Reports by congressional commissions, the mention of bioterrorism in President Obama's 2010 State of the Union address, 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. Continued attempts by terrorist groups to launch attacks targeted at U.S. citizens, including those in transit to U.S. soil, 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. 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. In contrast, other experts assert that the bioterrorism threat is less severe or pressing than that posed by more conventional terrorism or other issues facing the United States. 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. Stakeholders often measure federal efforts against the perceived magnitude of the threat. Thus, those who believe that bioterrorism poses a relatively low threat tend to conclude that the government has done too much. In contrast, those 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 agencies and vary widely in their resources, scope, and approach. For example, the Departments of State and Defense have cooperated with foreign governments and nongovernmental organizations to engage in nonproliferation, counterproliferation, and foreign disease outbreak detection efforts. The Departments of State and Commerce have strengthened export controls of materials that could be used for bioterrorism. The Department of Health and Human Services (HHS) has made investments in public health preparedness; response planning; foreign disease outbreak detection; and research, development, and procurement of medical countermeasures against biological terrorism agents (see " Medical Countermeasures " below). The intelligence community has engaged in intelligence gathering and sharing regarding bioterrorism. The Department of Justice performs background checks on people who want to possess certain dangerous pathogens. The Department of Homeland Security (DHS) has engaged in preparedness, response, and recovery-related activities, developed increased capabilities in environmental biosurveillance (see " Biosurveillance " below), and invested in expanding domestic bioforensics capabilities. The Environmental Protection Agency (EPA) has explored post-event infrastructure decontamination. Many agencies, jointly or separately, have invested in expanded biodefense infrastructure, including public and private high-containment laboratories for research, diagnostic, and forensics purposes. Lastly, the Executive Office of the President and other executive branch coordinating groups have engaged in risk assessment and strategic planning exercises to coordinate and optimize federal investment against bioterrorism and response capabilities. 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. Providing oversight and direction for individual biodefense agencies or programs is easier than addressing the entirety of the biodefense enterprise at once, but such an approach may focus too narrowly to improve the overall effort. 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. 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 consideration. This report does not attempt to address all biodefense issues of potential congressional interest. Although outside the scope of this report, state and local governments, private industry, and our international partners play key roles in defending against the threat of bioterrorism. 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. 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. In addition, the Bush Administration developed a series of national strategies and other guidance documents for homeland security generally and biodefense in specific. 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. Congress has acted to require federal strategic planning activities through provisions of the Homeland Security Act of 2002 ( P.L. 107-296 ), the Pandemic and All-Hazards Preparedness Act ( P.L. 109-417 ), and other legislation. In addition to establishing DHS, Congress has created offices and agencies within other Cabinet departments and assigned them specific planning activities. Finally, Congress established an office within the Executive Office of the President charged with preventing WMD proliferation and terrorism. Policymakers, analysts, and other experts have criticized federal efforts at strategic planning. Some experts have criticized White House led cross-agency planning as lacking metrics and measures, failing to encompass the full range of threats, and insufficiently meeting stated goals. Policymakers have critiqued efforts by federal agencies to develop multi-agency plans as lacking metrics. 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. Agency implementation, translating strategic goals into effective programs and policies, will remain a key component of successful federal biodefense activities. 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, as a body, could enact legislation to require a more robust and transparent government-wide strategic plan that articulates clear goals, metrics and priorities; a periodic comprehensive report detailing biodefense activities government-wide; or the development of a national framework to organize and prioritize biodefense investments. 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. Congress could also require the creation of implementation plans, linking agency activities with meeting the required, desired strategic goals. 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 Review or the National Strategy for Pandemic Influenza and its implementation guide, for cross-agency federal biodefense activities. Through oversight activities, congressional committees of jurisdiction have a key role in assessing the completeness of ongoing planning. Because of the broad oversight responsibilities of congressional committees, congressional policymakers may identify synergies and duplications between agency efforts more easily than decision-makers within individual agencies. 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 may also be able to assess whether current plans appropriately factor in the roles of private industry, states, and our international partners. Some experts have suggested that Congress might optimize oversight of federal homeland security efforts if fewer committees and subcommittees maintained jurisdiction over homeland security. 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. On the other hand, such consolidation might decrease the level of congressional scrutiny, since fewer committees with broader homeland security mandates might have less time and fewer resources to focus on individual agencies and activities. 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. Unfortunately, the nature of the bioterrorism threat, with its high consequences and low frequency, makes determining the bioterrorism risk difficult. Additionally, the presence of an intelligent adversary who can adapt to the presence of successful countermeasures complicates the use of standard risk assessment techniques. 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, but its use of these risk assessments for planning purposes has been strongly criticized by outside experts. These experts assert that the DHS risk assessments do not adequately address the decision-making process of an intelligent adversary. Regardless of the complexity of the risk assessment methodology, the inherent uncertainties associated with assessing risk in a counterterrorism context likely necessitate retaining some level of flexibility in managing risk. 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. Unlike most other terrorist attacks, a biological attack could infect victims without their knowledge. Days or weeks might pass before victims develop symptoms. Health practitioners treating infected, symptomatic individuals might be the first to 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. The sooner officials identify an attack, the sooner treatment of the exposed individuals could begin. Earlier treatment generally increases the likelihood of individual survival and recovery. The Bush Administration implemented a number of different detection approaches, including environmental detection, syndromic surveillance, and information sharing. 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. Similarly, the federal government has continued to invest in some global health activities partly to help identify when an emerging disease might pose a threat to the United States. Government and outside experts have both criticized and supported these efforts. Widespread deployment of environmental biosurveillance technologies by the federal government 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 dependability to allow for a federal response following detection of a bioterrorism event. 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. Congress may remain interested in these programs. The DHS has developed and deployed the next generation of environmental detectors more slowly than it originally predicted. Congress may seek to determine whether the current plans for capabilities and coverage of surveillance sufficiently protect the population. Appropriators could provide additional funds and authorizing committees could provide additional oversight or guidance to encourage the completion of the deployment of these detectors. Alternatively, the appropriation committees and the authorizing committees could determine that potential decreases in risk provided by this program does not support continued investment. 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. Effective medical countermeasures could significantly decrease the impact of a bioterrorist attack. Several federal agencies, described below, have 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. Many potential bioterrorism agents lack available medical countermeasures. To help address this, the federal government invested billions of dollars in research and development that might lead to effective medical countermeasures. The Department of Health and Human Services (HHS) 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). Additionally, efforts undertaken by the Department of Defense (DOD) to protect warfighters may also contribute to civilian biodefense. As a result of the 2010 Public Health Emergency Medical Countermeasures Enterprise review, HHS has called for the creation of dedicated centers to improve advanced development of medical countermeasures in both HHS and DOD and the establishment of a venture capital entity to spur private sector biodefense research investment. 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. 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. Policymakers often face the challenge of determining the optimal balance of funding between competing stages of the research and development process. While Congress, as a body, 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. Current fiscal pressures will likely exacerbate the difficult decisions regarding appropriate funding levels. Congress may consider whether the federal government appropriately leverages efforts by other stakeholders including state government, academia, and the private sector. Policymakers may also consider whether the federal government should reduce its dominant role in countermeasure 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. 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. As a single entity, the federal government is by far the largest procurer of bioterrorism medical countermeasures. It stockpiles countermeasures and keeps them ready for deployment to respond to a bioterrorism event. 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. These efforts have met with mixed success. 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. The HHS has also planned a public-private partnership that would create flexible manufacturing infrastructure to lower barriers to desired countermeasure manufacture. A variety of experts, commissions, and policymakers have characterized the federal government's efforts to partner with private sector countermeasure developers as underfunded, unclear, or insufficient. 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. Companies and think tanks continue to state that the government should better communicate to developers the countermeasures it would like 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. 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. Congress may choose, as it has in some previous years, to use money advance appropriated for countermeasure procurement to support countermeasure development. 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, Congress may provide additional appropriations or create new authorities for HHS, supporting recommendations formed by various assessments of HHS's countermeasure enterprise. 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. The Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), state and local governments, and industry partners play key roles in distributing emergency medical countermeasures. The FDA regulates distribution of pharmaceuticals and biological products and has certain authorities to permit the emergency use of unapproved products. The CDC maintains the Strategic National Stockpile (SNS) and when requested delivers it to state and local governments for distribution. State and local governments are responsible for developing and exercising distribution plans. In addition to producing emergency medical countermeasures, industrial partners store some of the SNS and may play a role in state and local distribution plans. 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 providing 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. Congress may face decisions regarding the acceptable ways to disseminate medical countermeasures in an emergency situation, whether the advantages of alternative distribution mechanisms outweigh the potential drawbacks of lowered oversight and control of countermeasure use, and whether the federal government has effectively leveraged private sector resources to improve distribution. Some experts have suggested the FDA should have new legal authorities and should develop new policy and regulatory frameworks to improve the distribution process during an emergency. Congress may consider whether current FDA authorities are adequate to address medical countermeasure emergency distribution issues and if not whether deficiencies should be addressed through new legislative activity or through solely executive branch action. While no mass-casualty bioterrorism event has yet occurred in the United States, some experts and policymakers assert that terrorist organizations are attempting to develop such a capability. 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 may 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.

Summary:
Reports by congressional commissions, the mention of bioterrorism in President Obama's 2010 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. Continued attempts by terrorist groups to launch attacks targeted at U.S. citizens have increased concerns that federal counterterrorism activities insufficiently address the threat. Key questions face congressional policymakers: How adequately do the efforts already under way address the threat of bioterrorism? Have the federal investments to date met the expectations of Congress and 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? 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, congressional commissions, nongovernmental organizations, industry representatives, and other experts have highlighted weaknesses or flaws in the federal government's biodefense activities. Reports by congressional commissions have stated that the federal government could significantly improve its efforts to address the bioterrorism threat. 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 oversight activities, continues to influence the federal response to the bioterrorism threat. Congressional policymakers may face many difficult choices about the priority of maintaining, shrinking, or expanding existing programs or creating new programs to address identified deficiencies. Augmenting or creating programs may result in additional costs in a time of fiscal challenges. Maintaining or shrinking programs may pose unacceptable risks, given the potential for significant casualties and economic effects from a large-scale bioterror attack.