Biosurveillance: Efforts to Develop a National Biosurveillance Capability Need a National Strategy and a Designated Leader
Released: 2010-06-30T00:00:00

Letter

Background

As shown in figure 1, biosurveillance is a concept that emerged in response to increased concern about biological threats from emerging infectious diseases and bioterrorism. Biosurveillance is carried out by and depends on a wide range of dispersed entities. Federal biosurveillance responsibilities, likewise, are spread across an array of agencies and provided for in multiple laws and presidential directives.

Social and Economic Conditions Contribute to the Threat of a Catastrophic Biological Event

In an era of rapid transit and global trade, the public health and agricultural industries, as well as natural ecosystems including native plants and wildlife, face increased threats of naturally occurring outbreaks of infectious disease and accidental exposure to biological threats. According to the World Health Organization (WHO), infectious diseases are not only spreading faster, they appear to be emerging more quickly than ever before. Since the 1970s, newly emerging diseases have been identified at the unprecedented rate of one or more per year. There are now nearly 40 diseases that were unknown a generation ago. In addition, during the last 5 years, WHO has verified more than 1100 epidemic events worldwide. Figure 2 shows select disease occurrences worldwide in recent decades. Additional information about the occurrences is available electronically in pop-up boxes on the map or in print in appendix II. Examples of emerging infectious disease include Severe Acute Respiratory Syndrome (SARS), H5N1 influenza (avian flu), and the H1N1 influenza that resulted in a global pandemic in 2009. The potential impact of these events is not limited to public health. For example, the avian influenza outbreaks in Asia and Eastern Europe were reminders that the public health sector is intrinsically linked to the agriculture, trade, tourism, economic, and political sectors.

Due to the rapid and constant movement of people and commodities— such as animals, plants, and food—biological agents can be carried by passengers or containers on airplanes and boats and slip across national borders unnoticed as infectious diseases are transferred from person to person through close contact with one another. Ecological changes, such as changes in land use, and the globalization of the food supply are also associated with the emergence and spread of infectious disease. Animals also face the threat of infectious disease, and in some cases diseases— known as zoonotic diseases—can be transferred between animals and people. Zoonotic diseases represent at least 65 percent of newly emerging and reemerging infectious diseases in recent decades. Many important factors contribute to the proliferation of zoonotic diseases, including the growth of human and domestic animal populations and the increasingly close physical proximity within which humans and their domestic animals live with wild animals.

Some disease agents can also be weaponized and used as weapons of mass destruction to disrupt economies and endanger human, animal, and plant health. Since the attacks of September 11, 2001, there has been concern that another terrorist attack on U.S. soil could involve biological or other weapons of mass destruction. Groups like the Center for Counterproliferation Research at the National Defense University and the Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism (established by the 9/11 Commission Act) have warned that the biological weapons threat is real, with evidence that terror groups like Al Qaeda have had active biological weapons programs in the past and approximately 12 countries are suspected of seeking biological weapons.

Emerging disease and bioterrorism concerns also surround the nation’s agriculture and food supply, as well. Plant resources in the United States, including crops, rangelands, and forests, are vulnerable to endemic, introduced, and emerging pathogens. More than 50,000 plant diseases occur in the United States, caused by a variety of pathogens. Increasing globalization and international trade activities create a likelihood that many other exotic plant pathogens will arrive in the United States in the coming years.

In addition, the United States faces growing food safety challenges from fresh and processed foods that become contaminated well before they reach the consumer, leading to outbreaks linked to foods that have not previously been associated with foodborne illnesses. For example, according to USDA, leafy greens are the category of produce most likely to be associated with an outbreak. Recent outbreaks of foodborne illness have also focused public attention on the increasing potential for widespread dissemination of contaminated products. For example, beginning in September 2006, the United States experienced an outbreak of E. coli 0157:H7 associated with the consumption of tainted spinach grown in California; this outbreak resulted in 205 victims in 26 states suffering severe disease. Three people died. Widespread outbreaks of other foodborne illnesses, such as Salmonella, have also occurred from contaminated peanut butter and tomatoes.

We reported in March 2005 that although the United States has never experienced a terrorist attack against agriculture, it is vulnerable for a variety of reasons, including the relative ease with which causative agents of diseases that could affect livestock and crops could be obtained and disseminated. Many of these diseases are endemic in other parts of the world and can be extracted from common materials, such as soil. Farms in general are easily accessible because they are located in rural areas and have minimal security, especially crop farms. Moreover, the highly concentrated breeding and rearing practices of our livestock industry may make it a vulnerable target for terrorists because diseases could spread rapidly and be difficult to contain. For example, between 80 and 90 percent of grain-fed beef cattle production is concentrated in less than 5 percent of the nation’s feedlots. Therefore, the deliberate introduction of a highly contagious animal disease in a single feedlot could have serious economic consequences. In addition, a number of disease causing agents can infect and be spread by wildlife. According to officials at DOI, it may be difficult to control a novel pathogen if it is introduced into native wildlife. These officials noted that the gregarious habits of many wildlife species can enhance their susceptibility to catastrophic losses from select diseases, and because of their mobility, there is potential for infectious disease to spread quickly to new locations and populations.

Finally, pathogens can be carried through or introduced into the environment, causing damage to health and economies. Drinking water utilities across the country have long been recognized as potentially vulnerable to terrorist attacks of various types, including physical disruption, bioterrorism, chemical contamination, and cyber attack. Damage or destruction by terrorists could disrupt not only the availability of safe drinking water, but also the delivery of vital services that depend on these water supplies, such as fire suppression. People and animals also face the threat of becoming ill from inhaling certain biological agents, some of which occur naturally in our environment and some that can be weaponized and intentionally released to cause catastrophic disruption. Concerns about weaponized airborne pathogens were amplified by the anthrax attacks conducted through the mail a month after the September 11, 2001, attacks on the World Trade Center and the Pentagon.

Laws and Presidential Directives Direct Agencies to Strengthen Biosurveillance and HSPD- 21 Calls for an Integrated National Biosurveillance Capability

As figure 3 shows, federal laws and directives call for HHS, USDA, DHS, and other federal agencies to take action to strengthen biosurveillance. The most recent of these—Homeland Security Presidential Directive-21— synthesizes and reiterates actions in other laws and directives, explicitly calling for a national biosurveillance capability. In calling for this national capability, HSPD-21 discusses certain aspects related to the personnel, training, equipment, and systems needed. For example, among the elements it describes as necessary for a robust and integrated national capability are enhanced clinician awareness, stronger laboratory diagnostic capabilities, integrated biosurveillance data, and an epidemiologic surveillance system with sufficient flexibility to tailor analyses to new syndromes and emerging diseases.

In the case of biological threats, timely detection of biological agents is a precursor to effective response; therefore, a national biosurveillance capability like the one described in HSPD-21 is an essential tool in the nation’s preparedness to confront catastrophic threats. Capabilities to carry out any broad emergency management mission—like biosurveillance—are made up of (1) planning, (2) organization and leadership, (3) personnel, (4) equipment and systems, (5) training, and (6) measurement/monitoring.

A national biosurveillance capability like the one described in HSPD-21 would largely rely on an interagency effort because the mission activities and accompanying resources that support the capability—personnel, training, equipment, and systems—are dispersed across a number of federal agencies. For example, HHS’s Centers for Disease Control and Prevention (CDC) has primary responsibility for human health and USDA for plant and animal health. Responsibility for various food sources is split between USDA and HHS’s Food and Drug Administration (FDA). DHS, as the agency with primary responsibility for securing the homeland, is responsible for coordinating efforts to prevent, protect against, respond to, and recover from biological attacks. The resources—personnel, training, equipment, and systems–that support a national biosurveillance capability reside within the separate agencies that acquire and maintain them in pursuit of their missions, which overlap with but are not wholly focused on biosurveillance.

A national biosurveillance capability also depends upon participation from state, local, and tribal governments. Few of the resources required to support the capability are wholly owned by the federal government. The responsibility and capacity for collecting most information related to plant, animal and human health, food, and environmental monitoring resides within state, local, and tribal governments, or private sector entities—such as hospital and other private health care providers. In the United States, state and local public health agencies have the authority and responsibility for carrying out most public health actions, and the federal government generally cannot compel state, local and tribal governments, or private sector entities to provide information or resources to support federal biosurveillance efforts. Instead, individual federal agencies, in pursuit of their missions, attempt to build relationships and offer incentives—like grants—to encourage voluntary cooperation with specifi c federal efforts.

In addition, although traditional disease surveillance systems designed to collect information on the health of humans, animals, and plants are the backbone of biosurveillance—because they, among other things, provide mechanisms for ongoing monitoring and specific information about outbreaks to inform response—they also rely on time-intensive testing and confirmation practices. The inherent time lag, combined with limitations arising from reliance on data not owned by the federal government, presents challenges that limit the promise of traditional disease surveillance alone to provide the timely detection and situational awareness that is the goal of a national biosurveillance capability. For additional information on the contributions and associated challenges of traditional federal surveillance activities to monitor for pathogens in plants, animals, humans, and food see appendix III. For more information on specific federal programs that can be used to support biosurveillance see appendix IV.

Federal Agencies Have Taken Actions That Support a National Biosurveillance Capability

Federal agencies have taken or are planning some actions to improve the personnel, training, and systems and equipment that support a national biosurveillance capability, including, but not limited to, planning to assess workforce needs, sponsoring recruitment and training efforts, seeking to facilitate information sharing, and applying technologies to enhance surveillance.

Federal Agencies Have Taken Actions to Help Ensure Availability of Personnel to Monitor Human, Animal, and Plant Health Domains for Biosurveillance Purposes

Some of the professions that underpin the surveillance mechanism for a national biosurveillance capability currently face and are expected to continue to confront workforce challenges—particularly workforce shortages; however, some federal agencies with key biosurveillance responsibilities have efforts underway to help confront those challenges. We reported in September 2009 that as the threats to national security— which include the threat of bioterrorism and pandemic outbreak—have evolved over the past decades, so have the skills needed to prepare for and respond to those threats. We also found that like other federal efforts to address modern national security challenges that require collaboration among multiple agencies, an effective biosurveillance capability relies on qualified, well-trained professionals with the right mix of skills and experience. Figure 4 provides examples of the workforce involved with detection and situational awareness activities that support biosurveillance.

The public health and health care workforce is expected to continue to confront shortfalls in the coming years, which could threaten the federal government’s ability to develop a national biosurveillance capability. According to CDC officials, serious public health and health care workforce shortages currently exist due to factors such as the exodus of retiring workers, an insufficient supply of trained workers, inadequate funding, and uncompetitive salaries and benefits. In discussing concerns about looming workforce shortages, CDC officials pointed to a December 2008 Association of Schools of Public Health estimate that by 2020 the nation will face a shortfall of over 250,000 public health workers. CDC officials said that states and communities nationwide report needing more public health nurses, informaticians, epidemiologists, laboratory workers, statisticians, and environmental health experts. Moreover, the Institute of Medicine stated in 2009 that the unevenness of organizational and technical capacity at state and local levels across the public health system weakens the nation’s preparedness to detect and, especially, to respond to and manage the consequences of a major health emergency.

We also reported in February 2009 that the animal health field faces workforce shortages that could affect the ability of professionals to be prepared and enabled to detect and warn of biological events. For example, USDA officials have expressed concern about the future size and skills of the veterinarian workforce, particularly veterinary pathologists who are integral to the work conducted in USDA’s diagnostic laboratories, including work on diseases that threaten animal and human health. Further, USDA officials have also expressed concern about the availability of taxonomists, whose expertise is critical to characterizing threats and providing warning of a potentially catastrophic biological event involving plants.

Although the workforce shortages threaten to diminish capacity to detect signals of potentially catastrophic biological events as they emerge, some federal agencies are planning or have taken actions to help mitigate them. In particular, in its National Biosurveillance Strategy for Human Health, CDC named the biosurveillance workforce as one of its priority areas. To enhance workforce capability, CDC’s strategy calls for assessing the current biosurveillance workforce capability, identifying and addressing gaps, ensuring the workforce is competent, developing recruitment and retention strategies for professionals across diverse fields, and establishing a national-level governance body for the biosurveillance workforce across agency boundaries and disciplines. CDC has also taken actions to help increase the number of public health workers, including extending service and learning fellowships in epidemiology, informatics, laboratory, and management.

Moreover, with respect to animal and plant workforce, the federal government is implementing measures to help ensure an adequate workforce. For example, we reported in February 2009 that USDA has set a goal of recruiting at all veterinary colleges and universities. In addition, USDA is using incentives, such as bonuses, to attract and maintain its veterinarian workforce. In addition, USDA has identified tactics to build the capacity and retain the experience of taxonomists. USDA is also using cooperative agreements and funding to enlist taxonomic services from nonfederal institutions to identify and confirm identifications of exotic plant pests. According to USDA officials, they have increased the number and variety of these agreements in recent years, increased availability of professionals who can help identify threats to plants by nearly 50 percent in the past 20 years, and created a career ladder to retain experienced and talented workers. Further, in response to recommendations we made in February 2009 to address veterinarian shortages, in November 2009, the Office of Personnel Management established the governmentwide Veterinary Medical Officer Talent Management Advisory Council. The purpose of the council is to lead the design and implementation of a governmentwide workforce strategy for federal veterinary medical workers. The council held its first meeting in March 2010 and is in the process of gathering workforce data from all federal agencies with veterinarian medical officers.

Federal Agencies Have Supported or Implemented Training and Accreditation Programs

Federal agencies have supported programs to help with workforce development at the state and local levels that respond partially to the ongoing challenge of maintaining a trained cadre of professionals who operate in fields where professional issues, systems, and technologies continue to evolve over time. Training and accreditation programs are essential to developing a knowledgeable workforce with the skills needed to identify potential threats to human, animal, and plant health. An effective medical response to a biological event would depend in part on the ability of individual clinicians and other professionals to identify, accurately diagnose, and effectively treat diseases, including many that may be uncommon. The opportunity to evaluate signs and symptoms of diseases of concern relies on trained professionals possessing the knowledge needed to identify and order the right lab test to confirm a diagnosis. In addition, detection and warning of a disease threat also relies on these professionals knowing who to call to report the finding.

One challenge federal officials relayed to us is that because the concept of biosurveillance is relatively new and has been evolving over the last decade, there are few if any specialties or concentrations in biosurveillance within epidemiology or other programs. They further noted that while some university programs are beginning to address the issues in their curricula, the general lack of biosurveillance or cross- domain specialties, curricula, and classes in these programs limits the feedback loop between academics and practitioners that helps support innovative solutions.

Another training challenge is keeping up with changes in issues, technologies, and systems. CDC officials told us that public health workers are always challenged with keeping abreast of developments. For example, when a new laboratory tool or method is developed, public health workers must be trained to use them. Epidemiologists also must be trained and educated about new or emerging health issues, infections, software, information technology systems, and tools. Clinicians require continuing education to remain astute. These CDC officials noted that maintaining expertise in a rapidly changing field is difficult, yet having professionals with the right expertise is critical in protecting the public’s health, as well as for emergency preparedness and response. For USDA, the increased risks to animal and public health from animal diseases have presented challenges because the expertise needed to identify and respond to the risks of zoonotic diseases has not been defined.

Further, a DOI official expressed concern about maintaining skills and expertise of wildlife health professionals. According to this official, identifying, characterizing, and mitigating threats involving free ranging fish and wildlife populations call for specific training and expertise in wildlife epidemiology and wildlife disease ecology. These officials expressed concern about whether federal inspectors receive sufficient training or have sufficient resources to address disease in free-ranging wildlife populations.

Federal agencies have taken actions to help respond to the challenges arising from evolving fields of study and increased risks of outbreaks impacting more than one domain. For example, in the National Biosurveillance Strategy for Human Health, CDC has called for the development of a national training and education framework to articulate professional roles and competencies necessary for biosurveillance. The strategy also noted that in addition to the traditional public health professions trained in surveillance, there is a need to recruit professionals from other diverse fields including informatics and computational sciences to enhance data sharing, as well as the plant and veterinary sciences to help understand how diseases flow among humans, animals, and plants. Along these lines, CDC has developed a public health informatics fellowship program, which is designed to help address the need for practitioners with a mastery of sophisticated electronic systems to facilitate communication and data exchange among public health personnel at the local, state, and federal levels. Officials at HHS also noted that the National Institute of Health’s National Library of Medicine has funded 18 University-Based Biomedical Informatics Research Training programs, of which 10 have special Public Health Informatics tracks.

USDA has also developed training programs to ensure their first detectors are knowledgeable on diseases and pests of significance. For example, USDA has an accreditation program for veterinarians and views the cadre of veterinarians it has accredited as the front line of surveillance for diseases of significance that are not specifically monitored through a program. These accredited state and federal veterinary officials—as we reported in 2005, approximately 80 percent of the veterinary workforce— are dispersed throughout the country and are trained to observe signs and symptoms of diseases and unusual occurrences of illness or death in animal populations. According to USDA, the United States depends extensively on accredited veterinarians for official functions, such as inspecting, testing, and certifying animal health. For plant surveillance, USDA’s National Plant Diagnostic Network began the National First Detector Training Program in 2003. The program offers training to aid USDA’s surveillance of plants for pests and diseases. First detectors are individuals who in the course of their activities are in a position to notice an unusual plant pest outbreak, a pest of concern, or symptoms of a pest of concern. The individuals may include growers, nursery producers, crop consultants, pesticide applicators, and master gardeners, among others. According to USDA officials, the training equips participants with the knowledge to detect and report unusual exotic pest or disease activity, which is key to initiating response and mitigation activities.

Federal Agencies Have Efforts Underway to Develop Equipment and Systems to Support Their Biosurveillance Missions

Our analysis of relevant presidential directives and our discussion with federal officials with central responsibilities for monitoring disease and protecting national security indicate that a national biosurveillance capability depends upon systems and equipment that enable rapid detection and communication of signals that might indicate a potentially catastrophic biological event, quick and effective analysis of those signals, and timely dissemination of high-quality and actionable information to decision makers. In this vein, federal agencies have taken various actions designed to promote timely detection and situational awareness by developing (1) information sharing and analysis mechanisms, (2) laboratory networks to enhance diagnostic capacity, and (3) equipment and technologies to enhance early detection and situational awareness.

Information Sharing and Analysis Mechanisms

Because the data needed to detect an emerging infectious disease or bioterrorism may come from a variety of sources, the ability to share and analyze data from multiple sources may help officials better collaborate to analyze data and quickly recognize the nature of a disease event and its scope. As illustrated in figure 5, observing related symptoms in human and animal populations, or cross-domain surveillance, may bring concerns into focus more quickly than monitoring human symptoms alone. This may be particularly important as many disease agents have the potential to be weaponized and many of the recent emerging infectious diseases are zoonotic.

In reviewing the federal response, we reported that the analysis of the outbreak continued for weeks as separate investigations of sick people and of dying birds. Only after the investigations converged, and after several parties had independently explored other possible causes, was the link made and the virus correctly identified.

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We concluded that the time it took to connect the bird and human outbreaks signaled a need for better coordination among public and animal health agencies.

One example of a federal initiative designed to improve sharing of biosurveillance information is DHS’s National Biosurveillance Integration Center’s (NBIC) Biological Common Operating Picture (BCOP), a manually updated Google Maps application of current worldwide biological events being tracked. Officials can view the BCOP on the Homeland Security Information Network. The BCOP provides a situational awareness tool for the National Biosurveillance Integration System (NBIS)—the community of federal and other stakeholders that have information that can be used to enhance the safety and security of the United States against potential biological events of national significance. NBIC supports the BCOP through a system—the Biosurveillance Common Operating Network (BCON)—that monitors, tracks, and disseminates available NBIS-partner information, but relies largely on information from publicly available sources, such as news articles. One of the primary data sources for BCON is an international information gathering service called Global Argus, a federally funded program in partnership with Georgetown University. The service searches and filters over 13,000 overseas media sources, in more than 34 languages.

A similar type of initiative underway at some federal agencies involves developing and maintaining communication tools for information sharing within specialized disciplines. These communication tools may include functions that allow users to send and receive information or view the status of ongoing events. One such tool is a Web-based forum that provides a secure environment for the exchange of information on case reports and allows users to request information or expertise from other users. For example, one such communication tool developed by CDC, known as Epi-X, provides a secure Web-based forum for public health officials to post case reports of conditions and ask other health officials whether they have also seen cases of the condition. The officials can also discuss similarities in the cases that may indicate how the disease is spreading and suggest mitigation measures—for example, product recalls—that could be implemented. In this way, health officials can leverage both information and analytical capacity across agencies, levels of government, and different regions of the country to help support the early detection and situational awareness goals of biosurveillance. For example, the forum may help them to more quickly and comprehensively determine whether diseases seem to be widespread and what caused them and to discuss treatment options in a secure environment. For more information on specific communication tools, see appendix IV.

In addition, we reported in May 2003 that electronic reporting of data can facilitate data exchange among different databases and allow more rapid and accurate analysis of information from multiple sources. CDC officials noted that laboratory reports could be received by CDC in 72 hours if exchanged through an electronic system, as opposed to the up to 2 weeks it can take for laboratory report hard copies to be sent through the mail. Further, because it facilitates data exchange, standardization can help support the vision of integrated surveillance systems articulated in HSPD-9 and 21. According to CDC officials, the potential benefits of electronic reporting of data in a standardized format are striking and can eliminate the need for analysts to dedicate valuable time to processing and translating data provided in different formats expressed using various terminologies. For example, during the 2001 anthrax event, the results of laboratory tests for anthrax were reported in different formats (e.g., emailed text, mailed hard copy, as attachments in different software programs), and using different terminology, such as “Bacillus anthracis,” “B. anthracis,” and “Anthrax.” These variations in report format and language required analysts at CDC to spend time translating and compiling the data into information that could inform decision making during the event.

To support effective and efficient information sharing, some agencies have efforts underway to promote electronic reporting of information in a standardized format. For example, CDC’s Public Health Information Network (PHIN) initiative aims to advance the development of interoperable surveillance and other public health systems at federal, state, and local levels. The initiative defines data and messaging standards and provides guidance for public health entities to follow in building systems that meet compatibility and interoperability standards for enhanced electronic information sharing. Additionally, HHS, through initiatives to support nationwide health information exchange, has defined specific standards that promote the exchange of biosurveillance information among health care providers and public health authorities.

Within CDC, several surveillance systems have been developed and implemented in accordance with PHIN standards to promote electronic information sharing. One of these is the National Electronic Disease Surveillance System (NEDSS). A primary goal of NEDSS is the ongoing, automatic capture and analysis of data that are already available electronically to minimize the problems of fragmented, disease-specific surveillance systems. The initiative is intended to promote efficient and effective data management and information sharing by eventually consolidating the data collection of CDC’s various programmatic disease surveillance activities in one place. For more information on programs that support standardization and electronic data exchange, see appendix IV.

To further enhance and support biosurveillance activities, CDC, DHS and other federal agencies have developed or taken action to gather electronic data from syndromic surveillance systems. Syndromic surveillance uses health-related data collected before diagnosis to look for signals or clusters of similar illnesses that might indicate an outbreak. Examples of syndromic surveillance data are prediagnostic health-related information like patients’ chief complaints recorded by a health care worker at the admissions desk of a hospital emergency room and information collected on over-the-counter sales of antidiarrheal medicines that could indicate gastrointestinal disease outbreaks. We reported in 2004 that because these syndromic systems monitor symptoms and other signs of disease outbreaks instead of waiting for clinically confirmed reports or diagnoses of a disease, some experts believe they can increase the speed with which outbreaks are identified. However, we also reported in September 2004 and November 2008 that the ability of syndromic surveillance to more rapidly detect emerging diseases or bioterror events has not yet been demonstrated, and questions about its cost-effectiveness arise. An example of a syndromic surveillance system is CDC’s BioSense—another CDC system that was developed and implemented in accordance with data and message standards defined by the PHIN initiative. BioSense collects electronic data that are voluntarily shared by participating state, local, and other federal public health entities, including data related to infections, injuries, and chronic diseases. Currently the system collects chief complaint data from 570 hospitals and 1,100 federal clinics, and sales data from over 10,000 pharmacies. Because the data and messages are sent and received in standardized formats, the data are integrated into the BioSense system, reducing the need for analysts to manually interpret or manipulate data and are analyzed by the system to enhance the nationwide situational awareness capabilities of public health analysts at CDC.

Even as standardization and data and information-sharing tools improve, other challenges will likely impede information sharing for biosurveillance purposes across federal, state, and local levels of government. We and others have noted that numerous challenges have impeded efforts to coordinate and collaborate across organizational boundaries to integrate biosurveillance and other national security activities. Some such challenges are inherently intergovernmental issues and arise because most of the information needed for biosurveillance is generated and owned outside of the federal government. Therefore, there is limited assurance that state and local governments can or will fully participate in federal information sharing and standardization initiatives like PHIN. CDC officials expressed concern about the differing levels of capacity and willingness among states to participate in data standardization and electronic information-sharing initiatives.

Moreover, information-sharing challenges also occur among the federal agencies. As we reported in December 2009, NBIC has faced collaboration challenges and has been largely unsuccessful in obtaining from federal partners key resources needed to support data integration and shared analytical capacity. Federal officials from agencies participating in the National Biosurveillance Integration System—such as CDC, USDA, and FDA—described challenges to sharing such information, including concerns about trust and control over sensitive information before it is vetted and verified. In addition, NBIC officials told us and we previously reported that much of the information available to help achieve biosurveillance goals is unstructured and not readily processed by a computer system; while, data that are more easily computer processed often lack the context needed to make appropriate conclusions about whether anomalies actually signal a potential problem.

Laboratory Networks to Enhance Laboratory Diagnostic Capacity

Over the past decade, the federal government has leveraged and enhanced its laboratory capabilities, capacity, resources, and expertise for detecting and warning about biological threat agents by developing and implementing laboratory networks at the federal, state, and local level. In addition, the federal government led an effort to establish a consortium of laboratory networks that further integrates a number of these networks. In June 2005, 10 federal agencies signed a Memorandum of Agreement establishing the Integrated Consortium of Laboratory Networks (ICLN). The purpose of this consortium is to establish a coordinated and operational system of laboratory networks that provide timely, high- quality, and interpretable results for early detection of acts of terrorism and other events that require integrated laboratory response capabilities. ICLN’s individual laboratory networks focus on detecting biological threat agents that affect humans, animals, or plants that contaminate the air, water, or food supply. These laboratory networks which comprise the ICLN are shown in table 1.

The federal government is developing and implementing equipment and technologies that can provide additional information to support early detection and situational awareness. For example, the federal government is applying diagnostic technologies to help detect and monitor biological events. Studying disease agents at the molecular level can provide information for situational awareness. Techniques to determine and attribute the source of biological events can be important for both natural and intentional events. In a natural event—such as a foodborne illness—it can help speed detection, focus the investigation, and characterize the extent and severity of disease. For intentional events, it can provide critical information to help determine the scope of the attack and contribute to law enforcement investigations. One example of such a system is CDC’s PulseNet, a national network of public health laboratories that perform DNA “fingerprinting” as a means to help with early identification of outbreaks of foodborne illness with a common source and enhance situational awareness during an event. The PulseNet program provides a tool for participating laboratories to upload and then compare the genetic “fingerprints” of foodborne pathogens isolated from samples taken from sick individuals. The network can identify and label each fingerprint pattern to permit the rapid comparison of these patterns with others in the PulseNet database. PulseNet officials told us that this process can take roughly 2 weeks after receiving a sample. FDA, USDA, CDC, and state public health officials have access to the PulseNet database. See appendix IV for more information on foodborne disease monitoring systems and diagnostic technologies.

Federal agencies have also developed technologies to detect biological agents in drinking water and air. Drinking water utilities across the country have long been recognized as potentially vulnerable to terrorist attacks of various types, including physical disruption, bioterrorism, chemical contamination, and cyber attack. People also face the threat of becoming ill from inhaling certain biological agents—whether naturally occurring or intentionally weaponized and released to cause disease and disruption. EPA has developed a system to detect contamination of drinking water and USPS, DOD, and DHS have developed sensor technologies to detect aerosolized biological agents in the air. EPA’s Water Security Initiative program developed a contamination warning system to allow local water utilities to monitor drinking water for contamination by chemical, biological, and radiological agents. The contamination warning system has been designed to provide timely detection and appropriate response to biological events.

The system, however, is not widely distributed. Currently, the Greater Cincinnati Water Works in Cincinnati, Ohio is the only locality that has the system fully operating. EPA is assisting local water districts in four other locations—New York City, San Francisco, Dallas, and Philadelphia—with implementation the contamination warning system as part of a five-city pilot project each of which EPA officials stated is to last for four years and be complete in 2012. Local water utilities are to implement this system on a voluntary basis and operate it at their own expense. According to EPA officials, no contamination warning systems has yet been proven to be effective and sustainable for drinking water systems, but the Water Security Initiative is attempting to design, deploy, and test an effective and sustainable system. For more information on the Water Security Initiative, see appendix IV.

USPS, DOD, and DHS have developed and implemented technologies to sample the air and test for specific biological agents. One of these, DHS’s Biowatch program, has been implemented in more than 30 metropolitan areas and tests for the presence of multiple biological threat agents. USPS has deployed an indoor monitoring system—Biohazard Detection System—at mail distribution centers nationwide that automatically detects and warns of the presence of the anthrax organism in the air surrounding mail-sorting equipment. DOD has also developed indoor and outdoor monitoring systems to detect airborne chemical, biological, radiological, or nuclear agents in order to protect military interests.

However, these sensor technologies are limited in their ability to provide early detection because there are constraints on the speed with which the diagnostic testing can be performed. For example, DHS’ Biowatch sensor technology depends on air filters which must be collected and transported to a laboratory for diagnostic testing, which can take more than a day. According to senior officials from the Office of Health Affairs and the Science and Technology Directorate at DHS, research and development to eliminate the need for manual collection of samples is underway, but the science needed to do so may not yet be fully mature. Additional information on the USPS, DOD, and DHS biodetection systems can be found in appendix IV.

A National Strategy and a Focal Point Could Help Guide Development of a National Biosurveillance Capability

While some high-level biodefense strategies have been developed, there is no broad, integrated national strategy that encompasses all stakeholders with biosurveillance responsibilities that can be used to guide the systematic identification of risk, assessment of resources needed to address those risks, and the prioritization and allocation of investment across the entire biosurveillance enterprise. Further, while numerous agencies have biosurveillance responsibilities, a single focal point for this effort has not been established. We have reported that developing effective national strategies and establishing a focal point with sufficient time, responsibility, authority, and resources can help ensure successful implementation of complex interagency and intergovernmental undertakings, such as providing a national biosurveillance capability.

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Establishing a Focal Point Could Help Ensure the Development and Implementation of a National Strategy

We reported in February 2004 that strategies themselves are not endpoints, but rather, starting points, and, as with any strategic planning effort, implementation is the key. This work also reported that the ultimate measure of these strategies’ value will be the extent to which they are useful as guidance for policy and decision makers in allocating resources and priorities. However, for an undertaking such as developing a national biosurveillance capability, those policy and decision makers are spread across the interagency and intergovernmental network. In our work related to combating terrorism, we reported that an interagency and intergovernmental undertaking can benefit from the leadership of a single entity with sufficient time, responsibility, authority, and resources needed to provide assurance that the federal programs are based upon a coherent strategy, are well coordinated, and that gaps and duplication in capabilities are avoided.

According to our analysis of requirements in laws and presidential directives related to biosurveillance, a focal point has not been established with responsibility and authority for ensuring the development of a robust, integrated, national biosurveillance capability. The mission responsibilities and resources needed to develop a biosurveillance capability are dispersed across a number of federal agencies, and, according to officials at a number of federal agencies—CDC, USDA, and DHS—chief among them, agencies have capabilities that could be leveraged to support a robust, integrated, national biosurveillance capability. However, our analysis indicates that no entity has the responsibility, authority, and accountability for working across agency boundaries to guide and oversee the development and implementation of a national effort that encompasses all stakeholders with biosurveillance responsibilities. For example, CDC has been given the operational lead for developing the vision of HSPD-21 for a human health biosurveillance capability. However, according to CDC officials, responsibility for developing a national biosurveillance capability that includes human as well as animal, plant, food, and environmental surveillance has not been assigned to a single entity such as an intergovernmental council, a federal agency, or an individual official.

Officials in various agencies have taken the lead to fulfill their agencies’ biosurveillance missions, but they lack authority to direct other agencies with whom they must partner to take specific action. For example, CDC has undertaken some efforts to coordinate federal efforts relating to human and zoonotic disease surveillance, but according to CDC officials, it has limited authority to ensure the implementation of specific activities at other agencies. According to CDC officials, an overarching organizational mechanism and clearly articulated roles and responsibilities across the separate surveillance programs that serve a range of purposes could help address common surveillance issues within CDC and across the biosurveillance enterprise by coordinating communication and planning. Officials from CDC, DOD, DHS, USDA, and HHS stated that having a focal point would help coordinate federal efforts to develop a national biosurveillance capability. Because the mission responsibilities and resources needed to develop a biosurveillance capability are dispersed across a number of federal agencies, efforts to establish a national biosurveillance capability could benefit from designated leadership—a focal point—that provides leadership for the interagency community.

Conclusions

The report of the Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism stated that an attempted biological attack somewhere in the world is likely is likely within the next few years and concluded that the nation was unprepared for such an event. A key component of preparedness is the ability to detect a dangerous pathogen early and assess its potential spread and effect. Various federal statutes and presidential directives call for biosurveillance actions, culminating with HSPD-2’s most recent call for a robust, integrated national biosurveillance system that draws upon and synthesizes the capabilities of multiple existing systems across a number of federal departments and agencies. The challenges in achieving this vision are many and difficult to successfully address, such as acquiring and retaining staff with sophisticated skills and melding disparate information and data systems. Biosurveillance must operate in a complex environment of many players and an evolving threat. Because a biological incident, originating from nature or deliberate acts, could emerge through any number of means—plant, animal, air, and human transmission—it is essential that federal agencies collaborate to leverage their capabilities and find effective and efficient solutions and strategies for detection and analysis. Although efforts like the National Biosurveillance Strategy for Human Health, USDA’s Strategy for the National Animal Health Surveillance System, and DHS’s National Biosurveillance Integration Center are potentially useful steps in developing a robust, national biosurveillance capability, they do not provide a unifying framework and structure for integrating dispersed capabilities and responsibilities. Further, none of the current players have the authority to guide and oversee the development and implementation of a national effort that encompasses all stakeholders with biosurveillance responsibilities. Without a unifying framework, structure, and an entity with the authority, resources, time, and responsibility for guiding its implementation, it will be very difficult to create an integrated approach to building and sustaining a national biosurveillance capability as envisioned in HSPD-21.

Recommendations for Executive Action

In order to help build and maintain a national biosurveillance capability— an inherently interagency enterprise—we recommend the Homeland Security Council direct the National Security Staff to, in coordination with relevant federal agencies, take the following two actions: (1) Establish the appropriate leadership mechanism—such as an interagency council or national biosurveillance director—to provide a focal point with authority and accountability for developing a national biosurveillance capability. (2) Charge this focal point with the responsibility for developing, in conjunction with relevant federal agencies, a national biosurveillance strategy that: defines the scope and purpose of a national capability; provides goals, objectives and activities, priorities, milestones, and assesses the costs and benefits associated with supporting and building the capability and identifies the resource and investment needs, including investment priorities; clarifies roles and responsibilities of leading, partnering, and supporting a articulates how the strategy is integrated with and supports other related strategies’ goals, objectives, and activities.

Agency Comments and Our Evaluation

We provided a draft of this report for review to the Departments of Homeland Security (DHS), Health and Human Services (HHS), Agriculture (USDA), Commerce (DOC), Defense (DOD), Interior (DOI), Justice (DOJ), State (State), Transportation (DOT), and Veterans Affairs (VA); the Environmental Protection Agency (EPA); the United States Postal Service (USPS); and the National Security Council (NSC). DHS provided written comments on the draft report, which are summarized below and presented in their entirety in appendix V of this report. DOC, DOD, DOI, DOJ, HHS, State, DOT, VA, EPA, USDA, USPS, and the NSC did not provide written comments. We incorporated technical comments from DOC, DOD, DOI, DOJ, HHS, State, DOT, VA, EPA, USDA, and the USPS where appropriate.

In written comments, DHS generally concurred with our findings and recommendations. In particular, DHS noted that it is important to develop a strategy that encompasses all biological domains. Further, DHS stated that the department’s National Biosurveillance Integration Center in conjunction with its NBIS partners, have identified strategic planning gaps and could also be helpful in providing leadership for the strategic planning effort. DHS also noted that the statutory responsibilities and expectations assigned to NBIS federal participants could serve as guideposts for any White House Homeland Security Council leadership mechanism.

We are sending copies of this report to the Special Assistant to the President for National Security Affairs; the Attorney General; the Secretaries of Homeland Security, Health Human and Services, Agriculture, Commerce, Defense, Interior, State, Transportation, and Veterans Affairs; the Administrator of the Environmental Protection Agency; the Postmaster General; and interested congressional committees. The report is also available at no charge on GAO’s Web site at http://www.gao.gov.

If you or your staff have any questions about this report please contact me at (202) 512-8777 or JenkinsWO@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 major contributions to this report are listed in appendix VI.

Appendix I: Objectives, Scope, and Methodology

The Implementing Recommendations of the 9/11 Commission Act of 2007 required GAO to describe the state of federal, state, local, and tribal government biosurveillance efforts, the duplication of biosurveillance efforts, the integration of biosurveillance systems, and the effective use of resources and expertise at these levels of governments. We are addressing these questions in a series of three reports. The first of the series, issued in December 2009, focused on the Department of Homeland Security’s (DHS) National Biosurveillance Integration Center (NBIC). This report describes domestic biosurveillance efforts at the federal level; we did not review efforts by the federal government to create or improve on international biosurveillance programs. A third report, which we expect to issue during the Winter of 2011, will describe biosurveillance efforts at the state, local, tribal, and territorial levels of government.

Specifically, this report examines the following: (1) federal agency efforts to provide resources—personnel, training, equipment, and systems—that support a national biosurveillance capability; and (2) the extent to which mechanisms are in place to guide development of a national biosurveillance capability.

To address these objectives, we reviewed key legislation, presidential directives, and agency-issued policies related to biosurveillance. Specifically, we reviewed the Homeland Security Act of 2002, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, the Pandemic and All Hazards Preparedness Act of 2006, the Implementing Recommendations of the 9/11 Commission Act of 2007, and Homeland Security Presidential Directives (HSPD) 5, 7, 8, 9, 10, and 21. These laws and presidential directives task various federal agencies with specific biosurveillance responsibilities and related mission activities, describe biosurveillance activities that agencies are to perform, and define key terms, among other things. To determine the elements of a capability, we reviewed DHS’s Target Capability List, which specifies that capabilities are made up of the personnel, training, equipment and systems, planning, and leadership necessary to accomplish a mission. We consulted our prior reports including reports on the public health system, emerging infectious diseases, the use of information technology tools to support homeland security and national security goals, protection of animal health and the agriculture sector, food safety and defense, and combating terrorism. See Related GAO Works for an expansive list.

We used the information in the laws and presidential directives, as well as previous GAO work, to identify federal departments and agencies responsible for biosurveillance. We also considered federal departments and agencies that NBIC had included among its National Biosurveillance Integration System (NBIS) partners. In addition to DHS, NBIC has identified 11 NBIS-partner agencies, which it considers to be part of the NBIS interagency community. Those departments and agencies are the Departments of Agriculture (USDA), Commerce, Defense (DOD), Health and Human Services (HHS), Interior, Justice, State, Transportation, Veterans Affairs, as well as the Environmental Protection Agency (EPA) and the United States Postal Service (USPS). We considered interviews we conducted with officials with responsibilities for participating in the NBIC community, as well as interviews with officials responsible for a number of other biosurveillance-related mission activities to inform the findings and underlying context of this report. Although we conducted interviews at multiple components of 12 federal departments, we focused on information collected at 7 federal departments that have key roles and responsibilities—based on agency mission, statutory responsibilities, presidential directives, or programmatic objectives—for biosurveillance and related mission activities, including protection of public health, agriculture, and national security. These departments are USDA, DOD, DHS, HHS, DOI, EPA, and USPS. Further, as USDA, HHS, and DHS have the larger and more direct mission responsibilities for biosurveillance and related mission activities, we focused most heavily on the contributions of their activities to support a national biosurveillance capability. For the purposes of this review, we limited our evaluation to domestic biosurveillance activities and how these domestic activities may contribute to a national biosurveillance capability. We did not review federal efforts to enhance international disease surveillance.

Specifically, we met with and reviewed documents from officials in the agencies shown in table 1.

We reviewed publicly available documents, including organizational charts, mission statements, memoranda of understanding, and program descriptions from these agencies to identify programs which may contribute to disease surveillance, early detection of biological events, or improved situation-specific information during a biological event. We also reviewed previously assembled lists of biosurveillance or disease surveillance programs compiled in our prior reports and by other federal agencies. These include a portfolio of biosurveillance programs completed by CDC in October 2008 and the U.S. Animal Health and Productivity Surveillance Inventory assembled by USDA. NBIC has a biosurveillance mission specified in the Implementing Recommendations of the 9/11 Commission Act of 2007, which requires interagency coordination across the federal government to detect and provide warning of biological events of national concern. As such, we reviewed NBIC operational documents that describe the federal agencies that participate in NBIC’s biosurveillance activities.

To determine the extent to which mechanisms are in place to support a national biosurveillance capability, we reviewed strategic plans issued for supporting the nation’s biodefense goals—which includes biosurveillance—for the extent to which these plans incorporated biosurveillance objectives. These plans included the National Health Security Strategy, the National Security Council’s National Strategy for Countering Biological Threats, and the National Response Framework. We also reviewed documents from individual agencies’ efforts to pursue their biosurveillance mission, in order to determine the extent to which individual agencies efforts may contribute to a national biosurveillance capability. These documents include: The National Biosurveillance Strategy for Human Health, NBIC’s Concept of Operations for the National Biosurveillance Integration System, USDA’s National Animal Health Surveillance System strategic plan, and FDA’s Food Protection Plan. We also reviewed reports issued by the National Academies of Science’s Institute of Medicine which analyzed the existing capacity of the United States to detect and respond to emerging microbial threats, the limitations of disease surveillance, and costs and benefits of existing biosurveillance programs. We reviewed the approach used and the information provided in the Institute of Medicine studies and found them to be credible for our purposes.

We met with federal officials who had responsibility for specific disease surveillance programs or were directly involved in other federal biosurveillance activities, such as representing the department as part of NBIC activities or having responsibility for implementing the department’s responsibilities in relevant HSPDs. We interviewed these officials on the function of the specific disease surveillance program, including the process of detection, information-sharing mechanisms, and time frames in which information is generated and shared. In addition, we interviewed these officials on the degree to which the federal government has built a national biosurveillance capability, how specific programs could contribute to a national capability for early detection or situational awareness of biological events, the degree to which federal programs are integrated with each other, and the limitations of these programs in supporting a national biosurveillance capability. We analyzed this information to determine how individual agencies’ programs could contribute to building the personnel, training, and equipment and systems needed for a national biosurveillance capability. We also interviewed agency officials from programs that have responsibilities for carrying out the relevant HSPDs to determine the extent to which individual agencies have created mechanisms for integrating data, information sharing, and implementing new biosurveillance techniques. We also interviewed these officials on the limitations individual agencies have in building this capability and compared it to our previous work on identifying a focal point. These officials included senior officials with CDC’s Biosurveillance Coordination Unit, HHS’s Office of the Assistant Secretary for Preparedness and Response, DHS’s NBIC, USDA’s Centers for Epidemiology and Animal Health, and DOD’s National Center for Medical Intelligence.

In addition, because public health activities are primarily administered at the state and local levels of government, we met with representatives from nonprofit and public health professional organizations that have biodefense or disease surveillance-related missions, as well as state and local organizations, in order to further identify federal programs or initiatives that may contribute to biosurveillance. These include the Association of State and Territorial Health Officials, the Council of State and Territorial Health Epidemiologists, and the National Association of County and City Health Officials. These organizations represent state and local epidemiologists, public health organizations, and officials involved in public health at the state and local levels. In particular, the Council of State and Territorial Health Epidemiologists coordinates the development of the National Notifiable Disease List. In addition, we met with experts from research organizations that study biodefense issues, including the University of Pittsburgh Center for Biosecurity, the Congressional Research Service, and the National Academies’s Institute of Medicine. These organizations identified biosurveillance efforts at the federal level, discussed the status of the federal government’s efforts to build a national biosurveillance capability, and described limitations on the federal government’s biosurveillance efforts and efforts to build a robust and integrated national biosurveillance capability.

During our review of documents and interviews with knowledgeable officials, we compiled a list of more than 100 programs from across the federal government which may be relevant to biosurveillance. We also asked federal officials to explain how these programs may contribute to detecting biological events or providing situation-specific information to decision makers during an ongoing event, and to identify other programs to consider for inclusion in our study. For each program identified, we interviewed officials and requested descriptive information on their program, such as the coverage and frequency of populations surveyed; diseases on which data are collected by these biosurveillance efforts and their characteristics; how data are used to conduct biosurveillance; how information is reported to support early detection of a biological event or improved information during an event; the status of these efforts; and costs to operate these efforts. These programs were included in our catalog because they may contribute to biosurveillance in one of the following five ways: 1. Provide information to establish disease baselines, such as infection rates and geographical distribution of disease outbreaks. 2. Provide opportunities for astute clinicians to detect outbreak signals, such as collecting syndromic data that, when analyzed, may indicate an emergent infectious disease. 3. Provide disease-specific information to enhance response; for instance, data which may be used to identify and trace sources of detected outbreaks. 4. Represent a surveillance effort designed to shorten the time to detect disease outbreaks, such as environmental sensors designed to detect specific biological agents. 5. Provide tools to integrate data or coordinate information sharing; for instance, communication platforms on which analysts can discuss biosurveillance issues of concern.

For each agency in our review, we compiled the information on each program into a standard profile and validated this information with program officials. We asked these program officials to verify the accuracy of the information, to add missing information, or make technical comments, which we incorporated as appropriate. We also requested officials to identify additional programs for us to consider including in this review, which we added as appropriate.

These selected efforts do not represent the total universe of biosurveillance efforts, nor does the catalog represent a statistically representative sample of federal biosurveillance efforts. In addition, we did not include programs or initiatives that are led by state, local, international, or private entities; do not specifically support biosurveillance activities; or are classified systems. Some programs or initiatives may be used to support the nature and purposes of biosurveillance on a case-by-case basis during a biological event, but may not regularly be used to support biosurveillance. For example, some systems we identified track weather patters or map transportation infrastructures, which may be used to estimate the severity of an outbreak or predict a disease’s epidemiology. These programs are not included in the selected catalog. Because these efforts are not included in the selected catalog, it does not represent the total universe of biosurveillance capabilities nor does it represent a statistically significant sample of biosurveillance efforts. Finally, we did not evaluate the efficiency or effectiveness of the biosurveillance efforts that we identify in the catalog.

We conducted this work from December 2008 through June 2010 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.

Appendix II: Full Text for Figure 2 Select Worldwide Disease Occurrences in Recent Decades

The following information appears as interactive content in the body of the report when viewed electronically. The content associated with each point on the map describes a disease event and includes information on the transmission and symptoms of the disease. The content appears in print form below in alphabetical order by disease name.

Appendix III: Traditional Monitoring Systems Provide Important but Limited Contributions to a National Biosurveillance Capability

Traditional disease surveillance systems designed to collect information on the health of humans, animals, and plants support biosurveillance efforts by recording national health and disease trends and providing specific information about the scope and projection of outbreaks to inform response. Traditional systems, however, rely on time-intensive testing and confirmation practices as well as data not owned by the federal government, which present challenges that limit their ability to provide timely detection and situational awareness.

Monitoring for disease at the national level establishes a baseline understanding of disease characteristics that enables officials to recognize anomalous disease occurrences within the United States. Detecting a signal that warns of a potential or imminent biological threat of national concern requires the ability 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. This information is also useful for projecting how an outbreak may progress during response to a potentially catastrophic biological event.

The U.S. government has a long history of monitoring human, animal, and plant health—in some cases for more than a century—to help limit malady, loss of life, and economic impact. Disease surveillance for human health at the national level was established to assess the status of the public’s health, develop policy to define public health priorities, and provide assurance of the prevention and control of disease. The federal government uses a nationally notifiable disease List as the foundation of its human health surveillance efforts.

Fifty-seven jurisdictions, including state and local health departments, voluntarily report cases of certain diseases named on the list of nationally notifiable diseases to the CDC. CDC uses these reports from the states to monitor national health trends, formulate and implement prevention strategies, and evaluate state and federal disease prevention efforts. In addition to the National Notifiable Disease Surveillance System, CDC maintains programs aimed at detecting and preventing specific diseases, such as influenza. (For more information on specific programs, see app. IV.) In general, these programs rely on participating health providers to send case reports to CDC on a periodic basis. According to CDC, the timeliest of these disease-specific surveillance programs have participants report the data weekly. Other programs may send information to the CDC on a monthly or annual basis. CDC compiles the data, checks for accuracy, clarifies inconsistencies, and reports national level data at regular intervals. Information that is collected through the National Notifiable Disease Surveillance System and other public health surveillance programs can be applied to determine the scope and forecast the course of an outbreak to enhance situational awareness to guide decision makers’ response efforts.

Similarly, to help protect the nation’s agricultural sector, USDA has routine reporting systems and disease-specific surveillance programs for domesticated animals and some wildlife that can provide information to support the early detection goal of biosurveillance. Information gathered through these efforts can also help characterize and project the nature and scope of an outbreak—for example, by providing the number of infected animals and where they are located—to enhance situational awareness. For instance, state animal health officials obtain information on the presence of specific, confirmed clinical diseases in livestock, poultry, and aquaculture in the United States from multiple sources—including veterinary laboratories, public health laboratories, and veterinarians—and report this information to the USDA’s National Animal Health Reporting System (for more information, see app. IV). USDA has also developed control and eradication programs of specific diseases that threaten the health of animals to reduce the incidence of disease and to provide timely detection of some foreign animal diseases, resulting in smaller outbreaks. These programs are carried out in targeted high-risk populations of various animal and aquaculture species to identify cases of the disease, stem the spread of disease, and take measures to ensure certain diseases that are no longer common in the United States do not reemerge.

In addition, USDA coordinates with state departments of agriculture, state foresters, universities, and industry partners to conduct pest detection surveys of agricultural plants and forests annually. By working with states to identify and prioritize pest threats of national interest and coordinate pest surveys, USDA’s Pest Detection Program provides nationwide information about the presence of select plant pests.

According to officials at DOI, currently there is no national reporting system for diseases of wildlife, making it difficult to track national trends in wildlife disease. DOI’s U.S. Geological Survey’s National Wildlife Health Center is changed with addressing wildlife disease throughout the U.S. This center provides disease diagnosis, field investigation, disease management and research, and training. It also maintains a database on disease findings in wild animals and on wildlife mortality events.

For foodborne illness, CDC, USDA, and FDA can partner to use their traditional surveillance activities to enhance situational awareness during outbreaks. First, CDC identifies an outbreak of foodborne illnesses based on reports from state and local health care providers. Then, it works with the other federal partners to characterize the extent of the illness and identify its source, using a system called OutbreakNet (see app. IV for more information). While CDC works with its external partners to collect additional information about identified cases—such as characteristics of the people affected, the types of food consumed, and the possible location of the consumption—FDA and USDA work with state and local food safety agencies to gather additional information about the source by conducting inspections and testing food samples.

Although information provided by traditional surveillance activities is essential for biosurveillance purposes, the nature of those systems presents inherent challenges that prevent them from being wholly sufficient as tools for timely detection and enhanced situational awareness. We and others have reported that traditional disease reporting has generally been slow and incomplete, and, therefore, not well suited to provide early detection and warning of a disease outbreak or pest infestation. For example, federal agencies collecting data from state, local, and private-sector entities generally rely on voluntary participation, which limits the federal government’s ability to institute controls at the initial collection and data entry points to help ensure accuracy, completeness, or timely reporting. As we reported in 2004, most states maintain a modified version of the national notifiable disease list that reflects the public health priorities of the particular state, but do not consistently reflect CDC’s list of notifiable diseases. Therefore, some local health care providers are not obligated to report diseases on the national notifiable disease list. For instance, five states, including Alabama, Nevada, New Hampshire, Oregon, and Washington do not require local health care providers to report cases of smallpox—which could be used by terrorists as a biological weapon—even though CDC requests this information.

We also previously reported that state officials have experienced significant underreporting by health care providers in their efforts to collect disease data and underreporting can adversely affect public health efforts by leading to erroneous conclusions about trends in incidence, risk factors for contracting a disease, appropriate prevention and control measures, and treatment effectiveness. According to the Institute of Medicine, many health care providers do not fully understand their role in infectious disease surveillance, including their role as a source of data. Furthermore, despite the existence of state notifiable disease lists and related laws, some providers may be unaware of basic reporting requirements.

Also posing a challenge to timely detection and situational awareness is the need for laboratory confirmation. Although mechanisms exist for reporting suspected cases of disease, traditional public health systems rely on laboratory-confirmed cases. Laboratory confirmation, while important to establishing accurate information, adds up to 2 weeks to the reporting process, as results are analyzed and communicated at the state and local levels before they are reported to federal health officials. Officials from CDC and USDA attribute this delay to the inability of labs to communicate test results electronically.

Timely detection and situational awareness are also problems for livestock biosurveillance. For example, we reported in 2005 that USDA does not always use rapid diagnostic tools to test animals at the site of an outbreak. Although, according to experts, on-site use of rapid diagnostic tools is critical to speeding diagnosis, containing the disease, and minimizing the number of animals that need to be slaughtered, USDA employd them only within selected laboratories. DOD used rapid diagnostic tools to identify disease agents on the battlefield, but USDA officials considered the technology to be still under development. A 2002 USDA exercise estimated that, under the current approach, a foreign animal disease such as Foot and Mouth Disease would spread rapidly, necessitating the slaughter of millions of animals and cause staggering financial losses— precisely the type of high-visibility destruction some experts told us terrorists seek. In response to our recommendation, USDA is in the process of evaluating the costs and benefits of using penside rapid diagnostic tools. In addition, we reported that animal numbers and locations are generally not known, and without a national animal identification program, surveillance, trace back, and disease containment is a challenge.

Appendix IV: Selected Systems Used in Federal Early Detection and Situational Awareness Activities

Below we describe selected systems owned or developed by federal agencies which may be used to detect or provide enhanced information about outbreaks relating to human, animal, and plant health, as well as monitoring food and the environment. This list encompasses information reported by federal agencies on electronic communications and surveillance systems as well as networks of laboratories and health officials engaged in disease surveillance.

Human Health, Animal, Plant, Food, Air, Water The Integrated Consortium of Laboratory Networks is to facilitate the development and maintenance of a system of laboratory networks that is built upon established laboratory networks such as the Food Emergency Response Network; the Laboratory Response Network; the National Animal Health Laboratory Network; the National Plant Diagnostic Network; the Environmental Response Laboratory Network; and other emerging networks within the federal government with responsibilities and authorities for laboratory preparedness and response. These networks are to provide timely, high-quality, and interpretable results for the early detection and effective consequence management of acts of terrorism and other events requiring an integrated laboratory response. The Integrated Consortium of Laboratory Networks has created a capabilities assessment of member network laboratories and established working groups to address deficiencies identified by member lab networks. Additionally, the Integrated Consortium of Laboratory Networks provides a forum for laboratory network representatives to provide assistance in the event of a biological, chemical, or radiological contamination emergency.

FY 2009 Costs (thousands)

In development since 2005 and will be transitioned to the Office of Health Affairs once operational (currently targeted for fiscal year 2011)

Diseases resulting from an act of terrorism involving a biological or chemical agent or toxin, radiological contamination, or a naturally occurring outbreak of an infectious disease that may result in a national epidemic.

Laboratory networks have modeled threats posed by chemical, biological, and radiological agents and are developing the capability to support characterization, containment, and recovery from such attacks.

The Department of Homeland Security’s BioWatch Program is an early warning system comprised of collectors capable of detecting aerosol releases of select biological agents, natural and man-made. The Program develops and disseminates guidance and other documents geared toward the public health community, which provide information necessary to prepare for and respond to the detection of an agent of interest. The rogram also evaluates state and local implementation of guidance documents through an active exercise program which serves to assure that BioWatch coverage areas have the capability to respond to a detection. According to DHS, the combination of early warning and rapid public health response can substantially minimize the potentially catastrophic impact on the population.

FY 2009 Costs (thousands)

System is operational. BioWatch sensors were first deployed to major urban areas across the United States in 2003 DHS has identified scenarios involving the release of biological materials in urban areas that could result in significant casualties and economic disruption.

Human Health, Animal, Plant, Food, Air, Water The Implementing Recommendations of the 9/11 Commission Act (9/11 Commission Act) established, within the Department of Homeland Security, the National Biosurveillance Integration Center. The center is tasked with enhancing the capability of the federal government to rapidly identify, characterize, localize, and track biological events of national concern by integrating and analyzing data related to human health, animal, plant, food, and environmental monitoring systems, and to disseminate alerts if any such events are detected. A central responsibility is to develop and oversee the National Biosurveillance Integration System, a federal interagency consortium and information management concept that was established to integrate and analyze biosurveillance-relevant information to achieve earlier detection and enhanced situational awareness.

FY 2009 Costs (thousands)

NBIC has been operational since 2007 Any bio-event involving the intentional use of biological agents as well as emergent biohazards, such as accidental release of biological agents or natural disease outbreaks.

A catastrophic biological event, such as a terrorist attack with a weapon of mass destruction or a naturally occurring pandemic could cause thousands of casualties or more, weaken the economy, damage public morale and confidence, and threaten national security.

Airbase/Port Detector System (Portal Shield)

The Portal Shield sensor system was developed to provide early warning of biological threats for high-value, fixed-site assets, such as air bases and port facilities. Portal Shield can detect and identify up to 10 biological warfare agents simultaneously, within 25 minutes of release.

FY 2009 Costs (thousands)

CBRNE operative personnel managing the system Biological agents could pose a threat to soldiers on the battlefield Electronic Surveillance System for the Early Notification of Community-based Epidemics (ESSENCE)

ESSENCE is used in the early detection of infectious disease outbreak and provides epidemiological tools that can be used to investigate disease oubreaks. It utilizes ambulatory data from hospitals and clinics. Epidemiologists can track, in near real time, symptoms being reported in a region through a daily feed of reported data (such as working diagnoses indicated by codes assigned by local health care staff). ESSENCE uses the daily data downloads, along with traditional epidemiological analyses that use historical data, for baseline comparisons in order to improve detection FY 2009 Costs (thousands)

Health surveillance is critical to medical readiness and force health protection.

Armed Forces Health Surveillance Center US Army Public Health Command (formerly known as US Army Center for Health Promotion and Preventative Medicine)

The mission of the Armed Forces Health Surveillance center is to analyze, interpret, and disseminate information related to the status, trends, and determinants of the health of the U.S. military service members and military-associated populations. The center identifies obstacles to medical readiness by linking various databases that communicate information relevant to service member health and fitness. The Armed Forces Health Surveillance Center maintains the Defense Medical Surveillance System, a database containing up- to-date and historical data on disease and medical events as well as longitudinal data on personnel and deployments. The Defense Medical Surveillance System provides the data supporting the Department of Defense Serum Repository which as of Spring 2010 includes over 50 million serum specimens drawn from servicemembers (since the late 1980s) and used to perform longitudinal analyses of service member health. The system also also supports the Defense Medical Epidemiology Database, an application that provides remote user access to selected deidentified data (i.e., data with patient identifying characteristics removed). The Armed Forces Health Surveillance Center also operates the Global Emerging Infectious Surveillance and Response System, a program that conducts laboratory-based surveillance for emerging infectious diseases within the U.S. military and in foreign civilian populations through leveraging a network of research and clinical laboratory partners in the United States and overseas.

FY 2009 Costs (thousands)

Defense Medical Surveillance System/DOD Serum Repository/ Defense Medical Epidemiology Database: $6,000 Global Emerging Infectious Surveillance and Response System: $52,000 All health threats to U.S. military personnel, including trauma, psychological stress, environmental hazards, and infectious diseases. Laboratory network surveillance is focused on infectious diseases affecting humans, including some animal diseases that also affect humans, as well as some pathogens that could contaminate food.

Health surveillance is critical to medical readiness and Force Health Protection.

Division of Migratory Bird Management The Division of Migratory Bird Management is largely responsible for monitoring the health of migratory bird populations and issuing guidelines for conservation and sustainable harvest. The Division of Migratory Bird Management program activities are restricted to sampling migratory bird populations and testing those populations for indicators of diseases affecting birds or zoonotic diseases that could affect human populations, such as avian (H5N1) influenza. The United States Geological Survey laboratory in Madison, Wisconsin conducts laboratory analysis of submitted samples. The Division of Migratory Bird Management also collaborates with USDA’s Animal and Plant Health Inspection Service to test bird samples and to survey bird populations.

FY 2009 Costs (thousands)

Infectious diseases affecting migratory birds Animal diseases can affect wildlife as well as livestock, pets, and companion animals. Some of these diseases may affect humans. Animal disease outbreaks can cause significant and potentially disruptive losses for animal producers, put financial strain on response systems, and affect regional and national economies.

Fish and Wildlife Service inspectors work with public health officials and other federal inspectors at ports of entry to enforce wildlife regulations and ensure compliance with international wildlife laws as they pertain to wild animal imports. Some inspections consist of examinations of import paperwork, while others may consist of physical inspections of the animals being imported to confirm that the shipment contents match corresponding documents. The decision to physically inspect a shipment could depend on the type of commodity, country of origin, or importer history. Random physical inspections are also conducted.

FY 2009 Costs (thousands)

FWS inspectors stationed at ports of entry Diseases affecting animal populations are not the primary focus of the wildlife inspection program; although, if wildlife inspectors note the presence or suspected presence of disease, they will notify the appropriate federal agency.

Animal diseases can affect wildlife as well as livestock, pets, and companion animals. Some of these diseases may affect humans. Animal disease outbreaks can cause significant and potentially disruptive losses for animal producers, put financial strain on response systems, and affect regional and national economies.

The National Wild Fish Health Survey is an ongoing effort to sample and test wild fish for both specific diseases identified as key threats and for emerging infectious diseases. Fish samples are collected by state and tribal governments for testing at one of Fish and Wildlife Service’s nine regional laboratories. A national database collects and maintains all laboratory test results. Fish and Wildlife Service inspectors also examine all federal fish hatcheries at least annually and some are examined biannually. States may also request testing in the event of a major fish die-off or apparent disease outbreak.

FY 2009 Costs (thousands)

Infectious diseases affecting fish populations Animal diseases can affect wildlife as well as livestock, pets, and companion animals. Some of these diseases may affect humans. Animal disease outbreaks can cause significant and potentially disruptive losses for animal producers, put financial strain on response systems, and affect regional and national economies.

Office of Ground Water and Drinking Water The Water Security Initiative addresses the risk of intentional contamination of drinking water distribution systems by promoting the voluntary adoption of online water quality monitoring, sampling and analysis, enhanced security monitoring, consumer complaint surveillance, public health surveillance, and a consequence management plan at local water utilities. EPA is implementing the Water Security Initiative by developing the conceptual design of a system for detection of and response to a contamination event; demonstrating the viability of such a system through pilots in five cities; and developing guidance and outreach to promote voluntary adoption of drinking water contamination warning systems. EPA has implemented a pilot drinking water contamination warning system with the Cincinnati Water Works in Cincinnati, Ohio, and has funded pilots in San Francisco, New York City, Philadelphia, and Dallas, all of which are underway.

FY 2009 Costs (thousands)

EPA provides guidance and best practice standards to facilitate the implementation of a contamination warning system in a drinking water utility, and local water utilities operate the system and respond to threats.

System is a pilot.

Chemical, biological, and radiological agents which could be present in drinking water Drinking water utilities have been recognized as being potentially vulnerable to physical disruption, bioterrorism, chemical contamination, and cyber attack. Damage or destruction of a water network could disrupt not only the availability of safe drinking water but also the delivery of vital services that depend on these water supplies, like fire suppression.

The Environmental Response Laboratory Network serves as a ntaional network of labs that can be accessed as needed to support large scal environmental responses by providing consistent analytical capabilities, capacities, and quality data in a systematic, coordinated response.

FY 2009 Costs (thousands)

System can be accessed as needed to support large-scale environmental responses Chemical, biological, and radiological agents present in air or water that can cause diseases resulting from a large-scale environmental disaster A catastrophic biological event, such as a terrorist attack with a weapon of mass destruction or a naturally occurring pandemic could cause thousands of casualties or more, weaken the economy, damage public morale and confidence, and threaten national security. 122 Cities Mortality Reporting System As part of its national influenza surveillance effort, CDC receives weekly mortality reports from 122 cities and metropolitan areas in the United States within 2-3 weeks from the date of death. These reports summarize the total number of deaths occurring in these cities/areas each week due to pneumonia and influenza. This system provides CDC with the preliminary information with which to evaluate the impact of influenza on mortality in the United States and the severity of the currently circulating virus strains.

FY 2009 Costs (thousands)

122 cities and metropolitan areas contribute data to the system Influenza viruses are found in human and many different animals, including ducks, chickens, pigs, whales, horses and seals. Seasonal Flu is a contagious respiratory illness caused by flu viruses. It can cause mild to severe illness, and at times can lead to death. Pneumonia is an infection of the lungs that is usually caused by bacteria or viruses. Globally, pneumonia causes more deaths than any other infectious disease, such as AIDS, malaria, or tuberculosis. However, it can often be prevented with vaccines and can usually be treated with antibiotics or antiviral drugs.

Arboviral Surveillance System (ArboNet)

ArboNet is an internet-based national arboviral surveillance system developed by state health departments and CDC in 2000. ArboNet collects reports of arboviral diseases and other data from all states and three local districts (New York City, Washington D.C, and Puerto Rico). Data are reported by local health departments weekly for routine analysis and dissemination. These data are summarized periodically in the Morbidity and Mortality Weekly Report and yearly in the MMWR Summary of Notifiable Diseases.

FY 2009 Costs (thousands)

Arboviruses, such as West Nile Virus, encephalitis, and yellow fever viruses West Nile virus is a mosquito-borne viral disease that is transmitted to humans through infected mosquitoes. Many people infected with the virus do not become ill or show symptoms. Symptoms that do appear may be limited to headache, sore throat, backache, or fatigue. There is no vaccine for the West Nile virus, and no specific treatment besides supportive therapies. The disease occurs in Africa, Eastern Europe, West Asia, and the Middle East. This disease appeared for the first time in the United States in 1999. Yellow fever is a mosquito-borne viral disease that occurs in tropical and subtropical areas. The yellow fever virus is transmitted to humans through a specific mosquito. Symptoms include fever, muscle pain, headache, loss of appetite, and nausea. There is no treatment for yellow fever beyond supportive therapies. A vaccine for yellow fever is available.

BioSense is a national program intended to improve capabilities for rapid disease detection, monitoring, and real-time situation awareness through access to specific health care data from participating organizations, including more than 500 acute-care hospitals, commercial laboratories, as well as Department of Defense and Veterans Affairs health care facilities. BioSense enables local and state public health departments to share and access data, providing a more complete picture of potential and actual health events both locally and across jurisdictional boundaries. Data received into the system are available simultaneously to state and local health departments, participating hospitals, and CDC through a Web-based application. BioSense securely processes, analyzes, and visualizes data to help characterize and monitor outbreaks and enable appropriate and timely public health interventions. Based on user feedback, BioSense is undergoing revision to deemphasize collection of detailed clinical data from hospitals at CDC and emphasize greater dependence on collection of data from existing automated surveillance systems operated by state and local health departments. The BioSense program also funds applied and developmental projects including Regional Surveillance collaboratives, state-based health information exchanges, Centers of Excellence in Public Health Informatics, and BioSense evaluations.

FY 2009 Costs (thousands)

BioSense is operational across the current participating health care facilities, health systems, and health department surveillance systems. A contract solicitation is underway to support BioSense redesign to enhance population coverage and stakeholder engagement.

All-hazards (with a focus on infectious diseases) affecting human health The BioSense program monitors 90 concepts (syndromes and sub-syndromes) that encompass infections, injuries, chronic diseases, exposures, miscellaneous conditions, and specified codes, and free-text search terms corresponding to these concepts. In addition to these health outcome data, patient demographics (age group, sex), date of diagnosis, and geographic location information is reported.

Human Health, Animal, Plant, Food, Air, Water as it relates to human health The mission of the Biosurveillance Coordination is to coordinate the development and support the implementation of an integrated, national biosurveillance plan for human health. The plan, a requirement outlined in Homeland Security Presidential Directive 21, includes the capacity to generate timely, comprehensive, and accessible information with proper context for public health decision making. Biosurveillance Coordination has developed the National Biosurveillance Strategy for Human Health and a companion document titled Concept Plan for Implementation of the National Biosurveillance Strategy for Human Health. Biosurveillance Coordination has begun to compile an inventory of biosurveillance systems, tools, collaboratives, programs, and registries within CDC. More information about these activities and final documents can be found at http://www.cdc.gov/osels/ph_surveillance/bc.html FY 2009 Costs (thousands)

Biosurveillance Indications and Warning Analytic Community (BIWAC)

Human Health, Animal, Plant, Food, Air, Water The Mission of the Biosurveillance Indications and Warning Analytic Community (BIWAC) is to provide a secure, interagency forum for timely collaborative exchange of critical information regarding Indications and Warning (I&W) of Biological events that may threaten U.S. National Interests. The BIWAC will conduct the collaborative exchange of critical Biosurveillance information through an encrypted information-sharing portal called “Wildfire,” and also through meetings and teleconferences.

FY 2009 Costs (thousands)

BIWAC partners contribute data to the system and share information via an online portal $801 (with additional in-kind support from partners)

Diseases of concern to BIWAC members, including foreign animal and plant diseases and pathogens of national significance (priority 1 and 2), and zoonotic diseases, particularly those with pandemic potential.

Border Infectious Disease Surveillance Project The Border Infectious Disease Surveillance Project serves as a binational early warning and active syndromic illness and disease monitoring network operating in the United States (U.S.)-Mexico Border Region and targets approximately 12 million people. The project conducts surveillance among residents of border states who visit participating clinics and hospitals. Using Web-based data entry, the project provides timely data sharing through data system and Epi-X notifications dependent on state health department and Mexican national policies.

FY 2009 Costs (thousands)

The Web-based system has been operational since 2006 Infectious diseases affecting humans of mutual interest to the United States and Mexico including syndroms compatible with bioterrorism agents The Border Infectious Disease Surveillance Project conducts surveillance for viral hepatitis (A,B,C,D,E); fever and rash syndromes (measles, rubella, dengue, flea-borne typhus, tick-borne ehrlichiosis); fever and neurologic illness/West Nile Virus; influenza; undifferentiated fever/dengue/rickettsial disease; severe acute vesicular rash/varicella; community acquired pneumonica/Coccioidomycosis; animal rabies; brucellosis; and foodborne infections such as Salmonella and E.coli 0157:H7.

The Early Aberration Reporting System provides a free-to-end-user analysis tool that allows state and local public health officials as well as disaster and response agencies and organizations to quickly detect syndromes that might indicate a public health emergency and to monitor progression and control. The Early Aberration Reporting System allows users to add anything that can be counted into the software, and it will detect trends indicating something out of the ordinary. The tool may be downloaded from CDC’s Web site. Unless a user initiates a submission, there is no link alerting CDC to investigate a potential public health emergency, and the user is responsible for initiating investigation and incident response. According to CDC, a new version of the system is scheduled for release in Summer 2010 and a version geared for local disaster management and monitoring organizations, both domestic and foreign, will be developed and fielded prior to 2011.

FY 2009 Costs (thousands)

Users contribute and may analyze only their own data. CDC does not currently receive data from the system, and the data from end users vary according to state regulations and the data-sharing agreements set up with data reporters A catastrophic biological event, such as a terrorist attack with a weapon of mass destruction or a naturally occurring pandemic could cause hundreds of thousands of casualties or more, weaken the economy, damage public morale and confidence, and threaten national security. Being able to monitor extent and impact is valuable for response coordinators.

Early Warning Infectious Disease Surveillance The Early Warning Infectious Disease Program is a collaboration of state, federal and international partners who are working to provide rapid and effective laboratory confirmation of urgent infectious disease case reports in the border regions of the United States, Canada, and Mexico. Activities include assessing surveillance and laboratory capacity on each side of the international border, improving electronic sharing of laboratory information, maintaining a database of all sentinel/clinical labs, and working to develop and agree on a list of notifiable conditions. The program was established in 2003 in order to enhance coordination between the United States, Canada, and Mexico to provide early warning and cross-border capability in the event of a disease outbreak.

FY 2009 Costs (thousands)

The program was established in 2003 A catastrophic biological event, such as a terrorist attack with a weapon of mass destruction or a naturally occurring pandemic could cause thousands of casualties or more, weaken the economy, damage public morale and confidence, and threaten national security.

The Electronic Disease Notification System is an electronic system used to notify state and local public health jurisdictions about diseases and disease outbreaks occurring among refugees and immigrants entering the United States. The system has a module to track tuberculosis and other quarantinable diseases in refugees and immigrants. CDC uses the system to electronically notify health departments of arriving refugees and immigrants with Class A and Class B quarantinable conditions, provide an electronic communication system for health departments to notify each other of persons with tuberculosis conditions who change jurisdictions, and provide health departments with an electronic system to record and evaluate the outcome of domestic follow-up examinations.

FY 2009 Costs (thousands)

Panel Physicians using required Department of State medical examination forms Quarantinable Diseases, as defined by executive order 13295, include cholera, diphtheria, infectious tuberculosis, plague, smallpox, yellow fever, viral hemorrhagic fevers (such as Marburg, Ebola and Congo-Crimean disease), SARS (severe acute respiratory syndrome), and influenza caused by novel or re-emergent influenza viruses that are causing or have the potential to cause a pandemic.

Tuberculosis is a bacterial disease that is usually transmitted by contact with an infected person. People with healthy immune systems can become infected but not ill. Symptoms include a bad cough, coughing up blood, pain in the chest, fatigue, weight loss, fever, and chills. Several drugs can be used to treat tuberculosis, but the disease is becoming increasingly drug resistant.

The Emerging Infections Program is a network of CDC and 10 state health departments working with collaborators, including academic institutions and other federal agencies. The network conducts active population-based surveillance and research for emerging infectious diseases of public health importance. Examples of programs included in the Emerging Infections Program network include Active Bacteria Core Surveillance (a program conducting laboratory-based surveillance for bacterial pathogens), FoodNet (a program to monitor the incidence of foodborne and waterborne diseases), and Influenza Projects (a program that tracks trends and characterizes outbreaks of severe influenza).

FY 2009 Costs (thousands)

Epidemic Information Exchange, Epi-X Epi-X connects state and local public health officials so that they can share information about outbreaks and other acute health events, including those possibly related to bioterrorism. It is intended to provide epidemiologists and others with a secure, Web-based platform that can be used to instant emergency notification of outbreaks and requests for CDC assistance. Epi-X provides tools for searching, tracking, and reporting on diseases.

FY 2009 Costs (thousands)

Epi-X has over 5,000 users who have the capability to provide data, including all state epidemiologists and local health officers from more than 150 major metropolitan cities or counties that can post data to the system. Epi-X scientific staff are available 24 hours a day, 7 days a week to post reports and notify users of urgent health events.

A catastrophic biological event, such as a terrorist attack with a weapon of mass destruction or a naturally occurring pandemic could cause thousands of casualties or more, weaken the economy, damage public morale and confidence, and threaten national security.

Foodborne Disease Active Surveillance Network (FoodNet)

As part of CDC’s Emerging Infections Program, FoodNet provides a network for responding to new and emerging foodborne diseases of national importance, monitoring the burden of foodborne disease, and identifying the sources of specific foodborne diseases. It consists of active surveillance and related epidemiological studies, which help public health officials better understand the epidemiology of foodborne diseases in the United States. Participating FoodNet sites may also be employed to coordinate enhanced surveillance and epidemiologic investigation if a novel foodborne disease threat is suspected in order to more rapidly identify the source and extent of the threat.

FY 2009 Costs (thousands)

Public health and food safety officials in the 10 FoodNet sites Foodborne illness harms human health, and outbreaks undermine consumer confidence in the safety of the nation’s food supply, and have serious economic consequences. For instance, the 2006 outbreak of E. coli O157:H7 linked to bagged spinach resulted in 205 confirmed illnesses, 3 deaths, and an estimated $100 million loss to industry.

The Global Disease Detection program focuses on gathering, analyzing, and sharing global information to identify and respond to emerging health threats. The program has three mechanisms to accomplish this focus: regional centers that are placed around the world and are concerned with the detection and control of emerging infectious disease; CDC staff placed overseas to support CDC’s mission; and the Global Disease Detection program operations center, which serves as the central clearinghouse focused on early detection of international events to which CDC may be asked to respond.

FY 2009 Costs (thousands)

The program began operating in 2004 A catastrophic biological event, such as a terrorist attack with a weapon of mass destruction or a naturally occurring pandemic could cause thousands of casualties or more, weaken the economy, damage public morale and confidence, and threaten national security.

Global Emerging Infections Sentinel Network (GeoSentinel)

GeoSentinel is a Web- and provider-based sentinel network. It consists of travel/tropical medical clinics around the world that participate in surveillance to monitor geographic and temporal trends in morbidity among travelers and other globally mobile populations. Passive surveillance and response capabilities are also extended to a broader network of GeoSentinel Network members.

FY 2009 Costs (thousands)

GeoSentinel was established in 1995 and is operational A catastrophic biological event, such as a terrorist attack with a weapon of mass destruction or a naturally occurring pandemic could cause thousands of casualties or more, weaken the economy, damage public morale and confidence, and threaten national security.

The Health Alert Network is a nationwide system serving as a platform for the distribution of health alerts, dissemination of prevention guidelines and other information, distance learning, national disease surveillance, and electronic laboratory reporting, as well as for CDC’s bioterrorism and related initiatives to strengthen preparedness at the local and state levels. Among other things, the Health Alert Network is to provide early warning alerts and to secure capability to securely transmit surveillance, laboratory, and other sensitive data.

FY 2009 Costs (thousands)

Not available The objective of influenza surveillance is to monitor the timing, geographic extent, and severity of influenza activity in the United States and its impact on the U.S. population over time. The system consists of nine complementary surveillance components, which include data on laboratory-based data describing the number and percentage of positive tests from laboratories across the country; the percentage of doctor visits for flu-like symptoms; the percentage of deaths reported to be caused by pneumonia and influenza in 122 U.S. cities; state and territorial epidemiologist reports of influenza activity; influenza-associated pediatric mortality; and reported pediatric influenza hospitalizations.

FY 2009 Costs (thousands)

Data on influenza are contributed by more than 120 laboratories, more than 2,400 sentinel health care providers, vital statistics in 122 cities, research and health care personnel at the Emerging Infections Program and influenza surveillance coordinators and state epidemiologists for 50 state health departments, New York City and the District of Columbia Influenza viruses are found in human and many different animals, including ducks, chickens, pigs, whales, horses, and seals. Seasonal flu is a contagious respiratory illness caused by flu viruses. It can cause mild to severe illness, and at times can lead to death.

The Laboratory Response Network is an integrated network of 165 public health and clinical laboratories that provide laboratory diagnostics and disseminated testing capability for public health preparedness and response. It ensures that all member laboratories collectively maintain current biological detection and diagnostic capabilities, as well as surge capacity for all biological and chemical agents likely to be used by terrorists. The network is based on the use of standard protocols and reagents, integrated data management, and secure communications.

FY 2009 Costs (thousands)

Members share data with each other A catastrophic biological event, such as a terrorist attack with a weapon of mass destruction or a naturally occurring pandemic could cause thousands of casualties or more, weaken the economy, damage public morale and confidence, and threaten national security.

Morbidity and Mortality Weekly Report The Morbidity and Mortality Weekly Report is the nation’s leading public health bulletin and the flagship publication of CDC. The Morbidity and Mortality Weekly Report includes reports on disease epidemics, trends, prevention and control of illness, injuries, and deaths. This information represents the primary manner that state and local public health officials, the media, and the public are informed of public health issues from CDC. The Morbidity and Mortality Weekly Report publishes data from the National Notifiable Disease Surveillance System each week and in an annual Summary of Notifiable Diseases. These data are the official statistics, in tabular and graphic form, for the reported occurrence of nationally notifiable infectious diseases in the United States.

FY 2009 Costs (thousands)

International and U.S. public health officials and scientists submit epidemiological and surveillance data about outbreaks or other health events. Other federal agencies, such as USDA, FDA, and EPA produce public health information for publication. The publication is also integrated with the Epi-X and National Notifiable Diseases Surveillance System, both of which contribute data for publication.

The Morbidity and Mortality Weekly Report published its first issue in 1961. The publication is updated weekly and monthly.

Not available The National Botulism Surveillance System compiles information on botulism cases that occur in the United States. CDC provides clinical, epidemiological, and laboratory consultation and testing services for suspected botulism cases 24 hours a day and is the only source for antitoxin in the US. CDC alerts other federal agencies concerning botulism outbreaks associated with commercially produced and distributed food products. Also, CDC conducts a yearly survey of state and territorial epidemiologists and of state public health laboratory directors to identify and compile all botulism cases that occurred in the previous year.

FY 2009 Costs (thousands)

Federal public health officials; annual report is compiled from data provided by state health departments Botulism is a rare but serious paralytic illness caused by a nerve toxin that is produced by theneurotoxin producing Clostridia. There are four types of botulism. Foodborne botulism is caused by eating foods that contain the botulinum toxin. Wound botulism is caused by toxin produced from a wound infected with Clostridium botulinum. Infant botulism is caused by consuming the spores of the botulinum bacteria, which then grow in the intestines and release toxin. Finally, Adult Colonization is a rare form of botulism, similar to Infant Botulism, and results from ingestion of spores by susceptable persons and subsequent growth and toxin production in the intestines. All forms of botulism can be fatal and are considered medical emergencies. Foodborne botulism can be especially dangerous because many people can be poisoned by eating a contaminated food.

National Notifiable Diseases Surveillance System CDC has responsibility for the collection and publication of data concerning nationally notifiable diseases. All 50 states, 5 territories, the District of Columbia, and New York City participate in the National Notifiable Diseases Surveillance System. The Council of State and Territorial Epidemiologists, with input from CDC, makes recommendations annually for additions and deletions to the list of nationally notifiable diseases. Reporting of nationally notifiable diseases to CDC by the states is voluntary. Reporting is currently mandated (i.e., by state legislation or regulation) only at the state level. The list of diseases that are considered notifiable, therefore, varies slightly by state. All states generally report the internationally quarantinable diseases (i.e., cholera, plague, and yellow fever) in compliance with the World Health Organization’s International Health Regulations.

FY 2009 Costs (thousands)

Public health officials in 50 states, 5 territories, the District of Columbia and New York City Most states have a list of notifiable diseases that approximates a national list of notifiable diseases maintained by the Council of State and Territorial Epidemiologists. This national list is reviewed and revised annually with input from CDC. States may modify their list of notifiable diseases to reflect the public health needs of their region.

National Molecular Subtyping Network for Foodborne Disease Surveillance (PulseNet)

PulseNet is an early warning system for outbreaks of foodborne diseases. The network has participants from public health laboratories in all 50 states, federal regulatory agencies, and some state agricultural laboratories and is coordinated by CDC. PulseNet contributes to the identification and investigation of outbreaks of foodborne and bacterial diseases through comparison of the molecular “fingerprints” of foodborne pathogens from patients and their food, water, and animal sources. Once an outbreak is detected, PulseNet identifies patients who are infected with isolates that have the outbreak DNA “fingerprint” and thus are likely to be part of the outbreak. If a foodborne pathogen is isolated from a suspected vehicle, PulseNet also links it to the outbreak if it displays the outbreak “fingerprint.” Finally, PulseNet provides leadership, expertise, training, and education in the field of foodborne and bacterial diseases.

FY 2009 Costs (thousands)

PulseNet participants enter data into the system using standardized equipment and methods Outbreaks of foodborne illness can harm human health, undermine consumer confidence in the safety of the nation’s food supply, and have serious economic consequences. For example, the 2006 outbreak of E. coli O157:H7 linked to bagged spinach resulted in 205 confirmed illnesses, 3 deaths, and an estimated $100 million loss to industry.

Human Health, Animals, Food, Water The National Outbreak Reporting System is a Web-based application for states to report foodborne, waterborne, and other outbreaks electronically. Information collected includes the number ill, dates and places of outbreak, percent of cases by age group and gender, symptoms, incubation period and duration of illness, implicated food or water item, contributing factors leading to food or water contamination, source of implicated food or water, and food recall or other public health response. Data are used for annual summary reports of foodborne illness as well as for the monitoring of multistate outbreaks. The National Outbreak Reporting System was developed by CDC as a successor system to the Electronic Foodborne Outbreak Reporting System.

FY 2009 Costs (thousands)

50 state and 15 territorial reporting areas provide information on the number and characteristics of foodborne, waterborne and other enteric disease outbreaks in their area Foodborne, waterborne and other enteric disease outbreaks Foodborne, waterborne and other enteric disease outbreaks have myriad causes (e.g., bacteria, viruses, parasites, toxins and chemicals). These agents cause a range of human illnesses through toxicity (toxins or chemicals) or by infection (pathogens).

National Respiratory and Enteric Virus Surveillance System The National Respiratory and Enteric Virus Surveillance System is a laboratory-based system that monitors temporal and geographic patterns associated with the detection of respiratory viruses including respiratory synctial virus, human parainfluenza viruses, respiratory and enteric adenoviruses, and rotaviruses. Influenza detections are also reported to the system, but are integrated with CDC influenza surveillance. Users upload data to the National Respiratory and Enteric Virus Surveillance System through a Web- based or telephone dial-in system.

FY 2009 Costs (thousands)

Commercial, public health, and clinical laboratories Respiratory viruses tracked in the system are generally transmitted through direct or close contact with contaminated secretions that are spread through droplets in the air or by contact with contaminated environmental surfaces. Enteric infections tracked in the system enter the body through the mouth and intestinal tract and are usually spread through contaminated food and water or by contact with vomit or feces.

OutbreakNet is a national network of epidemiologists and other public health officials coordinated by CDC who investigate outbreaks of foodborne, waterborne, and other enteric illnesses in the United States. OutbreakNet ensures rapid, coordinated detection and response to multistate outbreaks of foodborne illness and to promote more comprehensive outbreak surveillance. OutbreakNet seeks to improve the collaboration and partnership among officials in local, state, and federal agencies who work with foodborne and diarrheal disease outbreak surveillance and response. OutbreakNet works in partnership with U.S. state and local health departments, USDA, FDA, and PulseNet (a national surveillance network made up of state and local public health laboratories and federal food regulatory agency laboratories).

FY 2009 Costs (thousands)

Foodborne, waterborne and other enteric diseases Foodborne, waterborne and other enteric disease outbreaks have myriad causes (e.g., bacteria, viruses, parasites, toxins and chemicals). These agents cause a range of human illnesses through toxicity (toxins or chemicals) or by infection (pathogens).

The Public Health Information Network is an effort initiated by CDC to provide interoperability across public health functions and organizations, such as state and federal agencies, local health departments, public health labs, vaccine clinics, clinical care, and first responders. It is intended to, among other things, (1) deliver industry standard data to public health, (2) investigate bioterrorism detection, (3) provide disease tracking analysis and response, and (4) support local, state, and national data needs. It builds on existing CDC investments in other surveillance systems. The Public Health Information Network will not replace any of these systems but will provide an “umbrella” to support the interoperability of existing CDC surveillance, communications, and reporting systems.

FY 2009 Costs (thousands)

Not available CDC’S United States Quarantine Stations seek to limit the importation of infectious diseases into the United States by working with key partners to identify ill persons and potentially infectious items. Quarantine Stations enter reports into the Quarantine Activity Reporting System in real time to CDC-Atlanta that summarizes port activities at 20 ports of entry and land-border crossings where international travelers arrive. The reports are analyzed and evaluated daily and relevant information is captured and disseminated as part of a Disease and Activity Report which is sent to CDC leadership and relevant external partners. During 2009 Quarantine Station staff reported 3, 847 illnesses and 125 deaths, conducted 122 airline contact investigations involving 95 index cases, forwarded 9,778 migrant packets, processed 205 non-human primate shipments, released 125 drug shipments, and participated in 1,510 activities with external partners.

FY 2009 Costs (thousands)

CDC’s Quarantine Stations report data gathered from airline staff, state and local health departments, Customs and Border Protection personnel, emergency responders, and other first responders to infectious disease outbreaks A catastrophic biological event, such as a terrorist attack with a weapon of mass destruction or a naturally occurring pandemic could cause thousands of casualties or more, weaken the economy, damage public morale and confidence, and threaten national security.

Unexplained Deaths and Critical Illnesses Surveillance System As part of CDC’s Emerging Infections Program, the Unexplained Deaths and Critical Illnesses Surveillance System is expected to contain limited epidemiological and clinical information on previously healthy persons aged 1 to 49 years who have illnesses with possible infectious causes. It is also expected to provide active population-based surveillance through coroners and medical examiners at limited sites. National and international surveillance will be passive for clusters of unexplained deaths and illnesses.

FY 2009 Costs (thousands)

A catastrophic biological event, such as a terrorist attack with a weapon of mass destruction or a naturally occurring pandemic could cause thousands of casualties or more, weaken the economy, damage public morale and confidence, and threaten national security.

Electronic Laboratory Exchange Network, (eLEXNET) eLEXNET provides a Web-based system for real-time sharing of food safety laboratory data among federal, state, and local agencies. It allows public health officials at multiple government agencies engaged in food safety activities to compare and coordinate laboratory analysis findings in a secure setting. eLEXNET captures food safety sample and test result data from participating laboratories and uses them for risk assessment and decision support purposes, improving the early detection of problem products.

FY 2009 Costs (thousands)

FDA’s Center for Food Safety and Applied Nutrition manages eLEXNET, which has 1,800 users including 203 participating labs, 150 of which are FERN labs Outbreaks of foodborne illness can harm human health, undermine consumer confidence in the safety of the nation’s food supply, and have serious economic consequences. For instance, the 2006 outbreak of E. coli O157:H7 linked to bagged spinach resulted in 205 confirmed illnesses, 3 deaths, and an estimated $100 million loss to industry.

FDA and the Food Safety and Inspection Service at USDA The Food Emergency Response Network is a coordinated initiative between USDA’s Food Safety and Inspection Service and FDA to develop an integrated laboratory network capable of responding to national emergences. Laboratories participating in the network are responsible for detecting and identifying biological, chemical, and radiological agents in food. The primary objectives of the Food Emergency Response Network are to prevent attacks on the food supply through surveillance; to prepare for emergencies by strengthening lab capabilities; to respond to threats, attacks, and emergencies in the food supply; and to assist in recovery. Participating laboratories conduct investigations of terrorism-related events involving food and play a major role in method development and validation for detecting foodborne contamination.

FY 2009 Costs (thousands)

State food testing laboratories are the primary providers of data. Some federal, local, and county food testing laboratories also provide data Outbreaks of foodborne illness can harm human health, undermine consumer confidence in the safety of the nation’s food supply, and have serious economic consequences. For instance, the 2006 outbreak of E. coli O157:H7 linked to bagged spinach resulted in 205 confirmed illnesses, 3 deaths, and an estimated $100 million loss to industry.

Center for Animal Health Information and Analysis Animal and Plant Health Inspection Service The Center for Animal Health Information and Analysis analyzes biosurveillance data on animal diseases by conducting all-source intelligence and issue assessment of threats, identification of the hazards posed by animal diseases, analysis of risk and modeling of the spread of an animal disease, and the issuance of recommendations to target surveillance resources to animal threats. The center is organized into three teams: Global Intelligence and Forecasting focuses on improving animal health through intelligence and analysis; Risk Analysis identifies methods and approaches for estimating risks of animal disease outbreaks; and Spatial Epidemiology develops geospatial methods to collect and analyze data on farm animal locations and livestock concentration.

FY 2009 Costs (thousands)

Officials from the center analyze data from a variety of sources and issue alerts Animal diseases can affect wildlife as well as livestock, pets, and companion animals. Some of these diseases may affect humans. Animal disease outbreaks can cause significant and potentially disruptive losses for animal producers, put financial strain on response systems, and affect regional and national economies.

Animal and Plant Health Inspection Service The Emergency Management Response System is used to manage investigations of outbreaks of animal diseases in the United States. This Web-based task management system was designed to automate many of the tasks that are routinely associated with disease outbreaks and animal emergencies. The Emergency Management Response System is used for routine reporting of foreign investigations of animal disease, state-specific disease outbreaks or control programs, national responses, or natural disasters involving animals. The system also has a mapping feature, which allows for real-time identification of outbreaks to enable responders to respond more quickly by providing high-resolution maps to decision makers, government agencies, and the public. The system interfaces with state and federal diagnostic laboratories for reporting test results.

FY 2009 Costs (thousands)

State and federal animal health officials Animal diseases can affect wildlife as well as livestock, pets, and companion animals. Some of these diseases may affect humans. Animal disease outbreaks can cause significant and potentially disruptive losses for animal producers, put financial strain on response systems, and affect regional and national economies.

The emerging Veterinary event database Animal and Plant Health Inspection Service The emerging Veterinary event database stores syndromic surveillance information regarding adverse animal health events. USDA’s Center for Animal Health Information and Analysis uses publicly available information sources to gather information on these events. The database is used to establish a baseline for animal disease and catalog reports of adverse animal health events. Analysts use this information to produce reports on emerging disease. Access to the database is not restricted to personnel from the Center for Animal Health Information and Analysis.

FY 2009 Costs (thousands)

Minimal costs associated with employee time for maintenance Animal diseases can affect wildlife as well as livestock, pets, and companion animals. Some of these diseases may affect humans. Animal disease outbreaks can cause significant and potentially disruptive losses for animal producers, put financial strain on response systems, and affect regional and national economies.

National Agriculture Pest Information System Animal and Plant Health Inspection Service The National Agricultural Pest Information System is a database for collection, summarization, and standardized information on plant pests such as insects, diseases, weeds, and nematodes. Data are gathered by each of the states and by USDA’s Plant Protection and Quarantine. Emphasis is given to surveys for exotic pests, pests that may impact export of U.S. agricultural products, as well as pest and biological control agents identified by Plant Protection and Quarantine progam officials. The National Agricultural Pest Information System facilitates data management coordination for the plant pest survey data gathered on a national, regional, and/or state scale as part of the Cooperative Agricultural Pest Survey program sponsored by USDA.

FY 2009 Costs (thousands)

States participating in the Cooperaive Agricultural Pest Survey enter data into the system Plant resources in the United States, inlcluding crops, rangelands, and forests, are vulnerable to endemic, introduced, and emerging pathogens. More than 50,000 plant diseases occur in the United States, caused by a variety of pathogens. Increasing globalization and international trade activities create a strong likelihood that many other exotic plant pathogens will arrive in the United States in the coming years.

National Animal Health Laboratories Network Animal and Plant Health Inspection Service National Institute of Food and Agriculture The National Animal Health Laboratories Network was established as part of a strategy to coordinate and network the diagnostic testing capabilities of federal veterinary diagnostic laboratories with state and university diagnostic laboratories to improve early detection of, response to, and recovery from animal health emergencies, including bioterrorist events, newly emerging diseases, and foreign animal disease agents. The network is composed of 58 laboratories in 45 states. Current activities include a training program for technicians who test for certain high-risk diseases such as food and mouth disease and conducting surveillance for animal diseases, such as swine influenza virus and pseudorabies.

FY 2009 Costs (thousands)

State and university veterinary diagnostic labs (excludes funding provided to labs for testing, sample collection, or training)

Animal diseases can affect wildlife as well as livestock, pets, and companion animals. Some of these diseases may affect humans. Animal disease outbreaks can cause significant and potentially disruptive losses for animal producers, put financial strain on response systems, and affect regional and national economies.

National Animal Health Monitoring System Animal and Plant Health Inspection Service The mission of the National Animal Health Monitoring System is to deliver information and knowledge about animal health by conducting studies that generally focus on food animals, dairy, livestock, and poultry commodities. The studies are designed to gather information about industry practices, biosecurity, and prevalence of endemic diseases. The studies are conducted about every 5 years or more depending on budget/resources and needs of commodity stakeholders, and the results are published in an annual Animal Health Report. This information is used for surveillance planning to identify risk factors, so that surveillance can be targeted to key areas of concern.

FY 2009 Costs (thousands)

Data is provided by industries that are selected through the National Agricultural Statistics Service Animal diseases can affect wildlife as well as livestock, pets, and companion animals. Some of these diseases may affect humans. Animal disease outbreaks can cause significant and potentially disruptive losses for animal producers, put financial strain on response systems, and affect regional and national economies.

National Animal Health Reporting System Animal and Plant Health Inspection Service The National Animal Health Reporting System was designed to provide data from chief State animal health officials on the presence or absence of confirmed World Organization for Animal Health reportable diseases in specific commercial livestock, poultry, and aquaculture species in the United States. Within a state, data about animal disease occurrence are gathered from as many verifiable sources as possible and consolidated into a monthly report submitted to the National Surveillance Unit, where the information is verified, summarized, and compiled into a national report. The commodities currently covered are cattle, sheep, goats, equine, swine, commercial poultry, and commercial food fish. The National Animal Health Reporting System is a joint effort of the U.S. Animal Health Association, American Association of Veterinary Laboratory Diagnosticians, and USDA’s Animal and Plant Health Inspection Service.

FY 2009 Costs (thousands)

Federal cost is a portion of the overall budget of the National Surveillance Unit Animal diseases can affect wildlife as well as livestock, pets, and companion animals. Some of these diseases may affect humans. Animal disease outbreaks can cause significant and potentially disruptive losses for animal producers, put financial strain on response systems, and affect regional and national economies.

Animal and Plant Health Inspection Service The objective of the National Surveillance Unit includes developing and improving methods for surveillance and analysis of animal health related data; analyze surveillance data to provide actionable information; designing and evaluating national animal health surveillance systems; and communicating surveillance information to key partners. The National Surveillance Unit is the coordinating entity for the National Animal Health Surveillance System. The goal of the unit is to create a comprehensive, integrated national surveillance system for animal health. The National Surveillance Unit has created an inventory of biosurveillance systems focused on animal health which allows users to search for animal health surveillance systems by species, disease, source of data, sample type, category of system, and agency administering the system.

FY 2009 Costs (thousands)

NSU was founded in 2003 and is operational Animal diseases can affect wildlife as well as livestock, pets, and companion animals. Some of these diseases may affect humans. Animal disease outbreaks can cause significant and potentially disruptive losses for animal producers, put financial strain on response systems, and affect regional and national economies.

Animal and Plant Health Inspection Service The Offshore Pest Information System is a Web-based information-sharing tool that allows users to communicate in an organized manner about offshore animal and plant health events and issues. The system is a key instrument used to meet the goals of the International Safeguarding Information Program. This program is risk-focused and designed to collect, synthesize/analyze, communicate, and utilize relevant offshore animal and plant disease or pest information. The Offshore Pest Information System is secure and enables multiple users to access, respond to, and act upon information about international events that affect animal and plant health. Weekly reports are generated from events in the system’s database that are distributed to the system’s users and stakeholders.

FY 2009 Costs (thousands)

Animal and plant emerging diseases and pests Animal diseases can affect wildlife as well as livestock, pets, and companion animals. Some of these diseases may affect humans. Animal disease outbreaks can cause significant and potentially disruptive losses for animal producers, put financial strain on response systems, and affect regional and national economies. Plant resources in the United States, including crops, rangelands, and forests, are vulnerable to endemic, introduced, and emerging pathogens. More than 50,000 plant diseases occur in the United States, caused by a variety of pathogens. Increasing globalization and international trade activities create a strong likelihood that many other exotic plant pathogens will arrive in the United States in the coming years.

Rapid Syndrome Validation Project for Animals (RSVP-A)

Animal and Plant Health Inspection Service Rapid Syndrome Validation Project for Animals is a syndromic surveillance system to facilitate the early detection, reporting, and response to an infectious disease outbreak in animals. Veterinarians collect syndromic data on animals—such as neurologic dysfunction, birth defects, or unexpected death—on hand-held computers and send the data to a central database. USDA officials and other practitioners analyze the data and create alerts of a disease outbreak or summarize normal disease occurrence.

FY 2009 Costs (thousands)

Operational in pilot project phase Animal diseases can affect wildlife as well as livestock, pets, and companion animals. Some of these diseases may affect humans. Animal disease outbreaks can cause significant and potentially disruptive losses for animal producers, put financial strain on response systems, and affect regional and national economies.

Integrated Pest Management Pest Information Platform for Extension and Education National Institute of Food and Agriculture The Integrated Pest Management Pest Information Platform for Extension and Education is a system to analyze threats to plant health. The system utilizes modeling technology that allows stakeholders to access data online for the location of plant threats, as well as their severity, distribution, forecasting, and state-specific control recommendations. Data included are all hazards, and include weather patterns, observations of plant disease occurrences, and the results of sample testing that are contributed by the system’s users. The system is active in 41 states, 5 Canadian provinces, and Mexico.

FY 2009 Costs (thousands)

System has been operating since 2005 Plant resources in the United States, including crops, rangelands, and forests, are vulnerable to endemic, introduced, and emerging pathogens. More than 50,000 plant diseases occur in the United States, caused by a variety of pathogens. Increasing globalization and international trade activities create a strong liklihood that many other exotic plant pathogens will arrive in the United States in the coming years.

National Institute of Food and Agriculture The mission of the National Plant Diagnostic Network is to safeguard U.S. plant agriculture against introduced pests and pathogens by enhancing diagnostic and detection capabilities; improving communication among federal, state, and local agencies involved in monitoring for plant pests and pathogens; and delivering educational programs regarding the threats posed by their introduction. A single database captures data from voluntary information given to laboratories, such as from grower samples, bugs brought into laboratories, or from citizen complaints. The network, for example, funds diagnostic labs in all 50 states and sponsors training for individuals in the plant industry (from nursery owners to home gardeners). The National Plant Diagnostic Network also maintains a national database with plant disease reports, charts, and mapping tools.

FY 2009 Costs (thousands)

System has been operating since 2002 Plant resources in the United States, including crops, rangelands, and forests, are vulnerable to endemic, introduced, and emerging pathogens. More than 50,000 plant diseases occur in the United States, caused by a variety of pathogens. Increasing globalization and international trade activities create a strong liklihood that many other exotic plant pathogens will arrive in the United States in the coming years.

Upon arrival at a U.S. port-of-entry, all meat and poultry shipments must be reinspected by a Food Safety and Inspection Service import inspector before they are allowed into this country. Every lot of product is given a visual inspection for appearance and condition, and checked for certification and label compliance. In addition, the Automated Import Information System assigns various other types of inspection including product examinations and microbial and chemical laboratory analysis based on statistical and trend analysis of the product’s origin.

FY 2009 Costs (thousands)

Importers of meat and poultry products submit reports to the system Biological agents that can contaminate meat and poultry products Outbreaks of foodborne illness can harm human health, undermine consumer confidence in the safety of the nation’s food supply, and have serious economic consequences. For instance the 2006 outbreak of E. coli O157:H7 linked to bagged spinach resulted in 205 confirmed illnesses, 3 deaths, and an estimated $100 million loss to industry.

Food Safety and Inspection Service Incident Management System The Food Safety and Inspection Service’s Incident Management System is a web-based common operating platform that, according to USDA officials, allows program managers and users to rapidly identify, respond to, and track the agency’s response to significant incidents such as suspected tampering of products, threats to facilities, natural disasters, and Class 1 recalls with illness.

FY 2009 Costs (thousands)

Food Safety and Insepction Service Emergency Management Committee members and personnel granted access to the system Outbreaks of foodborne illness can harm human health, undermine consumer confidence in the safety of the nation’s food supply, and have serious economic consequences. For instance the 2006 outbreak of E. coli O157:H7 linked to bagged spinach resulted in 205 confirmed illnesses, 3 deaths, and an estimated $100 million loss to industry.

In April 2008, the Food Safety and Inspection Service implemented the Import Alert Tracking System, an automated data system that allows field employees to record information related to ineligible, illegal, or smuggled shipments of imported meat, poultry, or egg products found in commerce. The system enables better coordination in enforcement actions through quicker access to information collected on illegal entries. The system has been designed to automate the processes of incident notifications between Food Safety and Inspection Service program areas and creation of an incident report when appropriate.

FY 2009 Costs (thousands)

System is operational since 2005.

No direct costs - costs are included under the Food Safety and Inspection Service’s Incident Management System Outbreaks of foodborne illness can harm human health, undermine consumer confidence in the safety of the nation’s food supply, and have serious economic consequences. For instance the 2006 outbreak of E. coli O157:H7 linked to bagged spinach, resulted in 205 confirmed illnesses, 3 deaths, and an estimated $100 million loss to industry.

Laboratory Electronic Application for Results Notification The Laboratory Electronic Application for Results Notification program provides Food Safety and Inspection Service personnel, establishments, and state officials with reports on the status of meat, poultry, and egg product test samples. The application is an automated process that tracks each sample as it is received, analyzed, and results are reported. The Laboratory Electronic Application for Results Notification program allows field inspectors and agency staff to check on the status of individual samples or view circuit, district, and management summaries of results. Establishment and state officials will not have access to the intranet site, but they may receive e-mail reports on the status of individual samples.

FY 2009 Costs (thousands)

Food Safety and Insepction Service Laboratories Outbreaks of foodborne illness can harm human health, undermine consumer confidence in the safety of the nation’s food supply, and have serious economic consequences. For instance the 2006 outbreak of E. coli O157:H7 linked to bagged spinach, resulted in 205 confirmed illnesses, 3 deaths, and an estimated $100 million loss to industry.

Microbiological and Residue Computer Information System The Microbiological and Residue Computer Information System contains sample identification information and results for analyses submitted by inspection personnel to laboratories. These samples consist of meat, poultry, and egg products; and they are analyzed to ensure that they are safe, wholesome, unadulterated, and properly labeled. The samples are tested because they bear or contain residues of drugs, pesticides, other chemicals, or microbiological pathogens. Test results are used to alert agency personnel and the industry of contaminations and threats to consumer health and the need for protective actions such as product recalls. The Microbiological and Residue Computer Information System is also used for risk assessment and decision support purposes, improving early detection of problem products, enabling active food safety surveillance, and evaluating potential threats to the food supply.

FY 2009 Costs (thousands)

Food Safety and Insepction Service Laboratories Outbreaks of foodborne illness can harm human health, undermine consumer confidence in the safety of the nation’s food supply, and have serious economic consequences. For instance the 2006 outbreak of E. coli O157:H7 linked to bagged spinach, resulted in 205 confirmed illnesses, 3 deaths, and an estimated $100 million loss to industry.

The Pathogen Reduction Enforcement Program schedules tests, tracks food samples, and generates a series of reports concerning food testing eligibility and the status of food sample testing results. It collects and stores food manufacturing establishment addresses and product information, as well as the establishment’s performance in previous food safety tests. It uses this information to schedule and request the collection of food samples for testing. These tests results are used to alert agency personnel and the industry of contaminations, so an appropriate response can be issued. The Pathogen Reduction Enforcement Program is also used for risk assessment and decision support purposes, improving early detection of problem products, enabling active food safety surveillance, and evaluating potential threats to the U.S. food supply.

FY 2009 Costs (thousands)

Food Safety and Insepction Service Laboratories Outbreaks of foodborne illness can harm human health, undermine consumer confidence in the safety of the nation’s food supply, and have serious economic consequences. For instance the 2006 outbreak of E. coli O157:H7 linked to bagged spinach, resulted in 205 confirmed illnesses, 3 deaths, and an estimated $100 million loss to industry.

The Agriculture Quarantine Inspection Program partners with Customs and Border Protection to conduct hands-on inspection of agricultural commodities entering the United States to confirm that imports are free of pests and disease. Specifically, Customs and Border Protection officers inspect any incoming agricultural commodities, including plants, animals, food, or other miscellaneous goods—such as automobile parts where pests might hide and enter the United States—for the presence of pests. The Agriculture Quarantine Inspection Program operates Plant Inspection Stations, which process the pest interceptions made by Customs and Border Protection officers at ports, and identify pests and diseases on imported goods. This information is also filtered into USDA’s Plant Protection and Quarantine databases.

FY 2009 Costs (thousands)

The system is planned to be replaced by a more user-friendly system in the next five years Plant resources in the United States, including crops, rangelands, and forests, are vulnerable to endemic, introduced, and emerging pathogens. More than 50,000 plant diseases occur in the United States, caused by a variety of pathogens. Increasing globalization and international trade activities create a strong likelihood that many other exotic plant pathogens will arrive in the United States in the coming years. Animal diseases can affect wildlife as well as livestock, pets, and companion animals. Some of these diseases may affect humans. Animal disease outbreaks can cause significant and potentially disruptive losses for animal producers, put financial strain on response systems, and affect regional and national economies.Outbreaks of foodborne illness can harm human health, undermine consumer confidence in the safety of the nation’s food supply, and have serious economic consequences. For instance the 2006 outbreak of E. coli O157:H7 linked to bagged spinach, resulted in 205 confirmed illnesses, 3 deaths, and an estimated $100 million loss to industry.

The mission of the Cooperative Agricultural Pest Survey program is to identify exotic plant pests in the United States deemed to be of regulatory significance to USDA, state departments of agriculture, tribal governments, and cooperators. It facilitates this mission by working to confirm the presence or absence of environmentally and/or economically harmful plant pests. These pests can impact agriculture or the environment. The Cooperative Agricultural Pest Survey program also establishes and maintains a comprehensive network of cooperators and stakeholders to facilitate a plant protection mission.

FY 2009 Costs (thousands)

States provide information on plant pests and deliver samples for testing to USDA’s Plant Protection and Quarantine for further analysis. Results are disseminated back to participating states after testing has concluded. $9,098 was allocated to support pest detection activities. Of this, approximately $8,453.50 was given to the states via cooperative agreements to conduct pest detection activities.

Plant resources in the United States, including crops, rangelands, and forests, are vulnerable to endemic, introduced, and emerging pathogens. More than 50,000 plant diseases occur in the United States, caused by a variety of pathogens. Increasing globalization and international trade activities create a strong likelihood that many other exotic plant pathogens will arrive in the United States in the coming years.

Exotic Pest Information Collection and Analysis The purpose of Exotic Pest Information Collection and Analysis is to conduct plant pest biosurveillance for USDA’s Plant Protection and Quarantine. The program continuously gathers, evaluates, and communicates open-source information on quarantine-significant plant pests worldwide. The program also produces concise articles about relevant pieces of pest news, placing the news into a safeguarding context and providing important background information. The articles are distributed weekly in an e-mail notification and are archived in a Web-accessible, fully-searchable database (known as the Global pest and Disease Database).

FY 2009 Costs (thousands)

The Exotic Pest Information Collection and Analysis program team gathers publicly available information from the World Wide Web, including scientific journals, Web sites, listervs, and blogs Plant pests such as arthropods, nematodes, pathogens, mollusks, and weeds Plant resources in the United States, including crops, rangelands, and forests, are threateneded by exotic plant pests. Globalization and international trade increase the likelihood of exotic pest introduction into the United States. According to USDA, up-to-date pest information is essential for preparedness and early response.

The Global Pest and Disease Database is an archive of exotic pest information specific to Plant Protection Quarantine needs, for uses including the prioritization of pest threats to the United States, conducting risk assessments of plant pests, and completing domestic exotic pest surveys. The Exotic Pest Information Collection and Analysis program contains information on over 600 plant and animal plant pests not native to the United States. The Exotic Pest Information Collection and Analysis program is primarily intended for use within USDA but DHS officials, other federal agencies, and state agricultural agencies also have access to the system.

FY 2009 Costs (thousands)

Other USDA biosurveillance systems, such as the Exotic Pest Information Collection and Analysis system, the Offshore Pest Information System, and the New Pest Advisory Group Plant pests not known to occur in the United States or in limited distribution in the United States Plant resources in the United States, including crops, rangelands, and forests, are vulnerable to endemic, introduced, and emerging pathogens. More than 50,000 plant diseases occur in the United States, caused by a variety of pathogens. Increasing globalization and international trade activities create a strong likelihood that many other exotic plant pathogens will arrive in the United States in the coming years.

National Animal Health Surveillance System Animal and Plant Health Inspection Service The National Animal Health Surveillance System is a USDA initiative to integrate existing animal health monitoring programs and surveillance activities into a national, comprehensive, and coordinated system and develop new surveillance systems, methodology, and approaches. The system is an interdisciplinary network of partners working together to protect animal health and promote free trade through surveillance, control, and prevention of foreign, emerging, and endemic diseases.

FY 2009 Costs (thousands)

Exotic and endemic infectious diseases affecting animals and public health Animal diseases can affect wildlife as well as livestock, pets, and companion animals. Some of these diseases may affect humans. Animal disease outbreaks can cause significant and potentially disruptive losses for animal producers, put financial strain on response systems, and affect regional and national economies.

National Wildlife Health Center Wildlife Mortality Database (EPIZOO)

U.S. Geological Survey National Wildlife Health Center The USGS National Wildlife Center’s EPIZOO database is a data set that documents information on epidemics in wildlife. EPIZOO tracks die-offs throughout the United States and territories, primarily in migratory birds and endangered species. Data include locations, dates, species involved, history, population numbers, total sick and dead, and diagnostic information. The data are collected from a reporting network developed at the National Wildlife Health Center as well as from collaborators across the North American continent.

FY 2009 Costs (thousands)

Regular data are available from 1975 to the present; some data sets are available from earlier years Animal diseases can affect wildlife as well as livestock, pets, and companion animals. Some of these diseases may affect humans. Animal disease outbreaks can cause significant and potentially disruptive losses for animal producers, put financial strain on response systems, and affect regional and national economies.

U.S. Geolgocial Survey National Wildlife Health Center The Wildlife Health Diagnostic Database is a computerized record of specimens sent to the National Wildlife Health Center for processing and diagnostic testing. Data include history and recordkeeping information, types of tests run, and some initial diagnostic and testing results. Data from the system cannot be used as a representative sample of animal health diseases that exist in the wild, but it may be used to determine if a disease or animal health syndrome has occurred in the wild.

FY 2009 Costs (thousands)

Data have been available since 1975 Animal diseases can affect wildlife as well as livestock, pets, and companion animals. Some of these diseases may affect humans. Animal disease outbreaks can cause significant and potentially disruptive losses for animal producers, put financial strain on response systems, and affect regional and national economies.

The U.S. Forest Service Forest Health Protection program is responsible for detection and monitoring of forest health conditions on all forested lands in the United States. The program annually conducts aerial surveys of nearly 500 million acres of forested lands for unusual activities of forest insects and pathogens. The Forest Health Protection Program has developed a suite of forest health indicators that are to monitor forest health and facilitate the detection of the introduction of foreign pests. Pest risk assessments are used to target detection surveys in areas that are particularly vulnerable to invasion and establishment of invasive pests. Annual reports at the state, regional, and national levels assess trends in forest condition and highlight new or expanding outbreaks of forest pests.

FY 2009 Costs (thousands)

System is operational.

Plant resources in the United States, including crops, rangelands, and forests, are vulnerable to endemic, introduced, and emerging pathogens. More than 50,000 plant diseases occur in the United States, caused by a variety of pathogens. Increasing globalization and international trade activities create a strong likelihood that many other exotic plant pathogens will arrive in the United States in the coming years.

The Biohazard Detection System deployed by the USPS is a decentralized locally networked automated collection and identification system and is used to detect the biological agent causing anthrax that could be present in first-class mail. The system is installed in mail processing facilities nationwide. The system is integrated with mail processing and letters are automatically fed into the system where it detects the presence of anthrax. The detecting process runs continuously and alerts system operators if a presumptive positive case of anthrax is detected.

FY 2009 Costs (thousands)

Annual Operation and Maintenance Costs: $73.5M Anthrax is an acute infectious disease caused by a bacterium commonly found in the soil. Although anthrax can infect humans, it occurs most commonly in plant-eating animals. Human anthrax infections have usually resulted from occupational exposure to infected animals or from contaminated animal products. Anthrax infection can take one of three forms: coetaneous, usually through a cut or abrasion; gastrointestinal, usually by ingesting undercooked contaminated meat; or inhalation, by breathing airborne anthrax spores into the lungs. The symptoms are different for each form and usually occur within 7 days of exposure. Anthrax can be treated with antibiotics and a vaccine is available. In 2001, U.S. Postal Service employees and customers contracted anthrax after a domestic bioterrorism incident that spread anthrax spores through the U.S. mail and resulted in five deaths.

Appendix VI: GAO Contacts and Staff Acknowledgments

Acknowledgments

In addition to the contact named above, Anne Laffoon, Assistant Director; Michelle Cooper; Kathryn Godfrey; Amanda Krause,;Steven Banovac; and Susanna Kuebler made significant contributions to the work. Keira Dembowski, Jessica Gerrard-Gough, and Patrick Peterson also provided support. Tina Cheng assisted with graphic design. Amanda Miller and Russ Burnett assisted with design, methodology, and analysis. Tracey King provided legal support. Linda Miller provided communications expertise.

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