Failure of Concentric Regulatory Zones to Halt the Spread of COVID-19 in South Brooklyn, New York: October-November 2020

We relied on reports of confirmed case incidence and test positivity, along with data on the movements of devices with location-tracking software, to evaluate a novel scheme of three concentric regulatory zones introduced by then New York Governor Cuomo to address an outbreak of COVID-19 in South Brooklyn in the fall of 2020. The regulatory scheme imposed differential controls on access to eating places, schools, houses of worship, large gatherings and other businesses within the three zones, but without restrictions on mobility. Within the central red zone, COVID-19 incidence temporarily declined from 131.2 per 100,000 population during the week ending October 3 to 62.5 per 100,000 by the week ending October 31, but then rebounded to 153.6 per 100,000 by the week ending November 28. Within the intermediate orange and peripheral yellow zones combined, incidence steadily rose from 28.8 per 100,000 during the week ending October 3 to 109.9 per 100,000 by the week ending November 28. Data on device visits to pairs of eating establishments straddling the red-orange boundary confirmed compliance with access controls. More general analysis of device movements showed stable patterns of mobility between and beyond zones unaffected by the Governor's orders. A geospatial regression model of COVID-19 incidence in relation to device movements across zip code tabulation areas identified a cluster of five high-mobility ZCTAs with estimated reproduction number 1.91 (95% confidence interval, 1.27-2.55). In the highly populous area of South Brooklyn, controls on access alone, without restrictions on mobility, were inadequate to halt an advancing COVID-19 outbreak.

An overview of the listing process under the California Endangered Species Act

The California Endangered Species Act (CESA) is one of the most important legal tools available to the Fish and Game Commission and Department of Fish and Wildlife to protect the State’s wildlife resources. The listing process, together with the prohibitions in section 2080 of the Fish and Game Code, are the law’s regulatory teeth. At the same time, because any interested person can petition to list a species, the listing process invites citizen participation in the regulatory scheme. Listing decisions can be the difference between persistence and extinction of a species. They can also cause severe economic disruption and, for this reason, should in our view be made with due deliberation and based on the best available scientific information. Here we describe the complex roadmap that petitions must navigate and that is intended to assure that only native species that need protection get it.

Crypto assets regulation in the UK: an assessment of the regulatory effectiveness and consistency

Purpose The UK authority published its first regulatory guidance on crypto-assets in July 2019. This paper aims to critically evaluate the effectiveness of the crypto-asset regulation in the UK and the consistency of the existing regulatory scheme. Design/methodology/approach This paper adopts comparative methods to carry out the analysis. The paper begins by elaborating the development of crypto-assets alongside the financial innovation in the world and pinpointing the core Acts and Regulations applied to crypto-assets in the UK. The paper also discusses a court case in the EU to highlight an argument among legal professions concerning crypto-assets classification. Findings Through carefully analysing relevant primary and secondary legislation of the UK and EU, this paper identifies some unclarified issues in the regulatory framework and discovers three flaws in the regulatory system. The paper concludes that the effectiveness of the current regulatory scheme is poor and room for improvement exists. Originality/value The paper provides the first review and a thorough analysis of the Laws and Acts applied to the crypto-asset regulation in the UK. It also calls on a simpler and clearer regulatory scheme from the perspectives of market participants and consumers. The discovered issues in the crypto-asset regulation in the UK may urge authorities to improve the existing regulatory frameworks and legal provisions.

Multi-Stakeholder Frameworks for Rectification of Non-Compliance in Cleaning Supply Chains: The Case of the Cleaning Accountability Framework

There is now an expanding body of literature on the significant problem of business non-compliance with minimum labour standards including ‘wage theft’. Extended liability regulation beyond the direct employer is seen as one solution to this non-compliance in fragmented but hierarchically organised industries—such as the cleaning industry. This article uses empirical evidence to assess the effectiveness of one such regulatory scheme, the Cleaning Accountability Framework (CAF), in addressing non-compliance with minimum labour standards (including provisions of the Fair Work Act 2009 (Cth) and the Cleaning Services Award 2020). We find that CAF has been successful in identifying and rectifying certain non-compliance, improving working conditions for some cleaners involved in the scheme. We synthesise the key success factors of CAF in view of envisioning the adoption of such co-regulation frameworks in other industries. We also propose legal reforms that will support change across the cleaning industry.

New Visualization Models of Designation Pathway and Group Categorization of Device–Drug and Device–Biologic Combination Products Classification in the United States: Analysis of FDA Capsular Decisions

Objective The developer and sponsor of new combination products in US needs to forecast which classification and designation to the regulatory scheme of drug, biological product, or device would be required for the new products by the Food and Drug Administration (FDA). To improve the predictability and acceptability of the designation of new combination products for innovators, developers, and sponsors, and to encourage the development and early access of new combination products, we proposed new visualization models of the designation pathway and group categorization. Method We searched the website of the FDA on 15 November, 2020 to identify the regulatory scheme of the FDA’s 129 capsular decision cases of device–drug and device–biologics combination products and other publicly available cases the FDA designated to the drug/biologic or device regulatory scheme. Results By introducing a new definition for primary intended use (PIU) by developers and sponsors extracted from the classification factors of primary mode of action (PMOA), we developed new visualization models of the designation pathway and two-dimensional group categorization. And applying these models to the cases the FDA designated, we proposed a new group categorization of combination products while focusing on the device component function. Conclusions The new visualization models with PIU and PMOA and the new group categorization focusing on the device component function proposed in this study may increase predictability and acceptability of the classification of newly developed combination products into the regulatory scheme of drug, biological product, and device, for innovators, developers, and sponsors.

Regulating Medicines in the United States

This chapter examines the regulation of medicines in the United States. The US scheme for achieving the primary goals of medical product regulation is largely federal, governed by the Food, Drug, and Cosmetic Act and two provisions of the Public Health Service Act and administered by the US Food and Drug Administration (FDA), a federal executive branch agency within the US Department of Health and Human Services. Federal law generally requires research before a medical product enters the market, FDA authorization before market launch affirming that there is sufficient evidence of the product's safety and effectiveness, and continued monitoring and regulation after launch. These requirements and how they are implemented, however, reflect values and goals that, in some circumstances, can be in tension. The chapter then considers how the regulatory scheme for medicines seeks to reconcile these sometimes competing values and goals. It starts by describing what constitutes a medicine subject to FDA regulation and then explains how medicines reach the market, how the FDA and manufacturers assess and manage risks, and the incentives for innovation and rules for competition. The chapter also looks at innovative medical technologies that challenge the traditional US regulatory scheme, using those examples to explore the future of medicines regulation.

The Norwegian industry-led scheme restricting marketing of unhealthy food and beverages to children

Issue The Norwegian food industry has implemented a self-regulatory scheme to restrict the marketing of unhealthy foods and beverages to children under the age of 13 years. In the period 2014-2019, the scheme has treated 77 complaints and made 126 assessments of planned marketing campaigns. Description The aim of the evaluation was to explore perceptions of the scheme through interviews with stakeholders from the industry, non-governmental organizations (NGOs), and health authorities. Further, a survey among parents (n = 1117) with children under the age of 16 years was completed to map opinions on marketing of unhealthy foods and beverages to children. Results The stakeholders had different views of the scheme, where the industry was positive, while the NGOs had mostly critical views. The dispute relates mainly to the content of the scheme's code and guidance, and less to the practice of the scheme's committee. NGOs and health authorities argue that older children should be covered by the scheme, whereas the industry opposes this. However, the scheme specifies to take precautions when marketing to adolescents below 16 years. More than 40 percent of parents are worried that their child is excessively exposed to marketing of unhealthy foods and beverages and report that it affects their child. About one-third of the parents had heard about the scheme. Lessons The possibility of having an assessment of planned marketing campaigns is a strength; however, there are still disagreements concerning the scheme's code and guidance. To make complaints, consumers need to know how, complicating supervision. However, parents experience that children are exposed to marketing of unhealthy foods and beverages and support regulations protecting them from such marketing. Key messages The industry, NGOs, and authorities have different views about the scheme. Disagreement applies mainly to the age range that should be protected from marketing of unhealthy foods and beverages.

DIY Science: A Cure for Cancer of the Next Plague

A twenty-something college student with an interest in science sits in his garage. He is tinkering with genetic materials and gene editing. He has ordered materials over the internet, has all the items he could want, and even has his own test subject—himself. He could inject himself with whatever products his experimentation manufactures. Our hypothetical college student has all the materials in his hands to make the next greatest discovery in the fight against cancer, or to create—intentionally or by accident—a genetically modified disease that could be incredibly lethal to the entire globe. This twenty-something college student is one of many emerging do-it-yourself scientists (“DIYers”). The reality of do-it-yourself (“DIY”) science is here, and it might be severely under regulated. This type of research could pose significant risks to all of humanity if an appropriate regulatory scheme is not developed. Conversely, too much regulation could prevent innovation.

Epilogue

This epilogue looks at the modern bureaucratic state. It considers what it means for a state's regulatory scheme to be comprised of such a range of free-roaming and diverse actors who operate in a semi-autonomous social field and participate in shaping and regulating its operations. Consequently, the epilogue reflects on what forgiveness work means for rights, law, and the higher aims of the Qur'anic mandate of mercy. Mercy means a lessening of deserved punishment (leniency) and, at the same time, mercy's very presence suggests injustice lies everywhere. That is, where there is mercy, there is injustice. However, mercy can play a crucial role in bringing about justice. The insistence on mercy, even if it is a power from above, can offer a crucial corrective to injustice. In some ways, this feature of the legal system explains the involvement of government agents in forgiveness work and suggests the basis for the state's differential treatment of anti-death penalty or human right activists versus forgiveness workers.