The Cdc's Communicable Disease Regulations: Striking the Balance Between Public Health & Individual Rights

• Publication year: 2018

The CDC's Communicable Disease Regulations: Striking the Balance Between Public Health & Individual Rights

James J. Misrahi

THE CDC'S COMMUNICABLE DISEASE REGULATIONS: STRIKING THE BALANCE BETWEEN PUBLIC HEALTH & INDIVIDUAL RIGHTS^†

James J. Misrahi^*

Introduction

On January 19, 2017, the U.S. Department of Health and Human Services (HHS) published a final rule to update regulations administered by the Centers for Disease Control and Prevention (CDC) relating to the control of communicable diseases at 42 C.F.R part 70 (interstate)¹ and part 71 (foreign).² Individuals, stakeholders, and other interested parties, reflecting a variety of viewpoints, submitted 15,800 public comments in response to the Notice of Proposed Rulemaking (NPRM) published on August 15, 2016.³ The final rule became effective on March 21, 2017.⁴ The final rule significantly enhances the CDC's previous regulations that were largely silent regarding procedures for federal isolation, quarantine, and conditional release, and thus lacked transparency regarding the rights and remedies of individuals subject to these actions. The newly revised communicable disease regulations are consistent with the CDC's governing statutory authority, principles of federalism, and constitutional protections afforded to individuals under the Fourth and Fifth Amendments to the U.S. Constitution. This Article provides an overview of the newly revised regulations and explains how these regulations are designed to protect the public's health while safeguarding the constitutional rights of individuals subject to federal public health actions.

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I. A Brief History of Federal Quarantine

The federal government has a long history of acting to prevent the spread of communicable diseases. In 1796, Congress "enacted the first federal quarantine law in response to a yellow fever epidemic," which gave the President the authority to direct federal officials to "assist states in enforcing their own quarantine laws."⁵ In 1799, Congress repealed the 1796 Act and replaced it "with one establishing the first federal inspection system for maritime quarantines."⁶ In 1878, Congress again amended the Quarantine Act to assign responsibilities to the Marine Hospital Service, which was established in 1798 to provide for the health needs of merchant seamen, and placed it under the authority of the U.S. Department of the Treasury.⁷ The 1878 Quarantine Act, however, was extremely limited and provided that federal quarantine regulations could not conflict with those of state or local authorities.⁸ In 1893, Congress expanded the role of the Marine Hospital Service by enacting "An act granting additional quarantine powers and imposing additional duties upon the marine Hospital Service."⁹ While the 1893 Act did not preempt the role of the states, it nonetheless granted the Secretary of the Treasury the authority to issue additional rules and regulations to prevent the introduction of diseases, both foreign and interstate, when state and local ordinances were deemed insufficient.¹⁰ The Act also authorized direct federal enforcement of communicable disease regulations when state and municipal authorities refused to act.¹¹

The federal government's current authority for quarantine and isolation is based on the Public Health Service Act (PHSA), which Congress enacted in 1944.¹² The legislative history indicates, among other things, that the Act was

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intended to grant to the Surgeon General¹³ the basic authority to make regulations to prevent the spread of communicable diseases into the United States and between the states, "unencumbered by the confusing limitations found in the [1893] act."¹⁴ The 1944 Act continued the authority contained in the 1893 Act to "apprehend, detain, and examine persons entering the country from abroad," but added the authority to allow such persons to be released on condition, "for example, on condition that they report to public-health authorities for subsequent examination."¹⁵ The 1944 Act also explicitly conferred the authority, which Congress noted may have already existed under the 1893 Act, "to isolate infected persons for the purpose of interstate rather than foreign quarantine."¹⁶ The legislative history indicates that such authority "would be similar to the familiar quarantine power of State and local health officers."¹⁷ In regard to interstate quarantine, Congress indicated that the only communicable diseases that it believed merited isolation of infected persons at the time were "venereal diseases, experience having shown that many of those who chiefly spread such diseases move from place to place so rapidly as to make State and local law enforcement measures largely ineffectual."¹⁸ However, in light of the potential impact of other communicable diseases and the impossibility of foreseeing what preventive measures may become necessary, Congress noted that the statute was drafted broadly enough to encompass any communicable disease designated by the President as quarantinable.¹⁹

While the authority for federal quarantine originally resided with the U.S. Department of the Treasury, this responsibility was transferred to the Federal Security Agency (an independent agency of the U.S. government) in 1939, and

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subsequently to the Department of Health, Education, and Welfare (HEW) in 1953, later renamed HHS.²⁰ In 1967, responsibility for federal quarantine at ports of entry was transferred to the agency now known as the CDC.²¹ Before 2000, the Food and Drug Administration (FDA) administered interstate federal quarantine regulations.²² On August 16, 2000, the FDA transferred responsibility for interstate quarantine over persons to the CDC, while retaining its authority to control animals and other products that may transmit or spread communicable diseases interstate.²³ Currently, U.S. Quarantine Stations exist at twenty ports of entry and land-border crossings.²⁴ These stations are staffed with quarantine and medical public health officers from the CDC's Division of Global Migration and Quarantine (DGMQ), the organizational component within the CDC responsible for overseeing and implementing the CDC's quarantine regulations.²⁵

II. Statutory Framework for Federal Quarantine Authority

Section 361 of the PHSA authorizes the Surgeon General, with the approval of the HHS Secretary, to make and enforce regulations "to prevent the introduction, transmission, and spread of communicable diseases from foreign countries" into the United States or from one state or possession into another.²⁶ Section 361 is divided into five paragraphs, (a) through (e).²⁷

Paragraph (a) states that to execute the regulations, the Secretary may authorize measures based on his or her judgment, as may be necessary, including "inspection, fumigation, disinfection, sanitation, pest extermination, destruction of animals or articles found to be . . . sources of dangerous infection to human beings, and other measures."²⁸ This paragraph provides the legal authority for the bulk of the CDC's activities aimed at preventing the spread of communicable disease, including required reporting by airline and

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vessel operators of ill persons found on board;²⁹ public health measures in regard to infected or contaminated conveyances and animals or articles found on board such conveyances;³⁰ and oversight of certain animal importations, such as nonhuman primates.³¹

Paragraph (b) authorizes the "apprehension, detention, or conditional release of individuals . . . for the purpose of preventing the introduction, transmission, or spread of such communicable diseases as may be specified . . . in Executive orders of the President upon the recommendation of the Secretary, in consultation with the Surgeon General."³² The communicable diseases currently specified through an Executive Order include cholera, diphtheria, infectious tuberculosis (TB), plague, smallpox, yellow fever, viral hemorrhagic fevers (such as Marburg, Ebola, Lassa fever, and Crimean-Congo),³³ severe acute respiratory syndromes,³⁴ and influenza caused by novel or re-emergent influenza viruses that are causing or have the potential to cause a pandemic.³⁵

Paragraph (c) states that except as provided in paragraph (d), regulations regarding apprehension, detention, examination, or conditional release shall only be applicable to individuals coming into a state or possession from a foreign country or possession.³⁶ Thus, paragraph (c) provides the basis for the isolation, quarantine, or conditional release of foreign arrivals, while paragraph (d) provides the basis for these activities in regard to interstate travelers.

Paragraph (d) imposes two main requirements on the isolation, quarantine, or conditional release of interstate travelers: (1) the qualifying-stage requirement and (2) the requirement for an effect on interstate movement.³⁷ Both requirements must be satisfied. Paragraph (d) states that regulations "may provide for the apprehension and examination of any individual reasonably

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believed to be infected with a communicable disease in a qualifying stage."³⁸ As defined by this paragraph, a "qualifying stage" means that the communicable disease is in "a precommunicable stage, if the disease would be likely to cause a public health emergency if transmitted to other individuals" or "a communicable stage."³⁹ This paragraph also states "that if upon examination any such individual is found to be infected, he [or she] may be detained for such time and in such manner as may be reasonably necessary."⁴⁰ Additionally, it requires that the individual: (A) "be moving or about to move from a State to another State"; or (B) "be a probable source of infection to individuals who, while infected with such a disease in a qualifying stage, will be moving from a State to another State."⁴¹

Lastly, paragraph (e) states that nothing in § 361 nor in regulations promulgated under this authority, "may be construed as superseding...