Introduction

History

Policy

Bioagents

Scenarios

Biolabs

Government Response

Media

Boston Site

Advocacy

Scenarios

High-Risk Scenarios

The risks of biological agents causing harm to civilians are usually discussed in terms of intentional terrorist attacks or unanticipated risks, such as laboratory accidents, that could affect communities.

US Accidents and System Failures

Although there are a number of examples of laboratory accidents involving select agents, the increased investment in biodefense funding has created many more research sites in the United States. The present complexity of shipping, handling, and research has increased the risks of accidents that can pose harm within and beyond the laboratory.

The shipping of deadly, live bacteria is in theory controlled by regulations and permits and it might typically be handled by courier rather than sent through the mails. These safety provisions should work. In June 2004, though, it was discovered that researchers at the Children’s Hospital Oakland Research Institute in Oakland, California, were working with deadly, live anthrax bacteria when they thought they were using only a non-hazardous, dead bacterium. Six researchers, who were involved in a project on anthrax vaccine, handled the deadly bacteria and others may have been exposed.

That a deadly strain had been sent was not immediately reported. Researchers injected mice with what they thought were dead anthrax bacteria. It was only after several days, when all the mice in the experiment died, that the lead researchers were told there might be a problem. Then a second batch of mice was inoculated and cultures obtained from a dead mouse revealed virulent anthrax.

The source of the virulent bacterium was the Southern Research Institute of Frederick, Maryland, an affiliate of Fort Detrick. This company maintains two “hot labs,” one in Frederick and another in Birmingham, Alabama. Thomas Voss, in charge of the company’s emerging infectious disease program, initially said that “We receive [select] agents on a routine basis. But on our end, we ship very infrequently. I don’t even recall shipping live agents.” The deadly agent was shipped via FedEx, double-boxed.

The California Department of Health Services was called in, as were the FBI and the CDC. Samples of the anthrax bacterium were sent to CDC in Atlanta for testing.

The laboratory is located about a mile from the hospital itself, on Martin Luther King, Jr. Drive. The local community is largely working class and minority. A senior center is housed in the same building as the research institute. The local community was not informed about research on anthrax vaccine. The institute is not registered for work on live select agents. Before the 2001 anthrax letters, there were around 12 facilities working with the anthrax bacterium. Now it appears that there are 350.

[This information is taken from an article in the Oakland Tribune that was forwarded to ProMED, the clearinghouse for information on infectious diseases worldwide, which can be contacted at majordomo@promedmail.org for subscription and archives and other information.]

Examples from the History of Biological Weapons

The use of biological agents against communities or even in battle has been exceptionally rare. During World War II, the Japanese Imperial Army made various attempts, some of them successful, to use agents of plague and cholera and other diseases against Chinese cities and towns and also against Soviet soldiers. Accidents involving biological weapons that caused harm to civilians have also occurred. In 1973 there was a smallpox outbreak in the Soviet Union near a testing site for biological weapons. In 1979, also in the Soviet Union, around 70 people died from exposure to an anthrax aerosol (see the discussion of the Sverdlovsk epidemic below).

The fact that so few instances of intended or accidental harm have occurred means that scenarios are often imagined to structure plans to protect the civilian population. The means by which disease from biological weapons might be spread has relied on two main models. The first is an aerosol that disperses germs over an unprotected urban community. The second is the spread of disease by human-to-human contact. History offers important examples of how each could harm civilians.

Aerosols

US Army Tests, 1951-1953:
In the early 1950s, when the United States had a Cold War biological warfare program, its researchers tested the release of aerosols over three North American cities that resembled Soviet cities that might be targeted by anthrax. These cities were St. Louis, Missouri, Minneapolis, Minnesota, and the Canadian city of Winnipeg. The research project was called “St. Jo Program” and its results informed the US about the dispersal of anthrax-like spores from a spray generator in an urban environment at different seasons during the year. Here is an illustration from the 1954 report on the St. Jo project. The dotted lines show the predictable dispersal of an aerosol, while the wavy lines show how the aerosol actually dispersed. (“Preliminary Discussions of Methods for Calculating Munition Expenditure, with Special Reference to the St Jo Program,” 11 August, 1954, Camp Detrick, Frederick, MD).

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US Army Tests, 1962-1973
From 1962 to 1973, under Project 112, the US Army conducted many field tests of chemical and biological weapons in remote areas of the Pacific or Arctic or at special testing centers in the US, Canada, and the United Kingdom. At least 25 separate projects involved dispersing biological agents. Usually these agents were simulants of anthrax or other agents but at times with the agents for tularemia or Q fever were used. The achievement of Project 112 was to show that a region as large as a thousand square miles might be attacked by airplane with biological weapons agents. SHAD (Shipboard Hazard and Defense) was the naval part of Project 112.

Project 112 took place during the years of the Vietnam War. Veterans have been active in demanding the declassification of the Project 112 test information. They have been concerned about exposure to the different agents and also to chemical weapons such as sarin nerve gas. After a three year investigation, most information appears to have been released by the Department of Defense (http://deploymentlink.osd.milo/current_issues/shad_chart/). Vietnam veterans also track this release of data (http://www.vva.org/shad/).

Soviet Anthrax Accident, 1979:
In 1979, the Soviet Union was developing and producing anthrax in secret defiance of the Biological Weapons Convention. In early April of that year, citizens suddenly began to die of anthrax in the city of Sverdlovsk, in the Urals. The Soviet Union explained that infected meat had caused around 64 deaths. The CIA made the claim that a military facility in Sverdlovsk was a more likely source of infection.

In 1992, after the Soviet Union fell, a team of US and Russian researchers went to Sverdlovsk to find out what had happened. These investigators were able to show that on April 2, 1979, the people affected by anthrax were downwind of the military facility, called Compound 19. The first of the following maps shows where victims of the outbreak were during the nighttime in early April. The second map shows where they were during the daytime, which was southeast of the military facility. Wind data for April 2, 1979, indicates that a brisk wind was blowing nearly all day from the northwest, over Compound 19 and the nearby neighborhood and into the countryside. The third map shows the villages where animals died as a result of the wind-borne anthrax spores. Exactly what happened inside Compound 19 on April 2 is unknown, although it is certain that anthrax was prepared for weapons there and that aerosol experiments were conducted on monkeys. The most likely explanation is that a filtration device failed, which allowed an aerosol to escape. The report of the Sverdlovsk investigation appeared in Science (Matthew Meselson et al. “The Sverdlovsk Anthrax Outbreak of 1979” vol.266, no.5188: 1202-8). For more discussion of the creation of these maps and the background of the Sverdlovsk event, see Anthrax: The Investigation of a Deadly Outbreak (University of California Press, 1999) by Jeanne Guillemin.

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Contagion

In general the threat a BSL4 accident poses to the local community depends on how contagious the agent is. Historical reports of government laboratory workers becoming infected with dangerous diseases while exploring either the defensive or offensive aspects of biological warfare are rare. For example, at least two people who worked at Fort Detrick during the 1950s and 1960s died of accidental exposure to anthrax. But anthrax is not usually spread by contact from one person to another. More recent examples have involved scientists accidentally infected with the Ebola virus, which is not highly contagious.

Smallpox, which is very contagious, has caused concern for the harm it could do to unprotected civilians. The history of smallpox is long and complicated. For centuries it was a feared epidemic disease. Then it was realized that people could develop immunity to it, either by early exposure to mild forms or by vaccinations. By the 1960s, smallpox was a disease associated with poor countries that lacked effective public health programs. In 1972, a traveler returning from Iraq started a small smallpox epidemic in Yugoslavia. This outbreak was soon brought under control with quarantines and vaccinations. Fearing such contagion, the major nations of the world, through the World Health Organization, began an international effort to eradicate smallpox with aggressive vaccination campaigns in developing nations. The World Health Organization offers information on the history of smallpox (http://www.who.int/emc/diseases/smallpox/factsheet.html).

Once the World Health Organization declared smallpox eradicated in 1980, smallpox vaccination programs ended. Only two nations, the United States and the Soviet Union, were allowed to keep samples of smallpox strains. After the end of the Soviet Union, it was discovered that its biological warfare program had developed smallpox for possible use as an agent. In the United States, the concern grew that terrorists might gain access to Russian-held smallpox.

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Fictional Scenarios

Many fictional scenarios have been created in order to explore the ways in which the public might be better protected from both bioterrorism and from accidents involving infectious diseases. Here we present some examples of these imagined threats.

1. Bioterrorism and Contagion: “Dark Winter”

Drawing on concerns about possible bioterrorism, consultants from four different organizations devised a fictional contagion scenario called “Dark Winter” which described three states being attacked. In July 2001 “Dark Winter” was enacted with some well-known political and media figures playing the roles of the US President and other officials who would have to respond to a bioterrorist attack by Iraqi agents. The presumption was made that Iraq either had the smallpox virus or could obtain it from Russia. One of the political goals of the scenario was to underscore the need for national stockpiles of smallpox vaccine. In 2003 President George W. Bush initiated a national smallpox vaccination campaign, which was based on the perception that a smallpox bioterrorist threat was looming.

Criticisms of “Dark Winter” soon emerged. Experts thought that the high rate of contagion in the scenario, which allowed each one person infected to infect another 12 to 15 other people, was an exaggeration of what would happen in real life. They also criticized the way in which the scenario left out the active role an informed public could take in preventing the spread of the disease, by handwashing, staying at home, and wearing a simple mask. In the 1947 smallpox outbreak that threatened New York City, the public and the media worked together to allow vaccinations to take place with great efficiency and without the public panic and violence that were part of “Dark Winter.” These criticisms and other criticisms are found in journal articles by scientists and physicians in Emerging Infectious Diseases, volume 7, number 1, (2001); Nature, volume 414, number 13 (2001) and New England Journal of Medicine volume 348, number 5 (2003).

A descriptive summary of “Dark Winter” is available at the web site of the ANSER Institute (http://www.anser.org/darkwinter/index.cfm). The following is text taken from that summary:

On 22-23 June, the Center for Strategic and International Studies, the Johns Hopkins Center for Civilian Biodefense Studies, the ANSER Institute for Homeland Security, and the Oklahoma National Memorial Institute for the Prevention Terrorism, hosted a senior-level war game examining the national security, intergovernmental, and information challenges of a biological attack on the American homeland.

With tensions rising in the Taiwan Straits, and a major crisis developing in Southwest Asia, a smallpox outbreak was confirmed by the CDC in Oklahoma City. During the thirteen days of the game, the disease spread to 25 states and 15 other countries. Fourteen participants and 60 observers witnessed terrorism/warfare in slow motion. Discussions, debates (some rather heated) and decisions focused on the public health response, lack of an adequate supply of smallpox vaccine, roles and missions of federal and state governments, civil liberties associated with quarantine and isolation, the role of DoD, and potential military responses to the anonymous attack. Additionally, a predictable 24/7 new cycle quickly developed that focused the nation and the world on the attack and response. Five representatives from the national press corps (including print and broadcast) participated in the game, including a lengthy press conference with the President.

KEY PLAYERS

President	The Hon. Sam Nunn
National Security Advisor	The Hon. David Gergen
Director of Central Intelligence	The Hon. R. James Woolsey
Secretary of Defense	The Hon. John White
Chairman, Joint Chiefs of Staff	General John Tilelli (USA, Ret.)
Secretary of Health & Human Services	The Hon. Margaret Hamburg
Secretary of State	The Hon. Frank Wisner
Attorney General	The Hon. George Terwilliger
Director, Federal Emergency Management Agency	Mr. Jerome Hauer
Director, Federal Bureau of Investigation	The Hon. William Sessions
Governor of Oklahoma	The Hon. Frank Keating
Press Secretary, Gov. Frank Keating (OK)	Mr. Dan Mahoney
Correspondent, NBC News	Mr. Jim Miklaszewski
Pentagon Producer, CBS News	Ms. Mary Walsh
Reporter, British Broadcasting Corporation	Ms. Sian Edwards
Reporter, The New York Times	Ms. Judith Miller
Reporter, Freelance	Mr. Lester Reingold

The players were introduced to this crisis during a National Security Council meeting scheduled to address several emerging crises, including the deployment of a carrier task force to the Middle East. At the start of the meeting, the Director of Health and Human Services informed the President of a confirmed case of smallpox in Oklahoma City. Additional smallpox cases were soon identified in Georgia and Pennsylvania. More cases appeared in Oklahoma. The source of the infection was unknown, and exposure was presumed to have taken place at least nine days earlier due to the lengthy incubation period of smallpox. Consequently, exposed individuals had likely traveled far from the loci of what was now presumed to be a biological attack. The exercise spanned 13 days, and served as a vehicle to illustrate the following points.

“DARK WINTER” was developed and produced by:

The Center for Strategic and International Studies
http://www.csis.org/
Contact: Dr. John Hamre, President & CEO
(202) 775-3227

The Johns Hopkins Center for Civilian Biodefense Studies
http://www.hopkins-biodefense.org/ (later relocated to University of Pittsburg)
Contact: Dr. Tara O’Toole, Deputy Director
(410) 223-1667

The ANSER Institute for Homeland Security
http://www.homelandsecurity.org/
Contact: Col. Randy Larsen (Ret.), Director
(703) 416-3597

The Oklahoma City National
Memorial Institute for the Prevention of Terrorism
http://www.mipt.org/
Contact: General Dennis J. Reimer (Ret.), Director
(405) 232-5121

2. The Lone Operator and the BSL4 Facility

How could a lone operator enter the facility?

Members of the laboratory staff have specific and thorough training in handling extremely hazardous infectious agents and they understand the primary and secondary containment functions of the standard and special practices, the containment equipment, and the laboratory design characteristics. They are supervised by competent scientists who are trained and experienced in working with these agents. Access to the laboratory is strictly controlled by the laboratory director. The facility is either in a separate building or in a controlled area within a building, which is completely isolated from all other areas of the building. A specific facility operations manual is prepared or adopted. Personnel working in the facility would undergo thorough background checks by State and Federal agencies.

Only persons whose presence in the facility or individual laboratory rooms is required for program or support purposes are authorized to enter.

Access to the facility is limited by means of secure, locked doors; accessibility is managed by the laboratory director, biohazard control officer, or other person responsible for the physical security of the facility. Before entering, persons are advised of the potential biohazards and instructed as to appropriate safeguards for ensuring their safety. Authorized persons comply with the instructions and all other applicable entry and exit procedures. A logbook, signed by all personnel, indicates the date and time of each entry and exit.

The Biosafety Level 4 facility consists of either a separate building or a clearly demarcated and isolated zone within a building. The rooms in the facility are arranged to ensure passage through a minimum of two doors prior to entering the room(s) containing the Class III biological safety cabinet (cabinet room). Outer and inner change rooms separated by a shower are provided for personnel entering and leaving the cabinet room. A double-door autoclave, dunk tank, fumigation chamber, or ventilated anteroom for decontamination is provided at the containment barrier for passage of those materials, supplies, or equipment that are not brought into the cabinet room through the change room.

Access doors to the laboratory are self-closing and lockable. Inner and outer doors to the chemical shower and inner and outer doors to airlocks are interlocked to prevent both doors from being opened simultaneously.

Unless someone with legitimate access to the BSL4 laboratory intended to do harm, it would be difficult for a single individual to overcome these barriers.

3. BSL4 Accidents

BSL-4 uses several measures to ensure that infectious agents are properly contained or destroyed. They include microfiltration of air, air-lock buffer zones, “space suits” with positive-pressure air supply, chemical decontamination, and decontamination at high temperature for long periods of all materials produced in the facility.

Personnel enter and leave the laboratory only through the clothing change and shower rooms. They take a decontaminating shower each time they leave the laboratory. Personnel use the airlocks to enter or leave the laboratory only in an emergency.

Needles and syringes or other sharp instruments are restricted in the laboratory for use only when there is no alternative, such as for parenteral injection, phlebotomy, or aspiration of fluids from laboratory animals and diaphragm bottles. Plasticware should be substituted for glassware whenever possible.

Any windows are breakage-resistant and sealed.

Almost all of the requirements of Level 4 facilities deal with preventing accidents. The focus is almost only on accidents from within the Lab (preventing infections) not from outside forces. For example, what happens in case of massive power failure, fire, explosion?

4. Terrorist Groups

The BSL-4 facility would be constructed within an enclosed perimeter. In addition, there will be extra security for the BSL-4 lab building. Specialty designed security lighting, observation cameras and card reader systems will be installed for the BSL-4 facility. Personnel working in the facility would undergo thorough background checks by State and Federal agencies.

Biological materials to be removed from the Class III cabinet or from the Biosafety Level 4 laboratory in a viable or intact state are transferred to a nonbreakable, sealed primary container and then enclosed in a nonbreakable, sealed secondary container. This is removed from the facility through a disinfectant dunk tank, fumigation chamber, or an airlock designed for this purpose.

A system is established for reporting laboratory accidents and exposures and employee absenteeism, and for the medical surveillance of potential laboratory-associated illnesses. Written records are prepared and maintained. An essential adjunct to such a reporting-surveillance system is the availability of a facility for the quarantine, isolation, and medical care of personnel with potential or known laboratory-associated illnesses.

A terrorist group would most likely operate from outside the facility, unless they cooperate with someone who works there.

5. Long-term Unanticipated Risks: Secrecy, Innovation, and Training

It is unclear at present just how open the research on select agents at Level 4 labs will be and how much this research will draw on new biotechnologies. In 2003, the National Research Council (NRC) Committee on Research Standards and Practices to Prevent the Destructive Application of Biotechnology published its recommendations that scientific research be conducted with openness (Biotechnology in an Age of Terrorism: Confronting the Dual Use Dilemma, Washington, DC: National Academy Press). Nonetheless, if research is being done for national defense, it seems to follow that different levels of secrecy will be used to control it.

In an April 28, 2004, press announcement, the Bush administration stated that the goals of its national biodefense program include secret research. That is, the US intelligence community would be investigating the types of genetically-engineered “bugs” that terrorists could be developing to attack the US. No current information appears to exist that terrorists have the capability or intent to develop such special new agents. It could be that the US in the name of defense will pioneer new dangerous biological agents that, in turn, might be sought by other states or by terrorists.

In addition, the growth in Level 4 laboratories increases the numbers of scientists and technicians who are familiar with select agents such as anthrax and smallpox. While efforts are being made to register and check the security backgrounds of all those with access to select agents, over time it may not be possible to keep track of those who participated in, for example, the creation and testing of aerosols.

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