Mitigating Contaminant-Driven Risks for the Safe Expansion of the Agricultural-Sanitation Circular Economy in an Urbanizing World.

The widespread adoption of an agricultural circular economy requires the recovery of resources such as water, organic matter, and nutrients from livestock manure and sanitation. While this approach offers many benefits, we argue this is not without potential risks to human and environmental health that largely stem from the presence of contaminants in the recycled resources (e.g., pharmaceuticals, pathogens). We discuss context specific challenges and solutions across the three themes: (1) contaminant monitoring; (2) collection transport and treatment; and (3) regulation and policy. We advocate for the redesign of sanitary and agricultural management practices to enable safe resource reuse in a proportionate and effective way. In populous urban regions with access to sanitation provision, processes can be optimized using emergent technologies to maximize removal of contaminant from excreta prior to reuse. Comparatively, in regions with limited existing capacity for conveyance of excreta to centralized treatment facilities, we suggest efforts should focus on creation of collection facilities (e.g., pit latrines) and decentralized treatment options such as composting systems. Overall, circular economy approaches to sanitation and resource management offer a potential solution to a pressing challenge; however, to ensure this is done in a safe manner, contaminant risks must be mitigated.

Does "Low Cost" Urban Sanitation Exist? Lessons from a Global Data Set.

In this paper, we report results from, and demonstrate the value of, a global database for the collection and aggregation of reliable and comparable cost data for urban sanitation systems as they are built and operated on the ground (rather than the "as planned" costs that are often reported). We show that no particular "mode" of urban sanitation (for example "sewered sanitation" or "fecal sludge management") can be meaningfully described as "low cost" when compared to other modes. We show that economies of scale may operate for systems that transport waste from pits and sealed tanks by road as well as for sewerage. We use a case study example to show the value of being able to compare local costs to global benchmarks and identify that operational considerations such as low connection rates may be more significant in determining overall cost liabilities for urban sanitation than technical considerations such as population density, size, and degree of centralization/decentralization.

Burden of disease attributable to unsafe drinking water, sanitation, and hygiene in domestic settings: a global analysis for selected adverse health outcomes.

BACKGROUND: Assessments of disease burden are important to inform national, regional, and global strategies and to guide investment. We aimed to estimate the drinking water, sanitation, and hygiene (WASH)-attributable burden of disease for diarrhoea, acute respiratory infections, undernutrition, and soil-transmitted helminthiasis, using the WASH service levels used to monitor the UN Sustainable Development Goals (SDGs) as counterfactual minimum risk-exposure levels. METHODS: We assessed the WASH-attributable disease burden of the four health outcomes overall and disaggregated by region, age, and sex for the year 2019. We calculated WASH-attributable fractions of diarrhoea and acute respiratory infections by country using modelled WASH exposures and exposure-response relationships from two updated meta-analyses. We used the WHO and UNICEF Joint Monitoring Programme for Water Supply, Sanitation and Hygiene public database to estimate population exposure to different WASH service levels. WASH-attributable undernutrition was estimated by combining the population attributable fractions (PAF) of diarrhoea caused by unsafe WASH and the PAF of undernutrition caused by diarrhoea. Soil-transmitted helminthiasis was fully attributed to unsafe WASH. FINDINGS: We estimate that 1·4 (95% CI 1·3-1·5) million deaths and 74 (68-80) million disability-adjusted life-years (DALYs) could have been prevented by safe WASH in 2019 across the four designated outcomes, representing 2·5% of global deaths and 2·9% of global DALYs from all causes. The proportion of diarrhoea that is attributable to unsafe WASH is 0·69 (0·65-0·72), 0·14 (0·13-0·17) for acute respiratory infections, and 0·10 (0·09-0·10) for undernutrition, and we assume that the entire disease burden from soil-transmitted helminthiasis was attributable to unsafe WASH. INTERPRETATION: WASH-attributable burden of disease estimates based on the levels of service established under the SDG framework show that progress towards the internationally agreed goal of safely managed WASH services for all would yield major public-health returns. FUNDING: WHO and Foreign, Commonwealth & Development Office.

Rules for robots, and why medical AI breaks them.

This article critiques the quest to state general rules to protect human rights against AI/ML computational tools. The White House Blueprint for an AI Bill of Rights was a recent attempt that fails in ways this article explores. There are limits to how far ethicolegal analysis can go in abstracting AI/ML tools, as a category, from the specific contexts where AI tools are deployed. Health technology offers a good example of this principle. The salient dilemma with AI/ML medical software is that privacy policy has the potential to undermine distributional justice, forcing a choice between two competing visions of privacy protection. The first, stressing individual consent, won favor among bioethicists, information privacy theorists, and policymakers after 1970 but displays an ominous potential to bias AI training data in ways that promote health care inequities. The alternative, an older duty-based approach from medical privacy law aligns with a broader critique of how late-20th-century American law and ethics endorsed atomistic autonomy as the highest moral good, neglecting principles of caring, social interdependency, justice, and equity. Disregarding the context of such choices can produce suboptimal policies when - as in medicine and many other contexts - the use of personal data has high social value.

U.S. Adult Perspectives on Facial Images, DNA, and Other Biometrics.

Applications of biometrics in various societal contexts have been increasing in the United States, and policy debates about potential restrictions and expansions for specific biometrics (such as facial recognition and DNA identification) have been intensifying. Empirical data about public perspectives on different types of biometrics can inform these debates. We surveyed 4048 adults to explore perspectives regarding experience and comfort with six types of biometrics; comfort providing biometrics in distinct scenarios; trust in social actors to use two types of biometrics (facial images and DNA) responsibly; acceptability of facial images in eight scenarios; and perceived effectiveness of facial images for five tasks. Respondents were generally comfortable with biometrics. Trust in social actors to use biometrics responsibly appeared to be context specific rather than dependent on biometric type. Contrary to expectations given mounting attention to dataveillance concerns, we did not find sociodemographic factors to influence perspectives on biometrics in obvious ways. These findings underscore a need for qualitative approaches to understand the contextual factors that trigger strong opinions of comfort with and acceptability of biometrics in different settings, by different actors, and for different purposes and to identify the informational needs relevant to the development of appropriate policies and oversight.

The Perils of Parity: Should Citizen Science and Traditional Research Follow the Same Ethical and Privacy Principles?

The individual right of access to one's own data is a crucial privacy protection long recognized in U.S. federal privacy laws. Mobile health devices and research software used in citizen science often fall outside the HIPAA Privacy Rule, leaving participants without HIPAA's right of access to one's own data. Absent state laws requiring access, the law of contract, as reflected in end-user agreements and terms of service, governs individuals' ability to find out how much data is being stored and how it might be shared with third parties. Efforts to address this problem by establishing norms of individual access to data from mobile health research unfortunately can run afoul of the FDA's investigational device exemption requirements.

The Streetlight Effect: Regulating Genomics Where the Light Is.

Regulatory policy for genomic testing may be subject to biases that favor reliance on existing regulatory frameworks even when those frameworks carry unintended legal consequences or may be poorly tailored to the challenges genomic testing presents. This article explores three examples drawn from genetic privacy regulation, oversight of clinical uses of genomic information, and regulation of genomic software. Overreliance on expedient regulatory approaches has a potential to undercut complete and durable solutions.

Economic cost analysis of low-cost sanitation technology options in informal settlement areas (case study: Soweto, Johannesburg).

In Urban Africa, water and sanitation utility companies are facing a huge backlog of sanitation provision in the informal settlement areas. In order to clear this backlog, new investment is required. However, to select appropriate sanitation technologies, lifecycle costs need to be assessed. The aim of this research was to establish lifecycle costs for appropriate sanitation technologies in informal settlement areas. Three sanitation options were compared: simplified sewerage, urine diversion dry toilet (UDDT) and Ventilated Improved Pit (VIP) latrine. Three scenarios for simplified sewerage were considered; gravity flow into existing conventional sewers with treatment; new-build with pumping and treatment; and new-build gravity flow with treatment. The study revealed that simplified sewerage is the cheapest option for Soweto informal settlement, even when the costs of pumping and treatment are included. Gravity simplified sewerage with treatment is cheaper than the UDDT system and VIP latrine at all population densities above 158 and 172 persons/ha, respectively. The total annual cost per household of simplified sewerage and treatment was US$142 compared to US$156 and US$144 for UDDT and VIP latrine respectively. The costs of simplified sewerage could be recovered through a monthly household surcharge and cross-subsidy summing US$5.3 The study concluded that simplified sewerage system was the first choice for Soweto informal settlement areas, given the current population density.

HIPAA's Individual Right of Access to Genomic Data: Reconciling Safety and Civil Rights.

In 2014, the United States granted individuals a right of access to their own laboratory test results, including genomic data. Many observers feel that this right is in tension with regulatory and bioethical standards designed to protect the safety of people who undergo genomic testing. This commentary attributes this tension to growing pains within an expanding federal regulatory program for genetic and genomic testing. The Genetic Information Nondiscrimination Act of 2008 expanded the regulatory agenda to encompass civil rights and consumer safety. The individual access right, as it applies to genomic data, is best understood as a civil-rights regulation. Competing regulatory objectives-safety and civil rights-were not successfully integrated during the initial rollout of genomic civil-rights regulations after 2008. Federal law clarifies how to prioritize safety and civil rights when the two come into conflict, although with careful policy design, the two need not collide. This commentary opens a dialog about possible solutions to advance safety and civil rights together.

Impact of HIPAA's minimum necessary standard on genomic data sharing.

This article provides a brief introduction to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule's minimum necessary standard, which applies to sharing of genomic data, particularly clinical data, following 2013 Privacy Rule revisions. This research used the Thomson Reuters Westlaw database and law library resources in its legal analysis of the HIPAA privacy tiers and the impact of the minimum necessary standard on genomic data sharing. We considered relevant example cases of genomic data-sharing needs. In a climate of stepped-up HIPAA enforcement, this standard is of concern to laboratories that generate, use, and share genomic information. How data-sharing activities are characterized-whether for research, public health, or clinical interpretation and medical practice support-affects how the minimum necessary standard applies and its overall impact on data access and use. There is no clear regulatory guidance on how to apply HIPAA's minimum necessary standard when considering the sharing of information in the data-rich environment of genomic testing. Laboratories that perform genomic testing should engage with policy makers to foster sound, well-informed policies and appropriate characterization of data-sharing activities to minimize adverse impacts on day-to-day workflows.

Towards sustainable sanitation management: Establishing the costs and willingness to pay for emptying and transporting sludge in rural districts with high rates of access to latrines.

MOTIVATION: Proper management of fecal sludge has significant positive health and environmental externalities. Most research on managing onsite sanitation so far either simulates the costs of, or the welfare effects from, managing sludge in situ in pit latrines. Thus, designing management strategies for onsite rural sanitation is challenging, because the actual costs of transporting sludge for treatment, and sources for financing these transport costs, are not well understood. METHODS: In this paper we calculate the actual cost of sludge management from onsite latrines, and identify the contributions that latrine owners are willing to make to finance the costs. A spreadsheet-based model is used to identify a cost-effective transport option, and to calculate the cost per household. Then a double-bound contingent valuation method is used to elicit from pit-latrine owners their willingness-to-pay to have sludge transported away. This methodology is employed for the case of a rural subdistrict in Bangladesh called Bhaluka, a unit of administration at which sludge management services are being piloted by the Government of Bangladesh. RESULTS: The typical sludge accumulation rate in Bhaluka is calculated at 0.11 liters/person/day and a typical latrine will need to be emptied approximately once every 3 to 4 years. The costs of emptying and transport are high; approximately USD 13 per emptying event (circa 14% of average monthly income); household contributions could cover around 47% of this cost. However, if costs were spread over time, the service would cost USD 4 per year per household, or USD 0.31 per month per household-comparable to current expenditures of rural households on telecommunications. CONCLUSION: This is one of few research papers that brings the costs of waste management together with financing of that cost, to provide evidence for an implementable solution. This framework can be used to identify cost effective sludge management options and private contributions towards that cost in other (context-specific) administrative areas where onsite sanitation is widespread.

Economic regulation of next-generation sequencing.

Next-generation sequencing broadens the debate about appropriate regulatory oversight of genetic testing and may force scholars to move beyond familiar privacy and health and safety regulatory issues to address new problems with industry structure and economic regulation. The genetic testing industry is passing through a period of profound structural change in response to shifts in technology and in the legal environment. Making genetic testing safe and effective for consumers increasingly requires access to comprehensive genomic data infrastructures that can support accurate, state-of-the-art interpretation of genetic test results. At present, there are significant barriers to access and there is no sector-specific regulator with power to ensure appropriate data access. Without it, genetic testing will not be safe for consumers even when it is performed at CLIA-certified laboratories using tests that have been FDA-cleared or approved. This article explores the emerging structure of the genetic testing industry and describes its present economic regulatory vacuum. In view of this gap in regulation, the article explores whether generally applicable law, particularly antitrust law, may offer solutions to the industry's data access problems. It concludes that courts may have a useful role to play, particularly in Europe and other jurisdictions where the essential facilities doctrine enjoys continued vitality. After Verizon Communications v. Law Offices of Curtis V. Trinko, the role of U.S. federal courts is less certain. Congress has demonstrated willingness to address access issues as they emerged in other infrastructure industries in recent decades. This article expresses no preference between legislative and judicial solutions. Its aim is simply to highlight an emerging economic regulatory issue which, if left unresolved, presents real health and safety concerns for consumers who receive genetic tests.

Regulatory changes raise troubling questions for genomic testing.

By 6 October 2014, many laboratories in the United States must begin honoring new individual data access rights created by recent changes to federal privacy and laboratory regulations. These access rights are more expansive than has been widely understood and pose complex challenges for genomic testing laboratories. This article analyzes regulatory texts and guidances to explore which laboratories are affected. It offers the first published analysis of which parts of the vast trove of data generated during next-generation sequencing will be accessible to patients and research subjects. Persons tested at affected laboratories seemingly will have access, upon request, to uninterpreted gene variant information contained in their stored variant call format, binary alignment/map, and FASTQ files. A defect in the regulations will subject some non-CLIA-regulated research laboratories to these new access requirements unless the Department of Health and Human Services takes swift action to avert this apparently unintended consequence. More broadly, all affected laboratories face a long list of daunting operational, business, compliance, and bioethical issues as they adapt to this change and to the Food and Drug Administration's recently announced plan to publish draft guidance outlining a new oversight framework for lab-developed tests.

Mining the human genome after Association for Molecular Pathology v. Myriad Genetics.

The Supreme Court's recent decision in Association for Molecular Pathology v. Myriad Genetics portrays the human genome as a product of nature. This frames medical genetics as an extractive industry that mines a natural resource to produce valuable goods and services. Natural resource law offers insights into problems medical geneticists can expect after this decision and suggests possible solutions. Increased competition among clinical laboratories offers various benefits but threatens to increase fragmentation of genetic data resources, potentially causing waste in the form of lost opportunities to discover the clinical significance of particular gene variants. The solution lies in addressing legal barriers to appropriate data sharing. Sustainable discovery in the field of medical genetics can best be achieved through voluntary data sharing rather than command-and-control tactics, but voluntary mechanisms must be conceived broadly to include market-based approaches as well as donative and publicly funded data commons. The recently revised Health Insurance Portability and Accountability Act Privacy Rule offers an improved--but still imperfect--framework for market-oriented data sharing. This article explores strategies for addressing the Privacy Rule's remaining defects. America is close to having a legal framework that can reward innovators, protect privacy, and promote needed data sharing to advance medical genetics.

Minimizing liability risks under the ACMG recommendations for reporting incidental findings in clinical exome and genome sequencing.

Recent recommendations by the American College of Medical Genetics and Genomics (ACMG) for reporting incidental findings present novel ethical and legal issues. This article expresses no views on the ethical aspects of these recommendations and focuses strictly on liability risks and how to minimize them. The recommendations place labs and clinicians in a new liability environment that exposes them to intentional tort lawsuits as well to traditional suits for negligence. Intentional tort suits are especially troubling because of their potential to inflict ruinous personal financial losses on individual clinicians and laboratory personnel. This article surveys this new liability landscape and describes analytical approaches for minimizing tort liabilities. To a considerable degree, liability risks can be controlled by structuring activities in ways that make future lawsuits nonviable before the suits ever arise. Proactive liability analysis is an effective tool for minimizing tort liabilities in connection with the testing and reporting activities that the ACMG recommends.

Commentary on community-led total sanitation and human rights: should the right to community-wide health be won at the cost of individual rights?

The Millennium Development Goals (MDGs) set out to halve the proportion of the population without access to basic sanitation between 1990 and 2015. The slow pace of progress has lead to a search for innovative responses, including social motivation approaches. One example of this type of approach is 'Community-led Total Sanitation' (CLTS). CLTS represents a major shift for sanitation projects and programmes in recognising the value of stopping open-defecation across the whole community, even when the individual toilets built are not necessarily wholly hygienic. However, recent publications on CLTS document a number of examples of practices which fail to meet basic ethical criteria and infringe human rights. There is a general theme in the CLTS literature encouraging the use of 'shame' or 'social stigma' as a tool for promoting behaviours. There are reported cases where monetary benefits to which individuals are otherwise entitled or the means to practice a livelihood are withheld to create pressures to conform. At the very extreme end of the scale, the investigation and punishment of violence has reportedly been denied if the crime occurred while defecating in the open, violating rights to a remedy and related access to justice. While social mobilisation in general, and CLTS in particular, have drastically and positively changed the way we think about sanitation, they neither need nor benefit from an association with any infringements of human rights.