High-Threat Biological Agents: Characteristics, Effects, and Policy Implications

Congressional research reportOct 30, 2003

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High-Threat Biological Agents:

Characteristics, Effects, and

Policy Implications

Updated October 30, 2003

-name redactedAnalyst in Science and Technology Policy

Resources, Science, and Industry Division

Congressional Research Service ˜ The Library of Congress

High-Threat Biological Agents: Characteristics, Effects,

and Policy Implications

Summary

The anthrax mailings in 2001, which culminated in 5 deaths, 22 infections, and

contamination of both postal and congressional buildings, intensified concerns about

terrorist use of biological agents. This event increased Congressional interest in

actions to limit the vulnerability of the United States to such attacks. High-threat

biological agents, defined by the Centers for Disease Control and Prevention as

Category A pathogens, are considered relatively easy to disseminate, have high

mortality, and have the potential for major public health impacts.

High-threat biological agents cause different symptoms in their victims,

depending on the pathogen. Since the nature of these agents differs, no single

treatment can be given in the case of a biological attack. As a result, treatment of the

victims of a biological attack, especially one which is covert, may be difficult. The

identification process for many pathogens may be complicated by their incubation

period, and the lack of distinct symptoms early in the disease’s progress. The

difficulties in treating the various high-threat agents may place strain on the resources

of the medical system, especially in the case of mass casualties.

Protection from biological agents is an area of active research and development.

The range of protection and detection equipment available to first responders has led

to questions regarding equipment standardization and state and local preparedness.

Development and distribution of vaccines continues to be a contentious issue.

Attempts to detect biological releases using sensor technologies, or through analyzing

public health data, continue to be implemented, but these technologies are in

relatively early stages of development.

It is unclear whether terrorist groups are capable of effectively using biological

agents as weapons of mass destruction, but the relatively small amounts of pathogen

that may be needed to execute a significant attack is a source of concern. Some

suggest that terrorist interest in biological agents is increasing. However, others

assert that technical difficulties would make mass casualty attacks unlikely.

Current policies seek to reduce the proliferation of biological weapons by

relying on both domestic and international controls, to increase the number of

countermeasures available against such pathogens through research and development

activities, to improve the nation’s ability to detect pathogen releases, and to increase

the ability of hospitals and care providers to treat mass casualties.

Policymakers may be called upon to further address potential biological

terrorism vulnerabilities, including overseeing the use of atmospheric monitoring

equipment for pathogen detection; the direction of continued research and

development into biological agent detectors; review of further research into

protective equipment, prophylaxis and treatment against high-threat pathogens; and

assessment of first responder emergency preparedness. This report will be updated

as events warrant.

Contents

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

What Are High-Threat Biological Agents? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Anthrax (Bacillus anthracis) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Plague (Yersinia pestis) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Smallpox (Variola major) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Tularemia (Francisella tularensis) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Viral Hemorrhagic Fevers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Protection Against Biological Agents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Physical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Medical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Detection of Biological Agents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Atmospheric Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Biological Agent Detectors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Public Health Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Biological Agents as Weapons of Mass Destruction Versus as Weapons of

Terror . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Current Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Export Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Increased Domestic Regulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Faster Drug Authorization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Research and Development . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Biomedical Research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Increasing Detector Accuracy and Sensitivity . . . . . . . . . . . . . . . . . . . 14

Miniaturization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Better Understanding of Diffusion of Biological Releases . . . . . . . . . 15

Decontamination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Scientific Publication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Increases in Public Health . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Federal Response Teams . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Policy Implications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Countermeasure Development . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Detection of Biological Release . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Biological Detectors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Monitoring Public Health . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

First Responder Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Federal Emergency Response Teams . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Related CRS Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

High-Threat Biological Agents:

Characteristics, Effects, and Policy

Implications

Introduction

Since the anthrax mailings of 2001, policymakers have been implementing

programs to decrease the vulnerability of the United States to terrorist use of

biological weapons. This report discusses high-threat biological agents, focusing on

the Centers for Disease Control and Prevention (CDC) definition for Category A

pathogens (bacteria and viruses), their treatment and detection, current policies, and

possible future approaches to reducing their threat. Terrorist use of biological agents

would be a low probability, but potentially high consequence, event. While there is

still debate over whether terrorist groups have the ability to effectively use biological

weapons as a weapon of mass destruction, the anthrax mailings of 2001 highlighted

their potential as a terror weapon. Policy approaches for reducing vulnerability to

biological terrorism involve both addressing biological agents as a group, and

focusing on specific agents perceived as posing the greatest threat. Treatments for

exposed victims vary depending on the nature of the pathogen and experience in

treatment of these diseases is limited, due to the rarity of naturally occurring cases.

What Are High-Threat Biological Agents?

Biological agents, for the purposes of this report, are pathogens which can infect

and cause serious illness in humans.1 The level of threat a biological agent may

constitute is open to interpretation. Depending on what aspects of a pathogen are

considered priorities, different biological agents are likely to be identified as high

threat. For example, the National Institute of Justice provides an extensive list of

biological agents of concern in their handbook on purchasing protective equipment.2,3

In comparison, handbooks regarding battlefield treatment of biological weapon

For an introduction to biological weapons, see CRS Report RL31059, Biological Weapons:

A Primer by (name redacted).

An Introduction to Biological Agent Detection Equipment for Emergency First

Responders, NIJ Guide 101-00, National Institute of Justice, December 2001.

The NIJ list includes: Anthrax, Brucellosis, E. coli (O157:H7), Tularemia, Cholera,

Diphtheria, Glanders, Melioidosis, Plague, Typhoid Fever, Marburg Virus, Junin Virus, Rift

Valley Fever Virus, Smallpox, Venezuelan Equine Encephalitis, Yellow Fever Virus,

Dengue Fever Virus, Ebola Virus, Congo-Crimean Hemorrhagic Fever Virus, Typhus, Q

Fever, and Rocky Mountain Spotted Fever.

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casualties contain a shorter list of agents.4 The CDC identifies a number of different

categories of biological agents, and rank the various biological agents into categories.

Category A diseases — anthrax, plague, smallpox, tularemia, and viral

hemorrhagic fevers — are of the highest threat.5 The CDC views Category A

pathogens as easily disseminated or transmitted from person to person; resulting in

high mortality rates; having the potential for major public health impact; potentially

causing public panic and social disruption; and requiring special action for public

health preparedness. This is in contrast to the Category B agents which lack such

potential.6 The Category A pathogens will be discussed in this report.

Anthrax (Bacillus anthracis)

Anthrax is a disease caused by the bacterium Bacillus anthracis.7 Bacillus

anthracis responds to environmental stresses, such as nutrient depletion or oxygen

exposure, by forming spores. While the bacterium is dormant in spore form, these

spores are very hardy and can remain viable for decades in ideal conditions. Anthrax

spores are primarily found in soil, and are endemic to many parts of the world.

Anthrax is primarily an animal disease, infecting animals when they ingest Bacillus

anthracis spores during grazing. Anthrax is not a person-to-person contagious

disease.

The forms of anthrax infection are cutaneous, intestinal, and inhalation. The

type of anthrax infection depends on how the victim came into contact with the

spores. Cutaneous anthrax is the most common form of the disease and occurs when

anthrax spores contact broken skin. Intestinal anthrax occurs after consumption of

anthrax-spore-contaminated food, usually meat. Intestinal anthrax is less common

than cutaneous anthrax. Inhalation anthrax is the least common naturally occurring

form of anthrax. Inhalation anthrax occurs when spores are inhaled and germinate

in the lungs.

The symptoms usually appear 48 to 72 hours after exposure. The effects of the

three forms of the disease, differ from each other drastically. Cutaneous anthrax is

marked by a swollen, painless black ulcer where the infection occurred. In contrast,

intestinal anthrax is characterized by nausea, vomiting, and fever followed by

abdominal pain, vomiting of blood, and severe diarrhea. Inhalation anthrax manifests

with symptoms resembling a common cold: fever, fatigue, and a dry cough. The

symptoms progress to severe difficulty breathing and shock as the bacteria multiply.

These include: Anthrax, Brucellosis, Melioidosis, Glanders, Plague, Q Fever, Tularemia,

Smallpox, Venezuelan Equine Encephalitis, and Viral Hemorrhagic Fevers.

For information about the categories the CDC uses to define bioterrorism threats, see

[http://www.bt.cdc.gov].

Category B diseases include: Brucellosis, Salmonella species, E. coli (O157:H7), Shigella,

Glanders, Melioidosis, Psittacosis, Q fever, Typhus fever, Viral encephalitis, Cholera, and

Cryptosporidia.

For a summary of technical information on anthrax, see

[http://www.cdc.gov/ncidod/dbmd/diseaseinfo/anthrax_t.htm].

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The recovery rate for anthrax infection depends both on type of infection and

how early treatment begins. Early treatment of anthrax victims is strongly suggested,

as late treatment is not as effective in many cases. Cutaneous infection typically has

a fatality rate of less than 5% with early treatment, increasing to 20% without any

treatment. Intestinal anthrax has a higher mortality rate, with fatalities ranging from

25% to 75% depending on effectiveness of treatment. Some medical experts assert

that aggressive early treatment of intestinal anthrax will lower the fatality rate.8

Untreated inhalation anthrax is almost uniformly fatal. With early treatment within

the incubation period, the fatality rate can be dramatically reduced. In the aftermath

of the anthrax mailings of 2001, 5 of the 11 people diagnosed with inhalation anthrax

died, but historically greater than 90% of inhalation anthrax cases have been fatal,

even with treatment.9

All forms of anthrax are treated with antibiotics. Several different antibiotics

may be used, including ciprofloxacin, penicillin, and doxycycline. Some anthrax

strains may be less sensitive to antibiotics and therefore difficult to treat.

Prophylaxis is available to protect against anthrax both via vaccination and postexposure antibiotic treatment. While a vaccine against anthrax has been licensed by

the FDA, it is not currently available to the general public due to vaccine shortage.

The Department of Homeland Security, working with the Department of Health and

Human Services and other federal agencies, is coordinating development of civilian

anthrax vaccine policy. The Department of Defense anthrax vaccination policy, and

the amount of vaccine needed to implement this policy, includes vaccination of

troops thought to be potentially exposed to anthrax.10 After the anthrax mailings of

2001, those individuals thought to be potentially exposed to anthrax spores were

offered vaccination and antibiotic prophylaxis using the drug ciprofloxacin.

Plague (Yersinia pestis)

Plague is a disease caused by the bacterium Yersinia pestis. Plague bacteria are

sensitive to sunlight and humidity and do not form spores. Instead, plague bacteria

naturally reside in host creatures, such as rodents, and are found in many parts of the

world, including the United States. Plague usually travels within animal populations,

via insect vectors, generally migrating from one animal to another through biting

insects such as fleas.

Thomas V. Inglesby, Donald A. Henderson, John G. Bartlett, et al., “Anthrax as a

Biological Weapon: Medical and Public Health Management,” Journal of the American

Medical Association, Vol. 281, May 12, 1999, pp. 1735-1745, and Thomas V. Inglesby,

Tara O’Toole, Donald A. Henderson, et al., “Anthrax as a Biological Weapon, 2002:

Updated Recommendations for Management,” Journal of the American Medical

Association, Vol. 287, May 1, 2002, pp. 2236-2252.

Arthur M. Friedlander,”Anthrax,” Medical Aspects of Chemical and Biological Warfare,

Office of the Surgeon General, United States Army, Chapter 22, pp. 467-479.

For more information on the anthrax vaccine, see the Department of Defense’s Anthrax

Vaccination Immunization Program, found online at [http://www.anthrax.osd.mil/].

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The three kinds of plague are bubonic, septicemic, and pneumonic. Bubonic

plague and septicemic plague occur when plague bacteria enter the body through the

bite of an infected insect. Pneumonic plague occurs when plague bacteria are inhaled

into the lungs, or develops out of a bubonic or septicemic infection. Pneumonic

plague, unlike the other forms, does not have to pass through an insect vector. It is

person-to-person contagious.

Bubonic plague is the most well-known form. It is also known as the Black

Death, and was responsible for the European plagues of the 14th century. Victims of

bubonic plague develop swollen, painfully inflamed lymph glands,11 and also suffer

fever, headache, chills, and general weakness. Septicemic plague occurs in a manner

similar to bubonic plague, except the swelling of the lymph glands does not occur.

Instead, the bacteria multiply in the blood, causing shock and internal bleeding in

addition to the more general symptoms of fever and weakness. The symptoms of

pneumonic plague include fever, weakness and cough, possibly combined with

severe nausea, abdominal pain, diarrhea, and difficulty breathing.

The recovery rate for treatment of the different forms of plague vary. Naturally

occurring plague in the United States has an overall fatality rate of 14%. The

majority of these cases are bubonic with some septicemic, and very rarely

pneumonic, plague. The fatality rate for septicemic plague is markedly higher than

that for bubonic (33% versus 11% between 1980-1984),12 mainly ascribed to

difficulties in diagnosing septicemic plague at an early stage. Pneumonic plague has

a much higher fatality rate. It approaches 100% as the time between infection and

treatment increases. For effective treatment, therapy must begin within 18 hours or

victims are not likely to survive.13 For untreated forms, the fatality rate is 60% for

bubonic plague and 100% for septicemic and pneumonic plague.

All forms of plague are treated using antibiotic therapy. The Food and Drug

Administration has approved several antibiotics for treatment of plague, and others

not yet approved for such have been shown to be effective. Natural antibiotic

resistance in plague bacteria is known, so not all cases can be cured using a single

antibiotic.14

A plague vaccine has been approved for human use, but its production was

discontinued in 1998 because of manufacturing difficulties. Additionally, the

These are called “buboes” and give rise to the origin of this plague form’s name.

Thomas W. McGovern and Arthur M. Friedlander, “Plague,” Medical Aspects of

Chemical and Biological Warfare, Office of the Surgeon General, United States Army,

Chapter 23, pp. 479-502.

Ibid.

A study has shown that 13% of the Y. pestis strains in Madagascar are doxycyclineresistant. Thomas V. Inglesby, David T. Dennis, Donald A. Henderson, et al., “Plague as

a Biological Weapon: Medical and Public Health Management,” Journal of the American

Medical Association, Vol. 283, May 3, 2000.

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vaccine was not effective against pneumonic plague, limiting its utility. Several

Investigational New Drug (IND) vaccines are under development.15

Smallpox (Variola major)

Smallpox is a disease caused by the virus variola. Naturally occurring variola

virus has been eradicated, and the only remaining, legal stocks of the virus are held

at secured facilities in the United States and Russia.16 Smallpox is a person-to-person

contagious disease.

Typical victims of smallpox suffer an outbreak of rash, followed by scabbing

pustules covering their body. The rash and pustules form over a three week period

following an incubation time of approximately one to two weeks. Survivors of

smallpox are generally scarred by the disease. The disease has two rare variants; one

is known as flatpox, the other hemorrhagic smallpox.17

The fatality rates for the forms of the disease differ. For smallpox, the fatality

rate is approximately 30%, though in a population lacking natural resistance this rate

may increase. Both flatpox and hemorrhagic smallpox have a fatality rate

approaching 100%.

Smallpox has no specific treatment, though vaccination after exposure may

reduce the severity of the disease. An approved vaccine which protects against

smallpox is known, but it is not available to the general public. This vaccine has

recently been offered to select first responders and members of the military. For

more information regarding the smallpox disease and vaccination, see CRS Report

RS21288, Smallpox: Technical Background on the Disease and Its Potential Role in

Terrorism by (name redacted) and CRS Report RL31694,

Smallpox Vaccine Stockpile

and Vaccination Policy by (name redacted).

Tularemia (Francisella tularensis)

Tularemia is a disease caused by the bacterium Francisella tularensis.

Tularemia bacteria are fairly hardy, surviving for weeks in the environment, and

naturally reside in host creatures, such as rodents. Tularemia bacteria are found in

many parts of the world, including the United States. Tularemia, like plague, can be

transferred between animals via biting insects.

Mary Beth Nierengarten and Larry I. Lutwick, “Vaccine Development for Plague,”

Medscape Infectious Diseases, Vol. 4, 2002.

The United States maintains its store of smallpox virus at the Centers for Disease Control

and Prevention in Atlanta. Russia maintains its store of smallpox virus at Vector in

Koltsovo, Novosibirsk.

Another variola strain, variola minor, causes smallpox symptoms. Smallpox from variola

minor tends to be much less lethal than that caused by variola major.

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Naturally occurring cases of tularemia arise from the bite of an infected insect,

eating contaminated food or water, or breathing aerosols of bacteria.18 Tularemia

bacteria are very infectious, requiring very few bacteria to cause disease. The

different forms of exposure to tularemia bacteria lead to different symptoms. Those

who ingest contaminated food or are bitten by infected insects may develop swollen

and painful lymph glands and eyes, sore throat, or skin lesions. Victims exposed to

aerosolized tularemia bacteria develop symptoms similar to pneumonia: weakness,

fever, aches, cough, and chest pain. Tularemia has an incubation period of 3 to 5

days after exposure.

The recovery rate for tularemia depends on access to proper treatment.

Untreated tularemia has a fatality rate of 60%, but with proper treatment the fatality

rate can be reduced to 2%.

Tularemia can be treated using antibiotic therapy, but reportedly strains of F.

tularensis have been successfully engineered to be antibiotic resistant.19 Several

antibiotics are approved by the FDA to treat tularemia, and other antibiotics have

been shown to be successful against the disease.

Tularemia lacks an approved vaccine, though several IND vaccines are

undergoing testing. One IND vaccine has successfully been used to protect

laboratory personnel against inadvertent aerosol exposures.20

Viral Hemorrhagic Fevers

Viral hemorrhagic fevers are caused by viruses of the filovirus and arenavirus

family. These fevers include Ebola and Marburg.21 These viruses are rarely

encountered and are believed to be found in natural animal reservoirs, though the

exact nature of some of the reservoirs is unknown. Viral hemorrhagic fever viruses

are not especially hardy, and are generally transmitted through contaminated body

fluids, such as blood.22

Viral hemorrhagic fever symptoms depend on the exact disease, but most

include fever, muscle aches, and exhaustion. Severe cases of viral hemorrhagic fever

The United States reportedly averaged 124 cases of naturally occurring tularemia in 1999

and 2000. “Rare Rabbit Fever Reported in 3 Men,” The Associated Press, June 25, 2003.

Ken Alibek, Biohazard: The Chilling True Story of the Largest Covert Biological

Weapons Program in the World — Told from Inside by the Man Who Ran It, (New York,

NY: Random House) 1999.

Mary Beth Nierengarten and Larry I. Lutwick, “Developing New Tularemia Vaccines,”

Medscape Infectious Diseases, Vol. 4, 2002.

CDC Category A viral hemorrhagic fevers include the viruses which cause: Junin,

Machupo, Guanarito, Lassa Fever, Rift Valley Fever, Dengue fever, Ebola, Marburg, and

Hantaviruses . Not all diseases exist solely in the hemorrhagic form. For example, 80% of

Lassa fever cases are not hemorrhagic in nature.

Cases are known of viral hemorrhagic fever infection following the eating of infected

animals.

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also involve internal bleeding, or hemorrhage from the mouth, eyes, or ears. Blood

loss is not the common cause of death, but rather failure of internal organs.

The recovery rate for viral hemorrhagic fevers varies from 30% to 90%,

depending on the exact disease. Since many fevers occur in developing countries,

these recovery rates may not be representative of aggressive medical treatment. Viral

hemorrhagic fevers encountered in the United States may have a higher recovery rate

due to more advanced supportive treatment.

Viral hemorrhagic fevers have no established treatments besides supportive

care, though some medications are recommended against specific diseases. For

example, animal and clinical studies have shown that ribavirin, an anti-viral drug, has

some efficacy against Lassa fever and Crimean-Congo hemorrhagic fever, and could

be used under IND status.

Investigation into vaccines for viral hemorrhagic fevers is ongoing.23 Vaccines

have been developed that provide protection against some. With the exception of one

for yellow fever, these vaccines are not commercially available in the U.S. Access

to these vaccines is limited, and provided under IND protocols.

Protection Against Biological Agents

Protection against biological agents may be achieved through either physical or

medical means. Personal physical measures limit exposure by protecting the eyes,

lungs, and/or skin from biological contact and preventing contact with insect vectors.

Medical protection may be effective when the biological agent responds to drug

treatment or when an available, effective vaccine exists.

Physical

Personal physical protection against biological agents includes masks and

protective clothing. Protective masks filter the air inhaled by the wearer, removing

particles from the air. The most effective filters can remove almost 100% of aerosol

particles greater than one micron in size. By blocking inhalation of pathogens,

disease is avoided.

Protective garments, in the context of biological agents, are generally designed

to minimize inadvertent self-contamination with pathogen. Protective gloves,

disposable overgarments, and, in some cases, face shields provide requisite

protection from victims of contagious pathogens.

Such personal physical protections are used by medical professionals in the

treatment of victims of viral hemorrhagic fevers. Isolation and barrier methods

See, for example Philip Cohen, “Fast-acting Ebola Vaccine Offers Hope,”

NewScientist.com, August 6, 2003 and Nancy J. Sullivan et al., “Accelerated Vaccination

for Ebola Virus Haemorrhagic Fever in Non-human Primates,” Nature, Vol. 424 (2003) p.

681.

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provide medical professionals with protection from infection. In extreme cases,

additional precautions to avoid aerosol inhalation may be required.24

Medical

Medical protection against pathogens takes two tacks. One is the pre-exposure

vaccination of populations potentially at risk. For example, troops in the Middle East

have been vaccinated against smallpox and anthrax as protection against potential

military use. The other is the prophylactic use of antibiotics following known

exposure to a pathogen. This method was used after the anthrax mailings of 2001.

The availability of an effective, licensed vaccine is a requirement for protective

pre-exposure vaccination. For the high-threat biological agents found on the CDC

Category A listing, few vaccines are available. Licensed vaccines exist for both

anthrax and smallpox, but these vaccines are not in public distribution. Due to

national security needs, anthrax vaccine is being used to innoculate military

personnel, and a sufficient supply of vaccine has not become available to offer

vaccination to the general public. Recently, the supply of the smallpox vaccine has

become such that, in extremis, the entire population of the United States could be

vaccinated. Not all high-threat biological agents have a licensed vaccine, but some

have IND-stage vaccines which might be used in emergency situations. Use of IND

vaccines might be complicated by supply concerns, as only small amounts of these

vaccines exist.

Prophylactic use of antibiotics is only successful against bacteria. Viruses are

not sensitive to antibiotics, and so antibiotic use will not provide protection. Because

the treatment of many bacteria is most effective when treatment is begun at an early

stage, prophylactic use of antibiotics is usually recommended for those potentially

exposed.

Detection of Biological Agents

The detection of pathogens, especially in the case of a covert release, is a

complicated process. When victims of a release are hospitalized, identification of the

causal pathogen may quickly occur, as the combination of symptomatic patients and

ready access to large amounts of the pathogen provide much information towards its

identification.25 But, in the instance of suspected, small-scale releases, identification,

See “Notice to Readers Update: Management of Patients with Suspected Viral

Hemorrhagic Fever — United States,” Morbidity and Mortality Weekly, Vol. 44, June 30,

1995, pp. 475-479, and “Management of Patients with Suspected Viral Hemorrhagic Fever,”

Morbidity and Mortality Weekly Report, Vol. 37, 1988, pp.1-15.

This would only be the case with a known pathogen. As shown by the Sudden Acute

Respiratory Syndrome (SARS) outbreak, the cause of an emerging disease may be very

difficult to determine. For more information on SARS, see CRS Report RL31937 Severe

Acute Respiratory Syndrome (SARS): Public Health Situation and U.S. Response by (name

redacted) and CRS Report RL32072 Severe Acute Respiratory Syndrome (SARS): The

(continued...)

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and even detection, of a pathogen release may be difficult. Biological agents are

difficult to quickly detect, generally requiring laboratory work-up to detect and

identify pathogens. It may require several hours, at the minimum, to detect and

definitively identify specific pathogens. On the other hand, these laboratory-based,

molecular biology techniques are extremely sensitive and can detect very small

amounts of pathogen. The methods used to detect pathogens involve analysis of the

pathogen’s genetic sequence or enzymatic reaction. Scientists are working to

develop faster techniques for both detection and analysis.

Atmospheric Monitoring

President Bush, during remarks to new employees of the Department of

Homeland Security, announced the establishment of the BioWatch initiative.26 This

initiative consists of deploying early warning sensors in locations across the nation

to help detect biological attacks. This prototype atmospheric monitoring system is

being put in place using EPA air quality monitors.27 The monitoring system consists

of sampling equipment which collects particles present in the atmosphere. The

material collected is brought to a laboratory setting, analyzed, and tested for specific

pathogens. In theory, the laboratory results from this process could be available in

as little as 12 hours.28 It is reported that the laboratories which take part in the

Laboratory Response Network would be involved in performing detection and

analysis of these pathogens.29 Research and development of further refinements of

such monitoring technology is underway.30

Other commercial systems have been purchased and installed to detect airborne

pathogens and toxins. For example, the city of Honolulu has purchased and deployed

six stationary air monitors within the island of Oahu.31 The U.S. Postal Service is

(...continued)

International Response by (name redacted) and Tiaji Salaam.

Office of the Press Secretary, “Remarks by the President to the New Employees of the

U.S. Department of Homeland Security,” The White House, February 28, 2003.

Reportedly, 20 metropolitan areas have been selected for these systems. See Michael

Lasalandra, “Boston Joins National Bio-warfare Alert Network,” The Boston Herald, March

14, 2003, and “BioWatch Program Aims for Nationwide Detection of Airborne Pathogens,”

CIDRAP News, Feb 26, 2003 (revised March 10, 2003), found online at

[http://www.cidrap.umn.edu/cidrap/content/bt/bioprep/news/biowatch.html].

Marcus Warren, “Germ Attack Detectors for New York,” The Daily Telegraph (London),

January 23, 2003.

“Nationwide Monitoring System Planned for Detecting Bioterror Attack,” Associated

Press, January 22, 2003.

For example, Lawrence Livermore National Laboratory is attempting to partner with

industry to develop automated pathogen detection systems. See Jim McGee, “Nuclear Lab

Wants Partners for Progress in Chem-Bio Detectors,” CQ Homeland Security, October 20,

2003.

Treena Shapiro, “City To Monitor Events For Dangerous Toxins,” The Honolulu

Advertiser, March 24, 2003.

CRS-10

reportedly testing an indoor system to detect airborne biological agents.32 If effective,

it eventually will be installed in all 282 mail-processing plants nationwide to protect

postal workers.

Biological Agent Detectors

The field detection of biological agents is usually performed with screening

devices which detect specific pathogens. Typical screening devices use antibody

tests or fast, genetic tests using polymerase chain reaction (PCR) to provide a rapid

diagnostic for the presence of a given biological agent. Antibody tests are agent

specific, so different biological agents require the use of different antibody tests.

PCR screens determine if genetic markers are present, linking the test sample to a

known pathogen. Screening tests have varying sensitivity. For some highly

infectious pathogens, the detectable concentration of pathogen may be significantly

greater than the infectious dose.33 Consequently, such field devices are not generally

considered definitive tests for the absence of an agent, but rather are used to confirm

the presence of significant quantities of agent. Further development of field devices

is ongoing.34

Subsequent to an initial screening test, samples are sent to laboratories, where

more sensitive laboratory tests are used to ascertain the identity of any pathogen

present. In general, samples, even those that test negative through screening tests,

require laboratory-based confirmatory analysis. The burden of this process on the

public health laboratory system has been heavy.35

Public Health Monitoring

Monitoring the public health has emerged as a potentially important method in

detecting the covert release of pathogens. The Centers for Disease Control and

Prevention, in conjunction with the Department of Defense, the Association of Public

Health Laboratories, and others, have upgraded the Laboratory Response Network,

which connects hospitals, public health laboratories, and other resources to monitor

Don Oldenburg, “Detection Devices May Offer An Early Read on the Danger,” The

Washington Post, March 16, 2003, and CRS Report RL31280, The U.S. Postal Service

Response to the Threat of Bioterrorism Through the Mail by (name redacted).

For example, the public was cautioned during the time of the anthrax mailings that handheld assays for Bacillus anthracis spores were not guaranteed to detect spores at the

infectious dose lower limit. Centers for Disease Control and Prevention,”CDC Health

Advisory Hand-held Immunoassays for Detection of Bacillus anthracis Spores,” distributed

via Health Alert Network, October 18, 2001.

Tim Starks, “Lab-in-a-Box Detects Chemical, Biological Agents,” CQ Homeland Security,

October 10, 2003.

A poll conducted by the Association of Public Health Laboratories showed that during the

anthrax mailings, 98% of the respondents stated they required staff overtime to handle

bioterrorism samples and 85% of the respondents stated bioterrorism testing negatively

impacted testing of other routine samples. Public Health Laboratory Issues in Brief:

Bioterrorism Capacity, Association of Public Health Laboratories, October, 2002.

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and track disease outbreaks.36 It has been suggested that the first sign of a covert

pathogen release by terrorist groups may be a sudden increase in the number of

hospital patients exhibiting symptoms. By analyzing information from such patients,

a likely time and location of pathogen release might be discovered and consequence

management plans invoked.

Some cities have further expanded these programs by monitoring purchases

related to the public health. For example, some cities track pharmaceutical and other

medicinal sales, operating on the theory that this will provide even earlier detection

than hospital arrivals.37 It is expected that the early identification of a disease

outbreak will increase the treatment success and consequently lower the fatality rate.

Biological Agents as Weapons of Mass Destruction

Versus as Weapons of Terror

The likelihood of terrorist use of biological agents as a weapon of mass

destruction is an area of great debate. Biological agents have not been used to cause

mass casualties in modern times, and are incapable of destroying physical

infrastructure. This raises questions about the claim that they would be effective

weapons of mass destruction. The technical feasability of terrorist groups

disseminating biological agents is also open to question. Some believe that the

techniques and technologies required for processing and disseminating biological

agents are beyond the capabilities of a terrorist group, while others believe that

terrorist groups wishing to use biological weapons could easily do so. In contrast to

chemical agents, few biological agents are commercially available in large quantity,

and so are not readily available for purchase or theft. On the other hand, biological

agents are naturally occurring and self-replicating, which may ease the difficulties of

acquiring and manufacturing sizeable quantities.

Because pathogens are self-replicating, very small amounts can cause infection.

Large quantities are not required to cause mass casualties. It has been estimated that

approximately 100 lbs. of anthrax spores efficiently and uniformly disseminated by

airplane under ideal conditions in a metropolitan area could cause 150,000

casualties.38

Terrorist groups have shown interest in biological weapons, but few examples

of their successful use, and none as a weapon of mass destruction, exist. One wellknown example of biological-weapon use within the United States was by the

Rajneeshee cult in 1984. There, salmonella bacteria was disseminated through

Executive Summary on the Laboratory Response Network, Centers for Disease Control

and Prevention, April 17, 2002.

For example, it has been reported that New York City and Baltimore collect sales data

from drugstores to use as a factor in its public health monitoring. See Matt Crenson,

“Sneeze May Signal Attack,” Associated Press, November 4, 2002.

Health Aspects of Biological and Chemical Weapons, 1st Edition, World Health

Organization, 1970.

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intentional contamination of salad bars. Several hundred people were made ill over

a number of weeks.39 The Aum Shinrikyo cult also attempted to develop biological

weapons. While more well-known for their chemical weapon attack in the Tokyo

subway system in 1995, they cultured and attempted to disseminate Bacillus

anthracis by aerosolizing a liquid slurry of anthrax culture. The anthrax

disseminated was an avirulent strain and consequently no casualties occurred.40

Whether terrorist groups would choose biological weapons is unclear. Some

have asserted that such use would be incompatible with political goals that terrorist

groups have, e.g. formation of a nation-state. Others claim that a new stage of

superterrorism has begun, with the attacks of September 11th being indicative of a

greater willingness of terrorist groups to intentionally cause mass casualties. For

more information on the motivation of terrorist groups with respect to biological and

chemical weapons, see CRS Report RL31831, Terrorist Motivations for Chemical

and Biological Weapons Use: Placing the Threat in Context by (name redact

ed).

Weapons of terror, in contrast to weapons of mass destruction, may cause few

casualties but rather instill panic because of frightening aspects of their use. Some

argue that the use of biological agents as weapons of terror would require little

infrastructure and be an effective use of even limited supplies of pathogen. They

claim that release of small amounts of biological agent might cause a level of panic

disproportionate to the actual amount released, and point to the anxieties raised after

the mailings of the anthrax letters of 2001 as emblematic of the type of response that

can be generated by small-scale use of biological weapons. Others assert that the

significant investment of time, money, and trained personnel which would be

required to develop even small amounts of pathogen provides a serious disincentive

to terrorist groups. They state that terrorist groups are much more likely to use

conventional weapons than any weapon of mass destruction.

The anthrax mailings of 2001 highlighted the vulnerability of the United States

to biological attack, and reignited public interest in bioterrorism and domestic

preparedness. A series of letters containing freeze-dried anthrax of varying

coarseness were sent through the U.S. Postal Service to two U.S. Senators and two

news outlets. The anthrax spores contaminated postal equipment during mail

processing and subsequently infected postal workers with inhalation anthrax.

Questions regarding the identity of the mailer, the motivations of the mailer, and the

origin of the anthrax spores remain unanswered. For more information on the

anthrax mailings and the US Postal Services response, see CRS Report RL31280,

The U.S. Postal Service Response to the Threat of Bioterrorism Through the Mail by

(name redacted).

For an overview of the Rajneeshees’ use of Salmonella typhimurium in Oregon in 1984,

see W. Seth Carus, “The Rajneeshees (1984)” in Toxic Terror: Assessing Terrorist Use of

Chemical and Biological Weapons, Jonathan B. Tucker Ed., (Cambridge MA: MIT Press)

2000.

Kyle B. Olson, “Aum Shinrikyo: Once and Future Threat?,” Emerging Infectious

Diseases, Vol. 5, No. 4, July — August 1999.

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Current Policy

Current federal policy regarding biological weapons is a combination of nationstate level controls, increased domestic regulation, and accelerated research and

development of medicines, vaccines, and detectors. Additionally, professional

societies have increased self-monitoring actions.

Export Control

The United States maintains export policies with respect to selected pathogens

and biological dual-use equipment, primarily through the multilateral Australia

Group and the Wassenaar Arrangement. U.S. export controls aimed at creating

proliferation barriers include Export Administration Regulations and International

Traffic in Arms Regulations.41 These export controls are designed to inhibit nationstate level acquisition and proliferation of biological weapons. Because of the

commercial ubiquity of equipment potentially capable of producing biological

weapons, experts consider it difficult to block terrorist groups from developing smallscale production capability solely through export controls.42

Increased Domestic Regulation

Use, possession, and transfer of high-threat biological agents is now increasingly

regulated due to the USA PATRIOT Act (P.L. 107-56) and the Bioterrorism

Preparedness and Response Act (P.L. 107-188).43 Only persons with a bona fide

need for them are allowed to possess or use biological agents on the Select Agent

list.44 Additionally, university researchers experimenting on Select Agent pathogens

are required to pass a background check by the FBI.45 Individuals who are citizens

of the countries formally declared as sponsors of terrorism are not allowed access to

these pathogens.

Export Administration Regulations can be found at 15 CFR Parts 730-774. International

Traffic in Arms Regulations can be found at 22 CFR Parts 120-130. For more information

on the export control debate, see CRS Report RL30169, Export Administration Act of 1979

Reauthorization, coordinated by (name redacted).

For example, it has been reported that the Defense Threat Reduction Agency was able to

successfully build a small-scale facility capable of generating biological agents within the

United States. Part of the assembly of this facility included importation of a fermenter from

Germany. Judith Miller, Stephan Engelberg, and William Broad, Germs: Biological

Weapons and America’s Secret War, (New York, NY: Simon and Schuster) 2001.

For more information on these laws, see CRS Report RL31377, The USA PATRIOT Act:

A Legal Analysis by (name redacted) and CRS Report RL31263,

Public Health Security and

Bioterrorism Preparedness and Response Act (P.L. 107-188): Provisions and Changes to

Preexisting Law by (name redacted), (name redacted), and Mary E. Tiemann.

The Select Agent list can be found at 42 CFR 72, Appendix A.

“FBI Releases Application Forms for Researchers Working with CDC Select Agents,”

Washington Fax, March 14, 2003.

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Faster Drug Authorization

The Food and Drug Administration has altered selected rules governing the

degree of testing necessary before approving human-use of drugs.46 In cases where

testing effectiveness on humans would be unethical, drug approval could be made

based on the efficacy results from animal testing. Generally, vaccines and medicines

used by humans require full human testing. Some have advocated that foregoing

human clinical trials would speed development of new treatments against bioterror

agents, and potentially increase the amount of private sector research money invested

in bioterror defense.47

Research and Development

Defense against bioterrorism has spurred research and development activities.

The Department of Homeland Security has an active role in biological

countermeasure development, while the Department of Health and Human Services

continues to be at the forefront of bioterrorism research and development. Research

into new treatments and vaccines, detector sensitivity and miniaturization,

decontamination, and pathogen properties are being performed.

Biomedical Research. The federal government performs and funds research

and development of biodefensive measures. Such research includes discovery of new

vaccines and treatments, research into countermeasures against biological weapons,

as well as research into more fundamental, basic science, such as pathogen genetics

and the origins of virulence. The National Institutes of Health administers the bulk

of the Department of Health and Human Services biomedical research funding, while

the DARPA Biological Warfare Defense program and the Joint Service Chemical and

Biological Defense Program is funded by the Department of Defense. Development

of biological countermeasures and efforts to reduce the impact of a biological terror

attack is performed through the Department of Homeland Security’s Directorate of

Science and Technology as well. Federal research on high-threat pathogens is

performed at the U.S. Army Medical Research Institute of Infectious Diseases

laboratory at Fort Detrick, Maryland, and the Centers for Disease Control and

Prevention laboratory in Atlanta, Georgia.

Increasing Detector Accuracy and Sensitivity. Detecting and

identifying pathogens is an area of continued research. The ability of first responders

to identify biological agents when first encountering them is key to identifying

appropriate treatment for victims. Sensitive, rapid detection systems are under

development in the private sector as well as the Department of Energy’s National

Laboratories. New detectors based on different detection methods are being

investigated to ascertain their capabilities. The military, while already possessing

large, platform-based detection capabilities, is developing a new detection system,

For the announcement of this rule, see Federal Register, Vol. 67, No. 105, May 31, 2002,

pp. 37,988-37,998.

Marc Kaufman, “FDA Acts To Speed Bioterror Medicines,” The Washington Post, May

31, 2002.

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the Joint Biological Agent Identification and Diagnostic System (JBAIDS), which

will allow for fast, portable detection of biological agents.

Miniaturization. In concert with the need for more sensitive, accurate

detectors, reducing the size of such detectors is also an area of current research.

Technologies currently employed for analyzing the atmosphere for pathogens tend

to be large and complex. The goal of a compact, ideally easily portable, detector

system drives research efforts in detector miniaturization. The National Science

Foundation, the Department of Energy, and the Department of Defense have all

funded programs to develop smaller, handheld instruments to detect biological

pathogens in the environment.

Better Understanding of Diffusion of Biological Releases.

Understanding how an aerosol release might travel is another area where research

occurs. Computer modeling of aerosol properties, wind flow in urban settings and

within buildings, and the effects of initial conditions on final particle distribution all

may lead to more effective incident response and consequence management. The

Department of Health and Human Services uses such modeling in its emergency

response command center to help develop and prioritize response to a chemical or

biological release.48 Research in this area is conducted at the National Laboratories,

among other places.

Decontamination. After the anthrax mailings, the Hart Senate Office

Building required extensive decontamination to remove the residual anthrax spores.

Methods for decontaminating office buildings have not been widely tested, and

decontamination of the Hart Building using chlorine dioxide cost an estimated $42

million. The cleanup of the contaminated Brentwood facility, in Washington, DC,

and the Hamilton Township, New Jersey, facility is reportedly expected to cost over

$150 million.49 Research is underway to develop less costly methods of

decontaminating areas from biological agents and to assess the effectiveness of

current decontamination methods.

Scientific Publication

The federal government has historically supported the open publication of

federally funded research results, but a series of research publications in molecular

biology have increased concerns over whether publication of certain federally funded

extramural research results could threaten national security because of their possible

usefulness to terrorist groups. Some have suggested that federally funded extramural

research results should be reviewed for their security implications prior to their

publication in the open literature, while others have asserted that such review would

be damaging to scientific progress and productivity. If such review is deemed

necessary, an open question remains as to who would review these research results

and at what point in the research process they would be reviewed. Some publishers

Tamara Lytle, “Health Official Debuts High-Tech Center,” Orlando Sentinel, March 12,

2003.

Stephen Losey, “USPS: Mail Center Safe to Reopen After Anthrax Cleanup,” Federal

Times, March 10, 2003.

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have begun to implement self-regulatory measures regarding publication of

potentially sensitive manuscripts, but such steps have not been applied industry-wide.

Others claim that such a review process might be most effective if performed by a

federal agency. For more information, see CRS Report RL31695, Balancing

Scientific Publication and National Security Concerns: Issues for Congress by (nam

e redacted) and CRS Report RL31845,

“Sensitive But Unclassified” and Other Federal

Security Controls on Scientific and Technical Information: History and Current

Controversy by (name redacted).

Increases in Public Health

Significant investment in the public health system has been made to prepare the

medical community to respond to a bioterror event. This has included additional

funding from the CDC for the development of bioterror response plans and

increasing the preparedness of hospitals and other facilities for bioterror casualties.

Additionally, the National Strategic Stockpile, formerly called the National

Pharmaceutical Stockpile, has been expanded to contain antibiotics, medical

treatments, and antidotes.50 While there are still critics of the current state of

preparedness for a biological attack,51 Secretary of Health and Human Services

Thompson has stated that the country is well prepared to respond to possible

bioterrorism attacks.52 For a comprehensive overview, see CRS Report RL31719,

An Overview of the U.S. Public Health System in the Context of Bioterrorism by

(name redacted).

Federal Response Teams

Numerous federal response teams could be deployed in the event of biological

terrorism. In general, these teams would support local responders in detection,

decontamination, or treatment roles.53 A selection of these federal teams is described

below.

Reportedly, the National Strategic Stockpile now contains enough medicine for 12 million

people exposed to anthrax, 100 million people exposed to plague, and 50 million people

exposed to tularemia. Denise Grady and Lawrence K. Altman, “Experts See Gains and

Gaps in Planning for Terror Attack,” The New York Times, March 25, 2003.

For example the General Accounting Office has highlighted areas of deficiency in some

hospital bioterrorism preparedness and response. See General Accounting Office, Most

Urban Hospitals Have Emergency Plans But Lack Certain Capacities for Bioterrorism

Response, GAO-03-924, August 6, 2003.

Craig Gilbert, “Thompson Says U.S. Ready for Bioterror: Bush Tells Cabinet He Hopes

He Won’t Have to Use Full Capacity of Military,” Milwaukee Journal Sentinel, March 20,

2003.

Martin Edwin Andersen, “Urban Teams Readied for Mass Destruction Missions,” CQ

Homeland Security, August 12, 2003.

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One response team is the DOD’s Chemical/Biological Incident Response Force

(CBIRF).54 CBIRF can be deployed to aid in consequence management after a

chemical or biological terror attack. It possesses both decontamination and treatment

facilities and can be deployed domestically or internationally at short notice. This

rapid response force was on hand for the Atlanta Olympics in 1996 and is equipped

with state of the art equipment for dealing with chemical and biological threats. It

is located at Indian Head, Maryland, and could be deployed in the case of biological

or chemical terrorism.55

The FBI maintains a Hazardous Materials Response Unit which, in response to

crimes involving biological weapons, would be available to analyze and identify

pathogens and other threats present. This unit provided protocols for handling

evidence during the anthrax mailings of 2001.56

The U.S. Army Technical Escort Unit conducts biological detection,

decontamination, and removal of biological devices or hazards woldwide. While

commonly deployed to handle and secure discovered biological munitions, they also

have been used to provide support to other large national events.57

As part of the National Disaster Medical System, Disaster Mortuary Operational

Response Teams, Disaster Medical Assistance Teams, and four National Medical

Response Teams are available to be deployed to the scene of a national emergency.

This program was transferred to the Department of Homeland Security on March 1,

2003.58

The National Guard supports several Weapons of Mass Destruction Civil

Support Teams. They were established to support local resources in determining the

nature and extent of an attack or incident. These teams are able to deploy within four

hours of a given alert.

More information on the Chemical/Biological Incident Response Force can be found

online at [http://www.lejeune.usmc.mil/4thmeb/cbirf.htm].

Steve Vogel, “Specialized Marine Unit Readies To Respond to the Unthinkable: Force

Trains for Chemical, Biological or Radiological Attacks,” The Washington Post, February

17, 2003.

FBI Laboratory 2001 Report, Federal Bureau of Investigation, 2001.

More information can be found online at [http://teu.sbccom.army.mil/].

For more information see CRS Report RL31791, Emergency Management Funding for

the Department of Homeland Security: Information and Issues for FY2004 by (name redacted),

Coordinator, Rob Buschmann, Ben Canada, Wayne Morrissey, (name redacted), and

(name redacted).

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Policy Implications

Countermeasure Development

A topic of potential interest to policymakers is oversight of the federal

government’s development of biological countermeasures. Such countermeasures

include, but are not limited to, new detectors, treatments, medical prophylaxis, and

physical protection from biological agents. While the Department of Health and

Human Services has been designated the lead agency in providing bioterrorism

research and development, the Department of Homeland Security has been given a

role in setting priorities. In FY2004 budget, $266 million has been appropriated for

DHS’ Science and Technology Directorate’s biological countermeasures programs.

How the Department of Homeland Security will assist in setting priorities for HHS

research, and how the new Homeland Security Advanced Research Projects Agency

(HSARPA) will prioritize research it funds, are not currently well understood.

Because high-threat biological agents include both viral and bacterial agents, a

single treatment will not be successful against all illnesses. Some have suggested

that research into new antiviral and antibiotic compounds for use against biological

agents might provide additional health benefits, as these compounds may prove to be

effective medications for other, more common illnesses. Because of the shortage of

licensed vaccines for many high-threat pathogens, development of new vaccines has

been an area of congressional interest. The lack of a civilian market for biological

weapon vaccines has inhibited private sector investment and production of these

products. Since the natural incidence of disease from biological-weapon pathogens

is rare, and disease form is often different than that expected to result from a bioterror

attack, there has been little impetus to develop and market these vaccines. Some

have suggested that the federal government should take a role in providing research

incentives and a guaranteed market for any vaccines against biological weapons. A

variety of mechanisms have been suggested, including expedited drug approval

processes, tax incentives, liability protections, and expanded procurement practices.

A form of expedited drug approval has already been implemented by the FDA for

drugs involved in biodefense; it requires fewer animal studies before approval is

given for human use.59 For more information on federal vaccine policies, see CRS

Report RL31793, Vaccine Policy Issues for the 108th Congress by (name redacted) and

CRS Report RS21414, Mandatory Vaccinations: Precedent and Current Laws by

Angie A. Welborn.

President George W. Bush, in the 2003 State of the Union address, announced

a new proposal called Project BioShield. This proposal provides for expedited

acquisition authority, non-competitive procurement, and purchase of potential

biological countermeasures up to 5 years prior to their licensing. For more

See CRS Report RL31263, Public Health Security and Bioterrorism Preparedness and

Response Act (P.L. 107-188): Provisions and Changes to Preexisting Law by (name reda

cted), (name redacted), and Mary E. Tiemann and “HHS Accelerates Bioterrorism

Research: New Programs Expedite Ideas from Concerned Scientists,” U.S. Department of

Health and Human Services Press Release, Dec. 6, 2001.

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information on Project BioShield, see CRS Report RS21507 Project BioShield by

(name redacted).

Detection of Biological Release

The deployment of the BioWatch prototype biological agent detector has raised

questions about how this system will be used. Such a monitoring system for covert

releases of biological agents may provide important early notification of potential

danger. Since many pathogens have an incubation period of several days, it is often

difficult to begin treatment at an early stage. Early treatment of the inhalation form

of these diseases is essential to recovery, and a system that signaled pathogen release

before the appearance of symptoms in victims would be likely to increase the ability

of victims to receive medication and survive. By employing an array of such

sampling devices, a city-wide network might detect pathogen releases in smaller

amount and also aid in determining the epicenter of a release. Such information may

be important to identify the perpetrators of such an attack.

Since the BioWatch detectors are coupled to EPA air quality monitors, the

locations are determined by air quality considerations, and it is not readily apparent

that these locations will provide adequate sampling of populated areas. If the air

quality monitor is located well above street level, it may not detect the release of

biological agents at street level. Additionally, the effectiveness of these detectors in

identifying small releases or indoor release of biological agents is not established,

and so placement of these detectors may provide a false sense of security. Such a

detection system may also detect naturally occurring biological agents which are not

virulent. For example, anthrax spores naturally occur in some areas of the United

States, and may provide false indications of small-scale covert release. The

continued cost of these detectors, reported at $1 million per detector per year, is also

of concern.

An unknown aspect of the BioWatch program is the range of detector coverage.

It has been reported that each metropolitan area chosen will have 10 to 12 distinct

detectors built into different air quality monitors. Also, a reported goal of this

program is to provide detection for “80% of the American population by geographic

distribution.”60 Since the EPA air quality monitors are not evenly spread throughout

the various geographic areas of the country, it is not apparent whether the BioWatch

program will be expanded to other sorts of monitoring stations.

Biological Detectors

Development and production of easily portable or handheld biological detection

apparatus is another area where a pressing need has been identified. Antibody tests

and methods using recognition of pathogen genetic sequences only detect specific

pathogens. Unexpected pathogens, either rare or genetically modified, may elude

current detection equipment. Consequently, policymakers may decide to direct

“BioWatch Program Aims for Nationwide Detection of Airborne Pathogens,” CIDRAP

News, Feb. 26, 2003 (revised March 10, 2003), found online at

[http://www.cidrap.umn.edu/cidrap/content/bt/bioprep/news/biowatch.html].

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funding towards development of either a broad assortment of inexpensive testing

equipment or expanding the range of pathogens a given device can detect. As more

pathogen-specific detectors become available, the cost of testing per incident may

increase, as more pathogens are potentially screened, but may decrease as more

detectors are manufactured and distributed.

Monitoring Public Health

Policymakers may choose to address current methods of detecting bioterror

events. Tracking potential bioterror releases through monitoring hospital admissions

and physician reports may indeed detect a covert pathogen release, but such an

approach requires that individuals first fall ill from the pathogen release. Critics

claim that in the case of a contagious pathogen, such as pneumonic plague or

smallpox, the spread of the disease will occur at a rate greater than the government

response, as there will be a time delay due to the incubation period of the disease.

Thus, there will be an expanding number of people being infected even as public

health workers attempt to determine the epicenter of the release. Such an argument

has been made especially in the case of smallpox, as treatment for smallpox, once

symptoms have begun to appear, is unavailable. In the smallpox case, the debate

over which vaccination method should be used, the ring vaccination model based on

identifying the initial outbreak of the disease and then vaccinating contacts of the

victims of the initial outbreak, or the mass vaccination model, where people in a

geographic area are innoculated if smallpox is detected, has been very lively.

Advocates of establishing sensors to detect pathogen releases, before victims begin

to seek treatment, claim that the earlier the detection of an outbreak, the more

effective treatment will be.

Others have asserted that the current model will be effective in limiting

casualties from a pathogen release. They claim that increases in the public health

infrastructure have reduced the likelihood that hospitals and care-providers would be

overwhelmed by a bioterror event. While not rejecting the utility of developing other

detection devices to warn of a covert pathogen release, some scientists modeling

pathogen releases have stated that even reducing detection times from 48 to 6 hours

after release would not reduce overall casualties as much as an effective, efficient

public health response and treatment.61

First Responder Equipment

The amount of funds the federal government should provide to first responders

and whether all first responders should have standardized equipment is a topic of

congressional interest.62 First responder equipment is currently not nationally

standardized, with each jurisdiction purchasing its own equipment. Some first

Amanda Onion, “Calculating the Unthinkable: New Model Suggests Faster Methods

Needed to Deliver Anti-Anthrax Meds,” ABC News.com, March 18, 2003, and Lawrence M.

Wein, David L. Craft, and Edward H. Kaplan, “Emergency Response to an Anthrax Attack,”

Proceedings of the National Academy of Sciences, Vol. 100, 4346-4351 (2003).

Greg Seigle, “‘First Responders’ to Terrorism Seek Federal Strategy, Equipment,” Global

Security Newswire, March 6, 2002.

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responder teams feel well-equipped and prepared for a potential biological attack,

while others do not yet have necessary equipment.63 While the National Institute of

Justice has provided a manual outlining the criteria by which biological equipment

might be assessed,64 some first responders have claimed that the federal government

has not provided enough oversight and direction regarding such esoteric purchases.65

Advocates of allowing each community to choose what equipment to provide to first

responders point out that the needs of one community may not be the same as the

next, and, because of location, population, or previous expenditures, mandating

specific equipment purchases may not meet specific locality needs.66 The

Department of Homeland Security is slated to develop a Standards Program to

develop test and evaluation criteria and conduct analyses for first responder detection

equipment to help provide more guidance for first responder purchases.

Policymakers may ultimately determine the adequacy of current first responder

equipment and its availability, the amount of funds that first responders should

receive to purchase protective equipment, whether proper guidance has been given

by the federal government to state and local authorities regarding this equipment, and

what steps may be required, through oversight or legislation, to properly equip first

responders.

Federal Emergency Response Teams

The use of federal response teams to augment local first responder capabilities

has been questioned. While an investigation by the General Accounting Office in

2000 found that “Federal response teams do not duplicate one another,”67 there have

been concerns that the varied teams established by these agencies may be

redundant.68 Also, the general structure of establishing regional teams has been

questioned, since there would be a delay in response due to required travel time for

a team.69 On the other hand, others have advocated that parallel civilian and military

response teams may be necessary, since military teams might not be available to

civilians during wartime.

Kevin Flynn, “New York City Officials Defend Counterterror Training,” The New York

Times, February 14, 2003.

An Introduction to Biological Agent Detection Equipment for Emergency First

Responders, NIJ Guide 101-00, National Institute of Justice, December 2001.

Greg Seigle, “‘First Responders’ to Terrorism Seek Federal Strategy, Equipment,” Global

Security Newswire, March 6, 2002.

For more information on this topic, see CRS Report RL31475, First Responder Initiative:

Policy Issues and Options, by Ben Canada and CRS Report RL31680, Homeland Security:

Standards for State and Local Preparedness, by Ben Canada

General Accounting Office, Combating Terrorism: Federal Response Teams Provide

Varied Capabilities; Opportunities Remain to Improve Coordination, GAO-01-14,

November 2000.

Jonathan B. Tucker, “Chemical Terrorism: Assessing Threats and Responses,” in HighImpact Terrorism: Proceedings of a Russian American Workshop, (Washington, DC:

National Academy Press) 2002.

Joshua Green, “Weapons of Mass Confusion,” The Washington Monthly, May 2001.

CRS-22

Related CRS Products

CRS Report RL31059, Biological Weapons: A Primer, by (name redacted).

CRS Report RS21288, Smallpox: Technical Background on the Disease and Its

Potential Role in Terrorism, by (name redacted).

CRS Report RL31694, Smallpox Vaccine Stockpile and Vaccination Policy, by

(name redacted).

CRS Report RL31793, Vaccine Policy Issues for the 108th Congress, by (name redacted).

CRS Report RL31475, First Responder Initiative: Policy Issues and Options, by Ben

Canada.

CRS Report RL31791, Emergency Management Funding for the Department of

Homeland Security: Information and Issues for FY2004, by (name redacted),

Coordinator, Rob Buschmann, Ben Canada, Wayne Morrissey, (name reda

cted), and (name redacted).

CRS Report RL31263, Public Health Security and Bioterrorism Preparedness and

Response Act (P.L. 107-188): Provisions and Changes to Preexisting Law, by

(name redacted), (name red

acted), and Mary E. Tiemann.

CRS Report RL31719, An Overview of the U.S. Public Health System in the Context

of Bioterrorism, by (name redacted).

CRS Report RL31853, Food Safety Issues in the 108th Congress, by (name redacted).

CRS Report RL31831, Terrorist Motivations for Chemical and Biological Weapons

Use: Placing the Threat in Context, by (name redacted).

CRS Report RL30169, Export Administration Act of 1979 Reauthorization,

coordinated by (name redacted).

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