Order Code RL31059
CRS Report for Congress
Received through the CRS Web
Biological Weapons: A Primer
July 24, 2001
Specialist in National Defense
Foreign Affairs, Defense, and Trade Division
Congressional Research Service ˜ The Library of Congress
Biological Weapons: A Primer
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.
Background . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Origins of Current Interest . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
What Are Biological Weapons? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Nature of Biological Weapons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Threat Assessments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
U.S. Government Assessments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Foreign Countries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Terrorist Groups . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
National Commission and Panel Reports . . . . . . . . . . . . . . . . . . . . . . . . . .
U.S. Laws and Regulations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Biological Weapons Anti-Terrorism Act of 1989 (P.L. 101-298) . . . . . . .
Antiterrorism and Effective Death Penalty Act of 1996
(P.L. 104-132) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Recent Congressional Actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Current Federal Programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Department of Agriculture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Department of Commerce . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Department of Defense (DOD) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Department of Energy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Department of Health and Human Services (HHS) . . . . . . . . . . . . . . . . .
Department of Justice (DOJ) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Department of Veteran’s Affairs (VA) . . . . . . . . . . . . . . . . . . . . . . . . . . .
Environmental Protection Agency (EPA) . . . . . . . . . . . . . . . . . . . . . . . . .
Federal Emergency Management (FEMA) . . . . . . . . . . . . . . . . . . . . . . . .
The Biological Weapons Convention and the Australia Group . . . . . . . . . . . . . 15
Biological Weapons Convention of 1975 (BWC) . . . . . . . . . . . . . . . . . . . 15
The Australia Group and Export Controls . . . . . . . . . . . . . . . . . . . . . . . . 17
Centers for Disease Control and
Biological Agent/Equipment Control Lists . . . . . . . . . . . . . . . . . . . . . . . . 19
Biological Weapons: Issues for Congress
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
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
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.
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
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
Botulinum toxin is produced by the bacteria clostridium botulinum; Ricin is a toxin
obtainable from castor beans.
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.
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
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
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.
Office of Technology Assessment, U.S. Congress. Technologies Underlying Weapons of
Mass Destruction. 1993. p. 83.
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
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,
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
Ibid. p. 7.
Kaplan, p. 216.
Office of Technology Assessment, pp. 84-85.
Testimony before the Senate Foreign Relations Committee, March 21, 2000.
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
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
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
Combating Terrorism: Need for Comprehensive Threat and Risk Assessment of Chemical
and Biological Attack. General Accounting Office. GAO/NSIAD-99-163. September 1999.
Testimony of the Director of Central Intelligence before the Senate Foreign Relations
Committee. March 21, 2000.
General Accounting Office, Combating Terrorism: Need for Comprehensive Threat and
Risk Assessments of Chemical and Biological Attacks.GAO/NSIAD-99-163. September
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
! 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
Proliferation: Threat and Reesponse. Department of Defense. January 2001.
Jane’s U.S. Chemical-Biological Defense Guidebook, Jane’s Information Group, 1997. p.
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:
Patterns of Global Terrorism – 2000, Department of State, April 2001, p. 31.
Proliferation: Threat and Response, Section I, Transnational Threat, Department of
Defense, November 1997. p. 1.
Nuclear, Biological, and Chemical Weapons and Missiles: The Current Situation and
Trends. CRS Report RL30699. January 2, 2001;
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
Testimony of the Director of Central Intelligence before the Senate Foreign Relations
Committee. March 21, 2000.
! Continuing publicity over the vulnerability of civilian populations to biological
! 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
! 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
“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
“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
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.
Patterns of Global Terrorism 2000, Department of State, April 2001. p. 35.
DCI Testimony, SFRC, March 21, 2000.
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.
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
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]
New World Coming: American Security in the 21st Century. Appendix 1: Supporting
Research and Analysis. p. 49. [http://www.nssg.gov/NWR_A.pdf]
Ibid. p. 50
Ibid p. 51
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
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.
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.
Gilmore, Vol. I, p. 36.
Ibid, p. 12
Antiterrorism and Effective Death Penalty Act of 1996
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.
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.
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
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
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
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
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
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
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).
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
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.
According to HHS, ninety-seven Metropolitan Medical Response Systems will be in place
by the end of FY2001.
The Biological Weapons Convention and the
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
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
Testimony of Al Zelicoff, Sandia National Laboratories, before House Government Reform
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
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
National Security Subcommittee, June 5, 2001.
Indeed, the legal definition of biological weapon is dependent upon the intent of the pathogen
possessor to harm.
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.
Leonard, Jame F. “An Essential First Step”, Arms Control Today .May 200.
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.
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.
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,
Centers for Disease Control and
Biological Agent/Equipment Control Lists
Centers for Disease Control and Prevention List of Select Biological
Agents Subject to Regulation
Crimean-Congo haemorrhagic fever virus
Eastern Equine Encephalitis virus
Lassa fever virus
Rift Valley fever virus
South American Haemorrhagic fever viruses (Junin, Machupo, Sabia, Flexal,
Tick-borne encephalitis complex viruses
Variola major virus (Smallpox virus)
Venezuelan Equine Encephalitis virus
Viruses causing hantavirus pulmonary syndrome
Yellow fever virus
Brucella abortus, B. melitensis, B. suis
Burkholderia (Pseudomonas) mallei
Burkholderia (Pseudomonas) pseudomallei
Exemptions: vaccine strains as described in Title 9 CFR, Part 78.1 are exempt.
Clostridium perfringens epsilon 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.
List of Biological Agents for Export Control
Congo-Crimean haemorrhagic fever virus
Dengue fever virus
Eastern equine encephalitis virus
Lassa fever virus
Lymphocytic choriomeningitis virus
Monkey pox virus
Rift Valley fever virus
Tick-borne encephalitis virus (Russian Spring-Summer encephalitis virus)
Venezuelan equine encephalitis virus
Western equine encephalitis virus
Yellow fever virus
Japanese encephalitis virus
Rickettsia quintana (now known as Rochalimea quintana)
Japanese encephalitis virus
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.
Clostridium perfringens toxins
Staphylococcus aureus toxins
Kyasanur Forest virus
Louping ill virus
Murray Valley encephalitis virus
Omsk haemorrhagic fever virus
St Louis encephalitis virus
Enterohaemorrhagic Escheichia coli
* 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.
Australia Group Updated List of Animal Pathogens for Export
African swine fever virus
Avian influenza virus*
Foot and mouth disease virus
Goat pox virus
Herpes virus (Aujeszky’s disease)
Hog cholera virus (synonym. swine fever virus)
Newcastle disease virus
Peste des petite ruminants virus
Porcine enterovirus type 9 (synonym: swine vesicular disease virus)
Sheep pox virus
Teschen disease virus
Vesicular stomatitis virus
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
Xanthomonas campestris pv. citri
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 or genetic elements that contain
nucleic acid sequences associated with pathogenicity derived from the plant
pathogens identified on the export control list.
Australia Group List of Dual-use Biological Equipment for Export
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.
Fermenters capable of cultivation of pathogenic micro-organisms, viruses or
for toxin production, without the propagation of aerosols, and having all the
(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
3. Centrifugal Separators
Centrifugal separators capable of the continuous separation of pathogenic
micro-organisms, without the propagation of aerosols, and having all the following
(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.
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)
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