The Changing Character of Regulation: A Comparison of Europe and the United States

European and U.S. regulatory policies have changed considerably over the past 30 years. In Europe, since the mid-1980s, consumer and environmental regulation has become more politically salient and regulations have by and large become stricter. On the other hand, in the United States consumer and environmental issues have become less salient and contentious, and regulations have not become (comparatively) stricter. This apparent "flip-flop" of regulatory systems has not been analyzed in much detail to date. This perspective is an attempt to analyze some examples in which it has occurred and identifies one possible cause--namely, credibility.     

Forecasting environmental protection legislation using cross-impact analysis

This article describes a study carried out to forecast and compare the development of environmental regulations in five industrialized countries up to the year 2000. More particularly, the paper concentrates on the techniques used in the forecasting exercise, which included cross-impact analysis of models of the regulatory development process. Our experiences with this technique are reported and conclusions as to its value in forecasting environmental regulations drawn.     

Informing the Public About Uncertain Risks

Many problems arise in connection with the communication of risk information. In this article the content of the information communicated is taken as a starting-point for analyzing the risk communication process. We studied the way in which authorities communicated health risks to local residents in Dutch soil pollution situations and found that communication problems were characterized more by misunderstanding and conflict between parties with different views and interests than by a lack of understanding. Therefore, it is important to look more closely at the way the communicators of information (in our cases, officials) select risk information from risk assessments, and to study the effects that the information selected has on the receivers (in our cases, residents). Both the process of selection by the officials and the process of interpretation by the residents will be shown to be influenced by the different institutional backgrounds. The article presents a new approach to risk communication. Both the risk information presented by the authorities and the public reactions to this risk information are considered to reflect the institutional background of authorities and residents, and can be analyzed in these terms. Such an approach has consequences for the study of risk communication and the manner in which it is practiced.     

The Role of Performance Assessment in the Regulation of Underground Disposal of Radioactive Wastes: An International Perspective

Much has been written about the development and application of quantitative methods for estimating under uncertainty the long-term radiological performance of underground disposal of radioactive wastes. Until recently, interest has been focused almost entirely on the technical challenges regardless of the role of the organization responsible for these analyses. Now the dialogue between regulators, the repository developer or operator, and other interested parties in the decision-making process receives increasing attention, especially in view of some current difficulties in obtaining approvals to construct or operate deep facilities for intermediate or high-level wastes. Consequently, it is timely to consider the options for regulators' review and evaluation of safety submissions, at the various stages in the site selection to repository closure process, and to consider, especially, the role for performance assessment (PA) within the programs of a regulator both before and after delivery of such a submission. The origins and broad character of present regulations in the European Union (EU) and in the OECD countries are outlined and some regulatory PA reviewed. The issues raised are discussed, especially in regard to the interpretation of regulations, the dangers from the desire for simplicity in argument, the use of regulatory PA to review and challenge the PA in the safety case, and the effects of the relationship between proponent and regulator. Finally, a very limited analysis of the role of PA in public hearings is outlined and recommendations are made, together with proposals for improving the mechanisms for international collaboration on technical issues of regulatory concern.Until August 13, 1997, the author was employed as a Principal Pollution Inspector by the Environment Agency (EA) of England and Wales. Responsible for managing the development and application of the regulatory postclosure assessment capability of Her Majesty's Inspectorate of Pollution (HMIP) between 1982 and 1996, when HMIP was merged with the National Rivers Authority and the Waste Regulatory Authorities to form the EA on April 1, 1996. Represented HMIP/EA on a number of international committees related particularly to PA; 20 Bonser Road, Twickenham, Middlesex TW1 4RG, U.K.     

Information systems,inter-functional collaboration and innovation in Taiwanese high-tech manufacturing firms

This article investigates whether (1) cross-functional integration within a firm and the use of information systems (IS) that support information sharing with external parties can enhance integration across the supply chain and wider networks and (2) whether collaboration with customers, suppliers and other external parties leads to increased supply chain performance in terms of new product development and introduction of new processes. Data from a high-quality survey carried out in Taiwan in 2009 were used, and appropriate econometric models were applied. Results show that the adoption of IS that enhance information sharing is vital not only for the effective communication with suppliers and with wider network members, but their adoption also has a direct effect across a firm's innovative effort. Cross-functional integration appears to matter only for the introduction of an innovative process. Collaboration with customers and suppliers affected a product's design and its overall features and functionality, respectively.     

Public participation in life cycle assessment and risk assessment: a shared need.

Life cycle assessment (LCA) and risk assessment are operationally different but share the common purpose of supporting decisions about reducing threats to human welfare. Both analysis methods also involve a complex mixture of science and value judgments reflecting epistemological as well as moral and esthetic values. The inability of risk assessment and LCA to be "value free" has been a source of considerable controversy in both communities. Recognition of the contingent and social nature of human interpretation of the risks and environmental impacts created by public and private decisions has led to an increased appreciation of the importance of involving interested and affected parties in risk characterization. Comparison of the value-based nature of LCA and risk assessment demonstrates the need for participation in LCA. Although the need for participation by affected parties in decision-making processes is gaining acceptance, there is little agreement as to how participation should be structured. Risk assessment and LCA have a shared need for research examining the design and analysis of participation processes appropriate to a given decision context. A proposed framework recommends participation strategies designed to enhance the effectiveness of policy-driven analyses such as risk assessment and LCA based on the level of trust that interested and affected parties have for other policy participants.     

Communicating Food Risks in an Era of Growing Public Distrust: Three Case Studies

The communication and regulation of risk has changed significantly over the past 30 years in Europe and to a noticeable but lesser extent in the United States. In Europe, this is partly due to a series of regulatory mishaps, ranging from mad cow disease in the United Kingdom to contamination of the blood supply in France. In the United States, general public confidence in the American government has been gradually declining for more than three decades, driven by a mix of cultural and political conflicts like negative political advertising, a corrosive news media, and cuts in regulatory budgets. While the former approach is based on an objective assessment of the risk, the latter is driven more by the perception of the risk, consumer sentiment, political will, and sectoral advocacy. In this article, the author examines three U.S.‐based food case studies (acrylamide, bisphenol A, and artificial food colorings) where regulations at the local and state levels are increasingly being based on perceived risk advocacy rather than on the most effective response to the risk, be it to food safety or public health, as defined by regulatory interpretation of existing data. In the final section, the author puts forward a series of recommendations for how U.S.‐based regulators can best handle those situations where the perceived risk is markedly different from the fact‐based risk, such as strengthening the communication departments of food regulatory agencies, training officials in risk communication, and working more proactively with neutral third‐party experts.     

The Role of Cancer Risk in the Regulation of Industrial Pollution

The extent of carcinogen regulation under existing U.S. environmental statutes is assessed by developing measures of the scope and stringency of regulation. While concern about cancer risk has played an important political role in obtaining support for pollution control programs, it has not provided the predominant rationale for most regulatory actions taken to date. Less than 20% of all standards established to limit concentrations of chemicals in various media address carcinogens. Restrictions on chemical use are more frequently based on concerns about noncancer human health or ecological effects. Of the chemicals in commercial use which have been identified as potential human carcinogens on the basis of rodent bioassays, only a small proportion are regulated. There is an inverse relationship between the scope of regulatory coverage and the stringency of regulatory requirements: the largest percentages of identified carcinogens are affected by the least stringent requirements, such as information disclosure. Standards based on de minimis cancer risk levels have been established for only 10% of identified carcinogens and are restricted to one medium: water. Complete bans on use have affected very few chemicals. The general role that carcinogenicity now plays in the regulatory process is not dramatically different from that of other adverse human health effects: if a substance is identified as a hazard, it may eventually be subject to economically achievable and technically feasible restrictions.     

Risk Assessment and Risk Governance of Liquefied Natural Gas Development in Gladstone,Australia

This article is a retrospective analysis of liquefied natural gas development (LNG) in Gladstone, Australia by using the structure of the risk governance framework developed by the International Risk Governance Council (IRGC). Since 2010 the port of Gladstone has undergone extensive expansion to facilitate the increasing coal export as well as the new development of three recently completed LNG facilities. Significant environmental and socio‐economic impacts and concerns have occurred as a result of these developments. The overall aim of the article, therefore, is to identify the risk governance deficits that arose and to formulate processes capable of improving similar decision‐making problems in the future. The structure of the IRGC framework is followed because it represents a broad analytical approach for considering risk assessment and risk governance in Gladstone in ways that include, but also go beyond, the risk approach of the ISO 31000:2009 standard that was employed at the time. The IRGC risk framework is argued to be a consistent and comprehensive risk governance framework that integrates scientific, economic, social, and cultural aspects and advocates the notion of inclusive risk governance through stakeholder communication and involvement. Key aspects related to risk preassessment, risk appraisal, risk tolerability and acceptability, risk management, and stakeholder communication and involvement are considered. The results indicate that the risk governance deficits include aspects related to (i) the risk matrix methodology, (ii) reflecting uncertainties, (iii) cumulative risks, (iv) the regulatory process, and (v) stakeholder communication and involvement.     

Formulating Contextual Building Regulations for Hill Towns of India: The Case of Shimla

Hill towns of India are best known for their salubrious climate, scenic beauty, picturesque setting and healthy living environment. Hill towns have been experiencing high pressure for development for the last three decades and as a result, are facing numerous problems related to new development that is contextually inappropriate and leads to deteriorated living conditions and poor environmental quality. Most of the issues of existing development are due to contextually inappropriate building regulations, which are formulated without consideration of the geoenvironmental and developmental context of environmentally sensitive hill towns. Moreover, no scientific and systematic approach is followed for the formulation of regulations. A new approach based on various intrinsic characteristics and factors is required for formulation of building regulations in the particular context to hill towns of India. The relevant issues related to building regulations are highlighted in this paper along with the identification of a more suitable building regulatory system for the specific context of hill towns. The article suggests a new approach for the formulation of building regulations for hill towns, based on various intrinsic characteristics and different factors, which are crucial for contextual development in hill towns.     

Regulatory Models and the Environment: Practice, Pitfalls, and Prospects

Computational models support environmental regulatory activities by providing the regulator an ability to evaluate available knowledge, assess alternative regulations, and provide a framework to assess compliance. But all models face inherent uncertainties because human and natural systems are always more complex and heterogeneous than can be captured in a model. Here, we provide a summary discussion of the activities, findings, and recommendations of the National Research Council's Committee on Regulatory Environmental Models, a committee funded by the U.S. Environmental Protection Agency to provide guidance on the use of computational models in the regulatory process. Modeling is a difficult enterprise even outside the potentially adversarial regulatory environment. The demands grow when the regulatory requirements for accountability, transparency, public accessibility, and technical rigor are added to the challenges. Moreover, models cannot be validated (declared true) but instead should be evaluated with regard to their suitability as tools to address a specific question. The committee concluded that these characteristics make evaluation of a regulatory model more complex than simply comparing measurement data with model results. The evaluation also must balance the need for a model to be accurate with the need for a model to be reproducible, transparent, and useful for the regulatory decision at hand. Meeting these needs requires model evaluation to be applied over the "life cycle" of a regulatory model with an approach that includes different forms of peer review, uncertainty analysis, and extrapolation methods than those for nonregulatory models.     

Compliance Strategies and Regulatory Effectiveness of Performance-Based Regulation of Chemical Accident Risks

This paper investigates the role that performance-based regulations can play in linking a firm's environmental, health, and safety concerns with their corporate strategy. The specific focus is on the performance standards required by the Clean Air Act Amendments (CAAA) which require firms that store or use certain chemicals to develop a Risk Management Plan (RMP) for reducing the likelihood and impact of accidents at their plants. Data from a series of case studies and interviews of executives in chemical firms reveal that proactive companies integrated many of the requirements of the CAAA into their management systems prior to the regulatory requirements. Most of these firms tend to be large ones. Small firms often lack the resources to implement these regulations and hence have tended to have a more difficult time with compliance.     

Impact of Hazardous Substances Regulations on Small Firms in Delaware and New Jersey

Regulations under the 1990 Amendments to the Clean Air Act impose significant requirements on firms handling hazardous chemicals. The nature of the regulations would suggest that small firms, because of limited resources and other structural limitations, would experience more difficulty complying with the regulations than large firms. To understand the difficulties imposed by the regulations on small firms, we interviewed ten small firms in Delaware and New Jersey, states with existing hazardous regulations similar to those being considered by the U.S. Environmental Protection Agency, and evaluated their responses to state regulations. The impacts of the environmental regulations on the firms and on the risk levels of their businesses are discussed. Propositions for research into small firms compliance are developed. Possible means for reducing the regulatory burden on small firms while enhancing regulatory effectiveness are suggested.     

Informational Regulation of Environmental Risks

This paper examines the law and economics of informational regulation (IR) of environmental risks. Informational regulation here means regulation which provides to affected stakeholders information on the operations of regulated entities, usually with the expectation that such stakeholders will then exert pressure on these entities to comply with regulations in a manner which serves the interests of stakeholders. As such, IR reinforces and augments direct regulatory monitoring and enforcement through third-party monitoring and incentives. The paper provides two contrasting frameworks, from law and economics, to analyze the costs and benefits likely to arise from IR and concludes with a discussion of the appropriate scope of IR as a substitute for and complement of traditional environmental regulation and law.     

Applications of probabilistic risk assessments: the selection of appropriate tools

Probabilistic risk assessment (PRA) is an important methodology for assessing the risks of complex technologies. This paper discusses the strengths and weaknesses of PRA. Its application is explored in three different settings: adversarial policy processes, regulatory/licensing procedures, and plant safety audits. It is concluded that PRA is a valuable tool for auditing safety precautions of existing or planned technologies, especially when it is carried out as an interactive process involving designers and plant personnel who are familiar with actual, everyday operations. PRA has not proven to be as well-suited in providing absolute risk estimates in public-policy debates concerning the acceptability of a technology, or for the licensing and regulatory procedures. The reasons for this are discussed.     

The Significance of Socioeconomic and Ethnic Diversity for the Risk Communication Process

Risk communication is being characterized as one way of facilitating more effective, democratic and participatory risk management strategies. An emphasis on formal communication approaches as a means to improve decisions and decrease conflict will highlight the challenge of managing hazards within a culturally heterogeneous society. Communication and participatory strategies will be considered successful only if diverse communities can be engaged as partners in the policy process. Because responses to risks are embedded and evolve within broader social environments, achieving the promise of risk communication across a diverse society may not be possible absent an understanding of how sociocultural variables and past experiences shape the exchange of ideas or information in any particular situation. This paper considers the implications of ethnic and socioeconomic variability for the risk communication process, summarizing theoretical perspectives and empirical evidence on the link between sociocultural features and risk responses. Specifically, the factors that define the context of communication may influence: the initial framing of a risk issue, particularly, the adoption of an environmental justice vs. scientific/economic perspective; the perceived importance of various aspects of the decision problem; and prior beliefs about environmental hazards and agencies involved in risk management. Two examples of situations requiring communications about risk are presented and illustrate how these principles could operate in minority or lower-income communities. A significant challenge for health and regulatory officials will be to engage in an interactive process of information and opinion exchanges that is reasonable and effective within vastly different socioeconomic and cultural contexts.     

Promoting Transparency of Long-Term Environmental Decisions: The Hanford Decision Mapping System Pilot Project

Nuclear waste cleanup is a challenging and complex problem that requires both scientific analysis and dialogue among a variety of stakeholders. This article describes an effort to develop an online information system that supports this analytic-deliberative dialogue by integrating cleanup information for the Hanford Site, and making it more "transparent." A framework for understanding and evaluating transparency guided system development. Working directly with stakeholders, we identified information needs and developed new ways to organize and present the information so that it would be more transparent to interested parties, with the ultimate aim of fostering greater participation in decision dialogues and processes. The complexity of the information needed for dialogue suggested that several types of communication devices ("information structures") were warranted. Five information structures were developed for the pilot Decision Mapping System (http://nalu.geog.washington.edu/dms). Decision maps hyperlinked decision information to maps of Hanford. Background Information provided context in a narrative format. Decision Paths organized decision process information on a timeline and provided direct hyperlinks to online documentation. The Geographic Library hyperlinked decision documents to maps. Finally, a Discussion Forum allowed users to make comments and view remarks from others. Early lessons from this work suggest that transparency is integral to long-term management, a participatory design process contributed greatly to its perceived success, and better data integration to support decision making is needed. This work has broad implications for risk communicators and risk managers because it speaks to the design of information systems to support "analytic-deliberative" decision processes (i.e., those that rely upon both risk science and public dialogue).     

Defragmenting the Regulatory Process†

The regulatory process is often criticized for being cumbersome and slow, much like a computer whose hard drive is fragmented by files no longer used or useful. Like such a computer, the regulatory process contains many requirements of dubious utility. These include the Paperwork Reduction Act, the Regulatory Flexibility Act, and numerous executive orders. While other parts of the regulatory process such as notice and comment and cost‐benefit analysis have received much more academic attention, these other parts of the process deserve examination as well. This article argues that such an examination will reveal that these statutes and executive orders add little of value to the regulatory process while consuming agency resources. An improved requirement for cost‐benefit analysis with distributional analysis could easily replace virtually all of these requirements and improve regulations while reducing the time needed to promulgate regulations.     

Precautionary Regulation in Europe and the United States: A Quantitative Comparison

Much attention has been addressed to the question of whether Europe or the United States adopts a more precautionary stance to the regulation of potential environmental, health, and safety risks. Some commentators suggest that Europe is more risk-averse and precautionary, whereas the United States is seen as more risk-taking and optimistic about the prospects for new technology. Others suggest that the United States is more precautionary because its regulatory process is more legalistic and adversarial, while Europe is more lax and corporatist in its regulations. The flip-flop hypothesis claims that the United States was more precautionary than Europe in the 1970s and early 1980s, and that Europe has become more precautionary since then. We examine the levels and trends in regulation of environmental, health, and safety risks since 1970. Unlike previous research, which has studied only a small set of prominent cases selected nonrandomly, we develop a comprehensive list of almost 3,000 risks and code the relative stringency of regulation in Europe and the United States for each of 100 risks randomly selected from that list for each year from 1970 through 2004. Our results suggest that: (a) averaging over risks, there is no significant difference in relative precaution over the period, (b) weakly consistent with the flip-flop hypothesis, there is some evidence of a modest shift toward greater relative precaution of European regulation since about 1990, although (c) there is a diversity of trends across risks, of which the most common is no change in relative precaution (including cases where Europe and the United States are equally precautionary and where Europe or the United States has been consistently more precautionary). The overall finding is of a mixed and diverse pattern of relative transatlantic precaution over the period.