Showing posts with label regulation. Show all posts
Showing posts with label regulation. Show all posts

Tuesday, March 18, 2025

Book details knotty business of higher ed counsel

By attorney Louis H. Guard and academic Joyce P. Jacobsen, All the Campus Lawyers (2024) is a compelling recent read for anyone interested in the law of higher education—whether as a counselor, as a client, or as a victim of higher ed machinations. I've been all three.

Guard and Jacobsen both are affiliated with Hobart and William Smith Colleges—a beautiful double campus I visited just last summer, perched atop Seneca Lake in Geneva, New York, in the Finger Lakes region. Guard is a general counsel there, and Jacobsen a past president and economics professor.

All the Campus Lawyers thoroughly covers the many facets of higher ed practice nowadays, from civil rights and labor, to intellectual property, contracting, and cybersecurity. It is a lot to see it all in one place. At an overarching level of abstraction, the book—which is subtitled, "Litigation, Regulation, and the New Era of Higher Education"—ponders how and why law has become pervasive, and sometimes paralyzing, of higher ed. 

To my reading, Guard and Jacobsen are careful to avoid a normative agenda, and rather strive to be descriptive, instructive, and sometimes even inspiring. But I came away with an uneasy feeling in the belly that law, at least in practice, has a stranglehold on the free-wheeling nature of academic inquiry that classical-liberal society associates with the "quintessential marketplace of ideas." 

If higher ed is just a business—and maybe it always was—law, from the perspective of university counsel, seems to be part of the problem: supporting the business framing with defensive practice and risk aversion, and prizing the institution over the people who constitute it and whom it serves. No doubt my perception is colored by experience.

I stop by the Geneva, N.Y., Welcome Center in July 2024.
RJ Peltz-Steele CC BY-NC-SA 4.0
Another impression I had of the book was that it is siloed, tending to view the mission creep of law in the higher ed sector to the exclusion of the same phenomenon across American life. Indeed, what business, what person does not need a lawyer to navigate the world today, even if ordinary people have to manage without, usually to their detriment. I'm not sure the problem of law in higher ed can be examined exclusively of "the legalization of American society" (meaning ubiquity of law, not blessing of lawfulness).

Furthermore, there is, to my mind and at one level, a rather simple explanation for law's infiltration of higher ed. With a hat tip to Lincoln Steffens and Clark Mollenhoff: Follow the money. The relevant question might not be why law has become pervasive in higher ed, but why higher ed has become big business rather than collective good or philanthropy. Guard and Jacobsen are too ready to take that twist of mission for granted.

Despite my nitpicks, Campus Lawyers is a worthwhile read for a fuller understanding of the relationship between law and higher ed, and especially for insight into the modus operandi of university counsel.

Here is the publisher's description:

Not so long ago, colleges and universities had little interaction with the law. In the 1970s, only a few well-heeled universities even employed in-house legal counsel. But now we live in the age of tenure-denial lawsuits, free speech battles, and campus sexual assault investigations. Even athletics rules violations have become a serious legal matter. The pressures of regulation, litigation, and legislation, Louis Guard and Joyce Jacobsen write, have fostered a new era in higher education, and institutions must know how to respond.

For many higher education observers and participants, including most administrators and faculty, the maze of legal mandates and potential risks can seem bewildering. Guard, a general counsel with years of higher education law experience, and Jacobsen, a former college president, map this unfamiliar terrain. All the Campus Lawyers provides a vital, up-to-date assessment of the impact of legal concerns on higher education and helps readers make sense of the most pressing trends and issues, including civil rights; free speech and expression; student life and wellness; admissions, advancement, and community relations; governance and oversight; the higher education business model; and on-campus crises, from cyberattacks to pandemics.

As well as informing about the latest legal and regulatory developments affecting higher education, Guard and Jacobsen offer practical guidance to those in positions of campus authority. There has never been a more crucial time for college and university boards, presidents, inside and outside counsel, and other higher education leaders to know the law and prepare for legal challenges.

Of course, it remains to be seen what remains of higher ed after the Trump Administration. Guard and Jacobsen might have accomplished the equivalent of a book about the flu on the eve of the pandemic, in which case, we'll need a revised edition sooner rather than later.

Tuesday, February 4, 2025

RFK, Jr. hearing prompts reconsideration of civil, regulatory responsibility for vaccine misinformation

"Are you supportive of these onesies?" Sen. Sanders asks.
© C-SPAN (YouTube; license).
The showdown between Bernie Sanders and RFK, Jr., featuring anti-vacc onesies, got me thinking about articles published by a former student, later academic and bar colleague, positing tort and regulatory approaches to harmful vaccine misinformation.

I wrote in 2017 about physician-attorney Donald C. Arthur's Commercial Deception by Anti-Vaccine Homeopathic Websites: A Consumer Protection Approach, 10:1 Biotechnology & Pharmaceutical L. Rev. 1, 27 (2017). At the time, the article was behind a pay wall; it is now freely available.  Here is the abstract.

Some internet marketers offer for sale "vaccination substitutes" that can purportedly replace actual scientifically-tested and federally-approved vaccinations. Deceptive internet advertising for vaccine substitutes has dissuaded parents from vaccinating their children, resulting in a resurgence of vaccine-preventable childhood diseases. The Food and Drug Administration and Federal Trade Commission have the authority to address dangerously deceptive product claims, including those for homeopathic preparations that have thus far avoided safety and efficacy testing. This article presents the issues involved in deceptive advertising and proposes regulatory solutions.

When Dr. Arthur and I first discussed the project in the 2010s, he was thinking about a tort theory for liability for publishers of vaccine misinformation. The tort theory is fraught, but feasible. There are problems of proof, such as the attenuated causation linking the publication of misinformation with later disease, and the inevitable First Amendment defense, which at plaintiff's most fortunate still might require culpability in excess of ignorance.

Dr. Arthur split his research into two works. He published in 2016, I didn't mention in 2017, Negative Portrayal of Vaccines by Commercial Websites: Tortious Misrepresentation, 11:2 UMass L. Rev. 122 (2016), also freely available. Here is the abstract.

Commercial website publishers use false and misleading information to create distrust of vaccines by claiming vaccines are ineffective and contain contaminants that cause autism and other disorders. The misinformation has resulted in decreased childhood vaccination rates and imperiled the public by allowing resurgence of vaccine-preventable illnesses. This Article argues that tort liability attaches to publishers of commercial websites for foreseeable harm that results when websites dissuade parents from vaccinating their children in favor of purchasing alternative products offered for sale on the websites.

When Dr. Arthur wrote both these articles in 2016, it was before the first election of Donald Trump with attendant attempts to disarm and dismantle federal consumer protection systems. The tort theory looks better now. See Dorit Reiss & John Diamond, Tort Law: Liability for Anti-Vaccine Misinformation, 4 Judges Book 107 (2020) (not citing Arthur).

Dr. Arthur is an emergency medicine and preventive medicine physician.  He served 33 years in the U.S. Navy, culminating his career as Navy surgeon general and retiring at the rank of vice admiral. He served as chief executive officer of three hospitals, including the National Naval Medical Center in Bethesda, Maryland. Dr. Arthur teaches adjunct at UMass Law and for seven years practiced of counsel with the Law Offices of Beauregard, Burke and Franco.

HT @ Melissa Colten, UMass Law public interest fellow, whose curiosity reminded me of these articles.

Saturday, May 20, 2023

EPA floats PFAS limits for drinking water

Rawpixel CC0 1.0
PFAS has been much on the lips of regulators, lately and at last. 

As I wrote in 2021, the movie Dark Waters (2019), based on a true story, first brought PFAS to my attention. I'm happy to report that we've since replaced almost all of our PFAS-coated cookware. And just yesterday, I followed the recent custom of removing a burrito from its plastic-coated-paper wrapper before heating it in the microwave.

When John Oliver gave his classic treatment to PFAS in 2021, Europe was moving to regulate it, but the United States was doing very little. Per John Oliver's invitation, I confirmed that my local water authority in Rhode Island was not testing for PFAS in drinking water.

Now, with Biden Administration support announced in March, the U.S. Environmental Protection Authority has a PFAS website and proposed regulations for drinking water. The proposal would drop acceptable levels of six PFAS chemicals from 70 to 4 parts per million (ppt).

That's a start, but not a solution. 

PFAS might now be in the drinking water of as many as 200 million Americans, The Guardian reported in March. Research shows human health risk upon any exposure to PFAS, so no safe level is known. The EPA's own guidelines since last year have called for voluntary limits on two PFAS chemicals at 0.02 and 0.004 ppt, a Harvard expert explained. Meanwhile, it's not clear that scientific testing is accurate enough to detect PFAS levels that low. Thus, the EPA proposal is vulnerable to criticism for not reaching the full range of PFAS chemicals and not setting maximum levels low enough. But the challenge truly to ensure human health might be practically insurmountable.

Spurred by burgeoning state regulation meanwhile, the private sector is ramping up capacity to test for PFAS nationwide. In February, Maine Laboratories became the first commercial lab in that state to offer testing. Maine Labs sells test kits for drinking water, waste water, ground water, and soil, with a two-week turnaround for results. Maine Labs's CEO is Katie Richards, a close friend and former college roommate of one of my sisters.

Monday, July 4, 2022

Judge delays decision again on Mass. right to repair, cites need to study SCOTUS climate change ruling

pix4free
Last week, in West Virginia v. Environmental Protection Agency, the U.S. Supreme Court dealt a major blow to federal regulators on the climate change front, and the case has stalled, again, release of the trial court decision over the right-to-repair law in Massachusetts.

First, a word on West Virginia, in which the Court struck down climate change-combative regulations for being born of a breadth not sufficiently specifically authorized by Congress. Others will comment more ably than I on the constitutional law of it all, but from where I sit, the case was correctly decided. Before you throw your rotten tomatoes at me for composting, at least absorb my two cents on the matter: 

We have too long been under the rule of administrative fiat in the United States, rather than democratic lawmaking, because our dysfunctional Congress long ago abdicated its role as a co-equal branch of government. Early in the 20th century, the Court unwisely allowed the non-delegation doctrine to slip away, and with it went the checks and balances of the constitutional separation of powers itself. So we're overdue for a correction.

You don't want to hear it from me, but the same problem pertains in the Roe/Dobbs debacle, where the administrative fiats on privacy have been coming from the Court rather than the administrative state, but certainly not from Congress: same difference. People, especially people ill schooled in the separation of powers—wherefore the sorry state of K12?—look to monolithic government for answers to their problems. They don't much care which public office provides the answer. So they fail to distinguish a Supreme Court decision—West Virginia or Dobbs—that says not our job from one that says simply not. Protestors picketing the Supreme Court building in recent weeks were on the wrong side of the street.

Abdication is a win-win for lawmakers, who can rake in the dough from corporations for the small price of doing nothing while blaming other branches of government for failing to offer a fix. Lawmakers sat on their hands on privacy and women's rights for decades in the wake of Griswold and Roe, content to let the Court struggle to map fine lines. Now they pantomime outrage and aspersion when Roe goes away and there is no statutory civil rights framework to replace it, nor even a framework to protect interstate travel rights, which is well within congressional authority.

Anyway, the angle on West Virginia that interests me is that on July 1, the U.S. District Judge Douglas P. Woodlock again delayed his decision in automakers' challenge to the Massachusetts right-to-repair initiative, saying that he would have to study the impact, if any, of West Virginia on his rationale. (E.g., Repair Driven News.)

Issuance of the decision in the case has been delayed time and again this calendar year, and the case has spurred occasional fireworks. Chris Villani for Law 360 wrote in February how "[a]n exasperated federal judge said ... he was close to a verdict in a suit challenging Massachusetts' revised 'right to repair' law, yet he pressed attorneys for a group of manufacturers about why they didn't tell him that new Subaru and Kia vehicles complied with rules they claimed are impossible to follow."

It was not clear, later, whether Subaru and Kia had actually complied, or just turned off the offending telematic features in new cars to be sold in Massachusetts. Turning off an otherwise functional mechanism does not, Massachusetts AG Maura Healey opined, and I agree, comply with the consumer data access law.

Though the omission that aggravated the judge was explainable, the incident is demonstrative nonetheless of automakers' obfuscating foot-dragging in their conduct of the case overall. They threw every kitchen-sink theory and procedural roadblock at the Massachusetts law, because every day of noncompliance is money in the bank, never mind the merits, nor the defense cost to taxpayers.

Automakers' problem is less with telematics regulation and more with being regulated state by state, rather than by federal standards. Federal regulation, rather than state regulation, has two powerful advantages for industry. First, federal regulations are universal, rather than 50+ in number, which vastly reduces compliance costs. More efficiency in compliance costs is good for consumers, too. So that's fair.

Second, federal regulations come from a grinding rule-making process that is almost irretrievably contaminated by the mostly lawful if deeply lamentable corruption of the industry-state complex. So manufacturers can lobby their way free of meaningful burdens that would benefit consumers and protect social and economic rights. Less fair.

It is not clear why Judge Woodlock thinks that West Virginia might affect his ruling. I might be able to say if I followed the Massachusetts case more closely. Absent a study, my guess is that the issue has to do with preemption. One of the automakers' kitchen-sink challenges alleged that Massachusetts could not regulate telematics because federal regulation of the auto industry impliedly preempts state right-to-repair regulation. If the judge thought that the vitality of that theory depended on the breadth of the federal regulations, and the permissible breadth of federal regulations, when ambiguous, is necessarily narrowed by West Virginia, then maybe it's less likely that the federal regulations can be said impliedly to preclude state regulation.

I'm now piling supposition upon supposition, but if I'm right, the likelihood is that the trial court was going to rule in favor of industry, and it's possible but unlikely that West Virginia would change that. I put money on industry on this one back in the winter, too, in part because I supposed that the judge's exasperation was evoked by a seeming deception on the part of the soon-to-be-announced prevailing side, and in part because I'm a pessimist. Or, I like to think, a realist.

My will for public policy, though, if not my bet, is on the side of AG Healey. Previously, I've written favorably about right to repair as a bulwark of consumer protection, and I support the Massachusetts initiative.

The Massachusetts case is Alliance for Automotive Innovation v. Healey (D. Mass. filed Nov. 20, 2020).

Tuesday, October 5, 2021

Unregulated, 'Dark Waters' chemicals persist in cookware, clothing, sickening people, environment

Comedian and social critic John Oliver's latest top story on HBO's Last Night concerned PFAS, the artificial chemical substances behind non-stick coatings on cookware and incorporated into food wrappings and textiles, known to be highly dangerous to human health.


The stuff persists, Oliver explained, in new, unregulated, and unlabeled formulations, despite a horrific track record of illness, from obesity to terminal cancer, and environmental damage.  Oliver related recent history by quoting parts of the landmark New York Times Magazine feature by Nathaniel Rich in 2016, "The Lawyer Who Became Dupont's Worst Nightmare."  That piece inspired the unsettling 2019 feature film Dark Waters.  Oliver also excerpted a 2018 documentary, The Devil We Know.

PFAS, a "forever chemical" that persists in the environment for thousands of years, is now in the blood of virtually all Americans.  Food wrappings and clothing are our greatest risk, Oliver explained, and there is no labeling to warn us.

I just caught this on a spot-check. Adiós, sartén.
In my household, since Dark Waters brought the issue to our attention, we've exclusively adopted silicone tools to use with non-stick-coated cookware.  And at the first sign of scratching, out goes the pan or pot: a pricey luxury we are lucky to be able to afford, while we only worsen the environmental problem.  We have lately been investigating non-stick alternatives, and Oliver has ignited the gas burner under us to get moving on that.

PFAS is in the water supply, too, sometimes in alarming doses, 70 parts per trillion (ppt) being the EPA's recommended maximum concentration in drinking water.  Oliver pointed viewers to a "PFAS Contamination" interactive map created by the NGO Environmental Working Group.  The map is intriguing and informative to play around with, as it compiles water quality data from around the country.

But the most frightening takeaway from the map is the data it does not contain.  Data collection is hit or miss.  The closest results to me in East Bay Rhode Island come from a small school serving only 40 persons (4 ppt), a Massachusetts water district serving 13,627 persons (20 ppt), and the Pawtucket (R.I.) water system, serving 99,200 persons and reporting a PFAS excess at 74 ppt.

My local water authority, Bristol County (BCWA), says my water rather comes from Providence, which is not on the EWG data map, and where water quality reports appear to be missing.  It further undermines my confidence in the system that BCWA has been wanting to build a pipeline to Pawtucket, which offers, BCWA says, "another source of excellent quality water."

At last, Europe is moving ahead with regulation; I hope that will spur the United States to follow suit.

[UPDATE, 17 Oct. 2021:  Providence Water sent me a copy of the 2020 Water Quality Report in the mail. As anticipated by Oliver, there is no mention in the report of PFAS.]

Wednesday, January 20, 2021

Comparative law talks look to Biden Administration, covid-19 aftermath, EU market, juvenile justice

The winter-spring lecture series, "Contemporary Challenges in Global and American Law," from the Faculty of Law and Administration at Jagiellonian University (JU) in Kraków, Poland, and the Columbus School of Law at the Catholic University of America (CUA) in Washington, D.C., is free and already under way.

The series promises an exciting lineup, continuing from six lectures in fall 2020, all of which may be viewed online.  This semester's offerings kicked off last week, January 13, with London-Milan lawyer Vincenzo Senatore talking about covid-19 as force majeure in contract law, and comparing common law and civil law approaches.

One week from today, January 27, Professor Geoffrey P. Watson, director of the Comparative and International Law Institute at CUA, will talk on "International Law and the New Biden Administration."  Free registration is now open.

Stryjniak
Here's the line-up for February and March.  Watch the website for more in April and May.  Free registration is required for contemporaneous participation.

  • February 10 - Katarzyna Stryjniak, "EU and US Budget-Making: Process, Politics, and Policy in a COVID-Challenged World" 
  • February 24 - Heidi Mandanis Schooner, "How Well Did the Post-2008 Financial Crisis Regime Prepare the World for the COVID-19 Pandemic?"
  • March 2 - Cara H. Drinan, "The War on Kids: Progress and the Path Forward on Juvenile Justice"
  • March 24 - Gaspar Kot, "Sustainable Investment – The New Heart of EU Financial Market Regulation"

The lecture series grew out of a summer 2020 pilot program in which I was privileged to participate, and it's been a welcome way, during the pandemic, to connect with colleagues in Europe and take pride in former students.  Now a legal and policy officer with the European Commission, Kasia Stryjniak is a graduate of JU and CUA master's programs.  Gaspar Kot is near completion of the Ph.D. at JU, holds an LL.M. from CUA, coordinates the LL.M. program at JU, and was my co-author on a recent book chapter.

Tuesday, January 19, 2021

Class labor action fails on appeal, but highlights persistent failure to afford living wage for U.S. workers

Boston, Mass. (from Pixabay by StockSnap, licensed)
Notwithstanding its failure, a class labor action dismissed by the Massachusetts Appeals Court highlights the persistent legal norms that keep U.S. workers under compensated.

Siew-Mey Tam worked as a property manager for Federal Management Co. (FMC) in Boston, managing Mason Place, a 127-unit, subsidized-housing community in the heart of the city.  Dissatisfied with her terms of employment, Tam became the lead plaintiff in a class action accusing FMC of violating wage-and-hour laws.  The class was certified in 2015.

Among the issues in the case was FMC's classification of Tam and others as exempt administrative employees.  A company's ability to exploit so-called "salaried" workers with responsibilities that defy the number of work hours in the week facilitates subversion of already paltry U.S. minimum wages and evasion of overtime pay.  This is another in a genus of "misclassification" problems that form our bleak landscape of employment rights and was part of the back-and-forth tug of regulatory might in the Obama and Trump administrations.

In 2016, the threshold for overtime exemption under Department of Labor regulations pursuant to the Fair Labor Standards Act (FLSA) was $455 per week, or $23,660 per year.  For comparison, the intransigent federal minimum wage is, and has been since 2009, $7.25 per hour, or up to $15,080 per year.  The Massachusetts minimum wage in 2016 was $10 per hour, or up to $20,800 per year.  Having been unable to push a federal minimum-wage hike through Congress, the Obama Administration announced a doubling of the exemption threshold, to be effective December 1, 2016, from $455 per week, to $913 per week, or $47,476 per year, with automatic upward adjustments to follow beginning in 2020.

From the Economic Policy Institute
But that increase never happened.  A Texas judge blocked the regulations in November 2016 (N.Y. Times), and the Trump Administration in 2017 junked the upgrade.  The threshold remained at $455 for three more years, until the Trump Administration promulgated a more modest increase to $684 per week, or $35,568 per year, which took effect in 2020.  While the federal minimum wage remains at $7.25, the Massachusetts minimum wage has crept upward, in 2021 to $14.00 per hour, or up to $29,120, on its way to a living wage.

In the instant case, according to the court, "[i]t was uncontested that Tam worked more than 40 hours per week but generally was not paid overtime. Instead, the dispute was whether the nature of Tam's job meant that she was an exempt administrative employee to whom overtime pay was not due."  FMC maintained that in addition to a base salary in excess of the $455 threshold, Tam's "primary duty include[d] the exercise of discretion and independent judgment with respect to matters of significance," which regulations also require for "administrative" exemption.

Most of the appellate decision in Tam v. FMC concerns a deposition in 2016, in which, it seems from the court's description, the plaintiffs' case self-destructed.  Tam's answers supported the FMC position that she exercised considerable authority over the property.  Moreover, "Tam gave other answers that raised serious concerns about how the case and a related discrimination case against [FMC] were being litigated," pointing to inconsistencies in discovery responses.

"For example," the court observed, "confronted with a factual misstatement in her interrogatory answers filed in the [related] discrimination case, Tam attempted to address the misstatement by explaining that she had signed the answers without actually reading them, because she 'trust[ed her] lawyer.'"  The deposition was especially damaging because Tam was the lead plaintiff for the class.

The Appeals Court affirmed summary judgment and an award of pretrial costs against Tam and a co-plainitff, Raymond.  A collateral action against FMC remains pending.

Included in the affirmance was the dismissal of a separate retaliation claim by Raymond.

A former property manager for FMC, Raymond alleged that she was fired for her wage-and-hour complaints, a retaliation that would violate Massachusetts law.  The courts ruled that Raymond's claim came up short because she did not sufficiently notify FMC of the legal basis of her discontent.  An employee need not necessarily invoke a specific statute, the Appeals Court held, but the court characterized Raymond's objections as closer to "abstract grumblings" (quoting precedent) than to a reasonably understandable assertion of statutory rights.  That's a cautionary tale for low-wage employees who might not understand the legal nuances of classification and take as true an employer's declaration of what the law is.

The real shame of the case is what it reveals about the deplorable state of U.S. labor rights.  According to MIT, a living wage for a Boston worker is $670 per week, or $34,819 per year.  That's well more than the exemption threshold before 2020 and just about equivalent to the threshold now.  An exempt employee can be expected to work more than 40 hours per week, so can't hold down a second job—even assuming that it would be civilized to expect that, which it's not.

So the present regime sets an expectation that a worker earning a minimum living wage will work longer than a 40-hour week.  One might expect that administrative employees working more than 40 hours per week would do a little better than a living wage.  Meanwhile, hourly workers still fall far short.  And the per annum numbers I've used here assume 2,080 working hours per year: no break.  Federal law requires no paid vacation time.

The FLSA has been around since 1938.  It's at least arguable that the proceeds of industrialization and technology should be that people don't have to work as hard to survive.  Even by the time the FLSA turns 100, will employees working full time in the shining city on a hill be able to meet basic needs?

The case is Tam v. Federal Management Co., No. 19-P-1332 (Mass. App. Ct. Jan. 6, 2021).  Justice James R. Milkey authored the opinion of a unanimous panel that also comprised Justices Blake and Henry. 

Wednesday, September 11, 2019

Antitrust regulators need to up their game to meet challenges of media convergence, Argentine researchers write in UNESCO paper

Published by UNESCO, a new policy paper from Argentine researchers Martín Becerra and Guillermo Mastrini warns that antitrust regulation must adapt to the convergence of media, telecommunication, and internet to remain effective and preserve people's rights.

Prof. Mastrini

Becerra is a researcher with the National Scientific and Technical Research Council (CONICET), an Argentine government agency, and holds academic appointments at the National University of Quilmes (UNQ) and the University of Buenos Aires (UBA).  Mastrini also serves on the UBA faculty.

The researchers reach the counter-intuitive conclusion that the internet's accessibility to new market entrants, and the ease with which new communication technology should facilitate the balkanization of media services, ironically has worked to concentrate property, revenue, and audience globally.  Thus the role of the regulator is more important than ever, while anachronistic regulatory approaches remain siloed in sectors of disparate expertise.

Prof. Becerra
Becerra and Mastrini rather articulate a "relevant market" approach to organize regulatory authority.  At the same time, they eschew a one-size-fits-all approach to the different problems presented by different entities, namely internet "giants," telecommunication conglomerates, and media companies.  Moreover, the researchers stress that values of access to culture, freedom of expression, and pluralism should be baked into the regulatory framework.

The report is La convergencia de medios, telecomunicaciones e internet en la perspectiva de la competencia: Hacia un enfoque multicomprensivo (my translation: The Convergence of Media, Telecommunication, and Internet from the Perspective of Competition: Toward a Multiple-Understanding Approach) and is published by UNESCO as no. 13 in the series, Discussion Notebooks on Communication and Information, ISSN no. 2301-1424 (2019).  The report is in Spanish and includes an executive summary in translation.  HT @ Observacom.


Here is the executive summary:

The converging qualities of information and communication technologies challenge classic regulatory frameworks when regulating audiovisual media activities, on the one hand, and telecommunications, on the other. The digitalization of communications causes a metamorphosis in the definitions of what each sector encompasses and the emergence of actors that provide products and services and develop businesses in convergent markets simultaneously and in increasingly vast geographical areas.

Regulatory approaches that sought to protect freedom of expression in the media, guarantee access to cultural and informational resources and sustain economic competition to avoid distortion of markets today are being reviewed in light of the new reality of progressive integration and of the growing crosscutting elements within the media, telecommunications and Internet ecosystem. In fact, there are limitations that prevent responding effectively and consistently to the problems raised with the consolidation of the digital revolution.

This policy paper provides analytical tools based on comparative law and inquires about antitrust policies and their relationship with the objective of having diverse and pluralistic communication systems that stimulate public debate in democratic societies. Therefore, it has a multi-understanding approach, since one of its objectives is to facilitate the dialogue of areas that until now have had fields of study, normative translations and institutional expressions separated from each other.

After consulting Latin American regulators in the area of defense of competition, specialists in the region in the field and presenting an updated state of the art of the debate about the relevance of economic competition approaches to seek clear answers for the new problems of a convergent environment in communications, the document makes recommendations with the aim of improving the design of public policies both in the field of information and communication services, and in those that serve economic competition, harmonizing fields and disciplines that were not conceived in an articulated way.

In this context, the policy paper is proposed as an input for public policies and a contribution to optimize the understanding of current phenomena with deep repercussions in the culture, information and communication of societies and individuals.

En español:
Las cualidades convergentes de las tecnologías de información y comunicación desafían los encuadres normativos clásicos a la hora de regular las actividades de medios audiovisuales,  por  un  lado,  y  las  de  telecomunicaciones,  por  otro  lado.  La  digitalización de las comunicaciones provoca una metamorfosis en las propias definiciones de lo que cada sector abarcaba y el surgimiento de actores que proveen productos y servicios y desarrollan negocios en los mercados convergentes de modo simultáneo y en ámbitos geográficos cada vez más vastos.

Los enfoques regulatorios que buscaron como objetivos proteger la libertad de expresión en los medios de comunicación, garantizar el acceso a los recursos culturales e informacionales y sostener la competencia económica para evitar la distorsión de los mercados hoy están siendo revisados a la luz de la nueva realidad de la progresiva integración y de los cruces cada vez mayores dentro del ecosistema de medios, telecomunicaciones  e  Internet.  En  efecto,  hay  limitaciones  que  impiden  responder  de manera eficaz y consistente los problemas suscitados con la consolidación de la revolución digital.

El presente policy paper provee herramientas de análisis basadas en el derecho comparado e indaga sobre las políticas antitrust y su relación con el objetivo de contar con sistemas de comunicación diversos y plurales que estimulen el debate público en sociedades democráticas. Por ello es multicomprensivo, dado que uno de sus objetivos es facilitar el diálogo de áreas que hasta el presente han tenido campos de estudio, traducciones normativas y expresiones institucionales separadas entre sí.

Tras consultar a reguladores latinoamericanos del área de defensa de la competencia, a especialistas de la región en la materia y exponer un actualizado estado del arte del debate académico y de divulgación acerca de la pertinencia de los enfoques de competencia económica para satisfacer con respuestas claras los nuevos problemas propios  de  un  entorno  convergente  en  las  comunicaciones,  el  documento  formula  recomendaciones con el objetivo de mejorar el diseño de las políticas públicas tanto en el campo de los servicios de información y comunicación, como en el de las que atienden  a  la  competencia  económica,  armonizando  campos  y  disciplinas  que  no  fueron concebidos de modo articulado.
En este sentido, el policy paper se propone como un insumo de políticas públicas y una contribución para optimizar la comprensión de fenómenos actuales con hondas repercusiones en la cultura, la información y la comunicación de las sociedades y las personas.

Monday, July 15, 2019

'Genetically modified humans are among us'

An alum of my constitutional law class, Paul Enríquez, J.D., LL.M., Ph.D.—Structural and Molecular Biochemistry, is doing some stellar academic work at the cutting edge of genetic science and law and policy.  He privileged me with a sneak peak at his latest contribution to the legal literature, now available on SSRN, Editing Humanity: On the Precise Manipulation of DNA in Human Embryos, forthcoming in 97 N.C. L. Rev. Here is the abstract:

Genetically modified humans are among us. Emerging technologies for genome editing have launched humanity into the uncharted territory of modifying the human germline—namely, the reproductive cells and embryos that carry our genetic ancestry. Reports of the first live births of humans with edited genomes in China recently confirmed that the power to manipulate our genes at an embryonic stage is no longer theoretical. In the wake of enormous scientific progress, questions regarding how the law will treat this technological breakthrough abound.

This Article examines the legality of human genome editing, specifically germline genome editing (“GGE”), from administrative and constitutional law perspectives. It argues that the Food and Drug Administration’s (“FDA” or “Agency”) forbearance in claiming jurisdiction over GGE is creating a perilous void for an emerging field of law. At the same time, the contemporary de facto legislative ban on GGE clinical applications, which categorically prohibits the Agency from evaluating the safety and efficacy of any investigational new drug or biological product application derived from the technology, is unnecessary and creates more societal costs than benefits. On a broad scale, the ban embodies poor public policy because it prevents the FDA from exercising jurisdiction over matters that constitute extensions of the Agency’s traditional regulatory scope. An analysis of the law reveals salient regulatory gaps that could be viewed as rendering some types of GGE beyond the FDA’s regulatory reach. Notwithstanding those gaps, this Article argues that the FDA can work within the existing statutory framework to cure regulatory deficits and promulgate rules to regulate the technology and, thus, urges the FDA to exercise that jurisdiction. This Article ultimately demonstrates how law and policy converge into a proposed new regulatory paradigm for human GGE that flows from the D.C. Circuit’s ruling in United States v. Regenerative Sciences, LLC, which held that specific stem cell mixtures can be regulated as drugs or biological products within the meaning of the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act.

This Article further contends that efforts to ban GGE technologies cannot withstand constitutional scrutiny in the long run because they impinge on a cognizable fundamental right that protects select uses of GGE. This fundamental right flows from jurisprudence in the areas of procreative, parental, and—to some extent—privacy rights, but it is not absolute. The Article presents an interpretive model for this body of jurisprudence in the GGE context, which promotes extrapolation of applicable legal principles that can guide and promote coherent public policy. Launching from this jurisprudential departing point, this Article introduces a novel legal- and science-based normative framework to delineate primary limits for a right to perform GGE based upon four distinct categories: (1) therapeutic uses to remedy disease; (2) prophylactic purposes, which may or may not be therapeutic; (3) cosmetic or enhancement purposes; and (4) uses involving modification of traits that raise concerns of discrimination already prohibited by the law. This conceptual and structural approach outlines a legal blueprint for GGE clinical interventions, but more importantly it circumvents problems that dominate the existing literature, which arise from the conventional tendency to group GGE applications into therapeutic uses on one hand, and enhancements on the other.

Friday, February 23, 2018

I pledge not to accept NRA donations: Gun control and denial of opportunity to wound and kill




Let the record reflect that I’m an occasional NRA member and supporter of the Second Amendment—not for hunting, and not just for personal security, but mostly for the real need to be able to overthrow the government if—when—it comes to that.
 
But the NRA should be at the table talking about gun control.  The simple reality of preventing violent crime is that denying opportunity to would-be offenders is the only thing that works well.

That was my over-simplistic take-away from Tom Gash’s The Truth About Why People Do Bad Things (2016) (Amazon), which I just read coincidentally with Parkland.  It’s a fabulous book even if you do not have much interest in criminal law and policy, which I do not.  It’s an important book for anyone just to be an informed voter.  Tom Gash is a senior fellow at the Institute for Government in the U.K.  Hat tip to my uncle in London for putting me on to it. 


Gash dispels 11 myths about crime prevention.  Those chapters are well worth reading, so we don’t find ourselves recycling foolish misconceptions as we make crime policy.  Indeed, to read Gash’s account, the cycle of crime prevention policy over decades seems like an exercise in Groundhog Day.  In the big picture, there are two predominant ways of thinking about crime, and they’re both wrong.  One view says criminals are innately bad actors, so we need to create powerful disincentives, such as three-strikes laws, to make them do the right thing.  The other view says that crime is a socio-economic problem we can fix with education and jobs.  Wrong and wrong.  Not wholly wrong, but too wrong for either redressive strategy to be effective.

Needless to say, crime is more complicated than one worldview, and there is no one panacea.  However, there is one thing that works a lot of the time: denial of opportunity.  A lot of crime happens in the moment and is not wholly irrational.  A modest deterrent gives a person’s better angels a chance to be heard.  Something as simple as a bike lock makes a potential thief not become one.

So we come to guns.  As the Parkland teens and parents have said, access to “weapons of war” is just too easy.  A regulation as modest as a waiting period can mean denial of opportunity for someone who is emotionally imbalanced, whether in the moment or by pathology.

I support the Second Amendment, and I’m wary of bans on weapons we would need to overthrow a tyrannical government.  I support the First and Fourth Amendments too, but I understand parade permitting and search incident to arrest.  I would like to see the NRA, which I respect as a key protector of civil liberties, as a responsible participant in the discussion about reasonable regulation, rather than an increasingly alienated fall guy.