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. Climate change also has the potential to negatively impact  human health and the agriculture industry. Department of Homeland Security. Department of Health and Human Services. Environmental Protection Agency. 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. This  information is used to develop the BTRA to support DHS’s responsibilities  to protect against non-state actor intentional acts of bioterrorism. 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. 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. 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. 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. 2). 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. 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. However, there is no broad, integrated  strategy that can be used to identify risk, assess resources, and prioritize  investments. However, until the strategy is developed, we will not  know the extent it will address shared threat awareness, if at all. 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. 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. Within S&T, CBD officials stated that NBACC- produced products were used to inform the development of new biological  sensor technologies. Agency Comments and Our Evaluation

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. Medical and Public Health Consequence Modeling. 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.
Why GAO Did This Study

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.

What GAO Found

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.