Law Commons^™

Against 'Individual Risk': A Sympathetic Critique Of Risk Assessment, Matthew D. Adler

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"Individual risk" currently plays a major role in risk assessment and in the regulatory practices of the health and safety agencies that employ risk assessment, such as EPA, FDA, OSHA, NRC, CPSC, and others. Risk assessors use the term "population risk" to mean the number of deaths caused by some hazard. By contrast, "individual risk" is the incremental probability of death that the hazard imposes on some particular person. Regulatory decision procedures keyed to individual risk are widespread. This is true both for the regulation of toxic chemicals (the heartland of risk assessment), and for other health hazards, such as …

The Fda And The Tort System: Postmarketing Surveillance, Compensation, And The Role Of Litigation, Catherine T. Struve

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The dispute over FDA regulatory preemption is familiar: Preemption advocates assert that products liability suits stifle innovation, and proponents of tort liability counter that the FDA fails adequately to protect the public and that persons injured by defective products deserve compensation. The FDA's premarket approval process cannot detect all potential safety problems with a new drug; postmarketing surveillance is essential, and the FDA's efforts in that regard fall short. Advocates of preemption will find it difficult to establish that FDA regulation should entirely displace the tort system. This article examines whether a case could be made for an intermediate approach …

The Internet And Citizen Participation In Rulemaking, Cary Coglianese

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Each year, regulatory agencies promulgate thousands of important rules through a process largely insulated from ordinary citizens. Many observers believe the Internet could help revolutionize the rulemaking process, allowing citizens to play a central role in the development of new government regulations. This paper expresses a contrary view. In it, I argue that existing efforts to apply information technology to rulemaking will not noticeably affect citizen participation, as these current efforts do little more than digitize the existing process without addressing the underlying obstacles to greater citizen participation. Although more innovative technologies may eventually enable the ordinary citizen to play …

Architectural Censorship And The Fcc, Christopher S. Yoo

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Most First Amendment analyses of U.S. media policy have focused predominantly on “behavioral” regulation, which either prohibits the transmission of disfavored content (such as indecent programming) or mandates the dissemination of preferred content (such as children’s educational programming and political speech). In so doing, commentators have largely overlooked how program content is also affected by “structural” regulation, which focuses primarily on increasing the economic competitiveness of media industries. In this Article, Professor Christopher Yoo employs economic analysis to demonstrate how structural regulation can constitute a form of “architectural censorship” that has the unintended consequence of reducing the quantity, quality, and …

Images Of Representation, Elizabeth Magill

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This paper is one of a series of papers commemorating Richard Stewart’s important article, The Reformation of American Administrative Law. Among other things, Stewart’s 1975 article identified “interest representation” as the central idea that animated a series of important and disparate developments in administrative law doctrine.

This paper unpacks the idea of interest representation and identifies tension in that idea. It does so by asking a simple question: What is the function of representing interests in administrative process? The paper argues that, in Stewart’s work and in the law more generally, there are two distinct answers to that question. One …

Shifting Sands: The Limits Of Science In Setting Risk Standards, Cary Coglianese, Gary E. Marchant

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Regulators need to rely on science to understand problems and predict the consequences of regulatory actions, but over reliance on science can actually contribute to, or at least deflect attention from, incoherent policymaking. In this article, we explore the problems with using science to justify policy decisions by analyzing the Environmental Protection Agency's recently revised air quality standards for ground-level ozone and particulate matter, some of the most significant regulations ever issued. In revising these standards, EPA mistakenly invoked science as the exclusive basis for its decisions and deflected attention from a remarkable series of inconsistencies. For example, even though …

E-Rulemaking: Information Technology And The Regulatory Process, Cary Coglianese

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In order to channel interest in e-rulemaking toward effective and meaningful innovations in regulatory practice, the Kennedy School of Government's Regulatory Policy Program convened two major workshops, bringing together academic experts from computer sciences, law, and public management along with key public officials involved in managing federal regulation. This paper summarizes the discussions that took place at these workshops and develops an agenda for future research on information technology and the rulemaking process. It highlights the institutional challenges associated with using information technology in the federal regulatory process and suggests that in some cases existing rulemaking practices may need to …

Seeking Truth For Power: Informational Strategy And Regulatory Policy Making, Cary Coglianese, Richard Zeckhauser, Edward A. Parson

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Whether regulating mutual funds or chemical manufacturers, government's policy decisions depend on information possessed by industry. Yet it is not in any industry's interests to share information that will lead to costly regulations. So how do government regulators secure needed information from industry? Since information disclosed by any firm cannot be retrieved and can be used to regulate the entire sector, industry faces a collective action problem in maintaining silence. While collective silence is easy to maintain if all firms' interests are aligned, individual firms' payoffs for disclosure can vary due to heterogeneous effects of regulation and differing expectations about …

Fear Assessment: Cost-Benefit Analysis And The Pricing Of Fear And Anxiety, Matthew D. Adler

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Risk assessment is now a common feature of regulatory practice, but fear assessment is not. In particular, environmental, health and safety agencies such as EPA, FDA, OSHA, NHTSA, and CPSC, commonly count death, illness and injury as costs for purposes of cost-benefit analysis, but almost never incorporate fear, anxiety or other welfare-reducing mental states into the analysis. This is puzzling, since fear and anxiety are welfare setbacks, and since the very hazards regulated by these agencies - air or water pollutants, toxic waste dumps, food additives and contaminants, workplace toxins and safety threats, automobiles, dangerous consumer products, radiation, and so …

E-Rulemaking: Information Technology And The Regulatory Process: New Directions In Digital Government Research, Cary Coglianese

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Electronic rulemaking, or e-rulemaking, offers the potential to overcome some of the informational challenges associated with developing regulations. E-rulemaking refers to the use of digital technologies in the development and implementation of regulations. The use of these technologies may help streamline and improve regulatory management, such as by helping agency staff retrieve and analyze vast quantities of information from diverse sources. By taking better advantage of advances in digital technologies, agencies might also be able to increase the public's access to and involvement in rulemaking. Part I of this article details the rulemaking process, outlining the procedures agencies must currently …

Agency Choice Of Policymaking Form, Elizabeth Magill

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An administrative agency delegated some task--protect the environment, assure the integrity of the securities markets, improve auto safety--might carry out that obligation by adopting a rule, bringing or deciding a case, or announcing its interpretation of the statute. Although agencies are unique institutions in this respect, this state of affairs generates little comment. This Article aims to rectify that by identifying, evaluating, and coming to terms with the phenomenon of agency choice of policymaking form. That phenomenon can be simply stated: The typical administrative agency is authorized to use a range of distinct policymaking forms to effectuate its statutory mandate …

The Epa's Risky Reasoning, Cary Coglianese, Gary E. Marchant

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Regulators must rely on science to understand problems and predict the consequences of regulatory actions, but science by itself cannot justify public policy decisions. We review the Environmental Protection Agency's efforts to justify recent changes to its National Ambient Air Quality Standards (NAAQS) for ozone and particulate matter, showing how the agency was able to cloak its policy judgments under the guise of scientific objectivity. By doing so, the EPA evaded accountability for a shifting and incoherent set of policy positions that will have major implications for public health and the economy. For example, even though EPA claimed to base …

Risk Regulation, Endogenous Public Concerns, And The Hormones Dispute: Nothing To Fear But Fear Itself?, Howard F. Chang

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The dispute between the United States and the European Union (EU) regarding the EU ban on meat imports treated with hormones raises the question: How should regulators respond to public fears that are disproportionate to the risks as evaluated by experts in risk assessment? If regulators cannot eliminate public fears through education, then there is some social benefit from regulations that reduce the feared risks and thereby reduce public anxiety and distortions in behavior flowing from that anxiety. These considerations imply that we cannot simply ignore public fears that technocrats would deem "irrational." On the other hand, there is the …

Building Sector-Based Consensus: A Review Of The Epa's Common Sense Initiative, Cary Coglianese, Laurie K. Allen

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In the late 1990s, the U.S. Environmental Protection Agency (EPA) conducted what the agency considered to be a "bold experiment" in regulatory reinvention, bringing representatives from six industrial sectors together with government officials and NGO representatives to forge a consensus on innovations in public policy and business practices. This paper assesses the impact of the agency's "experiment" - called the Common Sense Initiative (CSI) - in terms of the agency's goals of improving regulatory performance and technological innovation. Based on a review of CSI projects across all six sectors, the paper shows how EPA achieved, at best, quite modest accomplishments. …

Risk, Death And Harm: The Normative Foundations Of Risk Regulation, Matthew D. Adler

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Is death a harm? Is the risk of death a harm? These questions lie at the foundations of risk regulation. Agencies that regulate threats to human life, such as the EPA, OSHA, the FDA, the CPSC, or NHTSA, invariably assume that premature death is a first-party harm - a welfare setback to the person who dies - and often assume that being at risk of death is a distinct and additional first-party harm. If these assumptions are untrue, the myriad statutes and regulations that govern risky activities should be radically overhauled, since the third-party benefits of preventing premature death and …

New Models Of Regulation And Interagency Governance, Christopher S. Yoo

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No abstract provided.

Performance-Based Regulation: Prospects And Limitations In Health, Safety And Environmental Protection, Cary Coglianese, Jennifer Nash

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Regulation aims to improve the performance of individual and organizational behavior in ways that reduce social harms, whether by improving industry's environmental performance, increasing the safety of transportation systems, or reducing workplace risk. With this in mind, the phrase "performance-based regulation" might seem a bit redundant, since all regulation should aim to improve performance in ways that advance social goals. Yet regulators can direct those they govern to improve their performance in at least two basic ways. They can prescribe exactly what actions regulated entities must take to improve their performance. Or they can incorporate the regulation's goal into the …

Ub Viewpoint – Dissolving The Shadows, Eric Easton

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No abstract provided.

Bounded Evaluation: Cognition, Incoherence, And Regulatory Policy, Cary Coglianese

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Cass Sunstein, Daniel Kahneman, David Schkade, and Ilana Ritov have recently advanced a cognitive explanation for incoherence in legal decisionmaking, showing how decision makers tend to make micro-level judgments that make little sense when viewed from a broader perspective. Among other things, they claimed to have discovered striking incoherence in regulatory policy evidenced by varied penalty levels across different statutes, with less serious violations sometimes backed up with higher penalties than more serious violations. This paper comments on Sunstein et al.'s treatment of incoherence in regulatory policy, arguing that the same cognitive limitations that Sunstein et al. argue lead to …

After "Hiding The Ball" Is Over: How The Nlrb Must Change Its Approach To Decision-Making, Michael Hayes

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Is the National Labor Relations Board (the NLRB or the Board), the agency that oversees federal labor law, still relevant? When this question is considered, as it frequently is by scholars, lawyers and officials of the NLRB itself, the focus typically is on whether changes in the workplace, the economy and society are diminishing the relevance of the Board. But there is a new and more immediate threat to the relevance of the Board that so far has been mostly ignored - that the Board is in danger of being rendered a superfluous legal institution in the scheme of American …

Reconsidering Estoppel: Patent Administration And The Failure Of Festo, R. Polk Wagner

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Last Term, in Festo Corporation v. Shoketsu Kinzoku Kogyo Kabashuki Co., the United States Supreme Court missed perhaps the most important opportunity for patent law reform in two decades. At the core of the failure to grasp the implications of "prosecution history estoppel" - a judicially-crafted principle limiting the enforceable scope of patents based on acts occurring during their application process - is the heretofore universal (but ultimately unsupportable) view of the doctrine as an arbitrary ex post limitation on patent scope. This Article demonstrates the serious flaws in this traditionalist approach, and develops a new theory of prosecution history …

Empirical Analysis And Administrative Law, Cary Coglianese

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Empirical research has been used to study many areas of law, including administrative law. In this article Professor Coglianese discusses the current and future role of empirical research in understanding and improving administrative rulemaking. Criticism of government regulation and calls for regulatory reform have grown in the last few decades. Empirical research is a valuable tool for designing reforms that will truly improve the effectiveness, efficiency, and legitimacy of regulatory governance. Specifically, Professor Coglianese discusses three areas of administrative law that have benefited from empirical research—economic review of new regulations, judicial review of agency rulemaking, and negotiated rulemaking.

Agencies are …

Assessing The Advocacy Of Negotiated Rulemaking: A Response To Philip Harter, Cary Coglianese

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For many years, advocates of negotiated rulemaking have advanced enthusiastic claims about how negotiated rulemaking would reduce litigation and shorten the rulemaking process. In an earlier study, I tested these claims systematically by assessing the effectiveness of negotiated rulemaking against existing rulemaking processes. I found that negotiated rulemaking neither saves time nor reduces litigation. Recently, Philip Harter, a longtime advocate of negotiated rulemaking, has criticized my study and asserted that negotiated rulemaking has succeeded remarkably in achieving its goals. Harter criticized the way I measured the length of the rulemaking process, claimed that I failed to appreciate differences in litigation, …

Federal Agency Ombuds: The Costs, Benefit And Countenance Of Confidentiality, Harold J. Krent

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No abstract provided.

Globalization And The Design Of International Institutions, Cary Coglianese

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In an increasingly globalized world, international rules and organizations have grown ever more crucial to the resolution of major economic and social concerns. How can leaders design international institutions that will effectively solve global regulatory problems? This paper confronts this question by presenting three major types of global problems, distinguishing six main categories of institutional forms that can be used to address these problems, and showing how the effectiveness of international institutions depends on achieving “form-problem” fit. Complicating that fit will be the tendency of nation states to prefer institutional forms that do little to constrain their sovereignty. Yet the …

International Administrative Law For The Internet: Mechanisms Of Accountability, Henry H. Perritt Jr.

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No abstract provided.

Monitoring Governmental Disposition Of Assets: Fashioning Regulatory Substitutes For Market Controls (With N. Zeppos), Harold J. Krent

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No abstract provided.

Is The Rule Of Necessity Really Necessary In State Administrative Law: The Central Panel Solution, Arnold Rochvarg

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The rule of necessity is a judicial doctrine that permits a judge or agency decision maker to decide a case even if he or she would ordinarily be disqualified due to bias or prejudice . The rationale of the doctrine is that if there is no other person who can make the decision, let the biased person decide the case rather than have no decision made at all. The rule of necessity has been used in state administrative proceedings liberally despite the fact that it is widely recognized as unfair. This article analyzes current approaches to the doctrine, and after …

Electronic Freedom Of Information, Henry H. Perritt Jr.

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No abstract provided.

Assessing Consensus: The Promise And Performance Of Negotiated Rulemaking, Cary Coglianese

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Over its thirteen year history, the negotiated rulemaking process has yielded only thirty-five final administrative rules. By comparison, the federal government publishes over 3,000 final rules each year through the ordinary notice-and- comment process. Why have federal agencies relied so little on negotiated rulemaking? I examine this question by assessing the impact of negotiating rulemaking on its two major purposes: (1) reducing rulemaking time; and (2) decreasing the amount of litigation over agency rules. My analysis suggests that the asserted problems used to justify negotiated rulemaking have been overstated and that the limitations of negotiated rulemaking have been understated. Negotiated …