixed polity and the three basic Community principles: institutional balance, institutional autonomy and loyal cooperation among European institutions and Member States. The model is then applied to gain a better understanding of the delegation problem. As is well known, a crucial normative obstacle to the delegation of regulatory powers to independent European agencies is the principle of institutional balance. By way of contrast, separation‐of‐powers has not prevented the US Congress from delegating extensive rule‐making powers to independent commissions and agencies. Comparison with the philosophy of mixed government explains this difference. The same philosophy suggests the direction of regulatory reform. The growing complexity of EC policy making should be matched by greater functional differentiation, and in particular by the explicit acknowledgement of an autonomous ‘regulatory estate’. At a time when the Commission aspires to become the sole European executive, as in a parliamentary system, it is particularly important to stress the importance of separating the regulatory function from general executive power. The notion of a regulatory estate is meant to emphasise this need.     

Assaults Against Inspectors: The Dangers in Enforcing Corporate Crime

This survey of regulatory inspectors reveals a surprising number of threats and assaults being made against inspectors in the course of enforcing regulatory provisions. Contrary to conventional images of regulatory enforcement, inspectors in some agencies face violent resistance from regulatory offenders that is similar to the violent resistance encountered by police officers. These findings provide support for the contention that regulatory enforcement and policing should be conceptualized as overlapping forms of law enforcement rather than as distinct governmental activities.     

信用评级机构的法律定位及其国际监管改革研究

信用评级机构是金融市场日益专业化过程中不可或缺的一员,通过其专业化的评价体系,对解决投资者和证券发行人之间的信息不对称问题发挥了很大的作用。但是,随着评级机构日益深入地参与到金融证券化的过程中,不可避免的利益冲突使其中立性、客观性等在一定程度上有所缺失。次贷危机发生后,对信用评级机构加强监管的呼声日益高涨,各国金融监管机构开始对信用评级机构进行全面的严格的监管,但是,由于评级业本身的自然垄断属性以及评级业务的专业性,使其定位上存在模糊之处。在分析信用评级机构存在的缺陷基础之上,对其法律定位进行探讨,并预测国际监管改革与合作的发展趋势是十分必要的。     

Credible Commitment in Non-Independent Regulatory Agencies: A Comparative Analysis of the European Agencies for Pharmaceuticals and Foodstuffs

Abstract: The creation of more and more supranational regulatory agencies has been one of the most significant institutional developments in the European Union during the last decade. Usually, these agencies evolve from EU committees and take over most of their structures. Accordingly, like most EU committees and the Commission, regulatory agencies are not independent, but act under the control of the member states. The question is, how far do they indicate a credible commitment of the Member States to long-term policy goals like health and consumer protection. This article compares the institutional structures and decision-making rules of the European Agency for the Evaluation of Medicinal Products and of the newly established European Food Safety Authority, in order to clarify the extent of credible commitment that the Member States show through the setting-up of these agencies. It concludes that the commitment of the Member States in the foodstuff sector is not as deep as in the pharmaceutical sector, and that the creation of the European Food Safety Authority will not lead to a success story similar to that of the European Agency for the Evaluation of Medicinal Products.     

Cloud computing and its implications for cybercrime investigations in Australia

The advent of cloud computing has led to a dispersal of user data across international borders. More than ever before, law enforcement investigations into cybercrime and online criminal activity require cooperation between agencies from multiple countries. This paper examines recent changes to the law in Australia in relation to the power of law enforcement agencies to effectively investigate cybercrime insofar as individuals and organisations make use of cloud infrastructure in connection with criminal activity. It concludes that effective law enforcement operations in this area require harmonious laws across jurisdictions and streamlines procedures for granting assistance between law enforcement agencies. In conjunction with these mechanical developments, this paper posits that law enforcement officers require a systematised understanding of cloud infrastructure and its operation in order to effectively make use of their powers.     

The liberal state and the rogue agency: FDA's regulation of drugs for mood disorders, 1950s-1970s

The theory of the liberal state does not generally contemplate the possibility that regulatory agencies will turn into "rogues," regulating against the interests of their clients and, indeed, the public interest. In the years between circa 1955 and 1975 this seems to have happened to one of the prime regulatory agencies of the US federal government: the Food and Drug Administration (FDA). Intent upon transforming itself from a traditional "cop" agency to a regulatory giant, the FDA campaigned systematically to bring down some safe and effective drugs. This article concentrates on hearings in the area of psychopharmacology regarding several antianxiety drugs, namely meprobamate (Miltown), chlordiazepoxide (Librium) and diazepam (Valium). In addition, from 1967 to 1973 this regulatory vengefulness occurred on a broad scale in the Drug Efficacy Study Implementation (DESI), an administrative exercise that removed from the market almost half of the psychopharmacopoeia. The article explores possible bureaucratic motives for these actions.