key: cord-0040504-wh41wczp
authors: Hunter, Nan D.
title: Federal Public Health Law
date: 2010-03-17
journal: The Law of Emergencies
DOI: 10.1016/b978-1-85617-547-0.00010-5
sha: 0b5e8c6fa299029beca996b95d1ea5382bc777e6
doc_id: 40504
cord_uid: wh41wczp

This chapter explains the origins and current operations of public health emergency law, at both the federal and state levels. When the colonies first formed the United States, there was no national public health law. In a time when traveling any significant distance was rare, infectious disease outbreaks and epidemics were often localized, to an extent that is difficult to imagine today. The origin of independent federal public health authority derives from laws designed to provide medical care for eighteenth-century merchant seamen, a group who traveled constantly and often had little access to care when they became ill in unfamiliar cities. Moreover, their illnesses threatened the mercantile trade that was essential to the economy of the fledging nation. The origins of what is now the U.S. Public Health Service (PHS) began in 1798, when Congress established a fund to provide treatment for sick and injured merchant seamen. The PHS is now a component of the U.S. Department of Health and Human Services (DHHS). The core of federal public health law is found in the statutes that grant authority for various actions to DHHS, PHS, and CDC.

Together, this chapter and the next one will explain the origins and current operations of public health emergency law, at both the federal and state levels. Consider as you read a hypothetical proposed by David Fidler, a law professor at Indiana University. Professor Fidler imagined a scene in which Dr. Evil, who is considering possible targets for a bioterrorist attack, seeks legal advice. Rumpole the Malevolent, his lawyer, advises Dr. Evil that "[y]our ideal legal target for a bioweapon attack is a country that, first of all, has a fragmented legal system, in that relevant legal powers to respond to a public health emergency are divided among actors at the national and local levels. Federalism is, for instance, a fragmented legal system" (Fidler, 2001) . Should the United States change its system? Is it feasible to do so?

When the colonies first formed the United States, there was no national public health law. In a time when traveling any significant distance was rare, infectious disease outbreaks and epidemics were often localized, to an extent that is difficult to imagine today. Recall from Chapter 1 that the Supreme Court stated in Jacobson v. Massachusetts that enactment of quarantine and other health laws fell within the "police power" of each state. Before 1796, quarantines were solely the responsibility of state and local governments. Early federal involvement was minor. When Congress first passed a law to address quarantine, in 1796, it simply allowed the national government to assist state governments in the event of disease outbreaks. That general policy preference has endured. The structure of public health law today continues to be based on the premise that state and local health officials will, at least initially, take lead responsibility for most public health emergencies. But the federal role has grown dramatically.

The origin of independent federal public health authority derives from laws designed to provide medical care for eighteenth-century merchant seamen, a group who traveled constantly and often had little access to care when they became ill in unfamiliar cities. Moreover, their illnesses threatened the mercantile trade that was essential to the economy of the fledging nation. The origins of what is now the U.S. Public Health Service (PHS) began in 1798, when Congress established a fund to provide treatment for sick and injured merchant seamen.

The marine hospital fund, as it was known, was financed by deductions from the sailors' wages used to build hospitals in port cities. By the end of the Civil War, many of these hospitals had been occupied by either the Union or Confederate armies, and only a handful were still operational. The trend toward federal control began after the Civil War. In 1870, the Secretary of the Treasury, in whose department the marine hospital fund was administered, initiated a major organizational reform of the system.

In the following decade, two critical events happened. The Treasury Department realigned the loose network of remaining hospitals into a Marine Hospital Service (MHS), administered centrally. A new position of supervising surgeon (later, the Surgeon general) was created to oversee the MHS. The second major event resulted from an 1877 yellow fever epidemic that spread rapidly from new orleans up the Mississippi River, a signal to the nation that increased mobility made localized control of infectious disease inadequate. Congress reacted by passing the national Quarantine Act of 1878, which conferred quarantine authority for the first time on a federal government agency, the MHS, and authorized the construction of federal quarantine facilities.

The first supervising surgeon, John Maynard Woodworth, continued the era of change by adopting a military model for the physicians in the MHS. They began wearing uniforms and served in the MHS as troops did in the military, subject to deployment to sites where they were needed. This development was formalized in 1889, with the renaming of the MHS physician group as the Commissioned Corps. In 1902, Congress changed the organizational name again, to the Public Health and Marine Hospital Service. Today, there remains a Commissioned Corps of health care professionals (including dentists, nurses, and pharmacists as well as doctors) in the PHS.

In the first half of the twentieth century, the Corps was increasingly used for military purposes. It had served an important role in the Spanish-American War in 1898, when PHS doctors cared for wounded service members and operated quarantine stations to prevent troops infected with yellow fever from returning to the states from Cuba or Puerto Rico. The 1902 legislation authorized the President to use PHS officers in times of threatened or actual war. President Wilson signed an Executive order in 1917 that provided for the PHS to be deployed in World War I. A 1943 law went further and authorized the President to convert the PHS into a military service during times of war.

The early twentieth century also saw the states that had their own quarantine facilities begin to turn them over voluntarily to the national government. This development came because the governments of states where major ports were located wanted to shift the cost of immigration-related health examinations and monitoring to Washington, where there was more expertise and a larger budget. In addition, local politics fostered graft. Politicians often rewarded supporters by appointing them as health officers to oversee incoming ships, a situation ripe for corruption. By 1921, all of the states had relinquished their role in policing persons and goods coming to the United States from abroad.

Quarantine work is essentially scientific in its nature, and our committee is a unit in feeling that such work cannot be carried on efficiently unless the tenure of office be independent of changes in administration and politics. The United States Public Health Service, by its organization, the character, training, and experience of its personnel and its opportunities for constant communication with all foreign ports, is admirably equipped to administer quarantine in a most efficient manner … One of the most important reasons for a national control is the absolutely imperative need that the office of Health Officer of a port be taken out of politics. … Under Federal control, there is continuity of service, uniformity of procedure and policy [and] constant supervision over the acts of the health officers … Dr. Charles L. Dana new York Times, January 2, 1916 In 1946, what had been a malaria control project centered in southern states became the Communicable Disease Center, with its headquarters in Atlanta. After several changes to the name, it became the Centers for Disease Control and Prevention (CDC). operating as a branch of the PHS, CDC has the most advanced disease surveillance system in the world.

The PHS is now a component of the U.S. Department of Health and Human Services (DHHS). The core of federal public health law is found in the statutes that grant authority for various actions to DHHS, PHS, and CDC. The bedrock question in this field is still how legal authority should be divided between federal and state governments. In reading the statutory sections that follow, ask yourself how Congress has delineated the different roles for federal and state officials in a time of public health crisis.

The Public Health Service Act U.S. Code, Title 42 § 243 General grant of author for cooperation (a) Enforcement of quarantine regulations; prevention of communicable diseases

The Secretary [of the Department of Health and Human Services] is authorized to accept from State and local authorities any assistance in the enforcement of quarantine regulations made pursuant to this chapter which such authorities may be able and willing to provide. The Secretary shall also assist States and their political subdivisions in the prevention and suppression of communicable diseases and with respect to other public health matters … (c) Development of plan …

(1) The Secretary is authorized to develop [and implement] a plan under which … resources of the Service … may be effectively used to control epidemics of any disease or condition and to meet other health emergencies or problems. …

(2) The Secretary may, at the request of the appropriate State or local authority, extend temporary (not in excess of six months) assistance to States or localities in meeting health emergencies of such a nature as to warrant Federal assistance. … § 247d. Public health emergencies (a) Emergencies

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 … Any such determination of a public health emergency terminates upon the Secretary declaring that the emergency no longer exists, or upon the expiration of the 90-day period beginning on the date on which the determination is made by the Secretary, whichever occurs first. Determinations that terminate under the preceding sentence may be renewed by the Secretary … Not later than 48 hours after making a determination under this subsection of a public health emergency (including a renewal), the Secretary shall submit to the Congress written notification of the determination. … § 264. Regulations to control communicable diseases (a) Promulgation and enforcement by Surgeon General

The Surgeon General, with the approval of the Secretary, 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. …

Regulations prescribed under this section shall not provide for the apprehension, detention, or conditional release of individuals except for the purpose of preventing the introduction, transmission, or spread of such communicable diseases as may be specified from time to time in Executive orders of the President … (c) Application of regulations to persons entering from foreign countries Except as provided in subsection (d) of this section, regulations prescribed under this section, insofar as they provide for the apprehension, detention, examination, or conditional release of individuals, shall be applicable only to individuals coming into a State or possession from a foreign country or a possession.

(d)(1) Apprehension and examination of persons reasonably believed to be infected

Regulations prescribed under this section may provide for the apprehension and examination of any individual reasonably believed to be infected with a communicable disease in a qualifying stage and (A) to be moving or about to move from a State to another State; or (B) to be a probable source of infection to individuals who, while infected with such disease in a qualifying stage, will be moving from a State to another State. Such regulations may provide that if upon examination any such individual is found to be infected, he may be detained for such time and in such manner as may be reasonably necessary. For purposes of this subsection, the term "State" includes, in addition to the several States, only the District of Columbia.

(2) For purposes of this subsection, the term "qualifying stage" with respect to a communicable disease, means that such disease (A) is in a communicable stage; or (B) is in a pre-communicable stage, if the disease would be likely to cause a public health emergency if transmitted to other individuals. … § 266. Special quarantine powers in time of war To protect the military and naval forces and war workers of the United States, in time of war, against any communicable disease specified in Executive orders …, the Secretary, in consultation with the Surgeon General, is authorized to provide by regulations for the apprehension and examination, in time of war, of any individual reasonably believed (1) to be infected with such disease and (2) to be a probable source of infection to members of the armed forces of the United States or to individuals engaged in the production or transportation of arms, munitions, ships, food, clothing, or other supplies for the armed forces. Such regulations may provide that if upon examination any such individual is found to be so infected, he may be detained for such time and in such manner as may be reasonably necessary. § 270. Quarantine regulations governing … civil aircraft

The Surgeon General is authorized to provide by regulations for the application to air navigation and aircraft of any of the provisions of sections 267 to 269 of this title and regulations prescribed thereunder, … to such extent and upon such conditions as he deems necessary for the safeguarding of the public health. § 271. Penalties for violation of quarantine laws Any person who violates any regulation prescribed under sections 264 to 266 of this title, … or who enters or departs from the limits of any quarantine station … in disregard of quarantine rules and regulations or without permission of the quarantine officer in charge, shall be punished by a fine of not more than $1,000 or by imprisonment for not more than one year, or both.

What are the most significant limitations on when the federal health officials can act to stop an infectious disease from spreading? Why doesn't the statute simply grant all authority to deal with infectious diseases to federal officials?

What conditions are necessary for a situation to qualify as a "public health emergency" under the Act? How do the federal public health powers differ once an emergency is declared? Is there any effective limitation on these powers? What about the constitutional rights of persons who might be quarantined?

What factors must be present for DHHS to have authority to quarantine individuals? one of these factors relates to diseases specified in Executive orders. Following is the current Executive order identifying diseases as to which DHHS has that power. (b) Severe Acute Respiratory Syndrome (SARS), which is a disease associated with fever and signs and symptoms of pneumonia or other respiratory illness, is transmitted from person to person predominantly by the aerosolized or droplet route, and, if spread in the population, would have severe public health consequences.

Section 2. The Secretary, in the Secretary's discretion, shall determine whether a particular condition constitutes a communicable disease of the type specified in section 1 of this order. In 2005, President Bush amended this order by Executive order 13375, which added the following to Section 1 of the 2003 order:

(c) Influenza caused by novel or re-emergent influenza viruses that are causing, or have the potential to cause, a pandemic.

If the CDC learned that several individuals with severe infectious bronchitis were about to enter the United States, what could CDC officials do?

Recall that in Chapter 4 we learned that agencies often promulgate regulations to fill in the details that are not specified in statutes. note that in several sections of the PHS Act above, Congress specifically called on DHHS to develop regulations. Do the following regulations help you identify where the line has been drawn between federal and state public health power?

As used in the federal regulations:

• Communicable diseases means illnesses due to infectious agents or their toxic products, which may be transmitted from a reservoir to a susceptible host either directly as from an infected person or animal or indirectly through the agency of an intermediate plant or animal host, vector, or the inanimate environment. • Communicable period means the period or periods during which the etiologic agent may be transferred directly or indirectly from the body of the infected person or animal to the body of another. • Incubation period means the period between the implanting of disease organisms in a susceptible person and the appearance of clinical manifestation of the disease. The master of any vessel or person in charge of any conveyance engaged in interstate traffic, on which a case or suspected case of a communicable disease develops shall, as soon as practicable, notify the local health authority at the next port of call, station, or stop, and shall take such measures to prevent the spread of the disease as the local health authority directs. § 70.5 Certain communicable diseases; special requirements

The following provisions are applicable with respect to any person who is in the communicable period of cholera, plague, smallpox, typhus or yellow fever, or who, having been exposed to any such disease, is in the incubation period thereof:

(a) Requirements relating to travelers.

(1) No such person shall travel from one State or possession to another, or on a conveyance engaged in interstate traffic, without a written permit of the Surgeon General or his/her authorized representative.

(2) Application for a permit may be made directly to the Surgeon General or to his/her representative authorized to issue permits. … § 70.6 Apprehension and detention of persons with specific diseases

Regulations prescribed in this part authorize the detention, isolation, quarantine, or conditional release of individuals, for the purpose of preventing the introduction, transmission, and spread of the communicable diseases listed in [the applicable] Executive Order.

Are there portions of the regulations that seem outdated? Which ones and why? The diseases for which travel permits are required have been largely eradicated in the United States. If one of those diseases were to reappear, what do you think the public reaction would be to a travel permit requirement?

The regulations provide no guidelines for determining whether state or local measures are "insufficient to prevent the spread of … communicable diseases." How much discretion do you think the federal officials should have in making that decision? What would the practical restraints be on initiating a federal takeover?

The regulations authorize the "apprehension and detention" of persons with certain diseases; which ones? They do not, however, provide for any due process protections for persons who are detained. Imagine that a person has been placed in quarantine and seeks a court order to secure certain rights. How should a judge respond? Recall the Greene case in Chapter 2.

The CDC has a separate set of regulations for persons entering any state from a foreign country (whether they are returning citizens or foreign nationals). The power that the CDC can exercise over international travelers stems from the following regulation:

Code of Federal Regulations, Title 42, Part 71 § 71.32 (a) Whenever the Director [of the CDC] has reason to believe that any arriving person is infected with or has been exposed to any of the communicable diseases listed in the [current] Executive Order, he/she may isolate, quarantine or place the person under surveillance and may order disinfection or disinfestation, fumigation, as he/she considers necessary to prevent the introduction, transmission or spread of the listed communicable diseases. …

As with the regulations for domestic interstate travelers, this regulation makes no explicit provision for procedural protections for a person who is detained.

In the fall of 2005, the CDC published a notice of proposed rulemaking (see Chapter 4) in which significant changes were proposed to the above regulations. As this book goes to press in 2009, the agency has taken no action either to finalize or withdraw them. The most controversial aspects of the proposed regulations concern (1) the nature of the new due process protections that would be afforded to those who are isolated or quarantined and (2) the obligations placed on airlines and their passengers. We will examine each in turn.

Many people confuse two commonly used terms: isolation and quarantine.

• Isolation means the separation and restriction of movement of persons who are known to have a specific infectious illness, during the period when the disease is communicable. • Quarantine means the separation and restriction of movement of persons who are not ill but who have been exposed or are believed to have been exposed to an infectious disease, during the period when it would be communicable.

As is true of the current regulations, the proposed regulations would be triggered by a link to a risk of interstate transmission and the inclusion of the disease in question in the list in the current Executive order. In an effort to modernize their procedures, the CDC also set forth a procedure for how the due process rights of detained individuals would be protected. Here is how the CDC describes its plan:

The proposed regulation establishes administrative procedures that afford individuals with due process commensurate with the degree of deprivation and the circumstances of controlling the spread of communicable disease. CDC quarantine officers are typically the first line of defense in preventing the importation of communicable diseases into the United States. Quarantine officers routinely conduct rapid assessments of ill passengers at airports and other ports of entry to assess the presence of communicable disease. Such assessments generally occur on a voluntary basis with the consent of the ill passenger. Where the quarantine officer reasonably believes that an ill passenger has a quarantinable disease, and the passenger is otherwise non-compliant, the quarantine officer may order the provisional quarantine of the passenger by serving the passenger with a written order, verbally ordering that the passenger be provisionally quarantined, or by ordering that actual restrictions be placed on a non-compliant passenger. The quarantine officer's reasonable belief would be informed by objective scientific evidence such as clinical criteria indicative of one of the specified quarantinable diseases, e.g., high fever, respiratory distress, and/or chills, accompanied by epidemiologic criteria such as travel to or from an affected area and/or contact with known cases.

Provisionally quarantined individuals are provided with a written order in support of the agency's determination at the time that provisional quarantine commences or as soon thereafter as the circumstances reasonably permit. The written provisional quarantine order provides the individual with notice regarding the legal and scientific basis for their provisional quarantine, the location of detention, and the suspected quarantinable disease. Under the proposed regulations, CDC may provisionally quarantine an individual for up to three business days unless the Director determines that the individual should be released or served with a quarantine order.

CDC does not intend to provide individuals with administrative hearings during this initial three-day period of provisional quarantine, but rather will afford an opportunity for a full administrative hearing in the event that the individual or group of individuals is served with a quarantine order, which potentially would involve a longer period of detention. … CDC believes that the provisional quarantine of individuals for up to three business days without an administrative hearing is reasonable because such a time frame is necessary to determine whether the individual has one of the specified quarantinable diseases. A provisional quarantine order is likely to be premised on the need to investigate based on reasonable suspicion of exposure or infection, whereas a quarantine order is more likely to be premised on a medical determination that the individual actually has one of the quarantinable diseases. Thus, during this initial three business day period, there may be very little for a hearing officer to review in terms of factual and scientific evidence of exposure or infection. Three business days may be necessary to collect medical samples, transport such samples to laboratories, and conduct diagnostic testing, all of which would help inform the Director's determination that the individual is infected with a quarantinable disease and that further quarantine is necessary.

In addition, because provisional quarantine may last no more than three business days, allowing for a full hearing, with witnesses, almost guarantees that no decision on the provisional quarantine will actually be reached until after the provisional period has ended, thus making such a hearing virtually meaningless in terms of granting release from the provisional quarantine.

In the event that further quarantine or isolation is necessary, the Director would issue an additional order based on scientific principles such as clinical manifestations, diagnostic or other medical tests, epidemiologic information, laboratory tests, physical examination, or other available evidence of exposure or infection. The length of quarantine or isolation would not exceed the period of incubation and communicability for the communicable disease as determined by the Director.

… [A]n opportunity for judicial review of the agency's decision exists via the filing of a petition for a writ of habeas corpus. This judicial review mechanism affords individuals under quarantine with the full panoply of due process rights typical of a court hearing. A petition for a writ of habeas corpus is the traditional mechanism by which individuals may contest their detention by the federal government.

In addition to this judicial review mechanism, as previously mentioned, the proposed regulations establish a procedure for individuals under quarantine to request an administrative hearing. The purpose of the administrative hearing is not to review any legal or constitutional issues that may exist, but rather only to review the factual and scientific evidence concerning the agency's decision, e.g., whether the individual has been exposed to or infected with a quarantinable disease. Such an administrative hearing would comport with the basic elements of due process. Under the proposed regulations, the Director would notice the hearing and designate a hearing officer to review the available evidence of exposure or infection and make findings as to whether the individual should be released or remain in quarantine. (2005) Essentially the same set of procedures -providing for provisional quarantine as well as quarantine, with limited review rights -would apply to international as well as interstate travelers under the proposed regulations.

Persons could be informed that they were being taken into provisional quarantine by a written order, but also by verbal notice or even simply by being told that they must step into the custody of federal public health officers. Why might this be problematic from a due process perspective? Why might the CDC believe that such methods were necessary? What is your view?

The CDC states that it is sufficient and "traditional" for the only method of challenging such detention to be for the individual to file a lawsuit seeking a writ of habeas corpus. (Recall what we learned about habeas corpus in Chapter 2.) Should other protections be in place as well? If so, what?

Where once the federal quarantine authority applied primarily to shipping, today the most common situation in which questions about quarantine of international travelers are likely to arise would involve the arrival of an international flight. The quarantine regulations proposed by CDC in 2005 would establish new rules for airlines and passengers, including:

Any airline operating an international flight bound for a U.S.

• airport must report to CDC before it landed whether any death or illness (as defined by CDC) had occurred on board. on each flight, the following information "shall be • solicited" from each passenger and made available to the CDC upon request: full name, emergency contact, e-mail address, home address, passport number, name of traveling companions, a personal phone number (preferably cell or home number rather than work number), and ports of call visited.

In addition, the CDC could order medical examination and monitoring for arriving passengers. The new rules would require that persons who receive an examination order "shall provide the Director that someone on the flight has a highly contagious form of tuberculosis. As a result, everyone is being taken to a nearby military base where you will live in the barracks for at least the next 3 days. While there, you will be provided with food, toiletries and housed in a small private room with a TV set and telephone. How would you respond?

Critical Thinking From the perspective of the airline industry, do you think the proposed new rules are workable and fair? How would you argue for or against their adoption if you were an airline lobbyist From the perspective of the individual traveler, do you have any objections to the proposed rules? What do you think public reaction would be if they were instituted? Are there alternative methods that you could suggest? the chapter by posing the question of whether the 1. divided nature of public health legal authorities might prove problematic in an emergency. What is your view as we finish the chapter? Describe in your own words the historical evolution and 2. growth of federal government power in this field. Consider the impact of other events at various points, such as wars, economic depressions, urbanization, and immigration. To make sure that you have it clearly in mind, diagram the steps 3. in imposing first provisional quarantine and then quarantine