CHAPTER SEVEN. BIOTERRORISM AND PUBLIC HEALTH

Thomas V. Inglesby, “Lessons From TOPOFF,” 116 Public Health Reports 64-68 (2001)

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The U.S. Congress, in an effort "to assess the nation's crisis and consequence management capacity under extraordinarily stressful conditions," directed the Department of Justice to conduct an exercise that would engage key personnel in the management of mock chemical, biological or cyber-terrorist attacks.

TOPOFF was a $3 million drill that tested the readiness of top government officials to respond to terrorist attacks directed at multiple geographic locations. It was the largest exercise of its kind to date. The exercise, which took place in May 2000 in three cities in the United States, simulated a chemical weapons event in Portsmouth, N.H., a radiological event in the greater Washington, D.C. area, and a bioweapons event in Denver, Colo. The bioterrorism component of the exercise centered on the release of an aerosol of Yersinia pestis, the bacteria that causes plague. Denver was selected in part because it had received domestic preparedness training and equipment. . . .

This article seeks to identify the medical and public health observations and lessons discovered in the biological weapons component (i.e., the Denver component) of the TOPOFF exercise. . . .

The information and statements that follow are derived from the insights and observations of 11 officials who were either participants, controllers, or observers of the Denver exercise. These officials included state and county health department officers, emergency medicine and emergency management professionals, an infection control professional from a participating hospital, and a number of participants and observers from federal health agencies. Most information was obtained through interviews that took place with the understanding that information that was provided for this article would not be attributed to its source. Information and commentary offered at public presentations after the conclusion of the exercise are also included. . . .

TOPOFF was widely considered a success in that it provided the most comprehensive effort, to date, to test the medical and public health system and infrastructure that would be called upon in the event of a bioterrorist action. The exercise effectively revealed a number of important vulnerabilities and challenges for the future. . . .

BACKGROUND AND CONTEXT OF THE EXERCISE

Officials were involved in the event as participants, controllers, or observers. Participants were the actual players of the exercise and, in general, operated within the parameters of their usual roles and authorities. Controllers maintained the structure of the exercise, which helped guide the unfolding scenario. Observers were generally agency heads who had policy responsibilities relevant to the events of the

exercise. A number of health agencies (including the county health agency, the state health agency, the Centers for Disease Control and Prevention [CDC], THE Office of Emergency Preparedness, and elements of the Public Health Service, as well as three hospitals in the Denver area [Swedish Medical Center, Medical Center of Aurora and Denver Health Medical Center]) participated in the exercise. Many persons from these institutions worked around the clock for days in attempts to cope with the unfolding medical and public health crisis depicted in the exercise.

TOPOFF was intended to be "player driven" which meant that the participants' decisions and the subsequent consequences were to be the primary drivers in the shaping of the exercise. In practice, the controllers guided a substantial portion of the exercise by giving participants "injects," which were new information or data delivered verbally or by written memorandum. Participants noted that much of the exercise was, in fact, scripted by the controllers through these injects, which made it unclear whether choices made by decision-makers were influencing unfolding events. One participant said that it appeared preordained that the plague epidemic would spread beyond local control. Other artificialities of the scenario included a greater risk of person-to-person spread than that which has been reported historically and a laboratory diagnostic process that was tested only on paper. None of those who were interviewed believed that these limitations were serious enough to invalidate the major observations and lessons revealed by the exercise.

The scope and complexity of the exercise were such that many of the events that occurred in the exercise could only be "notional" (i.e., they could not be acted out and, thus, occurred on paper only). Examples of notional events that occurred in the exercise included situations in which "thousands of panicked persons . . . [were] flooding into emergency departments" and "one million persons . . . [were] advised to stay in their homes." All media communication during the exercise was transmitted through the "Virtual News Network" (VNN). VNN was the virtual news agency that was used in the exercise to interview the exercise participants, to hold press conferences, and to disseminate information (notionally) to the public. No actual news agencies were involved in the exercise, nor was any of the news that was reported on VNN actually disseminated to the public.

TOPOFF was intended to be a "no notice" drill. Participants were given no formal advanced notice of the nature and timing of the event so as to engender as much verisimilitude as possible. In practical terms, however, it proved difficult to design such a large and sophisticated operation in total secrecy. Some participants in both the federal and state health agencies did have knowledge or a strong suspicion that the exercise would feature a plague outbreak, and that it would begin on the day it did, which allowed them to review the medical and public health implications of plague infection in anticipation of the event. However, a number of participants, including participants from the three hospitals, did not have advance knowledge of when the exercise was to begin or what weapons agent was to be used; they knew only that a bioterrorism exercise would take place sometime in May.

The exercise began on May 20, 2000, and ended on May 23.

OVERVIEW OF THE EXERCISE

May 17. An aerosol of plague (Y. pestis) bacilli is released covertly at the Denver Performing Arts Center.

May 20 (day 1 of exercise). The Colorado Department of Public Health and Environment receives information that increasing numbers of persons began to seek medical attention at Denver area hospitals for cough and fever during the evening of May 19. (For hospital participants, the exercise had begun on the evening of May 19 with the arrival of several sick patients.) By early in the afternoon of May 20, 500 persons with these symptoms have received medical care; 25 of the 500 have died. The Department of Public Health and Environment notifies the CDC of the increased volume of sick patients. Plague is confirmed first by the state laboratory and subsequently, in a patient specimen, by the CDC lab at Ft. Collins, CO. . . .

A public health emergency is declared by the state health officer. The state health officer places an official request for support from the Department of Health and Human Services' Office of Emergency Preparedness. The governor's Emergency Epidemic Response Committee . . . assembles to respond to the unfolding crisis. Thirty-one CDC staff are sent to Denver. The CDC is notified by the Denver police and the Federal Bureau of Investigation (FBI) that a dead man has been found with terrorist literature and paraphernalia in his possession; his cause of death is unknown. Hospitals and clinics in the Denver area, which just a day ago were dealing with what appeared to be an unusual increase in influenza cases, are recalling staffs, implementing emergency plans, and seeking assistance in the determination of treatment protocols and protective measures. By late afternoon, hospital staff are beginning to call in sick, and antibiotics and ventilators are becoming more scarce. Some hospital staff have donned protective respiratory equipment.

The governor issues an executive order that restricts travel (including travel by bus, rail and air) into or out of 14 Denver metropolitan counties; he also commandeers all antibiotics that can be used to prevent or treat plague. During a VNN press conference, at which a number of agencies are represented, the Denver police is informed that an outbreak of the plague has occurred in the city after a terrorist attack, and it is told of the governor's executive order. The public is also told to seek treatment at a medical facility if they are feeling ill or if they have been in contact with a known or suspected case of plague. Those who are healthy are directed to stay in their homes and to avoid public gatherings. The public is told that the disease can spread from person to person only "if you are within six feet of someone who is infected and coughing," and they are told that dust masks effectively prevent the spread of disease. Confirmed cases of plague are identified in Colorado locations other than Denver. Patient interviews suggest that most victims were at the Performing Arts Center days earlier. It is announced that the governor is working with the President of the United States to resolve the crisis and that federal resources are being brought in to support the state agencies. By the end of the day, 783 cases of pneumonic plague have occurred; 123 persons have died.

May 21 (day 2 of exercise). VNN reports that a national crash effort" is under way that aims to move large quantities of antibiotics to the region as the CDC brings in its "national stockpile," but the quantity of available antibiotics is uncertain. The report explains that

early administration of antibiotics is effective in the treatment of plague, but that antibiotic treatment must be started within 24 hours of the development of symptoms. A few hours later, a VNN story reports that hospitals are running out of antibiotics.

A "push-pack" from the National Pharmaceutical Stockpile (NPS) arrives in Denver, but there are great difficulties in moving antibiotics from the stockpile delivery point to the persons who need it for treatment and prophylaxis. Out-of-state cases begin to be reported. The CDC notifies bordering states of the epidemic. Cases are reported in England and Japan. Both Japan and the World Health Organization(WHO) request technical assistance from the CDC.

A number of hospitals in Denver are full to capacity, and by the end of the day, they are unable to see or to admit new patients. Thirteen hundred ventilators from the NPS are to be flown to Colorado. The number of bodies in hospital morgues is reported to have reached critical levels. By 5:00 p.m. mountain time, the CDC has performed an epidemiological investigation on 41 cases. The U.S. Surgeon General flies to Colorado to facilitate communications issues. Many states are now requesting components of the NPS from the CDC. By the end of the day, 1871 plague cases have occurred in persons throughout the United States, London and Tokyo. Of these, 389 persons have died.

May 22 (day 3 of exercise). Hospitals are understaffed and have insufficient antibiotics, ventilators, and beds to meet demand. They cannot manage the influx of sick patients into the hospitals. Medical care is "beginning to shut down" in Denver. A total of 151 patient charts have been reviewed by state and federal health officials who are pursuing the epidemiological investigation. There are difficulties getting antibiotics from the NPS to the facilities that need them. Details of a distribution plan are still not formalized.

Officials from the Department of Public Health and Environment and the CDC have determined that secondary spread of disease appears to be occurring. The population in Denver is encouraged to wear face masks. The CDC advises that Colorado state borders be cordoned off to limit further spread of plague throughout the United States and other countries. Colorado officials express concern about their ability to get food and supplies into the state. The governor's executive order is extended to prohibit travel into or out of the state of Colorado. By noon, there are reports of 3060 U.S. and international patients with pneumonic plague, 795 of whom have died.

May 23 (day 4 of exercise). There are conflicting reports regarding the number of sick persons and dead persons. Some reports show an estimated 3700 cases of pneumonic plague with 950 deaths. Others are reporting more than 4000 cases and more than 2000 deaths. . . .

LESSONS FROM THE EXERCISE

Leadership and the Complexity of the Decision-Making Process

Issues surrounding leadership, the role of authorities, and the processes of decision-making were widely considered to be highly problematic and deserving of careful review. Overall, leadership roles and the role of authorities in the crisis were uncertain. When a plague

outbreak was suspected, the governor's Emergency Epidemic Response Committee was convened to provide technical advice to the governor. Because the Colorado governor did not participate in TOPOFF, the role of the expert committee in the exercise de facto changed from providing expert advice to decision-making. By law, in an actual bioterrorist event, this committee would not have had the legal authority to make decisions in the absence of the governor. A number of those involved believed that the absence of the governor or an alternative elected official with legal and moral authority over the crisis had important consequences. To some observers, it appeared that the political ramifications of specific public health measures received less attention from the expert committee than would have occurred if an elected official had been making those decisions. It is probable that a governor would analyze decisions (e.g., how to triage scarce antibiotic resources, whether to impose home curfews, or whether to close city or state borders) in ways that would have differed from the deliberations of a committee of technical advisors.

Although the state public health agency was cited by some of the senior health participants as the agency with the highest authority in the exercise, two other participants in the exercise said that it was not clear who was in charge. Another observer said that the FBI was operating under the assumption that the State Attorney General's office was the organization with highest authority because this is the ranking state office to which the FBI reports in a crisis.

The decision-making process was inhibited by a number of substantial difficulties. The governor's Emergency Epidemic Response Committee and the larger committee of communitywide decision-making by conference call was highly inefficient and led to indecision and significant delays in the taking of action. A series of very large conference calls took place; these included officials from the city and state health departments, hospitals, the CDC, the Federal Emergency Management Agency (FEMA), and many other agencies. At some points, as many as 100 persons participated in these calls; many participants had never previously met or worked together. The roles, authorities and even the identities of those participating in the calls, as well as the leadership of and agendas for the calls, were unclear. Such conference calls occurred throughout the exercise, often with one running into the next.

Some participants attributed these difficulties to the decision-making processes of public health agencies. One observer commented about how "in public health, more decision-making is through democratic processes and consensus building, but for some decisions, this cannot work." . . . Another observer remarked, "the time frame that public health is accustomed to dealing with is not what is needed for bioterrorism. In [this type of crisis], one needs to make decisions quickly. You don't have the luxury of time to do more research.". . . One observer remarked, "With thousands standing outside hospitals awaiting prophylaxis, public health officials were citing papers. . . . Some from the CDC, state and local health agencies tried to look at this as a standard epidemiological investigation. In absolutely no way would this [scenario allow] a normal epidemiological investigation." . . .

As the exercise progressed, many health department officials became exhausted. "Even without the emotion of a real event, a feeling

of hopelessness quickly overwhelmed a number of public health officials, as well as those participating at medical facilities." One emergency management official stated, "There were not enough people to manage this event." Public health resources were clearly limited, despite the fact that the CDC had sent substantial technical expertise and human resources (31 members of the CDC staff) to the exercise on the first day of the event. It is unclear whether the impressively large scale and rapidity of the CDC response accurately reflected the human and technical resources that would be readily available had this truly been a no-notice event. As a point of comparison, the CDC was able to provide far fewer experts for on-site assistance during the 1999 West Nile Virus outbreak in New York City because of resource constraints. During TOPOFF, when cases of plague began to appear elsewhere in the country, it was clear that there were few CDC personnel left in reserve who could readily be deployed outside of the Denver area.

. . . Several different emergency operations centers (EOCs) were set up by a variety of state and federal law enforcement and emergency management agencies. The EOCs were intended to help coordinate management of the crisis, but it was unclear to some observers how a number of distinct EOCs would be able to coordinate management, make decisions or communicate information to medical and public health stakeholders, such as the hospitals. One public health official noted a widespread lack of familiarity with terms used by the emergency management community: "No one knew what a JIC [Joint Information Center], a JOC [Joint Operations Center], or DMORTs [Disaster Mortuary Assistance Teams] were."

The flow of information was another major concern of the participants. Several sources of incoming information and data that were made available, by injects, to decision-makers in the exercise would not have been readily available in a real epidemic. For example, it is unlikely that most health departments would have had the information systems in place to be able to say with speed and accuracy how many confirmed or even suspected cases of plague were believed to be present in hospitals or other health care facilities, let alone in Denver. It is also unlikely that health departments would have had the resources to acquire and analyze data rapidly enough to know the rate of secondary transmission or to pinpoint the outbreak's origin as quickly as was portrayed in the exercise. Without rapid access to this information and other data, decision-makers would have been even more ill-positioned to make important decisions, such as how and when to distribute antibiotics, make recommendations for containment measures, or communicate public education messages.

Participating officials who were using 800-MHz radios reported having been able to communicate efficiently, whereas communication by regular phone lines became highly dysfunctional. Hospital officials in particular had great difficulty communicating by phone with the health department or others involved with consequence management. Health department officials were not answering their usual phone lines throughout much of the crisis. They were at other operations centers, were participating in other conference calls, or were managing other aspects of the crisis. One participant said, "People were just not able to find the right persons. A significant amount of time was spent just exchanging phone, beeper, and fax numbers. All of this should be in place before a crisis."

Therapeutic Priorities and Antibiotic Distribution Mechanisms

Many of those interviewed expressed great concern about the processes needed for prioritizing and distributing antibiotics in the state. Local sources of antibiotics were quickly depleted in the early stages of the epidemic. One observer noted, "The state was very late to take control of medication and disbursement." Initially, there was no consensus about which groups should be assigned priority to receive antibiotics that were arriving via the NPS.

The governor's Emergency Epidemic Response Committee eventually decided to offer antibiotic prophylaxis to all Emergency Medical System personnel, police officers, hospital workers, and their respective families. . . . This decision caused consternation among some participants because it meant that the health department would need to justify the distribution of prophylactic antibiotics to family members of critical personnel at the same time that the city was unable to provide lifesaving antibiotics for some citizens who were already ill.

As the epidemic spread more widely, decisions regarding antibiotic distribution quickly became more complicated. There was disagreement among health experts regarding whether antibiotics should be reserved only for demonstrated contacts of case patients or whether they should be given to the general population. This argument reportedly lasted for many hours. . . .

The logistics of the distribution of antibiotics from the NPS was another process that raised concern. Local antibiotic supplies in Denver had been depleted early in the crisis. Material from the NPS was requested quickly during the outbreak, and its delivery was approved by the Surgeon General and the director of the CDC. The delivery of components of the NPS to Denver was largely notional, but material that resembled components of the stockpile was flown to an airport in Denver. Stockpile material delivered to the airport for the purposes of the drill was at one point being unbundled by a single individual who "had to count individual pills and put them into plastic baggies." Before she could even begin, there was a 6-hour delay during which terrible (notional) traffic was negotiated "in order to get the plastic baggies from Safeway."

In addition to deciding to deliver antibiotics to hospitals, the governor's Emergency Epidemic Response Committee decided to distribute prophylactic antibiotics through central antibiotic distribution facilities that were termed "points of distribution" (PODs). Although the governor's Emergency Epidemic Response Committee decided to open multiple PODs, only a sample POD was exercised during TOPOFF. One observer remarked, "They could take care of only 140 people/hour at the mass antibiotic prophylaxis [POD] center. For a city of one million, that's pitiful." Other concerns regarding the POD included the following: "No written guidelines were given out with the dispensed antibiotics. . . . Directions were too difficult to understand" and "Persons were allowed to take their antibiotics from a box, with little oversight regarding how much each took." Another commented, "What we needed from CDC was people to help us treat and give out antibiotics, not epidemiologists." As part of the exercise, 50 trainees from the Bureau of Alcohol, Tobacco and Firearms had been instructed to cause as

much unrest as possible at the POD. The unrest was largely notional, but one observer concluded that, in a real epidemic, each POD would "require several hundred people to staff it and provide security." No such staffing plan existed for the POD.

It also became clear that, if decision-makers required that receipt of antibiotic prophylaxis be linked to specific exposure criteria, there would be no reliable way to determine whether individuals had actually met those criteria; decision-makers would have to accept individuals at their word. It was not clear what people would be willing to say or do to obtain antibiotics for themselves or for their families.

At the time of termination of the exercise, at least 11 states were reporting cases of pneumonic plague, and some were demanding that they be given antibiotics from the NPS. When other states began to report cases, Denver was told by the Department of Health and Human Services authorities that no further antibiotic push-packs would be available, and that it would need to go to "vendor-managed inventory" (VMI . . .). How rapidly the VMI system would have delivered the large quantities of antibiotics that Denver was seeking was not clear and was not tested.

The Crises at Health Care Facilities

The large numbers of ill persons seeking medical care was one of the most serious challenges identified by the exercise, according to one senior health department official. Even at the outset of the epidemic, hospitals were quickly seeing far more cases than they could handle. Notional patient visits to the emergency department at one hospital were double and then triple the normal volumes. Within the short timeframe of the exercise, they quickly escalated to ten times the usual caseload.

It is important to emphasize that most of the events that occurred in health care facilities were notional. Participating hospital officials were given "injects" to relay the events of the unfolding exercise, such as what the caseload or body count had risen to and how many persons outside of the hospitals were (notionally) demanding antibiotics. Only a moderate number of patient-actors actually participated in the exercise at hospitals. Despite this, one of the major hospitals had to drop out of the exercise prematurely because it had so many actual patients that needed treatment that it could not spare the resources to participate even in the notional, "on-paper" elements of the exercise.

One public health participant noted that it appeared that the hospitals that participated in the exercise "were beyond capacity in less than 24 hours of the epidemic." A recently closed 200-bed hospital was (notionally) reopened, but was quickly filled until it could no longer admit additional patients. One participating hospital was unable to dispose of the bodies that accumulated in the emergency department and wards. By the end of the exercise, one hospital had (notionally) seen an incredible 3878 persons since the beginning of the exercise only a few days earlier. Of these, some 3200 were "worried well" -- persons who did not truly have pneumonic plague but were worried that they might have the disease or be developing it. TOPOFF did not address how health care facilities would distinguish between the uninfected "worried well,"

those with incubating or early symptoms of plague, and those with other illnesses.

Antibiotic supplies were a serious problem for the hospitals. When their own stocks were exhausted early in the exercise, hospitals called the state to request additional supplies. One participant said that the state replied that, in essence, hospitals were on their own regarding antibiotics. Hospitals attempted to contact area pharmacies, but found that no antibiotics were available. One hospital official noted that "medical and public health workers and first responders need to feel safe and need to have their families feel safe or they won't show up." But hospitals could not offer prophylactic antibiotics to all of their own staff, let alone their patients.

A number of other serious problems were catalogued. "There were not enough places to put sick people, triage people, or put dead bodies." Hospitals were competing for ventilators. It was not clear which health care workers should be wearing personal protective equipment or what form of protection was appropriate. Security at health care facilities would have played a major role in the crisis, but for understandable practical reasons, most security issues were treated entirely notionally during the exercise. The concept of a "security lockdown" was discussed, wherein all entrances to the hospital would be locked and guarded to keep out people. One hospital official expressed serious doubts that such control would ever really be possible in her hospital, which was not designed to accomplish this. Similarly, concern was expressed regarding how hospitals would have controlled the massive crowds that were notionally outside their doors, or if they would have been able to enforce an order forbidding contagious patients to leave. Another topic that wasn't directly addressed in the exercise is how decision-makers would know a hospital had been overwhelmed, given the absence of historical precedence or systems to make such a judgment.

The Need to Develop Principles of Disease Containment

Perhaps the issues that provoked the greater concerns and uncertainties with regard to TOPOFF were the series of containment measures that were undertaken to control the spread of the epidemic. One observer said, "Containing the epidemic did not receive high enough priority. No amount of incoming federal resources could stop the epidemic without a priority on containment." Another commented, "Hospitals were the squeaky wheel, and so we were preoccupied with reinforcing [efforts to treat] the mass of sick people." Even at the end of the exercise, there was still disagreement amongst decision-makers regarding what portion of resources should be dedicated to providing care for the sick and dying.

Early in the crisis, antibiotic prophylaxis and isolation of individual patients in hospitals were the primary epidemic containment measures. Less than one full day into the exercise, the epidemic was rapidly spreading -- long before health authorities had sufficient time to characterize the common source of the outbreak, the rate of secondary transmission, the response to antibiotics, or the results of other containment measures. The unfolding situation precipitated a series of increasingly stringent containment measures. By the end of the first day, the Emergency Epidemic Response Committee issued a travel advisory that restricted travel in 16 Denver metropolitan counties. However, as

one person noted, "the public was not [heeding] the voluntary travel advisory." Some people, in fact, were reported to have been racing out of the state. As part of the travel advisory, persons were advised to stay home unless they were close contacts of persons with diagnosed plague or were feeling sick; in the case of the latter, they were directed to seek medical care. As one observer noted, "They told one million people to stay in their homes. How would we have enforced this?" When asked what would be possible if the situation actually required it, the police and National Guard admitted to the Emergency Epidemic Response Committee that they would be unable to keep people at home. Another participant commented that, by the end of the exercise, "people had been asked to stay in their homes for 72 hours. . . . How were they supposed to get food or medicine?"

Throughout the unfolding epidemic, the determination of what information the public should be given and how quickly they should be given it was an important and difficult issue. "Should we tell people there is a terrorist link? Should we tell them that people are sick?" . . . It was clear that the public message itself would affect the capacity to control the epidemic . . . .

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When health officials were informed (by inject) on May 22 (5 days after the release of plague) that there were now more than 3000 persons with pneumonic plague, "it was not clear who they [the victims] were, where they lived, where they were exposed, how many of them were secondary cases.". . .

The governor's Emergency Epidemic Response Committee, in consultation with the CDC, discussed issuing an executive order that would close the Colorado state borders and the Denver International Airport. Not all committee members agreed that the borders should or could be closed. A number of senior observers said that recommendations for quarantine were made without sufficient consideration of the wide variety of ramifications. "With borders closed, how were we planning to feed four million people? . . . Many of the control measures ordered were delusional." One containment measure that was considered was the segregation of contacts at some locations, although this idea did not move forward out of committee. Another idea that was considered, but never publicly stated, was to have healthy persons go to areas termed "holding tanks"; when the seven-day incubation period of pneumonic plague had passed, persons would then be allowed to leave the state. Although, at the termination of the exercise, the Emergency Epidemic Response Committee had not officially reached a final decision regarding whether the state borders should be closed or how these measures would be enforced, it is notable that some senior TOPOFF participants stated that the decision to close state borders had been made.

Some time into the exercise, (notional) civil unrest broke out. People had not been allowed to shop. Stores were closed. Food supplies ran out because no trucks were being let into the state. Rioting began to occur. Gridlock occurred around the city, including around health care facilities. The use of snowplows was proposed as a way of clearing the road of cars. Given the constraints of the exercise, it was not possible to gauge the true extent of social disorder that a bioterrorist attack might evoke, but most observers and participants agreed that

serious civil disruption would be a genuine risk in such a crisis. The wide spectrum of disease containment measures that were considered or implemented illustrated the uncertainty surrounding what measures would, in fact, be feasible and effective. One senior health participant said that sufficient legal powers seemed to exist to carry out the decisions that were being made, and noted that legal authorities were not the problem. The critical issue was having access to the necessary scientific, technical, practical, and political expertise, and having sufficient reliable and timely information available to make sound decisions about how to contain the epidemic.

Comments offered by one senior health participant summarized the implications and lessons of disease containment: Many previous bioterrorism exercises dealt with non-contagious diseases. It is just beginning to dawn on us how dramatically different this was as the exercise ended. It terminated arbitrarily and many issues were left unresolved. It is not clear what would have happened if it had gone on. . . . There were ominous signs at the end of the exercise. Disease had already spread to other states and counties. Competition between cities for the NPS has already broken out. It had all of the [characteristics] of an epidemic out of control.

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Joseph Barbera, et al., “Large-Scale Quarantine Following Biological Terrorism in the United States,” 286 JAMA 2711

(2001)

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Throughout history, medical and public health personnel have contended with epidemics . . . . Historically, quarantine was a recognized public health tool used to manage some infectious disease outbreaks, from the plague epidemic in the 13th century to the influenza epidemics of the 20th century. During the past century in the United States, professional medical and public health familiarity with the practice of quarantine has faded. . . . Despite this lack of modern operational experience local, state, or federal incident managers commonly propose or have called for quarantine in the early or advanced stages of bioterrorism exercises. . . . A striking example of the inclination to resort to quarantine was demonstrated during a recent federally sponsored national terrorism exercise, TOPOFF 2000. . . .

Given the rising concerns about the threat of bioterrorism and the concomitant renewed consideration of quarantine as a possible public health response to epidemics, it is important that the implications of quarantine in the modern context be carefully analyzed.

Quarantine v. Isolation

. . . In the historical context, quarantine was defined as detention and enforced segregation of persons suspected to be carrying a contagious disease, Travelers or voyagers were sometimes subjected to quarantine before they were permitted to enter a country or town and mix with the inhabitants. . . .

Unfortunately, during modern bioterrorism response exercises, this term has been used broadly and confusingly to include variety of public health disease containment measures, including travel limitations, restrictions on public gatherings, and isolation of sick individuals to prevent the spread of disease. The authors believe that it is most appropriate to use quarantine to refer to compulsory physical separation, including restriction of movement, of populations or groups of healthy people who have been potentially exposed to a contagious disease, or to efforts to segregate these persons within specified geographic areas. . . We use the term isolation to denote the separation and confinement of individuals known or suspected . . . to be infected with a contagious disease to prevent them from transmitting disease to others. . . .

Legislative Framework for Disease Containment

[The article then discusses the distribution of responsibilities between local and state government and the general inadequacy of local and state legislation concerning quarantine.]

The federal government has the authority to enact quarantine when presented with the risk of transmission of infectious disease across

state lines. . . . [T]he CDC is the federal agency authorized to manage federal quarantine actions. The implementation apparatus for such an order could involve other agencies . . . . The federal government may also assert supremacy in managing specific intrastate incidents if so requested by that state’s authorities or if it is believed that local efforts are inadequate. . . .

For travelers seeking to enter the United States, the CDC has the authority to enact quarantine. . . . While rarely used, detention of arriving individuals, including U.S. citizens, is authorized to prevent the entry of specified communicable disease into the United States. [This could be described as isolation].

Currently, federal law authorizes cooperative efforts between the federal government and the state relating to planning, training, and prevention of disease epidemics and other health emergencies. Despite this, lines of authority between federal and state/local jurisdictions have not been sufficiently tested to ensure that all essential parties have clear understanding of the boundaries and interface between these potentially conflicting authorities. In a large-scale or rapidly evolving natural or deliberate biological incident, confusion and conflict in this public health authority may result. . . .

. . . .

Key Considerations in Quarantine Decisions

In most infectious disease outbreak scenarios, there are alternatives to large-scale quarantine that may be more medically defensible, more likely to effectively contain the spread of the disease, less challenging to implement, and less likely to generate unintended adverse consequences. Decisions to invoke quarantine, therefore, should be made only after careful consideration of 3 major questions . . . .

1. Do Public Health and Medical Analyzes Warrant the Imposition of large-Scale Quarantine?

Decision makers must consider whether large-scale quarantine implementation at the time of discovery of a disease outbreak has a reasonable scientific chance of substantially diminishing the spread of disease. There is no valid public health or scientific justification for any type of quarantine in the setting of disease outbreaks with low or no person-to-person transmission, such as anthrax. Despite this, quarantine has been invoked in anthrax bioterrorism hoaxes in recent years. Among the many disease that are termed contagious, only a limited number could pose a serious risk of widespread person-to-person transmission. Of these contagious diseases with potential for widespread person-to-person transmission, only a limited number confer sufficient risk of serious illness or death to justify consideration of sequestration of large groups or geographic areas. In addition to the agent characteristics, available treatment and prophylaxis options also create the context for the decision process. Public health responses must be accurately tailored to meet the specific risks and resource needs imposed by individual agents.

There are imaginable contexts in which a large-scale smallpox

outbreak would generate a reasonable consideration for quarantine. But even in the setting of a bioterrorist attack with smallpox, the long incubation period almost ensures that some persons who were infected in the attack will have traveled great distances from the site of exposure before the disease is recognized or quarantine could be implemented. . . .

2. Are the Implementation and Maintenance of Large-Scale Quarantine Feasible?

Is there a plausible way to determine who should be quarantined? Are there practically available criteria for defining and identifying a group or a geographic area that is at higher risk of transmitting a dangerous disease? As noted, depending on the disease-specific incubation period and due to the mobility of modern society, it is probable that a population exposed to a biological weapon will have dispersed well beyond any easily definable geographic boundaries before the infection becomes manifest and any disease containment measures can be initiated. Even within a specific locale, it will be initially impossible to clearly define persons who have been exposed and, therefore, at risk of spreading the disease. A quarantine of a neighborhood would potentially miss exposed individuals, but a large-scale quarantine of a municipality could include many with no significant risk of disease. Currently proposed or functional health surveillance systems have not yet demonstrated adequate proficiency in rapid disease distribution analysis.

Are resources available to enforce the confinement? The human and material resources that would be required to enforce the confinement of large groups or persons, perhaps against their will, would likely be substantial, even in a modest-sized quarantine action. The behavioral reaction of law enforcement or military personnel charged with enforcing quarantine should also be considered. It is possible that fear of personal exposure or public reaction to enforcement actions may compromise police willingness to enforce compliance.

Can the quarantined group be confined for the duration during which they could transmit the disease? Quarantine will not be over quickly. The period during which confined persons could develop disease might be days or weeks, depending on the specific infectious agent. Development of illness among detainees could prolong the confinement of those remaining healthy. Resources and political resolve must be sufficient to sustain a quarantine of at least days, and probably weeks. Furthermore, the multiple needs of detainees must be addressed in a systematic and competent fashion. . . .

3. Do the Potential Benefits of Large-Scale Quarantine Outweigh the Possible Adverse Consequences?

. . . .

What are the health risks to those quarantined? . . . [T]here are U.S. historical examples in which persons with clear evidence of infection with a contagious disease have been quarantined together with persons with no evidence of infection. It is now beyond dispute that such measures would be unethical today, but a recent event illustrates that this ethical principle might still be disregarded or misunderstood

[citing an incident in which an airplane full of passengers was isolated because one passenger had suspicious symptoms].

What are the consequences if the public declines to obey quarantine orders? It is not clear how those quarantined would react to being subjected to compulsory confinement. Civilian noncompliance with these public health efforts could compromise the action and even become violent. Historical quarantine incidents have generated organized civil disobedience and wholesale disregard for authority. . . . Some might lose confidence in government authorities and stop complying with other advised public health actions (e.g., vaccination, antibiotic treatment) as well. The possibility also exists for development of civilian vigilantism to enforce quarantine . . . . The rules of engagement that police are expected to follow in enforcing quarantine must be explicitly determined and communicated in advance. Protection of police personnel and their families against infection would be essential to police cooperation.

What are the consequences of restricting commerce and transportation to and from the quarantined area? Halting commercial transactions and the movement of goods to and from quarantined areas will have significant economic effects that may be profound and long term and reach well beyond the quarantined area. Much modern business practice relies on just-in-time supply chains. Shortages of food, fuel, medicines and medical supplies, essential personnel, and social services (sanitation) should be anticipated and provisions must be in place to deal with such issues. Post-quarantine stigmatization of the geographic location and of the population quarantined should be anticipated.

Conclusions and Recommendations

The essential first step in developing any disease containment strategy is to determine if the disease is communicable. If not, then no consideration of quarantine should be pursued. If the disease of concern is contagious, then the specific mechanism of disease transmission must drive the disease containment strategy (e.g., spread by cough at close distances or possibly over long range, as has occurred in smallpox outbreaks; or spread through person-to-person contact, as in Ebola outbreaks). Some progress in delineating disease containment strategies for bioterrorism-induced outbreaks has already occurred in the form of consensus public health and medical recommendations, though more diseases must be addressed and public health actions examined. Political leaders in particular need to understand that a single strategy for limiting the spread of all contagious diseases is not appropriate and will not work. The political consequences of public health actions such as large-scale quarantine must also be carefully examined and understood. Modern U.S. disaster response has consistently focused on assistance to those directly affected; in the case of bioterrorism, response will focus on both those potentially and actually infected. With implementation of quarantine, the perception may be that those potentially and actually infected have instead been secondarily harmed by response actions.

In an outbreak of a contagious disease, disease containment may be more effectively achieved using methods that do not attempt to contain large groups of people. As noted, persons with clinical or laboratory evidence demonstrating infection with a contagious disease

should be isolated, separate from those who do not have clinical or laboratory evidence of that disease. Depending on the illness, this isolation may be primarily respiratory, body fluid, or skin contact isolation rather than full physical separation from all healthy people.

Additionally, population-based public health intervention strategies should also be considered. Depending on the context, rapid vaccination or treatment programs, widespread use of disposable masks (with instructions), short-term voluntary home curfew, restrictions on assembly of groups (e.g., schools, entertainment sites) or closure of mass transportation (buses, airliners, trains, and subway systems) are disease containment steps that may have more scientific credibility and may be more likely to result in diminished disease spread, more practically achievable, and associated with less adverse consequences. For clarity, these alternative disease control measures should not be termed quarantine or quarantine actions.

During large-scale contagious disease outbreaks, decision makers would be critically dependent on the availability of timely, accurate information about what is happening and what interventions are desirable and feasible. Emergency management and public health officials will need real-time case data and the analytic capacity to determine the epidemiological parameters of the outbreak to make the most appropriate disease containment decisions. Clinicians will seek information about the natural history and clinical management of the illness and ongoing analyses of the efficacy of treatment strategies. Rapid communication between the medical and public health communities may be especially important and in most locales is currently not conveyed by electronic means or though routine, well-exercised channels.

Positive incentives may help to persuade the public to take actions that promote disease containment. The ready provision of adequate medical expertise, appropriate vaccines or antibiotics, or distribution of disposable face masks to the public in specific circumstances are examples of incentives that may positively influence population behavior to promote disease containment. Allowing family members to voluntarily place themselves at some defined, calculated risk of infection to care for their sick loved ones might encourage participation in a community’s overall disease containment strategy. Assisting family members in these efforts by offering them some forms of protection against the disease could be a valuable aspect of an integrated disease containment strategy. . . .

The development of strategies for communicating with the public throughout a disease outbreak is of paramount importance. Objectives of this strategy would include informing the public through multiple appropriate channels of the nature of the infectious disease and the scope of the outbreak, providing behavioral guidelines to help minimize spread of illness, and conveying details about how to get prompt access to effective treatment. Ideally, such messages would be conveyed by informed, widely recognized health experts such as the state health commissioner or U.S. Surgeon General. In a bioterrorist attack, the media’s appetite for information will be limitless and health authorities must be prepared to provide accurate and useful information on a nearly continuous basis. Advanced planning and preparation for such a media storm is essential. Once public credibility is lost, it will be difficult or impossible to recover. A well-informed public that

perceives health officials as knowledgeable and reliable is more likely to volunteer to comply with actions recommended to diminish the spread of the disease. Effective information dissemination would work to suppress rumors and anxiety and enlist community support.

It is clear that public health strategies for the control of potential epidemics need to be carefully reevaluated. This process should ensure that civil rights and liberties are kept at the forefront of all discussions . . . . Further delineation of the authority to impose quarantine is required, and the political and psychological implications must be addressed. Given the complex multidisciplinary nature of the problem, further analysis of possible disease containment strategies would ideally include experts from the fields of medicine, public health, emergency management, law, ethics, and public communication. . . .

* * *

Christopher F. Chyba, “Towards Biological Security, 81 Foreign Affairs 122 (2002)

* * *

The anthrax attacks on the United States in the autumn of 2001, and the fear and confusion that followed made clear that the country lacks a comprehensive strategy for biological security -- the protection of people and agriculture against disease threats, whether from biological weapons or natural outbreaks. Too often, thinking about biological security has been distorted by misplaced analogies to nuclear or chemical weapons. An effective strategy must leave these analogies largely behind and address the special challenges posed by biological threats.

A strategy for biological security must confront drug-resistant and emerging diseases -- more than 30 of which have entered the human population over the past quarter-century. There is no good analogue to this naturally occurring threat in the realm of nuclear or chemical weapons. Moreover, diseases may be targeted against livestock or crops as well as against human populations. And outbreaks of deadly, contagious, and long-incubating diseases such as smallpox have to be detected and stopped rapidly wherever in the world they occur. Fortunately, once formulated, a sound strategy for biological security will help sustain itself because many of its core provisions will benefit public health even apart from acts of bioterrorism.

In fact, many of the tools used to address natural disease threats will be needed to respond to an intentional attack. The U.S. response to the anthrax attacks has emphasized the importance of improving domestic defenses. These measures include stockpiling vaccines and antibiotics, as well as improving local and national disease surveillance and other public health tools. To be effective these domestic measures must be sustained for decades and keep pace with the biotechnology revolution. International steps -- such as improving surveillance for and response to outbreaks of infectious diseases and securing pathogen stocks worldwide -- are also crucial to an effective strategy. Yet most of these international measures have been ignored so far in the current focus on immediate domestic needs.

. . . .

Scientists can acquire potentially deadly biological agents in the course of legitimate research. For instance, U.S. and British government institutes previously distributed the Ames anthrax strain used in the autumn 2001 attacks to a dozen or so laboratories. Naturally occurring disease outbreaks are another source of lethal organisms: The Ames strain is common in eastern Texas, for example. Indeed, natural outbreaks are the ultimate origin of the agents historically used in nations' biological weapons programs. Moreover, the fermenters required to produce these biological agents in large quantities are widely used in the pharmaceutical, biotechnology, and even beer industries.

Weaponizing these diseases -- going from the organism to a preparation that is particularly suitable for distribution as a powder or liquid aerosol -- has proved difficult for terrorists. The Japanese group Aum Shinrikyo failed to weaponize anthrax despite devoting substantial financial and scientific resources to the task. But the group's repeated, unsuccessful attempts to spray liquid anthrax aerosol throughout downtown Tokyo in 1993 demonstrated that attacks designed to cause massive urban casualties were no longer in the realm of the fantastic. Then, last autumn's attacks in the United States, when professional-grade anthrax powder was sent through the mail, made clear that an individual or group has now either successfully crossed the weaponization threshold or succeeded in acquiring such material from a national weapons program.

Genetic modification of biological agents (to make them resistant to vaccines or antimicrobial drugs, for instance) probably remains beyond the capabilities of terrorist groups for the time being -- although the illicit Soviet program did carry out such work and scientists have in effect done the same in research contexts. This sort of biotechnical know-how is spreading quickly.

The challenges posed by biological nonproliferation -- the dual-use character of materials and equipment, the small amounts of agents initially needed and their availability from natural outbreaks, and the dynamic nature of biotechnology -- guarantee that an effective strategy for biological security will look very different from the corresponding techniques used to curtail the spread of nuclear or chemical weapons. Biological security requires a different mix of nonproliferation, deterrence, and defense.

. . . .

Deterrence through the threat of retaliation has been the central strategy for preventing the use of weapons of mass destruction against the United States or its allies. And deterrence may remain effective against a state's use of biological weapons. But biological terrorism by sub-national groups poses special challenges in this regard. Deterring any form of terrorism is difficult, since some terrorist groups may be unconcerned about retaliation or may hope to remain unidentified. But the biological case is especially problematic. Because some diseases incubate without symptoms for days or even weeks, tracing an attack back to its perpetrators can prove difficult. Terrorists might even hope that their attack would go unrecognized as such. For instance, when followers of the Bhagwan Shree Rajneesh infected 750 Oregonians with salmonella in 1984, it was more than a year before authorities determined that the infection had been intentionally spread.

The summer 1999 outbreak of the West Nile virus in New York illustrates how difficult it can be in some circumstances to distinguish an intentional attack from a natural outbreak. Before the disease killed seven people in the New York City area, West Nile had never before occurred in the western hemisphere. Due to bird migration, the virus has now spread to 27 states. Although the outbreak was apparently "natural" in origin, perhaps caused by an infected traveler or mosquito transported from the Middle East, it is remarkable that in April 1999, only a few months before the outbreak, an Iraqi defector had claimed that Saddam Hussein planned to weaponize the virus.

The United States should do what it can to increase the likelihood that an attack will be attributable. An essential resource is a DNA library of as many strains of relevant biological agents as can be assembled. DNA "fingerprinting" of the agent causing an outbreak is an important forensic tool, but it is most useful if the fingerprints are already on file. (DNA fingerprinting does not identify the perpetrator, however -- only the weapon used. In this sense it is more like ballistics testing than human fingerprinting.) The United States needs a DNA library not only of natural and weaponized strains within U.S. collections but also of those located in inventories around the world. . . .

In addition to the difficulties of attribution, some terrorist groups may also believe themselves to be invulnerable to retaliation, may be unconcerned by it, or may even intend to provoke it. Such groups are obviously poor candidates for deterrence through the threat of retaliation. However, deterrence by denial -- deterring enemies by convincing them that biological defenses are credible and that therefore an attack would be unlikely to succeed -- may be a more useful tool for biological security than it was for nuclear weapons. Of course, warning and prevention are preferable to coping with the consequences of an attack, so intelligence remains vital. But as the anthrax mail attacks made clear, biological terrorism can occur with little or no warning.

The intrinsic challenges of stopping the spread of biological weapons, and the difficulties posed for deterrence suggest that biological security strategy should lean more heavily toward defense than has been true of nuclear or chemical security strategy. Building biological defenses will of course require appropriate steps by the Defense and Justice Departments. But just as important, and for too long overlooked, biological security means improvements in domestic and international public health.

Prior to September 11, 2001, a number of analysts had in fact argued just this point: that a robust defense against bioterrorism must be based on improved public health. Because disease incubation times for some agents can be as long as weeks, the first responders to a biological attack are likely to be health care workers rather than fire, police, or military personnel. Public health surveillance for signs of unusual disease is therefore critical. Improvements in "sensitivity" and "connectivity" are required. Sensitivity means the recognition by health care workers that an illness is out of the ordinary; connectivity is the reporting of this recognition to local, state, and national authorities, and consequent timely help with diagnosis and treatment. The anthrax mail attacks tragically confirmed the importance of disease surveillance, since the speed with which doctors recognized the signs of anthrax infection determined whether patients were treated immediately or sent home, only to return later to die.

In 1999, the U.S. government initiated the Biological Preparedness and Response Program (BPRP) within the Centers for Disease Control and Prevention. This program put in place many of the crucial steps required for a domestic public health defense against bioterrorism. The BPRP created the National Pharmaceutical Stockpile (NPS) of antibiotics and other drugs that could be rapidly deployed to counter domestic outbreaks. The BPRP also funded pilot projects to bolster disease

surveillance, improved capacity at the state and local levels, and sponsored research. In fiscal year 2000, the BPRP budget stood at $155 million, an amount that some experts viewed as only one-tenth the funding needed for the tasks required. But at the time, there was legitimate disagreement -- indeed, there still is -- over the right balance between spending to prepare for rare but potentially disastrous events such as bioterrorism, and spending to counter naturally occurring infectious diseases that are already killing many individuals every day.

Nonetheless, the October 2001 anthrax crisis would have seemed far more dire had the NPS not existed, and the understandable public tendency to begin self-medicating with antibiotics would have been even more difficult to contain. One of the great hazards of this response is its likely acceleration of antibiotic resistance in bacteria -- resistance that can then be swapped between bacteria of different species. For the same reason, it is important that the poultry industry is reducing the quantities of antibiotics fed to healthy chickens, and analogous practices in other livestock industries should be similarly scrutinized. An effective biological security strategy must cast its net far wider than traditional national security issues.

Fortunately, many of the steps that are needed to prepare for bioterrorism will also improve recognition of and responses to natural disease outbreaks. Spending on biological defenses therefore represents a win-win situation in which society benefits even if no further bioterrorist attacks take place. The West Nile outbreak again provides an example: had better communication between veterinarians and public health officials existed in early summer 1999, when crows began to die in New York City, the outbreak could have been recognized months earlier.

After the anthrax mail attacks, attitudes toward domestic public health spending to prepare for bioterrorism rapidly changed. . . . Indeed, the 2002 emergency supplemental appropriations bill and a separate bioterrorism bill include billions of dollars in new spending for biological defense. These bills include steps to expand the pharmaceutical stockpile, increase stores of the smallpox vaccine, strengthen state and local preparedness, and improve food safety. Domestically, the right steps are being funded. The challenge will be to sustain this commitment as the psychological distance from September 11 grows.

Admittedly, not all measures taken against bioterrorism have dual uses. The NPS antibiotic supply is unlikely to be needed to counter natural outbreaks, and storing the smallpox vaccine prepares for a disease that no longer exists in the natural world. Because antibiotics have a finite shelf life, making the expanded NPS financially sustainable may require the government to create incentives for research into extending antibiotic shelf life (something that market forces themselves may not encourage) and ensuring sufficient extra production capacity in the event of a crisis.

Other forms of research must also continue. Standard antibiotics are effective against all the bacteria that are commonly listed as biological agents, but the Soviet bioweapons program produced strains of anthrax resistant to some antibiotics, and such bioengineering will become more widely available. Vaccines are available for some viral

agents, such as smallpox, but there are no effective drugs for others, such as many of the viral hemorrhagic fevers (e.g., Ebola or Marburg, which the Soviets reportedly weaponized). For the foreseeable future, therefore, we are locked into a kind of biological defensive arms race in which researchers will need to develop different or more broadly effective anti-microbial drugs and vaccines against possible new threats.

An effective defense against bioterrorism also requires the means to distribute vaccines and antimicrobial drugs effectively, perhaps amid the extremely challenging circumstances of public panic. The effects of public fear should not be underestimated, and the lessons from real or potential mass casualty situations involving invisible, lingering threats are sobering. Aum Shinrikyo's 1995 sarin nerve gas attack in the Tokyo subway system injured hundreds of Japanese citizens, but 5,000 sought help at hospital emergency rooms. Similarly, when the governor of Pennsylvania in 1979 suggested the evacuation of pregnant women and preschool children living within a five-mile radius of the Three Mile Island nuclear power plant -- in effect recommending that a few thousand people leave the area -- between one and two hundred thousand fled. Responses to these sorts of reactions should be planned before crises occur.

The U.S. government's response to last fall's bioterrorist attacks rightly highlighted the importance of domestic public health measures but showed little appreciation for the fact that no response can succeed if it stops at the nation's borders. International measures are crucial to a successful strategy for reasons as simple as arithmetic. Many diseases, such as plague and smallpox, have lengthy incubation times (an average of 2 to 3 days and 12 days, respectively). But the flight time between virtually any two cities in the world is now less than 36 hours. Carriers of smallpox, whether terrorists or unwitting victims, could transport the disease around the world before they ever showed signs of illness. Some 140 million people enter the United States by air every year. Although improvements to border protection are important, neither the United States nor other nations can hope to protect themselves exclusively by guarding their frontiers. For both humanitarian and national security reasons, outbreaks of emerging infectious diseases need to be addressed overseas as well as domestically. When possible they should be prevented, but if that does not happen, such outbreaks need to be detected, diagnosed, and controlled as quickly as possible.

Any outbreak of a highly contagious, lethal, and long-incubating disease such as smallpox poses a grave international threat. In 1972, a single religious pilgrim returned to Yugoslavia from Mecca via several days in Iraq, where he had contracted smallpox. Smallpox had spread to Iraq from Iran, where a family had introduced it after acquiring it while traveling through Afghanistan. The disease in Yugoslavia went undiagnosed while the original infected individual spread the disease to others, one of whom traveled 100 miles by bus. To contain the resulting outbreak, Tito's government vaccinated 18 million people and quarantined some 10,000 in commandeered hotels and apartment buildings ringed with troops and barbed wire. By comparison, on September 11, 2001, the United States had fewer than 15 million doses of smallpox vaccine available to a larger and far more mobile society. Epidemiological models indicate that quarantine can to some extent be traded off against vaccination to control an outbreak. But better preparation with appropriate vaccines or

drugs will diminish the curtailment of civil liberties that would otherwise be needed to control contagious outbreaks.

. . . .

Rapid detection of outbreaks requires improvements in international disease surveillance, for which the chronically under-funded World Health Organization (WHO) is central. In the event of a bioweapons attack abroad, reference laboratories (designed to examine environmental and medical samples) must be available overseas, or else U.S. domestic capacity will be swamped with international samples. Cost estimates begin in the tens of millions of dollars annually for minimal improvements in international disease surveillance and reference lab capacity, through the creation of regional WHO centers that build wherever possible on existing facilities. With its vast new spending on bioterrorism defense, the United States should allocate resources to fund these and other such serious, sustainable improvements in global public health. Whether the next threat is smallpox or a new AIDS-like epidemic disease, improving global infectious disease surveillance and response will be good for both humanitarian reasons and national security.

The United States is also creating a smallpox vaccine stockpile sufficient for all Americans. Although one recent epidemiological simulation suggests that a stockpile of 40 million doses would be sufficient to control likely outbreaks, it is difficult to predict whether a real attack would be as limited as that simulation assumes. Moreover, it should be clear from the public response to last autumn's anthrax scare that no White House will want to find itself in a position of having to explain to the American people why only some are eligible to receive vaccinations after an attack. The American people -- like most people throughout the world -- have for decades not been routinely vaccinated against smallpox, and the vaccine's effectiveness attenuates after ten years. The global population is now more vulnerable to smallpox than any large population has been since the illness devastated Native Americans after European explorers brought it to the Americas.

But even a stockpile for all U.S. citizens is insufficient. In the event of a smallpox outbreak overseas -- whether in a NATO ally or in the developing world -- humanitarian concern, international opinion, and its own self-interest will pressure the United States to shut down the outbreak and limit its spread. The WHO smallpox vaccine stockpile stands at half a million doses. The United States must either augment its national stockpile so that it can respond internationally without jeopardizing its own citizens or work with the WHO to increase international supplies. Of course, the United States should encourage other nations to do the same, but it should not allow others' inaction to prevent it from acting in its own security interest to improve global public health.

* * *

SIDEBAR: SMALLPOX?!? DIDN’T WE GOT RID OF THAT?

[The following is based on a report issued in January 2004 by the Democratic members of the House Select Committee on Homeland Security, and entitled A Biodefense Failure: The National Smallpox Vaccination Program One Year Later]

* * *

Smallpox has been called one of the great scourges of humanity. The disease is highly contagious, killing up to 30 percent of its victims and leaving many survivors disfigured and blind. For those displaying symptoms, there is no approved treatment. Smallpox became the target of a successful worldwide eradication campaign in the late 1970’s. More than 20 years later and with vaccination discontinued, American and much of the world has become immunologically “naïve” and susceptible to infection. The U.S. population today is vulnerable in the same way as colonial-era Native Americans . . . .

Although officially declared eradicated in 1979, stocks of the virus were maintained in some laboratories, and the world’s nations were asked to either declare or destroy their stocks. Only two declared repositories of the deadly virus remain, both in high security facilities in Atlanta, Georgia and Novosibirsk, Russia. However there is reason to believe the virus is not confined to be these two laboratories and it may be accessible to terrorists. . . .

If released, a smallpox attack would likely be devastating. Estimates range from thousands to millions of deaths, depending upon the type of attack scenario . . . . Without any prior vaccination, estimates of a smallpox release at an airport, resulting in rapid and widespread geographic diffusion of infected people, could cause over 50,000 deaths. Airborne dispersion could infect hundreds of thousands . . . . While some residual immunity in the population exists from those vaccinated prior to 1972, the degree of immunity is unknown. . . . As a result, the country could be thrown into disarray. . . .

If a smallpox attack does occur, a quick, deliberate response is essential to saving lives, preventing panic, and maintaining essential services. Health care workers and emergency responders already immune to the virus could be crucial in responding to any outbreak, assessing potential victims, administering treatment, caring for isolated and quarantined individuals, and vaccinating the public for protection. If smallpox is released, hospital workers and laboratory employees will be more essential than ever. Their own safety must be assured in order to keep hospitals open, diagnostic laboratories operating, and the health care system running. . . . [A]bout 2 million people, including ambulance drivers, police officers, and vaccinators would be needed for a mass vaccination effort.

. . . While it is true that the threat of smallpox could be eliminated if we revaccinated the entire population, and maintained this

protection until we were sure that all stockpiles of the virus in the world were secured, the only vaccine currently available presents its own risks.

The vaccine can have serious side effects for a small percentage of those vaccinated, and, because it involves a live virus, for those with whom vaccinated individuals come in contact. . . . [u]p to 1,250 serious reactions per 1 million vaccinations, including 2 deaths, have been predicted . . . .

[If those who are most at risk are screened out of the program a limited vaccination program of soldiers, health care workers, and first responders] can substantially reduce the smallpox threat while avoiding the public health risk of a mass vaccination. . . . In calling for such an action, federal officials must be careful in their planning, sincere in their belief of the threat of smallpox, and responsive to the needs of the state and local health departments and hospitals that must carry out vaccinations, as well as of the volunteers themselves. The federal government, however, has not taken strong, effective leadership. As a result, the National Smallpox Vaccination Program has failed and the nation remains vulnerable.

When announced December 13, 2002, the Administration called for a three phase civilian vaccination plan to enhance homeland security, as well as the vaccination of a half-million military personnel. Since 1999, Congress has appropriated $560 million to purchase enough vaccine for every man, woman, and child in the United States. Phase I involved the use of this stockpile to vaccinate volunteers who would constitute trained public health and health care response teams within every state. These teams would be responsible for responding to a possible outbreak, treating victims, and vaccinating others to keep the virus from spreading. CDC indicated the benchmark for measuring the state of preparedness would include the ability to vaccinate the entire state population with 10 days. Plans submitted to CDC by state and local jurisdictions indicated about 500,000 people would be vaccinated in this phase. CDC intended for these teams to be ready within 30 days after the program’s start. After this effort, Phase 2 of the plan envisioned the vaccination of up to 10 million additional health workers and traditional first responders over a one-year period. . . . Finally the Administration announced its intention to offer the smallpox vaccine to the general public on a restricted basis.

While the military vaccination program was completed successfully in October of 2003, with well over 500,000 personnel vaccinated, the civilian program has fared much more poorly.

. . . One year [after the initiation of the program] only 39,000 civilians have actually been vaccinated. . . . Only 4 states have even achieved over 50 percent of their projected vaccination numbers. In New York City, with a population of 8 million, only 342 people have been vaccinated . . . Chicago is even worse . . . . Nevada, known to contain high-value terrorist targets such as Las Vegas and Hoover Dam, has only 17 personnel vaccinated. . . .

State officials themselves report a widespread lack of preparedness. Survey results indicate that 28 states have not completed

Phase 1 of the vaccination program . . . . Moreover, in an anonymous survey question, where states could not be identified, state health officials reported that 40 percent of states cannot effectively vaccinate their populations within 10 days of smallpox outbreak . . . .

. . . The evidence suggests that the 39,000 who are vaccinated are not appropriately distributed across states to be effectively deployed for a response and that they are, in most cases, not integrated into a clear, local, state, or federal smallpox preparedness plan.

The Administration has been unable to restart a program that has been stalled since May of 2003, leaving a conspicuous gap in our biodefenses. There has been no attempt by the Administration to change this situation, and no indication of a strategy or intention of significant magnitude to do so. Instead, the program appears to be an embarrassing failure of the government, with serious implications for homeland security.

[The report then assesses the reasons for the program’s failure:]

The Administration failed to recognize that smallpox vaccinations would be a serious strain on state and local health care resources. . . . According to one study, the average cost of the program at the local level would be about $204 per vaccine, with some states estimating costs as high as $400. . . .

The provision of adequate compensation to those volunteers suffering side effects from vaccination is a critical element to a successful smallpox preparedness program . . . and sends a strong message to volunteers who participate . . . . Unfortunately, the Administration did not properly manage the critical issue of compensation. . . .

. . . .

The Administration has failed to adequately inform the public of the dangers of smallpox and convince essential health care workers to participate in the vaccination. . . . [W]orkers and the public have become complacent about the smallpox threat and resistant to vaccination. . . .

* * *

Heather H. Horton, James J. Misrahi, Gene W. Matthews, & Paula L. Kocher, Critical Biological Agents: Disease

Reporting as a Tool for Bioterrorism Preparedness (CDC 2003)

* * *

One measurement of the public health system’s level of bioterrorism preparedness is the quality and quantity of laws mandating the reporting of diseases caused by certain critical biological agents. . . . In fact, the timely and accurate reporting of diseases caused by such agents would likely be the triggering event for investigating and responding to a bioterrorism event. In order to assess the nation’s bioterrorism preparedness . . . CDC commissioned a study of state and local requiring the reporting of diseases . . . .

. . . .

. . . Not until 1925 did all states submit data on the occurrence of certain infectious diseases to the U.S. Public Health Service. Today, the Council of State and Territorial Epidemiologists in consultation with the CDC decides what diseases and conditions are nationally reportable to the CDC. The system, however, is voluntary, with states under no legal obligation to report information, revise their lists of reportable diseases, or follow unified standards . . . .

The CDC’s strategic plan for bioterrorism has focused on preparedness and prevention; detection and surveillance; diagnosis and characterization of biological and chemical agents; response; and communication. . . . [T]hey are necessarily dependent on a strong and flexible public health system at the state and local level. Advanced laboratory tests and caches of medical supplies are useful only if federal officials are aware that a suspected release of a biological agent has occurred. Accordingly, physicians and health care providers must not only be able to identify unusual patterns of disease and injury, but must report such unusual occurrences to appropriate public health officials to ensure a timely response.

CDC’s study of disease reporting laws examined the reporting requirements of 54 jurisdictions, including the 50 states . . . . Twenty-four critical biological agents were chosen for the study. . . .

. . . Terrorist experts are most concerned with category A agents because that have the greatest potential for harm if used in a bioterrorist attack. These agents can be easily disseminated or transmitted person-to-person; cause high mortality; would impact severely the public’s health; might cause public panic and social disruption; and require special action for public health preparedness. Six diseases are caused by category A agents: anthrax, botulism, hemorrhagic fevers, plague, smallpox, and tularemia.

Category B and C agents, while considered important in bioterrorism preparedness, are less of an immediate concern . . . .

Category B agents include pathogens that are foodborne or waterborne, including the diseases salmonella and cholera. . . . Category C agents include emerging pathogens that could be engineered for mass dissemination in the future, but are not at present likely to be used as a bioterrorism weapon. These agents result in such diseases as hantavirus, typhus fever, and viral encephalitis. . . .

. . . .

Persons who have a mandatory duty to report usually include physicians and other health care providers, laboratory directors, and hospital administrators. In addition some jurisdictions also list school principals, child care centers, nursing home administrators, personnel of food establishments, or anyone with knowledge of a case. The entities to which persons must report are, state, county, or local health agencies or other health authorities. . . .

The study revealed significant deficiencies in the immediate reporting of diseases associated with Category A agents, i.e., those with the greatest potential for harm . . . For example, while anthraxbotulism, and plague are reportable immediately in the vast majority of jurisdictions, hemorrhagic fevers and smallpox are immediately reportable only in 26 percent and 39 percent of the surveyed jurisdictions. Tularemia is reportable only in less than half of these jurisdictions. The study also revealed some weaknesses in the explicit reporting of Category B and C agents . . . . While it is reassuring that cholera, salmonella, and shigella are explicitly reportable in 100 percent of the jurisdictions surveyed, glanders, meliodosis, mycotoxins, and staphylococcal enteroxin are not explicitly reportable in most jurisdictions. Ricin poisoning and Q fever, moreover, are not explicitly reportable in 91 percent and 32 percent of jurisdictions. . . .

. . . [A]ll state should, at a minimum, mandate the immediate reporting of diseases caused by Category A agents . . . . Additionally guidelines or model laws [should be developed] for the reporting of all disease caused by Category A, B, or C agents. . . .

Disease reporting raises numerous practical and legal concerns for the physician, public, and patient. Statutes, in some places, may require revision; an expansion of state disease reporting laws to mandate, at a minimum, the reporting of diseases caused by Category A agents would not unduly increase the burden on health care providers and others under a legal obligation to report. Furthermore, the increased benefit to the public in preparedness for a bioterrorism event would clearly outweigh such a moderate increase in the burden of disease reporting.

An expansion of state disease reporting laws . . . is also not likely to raise legal concerns regarding patient privacy [either as a matter of constitutional law or as a matter of the privacy requirements of the HIPAA]. Furthermore, unlike the reporting of sexually transmitted diseases, an expansion of disease reporting requirements to include Category A critical biological agents is likely to raise fewer societal concerns of stigmatization and discrimination for those exposed to such agents.

[It] is also unlikely to lead to increased civil liability for physicians or other health care providers. . . .

Another concern with expansion of the disease-reporting list is the increased burden of compliance. State governments may wish to revise their lists of reportable diseases to remove agents not associated with bioterrorism or which pose less of a threat to public health. Furthermore, greater education about the role of physicians and health care providers as the first lines of defense against bioterrorism may lead to greater acceptance of an extended list of reportable disease among the health care community. Many physicians, for example, may not be aware that even common agents such as salmonella may be used as a bioterrorist weapon . . . . or lack training in the recognition of symptoms associated with such rare diseases as anthrax or smallpox.

Some health care practitioners may not see the need to expand the reporting of diseases cased by critical biological agents because many jurisdictions require the reporting of any disease of public health significance. Although these general disease reporting laws may be useful in capturing newly emerging or unrecognized diseases, they should not replace agent-specific reporting of diseases caused by critical biological agents. The lack of agent-specific disease reporting laws may lead to confusion over whether a particular disease is reportable and diminished capacity of health professionals, though lack of awareness and training, to recognize or diagnose certain bioterrorism-related diseases. . . .

In many jurisdictions failing to report a reportable disease also constitutes a misdemeanor punishable by fine or imprisonment. While some health care practitioners may question the need for penalties for non-reporting at all, under the belief, for example, that no responsible health care provider would fail to report a suspicion of smallpox, the existence of such laws nonetheless serve as an important tool in elevating the importance of the role of specific agents or diseases associated with bioterrorism. Furthermore, law not only serves as an educational tool in highlighting what conditions or conduct society deems of consequence, but also serves as a way to punish “bad actors” who may wish to harm the public’s health. The existence of these laws, moreover, may serve as an incentive for health care providers to obtain the training and skills to diagnose and respond to diseases whose occurrence are rare, but nonetheless of potential national importance.

* * *

Anthrax

Botulism

Hemorrhagic fever

Plague

Smallpox

Tularemia

Can be airborne and contracted by breathing of bacteria or spores; cannot be spread person-to-person; initially resembles a common cold; usually fatal.

Typically foodborne; among the most poisonous substance; causes blurred vision, difficulty swallowing; paralysis; often fatal.

A group of viruses such as Ebola, Lassa, and Marburg; causes fever, fatigue, aches, diarrhea; internal bleeding; often fatal.

Fever; headache; cough; may cause shock and death.

Spread person-to-person easily through saliva; causes fever, headaches;blisters; blindedness; fatal in 1/3 of cases.

One of the most infectious pathogenic bacteria; can be spread with aerosol; causes fever; chills; inflammation; hemorrhaging; can be fatal.

Treatable if antibiotics taken soon after exposure; limited supply of vaccine not available to public.

Treatable if assistance with breathing provided; antitoxin is effective if administered early.

There is no known cure or treatment.

Early treatment with antibiotics can be effective.

Vaccination effective. No treatment.

Vaccine under review by FDA.

Center for Law and Public Health, M odel State Emergency Health Powers Act (2001)

* * *

Section 103 Purposes.

(a) To require the development of a comprehensive plan to provide for a coordinated, appropriate response in the event of a public health emergency. (b) To authorize the reporting and collection of data and records, the management of property, the protection of persons, and access to communications. (c) To facilitate the early detection of a health emergency, and allow for immediate investigation of such an emergency by granting access to individuals' health information under specified circumstances. (d) To grant State and local officials the authority to use and appropriate property as necessary for the care, treatment, vaccination, and housing of patients, and to destroy contaminated facilities or materials. (e) To grant State and local officials the authority to provide care, treatment, and vaccination to persons who are ill or who have been exposed to contagious diseases, and to separate affected individuals from the population at large to interrupt disease transmission. (f) To ensure that the needs of infected or exposed persons are properly addressed to the fullest extent possible, given the primary goal of controlling serious health threats. (g) To provide State and local officials with the ability to prevent, detect, manage, and contain emergency health threats without unduly interfering with civil rights and liberties.

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ARTICLE II. PLANNING FOR A PUBLIC HEALTH EMERGENCY

Section 201. Public Health Emergency Planning Commission.

The Governor shall appoint a Public Health Emergency Planning Commission ("the Commission"), consisting of the State directors, or their designees, of agencies the Governor deems relevant to public health emergency preparedness, a representative group of state legislators, members of the judiciary, and any other persons chosen by the Governor. The Governor shall also designate the chair of the Commission.

. . . .

The Commission shall, within six months of its appointment, deliver to the Governor a plan for responding to a public health emergency, that includes provisions or guidelines on the following: (1) Notifying and communicating with the population during a state of public health emergency in compliance with this Act; (2) Central coordination of resources, manpower, and services, including coordination of responses by State, local, tribal, and federal agencies; (3) The location, procurement, storage, transportation, maintenance, and distribution of essential materials, including but not limited to

medical supplies, drugs, vaccines, food, shelter, clothing and beds; (4) Compliance with the reporting requirements in Section 301; (5) The continued, effective operation of the judicial system including, if deemed necessary, the identification and training of personnel to serve as emergency judges regarding matters of isolation and quarantine as described in this Act; (6) The method of evacuating populations, and housing and feeding the evacuated populations; (7) The identification and training of health care providers to diagnose and treat persons with infectious diseases; (8) The vaccination of persons, in compliance with the provisions of this Act; (9) The treatment of persons who have been exposed to or who are infected with diseases or health conditions that may be the cause of a public health emergency; (10) The safe disposal of infectious wastes and human remains in compliance with the provisions of this Act; (11) The safe and effective control of persons isolated, quarantined, vaccinated, tested, or treated during a state of public health emergency; (12) Tracking the source and outcomes of infected persons; (13) Ensuring that each city and county within the State identifies the following:

(i) sites where persons can be isolated or quarantined in compliance with the conditions and principles for isolation or quarantine of this Act; (ii) sites where medical supplies, food, and other essentials can be distributed to the population; (iii) sites where public health and emergency workers can be housed and fed; and (iv) routes and means of transportation of people and materials. . . .

The Commission shall distribute this plan to those who will be responsible for its implementation, other interested persons, and the public, and seek their review and comments. The Commission shall annually review its plan for responding to a public health emergency.

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ARTICLE III. MEASURES TO DETECT AND TRACK PUBLIC HEALTH EMERGENCIES

Section 301. Reporting.

A health care provider, coroner, or medical examiner shall report all cases of persons who harbor any illness or health condition that may be potential causes of a public health emergency. Reportable illnesses and health conditions include, but are not limited to, the diseases caused by the biological agents listed in 42 C.F.R. § 72, app. A (2000) and any illnesses or health conditions identified by the public health authority. In addition to the foregoing requirements for health care providers, a pharmacist shall report any unusual or increased prescription rates, unusual types of prescriptions, or unusual trends in pharmacy visits that may be potential causes of a public health emergency. Prescription-related events that require a report include, but are not limited to: (1) an unusual increase in the number of prescriptions or over-the-counter pharmaceuticals to treat conditions that the public health authority identifies through regulations; (2) an unusual increase in the number of prescriptions for antibiotics; and (3) any prescription that treats a disease that is relatively uncommon or may be associated with bioterrorism. The report shall be made electronically or in writing within 24 hours to the public health authority. The report shall include as much of the following infomnation

as is available: the specific illness or health condition that is the subject of the report; the patient's name, date of birth, sex, race, occupation, and current home and work addresses (including city and county); the name and address of the health care provider, coroner, or medical examiner and of the reporting individual, if different, and any other information needed to locate the patient for followup. For cases related to animal or insect bites, the suspected locating information of the biting animal or insect, and the name and address of any known owner, shall be reported. Every veterinarian, livestock owner, veterinary diagnostic laboratory director, or other person having the care of animals shall report animals having or suspected of having any diseases that may be potential causes of a public health emergency. . . .

. . . .

Section 302. Tracking.

The public health authority shall ascertain the existence of cases of an illness or health condition that may be potential causes of a public health emergency; investigate all such cases for sources of infection and to ensure that they are subject to proper control measures; and define the distribution of the illness or health condition. To fulfill these duties, the public health authority shall identify . . . all individuals thought to have been exposed to an illness or health condition that may be a potential cause of a public health emergency. [In addition] the public health authority shall counsel and interview such individuals where needed to assist in the positive identification of exposed individuals and develop information relating to the source and spread of the illness or health condition. . . . The public health authority shall, for examination purposes, close, evacuate, or decontaminate any facility or decontaminate or destroy any material when the authority reasonably suspects that such facility or material may endanger the public health. The public health authority may enforce the provisions of this Section in accordance with existing enforcement rules and regulations. An order of the public health authority given to effectuate the purposes of this Section shall be enforceable immediately by the public safety authority.

. . . .

Section 303. Information sharing.

Whenever the public safety authority or other state or local government agency learns of a case of a reportable illness or health condition, an unusual cluster, or a suspicious event that may be the cause of a public health emergency, it shall immediately notify the public health authority.

Whenever the public health authority learns of a case of a reportable illness or health condition, an unusual cluster, or a suspicious event that it reasonably believes has the potential to be caused by bioterrorism, it shall immediately notify the public safety authority, tribal authorities, and federal health and public safety authorities. Sharing of information on reportable illnesses, health conditions, unusual clusters, or suspicious events between public health and safety authorities shall be restricted to the information necessary

for the treatment, control, investigation, and prevention of a public health emergency.

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ARTICLE IV. DECLARING A STATE OF PUBLIC HEALTH EMERGENCY

A state of public health emergency may be declared by the Governor upon the occurrence of a "public health emergency" . . . . Prior to such a declaration, the Governor shall consult with the public health authority and may consult with any additional public health or other experts as needed. The Governor may act to declare a public health emergency without consulting with the public health authority or other experts when the situation calls for prompt and timely action. A state of public health emergency shall be declared by an executive order that specifies: (a) the nature of the public health emergency, (b)the political subdivision(s) or geographic area(s) subject to the declaration, (c) the conditions that have brought about the public health emergency, (d) the duration of the state of the public health emergency, if less than thirty (30) days, and (e) the primary public health authority responding to the emergency. The declaration of a state of public health emergency shall activate the disaster response and recovery aspects of the State, local, and inter-jurisdictional disaster emergency plans in the affected political subdivision(s) or geographic area(s). Such declaration authorizes the deployment and use of any forces to which the plans apply and the use or distribution of any supplies, equipment, and materials and facilities assembled, stockpiled, or available pursuant to this Act.

During a state of public health emergency, the Governor may: (1) Suspend the provisions of any regulatory statute prescribing procedures for conducting State business, or the orders, rules and regulations of any State agency, to the extent that strict compliance with the same would prevent, hinder, or delay necessary action (including emergency purchases) by the public health authority to respond to the public health emergency, or increase the health threat to the population. (2) Utilize all available resources of the State government and its political subdivisions, as reasonably necessary to respond to the public health emergency. (3) Transfer the direction, personnel, or functions of State departments and agencies in order to perform or facilitate response and recovery programs regarding the public health emergency. (4) Mobilize all or any part of the organized militia into service of the State. An order directing the organized militia to report for active duty shall state the purpose for which it is mobilized and the objectives to be accomplished. (5) Provide aid to and seek aid from other states in accordance with any interstate emergency compact made with this State. (6) Seek aid from the federal government in accordance with federal programs or requirements.

The public health authority shall coordinate all matters pertaining to the public health emergency response of the State. The public health authority shall have primary jurisdiction, responsibility, and authority for: (1) Planning and executing public health emergency assessment, mitigation, preparedness response, and recovery for the State; (2) Coordinating public health emergency response between State and local authorities; (3) Collaborating with relevant federal government authorities, elected officials of other states, private

organizations or companies; (4)Coordinating recovery operations and mitigation initiatives subsequent to public health emergencies; and (5) Organizing public information activities regarding public health emergency response operations.

After the declaration of a state of public health emergency, special identification for all public health personnel working during the emergency shall be issued as soon as possible. The identification shall indicate the authority of the bearer to exercise public health functions and emergency powers during the state of public health emergency. Public health personnel shall wear the identification in plain view.

. . . .

Section 404. Enforcement.

During a state of public health emergency, the public health authority may request assistance in enforcing orders pursuant to this Act from the public safety authority. The public safety authority may request assistance from the organized militia in enforcing the orders of the public health authority.

. . . .

Section 405. Termination of declaration.

The Governor shall terminate the declaration of a state of public health emergency by executive order upon finding that the occurrence of an illness or health condition that caused the emergency no longer poses a high probability of a large number of deaths in the affected population, a large number of incidents of serious permanent or long-term disability in the affected population, or a significant risk of substantial future harm to a large number of people in the affected population. Notwithstanding any other provision of this Act, the declaration of a state of public health emergency shall be terminated automatically after thirty (30) days unless renewed by the Governor under the same standards and procedures set forth in this Article. Any such renewal shall also be terminated automatically after thirty (30) days unless renewed by the Governor under the same standards and procedures set forth in this Article.

By a majority vote in both chambers, the State legislature may terminate the declaration of a state of public health emergency at any time from the date of original declaration upon finding that the occurrence of an illness or health condition that caused the emergency does not or no longer poses a high probability of a large number of deaths in the affected population, a large number of incidents of serious permanent or long-term disability in the affected population, or a significant risk of substantial future harm to a large number of people in the affected population. Such a termination by the State legislature shall override any renewal by the Governor.

All orders or legislative actions terminating the declaration of a state of public health emergency shall indicate the nature of the emergency, the area(s) that was threatened, and the conditions that make possible the termination of the declaration.

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ARTICLE V. SPECIAL POWERS DURING A STATE OF PUBLIC HEALTH EMERGENCY: MANAGEMENT OF PROPERTY

Section 501. Emergency measures concerning facilities and materials.

The public health authority may exercise, for such period as the state of public health emergency exists, the following powers over facilities or materials: (a) To close, direct and compel the evacuation of, or to decontaminate or cause to be decontaminated any facility of which there is reasonable cause to believe that it may endanger the public health. (b) To decontaminate or cause to be decontaminated, or destroy any material of which there is reasonable cause to believe that it may endanger the public health.

. . . .

Section 502. Access to and control of facilities and property generally.

The public health authority may exercise, for such period as the state of public health emergency exists, the following powers concering facilities, materials, roads, or public areas: (a) To procure, by condemnation or otherwise, construct, lease, transport, store, maintain, renovate, or distribute materials and facilities as may be reasonable and necessary to respond to the public health emergency, with the right to take immediate possession thereof. Such materials and facilities include, but are not limited to, communication devices, carriers, real estate, fuels, food, and clothing. (b) To require a health care facility to provide services or the use of its facility if such services or use are reasonable and necessary to respond to the public health emergency as a condition of licensure, authorization or the ability to continue doing business in the state as a health care facility. The use of the health care facility may include transferring the management and supervision of the health care facility to the public health authority for a limited or unlimited period of time, but shall not exceed the termination of the declaration of a state of public health emergency. (c) To inspect, control, restrict, and regulate by rationing and using quotas, prohibitions on shipments, allocation, or other means, the use, sale, dispensing, distribution, or transportation of food, fuel, clothing and other commodities, as may be reasonable and necessary to respond to the public health emergency. (d) To prescribe routes, modes of transportation, and destinations in connection with evacuation of persons or the provision of emergency services [or] to control or limit ingress and egress to and from any stricken or threatened public area, the movement of persons within the area, and the occupancy of premises therein, if such action is reasonable and necessary to respond to the public health emergency.

. . . .

Section 503. Safe disposal of infectious waste.

The public health authority may exercise, for such period as the state of public health emergency exists [the power to] adopt and enforce measures to provide for the safe disposal of infectious waste as may be

reasonable and necessary to respond to the public health emergency. Such measures may include, but are not limited to, the collection, storage, handling, destruction, treatment, transportation, and disposal of infectious waste. [The public health authority] also may require any business or facility authorized to collect, store, handle, destroy, treat, transport, and dispose of infectious waste under the laws of this State, and any landfill business or other such property, to accept infectious waste, or provide services or the use of the business, facility, or property if such action is reasonable and necessary to respond to the public health emergency as a condition of licensure, authorization, or the ability to continue doing business in the state as such a business or facility. The use of the business, facility, or property may include transferring the management and supervision of such business, facility, or property to the public health authority for a limited or unlimited period of time, but shall not exceed the termination of the declaration of a state of public health emergency. [The public health authority may] procure, by condemnation or otherwise, any business or facility authorized to collect, store, handle, destroy, treat, transport, and dispose of infectious waste under the laws of this State and any landfill business or other such property as may be reasonable and necessary to respond to the public health emergency, with the right to take immediate possession thereof. . . .

. . . .

Section 504. Safe disposal of human remains.

The public health authority may exercise, for such period as the state of public health emergency exists, the following powers regarding the safe disposal of human remains: (a) To adopt and enforce measures to provide for the safe disposal of human remains as may be reasonable and necessary to respond to the public health emergency. Such measures may include, but are not limited to the embalming, burial, cremation, interment, disinterment, transportation, and disposal of human remains. (b) To take possession or control of any human remains. (c) To order the disposal of any human remains of a person who has died of a contagious disease through burial or cremation within twenty-four (24) hours after death. To the extent possible, religious, cultural, family, and individual beliefs of the deceased person or his or her family shall be considered when disposing of any human remains. (d) To require any business or facility authorized to embalm, bury, cremate, inter, disinter, transport, and dispose of human remains under the laws of this State to accept any human remains or provide the use of its business or facility if such actions are reasonable and necessary to respond to the public health emergency as a condition of licensure, authorization, or the ability to continue doing business in the state as such a business or facility. The use of the business or facility may include transferring the management and supervision of such business or facility to the public health authority for a limited or unlimited period of time, but shall not exceed the termination of the declaration of a state of public health emergency. (e) To procure, by condemnation or otherwise, any business or facility authorized to embalm, bury, cremate, inter, disinter, transport, and dispose of human remains under the laws of this State as may be reasonable and necessary to respond to the public health emergency, with the right to take immediate possession thereof.

. . . .

Section 505. Control of health care supplies.

The public health authority may purchase and distribute anti-toxins, serums, vaccines, immunizing agents, antibiotics, and other pharmaceutical agents or medical supplies that it deems advisable in the interest of preparing for or controlling a public health emergency, without any additional legislative authorization. If a state of public health emergency results in a state-wide or regional shortage or threatened shortage of any product . . . whether or not such product has been purchased by the public health authority, the public health authority may control, restrict, and regulate by rationing and using quotas, prohibitions on shipments, allocation, or other means, the use, sale, dispensing, distribution, or transportation of the relevant product necessary to protect the public health, safety, and welfare of the people of the State. In making rationing or other supply and distribution decisions, the public health authority may give preference to health care providers, disaster response personnel, and mortuary staff.

During a state of public health emergency, the public health authority may procure, store, or distribute any anti-toxins, serums, vaccines, immunizing agents, antibiotics, and other pharmaceutical agents or medical supplies located within the State as may be reasonable and necessary to respond to the public health emergency, with the right to take immediate possession thereof. If a public health emergency simultaneously affects more than one state, nothing in this Section shall be construed to allow the public health authority to obtain anti-toxins, serums, vaccines, immunizing agents, antibiotics, and other pharmaceutical agents or medical supplies for the primary purpose of hoarding such items or preventing their fair and equitable distribution among affected states.

. . . .

Section 506. Compensation.

The State shall pay just compensation to the owner of any facilities or materials that are lawfully taken or appropriated by a public health authority for its temporary or permanent use under this Article according to the procedures and standards set forth in Section 805 of this Act. Compensation shall not be provided for facilities or materials that are closed, evacuated, decontaminated, or destroyed when there is reasonable cause to believe that they may endanger the public health pursuant to Section 501.

Section 507. Destruction of property.

To the extent practicable, consistent with the protection of public health, prior to the destruction of any property under this Article, the public health authority shall institute appropriate civil proceedings against the property to be destroyed in accordance with the existing laws and rules of the courts of this State or any such rules that may be developed by the courts for use during a state of public health emergency. Any property acquired by the public health authority

through such proceedings shall, after entry of the decree, be disposed of by destruction as the court may direct.

ARTICLE VI. SPECIAL POWERS DURING A STATE OF PUBLIC HEALTH EMERGENCY: PROTECTION OF PERSONS

Section 601. Protection of persons.

During a state of public health emergency, the public health authority shall use every available means to prevent the transmission of infectious disease and to ensure that all cases of contagious disease are subject to proper control and treatment.

. . . .

Section 602. Medical examination and testing.

During a state of public health emergency the public health authority may perform physical examinations and/or tests as necessary for the diagnosis or treatment of individuals. Medical examinations or tests may be performed by any qualified person authorized to do so by the public health authority.

Medical examinations or tests must not be such as are reasonably likely to lead to serious harm to the affected individual. The public health authority may isolate or quarantine, pursuant to Section 604, any person whose refusal of medical examination or testing results in uncertainty regarding whether he or she has been exposed to or is infected with a contagious or possibly contagious disease or otherwise poses a danger to public health.

. . . .

Section 603. Vaccination and treatment.

During a state of public health emergency the public health authority may exercise the following emergency powers over persons as necessary to address the public health emergency: (a) To vaccinate persons as protection against infectious disease and to prevent the spread of contagious or possibly contagious disease. Vaccination may be performed by any qualified person authorized to do so by the public health authority. A vaccine to be administered must not be such as is reasonably likely to lead to serious harm to the affected individual. To prevent the spread of contagious or possibly contagious disease the public health authority may isolate or quarantine, pursuant to Section 604, persons who are unable or unwilling for reasons of health, religion, or conscience to undergo vaccination pursuant to this Section. (b) To treat persons exposed to or infected with disease.Treatment may be administered by any qualified person authorized to do so by the public health authority. Treatment must not be such as is reasonably likely to lead to serious harm to the affected individual. To prevent the spread of contagious or possibly contagious disease the public health authority may isolate or quarantine, pursuant to Section 604, persons who are unable or unwilling for reasons of health, religion, or conscience to undergo treatment pursuant to this Section.

. . . .

Section 604. Isolation and quarantine.

During the public health emergency, the public health authority may isolate or quarantine an individual or groups of individuals. This includes individuals or groups who have not been vaccinated, treated, tested, or examined pursuant to Sections 602 and 603. The public health authority may also establish and maintain places of isolation and quarantine, and set rules and make orders. Failure to obey these rules, orders, or provisions shall constitute a misdemeanor. The public health authority shall adhere to the following conditions and principles when isolating or quarantining individuals or groups of individuals:

(1) Isolation and quarantine must be by the least restrictive means necessary to prevent the spread of a contagious or possibly contagious disease to others and may include, but are not limited to, confinement to private homes or other private and public premises.

(2) Isolated individuals must be confined separately from quarantined individuals.

(3) The health status of isolated and quarantined individuals must be monitored regularly to determine if they require isolation or quarantine.

(4) If a quarantined individual subsequently becomes infected or is reasonably believed to have become infected with a contagious or possibly contagious disease he or she must promptly be removed to isolation.

(5) Isolated and quarantined individuals must be immediately released when they pose no substantial risk of transmitting a contagious or possibly contagious disease to others.

(6) The needs of persons isolated and quarantined shall be addressed in a systematic and competent fashion, including, but not limited to, providing adequate food, clothing, shelter, means of communication with those in isolation or quarantine and outside these settings, medication, and competent medical care.

(7) Premises used for isolation and quarantine shall be maintained in a safe and hygienic manner and be designed to minimize the likelihood of further transmission of infection or other harms to persons isolated and quarantined.

(8) To the extent possible, cultural and religious beliefs should be considered in addressing the needs of individuals, and establishing and maintaining isolation and quarantine premises.

Persons subject to isolation or quarantine shall obey the public health authority's rules and orders; and shall not go beyond the isolation or quarantine premises. Failure to obey these provisions shall constitute a misdemeanor. . . .

Section 605. Procedures for isolation and quarantine.

(a) The public health authority may temporarily isolate or quarantine an individual or groups of individuals through a written directive if delay in imposing the isolation or quarantine would significantly jeopardize the public health authority's ability to prevent or limit the transmission of a contagious or possibly contagious disease to others. The written directive shall specify the following: (i) the identity of the individual(s) or groups of individuals subject to isolation or quarantine; (ii) the premises subject to isolation or quarantine; (iii) the date and time at which isolation or quarantine commences; (iv) the suspected contagious disease if known . . . . A copy of the written directive shall be given to the individual to be isolated or quarantined or, if the order applies to a group of individuals and it is impractical to provide individual copies, it may be posted in a conspicuous place in the isolation or quarantine premises. Within ten (10) days after issuing the written directive, the public health authority shall file a petition pursuant to Section 605(b) for a court order authorizing the continued isolation or quarantine of the isolated or quarantined individual or groups of individuals.

(b) The public health authority may make a written petition to the trial court for an order authorizing the isolation or quarantine of an individual or groups of individuals. A petition shall specify the following: (i) the identity of the individual(s) or groups of individuals subject to isolation or quarantine; (ii) the premises subject to isolation or quarantine; (iii) the date and time at which isolation or quarantine commences; (iv) the suspected contagious disease if known; (v) a statement of compliance with the conditions and principles for isolation and quarantine of Section 604(b); and (vi) a statement of the basis upon which isolation or quarantine is justified in compliance with this Article. . . . Notice to the individuals or groups of individuals identified in the petition shall be accomplished within twenty-four (24) hours in accordance with the rules of civil procedure. A hearing must be held on any petition filed pursuant to this subsection within five (5) days of filing of the petition. In extraordinary circumstances and for good cause shown the public health authority may apply to continue the hearing date on a petition filed pursuant to this Section for up to ten (10) days, which continuance the court may grant in its discretion giving due regard to the rights of the affected individuals, the protection of the public's health, the severity of the emergency and the availability of necessary witnesses and evidence. The court shall grant the petition if, by a preponderance of the evidence, isolation or quarantine is shown to be reasonably necessary to prevent or limit the transmission of a contagious or possibly contagious disease to others. An order authorizing isolation or quarantine may do so for a period not to exceed thirty (30) days. The order shall (a) identify the isolated or quarantined individuals or groups of individuals by name or shared or similar characteristics or circumstances; (b) specify factual findings warranting isolation or quarantine pursuant to this Act; (c) include any conditions necessary to ensure that isolation or quarantine is carried out within the stated purposes and restrictions of this Act; and (d) be served on affected individuals or groups of individuals in accordance with the rules of civil procedure. . . .

An individual or group of individuals isolated or quarantined pursuant to this Act may apply to the trial court for an order to show cause why the individual or group of individuals should not be released.

The court shall rule on the application to show cause within forty-eight (48) hours of its filing. If the court grants the application, the court shall schedule a hearing on the order to show cause within twenty-four (24) hours from issuance of the order to show cause. The issuance of an order to show cause shall not stay or enjoin an isolation or quarantine order. An individual or groups of individuals isolated or quarantined pursuant to this Act may request a hearing in the trial court for remedies regarding breaches to the conditions of isolation or quarantine. . . .

In any proceedings brought for relief under this subsection, in extraordinary circumstances and for good cause shown, the public health authority may move the court to extend the time for a hearing, which extension the court in its discretion may grant giving due regard to the rights of the affected individuals, the protection of the public's health, the severity of the emergency and the availability of necessary witnesses and evidence.

A record of the proceedings pursuant to this Section shall be made and retained. In the event that, given a state of public health emergency, parties can not personally appear before the court, proceedings may be conducted by their authorized representatives and be held via any means that allows all parties to fully participate.

The court shall appoint counsel at state expense to represent individuals or groups of individuals who are or who are about to be isolated or quarantined pursuant to the provisions of this Act and who are not otherwise represented by counsel. . . .

In any proceedings brought pursuant to this Section, to promote the fair and efficient operation of justice and having given due regard to the rights of the affected individuals, the protection of the public's health, the severity of the emergency and the availability of necessary witnesses and evidence, the court may order the consolidation of individual claims into group or claims where: (i) the number of individuals involved or to be affected is so large as to render individual participation impractical; (ii) there are questions of law or fact common to the individual claims or rights to be determined; (iii) the group claims or rights to be determined are typical of the affected individuals' claims or rights; and (iv) the entire group will be adequately represented in the consolidation.

. . . .

Section 607. Access to and disclosure of protected health information.

Access to protected health information of persons who have participated in medical testing, treatment, vaccination, isolation, or quarantine programs or efforts by the public health authority during a public health emergency shall be limited to those persons having a legitimate need to acquire or use the information . . . .

Section 608. Licensing and appointment of health personnel.

The public health authority may exercise, for such period as the state of public health emergency exists, the following emergency powers regarding licensing and appointment of health personnel: (a) To require

in-state health care providers to assist in the performance of vaccination, treatment, examination, or testing of any individual as a condition of licensure, authorization, or the ability to continue to function as a health care provider in this State. (b) To appoint and prescribe the duties of such out-of-state emergency health care providers as may be reasonable and necessary to respond to the public health emergency. . . . Any out-of-state emergency health care provider appointed pursuant to this Section shall not be held liable for any civil damages as a result of medical care or treatment related to the response to the public health emergency unless such damages result from providing, or failing to provide, medical care or treatment under circumstances demonstrating a reckless disregard for the consequences so as to affect the life or health of the patient. (c) To authorize the medical examiner or coroner to appoint and prescribe the duties of such emergency assistant medical examiners or coroners as may be required for the proper performance of the duties of the office. . . . Any emergency assistant medical examiner or coroner appointed pursuant to this Section and acting without malice and within the scope of the prescribed duties shall be immune from civil liability in the performance of such duties.

. . . .

ARTICLE VIII. MISCELLANEOUS

. . . .

Section 804. Liability.

Neither the State, its political subdivisions, nor, except in cases of gross negligence or willful misconduct, the Governor, the public health authority, or any other State or local official referenced in this Act, is liable for the death of or any injury to persons, or damage to property, as a result of complying with or attempting to comply with this Act or any rule or regulations promulgated pursuant to this Act during a state of public health emergency.

During a state of public health emergency, any person owning or controlling real estate or other premises who voluntarily and without compensation grants a license or privilege, or otherwise permits the designation or use of the whole or any part or parts of such real estate or premises for the purpose of sheltering persons, together with that person's successors in interest, if any, shall not be civilly liable for negligently causing the death of, or injury to, any person on or about such real estate or premises under such license, privilege, or other permission, or for negligently causing loss of, or damage to, the property of such person.

During a state of public health emergency, any private person, firm or corporation and employees and agents of such person, firm or corporation in the performance of a contract with, and under the direction of, the State or its political subdivisions under the provisions of this Act shall not be civilly liable for causing the death of, or injury to, any person or damage to any property except in the event of gross negligence or willful misconduct.

During a state of public health emergency, any private person, firm or corporation and employees and agents of such person, firm or

corporation, who renders assistance or advice at the request of the State or its political subdivisions under the provisions of this Act shall not be civilly liable for causing the death of, or injury to, any person or damage to any property except in the event of gross negligence or willful misconduct.

The immunities provided in this Subsection shall not apply to any private person, firm, or corporation or employees and agents of such person, firm, or corporation whose act or omission caused in whole or in part the public health emergency and who would otherwise be liable therefor.

. . . .

Section 805. Compensation.

Compensation for property shall be made only if private property is lawfully taken or appropriated by a public health authority for its temporary or permanent use during a state of public health emergency declared by the Governor pursuant to this Act.

Any action against the State with regard to the payment of compensation shall be brought in the courts of this State in accordance with existing court laws and rules, or any such rules that may be developed by the courts for use during a state of public health emergency. The amount of compensation shall be calculated in the same manner as compensation due for taking of property pursuant to non-emergency eminent domain procedures . . . .

. . . .

This Act does not explicitly preempt other laws or regulations that preserve to a greater degree the powers of the Governor or public health authority, provided such laws or regulations are consistent, and do not otherwise restrict or interfere, with the operation or enforcement of the provisions of this Act.

* * *

Kenneth R. Wing, “Policy Choices and Model Acts: Preparing for the Next Public Health Emergency,” 13 Health Matrix 71

(2003)

* * *

Let me start with some unkind comments about "model acts" and their drafters. Circulating a "model act" is the most cumbersome and ineffective way I can think of to inform the general public or state policymakers concerning important policy choices. If in fact the Center's experts or the CDC or anyone else has a clear vision of what needs to be done by the various states to prepare for the next public health emergency, they should say so -- as clearly and specifically as possible -- and provide the rest of us with a descriptive explanation of that vision and some insightful defense of the necessity and feasibility of achieving it. . . . If and when a state wants to adopt the Center's recommendations, surely someone will have to convert those policy choices into statutory terms. That's what statute drafting is all about: It's a technical and instrumental job, but it's one that ought to follow -- not precede -- the more fundamental task of deciding what that statute ought to say. For that matter, even if a state decides to do any or all of what the Center has proposed, just how to draft appropriate legislation to implement that choice will depend greatly upon the pre-existing legal structure of that particular state, something that varies from jurisdiction to jurisdiction. A one-size-fits-all "model act" would be of marginal value even for this purpose. More importantly, a "model act" is of virtually no value in doing what really needs to be done now: informing our state policymakers of the choices they should consider and the merits of the alternatives that face them.

But even to the extent that I can figure out what is proposed by the "model act" or how such measures might work . . . I'm not impressed with either the authors' ideas or their craftsmanship. As I decode the December [2002] draft, there are three major elements of the "model act": First, the "model act" would create what the authors’ call an emergency planning commission. Second, the act would require the reporting of various indicia of infectious diseases and other public health risks by health care providers; and it would create a "public health authority" empowered to investigate these reports and other potential causes of a public health emergency. Third, the "model act" would specify those circumstances under which the governor may declare a public health emergency and it would create a series of extraordinary powers concerning the public use of private property and the confinement of individuals during such an emergency. . . .

The emergency planning commission is described by Article II of the "model act" as a commission of legislators, judges, local public health officials, and other "interested persons" appointed by the governor who are empowered to write a "public health emergency plan," essentially a description of how the federal, state, and local governments will react and share authority in a public health emergency. It is hard to evaluate or critique this proposal without knowing more specifically what its authors have in mind. . . . If the objective of Article II is that the state should empanel -- as state's so often do -- still another study commission or advisory body, it seems unnecessary to

include this commission in an already cumbersome legislative package. I would argue that it is also inappropriate: Study commissions are hardly an efficient or expeditious vehicle for making important and difficult decisions. The December draft has a nonexclusive list of 15 categories of issues that the commission is required to address within a six month-time frame. Why create a study commission for this particular set of choices, leaving these choices to be reconsidered within the state legislature once the commission has completed its study? Why now, when common sense and recent events would dictate that speed is of the political essence?

On the other hand, if Article II of the "model act" is proposing a regulatory agency or that any of the commission's decisions would be binding, it is indeed an extraordinary proposal: Create a new governmental agency with members drawn from the various branches of government and include both local officials and "other interested persons." Give that body policymaking authority with minimal statutory limits on its scope. That's heady stuff. I can speculate that this agency would do lots of things -- both good and bad -- but again I return to essentially the same questions: What does the Center think this agency can and will do and why do they think it will do so better than the normal lawmaking apparatus of the states? It's nice to be original -- but why? Why this sort of commission and to what end? . . .

I also know that if a state were to create the type of commission suggested by the "model act" and give it binding regulatory authority, there would be serious constitutional objections to such legislation. The principles of separation of powers impose limits on the legislature's ability (a) to delegate legislative-type decisions to independent agencies, and (b) to give any authority to a governmental body made up of members of a mix of judicial, legislative, and executive actors. For that matter, no state law can authorize a commission to exercise binding authority over what the federal government can do, which is among the things that the "model act" empowers the commission to address. . .

Article III requires that health care providers (and coroners and medical examiners) report "all cases of persons who harbor any illness or health condition that may be potential causes of a public health emergency" to a [designated] state agency within 24 hours." Pharmacists are similarly required to report any unusual or increased use of prescription drugs that may indicate a public health emergency. (Veterinarians, live stock owners, and others have similar obligations with regard to animal diseases.) The information requirements are extensive: providers are required to report the name, address, medical condition, location, and essentially any other information that is considered relevant to the "potential cause of a public health emergency."

The public health authority (described in Article I of the "model act" as some designated state or local agency) is charged with the authority to investigate these reports, track individuals, and, if I am reading the "model act" correctly, "ensure that they are subject to proper control measures . . . ." This public health authority is also for examination purposes empowered to "close, evacuate, or decontaminate any facility . . . and destroy any material when the authority reasonably suspects that such facility or material may endanger the

public health." None of these powers are contingent on the existence of a declared emergency, as described below, but would be permanently authorized under the "model act."

I have no doubt that all states need to collect and analyze data on infectious diseases and other public health risks quickly and effectively. I also have no doubt that the states should structure and empower some agency to respond to identified public health risks. Indeed, all states do so in one way or another. My questions concerning the reporting requirements, the public health authority, and the broad investigational powers that would be created under the "model act," however, are not unlike those outlined above: Why should a state create such an extensive system of reporting and in this particular manner? Anyone familiar with the experience of tracking AIDS and HIV exposure knows that mandatory disclosure of individual-identifying data can be counterproductive (not to mention politically volatile). . . . The extent of the power of the public authority to investigate these reports is not clear from the "model act" but, as written, it is virtually without limit. As such, it is notable -- and somewhat ironic -- that there are no provisions for the protection of confidentiality or privacy written into the statute although, in a later article of the "model act," the authors have had the foresight to immunize public officials from liability for exceeding their powers.

More to the point, is there any evidence -- from the events of September 11, 2001, or otherwise -- that suggests such laws should be in place? Are state or local agencies even equipped to handle this volume of information? What would be the impact on the behavior of people seeking medical attention? Again, interesting ideas are interesting ideas, but a proposed solution to a problem -- let along a "model act" -- has to be tied to some assessment of the problem and its underlying causes. Why enact this type of legislation at this time? Many states have enacted comparable regulatory requirements but in much more limited circumstances -- reporting of gun shot wounds for instance --and under much more carefully prescribed limits on the government's investigational response. Even those programs are controversial. State and local public health agencies have long struggled to maintain a user-friendly public image and a posture that emphasizes their public health -- not their public safety character. The public health authority created by the "model act" would permanently obliterate that distinction. . . .

Article IV of the "model act" authorizes the governor to declare a "state of public health emergency." It specifies the power of the state legislature to terminate the state of emergency after sixty days (premised on certain legislative findings). In Articles V and VI the extraordinary powers that can be exercised by the state during a declared public health emergency are described . . . . But even apart from the concerns I have with the extent of the emergency powers envisioned by the authors of the "model act," I have a more basic constitutional concern with Article IV.

Under the constitutional structure in most states, the governor, as the chief executive, has inherent powers to act in an emergency, apart from any gubernatorial powers that may be created by the state's statutes. The exact limits on the governor's emergency powers are not

clear, as, by their nature, they are infrequently exercised and litigated.

. . . .

. . . [T]he "model act" -- by defining what can be done by whom and under what circumstances -- would necessarily limit the authority of the governor to act in any ways other than those set out in that legislation. If I were in the governor's office, or even just concerned about the integrity of that office, I would be opposed to such a proscriptive effort -- especially one in an area of such immediate concern. Among other concerns, would I want the scope of my authority in a public health emergency to be limited to that which is the end-product of a legislative debate? Politics being politics, isn't it just as likely that that legislation will be influenced by people who want to tie the governor's hands -- possibly for reasons wholly unrelated to public health emergencies? More to the point, the next public health emergency may involve nuclear exposure or some result of Mother Nature's, not some bioterrorist's, wrath. A statute drawn in anticipation of the most recent public health emergency may actually inhibit the discretion of the governor to act in another unanticipated fashion. The fact that what happens next may be what no one has anticipated is, after all, undeniably part of our post-September 11, 2001, world.

. . . .

I would rather accept the status quo: The governor is empowered to act in an emergency in whatever way she thinks appropriate. The courts can adjudicate the legitimacy of those actions on a case-by-case basis. The legislatures can enact, post hoc, remedial legislation. With most problems in most times, that is, admittedly, not a recipe for good public policymaking. For emergencies of the sort we are considering here, it is the proper and more workable order of action. And that's not just my own idea of good policy, it's the way the state and federal constitutions read or, to be more accurate, it is what has been read into our constitutional structure in order to make it workable. . . .

As noted earlier, the powers outlined in Articles V and VI of the "model act" have drawn the most public attention and controversy. Article V is entitled "Special Powers During a State of Public Health Emergency: Management of Property."

. . . .

The provisions of Articles V and VI only outline the powers that the "model act" would allow the state during a declared emergency. In statutory interpretation, as in so many other things in life, the devil may be found in the details as often as in the broad outlines of an enactment. Words like "reasonable and necessary" and "preponderance of the evidence" carry a lot of legal baggage. The details of how and when isolation orders would be issued might create a program so constrained that it becomes a rare event, even in emergencies. Again, if the authors of the "model act" really want the states to consider authorizing public officials to do what the language of the "model act" suggests, we would be all better served with a textual description of what is proposed and,

most importantly, some justification for creating what, even in its broad outlines, appears to be a public health version of martial law.

I could go through these subsections line-by-line, or spend hours (or pages) raising questions about the "temporary" isolation of groups of people without notice or requiring medical providers to participate in mass testing programs as a condition of their licensure or any one of a number of other specific provisions. But my basic question would in all cases have the same common element: Why? What is it that we have learned about the public health risks that we face that would counsel creating this elaborate and draconian apparatus? What is it that we cannot do now, under existing statutory enactments or through the implied powers of the governor, that we need to empower some public authority to do through such sweeping legislation? Why, for that matter, recommend that state legislatures even consider such legislation -- given the media circus that would likely surround such deliberations? There are lots of theories of liberty and reasoned justifications for its denial. Under most, individual and economic liberty is assumed the status quo and its denial is selectively justified and done so in a particularized fashion. Why do we need all of what is outlined in the "model act"?

I can think of circumstances under which some individuals may have to be isolated or quarantined involuntarily. There might even be extraordinary circumstances under which isolation or quarantine should be mandated on the basis of a "group" -- although again I find myself wondering exactly what the authors meant by such terminology in Articles V and VI. I also can imagine events that would necessitate some massive marshalling of medical resources, both public and private. But why create the regulatory apparatus for doing so in advance? Why do so in such plenary and heavy-handed terms? Is there any reality-based evidence that American providers need to be regulated in such a fashion during an emergency? Why not improve education and communication and funding such that providers can and will do what the "model act" would simply require under penalty of criminal sanctions? Again I reflect on what we learned in the Fall of 2001 about the behavior in a public health emergency of government officials, medical care providers, businesses and property owners, and thousands of ordinary Americans. Not then nor now do I find myself wishing that the Model State Emergency Health Powers Act had been in effect. There are some things I do wish had been in existence and will be in the next comparable scenario: more funding for state and local health departments, new procedures for communicating across jurisdictions and from public health to public safety agencies, better training for emergency medical personnel, and so on. I find little to suggest that what we need is the ability to quickly suspend civil rights and to empower public health officials to command and control all public and private resources. If my state is ever faced with a public health emergency, I would prefer that we respond to it on a case-by-case basis and in the ad hoc way anticipated under our constitutional system.

Surely what we need in the state of Washington and in many other states is a discussion of how to prepare for the next public health emergency. I strongly suspect that that discussion will focus quickly on staffing, infrastructure, and other resource and organizational problems. We also should discuss the adequacy of our state's legal structure. Among other things, we should immediately figure out the parameters of the governor's emergency powers under our state's

constitutional structure. . . . It is possible that we may decide that given our constitutional structure and existing statutory framework remedial legislation should be adopted. But it’s also possible that nothing more can or should be added to our legal structure. We may find instead that what we need is more resources and more expertise and better coordination of both. Not incidentally, to the extent that we do decide to empower a public health authority to do some of the more draconian things outlined in the "model act," both as a political and constitutional matter, we should be doubly sure that the resources and expertise are available to do those things accurately and effectively.

It is entirely possible that the most basic assumption underlying the "model act" is flawed. If in fact there is a need for some remedial legislation of the type outlined in the "model act,” or, for that matter, any other, it may need to be federal legislation, not state legislation. Anthrax doesn't respect state borders or jurisdictional niceties. Whatever public health emergency we experience in Washington is likely to be a problem for Oregon and Idaho and, for that matter, Canada as well. Think about the number of Washingtonians that get on and off airplanes, trains, or Interstate 5 each day. In both practical and constitutional terms, public health emergencies that reach across state borders can only be resolved at the federal level. That may not be what conservative politicians like to hear, but interstate problems, including interstate public health emergencies are the province of congressional, not state authority; for that matter, interstate activities are one area in which the states cannot act even in the absence of federal action. As I have said so often above, I have a hard time deciphering what the authors of the "model act" envision we need, but it seems rather odd to me that they have chosen to implement that vision through a model state law. At the very least, it would seem the federal/state issue deserves some prefactory attention in their proposal, particularly as it is quite possible that at least portions of their vision could only be enacted as a matter of federal law.

* * *

Lawrence O. Gostin, “When Terrorism Threatens Health: How Far Limitations on Personal and Economic Liberties Justified?” 55 Florida Law Review 1105, 1159-69 (2003)

* * *

. . . The relative low cost, ease of transport, and difficulty of detection makes bioweapons attractive to those intending to inflict harm and widespread fear on civil society. The fact that several countries have developed such weapons and fringe groups have used them (with minor success), is further evidence that bioweapons are technically feasible and that some people desire the capability. Biological agents already have been used within the United States, and there are strong indicators that the public health infrastructure is currently unprepared to cope with a large-scale attack. These risks require society to contemplate measures designed to avert an attack or minimize the impact should an attack occur.

The question faced is not whether the government should have liberty-limiting authority designed to cope with an attack, but what powers the state should have under what circumstances. American society prizes liberty and freedom, openness and tolerance; these values are part of the national identity and seem sometimes to rise to the level of inviolable tenets. These values, important in their own right, need to be balanced against equally valid values of population health and safety.

The task for society is to grant government power in a way that clearly separates the warranted from the unwarranted. That task is difficult enough even though most clear thinkers agree in principle about the legitimacy of state action in these contexts. What is still more difficult is setting justifiable boundaries for state action to address moderate risk situations where government cannot be sure of the precise parameters of the threat society faces. How can the law help assure that citizens' lives are secure, while preserving their values?

The answer to this question first requires a careful balance between individual and collective interests. The law must seriously consider authentic . . . claims to human dignity and tolerance of [diversity and individual choice]. At the same time, legal scholars should recognize that individual choices are shaped by the social context in which people live. The law also must take account of bona fide group interests, including a community's claim to a certain level of health, safety, and security. The law's objective, then, should be to take both private (personal freedom) and public (the social dimensions of human existence) interests seriously, recognizing that neither is dispensable.

The problem with constructing legal standards and procedures for state action is that any formulation necessarily expresses a preference for one set of interests over another, even if government seeks to respect both. Setting the legal standard too high effectively thwarts

legitimate collective interests because, in practice, government action is chilled if not blocked. Setting the standard too low results in the opposite error of excessive deference to state action. The law cannot calibrate precisely enough to split the difference exactly.

. . . [T]here is no reason, a priori, for choosing one set of values over the other. In particular, I do not concede that liberalism should be the default preference. Rights, in other words, do not invariably trump common good. Thus, if government can point to a moderate risk and propose interventions that are reasonably well targeted and not unduly burdensome, the law should permit a sphere of state action. By doing so, each person bears a small burden (equitably distributed), but as members of a community all gain in the social exchange.

My refusal to cede to the primacy of individualism is animated by my concern for public safety in a health emergency. It is important that the government has the authority to act quickly should a bioterrorist attack occur. Quick action will be required on the part of both federal and local governments to minimize the impact of the attack and to protect the population. The federal government will need to move supplies from the National Pharmaceutical Stockpile in ways that distribute resources fairly and quickly enough to help those affected. Similarly, plans designed to mobilize experts from the CDC must provide for a prompt response, and the federal government must be prepared to provide support for state and local governments that may be overwhelmed by the sudden drastic increase in public health needs.

State and local governments must have the ability to act quickly as well. If a contagious disease agent is used, compulsory powers, like quarantine, will be effective only if they are used during the early stages of the outbreak. Otherwise, those who were initially infected will spread the disease to their contacts, and those contacts to their own contacts, until the geographical area affected is too vast to make quarantine plausible and effective. Laws and regulations that provide for compulsory powers in a fair and expeditious manner must be in place in order to avoid delays that would render the quarantine moot. In addition, state and local governments must have surveillance mechanisms in place for early detection. Timely identification of a health threat will facilitate distribution of needed resources (e.g., medical personnel, medicine, and hospital equipment) in an equitable and expedient way. While careful consideration of policy choices and extensive deliberation are hallmarks of democracy, this reflection must take place now, so that when the government is called upon to act, it is able to do so in time to be useful.

A. Elements of the Framework

A successful framework would allow the government to act quickly in response to an emergency, but not allow individual liberties to be reduced to an unacceptable level. The best way to work toward this balance is to make use of traditionally successful mechanisms, like the democratic process, checks and balances, clear criteria for decision making, and judicial procedures designed to control the abuse of power by governmental agencies. In addition, the framework could adopt the modern concept of "shielding" -- the governmental duty to engage the community in voluntary measures of self-protection as a "less

restrictive alternative" to compulsion. This would involve government/community partnerships, including effective state communication about health risks and self-preservation.

In truth, adoption of this framework will not guarantee an appropriate balance between liberty and security. The framework cannot assure that politically accountable government will act for the common good if liberalism remains the prevalent social value. The framework, however, is more likely to prevent government overreaching because it relies on a model of separation of powers. Yet, if the electorate gains confidence that checks on power will prevent governmental excesses, perhaps it will cede greater authority to the state to protect the public's health. That, at least, is the theory behind strong powers hedged with substantive and procedural safeguards.

1. The Democratic Process

Public health policy is riddled with contradictions. Agency officials seek power without constraint. Since they are "experts," they resist substantive or procedural fetters on their decisions. Public health officials often distrust the lay public or their elected representatives, believing they do not understand the sciences of public health and are ill-suited to make sound judgments about infectious disease. The liberal public, on the other hand, prefers strict limits on agency action. They, in turn, often do not trust "experts" to provide objective information and respect individual rights.

The resolution of these differences should take place in the policy making branch of government. Legislators, although not experts, have a fiduciary duty to the public, which should include assuring the public's health and safety. At the same time, the legislature is accountable to the electorate and should avoid undue restrictions on individual freedoms. Legislatures obviously cannot make detailed choices in response to an emergency but, as suggested below, should put in place clear criteria and procedures for agency action.

One of the best ways to ensure that trade-offs are legitimate is to submit them to the democratic process. Democracy, of course, is a highly complex abstraction, but I use it here in at least two respects: civic deliberation and representational policy-making. As to the first, forward thinkers urge greater community involvement in public health decision making so that policy formation becomes a genuinely civic endeavor. Under this view, citizens would strive to safeguard their communities by civic participation, open fora, and capacity building to solve health problems. Public health authorities, for example, might practice more deliberative forms of democracy, involving closer consultation with consumers and the voluntary organizations that represent them (e.g., town meetings and consumer membership on government advisory committees). Meaningful public involvement should result in stronger support for health policies and encourage citizens to take a more active role in protecting themselves and their neighbors.

Representational policy-making is the process through which hard choices are submitted to the legislature for decision. However, in many cases, public health officials, outside the gaze of the media and the political process, make choices covertly. Alternatively, society

sometimes appears willing to wait until a public health emergency arises to submit the problem to the legislature. Representational policy-making works best when the legislative branch deliberates well in advance of a disaster. Through rigorous debate, legislators can consider the relative importance of community values, in addition to various alternatives for accomplishing goals. Democratic deliberation allows key issues to be contemplated publicly, and elected officials to be held accountable for the decisions made. It is important that these discussions take place overtly; the alternative is for a reactionary approach to emergency management that has less potential for considered decision making.

2. Checks and Balances

Although the legislative branch should set the broad parameters for public health policy, there ought to be an important role for the other branches of government. The executive branch is responsible for implementing public health policy. Public health agencies have flexibility to interpret legislative standards, set regulatory policy, and exercise judgment in enforcement actions. The judiciary's role is to ensure that the legislature sets policy (and the executive enforces policy) within constitutional parameters; the agency acts within the scope of the legislative delegation of power; and the agency complies with legislative criteria and procedures for action. Distributing power throughout the three branches of government allows some assurance that none of the branches will overreach in ways that are detrimental to individual freedoms.

A system of checks and balances provides the best prospect for sorting out warranted from unwarranted use of power. If the public health agency acts to reduce a significant health risk, it will be more likely to gain support from other branches of government. If it acts arbitrarily or discriminatorily, the other branches are more likely to hold the agency to account.

Although a classic design for separation of powers is important, it helps solve only one of the problems addressed in this Article. Checks and balances primarily restrain government by making it more difficult for any single branch to act. This has the undisputed value of curbing abuse of power, but may dampen decisive action to avert health threats. Separation of powers offers little to ensure that government meets its responsibilities of public security.

3. Standards of Decision Making

The legislature also should specify clear criteria for the exercise of public health powers. Objective standards have at least two positive effects. First, the political branch of government specifies in advance of a threat the conditions under which it will countenance the use of compulsion. The legislature, as discussed above, can deliberate about the appropriate conditions for coercion and remains politically accountable. Second, the use of clear criteria has a constraining effect on public health agencies. Deciding ahead of time what elements must be present for the executive branch to intervene offers some protection against policy based on suspect motives or irrational public fear. By circumscribing the conditions under which agencies can exercise power, it is possible to permit effective action while reigning in governmental

excesses.

Most existing infectious disease statutes afford agencies broad discretion without setting clear standards for the exercise of power. This approach affords public health officials broad authority and makes it difficult to hold them accountable. Although health officials may prefer wide statutory mandates that grant them flexibility, they are not well served by such legislative inattention to standards. If agencies need to exercise strong power, they are more likely to gain political and public acceptance if they can point to a clear legislative standard supporting their decisions.

4. Procedural Protections

Clear standards for agency action can limit discretion, helping ensure that power is exercised only where needed. Yet, there is still a need for procedural safeguards. Procedural due process has an instrumental and normative value in the context of a public health emergency. Primarily, due process helps ensure that compulsory powers are correctly applied. By affording individuals the right to a fair hearing, there is increased certainty that the individual actually is infectious, poses a risk to others, and cannot or will not comply with public health advice.

Even if due process cannot always ensure the accuracy of decision making, there is a normative value in granting a right to a hearing. Government demonstrates respect for individuals by allowing them to see the evidence against them and present their case to an impartial fact finder. There is a self-expressive importance to procedural due process; fair procedures allow individuals to convey a sense of grievance that has intrinsic worth. There also is a value to racial, ethnic, or religious groups that feel singled out unfairly for coercion. By allowing members of the group to articulate the perceived unfairness in an open and deliberative process, the group gains a collective sense of being heard.

Procedural due process also is important to public acceptance of the legitimacy of the governmental action. The public is more likely to agree to liberty-limiting powers if there is recourse for challenging those that are perceived as unjust. Procedural safeguards can be seen as a hedge against many of the wrongful actions of government such as arbitrary interference, individual discrimination, and group prejudice. As a result, procedural protections should be integrated into the law whenever serious curtailments of individual liberty are envisioned.

5. "Shielding": Government/Community Relationships as a Less Restrictive

Some scholars advocate government engagement with the community to promote measures of self-protection -- a modern concept known as "shielding." Shielding operates on a macro-level, known as "community-shielding," and on a micro-level, labeled "self-shielding." It empowers the public to engage in protective measures that have positive security and protective impact at the individual, community, and ultimately, national level. To be successful, shielding requires "partnership of government, business, media, and the public, operating under the best scientific and medical practices, to break the disease cycle and ensure

minimal disruption to the routine activities of the nation."

Shielding often is seen as an alternative to compulsory measures. Scholars particularly urge its use as a non-coercive model of mass civil confinement: "a form of insulation wherein individuals and groups employ a self-imposed isolation, or quarantine, within their natural surrounding for a temporary period of time." Under this reasoning, government, far in advance of an actual attack, should "prepare the public to stay in place voluntarily, to resist the impulse to flee to family and friends outside the initial danger zone."

The shielding concept could usefully be placed within the legal framework for bioterrorism preparedness by requiring government to supplement (although not supplant) compulsory powers with voluntary approaches. As a form of least drastic means, the law would require public health authorities to provide mechanisms for keeping the public informed about the health emergency, its effects, and the ways in which the public can minimize the impact of the event on themselves and their communities. Preparing a means of effective communication is important in gaining the public's trust and avoiding panic. In addition, it allows the state to use the resources of the community effectively.

Public cooperation is important to the success of counter-bioterrorism interventions. If resources, like medicines, vaccines, or other supplies, need to be distributed, the public will need to follow public health advice and approach distribution points in a rational state of mind to prevent chaos. Similarly, if quarantine or isolation is mandated, the cooperation of the public is crucial to its success. A panicked public will require a much greater force of peacekeepers-police or the National Guard, for instance-to maintain order. Building the public's trust through communicating correct and timely information is crucial to successful management of any emergency.

In addition to helping maintain order, communicating clearly with the public will contribute to individuals coping with the threat. Community members can make real contributions to emergency management. Civic groups can use existing channels of communication to organize volunteers or serve as distribution points and educators can be used to spread important messages. In addition to building trust and reducing panic, effective communication can ensure that existing community resources are used to the maximum benefit.

The framework offered contemplates strong public health powers hedged by classic safeguards-democratic processes, checks and balances, substantive criteria, procedural due process, and less restrictive alternatives. Rather than shying away from effective government action, the framework authorizes it within clearly defined parameters. The framework, therefore, takes both personal and collective interests seriously. It aspires to sort out clearly warranted (the significant risk category) from unwarranted (the arbitrary or discriminatory category) state action. Ultimately, policy will be formed within the political process. This will leave some discontented, particularly those who believe strongly that either individualism or public security is sacrosanct.

. . . .

This article is more explanatory and analytical than prescriptive. I do suggest a framework for sorting out warranted from unwarranted state action and for working through the hard cases. Nevertheless, the framework offered cannot do the hard work required to resolve the inevitable tensions. What it can do is structure decisions to prevent state overreaching. By providing classic safeguards, the framework might facilitate political decisions to allow the exercise of power to safeguard the public's health. In the end, it is likely that neither side of the political divide will be entirely satisfied. For those who see the world as a struggle between an oppressive state and individuals desiring freedom, even strong safeguards may not suffice. For those who see a beneficent government seeking to protect its citizens, the framework offers little encouragement because of its focus on governmental restraint. My overriding purpose is to build a bridge between two often diametrically opposed political theories, demonstrating why each has importance in the perennial, often contentious debate, on liberty and the public's health.

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Notes to Chapter Seven

1. For additional descriptions of the TOPOFF exercise and the lessons that may have been learned, see Donald A. Henderson, et al., “A Plague On Your City: Observations From TOPOFF,” 32 Clinical Infectious 436 (2001); Richard E. Hoffman & Jane E. Norton, “Lessons Learned From a Full-Scale Bioterrorism Exercise,” 6 Emerging Infectious Diseases 652 (2000).

Since the first TOPOFF, there have been several other simulated exercises, testing the ability of federal, state, and local public health agencies to respond collectively to a disaster -- often demonstrating some of the same organizational and management problems encountered in the Colorado exercise. For one example, see Joint Center for Lessons Learned, “Smallpox Strikes Puerto Rico in Bioterrorism Exercise,” Journal of Homeland Security (August 9, 2004)(available at http://www.homelandsecurity.org/journal/articles (last visited April 2005); see also a simulated smallpox attack on Oklahoma City, described at http://www.homelandsecurity.org/darkwinter (last visited April 2005).

According to that homeland security website, the Oklahoma exercise demonstrated five “learning points”: biological weapons could threaten vital national security interests, current organizational structures are not well suited to managing a biological attack, there is no surge capacity in our health system, dealing with the media is critical, and should a contagious bioweapon pathogen be used, containing the spread of disease will present significant ethical, political, cultural, operational, and legal challenges.”

TOPOFF 2 was held in May of 2003: a simulated release of the plague in Chicago. As of the Spring of 2005, plans were in place for “TOPOFF 3,” a simulation of a smallpox outbreak in New Jersey and a chemical attack in Connecticut. Se http://www.dhs.gov/dhs.public/ (last visited April 2006).

2. One thing is clear, the threat of a fast-spreading, infectious disease, whether introduced by terrorists or by Mother Nature, presents unique problems that will be measured not only in terms of the immediate impact -- widespread illness and death -- but in terms of long term social and economic consequences. A fast-spreading disease would quickly exhaust local first-aid and medical resources, and, possibly, even the food and water supply. People would stop reporting to work (and some of those people would have first-response and medical responsibilities). The state and the federal governments may act to support local efforts, but even their resources may be at best only able to contain the spread of the disease. Scenarios involving hundreds or even thousands of casualties are imaginable.

What would happen then? The result might be a loss of confidence in the ability of the government to govern, possibly even a loss of respect for the rule of law. Most Americans have ambivalent feelings about “big government” intervention, but most Americans also have lived their lives in a world in which they could confidently assume that their government, big or otherwise, could maintain order and resolve virtually

any widespread problem. For them, an unchecked, epidemic disease would be a unique and potentially unsettling experience.

3. As several of the articles excerpted in this chapter argue, Americans need to increase their level of preparation for what appears to be the inevitable: either a naturally created, fast-moving outbreak of an infectious disease, or the release by terrorists of some comparable biological threat. Indeed, “preparedness” seems to be the new buzz word of public health policymaking. But what exactly do we have to do to be prepared? Part of the answer may simply be to educate ourselves and overcome the “it can’t happen here” complacency that many Americans seem to exhibit, or at least they did until the fall of 2001. Other suggestions are more concrete:

-- more and more coordinated laboratories to identify diseases and biological agents better and quicker;

-- more and better trained staffing for state and local health departments;

-- better (and more sophisticated) communication between local, state, and federal agencies, between government agencies and private health care providers, and between private providers -- even those who normally compete for the same health care business and don’t like to talk freely to each other;

-- better communication between public health agencies and the mass media;

-- better education of private health care workers as to what to do (e.g., identify and report signs of contagious diseases) and what not to do (e.g., prescribing antibiotics to patients who are worried about future terrorists attacks).

All of these recommendations, of course, apply to the public health system generally and not just to that portion of the public health infrastructure that is designed to respond to bioterrorism or the outbreak of an epidemic disease. All of these recommendations also sound like good ideas. But how do we make these things happen? Just dedicate more money to these sorts of activities? Increase federal oversight of state and local public health agencies? Create independent private organizations to assess our preparedness and any future progress? Do we need a “super-agency” or a “bioterrorist czar”?

More basically, why haven’t these problems been fixed already? After all, none of these recommendations is anything more than common sense. Who has failed: our leaders, our policymakers, or all of us who select and support them?

4. There has been some improvement, albeit limited, in our public health preparedness in the last few years. Following the September 11, 2001, terrorist attacks, Congress enacted legislation making nearly $1 billion available to state and local health departments to upgrade their facilities and to enhance interagency cooperation. Public Health

Security and Bioterrorism Preparedness and Response Act of 2002, Pub. L. No. 107-188. Annual appropriations for the program in subsequent years were even greater. An evaluation of this program in 2004 reported that there had been many improvements in public health emergency preparedness, especially in areas of improved communications, developments of response plans, and training of staff. (Note that these were among the key areas of concern in evaluating the TOPPOFF exercise.) On the other hand, the survey clearly regarded this $1 billion-plus effort as only partially successful: “These survey findings lead to two conclusions about the federal role in improving local bioterrorism preparedness. First, continued national progress will require sustained and increased federal support. Second, federal and state governments must make a concerted effort to optimize the use of current funding so that it meets local needs.” National Association of County and City Health Officers, “The Impact of Federal Funding on Local Bioterrorism Preparedness,” Research Brief Issue 5, No.9 (April 2004). Translated from the bureaucratic to plain English this means: we need more resources and we have a long way to go.

For a more recent assessment of bioterrorism preparedness and public health agencies, see http://healthyamericans.org/state/bioterror/ (last visited April 2005).

5. If and when federal agencies respond to a local or state public health problem, there are a myriad of legal problems involved in sorting out who can do what and under which circumstances. Americans need to be prepared, but, American lawyers need to enhance their level of legal preparedness as well.

As will be discussed further infra, state and local public health laws need to be understood, coordinated, and, where necessary, revised in preparation for the next terrorist attack or epidemic outbreak. Many local and state public health laws were devised in other contexts and other eras. As the Barbera article argues, laws allowing for quarantine or isolation are likely to be out-of-date and in need of revision. Horton et al., would argue that most state laws requiring surveillance and reporting are also inadequate.

What other laws need to be examined and revised? More broadly, what else should lawyers be doing to prepare themselves?

The Office of the Legal Counsel at CDC has attempted to specify the elements of the public health system’s legal preparedness that will need to be improved in order for the legal community to respond effectively to a bioterrorist or epidemic event:

The first step in fleshing out the concept of public health legal preparedness is to unpack its four core elements. . . .

Laws or legal authorities clearly are the beginning point for public health legal preparedness, just as epidemiology is for outbreak investigation. Laws are the authoritative utterances of public bodies and come in many stripes, among them statutes, ordinances, and judicial rulings as well as the policies of such public bodies as school boards, mosquito control districts, transportation commissions, and land use planning bodies.

At the operational level, public health laws also include such "implementation tools" as executive orders, administrative rules and regulations, memoranda of understanding (e.g., between health departments and private hospitals for surge capacity or between health departments and law enforcement agencies for joint investigation of suspected terrorism), and mutual aid agreements among localities, states, or nations.

Laws, however, are neither self-creating nor self-enforcing. Thus the second core element is the competencies of the people who serve as the agents of public health legal preparedness. In the public sector these include elected officials, public health professionals, their legal counsel, government agency administrators, judges, law enforcement officials, and others. In the private sector are included medical practitioners, hospital and health plan administrators, community organizations, a wide range of service and advocacy organizations, and their legal counsel. Also important are the researchers, educators, and other scholars who develop the science base for public health legal preparedness and who educate practitioners in public health law. . . .

The third core element is information for these agents' use in shaping and applying public health laws. Examples include repositories of public health laws, updates on new enactments and judicial rulings, reports on innovations and public health law "best practices," and public health law practice guidelines. A surprising finding is how rare such information resources are. With some exceptions, there appear to be few, if any, published manuals on public health emergency law for government and hospital attorneys, "bench books" for judges to brief themselves on evidentiary standards for public health search warrants and quarantine orders, or databases of extant state and municipal public health emergency statutes and regulations.

The fourth core element is coordination of legal authorities across the multiple sectors that bear on public health practice and policy and across the vertical dimension of local-state-federal-international jurisdictions. Coordination is critical precisely because the public health system is richly multidisciplinary, multi-sectoral, and cross-jurisdictional.

Anthony, Moulton, Richard N. Gottfried, Richard A. Goodman, Anne M. Murphy, & Raymond D. Rawson, “What is Public Health Legal Preparedness?” 31 J. L. Med. & Ethics 672, 671 (2003).

6. The interplay of federal and state authority may be particularly problematic -- and far more complicated than the description summarized in the Barbera excerpt. Any use of federal authority will have to be implemented under some specific federal statute (and not merely because of an impact on interstate commerce, as the authors of the Barbera article seem to believe) and may only be triggered, in some cases, by specific presidential declaration. Nor does the invitation of a state, by itself, legitimatize federal action. At least at the agency level, all federal action must derive from some federal statutory foundation.

Some statutory groundwork for federal intervention has been secured. As discussed in Chapter 2, there is federal statutory authority for the CDC to act to prevent infectious diseases from entering the country, and from crossing state borders, including the authority to quarantine people who may be infected. See discussion of 42 U.S.C. § 264 and its implementing regulations, 42 C.F.R. § 70 et seq. in Chapter 3. Note that 42 C.F.R. § 70.2 provides for federal intervention when a state or local government’s efforts to stop the spread of an infectious disease are inadequate; presumably this would provide some basis for federal action, even without the invitation or consent of a state. In addition, 42 U.S.C. § 243 authorizes CDC to act in concert with state or local public health authorities in matters relating to infectious diseases where the CDC is requested to do so.

Even where there is statutory authority for the CDC to act in matters relating to bioterrorism, there still may be legal problems associated with federal intervention. The legality of the use of military resources is a particularly problematic (and politically volatile) problem that lawyers should be prepared to address -- and, as with all other decisions made in these circumstances -- address very quickly. The Posse Comitatus Act, 18 U.S.C. § 1385, is a general prohibition on the use of military forces to enforce domestic criminal laws. Among other things, this would prevent the use of the army or other Department of Defense personnel in the enforcement of state or local isolation or quarantine laws, even if other federal personnel, such as those from the CDC, are involved in the implementation of those activities. The President does have the constitutional authority to authorize the use of military force -- essentially declaring martial law. The Insurrection Act, 10 U.S.C. §§ 331-334, also allows the President to authorize the use of military personnel in emergencies. There is also limited authority under 10 U.S.C. § 382 for the Secretary of defense to extend assistance to the Department of Justice in some bioterroist emergencies. Otherwise, federal military personnel may have to limit their roles to “support” of other federal agencies and avoid engaging in what could be considered a violation of the Posse Comitatus Act.

Establishing the statutory basis for federal action, of course, is only one step in establishing the legal framework within which federal, state, and local public health agencies can act in concert. A myriad of other legal questions will have to be answered. (For just one example, see 42 U.S.C. § 233, limiting liability for health workers who participate in certain specified smallpox countermeasures.) Moreover, as illustrated in the TOPOFF exercise and discussed by the Barbera and Horton articles, some of the most difficult legal decisions will have to be made as part of the rapid implementation of the activities that these statutes and regulations authorize. Simply deciding who can decide certain legal questions will be difficult.

7. A “bioterrorist attack” need not, of course, come from sources outside of the United States or, for that matter, necessarily be an intentional attack. The release of a fast-spreading infectious disease could be accidental or due to the careless practices of otherwise legitimate researchers. For one discussion of the likelihood of such an event, see National Research Council, National Academies, Biotechnology

Research In an Age of Terrorism 17-29 (2004)(available on line at http://lab.nap.edu/nap-cgi/discover (last visited April 2005).

8. The full (and most recent) version of the Model State Emergency Health Powers Act can be found at the Center’s website, http://www.healthlaw.net (last visited April 2005). The model act has drawn a considerable amount of commentary, much of it critical, but it has sparked a healthy debate and led to the consideration and, in some cases, enactment of legislation in a number of states. For a defense of the model act, see James G. Hodge, Jr., “Bioterrorism Law and Policy: Critical Choices for Public Health,” 30 Journal of Law, Medicine, & Ethics 254 (2002).

George Annas has been a particularly vocal critic of the act and its underlying philosophy. As he stated in an article written in the same symposium as the Wing article:

Of course, state public health, police, fire, and emergency planners should be clear about their authority, and to the extent the model act encourages states to review their emergency laws this is constructive. On the other hand, many of the provisions of this model act, especially those giving authority of public health officials over physicians and hospitals, and authority to quarantine without meaningful standards, seem to be based on the assumption that neither physicians nor the public are likely to cooperate with public health officials in the aftermath of a bioterrorist attack, and that panic is likely. . . .

[There are] three major objections to the initial version of the model act. First, it is far too broad, applying as it does not just to a smallpox attack, but to non-emergency conditions as diverse as our annual flu epidemic and the HIV epidemic. Second, although it may make sense to put public health officials in charge of responding to a smallpox attack, it may not make sense to put them in charge of responding to every type of a bioterrorism event. . . .

The third objection to the act is that there is no evidence from either 9/11 or the anthrax attacks that physicians, nurses, or members of the public panic, are reluctant to cooperate in responding to a bioterrorism attack, or are reluctant to take drugs or vaccines recommended by public health officials. . . . .

George J. Annas, “Blinded by Terrorism: Public Health and Liberty in the 21st Century,” 13 Health Matrix 33, 50-52 (2003). For development of some of these same critiques, see George J. Annas, “Bioterrorism, Public Health, and Civil Liberties,” 346 New Eng. J. Med. 1337-1342 (2002). See also his response to Gostin’s Florida Law Review article, “Puppy Love, Bioterrorism, Civil Rights, and Public Health,” 55 Fla. L. Rev. 1171 (2003).

9. As discussed in the article by Chyba, the events of September 11, 2001, and to a lesser extent, the “anthrax scare” that followed changed the way that many Americans think about their world and its security. David Fidler has argued that one useful way to consider the changes that

have taken place is to look at the growing connections between traditional public health concerns and national security:

Public health problems, especially infectious diseases, have been the focus of diplomatic activity among states since at least the mid-nineteenth century. The prevention and control of infectious diseases has, therefore, been a foreign policy concern of states for a long time. Public health as a foreign policy concern is not the same thing, however, as public health constituting an issue of national security. Traditionally, for most states, national security is one of the most important, if not the most important, foreign policy concern. Although public health has been the subject of diplomatic activity for over 150 years, other foreign policy concerns, such as the balance of military power and international trade, have been more important to statecraft than public health.

. . . .

. . . The development of the public health-national security linkage in the 1990s flows from four important causes: (1) the devastating scale of the HIV/AIDS pandemic in the developing world; (2) the recognition of the global problem of emerging and reemerging infectious diseases; (3) renewed concerns about the proliferation of biological weapons by states; and (4) increased fears about the use of biological weapons by terrorists.

. . . .

. . . [A] new concept of "public health security" has entered both the public health and national security communities -- communities that have traditionally had little to do with each other. Public health security consists of the policy areas in which national security and public health concerns overlap. . . . The analytical challenge comes in defining the extent to which public health and national security overlap as policy endeavors and the importance of the overlap for policy purposes.

David P. Fidler, “Public Health and National Security in the Global Age: Infectious Diseases, Bioterrorism, and Realpolitik,” 35 Geo. Wash. Int. L. Rev. 787, 789 (2003). Fidler, like Chyba, also has argued that Americans should also adjust their thinking about public health to consider public health-related issues from an international perspective, rather than a set of issues that largely concern domestic policy. See David P. Fidler, “A Globalized Theory of Public Health Law,” 30 J.L. Med. & Ethics 150 (2002); see also David P. Fidler, “Bioterrorism, Public Health, and International Law,” 3 Chi. J. Int. L. 7 (2002).

Appendix to Chapter Seven: Project Bioshield

The following remarks were made by President Bush at the ceremonial signing of the Project Bioshield Act of 2004, Pub. L. No. 108-276:

On September the 11th, 2001, America saw the destruction and grief terrorists could inflict with commercial airlines turned into weapons of mass murder. Those attacks revealed the depth of our enemies’ determination, but not the extent of their ambitions. We know that the terrorists seek an even deadlier technology. And if they acquire chemical, biological, or nuclear weapons, we have no doubt they will use them to cause even greater harm.

The bill I am about to sign is an important element in our response to that threat. By authorizing unprecedented funding and providing new capabilities, Project Bioshield will help America purchase, develop, and deploy cutting-edge defenses against catastrophic attack.

This legislation represents the collective foresight and considered judgment of United States senators and members of the House of Representatives from both parties -- many of who experienced bioterror first hand when anthrax and ricin were found on Capitol Hill. It reflects 18 months of hard work and cooperation . . . . It sends a message about our direction in the war on terror. We refuse to remain idle while modern technology might be turned against us; we will rally the great promise of American science and innovation to confront the greatest danger of our time.

. . . .

Project Bioshield will transform our ability to defend the nation in three essential ways. First, Project Bioshield authorizes $5.6 billion over 10 years for the government to purchase and stockpile vaccines and drugs to fight anthrax, smallpox, and other potential agents of terror. The DHHS has already taken steps to purchase 75 million doses of an improved anthrax vaccine for the Strategic National Stockpile. Under Project Bioshield, DHHS is moving forward with plans to acquire a safer, second generation smallpox vaccine, an antidote to botulinism toxin, and better treatments for exposure to chemical and radiological weapons.

Private industry plays a vital role in our biodefense efforts by taking risks to bring new treatments to the market, and we appreciate those efforts.

By acting as a willing buyer for the best new technologies, the government ensures that our drug stockpile remains safe, effective, and advanced. The federal government and our medical professionals are working together to meet the threat of bioterrorism -- we’re making the American people more secure.

second, Project Bioshield gives the government new authority to expedite research and development of the most promising and time-sensitive medicines to defend against bioterror. We will waste no time putting those new powers to use. Today, Secretary Thompson will direct the NIH to launch two initiatives -- one to speed the development of new treatments for victims of a biological attack, and another to expedite the development of treatments for victims of a radiological or nuclear attack. Under the old rules, grants of this kind of research often took 18 to 24 months to process. Under Project Bioshield, DHHS expects the process to be completed in about six months. Our goal is to translate today’s promising medial research into drugs and vaccines to combat a biological attack in the future -- and now we will not let bureaucratic obstacles stand in the way.

Third, Project Bioshield will change the way the government authorizes and deploys medical defenses in a crisis. When I sign this bill, the FDA will be able to permit rapid distribution of promising new drugs and antidotes in the most urgent circumstances. This will allow patients to quickly receive the best available treatments in an emergency. Secretary Thompson has directed the FDA to prepare guidelines and procedures for implementing this new authority. By acting today, we are making sure we have the best medicine possible to help the victims of a biological attack.

Project Bioshield is part a broader strategy to defend American against the threat of weapons of mass destruction. Since September the 11th, we’ve increased funding for the Strategic National Stockpile by a factor of five, increased funding for biodefense research at NIH by a factor of 30, secured enough smallpox vaccine for every American, worked with cities on plans to deliver antibiotics and chemical antidotes in an emergency, improved the safety of our food supply, and deployed advanced environmental detectors under the BioWatch program to provide the earliest possible warning of a biological attack.

The threat of bioterrorism has brought new challenges to our government, to our first responders, and to our medical personnel. We are grateful for their service. Not long ago, few of these men and women could have imagined duties like monitoring the air for anthrax, or delivering antibiotics on a massive scale. Yet, this is the world as we find it; this nation refuses to let out guard down.

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