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Introduction

Biological weapons in the possession of hostile states or terrorists pose unique and grave threats to the safety and security of the United States and our allies.


Biological weapons attacks could cause catastrophic harm. They could inflict widespread injury and result in massive casualties and economic disruption.

—Homeland Security Presidential Directive 10: Biodefense for the 21st Century, 2004

THIS IS THE CHALLENGE

The U.S. government has made the countering of biological weapons a top priority for well over a decade. With the international community, the United States recognizes that the biotechnology revolution, which promises a better quality of life for all people, also offers the capability for misuse. Biotechnology is powerful, relatively inexpensive, and increasingly accessible to U.S. adversaries, from nation-states, to nonstate actors including terrorists, to deranged individuals. Rapid advances in molecular biology and genomics, including the introduction of new drug-resistant agents, mean that the threat is dynamic and adaptive and that attacks could be increasingly lethal. Defending against bioterrorism may be the greatest among U.S. national security challenges.

THE THREAT IS GROWING

Today the nation is a long way from being able to meet the challenges posed by a bioterrorist attack. The United States currently has little ability to prevent or detect a biological attack, and the nation’s response systems are unproven. Biological weapons are easily concealed and hard to track. Biological attacks are potentially repeatable, and attribution is extremely difficult, as was learned from the anthrax attacks in the United States in the fall of 2001. A National Intelligence Council assessment in 2004 concluded that “over the next 10 to 20 years there is a risk that advances in biotechnology will augment not only defensive measures but also offensive biological warfare (BW) agent development and allow the creation of advanced biological agents designed to target specific systems—human, animal, or crop” (National Intelligence Council, 2004, p. 36). The report states further that “as biotechnology advances become more ubiquitous, stopping the progress of offensive BW programs will become increasingly difficult” (p. 36). Before September 11, 2001 (9/11), a report by the U.S. Commission on National Security in the 21st Century (commonly known as the Hart-Rudman Commission), New World Coming: American Security in the 21st Century, was published; the report stated that serious threats “may consist instead of unannounced attacks by subnational groups using genetically engineered pathogens against American cities” (U.S. Commission on National Security in the 21st Century, 1999, p. 2).

Improving the U.S. capability to prevent, detect, and respond to the use of biological weapons is clearly a matter of national urgency. According to recent congressional testimony by the Director of National Intelligence, al-Qaeda and other terrorist groups continue to show interest in these weapons (Negroponte, 2007).1

The Commission on the Intelligence Capabilities of the United States Regarding Weapons of Mass Destruction (referred to herein as the WMD Commission) in March 2005 reaffirmed the complexity, gravity, and urgency of the threat, as well as the inadequacy of the government’s response. “We are concerned,” the report states, “that terrorist groups may be developing biological weapons and may be willing to use them. Even more worrisome, in the near future, the biotechnology revolution will make even more potent and sophisticated weapons available to small or relatively unsophisticated groups. In response to this mounting threat, the Intelligence Community’s performance has been disappointing” (WMD Commission, 2005, p. 504). In short, the WMD Commission found that the U.S. government has been unacceptably slow to develop an effective strategic capability to prevent, detect, and respond to a biological attack.

A decade ago, experts both inside and outside government argued for a strategic, collaborative, and integrated approach to risk assessment and risk management among federal, state, and local governments, law enforcement, the military, the private sector, the media, and the medical, scientific, and academic communities (Drell et al., 1999, pp. 125-126). The

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A critical assessment of the intelligence community’s efforts, even after 9/11, to determine al-Qaeda’s biological weapons capability is contained in WMD Commission (2005).



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1 Introduction Biological weapons in the possession of hostile states or terrorists pose unique and grave threats to the safety and security of the United States and our allies. Biological weapons attacks could cause catastrophic harm. They could inflict widespread injury and result in massive casualties and economic disruption. —Homeland Security Presidential Directive 10: Biodefense for the 2st Century, 2004 THIS IS THE CHALLENGE Rudman Commission), New World Coming: American Se- curity in the 2st Century, was published; the report stated The U.S. government has made the countering of biologi- that serious threats “may consist instead of unannounced cal weapons a top priority for well over a decade. With the in- attacks by subnational groups using genetically engineered ternational community, the United States recognizes that the pathogens against American cities” (U.S. Commission on biotechnology revolution, which promises a better quality of National Security in the 21st Century, 1999, p. 2). life for all people, also offers the capability for misuse. Bio- Improving the U.S. capability to prevent, detect, and technology is powerful, relatively inexpensive, and increas- respond to the use of biological weapons is clearly a mat- ingly accessible to U.S. adversaries, from nation-states, to ter of national urgency. According to recent congressional nonstate actors including terrorists, to deranged individuals. testimony by the Director of National Intelligence, al-Qaeda Rapid advances in molecular biology and genomics, includ- and other terrorist groups continue to show interest in these ing the introduction of new drug-resistant agents, mean that weapons (Negroponte, 2007).1 the threat is dynamic and adaptive and that attacks could be The Commission on the Intelligence Capabilities of the increasingly lethal. Defending against bioterrorism may be United States Regarding Weapons of Mass Destruction (re- the greatest among U.S. national security challenges. ferred to herein as the WMD Commission) in March 2005 reaffirmed the complexity, gravity, and urgency of the threat, THE THREAT IS GROWING as well as the inadequacy of the government’s response. “We are concerned,” the report states, “that terrorist groups Today the nation is a long way from being able to meet the may be developing biological weapons and may be willing challenges posed by a bioterrorist attack. The United States to use them. Even more worrisome, in the near future, the currently has little ability to prevent or detect a biological biotechnology revolution will make even more potent and attack, and the nation’s response systems are unproven. sophisticated weapons available to small or relatively unso- Biological weapons are easily concealed and hard to track. phisticated groups. In response to this mounting threat, the Biological attacks are potentially repeatable, and attribution Intelligence Community’s performance has been disappoint- is extremely difficult, as was learned from the anthrax attacks ing” (WMD Commission, 2005, p. 504). In short, the WMD in the United States in the fall of 2001. A National Intelli- Commission found that the U.S. government has been unac- gence Council assessment in 2004 concluded that “over the ceptably slow to develop an effective strategic capability to next 10 to 20 years there is a risk that advances in biotech- prevent, detect, and respond to a biological attack. nology will augment not only defensive measures but also A decade ago, experts both inside and outside government offensive biological warfare (BW) agent development and argued for a strategic, collaborative, and integrated approach allow the creation of advanced biological agents designed to to risk assessment and risk management among federal, state, target specific systems—human, animal, or crop” (National and local governments, law enforcement, the military, the Intelligence Council, 2004, p. 36). The report states further private sector, the media, and the medical, scientific, and that “as biotechnology advances become more ubiquitous, academic communities (Drell et al., 1999, pp. 125-126). The stopping the progress of offensive BW programs will be- come increasingly difficult” (p. 36). Before September 11, 1A critical assessment of the intelligence community’s efforts, even after 2001 (9/11), a report by the U.S. Commission on National 9/11, to determine al-Qaeda’s biological weapons capability is contained in Security in the 21st Century (commonly known as the Hart- WMD Commission (2005). 

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 INTRODUCTION steps taken by the federal government to develop a national kinds, not just bioterrorism, and serves as guidance for the strategy and the collaborative network to support it (see the specific application of efforts against bioterrorism. next section) are still incomplete. The completion of these The Department of Homeland Security has made the steps would require continuous multidisciplinary analysis preparation against biological weapons attacks a priority and engage multiple stakeholders across functional disci- and deployed the BioWatch Program to provide early warn- plines as well as across federal, state, local, and tribal govern- ing of an outdoor pathogen release in selected areas across ments. The anthrax attacks in the United States in the period the United States (Congressional Research Service, 2003). after 9/11 added urgency to the need for such an effort. The BioWatch Program has three main elements: sampling, analysis, and response. The Environmental Protection Agency maintains the sensors that collect airborne particles. THE GOVERNMENT HAS TAKEN ACTION The Centers for Disease Control and Prevention coordinates Executive and legislative actions taken since 9/11 have analyses. Local jurisdictions are responsible for the public sharpened the federal government’s focus on bioterrorism. health response to positive findings. The Federal Bureau of The Congress in November 2002 passed and the president Investigation is designated as the lead agency for the law signed the Homeland Security Act (Public Law No. 107- enforcement response if a bioterrorism event is detected. 296), which established the Department of Homeland Se- In January 2007, the White House issued Homeland curity (DHS) and gave it the responsibility for developing Security Presidential Directive 18 (HSPD-18): Medical countermeasures to biological agents. In April 2004, Presi- Countermeasures Against Weapons of Mass Destruction dent Bush issued Homeland Security Presidential Directive (The White House, 2007), which builds on HSPD-10 while 10 (HSPD-10): Biodefense for the 2st Century, which di- “maturing” some of its basic assumptions and applying them rects DHS, “in coordination with other Federal departments broadly to the chemical, biological, radiological, nuclear and agencies,” to conduct assessments of the biological (CBRN) challenge. Significantly, HSPD-18 mandates more threat (The White House, 2004). incremental, integrated, and flexible policies on prepared- The first Department of Homeland Security bioterrorism ness and response to potential weapons of mass destruction risk assessment—referred to in this report as the Biologi- attacks. It concedes that the development and stockpiling of cal Threat Risk Assessment, or BTRA—was completed on medical countermeasures against every possible biological January 31, 2006. The report documenting the analysis, threat is not feasible today, and it calls for an integrated Bioterrorism Risk Assessment (DHS, 2006) was published on CBRN risk assessment. October 1, 2006, by the DHS Biological Threat Character- ization Center (BTCC) of the National Biodefense Analysis THE NATIONAL RESEARCH COUNCIL and Countermeasures Center (NBACC). This assessment ESTABLISHED THIS COMMITTEE and report satisfied the requirements of the National Strat- egy for Homeland Security (Office of Homeland Security, At the request of the Department of Homeland Security, 2002) and of HSPD-10 for DHS to assess the biological the National Research Council established the Committee weapons threat. DHS intended that the BTRA of 2006 be an on Methodological Improvements to the Department of “end-to-end risk assessment of the bioterrorism threat” with Homeland Security’s Biological Agent Risk Analysis to potential catastrophic consequences to human health and the provide a review, carried out in two reports (an interim report national economy and that it “assist and guide biodefense focused on near-term improvements and the final report to strategic planning” (DHS, 2006, Ch. 1, p. 1) in response to recommend longer-term improvements), of the methodology the HSPD-10 directive to “conduct biennial assessments of described in Bioterrorism Risk Assessment (DHS, 2006). biological threats.” Guided by the primary customers for The interim report, prepared by the committee in 2006, is information from the assessment—for example, the White included as Appendix J of the present report. House Homeland Security Council, the Department of To address its charge, the committee carried out the fol- Health and Human Services, various offices of the Depart- lowing activities: ment of Homeland Security, the Department of Agriculture, and the Environmental Protection Agency—the BTRA of • It held four 2-day meetings at the National Academies 2006 was designed to produce assessments in the form of in Washington, D.C., in August and November 2006 risk-prioritized groups of biological threat agents. These and in January and May 2007, used for information prioritized lists could then be used to identify gaps or vul- gathering and report organization and writing; nerabilities in the nation’s biodefense posture and to make • It heard and discussed presentations from government, recommendations for rebalancing and refining investments academic, and medical experts; in overall U.S. biodefense policy. • It received briefings on risk assessment for biological National Strategy for Combating Terrorism (The White pathogens from representatives of the White House House, 2006) describes U.S. efforts against terrorism of all Homeland Security Council, the DHS Office of Science

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 DEPARTMENT OF HOMELAND SECURITY BIOTERRORISM RISK ASSESSMENT • DHS should establish a clear statement of the long- and Technology, DHS’s National Biodefense Analysis term purposes of its bioterrorism risk analysis. and Countermeasures Center (NBACC), Battelle Me- • DHS should improve its analysis of intelligent morial Institute, and the Homeland Security Center for adversaries. Risk and Economic Analysis of Terrorism Events; • DHS should increase its risk analysis methodology’s • It reviewed DHS’s Bioterrorism Risk Assessment, pub- emphasis on risk management. lished in October 2006; and • Committee members visited the Battelle Memorial Institute in Columbus, Ohio, for further consultations The interim report also commented on the technical as- on October 2-3, 2006, because NBACC contracted pects of Battelle’s technique and the broader suitability of with Battelle to produce a computational engine to as- PRA. At the time it was written and under the circumstances sess the “normalized risk” of 28 pathogens as that risk of the writing of its interim report—that is, based solely on relates to death, morbidity, and direct economic costs.2 DHS presentations made at a single 2-day meeting and prior In federal fiscal year (FY) 2007, DHS directed Battelle to committee receipt of any complete written documenta- to improve and refine its probabilistic risk assessment tion of DHS’s methodology—the committee was guardedly (PRA). optimistic that DHS was on the right track. As is explained more fully in Chapter 3 of the present report, when the committee was able to examine DHS’s Bioterrorism Risk COMPLETION OF THE INTERIM REPORT Assessment (DHS, 2006), which describes the methodology The seven tasks of the committee with respect to the of the BTRA, it found underlying the analysis several aspects interim report of December 2006 (see Appendix J) were as of the event-tree structure that inherently limit the ability to follows: perform reliable risk assessment and to serve as a tool for risk managers. • To assess the adequacy of the DHS’s current meth- The committee pointed out in its interim report that the odology as a foundation for the desired risk analysis inability to model intelligent adversaries was a major weak- capabilities; ness in the BTRA methodology, and it recommended that • To identify any other risk analyses that rely on the DHS remedy that failing. The committee agreed that other major components of the existing methodology, proba- work planned by DHS for FY 2007, notably in improving bilistic risk analysis and multi-attribute risk analysis the elicitation of information from subject-matter experts and and which could guide DHS’s future developments; improving the modeling of consequences, was of value, and • To assess the feasibility of incorporating models of so it did not believe that a wholesale course correction was second-order economic effects into the methodology needed in FY 2007. during FY 2007; • To identify better methods, if any, for handling the high OVERVIEW OF THE FINAL REPORT degrees of uncertainty associated with the risk analyses AND OF ITS RECOMMENDED of biological agents; METHODOLOGICAL IMPROVEMENTS • To recommend near-term improvements to enhance the transparency of the method and its usefulness to Structure of the BTRA of 2006 Examined decision-makers; • To discuss how the methodology could be extended As indicated above, it was only after the issuance of its to risks associated with classes of agents, including interim report that the committee was provided with a copy enhanced or engineered agents that have yet to be of the DHS (2006) report documenting the BTRA method- developed; ology. The committee then gained additional information at • To discuss the feasibility of extending the methodol- subsequent meetings (as well as at focused visits to Battelle ogy to also serve as a framework for risk analysis of in Columbus, Ohio, with DHS personnel) that allowed spe- chemical or radioactive threats. cific examination of the technical content of the DHS (2006) report. This revised and more detailed picture assembled by In the interim report, the committee made three the committee revealed that PRA, as used in the BTRA of recommendations: 2006, is the wrong framework for modeling risks that are inherently dependent on the choices made by intelligent adversaries. The normalized risk assessments produced by such a process can be biased in ways and magnitude that 2 In general usage, the distinction between “direct” and “indirect” costs is cannot be determined. not precise. “Direct” refers to costs such as those associated with closing a In Chapter 3, the committee examines the structure of facility or controlling an epidemic. Other, or “indirect,” costs are those that the BTRA of 2006 more closely, explains the need to model result from these actions, such as lost business or reduced productivity.

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 INTRODUCTION intelligent adversaries, and addresses other mathematical and adopt, and perhaps disseminate for government-wide use. structural weaknesses of the BTRA. The detailed and care- The committee employs the broad term “risk analysis” to ful mathematical description and assessment of the BTRA incorporate the elements of problem formulation, risk as- described in Chapters 3 and 7, representing a major activity sessment, risk communication, and risk management. The of the committee, were not completed in time to be included committee regards the following four principles as central in the committee’s interim report. As a result, the last recom- to the risk analysis of the bioterrorism threat: mendation in Chapter 7 of this final report represents a sig- nificant change in the overall assessment of the BTRA from • Risk analysis needs to address bioterrorism uncertain- that made on page 12 of the interim report (page 146 of the ties: Probabilistic risk assessment is a proven tech- interim report as reprinted in Appendix J): “DHS’s current nique that can be used for managing the risks from methodology is adequate but incomplete.” bioterrorism. Chapter 4 establishes the need for risk management, in • Bioterrorism risk analysis requires access to multidis- part by looking at the “stakeholders,” or various users of ciplinary expertise: Key disciplines include biology, DHS’s assessment information, and recommends that the epidemiology, psychology, public communications, DHS risk analysis be part of a decision support system. In decision analysis and risk analysis, operations research, Chapter 7 and in Appendixes D, E, and F, the committee probability, and statistics. provides three methods of doing this modeling. • Risk analysis must be responsie to dynamic terrorism threats: Risk analysis must take into account changing threat conditions and their resource implications over Hypothetical Anthrax-Attack Scenario Employed time. Intelligent adversaries will adjust their strategies Thoughtfully developed, scenario-based exercises can and tactics to counter the U.S. ability to detect, prepare provide unique insights of value to public- and private-sector for, and respond to their attacks. Therefore, the nature decision makers responsible for the prevention of, prepara- of risk is a continuing evolution and will always be tion for, and response to bioterrorism. The notional scenario difficult to estimate. that the committee employs in this report, taken from Home- • The purpose of risk assessment is to support risk man- land Security Council (2004), can be used to add specificity agement: Policy makers should develop risk mitigation to discussions throughout the report. This scenario, involving measures that are informed by risk analysis, including an aerosol anthrax attack in a highly populated U.S. city, be- assessment of social, psychological, direct, and indirect gins with a single aerosol anthrax attack delivered by a truck economic impacts, and should apply such measures in using a concealed improvised spraying device in one densely a manner that consciously seeks to avoid unintended populated urban city with a significant commuter workforce. consequences. Anthrax spores, delivered by aerosol, result in inhalation anthrax, which develops when the spores are inhaled into Technical and Process Improvements Recommended the lungs and germinate into vegetative bacteria capable of causing disease. A progressive infection follows. Attacks This final report is intended to help DHS evaluate its are made in five separate metropolitan areas in a sequential progress on and to improve its methodological approach to manner. Three cities are attacked initially, followed by two biological agent risk assessment. The committee’s charge, additional cities 2 weeks later. The crisis stresses and breaks addressed in this report, is as follows: the response capabilities of all relevant public and private institutions, rapidly leading to 328,400 exposures; 13,200 • Recommend how the methodology can incorporate fatalities; and 13,300 other casualties. The full political, changing probability distributions that reflect how psychological, social, and economic impacts of the attack various actors (e.g., terrorists, first responders, public adversely affect national financial markets and consumer health community) adjust their choices over time or in confidence, devastate the local and regional economy, and different contexts; cause public faith in government to plummet across the • Recommend further improvements to the consequence country. analysis component of the methodology, including its models of economic effects; • Identify any emerging methods for handling large de- Lexicon of Risk Terminology Developed grees of uncertainty (e.g., fuzzy logic, possibility analy- This final report stresses the importance of clarity, preci- sis) that merit consideration for future incorporation; sion, and consistency in defining risk terminology. To ensure • Recommend further improvements to the transparency internal consistency in its own report, the committee devel- and usability of the methodology; oped a lexicon (Appendix A) which serves as an example • Discuss in more detail beyond the first report how the of the sort of clear terminology that DHS should develop, methodology could be extended to risks associated with

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10 DEPARTMENT OF HOMELAND SECURITY BIOTERRORISM RISK ASSESSMENT classes of agents, including enhanced or engineered In the committee’s view, it is imperative that the bioter- agents that have yet to be developed; and rorism threat risk assessment be used to facilitate a coherent • Discuss in more detail beyond the first report the feasi- strategy of risk management against a grave and growing bility of extending the methodology to also serve as a threat to U.S. security. The committee believes that its work framework for risk analysis of chemical or radioactive will assist the federal government, as a top priority, to mature threats. the DHS risk assessment methodology as the foundation of risk management by all the relevant stakeholders. In January 2006, the Office of Management and Budget (OMB) issued technical guidance for risk assessment. A REFERENCES report from the National Research Council (NRC, 2007) Congressional Research Service. 2003. The Biowatch Program: Detection entitled Scientific Review of the Proposed Risk Assessment of Terrorism. Report RL32152. Available at www.fas.org/sgp/crs/terror/ Bulletin from the Office of Management and Budget identi- RL32152.html#_1_1. Accessed July 23, 2007. fied, in the OMB guidance, many of the same problems cited DHS (Department of Homeland Security). 2006. Bioterrorism Risk Assess- in the present report: unclear technical definitions, improper ment. Biological Threat Characterization Center of the National Biode- uncertainty analysis and use of expected values, and poorly fense Analysis and Countermeasures Center. Fort Detrick, Md. Drell, Sidney D., Abraham D. Sofaer, and George D. Wilson (eds.). 1999. conceived consequence analysis. The present report recom- The New Terror: Facing the Threat of Biological and Chemical Weap- mends technical and process improvements that are intended ons. Stanford, Calif.: Hoover Institution Press. to make DHS risk assessment methodology more under- Homeland Security Council. 2004. “Scenario 2: Biological Attack—Aerosol standable, more credible, easier to communicate, and both Anthrax,” in Planning Scenarios. July. Available at www.globalsecurity. defensible and useful at every major decision-making point org/security/library/report/2004/hsc-planning-scenarios-jul04.htm#toc. Accessed November 14, 2007. in a comprehensive and effective risk management system. National Intelligence Council. 2004. Mapping the Global Future: Report of In Chapter 2 the committee examines the broader context the National Intelligence Council’s Project Based on Consultation with of the risk assessment methodology; in Chapter 3 it examines Nongovernmental Experts Around the World. Washington, D.C.: U.S. the implementation of the BTRA by the Battelle Memorial Government Printing Office. Institute, Columbus, Ohio; and in Chapters 3 through 7 the Negroponte, John D. 2007. Annual Threat Assessment (unclassified for the Record). Testimony before the Senate Select Committee on Intelligence. committee recommends improvements in the methodology. U.S. Senate. Washington, D.C. January 11. The report’s 13 appendixes provide the following: NRC (National Research Council). 2007. Scientific Review of the Proposed Risk Assessment Bulletin from the Office of Management and Budget. • A: A lexicon containing the technical terms used in this Washington, D.C.: The National Academies Press. report; Office of Homeland Security. 2002. National Strategy for Homeland Security. Available at www.dhs.gov/xlibrary/assets/nat_strat_hls.pdf. • B: A concise mathematical description of the 2006 Accessed November 1, 2006. BTRA event tree; U.S. Commission on National Security in the 21st Century. 1999. New • C: A numerical example illustrating the simplification World Coming: American Security in the 21st Century. Washington, of probability assessment; D.C.: U.S. Government Printing Office. • D: An alternative model for risk assessment using deci- The White House. 2004. Homeland Security Presidential Directive 10 [HSPD-10]: Biodefense for the 21st Century. Available at www.fas. sion trees: org/irp/offdocs/nspd/hspd-10.html. Accessed January 16, 2008. • E: An alternative model for risk assessment using math- The White House. 2006. National Strategy for Combating Terrorism. ematical optimization; Available at www.state.gov/s/ct/rls/wh/71803.htm#overview. Accessed • F: An alternative model and example of risk assessment July 23, 2007. using game theory; The White House. 2007. Homeland Security Presidential Directive 18 [HSPD-18]: Medical Countermeasures Against Weapons of Mass • G: A discussion of alternative means to quantify Destruction. Available at www.fas.org/irp/offdocs/nspd/hspd-18.html. uncertainty; Accessed January 16, 2008. • H: A discussion of the role of interdependencies in WMD Commission (Commission on the Intelligence Capabilities of the managing risk; United States Regarding Weapons of Mass Destruction). 2005. The • I: An independent review of the BTRA of 2006; Report on the Intelligence Capabilities of the United States Regarding Weapons of Mass Destruction. Available at www.wmd.gov/report. Ac- • J: A reprint of the committee’s interim report; cessed January 16, 2008. • K: The meeting agendas of the committee; • L: Biographies of committee members; and • M: A list of acronyms used in this report.