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Abstract: 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 EPA claimed to base its standards on a singular concern for public health, it set its standards at levels that will still lead to hundreds, if not thousands, of deaths each year. In other ways, EPA's positions were like shifting sands, changing at points that apparently were expedient for the agency. Such an outcome should not be unexpected when an agency misuses science as a policy rationale, but it also need not be inevitable if agencies accept the limits of science in justifying risk standards. We conclude by offering a set of principles to give direction to standard setting by EPA and other agencies. In the case of EPA's air quality program, Congress will likely need to amend the Clean Air Act to enable EPA to break free of the conceptual incoherence in which it now finds itself mired. Decision makers in any setting, though, can avoid the problem of shifting sands by carefully understanding what science can and cannot do.
Risk management, administrative law, environmental regulation
Abstract: This paper represents a very early stage of a collaborative research project on transnational NT regulation. In this project, we seek to apply a multidisciplinary perspective to the question of regulation of nanotechnology (NT). We begin in Section I by considering the nature of NT and some risks it may pose as it is more fully developed and utilized over time. We next consider the nature of transnational "regulation," suggesting the range of legal, institutional and substantive forms this term can encompass. Because NT and its regulation are (like our project) at such early stages of development, we emphasize the importance of regulatory flexibility. In Section II, we consider a series of strategic choices that must be faced in designing transnational regulation in any issue area, including NT; these include the level and scope of regulation, the actors authorized to promulgate regulatory norms, the legal and institutional form of regulation, and finally its substantive content. In Section III, we argue that it is useful, although not definitive, to study models of transnational regulation developed for similar issues arising out of other forms of technology. While few if any of these models will be directly applicable to the unique characteristics of NT, the designers of these regulatory regimes faced similar strategic choices as well as similar problems, and the models they created can offer useful lessons. We briefly discuss a few potential models to illustrate the approach. Our larger research project will expand the study of transnational models beyond those discussed here, with a view to developing more specific recommendations for NT regulation. Consistent with our emphasis on regulatory flexibility, we conclude by tentatively suggesting a sequencing of regulatory approaches designed to allow NT regulation to develop over time into broader, more elaborate and more highly legalized form as we gain greater knowledge of, and experience with, the benefits and costs of NT.
nanotechnology, regulation, international law, technology, international relations, soft law
Abstract: With nanotechnology now a major funding priority for governments and industry around the world, devising the manner and timing of regulation presents a challenge. Too much regulation too soon could hinder development of beneficial technologies, while too little regulation too late may allow dangerous technologies to enter the market. Kenneth Abbott, Gary Marchant, and Douglas Sylvester argue that any solution to this regulatory dilemma must have four basic characteristics: the solution must be flexible, innovative, international, and official. In this Article, they advocate a framework convention on nanotechnology as a regulatory tool meeting these four requirements. The authors use a series of case studies to reveal framework convention best practices, and conclude with a summary of how a nanotechnology framework convention might be structured.
nanotechnology, regulation, international law, technology, international relations, soft law, framework, convention, environmental, trade, Gatt, WTO, tobacco convention
Abstract: As an international policy issue, nanotechnology (NT) presents a unique set of attributes and poses an extraordinary set of regulatory challenges. Given that NT is a major funding priority for governments and industry groups around the world, it is expected to rapidly evolve and advance, presenting risks and benefits that are still largely unknown and even unanticipated. While some politicians, social scientists and activists call for robust regulatory oversight, regulators struggle with their lack of data and knowledge, still far more limited than the levels of information they typically require as a prerequisite for regulatory action. This situation poses a dilemma: while the lack of regulation has the potential to undercut public confidence in this nascent technology, premature and inappropriate regulation could impede the development of socially beneficial products and applications. One regulatory tool that may prove useful is an international framework convention for NT. This paper describes the concept of the framework convention, briefly discusses several examples of framework conventions and related agreements that may provide relevant analogues or lessons for NT, and concludes with a summary on how a framework convention on NT might be structured.
Abstract: Like all technologies, nanotechnology will inevitably present risks, whether they result from unintentional effects of otherwise beneficial applications or from the malevolent misuse of technology. Increasingly, risks from new and emerging technologies are being regulated at the international level, although governments and private experts are only beginning to consider the appropriate international responses to nanotechnology. In this paper, we explore both the potential risks posed by nanotechnology and potential regulatory frameworks that law may impose. In so doing, we also explore the various rationales for international regulation including the potential for cross-boundary harms, sharing of regulatory expertise and resources, controlling protectionism and trade conflicts, avoiding a "race to the bottom" in which governments seek economic advantage through lax regulation, and limiting the "nano divide" between North and South. Finally, we examine some models for international regulation and offer tentative thoughts on the prospects for each.
nanotechnology, regulation, international law, technology
Abstract: Risk management of nanotechnology is challenged by enormous uncertainties about the properties, risks, benefits, and future direction of nanotechnology applications. Because of these uncertainties, traditional risk management principles including acceptable risk, cost-benefit analysis and feasibility are unworkable, as is the more recent precautionary principle. Yet simply waiting for these uncertainties to be resolved before attempting to manage nanotechnology risks would not be prudent, in part because of growing public concerns driven by risk perception heuristics such as affect and availability. A more reflexive, incremental, and cooperative approach is required. Such an approach will not only help manage emerging risks from nanotechnology, but will also serve as a model for managing future technologies.
Technology, Psychology, Heuristics, Nanotechnology, Regulation, International, precautionary, risk regulation, risk perception, voluntary programs, norms
Abstract: 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 its revised standards on a singular concern for public health, it set the new standards at levels that will still lead to hundreds, if not thousands, of deaths each year. The EPA's claim to rely solely on science contributed to positions that ultimately failed to meet the law's aspiration of reasoned decision-making by administrative agencies.
Environmental Protection Agency, air quality, air quality standards, EPA, regulation, Clean Air Act, public health, pollution, National Ambient Air Quality Standards, environmental regulation, administrative law, judicial review
Abstract: Risk management of nanotechnology is challenged by the enormous uncertainties about the risks, benefits, properties, and future direction of nanotechnology applications. Because of these uncertainties, traditional risk management principles such as acceptable risk, cost-benefit analysis, and feasibility are unworkable, as is the newest risk management principle, the precautionary principle. Yet, simply waiting for these uncertainties to be resolved before undertaking risk management efforts would not be prudent, in part because of the growing public concerns about nanotechnology driven by risk perception heuristics such as affect and availability. A more reflexive, incremental, and cooperative risk management approach is required, which not only will help manage emerging risks from nanotechnology applications, but will also create a new risk management model for managing future emerging technologies.
technology, heuristic, risk, regulation, uncertainty, braithwaite, model, emerging, psychology, precautionary
Abstract: Epigenetics is one of the most scientifically important, and legally and ethically significant, cutting-edge subjects of scientific discovery. Epigenetics link environmental and genetic influences on the traits and characteristics of an individual, and new discoveries reveal that a large range of environmental, dietary, behavioral, and medical experiences can significantly affect the future development and health of an individual and their offspring. This article describes and analyzes the ethical and legal implications of these new scientific findings.
Epigenetics, genetic, environmental
Abstract: The traditional assumption in most genetic research is that the donors of genetic material used in research act altruistically and are entitled to no property rights or direct benefit-sharing in the fruits of the research. This traditional assumption is now being challenged from several different directions. Some international ethics guidelines, advocacy organizations for families suffering from genetic diseases, and special populations such as Indian tribes are all pushing for greater control, rights, and benefit-sharing for genetic donors. The failure to resolve the tensions between these new demands and the traditional assumption of genetic research has the potential to create a bottleneck in the supply of genetic samples vital to the advancement of genetic research. This Article traces the recent controversies and trends that are challenging the traditional assumption that DNA donors in genetic research have no property or other rights in their donated material and outlines some alternative approaches for resolving this problem.
Genetic research, property rights, benefit-sharing
Abstract: Forthcoming in Regulation and Governance (2009). Although it is often argued that government oversight is needed to assure public opinion does not mistakenly view nanotechnology as dangerous or to restore public trust in government agencies, a question that we ask in this article, and one that implicates many of the themes raised in the other papers in this symposium, is whether governments can truly play this role. In short, as the world lurches toward regulation of NT we should ask: Why the rush? Can anticipatory regulation, perceived as the government doing something, fulfill the competing hopes to "restore trust," "pave-the-way," "increase awareness," or "satisfy democratic notions of accountability"? Or, is regulation more likely to increase existing divisions about nanotechnology's future?
Nanotechnology, Regulation, Technology, Genetics, Genetically modified, Governance, Risk, Cognitive, Psychology, Culture, Public Engagement
Abstract: The tort system generally treats plaintiffs as indistinguishable black boxes, entitled to compensation when a defendant's wrongful act or defective product causes some manifest disease or injury. This paradigm is likely to change dramatically with recent advances in genetic and related technologies. By peering inside the individual plaintiff to identify cellular and molecular markers that indicate both the status and etiology of pre-symptomatic disease processes, it will be possible to differentiate among individuals with respect to susceptibility and predispositions. This article surveys potential, and in some cases existing, uses of such biomarkers in toxic injury litigation and assesses the doctrinal, procedural, policy, and normative issues they present.
Abstract: The tort system generally treats plaintiffs as indistinguishable black boxes, entitled to compensation when a defendant's wrongful act or defective product causes some manifest disease or injury. This current paradigm is likely to change dramatically with recent advances in genetic and related technologies. These new technologies will permit differentiation of individuals with respect to susceptibility and predispositions, and to peer inside the individual plaintiff to identify cellular and molecular markers that identify both the status and etiology of pre-symptomatic disease processes. This Article surveys potential, and in some cases existing, uses of such biomarkers in toxic injury litigation, and assesses the doctrinal, procedural, policy and normative issues presented by these biomarker applications.
Abstract: In this Chapter, we set out the pivotal questions relating to the United States approach to nanotechnology and other emerging technologies. We note how the experiences of biotechnology regulation are likely to continue to inform United States approaches. After setting out these principles, we discuss three regulatory experiences and approaches that we believe do and will inform United States regulatory policy going forward. We examine the Coordinated Framework for the regulation of biotechnology and, in so doing, look at the actions of three separate agencies: (1) EPA; (2) FDA; and (3) NIOSH. We conclude with a high-level discussion of the various issues that remain unresolved in the United States approach.
nanotechnology, regulation, technology, biotechnology, EPA, FDA, NIOSH, risk
Abstract: As policymakers struggle to develop regulatory oversight models for nanotechnologies, there are important lessons that can be drawn from previous attempts to govern other emerging technologies. Five such lessons are: (1) public confidence and trust in a technology and its regulatory oversight is probably the most important factor for the commercial success of a technology; (2) regulation should avoid discriminating against particular technologies unless there is a scientifically-based rationale for the disparate treatment; (3) regulatory systems need to be flexible and adaptive to rapidly changing technologies; (4) ethical and social concerns of the public about emerging technologies need to be expressly acknowledged and addressed in regulatory oversight; and (5) international harmonization of regulation may be beneficial in a rapidly globalizing world.
nanotechnology, regulation, international law, technology, international relations, soft law, biotechnology, genetics
Abstract: Profs. Kenneth Abbott, Gary Marchant, and Douglas Sylvester argue that regulation of nanotechnology should be flexible and adaptive; innovative; international; and official. In order to meet these requirements, the authors call for negotiation of an international framework convention on nanotechnology as soon as possible. In response, Lynn Bergeson appreciates the inherent logic and appeal of their proposal, but questions whether the timing is right for the necessary parties to undertake the concerted effort needed to create such a convention. Similarly, David Rejeski applauds the idea, but wonders whether competitive pressures and government inaction leave any room for negotiation of such a convention or whether dramatic developments will be necessary to prompt action. On the other hand, Brent Blackwelder believes that the risks posed by nanotechnology are so great that there is no time to negotiate a convention and that a moratorium on nanotechnology should precede any other regulatory efforts.
Abstract: In less than a decade, nanotechnology has exploded from a relatively obscure and narrow technical field to a scientific, economic, and public phenomenon. The precipitous emergence of such a broad and significant technology has created an unprecedented opportunity to craft new regulatory or oversight approaches on a clean slate. Indeed, discussions of appropriate forms of regulatory oversight for nanotechnology have shadowed the exponential growth of the technology itself, with a rapid proliferation in calls and proposals for regulation. The actual adoption of nanotechnology regulations, however, has increasingly lagged both the technology and the academic and policy debate. Regulatory scholars, including ourselves, have raised the option of international harmonization since the outset of the discourse on nanotechnology regulation. Despite these initial calls for harmonization, however, very little has occurred and the time for progress in this area may be quickly dwindling. Ultimately, there are appealing arguments for harmonization, summarized in part I below. To be sure, for the reasons stated in part II, formal international regulation, as traditionally understood and applied, is unlikely to be feasible anytime soon. Yet less formal "governance" approaches may still hold promise for promoting the international coordination, if not harmonization, of nanotechnology regulation; we explore these approaches in Part III.
Nanotechnology, regulation, international law, technology, soft law, cognitive, harmonization, environmental
Abstract: Regulatory oversight of nanotechnology is necessary yet problematic. The necessity of regulation, now or later, is driven by two related concerns. First, some nanotechnologies, if left unregulated, are likely to pose very real if currently unknowable risks of significant health or environmental damage. Second, public confidence in new technologies and in the regulatory agencies that govern them may be permanently damaged if injurious nanomaterials are released without adequate, or at least the perception of adequate, oversight.
Of late, we have seen numerous proposals for “soft law” solutions, at least in the short term, as well as the implementation of some soft law mechanisms. None are based on the traditional command–and-control approach, under which government agencies enact detailed regulatory requirements enforced by the threat of penalty. Instead, all reflect a variety of voluntary, cooperative or partnership approaches. However, although these approaches have many advantages, none of the currently operational regimes has fully achieved two obvious and oft-cited goals of nanotechnology regulation: (1) broad industry participation, with sufficient data submission to aid regulators in risk assessments; and (2) reassurance of public stakeholders as to government’s role in regulating emerging technologies.
This article therefore proposes another soft law option that may better achieve these goals. We propose a voluntary certification scheme under which companies that produce nanotechnology products may obtain a government-supervised certification for specific products if the firms subject those products to specified safety testing, data disclosure and risk management measures. Given differing national regulatory approaches, our proposal is designed primarily for the United States. However, there is nothing in the proposal that could not be adapted for use in other jurisdictions, indeed, nothing to prevent creation of an equivalent international scheme.
Part II sets up the need for new approaches by explaining why regulation of nanotechnology is largely infeasible under traditional approaches. Part III summarizes the experience and promise of current soft law regimes, as well as some of their limitations. This Part also identifies some features of successful certification systems and discusses their relevance to a nanotechnology certification system. Part IV introduces our proposal for a voluntary safety testing certification scheme, and discusses the ways in which such a scheme might gain the trust of consumers and other relevant audiences. Part V considers the elements of the scheme in greater detail. The final section is a brief conclusion.
nanotechnology, trust, certification, soft law, voluntary reporting, fda, reach, regulation, cognitive, psychology, governance, risk
Abstract: One direct mechanism for improving public confidence in genetically modified foods may be to provide a greater role for the public in making policy decisions about such products. There are compelling normative and practical reasons for involving the public in such decisions. Yet, effective and meaningful public participation is made difficult by several factors, most importantly the lack of knowledge by most members of the public about scientific subjects, including biotechnology. A number of mechanisms for public participation exist, but most suffer from one of two principal limitations. Either they provide for only a small number of participants, usually representatives of interest groups, or they provide for widespread public participation but have no means for ensuring that the public input is informed. The recently completed national debate on GM foods in the United Kingdom illustrates many of the difficulties in providing for informed and effective public participation. New innovative approaches, such as on-line deliberations, are needed to achieve the goal of meaningful public participation in science-based policy decisions about genetically modified foods.
Science, public participation, policy
Abstract: It may be an understatement to suggest that health care in the United States is in a state of flux. Whether one looks at the science, the policy, the ethics or the business of medicine, Americans are witnessing changes like they never have in the past. Though many of these trends are affected by the vast numbers of people needing ever-increasing modes of treatment, one trend heads in the other direction: toward a focus on the needs of the individual. We are on the verge of a fundamental transformation from the “one size fits all” approach of the past to what may be called “personalized medicine”. In this approach, pharmaceuticals and other treatments are tailored to an individual’s genetic profile. This rapid change under way in the practice of medicine will have profound significance and implications for the practice of law. In a few important ways, Arizona is poised to be at the forefront of this paradigm shift to personalized medicine in both its medical and legal contexts. Arizona is also at the forefront in training the professionals who will be needed to implement the new paradigm of PM. The new Phoenix medical school will include an innovative teaching module in PM. The University of Arizona College of Pharmacy is pioneering a clinical pharmacogenomics program. And ASU’s Sandra Day O’Connor College of Law recently launched the world’s first LLM degree program for lawyers that specifically focuses on legal aspects of genomics and biotechnology, of which PM is a major emphasis.
Personalized medicine, genetics, biotechnology
Abstract: Since the beginning of the modern environmental legal framework in the early 1970s, the credibility of government science has been the focus of constant scrutiny and controversy. This article examines the role of science in environmental regulatory decisions and identifies some persistent problems and recent controversies over the role of science in regulatory decisions. It then proposes two new alternative institutional innovations for improving the science on which the government's environmental decisions rest: a Scientific and Engineering Investigation Board, which would be appointed by EPA and work with key stakeholders to frame and promote progress on scientific issues at the early stages of the regulatory process, and an Institute for Scientific Assessments, which would be an independent agency that would review and resolve key issues of science for use in regulatory decisions. Both proposals seek to minimize the influence of politics on science.
Abstract: Legal analysis of genetics has so far focused primarily on DNA forensic evidence used in criminal cases and potential discriminatory uses of genetic information in employment or insurance contexts. Toxic torts is another area of the law that will both use, and be transformed by, genetic information. Genetic data have many potential applications to toxic torts, such as in proving or disproving causation or establishing the appropriate amount of damages to injured plaintiffs. Genetic variations that affect the individual susceptibility and hence relative risk of exposed persons, or genetic changes which provide objective, quantitative proof of exposure, can greatly reduce much of the uncertainty and arbitrariness that currently hinders toxic tort litigation. Through these and other applications, genetic evidence may be beneficial to either plaintiffs or defendants in particular lawsuits. Genetic information potentially relevant to toxic tort litigation can be divided into two major categories. The first involves inherited genetic variations that affect an individual's susceptibility to disease as a result of toxic exposures. The second consists of genetic changes that occur in individual cells as a result of toxic exposures during the person's lifetime. These mutations are usually not passed on to future generations (unless they occur in reproductive cells), but can provide useful biomarkers of exposure or the early stages of the disease process in the exposed individual. As discussed below, both types of genetic information have multiple potential applications in toxic tort litigation, and indeed are already beginning to be applied in individual cases.
Genetics, toxic torts, litigation
Abstract: In June 1986, the federal government, through the Office of Science and Technology Policy, published its Coordinated Framework for Regulation of Biotechnology. Unfortunately, the failure to agree on clear, common definitions of fundamental terms such as "release into the environment" and "genetically engineered" microorganism has led to confusion and violations of the regulations. A novel organism with new traits created in a laboratory might present a risk similar to that presented by an existing species imported from a different continent. A genetically engineered microorganism under development for use in the environment must be field tested many times before it will be ready for the market. An efficient method for allocating scarce governmental resources available for biotechnology regulation would be to create risk categories subject to different levels of regulatory scrutiny, depending on the magnitude of the hazards involved First, no genetically engineered microorganism will be released into the environment without at least an abbreviated review by a federal agency. Most of the worst-case scenarios for deliberate release experiments involve the proliferation and widespread dispersal of the genetically engineered microorganism. The federal government, in drafting its Coordinated Framework for Regulation of Biotechnology, attempted to balance the interests of those seeking protection of the public health and the environment with the interests of the industry in avoiding a stifling regulatory burden.
Coordinated Framework for Regulation of Biotechnology, Public Health Law, Genetically Engineered Microorganism
Abstract: Due to the difficulties of proving causation in most toxic tort suits, plaintiffs and defendants in toxic tort litigation have begun to develop and use scientifically sophisticated risk assessments as evidence in proving or disproving causation. This use has led to two new trends in tort liability. First, there is the trend in which risk assessment is used by plaintiffs to buttress claims for future injury or increased risk. Second, there is the trend in which risk assessment is used by defendants to establish that other factors caused, in whole or in part, plaintiffs’ injuries. This article evaluates these two recent trends by describing and evaluating the applicable traditional legal doctrine, the recent case law establishing the trend, the manner in which risk assessment is used as evidence in the recent cases, the academic commentary on the trend, and the likely future development of the trend. After this evaluation, the article concludes that although use of risk assessment by plaintiffs to establish increased risk and by defendants to prove alternative causation is relatively recent, it has already had a substantial effect on tort liability and will continue such impact in the future, and therefore are of substantial risk to all possibly parties in such toxic tort litigation.
Toxic Tort Litigation, Risk Assessment Evidence, Causation
Abstract: This Article uses the lessons learned from other emissions trading programs to assess the potential effectiveness of various approaches to the control of greenhouse gases and recommends the design of a CO2 emissions policy. Section II examines the relative effectiveness of a CO2 offset program compared to traditional regulatory standards, a carbon tax, and emissions trading programs for other air pollutants. Section III develops the optimal design of a CO2 offset program. A total of twenty policy choices encountered in the design of such a program are evaluated and the best option for each policy choice is identified. Appendix A presents the twenty policy choices and the available options. In analyzing these policy choices, Section III identifies the important issues in designing and implementing a CO2 offset policy, and outlines the most feasible and effective blueprint for such a program.
Emissions, CO2, offset program
Abstract: The sequencing of the human genome revealed that the variation in the genetic material between any two individuals averages approximately one variation for every 1000 base pairs of DNA. Genetic differences in susceptibility provide an important part of the answer of why do some people get sick from certain exposures while others do not. This article examines the implications of recent findings of relatively common genetic variants, known as “polymorphisms,” within the population affecting susceptibility to environmental exposures. In particular, the Article examines the potential applications of such information in toxic tort litigation and environmental regulation. The study of differences in genetic susceptibility to environmental toxicants is sometimes referred to as “toxicogenetics.”
Genetics, toxicogenetics toxicants
Abstract: Advances in genomics, the study of the structure and function of our genetic makeup, are fundamentally transforming toxicology, the science of how toxic substances affect our bodies. These changes will inevitably spill over into the legal regimes that frequently rely on toxicological data, including toxic torts and environmental regulation. Two key applications of genomic data for toxic torts and environmental regulation are (i) the study of the expression of genes in cells or tissues in response to toxicant; and (ii) the identification of genetic variations affecting susceptibility to toxic agents. This article will address the application of toxicogenomics to toxic torts and environmental regulation. After first describing the scientific background of toxicogenomics, this article explores some potential uses of toxicogenomic data in regulation and litigation involving toxic substances.
Genomics, toxicogenomics, genes
Abstract: "Confidence-building measures" (CBMs) are concrete, incremental steps, acceptable to all parties, that can be implemented relatively easily to reduce tensions and build trust in a time of conflict. The concept of CBMs arose in the sphere of international relations, and such measures are frequently used in international conflicts as the initial steps for reducing hostilities between enemies. In this international context, CBMs usually involve some mix of communication, constraint, transparency, or verification measures. CBMs are not intended to provide an ultimate solution to a conflict, but rather to reduce tensions and increase trust. This promotes a climate that is more conducive to negotiations and cooperation on a longer-term solution. CBMs are thus intended as pragmatic steps toward more substantial and enduring objectives. The concept of CBMs may be useful for conflicts over genetically modified (GM) foods and other biotechnology products. Biotechnology has the potential to provide many health, environmental, and economic benefits to society, but the realization of those benefits is called into question by public mistrust of this nascent technology. While the American public has not shown the widespread hostility to GM products that has been experienced in Europe, public opinion polls consistently show a strong undercurrent of concern and lack of confidence in the governmental and industry institutions controlling the development of biotechnology.
Confidence-building measures, international relations, genetically modified foods
Abstract: Few provisions of environmental statutes have provoked more confusion, uncertainty, disagreement, and changes in direction and policy than has section 112 of the Clean Air Act, 42 U.S.C. § 7412 (1982). Implementation of section 112 has been hampered by a fundamental dispute over what factors should, should not, or must not be considered in setting national emission standards for hazardous air pollutants, and what levels of health risk posed by emissions of such substances are acceptable. Some of the most contentious issues arising under section 112 were addressed by the U.S. Court of Appeals for the D.C. Circuit in Natural Resources Defense Council v. EPA, 824 F.2d 1146 (D.C. Cir. 1987). This article analyzes the court’s holdings regarding two of the most controversial issues regarding section 112 rule-making, and their effect upon future environmental regulation.
Natural Resources Defense Council v. EPA, Environmental Protection Agency, Air Pollution
Abstract: This Article critiques the EPA’s refusal to consider economic impacts and health disbenefits in revising the ozone standard on both policy and legal grounds. For each of these two factors, it is first argued that consideration of the factor is necessary for rational decision-making. Second, the EPA’s argument that the Clean Air Act precludes the Agency from considering each factor is shown to be untrue, and indeed is inconsistent with the statutory languages and objectives. Part I briefly summarizes the EPA’s decision to revise the ozone standard. Part II examines the policy and legal flaws in the EPA’s decision not to consider costs, while Part III addresses parallel flaws in the EPA’s refusal to consider the health disbenefits of the revised ozone standard.
EPA, Clean Air Act, ozone standard
Abstract: Environmental protection necessarily requires choices. While expected to make reasonable choices, environmental agencies often bow to internal incentives and external pressures to do just the opposite. Courts have rarely reversed explicitly on the grounds that an agency has adopted an unreasonable result. Simply by interpreting the Administrative Procedure Act to require that agency actions do more good than harm, courts could spark a chain reaction that would improve agency performance, foster a more explicit and accountable balancing of interests in the legislative process, and lay the foundation for a more effective hard look executive oversight. Eventually, these trends would, in turn, diminish the need for intrusive judicial scrutiny. The public would benefit by achieving more environmental protection at less cost, thereby freeing resources to address other pressing social problems.
Environmental Law, Administrative Procedure Act,
Abstract: Genomic data have the potential to transform the doctrine and practice of toxic tort litigation. This article discusses potential applications of two types of data in toxic tort litigation: (i) genetic variations in susceptibility to toxic exposures; and (ii) genetic biomarkers of exposure and early toxicological effects. Several different applications of these types of genetic data are likely for proving or disproving exposure, causation, and damages, some of which have already been attempted by toxic tort litigants. Most potential applications of genomic data will fit into existing tort doctrinal templates, but will raise new evidentiary, policy and ethical issues.
Genomics, Toxic Torts, Biomarkers, Ethics
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