Primer: The Relevant Executive Regulatory Powers and Responses to COVID-19 – N.Y.U. Journal of Legislation & Public Policy

By: NYU Journal of Legislation & Public Policy Quorum

April 19, 2020

Introduction

The novel coronavirus is a global health crisis unprecedented in scale, revealing both expected and unexpected pressure points in public policy. With the world at a standstill, governments rattled by economic collapse, and hospitals faltering under the strain, all eyes have turned to how scientists, healthcare workers, and policymakers will solve a global pandemic. While the U.S. federal government does not traditionally have police power over the health, safety, and wellbeing of state citizens, it does have expanded powers in emergencies. Some of these powers are contingent on state requests while others may be unilaterally invoked. To date, the Trump Administration has used a suite of regulatory powers to respond to the crisis.

In an effort to clarify the extent of the powers available to the executive branch during this emergency, we created the following list of the relevant powers that have been used to respond to COVID-19. To provide an extensive overview of federal power, we include both the relevant public-health-specific powers as well as more general emergency powers.

This list is intended to be an ongoing informational resource, not a legal analysis. Please email Tom McBrien (tmm577@nyu.edu) with any questions, updates, or corrections. As of initial publication of this article, we have included all federal regulations that are currently in force on April 18, 2020 to police the threat of coronavirus.

1. General Emergency Declarations

National Emergency Declaration Under Section 201 of the National Emergencies Act of 1976 (50 U.S.C. § 1621)

Overview: The President may declare a national emergency under the National Emergencies Act (“NEA”),¹ enabling him or her to invoke special powers from more than 100 disparate provisions of law.

There are more than a hundred powers the President could invoke if desired. These include everything from waiving vehicle weight limits for bulk shipments to freezing bank accounts, unilaterally limiting international trade, or shutting down radio stations.² Like the Stafford Act’s emergency provision, but unlike its more powerful disaster provision (both discussed below), the NEA empowers the president to define “emergency.”³ Also unlike the Stafford Act, there is no statutory language requiring the President’s exercise of powers directly relate to the emergency.⁴

President Trump used this power on March 13 to enable HHS Secretary Azar to waive certain Social Security Act requirements, discussed below.⁵ Interestingly, the President only had to declare an emergency under the Stafford Act or the National Emergencies Act to enable these waivers, but he declared both, perhaps for dramatic effect or perhaps to retain the option to invoke more powers under the NEA. Previous uses of these powers include President Trump’s declaration of an emergency on the southern border in 2019 and then-President Obama’s emergency declaration in response to the H1N1 influenza outbreak. There are currently 35 ongoing national emergencies declared under this act.

Emergency Declaration Under Section 501(b) of the Stafford Act of 1988

Overview: The President may declare an “emergency” under the Stafford Act, enabling the federal government to provide financial and physical support to States.⁶

The President can only make this declaration following the request of a State governor or the Chief Executive of a Tribal government⁷ unless the “subject area” of the emergency is one in which “the United States [federal government] exercises exclusive or preeminent responsibility and authority,”⁸ a definition that has not been litigated before. An “emergency” is defined as “any occasion or instance for which . . . Federal assistance is needed to supplement State and local efforts and capabilities to save lives and to protect property and public health and safety.”⁹ The declaration allows the President to direct federal agencies to use their existing resources to coordinate disaster relief and assist state and local authorities.¹⁰

Using this power, the federal government can help distribute medicine and food, provide grants to individuals for temporary housing and personal needs, and assist state governments in organizing, funding, and overseeing emergency response measures.¹¹ While emergency declarations usually limit federal funding to $5 million,¹² the President is authorized to increase funding above the limits¹³ but must notify Congress.¹⁴ For example, in the current crisis, FEMA has a reported $40 billion in funding through its Disaster Relief Fund.¹⁵ In a particularly grim example, FEMA requested 100,000 body bags from the Department of Defense that it will use to supplement State reserves. An emergency declaration does not permit the government to waive any individual constitutional rights.¹⁶

This is only the second time a President has declared a Stafford Act emergency in response to a disease outbreak.¹⁷ The only other time was when Bill Clinton declared an emergency for outbreaks of West Nile Virus in New York and New Jersey.¹⁸

Major Disaster Declaration Under Section 501(b) of the Stafford Act

Overview: The President may also declare a “major disaster” under the Stafford Act, enabling the federal government to provide more funding and powers to respond.¹⁹

This declaration frees up relief above and beyond that available for an emergency, including direct relief to affected communities in the form of “unemployment assistance, food coupons, legal services, grants to assist low-income migrant and seasonal farmworkers, emergency public transportation, and emergency communications.”²⁰ Some of the provisions of the statute are very broad, such as one allowing the federal government to “[p]erform[] on public or private lands . . . any work or services essential to saving lives and protecting and preserving property or public health and safety, including– . . . reduction of immediate threats to life, property, and public health and safety.”²¹ The statute also allows the federal government to use Department of Defense resources.²²

Unlike a Stafford emergency declaration, the President cannot unilaterally declare a Stafford major disaster declaration. He or she can only do so in response to a request from a governor or tribal chief executive.²³

A “major disaster” is more narrowly defined than an emergency. The statutory language provides that it can only be decreed for a “natural catastrophe (including any hurricane, tornado, storm, high water, wind-driven water, tidal wave, tsunami, earthquake, volcanic eruption, landslide, mudslide, snowstorm, or drought or regardless of cause, any fire, flood or explosion).”²⁴

President Trump is the first President to define a pandemic as a major disaster for the purposes of this statute.²⁵ Under this statute, he declared a major disaster for multiple states including Hawai’i, Virginia, Tennessee, New York, Washington, and California.

Defense Production Act

Overview: The Defense Production Act (“DPA”) of 1950, originally a Cold-War-era military production statute, enables the federal government to enlist private industry to make supplies in an emergency.²⁶

Under the DPA, the President may demand private industry fill government orders for items such as emergency medical equipment and may act to increase industry’s industrial capacity.²⁷ Under Title I of the DPA, the President may force private actors to fill government purchase orders before any other purchase orders.²⁸ The President may do this only after a finding that (1) critically essential materials for the national defense are scarce, and (2) the needs of national defense cannot be met otherwise.²⁹ Under Title III of the DPA, the President may enhance the nation’s ability to produce critical supplies by using loans, loan guarantees, direct purchases, and the authority to procure and install equipment in private industrial facilities.³⁰ Title III also creates a treasury account for funds to be used pursuant to this section.³¹ Projects that cost more than $50 million must be authorized by Congress, but this requirement can be waived during an emergency.³² For both Title I and Title III, Executive Order 13603 enables the President’s agents, such as HHS Secretary Azar and FEMA managers, to use the President’s powers under the DPA.³³

President Trump first invoked the statute in mid-March, but initially seemed hesitant to use it, claiming he “only signed the Defense Production Act . . . should we need to invoke it in a worst case scenario in the future.” Recently, however, the federal government has used the DPA more aggressively. The President ordered HHS Secretary Azar and the administrator of FEMA to “use any and all authority available under the Act to acquire” N95 respirators from 3M, which may include banning the company from sending masks to other countries. The act was also invoked to require General Motors to produce ventilators more quickly.

Foreign Travel Restrictions Based on the Immigration & Nationality Act

Overview: The President has also used his powers under the Immigration and Nationality Act to bar entrance to the country.

Under the INA, the President may “suspend the entry of all aliens or any class of aliens” upon a finding that “the entry of any aliens or of any class of aliens into the United States would be detrimental to the interests of the United States.”³⁴

President Trump has invoked this power multiple times during the coronavirus pandemic, first limiting the entry of all aliens who were physically present in China, followed by Iran, 26 European states in the Schengen Area, and finally Canada and Mexico.³⁵

2. Public-Health Declarations

Public Health Emergency Declaration Under the Public Health Service Act

Overview: When the Secretary of Health and Human Services (“HHS”) declares a public health emergency in conjunction with a presidential emergency declaration, he or she may coordinate a response to the pandemic by taking actions such as waiving medical licensing requirements and injecting funds into the healthcare system.³⁶

Under a public health emergency, the Secretary may take actions to help healthcare providers assign personnel more flexibly, free up additional federal resources, and encourage interjurisdictional coordination. Specifically, the Secretary may direct funds toward pandemic research and treatment through grants, awards, and contracts;³⁷ establish communications lines between different levels of government and health care entities;³⁸ and “carry out other activities, as the Secretary determines applicable and appropriate.”³⁹

When the President declares an emergency under the Stafford Act or National Emergencies Act, the Secretary may waive section 1135 of the Social Security Act, enabling even more flexibility. For example, physicians and other healthcare professionals can now receive Medicare, Medicaid, and SCHIP reimbursements when working in states in which they’re not licensed. Certain patient privacy requirements under HIPAA are waived when a hospital is undergoing an emergency, and certain conditions of participation in Medicare, Medicaid, and SCHIP are relaxed.⁴⁰

Exercising this power, HHS Secretary Alex Azar declared a state of public health emergency within the United States on January 31, waiving section 1135 and enabling branches of HHS to respond to the pandemic.⁴¹ For example, the CDC used this authority to isolate and quarantine U.S. citizens returning from Hubei Province, China, and two cruise ships.⁴² This is the first time the CDC has exercised its quarantine authority in 50 years, other than to address one-off suspected cases.⁴³

The extent of this power has not been tested in courts. The federal government has statutory authority to take further actions deemed reasonably necessary to prevent the spread of the virus, but the precise extent of this authority is unknown.⁴⁴

Antiviral and Vaccine Research Under the Food, Drug, and Cosmetic Act

Overview: The HHS Secretary may declare an emergency justifying the emergency use authorization (“EUA”) of medical countermeasures.⁴⁵

This power allows the FDA Commissioner to either (a) allow the use of an unapproved drug, vaccine, or medical device, or (b) to allow the use of an approved medical product in an unapproved setting. It can only be invoked under certain legal and scientific criteria.

The Trump Administration used this power to issue an emergency use authorization for chloroquine and hydroxychloroquine to treat coronavirus. The power was also used in response to the 2009 H1N1 influenza outbreak when the FDA approved the emergency use of antivirals for certain patients and health care settings.

Immunity from Liability Under the Public Readiness and Emergency Preparedness Act (“PREP Act”)

Overview: Under the PREP Act, the federal government and private actors are immune from liability, except willful misconduct, for claims of loss related to the use of countermeasures against a public health emergency.⁴⁶

The Department of HHS and private companies that manufacture, test, develop, distribute, administer, and use medical countermeasures to COVID-19 are likely immunized from liability. These countermeasures fit into three statutory categories: (1) “qualified pandemic or epidemic products;” (2) “security countermeasures;” and (3) products authorized for emergency use. Secretary of HHS Azar invoked this statute on March 17, 2020.

3. Useful resources

A timeline of the coronavirus and the federal response. (Just Security)
- Privacy International tacks privacy implications of COVID-19 surveillance worldwide. (Privacy International)
- World Health Organization virus tracking (WHO)
- Just Security articles about legal and policy responses to COVID-19. (JustSecurity)
- European Journal of International Law coverage of the COVID-19 response. (EJIL)
- Lawfare articles about legal and policy responses to COVID-19. (Lawfare)
- MultiState’s ongoing tracker of all state and local responses to COVID-19. (MultiState)
- The Network for Public Health Law has many good resources, especially this slideshow (updated daily). (NPHL)

Conclusion

COVID-19, while perhaps not unforeseeable, is nonetheless a unique challenge for our government and society. Of course, federal and state legislatures, executives, and the private sector each have their own powers and restrictions; they must all play a critical role in the response. With its ability to direct large amounts of funding, orchestrate production of necessary materials, waive laws that constrain the healthcare response, and set up communications networks, the executive branch is uniquely situated to respond to the virus.

Quorum wants to thank Tom McBrien for researching and writing this piece. Sophia Elliot contributed extensive research; Danielle Schulkin, Katie McFarlane, and Chris Shenton helped frame and edit the piece; and Ithamar Zacharie and Catherine Larsen contributed editing and source substantiation.

NYU Journal of Legislation & Public Policy Quorum

Suggested Citation: Primer: The Relevant Executive Regulatory Powers and Responses to COVID-19, N.Y.U. J. Legis. & Pub. Pol’y Quorum (2020).

1
50 U.S.C.A. § 1621 (West 2019).
2
See Elizabeth Goitein, Trump’s Reasonable—And Yet Still Worrisome—Emergency Declaration, The Atlantic (Mar. 16, 2020), https://www.theatlantic.com/ideas/archive/2020/03/trumps-emergency-declaration-coronavirus/608083
3
50 U.S.C.A. § 1621(b) (West 2019).
4
See Goitein, supra note 2.
5
Alexandra Phelan, Explainer: National Emergency Declarations and COVID-19, Just Security (Mar. 13, 2020), https://www.justsecurity.org/69190/explainer-national-emergency-declarations-and-covid-19.
6
42 U.S.C. § 5192(a) (West 2020).
7
Id. § 5191(a), (c).
8
Id. § 5191(b).
9
Id. § 5122(1); see also Phelan, supra note 5.
10
See Mark Nevitt, The Coronavirus, Emergency Powers, and the Military: What You Need to Know, Just Security (Mar. 16, 2020), https://www.justsecurity.org/69215/the-coronavirus-emergency-powers-and-the-military-what-you-need-to-know.
11
See Goitein, supra note 2.
12
42 U.S.C. § 5193(b)(1) (West 2020).
13
Id. §5193(b)(2).
14
Id. §5193(b)(3).
15
See Goitein, supra note 2; Nevitt, supra note 10.
16
See Nevitt, supra note 10.
17
Goitein, supra note 2.
18
Nevitt, supra note 10.
19
See Phelan, supra note 5.
20
Goitein, supra note 2.
21
42 U.S.C. §5170(b)(a)(3)(I).
22
Id. §5170(c).
23
Id. §§5170(a)–(b).
24
42 U.S.C. §5122 (West 2012).
25
See Nevitt, supra note 10.
26
Kelly Magsamen, Katrina Mulligan & Frank Kendall, To Respond to the Coronavirus, Trump Should Take 6 Immediate Steps on the Defense Production Act, Center for American Progress (Mar. 19, 2020), https://www.americanprogress.org/issues/security/news/2020/03/19/482048/respond-coronavirus-trump-take-6-immediate-steps-defense-production-act/.
27
Id.
28
Id.
29
Id.
30
Id.
31
Id.
32
Id.
33
Id.
34
8 U.S.C. 1182(f) (West 2013).
35
See Magsamen, Mulligan & Kendall, supra note 26.
36
Public Health Service Act, 42 U.S.C.A § 247d (West 2019). This could also apply in situations such as bioterrorism threats. Id. § 247d(a)(2).
37
42 U.S.C.A. § 247d(b)(2)(B) (West 2019).
38
Id. § 247d(b)(2)(A).
39
Id. § 247d(b)(2)(F)
40
James G. Hodge, Jr., COVID-19 Emergency Legal Preparedness Primer, Network for Pub. Health L. (Mar. 16, 2020), https://www.networkforphl.org/wp-content/uploads/2020/03/Western-Region-Primer-COVID-3-26-2020.pdf (last visited Mar. 26, 2020).
41
Id.
42
Lawrence O. Gostin, James G. Hodge Jr. & Lindsay F. Wiley, Presidential Powers and Response to COVID-19, JAMA (Mar. 18, 2020), https://jamanetwork.com/journals/jama/fullarticle/2763423.
43
Id.
44
Id.
45
21 U.S.C.A. § 360bbb-3 (West 2017).
46
See 42 U.S.C.A. § 247d-6d (West 2019).