Biodefense: Federal Efforts to Develop Biological Threat Awareness

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.

Key Biodefense Terminology  Biodefense—To prevent, protect against, and  mitigate biological threats that could have  catastrophic consequences to the nation.  Threat—For the purposes of this report, we  use the term threat to describe both the  intentional use of biological weapons by  individuals or entities and naturally occurring  biological events that have the potential to  have catastrophic biological consequences for  the United States including loss of life or  national security and economic welfare  effects.  Agent—Microorganism (or derived toxin) or  pest that causes disease in humans, animals,  or plants.  Characterization (of agents, pests and  biological events)—Agents and pests can be  characterized by applying modern scientific  techniques that describe their properties,  behaviors, life cycle, or genetic makeup.  Biological events can be characterized by  evaluating specific disease outbreaks to  understand what the outbreak is and how  serious it is likely to be by monitoring such  things as the cause, speed, duration, and  means of transmission.  Surveillance—In the biological context, the  ongoing collection, analysis, and  interpretation of data to help look for  pathogens in plants, animals, and humans; in  food supplies; and in the environment.  Detection—In the biological context, involves  recognition of signs and signals to discern  whether disease occurrence is abnormal  based on its general characteristics, as well  as where, when, and how severely the  disease has historically occurred. supply, or used to contaminate the water supply. These specific types of  threats, whether naturally occurring or deliberate, may contribute to  Global Catastrophic Biological Risks, a term of art that that represents  extraordinary biological disaster beyond the collective capability of  national and international governments and the private sector to control.

In 2004, Homeland Security Presidential Directive (HSPD) 10 identified  four key areas—or pillars—of national biodefense. One of the pillars of  biodefense identified in HSPD-10 is threat awareness, which consists of  activities such as collecting and analyzing intelligence, developing risk  assessments, and anticipating future threats. For example, such  information may include assessment about where biological threat agents  might come from, how outbreaks may unfold, and the effectiveness of  available defenses against them. Threat awareness is vital to help identify  necessary biodefense capabilities to help identify, protect against, and  respond to National or Global Catastrophic Biological Risks and help  ensure investments are prioritized to make effective use of federal funds.

Protecting humans, animals, plants, food, and the environment (air, soil,  and water) from potentially catastrophic effects of intentional or natural  biological events entails numerous activities carried out within and among  multiple federal agencies and their nonfederal partners. The Department  of Homeland Security (DHS) plays a lead role in interagency coordination  and planning for emergency response to biological incidents in the United  States and is responsible for assessing the risks to the civilian population  posed by various biological agents. DHS conducts multiple efforts to  enhance biological threat awareness, including development of the  Bioterrorism Risk Assessment (BTRA) with input from other key federal  agencies, such as the Departments of Defense (DOD) and Health and  Human Services (HHS). DHS also operates the National Biodefense  Analysis and Countermeasures Center (NBACC), which, among other  activities, carries out research to better characterize individual biological  agents and provide timely scientific data, knowledge products, and  expertise to support threat analyses.

You asked us to review how key biodefense agencies develop and share  threat awareness information, and how this 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 federal agencies have developed  shared threat awareness, and (3) how NBACC determines what  additional threat characterization knowledge to pursue.

To conduct work related to all three objectives, we analyzed government- wide policies, directives, and strategies related to biodefense, including  HSPD-9 (Defense of United States Agriculture and Food), HSPD-10  (Biodefense for the 21st Century), and the National Strategy for  Countering Biological Threats, among others. We analyzed these  documents to understand agencies’ roles and responsibilities regarding  biodefense, specifically those pertaining to threat awareness activities.  We identified the key biodefense agencies by reviewing the biodefense  policies mentioned above, as well as through interviews with DHS officials  who identified the key agencies with which they collaborate on threat  awareness activities. The agencies we identified through these policy  reviews and interviews were DHS, DOD, HHS, the U.S. Department of  Agriculture (USDA), and the Environmental Protection Agency (EPA).

To describe how these five key agencies conduct their threat awareness  activities and use this information to support investment decisions, we  reviewed agency-specific strategies and plans related to their biodefense  activities, including those from NBACC, DOD’s Chemical and Biological  Defense Program, the multiagency Public Health Emergency Medical  Countermeasures Enterprise (PHEMCE), and USDA’s Animal and Plant  Health Inspection Service (APHIS). We also analyzed information  provided by agencies and conducted interviews with agency officials  related to agencies’ threat awareness activities to determine how threat  awareness is conducted and how it informs other biodefense  investments. For example, we reviewed documents such as threat  assessments, including the 2010 and 2016 BTRAs; scientific reports on  biological agent characteristics; modeling studies of the potential impact  of various biological threats; and response guidelines informed by  biological threat awareness activities. For additional context and support,  we also reviewed prior GAO work related to biodefense and reports from  other organizations, such as the Congressional Research Service, the  Bipartisan Weapons of Mass Destruction Terrorism Research Center, the  Blue Ribbon Study Panel on Biodefense, and the National Research  Council of the National Academies.

To determine the extent that federal agencies have developed shared  threat awareness and how NBACC determines what additional threat  characterization knowledge to pursue, we conducted a site visit to  NBACC at Fort Detrick, Maryland, to meet with DHS officials and NBACC  staff to discuss the collaborative efforts among the key biodefense  agencies in conducting and reviewing the BTRA. We interviewed agency  officials from DHS, DOD, HHS, USDA, and EPA to understand the types  of collaborative activities they engage in, examine the opportunities  available to share threat awareness information, and identify any  challenges in sharing information across agencies. We compared the  activities to leading practices we have identified in prior work to enhance  and sustain interagency collaboration. We also examined existing policy,  strategies, and structures that could enable shared threat awareness  activities, including the recent National Defense Authorization Act (NDAA)  mandate to create a national biodefense strategy. We analyzed  NBACC’s strategic plans and annual plans from fiscal year 2011 through  fiscal year 2017, as well as funding information, to identify biodefense- related investments. We also met with key DHS officials involved in  planning NBACC’s threat awareness projects to determine how priorities  are set for NBACC’s biodefense investments.

We conducted this performance audit from April 2016 to October 2017 in  accordance with generally accepted government auditing standards.  Those standards require that we plan and perform the audit to obtain  sufficient, appropriate evidence to provide a reasonable basis for our  findings and conclusions based on our audit objectives. We believe that  the evidence obtained provides a reasonable basis for our findings and  conclusions based on our audit objectives.

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 Challenges of Threat Awareness in a Vast and Evolving Biological Threat Landscape

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.

Intelligence Gathering and Global Surveillance, Research, and Analysis Are Designed to Inform Biological Threat Awareness and Investment Decisions

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.

Agencies Rely on Intelligence Gathering, Scientific Research, and Analysis Activities to Develop Biological Threat Awareness

Intelligence Collection and Global Disease Surveillance

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.

Modeling Studies and Other Analytical Work

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.

Agencies Reported Using Biological Threat Awareness Information to Help Prioritize Their Various Biodefense Activities and Investments

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.

Multiple Mechanisms Exist to Share Biological Threat Information, and New Biodefense Strategy Could Help Agencies Better Use Threat Information to Leverage Resources across the Enterprise

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.

Federal Partners Share Biological Threat Information through a Combination of Working Groups, Interagency Agreements, and Other Mechanisms

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.

Biodefense Strategy Provides an Opportunity to Use Enterprise-Wide Threat Awareness to Help Leverage Resources and Inform Resource Tradeoffs

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.

NBACC Threat Characterization Research Is Largely Driven by Knowledge Gaps Identified through the BTRA Process

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.)

Priority Knowledge Gaps and Research Needs

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.

Appendix I: Bioterrorism Risk Assessment

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.

BTRA 5.0 Updates and Prior Recommendations

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.

Additional BTRA Tools and Model Development

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.

Appendix III: GAO Contact and Staff Acknowledgments

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.

Biosurveillance: Efforts to Develop a National Biosurveillance Capability  Need a National Strategy and a Designated Leader. GAO-10-645.  Washington, D.C.: June 30, 2010.

Agricultural Quarantine Inspection Program: Management Problems May  Increase Vulnerability of U.S. Agriculture to Foreign Pests and Diseases.  GAO-08-96T. Washington, D.C.: October 3, 2007.

Global Health: U.S. Agencies Support Programs to Build Overseas  Capacity for Infectious Disease Surveillance. GAO-07-1186. Washington,  D.C.: September 28, 2007.