Several presidential directives and national strategies establish biodefense policy for the federal government. These directives establish overall goals and policies as well as assign specific responsibilities to federal agencies. See table 1 for relevant directives and strategies. Among these directives, the White House released HSPD-10 in 2004, which outlines the structure of the biodefense enterprise and discusses various federal efforts and responsibilities that help to support it. The directive organizes biodefense efforts into four key pillars, consisting of threat awareness, prevention and protection, surveillance and detection, and response and recovery. Each of these pillars comprise numerous activities—such as conducting research on emerging pathogens that could pose a threat—that are carried out by multiple federal agencies and generally require coordination across the entire biodefense enterprise. The biological threat landscape is vast and requires a multidisciplinary approach to developing threat awareness. Synthetic biology, if used to create and combine agents, also poses a significant threat and potentially complicates the ability to assess the biological threat landscape. Despite ratification of the Biological Weapons Convention in 1975 and the end of the Cold War decades later, the threat of biological warfare persists today. For example, as the Blue Ribbon Study Panel on Biodefense reported, the State Department assessed in 2015 that China, Iran, North Korea, Russia, and Syria continue to engage in dual-use or biological weapons-specific activities and are failing to comply with the convention, to which each of these countries has agreed. Additionally, the revolution in biotechnology presents opportunities to advance the life sciences, yet that same technology in the wrong hands could be used to create biological weapons. For example, nonstate actors such as terrorist organizations, domestic militia groups, and “lone wolves” have both the interest and capacity to develop biological weapons. The intelligence community plays a key role in assessing these types of threats. Threat awareness is also challenged by the unpredictable nature of naturally occurring disease, which could affect human and animal health and agricultural security, potentially causing global catastrophic biological risks which could lead to loss of life, and sustained damage to the economy, societal stability, or global security. To assess and develop means to combat these threats, many federal agencies conduct biological threat awareness activities, which may include a combination of risk assessment and key activities to better understand certain characteristics of biological threats. For example, the genetic compositions of some viruses naturally change, as exemplified in 2009, when an H1N1 influenza virus emerged with a new combination of genes, causing a global pandemic. According to the Centers for Disease Control and Prevention (CDC)—an entity within HHS—when these significant genetic changes occur in a virus, most people have little or no immunity to the new virus. Climate change also has the potential to negatively impact human health and the agriculture industry. As we reported in October 2015, climate change may contribute to the spread of vector-borne diseases that are transmitted to humans by animals, including invertebrate animals such as mosquitoes and ticks. Examples of vector- borne diseases that currently pose health risks in some regions of North America include chikungunya disease, dengue fever, Lyme disease, and West Nile virus fever. Additionally, habitat loss and human encroachment on rural and wildlife environments are bringing populations of humans and animals into closer and more frequent contact, increasing the risk of disease transmission among people, pets, livestock, and wildlife. Finally, the scientific community must safeguard the biological agents it uses to assess threats. Protecting laboratory workers and the population at large from intentional or accidental release of dangerous pathogens during the pursuit of more knowledge about them is also challenging. Recent high-profile events, such as a DOD laboratory inadvertently shipping incompletely inactivated samples of Bacillus anthracis, the bacterium that causes anthrax, to almost 200 laboratories worldwide over the course of 12 years and the unexpected discovery of misplaced vials of smallpox (variola) virus at the National Institutes of Health (NIH) campus, also highlight the threat due to improper handling and unknown storage of dangerous biological agents. Several federal departments and agencies have responsibilities as part of their mission to assess the threat of biological agents and carry out key biodefense roles as delineated in HSPD-10 and the National Strategy for Countering Biological Threats, among other documents. National Biodefense Analysis and Countermeasures Center (NBACC) NBACC consists of two centers: National Biological Threat Characterization Center Its mission supports national goals to deter and reduce the impact of current and newly identified biological threats by providing timely scientific data, knowledge products, and expertise required for accurate and informed threat analyses and biodefense planning, preparedness, response, and recovery. National Bioforensics Analysis Center It serves as the lead federal facility to conduct and facilitate the technical forensic analysis and interpretation of materials from biocrime and bioterror investigations or those recovered following a biological attack in support of the lead federal agency. Department of Homeland Security. DHS is the principal federal department with responsibility for domestic incident management and supports federal efforts to prepare for, respond to, and recover from domestic biological attacks. Within DHS, the Science & Technology Directorate’s (S&T) Chemical and Biological Defense (CBD) Division leads key efforts related to enhancing threat awareness with a focus on bioterrorism. S&T develops Material Threat Assessments in collaboration with HHS, as well as the BTRA, which includes assessments of the relative risks posed by biological agents based on variable threats, vulnerabilities, and consequences. S&T also operates NBACC, which conducts scientific research and develops reports and products specifically intended to address identified knowledge gaps associated with current and future biological threats, including the characterization of key attributes of biological attacks by an adversary such as agent acquisition; agent production; dissemination methods; virulence; and the effectiveness of potential countermeasures. Department of Defense. DOD is responsible for protecting U.S. armed forces from biological threats worldwide and conducts a range of efforts to support research, development, and acquisition of medical countermeasures and other technologies to prevent or mitigate the health effects of biological agents and naturally occurring diseases. Multiple organizations across DOD are responsible for a number of activities, including (1) determining requirements; (2) providing science and technology expertise; (3) conducting research, development, test, and evaluation; and (4) providing oversight. This enterprise is structured to conduct research and develop defenses against chemical and biological threats. Department of Health and Human Services. HHS is the federal agency primarily responsible for identifying needed medical countermeasures to prevent or mitigate potential health effects from exposure to biological agents for the nation and engaging with industry to develop them. In 2006, HHS established the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE), a federal interagency body that is responsible for providing recommendations on medical countermeasure priorities and development and acquisition activities. Within HHS, the Office of the Assistant Secretary for Preparedness and Response (ASPR) leads PHEMCE and the federal medical and public health response to public health emergencies, including strategic planning, medical countermeasure prioritization, medical countermeasure requirements development, and support for developing and procuring medical countermeasures for the Strategic National Stockpile. CDC maintains the Strategic National Stockpile and supports state and local public health departments’ efforts to detect and respond to public health emergencies, including providing guidance and recommendations for the mass distribution and use of medical countermeasures, among other activities. The agency also engages in laboratory detection of diseases and epidemiological investigation of outbreaks to protect the nation from health, safety, and security threats, both foreign and in the United States. The Food and Drug Administration (FDA) conducts research and performs vulnerability assessments to help prevent adulteration of the food supply. NIH conducts and funds basic and applied research to develop new or enhanced medical countermeasures and related medical tools and provides oversight and guidance on biosafety and biosecurity to research laboratories. U.S. Department of Agriculture. USDA is the lead agency with responsibility to protect and improve the health, quality, and marketability of our nation’s agricultural products. Within USDA, the Animal and Plant Health Inspection Service (APHIS) is responsible for working to prevent, control, or eliminate harmful pests, pathogens, and diseases of animals and plants. APHIS consists of multiple component units with key roles in biodefense including Veterinary Services, and the Plant Protection and Quarantine (PPQ) program. These offices are supported by multiple research centers and laboratory networks, as well as the Agricultural Research Service (ARS), which conducts a wide range of research addressing agricultural issues of high national priority. Environmental Protection Agency. EPA is the lead agency for environmental cleanup and remediation, including indoor cleanups. EPA is also the lead federal agency for protecting drinking water and wastewater infrastructure. In addition, EPA provides technical assistance and operational support for sampling, characterization, decontamination, clearance, and waste-management efforts. According to EPA officials, if there is potential for environmental contamination due to a biological incident, HHS collaborates with EPA in developing and implementing sampling strategies and sharing results. EPA’s Office of Research and Development’s Homeland Security Research Program aims to help increase the capabilities of EPA and communities to prepare for and respond to chemical, biological, and radiological disasters. EPA’s Water Security Division also provides resources to monitor incidents and threats. Key biodefense agencies, including DHS, DOD, HHS, USDA, and EPA rely on intelligence and global surveillance information, scientific study of disease agent characteristics, and analysis to better understand threats and help make decisions about biodefense investments. Figure 1 depicts the three components of threat awareness described in this report. Key federal biodefense agencies use intelligence to understand adversaries’ capabilities to cause harm with a biological weapon and conduct global disease surveillance to monitor threats from naturally occurring agents. DHS and DOD rely on information from the intelligence community about adversaries’ capabilities to acquire, produce, reengineer, and disseminate a biological agent. For example, DHS solicits information from the intelligence community to create models on nonstate actors’ possible target (e.g., a transportation hub), the possible agent and amount used, and the method of attack. DHS also gathers information on terrorist organizations’ financial and technical resources to help determine their capabilities in staging an attack. This information is used to develop the BTRA to support DHS’s responsibilities to protect against non-state actor intentional acts of bioterrorism. For more information on the BTRA and its development and evolution, see appendix I. Predicting the Threat of Zika Virus Spread to the United States Based on Chikungunya and Dengue Zika virus is a flavivirus that is primarily spread in humans by the same mosquitos that also spread dengue, chikungunya, and other viruses. The first confirmed local transmission of this emerging threat in Brazil occurred in May 2015. Since that time, the Centers for Disease Control and Prevention’s (CDC) Global Disease Detection Operations Center has been monitoring the spread of the epidemic from Brazil to other countries in the Americas. By early 2016, the Zika virus had spread to dozens of countries, including local transmission in U.S. territories. At this time, CDC activated its Emergency Operations Center to respond to outbreaks of Zika occurring in the Americas, and enhance disease surveillance and response coordination. In February 2016, the director of CDC said that recent chikungunya and dengue outbreaks in the United States suggest that Zika outbreaks in the U.S. mainland may be relatively small and localized, which can be attributed to better infrastructure and mosquito control than that found in Latin America. In contrast, he said outbreaks of dengue and chikungunya suggest that Zika virus may spread widely in the U.S. territories. CDC estimates of Zika virus cases for 2016 support the CDC director’s prediction, with 224 locally acquired mosquito-borne cases in the United States (in Florida and Texas) compared to nearly 36,000 locally acquired cases in U.S. territories (largely in Puerto Rico). Efforts to improve international capacity for virus surveillance support CDC’s ability to characterize emerging threats and enhance threat awareness. subjects. It projects foreign capabilities in particular warfare areas out 20 years in the future. Other agencies, such as HHS and USDA, rely on global disease surveillance to identify and characterize naturally occurring disease events that may impact human, animal, or plant health. Although surveillance and detection activities constitute an entire separate pillar of the biodefense enterprise, these activities can also help federal agencies enhance threat awareness by providing information about emerging global disease events that might affect the United States. For example, within HHS, CDC’s Global Disease Detection program conducts global surveillance on emerging infectious disease events to rapidly detect and monitor the characteristics of the disease event to determine whether and what kind of threat it poses to the U.S. population. Similarly, within USDA, APHIS conducts surveillance of foreign animal diseases and plant pests and pathogens to determine what threat they may pose to the U.S. agriculture industry. APHIS officials said they have a number of relationships and sources they use to gather information on traditional and emerging animal diseases. These include the National Center for Medical Intelligence within DIA, DHS’s National Biosurveillance Integration Center, CDC, and the World Organisation for Animal Health. USDA’s Risk Identification and Risk Assessment unit conducts open source monitoring globally to identify situations of greatest risk to the animal agriculture community. For plant surveillance, USDA’s PestLens is an offshore open-source monitoring and analysis function designed to identify emerging pests and diseases. The PestLens team stationed overseas evaluates these potential threats for their impact on trade and identifies threats to look for at ports. It conducts research to determine whether there are outbreaks of disease or pests in other countries. Epidemiology Terms Virulence is the relative capacity of a pathogen to overcome body defenses. Pathogenesis is the process by which an infection leads to disease. Infectious dose is an estimate of the amount of a pathogen required to cause illness. Zoonotic disease is an infectious disease that is transmissible from animals to humans. Agencies use scientific research to help understand the characteristics of various threat agents, including their virulence, stability, and ability to be dispersed through various methods. Agencies also perform or contract for scientific research on emerging pathogens to understand their means of transmission, host susceptibility, and effects of infection. Research is conducted on agents that may be used intentionally as biological weapons or on disease-causing agents that may exist in nature and contribute to outbreaks or pandemics, such as influenza viruses. One example of DHS-conducted scientific research is NBACC’s work to understand properties associated with agent acquisition, production, dissemination, stability, virulence and pathogenesis, and existing medical countermeasure efficacy. A DOD example of scientific research is DTRA’s efforts to characterize biological agents (virulence, dissemination, infectious dose, etc.). For instance, DTRA might fund research to determine whether current diagnostic tools would be adequate if the Ebola virus’s genetic sequence were to change. For conducting scientific research to characterize naturally occurring threats, HHS and USDA agencies engage in a spectrum of activities. Within HHS, CDC, NIH, and FDA all conduct various scientific research to characterize biological agents. For example, CDC conducts characterization of infectious diseases, including analyses of pathogenesis, and works to identify uncommon signals of disease and conduct research to assess zoonotic potential. One effort CDC has to characterize an infectious disease is the Influenza Risk Assessment Tool that assesses potential pandemic risk. NIH also conducts characterization research—such as pathogenesis, infectious dosage rates, and potential effects if agents are aerosolized—primarily for known public health threats, which may also be used as inputs into modeling. Additionally, FDA conducts scientific food defense research to understand, among other things, thermal stability and inactivation of biological agents. Within USDA, ARS also conducts basic biological research on animal and plant pathogens. Because of the sheer volume of animal diseases, ARS takes a strategic approach to research and study families of viruses, rather than a single virus. For example, ARS officials said they were able to leverage ongoing research on flaviviruses when Zika virus, a flavivirus, emerged in the Americas. ARS is also trying to use more predictive biology to anticipate and properly prepare for new and emerging pathogens—such as understanding vector-borne virus adaptability to potentially prevent transmission to humans—to ensure the public and animal health, as 70 percent of new and emerging diseases are zoonotic. ARS researchers also look at pests and pathogens not currently in the United States to help identify countermeasures, should they appear. Additionally, EPA conducts research to fill science gaps associated with environmental contamination resulting from accidental or intentional releases of biological agents. For example, EPA studies the behavior of biological agents in the environment to inform strategies for characterization and remediation. Research includes developing methods for characterization of persistent biological contamination, mitigating its impacts, cleaning it up in the environment, and managing the subsequent waste. All agencies we interviewed described modeling studies and other analytical work they conduct to help determine the scope and impact of possible biological threats. For example, because biological threat agents cannot be released into the air in operational environments due to health risks, programs such as DHS’s BioWatch Program rely on computer modeling and attack simulations to assess the performance of biological detection systems. DHS also uses the BTRA modeling to assess potential public health impacts and mitigation efforts for potential biological attacks (see app. I). Similarly, according to DOD officials, DTRA develops and employs modeling and simulation tools for consequence assessment of biological attacks within and outside of the United States. HHS conducts public health consequence modeling for various types of attacks with specific agents, which uses inputs from DHS Material Threat Assessments to help determine the unmitigated medical consequences. Unmitigated consequence estimates are modeled based on factors such as projected spread patterns, infectious dose rates, and estimated time frames, which can help inform response efforts that could mitigate these consequences such as needed prophylaxis and medical countermeasures as part of the PHEMCE process. The public health and medical consequence assessment is the first step in developing the documents necessary for the PHEMCE to establish medical countermeasure requirements. This analysis allows PHEMCE to determine how many lives could be saved if a medical countermeasure were developed, procured, and deployed, and informs HHS decisions regarding the development of medical countermeasures that might be needed during an event. HHS and USDA also conduct disease patterns and pathways analysis to determine the routes by which certain pathogens found overseas might arrive in the United States. For example, CDC conducts modeling to identify modes of transmission, sources and nodes; and to project epidemiological patterns. One such example is a 2015 CDC study to estimate future numbers of Ebola patients needing treatment at any one time in the United States. The model was developed to help public health officials assess the potential risk for Ebola virus infection in individual travelers and the subsequent need for postarrival monitoring. USDA units also use pathways analysis to assess the likelihood and means by which animal diseases and plant pests might arrive in the United States. For example, USDA Plant Protection and Quarantine (PPQ) evaluates the environmental and economic impacts of pest introduction, and the pathways by which certain pests might arrive (e.g., imported commodities via ship or rail). Additionally, EPA supports water utilities by providing models, tools, and guidance that help harden their infrastructure to respond to and recover from contamination incidents and other disasters, as contamination of drinking water can result from acts of terrorism. Agency officials in our review described how their threat awareness activities help identify biological threat agents of concern and broad- based capability needs, which help guide their biodefense investment decisions. For example, agencies use threat information to determine which agents represent their highest priorities based on the potential of those agents to cause catastrophic harm. Officials from HHS and USDA also described properties or criteria against which they evaluate emerging or reemerging biological agents while conducting surveillance activities to determine whether they pose a serious threat, such as: health effects after exposure to an agent or toxin, degree of contagiousness, economic and trade impact, and likely transmission routes. This threat assessment activity allows agencies to characterize and respond to urgent or real-time disease events, such as a Zika virus or an avian influenza outbreak. In addition to agent-specific approaches, some agencies also reported using threat awareness information as part of efforts to identify and develop broader capabilities that would prepare them to respond to more than one agent. For example, DOD looks at what types of protective equipment are needed to complete the mission in the face of various threats, rather than starting with an individual threat agent. DOD’s Joint Requirements Office (JRO) uses a broad capability-based approach by performing operational risk assessments to evaluate current and future capability needs that will translate into military service requirements. Additionally, HHS, through PHEMCE, reported working on broad capabilities-based investments for medical countermeasures that provide more flexible and sustainable capabilities over the long term. In this regard, PHEMCE seeks to promote technologies that have more than one application or are able to be quickly modified to respond to new threats. For example, according to the PHEMCE Strategy and Implementation Plan, HHS agencies continue to expand their broad-spectrum antimicrobial programs to address both biodefense disease threats, such as plague and tularemia, and the more general public health concern of antimicrobial resistance. Investments in multiplex diagnostic tools also represent a move beyond single-agent detection capabilities. Once threats have been established and capability gaps have been identified, agencies reported using threat awareness information to help prioritize their investments across various biodefense enterprise activities—threat awareness, prevention and protection, surveillance and detection, and response and recovery—to support their missions (see fig. 2). The following figures present examples, based on our analysis of agency documents and interviews, of how agencies use threat awareness information to help direct resources and investments across the biodefense pillars. This presentation is not a comprehensive catalogue of all biodefense investments in these areas, but rather examples of the diversity of activities agencies conduct to fulfill their biodefense missions for threat awareness, prevention and protection, surveillance and detection, and response and recovery. Appendix II includes information organized by agency. Federal agencies with key roles in biodefense share biological threat information through many different mechanisms designed to facilitate collaboration among government partners, including working groups and interagency agreements. However, as we and others have observed in recent reports, opportunities remain to enhance threat awareness across the entire biodefense enterprise, leverage shared resources, and inform budgetary tradeoffs among various threats and agency programs. Officials from key federal agencies, including DHS, DOD, EPA, HHS, and USDA, identified multiple mechanisms that facilitated biodefense collaboration and shared awareness of biological threats. These mechanisms often serve multiple purposes; for example, a working group can develop policy and also aid in information sharing, among other benefits. Officials from these key biodefense agencies reported using collaborative mechanisms to share biological threat information, as well as to coordinate activities, avoid duplication and overlap, implement specific programs for addressing biological threats, and assist in policy development at the agency and White House level. The existence of working groups and similar bodies to help promote information sharing, align policies and procedures, and coordinate to leverage resources is consistent with key practices and mechanisms that we have previously reported as useful for enhancing and sustaining interagency collaboration. Figure 7 provides examples of collaborative mechanisms identified for biodefense. Officials at key federal agencies reported participating in several types of collaborative mechanisms, including interagency bodies, working groups at the agency and executive level, formalized agreements, colocation, joint projects and funding efforts, and shared expertise. Examples within each mechanism include the following: Interagency bodies. Key federal agencies reported participating in formal interagency bodies that have their own authority and resources and are established to coordinate activities related to biodefense. One such group is PHEMCE, the federal interagency decision-making body for medical countermeasure development and acquisition. PHEMCE is led by HHS, and includes both internal HHS partners, such as CDC, FDA, and NIH, and external interagency partners, such as DOD, DHS, USDA, and the Department of Veterans Affairs. In addition, other key agency officials reported participating in interagency bodies coordinated by HHS and USDA to determine additions and removals to the select agent list. Working groups. Officials in each of the key agencies said they participate in established and ad hoc working groups to provide subject- matter knowledge and expertise, share information, prioritize research, and avoid duplicating efforts. For example, officials from over a dozen agencies and components participate in an Interagency Bioterrorism Working Group through DHS that provides a conduit for interagency review of technical inputs and assumptions for biological agents and other parameters in the BTRA. DHS officials stated that this working group also works to obtain wider interagency understanding and ownership of the DHS BTRA. Officials from DOD’s JPEO-CBD also stated that they sit on multiple interagency working groups with DHS officials that focus on combating terrorism, biosurveillance, and research and development, among other topics. Similarly, CDC officials stated they participated on approximately 10 to 20 separate working groups with specialized purposes, such as integrated process teams for specific research programs. Collaborative mechanisms within the Executive Office of the President. Some working groups and other collaboration mechanisms have been led by the National Security Council and other offices within the Executive Office of the President in order to ensure a comprehensive and coordinated approach to biodefense across agencies. For example, the Subcommittee on Biological Defense Research and Development was led by the White House Office of Science and Technology Policy and included representatives from 16 agencies and three White House offices. This subcommittee evaluated U.S. biological defense capabilities to identify future priorities and actions. The National Security Council has also led integrated policy committees focused on a particular threat or range of threats, such as genome editing and synthesis and select agents and toxins. Written interagency agreements. Agencies have executed written agreements in order to define their relationships for a particular aspect of biodefense. For example, in March 2015, DOD, DHS, and EPA renewed a formalized relationship through a memorandum of understanding for chemical and biological defense research, development, and acquisition—all of which require shared threat awareness. The agreement identifies roles and responsibilities for chemical and biological defense, establishes senior and technical working groups, and establishes cross-agency responsibilities. In particular, DOD, DHS, and EPA agreed to exchange and identify program needs and overlapping interests; establish interagency agreements between parties for joint projects and funding; conduct research and provide data to the partner agencies; and facilitate the establishment of interagency projects and working groups. DOD officials stated that the activities carried out under the memorandum have varied over time, but ongoing collaborative activities included efforts in biosurveillance, wearable sensors, decontamination, and a repository for threat agent data. Joint facility locations. As we reported in 2014, to maximize resource sharing and facilitate scientific exchange on the study of biological threat agents and other pathogens, DOD, HHS, and DHS share a joint biological campus, known as the National Interagency Biodefense Campus, located at Fort Detrick, Maryland. DHS officials said that, in addition to gaining efficiencies by sharing biosecurity and infrastructure requirements among all three facilities (U.S. Army Medical Research Institute of Infectious Diseases, DHS’s NBACC, and NIH’s Integrated Research Facility), personnel at the three laboratories can communicate more regularly than would otherwise be possible with different locations. The agencies represented on the National Interagency Biodefense Campus also conduct a research consortium to coordinate projects. Joint funding and program efforts. Key federal biodefense agencies have provided funding to partner organizations and agencies in order to obtain technical assistance or expertise for individual projects. DOD and EPA officials stated that DHS’s S&T Directorate often funds subject- matter experts to perform research and testing to assist in the development of answers to technical questions. For example, DHS funded staff at the U.S. Army Medical Research Institute of Infectious Diseases to research the characteristics of a particular agent in an aerosolized environment. Leveraging expertise. Agency officials also stated how more informal mechanisms, such as relationships between key personnel and soliciting input for research projects, provide the opportunity to leverage expertise to share threat awareness information and can increase collaboration and positive results between agencies. For example, DHS holds interagency stakeholder panels and outreach events (separate from existing working groups) to gather expertise during development of several biodefense products, including the BTRA. DHS officials said that DOD personnel from DTRA and DHS’s Biological Threat Characterization Program also conduct joint program reviews, and DHS personnel contribute expertise to DTRA’s contract evaluation teams. The collaborative mechanisms in which the key agencies in our review participate may facilitate information sharing in support of specific federal activities and in individual programs, or in response to specific biological events after they begin to unfold, but there is no mechanism in place to develop enterprise-wide threat awareness and assess the relative risks. For example, the BTRA is a dedicated effort to identify and assess the risk of biological events that stem from nonstate actors intentionally seeking to harm U.S. interests using biological agents. By design, it is focused on the consequences and likelihood of terrorist events threatening human health, and does not assess the risk from other types of biological threats. However, there is no similar comprehensive mechanism in place that integrates threat awareness information for all sources of intentional biological threats, as well as naturally occurring events that could harm or destabilize U.S. interests by catastrophically affecting humans, animals, and plants. Similarly, HHS officials stated that PHEMCE is a primary mechanism used to communicate threat awareness and other information on biodefense. However, the primary purpose of PHEMCE is to make decisions about human health countermeasures to be acquired for the Strategic National Stockpile. As a result, biological threat information pertaining to other domains, such as plant or animal health, may not be discussed and shared within this venue without a connection to human health. In addition, there is no existing mechanism that can leverage threat awareness information to direct resources and set budgetary priorities across all agencies for biodefense. Agencies use threat awareness mechanisms for resource planning according to the individual agency’s mission. For example, DOD guidance states that budgeting and planning for biodefense relies, in part, on DIA’s CBRN Warfare Capstone Threat Assessment. Similarly, DHS officials stated they use the BTRA to help plan DHS investments in future research or to help inform domestic biodefense preparations. According to DOD officials, because the DOD mission is different, they only use the BTRA indirectly and do not specifically rely on it for prioritizing activities or planning efforts. HSPD-10 requires the development of periodic assessments of the evolving biological weapons threats. DHS officials stated that the BTRA was created, in part, to fulfill the need for an assessment of the risk of intentional use of biological weapons by nonstate terrorists. However, the nation faces other biological threats, including naturally occurring diseases that affect human, animal, and plant health, and biological weapons used by state actors. Without a mechanism that is able to assess the relative risk from biological threats across all sources and domains, the nation may be unable to prioritize resources, defenses, and countermeasures against the most pressing threats. We previously reported in 2011 that the overarching biodefense enterprise would benefit from strategic oversight mechanisms, including a national strategy, to ensure efficient, effective, and accountable results. We noted that the complexity and fragmentation of roles and responsibilities across numerous federal and nonfederal entities presents challenges to ensuring efficiency and effectiveness across the entire biodefense enterprise. In light of that complexity and fragmentation, we observed that a national biodefense strategy could help address the key fragmentation issues across the biodefense enterprise, such as ensuring strong linkage and identifying gaps in investments across the four pillars. In response to our observations, National Security Council staff in December 2014 identified three presidential policy documents—the National Strategy for Countering Biological Threats, the National Biosurveillance Strategy, and Presidential Policy Directive 8—they reported work in concert to provide comprehensive strategic guidance. However, none of these documents comprehensively addresses all four pillars of biodefense, and, even when taken together, they do not fully address the fragmentation issues we have previously identified. Other independent observers have also commented on challenges presented by fragmentation and complexity across the biodefense enterprise. For example, in October 2015, the Blue Ribbon Study Panel on Biodefense reported that the United States lacked strategic leadership to promote collaboration within the federal government and other biodefense partners and achieve innovation throughout the enterprise. The study panel also recommended that the federal government develop, implement, and update a comprehensive national biodefense strategy that would define all organizational structures, future plans, and resource requirements along with unified budgetary authority. We testified in 2016 that several high-level biodefense strategies had been created in the past. However, there is no broad, integrated strategy that can be used to identify risk, assess resources, and prioritize investments. For example, the National Security Council’s National Strategy for Countering Biological Threats is focused solely on outlining the federal government’s approach to reducing the risks of biological weapons proliferation and terrorism, while the National Health Security Strategy authored by the Assistant Secretary for Preparedness and Response (ASPR) seeks to strengthen communities’ abilities to protect against and respond to any incidents with negative health consequences. While these and other strategies, such as the National Strategy for Biosurveillance, address aspects of biodefense, no single strategy provides a comprehensive approach for the nation to prepare and plan for biological threats. In addition, as we reported in 2016, the individual strategies related to pieces of the biodefense enterprise do not currently address the need for prioritization and tradeoffs among approaches when faced with limited resources and expansive threat. In addition, there is no individual or entity with responsibility, authority, and accountability for overseeing the entire biodefense enterprise. White House officials have previously told us that the National Security Council and the Homeland Security Council act together as focal points for federal biodefense efforts. As noted above, many federal departments and agencies participate in National Security Council groups and mechanisms, and biodefense efforts at the White House level are recognized collaboration mechanisms. However, as described in the Blue Ribbon Study Panel report and reported to us by HHS and DHS officials, these mechanisms may not persist from one presidential administration to the next. As a result, any mechanism located within bodies such as the National Security Council and Homeland Security Council may not provide the continuity and leadership needed to address persistent biological threats. The absence of mechanisms to develop shared threat awareness across the full set of biological threats and use that information to identify opportunities for leveraging resources to mitigate risk across the enterprise is another example of the fragmentation we have previously identified. However, opportunities exist to enhance shared threat awareness across the biodefense enterprise. Enacted on December 23, 2016, the National Defense Authorization Act (NDAA) for Fiscal Year 2017 required DOD, HHS, DHS, and USDA to jointly develop a national biodefense strategy and associated implementation plan. The law requires the strategy and implementation plan to: inventory and assess all existing strategies, plans, policies, laws, and interagency agreements related to biodefense; describe biological threats from warfare, terrorism, naturally occurring infectious disease, and accidental exposure; describe current federal efforts preventing the proliferation and use of biological weapons, preventing accidental or naturally occurring outbreaks, and mitigating the effects of an epidemic; describe roles and responsibilities of the agencies for biodefense; describe interagency capabilities required to support the national recommend actions for strengthening current biodefense capabilities and structures, and for improving interagency coordination. According to DHS officials, as of September 2017, the White House National Security Council is currently overseeing an interagency workgroup to develop that strategy. DOD officials confirmed that the process to create such a strategy is under way, and the effort may include revising or consolidating existing guidance in addition to developing a new national biodefense strategy. As the departments fulfill their obligations under the NDAA for 2017, key federal organizations have the opportunity to institutionalize mechanisms to help the nation make the best use of limited biodefense resources, to include broader shared threat awareness to inform opportunities to leverage resources. However, until the strategy is developed, we will not know the extent it will address shared threat awareness, if at all. The NDAA for 2017 requires the strategy to be submitted to Congress not later than 275 days after enactment (September 2017) and requires us to review it 180 days after the date of submittal. We will continue to monitor progress toward developing strategic mechanisms to help confront fragmentation and complexity across the biodefense enterprise. According to DHS officials, the threat characterization research agenda at NBACC is based primarily on the results and knowledge gaps identified through evaluation of the BTRA. Each year NBACC produces an annual plan that, among other elements, outlines new research projects intended to address priority knowledge gaps for identified biological threat agents. These projects are identified through a multistep process that incorporates a combination of DHS-designated priorities, interagency stakeholder input, and additional planning criteria, such as resource availability and ongoing maintenance of required technical capabilities. (See fig. 8.) The first step in the project selection process is the identification of knowledge gaps by officials within DHS’s Biological Threat Characterization Program (BTCP) based on their evaluation of the BTRA. According to these officials, identification of the most critical knowledge gaps involves determining which inputs have a relatively high impact on BTRA consequence estimates and have a relatively high degree of uncertainty, for example, because data about agent attributes are limited. The officials said they aim to enhance the value of BTRA conclusions by increasing the accuracy and completeness of the data used as modeling inputs through the work of NBACC. DHS has historically relied on the opinions of subject-matter experts to review the BTRA and support determinations regarding data quality but has also recently developed more quantitative methods to integrate BTRA results into the research planning and prioritization process for NBACC. Using data from the 2010 BTRA, DHS identified a total of 22 priority knowledge gaps that it is currently working to address through NBACC research and plans to complete within 6 to 10 years. BTCP program officials reported that although research priorities generally target Tier 1 Select Agents, they also seek to advance research projects that broadly encompass (1) a variety of biological threat agents (e.g., bacteria, viruses, and toxins); (2) agents representing different characteristics that affect threat (e.g., means of acquisition or production, dissemination and exposure attributes, and expected medical consequences), and (3) a selection of traditional, emerging, enhanced, and advanced biological threat agents. In addition to the identification of BTRA-related knowledge gaps, BTCP officials stated that emerging events and specific stakeholder needs could also influence research priorities. For example, during the 2014 Ebola outbreak, BTCP officials directed NBACC to perform research to better understand the risk factors associated with disease transmission, such as the persistence of the virus on various surfaces, and the efficacy of common disinfectants to inform decontamination and public health response efforts. DHS officials also noted that the needs of the Federal Bureau of Investigation, particularly through its casework at the National Bioforensics Analysis Center, may drive some of NBACC’s research priorities. The second step in the process for identifying NBACC threat characterization research projects includes the development of a proposed annual research plan. The annual plan is developed using a combination of inputs including DHS’s research priorities, annual NBACC budgetary resources, and technical capability and staff development needs. Although the plan documents the DHS knowledge gaps that serve as a key driver for developing specific project proposals, in some cases these gaps are identified only as general areas of research, such as the virulence of specified threat agents, which could require a broad scope of research to address. As the plan notes, these priority knowledge gaps exceed the resources available for threat characterization each year. For this reason, NBACC uses a combination of additional criteria to further refine research priorities and select projects for inclusion in the new scope of work, such as consideration of the time and resources required and which knowledge gaps are most likely to provide clear and compelling answers through experimentation. Other factors that may influence final project selection include addressing the knowledge gaps that could be completed reasonably comprehensively in 3 to 4 years or may have potential to provide a framework to better understand other priority agents or emerging threats, such as the Ebola virus or other infectious diseases (see fig. 9). In developing the annual research plan, NBACC also sets aside a small portion of its threat characterization budget to respond to emerging requests, and the plan notes that project plans may be readjusted due to any emerging requirements. The annual plan also identifies priorities needed to maintain four core technical capabilities (aerobiology, bacteriology, virology, and comparative medicine) and accreditation standards required to perform ongoing threat characterization research on potential threat agents in a maximum security national biocontainment laboratory. For example, one of the priorities identified within the 2016 annual plan includes the installation and verification of new equipment intended to enhance aerobiology capabilities. Each annual plan includes a crosswalk between the proposed projects and the associated capabilities that will be utilized. For example, the 2016 NBACC annual plan outlines a scope of work that includes seven research studies that collectively cover all four of the core technical capabilities. Examples of some of the research conducted in recent years include assessment of the decay rates of aerosolized Tier 1 agents and the virulence of select agents based on particle size and production methods. Once NBACC develops a proposed annual research plan, stakeholders review it before the plan goes for S&T approval. According to S&T officials we interviewed, the BTCP program solicits input and feedback on the draft annual plan from interagency stakeholders within DOD, HHS, and the Intelligence Community, among others. According to these officials, the community of practice for conducting this type of research is small and is generally well coordinated to avoid potential duplication of work. Once S&T officials approve the plan, it then undergoes a final approval process through DHS’s Compliance Review Group to ensure adherence with the Biological Weapons Convention. According to S&T officials, they also participate in periodic project reviews to maintain oversight regarding the extent to which each research study is achieving its objectives, and an overall assessment is performed as part of the annual evaluation process of the NBACC contract performer. The purpose of these periodic reviews is to help identify any changes to the project plan that may be required and help ensure that the research is making progress toward addressing identified knowledge gaps. S&T officials stated that although some projects have been modified based on preliminary results, they rely much more heavily on advance review of the experimental methodology by technical subject-matter experts before a project is initiated to help ensure the research will address identified gaps and help inform future iterations of the BTRA. Consistent with its strategic goals, S&T officials reported that NBACC research has directly contributed to the closing of identified knowledge gaps and the development of capabilities that are used to respond to emerging threat characterization needs. According to these officials, NBACC products have improved BTRA consequence and hazard modeling by reducing the uncertainty associated with key data inputs. Specifically, officials cited that significant changes were made to the underlying risk models as a result of NBACC research conducted since the completion of the 2010 BTRA, including updates to 62 individual data points associated with eight biological hazards. As noted in the 2016 NBACC annual plan, the limited research available on authentic threat agents has historically entailed the use of data from surrogate or unrelated biological agents to evaluate the threat and consequences of a biological attack on the homeland. According to S&T officials, the use of authentic threat agents at NBACC addresses this shortcoming and has enhanced confidence in estimates of risk and operational response planning. Although NBACC research currently remains focused on closing specific knowledge gaps, officials noted that this research is also intended to lay a foundation for more predictive modeling, such as using the data to identify shared characteristics among a class of agents. Although the focus of NBACC threat characterization research is generally on the intentional use of Tier 1 biological agents, S&T officials stated that NBACC capabilities could also be employed to address challenges associated with emerging infectious diseases. They further noted that, because many of the high-priority biological threat agents that affect humans also may affect livestock, NBACC’s studies could also be useful for informing risk associated with animal health. NBACC expertise has also been leveraged by other DHS components. For example, S&T officials reported that the U.S. Coast Guard requested information from NBACC to help inform its global vaccine program for its workforce, and DHS’s National Protection and Programs Directorate and the Secret Service have requested NBACC to review their own biological risk assessments. Within S&T, CBD officials stated that NBACC- produced products were used to inform the development of new biological sensor technologies. In addition to sharing NBACC research findings through briefings and reports, NBACC officials also reported that they are currently pursuing efforts to establish an electronic repository for NBACC scientific products at the Unclassified/ For Official Use Only, Secret, and Top Secret levels. The goal of this repository site is to facilitate the ability of end users to search, view, and download documents according to their approved access. We provided a draft of this report to DHS, DOD, EPA, HHS, and USDA for review and comment. Each of these departments provided technical comments that we incorporated as appropriate. We are sending copies of this report to the appropriate congressional committees; the Secretaries of Agriculture, Defense, Health and Human Services, and Homeland Security; and the EPA Administrator. In addition, the report is available at no charge on the GAO website at http://www.gao.gov. If you or your staff have any questions about this report, please contact me at (404) 679-1875 or curriec@gao.gov. Contact points for our Offices of Congressional Relations and Public Affairs may be found on the last page of this report. GAO staff who made key contributions to this report are listed in appendix III. The Department of Homeland Security (DHS) is responsible for assessing the risks posed by biological agents as directed by the Project BioShield Act of 2004 and Homeland Security Presidential Directives 10— Biodefense for the 21st Century, and 18—Medical Countermeasures against Weapons of Mass Destruction. To this end, DHS’s Science & Technology Directorate (S&T) has developed four Bioterrorism Risk Assessments (BTRA) since 2006 to assess the relative risks posed by various biological agents based on estimates of likelihood and consequence parameters for a number of potential attack scenarios. The BTRA is a probabilistic risk assessment intended to quantify risk for rare yet potentially catastrophic intentional attacks using biological agents by nonstate actors. Results are based on risk modeling for a vast number of potential scenarios derived from multiple event trees representing specific decisions or actions an adversary may pursue. The most recent iteration issued in 2017, called the BTRA 5.0, includes over 600,000 scenarios with predicted impacts on human health, fatalities, and economic costs. These consequence estimates are based in part on inputs provided or validated by the Intelligence Community, various estimates of likelihood, and applicable consequence parameters, such as specific agent attributes and threat characterization research results from the National Biodefense Analysis and Countermeasures Center (NBACC). The BTRA incorporates a number of different models related to the various attack scenarios being assessed. For example, DHS utilizes unique models to assess risk for indoor attacks (in 12 different target categories, such as transportation hubs and sporting events), outdoor attacks (including the top 100 most populated U.S. cities and their associated weather patterns), and potential dissemination via food or water systems, as well as a model that estimates the ability for the public health system to mitigate potential illnesses or fatalities based on disease progression, response timelines, and available medical countermeasures. According to S&T officials, one of the key updates in the BTRA 5.0 is the introduction of adversary-decision models, which allow BTRA program officials to incorporate inputs from subject-matter experts and other data sources regarding the likelihood of various attack scenarios. Selected factors that are considered to help identify potential agents or dissemination methods chosen by an adversary include data on agent acquisition or the means of production in various countries, as well as the likelihood of interdiction during transport. According to S&T officials, the BTRA 5.0 is intended to address previous recommendations of the National Research Council of the National Academies (National Academies) and provide additional information regarding data and intelligence inputs provided by subject-matter experts. The BTRA 5.0 was released in May 2017 and represents the first full BTRA product since 2010. According to BTRA program officials, a series of limited reports were issued in 2012, but S&T management instructed the division to address previous criticisms of the BTRA, including the National Academies’ recommendations, before developing another full report. S&T program officials reported taking action on 12 of the 13 National Academies’ recommendations, and determined, after subsequent review by DHS, that no action was required to address the final recommendation. Some notable changes that DHS reported making in response to the National Academies’ recommendations include: Officials reported implementing adversary-decision models to assess the probabilities of terrorist decisions for transporting materials and selecting targets to respond to National Academies’ criticism that the BTRA methodology may not fully consider adversaries’ efforts to maximize their chance of success. Officials reported publishing models and methodology reports and sending biological data for interagency review to respond to the National Academies’ recommendation to improve transparency. In addition, officials said that DHS had made this information available to stakeholders on a secured electronic site for those with access. Officials reported developing additional tools and methods to assess consequences and probabilities of changing threats to address the National Academies’ concern that the BTRA did not allow for incorporation of newly recognized threats or those that may not yet be well understood. Officials reported developing an economic consequence model and beginning to incorporate assessments of agricultural risk in addition to human mortality and morbidity to respond to the National Academies’ recommendation that DHS add economic and agricultural effects, among other losses, to its consequence modeling. According to S&T officials, another change implemented in the BTRA 5.0 is an effort to collect more detailed information about the sources and confidence level of the data inputs provided by subject-matter experts. These officials reported that they obtained expertise by survey primarily from terrorism subject matter experts, including members of the Intelligence Community. Data results now indicate whether inputs are based upon official reporting or the contributor’s opinion based upon subject knowledge. DHS also reported working on additional tools and models that officials expected would enhance the BTRA and make the results more useful to stakeholders. The following are examples of new developments identified to us by S&T officials: Research Prioritization Matrix (RPM) Tool. The RPM tool is intended to help identify areas of research that will be of greatest benefit to further inform future iterations of the BTRA. The RPM Tool uses a mathematical formula to develop a score based on numerous factors including (1) estimates of likelihood and consequences calculated by the BTRA, (2) the results of a sensitivity analysis of individual data parameters, and (3) an estimate of the confidence in the underlying and supporting data. According to officials, the result is a parameter and agent-specific score that can be used to support decisions regarding research prioritization in a structured, transparent manner that can be tracked over time to demonstrate progress. For example, a specific parameter in the RPM tool may include the decay rate of an agent in a particular substance (for example, in food items), and another parameter might be how much of a certain agent can likely be produced by certain adversaries. According to S&T officials, the RPM tool was recently updated with the latest data and results from the BTRA 5.0 and is expected to be more influential on the development of the research plan for fiscal year 2018. S&T program officials also said that the RPM tool will be made available to other federal entities so that they may use it for their own research prioritization needs, as well as customize the results, such as restricting the model to include only indoor attacks. Agricultural Terrorism Modeling. S&T officials have initiated efforts to develop additional modeling of potential agricultural impacts of a biological attack. Although a risk assessment of agricultural terrorism was completed in 2012 that assessed potential impacts from five animal diseases and two plant pathogens, officials reported that it was criticized for having substandard modeling and employing limited scenarios. The current effort includes representatives from the U.S. Department of Agriculture, the Food and Drug Administration, and the Federal Bureau of Investigation, and is focused on development of modeling for biological attacks on agriculture that may occur pre- harvest (before food processing begins) to differentiate it from attacks on the food system itself. DHS and stakeholders are currently evaluating available modeling tools and they plan to include the new modeling within the BTRA 6.0. Key threat awareness activities identified by the agency The U.S. Department of Agriculture (USDA) operates numerous programs designed to help prevent the entry and spread of agricultural pests and diseases, and protect the health of U.S. agricultural resources by addressing zoonotic diseases (transmissible from animals to humans) and implementing surveillance, preparedness and response, and control efforts. Examples of program activities include the following: High Consequence List. A three-tier classification system of foreign animal diseases determined to pose a significant threat to animal health if introduced into the United States. The list was developed in 2013 to help prioritize investments in the National Veterinary Stockpile. produced annually to provide an assessment of pests deemed most important in terms of likelihood or potential consequence. These guidelines define the procedures that stakeholders are to use to identify, characterize, survey, and respond to a particular pest if detected in the United States. Vulnerability Assessments. The Food Safety and Inspection Service conducts vulnerability assessments that, among other things, can inform the development of countermeasures to help prevent or mitigate the impacts of an intentional attack on the food supply. Scientific Research. The Agricultural Research Service conducts research to help characterize the status of diseases worldwide and assess their spread patterns. This work can also include basic research on various biological agents, as well as identification of specific scientific and technology gaps related to effective preparedness and response efforts. Chemical and Biological Defense (JPEO-CBD) manages the development and acquisition of different technologies and prototypes in order to provide biological defense products to the military services. The technologies can include biological detection systems and laboratory equipment, medical countermeasures, protective equipment for individual warfighters to provide deployed units detection and protection capabilities against different types of biological weapons. Threat assessment. The Defense Intelligence Agency produces the Chemical, Biological, Radiological, and Nuclear Warfare Capstone Threat Assessment, a report on chemical and biological programs of countries and technology that could be used by adversaries in a threat environment. DOD officials said that JPEO-CBD uses the report to identify biological warfare threats against military and civilian populations and help prioritize resources and investments into research and development. assessments of potential impacts to water systems and the environment in the event of a biological incident. EPA officials said EPA relies on the Department of Homeland Security’s Bioterrorism Risk Assessment and information on adversary capabilities and tactics to better assess potential environmental countermeasures for attacks on water systems and indoor/outdoor areas, to steer research resources, and to support responders who may need to address the consequences of an attack. EPA Water Security Division officials said they develop tools, training, and programs to address intentional contamination, detection in distribution networks, vulnerability assessments, emergency response capabilities, and how to monitor incidents and threats. Research and Development. The Office of Research and Development’s Homeland Security Research Program aims to help increase the capabilities of EPA and communities to prepare for and respond to chemical, biological, and radiological disasters. EPA relies on information from the BTRA in addition to its own research to inform preparedness activities and its research agenda. EPA’s homeland security research is organized into three topic areas that support these objectives: (1) characterizing contamination and assessing exposure; (2) water system security and resilience; and (3) remediating wide areas. (PHEMCE). Includes various HHS agencies and other federal departments, such as the Department of Defense (DOD), DHS, and the U.S. Department of Agriculture, to advise the Secretary of HHS on medical countermeasure priorities and approaches to the development, acquisition, stockpiling, and distribution of medical countermeasures for biological weapons attack agents, pandemic influenza, and other emerging infectious diseases. Global disease surveillance. Helps identify and respond to emerging infections, including pathogenic avian influenza, which remains an urgent global infectious disease threat. Medical and Public Health Consequence Modeling. HHS’s medical and public health consequence modeling reports use the exposure information from DHS’s material threat assessments (MTA) to calculate the number of individuals who may become ill, be hospitalized, or die based on the MTA scenario with and without medical countermeasures. HHS reported using the modeling reports as part of an assessment process to establish requirements for medical countermeasures that need to be developed and acquired to respond to a biological incident. aimed at reducing large public health consequences of attacks on the food supply. FDA assesses public health and economic impact of an attack, the accessibility of a target and ease of an attack, the ability to recover, the loss of production due to an attack, and target selection. FDA also said it considers the health, economic, and psychological impacts of an attack on the food industry. Scientific Research. Studies include thermal stability of microbial agents and ability to inactivate biological agents in the food supply, and studies of pathogenic properties of viruses to help understand the epidemiology, transmission, evolution and origin of an outbreak. which is a system of environmental monitoring intended to provide early warning and detection of a biological attack. DHS also houses and supports the National Biosurveillance Integration Center—a collaboration of 14 federal partners intended to integrate information about threats to human, animal, plant, and environmental health from thousands of sources to develop a more comprehensive picture of the threat landscape. Research and Analysis. DHS operates the National Biodefense Analysis and Countermeasures Center, which conducts scientific research and develops reports and products intended to address identified knowledge gaps associated with current and future biological threats, including the effectiveness of potential countermeasures and the characterization of key attributes of biological attacks by an adversary such as agent acquisition; agent production; dissemination methods; and virulence. Additional research and analysis efforts are supported by the Biodefense Knowledge Center and multiple National Laboratories. In addition to the contact named above, Kathryn Godfrey (Assistant Director), Ryan Lambert (Analyst-in-Charge), Amy Bowser, Ben Emmel, Ashley Grant, Eric Hauswirth, Susanna Kuebler, Cody Raysinger, and Amber Sinclair made key contributions to this report. Biological Defense: Additional Information That Congress May Find Useful as It Considers DOD’s Advanced Development and Manufacturing Capability. GAO-17-701. Washington, D.C.: July 17, 2017. Chemical and Biological Defense: DOD Has Identified an Infrastructure Manager and Is Developing the Position’s Roles and Responsibilities. GAO-17-522R. Washington, D.C.: July 7, 2017. Emerging Infectious Diseases: Actions Needed to Address the Challenges of Responding to Zika Virus Disease Outbreaks. GAO-17-445. Washington, D.C.: May 23, 2017. Avian Influenza: USDA Has Taken Actions to Reduce Risks but Needs a Plan to Evaluate Its Efforts. GAO-17-360. Washington, D.C.: April 13, 2017. Defense Civil Support: DOD, HHS, and DHS Should Use Existing Coordination Mechanisms to Improve Their Pandemic Preparedness. GAO-17-150. Washington, D.C.: February 10, 2017. Bioforensics: DHS Needs to Conduct a Formal Capability Gap Analysis to Better Identify and Address Gaps. GAO-17-177. Washington, D.C.: January 11, 2017. Defense Intelligence: Additional Steps Could Better Integrate Intelligence Input into DOD’s Acquisition of Major Weapon Systems. GAO-17-10. Washington, D.C.: November 1, 2016. High-Containment Laboratories: Actions Needed to Mitigate Risk of Potential Exposure and Release of Dangerous Pathogens. GAO-16-871T. Washington, D.C.: September 23, 2016. High-Containment Laboratories: Improved Oversight of Dangerous Pathogens Needed to Mitigate Risk. GAO-16-642. Washington, D.C.: August 30, 2016. Biodefense: The Nation Faces Multiple Challenges in Building and Maintaining Biodefense and Biosurveillance. GAO-16-547T. Washington, D.C.: April 14, 2016. Emerging Infectious Diseases: Preliminary Observations on the Zika Virus Outbreak. GAO-16-470T. Washington, D.C.: March 2, 2016. Air Travel and Communicable Diseases: Comprehensive Federal Plan Needed for U.S. Aviation System’s Preparedness. GAO-16-127. Washington, D.C.: December 16, 2015. Emerging Animal Diseases: Actions Needed to Better Position USDA to Address Future Risks. GAO-16-132. Washington, D.C.: December 15, 2015. Biosurveillance: DHS Should Not Pursue BioWatch Upgrades or Enhancements Until System Capabilities Are Established. GAO-16-99. Washington, D.C.: October 23, 2015. Climate Change: HHS Could Take Further Steps to Enhance Understanding of Public Health Risks. GAO-16-122. Washington, D.C.: October 5, 2015. Biosurveillance: Challenges and Options for the National Biosurveillance Integration Center. GAO-15-793. Washington, D.C.: September 24, 2015. Chemical and Biological Defense: Designated Entity Needed to Identify, Align, and Manage DOD’s Infrastructure. GAO-15-257. Washington, D.C.: June 25, 2015. Biological Defense: DOD Has Strengthened Coordination on Medical Countermeasures but Can Improve Its Process for Threat Prioritization. GAO-14-442. Washington, D.C.: May 15, 2014. National Preparedness: HHS Is Monitoring the Progress of Its Medical Countermeasure Efforts but Has Not Provided Previously Recommended Spending Estimates. GAO-14-90. Washington, D.C.: December 27, 2013. Homeland Security: An Overall Strategy Is Needed to Strengthen Disease Surveillance in Livestock and Poultry. GAO-13-424. Washington, D.C.: May 21, 2013. Influenza: Progress Made in Responding to Seasonal and Pandemic Outbreaks. GAO-13-374T. Washington, D.C.: February 13, 2013. Managing for Results: Key Considerations for Implementing Interagency Collaborative Mechanisms. GAO-12-1022. Washington, D.C.: September 27, 2012. Biosurveillance: DHS Should Reevaluate Mission Need and Alternatives before Proceeding with BioWatch Generation-3 Acquisition. GAO-12-810. Washington, D.C.: September 10, 2012. Chemical, Biological, Radiological, and Nuclear Risk Assessments: DHS Should Establish More Specific Guidance for Their Use. GAO-12-272. Washington, D.C.: January 25, 2012. Biosurveillance: Nonfederal Capabilities Should Be Considered in Creating a National Biosurveillance Strategy. GAO-12-55. Washington, D.C.: October 31, 2011. National Preparedness: Improvements Needed for Acquiring Medical Countermeasures to Threats from Terrorism and Other Sources. GAO-12-121. Washington, D.C.: October 26, 2011. Homeland Security: Challenges for the Food and Agriculture Sector in Responding to Potential Terrorist Attacks and Natural Disasters. GAO-11-946T. Washington, D.C.: September 13, 2011. Homeland Security: Actions Needed to Improve Response to Potential Terrorist Attacks and Natural Disasters Affecting Food and Agriculture. GAO-11-652. Washington, D.C.: August 19, 2011. National Preparedness: DHS and HHS Can Further Strengthen Coordination for Chemical, Biological, Radiological, and Nuclear Risk Assessments. GAO-11-606. Washington, D.C.: June 21, 2011. Live Animal Imports: Agencies Need Better Collaboration to Reduce the Risk of Animal-Related Diseases. GAO-11-9. Washington, D.C.: November 8, 2010. 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Summary: Biological threats come from a variety of sources and can pose a catastrophic danger to public health, animal and plant health, and national security. Threat awareness, which consists of activities such as collecting and analyzing intelligence, developing risk assessments, and anticipating future threats, is vital to help federal agencies identify necessary biodefense capabilities and ensure investments are prioritized to make effective use of federal funds. GAO was asked to review how key federal agencies develop and share threat awareness information, and how that information informs further investments in biodefense. This report describes: (1) the types of actions that key federal agencies have taken to develop biological threat awareness, and how that information is used to support investment decisions; (2) the extent to which these agencies have developed shared threat awareness; and (3) how DHS's NBACC determines what additional threat characterization knowledge to pursue. GAO analyzed federal policies, directives, and strategies related to biodefense, as well as agency documents such as threat assessments and modeling studies. We identified five key biodefense agencies based on review of the roles designated in these documents. GAO interviewed officials from these agencies about threat awareness activities, and reviewed prior GAO work and related biodefense studies. Each of the key agencies reviewed a draft of this report and provided technical comments that GAO incorporated as appropriate. Key biodefense agencies—the Departments of Homeland Security (DHS), Defense (DOD), Agriculture (USDA), and Health and Human Services (HHS), and the Environmental Protection Agency—conduct a wide range of activities to develop biological threat awareness for intentional and naturally occurring threats, and reported using that information to support investment decisions. Intelligence gathering: Agencies use a combination of intelligence gathering on adversaries' capabilities to cause harm with a biological weapon and global disease surveillance to monitor threats from naturally occurring health threats that might impact humans, animals, or plants. Scientific research: Agencies use traditional laboratory research to help understand the characteristics of various threat agents, including their virulence, stability, and ability to be dispersed through various methods. Scientific research is also performed on emerging pathogens to understand their means of transmission, host susceptibility, and effects of infection. Analysis activities: Agencies use modeling studies and other analytical work to help determine the scope and impact of possible biological threats. These three activities help agencies identify and prioritize the most dangerous biological threats, which can then be used to guide biodefense investments. For example, USDA told GAO it uses threat information to determine which foreign animal diseases represent its highest priorities based on the potential of those agents to cause catastrophic harm, and those priorities are used to inform investments. Similarly, HHS said it conducts threat awareness activities to help inform the development and acquisition of human medical countermeasures. Federal agencies with key roles in biodefense share biological threat information through many different mechanisms designed to facilitate collaboration among government partners, including working groups and interagency agreements. For example, agency officials reported using collaborative mechanisms to coordinate activities and avoid duplication and overlap. However, as GAO and others have noted, opportunities exist to better leverage shared resources and inform budgetary tradeoffs. Recent legislation requires key biodefense agencies to create a national biodefense strategy that has the potential to help address these issues, by, among other things, supporting shared threat awareness. Until the strategy is developed, the extent to which it will meet this need is unknown. The threat characterization research agenda at DHS's National Biodefense Analysis and Countermeasures Center (NBACC) is based primarily on the results and knowledge gaps identified through the Bioterrorism Risk Assessment (BTRA). According to DHS officials, the knowledge gaps deemed most critical include data about biological agents that have a high impact on BTRA consequence estimates and also a high degree of uncertainty. Each year NBACC produces an annual plan that outlines new research projects intended to address these knowledge gaps, and incorporates additional planning criteria, such as interagency stakeholder input, resource availability, and maintenance of required technical capabilities. According to DHS officials, the results of NBACC research were used to directly enhance the BTRA, including updating data associated with eight biological agents since 2010.