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New Realities Require New Priorities: Rethinking Sustainable Development Goals in the Anthropocene
Get PDFThe United Nations 17 sustainable development goals are nominally unprioritized. However, numerically and rhetorically, the list effectively makes development goals more important than the environmental goals. This de facto prioritization, however, is deeply flawed in two respects. First, as early sustainable development theorists acknowledged, the environment is the boundary of, not co-equal to, development, constraining potential progress both economically and socially. The Anthropocene’s rapidly accelerating deterioration of the global ecological and physical processes that make human development possible will ultimately constrain development options and potential. Second, human priorities will also change dramatically as adaptation to climate change — the most visible impact of the Anthropocene — becomes a pressing and unavoidable necessity. Development will become secondary to survival for vast expanses of the human global population, who will demote environmental goals where health and security are at stake. Investing in the long-term resilience of our changing environment, in the resilience of humanity’s response to that changing environment, and in the harmonization of these two new sets of goals, therefore, are the necessary first steps to ensuring that the other sustainable development goals have any prayer of becoming achievable. The Anthropocene calls the entire sustainable development project into existential doubt — or at least puts it into hibernation until these new higher priorities are satisfied — a fact that the purveyors of sustainable development goals would do well to acknowledge
Federal Regulatory Responses to the Prescription Opioid Crisis: Too Little, Too Late?
Get PDFPart I of this Article suggests that the medical establishment shares more blame for the crisis than many commentators seem to appreciate. Part II canvasses a variety of ways in which the federal government has responded to the opioid problem during the last few years before delving more deeply into the FDA’s role in the mess, assessing the different tools that it has tried to use as well as some that it failed to employ. This Article concludes that the agency should have allowed only a narrowly defined subset of physicians to prescribe opioid analgesics, even though the medical community would have pitched a fit about any such an intrusion on its prerogatives, to say nothing of the drug manufacturers aghast at the prospect of far more modest sales. Greater use of such restrictions on distribution might have worked to nip this disaster in the bud, and it needs more serious consideration by the FDA before the next one comes down the pike
Visibility Protection Under the Clean Air Act
Get PDFThe Clean Air Act’s (CAAs) visibility protection program was created in 1977 and expanded in 1990. It applies to states with sources of air emissions that impact 156 Federal Class I areas, which include national parks and wilderness areas. Such states are required to develop haze implementation plans (SIPs) to control emissions in order to restore natural visibility in Class I areas. Initially, large stationary sources that began operating between 1962 and 1977 were to install the Best Available Retrofit Technology (BART) based on regulations issued by EPA. This process resulted in complex rules, litigation, and political maneuvering. Subsequently, the CAA was expanded to include a regional haze program that requires haze SIPs to provide for reasonable progress using a phased approach to visibility protection. The requirements apply to nearly all pollution-emitting stationary sources. For some states, the regulations provide an alternative approach to BART requirements. If a state does not develop a haze SIP that receives EPA’s approval, EPA must promulgate a federal implementation plan (FIP). This article covers the regulatory development of this program and the litigation that has helped shape the program. It discusses the efforts to protect the visibility in the Grand Canyon National Park. It discusses the State of Utah’s efforts to comply with the CAA’s visibility requirements. It concludes with a discussion of the many obstacles that make the achievement of the visibility goals problematic. This article was written in December 2017. It was accepted for publication by the George Washington Journal of Energy and Environmental Law in January 2018 for publication in the summer of 2018, volume 9. The article was updated in the spring of 2018 and again in the summer of 2018. As of the end of July 2019, it has not yet been published
Atomizing the Clean Water Act: Ignoring the Whole Statute and Asking the Wrong Questions
Get PDFWhen attempting to resolve difficult issues of statutory construction involving complex statutes, courts sometimes focus on individual words and phrases without evaluating how they fit within the text and structure of the whole statute. We call this “atomization” of the statutory text. Judges have fallen into this trap in construing the Clean Water Act (CWA) and other lengthy, complex federal environmental statutes. That tendency contributes to ongoing confusion about the scope and coverage of the CWA. During the 2019-2020 Term, the U.S. Supreme Court will resolve a circuit split in the most recent line of cases exhibiting this tendency. Courts have struggled to ascertain the scope of CWA permitting jurisdiction when pollutants reach water bodies through an intermediary conduit such as groundwater. Some courts have “atomized” that analysis, leading to further analytical confusion. Evaluating this issue in light of the functions CWA permits serve in the whole statutory scheme leads to more logical results. The “conduit” cases thus serve as a good example of the perils of atomization, and how it can be avoided through a whole text analysis. That method, in turn, can allow courts to avoid altogether separate debates about the relevance of legislative history and other non-textual indicia of congressional purpose in statutory construction
#SQUADGOALS: A Response to Seth Waxman
Get PDFFormer Solicitor General Seth Waxman’s recent remarks, framing our current age of patent law in the Supreme Court as “interesting times,” unquestionably captures the exhilaration of an active Supreme Court in this area of the law. Waxman knows his way around patent cases decided by the Supreme Court — he presented arguments in four of the six patent cases in the 2016 Term — but he also has an extensive appellate practice before the Court of Appeals for the Federal Circuit (“Federal Circuit”), which has exclusive appellate jurisdiction over patent cases. Given his substantial experience in patent appellate litigation, Waxman is a reliable observer of patent law and practice over the years, especially in the Supreme Court. In his remarks, he suggests that the Supreme Court’s “attention to patents” of late has been marked by an increase in the number of cases that it selects for its docket, by the tendency of such cases to foster uncertainty, by the lack of robust dissent in its unanimous patent cases, and by its disconnection of meaningful context from the Federal Circuit, Congress, or lower courts from its decisions. The result, he claims, is a level of uncertainty particularly poisonous to patent law because of its utilitarian nature, where the entirety of the scheme is premised on investment ex ante. Fearing that this attention will continue “for the foreseeable future,” Waxman proposes that the Court pause its patent agenda and proceed cautiously to avoid unraveling more incentives for innovation. Waxman leaves it to the reader to conclude whether these times are a blessing or a curse, but his account of the past decade’s “trends and themes” strikes a Chicken Little tone while highlighting a frenetic pace, substantial changes, uncertainty, skepticism, lopsidedness, and devaluation. In this response, I propose a more optimistic view. The problems that Waxman worries over are actually inherent to some of patent law’s values, in good and bad ways, which will keep the times interesting. In exploring some of his themes below, I lean on baseball and popular neuroscience to reframe these conflicting values positively. In doing so, I propose recasting the institutional players in patent law, including the Supreme Court and the Federal Circuit, as cooperative rivals that render the patent system more robust (and, indeed, interesting) for our times
Conflicts of Interest and Academic Research
Get PDFThis chapter discusses financial conflicts of interest in academic research. After exploring the definition of conflicts of interest, the chapter focuses on the manner in which conflicts are addressed by policies promulgated by the U.S. federal government, research institutions and scholarly journals. It concludes with suggestions for further research and policy analysis
Clean Drinking Water: A Stream of Success and Opportunity for Reform
Get PDFThe SDWA was a major regulatory step in protecting the nation’s drinking water and the public’s health. Creating a uniform set of regulations for levels of viruses, bacteria, and chemicals ensured cleaner water for all citizens and ultimately has allowed the United States to provide some of the cleanest water worldwide. The revisions made in 1986, 1996, and 2016 have continued to expand the SDWA by listing more contaminants for regulation as well as providing more federal funding to assist water providers in meeting these objectives
Private Law, Conflict of Laws, and a Lex Mercatoria of Standards-Development Organizations
Get PDFTechnical standards created by industry standards-development organizations (SDOs) enable interoperability among products manufactured by different vendors. Over the years, SDOs have developed policies to reduce the risk that SDO participants holding patents covering the SDO’s standards will disrupt or hinder the development and deployment of these standards. These policies, including commitments to license standards-essential patents (SEPs) on terms that are fair, reasonable and non-discriminatory (FRAND), gain transnational application given the international character of SDO activities and are most effectively interpreted and applied on the basis of private law (contractual) principles. However, SDO policies are typically embodied in an SDO’s governing documents, which are in turn regulated by the law of the jurisdiction in which the SDO is based. This somewhat arbitrary linkage of SDO policies to national and state law has created inconsistencies in their interpretation and threatens to spark jurisdictional competition in an unproductive race to the bottom. This paper poses the question whether it would be possible to decouple SDO policy interpretation from the patchwork of national and state laws that purport to govern such policies in favor of a common lexicon of interpretive principles derived from the shared understanding of SDO participants: a “lex mercatoria” of standardization
Data Re-Use and the Problem of Group Identity
Get PDFReusing existing data sets of health information for public health or medical research has much to recommend it. Much data repurposing in medical or public health research or practice involves information that has been stripped of individual identifiers but some does not. In some cases, there may have been consent to the reuse but in other cases consent may be absent and people may be entirely unaware of how the data about them are being used. Data sets are also being combined and may contain information with very different sources, consent histories, and individual identifiers. Much of the ethical and policy discussion about the permissibility of data reuse has centered on two questions: for identifiable data, the scope of the original consent and whether the reuse is permissible in light of that scope, and for de-identified data, whether there are unacceptable risks that the data will be reidentified in a manner that is harmful to any data subjects. Prioritizing these questions rests on a picture of the ethics of data use as primarily about respecting the choices of the data subject. We contend that this picture is mistaken; data repurposing, especially when data sets are combined, raises novel questions about the impacts of research on groups and their implications for individuals regarded as falling within these groups. These impacts suggest that the controversies about de-identification or reconsent for reuse are to some extent beside the point. Serious ethical questions are also raised by the inferences that may be drawn about individuals from the research and resulting risks of stigmatization. These risks may arise even when individuals were not part of the original data set being repurposed. Data reuse, repurposing, and recombination may have damaging effects on others not included within the original data sets. These issues of justice for individuals who might be regarded as indirect subjects of research are not even raised by approaches that consider only the implications for or agreement of the original data subject. This chapter argues that health information should be available for reuse, information should be available for use, but in a way that does not yield unexpected surprises, produce direct harm to individuals, or violate warranted trust
Employees as Regulators: The New Private Ordering in High Technology Companies
Get PDFThere is mounting public concern over the influence that high technology companies have in our society. In the past, these companies were lauded for their innovations, but now as one scandal after another has plagued them, from being a conduit in influencing elections (think Cambridge Analytica) to the development of weaponized artificial intelligence, to their own moment of reckoning with the #MeToo movement, these same companies are under scrutiny. Leaders in high technology companies created their own sets of norms through private ordering. Their work was largely unfettered by regulators, with the exception of the Securities and Exchange Commission’s oversight of public companies. Now, however, white-collar employees at high technology companies are speaking out in protest about their respective employers’ actions and changing private ordering as we know it. In essence, employees are holding companies accountable for the choices they make, whether it is what area to work (or not work) in or eliminating a practice that has systemic implications, such as mandatory arbitration provisions for sexual misconduct cases. This Article builds upon my prior work on the role of corporations and social movements, analyzing how employees in high technology companies have redefined the contours of private ordering and, in the process, have also reimagined what collective action looks like. Because these workers are in high demand and short supply, they are able to affect private ordering in a way that we have not seen before. As a result, they have the potential to be an important check on the high technology sector