Federal Efforts to Address the Threat of
Bioterrorism: Selected Issues for Congress
Frank Gottron
Specialist in Science and Technology Policy
Dana A. Shea
Specialist in Science and Technology Policy
August 6, 2010
Congressional Research Service
7-5700
www.crs.gov
R41123
CRS Report for Congress
P
repared for Members and Committees of Congress
Federal Efforts to Address the Threat of Bioterrorism: Selected Issues for Congress
Summary
Recent reports by congressional commissions and others, the inclusion of bioterrorism issues in
President Obama’s State of the Union address, and issuance of executive orders have increased
congressional attention to the threat of bioterrorism. Federal efforts to combat the threat of
bioterrorism predate the anthrax attacks of 2001 but have significantly increased since then. The
U.S. government has developed these efforts as part of and in parallel with other defenses against
conventional terrorism. The continued attempts by terrorist groups to launch attacks targeted at
U.S. citizens have increased concerns that federal counterterrorism activities insufficiently
address the threat.
Several strategy and planning documents direct the federal government’s biodefense efforts.
Many different agencies have a role. These agencies have implemented numerous disparate
actions and programs in their statutory areas to address the threat.
Despite these efforts, many experts, including congressional commissions, non-governmental
organizations, and industry representatives, have highlighted weaknesses or flaws in the federal
government’s biodefense activities. Recent reports by congressional commissions have stated that
the federal government could significantly improve its efforts to address the bioterrorism threat.
Key questions face congressional policymakers: How sufficiently do the efforts already underway
address the threat of bioterrorism? Have the federal investments to date met the expectations of
Congress or other stakeholders? Should Congress alter, augment, or terminate these existing
programs in the current environment of fiscal challenge? What is the appropriate federal role in
response to the threat of bioterrorism, and what mechanisms are most appropriate for involving
other stakeholders, including state and local jurisdictions, industry, and others?
Congressional oversight of bioterrorism crosses the jurisdiction of many congressional
committees. As a result, congressional oversight is often issue-based. Because of the diversity of
federal biodefense efforts, this report does not provide a complete view of the federal
bioterrorism effort. Instead, this report focuses on four areas under congressional consideration
deemed critical to the success of the biodefense enterprise: strategic planning; risk assessment;
surveillance; and the development, procurement, and distribution of medical countermeasures.
Congress, through authorizing and appropriations legislation and its oversight activities,
continues to influence the federal response to the bioterrorism threat. Congressional policymakers
will likely face many difficult choices about the priority of maintaining, shrinking, or expanding
existing programs versus creating new programs to address identified deficiencies. Augmenting
such programs may incur additional costs in a time of fiscal challenges while maintaining or
shrinking such programs may pose unacceptable risks, given the potential for significant
casualties and economic effects from a large-scale bioterror attack.
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Federal Efforts to Address the Threat of Bioterrorism: Selected Issues for Congress
Contents
Introduction ................................................................................................................................ 1
Strategic Planning ....................................................................................................................... 4
Options for Congress ............................................................................................................ 5
Risk Assessment ......................................................................................................................... 6
Options for Congress ............................................................................................................ 7
Biosurveillance ........................................................................................................................... 8
Options for Congress ............................................................................................................ 9
Medical Countermeasures ........................................................................................................... 9
Research and Development ................................................................................................. 10
Options for Congress .................................................................................................... 10
Procurement........................................................................................................................ 11
Options for Congress .................................................................................................... 12
Distribution......................................................................................................................... 12
Options for Congress .................................................................................................... 13
Conclusion................................................................................................................................ 13
Contacts
Author Contact Information ...................................................................................................... 13
Congressional Research Service
Federal Efforts to Address the Threat of Bioterrorism: Selected Issues for Congress
Introduction
Recent reports by congressional commissions and others, the inclusion of bioterrorism issues in
President Obama’s State of the Union address,1 and the issuance of executive orders have
increased congressional attention to the threat of bioterrorism. Federal efforts to combat the threat
of bioterrorism predate the anthrax attacks of 2001 but have significantly increased since then.
The U.S. government has developed these efforts as part of and in parallel with other defenses
against conventional terrorism. The continued attempts by terrorist groups to launch attacks
targeted at U.S. citizens, including those in transit to U.S. soil,2 have increased concerns that
federal counterterrorism activities, and the investments that underlie them, insufficiently address
the threat.
Experts differ in their assessments of the threat posed by bioterrorism. Some claim the threat is
dire and imminent.3 The congressionally mandated Commission on the Prevention of WMD
Proliferation and Terrorism concluded that
unless the world community acts decisively and with great urgency, it is more likely than not
that a weapon of mass destruction will be used in a terrorist attack somewhere in the world
by the end of 2013.
The Commission further believes that terrorists are more likely to be able to obtain and use a
biological weapon than a nuclear weapon.4
In contrast, other experts assert the bioterrorism threat is less severe or pressing than that posed
by more conventional terrorism or other issues facing the United States.5 The Scientists Working
Group on Biological and Chemical Weapons concluded that
Public health in the United States faces many challenges; bioterrorism is just one. Policies
need to be crafted to respond to the full range of infectious disease threats and critical public
health challenges rather than be disproportionately weighted in favor of defense against an
exaggerated threat of bioterrorism.6
1 President Obama stated, “And we are launching a new initiative that will give us the capacity to respond faster and
more effectively to bioterrorism or an infectious disease—a plan that will counter threats at home and strengthen public
health abroad.” Office of the Press Secretary, The White House, Remarks by the President in State of the Union
Address, January 27, 2010.
2 See, for example, the purported attempt by Umar Farouk Abdulmutallab to detonate explosives in mid-flight on
Northwest Airlines Flight 253 from Amsterdam, Netherlands, to Detroit, Michigan. See Indictment in U.S. v.
Abdulmutallab, January 6, 2010. http://www.mied.uscourts.gov/hpc/docs/1.Indictment.pdf
3 For examples of experts who think the threat of bioterrorism is greater than has been recognized, see Richard Danzig,
Catastrophic Bioterrorism: What Is to Be Done? Center for Technology and National Security, National Defense
University, Washington, DC, August 2003, and The Commission on the Prevention of WMD Proliferation and
Terrorism, World at Risk: The Report of the Commission on the Prevention of WMD Proliferation and Terrorism,
December 2008.
4 The Commission on the Prevention of WMD Proliferation and Terrorism, World at Risk: The Report of the
Commission on the Prevention of WMD Proliferation and Terrorism, December 2008, p. XV.
5 For examples of experts who downplay the threat posed by bioterrorism, see Milton Leitenberg, Assessing the
Biological Weapons and Bioterrorism Threat, Strategic Studies Institute, U.S. Army War College, Washington, DC,
2005, and Scientists Working Group on Biological and Chemical Weapons, Center for Arms Control and Non-
Proliferation, Biological Threats: A Matter of Balance, January 26, 2010.
6 Scientists Working Group on Biological and Chemical Weapons, “Biological Threats: A Matter of Balance,” Bulletin
(continued...)
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Federal Efforts to Address the Threat of Bioterrorism: Selected Issues for Congress
Stakeholders often measure federal efforts against the perceived magnitude of the threat. Thus,
experts who believe bioterrorism poses a relatively low threat tend to conclude that the
government has done too much. In contrast, experts who perceive a greater threat conclude that
the federal government needs to do more, whether under existing programs or new ones. Many
experts come to mixed conclusions: they regard some programs as effective but identify others as
insufficient.
The federal government’s biodefense efforts span many different agencies and vary widely in
their resources, scope, and approach. For example, the Departments of State and Defense have
engaged in nonproliferation and counterproliferation efforts.7 The Departments of State and
Commerce have strengthened export controls of materials that could be used for bioterrorism.8
The Department of Health and Human Services (HHS) has made investments in public health
preparedness; response planning;9 and research, development, and procurement of medical
countermeasures against biological terrorism agents.10 The intelligence community has engaged
in intelligence gathering and sharing regarding bioterrorism.11 The Department of Justice
performs background checks on people who want to possess certain dangerous pathogens.12 The
Department of Homeland Security (DHS) has engaged in preparedness, response, and recovery-
related activities,13 developed increased capabilities in environmental biosurveillance (see
“Biosurveillance” below), and invested in expanding domestic bioforensics capabilities.14 The
(...continued)
of the Atomic Scientists, February 2, 2010.
7 For information on these topics, see CRS Report RL31559, Proliferation Control Regimes: Background and Status,
coordinated by Mary Beth Nikitin; CRS Report RL33865, Arms Control and Nonproliferation: A Catalog of Treaties
and Agreements, by Amy F. Woolf, Mary Beth Nikitin, and Paul K. Kerr; and CRS Report RL34327, Proliferation
Security Initiative (PSI), by Mary Beth Nikitin.
8 Examples of such export control restrictions include the International Traffic in Arms Regulations (ITAR) and the
Export Administration Regulations (EAR), which are the primary set of U.S. export control regulations, and other
multilateral agreements, such as participation in the Australia Group.
9 For information on these topics, see CRS Report R40159, Public Health and Medical Preparedness and Response:
Issues in the 111th Congress, by Sarah A. Lister.
10 For example, the National Institute of Allergy and Infectious Diseases (NIAID) developed an extensive research
program into potential bioterrorism pathogens. See National Institute of Allergy and Infectious Diseases, National
Institutes of Health, Department of Health and Human Services, NIAID Biodefense Research Agenda for CDC
Category A Agents-Progress Report, August 2003; National Institute of Allergy and Infectious Diseases, National
Institutes of Health, Department of Health and Human Services, NIAID Biodefense Research Agenda for Category B
and C Priority Pathogens, January 2003; and National Institute of Allergy and Infectious Diseases, National Institutes
of Health, Department of Health and Human Services, NIAID Strategic Plan for Biodefense Research-2007 Update,
September 2007. See also Public Health Emergency Medical Countermeasures Enterprise, Biomedical Advanced
Research and Development Authority (BARDA), U.S. Department of Health and Human Services, DRAFT BARDA
Strategic Plan for Medical Countermeasure Research, Development, and Procurement, July 5, 2007.
11 For example, the National Counterterrorism Center has established a working group on chemical, biological,
radiological, nuclear counterterrorism. See CRS Report R41022, The National Counterterrorism Center (NCTC)—
Responsibilities and Potential Congressional Concerns, by Richard A. Best Jr. For an overview of homeland security
related intelligence issues, see CRS Report RL33616, Homeland Security Intelligence: Perceptions, Statutory
Definitions, and Approaches, by Mark A. Randol.
12 For additional information on this program, see CRS Report R40418, Oversight of High-Containment Biological
Laboratories: Issues for Congress, by Frank Gottron and Dana A. Shea.
13 For example, see Department of Homeland Security, National Response Framework: Biological Incident Annex,
January 2008, http://www.fema.gov/pdf/emergency/nrf/nrf_BiologicalIncidentAnnex.pdf.
14 Bioforensics is the scientific analysis of biological evidence. The capability expansion includes the creation of the
National Bioforensic Analysis Center as the lead federal facility to conduct and facilitate the technical forensic analysis
and interpretation of materials recovered following a biological attack.
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Federal Efforts to Address the Threat of Bioterrorism: Selected Issues for Congress
Environmental Protection Agency (EPA) has explored post-event infrastructure
decontamination.15 Many agencies, jointly or separately, have invested in expanded biodefense
infrastructure, including public and private high containment laboratories for research, diagnostic,
and forensics purposes.16 Lastly, White House-led efforts and other coordinating groups have
engaged in risk assessment and strategic planning exercises to coordinate and optimize federal
investment against bioterrorism and response capabilities.17
Conflicting views of the bioterrorism threat and the breadth of the federal biodefense effort,
which crosses congressional committee jurisdictions, complicate congressional oversight of the
overall biodefense enterprise. In contrast to addressing the entirety of the biodefense enterprise at
once, providing oversight and direction to individual components or agencies is relatively easy;
but such an approach may focus too narrowly to improve the overall efforts. An alternative
approach identifies key areas or activities that shape federal agency efforts. The Bush
Administration identified four such “pillars” as organizing principles for the federal biodefense
efforts: threat awareness; prevention and protection; surveillance and detection; and response and
recovery.18 Each of these pillars may have several agencies performing critical parts of the
activity. Congressional oversight and direction of biodefense efforts has followed a similar but
not identical path. Congress has provided oversight and direction on the basis of both individual
agency biodefense activity and on those cross-agency themes and policies deemed most important
by congressional policymakers.
Because of the diversity of federal biodefense efforts, this report cannot address all aspects and
associated programs related to this issue. Instead, this report focuses on four areas under
congressional consideration deemed critical to the success of the biodefense enterprise: strategic
planning; risk assessment; surveillance; and the development, procurement, and distribution of
medical countermeasures. This report also focuses on the effectiveness and sufficiency of
programs implementing these aspects of the federal biodefense efforts, outside analysts’
suggestions for improving the government’s efforts, and current issues under congressional
15 For additional information on EPA’s research in this area, see http://www.epa.gov/NHSRC/decondeconrh.html.
16 For more information on this expansion of capacity, see CRS Report R40418, Oversight of High-Containment
Biological Laboratories: Issues for Congress, by Frank Gottron and Dana A. Shea.
17 The Obama Administration has released strategy documents addressing biodefense planning and response. See
National Security Council, Executive Office of the President, National Strategy for Countering Biological Threats,
November 2009; Executive Order 13527, “Establishing Federal Capability for the Timely Provision of Medical
Countermeasures Following a Biological Attack,” 75 Federal Register 737-738, January 6, 2010; and Office of the
Press Secretary, The White House, “Executive Order—Optimizing the Security of Biological Select Agents and Toxins
in the United States,” July 2, 2010. The Bush Administration released a series of homeland security strategies and
presidential directives incorporating responses to the bioterrorism threat. Similarly, documents to establish cross-
agency coordination, such as that developed by the National Science and Technology Council on foreign animal
disease (Subcommittee on Foreign Animal Disease Threats, Committee on Homeland and National Security, National
Science and Technology Council, Protecting Against High Consequence Animal Diseases: Research & Development
Plan for 2008-2012, January 2007) or that developed by the Department of Homeland Security to coordinate homeland
security research and development (Science and Technology Directorate, Department of Homeland Security,
Coordination of Homeland Security Science and Technology, December 2007 (Revised January 2008)), have been
released. Lastly, the federal government has tested its response capabilities through drills and exercises including
responses to bioterrorism. One example is the National Exercise Program (formerly TOPOFF exercises), which
included bioterrorism scenarios in several cases. See CRS Report RL34737, Homeland Emergency Preparedness and
the National Exercise Program: Background, Policy Implications, and Issues for Congress, coordinated by R. Eric
Petersen.
18 The Executive Office of the President, “Biodefense for the 21st Century,” Homeland Security Presidential Directive
10/HSPD-10, April 28, 2004.
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consideration. This report does not attempt to address all biodefense issues of potential
congressional interest. The footnotes provide references to related CRS reports and other sources
for further information.
Strategic Planning
Although the federal government had previously undertaken efforts to address the bioterrorism
threat, the events of September 11, 2001, and the subsequent anthrax mailings led to an increased
focus on terrorism in general and especially on biological weapons of mass destruction (WMDs).
The Bush Administration established a homeland security apparatus within the White House.19
Congress and the Bush Administration created the DHS as a focal point in the federal
preparedness, response, and recovery to terrorism and imbued it with a variety of new
authorities.20 In addition, the Bush Administration developed a series of national strategies and
other guidance documents for homeland security generally and biodefense in specific.21 Beyond
these cross-governmental strategy documents, many agencies developed more focused strategic
plans for their individual operations against bioterrorism. The Obama Administration has
continued this focus on bioterrorism by issuing additional guidance and directives.22
Congress has acted to require federal strategic planning activities through provisions of the
Homeland Security Act of 2002 and other legislation. In addition to establishing DHS, Congress
has created offices and agencies within other Cabinet departments and assigned them specific
19 Executive Order 13228 (October 8, 2001) and Homeland Security Presidential Directive-1 (October 29, 2001)
established the Office of Homeland Security and the Homeland Security Council and created the position of Assistant
to the President for Homeland Security. President Obama ordered a review of the White House organization for
counterterrorism and homeland security through Presidential Study Directive 1 (February 23, 2009). The result of this
review was reportedly to fold the Homeland Security Council into the National Security Council and merge the staff of
the Homeland Security Council and the National Security Council into a single staff (Helene Cooper, “In Security
Shuffle, White House Merges Staffs,” New York Times, May 26, 2009).
20 The Homeland Security Act of 2002 (P.L. 107-296) created the Department of Homeland Security. For an overview
of the process of creating the department, see CRS Report RL31493, Homeland Security: Department Organization
And Management - Legislative Phase, by Harold C. Relyea.
21 The Bush Administration released several national strategies to address homeland security for the nation, which
included protecting against biological attack as a component. See, for example, Office of Homeland Security, National
Strategy for Homeland Security, July 2002, and Homeland Security Council, National Strategy for Homeland Security,
October 2007. The Obama Administration has released a strategy for countering biological threats. See National
Security Council, Executive Office of the President, National Strategy for Countering Biological Threats, November
2009. Biodefense-related strategies and guidance include a series of presidential directives, such as The White House,
“National Strategy to Combat Weapons of Mass Destruction,” Homeland Security Presidential Directive/HSPD-4,
December 2002; The White House, “Defense of United States Agriculture and Food,” Homeland Security Presidential
Directive/HSPD-9, January 30, 2004; The Executive Office of the President, “Biodefense for the 21st Century,”
Homeland Security Presidential Directive 10/HSPD-10, April 28, 2004; The White House, “Medical Countermeasures
against Weapons of Mass Destruction,” Homeland Security Presidential Directive/HSPD-18, January 31, 2007; and
The White House, “Public Health and Medical Preparedness,” Homeland Security Presidential Directive/HSPD-21,
October 18, 2007.
22 For example, National Security Council, Executive Office of the President, National Strategy for Countering
Biological Threats, November 2009; Department of Health and Human Services, National Health Security Strategy of
the United States of America, December 2009; Executive Order 13527, “Establishing Federal Capability for the Timely
Provision of Medical Countermeasures Following a Biological Attack,” 75 Federal Register 737-738, January 6, 2010;
and Office of the Press Secretary, The White House, “Executive Order—Optimizing the Security of Biological Select
Agents and Toxins in the United States,” July 2, 2010.
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planning activities.23 Finally, Congress established an office within the Executive Office of the
President charged with preventing WMD proliferation and terrorism.24
Policymakers, analysts, and other experts have criticized federal efforts at strategic planning.25
With respect to the White House, some experts have criticized cross-agency planning as lacking
metrics and measures, failing to encompass the full range of threats, and insufficiently meeting
stated goals.26 Policymakers have critiqued efforts by federal agencies to develop multi-agency
plans as lacking metrics.27 Even when considering efforts within individual agencies, experts
have levied criticisms of research plans, stating that the correspondence between strategic goals,
operational outcomes, and program investments has not been made clear.28
Options for Congress
Given these criticisms, Congress could choose to recommend changes in the strategic planning
process, either government-wide or at the agency level, to address specific deficiencies. For
example, Congress might require a more robust and transparent government-wide strategic plan
articulating clear goals, metrics and priorities; the development of a national framework to
organize and prioritize biodefense investments; or a periodic comprehensive report detailing
biodefense activities government-wide. Alternatively, Congress might require the Administration
to perform internal or external reviews of policies and activities to determine their sufficiency and
then direct the Administration to formulate new or revised policies as recommended by the
reviews.29 Similarly, Congress could require the creation of implementation plans, linking agency
activities with meeting the required, desired strategic goals.
Through its oversight activities, Congress may have a key position in assessing the completeness
of ongoing planning. Because of the broad oversight responsibilities of congressional committees,
23 For example, through the Pandemic and All-Hazard Preparedness Act (P.L. 109-417), Congress created the
Biodefense Advanced Research and Development Authority in HHS to plan and support the development of
bioterrorism medical countermeasures.
24 The Implementing Recommendations of the 9/11 Commission Act of 2007 (P.L. 110-53) created the Office of the
United States Coordinator for the Prevention of Weapons of Mass Destruction Proliferation and Terrorism, which is to
be headed by a Senate-confirmed coordinator.
25 See, for example, The Commission on the Prevention of WMD Proliferation and Terrorism, World at Risk: The
Report of the Commission on the Prevention of WMD Proliferation and Terrorism, December 2008.
26 See, for example, Al Mauroni, Progress of “Biodefense for the 21st Century” – A Five-Year Evaluation, 2009.
27 See, for example, hearings held in the House regarding DHS efforts to develop a cross-governmental homeland
security research and development plan. House Committee on Homeland Security, Subcommittee on Emerging
Threats, Cybersecurity, and Science and Technology, “A Roadmap for Security? Examining the Science and
Technology Directorate’s Strategic Plan,” Serial No. 110-53, June 27, 2007; House Committee on Homeland Security,
Subcommittee on Emerging Threats, Cybersecurity, and Science and Technology, “The Future of Science and
Technology at the Department of Homeland Security,” Serial No. 110-102, April 01, 2008; and House Committee on
Science and Technology, Subcommittee on Technology and Innovation, “Developing Research Priorities at DHS’s
Science and Technology Directorate,” Hearing, October 27, 2009.
28 See, for example, National Academy of Public Administration, Department of Homeland Security Science and
Technology Directorate: Developing Technology to Protect America, June 2009.
29 For example, the HHS Interim Implementation Guide for the National Health Security Strategy of the United States
of America identifies a series of executive-branch-directed reviews of biodefense to be performed in the near future.
Additionally, HHS has used select advisory boards to perform reviews or assessments of specific portions of the federal
biodefense enterprise. See, for example, reports issued by the National Biodefense Science Board (NBSB) at
http://www.hhs.gov/aspr/omsph/nbsb/.
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congressional policymakers may identify synergies and duplications between agency efforts more
easily than decision-makers within individual agencies.30 Congress, through its oversight
activities, may also identify areas where executive branch resource allocation does not reflect
need or congressional intent. A congressional perspective may highlight unnecessary duplication
or gaps in federal planning for the various necessary stages of response to a bioterrorism event.
Congress might mandate the augmentation of government-wide planning documents, such as the
National Response Framework, or the development of a forward-looking planning document,
similar to the Quadrennial Homeland Security Review31 or the National Strategy for Pandemic
Influenza and its implementation guide,32 for cross-agency federal biodefense activities.
Some experts have suggested that Congress might optimize oversight of federal homeland
security efforts if fewer committees and subcommittees maintained jurisdiction over homeland
security.33 Proponents with this perspective argue that congressional oversight would become
more focused and holistic because of the centralization of oversight authority. Additionally, this
might reduce the amount of time homeland security officials spend testifying before Congress.
Alternatively, such consolidation might decrease the level of congressional scrutiny, since fewer
committees with broader homeland security mandates might have less time and resources to focus
on individual agencies and activities.
Risk Assessment
Ideally, a full understanding of the risk posed by bioterrorism would underpin the government’s
biodefense efforts. By understanding the bioterrorism risk, the federal government could
determine the appropriate level of federal response and investment against this risk. The
Government Accountability Office (GAO) has called for increased risk assessment activities in
biodefense for many years.34 Unfortunately, the nature of the bioterrorism threat, with its high
consequences and low frequency, makes determining the bioterrorism risk difficult. Additionally,
30 For example, investigation by the Government Accountability Office identified the duplication and potential waste of
anthrax vaccine occurring in the Department of Defense and the Department of Health and Human Services.
Government Accountability Office, “Project BioShield: Actions Needed to Avoid Repeating Past Mistakes,” GAO-08-
208T, October 23, 2007.
31 The Implementing Recommendations of the 9/11 Commission Act of 2007 (P.L. 110-53) amended the Homeland
Security Act of 2002 to require a quadrennial homeland security review. The first such review was issued in February
2010. See Department of Homeland Security, Quadrennial Homeland Security Review: A Strategic Framework for a
Secure Homeland, February 2010.
32 Homeland Security Council, Executive Office of the President, National Strategy for Pandemic Influenza, November
2005 and Homeland Security Council, Executive Office of the President, National Strategy for Pandemic Influenza
Implementation Plan, May 2006.
33 Both the 9/11 Commission and the Commission on the Prevention of WMD Proliferation and Terrorism
recommended that Congress create a single committee in each chamber for oversight and review of homeland security
(National Commission on Terrorist Attacks upon the United States, The 9/11 Commission Report, p. 421 and
Commission on the Prevention of WMD Proliferation and Terrorism, World at Risk: The Report of the Commission on
the Prevention of WMD Proliferation and Terrorism, December 2008, p. 91). Other groups have also called for change
in the current congressional oversight of the Department of Homeland Security (Jena Baker McNeill, Heritage
Foundation, “Homeland Security Oversight Reform Requires Leadership,” WebMemo 2143, November 25, 2008).
34 For example, the General Accounting Office, now the Government Accountability Office, identified a need for
comprehensive threat and risk assessments of chemical and biological attacks in the terrorism context prior to the 2001
anthrax attacks (General Accounting Office, “Combating Terrorism: Need for Comprehensive Threat and Risk
Assessments of Chemical and Biological Attacks, GAO/NSIAD-99-163, September 1999).
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the presence of an intelligent adversary who can adapt to the presence of successful
countermeasures complicates the use of standard risk assessment techniques.35 Despite these
challenges, risk assessment activities can help agencies use risk-informed decision-making
processes to plan, prioritize, and invest wisely. In contrast, investment based on uninformed
hypotheses or on an ad hoc basis may allow improperly identified or assessed risks to go
unmitigated or result in overinvestment against low-risk events.
The Bush Administration identified bioterrorism risk assessment as a key component of its
biodefense strategy. As a consequence, DHS engages in a bioterrorism risk assessment process on
a two-year cycle. Other agencies also engage in risk assessment activities, but they vary from
DHS’s efforts in approach, assumptions, emphasis, and purpose.
Risk assessment processes depend heavily on the information used as input, the quantitative and
qualitative factors used to interpret that information, and the robustness of the assessment
process. These factors complicate comparisons between bioterrorism risk assessments performed
for different purposes or among assessments of other threats. The DHS has begun this comparison
on a limited scale,36 but its use of these risk assessments for planning purposes has been strongly
criticized by outside experts. These experts assert these risk assessments do not adequately
address the decision-making process of the terrorist.37 Regardless of the complexity of the risk
assessment methodology, the inherent uncertainties associated with assessing risk in a
counterterrorism context likely mandate retaining some level of flexibility in managing risk.38
Options for Congress
A key question for congressional policymakers is: to what extent should bioterrorism and other
risk assessments inform agency and government-wide priorities and policies? Congress could
mandate risk-informed decision making based on the intelligence community’s assessment of
current and future bioterrorism-related threats, endorse a particular risk assessment method, or
require the establishment of measures of robustness. It could require agencies to harmonize their
risk assessment methodologies or mandate the development of a government-wide risk
assessment process rather than individual agency-level assessments. Alternatively, Congress
could direct agencies to rely less on the risk assessment process and instead set priorities based on
other factors, such as expert judgment.
35 Even defining the adversary presents a challenge. For example, foreign or domestic individuals, cells, or
transnational organizations with or without access to state-sponsored resources could each qualify as the adversary.
Different definitions of adversary may dramatically alter risk assessments and thus the government efforts to respond to
the risk posed.
36 Homeland Security Directive 18 directs DHS to create a risk assessment that considers chemical, biological,
radiological, and nuclear threats.
37 National Research Council, Committee on Methodological Improvements to the Department of Homeland Security’s
Biological Agent Risk Analysis, Department of Homeland Security Bioterrorism Risk Assessment: A Call for Change,
Washington, DC: National Academies Press, 2008.
38 For a discussion on DHS’s risk assessment processes, see CRS Report RL33858, The Department of Homeland
Security’s Risk Assessment Methodology: Evolution, Issues, and Options for Congress, by Todd Masse, Siobhan
O’Neil, and John Rollins.
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Biosurveillance
Unlike most other terrorist attacks, bioterrorists could covertly infect victims without their
knowledge. Days or weeks might pass before victims develop symptoms. Health practitioners
treating infected, symptomatic individuals may first identify that a bioterrorism attack had
occurred. The Bush Administration prioritized the development and deployment of
biosurveillance technologies in an attempt to identify a bioterrorism attack as soon after an attack
as possible.39 The earlier officials identify an attack, the earlier treatment of the exposed
individuals could begin. Earlier treatment generally increases the likelihood of individual
recovery and survival.40
The Bush Administration implemented a number of different detection approaches, including
environmental detection, syndromic surveillance,41 and information sharing.42 Through these
efforts, the federal government aims to identify bioterrorism events at various scales, ranging
from large, aerially disseminated releases to smaller releases infecting only a few individuals. The
federal government, in collaboration with state and local jurisdictions, enhanced the existing
network of public health laboratories to ensure that diagnostic laboratories could correctly handle
and analyze clinical samples related to potential bioterrorism events.43 Similarly, the federal
government has continued to invest in some global health activities partly in order to help identify
when an emerging disease might pose a threat to the United States.44
Various government and outside experts have criticized or supported these efforts.45 Widespread
deployment of environmental biosurveillance technologies began after the anthrax mailings, and
federal efforts to further develop these technologies have also increased. Questions remain
regarding the effectiveness of their detection ability, especially in comparison to the innate
detection ability of the medical system through astute physicians. A repeated criticism of
biosurveillance activities is that the detection system may lack sufficient sensitivity and
39 President Bush announced during the 2003 State of the Union address the deployment of the “nation’s first early
warning network of sensors to detect biological attack” (Executive Office of the President, The White House, State of
the Union Address, January 28, 2003).
40 Computer modeling has shown that the number of casualties and fatalities resulting from a biological attack increases
if treatment is delayed. See, for example, L.M. Wein, D.L. Craft, and E.H. Kaplan, “Emergency Response to an
Anthrax Attack,” Proc. Natl. Acad. Sci., 100(7), 2003, pp. 4346-51.
41 The term applies to using health-related data that precede diagnosis as a signal of an outbreak or possible bioterrorist
attack. See http://www.cdc.gov/ncphi/disss/nndss/syndromic.htm.
42 These activities included the deployment of the BioWatch program, the development of the Biological Warning and
Incident Characterization system, and the establishment of the National Biosurveillance Integration Center through the
Department of Homeland Security, the establishment of the BioSense Program through the Centers for Disease Control
and Prevention (CDC), and the expansion of the Electronic Surveillance System for Early Notification of Community-
based Epidemics, or ESSENCE, program in the Department of Defense.
43 For more on the Laboratory Response Network, see http://www.bt.cdc.gov/lrn/.
44 For example, see CRS Report R40239, Centers for Disease Control and Prevention Global Health Programs:
FY2001-FY2011, by Tiaji Salaam-Blyther.
45 See, for example, Government Accountability Office, “Biosurveillance: Developing a Collaboration Strategy Is
Essential to Fostering Interagency Data and Resource Sharing,” GAO-10-171, December 18, 2009; Government
Accountability Office, “Biosurveillance: Preliminary Observations on Department of Homeland Security’s
Biosurveillance Initiatives,” GAO-08-960T, July 16, 2008; and National Research Council, BioWatch and Public
Health Surveillance: Evaluating Systems for the Early Detection of Biological Threats. Abbreviated Version: Summary,
December 7, 2009.
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dependability to allow for a federal response following detection of a bioterrorism event.46
Technical difficulties persist in making a detection system sufficiently sensitive to detect very low
levels of pathogens while maintaining a very low number of false alarms. Frequent false alarms
pose a high cost in terms of resource consumption and responder opportunity costs. Additionally,
frequent false alarms may lead responders and the public to assume that all alarms are likely
false, and thus they may not take alarms seriously. Other widely discussed issues include the
extent to which the federal government should protect the population of the United States with
such systems, through environmental sensing or other methods, and how the federal government
should deploy the limited number of available systems.
Options for Congress
Congress will likely remain interested in these programs. The DHS has developed and deployed
the next generation of environmental detectors more slowly than it originally predicted.47
Congress could provide additional funds, oversight, or guidance to encourage the completion of
the deployment of these detectors. Congress may seek to determine whether the current plans for
capabilities and coverage of surveillance sufficiently protect the population. Congress may also
address concerns about the interactions between DHS and local jurisdictions. Local jurisdictions
have identified fiscal burdens from this federal program, and questions remain about their proper
role in the response to positive test results. Congress could attempt to alleviate these concerns by
providing additional resources to local jurisdictions or by providing additional guidance to DHS
regarding its relationships with local jurisdictions.
Medical Countermeasures
Effective medical countermeasures48 could significantly decrease the impact of a bioterrorist
attack. The federal government has devoted many resources to the development, procurement,
and distribution of medical countermeasures that could help respond to a bioterrorist attack. Since
2001, the federal government has often reexamined programs in these areas. Outside observers,
Congress, and the executive branch have scrutinized, suggested improvements to, and further
refined these policies.49
46 See, for example, testimony by Tara O’Toole, Director, Center for Biosecurity of University of Pittsburgh Medical
Center, before the Senate Committee on Homeland Security and Governmental Affairs, October 23, 2007. Dr. O’Toole
is now the DHS Under Secretary for Science and Technology.
47 House Committee on Appropriations, Subcommittee on Homeland Security, “House Appropriations Subcommittee
on Homeland Security Holds Hearing on Biosurveillance Investments,” Hearing Transcript, February 25, 2010. See
also Government Accountability Office, “Department of Homeland Security: Assessments of Selected Complex
Acquisitions,” GAO-10-588SP, June 30, 2010.
48 Medical countermeasures include vaccines, antiviral, antibiotic, and other therapeutic medications.
49 See, for example, Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism,
Prevention of WMD Proliferation and Terrorism Report Card, January 2010; C. Maher and B.D. Lushniak,
“Availability of Medical Countermeasures for Bioterrorism Events: US Legal and Regulatory Options,” Clinical
Pharmacology & Therapeutics, 85, June 2009, pp. 669-671; and The White House, Executive Order - Medical
Countermeasures Following a Biological Attack, December 30, 2009.
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Research and Development
Many potential bioterrorism agents lack available medical countermeasures.50 Therefore, the
federal government has invested billions of dollars in research and development that might lead to
effective medical countermeasures. The Department of Health and Human Services has played a
key role in supporting the development of medical countermeasures, mainly through the National
Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority
(BARDA).51 Additionally, efforts undertaken by the Department of Defense to protect warfighters
may also contribute to civilian biodefense.52
Some scientists have criticized the federal investment in biodefense countermeasures. They claim
that the relative threat of bioterrorism does not justify the large investment in biodefense and that
these efforts would provide greater benefits if directed to other areas of research and
development, such as more conventional public health threats.53 Additionally, Congress has
questioned the balance of investment among the various stages of research and development,
identifying funding gaps that may pose barriers to the conversion of research results into
deployable countermeasures. Congress also identified deficiencies in executive branch
management of the countermeasure development process. These observations led Congress to
establish BARDA to fund and coordinate the conversion of promising research results into
deployable products.54
Options for Congress
Policymakers often face the challenge of determining the optimal balance of funding between
competing stages of the research and development process. While Congress has supported a
historic increase in biodefense-related basic research funding at NIH, critics have suggested that
the federal government has underfunded the critical next stages of research and development that
convert promising research results into usable products.55 Current fiscal pressures will likely
exacerbate the difficult decisions regarding appropriate funding levels. Policymakers may also
consider whether the federal government should reduce its dominant role in countermeasure
50 For the list of the Department of Health and Human Services top priority needed countermeasures, see Public Health
Emergency Medical Countermeasures Enterprise, U.S. Department of Health and Human Services, HHS Public Health
Emergency Medical Countermeasure Enterprise Implementation Plan for Chemical, Biological, Radiological and
Nuclear Threats, April 2007, p. 10.
51 See, for example, Public Health Emergency Medical Countermeasures Enterprise, Biomedical Advanced Research
and Development Authority (BARDA), U.S. Department of Health and Human Services, DRAFT BARDA Strategic
Plan for Medical Countermeasure Research, Development, and Procurement, July 5, 2007.
52 One such example is the Transformational Medical Technologies (TMT) program, a Department of Defense program
to better prepare and protect the warfighter against emerging, genetically engineered, and unknown biothreat agents.
For more information on TMT, see https://tmti.jscbis.apgea.army.mil and Chemical and Biological Defense Program,
Department of Defense, Transformational Medical Technologies Initiative (TMTI) – OUSD (AT&L) FY2007, online at
http://www.acq.osd.mil/cp/cbdreports/tmti.pdf.
53 For example, Scientists Working Group of Biological and Chemical Weapons, Center for Arms Control and Non-
Proliferation, Biological Threats: A Matter of Balance, January 26, 2010.
54 The Pandemic and All-Hazards Preparedness Act of 2006 (PAHPA; P.L. 109-417) established the Biomedical
Advanced Research and Development Authority.
55 See, for example, Alliance for Biosecurity, Letter to President Barack Obama, September 15, 2009,
http://www.allianceforbiosecurity.org/pdf/2277113.pdf, or Center for Biosecurity of the University of Pittsburgh
Medical Center, Letter to President Barack Obama, March 9, 2009, http://www.upmc-biosecurity.org/website/
resources/commentary/2009-03-09-white_house_barda_fy10.html.
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research and development in favor of a greater role for investment by industry. Congress may
again consider incentive-based approaches, such as tax cuts and credits or patent protections, or
demand-based approaches, such as increased funding to support larger contract awards.56
Alternatively, Congress might conclude that the government needs to take a larger role in
developing countermeasures in areas where the private sector has failed to produce desired
countermeasures.
Procurement
The federal government is by far the largest procurer of bioterrorism medical countermeasures. It
stockpiles them and keeps them ready for deployment to respond to a bioterrorism event.57 The
relatively small market for most bioterrorism countermeasures provides little incentive for
companies to invest in developing a countermeasure when compared with the larger potential
market of other products of the same industry, such as anti-cholesterol drugs. The federal
government has experienced difficulties in obtaining desired countermeasures because of this
relatively small market. The executive branch and Congress have taken several steps to encourage
companies to enter the medical countermeasure field. These activities include providing liability
protection to companies developing medical countermeasures, guaranteeing a government market
for countermeasures, and more clearly communicating the government’s countermeasure needs
and priorities.58 These efforts have met with mixed success.59 In the face of a need for medical
countermeasures against emerging natural threats, such as pandemic influenza, HHS has also
invested in medical countermeasure infrastructure to provide a more rapid response.60
A variety of experts, commissions, and policymakers have assailed these efforts as underfunded,
unclear, or insufficient.61 Given the large costs of bringing a product to market, government
assurances of a planned purchase seem insufficient to entice companies into this field. Private
companies faced with the potential for liability following adverse reactions to a fielded medical
countermeasure expressed reluctance to develop countermeasures. This led Congress to enact
measures to protect companies from such liability.62 Companies and think tanks continue to state
that the government should better communicate to developers the countermeasures it would like
56 Previous congresses considered such provisions including S. 975 in the 109th Congress. See CRS Report RL32917,
Bioterrorism Countermeasure Development: Issues in Patents and Homeland Security, by Wendy H. Schacht and John
R. Thomas.
57 The federal government maintains a Strategic National Stockpile of certain medical countermeasures against national
need. This stockpile is regularly rotated and thus serves as a continuing government demand for certain medical
countermeasures.
58 See CRS Report R41033, Project BioShield: Authorities, Appropriations, Acquisitions, and Issues for Congress, by
Frank Gottron.
59 For recent commentary, see Government Accountability Office, “Project BioShield Act: HHS Has Supported
Development, Procurement, and Emergency Use of Medical Countermeasures to Address Health Threats,” GAO-09-
878R, July 24, 2009, and Government Accountability Office, “Project BioShield: HHS Can Improve Agency Internal
Controls for Its New Contracting Authorities,” GAO-09-820, July 2009.
60 CRS Report R40554, The 2009 Influenza Pandemic: An Overview, by Sarah A. Lister and C. Stephen Redhead.
61 The Commission on the Prevention of WMD Proliferation and Terrorism, World at Risk: The Report of the
Commission on the Prevention of WMD Proliferation and Terrorism, December 2008, and Center for Biosecurity of
the University of Pittsburgh Medical Center, Letter to President Barack Obama, March 9, 2009, http://www.upmc-
biosecurity.org/website/resources/commentary/2009-03-09-white_house_barda_fy10.html.
62 CRS Report RS22327, Pandemic Flu and Medical Biodefense Countermeasure Liability Limitation, by Edward C.
Liu.
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to procure. Think tanks and industry have also criticized actions they interpret as weakening the
government’s commitment to guaranteeing a government market by diverting funds designated
for that program to other uses.63 They assert such actions reinforce industry’s perception of the
government as an unreliable partner in the development enterprise. In addition, GAO has
cautioned against the federal government failing to have and make clear expectations regarding
countermeasure and company performance.64
Options for Congress
Congressional policymakers will likely face decisions in the 111th Congress regarding the transfer
of funds from an account designated for the procurement of countermeasures to one that is
devoted to the development of countermeasures.65 In addition, policymakers may assess whether
previously enacted programs draw new investors into countermeasure manufacturing or whether
the federal government must consider other, more novel manufacturing incentives. Congress may
also examine whether the procurement prioritization matches the risk assessments and the
strategic plans developed by the executive branch. Finally, the results of a recently announced
end-to-end assessment of HHS’s investment strategy may provide recommendations and requests
for congressional action.66
Distribution
Even when effective medical countermeasures against potential bioterrorism pathogens exist,
their distribution to individuals affected by an attack remains a challenge. The federal government
has attempted to address this need through programs that stockpile and distribute stores of
medical countermeasures, the development of alternative distribution mechanisms outside the
normal health care setting, and the consideration of other options, such as pre-event distribution
or prophylaxis.67
63 For a discussion of this issue, see CRS Report R41033, Project BioShield: Authorities, Appropriations, Acquisitions,
and Issues for Congress, by Frank Gottron.
64 Government Accountability Office, “Project BioShield: Actions Needed to Avoid Repeating Past Problems with
Procuring New Anthrax Vaccine and Managing the Stockpile of Licensed Vaccine,” GAO-08-88, October 23, 2007.
65 Congress has transferred over $1 billion out of the Project BioShield fund for procuring medical countermeasures to
support countermeasure research and development and pandemic influenza preparedness. For further discussion of the
policy implications of these transfers, see CRS Report R41033, Project BioShield: Authorities, Appropriations,
Acquisitions, and Issues for Congress, by Frank Gottron.
66 Department of Health and Human Services, Interim Implementation Guide for the National Health Security Strategy
of the United States of America, December 2009, p.18. The National Defense Science Board and the Institute of
Medicine have recommended ways to encourage industry participation in countermeasure development. See National
Biodefense Science Board, Optimizing Industrial Involvement in Medical Countermeasure Development: A Report of
the National Biodefense Science Board, February 2010 and Institute of Medicine, The Public Health Emergency
Medical Countermeasures Enterprise: Innovative Strategies to Enhance Products from Discovery through Approval,
An Institute of Medicine Workshop, February 2010.
67 These programs include the Strategic National Stockpile (see http://www.bt.cdc.gov/stockpile/); the MedKit pilot
program of personal medical stockpiles provided by the government and stored at home (see http://www.bt.cdc.gov/
agent/anthrax/prep/pdf/medkit-evaluation-summary-2007.pdf), and the use of the U.S. Postal Service to distribute
countermeasures (see Executive Order 13527, “Establishing Federal Capability for the Timely Provision of Medical
Countermeasures Following a Biological Attack,” 75 Federal Register 737-738, January 6, 2010).
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Experts have especially focused on the ability of the federal and state governments to distribute
medical countermeasures to those infected in a timely way so as to minimize casualties and
fatalities. Much of a successful bioterrorism response relies on the provision of effective medical
countermeasures to the exposed. Experts question whether the federal government can distribute
federal stockpiles to states and localities in the midst of an emergency, whether state governments
have sufficient manpower or organization to receive federal stockpiles and effectively
disseminate them, and whether federal and state governments have sufficiently conceptualized
and practiced alternative mechanisms of distribution.68
Options for Congress
Congress may face decisions regarding the acceptable ways to disseminate medical
countermeasures in an emergency situation, the role of the federal government during a
bioterrorism event, and whether the advantages of alternative distribution mechanisms outweigh
the potential drawbacks of lowered oversight and control of countermeasure use.
Conclusion
While no mass-casualty bioterrorism event has yet occurred, some experts and policymakers
assert that terrorist organizations are attempting to develop such a capability.69 The federal
government has been preparing for a bioterrorism event for many years. Multiple programs in
many agencies attempt to prepare for and respond to a bioterrorism event. Whether these
programs are sufficient, redundant, excessive, or need improvement has been a topic of much
debate. Congress, through oversight activities as well as authorizing and appropriations
legislation, continues to influence the federal response to the bioterrorism threat. Congressional
policymakers will likely be faced with many difficult choices about the priority of maintaining,
shrinking, or expanding existing programs versus creating new programs to address identified
deficiencies. Augmenting such programs may incur additional costs in a time of fiscal challenges
while maintaining or shrinking such programs may be deemed as incurring unacceptable risks,
given the potential for significant casualties and economic effects from a large-scale bioterror
attack.
Author Contact Information
Frank Gottron
Dana A. Shea
Specialist in Science and Technology Policy
Specialist in Science and Technology Policy
fgottron@crs.loc.gov, 7-5854
dshea@crs.loc.gov, 7-6844
68 For one view of the state of public health preparedness for bioterrorism, see Trust for America’s Health, Ready or
Not? Protecting the Public’s Health from Diseases, Disasters, and Bioterrorism 2009, December 2009. The Cities
Readiness Initiative is a Centers for Disease Control and Prevention program to help local jurisdictions improve their
distribution capabilities. See http://emergency.cdc.gov/cri/facts.asp.
69 See, for example, Rolf Mowatt-Larssen, Al Qaeda Weapons of Mass Destruction Threat: Hype or Reality? A
Timeline of Terrorists’ Efforts to Acquire WMD, January 2010.
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