The public health emergency caused by the COVID-19 pandemic stimulated stakeholders from diverse disciplines and institutions to establish new collaborations to produce informed public health responses to the disease. Wastewater-based epidemiology for COVID-19 grew quickly during the pandemic and required the rapid implementation of such collaborations. The objective of this article is to describe the challenges and results of new relationships developed in Detroit, MI, USA among a medical school and an engineering college at an academic institution (Wayne State University), the local health department (Detroit Health Department), and an environmental services company (LimnoTech) to utilize markers of the COVID-19 virus, SARS-CoV-2, in wastewater for the goal of managing COVID-19 outbreaks. Our collaborative team resolved questions related to sewershed selection, communication of results, and public health responses and addressed technical challenges that included ground-truthing the sewer maps, overcoming supply chain issues, improving the speed and sensitivity of measurements, and training new personnel to deal with a new disease under pandemic conditions. Recognition of our complementary roles and clear communication among the partners enabled city-wide wastewater data to inform public health responses within a few months of the availability of funding in 2020, and to make improvements in sensitivity and understanding to be made as the pandemic progressed and evolved. As a result, the outbreaks of COVID-19 in Detroit in fall and winter 2021–2022 (corresponding to Delta and Omicron variant outbreaks) were tracked in 20 sewersheds. Data comparing community- and hospital-associated sewersheds indicate a one- to two-week advance warning in the community of subsequent peaks in viral markers in hospital sewersheds. The new institutional relationships impelled by the pandemic provide a good basis for continuing collaborations to utilize wastewater-based human and pathogen data for improving the public health in the future.

As researchers on molecular methods of wastewater analysis (1, 2), we agree with J. I. Levy et al. (“Wastewater surveillance for public health,” Perspectives, 6 January, p. 26) that community-level monitoring can be an efficient way of detecting new outbreaks of disease and activating or prioritizing local public health actions. This approach to monitoring also serves to assess the effectiveness of mitigation and includes communities with minimal individual testing. However, Levy et al. say little about the ethical or legal considerations that must be considered when expanding wastewater surveillance to new targets or communities. Although wastewater monitoring itself is not new, recent pandemic-stimulated growth in monitoring infrastructure and personnel, technological innovations, and proposals for wider application have made the need for ethical review and oversight urgent. Given that interest in and applications of wastewater surveillance continue to grow, the scientific community and government officials have an obligation to use the technology ethically and legally, ensuring that personal data remains private and vulnerable groups are protected (2, 3).

The emerging global climate crisis threatens human health in unprecedented ways, yet global health concerns have not been sufficiently considered within international climate change efforts. A more collaborative pathway could advance efforts to mitigate and adapt to climate change while protecting public health and social justice.

Despite a recent wave in global recognition of the rights of transgender and gender-diverse populations, referred to in this text by the umbrella label of trans*, international law continues to presume a cisgender binary definition of gender - dismissing the lived realities of trans* individuals throughout the world. This gap in international legal recognition and protection has fundamental implications for health, where trans* persons have been and continue to be subjected to widespread discrimination in health care, longstanding neglect of health needs, and significant violations of bodily autonomy.

The COVID-19 pandemic has invited dramatic investment in and expansion of wastewater surveillance. This surveillance may enable early detection of an increasing presence of COVID-19 in the community. But the same technology may simultaneously or soon be turned to other uses, including for drug interdiction, community wellness, or environmental monitoring. All of these uses raise urgent legal and ethical questions. But the legal literature, to date, has almost uniformly failed to even consider the ramifications of wastewater-based epidemiology. Indeed, we are aware of only two articles discussing wastewater surveillance in the legal literature—one of which is our own prior work. In prior work, we have raised questions about the legal and ethical dimensions of wastewater surveillance in response to the COVID-19 pandemic. But that work arrived in the earliest days of the pandemic, when research efforts were not yet well established or as broadly implemented, and when legal and ethical consideration was focused almost exclusively on the drastic public health emergency at issue. This Article thus expands the extant literature by considering the legal and ethical dimensions of wastewater surveillance more thoroughly and more broadly. It arrives at an auspicious time, as the United States moves into a vaccine-mediated phase in which COVID-19 is less likely to give rise to broad stay-at-home orders and more likely to trigger narrower, more targeted interventions. It seeks to offer guidance for the legal and ethical use of wastewater surveillance along two dimensions. The first considers the circumstances under which wastewater monitoring should be deployed for detecting and responding to COVID-19 specifically. The second zooms out, to consider whether and how this surveillance infrastructure, largely created in response to the COVID-19 pandemic, might be deployed for other uses, and examines the legal and ethical difficulties that may attend these broader uses. This Article proceeds in three parts. Part I reviews the state of the science for wastewater-based epidemiology, focusing specifically on how this technique has been deployed to monitor for or detect the virus that causes COVID-19. One of the authors is a research scientist currently working to establish and oversee wastewater-based epidemiological efforts related to COVID-19 monitoring in the City of Detroit, Michigan, and Part I draws on that expertise. Part II then moves from what is possible to what is legal and ethical. If wastewater-based epidemiology is to be deployed now and in the future for detecting and responding to COVID-19, what parameters should guide the collection of wastewater signals, and how should that data be used by policymakers and others to enact further public health protections? Finally, Part III broadens its scope beyond COVID-19. Wastewater surveillance for COVID-19 sentinel surveillance can be well justified, provided guidelines are established ex ante for public health response to monitoring results. Other uses of wastewater surveillance infrastructure, however, may raise substantial privacy concerns, particularly if this infrastructure becomes denser and correspondingly more granular in the data it discloses. Such uses may, in turn, undermine both the legal soundness of and public trust in wastewater monitoring writ large. Keywords: wastewater, wastewater monitoring, ethical and legal implications

Scarcity of medical resources and services during public health emergencies raises challenging legal and ethical questions. The COVID-19 pandemic has strained the capacity of health systems, and revealed some of the shortcomings of previous efforts to plan for and implement ethical and effective allocation protocols for scarce medical resources and services. Governments and health institutions have ample authority and expertise, but often lack the political and economic support needed to avoid shortages and mitigate their severity. Legal issues that may arise in this context include liability for health care professionals and institutions that must make allocation decisions when resources are scarce and civil rights concerns over discrimination in crisis standards of care protocols or their implementation. In the short term, federal and state officials must expand available resources to mitigate resource scarcity in the COVID-19 response. They must provide legal and practical guidance to health care and public health entities that may need to implement crisis standards of care, and ensure that scarce resources — including newly-developed treatments and vaccines — are allocated consistent with legal and ethical responsibilities that protect the most vulnerable persons through fair and equitable prioritization. In the longer term, federal and state officials should support efforts to clarify and incorporate protections into crisis standards of care plans that prioritize antidiscrimination, fairness, and equity in allocation decision making. This paper was prepared as part of the COVID-19 Policy Playbook: Legal Recommendations for a Safer, More Equitable Future, a comprehensive report published by Public Health Law Watch in partnership with the de Beaumont Foundation and the American Public Health Association.

Community mitigation measures that limit contacts between people can be an effective strategy to reduce the spread of COVID-19. Government powers can be used to require or encourage these measures through an array of social distancing strategies such as movement and gathering restrictions, closure of in-person operations of non-essential personal, recreational, and commercial activities, and physical separation and facemask-wearing requirements. Such strategies have been integral to the COVID-19 pandemic response in the United States. This Chapter examines the legal, ethical, and political issues raised by the government’s use of these social distancing strategies, highlighting how state governments in particular have used these tools and how they have been adapted over time as successive waves of COVID-19 cases have emerged. Often politically controversial, numerous legal challenges have been brought against government orders that restrict movement, impose gathering limits, and close businesses. The government has prevailed in most of these legal challenges, due to the deference typically given by courts to government-imposed restrictions that seek to balance public health and other considerations under circumstances of scientific uncertainty. However, recent Supreme Court rulings portend changes to the legal landscape that may render government public health powers more vulnerable to challenge when religious exercise rights are implicated. Government officials have an obligation to take affirmative steps to minimize the need for social distancing orders and to ensure that when restrictions and closures are in place that supportive policies mitigate disparate burdens on vulnerable and marginalized communities. This paper was prepared as part of the COVID-19 Policy Playbook: Legal Recommendations for a Safer, More Equitable Future, a comprehensive report published by Public Health Law Watch in partnership with the de Beaumont Foundation and the American Public Health Association.

This Report, including 39 chapters by more than 50 experts, updates and expands the initial rapid COVID-19 legal assessment published in August 2020. The failures we noted in the first Report have only worsened, culminating in the sad moment in February when the country reached 500,000 deaths. For Volume II of the Report, our team has revisited the legal issues we first surveyed early in the pandemic, and have added new topics, including education, data systems, and the lessons of the 2020 pandemic election. Even for the subjects covered previously, this Report consists of largely new material, including new, post-election recommendations, which we highlight in this summary. Volume I confronted a historic failure of law and policy. Volume II points to a historic opportunity to remake our institutions, public and clinical health law and policy, and the social contract. Once again, we have asked our authors to focus on how law has served the nation’s response to COVID-19, and to offer concrete suggestions for immediate and long-term changes to better serve the health of the nation. Each of the six sections of the Report addresses a big question: 1. How can government power best be used to prevent and control pandemics like COVID-19? 2. How can law help best harness the power and overcome the limitations of a divided system of federal, state, and local governments? 3. What reforms are needed to get high quality, affordable health care to everyone during the pandemic and beyond? 4. What can law do to help ensure access to essential medicines and medical supplies? 5. What legal steps are needed to protect American workers and their families from COVID-19 and its economic side effects? 6. Finally, and most importantly, what must be done through law to knock down the structures of racism and inequality that produce health inequity now, and prevent the American people from working together for health and prosperity in the future? This Report offers more than 100 specific legal recommendations for the president and Congress, governors and state legislatures, and mayors and city councilors across the country.

COVID-19: The Promise and Failure of Law in an Inequitable Nation Wendy E. Parmet JD, Scott Burris JD, Lance Gable JD, MPH, Sarah de Guia JD, Donna E. Levin JD, and Nicolas P. Terry LLM Affiliation Wendy E. Parmet is with the Center for Health Policy & Law, Northeastern University, Boston, MA. Scott Burris is with the Center for Public Health Law Research, Temple University, Philadelphia, PA. Lance Gable is with Wayne State University Law School, Detroit, MI. Sarah de Guia is with ChangeLab Solutions, Oakland, CA. Donna E. Levin is with the Network for Public Health Law, Edina, MN. Nicolas P. Terry is with the Hall Center for Law and Health, Robert H. McKinney School of Law, Indiana University, Indianapolis.CopyRightCorrespondence should be sent to Wendy E. Parmet, 416 Huntington Ave, Boston, MA 02115 (e-mail: w.parmet@northeastern.edu). Reprints can be ordered at http://www.ajph.org by clicking the “Reprints” link.CONTRIBUTORSAll authors contributed equally to this editorial. https://doi.org/10.2105/AJPH.2020.306008 Accepted: October 10, 2020 Published Online: December 16, 2020

COVID-19 is the new disease this country had been preparing to take on for decades. So far, the response has been a failure, with huge human and economic costs. While peer countries have managed to get the pandemic under a degree of control, the United States seems pathologically unable or unwilling to prevent rising cases and deaths. This is not a failure of resources: although decades of cutting health agency budgets is a big part of our problem, we remain a country rich in money and expertise. This is not a failure of individual courage; from health care workers through transport workers to people who produce and deliver food supplies, essential workers have shown up and done their jobs at significant personal risk. This has been, first and foremost, a failure of leadership and the development or implementation of an effective response. The law is integral to effective emergency preparedness and response. It sets out the powers and duties of officers and agencies, creates standards of conduct and performance, channels resources to individuals and institutions, and sets limits on arbitrary or

Professor Eleanor Kinney long served as a foundational scholar at the intersection of law and public health, pushing scholarship forward across the fields explored in this special issue. Yet, while this special issue is largely confined to the domestic legal space, Professor Kinney also served as an early and influential scholar on the international human right to health, and this contribution has proven central to the field of health and human rights over the past two decades. Having worked alongside Professor Kinney throughout these years, drawing on her research in framing our own scholarship, it is an honor to reflect on her seminal works that have defined the field and influenced rights-based health policy – developing the right to health under international law and implementing that right in U.S. health policy.

The water contamination crisis that has affected residents of Flint, Michigan, over the past 5 years comprises one of the most devastating—and completely avoidable—public health catastrophes in rec...

Scientists have observed that molecular markers for COVID-19 can be detected in wastewater of infected communities both during an outbreak and, in some cases, before the first case is confirmed. The CDC and other government entities are considering whether to add community surveillance through wastewater monitoring to assist in tracking disease prevalence and guiding public health responses to the COVID-19 pandemic. This scientific breakthrough may lead to many useful potential applications for tracking disease, intensifying testing, initiating social distancing or quarantines, and even lifting restrictions once a cessation of infection is detected and confirmed. Yet, new technologies developed in response to a public health crisis may raise difficult legal and ethical questions about how such technologies may impact both the public health and civil liberties of the population. This Article describes recent scientific evidence regarding COVID-19 detection in wastewater, identifying public health benefits that may result from this breakthrough, as well as the limitations of existing data. The Article then assesses the legal and ethical implications of implementing policy based on positive sewage signals. It concludes that the first step to implementing legal and ethical wastewater monitoring is to develop scientific understanding. Even if reliability and efficacy are established, limits on sample and data collection, use, and sharing, must also be considered to prevent undermining privacy and autonomy in order to implement these public health strategies consistent with legal and ethical considerations.

Potential shortages of medical resources and services related to COVID-19 present government officials and emergency planners with difficult choices. If resources become too scarce, health care professionals and institutions may need to implement triage protocols adopting crisis standards of care. COVID-19 patient surges tested the health care system in March and April 2020, and highlighted the need to prepare to accommodate larger patient capacity in the near future. As a primary consideration, governments and health care institutions should utilize existing powers and resources to avoid shortages and mitigate their severity. If shortages do occur, most states have begun to develop crisis standards of care protocols to assist in making decisions about allocating scarce resources. These protocols attempt to maximize the number of lives saved. Many protocols give priority access to health care and other essential workers. These protocols should be structured to facilitate fair and equitable access, although several have been found to be inconsistent with federal anti-discrimination law. Legal issues that may arise in this context include liability for health care professionals and institutions who decide to not allocate resources to patients who later suffer harm, and civil rights concerns over discrimination in the protocols or their implementation. Liability shields have been put in place by many states to protect health care professionals from lawsuits based on allocation decisions. Federal and state officials should support efforts to clarify and incorporate protections into crisis standards of care plans that prioritize anti-discrimination, fairness, and equity in allocation decision making. This paper was prepared as part of Assessing Legal Responses to COVID-19, a comprehensive report published by Public Health Law Watch in partnership with the de Beaumont Foundation and the American Public Health Association.

Wayne State University Law School, Detroit, Michigan. Correspondence: Lance Gable, JD, MPH, Wayne State University Law School, 471 W. Palmer St, Detroit, MI 48202 ([email protected]). The author declares no conflict of interest.

Government powers support the use of physical distancing measures as a strategy to mitigate the spread of COVID-19. This Chapter examines the efforts of governments to limit mass movement and large gatherings, close businesses and schools, and restrict non-essential personal, recreational, and commercial activities. Government legal authority to impose these restrictions to stop the transmission of an infectious disease such as COVID-19 is quite broad, and these measures are essential tools to reduce the community spread of COVID-19. However, government orders that restrict movement or activity must consider the effects on constitutional rights; the economic, social, and health impacts that restrictions impose; and the potential for inequitable burdens on marginalized communities if supportive policies are not implemented along with restrictions. Movement and activity restrictions in the form of stay-at-home orders, gathering size limitations, and business and school closures have been instituted widely during the initial COVID-19 response, primarily by state governments, although local governments have also imposed these measures as well. Often politically controversial, numerous legal challenges have been brought against government orders restricting movement, imposing gathering limits, and closing businesses. The government has prevailed in most of these legal challenges, and this deference to government-imposed restrictions demonstrates an appropriate balancing of public health and other considerations under circumstances of scientific uncertainty. However, government officials must take affirmative steps to set up systems that render widespread restrictions on movement and activity less necessary to contain COVID-19 and to ensure that when restrictions and closures are in place that supportive policies mitigate disparate burdens on marginalized communities. This paper was prepared as part of Assessing Legal Responses to COVID-19, a comprehensive report published by Public Health Law Watch in partnership with the de Beaumont Foundation and the American Public Health Association.

Chronic and noncommunicable health conditions, including heart disease, stroke, diabetes, hypertension, cancer, and asthma, are leading causes of death and disability in the United States, with 2 in 5 adults afflicted with multiple conditions. Deaths from heart disease are increasing in the majority of counties. While deaths from stroke had been declining for decades, decreases in stroke deaths have stalled in the majority of states since 2013. In addition, individuals with lower socioeconomic status and those who identify as members of racial and ethnic minority groups experience higher rates of chronic diseases, less access to quality health care, and worse health outcomes. The effects of chronic and noncommunicable conditions also extend far beyond health outcomes. Direct costs of treating chronic conditions and indirect costs including loss of productivity amount to an estimated $3.7 trillion. Legal and public health experts recognize that law functions as a key determinant of public health. Legal frameworks and interventions can be used to address the increasing population health burden from chronic diseases and the associated risk factors, as the Centers for Disease Control and Prevention (CDC) has long recognized. However, law must be both quantified and measured in terms of outcomes to understand its impact. As the field of legal epidemiology—the