COVID-19

Becoming “[COVID]aware” of the Debate Around Contact Tracing Apps

December 6, 2020
COVID-19, Data Privacy, Public Health, Regulatory

Ellie Soskin, MJLST Staffer

As COVID-19 cases continue to surge, states have ramped up containment efforts in the form of mask mandates, business closures, and other public health interventions. Contact tracing is a vital part of those efforts: health officials identify those who have been in close contact with individuals diagnosed with COVID-19 and alert them of their potential exposure to the virus, while withholding identifying information. But traditional contact tracing for a true global pandemic requires a lot of resources. Accordingly, a number of regions have looked to smartphone-based exposure notification technology as an innovative way to both supplement and automate containment efforts.

Minnesota is one of the latest states to adopt this approach: on November 23rd, the state released “COVIDaware” a phone application designed to notify individuals if they’ve been exposed to someone diagnosed with COVID-19. Minnesota’s application utilizes a notification technology developed jointly by Apple and Google, joining sixteen other states and the District of Columbia, with more expected to roll out in the coming weeks. The nature of the technology raises a number of complex concerns over data protection and privacy. Additionally, these apps are more effective the more people use them and lingering questions remain as to compliance and the feasibility of mandating use.

The joint Apple/Google notification software used in Minnesota is designed with an emphasis on privacy. The software uses anonymous identifying numbers (“keys”) that change rapidly, does not solicit identifying information, does not provide access to GPS data, and only stores data locally on each user’s phone, rather than in a server. The keys are exchanged via localized Bluetooth connection operating in the background. It can also be turned off and relies wholly on self-reports. For Minnesota, accurate reports come in the form of state-issued verification codes provided with positive test results. The COVIDaware app checks daily to see if any keys contacted within the last 14 days have recorded positive test results. Minnesota policymakers, likely aware of the intense privacy concerns triggered by contact tracing apps, have emphasized the minimal data collection required by COVIDaware.

The data privacy regulatory scheme in the United States is incredibly complex, as there is no single unified federal data protection policy. Instead, the sphere is dominated by individual states. Federal law enters into the picture primarily via the Health Insurance Portability and Accountability Act (“HIPAA”), which does not apply to patients voluntarily giving health information to third parties. In response to concerns over contact tracing app data, multiple data privacy bills were introduced to Congress, but even the bipartisan “Exposure Notification Privacy Act” remains unpassed.

Given the decentralized nature of the internet, applications tend to be designed to comply with all 50 states’ policies. However, in this case, state-created contact tracing applications are designed for local use, so from a practical perspective states may only have to worry about compliance with neighboring states’ data privacy acts. The Minnesota Government Data Practices Act passed in 1974 is the only substantive Minnesota state statute affecting data collection and neighboring states’ (Wisconsin, Iowa, North Dakota, and South Dakota) laws have similarly limited or dated schemes. In this specific case, the privacy-focused Apple/Google API that forms the backbone of COVIDaware and the design of the app itself, described briefly above, likely keep it complaint. In fact, some states have expressed frustration at the degree of individual privacy afforded by the Apple/Google API, saying it can stymie coordinated public health efforts.

Of course, one solution to even minimal data privacy concerns is simply not to use the application. But the efficacy of contact tracing apps depends entirely on whether people actually download and use them. Some countries have opted for degrees of mandatory use: China has mandated adoption of its contact tracing app for every citizen, utilizing unprecedented government surveillance to flag individuals potentially exposed, and India has made employers responsible for ensuring every employee download its government-developed contact tracing app. While a similar employer-based approach is not legally impossible in the United States, any such mandate would be legally complex, and anyone following the controversy over mask mandates should instinctively recognize that a mandated government tracking app is a hard sell (to put it lightly).

But mandates may not even be necessary. Experts have emphasized that universal compliance isn’t necessary for an app to be effective: every user helps. Germany and Ireland have not mandated use, but have download rates of 20% and 37% respectively. Some have proposed small, community-focused launches of tracking apps, similar to successful start-ups. With proper marketing and transparency, states need not even enter the sticky legal mess that is mandating compliance.

Virtually every policy response to COVID in the United States has been met with heated controversy and tracking apps are no different. As these apps are in their infancy, legal challenges have yet to emerge, but the area in general is something of a minefield. The limited and voluntary nature of Minnesota’s COVIDaware app likely places it out of the realm of significant legal challenges and significant data privacy concerns, at least for the moment. The general conversation around contact tracing apps is a much larger one, however, and has helped put data privacy and end user control into the global conversation.

When Divides Collide: How COVID-19 Has Further Exposed the Link Between the Digital Divide and the Education Gap

November 15, 2020
COVID-19, Economy, Education, Social Welfare

Schuyler Troy, MJLST Staffer

As we enter what public health experts warn will be the worst phase yet of the coronavirus pandemic, many Americans have been forced to reckon with the world of remote work—as of June 2020, 42 percent of the U.S. work force was working from home full time. Zoom, the now-ubiquitous video teleconferencing platform, saw an increase in meeting participation from approximately 10 million daily participants in December 2019 to at least 200 million by the end of March 2020. Zoom snafus have taken their place in the cultural zeitgeist, ranging from relatively harmless and even humorous technical snafus to more serious issues like “Zoombombing” and privacy concerns.

Among the more serious problems coming into sharper focus is the effect that remote learning has had on school-aged children, their parents, and their teachers. Without a national strategy regarding how to reopen schools for in-person instruction, states and localities were left to devise what ultimately became a patchwork of solutions. As of September 2, 2020, 73 percent of the largest school districts in the United States had chosen to offer only remote instruction at least to start the year, affecting more than 8 million students.

Early data from this massive shift to remote instruction has revealed some worrying signs. A majority of teachers across the United States report that fewer than half of their students are attending remote classes; 34 percent of teachers report that only 1 in 4 students are attending remote classes. Perhaps more distressing is the data showing stagnation in academic progress. Researchers at Brown University and Harvard University analyzed data gathered for over 800,000 students across the United States and found that through late April 2020, “student progress in math had decreased by about half in classrooms located in low-income ZIP codes, [and] by a third in classrooms in middle-income ZIP codes” as compared to a typical school year. An analysis by McKinsey & Company indicates that the effects on Black and Hispanic students could be even more pronounced.

While racial and socioeconomic education achievement gaps are not new, the shift to remote instruction nationwide appears to have exacerbated them. Pew Research data provides some clues as to one factor that may be driving this phenomenon: lack of access to reliable, high-speed Internet that is necessary for videoconferencing and online coursework. As of 2019, 61 percent of Hispanic Americans and 66 percent of Black Americans used broadband to access the Internet, as compared to 79 percent of white Americans. Only 56 percent of Americans making under $30,000 per year had access to broadband Internet at home, as compared to 92 percent of Americans making over $75,000. Rural communities, which tend to have higher poverty rates than urban and suburban communities, are also less likely to have access to broadband Internet; only 63 percent of rural communities had access to broadband Internet, as compared to 75 percent of urban communities and 79 percent of suburban communities.

Taken together, the data paints a clear and rather sobering picture: remote instruction is leaving some of America’s most vulnerable students even further behind than before.

Congress has taken action in recent years to address the broadband access disparity with the Digital Equity Act, introduced in the Senate in 2019 but not yet passed, which would require the National Telecommunications and Information Administration to establish grant programs promoting digital equity and inclusion, and building capacity for state governments to increase adoption of broadband by their residents. President-elect Joe Biden also pledged throughout the 2020 presidential campaign to expand access to broadband Internet through infrastructure plans and subsidies to low-income Americans who cannot afford broadband. With seeming bipartisan agreement, a rarity in today’s polarized Congress, the United States may be on track to begin closing the digital divide. How that affects the education gap is yet to be seen, but there is good reason to believe closing the digital divide will help narrow the education gap as well.

Pandemics are fairly rare, but they are near impossible to predict, either in frequency or severity. The world was caught off-guard by COVID-19, but the lessons learned, including the lessons on remote instruction, can and should endure. Further, remote instruction is now another metaphorical “tool in the belt” for school districts; many districts are now considering eliminating snow days and replacing them with remote instruction. The sooner there is action on bridging the digital divide, the better the chances that students have to maintain their learning goals.

FDA Approval of a SARS-CoV-2 Vaccine and Surrogate Endpoints

November 1, 2020
COVID-19, Food and Drug Law, Health, Healthcare, Public Health

Daniel Walsh, Ph.D, MJLST Staffer

The emergence of the SARS-CoV-2 virus has thrown the world into chaos, taking the lives of more than a million worldwide to date. Infection with SARS-CoV-2 causes the disease COVID-19, which can have severe health consequences even for those that do not succumb. An unprecedented number of vaccines are under development to address this challenge. The goal for any vaccine is sterilizing immunity, which means viral infection is outright prevented. However, a vaccine that provides only partially protective immunity will still be a useful tool in fighting the virus. Either outcome would reduce the ability of the virus to spread, and hopefully reduce the incidence of severe disease in those who catch the virus. An effective vaccine is our best shot at ending the pandemic quickly.

For any vaccine to become widely available in the United States, it must first gain approval from the Food and Drug Administration (FDA). Under normal circumstances a sponsor (drug manufacturer) seeking regulatory approval would submit an Investigational New Drug (IND) application, perform clinical trials to gather data on safety and efficacy, and finally file a Biologics License Application (BLA) if the trials were successful. The FDA will review the clinical trial data and make a determination as to whether the benefits of the therapy outweigh the risks, and if appropriate, approve the BLA. Of course, degree of morbidity and mortality being caused by COVID-19 places regulators in a challenging position. If certain prerequisites are met, the FDA as the authority to approve a vaccine using an Emergency Use Authorization (EUA). As pertaining to safety and efficacy, the statutory requirements for issuing an EUA are lower than normal approval. It should also be noted that an initial approval via EUA does not preclude eventual normal approval. Full approval of the antiviral drug remdisivir is an example of this occurrence.

In any specific instance, the FDA must conclude that a reason for using the EUA process (in this case SARS-CoV-2):

can cause a serious or life-threatening disease or condition . . . based on the totality of scientific evidence available . . . including data from adequate and well-controlled clinical trials, if available, it is reasonable to believe that . . . the product may be effective in diagnosing, treating, or preventing [SARS-CoV-2] . . . the known and potential benefits of the product, when used to diagnose, prevent, or treat [SARS-CoV-2], outweigh the known and potential risks of the product . . . .

21 USC 360bbb-3(c). On its face, this statute does not require the FDA to adhere to the full phased clinical trial protocol in grating an EUA approval. Of course, the FDA is free to ask for more than the bare minimum, and it has wisely done so by issuing a set of guidance documents in June and October. The FDA indicated that, at the minimum, a sponsor would need to supply an “interim analysis of a clinical endpoint from a phase 3 efficacy study;” that the vaccine should demonstrate an efficacy of at least 50% in a placebo controlled trial; that phase 1 and 2 safety data should be provided; and that the phase 3 data “should include a median follow-up duration of at least two months after completion of the full vaccination regimen” (among other requirements) in the October guidance.

It is clear from these requirements that the FDA is still requiring sponsors to undertake phase 1, 2, and 3 trials before FDA will consider issuing an EUA, but that the FDA is not going to wait for the trials to reach long term safety and efficacy endpoints, in an effort to get the public access to a vaccine in a reasonable time frame. The Moderna vaccine trial protocol, for example, has a study period of over two years. The FDA also has a statutory obligation to “efficiently review[] clinical research and take[] appropriate action . . . in a timely manner.” 21 USC § 393(b)(1).

One method of speeding up the FDA’s assessment of efficacy is a surrogate endpoint. Surrogate endpoints allow the FDA to look at an earlier, predictive metric of efficacy in a clinical trial when it would be impractical or unethical to follow the trial to its actual clinical endpoint. For example, we often use blood pressure as a surrogate endpoint when evaluating drugs intended to treat stroke. The FDA draws a distinction between candidate, reasonably likely, and validated surrogate endpoints. The latter two can be used to expedite approval. However, in its June guidance, the FDA noted “[t]here are currently no accepted surrogate endpoints that are reasonably likely to predict clinical benefit of a COVID-19 vaccine . . . . [and sponsors should therefore] pursue traditional approval via direct evidence of vaccine safety and efficacy . . . .” This makes it unlikely surrogate endpoints will play any role in the initial EUAs or BLAs for any SARS-CoV-2 vaccine.

However, as the science around the virus develops the FDA might adopt a surrogate endpoint as it has for many other infectious diseases. Looking through this list of surrogate endpoints, a trend is clear. For vaccines, the FDA has always used antibodies as a surrogate endpoint. However, the durability of the antibody response to SARS-CoV-2 has been an object of much concern. While this concern is likely somewhat overstated (it is normal for antibody levels to fall after an infection is cleared), there is evidence that T-cells are long lasting after infection with SARS-CoV-1, and likely play an important role in immunity to SARS-CoV-2. It is important to note that T-Cells (which coordinate the immune response and some of which can kill virally infected cells) and B-Cells (which produce antibody proteins) are both fundamental, and interdependent pieces of the immune system. With this in mind, when developing surrogate endpoints for SARS-CoV-2 the FDA should consider whether it is open to a more diverse set of surrogate endpoints in the future, and if so, the FDA should communicate this to sponsors so they can begin to build the infrastructure necessary to collect the data to ensure vaccines can be approved quickly.

Extracting Favors: Fossil-Fuel Companies Are Using the Pandemic to Lobby for Regulatory Rollbacks and Financial Bailouts

October 17, 2020
Climate Change, COVID-19, Energy Law, Environment, Environmental Law, Regulatory

Christopher Cerny, MJLST Staffer

In the waning months of World War II, Winston Churchill is quoted, perhaps apocryphally, as saying, “[n]ever let a good crisis go to waste.” It seems fossil-fuel companies have taken these words to heart. While in the midst of one of the greatest crises of modern times, oil, gas, and coal companies are facing tremendous economic uncertainty, not only from the precipitous drop in demand for gasoline and electricity, but also from the rise of market share held by renewable energy. In response, industry trade groups and the corporations they represent are engaged in an aggressive lobbying campaign aimed at procuring financial bailouts and regulatory rollbacks. The federal government and some states seem inclined to provide assistance, but with the aforementioned rise of renewable energy, many see the writing on the wall for some parts of the fossil-fuel industry.

The ongoing COVID-19 pandemic continues to inflict immeasurable havoc on a global scale. The virus and the mitigation efforts designed to curb its spread have dramatically changed the way humankind interacts with each other and the world around us. In the United States, nearly all states at one time or another implemented mandatory shelter-at-home orders to restrict movement and prevent the further spread of the novel coronavirus. These orders have, in many ways, completely restructured society and the economy, with perhaps no sector being more impacted than transportation. At the peak of the virus in the United States, air travel was down 96% and, in April 2020, passenger road travel was down 77% from 2019. Similarly, the pandemic has altered America’s energy consumption. For example, the Midcontinent Independent System Operator reports a decrease in daily weekday demand in March and April of up to 13% and a national average decline of as much as 7% for the same time frame. A secondary impact of these market disruptions is on the fossil-fuel industry. The decrease in electricity demand has further diminished the already declining coal market, while the fall off in travel and transportation has radically impacted oil prices.

On April 20, a barrel of oil traded for a loss for the first time ever when demand fell so low that the cost storing oil exceeded its sale price. While the price of a barrel of oil, the world’s most traded commodity, has since improved, as of October 1st, the U.S. stock index for domestic oil companies remains down 57% in 2020. Similarly, coal consumption in the United States is projected to decline 23% this year. Natural gas remains resilient, with U.S. demand only dropping 2.8% between January and May of 2020. However, much of natural gas’s buoyancy comes at the expense of lower prices. These numbers are dire, especially for coal and oil, two domestic industries already on the decline due to the rise in renewable energy.

Fossil-fuel companies have gone on the offensive. The oil and gas industry is responding to these calamitous figures and grim financials by lobbying state and federal lawmakers for financial bailouts and the relaxation of environmental regulations. The California Independent Petroleum Association, an oil and gas trade group, requested an extension for compliance with an idle well testing plan that would push 100% program compliance from 2025 to 2029. Further, the trade group asked California to scale back on Gov. Gavin Newsom’s plan to increase the staff of the California Energy Management Division, the state agency charged with oversight of oil and gas drilling. In Texas, the Blue Ribbon Task Force on Oil Economic Recovery, created at the behest of the state oil and gas regulatory body and composed of representatives and leaders of Texas’s oil and gas trade groups, recommended the suspension of particular environmental testing and extensions for environmental reporting to the state agency. The Louisiana Oil and Gas Association asked Louisiana Gov. John Bel Edwards to suspend the state’s collection of severance taxes.

On the national stage, the Independent Petroleum Association of America asked the Chairman of the Federal Reserve to support changes to the Main Street Lending Program, a part of the CARES Act, to expand the eligibility requirements to include many oil and gas producers. The American Fuel and Petrochemical Manufacturers, a refiners trade association, called on the Trump administration and the Environmental Protection Agency (EPA) to waive biofuel policies that mandate the blending of renewable corn-derived ethanol in petroleum refining. The American Petroleum Institute also reached out to the Trump administration seeking the waiver of record keeping and training compliance.

Not to be left behind, the coal industry ramped up its lobbying as well. In an opinion piece, the CEO of America’s Power, a coal trade group extolled the virtues of the fleet of coal power plants and their necessity in the recovery from the COVID-19 pandemic. The National Mining Congress, the coal industry’s lobbying arm, sent a letter to the Trump administration and Congressional leaders asking for an end to the industry’s requirements to pay into funds for black lung disease and polluted mine clean-up

These lobbying efforts are being met with varied levels of success. In a move that garnered criticism from the Government Accountability Office, the Department of the Interior through the Bureau of Land Management cut royalties on oil and gas wells leased by the federal government, saving the industry $4.5 million. The EPA scaled back enforcement of pollution rules, instead relying on companies to monitor themselves. The Governors of Texas, Utah, Oklahoma, and Wyoming sent a letter asking the EPA to waive the biofuel blending regulations in support of the refiners trade group. In September, the EPA denied the request. The Governor of Louisiana agreed to delay the collection of the severance tax, a revenue source for the state that can normally bring in $40 million per month. The Louisiana state legislature later voted to reduce the severance tax on oil and gas from 12.5% to 8.5% for the next eight years. The EPA finalized a rule that it is not “appropriate and necessary” to regulate certain hazardous air pollutants, including mercury, emitted from coil and oil fired power plants.

It is difficult to discern what impact these industry efforts and resulting government actions will have in the long term. The financial measures may have propped up an industry that otherwise would have suffered permanent damage and bankruptcies without the influx of relief and capital. However, environmental groups are more concerned with the regulatory rollbacks. For example, after the EPA chose to allow companies to self-monitor pollution, there was a year-over-year decline of 40% in air emissions tests at industrial facilities and over 16,500 facilities did not submit required water quality reports. The ramifications of the state and federal acquiescence to the fossil-fuel industry’s requested regulatory non-compliance may end up costing the American tax payers millions of dollars, causing irreparable immediate harm to the environment, and delaying critical action needed to mitigate anthropogenic climate change.

It’s a Small World, and Getting Smaller: The Need for Global Health Security

October 10, 2020
COVID-19, Economy, Health, Healthcare, Public Health

Madeline Vavricek, MJLST Staffer

The word “unprecedented” has been used repeatedly by every news organization and government official throughout the last several months. Though the times that we live in may be unprecedented, they are far from being statistically impossible—or even statistically unlikely. Based on the most recent implementation of the International Health Regulations released by the World Health Organization (WHO) in 2005, more than 70% of the world is deemed unprepared to prevent, detect, and respond to a public health emergency. The reality of this statistic was evidenced by the widespread crisis of COVID-19. As of September 29, 2020, the global COVID-19 death toll passed one million lives, with many regions still reporting surging numbers of new infections. Experts caution that the actual figure could be up to 10 times higher.

The impact of COVID-19 has made pandemic preparedness paramount in a way modern times have yet to experience. While individual countries look inward towards their own national response to the coronavirus, it is apparent now more than ever that global issues demand global solutions. The ongoing COVID-19 pandemic indicates a need for increased resiliency in public health systems to manage infectious diseases, a factor known as global health security.

The Centers for Disease Control and Prevention (CDC) defines global health security as “the existence of strong and resilient public health systems that can prevent, detect, and respond to infectious disease threats, wherever they occur in the world.” Through global health security initiatives, organizations such as the Global Health Security Agenda focus on assisting individual countries in planning and resource utilization to address gaps in health security in order to benefit not only the health and welfare of the individual countries, but the health and welfare of the world’s population as a whole. The Coronavirus has been reported in 214 countries, illustrating that one country’s health security can impact the health security of dozens of others. With the ever-increasing spread of globalization, it is easier for infectious diseases to spread more than ever before, making global health security even more essential than in the past.

Global health security effects more than just health and pandemic preparedness worldwide. Johnson & Johnson Chief Executive Officer Alex Gorsky recently stated that “[g]oing forward, we’re going to understand much better that if we don’t have global public health security, we don’t have national security, we don’t have economic security and we will not have security of society.” As demonstrated by COVID-19, failure to adequately prevent, detect, and respond to infectious diseases has economic, financial, and societal impacts. Due to the Coronavirus, the Dow Jones Industrial Average and the Financial Times Stock Exchange Group saw their biggest quarterly drops in the first three months of the year since 1987; industries such as travel, oil, retail, and others have all taken a substantial hit in the wake of the pandemic. Unemployment rates have increased dramatically as employers are forced to lay off employees across the majority of industries, amounting in an estimated loss of 30 million positions in the United States alone. Furthermore, Coronavirus unemployment has been shown to disproportionally affect women workers and people of color. The social and societal effects of COVID-19 continue to emerge, including, but not limited to, the interruption of education for an estimated 87% of students worldwide and an increase in domestic violence rates during shelter in place procedures. The ripple effect caused by the spread of infectious disease permeates nearly every aspect of a nation’s operation and its people’s lives, well beyond that of health and physical well-being.

With a myriad of lessons to glean from the global experience of COVID-19, one lesson countries and their leaders must focus on is the future of global health security. The shared responsibility of global health security requires global participation to strengthen health both at home and abroad so that future infectious diseases do not have the devastating health, economic, and social consequences that the coronavirus continues to cause.

A Cold-Blooded Cure: How COVID-19 Could Decimate Already Fragile Shark Populations

October 10, 2020
Animal Law, Bioethics, COVID-19, Environment, Environmental Law, Healthcare, Maritime Law, Pharmaceuticals, Public Health

Emily Kennedy, MJLST Staffer

Movies like Jaws, Deep Blue Sea, and The Meg demonstrate that fear of sharks is commonplace. In reality, shark attacks are rare, and such incidents have even decreased during the COVID-19 pandemic with fewer people enjoying the surf and sand. Despite their bad, Hollywood-driven reputation sharks play a vital role in the ocean ecosystem. Sharks are apex predators and regulate the ocean ecosystem by balancing the numbers and species of fish lower in the food chain. There are over 500 species of sharks in the world’s oceans and 143 of those species are threatened, meaning that they are listed as critically endangered, endangered, or vulnerable. Sharks are particularly vulnerable because they grow slowly, mature later than other species, and have relatively few offspring. Shark populations are already threatened by ocean fishing practices, climate change, ocean pollution, and the harvesting of sharks for their fins. Sharks now face a new human-imposed threat: COVID-19.

While sharks cannot contract the COVID-19 virus, the oil in their livers, known as squalene, is used in the manufacture of vaccines, including COVID-19 vaccines currently being developed. Shark squalene is harvested via a process known as “livering,” in which sharks are killed for their livers and thrown back into the ocean to die after having their livers removed. The shark squalene is used in adjuvants, ingredients in vaccines that prompt a stronger immune response, and has been used in U.S. flu vaccines since 2016. Approximately 3 million sharks are killed every year to supply squalene for vaccines and cosmetic products, and this number will only increase if a COVID-19 vaccine that uses shark squalene gains widespread use. One non-profit estimates that the demand for COVID-19 vaccines could result in the harvest of over half a million sharks.

Sharks, like many other marine species, are uniquely unprotected by the law. It is easier to protect stationary land animals using the laws of the countries in which their habitats are located. However, ocean habitats largely ungoverned by the laws of any one country. Further, migratory marine species such as sharks may travel through the waters of multiple countries. This makes it difficult to enact and enforce laws that adequately protect sharks. In the United States, the Lacey Act, the Endangered Species Act, and the Magnuson-Stevens Fishery Conservation and Management Act govern shark importation and harvesting practices. One area of shark conservation that has gotten attention in recent years is the removal of shark fins for foods that are considered delicacies in some countries. The Shark Conservation Act was passed in the United States in response to the crisis caused by shark finning practices, in addition to the laws that several states had in place banning the practice. The harvest of shark squalene has not garnered as much attention as of yet, and there are no United States laws enacted to specifically address livering.

Internationally, the Convention on the Conservation of Migratory Species of Wild Animals (CMS) and the International Plan of Action for the Conservation and Management of Sharks (IPOA) are voluntary, nonbinding programs. Many of the primary shark harvesting nations have not signed onto CMS. The Convention on International Trade in Endangered Species of Wild Flora and Fauna (CITES) is binding, but there are loopholes and only 13 shark species are listed. In addition to these international programs, some countries have voluntarily created shark sanctuaries.

Nations that have refused to agree to voluntary conservation efforts, that circumvent existing international regulations, and lack sanctuaries leave fragile shark species unprotected and under threat. The squalene harvesting industry in particular lacks transparency and adequate regulations, and reports indicate that protected and endangered shark species end up as collateral damage in the harvesting process. A wide array of regional and international interventions may be necessary to provide sharks with the conservation protections they so desperately need.

Research and development of medical cures and treatments for humans often comes with animal casualties, but research to development of the COVID-19 vaccine can be conducted in a way that minimizes those casualties. There is already some financial support for non-animal research approaches and squalene can also be derived and synthesized from non-animal sources. Shark Allies, the conservation group that created a Change.org petition that now has over 70,000 signatures, suggests that non-shark sources of squalene be used in the vaccine instead, such as yeast, bacteria, sugarcane, and olive oil. These non-animal adjuvant sources are more expensive and take longer to produce, but the future of our oceans may depend on such alternative methods that do not rely on “the overexploitation of a key component of the marine environment.”

COVID-19: Substantiating the Impacts of Environmental Racism

May 15, 2020
COVID-19, Environmental Justice, Environmental Law

Jessamine De Ocampo, MJLST Staffer

The Coronavirus (COVID-19) Pandemic is highlighting the numerous socio-economic inequalities in America. Because of these inequalities minorities are dying at disproportionally high rates. In addition to various barriers to health care, minority communities are inequitably exposed to hazardous environmental conditions that may end up affecting their long-term health. Under-served communities, including communities of color and the poor, are disproportionately impacted by environmental problems. Under-served communities historically lack the political power to prevent new sources of pollution and eradicate existing ones. As a result, generations of inequity and unjust systems have placed certain communities at higher risk than others. For example, in Harris County, Texas, 40 percent of those who died from COVID-19 were African-American, though African-American’s accounted for only 20 percent of the county’s population. Similar COVID-19 fatality patterns can be seen in Georgia, Detroit, Michigan, Minneapolis, Minnesota, and Chicago, Illinois. Environmental justice advocates have long argued that environmental racism is killing their communities, but COVID-19 brings new light into just how detrimental the severity of environmental racism can be.

Environmental justice advocates seek to shield low-income and minority communities from the worst impacts of air pollution and environmental degradation. A recent Harvard study analyzed thousands of US counties in order to find a link between air pollution and COVID-19 fatalities. The study reflects that coal plants, waste incinerators, refineries, landfills, mines, smelting plants, and other sites, often located in communities of color, have long emitted toxic pollutants into the water and particulate matter into the air, increasing air pollution which in turn leads to various pulmonary and cardiovascular diseases. These chronic health issues increase chances of contracting severe cases of COVID-19.

In Louisiana, between Baton Rouge and New Orleans, exists an industrial corridor stretching about 85 miles, containing more than 140 chemical factories and oil refineries. This area is commonly known as Cancer Alley. These chemical factories and oil refineries release large amounts of particulate matter, which has been listed as a known carcinogen by the International Agency for Research on Cancer. Cancer Alley is one of the most polluted places in America, and someone has died from cancer in almost every household in the area. In the community of Reserve, a predominantly African-American working class neighborhood nestled in the middle of Cancer Alley, the risk of cancer from air toxicity is 50 times the national average. Now, Cancer Alley has one of the highest COVID-19 death rates in the country.

Similarly, Native American Tribes have long held the burden of having their lands used for toxic dumping sites. Environmental injustice, among other facts, has led to varying risks of illness on Indian lands. Now, they are bracing for the worst impacts of COVID. Kevin Allis, chief executive of the National Congress of American Indians stated “When you look at the health disparities in Indian Country — high rates of diabetes, cancer, heart disease, asthma and then you combine that with the overcrowded housing situation where you have a lot of people in homes with an elder population who may be exposed or carriers — this could be like a wildfire on a reservation and get out of control in a heartbeat.” And then, there are the residents of Oakland, California where mainly low-income African American and Latino residents are exposed to a disproportionate amount of airborne toxins as compared to the rest of the surrounding Alameda County. East and West Oakland residents have higher rates of asthma, strokes and congestive heart failures and during the COVID pandemic, these communities are the hardest hit in Alameda County.

Robert Bullard, who some consider the “father of environmental justice” stated in a recent interview:

When you have poverty, lack of access to health care, [high rates of] uninsured, many who have no private automobiles and are dependent on the buses and public transportation, and neighborhoods in pollution sacrifice zones you’re going to get people who are vulnerable. The coronavirus is basically taking advantage of those vulnerabilities, and you’re seeing it play out in the deaths.

While the environmental movement has taken off in recent years with the growing certainty of climate change, environmental justice cases have almost slipped through the cracks. As organizations begin to plan for a new world shaped by lessons learned during the pandemic, the influence the environment has on health, and the disproportionate burden on minority communities, needs to bear a greater weight in our political discourse. As former democratic primary candidate and current Vermont Senator, Bernie Sanders stated, “access to a clean and healthy environment is a fundamental right of citizenship. To deny such rights constitutes an environmental injustice that should never be tolerated.” The death rates and disproportionate effect of the COVID-19 pandemic on minority groups only compounds the evidence that unhealthy environments are detrimental to society/humanity. In addition to monitoring the biological environmental consequences of our societies, we also need to be considering the social consequences.

Coronavirus Accelerates the Switch to Remote Online Notarization

May 13, 2020
COVID-19, New Technology

Stephen Wood, MJLST Staffer

The legal profession has been relatively quick to adapt to challenges posed by the COVID-19 pandemic. Despite widespread stay-at-home orders, technology enables lawyers and the courts to continue to conduct much of their business that has historically been required to be done in person. While telephonic U.S. Supreme Court oral arguments are unlikely to persist once things normalize, other changes may be here to stay. One example is the move to Remote Online Notarization. Official transactions such as the conveyance of real estate, granting of powers of attorney, and establishment of a prenuptial agreements must be certified by a notary for the purpose of preventing fraud and forgery. Before the pandemic, a majority of states still required this process to be conducted in person.

The first state to authorize RON was Virginia in 2011, and since then, twenty-one states had followed their lead. Nearly all the of the remaining states had laws introduced to authorize RON, but for one reason or another, they had not yet been passed. In the last few months, this has quickly changed. At least 44 states now authorize the process to be conducted remotely. Wisconsin is one state that has done so through state law rather than executive order. The Act, 2019 Wisconsin Act 125, was passed on March 3, 2020 and takes effect May 1, 2020. Until then, an emergency rule authorizes the same. However, there are limitations as to which documents apply. Meanwhile, the vast majority of states have authorized RON through executive orders or proclamations by their governors. Even before the pandemic, it was predicted that RON would become the norm, but COVID-19 is certainly speeding up the process.

COVID-19, Remote Technology, and Due Process in Administrative HearingsBrent

May 13, 2020
Administrative Law, COVID-19, New Technology

Brent Murcia, MJLST Staffer

Wherever you look, it seems like COVID-19 is dominating all the headlines these days (even this blog!)—and with good reason. The pandemic is a public health crisis on a massive scale, forcing all of us to change our lives to “socially distance” and help “flatten the curve.”

As of April 7, 95% of Americans were under some sort of “stay at home” order. With life-as-usual on hold, many people are turning to technology to keep things running. For example, in Boston, some celebrated St. Patrick’s Day with virtual concerts. Some people celebrated Earth Day by tuning into National Park webcams. And of course, everyone from Minnesota Law students to the UK Cabinet is holding meetings (and happy hours!) on Zoom.

The legal system, of course, is not immune from the effects of this pandemic. Staff at government agencies, private law firms, and nonprofits are working from home. Some state legislatures are allowing remote voting for the first time. Many prisons have suspended in-person visits, including legal visits. Courts across the country are closed, delayed, or operating remotely. In section 150002 of the recent COVID-19 relief bill (the “CARES Act”), Congress authorized emergency video and telephone hearings for a variety of court proceedings, including detention hearings and felony pleas and sentencing. Even the United States Supreme Court will be moving to argument over the phone in May.

As with many things in society these days, a number of these changes would have been unthinkable two months ago. Who could have imagined that certain courts, many of which require paper filings and ban the use of electronic devices in courtrooms, would soon holdarguments via video conference? The Supreme Court itself has famously never allowed live broadcasts of arguments (a subject of considerable debate). But with arguments moving to the phone, the Court will now allow the public to listen in real time.

As one would expect, the rollout of these sudden changes has not been entirely smooth. In many courts, things have gone well, with only “momentary audio hiccups and minor glitches.” But in March, a D.C. Circuit judge was dropped from an argument and missed several minutes. Last week, a Florida judge complained of lawyers making court appearances shirtless or in pajamas. One Australian barrister described remote court hearings as follows: “The judge couldn’t see anyone; lines dropped out regularly; witnesses didn’t know where to go; … subpoenaed material could not be accessed by anyone; feedback made it impossible to proceed.”

Some of these problems are silly—in the grand scheme of things, we have bigger worries than appropriate Zoom dress codes. But others have the potential to fundamentally impact proceedings—possibly affecting parties’ due process rights. This blog post briefly explores some of the issues that COVID-19 has brought to the forefront, with a particular focus on administrative processes. (For a comprehensive listing of the ways in which different federal administrative agencies are holding their hearings, see this great blog post from the Yale Journal on Regulation).

Remote Hearings—An Overview

Remote proceedings are not exactly new. Even before the pandemic took hold, CourtCall—a company that facilitates remote appearances—had hosted six million such appearances since 1996. Many courts have long allowed certain remote appearances (sometimes requiring the consent of the parties, sometimes not). According to the Administrative Conference of the United States (ACUS), some agencies already conducted thousands of video hearings a year even before the pandemic. Still, until recently, such appearances were the exception, not the norm. And the use of remote technologies has generated controversy, even before its sudden widespread adoption.

Problems with Remote Hearings

Some people have expressed skepticism about the use of remote hearings, emerging in part from evidentiary concerns. As the BBC recently reported, video calls can make it “harder to process non-verbal cues like facial expressions, the tone and pitch of the voice, and body language.” That BBC story also referred to a 2014 study which found that even a 1.2 second transmission delay on a videoconferencing system “made people perceive the responder as less friendly or focused.” These effects can matter, considering the importance of perception and non-verbal cues in courtrooms. Additionally, one 1996 study in the University of Michigan Journal of Law Reform (before the advent of video technology) found that “parties to telephone hearings are less likely to exercise their rights to submit evidence through witnesses and documents than are parties to in-person hearings.”

Remote hearings can be particularly problematic in immigration hearings, which often involve language interpretation and the recounting of traumatic events. In early March—even before COVID-19 closures began—immigration courts in Texas began a pilot program to hold more hearings for unaccompanied children over videoconference, attempting to reduce a backlog of cases. One immigration attorney, forced by the virus to work with clients remotely, described the difficulty of doing so: “[w]e’re asking kids to open up and talk about the most personal and traumatic experiences of their lives and not even be making direct eye contact with them.” Remote hearings can affect the outcome of cases; a 2017 Government Accountability Office (GAO) study found that video hearings caused difficulties with language interpretation and affected immigration judges’ assessments of respondents’ credibility. A study in the Northwestern University Law Review found that respondents in video hearings were more likely to be deported. The American Immigration Lawyers Association opposes the use of video hearings for immigration for these reasons.

Problems with remote hearings also arise in settings that require public participation—like rulemakings and permit applications. In Minnesota, for instance, the state Pollution Control Agency (MPCA) recently delayed publication of a proposed Clean Cars rule, recognizing the importance of in-person comment and“ensuring that the public has opportunity to participate in the rule-making process.” At the same time, the MPCA moved forward with public meetings about Clean Water Act permits for the controversial Line 3 pipeline project, holding the meetings over the phone. More than 1,600 people called into the meetings, but only 400 were able to speak due to high volume. Some local organizers collected video comments, attempting to put a face to the public input, and called for the agency to hold in-person meetings once the pandemic has passed.

Finally, depending on the circumstances, remote hearings can also run afoul of specific public process requirements and open meeting laws. Lawyers in New Jersey, for instance, have highlighted a number of legal concerns arising from virtual land use board hearings. Laws about when and how meetings may be held electronically vary state to state; and amidst the pandemic, governors and legislatures have taken varying steps to clarify that authority. In Minnesota, the state legislature amended the open meeting law to account for the pandemic, expanding the circumstances under which meetings may be held remotely.

Benefits of Remote Hearings

Despite all of these problems, some lawyers have actually long advocated for an increase in virtual hearings. One common argument is that online hearings can help improve access to justice, addressing backlogs of millions of cases in some courts and agencies. Some argue that our current legal process is built more around “serving a place than serving justice.” One paper surveyed a number of other reasons why remote hearings may help in some contexts. Remote hearings can help in international cases or cases where the parties and witnesses live far apart; they can help with safety and security for parties, witnesses, and judges; they can help alleviate scheduling issues; and they can help in cases where traveling to court presents a significant burden for an individual, perhaps for economic reasons or due to a disability. (For a thorough summary of some of the ways in which technology—not just remote hearings—can help improve access to justice, see this 2012 article in the Harvard Journal of Law & Technology).

Further, while some arguments against remote hearings focus on the importance of non-verbal cues in proceedings, others have disputed that importance. Some research has pointed out that there can be as much pseudoscience as science in attempts to interpret witness behavior. Some have questioned whether witness demeanor is even useful at all for assessing credibility. And while non-verbal cues can and do shape judge and jury reactions, this may not always be a good thing—reactions to certain behaviors can be shaped by implicit bias, furthering racial and other disparities. More research is likely needed on whether these disparities are exacerbated or lessened by different types of virtual hearings.

Finally, remote court hearings can create significant cost savings. For example, according to ACUS, the Social Security Administration’s Office of Disability Adjudication and Review saved $59 million in 2010 from using video hearings. These savings matter to people who have to navigate the legal system. A 2014 NPR investigation found, for example, that “the costs of the criminal justice system in the United States are paid increasingly by the defendants and offenders.” Many defendants are required to pay hundreds or thousands of dollars in court costs, even for constitutionally required services. Reducing court costs could help lower fees, reducing the burden on low-income parties. Additionally, law firms are saving money from virtual hearings too, potentially reducing the cost of legal services and improving access to representation down the road.

The potential for improved access and reduced costs from virtual hearings is promising, but comes with an important caution. As British lawyer Richard Atkinson wrote for The Guardian in 2012: “A more efficient justice system is possible, but the government needs to recognise that speed does not always equate to efficiency and efficiency should never be promoted over justice.”

Looking Forward

As the effects of social distancing wear on, many of us look forward to the day when we can finally go “back to normal.” Without question, it will be a happy day when we can be with our loved ones, our friends, and our coworkers again. Lawyers will also be happy to return to the office, meet with clients in person, and advocate in real courtrooms.

At the same time, questions about remote hearings will not go away. Looking backward, some litigators will likely contest whether certain remote hearings conducted during COVID-19 were permissible. Looking forward, others will use our social distancing experience to argue that we should expand or reduce the use of remote hearings in the future.

There are no universal answers to these questions—the appropriateness of remote hearings depends on the applicable laws and the context of the case. In some cases, remote hearings can adversely affect parties’ rights; in others, they can actually improve access to justice. As one English judge wrote recently, “[i]t remains the obligation of all involved and at all stages of the hearing, to continue to evaluate whether fairness to all the parties is being achieved. Fairness cannot be sacrificed to convenience.” Our task, in these unprecedented times, is to move forward as best and as fairly we can—and to learn from these new experiences to better inform our approach to technology in the courtroom in the future.

COVID-19, Remote Technology, and Due Process in Administrative Hearings

May 13, 2020
Administrative Law, COVID-19, New Technology

Brent Murcia, MJLST Staffer

Wherever you look, it seems like COVID-19 is dominating all the headlines these days (even this blog!)—and with good reason. The pandemic is a public health crisis on a massive scale, forcing all of us to change our lives to “socially distance” and help “flatten the curve.”

As of April 7, 95% of Americans were under some sort of “stay at home” order. With life-as-usual on hold, many people are turning to technology to keep things running. For example, in Boston, some celebrated St. Patrick’s Day with virtual concerts. Some people celebrated Earth Day by tuning into National Park webcams. And of course, everyone from Minnesota Law students to the UK Cabinet is holding meetings (and happy hours!) on Zoom.

The legal system, of course, is not immune from the effects of this pandemic. Staff at government agencies, private law firms, and nonprofits are working from home. Some state legislatures are allowing remote voting for the first time. Many prisons have suspended in-person visits, including legal visits. Courts across the country are closed, delayed, or operating remotely. In section 150002 of the recent COVID-19 relief bill (the “CARES Act”), Congress authorized emergency video and telephone hearings for a variety of court proceedings, including detention hearings and felony pleas and sentencing. Even the United States Supreme Court will be moving to argument over the phone in May.

As with many things in society these days, a number of these changes would have been unthinkable two months ago. Who could have imagined that certain courts, many of which require paper filings and ban the use of electronic devices in courtrooms, would soon holdarguments via video conference? The Supreme Court itself has famously never allowed live broadcasts of arguments (a subject of considerable debate). But with arguments moving to the phone, the Court will now allow the public to listen in real time.

As one would expect, the rollout of these sudden changes has not been entirely smooth. In many courts, things have gone well, with only “momentary audio hiccups and minor glitches.” But in March, a D.C. Circuit judge was dropped from an argument and missed several minutes. Last week, a Florida judge complained of lawyers making court appearances shirtless or in pajamas. One Australian barrister described remote court hearings as follows: “The judge couldn’t see anyone; lines dropped out regularly; witnesses didn’t know where to go; … subpoenaed material could not be accessed by anyone; feedback made it impossible to proceed.”

Some of these problems are silly—in the grand scheme of things, we have bigger worries than appropriate Zoom dress codes. But others have the potential to fundamentally impact proceedings—possibly affecting parties’ due process rights. This blog post briefly explores some of the issues that COVID-19 has brought to the forefront, with a particular focus on administrative processes. (For a comprehensive listing of the ways in which different federal administrative agencies are holding their hearings, see this great blog post from the Yale Journal on Regulation).

Remote Hearings—An Overview

Remote proceedings are not exactly new. Even before the pandemic took hold, CourtCall—a company that facilitates remote appearances—had hosted six million such appearances since 1996. Many courts have long allowed certain remote appearances (sometimes requiring the consent of the parties, sometimes not). According to the Administrative Conference of the United States (ACUS), some agencies already conducted thousands of video hearings a year even before the pandemic. Still, until recently, such appearances were the exception, not the norm. And the use of remote technologies has generated controversy, even before its sudden widespread adoption.

Problems with Remote Hearings

Some people have expressed skepticism about the use of remote hearings, emerging in part from evidentiary concerns. As the BBC recently reported, video calls can make it “harder to process non-verbal cues like facial expressions, the tone and pitch of the voice, and body language.” That BBC story also referred to a 2014 study which found that even a 1.2 second transmission delay on a videoconferencing system “made people perceive the responder as less friendly or focused.” These effects can matter, considering the importance of perception and non-verbal cues in courtrooms. Additionally, one 1996 study in the University of Michigan Journal of Law Reform (before the advent of video technology) found that “parties to telephone hearings are less likely to exercise their rights to submit evidence through witnesses and documents than are parties to in-person hearings.”

Remote hearings can be particularly problematic in immigration hearings, which often involve language interpretation and the recounting of traumatic events. In early March—even before COVID-19 closures began—immigration courts in Texas began a pilot program to hold more hearings for unaccompanied children over videoconference, attempting to reduce a backlog of cases. One immigration attorney, forced by the virus to work with clients remotely, described the difficulty of doing so: “[w]e’re asking kids to open up and talk about the most personal and traumatic experiences of their lives and not even be making direct eye contact with them.” Remote hearings can affect the outcome of cases; a 2017 Government Accountability Office (GAO) study found that video hearings caused difficulties with language interpretation and affected immigration judges’ assessments of respondents’ credibility. A study in the Northwestern University Law Review found that respondents in video hearings were more likely to be deported. The American Immigration Lawyers Association opposes the use of video hearings for immigration for these reasons.

Problems with remote hearings also arise in settings that require public participation—like rulemakings and permit applications. In Minnesota, for instance, the state Pollution Control Agency (MPCA) recently delayed publication of a proposed Clean Cars rule, recognizing the importance of in-person comment and“ensuring that the public has opportunity to participate in the rule-making process.” At the same time, the MPCA moved forward with public meetings about Clean Water Act permits for the controversial Line 3 pipeline project, holding the meetings over the phone. More than 1,600 people called into the meetings, but only 400 were able to speak due to high volume. Some local organizers collected video comments, attempting to put a face to the public input, and called for the agency to hold in-person meetings once the pandemic has passed.

Finally, depending on the circumstances, remote hearings can also run afoul of specific public process requirements and open meeting laws. Lawyers in New Jersey, for instance, have highlighted a number of legal concerns arising from virtual land use board hearings. Laws about when and how meetings may be held electronically vary state to state; and amidst the pandemic, governors and legislatures have taken varying steps to clarify that authority. In Minnesota, the state legislature amended the open meeting law to account for the pandemic, expanding the circumstances under which meetings may be held remotely.

Benefits of Remote Hearings

Despite all of these problems, some lawyers have actually long advocated for an increase in virtual hearings. One common argument is that online hearings can help improve access to justice, addressing backlogs of millions of cases in some courts and agencies. Some argue that our current legal process is built more around “serving a place than serving justice.” One paper surveyed a number of other reasons why remote hearings may help in some contexts. Remote hearings can help in international cases or cases where the parties and witnesses live far apart; they can help with safety and security for parties, witnesses, and judges; they can help alleviate scheduling issues; and they can help in cases where traveling to court presents a significant burden for an individual, perhaps for economic reasons or due to a disability. (For a thorough summary of some of the ways in which technology—not just remote hearings—can help improve access to justice, see this 2012 article in the Harvard Journal of Law & Technology).

Further, while some arguments against remote hearings focus on the importance of non-verbal cues in proceedings, others have disputed that importance. Some research has pointed out that there can be as much pseudoscience as science in attempts to interpret witness behavior. Some have questioned whether witness demeanor is even useful at all for assessing credibility. And while non-verbal cues can and do shape judge and jury reactions, this may not always be a good thing—reactions to certain behaviors can be shaped by implicit bias, furthering racial and other disparities. More research is likely needed on whether these disparities are exacerbated or lessened by different types of virtual hearings.

Finally, remote court hearings can create significant cost savings. For example, according to ACUS, the Social Security Administration’s Office of Disability Adjudication and Review saved $59 million in 2010 from using video hearings. These savings matter to people who have to navigate the legal system. A 2014 NPR investigation found, for example, that “the costs of the criminal justice system in the United States are paid increasingly by the defendants and offenders.” Many defendants are required to pay hundreds or thousands of dollars in court costs, even for constitutionally required services. Reducing court costs could help lower fees, reducing the burden on low-income parties. Additionally, law firms are saving money from virtual hearings too, potentially reducing the cost of legal services and improving access to representation down the road.

The potential for improved access and reduced costs from virtual hearings is promising, but comes with an important caution. As British lawyer Richard Atkinson wrote for The Guardian in 2012: “A more efficient justice system is possible, but the government needs to recognise that speed does not always equate to efficiency and efficiency should never be promoted over justice.”

Looking Forward

As the effects of social distancing wear on, many of us look forward to the day when we can finally go “back to normal.” Without question, it will be a happy day when we can be with our loved ones, our friends, and our coworkers again. Lawyers will also be happy to return to the office, meet with clients in person, and advocate in real courtrooms.

At the same time, questions about remote hearings will not go away. Looking backward, some litigators will likely contest whether certain remote hearings conducted during COVID-19 were permissible. Looking forward, others will use our social distancing experience to argue that we should expand or reduce the use of remote hearings in the future.

There are no universal answers to these questions—the appropriateness of remote hearings depends on the applicable laws and the context of the case. In some cases, remote hearings can adversely affect parties’ rights; in others, they can actually improve access to justice. As one English judge wrote recently, “[i]t remains the obligation of all involved and at all stages of the hearing, to continue to evaluate whether fairness to all the parties is being achieved. Fairness cannot be sacrificed to convenience.” Our task, in these unprecedented times, is to move forward as best and as fairly we can—and to learn from these new experiences to better inform our approach to technology in the courtroom in the future.

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