Biological Weapons: A Primer

Order Code RL31059

CRS Report for Congress

Received through the CRS Web

Biological Weapons: A Primer

July 24, 2001

name redacted

Specialist in National Defense

Foreign Affairs, Defense, and Trade Division

Congressional Research Service ˜ The Library of Congress

Biological Weapons: A Primer

Summary

In the past decade, public and congressional concerns over biological weapons

(BW), and bioterrorism in particular, have sharply increased. Though the use of living

organisms (e.g. bacteria, viruses, fungi) to harm or kill humans, livestock, or plants

has never occurred on a large scale, many government officials are viewing a BW

attack as a “when, not if” scenario. Some experts, however, question this assertion,

noting that BW production and employment is significantly more difficult than often

portrayed, and that there are significant political down sides for any nation or group

who would employ them. There have been a number of calls from Congress, the

GAO, and congressionally–mandated commissions for a comprehensive integrated

national threat assessment to be performed, so that perceived vulnerabilities alone do

not drive government’s response.

The United States has both statutes and regulations that govern possession and

use of dangerous biological agents, though some have deemed these too loose to

maintain effective control of these agents. Though no legislation has been introduced

to date in the 107th Congress, legislation considered in the 106th Congress may be

reintroduced later in the session.

Federal programs intended to deter, respond to, and/or mitigate a BW attack

exist in a broad range of government departments and agencies, and have been subject

to criticism for lack of coordination. Vice-president Cheney is overseeing a review

of all programs related to chemical/biological/radiological/nuclear threat response, and

in October 2001 is expected to provide recommendations, which would be

implemented under the direction of the Federal Emergency Management Agency.

As a state party to the Biological Weapons Convention, the United States has

participated in a decade-long effort to negotiate a protocol to the Convention that

would improve assurance of compliance. It had been hoped that a draft protocol

would be ready for consideration by the BWC Review Conference in November 2001,

however significant remaining disagreements ( both between the United States and its

Western Group allies and with developing countries) over the effectiveness of

verification measures, technology assistance, and protection of commercial

proprietary information appear to have stalled this effort.

Contents

Background . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Origins of Current Interest . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

What Are Biological Weapons? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Nature of Biological Weapons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Threat Assessments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

U.S. Government Assessments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Foreign Countries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Terrorist Groups . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

National Commission and Panel Reports . . . . . . . . . . . . . . . . . . . . . . . . . . 9

U.S. Laws and Regulations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Biological Weapons Anti-Terrorism Act of 1989 (P.L. 101-298) . . . . . . . 10

Antiterrorism and Effective Death Penalty Act of 1996

(P.L. 104-132) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Recent Congressional Actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Current Federal Programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Department of Agriculture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Department of Commerce . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Department of Defense (DOD) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Department of Energy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Department of Health and Human Services (HHS) . . . . . . . . . . . . . . . . . 13

Department of Justice (DOJ) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Department of Veteran’s Affairs (VA) . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Environmental Protection Agency (EPA) . . . . . . . . . . . . . . . . . . . . . . . . . 14

Federal Emergency Management (FEMA) . . . . . . . . . . . . . . . . . . . . . . . . 14

The Biological Weapons Convention and the Australia Group . . . . . . . . . . . . . 15

Biological Weapons Convention of 1975 (BWC) . . . . . . . . . . . . . . . . . . . 15

The Australia Group and Export Controls . . . . . . . . . . . . . . . . . . . . . . . . 17

Appendix:

Centers for Disease Control and

Australia Group

Biological Agent/Equipment Control Lists . . . . . . . . . . . . . . . . . . . . . . . . 19

Biological Weapons: Issues for Congress

Background

Origins of Current Interest

A number of factors have contributed to the greatly heightened interest in

biological weapons (BW) over the last several years. The Persian Gulf War brought

to light Iraq’s BW capabilities, and years of post-war confrontations with United

Nations inspectors served to keep public awareness high. Investigations of the Aum

Shinrikyo, the Japanese terrorist group that released a chemical nerve agent in the

Tokyo subway, revealed it had acquired and sought to weaponize biological agents

as well. The bombings of the World Trade Center and the Oklahoma City Federal

Building, though using only conventional explosives, brought the reality of very large

scale terrorist attacks to U.S. shores. The Defense Department, the Central

Intelligence Agency, and several independent studies have all spotlighted biological

weapons as a growing concern both for the U.S. military and the general population.

On the other hand, a significant number of experts have begun to question whether

the concern over biological weapons is out of proportion to the actual threat.1

Nevertheless, the potential vulnerability of the general public and the military and the

relatively limited BW defense capabilities currently available, though long-standing,

have been highlighted as never before. These events, accompanied by BW-related

novels and movies which attract public interest and a strong press interest in

biological weapons, will continue to make them a focal point for federal, state, and

local governments.

What Are Biological Weapons?

A biological weapon is a biological agent that is intentionally used to harm or

kill humans, animals, or plants. Biological agents, unlike chemical weapon agents, are

living organisms. Types of agents typically considered for use as biological weapons

are bacteria, viruses, rickettsiae, or fungi. A unique agent category, bridging the

1

Countering the Changing Threat of International Terrorism. National Commission on

Terrorism, June 2000; Global Trends 2015. National Foreign Intelligence Board, December

2000; Weapons of Mass Destruction: Threat and Response 2001. Department of Defense,

January 2001; Toward a National Strategy for Combating Terrorism. Advisory Panel to

Assess Domestic Response Capabilities for Terrorism Involving Weapons of Mass

Destruction, Second Annual Report, December 2000; Combating Chemical, Biological,

Radiological, and Nuclear Terrorism: A Comprehensive Strategy. Center for Strategic and

International Studies, December 2000. Hype or Reality: The “New Terrorism” and Mass

Casualty Attacks. Brad Roberts, ed.,Chemical and Biological Arms Control Institute.

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chemical and biological distinction, is toxins. These are biologically produced

chemicals such as shellfish toxin, snake venom, botulinum toxin, or ricin.2

For arms control and legal purposes, the definition of biological weapons has

proven a challenge. The agents themselves are in wide-spread use for legitimate

medical research, and are often stored in significant quantity. Consequently, their

production and possession cannot be completely prohibited without severe effect on

legitimate and desirable activities. Hence, statutory and treaty language has focused

on the use or the intention to use biological agents to harm, and their possession in

quantities incompatible with legitimate purposes, rather than on the agents

themselves.(See U.S. Laws and Regulations)

The number of biological agents that have been seriously considered for use as

weapons is relatively small because most agents do not meet the necessary criteria.

(For discussion of the criteria, see The Nature of Biological Weapons.) Two

organizations, however, maintain rather extensive lists of agents that could possibly

be used as biological weapons. The U.S. Centers for Disease Control and Prevention

have established a list of agents whose transfer and possession are under regulatory

control in the United States. The Australia Group, an informal association of nations

seeking to stem CBW proliferations, maintains a list of agents over which member

countries, including the United States, have pledged to maintain export controls. (See

Appendix)

Nature of Biological Weapons

Biological weapons are unique, presenting a complex array of differing

characteristics. They have never been used on a large-scale, and incidents of smallscale use are isolated and rare. Though some nations, including the United States,

have produced BW stockpiles in the 20th Century, military leaders have generally

viewed biological weapons with ambivalence.3 They can be unpredictable in the

lethality, geographical extent, and onset of their effects, and conceivably present as

great a threat to one’s own forces as those of the enemy. While these considerations

may cause reservations among military planners, they may not with those terrorists

who are unconcerned about indiscriminate harm.

Though there are literally thousands of biological pathogens, relatively few have

met the criteria for an effective biological weapon. The traditional requirements for

a “battlefield” biological weapon are summarized below. Some of these requirements,

however, may be irrelevant to a terrorist group unconcerned about the extent of harm

caused, or to a nation state using BW as a strategic weapon. For instance, military

planners have avoided highly contagious diseases (e.g. smallpox) for fear of epidemic

spreading to their own forces. An uncontrolled epidemic, however, may be the

2

Botulinum toxin is produced by the bacteria clostridium botulinum; Ricin is a toxin

obtainable from castor beans.

3

In 1969, after review under the Nixon Administration, the United States unilaterally

foreswore biological weapons, and destroyed its BW stockpile. Major factors in this decision

were the unpredictability of biological weapons, and faith in the U.S. nuclear arsenal for

purposes of deterrence and retaliation.

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desired result for a millenarian terrorist group or a nation-state seeking to destabilize

an adversary who is at distance. These traditional requirements

! Relatively small dose to infect

! High virulence

! Capable of being widely dispersed

! Survivable in storage and through dispersal

! Insusceptible to common medical treatment

! Short period between infection and symptom onset

! Minimal contagiousness to avoid infecting one’s own forces

! Availability of protective measures for one’s own forces, if infected

Another characteristic of concern for those who would attempt clandestine BW

use is natural occurrence in the target area. If natural outbreaks of a disease (e.g.

cholera or typhoid) are relatively common, it could be used as a biological weapon

with increased probability of plausible denial. Biological weapons could also lend

themselves to “false flag” attacks, in which the perpetrator plants evidence

incriminating another group or nation. These characteristics could enhance BW’s

attractiveness for some terrorists

It is often maintained that biological weapons are relatively easy to produce and

use. This statement, however, is valid only in comparison to chemical and nuclear

weapons production and use. Biological weapons do pose some significant challenges

for potential users. Some nations have been attempting for years to develop a BW

capability with apparently limited success. The terrorist group Aum Shinrikyo in

Japan – although it had substantial financial resources, laboratories, and trained

scientists – was unable to develop an effective biological weapon over several years.4

Giving a sense of the challenges involved, the following is a summary of a flowchart

developed by the U.S. Office of Technology Assessment showing the steps involved

in developing and using a biological weapon.5

! Obtain microbial seed stock

! Test suitability for weapon purposes

! Develop and test production process

! Mass produce and harvest agent

! Induce spore formulation or freeze-dry

! Micro-encapsulate (optional)

! Acquire/build/test delivery system

! Fill munitions or delivery system

! Transport and disseminate on target area

These steps present differing levels of challenge. Obtaining seed stocks has been

relatively easy in the past, though heightened awareness and new regulatory steps

have raised this threshold; certainly in the United States and, to a lesser extent world4

Kaplan, David E., “Aum Shinrikyo”, in Toxic Terror: Assessing Terrorist Use of Chemical

and Biological Weapons. Jonathan Tucker, ed. MIT Press, 2000. p.207.

5

Office of Technology Assessment, U.S. Congress. Technologies Underlying Weapons of

Mass Destruction. 1993. p. 83.

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wide. Producing significant amounts of a pathogen could take as little time as several

days, and requires only equipment that is commercially available. The former director

of Great Britain’s CBW defense research program has estimated that a small BW

production facility could be operated by ten trained personnel, though brief

production of BW agents in small quantities could be produced by fewer personnel. 6

The more difficult challenges arise in weaponizing and delivering the pathogen.

Ideally, the pathogen particles must be of an appropriate size for inhalation, and

achieving this has been described as “one of the more technically demanding aspects

of weaponization.”7 The pathogen must also be stabilized during storage and

delivery. Though “simple aerosolizers” can be used to deliver BW agents, the Aum

Shinrikyo’s repeated failures in BW aerosol dispersal in Japan gives some indication

of the difficulties in developing an effective delivery system.8 Throughout all the steps

of BW production and delivery, those involved must also take extraordinary care to

ensure they themselves are not infected inadvertently, unless they are dealing with

plant or livestock pathogens that do not infect humans.

These challenges notwithstanding, most observers agree that the increasing

availability of technology and numbers of trained biotech personnel will continue to

erode the technical obstacles to BW production and use.9

Threat Assessments

In congressional testimony, CIA Director George Tenet noted that “chemical and

biological weapons pose, arguably, the most daunting challenge for intelligence

collectors and analysts.”10 Large-scale weapons systems are more easily detectable

by national technical intelligence means. BW facilities and weapons are notably

easier to hide, and often require human intelligence sources to identify and evaluate.

Consequently, little detailed information is available in unclassified form.

Until recent years, the BW threat was viewed as limited to U.S. armed forces

who might engage an adversary with biological weapons capability. Hence, the

emphasis was on national programs, and assessments focused on national

biotechnological capabilities, as the two U.S. government reports summarized below

indicate. As the potential for BW terrorism began to receive greater attention, many

public officials have assumed the position that a BW attack upon the U.S. civilian

population is “not a question of if, but when.” As some observers have pointed out,

6

Pearson, Graham. “The Threat of Deliberate Disease in the 21st Century”, Biological

Weapons Proliferation: Reasons for Concern, Courses of Action. Henry L. Stimson Center

Report No. 24, January 1998. p. 7. Also available at

[http:www.brad.ac.uk/acad/sbtwc/other/disease.htm]

7

Ibid. p. 7.

8

Kaplan, p. 216.

9

Office of Technology Assessment, pp. 84-85.

10

Testimony before the Senate Foreign Relations Committee, March 21, 2000.

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this viewpoint is driven more by the extent of domestic population’s vulnerability to

a BW attack than by a “validated threat assessment” estimating the likelihood of such

an attack occurring.11 For some, CIA reports of the followers of terrorist leader

Osma bin Laden trying to acquire BW-related materials is sufficient basis to assume

he will eventually undertake a BW attack against U.S. citizens.12 Others suggest that

there are a variety of factors, both technical and political, that should be considered

in assessing the likelihood of this occurring. It can also be noted that if a terrorist’s

goals are to gain publicity, engender fear, and cause his enemies to adopt significant

defensive measures, simply implying the possibility of BW possession may be

sufficient. The considerable funds expended and extensive measures undertaken in

the last several years by U.S. federal, state, and local governments to prepare for a

possible BW attack are indicative.

Threat assessments by their nature will always be imprecise. They are based

upon available information and intelligence, which is often sketchy and unconfirmed.

Consequently, regardless of the methodology used to analyze the data, a significant

degree of uncertainty generally remains. As was demonstrated with the unanticipated

Indian and Pakistani nuclear weapons tests in 1998, even large national nuclear

weapons programs can evade accurate assessment. It is even more difficult when

attempting to monitor or predict the activities of loosely organized terrorist groups

and a type of weapon that requires considerably less infrastructure. It is this

uncertainty, when juxtaposed with the theoretical potential for casualties, that

encourages decision-makers to err on the side of greater caution when considering the

BW threat.

U.S. Government Assessments

While the Central Intelligence Agency has issued, in classified form, the National

Intelligence Estimate regarding foreign-based terrorism, there is still no single

integrated assessment covering both foreign and domestic threats. And, as the

General Accounting Office has repeatedly noted, there has been no national risk

assessment undertaken.13

Foreign Countries. Two U.S. government reports provide information on

national BW programs. Both of these reports focus on capabilities and do not address

the intentions of the nations involved. Adherence To and Compliance With Arms

Control Agreements: Report to Congress, published by the former Arms Control and

Disarmament Agency (ACDA), has provided some information on countries that are

parties to the Biological Weapons Convention, yet who are suspected or known to

11

Combating Terrorism: Need for Comprehensive Threat and Risk Assessment of Chemical

and Biological Attack. General Accounting Office. GAO/NSIAD-99-163. September 1999.

12

Testimony of the Director of Central Intelligence before the Senate Foreign Relations

Committee. March 21, 2000.

[http://www.cia.gov/cia/public_affairs/speeches/dci_speech_032100.html]

13

General Accounting Office, Combating Terrorism: Need for Comprehensive Threat and

Risk Assessments of Chemical and Biological Attacks.GAO/NSIAD-99-163. September

1999.

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possess a bioweapons capability. The Department of Defense offers some unclassified

information on nations who are not parties to the BWC (and consequently not

included in the ACDA report) in its latest annual report on proliferation.14 The ACDA

and DOD national assessments are summarized below, in alphabetical order by nation:

! China – Possessed a BW program prior to joining the BWC, and it is “likely”

that China continues to maintain that program covertly.

! Egypt – Possessed a BW program prior to signing the BWC. Egypt has not

ratified the BWC, and it is “likely” that it still has a biological weapons

capability.

! Iran – Has produced BW agents and “apparently” weaponized a small quantity.

Iran has used civilian medical, educational, and scientific organizations, in

addition to its biotechnology and pharmaceutical industries, to provide cover

for its biological warfare program.

! Iraq – Since 1972 has developed, produced, and stockpiled BW agents and

weapons. Though Iraq has made substantial disclosures to the United Nations

about its BW program, they are incomplete and have led to the assessment that

Iraq still possesses a BW program, and may have BW agents still stockpiled.

! Libya – Has been seeking a BW capability for years, but has been hampered by

lack of expertise. Libya’s program remains in the R&D stage though it may

be able produce small amounts of biological agents. Without foreign

assistance, it is unlikely to make significant progress in agent weaponization.

! North Korea – Has conducted BW research for over thirty years, and is

believed capable of limited BW production and weaponization. Nongovernmental sources have suggested that the majority of North Korea’s

investment has been focused on defensive BW measures, though

acknowledging a limited offensive capability.15

! Russia – Acknowledged in 1992 that it had conducted a covert offensive BW

program, and claimed to have ended it. Its declarations under the BWC since

1992 have been incomplete and misleading, leading to the suspicion that an

offensive program still exists. The continued presence of “old hands” at

certain facilities, denial of visitations to some former BW research/production

sites, and information from defectors regarding “ongoing offensive biological

warfare activities” contribute to these suspicions. The Russian BW effort was

very extensive, exploring the full range of human, animal, and plant pathogens,

and experimenting with genetic engineering to enhance agent effectiveness.

! Syria – has sought a BW arsenal for some time, and it is assessed as “highly

probable” that it is developing an offensive BW capability. However, it is

14

Proliferation: Threat and Reesponse. Department of Defense. January 2001.

15

Jane’s U.S. Chemical-Biological Defense Guidebook, Jane’s Information Group, 1997. p.

237.

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believed Syria has not yet weaponized biological agents and would require

foreign assistance to manufacture significant amounts of biological weapons.

The Secretary of State has designated six of the countries listed above as statesponsors of terrorism – Iran, Iraq, Libya, North Korea, and Syria.16 Cuba, another

designated state-sponsor of terrorism, has a well-developed biotechnology sector, and

has been on a “watch list” for BW proliferation, but has not been listed by ACDA or

DOD in their threat assessments. Most observers believe that there is a low

probability of state-sponsors providing biological weapons to terrorist groups to use

at their discretion.17 This opinion generally hinges on the assumption that these

nations hold biological weapons to be too valuable or too dangerous to be trusted

outside of government control. However, should a state decide to use BW, its client

terrorist groups could be enlisted in the effort, and would provide at least a minimal

level of plausible denial.

In addition to the countries noted above, there are several countries about which

there is occasional press speculation, but no confirmed information, regarding BW

programs. These include India, Israel, Pakistan, and Taiwan. South Africa has

acknowledged that under the Apartheid-era governments an offensive BW program

did exist, but has since been dismantled.18

Terrorist Groups. The Japanese Aum Shinrikyo sect is the only terrorist

group known to have produced and attempted to weaponize biological agents.19 The

Muslim extremist Usama Bin Ladin, who is believed to have organized the bombing

of the U.S. embassies in Kenya and Tanzania, is apparently seeking to obtain

biological toxin weapons.20 Aside from these cases, unclassified sources provide

almost no information on which to judge the extent of the BW threat from terrorist

groups or individuals.

Those who believe that biological weapons are becoming more attractive to

terrorist groups attribute this to several factors:

16

Patterns of Global Terrorism – 2000, Department of State, April 2001, p. 31.

17

Proliferation: Threat and Response, Section I, Transnational Threat, Department of

Defense, November 1997. p. 1.

18

Nuclear, Biological, and Chemical Weapons and Missiles: The Current Situation and

Trends. CRS Report RL30699. January 2, 2001;

19

In 1984, the Rajneeshee religious sect poisoned local restaurant salad bars in rural Oregon

with Salmonella bacteria in hopes of reducing voter turnout in a local election, thereby

allowing Rajneeshee candidates a victory. Over 700 people were sickened, and for quite some

time public health officials considered the outbreak to be a natural occurrence. This incident

is often cited in literature on terrorism, though it lacks the coercive element of traditional

terrorism, and is perhaps more appropriately categorized as a simple criminal use of a

biological agent.

20

Testimony of the Director of Central Intelligence before the Senate Foreign Relations

Committee. March 21, 2000.

[http://www.cia.gov/cia/public_affairs/speeches/dci_speech_032100.html]

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! Continuing publicity over the vulnerability of civilian populations to biological

weapons.

! An increase in terrorist groups whose ideology embraces or does not shy from

large numbers of indiscriminate casualties.

! Increased awareness of the strong psychological, as well as physical, effects of

biological weapons.

! Increasing diffusion of bio-technological expertise.

Among government sources, the State Department’s most recent edition of

Patterns of Global Terrorism 2000 remained unchanged from previous years in its

assessment that:

“Most terrorists continued to rely on conventional tactics,...but some

terrorists –such as Usama bin Laden and his associates – continued to seek

chemical, biological, radiological, and nuclear capabilities.” 21

Before the Senate Foreign Relations Committee, CIA Director George Tenet has

testified:

“Beyond state actors, there are a number of terrorist groups seeking to

develop or acquire biological and chemical weapons capabilities. Some

such groups—like Usama bin Ladin’s—have international networks, adding

to uncertainty and the danger of a surprise attack. There are fewer

constraints on non-state actors than on state actors. Adding to the

unpredictability are the “lone militants,” or the ad hoc groups here at home

and abroad who may try to conduct a biological and chemical weapons

attack.22

Both the State Department and the Central Intelligence Agency focus on foreign

terrorist groups. However, the possibility of domestic-based BW terrorism came to

the fore with the 1995 arrest of an individual with white supremacist associations in

possession of freeze-dried bubonic plague bacteria.23 Since then the number of BWrelated threats and hoaxes has continued to rise. There have been a number of calls

for a comprehensive domestic terrorist threat assessment, but none has been

undertaken. Though it might seem that the Federal Bureau of Investigation would be

the logical agency to do this, the FBI is a law enforcement, not an intelligence

collection, agency. Consequently, its investigative activities must be tied to evidence

of suspected or actual crimes and their prosecution, rather than the kind of sweeping

intelligence collection needed to prepare an overall domestic BW threat assessment.

21

Patterns of Global Terrorism 2000, Department of State, April 2001. p. 35.

22

DCI Testimony, SFRC, March 21, 2000.

23

Testimony of Robert Burnham, Chief, Domestic Terrorism Section, Federal Bureau of

Investigation before the Transportation and Infrastructure Subcommittee on Oversight and

Investigations. May 19, 1999.

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Indeed, no government agency possesses a domestic mandate to collect intelligence

equivalent to that of the U.S. intelligence community collecting overseas, and seeking

such a mandate could raise significant constitutional issues.

National Commission and Panel Reports

Two recent executive branch and congressional commissions have published

reports that address the threat of biological weapons. The U.S. Commission on

National Security/21st Century, widely known as the Hart-Rudman Commission,

comprised former senior government officials and military commanders, private

sector executives, and journalists .24 In its sweeping 3-volume examination of national

security challenges, the Commission asserts that the “United States should assume

that it will be a target of terrorist attacks against its homeland using weapons of mass

destruction.”25 The Commission also concludes that:

“biological weapons are the most likely choice of means for disaffected

states and groups of the 21st century. They are nearly as easy to develop

as chemical weapons, they are far more lethal, and they are likely to

become easier to deliver”.26

Perhaps more significantly, the Hart-Rudman Commission also predicts that:

“The design and deployment of genetically engineered pathogens could

thwart most antibiotics and vaccines, and readily outcycle our detection,

antidote development, and distribution timelines.”27

The Congressionally-mandated Advisory Panel to Assess Domestic Response

Capabilities For Terrorism Involving Weapons of Mass Destruction, popularly known

as the “Gilmore Panel” has published two annual reports.28 The Panel adopts a more

24

The United States Commission on National Security/21st Century was originally chartered

in 1998 by the Secretary of Defense, as the National Security Study’s Senior Advisory Board.

It continues to operate as a Federal advisory committee in accordance with the Federal

Advisory Committee Act (Public Law 92-463). [http://www.nssg.gov]

25

New World Coming: American Security in the 21st Century. Appendix 1: Supporting

Research and Analysis. p. 49. [http://www.nssg.gov/NWR_A.pdf]

26

Ibid. p. 50

27

Ibid p. 51

28

First Annual Report to the President and the Congress: Assessing the Threat. Advisory

Panel to Assess Domestic Response Capabilities For Terrorism Involving Weapons of Mass

Destruction. December 1999.

Second Annual Report to the President and the Congress: Toward a National Strategy

for Combating Terrorism. Advisory Panel to Assess Domestic Response Capabilities For

Terrorism Involving Weapons of Mass Destruction. December 2000.

The Secretary of Defense, in consultation with the Attorney General, the Secretary of Energy,

the Secretary of Health and Human Services, and the Director of the Federal Emergency

(continued...)

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conservative position regarding the likelihood of domestic bioterrorism resulting in

mass casualties. Citing the technical difficulties and the relative unlikelihood of a

terrorist group combining the scientific expertise and the willingness to commit mass

murder, the Panel’s report advises against focusing exclusively on worst case

scenarios and suggests that recent spending levels are less threat-based than an

“overcompensation for years of neglect”.29 The Commission also suggests particular

attention to the possibility of terrorist attacks against U.S. agriculture, deeming this

the easiest application of BW, and virtually “risk-free” for the perpetrators.30 The

Commission echoes the call for an integrated national threat assessment, which

includes potential U.S.-based threats, to permit more rational allocation of resources.

U.S. Laws and Regulations

Biological Weapons Anti-Terrorism Act of 1989 (P.L. 101-298)

This act implements the Biological Weapons Convention of 1975, criminalizing

the production, stockpiling, transfer, acquisition, and possession of any biological

agent, toxin, or delivery system for use as a weapon. The act specifically exempts

agents intended for protective or peaceful purposes. The 1996 Antiterrorism and

Effective Death Penalty Act amended this law to extend its coverage to threats or

attempts to use biological agents as weapons, and to include bio-engineered agents.

Violators can be imprisoned for any term of years, including life imprisonment.

This act also provides the Attorney-General with the authority to request a

seizure warrant for any covered agent that is of a type or quantity that has “no

apparent justification for prophylactic, protective, or other peaceful purposes.” The

Attorney-General is also authorized to obtain a civil injunction against conduct

prohibited under this act.

The primary issue of concern regarding this act is the challenge it provides for

criminal prosecution. Intent to use an agent as a weapon must be proven, and it is an

affirmative defense that possession or other activity with the agent is intended for

peaceful purposes. Some have argued this makes it far too easy for a group or

individual to have legal possession of potentially very dangerous pathogens, and

places too high a burden of proof upon the prosecution. These concerns were, in

part, the reason for certain provisions of the Antiterrorism and Effective Death

Penalty Act of 1996 discussed below.

28

(...continued)

Management Agency, entered into a contract with the National Defense Research Institute

(NDRI), a federally funded research and development center (FFRDC) at RAND, to establish

the Advisory Panel in accordance with Section 1405 of the National Defense Authorization

Act for Fiscal Year 1999, P.L.105-261.

29

Gilmore, Vol. I, p. 36.

30

Ibid, p. 12

CRS-11

Antiterrorism and Effective Death Penalty Act of 1996

(P.L. 104-132)

Subtitle B (Sec. 511) of this legislation directs the Secretary of Health and

Human Services to 1) maintain a list of biological agents that have the “potential to

pose a severe threat to public health” and 2) to promulgate rules for the transfer of

listed agents to ensure proper training of personnel and laboratory facilities, and

proper safeguards to prevent access to these agents for criminal or terrorist purposes.

Fulfilling this statutory requirement, the Centers for Disease Control and Prevention

(CDC) promulgated federal regulation 42 CFR Part 72.

The regulation requires any person or institution either transferring or receiving

listed agents to 1) register with CDC; 2) to report shipments or transfers, noting endusers and purposes; 3) comply with appropriate federal biosafety requirements, and

4) submit to random or “for cause” inspections to assure compliance. One criticism

of this legislation and the implementing regulation is that they focus solely on agent

transfers, and consequently do not capture those institutions or individuals who

currently possess listed agents, but have no cause to transfer them. Therefore, it still

remains legal to possess these agents without registration, as long as no transfers take

place. This continues to concern some lawmakers and members of the law

enforcement community. In May 1999, the House Committee on Commerce

Subcommittee on Oversight and Investigations held a hearing to address this issue.31

Department of Justice officials testified that the department had been working with

Health and Human Services to draft new legislation addressing this issue, and it would

be presented by the Administration “in the near future,” however, no Administrationsponsored legislation has as yet been introduced.

Recent Congressional Actions

Near the end of the 106th Congress, Senators Kyl and Feinstein introduced S.

3205, the Counterterrorism Act of 2000, which mandated reports from the Attorney

General and the Secretary of Health and Human Services on ways to improve controls

over biological pathogens and BW-related equipment, and ways to improve physical

security in facilities that handle these pathogens. This legislation passed the Senate

by unanimous consent on November 14, 2000, but the House did not act upon it

before adjournment sine die.

Also in the 106th Congress, Sen. Biden introduced S. 3202, The Dangerous

Biological Agent and Toxin Control Act of 2000. This legislation sought to tighten

restrictions on the possession and transfer of biological pathogens. It did not receive

Senate consideration before the 106th Congress adjourned.

These bills have not been re-introduced in the 107th Congress. Indeed, no

legislation directly related to biological weapons has been introduced in the 107th.

31

U.S. Congress. House of Representatives. Committee on Commerce, Subcommittee on

Oversight and Investigations. The Threat of Bioterrorism in America: Assessing the

Adequacy of the Federal Law Relating to Dangerous Biological Agents. Hearing, May 20,

1999. Serial No. 106-19.

CRS-12

The focus during this Congress has been on the larger issue of “homeland security”,

which, among a broad range of issues, encompasses U.S. capabilities to respond to

the use of biological weapons. Three bills on “homeland security” have been

introduced in the 107th Congress: H.R. 525, H.R. 1198, and H.R. 1292. (For further

information see the CRS Terrorism Electronic Briefing Book

[http://www.congress.gov/brbk/html/ebter1.html]

Current Federal Programs

The federal programs related to biological weapons are all defensive in nature,

and with the exception of the Department of Defense programs are in response to

increased concerns about possible bioterrorism. They focus on improving pathogen

detection, developing new treatments and vaccines, and upgrading incident response

capabilities. Almost every cabinet-level department is currently playing some role in

these efforts. A brief summary of the major federal BW-related programs follows.

More detailed information can be found in individual agency budget documentation

and in the Office of Management and Budget’s Annual Report to Congress on

Combating Terrorism

Department of Agriculture

The Department of Agriculture (USDA) is seeking to improve detection

techniques for the more highly infectious plant and animal pathogens, making it

possible to locate their precise geographical origins. The Animal and Plant Health

Inspection Service is undertaking to establish a “genetic fingerprint” library of animal

pathogens, and is intensifying its emergency management training and education to

cope with animal and disease outbreaks. The Plum Island Animal Disease Center

(NY)[http://www.ars.usda.gov/plum/bsl4.htm] may be upgraded to a Biosafety Level

4 facility, and new Level 2 and Level 3 research laboratories are to be built at the

National Animal Disease Center (IA)[http://www.nadc.ars.usda.gov/].

Department of Commerce

The primary BW-related efforts of the Commerce Department are centered in

the Office of Chemical and Biological Controls and Treaty Compliance located in the

Bureau of Export Administration (BXA) [http://www.bxa.doc.gov/]. This office

oversees the enforcement of export controls on biological pathogens and BW-related

equipment and technology that have been established in cooperation with the

Australia Group.

Department of Defense (DOD)

The Department of Defense’s primary focus regarding biological weapons is the

protection of U.S. armed forces, though it is prepared to offer assistance to civilian

authorities as required in the event of a BW terrorist attack. The DOD Chemical and

Biological Defense Program [http://www.acq.osd.mil/cp/index.html] divides its BW

defensive programs into four areas: contamination avoidance, NBC battle

management, protection, and decontamination. Much of DOD’s vanguard research

CRS-13

is being conducted by the Defense Advanced Research Agency (DARPA)

[http://www.darpa.mil/] by its Defense Science Office, Microsystems Technology

Office, and Special Projects Office. Among the subjects currently under study are:

! Advanced Consequence Management

! Advanced Diagnostics

! Pathogen Genomic Sequencing

! Unconventional Pathogen Countermeasures

! Air and Water Purification

! Component Technologies for Bio Agents Sensors

! Sensor Integration and Modeling for Biological Agent Detection (SIMBAD)

Department of Energy

Though the Department of Energy has traditionally focused on nuclear weapons,

since the end of the Cold War and the emergence of concern over biological

weapons, the department has initiated several BW-related defensive research and

development programs under the Chemical and Biological Nonproliferation Program

[http://www.nn.doe.gov/cbnp/index.shtml]. Technology research is divided into four

areas: detection equipment, DNA characterization of pathogens, modeling pathogen

dispersion patterns, and large-scale decontamination. Two “demonstration and

application” programs are the Biological Aerosol Sentry and Information System

(BASIS) and the Program for Response Operations and Technology Enhancements

for Chemical/Biological Terrorism (PROTECT). BASIS would provide an area

detection system for use at large-scale civilian events, providing agent identification,

along with location, duration, and level of exposure. PROTECT is a system intended

for large civilian facilities that may be at risk for a BW attack (e.g., airports,

subways). The system will integrate detection, dispersion modeling, and

decontamination technologies customized to a given facility, and capable of providing

alarms and response options to emergency personnel. DOE also participates in U.S.

efforts to redirect former Soviet biological weapons scientists to peaceful research

activities by funding collaborative research programs through the DOE Initiatives for

Proliferation Prevention Program. 32

Department of Health and Human Services (HHS)

The Department of Health and Human Services, through its Centers for Disease

Control and Prevention (CDC) [http://www.bt.cdc.gov/index.asp], is seeking to

improve the laboratory and epidemiology capabilities of public health surveillance

systems at the state, local, and federal level. The HHS Office of Emergency

Preparedness [http://ndms.dhhs.gov/] is developing Metropolitan Medical Response

Systems [http://www.mmrs.hhs.gov/] in major urban areas to coordinate the response

32

The General Accounting Office has published a brief assessment of this effort: Biological

Weapons: Effort to Reduce Former Soviet Threat Offers Benefits, Poses New Risks (Letter

Report, 04/28/2000, GAO/NSIAD-00-138).

CRS-14

of a region’s medical and emergency personnel in the event of a biological incident.33

HHS is also overseeing the creation of a National Pharmaceutical Stockpile that can

be tapped in the event of a mass-casualty incident. HHS research and development

efforts are centered on vaccines, new therapeutic drugs, diagnostic techniques, and

genomics. The Food and Drug Administration has also received funds to expedite

pharmaceutical review and approval for drugs intended to combat BW agents.

Department of Justice (DOJ)

In addition to its law enforcement responsibilities, the Department of Justice,

until recently, assumed responsibility for providing equipment grants to state and local

first responders through the Office of Justice Programs. Within the Federal Bureau

of Investigation, the National Domestic Preparedness Office [http://www.ndpo.gov/]

was given coordination responsibility for domestic preparedness programs throughout

the Federal Government, and sought to be the “clearinghouse” for assistance to state

and local authorities. The Bush Administration is now transferring these

responsibilities from DOJ to the Federal Emergency Management Agency.

Department of Veteran’s Affairs (VA)

The Department of Veteran’s Affairs has entered into an inter-agency agreement

with HHS’s U.S. Public Health Service to warehouse a portion of the National

Pharmaceutical Stockpile. The VA is also setting up a training program for civilian

hospital personnel to prepare them to treat patients exposed to both biological and

chemical weapons.

Environmental Protection Agency (EPA)

The Environmental Protection Agency focuses primarily on hazardous materials

spills, however its HAZMAT On-Scene Coordinators and Environmental Response

Team are participating in bioterrorism exercises with other agencies. The EPA is also

undertaking an assessment of the vulnerability of the national drinking water supply

to terrorist action and ways to reduce that vulnerability.

Federal Emergency Management (FEMA)

On May 8th, 2001, President Bush directed the Federal Emergency Management

Agency to create the Office of National Preparedness, and it was officially established

on June 18th. This office will coordinate all federal programs dealing with weapons

of mass destruction consequence management within the Departments of Defense,

Health and Human Services, Justice, Energy, the Environmental Protection Agency,

and other federal agencies. It will be responsible for implementing the

recommendations of Vice-President Cheney’s review of the Federal Government’s

counter-terrorism efforts. This review is expected to be completed by October 2001.

33

According to HHS, ninety-seven Metropolitan Medical Response Systems will be in place

by the end of FY2001.

CRS-15

The Biological Weapons Convention and the

Australia Group

Biological Weapons Convention of 1975 (BWC)

The United States ratified the BWC in 1975. Parties to the BWC have agreed

not to develop, produce, stockpile, or otherwise acquire or retain: 1) Microbial or

other biological agents, or toxins whatever their origin or method of production, of

types and in quantities that have no justification for prophylactic, protective, or other

peaceful purposes; and 2) weapons, equipment, or means of delivery designed to use

such agents or toxins for hostile purposes or in armed conflict.

They also have agreed not to transfer directly or indirectly, or to assist any

State, group of States or international organizations to manufacture or otherwise

acquire any of the BW agents, toxins, weapons, equipment, or means of delivery. The

BWC also requires all parties to destroy their BW stockpiles within nine months of

ratification. The United States ratified the BWC in 1975 and enacted implementing

legislation in 1989 (P.L. 101-298). The BWC codified what the United States had

already unilaterally undertaken in 1969 when President Nixon ended the U.S.

biological weapons program and ordered the stockpile destroyed.

The BWC was negotiated in a relatively short period of time (1969-1972)

primarily because it contains no provisions for enforcement or verification of

compliance, which are often the most difficult elements of an arms control treaty to

conclude. Efforts to remedy this lack began in 1986 when the States Parties agreed

to certain confidence-building measures. Compliance with even these unverified

information exchanges was limited.34 Since 1991 a so-called Ad Hoc Group of

Government Experts has sought first to identify possible verification measures, and

then to negotiate a verification protocol which could have a reasonable chance of

acceptance by the BWC Review Conference in 2001.

A number of factors have informed the U.S. position in the BWC Protocol

negotiations. Perhaps the single most important is the assertion that the BWC is

inherently unverifiable, and that the best that can be hoped for is a “bolstering of

confidence” regarding compliance. The reasons the United States has long held that

the BWC is not verifiable are many, but almost all stem from the uniqueness of

biological weapons. All other subjects of arms control agreements are: countable

(aircraft, missiles), measurable (nuclear detonations), or not naturally occurring (nerve

agents).35 None of these conditions is true for biological weapons. Biological

34

These measures comprised sharing information on biocontainment facilities, biodefense

programs; previous bioweapons programs, and current vaccine facilities. Fewer than 50% of

the Parties ever filed declarations, and most have been incomplete or suspected of

inaccuracies. See Pearson, Graham, “The Protocol to the Biological Weapons Convention Is

Within

Reach”,

Arms

Control

Today,

June

2000.

[http://www.armscontrol.org/ACT/june00/bwcjun.htm]

35

Testimony of Al Zelicoff, Sandia National Laboratories, before House Government Reform

(continued...)

CRS-16

pathogens are naturally ubiquitous, most often identified only with difficulty, and their

possession (or the possession of equipment to produce them) is necessary for a wide

range of perfectly legitimate and beneficial purposes, e.g. pharmaceutical and medical

research.36 The facilities required to produce biological weapons may be quite small,

have no visible “signature”, and could otherwise carry out legitimate activities.

Hence, the universe of potential BW facilities that would have to be monitored to

achieve total verification is virtually limitless.

Once non-verifiability is assumed, it raises the threshold for the costs or risks that

are deemed acceptable in obtaining an agreement. In the calculation of benefit and

risk, the United States has accepted as fundamental principles the protection of the

U.S. biotechnology industries’ confidential business information and the security of

U.S. biodefense programs. Simply put, the U.S. believes that the low level of

compliance assurance expected from the BWC Protocol does not justify placing these

commercial and defense interests at any significant risk through broadly defined

declarations or inspection procedures. This position has put the United States at odds

with most of its European allies, who favor a more stringent and intrusive regime.

Another fundamental principle for the United States is the maintenance of

existing non-proliferation export controls, independent of the BWC. The NonAligned Movement (NAM) of developing nations has quite energetically sought to

prohibit such controls and to require/encourage technology transfer within the

framework of the Protocol, making such measures a fundamental condition for their

acceptance of any protocol. The United States and its European allies continue to

resist these efforts, emphasizing that the BWC Protocol is to address security issues

and is not a “trade treaty.” This issue is still seen by many as a “show-stopper”,

unless the NAM nations modify their stance, which is deemed unlikely.

U.S. negotiators have also emphasized that any protocol would apply only to

BWC state parties. Several nations hostile to the United States are suspected or

known to have BW programs, and are not BWC state parties (e.g. Iraq, North

Korea). Consequently, a protocol would have no effect on their conduct. This

unmitigated threat is then perceived to place even greater importance on preventing

the inadvertent release of technologically valuable information through declarations

or visit/inspections.

Finally, U.S. negotiators have kept in mind the need for Senate advice and

consent to any protocol, and the difficulties experienced in this process with the

somewhat less controversial Chemical Weapons Convention. Some consideration,

therefore, must be given to possible Senate reaction to protocol provisions to avoid

a contentious, and possibly unsuccessful, ratification effort.

In the BWC Protocol negotiations, these principles have led the United States

to favor narrower declaration thresholds and reporting requirements for facilities, to

35

(...continued)

National Security Subcommittee, June 5, 2001.

36

Indeed, the legal definition of biological weapon is dependent upon the intent of the pathogen

possessor to harm.

CRS-17

oppose random visits to declared facilities, to seek restrictions on the number of

mandatory on-site visits, and to support managed-access under the final control of the

visited/inspected facility. These positions, held to protect U.S. commercial and

biodefense information, have led some to characterize the U.S. position as somewhat

paradoxical, i.e. expressing concerns over the lack of verifiability inherent in the

Protocol draft, yet opposing tighter verification measures.

In press reports and in testimony before the House Committee on Government

Reform National Security Subcommittee, there has been criticism that the United

States has failed to assume a leadership role in the Protocol negotiations or has been

“paralyzed” owing to bureaucratic conflict within the government 37. The relative

silence of the U.S. delegation in Geneva, has resulted in our European allies taking

the initiative and pressing for a more elaborate and intrusive regime (based largely

upon the Chemical Weapons Convention) than the United States will support. This

has led some to believe that the U.S. commitment to completing negotiations is not

whole-hearted, and that perhaps the United States would prefer the negotiations to

drift indefinitely.38 These speculations have increased with reports that a Bush

Administration review panel has concluded that the so-called Chairman’s Draft of the

Protocol under consideration should not be accepted. There has also been speculation

that the Administration will not, however, announce an outright rejection of the

protocol draft, owing to concerns over the internationally sensitive issue of U.S.

unilateralism, but rather will simply continue negotiations. To those who emphasize

a need to complete negotiations so that the Protocol can be considered for approval

by the November 2001 BWC Review Conference, the United States has maintained

that it will not “negotiate against a deadline.”

The Australia Group and Export Controls

The United States, in coordination with the 30-member Australia Group

maintains export controls over selected microorganisms, toxins, and biotechnology.

The Australia Group is an informal consortium of nations formed in 1984 to combat

the proliferation of chemical and biological weapons.39 The AG has developed lists

of agents and equipment over which each member has agreed to maintain export

controls. It has also developed more extensive “warning lists” of dual-use materials

which are circulated to commercial industry with a request to voluntarily report

potentially suspicious transactions to their national government. The AG also serves

as an information-sharing forum among its members.

37

Zelicoff.

38

Leonard, Jame F. “An Essential First Step”, Arms Control Today .May 200.

39

The Australia Group’s members are: Argentina, Australia, Austria, Belgium, Canada, Czech

Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,

Japan, Luxembourg, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Slovak

Republic, South Korea, Spain, Sweden, Switzerland, United Kingdom, United States, and the

European Community Commission as an observer.

CRS-18

The biological agents and equipment under U.S. export control are listed on the

Commerce Control List.40 Export licenses are required for these items for all

destinations, except Canada, and re-export or transfer is also prohibited without

licensing. The Bureau of Export Administration considers license applications on a

case-by-case basis, and will deny a license if it determines there is an unacceptable risk

the materials could be used in a biological weapons project.

40

The Commerce Control List can found in .pdf format on the Department of Commerce Web

site: [http://w3.access.gpo.gov/bxa/ear/ear_data.html]. For more detailed information on BW

export controls, see the Bureau of Export Administration’s Foreign Policy report 2000,

Chapter 7.

[http://www.bxa.doc.gov/press/2000/Reports/ForPolTOC.html]

CRS-19

Appendix:

Centers for Disease Control and

Australia Group

Biological Agent/Equipment Control Lists

Centers for Disease Control and Prevention List of Select Biological

Agents Subject to Regulation

Viruses

Crimean-Congo haemorrhagic fever virus

Eastern Equine Encephalitis virus

Ebola viruses

Equine Morbillivirus

Lassa fever virus

Marburg virus

Rift Valley fever virus

South American Haemorrhagic fever viruses (Junin, Machupo, Sabia, Flexal,

Guanarito)

Tick-borne encephalitis complex viruses

Variola major virus (Smallpox virus)

Venezuelan Equine Encephalitis virus

Viruses causing hantavirus pulmonary syndrome

Yellow fever virus

Bacteria

Bacillus anthracis

Brucella abortus, B. melitensis, B. suis

Burkholderia (Pseudomonas) mallei

Burkholderia (Pseudomonas) pseudomallei

Clostridium botulinum

Francisella tularensis

Yersinia pestis

Exemptions: vaccine strains as described in Title 9 CFR, Part 78.1 are exempt.

Rickettsiae

Coxiella burnetii

Rickettsia prowazekii

Rickettsia rickettsii

Fungi

Coccidioides immitis

Toxins

Abrin

Aflatoxins

CRS-20

Botulinum toxins

Clostridium perfringens epsilon toxin

Conotoxins

Diacetoxyscirpenol

Ricin

Saxitoxin

Shigatoxin

Staphylococcal enterotoxins

Tetrodotoxin

T-2 toxin

Exemptions: Toxins for medical use, inactivated for use as vaccines, or toxin

preparations for biomedical research use at an LD50 for vertebrates of more than 100

nanograms per kilogram body weight are exempt. National standard toxins required

for biologic potency testing as described in 9 CFR Part 113 are exempt.

CRS-21

Australia Group

List of Biological Agents for Export Control

Viruses

Chikungunya virus

Congo-Crimean haemorrhagic fever virus

Dengue fever virus

Eastern equine encephalitis virus

Ebola virus

Hantaan virus

Junin virus

Lassa fever virus

Lymphocytic choriomeningitis virus

Machupo virus

Marburg virus

Monkey pox virus

Rift Valley fever virus

Tick-borne encephalitis virus (Russian Spring-Summer encephalitis virus)

Variola virus

Venezuelan equine encephalitis virus

Western equine encephalitis virus

White pox

Yellow fever virus

Japanese encephalitis virus

Rickettsiae

Coxiella burnetii

Rickettsia quintana (now known as Rochalimea quintana)

Rickettsia prowasecki

Japanese encephalitis virus

Bacteria

Bacillus anthracis

Brucella abortus

Brucella melitensis

Brucella suds

Chlamydia psittaci

Clostridium botulinum

Francisella tularensis

Pseudomonas mallet

Pseudomonas pseudomallei

Salmonella typhi

Shigella dysenteriae

Vibrio cholerae

Yersinia pestis

CRS-22

Genetically Modified Micro-organisms

Genetically modified micro-organisms or genetic elements that contain nucleic acid

sequences associated with pathogenicity and are derived from organisms in the core

list. Genetically modified micro-organisms or genetic elements that contain nucleic

acid sequences coding for any of the toxins in the core list.

Toxins

Botulinum toxins

Clostridium perfringens toxins

Conotoxin

Ricin

Saxitoxin

Shiga toxin

Staphylococcus aureus toxins

Tetrodotoxin

Verotoxin

Microcystin (Cyanginosin)

Warning List

Viruses

Kyasanur Forest virus

Louping ill virus

Murray Valley encephalitis virus

Omsk haemorrhagic fever virus

Oropouche virus

Powassan virus

Rocio virus

St Louis encephalitis virus

Bacteria

Clostridium perfringens*

Clostridium tetani*

Enterohaemorrhagic Escheichia coli

Legionella pneumophila

Yersinia pseudotuberculosis

* The Australia Group recognizes that these organisms are ubiquitous, but, as they

have been acquired in the past as part of biological weapons programs, they are

worthy of special caution.

Genetically Modified Micro-organisms

Genetically modified mico-organisms or genetic elements that contain nucleic acid

sequences associated with pathogenicity and are derived from organisms in the

warning list. Genetically modified mico-organisms or genetic elements that contain

nucleic acid sequences coding for any of the toxins in the warning list.

Toxins

Abrin

Cholera toxin

Tetanus toxin

Trichothecene mycotoxins

CRS-23

Australia Group Updated List of Animal Pathogens for Export

Control

Viruses

African swine fever virus

Avian influenza virus*

Bluetongue virus

Foot and mouth disease virus

Goat pox virus

Herpes virus (Aujeszky’s disease)

Hog cholera virus (synonym. swine fever virus)

Lyssa virus

Newcastle disease virus

Peste des petite ruminants virus

Porcine enterovirus type 9 (synonym: swine vesicular disease virus)

Rinderpest virus

Sheep pox virus

Teschen disease virus

Vesicular stomatitis virus

Bacteria

Mycoplasma mycoides

Genetically modified Micro-organisms

Genetically modified micro-organisms or genetic elements that contain

nucleic acid sequences associated with pathogenicity and are derived from

organisms in the list.

Australia Group List of Plant Pathogens for Export Control

Bacteria

Xanthomonas albilineans

Xanthomonas campestris pv. citri

Fungi

Colletotrichum coffeanum var. virulans

Cochliobolus miyabeanus (Helminthosporium oryzae)

Microcyclus ulei (syn. Dothidella ulei)

Puccinia graminis (syn. Puccinia graminis f. sp. tritici)

Puccinia striiformis (syn. Puccinia glumarum)

Pyricularia grisea / Pyricularia oryzae

Genetically-modified Micro-organisms

Genetically-modified micro-organisms or genetic elements that contain

nucleic acid sequences associated with pathogenicity derived from the plant

pathogens identified on the export control list.

CRS-24

Australia Group List of Dual-use Biological Equipment for Export

Control

.

1. Complete containment facilities at P3, P4 containment level

Complete containment facilities that meet the criteria for P3 or P4 (BL3,

BL4, L3, L4) containment as specified in the WHO Laboratory Biosafety manual

(Geneva, 1983) should be subject to export control.

2. Fermenters*

Fermenters capable of cultivation of pathogenic micro-organisms, viruses or

for toxin production, without the propagation of aerosols, and having all the

following characteristics:

(a) capacity equal to or greater than 300 litres;

(b) double or multiple sealing joints within the steam containment area;

(c) capable of in-situ sterilisation in a closed state.

* Sub-groups of fermenters include bioreactors, chemostats and continuous-flow

systems.

3. Centrifugal Separators

Centrifugal separators capable of the continuous separation of pathogenic

micro-organisms, without the propagation of aerosols, and having all the following

characteristics:

(a) flow rate greater than 100 litres per hour;

(b) components of polished stainless steel or titanium;

(c) double or muliple sealing joints within the steam containment area;

(d) capable of in-situ steam sterilisation in a closed state.

4. Cross-flow Filtration Equipment

Cross-flow filtration equipment designed for continuous separation of

pathogenic microorganisms, viruses, toxins and cell cultures without the

propagation of aerosols, having all the following characteristics:

(a) equal to or greater than 5 square metres;

(b) capable of in-situ sterilisation.

5. Freeze-drying Equipment

Steam sterilisable freeze-drying equipment with a condensor capacity greater

than 50 kgs of ice in 24 hours and less than 1000 kgs of ice in 24 hours.

CRS-25

6. Equipment that incorporates or is contained in P3 or P4 (BL3, BL4, L3,

L4) containment housing, as follows:

(a) Independently ventilated protective full or half suits;

(b) Class III biological safety cabinets or isolators with similar performance standards.

7. Aerosol inhalation chambers

Chambers designed for aerosol challenge testing with pathogenic

microorganisms, viruses or toxins and having a capacity of 1 cubic metre or greater.

The experts propose that the following item be included in awareness raising

guidelines to industry:

1. Equipment for the micro-encapsulation of live micro-organisms and toxins in

the range of 1-10 nanometer particle size, specifically:

(a) Interfacial polycondensors;

(b) Phase separators.

2. Fermenters of less than 300 litre capacity with special emphasis on aggregate

orders or designs for use in combined systems.

3. Conventional or turbulent air-flow clean-air rooms and self-contained

fan-HEPA filter units that may be used for P3 or P4 (BL3, BL4, L3, L4)

containment facilities.

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