6

Legal and Regulatory Authority

The Centers for Disease Control and Prevention (CDC) exercised broad regulatory authority throughout the COVID-19 pandemic, with many of its actions challenged in, or even blocked by, the courts. The committee believes that the CDC should be afforded ample legal authority to carry out its mission using evidence-based measures to reduce the interstate or international spread of infectious diseases. This would require legal reforms, including modernizing the Public Health Service Act of 1944 (PHSA),¹ which was enacted well before major societal changes—including globalization—that can amplify the threat of rapidly moving infectious diseases. In addition to statutory reform, the CDC may also have to update its regulations to better respond to emerging health threats and include use of digital technology for contact tracing and monitoring to enable their use while respecting rights to privacy and freedom of movement. This chapter discusses potential changes to laws and regulations that may be required to implement recommended measures on infrastructure, workforce, data systems, as well as important reforms to ensure the CDC has the powers required to safeguard the American public.

___________________

¹ Public Health Service Act of 1944, Public Law 78-410, 78th Cong., 2nd sess. (July 1, 1944), 42.

THE CDC’S LEGAL AND REGULATORY AUTHORITY DURING OUTBREAKS: OVERVIEW

The PHSA authorizes the secretary of the Department of Health and Human Services (HHS) to take regulatory action² to prevent the introduction and spread of infectious diseases; this authority has subsequently been delegated to the CDC.

The Agency’s Division of Global Migration and Quarantine (DGMQ) is responsible for drafting regulations and undertakes operations related to this regulatory authority. These include the authority to test, medically examine, detain, and release persons entering the United States who are suspected of carrying communicable diseases, including passengers and crew members (CDC, 2021c). The DGMQ provides this operational support through its work at U.S. ports of entry, by administering interstate and foreign quarantine regulations, and developing requirements for the testing, medical examination, and treatment of immigrants and refugees (CDC, 2021b). Together, the PHSA and Immigration and Nationality Act of 1952³ and the PHSA authorize the federal government to develop medical examination requirements for immigrants and refugees entering the United States (CDC, 2021b). The Immigrant, Refugee, and Migrant Health branch of the DGMQ establishes medical screening protocols for physicians and other health care professionals to use worldwide in conducting medical examinations before individuals arrive in the United States to visit, live, and/or work.

The CDC is authorized to issue a federal isolation or quarantine order if a quarantinable disease⁴ is suspected or identified (CDC, 2021c). Additionally, the CDC has the authority to restrict the importation of animals, animal products, human remains, or any other items that may pose public health threats. The U.S. quarantine stations also have the authority to implement the International Health Regulations (IHR) of 2005 which the World Health Organization (WHO) adopted to support global health security. The IHR, revised in 2005 in the aftermath of the SARS outbreaks, have been adopted by 196 countries, including the United States. While safeguarding global health security, the IHR also seek to prevent unwarranted travel and trade restrictions that might unnecessarily disrupt traffic and trade (CDC, 2021b; Gostin, 2021)

___________________

² These federal regulations apply to all persons, vehicles, animals regulated by the CDC, articles, and human remains entering the United States from another country by land, air, or sea.

³Immigration and Nationality Act of 1952, Public Law 82-414, 82nd Cong., 2nd sess. (June 27, 1952).

⁴ Diseases are established as quarantinable by way of executive order of the president. More information about quarantinable diseases can be found at https://www.cdc.gov/quarantine/aboutlawsregulationsquarantineisolation.html (accessed March 2, 2022).

The congressional authorization of the CDC’s regulatory powers may be interpreted broadly or narrowly. A broad interpretation of the PHSA would allow the CDC to adopt most evidence-based prevention or response measures that are constitutionally permissible for a federal executive-branch agency. In recent rulings enjoining some of the CDC’s COVID-19 orders related to the CDC’s repeated issuance of eviction moratoriums, however, the Supreme Court and several lower federal courts have indicated that the CDC’s statutory authority be interpreted far more narrowly. Some lower courts have also held that Congress is constitutionally prohibited from delegating authority to administrative agencies in broad, catch-all terms. The U.S. Supreme Court has intimated in existing opinions that it may endorse a similar constitutional approach in the near future (Gostin et al., 2022). If the CDC is to be able to exercise powers to protect the public’s health, it will likely require congressional reforms of the PHSA.

Uncertainty about the scope and limits of CDC authority could hinder pandemic prevention and response. Congress should modernize the CDC’s powers by specifying the conditions under which it may, inter alia, (1) regulate interstate and international travel, (2) require use of personal protective equipment (PPE), (3) mandate sanitation measures, (4) limit mass gatherings, (5) regulate gathering places, or (6) adopt protections to support compliance with public health guidance. In addition, the CDC should initiate rulemaking building on the 2017 revised rules to clarify the standards and procedures governing such orders. This chapter first describes the sources and uses of the CDC’s powers and recent court rulings enjoining its orders. This is followed by a discussion of reforms recommended by the committee to ensure the CDC’s powers are comprehensive, constitutional, effective, and flexible. The Committee also suggests reforms to safeguard constitutionally protected individual rights, such as rights to privacy, assembly, travel, and liberty.

RECENT COURT INTERPRETATIONS OF THE CDC’S AUTHORITY

Recent court rulings have contributed to uncertainty regarding the scope of the CDC’s authority. The PHSA gives the CDC powers to prevent the international and interstate spread of communicable disease. In addition to authorizing certain containment measures in specific terms (e.g., detention of international travelers and decontamination of articles in interstate commerce), Congress authorized “other measures” officials deem “necessary.”⁵ Recent court rulings have interpreted this language narrowly, limiting the CDC to measures “similar to” those specifically listed,⁶ which “directly relate to preventing the interstate spread of disease by identifying,

___________________

⁵ Public Health Service Act of 1944.

⁶Tiger Lily, LLC v. Dep’t of Housing and Urban Dev., 5 F.4th 666, 671 (6th Cir. 2021).

isolating, and destroying the disease itself.”⁷ These rulings were preliminary, but appeals that could lead to final decisions on the merits may be dismissed on procedural grounds as moot. Thus, the scope of the CDC’s authority—particularly when narrowly targeted containment efforts fail—is uncertain. At the same time, the Supreme Court has interpreted certain federal agency powers narrowly, such as its decision in January 2022 to block the Occupational Safety and Health Administration’s (OSHA’s) vaccinate- or-test mandate for large employers (Gostin et al., 2022).

Specific and Broadly Delineated Powers Granted by the Public Health Service Act

The PHSA grants the CDC a combination of specific and broadly delineated powers. Sections 361 and 362 of the PHSA⁸ authorize federal health officials⁹ “to prevent the introduction, transmission, or spread of communicable diseases” into the United States from foreign countries and across state and territorial borders within the United States. These provisions are in a part of the PHSA titled “Quarantine and Inspection.” However, they authorize at least some additional measures.

Congress granted the CDC some powers in specific terms; others are more broadly delineated. The first sentence of Subsection 361(a) is framed broadly. It states that the CDC director is “authorized to make and enforce such regulations as in his judgment are necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the States or possessions, or from one State or possession into any other State or possession.” The second sentence of Subsection 361(a) provides a nonexhaustive list of specific measures that are authorized by the first sentence: “For purposes of carrying out and enforcing such regulations, the [CDC director] may provide for such inspection, fumigation, disinfection, sanitation, pest extermination, destruction of animals or articles found to be so infected or contaminated as to be sources of dangerous infection to human beings, and other measures, as in his judgment may be necessary.” Subsections 361(b) through (d) refer specifically to the use of Subsection 361(a) powers to apprehend, detain, examine, and conditionally release individuals and impose particular conditions on these measures. Section

___________________

⁷Ala. Ass’n of Realtors v. Dep’t of Health and Human Svcs. 141 S.Ct. 2485, 2488 (2021).

⁸ Sections 361 and 362 of the PHSA are codified at 42 U.S.C. §§264 and 265. This chapter uses the section numbering from the original legislation because that is how federal officials and lawmakers typically refer to these provisions.

⁹ In 1944, Congress granted the powers discussed in this paper to the Surgeon General. In 1966, these powers were transferred to the secretary of Health and Human Services (HHS), who in turn delegated them to the CDC director and FDA commissioner. The FDA uses this authority to regulate “Section 361 products.”

362 provides specific authority to prohibit introduction of persons or property into the United States from foreign countries designated by the CDC director. Additional provisions scattered throughout Title III of the PHSA set forth penalties for violations (Section 368), provide for acceptance of enforcement assistance from state and local officials (Section 311), and direct customs and Coast Guard officers to provide enforcement assistance (Section 365). Subsection 361(e)—which was added to the PHSA in 2002—provides that federal measures adopted under Section 361 preempt state and local laws that conflict with federal requirements.

The CDC has promulgated regulations interpreting these provisions most recently in 2017. The 2017 “Final Rule for Control of Communicable Diseases: Interstate and Foreign” is codified at 42 CFR Part 70 (interstate spread) and Part 71 (spread from foreign countries into the United States). Table 6-1 provides an overview of the major powers granted to the CDC by the PHSA. As with statutory reform, regulatory actions can be laborious and political. It took the CDC several iterations and more than a decade to finalize its 2017 Final Rule.

TABLE 6-1 Powers Granted to the CDC by the Public Health Service Act of 1944

^a Current list of quarantinable diseases: cholera, diphtheria, infectious tuberculosis, plague, smallpox, yellow fever, viral hemorrhagic fevers, severe acute respiratory syndromes, influenza viruses with pandemic potential, and measles.

Power to Apprehend, Detain, and Conditionally Release Individuals

Under Section 361(b), the CDC’s power to apprehend, detain, or conditionally release individuals is triggered by a finding that these actions are necessary to prevent the cross-border spread of a communicable disease that the president has designated as quarantinable in an executive order. Currently, the list of quarantinable diseases is limited to cholera, diphtheria, infectious tuberculosis, plague, smallpox, yellow fever, viral hemorrhagic fevers, severe acute respiratory syndromes, influenza viruses with pandemic potential, and measles.¹⁰ If the CDC sought to apprehend, detain, or conditionally release individuals based on the risk of any other communicable disease, the president would first have to issue an executive order amending the list of quarantinable diseases. The PHSA amendments in 2002 streamlined the process for updating the list. Section 361(c) specifies that these powers may be used to detain individuals entering the United States from a foreign country. Section 361(d) specifies that these powers may be used to detain individuals posing a risk of interstate spread only if the individual is “reasonably believed to be infected with a communicable disease in a qualifying stage” and “moving or about to move from” one state to another or “a probable source of infection” to other individuals who will be moving from one state to another while infected.

Regulations codified at 42 CFR §70.5, 70.6, 70.10, 70.12 et seq., and 71.29 et seq. (adopted in 2017) include extensive provisions to ensure the CDC orders for apprehension, screening, medical examination, isolation, quarantine, and conditional release are consistent with constitutional principles of federalism, separation of powers, and protections for individual rights (Gostin and Hodge, 2017).

Power to Inspect, Disinfect, and Destroy Animals and Articles

Under Section 361(a), the CDC may order “inspection, fumigation, disinfection, sanitation, pest extermination, [and] destruction of animals or articles” infected or contaminated by any communicable disease deemed “dangerous” to humans. Under 42 CFR §71.32, the CDC has determined this authority should only be used to prevent international spread if the disease is quarantinable. 42 CFR §70.2, which governs use of these measures to prevent interstate spread, is not limited to quarantinable diseases. It does, however, require a determination that the measures taken by state, territorial, and local health authorities are “insufficient to prevent” the interstate spread of disease.

___________________

¹⁰ Exec. Order No. 13295 (Apr. 4, 2003) as amended by Exec. Order No. 13375 (Apr. 1, 2005); Exec. Order No. 13674 (Jul. 31, 2014); and Exec. Order No. 14047 (Sept. 17, 2021). 70 FR 17299.

Power to Implement Border Controls

Section 362 states that the CDC’s power to prohibit, in whole or in part, “introduction of persons and property” from foreign countries designated by the CDC director is triggered by a finding that “by reason of the existence of any communicable disease in a foreign country there is serious danger of the introduction of such disease” into the United States. Additionally, CDC officials must find that the danger of introduction into the United States is “so increased by the introduction of persons or property” from the designated country or that border controls are “required in the interest of the public health.” Border controls are authorized for the period of time deemed “necessary” to avert serious danger of the introduction of a communicable disease into the United States.

A regulation promulgated by the CDC clarifies the agency’s interpretation of the scope and limits of its authority under Section 362. 42 CFR §71.40 narrows Section 362 by limiting its application to quarantinable diseases. However, the regulation also defines key terms in the statute broadly to maximize the measures the CDC may undertake to control quarantinable diseases. The regulation specifies that the CDC director’s authority to “prohibit introduction” of persons “into the U.S.” covers situations where the communicable disease at issue is already present within the United States and includes authority to “physically expel” individuals from the United States.

Power to Implement Other “Necessary Measures” to Prevent Cross-Border Disease Spread

The legislative history of the PHSA indicates that Congress intentionally chose broad language to authorize “other measures, as in [the CDC director’s] judgement may be necessary” to prevent the spread of communicable disease into the United States from foreign countries or across state and territorial borders.¹¹ Administrative officials and judges may read

___________________

¹¹ A recent report by the Congressional Research Service notes that legislators viewed Section 361’s broadly framed first sentence as a continuation of an 1893 statute authorizing “regulations to prevent the spread into the country, or between the States, of contagious or infectious diseases,” but only if state and local regulations were nonexistent or inadequate. Act of Apr. 29, 1878 §5, ch. 66. The drafters of Section 361 understood that it would be “confined to matters pertaining to the interstate movement of people or things over which the States have both constitutional and practical difficulties in achieving effective control.” However, they also emphasized that “these provisions are written in broader terms in order to make it possible to cope with emergency situations which we cannot now foresee” (Hearing Before a Subcomm. on Interstate & Foreign Commerce on H.R. 3379: A Bill to Codify the Laws Relating to the Public Health Service, and for Other Purposes, 78th Cong. 64 [1944]). In a committee hearing, the Surgeon General argued that Section 361 “may be very important because of the

this power narrowly or broadly. If it is read broadly, this language “might encompass the authority to implement any evidenced-based public health measures that do not . . . exceed constitutional limits.”¹² The text of the PHSA does not limit the “necessary measures” provision to quarantinable communicable diseases.

The CDC’s regulations implementing Section 361(a) provide minimal guidance regarding how this catch-all authority may be used. Under 42 CFR §70.2, the CDC’s power to prevent the interstate spread of disease is conditioned on a determination “that the measures taken by [state, territorial, and local health authorities] are insufficient to prevent” the interstate spread of disease. In addition, §70.2 adopts a “reasonably necessary” standard to clarify that the PHSA’s use of “necessary” does not require that the measure in question must be the only available means to an end.

The CDC’s Regulatory Powers and Federal Emergency Declarations

The CDC powers previously described are not “emergency powers” per se. The PHSA and other statutes authorize federal officials to issue several distinct types of emergency and disaster declarations or determinations. Most relevant for the current purposes, Section 319(a) of the PHSA authorizes the HHS secretary to determine that “a) a disease or disorder presents a public health emergency (PHE); or b) that a public health emergency, including significant outbreaks of infectious disease or bioterrorist attacks, otherwise exists.” A federal PHE determination allows the HHS secretary greater flexibility to suspend, waive, or modify certain regulatory requirements that might otherwise impede the health care system’s emergency response, to make grants, to enter into contracts, and to access emergency and reserve funds. A PHE determination does not formally expand the CDC’s statutory authorization in any way, but courts are likely to afford the CDC more deference in a declared health emergency. This differs from how state statutes typically authorize public health agencies to exercise a combination of general regulatory powers—which do not depend on a pending declaration—and emergency powers, which equip executive-branch officials with expanded delegations of authority while an emergency or disaster or PHE declaration is in effect. Although the HHS secretary’s determination does not formally expand the CDC’s regulatory

___________________

possibility that strange diseases may be introduced in the country and become a threat,” and “[f]lexibility in dealing with such contingencies would be very helpful” (Hearing before a Subcomm. on Educ. and Labor, 78th Cong. 6 [1944]; Congressional Research Service, Scope of CDC Authority Under Section 361 of the Public Health Service Act [Apr. 13, 2021] at 9-10).

¹² Id. at 4.

powers, the CDC may choose to take the HHS secretary’s PHE determination into account when determining whether a measure is “necessary” under Section 361 or 362.

CDC COVID-19 Orders Relying on Broad Interpretation of the Public Health Service Act

In the roughly 75 years since the CDC’s founding and the PHSA’s passage, the United States had not experienced a public health emergency of the scale and nature of the COVID-19 pandemic. During the response to the pandemic, the CDC has issued orders that have relied on a broad interpretation of the PHSA. In litigation defending its COVID-19 orders, the CDC has argued that judges should read Section 361 broadly to authorize restrictions and mandates for individuals, businesses, and airports, ports, and carriers—including face-mask requirements for public transit, vaccination requirements for cruise ships, testing requirements for air passengers entering the United States, and a moratorium on residential evictions. These measures were unprecedented for the CDC. The CDC had previously ordered targeted screening, isolation, and quarantine for containment and prevention purposes, but had rarely, if ever, ordered mitigation measures that apply to the general public in the absence of individualized risk assessment. An overview of orders issued by the CDC and operationalized with support from DGMQ is provided in Table 6-2.

Screening and Orders for Collection of Contact Information

Prior to and during the COVID-19 pandemic, Customs and Border Protection (CBP) performs most of the screening utilizing CDC protocols. However, the CDC has instituted screening programs for travelers entering the United States in circumstances of increased need for intervention. The CDC will screen with assistance from Customs and Border Protection¹³ and has also issued orders requiring airlines to collect contact information for passengers arriving in the United States from specified foreign countries (Bajema et al., 2020; Brown et al., 2014). On October 25, 2021, the CDC issued an expanded order to collect contact information from all airline passengers en-

___________________

¹³ See, e.g., Clive M. Brown et al., Airport Exit and Entry Screening for Ebola—August–November 10, 2014, 63 Morbidity & Mortality Weekly Rpt. 1163 (2014). Out of 256 individuals across 34 jurisdictions for whom CDC staff recommended SARS-CoV-2 testing in January 2020—at a time when testing was available in the United States solely through the CDC—six were identified through airport screening. The CDC has not specified whether any of the six identified through airport screening were among the 11 who tested positive in the United States in January 2020. See Kristina L. Bajema, et al.

tering the United States from foreign countries.¹⁴ This order replaced a series of prior orders that began in early 2020 applying to passengers arriving from specific countries. These activities rely on Section 361 and other authorities scattered throughout Title III of the PHSA, as implemented in 42 CFR §71.4.

Isolation and Quarantine Orders

The CDC has occasionally issued isolation and quarantine orders under Section 36, including an isolation order in 2007, for an individual believed to be infected with extensively drug-resistant tuberculosis (Parmet, 2007).¹⁵ In late January 2020 the CDC issued quarantine orders—for the first time in more than 50 years—for 195 U.S. citizens whom the State Department repatriated from mainland China after they were believed to have been exposed to SARS-CoV-2 in Hubei province (CDC, 2020a,b). These orders rely on PHSA Sections 361(a) and (b).

Cruise Ship Operations

On March 14, 2020, as noted in Box 6-1, the CDC relied on Section 361(a) to issue an order suspending cruise ship operations from U.S. ports of call.¹⁶ This order was extended until October 30, 2020, when the CDC replaced its “no-sail” order with a “conditional-sail” order¹⁷ that set forth extensive sanitation, screening, and testing requirements for cruise ship operators before the CDC would permit them to resume sailing. Cruise operators could avoid the requirement to complete a “test sail” without paying passengers by ensuring at least 98 percent of crew and 90 percent of passengers were fully vaccinated (CDC, 2022b).

The CDC did not tether rescission of the March 2020 no-sail order to rescission of the HHS secretary’s PHE declaration, which was first issued on January 31, 2020, and remains in effect as of this writing. In October 2020, however, the agency chose to specify that the conditional-sail order would be automatically rescinded upon “expiration” of the PHE determination (CDC, 2022a). This choice was consistent with the agency’s discretionary reliance on the PHE determination to determine how long its order would meet the statutory standard of “necessity” under Section 361(a).

___________________

¹⁴ CDC, Requirement for Airlines and Operators to Collect and Transmit Designated Information for Passengers and Crew Arriving into the U.S.; Requirement for Passengers to Provide Designated Information (October 25, 2021).

¹⁵ This text was modified after release of the report to the study sponsor to correctly represent isolation orders made by the CDC.

¹⁶ CDC, No Sail Order and Other Measures Related to Operations (March 14, 2020). 85 FR 16628.

¹⁷ CDC, Framework for Conditional Sailing Order (October 30, 2020). 85 FR 70153.

Border Control

On March 20, 2020, the CDC issued an order suspending crossings at U.S. land borders by “persons traveling from Canada or Mexico (regardless of their country of origin) who would otherwise be introduced into a congregate setting in a land Port of Entry (POE) or Border Patrol station.”¹⁸ The order emphasized crowded conditions at immigration processing fa-

___________________

¹⁸ CDC, Order Suspending Introduction of Certain Persons from Countries Where a Communicable Disease Exists (March 20, 2020).

cilities, which are “not equipped to quarantine, isolate, or enable social distancing.”¹⁹ Under the order, which has been periodically renewed by the Trump and Biden administrations and remains in effect as of this writing, U.S. border authorities have relied on what has become known as the “Title 42 process”—named for the title of the U.S. Code where the PHSA is codified—to expel nearly 1.5 million migrants without screening them to determine whether they qualify for asylum (Montoya-Galvez, 2022). Because the CDC lacks implementation capacity, the border crossing order is implemented by CBP pursuant to a request from the CDC director to the Department of Homeland Security (DHS) and at the direction of the president. The order references “public health emergency” conditions generally, but it does not include an automatic rescission provision tethered to rescission of the HHS secretary’s Section 319 determination.

Residential Eviction Moratorium Orders

On September 4, 2020, following initial congressional authority, the CDC issued an order strictly regulating residential evictions for nonpayment of rent.²⁰ The order applied to tenants who met income eligibility criteria and had exhausted available means of obtaining assistance. To establish the nexus with the interstate spread of disease, the order required tenants to provide a declaration under penalty of perjury that they would likely be homeless or forced to move into a congregate or shared living situation if evicted. The order relied on PHSA Section 361(a) (CDC, 2021a; Congressional Research Service, 2021a).

The CDC supported the order with data showing the effect of homelessness on the spread of infectious diseases. Congress first initiated the order under the CARES Act from March 2020 to July 2020. Once expired, the CDC’s eviction moratorium took effect on September 4, 2020, and was extended periodically until June 30, 2021 (Congressional Research Service, 2021a). After the CDC allowed its standing eviction moratorium to lapse and in response to litigation threatening to block the moratorium on the grounds that it exceeded its authority, the CDC issued a new order on August 3, 2021, limited to counties meeting the CDC’s thresholds for substantial or high rates of community transmission.²¹ The eviction mora-

___________________

¹⁹ Id.

²⁰ The initial CDC order was issued shortly after a prior eviction moratorium instituted by Congress under Section 4024 of the CARES Act had expired, but the CDC moratorium was broader than the legislative one, which applied only to tenants receiving federal rental assistance.

²¹ CDC, Temporary Halt in Residential Evictions in Communities with Substantial or High Transmission of COVID-19 To Prevent the Further Spread of COVID-19, 86 Fed. Reg. 43244 (August 6, 2021).

torium orders did not include an automatic rescission provision tethered to rescission of the HHS secretary’s PHE determination. The CDC eviction moratoria went well beyond its previous orders, as it focused on housing and homelessness and was struck down by the U.S. Supreme Court despite previously allowing the moratorium to stand just weeks earlier.²²

Transit Face-Mask Order

Under PHSA Section 361(a), on January 29, 2021, the CDC issued an order requiring workers and passengers to wear face masks on shared conveyances and in transportation hubs. In addition to Section 361, the order referenced the CDC’s regulations relating to carriers.²³ To establish the order’s nexus to interstate and international commerce and travel, the CDC emphasized that “intrastate transmission of the virus has led to—and continues to lead to—interstate and international spread of the virus, particularly on public conveyances and in travel hubs, where passengers who may themselves be traveling only within their state or territory commonly interact with others traveling between states or territories or internationally.”²⁴ The Transportation Security Administration (TSA) issued a security directive to enforce the CDC’s order.

The TSA’s Security Directive was periodically renewed and was set to expire on May 3, 2022. But on April 18, a federal judge in the Middle District of Florida issued a nationwide injunction against enforcement of the transit mask requirement. The TSA immediately stopped enforcement of the order. While the CDC did not indicate it would reinstitute the mask order at the time, it informed the Department of Justice (DOJ) that having the power to order mask use was still “necessary.” At the time of writing, the DOJ had filed an appeal against the judge’s ruling to the U.S. Court of Appeals for the 11th Circuit. The DOJ did not seek an emergency stay of the judge’s nationwide injunction (Gostin and Hosie, 2022).

The CDC’s transit mask order was enforced by the TSA and other federal transit agencies and “may be enforced by cooperating state and local authorities.”²⁵ The CDC does not have authority to direct the TSA to enforce its orders, but the president has the authority to coordinate the actions of federal agencies. President Biden signed an executive order on January 21, 2021, directing the HHS secretary, the TSA, and “any other executive . . . agencies . . . that have relevant regulatory authority” to take action,

___________________

²² 141 S. Ct. 2320 (2021).

²³ 42 CFR §71.31(b) and 71.32(b).

²⁴ CDC, Requirement for Persons to Wear Masks While on Conveyances and at Transportation Hubs, 86 Fed. Reg. 8025 (January 29, 2021).

²⁵ Id.

“to the extent appropriate and consistent with applicable law, to require masks to be worn in compliance with CDC guidelines” in airports and on public transportation.²⁶ The DHS responded by issuing an emergency determination indicating that TSA will support the CDC “in the enforcement of any orders or other requirements necessary to protect the transportation system….”²⁷ The TSA then issued a series of security directives to enforce the CDC’s order.²⁸

The CDC’s transit mask order includes an automatic rescission provision tethered to the HHS secretary’s PHE determination. As for the cruise conditional-sail order, this choice was not mandated by statute, but is consistent with the CDC’s discretionary reliance on a PHE determination in determining how long its order would meet the “necessity” standard under Section 361(a).

Predeparture Testing Requirements for Air Passengers Entering the United States and Vaccination Requirements under Immigration Authorities

On December 25, 2020, the CDC issued an order requiring airlines to ensure that all passengers aged two and older (including U.S. citizens) arriving in the United States from the United Kingdom submit predeparture test results (U.S. Embassy & Consulates in the United Kingdom, 2021). This order was issued in the context of reports that the more transmissible SARS-CoV-2 alpha variant was widely circulating in the United Kingdom. On January 12, 2021, the CDC issued a new order requiring predeparture testing for all airline passengers aged two and older arriving from any foreign country (CDC, 2022c). The later order, which has been periodically renewed and remains in effect as of this writing, allows an exemption for passengers who provide documentation of recent infection. In addition to referring to PHSA Section 361(a), these orders referenced the CDC’s regulations relating to “public health prevention measures, at U.S.²⁹ ports of entry or other locations, through noninvasive procedures . . . to detect the potential presence of communicable disease” and issuance of “controlled free pratique” stipulating conditions for carriers’ entry, disembarkation, or

___________________

²⁶ Executive Order 13998, 86 Fed. Reg. 7205 (January 21, 2021).

²⁷ DHS, Determination of a National Emergency Requiring Actions to Protect the Safety of Americans Using and Employed by the Transportation System (DHS Determination 21-130) (January 27, 2021).

²⁸ TSA, Security Measures—Mask Requirements (TSA Security Directive 1582/84-21-01) (January 31, 2021).

²⁹ 42 CFR §71.20.

operation in certain stipulated conditions.³⁰ These orders also include an automatic rescission provision tethered to the PHE determination.

On October 25, 2021, President Biden issued an order rescinding country-specific prohibitions on entry into the United States and replacing them with a directive that noncitizen nonimmigrants entering the United States by air must provide proof of vaccination for COVID-19.³¹ The presidential order relies on the president’s immigration powers, not the CDC’s powers. Thus, the order does not apply to U.S. citizens.³²

Court Rulings on COVID-19 Relying on Narrow Interpretation of the Public Health Service Act

Recent court rulings have interpreted the PHSA narrowly. In 2021, the Supreme Court and lower federal courts enjoined the CDC’s eviction moratorium order in Alabama Association of Realtors v. Department of Health and Human Services. The same year, a federal district court judge enjoined the CDC’s cruise conditional-sail order and a circuit court panel declined to postpone implementation of the injunction in Florida v. Becerra. Also in 2021, a federal district court judge enjoined the CDC’s border control order, but a circuit court panel postponed implementation of the injunction in Huisha-Huisha v. Mayorkas. Additionally, a suit challenging the CDC’s transit mask order is pending in federal district court.

Enjoinment of the CDC’s Eviction Moratorium Order

In Alabama Association of Realtors v. Department of Health and Human Services, the U.S. Supreme Court enjoined the CDC’s eviction moratorium order, holding that the plaintiffs were substantially likely to succeed on their claim that the order exceeded the CDC’s statutory authority. The Supreme Court’s ruling followed a series of lower court rulings, in which most courts determined that the CDC had exceeded its statutory authority.³³ The Supreme Court majority based its decision on statutory

___________________

³⁰ 42 CFR §71.31(b).

³¹ Proclamation 10294, Advancing the Safe Resumption of Global Travel During the COVID-19 Pandemic, 86 Fed. Reg. 206 (Oct. 25, 2021).

³² This paragraph was modified after release of the report to the study sponsor to clarify the type of entrant and mode of travel covered by this presidential order.

³³ See, e.g., Tiger Lily, LLC v. Dep’t of Housing & Urban Dev., 5 F.4th 666 (6th Cir. 2021) (holding eviction order exceeded CDC’s statutory authority); Terkel v. Ctrs. for Disease Control & Prevention, 521 F. Supp. 3d 662 (E.D. Tex. 2021) (accord); Skyworks, Ltd. v. Ctrs. for Disease Control & Prevention, 524 F.Supp.3d 745 (N.D. Ohio 2021) (accord); but see Chambliss Enterprises v. Redfield, 508 F.Supp.3d 101 (W.D. La. 2020) (holding CDC’s eviction order did not exceed its statutory authority).

interpretation alone, without resorting to constitutional arguments that would constrain Congress’s ability to empower the CDC to regulate residential evictions in more specific terms. The Court reasoned that the second sentence of Section 361(a), which lists specific examples of how the CDC may use its power, “informs the grant of authority” in the first sentence.³⁴ The Court described the examples listed in the second sentence as measures that “directly relate to preventing the interstate spread of disease by identifying, isolating, and destroying the disease itself.”³⁵ In contrast, the court determined the eviction moratorium “relates to interstate infection far more indirectly: If evictions occur, some subset of tenants might move from one State to another, and some subset of that group might do so while infected with COVID–19.”³⁶ Thus, the court concluded the CDC order should be enjoined pending appeal because “reading both sentences together, rather than the first in isolation, it is a stretch to maintain that §361(a) gives the CDC the authority to impose this eviction moratorium.”³⁷

Enjoinment of the CDC’s Cruise Conditional-Sail Order

In Florida v. Becerra, a federal district court judge granted Florida’s request for a preliminary injunction blocking the CDC from enforcing its cruise ship conditional-sail order.³⁸ The judge held that the state was likely to succeed on the merits of its claims because—among other arguments discussed in the following—the order exceeded the CDC’s authority. The Eleventh Circuit initially stayed the district court’s order, postponing implementation of the injunction and permitting the CDC to enforce the cruise ship order while litigation continued. A week later, shortly after Florida filed a petition asking the Supreme Court to intervene in the case, the Eleventh Circuit reversed this ruling, effectively blocking CDC enforcement. Thus far, the Eleventh Circuit’s decision appears to have dissuaded the Supreme Court from intervening in the litigation (which continues).

The district court’s opinion determined that the second sentence of Section 361(a) (listing specific examples) “operates to limit CDC’s enforcement and implementation authority to only those actions resembling ‘inspection, fumigation, disinfection, ... [and] pest extermination.’”³⁹ The court described the cruise ship orders as “halting commerce by a fifteen-month closure of one or more industries” and determined that action was not “similar in scope and character the measures contemplated and autho-

___________________

³⁴ Ala. Ass’n of Realtors, 141 S.Ct. at 2488.

³⁵ Id. (emphasis added).

³⁶ Id.

³⁷ Id.

³⁸Florida v. Becerra, 544 F.Supp.3d 1241 (M.D. Fla. 2021).

³⁹ Id. at 1268.

rized by Congress when enacting the statute.”⁴⁰ In dicta, the judge opined that “halting other public movement and activity nationwide” would also exceed the CDC’s authority.⁴¹ To support his reading, the judge reasoned that prior to the COVID-19 pandemic, federal health officials had deployed measures that “resemble” the examples specifically enumerated in Section 361(a) but had not done anything resembling “the conditional sailing order’s mandates.”⁴²

Enjoinment of the CDC’s Border-Control Order

In Huisha-Huisha v. Mayorkas, a federal district court judge granted the plaintiff class’s request for a preliminary injunction blocking the administration from relying on the CDC’s Section 362 authority to expel migrants. The judge reasoned that Section 362, which allows the CDC to suspend introduction of persons into the United States “simply contains no mention of the word “expel”—or any synonyms thereof—within its text.” Consistent with what the Supreme Court has called the “major questions doctrine,” the judge reasoned that courts “expect Congress to speak clearly if it wishes to assign to an agency decisions of vast ‘economic and political significance,’”⁴³ the judge ruled that the CDC had exceeded its authority. A three-judge panel of the DC Circuit granted the Biden administration’s request to stay the district court’s injunction while their appeal is pending.⁴⁴ As of this writing, the appeal is under review and the administration continues to enforce the order.

Pending Suit Challenging the CDC’s Transit Mask Order

The CDC’s transit mask order has also been challenged in lawsuits filed in 2021 by private parties in the Middle District of Florida⁴⁵ and a new suit filed in February 2022 by the state of Texas (joined by a private plaintiff) in the Eastern District of Texas.⁴⁶ The judges assigned to hear these cases

___________________

⁴⁰ Id.

⁴¹ Id.

⁴² Id. at 1269.

⁴³Huisha-Huisha v. Mayorkas, __F.Supp.3d.__, 2021 WL 4206688, *11 (D.D.C. 2021).

⁴⁴Huisha-Huisha v. Mayorkas, Civ. No. 1:21-cv-00100-EGS (D.C. Cir., September 30, 2021) (granting motion for a stay pending appeal).

⁴⁵Health Freedom Def. Fund v. Biden, Civ No. 8:21-cv-1693-KKM-AEP (M.D. Fla., November 19, 2021) (denying defendant’s motion to transfer action to another judge hearing a similar challenge); Wall v. Ctrs. for Disease Control, Case No: 6:21-cv-975-PGB-DCI (M.D. Fla, December 18, 2021) (dismissing claims on procedural grounds without prejudice and thus allowing the plaintiff to refile in the future).

⁴⁶Van Duyne v. Ctrs. for Disease Control, Case No. 4:22-cv-00122-O (N.D. Tex.) (complaint filed February 16, 2022).

have not yet opined on the merits of the plaintiffs’ challenges, but the order could be vulnerable under a narrow reading of Section 361(a) given that the statute does not specifically endorse orders mandating the use of PPE. Alternatively, the judges could find that the transit mask order “directly relate[s] to preventing the interstate spread of disease by . . . isolating . . . the disease itself” (the Supreme Court’s formulation in Alabama Association of Realtors) and thus is similar enough to the examples specified in Section 361(a) to fall within the CDC’s authority.

Taking all these, and other, cases as a whole, it is apparent to the committee that the CDC interventions to stem the introduction to or spread of disease within the United States have often been delayed or blocked by the courts. This underscores the need for legislative and regulatory reform to ensure the CDC can exercise needed authority to protect the American population.

MODERNIZING THE CDC’S PANDEMIC PREVENTION AND RESPONSE AUTHORITY

The committee concludes that reforms are needed to modernize the CDC’S pandemic prevention and response powers and to provide appropriate substantive and procedural safeguards of individual liberties. In the wake of recent court decisions, there is considerable uncertainty about the extent of the CDC’s power to implement measures that are not specifically listed as examples in the PHSA. Uncertainty about the scope of the CDC’s authority is particularly concerning given the limitations of other government actors. It is also concerning because the CDC must be able to act decisively and lawfully in a public health crisis.

State, tribal, local, and territorial (STLT) entities lack comprehensive authority over international and interstate commerce and travel. Congress lacks capacity for the swift responses and nimble adjustments required to prevent or manage a pandemic. The courts could interpret the Supreme Court’s opinion in Alabama Association of Realtors to permit the CDC to require face coverings, proof of a negative test, self-quarantine on arrival, or proof of vaccination on interstate conveyances and in transit hubs. However, additional clarification from the courts may not be forthcoming.

Harmonization of STLT efforts is necessary for best use of regulatory authority and infectious disease mitigation. As highlighted in the “Improving Coordination and Collaboration to Enhance Disease Control” chapter conclusions, including federal interagency partners and interstate relationships in coordination efforts could provide the CDC with greater opportunities to best support state jurisdictions effectively.

To mitigate the chilling effect of uncertainty and incorporate lessons learned from the COVID-19 pandemic, the committee recommends that

Congress modernize the CDC’s pandemic prevention and response powers. In addition, regardless of whether Congress amends Section 361, we recommend that the CDC initiate rulemaking to clarify its interpretation of the broadly delineated “necessary measures” provision and adopt procedural requirements and substantive standards to govern the use of its powers. Our recommended reforms will need to be consistent with constitutional limits and must ensure the CDC’s powers are comprehensive, effective, flexible, and exercised in ways that are consistent with principles of good governance and equity.

Constitutional and Statutory Limits on Expansion of the CDC’s Authority

Reforms to modernize the PHSA must be consistent with constitutional and statutory limits on expansion of the CDC’s authority, namely: federalism limits, separation of powers and administrative law limits, and protections for individual rights. The balance the committee is seeking is to ensure prompt exercise of all powers needed to protect the public from the introduction or spread of infectious diseases, while ensuring that the CDC acts according to the available scientific evidence and consistent with the protection of individual rights. The committee also wishes to ensure that CDC powers are exercised fairly and equitably.

Federalism Limits

The powers that Congress delegates to the CDC must fall within the limited federal powers enumerated in the Constitution, including the power to regulate interstate commerce and travel, the power to attach conditions to federal spending, and various foreign policy powers, including treaties. If the spread of a communicable disease is confined to a single state—and likely to remain so—then the federal government’s regulatory power is far more limited. Federal influence can be expanded by constitutionally conditioning acceptance of federal funds on adoption of specific public health measures. However, spending conditions would not readily enable the flexible powers the CDC needs for pandemic prevention and response.

Separation of Powers and Administrative Law Limits

Some lower federal courts have gone further than the Supreme Court majority by basing their decisions enjoining the CDC’s orders on constitutional constraints that limit Congress’s ability to delegate authority to the CDC in broadly delineated terms. For example, in Tiger Lily, LLC, the Sixth Circuit reasoned that the CDC’s broad interpretation of Sec-

tion 361(a) should be rejected under the major questions doctrine, which holds that “Congress must ‘enact exceedingly clear language if it wishes to significantly alter the balance between federal and state power and the power of the Government over private property.’”⁴⁷ In addition, the Sixth Circuit suggested the CDC’s broad interpretation of Section 361(a)’s “other measures” language “could raise a nondelegation problem (Congressional Research Service, 2021b)” The nondelegation doctrine holds that Congress is constitutionally prohibited from delegating authority to the executive branch in “open-ended” terms that do not provide sufficient standards to limit agency discretion over policy choices. The Sixth Circuit explicitly rejected the CDC’s argument that public health necessity provided a sufficient standard to guide the agency’s exercise of discretion. Similarly, in Florida v. Becerra, the federal district court judge reasoned that if Congress had intended to give the CDC such broad authority under Section 361(a), it would amount to an unconstitutional delegation of legislative power. This reasoning informed his narrow interpretation of the statute’s language, based on the principle that judges should endeavor to construe statutes in ways that avoid rendering them unconstitutional.

The doctrines endorsed by some lower court judges in the eviction moratorium and cruise conditional-sail cases are highly controversial. Legal scholars have pointed out that they have not yet won the support of a majority of the Supreme Court, but that could change in the near future. Such a change “would mark a radical break with constitutional practice and could entail the wholesale repudiation of modern American governance” (Mortenson and Bagley, 2021, p.278). It would have particularly devastating consequences for pandemic prevention and response capabilities, given how legislatures have traditionally relied on broadly delineated delegations of authority to health agencies to control communicable diseases using measures consistent with public health necessity.

Reforms should also require the CDC to follow appropriate procedures to ensure its orders are promulgated transparently and through processes that foster the public’s trust and cooperation. The Administrative Procedure Act (APA), Congressional Review Act (CRA), and other statutes set forth procedures that agencies must follow when they issue rules. In Florida v. Becerra, the federal district court judge determined that CDC’s cruise conditional-sail order was a “rule” within the meaning of the APA and, therefore, the state was likely to succeed on its claim that the CDC had failed to follow required notice and comment procedures. The Government Accountability Office (GAO) has opined that the CDC’s transit mask order is a “rule” for the purposes of the CRA and that the CDC violated the CRA

___________________

⁴⁷ Quotation from another decision. U.S. Forest Serv. v. Cowpasture River Pres. Ass’n, 140 S. Ct. 1837, 1849–1850 (2020).

by failing to submit it for congressional review.⁴⁸ Similar claims have been raised against the CDC’s other orders, but the Supreme Court has not yet reached these questions.

The procedures that govern the CDC’s exercise of its authority under Section 361(a) and Section 362 are not detailed in the statute or accompanying regulations. In some of its COVID-19 orders, the CDC asserted that the order was not a “rule” subject to the APA’s notice and comment requirements, and, in the alternative, if it were a rule, then the APA’s “good cause” exception applied.⁴⁹ But lower court decisions indicate that in the future, the CDC may need to engage in more formal procedures. New legislation or CDC rulemaking should set forth these procedures more clearly.

Protections for Individual Rights

It will be critical that the CDC’s actions respect constitutional and statutory protections for individual rights. To date, the CDC’s COVID-19 orders have not been successfully challenged on these grounds. Were the CDC to limit gatherings or restrict gathering places, businesses, or travel in the future, court decisions reviewing state and local COVID-19 orders would provide useful guidance. The First Amendment’s Free Exercise and Establishment Clauses and the federal and state Religious Freedom Restoration Acts protect religious liberty. Under the new Supreme Court majority’s emerging jurisprudence, if a CDC order includes any secular exemption, the lack of a religious exemption on equal or better terms may trigger strict scrutiny by the courts.⁵⁰ First Amendment protections for freedom of expression and assembly may limit the extent to which gathering limits restrict political events or protests.⁵¹ The Second Amendment’s protection for the

___________________

⁴⁸ GAO, Centers for Disease Control & Prevention—Applicability of Congressional Review Act to Requirement for Persons to Wear Masks While on Conveyances and at Transportation Hubs (December 14, 2021).

⁴⁹ 5 U.S.C. §553(b)(3)(B).

⁵⁰ See, e.g., Tandon v. Newsom, 141 S.Ct. 1294 (2021) (barring California officials from enforcing generally applicable gathering restrictions against religious gatherings, including in private homes); but see Does 1-3 v. Mills, 142 S.Ct.17 (2021) (denying an application for injunctive relief and thus allowing Maine officials to implement a vaccination requirement for health care workers that allowed medical exemptions, but not religious exemptions).

⁵¹ The lower courts have applied more deferential (rational basis) review to restrictions on social gatherings compared to the heightened or strict scrutiny some have applied to restrictions on gatherings for religious or political purposes. See Henry v. DeSantis, 461 F.Supp.3d 1244, 1254 (S.D. Fla. 2020) (denying a request for preliminary injunction for a plaintiff who did not have any specific plans to engage in political protests after finding no “generalized right of social association under the First Amendment’s freedom of association”).

right to bear arms may constrain restrictions that affect firearm purchases.⁵² The extent to which the Constitution protects freedom of movement and travel during PHEs is uncertain. At least one lower court closely scrutinized a state order requiring interstate travelers to self-quarantine, but found the requirement satisfied the strict scrutiny standard because a less restrictive alternative was not reasonably available at the time.⁵³ Privacy protections apply to the CDC’s collection, storage, and use of personal health information. The Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule does not govern the CDC’s actions, and exceptions to the Privacy Rule allow covered entities to share protected health information with the CDC or other federal or STLT public health authorities.⁵⁴ The CDC is governed by the Privacy Act of 1974⁵⁵ and the Confidential Information Protection and Statistical Efficiency Act of 2002,⁵⁶ which establish data security and confidentiality requirements for personally identifiable information collected and stored by federal agencies.

Clarifying the Scope and Limits of the CDC’s Authority

We recommend that Congress modernize the PHSA to clarify the scope and limits of the CDC’s authority when narrowly targeted containment measures fail. To fill gaps in STLT powers and ensure capacity for a nationally coordinated response to prevent and mitigate future pandemics, we recommend that Congress amend the PHSA to specify that the “necessary measures” authorized in Section 361(a) may include regulation of international and interstate travel, requirements to wear face coverings or other PPE, restrictions on mass gatherings, occupancy limits or sanitation requirements for gathering places, protections to support compliance with public

___________________

⁵² See, e.g., McDougall v. County of Ventura, Civ. No. 20-56220 (9th Cir. January 20, 2022) (holding that COVID-19 orders closing gun shops failed strict scrutiny and, in the alternative, failed intermediate scrutiny); but see Dark Storm Industries LLC v. Cuomo, 471 F.Supp.3d 482 (N.D.N.Y 2020) (granting summary judgment against plaintiffs after applying intermediate scrutiny to their claim alleging governor’s order closing gun shops violated their Second Amendment rights) (judgment vacated and appeal dismissed as moot on October 5, 2021).

⁵³Bayley’s Campground, Inc. v. Mills, 958 F.3d 153 (2021) (assuming, without deciding, that strict scrutiny was the proper standard for reviewing Maine’s executive order requiring interstate travelers to self-quarantine on arrival and prohibiting them from doing so in temporary lodgings within the state, but finding strict scrutiny was probably satisfied because no less restrictive alternative was reasonably available at a time when COVID-19 testing was not readily accessible). Other courts applying more deferential standards to self-quarantine requirements for interstate travelers relied on an interpretation of Jacobson v. Massachusetts that the Supreme Court has indicated it disfavors.

⁵⁴ 45 CFR §164.512(b).

⁵⁵ 5 U.S.C. §552a.

⁵⁶ 44 U.S.C. §3501 et seq.

health guidance, as well as other necessary powers. As for the measures specified in Section 361(a)–(d), use of these powers would be contingent on a finding by the CDC director that they “are necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the States or possessions, or from one State or possession into any other State or possession.”⁵⁷ The COVID-19 pandemic has revealed how a coordinated, evidence-based national strategy is needed to prevent and control dangerous infectious disease outbreaks. The CDC ought to have ample powers to do that, consistent with the federal government’s constitutional obligations to prevent hazards in interstate or international commerce and act expressly in the interests of national security.

It is also important to ensure that the CDC does not overreach or exceed its legitimate regulatory authority. PHSA amendments will need to specify the conditions that must be met before the CDC may use its Section 361(a) powers to mandate protections that apply to the general public regardless of known or suspected infection or exposure. A particularly apt guardrail that the CDC voluntarily adopted for some, but not all, of its COVID-19 orders was an automatic rescission provision tethering the continued necessity of the CDC’s order under Section 361(a) to the termination of the HHS secretary’s PHE determination under Section 319. The current text of the PHSA does not condition any of the CDC’s powers on the existence of a PHE. Some uses of Section 361(a) powers—such as the CDC’s isolation of an individual traveler reasonably believed to be infected with extensively drug-resistant tuberculosis or the Food and Drug Administration’s (FDA) prohibition on the sale of pet turtles that may carry salmonella⁵⁸—should not be conditioned on a PHE. But intrusive or disruptive measures applied to the general public in the absence of individualized risk assessments to determine known or suspected infection or exposure should be contingent on the HHS secretary’s PHE determination and additional criteria by which the HHS secretary may determine that more narrowly targeted interventions are insufficient to prevent the interstate spread of disease.

We recommend that Congress amend the PHSA to add a new subsection. The new subsection would parallel Sections 361(b)–(d), which set forth the conditions under which Section 361(a) powers may be used to apprehend, detain, or conditionally release individuals. Drawing on language used in other subsections, our proposed new Section 361(f) would be as follows:

___________________

⁵⁷ 42 U.S. Code §264.

⁵⁸Independent Turtle Farmers of Louisiana, Inc. v. U.S., 703 F.Supp.2d 604 (W.D. La. 2010) (upholding an FDA ban on sale of small turtles under Section 361). Like the CDC, the FDA has powers under Section 361(a) thanks to a delegation of authority from the HHS secretary.

This language would provide the specificity some federal judges require while also imposing appropriate limits that are not currently mandated by statute. Key terms (e.g. “gatherings” and “gathering places”) would be left for the CDC to define via rulemaking.

We recommend that Congress preserve the language in Section 361(a) authorizing “other measures” officials deem necessary. A future threat could pose unforeseen dangers or require measures that lawmakers cannot anticipate in specific terms. In such a scenario, the courts may be more forgiving of the CDC’s use of broadly delineated powers than they have been during the COVID-19 pandemic. One approach would be to amend Section 361(e) to add a savings clause expressly stating: “Regulations prescribed under this section shall not preempt state and local regulations that are more protective of public health.”

We recommend that the CDC’s exercise of Section 361 powers establish a federal floor of public health protection without preempting state and local governments from adopting evidence-based additional layers of protection. Were the issue to be litigated—and to date it has not been—courts may interpret the current language in Section 361(e) to spare more stringent state and local laws from federal preemption. However, Congress could speak even more clearly on this issue to prevent federal officials

from using Section 361 powers to prohibit state and local public health protections.

For some measures adopted in some settings, federal resources for implementation and enforcement are likely to be inadequate—even when the president directs other federal agencies to assist. But a CDC order that creates a floor of protections by preempting conflicting state laws could empower local governments to implement and enforce public health protections using their own resources, without interference from state governments who oppose them.

Rulemaking to Clarify the Scope and Limits of the CDC’s Powers Under Section 361(a)

We recommend that the CDC initiate rulemaking to clarify the scope and limits of its powers under Section 361(a). Whether or not Congress amends Section 361, the CDC should adopt definitions, procedural requirements, and substantive standards to govern orders that are not based on known or suspected infection or exposure of specific individuals. In a multiyear process completed in 2017, the CDC modernized its regulations for interstate and international quarantine and isolation of individuals. The 2017 rules adopt significant protections to ensure the CDC’s quarantine, isolation, and conditional release orders are consistent with the best available scientific evidence and constitutional protections. But these reforms failed to address the scope and limits of the CDC’s authority to mitigate widespread community transmission when targeted containment efforts fail.

New regulations applicable to the CDC’s use of its powers under the “necessary measures” provision in Section 361(a) would guide officials when they exercise discretion under existing (or newly amended) statutory authorities. However, such regulatory reforms may not overcome narrow statutory interpretations by the federal courts.

SURGE FUNDING FOR OUTBREAK RESPONSE

Challenges in Obtaining Timely Surge Funding

Historically, funding for large-scale public health emergencies has primarily relied on redirecting (i.e., reprogramming) appropriated funds from other day-to-day mission requirements, generally from HHS annual budgets (Alton and Carlin, 2020). During certain infectious disease outbreaks—such as the H1N1 influenza pandemic (2009), the Ebola virus disease epidemic (2014–2016), the Zika virus disease outbreak (2015–2016), and the COVID-19 pandemic—Congress passed supplemental appropriations to fund response activities. However, the surge funding often came late, and these congressional actions were often politically controversial.

The Public Health Emergency Fund (PHEF),⁵⁹ established in 1983, is available to the secretary of HHS without fiscal year limitation to take appropriate action in response to a public health emergency.⁶⁰ Apart from special congressional appropriations from the PHEF during a PHE,⁶¹ reserve funds for outbreak response primarily come from HHS and its various operating divisions (Alton and Carlin, 2020). In responding to the 2009 H1N1 influenza pandemic, multiple HHS programs “assessed” funds to be reprogrammed, as allowed by statute, to cover costs for development and production of the vaccine. This maneuver adversely impacted multiple programs for many years. For instance, the Strategic National Stockpile⁶² (SNS) had programmed funds to obligate to a vaccine contract to the Chemical, Biological, Radiological and Nuclear Office (CBRN) that were lost to funding for the H1N1 event and never replaced (Congressional Research Service, 2009; Simon and Evstatieva, 2020). This initiated a shortfall in medical countermeasures for CBRN events that continues today (Burel, 2020). Similarly, in an effort to respond to the Zika crisis (2015–2016), the CDC had to move funds from critical programs to cover costs that were immediately required (Boddie, 2015; DeLauro, n.d.). During the Ebola epidemic (2014–2016), the SNS had to move money planned for purchasing medical countermeasures for CBRN emergency response, resulting in shortfalls in other critical material needs (Boddie, 2015; DeLauro, n.d.).

___________________

⁵⁹ “There is established in the Treasury a fund to be designated as the “Public Health Emergency Fund” to be made available to the secretary without fiscal year limitation to carry out subsection (a) only if a public health emergency has been declared by the secretary under such subsection or if the secretary determines there is the significant potential for a public health emergency, to allow the secretary to rapidly respond to the immediate needs resulting from such public health emergency or potential public health emergency. The secretary shall plan for the expedited distribution of funds to appropriate agencies and entities. There is authorized to be appropriated to the Fund such sums as may be necessary . . .” Public Health Emergencies, 42 U.S. Code §247d. (1983).

⁶⁰ See Pub. L. No. 98-49, 97 Stat. 245 (1983).

⁶¹ “If the secretary determines, after consultation with such public health officials as may be necessary, that—(1) a disease or disorder presents a public health emergency; or (2) a public health emergency, including significant outbreaks of infectious diseases or bioterrorist attacks, otherwise exists, the secretary may take such action as may be appropriate to respond to the public health emergency, including making grants, providing awards for expenses, and entering into contracts and conducting and supporting investigations into the cause, treatment, or prevention of a disease or disorder . . .” Public Health Emergencies, 42 U.S. Code §247d. (1983) (Source: https://www.law.cornell.edu/uscode/text/42/247d; accessed March 4, 2022).

⁶² The Strategic National Stockpile, within the Office of the Assistant Secretary for Preparedness and Response, is “part of the federal medical response infrastructure and can supplement medical countermeasures needed by states, tribal nations, territories and the largest metropolitan areas during public health emergencies.” More information is available from https://www.phe.gov/about/sns/Pages/default.aspx (accessed March 4, 2022).

The mere existence of federal mechanisms to mobilize assistance to state and local governments does not guarantee adequate and timely funding during an outbreak (Katz et al., 2017). For instance, political contentions can delay passage of emergency appropriations legislation acceptable to both Congress and the White House. Likewise, Congress took a full year to authorize President Obama’s emergency funding request for the Zika response (Gostin, 2018). Funding for the Ebola response was delayed for months (NACCHO, 2017). Congress did not appropriate funding for the Ebola response until December 2014, even though the federal, state, and local public health response had been ongoing since summer 2014 and the first case in the United States was confirmed that September.

These challenges underscore the extent to which the current method of emergency response funding from committed appropriations is neither suitable nor sufficient. Reliance on supplemental appropriations for every discrete response raises the possibilities that Congress (1) may choose not to approve funds (DeBonis, 2021), (2) will approve inadequate funds (O’Toole, 2007), (3) will direct funding in particular directions which do not align with public health priorities, and (4) will act too slowly to contain contagious disease (DeLauro, n.d.).

Ways to Streamline Mechanisms for Surge Funding

The Committee considered a range of opportunities to streamline and expedite surge funding mechanisms by mitigating the challenges inherent in the current structure. Proposed alternatives include:

• Establishing a new public health emergency contingency fund that can be triggered under certain criteria during a public health emergency,
• Establishing a fund similar to the HHS’s Federal Emergency Management Agency’s (FEMA) Disaster Relief Fund (DRF) (FEMA, 2013), or
• Appropriating funds to the existing enacted Public Health Emergency Fund that has not received appropriations since FY1999, with the account maintaining a zero balance since 2012 (Katz et al., 2017), and
• Appropriating funds to the proposed Infectious Disease Rapid Response Reserve Fund⁶³ (Alton and Carlin, 2020).

___________________

⁶³ “There is established in the Treasury a reserve fund to be known as the “Infectious Diseases Rapid Response Reserve Fund” (the “Reserve Fund”): Provided, That of the funds provided under the heading “CDC-Wide Activities and Program Support” [132 Stat. 3073], $50,000,000, to remain available until expended, shall be available to the Director of the CDC for deposit in the Reserve Fund” (Infectious Diseases Rapid Response Reserve Fund, 42 U.S. Code §247d-4a, 2018).

The Committee’s recommended solution is to appropriate funds to the PHEF to be controlled by the secretary of HHS and used subsequent to a declared PHE. This would serve to prevent reliance on supplemental appropriations and congressional approval of funds (DeLauro, n.d.). This solution would also place a cabinet-level official responsible to reporting to Congress that criteria for release of funds have been met, similar to the Stafford Act.⁶⁴ Importantly, these funds would “supplement, but do not supplant, other federal, state, and local funds provided for public health grants, awards, contracts, and investigations” (ASPR, 2019) upon declaration of a public health emergency. In an effort to replenish the Public Health Emergency Fund, the Public Health Emergency Response and Accountability Act was introduced in July 2021.⁶⁵ The bill also exempts the Public Health Emergency Fund from sequestration, which is a process of automatic, usually across-the-board spending reductions under which budgetary resources are permanently canceled to enforce specific budget policy goals (H.R.5723—116th Congress [2019–2020]: Public health emergency fund act, 2020).

This solution offers several advantages. It utilizes established legislative authority without the need for an additional fund or the need for additional wholly new legislative authority. Adding another new fund may prove confusing to the Congress and difficult for HHS and Office of Management and Budget (OMB) to determine the appropriate target for funds and use for a response. The solution also establishes a ready reserve of funds in the PHEF without fiscal year limitation, thus would not require additional congressional action during an immediate response. Because the fund provides “no-year money that can be carried over if it is not needed right away, it obviates the need for future emergency supplementals” (Alton and Carlin, 2020). Immediately upon declaration of a PHE, it would allow the DGMQ among other HHS operational divisions and their sub-elements to access those funds for testing equipment, other materials, facilities, contract staff support, and quarantine facilities. Moreover, a surge capability could be added to existing legislated authorities that would allow a limited use of these funds prior to a full PHE declaration, much like FEMA’s Disaster Relief Fund that can be used prior to a hurricane land fall. The Post-Katrina Emergency Response Act (PKEMRA) could be used as model.⁶⁶ This could

___________________

⁶⁴ The Robert T. Stafford Disaster Relief and Emergency Assistance Act, PL 100-707, was signed into law November 23, 1988, and amended the Disaster Relief Act of 1974, PL 93-288. The Stafford Act constitutes the statutory authority for most federal disaster response activities, especially as they pertain to FEMA and FEMA programs.

⁶⁵https://www.congress.gov/bill/117th-congress/senate-bill/2467/text?r=53&s=1 (accessed March 4, 2022).

⁶⁶ More information about the Post-Katrina Emergency Response Act is available from https://emilms.fema.gov/is_0822/groups/20.html (accessed March 4, 2022).

be of particular importance for the DGMQ, because border measures must be used very early in an outbreak if they are to have any value in mitigating the spread. The Fund⁶⁷ may also be used to facilitate cross-sectorial coordination (Alton and Carlin, 2020). Furthermore, this solution would likely garner public support. A 2016 survey by the Annenberg Public Policy Center shows that 63 percent of people said they support having a fund that the president can draw on to deal with an epidemic without having to ask Congress (Annenberg Public Policy Center, 2016; Kodjak, 2016).

This recommended solution does have potential drawbacks, however. It might easily be ignored by appropriators until a need actually exists, although this might be mitigated by a mandatory appropriation to start to replenish funds as they are used. Additionally, it could detract from congressional appropriation of additional supplemental funds, if the balance is determined at the outset of the response to be sufficient. Congress might also insist on depletion of funds prior to supplemental appropriation. Another disadvantage is its potential to limit the discretion of Congress to further specifically direct appropriations to the fund according to congressional-response priorities, rather than the executive-branch response priorities—although this might be an advantage from the perspective of the executive branch. Importantly, this solution would require the establishment of guard rails and clear congressional reporting. Furthermore, the PHEF does not have a strong existing track record to draw on. HHS officials reported that the Public Health Emergency Fund was last used in 1993, in response to a Hantavirus outbreak in the Southwest United States (GAO, 2018). Since its inception, Congress has only allocated funds to the PHEF on two occasions, first in 1987 and the most recent allocation being in FY1999 (DeLauro, n.d.; NACCHO, 2017). Due to congressional reticence to appropriate to the PHEF, it now sits nearly empty (DeLauro, n.d.). The availability of a standing contingency fund for public health emergencies through legislative reform could be key for a rapid and effective response to infectious disease threats. This notion is further discussed in the “Changes in the DGMQ’s Organizational Capacity and Infrastructure” chapter, which details the current DGMQ budget and spending in addition to the emphasis on the urgent need for a sustainable and proactive emergency funding system.

Possible Fund Allocation Criteria and Response/Reporting Requirements

The Committee identified a set of possible criteria for fund allocation:

• When a public health emergency declaration has been made;
• When state or Indian Tribal Government resources are over-

___________________

⁶⁷ 42 U.S. Code §247d—Public health emergencies.

• whelmed, similar to requests for support made through FEMA regional offices.⁶⁸ Such requests might require (1) confirmation that appropriate action has been taken by local emergency response authorities, (2) a description of efforts and resources utilized to alleviate the emergency, and (3) a description of the type and extent of additional federal assistance required;
• When positivity rates reach an established threshold, which would require the development of escalation criteria based on Laboratory Response Network detection⁶⁹ (Katz et al., 2017);
• When the number of refugee arrivals exceeds initial planning figures (CERF, 2017);
• When evidence of a new outbreak at a large scale requires international assistance (CERF, 2017).

The committee also identified a set of reporting and accountability requirements. In addition to normal Public Health Emergency reporting requirements the secretary of HHS must report to Congress: (1) an explanation of why currently nonemergency appropriated funds are insufficient for the response; (2) a description of the activities that will be funded; (3) a preliminary estimate of the amount of funding that will be required for the response; and (4) a description of the STLT or Indian tribal government resources that will also be used to mitigate the public health emergency.

The purpose of specifying criteria and requiring reporting and accountability mechanisms is to ensure that HHS, and its subsidiary the CDC, uses surge funding in an appropriate and effective way, and does not simply use emergency funding for day-to-day operations.

CONCLUSIONS AND RECOMMENDATIONS

Conclusions

By constitutional design, the United States has several levels of government, including federal, state, tribal, territorial, and local. Executive and legislative branches at each level of federal, state, territorial, and tribal governments hold overlapping powers to prevent and manage communicable disease outbreaks, epidemics, and pandemics.

___________________

⁶⁸ More information about FEMA’s role in this regard is available from https://www.fema.gov/disaster/how-declared (accessed March 4, 2022).

⁶⁹ The Laboratory Response Network is “ . . . an integrated network of state and local public health, federal, and military laboratories [that]provides diagnostic capacity to detect biological events and other PHEs across the United States. These networks allow rapid detection and reporting of events at the state and federal levels for decision-making” (Katz et al., 2017).

Recommendations

REFERENCES

CDC. 2021b. Division of Global Migration and Quarantine laws and regulations. Division of Global Migration and Quarantine. https://www.cdc.gov/ncezid/dgmq/laws-and-regulations.html (accessed May 22, 2022).

CDC. 2021c. Legal authorities for isolation and quarantine. https://www.cdc.gov/quarantine/aboutlawsregulationsquarantineisolation.html (accessed March 2, 2022).

CDC. 2022a. CDC COVID-19 orders for cruise ships. https://www.cdc.gov/quarantine/cruise/COVID19-cruiseships.html (accessed March 15, 2022).

CDC. 2022b. Operations manual for CDC’s COVID-19 program for cruise ships operating in U.S. waters. https://www.cdc.gov/quarantine/cruise/COVID19-operations-manual-cso.html (accessed May 22, 2022).

CDC. 2022c. Requirement for proof of negative COVID-19 test or documentation of recovery from COVID-19. https://www.cdc.gov/coronavirus/2019-ncov/travelers/testing-international-air-travelers.html#:~:text=Yes%2C%20at%20this%20time%20all,documentation%20of%20recovery%20unless%20exempted (accessed May 22, 2022).

CERF (Central Emergency Response Fund). 2017. CERF rapid response: Overview of methodology. https://cerf.un.org/sites/default/files/resources/cerf_ag_rapid_response_en.pdf (accessed May 22, 2022).

Congressional Research Service. 2009. The 2009 influenza pandemic: An overview. https://crsreports.congress.gov/product/pdf/R/R40554 (accessed May 22, 2022).

Congressional Research Service. 2021a. Federal eviction moratoriums in response to the COVID-19 pandemic.

Congressional Research Service. 2021b. Scope of CDC authority under Section 361 of the Public Health Service Act (PHSA). https://crsreports.congress.gov/product/pdf/R/R46758 (accessed May 22, 2022).

DeBonis, M. 2021. After Kentucky devastation, critics seize on Rand Paul’s record opposing disaster bills. The Washington Post, December 14.

DeLauro, R. n.d.. Why we need a public health emergency fund. https://delauro.house.gov/public-health-emergency-fund (accessed March 20, 2022).

FEMA (Federal Emergency Management Agency). 2013. Disaster relief fund: Appropriation overview. https://www.fema.gov/pdf/about/budget/11f_fema_disaster_relief_fund_dhs_fy13_cj.pdf (accessed May 20, 2022).

GAO (General Accounting Office). 2018. Opioid crisis: Status of public health emergency authorities. https://www.gao.gov/products/gao-18-685r (accessed May 15, 2022).

Gostin, L. O. 2018. Public health emergency preparedness: Globalizing risk, localizing threats. JAMA 320(17):1743-1744.

Gostin, L. O. 2021. Global health security: A blueprint for the future. Cambridge, MA: Harvard University Press.

Gostin, L. O., and J. G. Hodge. 2017. Reforming federal public health powers. JAMA 317(12):1211.

Gostin, L. O., and D. Hosie. 2022. No matter how you feel about masks, you should be alarmed by this judge’s decision. The New York Times, April 25.

Gostin, L. O., W. E. Parmet, and S. Rosenbaum. 2022. The U.S. Supreme Court’s rulings on large business and health care worker vaccine mandates. JAMA 327(8):713.

H.R.5723—116th Congress (2019–2020): Public Health Emergency Fund Act. (2020). https://www.congress.gov/bill/116th-congress/house-bill/5723 (accessed May 24, 2022).

Katz, R., A. Attal-Juncqua, and J. E. Fischer. 2017. Funding public health emergency preparedness in the United States. American Journal of Public Health 107(S2):S148-S152.

Kodjak, A. 2016. A permanent fund that could help fight Zika exists, but it’s empty. https://www.npr.org/sections/health-shots/2016/06/03/480565668/a-permanent-fund-to-help-fight-zika-exists-but-its-empty (accessed March 20, 2022).

Montoya-Galvez, C. 2022. Biden administration defends Trump-era migrant expulsions citing “serious” COVID-19 risk. https://www.cbsnews.com/news/immigration-title-42-biden-trump-migrant-expulsions (accessed February 28, 2022).

Mortenson, J. D., and N. Bagley. 2021. Delegation at the founding. Columbia Law Review 121(2):277-368. https://repository.law.umich.edu/articles/2200.

NACCHO (National Association of County and City Health Officials). 2017. Statement of policy: Public health emergency response fund. https://www.naccho.org/uploads/downloadable-resources/17-05-Public-Health-Emergency-Response-Fund.pdf (accessed March 15, 2022).

O’Toole, T. 2007. Testimony given to the U.S. Congress, Senate, Committee on Homeland Security and Governmental Affairs. In Six years after anthrax: Are we better prepared to respond to bioterrorism? United States Senate Committee on Homeland Security and Governmental Affairs.

Parmet, W. E. 2007. Legal power and legal rights—isolation and quarantine in the case of drug-resistant tuberculosis. New England Journal of Medicine 357(5):433-435.

Pereira, I. 2020. Feds backtrack on transfer of quarantined coronavirus patients to Alabama. ABC News. https://abcnews.go.com/Health/feds-backtrack-transfer-quarantined-corona-virus-patients-alabama/story?id=69162771 (accessed May 24, 2022).

Simon, S., and M. Evstatieva. 2020. A revamped Strategic National Stockpile still can’t match the pandemic’s latest surge [interview]. November 23. https://www.npr.org/transcripts/937978556 (accessed May 24, 2022).

U.S. Embassy & Consulates in the United Kingdom. 2021. Important information about COVID-19 tests for travelers to and from the UK and U.S. https://uk.usembassy.gov/information-about-COVID-tests-for-travelers-from-the-uk-to-us (accessed March 20, 2022).

Whitcomb, D. 2020. Trump administration backs off sending coronavirus patients to Alabama governor. Reuters. https://www.reuters.com/article/us-china-health-usa-alabama/trump-administration-backs-off-sending-coronavirus-patients-to-alabama-governor-idUSKCN20I01W (accessed May 24, 2022).