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steps taken by the federal government to develop a national strategy and the collaborative network to support it (see the next section) are still incomplete. The completion of these steps would require continuous multidisciplinary analysis and engage multiple stakeholders across functional disciplines as well as across federal, state, local, and tribal governments. The anthrax attacks in the United States in the period after 9/11 added urgency to the need for such an effort.


Executive and legislative actions taken since 9/11 have sharpened the federal government’s focus on bioterrorism. The Congress in November 2002 passed and the president signed the Homeland Security Act (Public Law No. 107-296), which established the Department of Homeland Security (DHS) and gave it the responsibility for developing countermeasures to biological agents. In April 2004, President Bush issued Homeland Security Presidential Directive 10 (HSPD-10): Biodefense for the 21st Century, which directs DHS, “in coordination with other Federal departments and agencies,” to conduct assessments of the biological threat (The White House, 2004).

The first Department of Homeland Security bioterrorism risk assessment—referred to in this report as the Biological Threat Risk Assessment, or BTRA—was completed on January 31, 2006. The report documenting the analysis, Bioterrorism Risk Assessment (DHS, 2006) was published on October 1, 2006, by the DHS Biological Threat Characterization Center (BTCC) of the National Biodefense Analysis and Countermeasures Center (NBACC). This assessment and report satisfied the requirements of the National Strategy for Homeland Security (Office of Homeland Security, 2002) and of HSPD-10 for DHS to assess the biological weapons threat. DHS intended that the BTRA of 2006 be an “end-to-end risk assessment of the bioterrorism threat” with potential catastrophic consequences to human health and the national economy and that it “assist and guide biodefense strategic planning” (DHS, 2006, Ch. 1, p. 1) in response to the HSPD-10 directive to “conduct biennial assessments of biological threats.” Guided by the primary customers for information from the assessment—for example, the White House Homeland Security Council, the Department of Health and Human Services, various offices of the Department of Homeland Security, the Department of Agriculture, and the Environmental Protection Agency—the BTRA of 2006 was designed to produce assessments in the form of risk-prioritized groups of biological threat agents. These prioritized lists could then be used to identify gaps or vulnerabilities in the nation’s biodefense posture and to make recommendations for rebalancing and refining investments in overall U.S. biodefense policy.

National Strategy for Combating Terrorism (The White House, 2006) describes U.S. efforts against terrorism of all kinds, not just bioterrorism, and serves as guidance for the specific application of efforts against bioterrorism.

The Department of Homeland Security has made the preparation against biological weapons attacks a priority and deployed the BioWatch Program to provide early warning of an outdoor pathogen release in selected areas across the United States (Congressional Research Service, 2003). The BioWatch Program has three main elements: sampling, analysis, and response. The Environmental Protection Agency maintains the sensors that collect airborne particles. The Centers for Disease Control and Prevention coordinates analyses. Local jurisdictions are responsible for the public health response to positive findings. The Federal Bureau of Investigation is designated as the lead agency for the law enforcement response if a bioterrorism event is detected.

In January 2007, the White House issued Homeland Security Presidential Directive 18 (HSPD-18): Medical Countermeasures Against Weapons of Mass Destruction (The White House, 2007), which builds on HSPD-10 while “maturing” some of its basic assumptions and applying them broadly to the chemical, biological, radiological, nuclear (CBRN) challenge. Significantly, HSPD-18 mandates more incremental, integrated, and flexible policies on preparedness and response to potential weapons of mass destruction attacks. It concedes that the development and stockpiling of medical countermeasures against every possible biological threat is not feasible today, and it calls for an integrated CBRN risk assessment.


At the request of the Department of Homeland Security, the National Research Council established the Committee on Methodological Improvements to the Department of Homeland Security’s Biological Agent Risk Analysis to provide a review, carried out in two reports (an interim report focused on near-term improvements and the final report to recommend longer-term improvements), of the methodology described in Bioterrorism Risk Assessment (DHS, 2006). The interim report, prepared by the committee in 2006, is included as Appendix J of the present report.

To address its charge, the committee carried out the following activities:

  • It held four 2-day meetings at the National Academies in Washington, D.C., in August and November 2006 and in January and May 2007, used for information gathering and report organization and writing;

  • It heard and discussed presentations from government, academic, and medical experts;

  • It received briefings on risk assessment for biological pathogens from representatives of the White House Homeland Security Council, the DHS Office of Science

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