Private roles in food safety provision: the law and economics of private food safety

Private food safety standards play a crucial role in ensuring the safety of the foods we consume. A voluntary instrument, private standards are so widespread to have become de facto mandatory for suppliers who wish to access the most profitable markets. Developed by retailers and business coalitions and enforced through third-party certification, private food safety standards constitute one of the principal food safety governance instruments of agribusiness value chains. Albeit private and voluntary, such standards have profound public implications because they contribute to food safety and protect consumers’ health. This article uses law and economics theory to identify their strengths and vulnerabilities and understand the relationship between public and private regulation. Specifically, it examines whether private standards can fulfill the public interest objective of protecting consumers’ health and whether they compete with or rather complement public regulation. The article argues that private standards have emerged in response to food scares to coordinate complex food value chains and have become ever more relevant in the context of intense market globalization, an area in which public regulation often failed. Among the advantages of private standards, are their flexibility and ability to rapidly respond to new risks. Through their focus on management-based regulation and strong market incentives for producers, private standards promote compliance better than traditional inspection methods. Private standards also present several gray areas including increased risk of capture due to their limited transparency and gaps in enforcement by third-party certifiers. The article suggests areas that deserve additional scrutiny, especially the opacity of standards vis-à-vis consumers and the public sector and the quality and reliability of third party certification.     

Emergent patterns in the regulation of pharmaceuticals: institutions and interests in the United States,Canada, Britain,and France

Although industrialized nations regulate pharmaceuticals to ensure their safety and efficacy, they balance these concerns with those related to the timeliness of the approval process and the burdens involved in meeting regulatory criteria. The United States, Canada, Britain, and France have adopted different approaches to the regulation of pharmaceuticals that place varying emphases on these competing goals and involve the participation of private interests to different extents. The regulatory approval processes and the government-industry relationships inherent within them are compared in the United States, Canada, Britain, and France by analyzing five features that distinguish the U.S. pluralist from the European corporatist approaches to policy development: representation (internal versus external), process (closed versus open), stance (informal, accommodative versus formal, adversarial), institutional power (fragmented versus centralized), and resources. An institutional framework further characterizes these approaches as based on models of managerial discretion and adjudication (United States), consultation (Canada), and bargaining (Britain, France) to clarify the patterns that emerge. While the approach that most effectively supports product safety involves managerial discretion as occurs in the United States, formal mechanisms for negotiation might be incorporated rather than a reliance on the judicial process. In an era of globalization and regulatory harmonization such divergence has significant implications. First, where harmonization in Europe involves the mutual recognition of one country's product licensing decision by the others, differences in evaluative processes remain important. Second, as harmonization leads to a common set of regulatory criteria, the criteria adopted tend to be those of nations with the least stringent regulatory standards, making evident the need for more responsive systems of post-market surveillance to protect the public interest.     

The development of technical and spectrum requirements for meeting federal, state and local public safety agency communication requirements through the year 2010, establishment of rules and requirements for priority access service--FCC. Final rule

The Federal Communications Commission (Commission) adopted a First Report and Order ("First Report") contemporaneously with a Third Notice of Proposed Rulemaking that is summarized elsewhere in this edition of the Federal Register. In the First Report, the Commission amends its rules relating to public safety communications in the 764-806 MHz band ("700 MHz band") that the Commission previously reallocated for public safety services and in general. This action commences the process of assigning licenses for frequencies in the 700 MHz band and addresses an urgent need for additional public safety radio spectrum and the need for nationwide interoperability among local, state, and federal entities. By this action, the Commission also takes additional steps toward achieving its goals of developing a flexible regulatory framework to meet vital current and future public safety communications needs and ensuring that sufficient spectrum to accommodate efficient, effective telecommunications facilities and services will be available to satisfy public safety communications needs into the 21st century.     

Fostering rational regulation of patient safety

After decades of inattention to the problem of medical injuries, patient safety is now occupying a prominent place on the health policy agenda and garnering renewed regulatory interest. Health care providers' behavior, with respect to patient safety and health care quality improvement, is now being shaped by top-down regulation through statutes and administrative agency oversight, as well as bottom-up drivers such as tort litigation and the forces of the consumer-driven health care market. Patient safety today exemplifies that eclectic mix of regulation that can occur when a new problem is exposed to the general public; it also demonstrates the difficulties of coordinating regulatory signals from multiple sources and regulating incomplete information. This article reviews the evolution of the regulatory environment for patient safety, examines some of the tensions and challenges that currently define patient safety oversight, and suggests strategies for more rational and responsive regulation.     

Really Responsive Risk‐Based Regulation

Regulators in a number of countries are increasingly developing “risk‐based” strategies to manage their resources, and their reputations as “risk‐based regulators” have become much lauded by regulatory reformers. This widespread endorsement of risk‐based regulation, together with the experience of regulatory failure, prompts us to consider how risk‐based regulators can attune the logics of risk analyses to the complex problems and the dynamics of regulation in practice. We argue, first, that regulators have to regulate in a way that is responsive to five elements: (1) regulated firms' behavior, attitude, and culture; (2) regulation's institutional environments; (3) interactions of regulatory controls; (4) regulatory performance; and (5) change. Secondly, we argue that the challenges of regulation to which regulators have to respond vary across the different regulatory tasks of detection, response development, enforcement, assessment, and modification. Using the “really responsive” framework, we highlight some of the strengths and limitations of using risk‐based regulation to manage risk and uncertainty within the constraints that flow from practical circumstances and, indeed, from the framework of risk‐based regulation itself. The need for a revised, more nuanced conception of risk‐based regulation is stressed.     

The development of technical and spectrum requirements for meeting federal, state and local public safety agency communication requirements through the year 2010, establishment of rules and requirements for priority access service--FCC. Proposed rule

The federal Communications Commission (Commission) adopted a Third Notice of Proposed Rule Making ("Third Notice") contemporaneously with a First Report and Order ("First Report") that is summarized elsewhere in this edition of the Federal Register. By its Third Notice, the Commission makes a range of proposals and seeks comment relating to public safety communications in the 746-806 MHz band ("700 MHz band") and in general. The Commission invites comment on how to license the 8.8 megahertz of 700 MHz band spectrum designated as reserved in the First Report and on whether to directly license each state or use a regional planning process to administer the nationwide interoperability frequencies (2.6 MHz of spectrum designated in the First Report) pursuant to the national interoperability plan to be established by the National Coordination Committee. The Third Notice also discusses protection requirements for the Global Navigation Satellite Systems and offers proposals to facilitate use of nationwide interoperability in public safety bands below 512 MHz. Finally, because many of the automated and intelligent machines and systems on which public safety entities depend for their operations were not designed to take into account the date change that will occur on January 1, 2000, the Commission also seeks comment on how best to ascertain the extent, reach, and effectiveness of Year 2000 compliance initiatives that have been or are being undertaken by public safety entities, to better understand the nature of the Year 2000 problem and the potential risks posed to public safety communications networks. This action addresses an urgent need for additional public safety radio spectrum and the need for nationwide interoperability among local, state, and federal entities. By this action, the Commission also takes additional steps toward achieving its goals of developing a flexible regulatory framework to meet vital current and future public safety communications needs and ensuring that sufficient spectrum to accommodate efficient, effective telecommunications facilities and services will be available to satisfy public safety communications needs into the 21st century.     

论个人信息保护的行政规制路径

个人信息保护存在私法诉讼与行政规制两种主要路径,私法诉讼多以侵权之诉的形式展开。由于个人信息处理者与信息主体的地位失衡,信息主体举证困难,维权难度高;由于损害难以界定,诉讼存在成本与收益不均衡的激励困境;同时,个别性的诉讼也难以有效回应系统性的社会风险。行政规制路径以基本权利的国家保护义务作为法权基础,在专业性、信息充分程度、治理效率等方面具有比较优势。个人信息保护立法应当更妥善地处理两种路径的协调。未来个人信息保护的行政规制路径需要进一步明确规制体制,充分运用行政处罚、自我规制、内部管理型规制、第三方规制等多元化的规制机制。     

行政立法中的最好行政

在现代社会,行政除扮演“传送带”角色外,还承担起积极的形成功能。因此,现代行政法在守望司法审查面向的传统控权理念的同时,还应当加强对行政实体问题的关注。对涉及大量管制事项的行政立法而言,这就需要在“最好行政”的指针下,选择恰当的管制方式,并经由整体制度的设计,实现管制目标,促进公共福祉。     

Signaling Environmental Stewardship in the Shadow of Weak Governance: The Global Diffusion of ISO 14001

This article examines how the quality of domestic regulatory institutions shapes the role of global economic networks in the cross‐national diffusion of private or voluntary programs embodying environmental norms and practices. We focus on ISO (International Organization for Standardization) 14001, the most widely adopted voluntary environmental program in the world, which encourages participating firms to adopt environmental stewardship policies beyond the requirement of extant laws. We hypothesize that firms are motivated to signal environmental stewardship via ISO 14001 certification to foreign customers and investors that have embraced this voluntary program, but only when these firms operate in countries with poor regulatory governance. Using a panel of 129 countries from 1997 to 2009, we find that bilateral export and bilateral investment pressures motivate firms to join ISO 14001 only when firms are located in countries with poor regulatory governance, as reflected in corruption levels. Thus, our article highlights how voluntary programs or private law operates in the shadow of public regulation, because the quality of public regulation shapes firms' incentives to join such programs.     

The politics of managed competition: public abuse of the private interest

The doctrine of managed competition in health care sought to achieve the social goals of access and efficiency using market incentives and consumer choice rather than governmental regulation and public administration. In retrospect, it demanded too much from both the public and the private sectors. Rather than develop choice-supporting rules and institutions, the public sector has promoted process regulation and benefit mandates. The private health insurance sector has pursued short-term profitability rather than cooperate in the development of fair competition and informed consumer choice. Purchasers have subsidized inefficient insurance designs in order to exploit tax and regulatory loopholes and to retain an image of corporate paternalism. America's health care system suffers from the public abuse of private interests and the private abuse of the public interest.     

Tripartism: Regulatory Capture and Empowerment

The features of regulatory encounters that foster the evolution of cooperation often also encourage the evolution of capture and corruption. Solutions to the problems of capture and corruption—limiting discretion, multiple-industry rather than single-industry agency jurisdiction, and rotating personnel—inhibit the evolution of cooperation. Tripartism—empowering public interest groups—is advanced as a way to solve this policy dilemma. A game-theoretic analysis of capture and tripartism is juxtaposed against an empowerment theory of republican tripartism. Surprisingly, both formulations lead to the conclusion that some forms of capture are desirable. The strengths from converging the weaknesses of these two formulations show how certain forms of tripartism might prevent harmful capture, identify and encourage efficient capture, enhance the attainment of regulatory goals, and strengthen democracy. While the case we make for tripartism is purely theoretical and general in its application to all domains of business regulation, our conclusion is a call for praxis to fish out the contexts in which the theory is true or false.     

美国联邦政府的煤矿安全生产监管制度研究

中美两国都是世界上最主的煤炭生产国和消费国.但是,两国的煤矿安全状况却存在较大差异.除了煤炭产业结构、技术水平和资源禀赋等因素之外,煤矿安全监管法治建设也是导致这一差异的重原因.美国煤矿安全生产立法经历多轮修订,不断纠正历次重大煤矿事故暴露出的监管缺陷,建立起独立高效的煤矿安全监管体系,完善煤矿安全监察和事故调查程序,优化了法律责任和执法机制.此外,煤矿安全监察员和煤矿从业人员的强制培训制度,也可以有效加强监管机构的监管能力和监管对象的合规水平.而美国矿山安全和健康委员会独立负责的行政复议,有效保障了对行政执法行为的纠错和对相对人的救济功能.这些经验值得中国参考借鉴.     

Will EMTALA changes leave emergency patients dying on the hospital doorstep?

Despite charges that it is at times ambiguous and overly burdensome, the Emergency Medical Treatment and Labor Act (EMTALA) remains an important protection for patients, and a valuable instrument for enforcing public policy goals in the area of emergency healthcare services. The 250 Yard Rule is a small but crucial part of EMTALA, extending the statute's protections to emergency patients who have narrowly failed to reach the hospital's entrance. Following recent revisions to EMTALA's implementing regulations, some health-care law practitioners and senior federal regulators have opined that enforcement of the 250 Yard Rule will be dramatically curtailed. This Article explores the legal and public policy origins of the 250 Yard Rule and their continuing applicability in the current regulatory environment. The Article concludes that the regulatory basis for the 250 Yard Rule remains intact and that the legislative intent behind EMTALA, as well as ongoing public policy goals, dictate that the 250 Yard Rule be preserved.     

Reviewable Automated Decision-Making

In this paper we introduce the concept of ‘reviewability' as an alternative approach to improving the accountability of automated decision-making that involves machine learning systems. In doing so, we draw on an understanding of automated decision-making as a socio-technical process, involving both human (organisational) and technical components, beginning before a decision is made and extending beyond the decision itself. Although explanations for automated decisions may be useful in some contexts, they focus more narrowly on the model and therefore do not provide the information about that process as a whole that is necessary for many aspects of accountability, regulatory oversight, and assessments for legal compliance. Drawing on previous work on the application of administrative law and judicial review mechanisms to automated decision-making in the public sector, we argue that breaking down the automated decision-making process into its technical and organisational components allows us to consider how appropriate record-keeping and logging mechanisms implemented at each stage of that process would allow for the process as a whole to be reviewed. Although significant research is needed to explore how it can be implemented, we argue that a reviewability framework potentially offers for a more useful and more holistic form of accountability for automated decision-making than approaches focused more narrowly on explanations.     

Race categorization and the regulation of business and science

Despite the lack of consensus regarding the meaning or significance of race or ethnicity amongst scientists and the lay public, there are legal requirements and guidelines that dictate the collection of racial and ethnic data across a range of institutions. Legal regulations are typically created through a political process and then face varying kinds of resistance when the state tries to implement them. We explore the nature of this opposition by comparing responses from businesses, scientists, and science-oriented businesses (pharmaceutical and biotechnology companies) to U.S. state regulations that used politically derived racial categorizations, originally created to pursue civil rights goals. We argue that insights from cultural sociology regarding institutional and cultural boundaries can aid understanding of the nature of resistance to regulation. The Food and Drug Administration's guidelines for research by pharmaceutical companies imposed race categories on science-based businesses, leading to objections that emphasized the autonomy and validity of science. In contrast, similar race categories regulating first business by the Equal Employment Opportunity Commission (EEOC) and later scientific research sponsored by the National Institutes of Health (NIH) encountered little challenge. We argue that pharmaceutical companies had the motive (profit) that NIH-supported scientists lacked and a legitimate discourse (boundary work of science) that businesses regulated by the EEOC did not have. The study suggests the utility of a comparative cultural sociology of the politics of legal regulation, particularly when understanding race-related regulation and the importance of examining legal regulations for exploring how the meaning of race or ethnicity are contested and constructed in law.     

Public Preferences for Bipartisanship in the Policymaking Process

At a time of a high level of polarization in Congress, public opinion surveys routinely find that Americans want politicians to compromise. When evaluating legislation, does the preference for bipartisanship in the legislative process trump partisan identities? We find that it does not. We conduct two experiments in which we alter aspects of the political context to see how people respond to parties (not) coming together to achieve broadly popular public policy goals. Although citizens can recognize bipartisan processes, preferences for bipartisan legislating do not outweigh partisan desires in the evaluation of public policies.     

The Shadows of the Law: Contemporary Approaches to Regulation and the Problem of Regulatory Conflict

Regulatory analyses often assume that compliance is desirable, with literature focusing on strategies to encourage "excellence" in adherence to regulatory goals. Yet, it is not unusual for disparate regulatory goals to exist that are based on competing values of what constitutes the "good society." It is this conflict that forms the substance of this paper. In cases of competing regulatory goals, techniques that encourage exemplary compliance in one area can create incentives to breach regulatory provisions of a competing regime. In such cases, generic regulatory techniques are unable to provide a useful means for resolving regulatory conflict but do allow a political delegation of conflict resolution to the "scientific" strategies of the regulator. In turn, the regulator places responsibility on companies for resolving competing regulatory demands. Successive delegation leads to juridification as well as regulators vying to retain primacy for their regime. This problem is examined through analysis of responsibilities for subcontractor safety under Australian health and safety law and sections of the Australian Trade Practices Act 1974 aimed at protecting competition.     

Geopolitics and the Regulation of Economic Life

The nation‐state should be a central unit of analysis for research into international and transnational regulation. Considering the research implications of this, we focus on the emergence stage of the regulatory process. We discuss how knowledge is contested in discussions between states over regulatory problems. We argue that a range of factors, not just a narrowly conceived national interest, influence their incentive to cooperate. Research is needed into whether regulatory problems at this level pose new or additional issues for states. Other stages of the regulatory process need to be similarly examined, likewise the interaction between the stages themselves.     

The cost of regulation in a decentralized context: the case of the Spanish regions

The impact of regulation on productivity is an issue that has attracted increasing interest in recent decades, as some scholars have argued that the proliferation of red tape may be the cause of slower growth rates in some western economies. Regulation (and other public instruments) has significant effects that may be either benign or harmful. Justified and well designed regulation protects consumers from potentially unsafe products, limits pollution, enhances workplace safety and contributes to public health and safety, as well as a more productive and fair society. However, an overabundance of rules or badly designed regulation can cause confusion and delay, impose unreasonable compliance costs in terms of capital investment, labour and official paperwork, retard innovation, lower productivity and, accidentally, distort incentives for private initiative. The objective of this paper is to examine the possible impact of regulatory activity in the Spanish regions over the past decade (1989–2001) on growth and productivity.     

The Dangers of Hanging Baskets: 'Regulatory Myths' and Media Representations of Health and Safety Regulation

The successful enforcement of health and safety regulation is reliant upon the ability of regulatory agencies to demonstrate the legitimacy of the system of regulatory controls. While 'big cases' are central to this process, there are also significant legitimatory implications associated with 'minor' cases, including media-reported tales of pettiness and heavy-handedness in the interpretation and enforcement of the law. The popular media regularly report stories of 'regulatory unreasonableness', and they can pass quickly into mainstream public knowledge. A story's appeal becomes more important than its factual veracity; they are a form of 'regulatory myth'. This paper discusses the implications of regulatory myths for health and safety regulators, and analyses their challenges for regulators, paying particular attention to the Health and Safety Executive (HSE) which has made concerted efforts to address regulatory myths attaching to its activities. It will be shown that such stories constitute sustained normative challenges to the legitimacy of the regulator, and political challenges to the burgeoning regulatory state, because they reflect some of the key concerns of late-modern society.