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.     

Private Regulation of Food Safety by Supermarkets

Food safety is a highly debated issue. Food industry organizations, retailers and national and transnational governments have been trying to find new ways to regulate food safety. Can private regulation of food safety meet the high expectations? A review of existing literature shows some conditions to be important for effectively protecting public interests by private regulation. In particular, retailers worldwide are actively engaged in setting food safety standards for their suppliers. A case study of food safety regulation by Dutch retailers shows that they can force food industry organizations and producers to accept food safety standards because of their economic (market) power.     

Business Responses to the Regulation of Health and Safety in England*

The material in this article is extracted from an empirical study of industrial and agricultural businesses' responses to regulation of health and safety in the workplace. The study critically assesses the philosophy of self-regulation which underpins the regulatory framework in England and within the context of the expectations of employers built into that philosophy, attempts to distinguish between different models of employers in relation to their levels of motivation toward health and safety issues; their knowledge and comprehension of the law; their general approach to compliance with regulations; and their response to inspectors' enforcement activities. The article concludes that self-regulation is only capable of operating under very narrow conditions. It is at its most successful within the largest and most hazardous companies, despite the fact that the inspectorates devote the greatest concentration of enforcement and advisory resources to these sites. Companies which do not have a natural interest in safety require considerable advice, encouragement and coercion. In some situations deterrent penalties may be required in order to achieve a sustained improvement in standards. The research suggests that greater attention should be paid to the variety of employers and their compliance strategies, and to the potential for better targeting of regulatory efforts.     

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.     

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.     

Stemming the flow of bood? The illusion of self-regulation

This paper considers the viability of the self-regulation of occupational safety. It reports upon case studies of six companies currently operating in the UK chemicals sector. These companies and this sector provide highly favourable ‘testing sites’ for self-regulatory practices. However, through an examination of the power and location of safety staff within organisations, forms of management accountability, the state of safety training, and the mechanisms for communicating compliance problems, it becomes clear that many of the fundamental elements of self-regulation are not being met. This highlights the dangers of placing faith in self-regulation as a strategy that can be generalized, and indicates that compliance with safety regulations and standards must be forced upon companies by various stakeholding groups.     

对公共风险的政府规制——阐释与评述

现代社会存在着诸多公共风险,也存在着诸多针对公共风险的政府规制。如何理解公共风险,这是政府规制成立的逻辑起点。与私人风险是由一方的故意或者过失而引起的不同,公共风险在本质上是一种与道德无涉且在功能上有利于减少风险和增进公共福祉的行为。但是一旦从风险变成事故,公共风险却会对社会造成极大损害。如何治理公共风险?业已成为我们所要面对的重要课题。传统的侵权法由于技术上的局限,已经不胜任对公共风险的治理。政府规制在现代社会中发挥了越来越多的作用。当政府介入公共风险的治理之后,原先通过事后损害赔偿来保护个人权利的法律制度逐步让位于通过准入、标准和信息披露等构筑起来的以安全为目的的政府规制,而且这种制度的核心也不再是着眼于个案式的正义实现,而是为了减少整体风险。     

The regulation of nursing in Australia: a comparative analysis

This article uses the International Council of Nurses framework for nursing regulation to examine Nurses Acts in Australian States and Territories. It measures their compliance with the standards contained in the framework and exposes the anomalies among jurisdictions in spite of mutual recognition legislation now in force in all jurisdictions, including the Commonwealth. It also provides examples of difficulties encountered with cross-border practice and concludes that there is an urgent need for national nursing legislation.     

Does (better) regulation really matter? Examining public financial management legislation in Greece

Greece is thought to suffer from weak implementation of the law, including weak legislative monitoring and enforcement, a situation that undermines confidence in the rule of law. In recent years, increasing importance has been given to better regulation, namely the improvement of the quality of legislation with regards to state functioning. The purpose of this article is to examine the contribution of better regulation in the compliance of public entities with budgetary laws and regulations. The survey was the first such study to be conducted in Greece, and distributed questionnaires to auditors of the Hellenic Court of Audit, which is the Supreme Audit Institution charged with the authority to conduct external auditing of public entities and their executives. The survey results have confirmed the sense of weakness mentioned above, as most respondents considered the existing legislative framework of public financial management to be unclear, a situation that deterred compliance. Improved law design is expected to ameliorate compliance by public sector bodies, which apparently violate the law more due to its ambiguity and complexity rather than to any deliberate intention. Therefore, non-compliance should be better addressed through simplification of regulations rather than coercive enforcement.     

Business Response to Regulation: An Economist's Perspective

This chapter presents an economist's perspective on the interrelationship of the compliance and enforcement decisions of business and regulators in the context of regulations governing occupational health. Assuming profit-maximizing firms and harm-minimizing enforcement agencies, it is argued that a degree of preventive activity would be undertaken by businesses even in the absence of regulation. However, if employees are not fully informed about the risks of the workplace, it is likely that the profit-maximizing level of prevention will be less than socially optimal, and consequently there will be a need for regulation. An enforcement agency which attempts to minimize harm through inducing compliance with regulatory standards will be faced with similar informational difficulties to individual employees, and this suggests some scope for cooperative gains with individual firms through negotiated compliance, rather than prosecution.     

Data registers in respiratory medicine: a pilot project evaluating compliance with privacy laws and the National Statement on Ethical Conduct in Research Involving Humans

This article reports on data from a small pilot survey evaluating the compliance of voluntary databases in respiratory medicine with privacy laws and the National Health and Medical Research Council's National Statement on Ethical Conduct in Research Involving Humans. The increasing complexity of privacy law, including the recent private sector amendments, creates many challenges for database administrators. The impact of privacy laws upon voluntary or non-statutory databases, and upon doctors reporting patient data to such databases, is far from straightforward. The article suggests way in which the law might be adapted in order to better facilitate the role of voluntary data registers in health research and public health surveillance, while still protecting the privacy of patient information. The article also briefly considers how database administrators might "future-proof" their existing data holdings to ensure compliance with legal and ethical standards.     

Orchestration as a form of public action: The EU engagement with voluntary sustainability standards

EU authorities have come to engage with transnational private standards in the domain of sustainability in forms which are different from the traditional interplay based on agency relations and incorporation by reference. This phenomenon is evident in the domain of global value chain sustainability where the employment of voluntary sustainability standards (VSS) is permitted in certain EU measures. This contribution depicts the main features of orchestration as a distinct form of public action involving transnational private regulation. It lays down the reasons underpinning public ‘use’ of forms of public authority, it highlights the potential for orchestration in publicising transnational private rules and it exposes the hidden dynamics stemming from the interplay between public and private rules. It discusses the conditions under which orchestration can enhance the effectiveness of public measures, and how orchestration can transform transnational private regimes by steering their substance and procedures.     

Public trust and privacy in shared electronic health records

The development of information and communication technology in health care, also called eHealth, is expected to improve patient safety and facilitate more efficient use of limited resources. The introduction of electronic health records (EHRs) can make possible immediate, even automatic transfer of patient data, for health care as well as other purposes, across any kind of institutional, regional or national border. Data can thus be shared and used more effectively for quality assurance, disease surveillance, public health monitoring and research. eHealth may also facilitate patient access to health information and medical treatment, and is seen as an effective tool for patient empowerment. At the same time, eHealth solutions may jeopardize both patient safety and patients' rights, unless carefully designed and used with discretion. The success of EHR systems will depend on public trust in their compatibility with fundamental rights, such as privacy and confidentiality. Shared European EHR systems require interoperability not only with regard to technological and semantic standards, but also concerning legal, social and cultural aspects. Since the area of privacy and medical confidentiality is far from harmonized across Europe, we are faced with a diversity that will make fully shared EHR systems a considerable challenge.     

Long-term care under fire: a case for rational enforcement

Despite reforms to ensure that nursing homes maintain compliance with federal quality standards, one-fourth of all homes nationwide continue to be cited for deficiencies that either caused actual harm to residents or carried the potential for death or serious injury. This pattern has not changed since the July 1995 reforms were implemented. Although the reforms equipped federal and state regulators with many alternatives and tools to help promote sustained compliance with Medicare and Medicaid standards, the way in which states and HCFA have applied them appears to have resulted in little headway against the pattern of serious and repeated noncompliance. Such performance may do little to dispel concerns over the health and safety of frail and dependent nursing home residents.     

Risk assessment and geography teachers: a survey

Recently the issue of health and safety procedures on field trips and school visits has come to the fore, as a result of a series of tragedies involving the deaths of pupils. A review of some of the recent court cases and inquests involving the victims of field trips was undertaken. This indicated that schools and teachers are failing to implement risk assessment procedures which are a requirement of the Management of Health and Safety at Work Regulations 1999. The research focuses on the perceptions and practices of geography teachers as leaders of field trips. A central question is whether or not geography field trips are operating to acceptable safety standards. A questionnaire was constructed which set out to explore a sample of Northern Ireland geography teachers' attitudes to issues of liability and risk assessment. The findings indicate that teachers' compliance with Regulation 3, the requirement to conduct adequate risk assessments is variable, and a small proportion never undertake any risk assessments. The majority of respondents indicated that they had not received any training in conducting risk assessments. The findings raise concerns about the self‐regulation of safety procedures by teachers on field trips.     

Supply chains,contractual governance and certification regimes

Contractual governance of the food supply chain is on the rise. In this paper we focus on a particular set of instruments for transnational governance of food supply chains: transnational contracts and agreements. Looking at transnational contracts as instruments for implementation of transnational private regulation, we compare different mechanisms for the enforcement of safety and sustainability standards in global food supply chains. We conclude that the regime of contractual remedies follows different logics from the ones of regulatory and certification regime. (1) The former aims at redressing the victim of the breach inducing compliance through a re-active approach; whereas the latter pro-actively tries to restore compliance with regulatory process in order to pursue regulatory objectives. (2) The former focuses mainly on products, the latter on process. (3) The former concentrates on individual transactions while the latter focuses on the interdependence of contractual relationships along the chain and creates collective governance mechanisms. This paper suggests that the combination of the two sets of remedies may reinforce coordination and cooperation along the chain, therefore improving the level of quality, safety or sustainability of certified production. A higher level of awareness about the impact of standards and certification on the contract rules on remedies can have other positive consequences: it may improve contract drafting, leading the parties to coordinate different remedial systems when addressing the consequences of the breach and the ones of certification remedies; it may help courts to better define the scope and preconditions of contractual remedies and their effects on transnational regulation; it may guide law makers and standard setting institutions, when providing principles, rules or guidance concerning the consequences of the breach within contracts and along the chain, particularly in the food sector. From this perspective, the current work conducted by Unidroit and Fao for the production of a Legal Guide on contract farming could represent an important opportunity to define the links between multiple remedial regimes in food chains.     

Medicare and Medicaid programs; hospital conditions of participation: patients' rights. Final rule

This final rule finalizes the Patients' Rights Condition of Participation (CoP) which is applicable to all Medicare- and Medicaid-participating hospitals and contains standards that ensure minimum protections of each patient's physical and emotional health and safety. It responds to comments on the following standards presented in the July 2, 1999 interim final rule: Notice of rights; exercise of rights; privacy and safety; confidentiality of patient records; restraint for acute medical and surgical care; and seclusion and restraints for behavior management. As a result of comments received, we have revised the standards regarding restraint and seclusion and set forth standards regarding staff training and death reporting.     

Health Care Financing Administration: adoption of the National Bureau of Standards fire safety evaluation system for health care facilities. Notice of comment period

The Department of Health, Education, and Welfare is proposing to extend use of the new Fire Safety Evaluation System (FSES) to all hospitals participating in the Medicare and Medicaid programs. We are seeking public comment on this proposal and on whether to apply the FSES to intermediate care and skilled nursing facilities. The Fire Safety Evaluation System (FSES) was designed by the National Bureau of Standards. It defines the combinations of widely accepted fire safety systems and structural arrangements which can be used by health care facilities to meet safety standards equal to or exceeding those in the Life Safety Code. The FSES provides a framework which guarantees that the high standards of fire safety necessary to protect patients will be met and which is flexible enough to allow for new advances in safety technology and practice. It is based on our experience, which clearly demonstrates that the Life Safety Code can be implemented more effectively and without waste if certain changes are made in the procedures for achieving these mandated levels of safety.     

Joint Commission completes transition to functional standards

The Joint Commission's new emphasis on performance-based standards led it to identify functions it believed were likely to have the most significant impact on patient outcomes. Carrying out these functions requires an interdisciplinary team approach to patient care. Thus, the old strategy of handing out one manual chapter to each department head and asking him or her to implement the standards in that chapter will not work in 1995. Rather, providers will have to allocate already stretched human and financial resources to redesign their methods of assessing and improving patient outcomes in order to comply with yet another major revision of the Accreditation Manual for Hospitals. To ensure an adequate understanding of and compliance with Joint Commission standards, organizations should make the entire CAMH "required reading" for its leadership and make it available in strategic areas of the hospital for review by all employees. While the Joint Commission recognizes that its new functional approach will take some time to implement, all providers that want to ensure that they remain accredited should begin now to orient their leadership, staff, and employees to the new functional standards in the CAMH and the ways in which those standards affect patient outcomes.     

Management-Based Regulation: Prescribing Private Management to Achieve Public Goals

We analyze a little-studied regulatory approach that we call management-based regulation. Management-based regulation directs regulated organizations to engage in a planning process that aims toward the achievement of public goals, offering firms flexibility in how they achieve public goals. In this article, we develop a framework for assessing conditions for using management-based regulation as opposed to the more traditional technology-based or performance-based regulation. Drawing on case studies of management-based regulation in the areas of food safety, industrial safety, and environmental protection, we show how management-based regulation can be an effective strategy when regulated entities are heterogeneous and regulatory outputs are relatively difficult to monitor. In addition to analyzing conditions for the use of management-based regulation, we assess the range of choices regulators confront in designing management-based regulations. We conclude that management-based regulation requires a far more complex intertwining of the public and private sectors than is typical of other forms of regulation, owing to regulators' need to intervene at multiple stages of the production process as well as to the degree of ambiguity over what constitutes "good management."