Text of the Report - p. 3

[johnkarls]

Biological and Nuclear Risks

°°°

Unlike the uncertainties of a biological attack, which could occur

silently and without being noticed for a number of days, a nuclear

attack would be obvious, and most people understand the level of dev

astation and death it could cause. Still, it is instructive to review the

damage that would follow a nuclear incident. Perhaps the best descrip

tion has been provided by a member of our Commission, Graham Alli

son, director of the Belfer Center for Science and International Affairs

at Harvard University, in his book Nuclear Terrorism: The Ultimate

Preventable Catastrophe (2004).
Allison’s scenarios:

New York City—Al Qaeda rents a van, drives a Russian 10kiloton nuclear bomb into Times Square, and detonates it.
Times Square disappears instantly, as the heat from the blast
would reach tens of millions of degrees Fahrenheit. The theater
district, Grand Central Terminal, Rockefeller Center, Carnegie
Hall, and Empire State Building would be gone, literally in a
flash. Buildings further away, such as the United Nations Headquarters on the East River, the Flatiron Building, and the Metropolitan Museum would look like bombed-out shells. Half a
million people who at noontime are in that half-mile radius of
the blast site would be killed. Hundreds of thousands of others
would die from collapsing buildings, fire, and fallout.

San Francisco—A nuclear bomb is detonated in Union
Square. Everything to the Museum of Modern Art would be
vaporized. Massive destruction would exist from the
Transamerica Building to Nob Hill.

Chicago—A nuclear bomb explodes at Sears Tower.
Everything from Navy Pier to the Eisenhower Expressway disappears. The United Center and Grant Park are destroyed. A
firestorm sweeps from the White Sox’s U.S. Cellular Field on
the South Side to the Cubs’ Wrigley Field on the North Side.

Washington—A nuclear bomb at the Smithsonian Institution would destroy everything from the White House to the
Capitol lawn. The Supreme Court would be rubble. The Pentagon, across the Potomac River, would be engulfed in flames.

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°°°

For all these reasons, our Commission joins the calls made by many
others before us emphasizing the urgency of securing nuclear materials useful for weapons—right now, before they fall into the hands of
terrorists.

At the same time, we cannot lose sight of concerns regarding the
spread of nuclear weapons. Since the United States exploded the first
nuclear bomb in 1945, seven additional states are known or suspected
to have joined the nuclear weapons club: Russia, China, the United
Kingdom, France, Israel, India, and Pakistan. In addition, South Africa
built six nuclear weapons in the 1980s and dismantled them just before
power was transferred to the post-apartheid government. North Korea
conducted a nuclear weapons test in 2006, thus becoming the first
country to have ratified the NPT and then break out of it by producing
a nuclear weapon. In the past several years, the United States and Russia have significantly reduced their arsenals of nuclear weapons, while
Pakistan, India, and China have been increasing their nuclear capabilities and reliance upon nuclear weapons in their strategic postures.

The emergence of this new kind of arms race in Asia raises the
prospect of a nuclear war whose effects would be catastrophic both
regionally and globally. Analysts estimate that a nuclear exchange
between India and Pakistan that targets cities would kill millions of
people and injure millions more. The risk of a nuclear war between the
two neighbors is serious, given their ongoing dispute over Kashmir and
the possibility that terrorist attacks by Pakistani militant groups might
ignite a military confrontation.

Pakistan’s nuclear weapons program is driven by its perception of
the conventional and nuclear threat from India, while India’s program is
focused on both Pakistan and China. China is also fueling the arms race,
both by increasing its own strategic forces and by not stopping Chinese
entities from supporting Pakistan’s strategic programs. At present, all
three are expanding their nuclear arsenals with no clear end in sight.

At the same time, nuclear developments in Iran, North Korea, and
Syria are also disturbing, because they represent a possible tipping
point toward cascading nuclear proliferation. The continued production and testing of nuclear weapons by North Korea could provoke
Japan or South Korea to reconsider its nuclear postures. Similarly, Iran’s

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continued pursuit of a fissile material production capability, combined
with the recent revelation that Syria was constructing a plutonium production reactor with North Korean assistance, increases the pressure on
Saudi Arabia, Egypt, and other states in the region to pursue their own
programs. In this context, increased U.S., French, Russian, and Chinese contributions to civilian nuclear programs in the Middle East and
South Asia are potentially destabilizing, if not managed properly.

The path leading to proliferation apparently was not difficult to
follow. Some states pursued the development of nuclear technologies
and capabilities within their own borders, and some relied on direct
state-to-state transfers. Others employed espionage to acquire the
technology and knowledge they needed, and still others relied on independent, illicit procurement agents to acquire nuclear technology that
was mainly dual-use from other weapons and civil nuclear programs.
Some benefited from the marketing of nuclear technology and expertise by scientists from other state programs. Most used a combination
of these methods as they tried to achieve their goal.

Several states have tapped into black markets and illicit networks
that supply nuclear materials, designs, and expertise to almost any
buyer who is interested. The best known of these networks, run by the
Pakistani scientist A. Q. Khan, assisted Iran, Libya, North Korea, and
perhaps others in acquiring the technologies and designs needed to
develop illicit nuclear programs. It unraveled in 2003 after authorities
intercepted the BBC China, a cargo ship on its way to Libya with gas
centrifuge components on board. It is unlikely that Khan’s network
could be reconstituted, but black-marketing of dangerous technologies,
designs, and expertise continues to this day and is a major concern.

The recent discovery that North Korea provided Syria with a
nuclear reactor for plutonium production escalates existing concerns
about future nuclear proliferation. North Korea, after all, has already
sold nuclear weapons–capable ballistic missiles to Pakistan, Iran, and
several other states in the Middle East.

Nonetheless, past decisions by other countries may offer some
hope for U.S. and international nonproliferation efforts. Belarus, Kazakhstan, and Ukraine agreed to the removal of nuclear weapons from
their territory after the fall of the Soviet Union, and South Africa
agreed to give up its nuclear weapons in 1991. Taiwan, South Korea,
Argentina, Brazil, and Libya formerly had nuclear weapons programs

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but have reversed course. An additional 20 countries that at one time
considered building nuclear weapons ultimately subscribed to norms
of nonproliferation. But even when countries give up their nuclear
weapons programs, there is still a risk that their nuclear know-how and
materials will fall into the hands of terrorists or others.

At the moment, al Qaeda is judged to be the sole terrorist group
actively intent on conducting a nuclear attack against the United States.
For the foreseeable future, no extremists or groups to which they belong
will be able on their own to produce nuclear weapons–usable materials.
As a result, terrorists can successfully employ a nuclear device only if
they acquire a weapon or weapons-usable materials from a state nuclear
program. It is therefore imperative that authorities secure nuclear
weapons and materials at their source.

Al Qaeda began its efforts to acquire nuclear weapons–usable
material in the early 1990s. While bin Laden was living in Sudan, his
aides received word that a Sudanese military officer was offering to sell
weapons-grade uranium. Bin Laden was willing to pay full price for the
material: $1.5 million. After the purchase, however, the al Qaeda members realized that they had been scammed. This failure apparently did
not discourage bin Laden—and his persistence highlights the seriousness of his interest. In the spring of 2001, bin Laden met with a Pakistani former nuclear scientist, Bashiruddin Mahmood, and discussed
the development of nuclear and other weapons of mass destruction.

Today, all of this still points to intent but not capability. U.S. government officials and recognized experts have testified that al Qaeda
probably does not currently have the nuclear materials or the technical
expertise necessary to produce a nuclear weapon. However, they also
recognize that the terrorists’ ability to produce such a device could
increase dramatically should they recruit just one or two individuals
with access to nuclear materials or with knowledge of nuclear weapons
designs.

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two

Findings and Recommendations



Biological Proliferation and Terrorism

Only a thin wall of terrorist ignorance and inexperience now protects us.
—Former Secretary of the Navy Richard Danzig

Biological science and technology today transcend borders. These
fields engage a vast and expanding array of actors in the government,
private, and commercial sectors, and they are advancing at a remarkable pace. The more that sophisticated capabilities, including genetic
engineering and gene synthesis, spread around the globe, the greater
the potential that terrorists will use them to develop biological
weapons. The challenge for U.S. policymakers is to prevent that potential from becoming a reality by keeping dangerous pathogens—and the
equipment, technology, and know-how needed to weaponize them—
out of the hands of criminals, terrorists, and proliferant states.

The Commission believes that much more can be done to prevent
biological weapons (BW) proliferation and terrorism—even as we recognize it is unrealistic to think that we can completely eliminate the
possibility of misuse. Accordingly, we recommend a number of initiatives to enhance efforts at prevention, in addition to existing programs
by the Department of Health and Human Services and the Department of Homeland Security to mitigate the consequences of a biological weapons attack.

Consistent with its legislative mandate, this Commission has
focused on assessing and making recommendations on how to improve
measures for the prevention of biological proliferation and terrorism.
Nevertheless, countering the threat of BW proliferation and terrorism
will require concerted action across a policy continuum that extends
from prevention to consequence management. Prevention alone is not
sufficient, and a robust system for public health preparedness and

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Findings and Recommendations

response is vital to the nation’s security. In order to deter biological
attacks, we need to demonstrate—through effective preparedness
measures and public exercises—that we are capable of blunting the
impact of an attack and thus thwarting the terrorists’ objectives.

To date, the U.S. government has invested most of its nonproliferation efforts and diplomatic capital in preventing nuclear terrorism.
The Commission believes that it should make the more likely threat—
bioterrorism—a higher priority. Only by elevating the priority of the
biological weapons threat will it be possible to bring about substantial
improvements in global biosecurity. To this end, the new administration should urgently develop a comprehensive approach to the prevention of biological proliferation and terrorism.

Domestic Findings and Recommendation

Securing Dangerous Pathogens

A major hurdle for terrorists seeking biological weapons is the difficulty of acquiring disease-causing microbes (chiefly bacteria and
viruses) and toxins (poisonous substances produced by living creatures) that can be harnessed to incapacitate or kill humans, livestock,
or crops. Although dangerous pathogens such as the anthrax bacterium
can be isolated from natural sources, it would generally be easier for
terrorists to steal or divert well-characterized “hot” strains from a
research laboratory or culture collection.

To reduce the likelihood of theft or diversion, in 1996 Congress
created the Select Agent Program, which established a list of pathogens
and toxins of bioterrorism concern. The initial regulations required the
reporting of all transfers of these “select agents” to other laboratories
and mandated that the facilities involved in the transfers be registered
with the Department of Health and Human Services (HHS) or the
Department of Agriculture (USDA).

In 2002, in response to the anthrax letter attacks of autumn 2001,
Congress expanded the list of select agents and added a requirement
that all U.S. laboratories that possess or transfer select agents must register with one of the two departments. In addition, all such laboratories
must implement enhanced security measures including physical access
controls and the FBI vetting of all scientists, technicians, and laboratory
officials before they are allowed to work with select agents. Biodefense

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Biological Proliferation and Terrorism

researchers at U.S. Army laboratories must submit to a more stringent
vetting process that includes a background investigation and a security
clearance. Nevertheless, in August 2008, the Department of Justice
identified Bruce E. Ivins, a U.S. Army researcher, as the sole perpetrator of the 2001 anthrax letter attacks, a development that has raised
questions about the adequacy of current personnel vetting procedures.

Since the 2001 terrorist attacks on the United States, the Departments of Defense, Health and Human Services, Homeland Security,
and other agencies have spent or allocated nearly $50 billion for civilian
biodefense. This huge influx of funding has been accompanied by the
design and construction of numerous federal, state, and private high-
containment laboratories (at Biosafety Level 3), as well as maximum-
containment laboratories (at Biosafety Level 4), that work with the most
dangerous pathogens. For example, the number of Biosafety Level 4
(BSL-4) labs is expected to triple from 5 in 2001 to 15 in 2012. This
rapid expansion of laboratory capacity has been justified by the need for
research on measures to counter both deliberate acts of bioterrorism
and the global spread of emerging infectious diseases of natural origin,
such as SARS (severe acute respiratory syndrome) and avian influenza.

At the same time, the dramatic increase in the number of high-
containment labs in the absence of a comprehensive regulatory framework has raised safety, security, and terrorism concerns. At present,
some 400 research facilities in the United States are authorized to store
and handle select agents, and nearly 15,000 individuals have been
approved to work with them. The rapid growth in the number of facilities and people handling select agents has increased the risk of laboratory accidents or intentional misuse by insiders. Moreover, no single
entity in the executive branch is responsible for overseeing and managing the risks associated with all the high-containment (BSL-3) laboratories operated by the U.S. government, industry, or academia.

Promoting a Biosecurity Culture

The government and the private sector must urgently address both
biosafety concerns (preventing the accidental infection of laboratory
workers and the release into the environment of dangerous pathogens)
and biosecurity concerns (preventing the theft or diversion of dangerous pathogens for nefarious purposes).

The nuclear age began with a mushroom cloud—and all those who

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Findings and Recommendations

worked in the nuclear industry in any capacity, military or civilian,
instantly understood that they must work and live under a clear and
undeniable security mandate. But the life sciences community has
never experienced a comparable iconic event to focus their attention
on security. Instead, most biologists view their research as an absolute
good that promotes human health and prosperity, and they jealously
guard their independence. There is understandable tension between
the biology community and the government with regard to regulatory
and oversight efforts, such as the Select Agent Rules. Although the
recent assertion that a U.S. Army scientist was responsible for the
anthrax letter attacks has created some awareness of the need for
greater security, much still remains to be accomplished.

The choice is stark. The life sciences community can wait until a
catastrophic biological attack occurs before it steps up to its security
responsibilities. Or it can act proactively in its own enlightened self-
interest, aware that the reaction of the political system to a major
bioterrorist event would likely be extreme and even draconian, resulting in significant harm to the scientific enterprise.

Because science is a global activity, any biosecurity regime must
ultimately be international in nature. As a first step, it is necessary for
the United States to put its own house in order and lead the rest of the
world by providing the highest standards of biosafety and biosecurity.
The U.S. goal must be to keep dual-use materials, technology, and
expertise out of the hands of terrorists and proliferators.

The U.S. government has sought to foster the development of a
“culture of security awareness” within the life sciences community to
prevent the misuse of biology for warfare or terrorism. However, scientists in academia and industry generally view the Select Agent Program
as an unnecessary burden rather than as an important means of preventing bioterrorism. To help change this attitude, federal agencies
have launched a number of outreach and education efforts.

In 2005, the FBI established the Science and Technology Outreach Program (since renamed the Biological Sciences Outreach Program) to increase its dialogue with the academic, biotechnology, and
public health communities and thereby gain their aid in thwarting
bioterrorists. That same year, the Bureau established the National
Security Higher Education Advisory Board, which consists of about 20
presidents of major U.S. research universities. The advisory board aims

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Biological Proliferation and Terrorism

to promote communication between the U.S. government and academic leaders on issues related to homeland security, law enforcement, and visa and immigration policies.

Meanwhile, in 2004, the Department of Health and Human Services created the National Science Advisory Board for Biosecurity to
consider how to minimize the risk that advances in bioscience and
biotechnology could be misused to threaten public health and national
security. This committee is developing guidelines to improve the oversight of biological research.

Microbial Forensics

Microbial forensics is a new science that involves the use of molecular
tools, such as DNA sequencing and isotopic analysis, to analyze a
microbial pathogen or toxin. Such techniques can help determine the
source of a particular strain of pathogen, thereby providing useful
investigative leads. When combined with more traditional techniques,
such as the analysis of hair, fibers, and fingerprints, microbial forensics
can narrow the range of suspects in a bioterror attack. The FBI investigation into the anthrax-tainted letters of autumn 2001 provided a
strong impetus for the rapid development of this new field. Analysis of
subtle variations in the DNA sequences of different anthrax bacterial
strains ultimately made it possible to pinpoint the source of the material used in the 2001 attacks to a single flask at the U.S. Army’s biodefense research center at Fort Detrick, in Maryland.

A number of U.S. government agencies are currently involved in
microbial forensics. In partnership with the FBI, the Department of
Homeland Security’s Science and Technology Directorate operates the
National Bioforensic Analysis Center, which President George W.
Bush designated in 2004 as the lead federal facility to conduct and
facilitate the technical forensic analysis and interpretation of materials
from biocrime and bioterror investigations.

RECOMMENDATION 1: The United States should undertake a series of mutually reinforcing domestic measures to prevent bioterrorism: (1) conduct a comprehensive review of the
domestic program to secure dangerous pathogens, (2) develop
a national strategy for advancing bioforensic capabilities, (3)
tighten government oversight of high-containment laborato

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ries, (4) promote a culture of security awareness in the life sciences community, and (5) enhance the nation’s capabilities for
rapid response to prevent biological attacks from inflicting
mass casualties.

The Commission believes there are a number of specific actions
that the United States should undertake to implement this recommendation.

ACTION: The Department of Health and Human Services

should lead an interagency review of the domestic program to

secure dangerous pathogens.

Congress passed legislation in 2002 strengthening the Select Agent
Program, which had been established to secure dangerous pathogens
used in research laboratories. But since the tightened regulations have
gone into effect, the U.S. government has not conducted an internal
review of the program’s effectiveness in improving biological security
and its impact on legitimate scientific research. A representative of a
leading professional association in the life sciences expressed to the
Commission the concerns of some of its members, who feel that the
Select Agent Program is impeding collaboration with foreign scientists
and blocking transfers of endemic pathogens from developing countries
for study in U.S. laboratories. Although the Centers for Disease Control
and Prevention (CDC) recently commissioned the Homeland Security
Institute to review some aspects of the Select Agent Program, this effort
is too narrow in scope and does not include the full set of stakeholders.

The Commission believes that an interagency review of the implementation of the Select Agent Program is long overdue. Issues or concerns emerging from such a review should be addressed during the
first year of the new administration. The review should explore ways of
implementing the Select Agent Program so that it continues to prevent
the misuse of dangerous pathogens without hampering vital domestic
research and international collaboration.

ACTION: The Department of Homeland Security should

take the lead in developing a national strategy for advancing

microbial forensics capabilities.

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Biological Proliferation and Terrorism

Microbial forensics, a set of genetic and physical techniques for
analyzing a biological or toxin agent that has been acquired by a proliferant state or terrorist group, can clarify where a breach in laboratory
security has occurred. It can also help identify the perpetrators of a
biological weapons attack and support their criminal prosecution. For
deterrence, defense, and law enforcement purposes, the U.S. government is currently making a concerted effort to increase the likelihood
that biological materials that have been obtained illicitly or used in an
attack can be traced back to their source and perhaps linked to a terrorist organization or its state sponsor.

The Commission supports these efforts but believes they are not
sufficient. By the end of 2009, the U.S. government must develop a
national strategy for acquiring a state-of-the-art capability for microbial
forensics. Such a national strategy should (1) facilitate the development
and maintenance of a comprehensive library of pathogen reference
strains; (2) establish a government-wide set of standard procedures for
collecting, processing, and analyzing samples to improve consistency and
quality, and identify both a lead agency to direct this effort and the roles
and responsibilities of support agencies; and (3) fund basic research to
support the further development of microbial forensic techniques.

ACTION: The Department of Health and Human Services,
in coordination with the Department of Homeland Security,
should lead an interagency effort to tighten government oversight of high-containment laboratories.

Despite the inherent safety and security risks associated with high-
containment laboratories, such facilities in the United States are not
specifically regulated; they become subject to federal oversight only if
they are government-funded or possess pathogens and toxins on the
Select Agent List. Thus many BSL-3 laboratories that work with dangerous but unlisted pathogens, such as the SARS virus, operate outside
of federal regulation and indeed even federal knowledge of their existence. Moreover, the number of scientists working with dangerous
pathogens is increasing—and many are working with them for the first
time. These changes have led to a higher incidence of accidents and
laboratory-acquired infections and to new biosecurity concerns.

The problems have been exacerbated by the unbridled growth in the

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number of high-containment laboratories since 2001, which has occurred
without effective and coordinated federal oversight. In October 2007, the
Government Accountability Office underscored this deficiency, reporting
that “no single federal agency has the mission and, therefore, is accountable for tracking the number of all BSL-3 and BSL-4 labs within the
United States. . . . Therefore, no agency is responsible for determining
the aggregate risks associated with the expansion of these labs.”

The Commission believes that safety and security considerations
warrant direct federal oversight of all high-containment laboratories.
We recommend that the next administration take appropriate action to

(1) determine present and future requirements for research on biodefense threats and emerging infectious diseases, and plan future expansion to minimize the associated safety and security risks; (2) require
federal registration of all BSL-3 and BSL-4 facilities (whether or not
they work with select agents), identify a lead federal agency to oversee
and enforce the registration process, and create a government-wide
database of all high-containment labs in the United States; (3) implement a common set of safety and security requirements for all high-
containment labs; and (4) mandate standard biosafety and biosecurity
training for all personnel who work in high-containment labs, and fund
the development of educational materials for that purpose.
The new administration should act immediately to complete its
assessment of national requirements for high-containment laboratories
and take the action necessary to establish federal oversight of all BSL-3
and BSL-4 laboratories in the United States. The government should
also consider centralizing the regulatory functions for biosafety and
biosecurity by developing a new oversight mechanism for high-
containment laboratories that combines the existing CDC/USDA
Select Agent Program and the National Institutes of Health Guidelines
for Research Involving Recombinant DNA Molecules.

ACTION: The Department of Health and Human Services

and Congress should promote a culture of security awareness

in the life sciences community.

Members of the life sciences community—universities, medical
and veterinary schools, nongovernmental biomedical research insti

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tutes, trade associations, and biotechnology and pharmaceutical companies—must foster a bottom-up effort to sensitize researchers to
biosecurity issues and concerns. Scientists should understand the ethical imperative to “do no harm,” strive to anticipate the potential consequences of their research, and design and conduct experiments in a
way that minimizes safety and security risks.

At present, no clear procedures, structures, or support systems
exist for addressing the problem of dual-use research in the life sciences. The next administration should create a domestic review and
oversight system for such research. The Commission also calls on the
leaders of the life sciences community, both inside and outside of government, to speak out clearly and frequently about the professional
responsibility of scientists to prevent the misuse of biology for hostile
purposes. Congress should hold hearings to discuss the problem and
should foster practical solutions for addressing it.

Several other bottom-up steps are also warranted. The currently
separate concepts of biosafety and biosecurity should be combined
into a unified conceptual framework of laboratory risk management.
This framework should be integrated into a program of mandatory
education and training for scientists and technicians in the life sciences
field, whether they are working in the academy or in industry. Such
training should begin with advanced college and graduate students
and extend to career scientists. The U.S. government should also
fund the development of educational materials and reference manuals
on biosafety and biosecurity issues. At the same time, the responsibilities of laboratory biosafety officers should be expanded to include
laboratory security and oversight of select agents, and all biosafety
officers should be tested and certified by a competent government
authority.

Finally, whistleblower mechanisms should be established within
the professional life sciences community so that scientists can report—
without risk of retaliation—their concerns about safety and security,
including suspicious or aberrant behavior on the part of colleagues.
For example, a help line might be established under the auspices of a
nongovernmental or professional organization that would receive
reports from scientists about suspicious activities and then initiate
investigative action when appropriate.

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ACTION: The Department of Health and Human Services,
in coordination with the Department of Homeland Security,
should take steps to enhance the nation’s capacity for rapid
response to prevent an anthrax attack from inflicting mass
casualties.

Since 2001, the U.S. government has taken important steps to prepare a national response to a bioterrorist attack involving anthrax bacterial
spores, the most likely near-term biological threat to the United States.
Because the risk of bioterrorists’ using anthrax is real and the timeline for
responding to an attack is extremely unforgiving, the United States must
make a concerted effort to improve its capabilities in this area. Although
our mandate is to examine preventive measures, the Commission believes
that a substantially greater effort is needed to develop and make operational a response plan that can counter an anthrax attack effectively. This
plan would also help deter such an attack by significantly reducing its
probability of success. Establishing an effective system to respond to an
anthrax attack would also improve the nation’s ability to manage other
public health disasters, be they natural or man-made.

Inhalational anthrax can be prevented in exposed individuals if
effective oral antibiotics are administered during the first 48 hours
after infection—before the onset of acute symptoms, when the disease
becomes highly lethal and difficult to treat. Although the Department
of Health and Human Services has maintained a national stockpile of
medical countermeasures since 1999, distributing these items during a
national emergency remains a major challenge. In the case of inhalational anthrax, the 48-hour window imposes an extremely demanding
timeline for executing an effective medical response: the U.S. government must detect an aerosol attack soon after it occurs, immediately
set the response plan in motion, and distribute stockpiled antibiotics to
the affected states, which in turn must dispense them to the local population—all within two days.

In October 2008, Health and Human Services Secretary Michael
Leavitt announced that his department is working with the U.S. Postal
Service to assist state and local authorities in addressing the distribution problem. In the event of an anthrax attack, mail carriers,
escorted by police officers, would quickly deliver a short-term supply

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of antibiotics from the national stockpile to all residences in the
affected area, giving state and local public health authorities enough
time to set up dispensing centers for longer-term (60-day) antibiotic
treatment. We have not had time to review this new initiative but are
inclined to doubt that it fully satisfies this vital need. The United States
still does not have and must quickly develop a fully comprehensive and
tested system for the rapid delivery of lifesaving medical countermeasures against anthrax and other bioterrorist threats.

As a first step in addressing these issues, the Bush administration
submitted a fiscal year 2009 budget amendment request asking Congress for an additional $969 million to fund the development and manufacture of medical countermeasures, innovative approaches to
distribution and decontamination, and upgrades to the BioWatch network of air samplers designed to permit early detection of a bioterrorist attack. These urgent funding requirements should be taken up early
in the next Congress. In addition, the next administration should, as a
matter of national priority, fully implement an effective anthrax preparedness strategy.

The Commission believes that an innovative approach will be
needed to solve the problem of how to rapidly dispense antibiotics and
other medical countermeasures to the exposed population should a
large-scale bioterrorist attack occur. Serious consideration should be
given to harnessing the existing distribution networks of large retail
stores and forging effective public-private partnerships. Furthermore,
the dispensing system for medical countermeasures should be exercised
and reviewed regularly to demonstrate both to the American public and
to our enemies that the U.S. government takes the threat of bioterrorism
seriously and is fully prepared to defend the population. “Red-teaming”
exercises, in which deliberate attempts are made to disrupt the dispensing system, are also useful for identifying areas of weakness. These exercises should assess the emergency response and treatment capabilities of
hospitals as well as the effectiveness of public health networks for gathering and evaluating hospital reports of infectious disease cases.

Another potential gap in U.S. biological defenses is the threat of
bioterrorist attacks with strains of anthrax that have been genetically
modified to make them resistant to standard antibiotics. Given this
potential threat, additional funding is needed for the National Institutes
of Health and the private sector to develop new classes of antibiotics, as

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well as antitoxin treatments that can neutralize the deadly toxins
released by the anthrax bacterium in an infected individual.

Finally, an effective public information strategy is essential to educate and inform the U.S. population during a bioterrorist attack, so that
citizens are able to take effective action to minimize their risk of exposure, prevent the person-to-person spread of contagious agents, and
diagnose and treat themselves and their loved ones at home when possible so that hospitals and other treatment centers are not inundated.
Such a public information strategy was sorely lacking during the 2001
anthrax letter attacks. The Department of Health and Human Services
and Department of Homeland Security, in cooperation with state and
local health departments and emergency responders, should prepare
specific messages that can be disseminated after a bioterrorist attack to
facilitate citizens’ self-protection and self-decontamination.

International Findings and Recommendation

Biological Weapons Convention

The cornerstone of international efforts to prevent biological weapons
proliferation and terrorism is the 1972 Biological Weapons Convention
(BWC). This treaty bans the development, production, and acquisition
of biological and toxin weapons and the delivery systems specifically
designed for their dispersal. The BWC forbids member states (now
numbering more than 160) from assisting other governments, non-state
entities, or individuals in obtaining biological weapons. In addition, the
convention requires each state party to take “any necessary measures to
prohibit and prevent” the activities banned by the treaty on its territory
and other areas under its jurisdiction and control. This provision has
been interpreted as obligating each member state to adopt domestic
legislation imposing criminal sanctions on its citizens for developing or
producing biological weapons, and to secure dangerous pathogens from
unauthorized access or theft. Although the negotiation of the BWC was
a major achievement of arms control, the treaty has been marred by
serious violations and a lack of universal membership.

Unlike many other arms control treaties, the BWC does not contain any formal verification mechanisms, nor does it establish an international implementing organization. The treaty was negotiated at the
height of the Cold War, when the Soviet Union refused in principle to

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accept any on-site arms control measures, leaving bilateral consultations or an investigation by the United Nations Security Council as the
only avenues for addressing concerns about noncompliance. In fact,
violations of the BWC are extraordinarily difficult to verify. Because
biological activities, materials, and equipment can be used for good as
well as harm, compliance ultimately depends on the underlying intent,
which may be peaceful or offensive. Yet evidence for the intent to use
biology as a weapon is hard to discern: nefarious purposes can easily be
concealed within a host of legitimate activities, such as pharmaceutical
development, vaccine production, and general life sciences research.

Despite these serious verification challenges, the perceived weakness of the Biological Weapons Convention prompted many countries in
the early 1990s to call for the negotiation of a legally binding verification
regime to supplement the convention. The U.S. government under President George H. W. Bush opposed this proposal, arguing that because
biotechnology is essentially dual-use, effective verification of the convention by an international regime was impossible. In 1994, however, the
Clinton administration sidestepped the verification issue and decided to
support the negotiation of a protocol to the BWC as a means of promoting greater transparency and of deterring noncompliance.

International negotiations began in Geneva in 1995, but major disagreements soon emerged. Russia, still suspected of harboring an illicit
biological weapons program and apparently seeking to limit the prohibitions of the BWC, insisted that key terms in the convention be defined
narrowly. Iran, China, Pakistan, India, and other members of the Non-
Aligned Movement demanded that the protocol end all national export
controls, on the grounds that such controls “discriminated” against
developing countries. Finally, the European Union and others pressed
for intrusive inspections that went much further than U.S. proposals
for greater transparency, raising both national security and commercial
concerns that sensitive information might be compromised.

In mid-2001, after more than six years of talks and the introduction
of a compromise text by the chairman of the negotiating forum, the
United States withdrew its support for the draft Biological Weapons
Convention Protocol, prompting widespread international criticism.
The United States concluded that the confidence-building transparency sought by the protocol could be achieved only at the unacceptable cost of (1) creating the false perception that the convention was

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Findings and Recommendations

verifiable by an international organization, (2) acquiescing to an international inspection regime that could jeopardize sensitive U.S. information, and (3) accepting Russian and Non-Aligned Movement demands
that would have seriously undermined international biological weapons
nonproliferation efforts and the convention itself. These concerns
remain valid today, when the continuing global spread of dual-use biological materials, equipment, and facilities has only made verifying
compliance to the BWC more difficult.

In 2002, at the convention’s fifth review conference, the member
states agreed to suspend the protocol negotiations indefinitely. Instead,
they adopted a U.S. proposal to hold a series of annual expert and political meetings between the review conferences held every five years.
Launched in 2003, these annual meetings have focused on the prevention of bioterrorism by addressing such topics as domestic legislation
implementing the BWC, pathogen and laboratory security, infectious
disease detection and response, scientific codes of conduct, and investigations of alleged use of biological weapons. The annual meetings
have proven useful for increasing international awareness of biological
security issues, and the Sixth Review Conference in 2006 renewed the
intersessional work program until the next review conference in 2011.

Biological Threat Reduction

Cooperative threat reduction (CTR) is a series of U.S. government programs that were originally designed to secure and dismantle WMD
stockpiles from the former Soviet Union (FSU). U.S. biological CTR
efforts in Russia and the former Soviet republics have focused on three
objectives: (1) dismantling former biological weapons production facilities, (2) improving the security of collections of dangerous pathogens,
and (3) engaging former biological weapons scientists and redirecting
them into peaceful areas of research. In recent years, the United States
has sharply cut back its biological CTR programs in Russia because of
bureaucratic and political difficulties in dealing with the Russian government, which has refused U.S. requests for greater transparency at former biological weapons facilities controlled by the Ministry of Defense.

The U.S. government is also pursuing biosecurity cooperation and
engagement outside the former Soviet Union. The Biosecurity Engagement Program, launched in 2006 by the State Department, seeks to
promote pathogen security and collaborative bioscience research in

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Biological Proliferation and Terrorism

critical regions of the world. The objective of the program is to promote
legitimate bioscience research in select countries while addressing their
dangerous blend of bioterrorism threats, emerging infectious diseases,
poorly secured collections of dangerous pathogens, and rapidly expanding biotechnology industries. Initially it is focusing on countries in
South Asia, Southeast Asia, and the Middle East that have indigenous
terrorist groups interested in acquiring biological weapons. Pilot efforts
in Indonesia and the Philippines include conducting risk assessments;
developing country-level strategies for bilateral engagement on laboratory biosafety, pathogen security, and the monitoring of outbreaks of
infectious disease; and developing a grants assistance program to promote research collaboration between U.S. and local institutions. This
effort must be expanded to additional regions.

Global Monitoring of Infectious Disease Outbreaks

Crucial to mounting a defense against biological weapons development
and attack is the early detection and reporting of outbreaks of infectious disease, a capability known as disease surveillance. Today, a number of surveillance networks provide early warning of outbreaks
throughout the world. Although these networks are designed primarily
to detect naturally occurring infections such as SARS, Ebola, West
Nile virus, and avian influenza, they could also detect deliberate
attacks using biological weapons.

The World Health Organization (WHO) is the focal point of international disease surveillance efforts. The WHO’s International Health
Regulations (IHR) require participating states to notify the WHO of a
potential “public health emergency of international concern” so that an
epidemic can be contained before it spreads across borders. The regulations also require WHO member states to meet specified benchmarks for national disease surveillance and response capabilities. In
addition, an operations center at WHO Headquarters is responsible
for integrating the outbreak reports it receives from member states
into the Global Outbreak Alert and Response Network and dispatching response teams from approximately 150 partner organizations
around the globe with the goal of containing disease outbreaks close to
where they originate. Disease surveillance and reporting remains a difficult and demanding task, however, and outbreak information is not
always provided by WHO member states on a timely basis.

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