Top Regulatory News of 2021

In lieu of our regular Friday feature—the Week in Review—The Regulatory Review is recapping some of the top regulatory news from the past year, including the coronavirus pandemic, the Biden Administration’s first regulatory initiatives, and more. We are also pleased to highlight some of the regulatory scholarship featured this year in the Week in Review.

JANUARY

• The U.S. Congress certified the electoral college vote ratifying President-Elect Joe Biden’s victory over President Donald J. Trump. Congress reconvened to certify the electoral college results after a mob of President Trump supporters stormed the U.S. Capitol building during the certification process. The attack on the Capitol occurred after President Trump addressed his supporters, urging them to contest the results of the presidential election. When Congress reconvened, some U.S. Senators withdrew their objections to the election results. Senator Kelly Loeffler (R-Ga.) said that the storming of the Capitol building “forced me to reconsider, and I cannot now in good conscience object to certification of these electors.” In a statement after the certification, President Trump committed to an “orderly transition” of power.
• Following the storming of the U.S. Capitol by supporters of President Donald J. Trump, the U.S. House of Representatives voted to impeach President Trump for the second time, this time for “incitement of insurrection.” Opponents of impeachment were concerned that a Senate trial at the beginning of a Biden Administration will further divide the country. But in a statement delivered at the opening of the impeachment debate, House Speaker Nancy Pelosi (D-Calif.) argued that the President must be impeached because he is “a clear and present danger to the nation we all love.” Despite calls from Democrats for the Senate trial to begin immediately, Senate Majority Leader Mitch McConnell (R-Ky.) has stated that the trial will not begin until after the Senate reconvenes on January 19.

FEBRUARY

• The U.S. Census Bureau announced that it will not release the data necessary for voting redistricting until September 2021—a six-month delay from its original March 2021 deadline. The Census Bureau explained that the delay is necessary to ensure the accuracy of redistricting data. According to news reporting, the coronavirus pandemic and the Trump Administration’s efforts to cut the census collection short contributed to the delay. Kathay Feng, national redistricting director of Common Cause, posited that the delay will enable widespread gerrymandering, reportedly saying that “legislators will simply use a special session to secretly pass maps with zero public scrutiny, and then count on a tight timetable to eke out at least one election cycle.”
• President Biden issued an executive order to increase health care accessibility and affordability by strengthening Medicaid and the Affordable Care Act (ACA). Responding to “exceptional circumstances” caused by the ongoing coronavirus pandemic, President Biden created a special enrollment period for uninsured individuals to get health care coverage through the Federally Facilitated Marketplace. President Biden also directed the heads of agencies and departments with responsibilities related to Medicaid and the ACA to ensure that existing regulations prioritize access to health care.

MARCH

• The U.S. House of Representatives passed the American Rescue Plan Act of 2021 in a partisan 220-211 vote, sending the $1.9 trillion COVID-19 relief package to President Joe Biden for his signature. The Act includes $1,400 stimulus checks to qualifying households, continues $300 supplemental unemployment insurance payments, and increases the child tax credit to $3,000 per child. House Minority Leader Kevin McCarthy (R-Calif.) reportedly criticized the bill as “a laundry list of left-wing priorities that predate the pandemic.” House Rules Committee Chairman Jim McGovern (D-Mass.) reportedly retorted that Republicans opposing the package would be “the first ones in line at the press conferences to announce the money for their cities and towns and for struggling families.”
• The Centers for Disease Control and Prevention (CDC) updated its guidance for schools reopening during the coronavirus pandemic. The CDC recommended that mask-wearing elementary school students and some middle and high school students only need to maintain three feet of distance while inside the classroom, decreasing the distancing guidelines from six feet. CDC Director Rochelle Walensky stressed the importance of in-person instruction for students and said that “CDC is committed to leading with science and updating our guidance as new evidence emerges.” Pedro Martinez, the superintendent of the San Antonio Independent School District, reportedly identified the prior social distancing recommendations as the biggest challenge for in-person learning and called the updated guidance a “game changer.”

APRIL

• President Joseph R. Biden announced that all adults in America will be eligible to receive a COVID-19 vaccine by April 19 and that most people will receive at least one dose by the end of May. The Biden Administration had set a goal to administer 200 million doses of the vaccine by April 30, his first 100 days in office, and this announcement marks 150 million doses administered. President Biden, however, cautioned that although this announcement marks progress toward the end of the pandemic, the public should still remain vigilant in preventing the spread of the virus.
• The CDC updated its mask guidance for vaccinated individuals. Most individuals considered fully vaccinated—generally two weeks after their final shot—are not required to wear masks in most outdoor settings, according to the CDC’s new recommendation. The CDC however, still urges all individuals to continue wearing masks while indoors or in crowded outdoor settings, regardless of their vaccination status.

MAY

• President Joseph R. Biden issued an executive order focused on enhancing cybersecurity in the United States following recent cybersecurity incidents such as SolarWinds, Microsoft Exchange, and the Colonial Pipeline incident. The order requires all federal information systems to meet stronger standards, and it encourages the private sector to follow suit. The order will also establish a cybersecurity safety review board and a pilot program to establish a system that will enable all parties to quickly identify if software was developed in a secure way. U.S. Senator Mark Warner (D-Va.), chairman of the U.S. Senate Select Committee on Intelligence, praised the order as a “good first step,” while calling on Congress to “step up and do more to address our cyber vulnerabilities.”
• The U.S. Environmental Protection Agency (EPA) proposed a rule to decrease the use and production of hydrofluorocarbons (HFCs), environmentally harmful gases commonly used in refrigerators and air conditioners. EPA expects that the new rule will decrease HFCs by 85 percent in 15 years, preventing a predicted 0.5 degrees Celsius global temperature increase by 2100. EPA Administrator Michael S. Regan emphasized that the proposed rule is important because HFCs “can be hundreds to thousands of times more powerful than carbon dioxide at warming the planet.”

JUNE

• The Biden Administration released its first Unified Agenda of Federal Regulatory and Deregulatory Actions detailing the priorities and plans of federal agencies and reporting their recent actions. Many proposed actions reverse policies implemented by the Trump Administration, including plans to reverse Trump-era fuel economy standards back to maximum levels for passenger vehicles, propose disclosure rules for corporate board diversity and climate-related risks, and tighten regulations around oil and gas emissions and leasing. Sharon Block, acting Administrator of the Office of Information and Regulatory Affairs, said that the agenda demonstrated a commitment to “rolling back the obstacles to recovery, equity and sustainability that the prior Administration put in place.”
• The Supreme Court unanimously held that the National Collegiate Athletic Association (NCAA) cannot ban schools from providing their athletes with education-related benefits, such as graduate scholarships or tutoring. The Court ruled, however, that the NCAA was still free to enforce rules that prohibit benefits to athletes unrelated to education and that the NCAA was free to determine what types of benefits are related to education. The Association had previously argued that such a ruling would blur the line between college and professional sports. Herbert Hovenkamp, professor at the University of Pennsylvania Law School, stated that, although the current ruling does not allow “a free for all for the big colleges to start competing for athletes,” there may be future cases that seek to expand the ability of schools to bid on college athletes.

JULY

• Acting U.S. Food and Drug Administration (FDA) Commissioner, Janet Woodcock, requested an internal investigation of the process that led to FDA’s approval of Aduhelm, a drug created to treat Alzheimer’s disease. Woodcock’s request came after three FDA advisory panel members resigned after Aduhelm was approved and an FDA committee questioned the drug’s efficacy. Woodcock’s letter called on the U.S. Department of Health and Human Services Office of Inspector General to review the interactions between the drug’s developer and FDA for compliance with FDA policies. Woodcock explained that FDA believed an independent investigation would best ensure transparency and public trust.
• The White House issued a memorandum under its Justice40 Initiative, an effort to ensure that “40 percent of the overall benefits” from federal climate and clean energy investments reach communities that have been historically marginalized and disadvantaged by pollution. The White House’s memorandum identified 21 initial programs that will maximize benefits for disadvantaged communities, including the U.S. Department of Agriculture’s Rural Energy for America Program and the U.S. Department of Homeland Security’s Flood Mitigation Assistance Program. In the memo, the White House also directed agencies to identify additional programs that fall under the initiative, such as those that make investment benefits related to climate change, clean energy, affordable and sustainable housing, and clean water.

AUGUST

• FDA issued full approval for the Pfizer COVID-19 vaccine for individuals ages 16 and older. The Pfizer COVID-19 vaccine had previously been granted emergency use authorization for individuals ages 12 and older. FDA continued the Pfizer vaccine’s emergency use authorization for individuals between 12 and 15 years old. Peter Marks, director of the Center for Biologics Evaluation and Research at FDA, stated that although FDA approved the vaccine “expeditiously,” the approval “was fully in keeping with FDA’s existing high standards for vaccines in the United States.”
• The U.S. Supreme Court declined to pause enforcement of a federal court decision requiring the Biden Administration to reinstate the Trump-era Migrant Protection Protocols Program, also known as the “Remain in Mexico” program. The program allows the U.S. Department of Homeland Security to deport individuals seeking entry to the United States from Mexico while their applications for asylum are evaluated. The Supreme Court reasoned that the federal government, which requested the Court to halt the reinstatement of the program, is unlikely to demonstrate that its rescission of the program “was not arbitrary and capricious” under the Administrative Procedure Act.

SEPTEMBER

• President Joseph R. Biden issued an executive order to require federal employees to vaccinate themselves against COVID-19. Under the new mandate, federal employees cannot decline vaccination in favor of regular testing. This executive order contributes to the Biden Administration’s Path Out of the Pandemic plan, which directs the U.S. Department of Labor to develop a COVID-19 vaccination or testing mandate for businesses with 100 or more workers and a rule requiring businesses to provide paid time off to become vaccinated, among other measures.
• The Supreme Court ruled that the CDC’s nationwide moratorium on evictions is unlawful. The Court reasoned that, although there is a strong public interest in combating COVID-19, the CDC overstepped its authority in issuing the moratorium. The Court also noted that if there is to be a federal eviction moratorium, Congress “must specifically authorize it.” Three justices dissented, arguing that it was not clear the CDC lacked the authority to issue the moratorium. They stated that “public interest strongly favors respecting the CDC’s judgment at this moment.”

OCTOBER

• The Biden Administration authorized the admission of 125,000 refugees to the United States for the 2022 fiscal year. The Administration allocated refugee entry for regions of “special humanitarian concern,” allowing 40,000 individuals entry from Africa, 35,000 from Near East and South Asia, 15,000 from Latin America and the Caribbean, 15,000 from East Asia, and 10,000 from Europe and Central Asia. The Biden Administration left 10,000 spots unallocated for use as needed. In addition, the Biden Administration may transfer unused spots from one region to another region where refugees are in greater need for asylum. The Biden Administration specifically identified individuals from Cuba, Eurasia and the Baltics, Iraq, El Salvador, Guatemala, and Honduras, along with individuals from any U.S. Embassy, as qualifying as refugees.
• The U.S. Department of Homeland Security (DHS) issued a proposed rule that would “preserve and fortify” the Deferred Action for Childhood Arrivals (DACA) policy. The proposed rule follows a Texas federal court order that prevents DHS from granting new DACA requests, but allows renewals. The Biden Administration appealed the ruling, which will not be impacted by the new rule. Marielena Hincapié, executive director of the National Immigration Law Center, explained that the new rule does not substantially change the original DACA policy, but rather is an attempt to “write things out in more detail” in response to the Texas court order. DHS Secretary Alejandro Mayorkas called the proposed rule “an important step” toward protecting DACA recipients by reinforcing their status as individuals who are “not a priority for removal.” Secretary Mayorkas also noted that “only Congress can provide permanent protection” through immigration reform.

NOVEMBER

• A federal appeals court granted an order to temporarily block the Occupational Safety and Health Administration’s standard that required companies with 100 or more employees to implement COVID-19 vaccination policies. In response to the order, the Occupational Safety and Health Administration announced that it will pause the enforcement of its standard. The Biden Administration reportedly encouraged employers to implement the rule anyway in spite of the court order.
• FDA amended the authorization of COVID-19 booster shots to extend to all individuals who are 18 or older and have received their initial Moderna or Pfizer-BioNTech vaccinations at least six months prior. FDA’s amended authorization also allows boosters for those who are 18 or older and have received a Johnson & Johnson vaccine at least two months prior to receiving a booster. Discussing the authorizations, acting FDA Commissioner Janet Woodcock stated the booster shots will help “to provide continued protection against COVID-19, including the serious consequences that can occur, such as hospitalization or death.”

DECEMBER

• FDA lifted strict restrictions on mifepristone, a medication used to terminate early pregnancies. Like other prescription medications, patients typically take the pill at home. But unlike other prescription medications, FDA required patients to see a medical provider in-person to receive the pill, despite its strong safety record. The Biden Administration temporarily lifted the in-person requirement during the COVID-19 pandemic, allowing patients to receive the pill by mail following a telehealth appointment. FDA has made that change permanent, enabling patients to continue accessing the abortion pill from home post-pandemic. Advocates argue that this move is particularly helpful for low-income patients and those who live in rural areas far from the nearest clinic.
• President Joseph R. Biden released his winter COVID-19 plan, which will require private health insurers to reimburse individuals for at-home rapid COVID-19 tests. The plan also includes steps to increase access to COVID-19 booster shots and at-home tests, stockpile antiviral pills, and prepare federal response teams to help states manage outbreaks. In addition, President Biden extended a mask mandate for travelers until March. The mandate, which was set to expire in January, applies to individuals on airplanes, trains, and public transportation, and in transportation hubs. The Biden Administration will also require all international travelers to take a COVID-19 test within one day of departing for the United States.

HIGHLIGHTS OF WHAT WE WERE READING THIS YEAR

• In a paper issued by the University of Pennsylvania’s Center for Ethics and Rule of Law, senior fellow Alexandra Meise argued that the United States lacks a consistent, comprehensive approach to addressing climate change. Meise argued that the federal government, civil society, and business each approach climate change from different perspectives, leaving a fractured backdrop upon which state and local governments must battle to impose their own climate change policies. Meise asserted that one way the Biden Administration can create a centralized, intersectoral approach is by establishing a blue-ribbon commission of leaders across various levels of government, business sectors, and climate experts.
• In a recent National Bureau of Economic Research working paper, Ann Bartel, professor at Columbia Business School, and her coauthors studied the effects of New York State’s paid family leave policy on employers. The law went into effect in 2018 and required most private employers to provide 8 weeks of paid leave. The study found that, within the first year of the policy, employers improved their ability to manage longer employee absences. By its second year, the paid family leave policy had resulted in an increase in employees who took family leave. Bartel and her coauthors concluded that most New York employers were supportive of the paid family leave policy.
• In an article in The New England Journal of Medicine, University of Pennsylvania Law School professor Anita Allen analyzed the progress and future of health information privacy and regulation under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), which turned 25 years old in August. Allen argued that privacy for medical information is still imperative even as norms around health disclosure in the United States shift toward transparency. Allen noted, however, that HIPAA as a regulatory framework is well suited to adapt to changes in societal expectations of privacy and innovation. Allen concluded that HIPAA has “paved the way” in providing access to quality health care through “strong, well-informed regulations.”
• In a report, Climate Action Tracker found that current global policies aimed at limiting the increase of the Earth’s temperature will fail to meet the goal of a 1.5 degree decrease in temperature by the end of the century. The organization estimated that the 2030 emission reduction targets would collectively achieve a 2.4 degree Celsius increase by 2100. The organization argued that all countries must eliminate the use of coal power by 2040 and that developed countries should be coal-free by 2030. Climate Action Tracker emphasized that switching from coal to natural gas is not “compatible” with global climate reduction agreements to lower carbon emissions by 1.5 degrees. In addition, the organization suggested that countries back up their carbon reduction goals with more “robust legislation and detailed plans.”
• In a Brookings Institution report, Sanjay Patnaik and Kelly Kennedy argued that the Biden Administration and the U.S. Congress should charge a price on carbon emissions—otherwise known as carbon pricing. Patnaik and Kennedy contended that carbon pricing can contribute significantly to halving carbon emissions by 2030, as required by President Biden’s climate goals. Patnaik and Kennedy also advocated a carbon border adjustment tax, which protects domestic companies by charging foreign imports for their carbon emissions. Patnaik and Kennedy noted, however, that policymakers must implement domestic carbon pricing before a carbon border adjustment tax to avoid retaliation in global trade from countries such as China and India. Finally, Patnaik and Kennedy maintained that establishing carbon pricing will allow U.S. companies to make long-term plans and competitive investments.
• In a report to Congress, the U.S. Government Accountability Office (GAO) found that the Justice Department and the Interior Department failed to comply with statutory requirements to address the missing or murdered Indigenous women crisis. In the United States, violence is committed against Indigenous women at disproportionately high rates. Yet, according to GAO, the full scope of the crisis is unknown because federal databases do not accurately track the number of missing or murdered Indigenous women nationwide. GAO recommended that the Justice Department create a plan to complete data analyses on missing or murdered Indigenous women and confer with tribal organizations about their ability to submit missing persons data to federal databases. GAO also urged both agencies to share a plan for establishing the Joint Commission on Reducing Violent Crime Against Indians, an overdue statutory obligation.