Law Commons^™

Meat, The Future: The Role Of Regulators In The Lab-Grown Revolution, Joseph B. Davault, Michael S. Sinha

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The United States is one of the largest consumers of meat globally. The production of meat contributes substantially to climate change due to the levels of greenhouse gasses emitted and the amount of land, water, feed, and other natural resources required to raise animals used for meat. Traditional meat production is another major source for the emergence of zoonotic diseases and antimicrobial-resistant pathogens. Nevertheless, Americans consume more meat now than at any time in the nation’s history.

Advocates for policy change aimed at addressing the risks associated with meat production have typically focused on reducing meat consumption, alternatives to meat, …

Labeling Energy Drinks: Tackling A Monster Of A Problem, Meredith P. Mulhern, Michael S. Sinha

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Energy drinks first rose to popularity in the 1980s. Red Bull energy drinks were the first of its kind, opening the door to a new consumer and regulatory landscape. Since Red Bull first launched, multiple companies have released countless new energy drink products. Some energy drinks, like Red Bull, contain less than 100 mg of caffeine per 8 oz can. However, other energy drinks contain much higher amounts of caffeine. A 12 oz can of Celsius contains 200 mg of caffeine, and up until recently, Celsius offered a product called Celsius Heat, a 12 oz can containing 300 mg of …

I’M Not Lovin’ It: Re-Thinking Fast Food Advertising, Brody Shea, Michael S. Sinha

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In 1971, the Federal Trade Commission (“FTC”) and the Food and Drug Administration (“FDA”) agreed to prevent injury and deception to the consumer in advertising, detailing their respective roles in a Memorandum of Understanding (“MOU”).¹ The MOU proscribes that the FTC regulates truth in advertising relating to foods, drugs, devices and cosmetics while the FDA controls labeling and the misbranding of foods, drugs, devices, and cosmetics shipped in interstate commerce.² The MOU has been amended and an addendum added since 1971, but the material provisions have remained consistent for over a half-century.³

Importantly, the FDA and the …

Standards And The Law, Cary Coglianese

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The world of standards and the world of laws are often seen as separate, but they are more closely intertwined than many professionals working with laws or standards realize. Although standards are typically considered to be voluntary and non-binding, they can intersect with and affect the law in numerous ways. They can serve as benchmarks for determine liability in tort or contract. They can facilitate domestic and international transactions. They can prompt negotiations over the licensing of patents. They can govern the development of forensic evidence admissible in criminal courts. And standards can even become binding law themselves when they …

Solving The Congressional Review Act’S Conundrum, Cary Coglianese

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Congress routinely enacts substantive statutes that require federal agencies to adopt regulations. When agencies issue regulations under these statutes, their rules are then subject to potential disapproval by Congress under a process outlined in a separate procedural statute known as the Congressional Review Act (CRA). If Congress passes a CRA disapproval resolution, this voids the disapproved regulation and triggers a provision in the CRA that prohibits the agency from adopting any subsequent regulation that is “substantially the same” as the disapproved one. But a CRA disapproval resolution does nothing to eliminate the agency’s obligation under the substantive statute to put …

Regulating Machine Learning: The Challenge Of Heterogeneity, Cary Coglianese

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Machine learning, or artificial intelligence, refers to a vast array of different algorithms that are being put to highly varied uses, including in transportation, medicine, social media, marketing, and many other settings. Not only do machine-learning algorithms vary widely across their types and uses, but they are evolving constantly. Even the same algorithm can perform quite differently over time as it is fed new data. Due to the staggering heterogeneity of these algorithms, multiple regulatory agencies will be needed to regulate the use of machine learning, each within their own discrete area of specialization. Even these specialized expert agencies, though, …

Antipolitics And The Administrative State, Cary Coglianese, Daniel Walters

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The modern administrative state plays a vital role in governing society and the economy, but the role that politics should play in administrators’ decisions remains contested. The various regulatory and social service agencies that make up the administrative state are staffed with experts who are commonly thought to be charged with making only technocratic judgments outside the pressures of ordinary politics. In this article, we consider what it might mean for the administrative state to be antipolitical. We identify two conceptions of an antipolitical administrative state. The first of these—antipolitics as antidiscretion—holds that, in a democracy, value judgments should only …

Re-Regulating Dietary Supplements, Jessie L. Bekker, Alex Flores, Michael S. Sinha

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In 1994, Congress introduced the Dietary Supplement Health and Education Act (DSHEA) to create a regulatory framework for the dietary supplement industry. Since the passage of DSHEA nearly thirty years ago, U.S. adults have steadily increased their annual consumption of dietary supplements. The once $4 billion industry comprising approximately 4,000 products has swelled to a $40 billion trade with anywhere from 50,000 to 80,000 dietary supplements available over-the-counter.

Despite the increased market size of dietary supplements, the Food and Drug Administration’s (FDA) pre-market authority to regulate the introduction of dietary supplements into the stream of commerce has remained subdued. Under …

Outsourcing Self-Regulation, Marsha Griggs

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Answerable only to the courts that have the sole authority to grant or withhold the right to practice law, lawyers operate under a system of self-regulation. The self-regulated legal profession staunchly resists external interference from the legislative and administrative branches of government. Yet, with the same fervor that the legal profession defies non-judicial oversight, it has subordinated itself to the controlling influence of a private corporate interest. By outsourcing the mechanisms that control admission to the bar, the legal profession has all but surrendered the most crucial component of its gatekeeping function to an industry that profits at the expense …

Solving The Congressional Review Act’S Conundrum, Cary Coglianese

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Congress routinely enacts statutes that require federal agencies to adopt specific regulations. When Congress passed the Dodd-Frank Wall Street Reform and Consumer Protection Act in 2010, for example, it mandated that the Securities and Exchange Commission (SEC) adopt an anti-corruption regulation requiring energy companies to disclose payments they make to foreign governments. Although the Dodd-Frank Act specifically required the SEC to adopt this disclosure requirement, the agency’s eventual regulation was also, like other administrative rules, subject to disapproval by Congress under a process outlined in a separate statute known as the Congressional Review Act (CRA).

After the SEC issued its …

Building Better Compliance, Cary Coglianese

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A response to Dorothy Lund & Natasha Sarin: "Corporate Crime and Punishment: An Empirical Study"

President Biden's Executive Order On Competition: An Antitrust Analysis, Herbert J. Hovenkamp

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In July, 2021, President Biden signed a far ranging Executive Order directed to promoting competition in the American economy. This paper analyzes issues covered by the Order that are most likely to affect the scope and enforcement of antitrust law. The only passage that the Executive Order quoted from a Supreme Court antitrust decision captures its antitrust ideology well – that the Sherman Act:

rests on the premise that the unrestrained interaction of competitive forces will yield the best allocation of our economic resources, the lowest prices, the highest quality and the greatest material progress, while at the same time …

Confronting Complexity With Regulatory Excellence: Recommendations In The Wake Of The Philadelphia Refinery Explosion, Cary Coglianese

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Following the June 2019 explosion at the Philadelphia Energy Solutions (PES) refinery, the city of Philadelphia now confronts major challenges associated with the future of the refinery site. Whether the site is reopened as a refinery or other chemical-processing operation, or redeveloped for other uses, the city will face challenges endemic to all kinds of public policy issues: complexity, uncertainty, dynamism, tradeoffs, and value choices. This testimony, delivered to the City of Philadelphia Refinery Advisory Group’s Environment Committee, offers three main suggestions to help guide Philadelphia officials in dealing with the future of the PES refinery site. First, city officials …

Assessing Automated Administration, Cary Coglianese, Alicia Lai

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To fulfill their responsibilities, governments rely on administrators and employees who, simply because they are human, are prone to individual and group decision-making errors. These errors have at times produced both major tragedies and minor inefficiencies. One potential strategy for overcoming cognitive limitations and group fallibilities is to invest in artificial intelligence (AI) tools that allow for the automation of governmental tasks, thereby reducing reliance on human decision-making. Yet as much as AI tools show promise for improving public administration, automation itself can fail or can generate controversy. Public administrators face the question of when exactly they should use automation. …

Moving Toward Personalized Law, Cary Coglianese

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Rules operate as a tool of governance by making generalizations, thereby cutting down on government officials’ need to make individual determinations. But because they are generalizations, rules can result in inefficient or perverse outcomes due to their over- and under-inclusiveness. With the aid of advances in machine-learning algorithms, however, it is becoming increasingly possible to imagine governments shifting away from a predominant reliance on general rules and instead moving toward increased reliance on precise individual determinations—or on “personalized law,” to use the term Omri Ben-Shahar and Ariel Porat use in the title of their 2021 book. Among the various technological, …

Algorithm Vs. Algorithm, Cary Coglianese, Alicia Lai

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Critics raise alarm bells about governmental use of digital algorithms, charging that they are too complex, inscrutable, and prone to bias. A realistic assessment of digital algorithms, though, must acknowledge that government is already driven by algorithms of arguably greater complexity and potential for abuse: the algorithms implicit in human decision-making. The human brain operates algorithmically through complex neural networks. And when humans make collective decisions, they operate via algorithms too—those reflected in legislative, judicial, and administrative processes. Yet these human algorithms undeniably fail and are far from transparent. On an individual level, human decision-making suffers from memory limitations, fatigue, …

From Negative To Positive Algorithm Rights, Cary Coglianese, Kat Hefter

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Artificial intelligence, or “AI,” is raising alarm bells. Advocates and scholars propose policies to constrain or even prohibit certain AI uses by governmental entities. These efforts to establish a negative right to be free from AI stem from an understandable motivation to protect the public from arbitrary, biased, or unjust applications of algorithms. This movement to enshrine protective rights follows a familiar pattern of suspicion that has accompanied the introduction of other technologies into governmental processes. Sometimes this initial suspicion of a new technology later transforms into widespread acceptance and even a demand for its use. In this paper, we …

Racial Justice And Administrative Procedure, Sophia Z. Lee

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This article argues that commemorating the Administrative Procedure Act (APA) should involve accounting for the role it has played in both advancing and thwarting racial justice, as well as the role racial justice advocates have played in shaping its interpretation. The APA was not designed to advance racial justice; indeed, its provisions insulated some of the mid-twentieth century's most racially pernicious policies from challenge. Yet racial justice advocates have long understood that administrative agencies could be a necessary or even uniquely receptive target for their efforts and the APA shaped those calculations. Along the way, racial justice advocates left their …

Regulating New Tech: Problems, Pathways, And People, Cary Coglianese

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New technologies bring with them many promises, but also a series of new problems. Even though these problems are new, they are not unlike the types of problems that regulators have long addressed in other contexts. The lessons from regulation in the past can thus guide regulatory efforts today. Regulators must focus on understanding the problems they seek to address and the causal pathways that lead to these problems. Then they must undertake efforts to shape the behavior of those in industry so that private sector managers focus on their technologies’ problems and take actions to interrupt the causal pathways. …

Presidential Primacy Amidst Democratic Decline, Arshaf Ahmed, Karen Tani

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Fifty years ago, when the Harvard Law Review asked Professor Harry Kalven, Jr., to take stock of the Supreme Court’s 1970 Term, Kalven faced a task not unlike Professor Cristina Rodríguez’s. That Term’s Court had two new members, Justices Harry Blackmun and Warren Burger. The Nixon Administration was young, but clearly bent on making its own stamp on American law, including via the Supreme Court. Kalven thus expected to see “dislocations” when he reviewed the Court’s recent handiwork. He reported the opposite. Surveying a Term that included such cases as Palmer v. Thompson, Younger v. Harris, Boddie v. …

The Deregulation Deception, Cary Coglianese, Natasha Sarin, Stuart Shapiro

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President Donald Trump and members of his Administration repeatedly asserted that they had delivered substantial deregulation that fueled positive trends in the U.S. economy prior to the COVID pandemic. Drawing on an original analysis of data on federal regulation from across the Trump Administration’s four years, we show that the Trump Administration actually accomplished much less by way of deregulation than it repeatedly claimed—and much less than many commentators and scholars have believed. In addition, and also contrary to the Administration’s claims, overall economic trends in the pre-pandemic Trump years tended simply to follow economic trends that began years earlier. …

Unrules, Cary Coglianese, Gabriel Scheffler, Daniel Walters

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At the center of contemporary debates over public law lies administrative agencies’ discretion to impose rules. Yet, for every one of these rules, there are also unrules nearby. Often overlooked and sometimes barely visible, unrules are the decisions that regulators make to lift or limit the scope of a regulatory obligation, for instance through waivers, exemptions, and exceptions. In some cases, unrules enable regulators to reduce burdens on regulated entities or to conserve valuable government resources in ways that make law more efficient. However, too much discretion to create unrules can facilitate undue business influence over the law, weaken regulatory …

Lifting Labor’S Voice: A Principled Path Toward Greater Worker Voice And Power Within American Corporate Governance, Leo E. Strine Jr., Aneil Kovvali, Oluwatomi O. Williams

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In view of the decline in gain sharing by corporations with American workers over the last forty years, advocates for American workers have expressed growing interest in allowing workers to elect representatives to corporate boards. Board level representation rights have gained appeal because they are a highly visible part of codetermination regimes that operate in several successful European economies, including Germany’s, in which workers have fared better.

But board-level representation is just one part of the comprehensive codetermination regulatory strategy as it is practiced abroad. Without a coherent supporting framework that includes representation from the ground up, as is provided …

Due Process In Antitrust Enforcement: Normative And Comparative Perspectives, Christopher S. Yoo, Yong Huang, Thomas Fetzer, Shan Jiang

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Due process in antitrust enforcement has significant implications for better professional and accurate enforcement decisions. Not only can due process spur economic growth, raise government credibility, and limit the abuse of powers according to law, it also promotes competitive reforms in monopolized sectors and curbs corruption. Jurisdictions learn from the best practices in the investigation process, decisionmaking process, and the announcement and judicial review of antitrust enforcement decisions. By comparing the enforcement policies of China, the European Union, and the United States, this article calls for better disclosure of evidence, participation of legal counsel, and protection of the procedural and …

Privacy Vs. Transparency: Handling Protected Materials In Agency Rulemaking, Christopher S. Yoo, Kellen Mccoy

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Agencies conducting informal rulemaking proceedings increasingly confront conflicting duties with respect to protected materials included in information submitted in public rulemaking dockets. They must reconcile the broad commitment to openness and transparency reflected in federal law with the duty to protect confidential business information (CBI) and personally identifiable information (PII) against improper disclosure.

This Article presents an analysis of how agencies can best balance these often-countervailing considerations. Part I explores the statutory duties to disclose and withhold information submitted in public rulemaking dockets placed on agencies. It also examines judicial decisions and other legal interpretations regarding the proper way to …

Bankruptcy For Banks: A Tribute (And Little Plea) To Jay Westbrook, David A. Skeel Jr.

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In this brief essay, to be included in a book celebrating the work of Jay Westbrook, I begin by surveying Jay’s wide-ranging contributions to bankruptcy scholarship. Jay’s functional analysis has had a profound effect on scholars’ understanding of key issues in domestic bankruptcy law, and Jay has been the leading scholarly figure on cross-border insolvency. After surveying Jay’s influence, I turn to the topic at hand: a proposed reform that would facilitate the use of bankruptcy to resolve the financial distress of large financial institutions. Jay has been a strong critic of this legislation, arguing that financial institutions need to …

Compliance Management Systems: Do They Make A Difference?, Cary Coglianese, Jennifer Nash

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Regulatory compliance is vital for promoting the public values served by regulation. Yet many businesses remain out of compliance with some of the regulations that apply to them—presenting not only possible dangers to the public but also exposing themselves to potentially significant liability risk. Compliance management systems (CMSs) may help reduce the likelihood of noncompliance. In recent years, managers have begun using CMSs in an effort to address compliance issues in a variety of domains: environment, workplace health and safety, finance, health care, and aviation, among others. CMSs establish systematic, checklist-like processes by which managers seek to improve their organizations’ …

Ai In Adjudication And Administration, Cary Coglianese, Lavi M. Ben Dor

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The use of artificial intelligence has expanded rapidly in recent years across many aspects of the economy. For federal, state, and local governments in the United States, interest in artificial intelligence has manifested in the use of a series of digital tools, including the occasional deployment of machine learning, to aid in the performance of a variety of governmental functions. In this paper, we canvas the current uses of such digital tools and machine-learning technologies by the judiciary and administrative agencies in the United States. Although we have yet to see fully automated decision-making find its way into either adjudication …

Comments On Rights To Federally Funded Inventions And Licensing Of Government Owned Inventions, National Institute Of Standards And Technology (Nist), United States Department Of Commerce, Notice Of Proposed Rulemaking. 86 Fr 35. Agency/Docket Number: 201207-0327, Joshua D. Sarnoff, Liza Vertinsky, Yaniv Heled, Ana Santos Rutschman, Cynthia M. Ho

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This letter is written in response to the notice of proposed rulemaking published in the Federal Register on January 4, 2021, seeking public comments on the revised regulations proposed by NIST to the University and Small Business Patent Procedure Act of 1980 (the “Bayh-Dole Act”). We submit this letter as academics who engage in research on patent law and biomedical innovation. The arguments also reflect practical knowledge that one of us has acquired from a decade of working with U.S. universities and biotech companies in the process of technology transfer as a lawyer practicing in two highly regarded Boston law …

What Regulators Can Learn From Global Health Governance, Cary Coglianese

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The Great Pandemic of 2020 shows how much public health around the world depends on effective global and domestic governance. Yet for too long, global health governance and domestic regulatory governance have remained largely separate fields of scholarship and practice. In her book, Global Health Justice and Governance, Jennifer Prah Ruger offers scholars and practitioners of regulatory governance an excellent opportunity to see how domestic regulation shares many of the same problems, strategies, and challenges as global health governance. These commonalities reinforce how much national and subnational regulators can learn from global health governance. Drawing on insights from Prah …