Biosurveillance: Nonfederal Capabilities Should Be Considered in Creating a National Biosurveillance Strategy
Released: 2011-10-31T00:00:00

Letter

Background

Biosurveillance in Brief

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, including state, tribal, local, and insular jurisdictions. As we reported in June 2010, because of the vast array of activities and entities associated with effective biosurveillance, ongoing interagency and intergovernmental collaboration is crucial.

The backbone of biosurveillance is traditional disease-surveillance systems. Traditional disease-surveillance systems are designed to collect information on the health of humans and animals to support a variety of public-welfare and economic goals. These systems support biosurveillance efforts by recording national health and disease trends and providing specific information about the scope and projection of outbreaks to inform response. State and local public-health agencies have the authority and responsibility for carrying out most public-health actions, including disease surveillance and response to public-health emergencies in their jurisdictions. State laws or regulations mandate disease reporting at the state and local level, bu state-based systems are coordinated at the national level by a voluntary set of reporting criteria and case definitions. For example, the mainst traditional disease surveillance in humans is the National Notifiable Diseases Surveillance System, through which state public-health departments voluntarily report their notifiable disease data to CDC. The National Notifiable Disease List includes those diseases that CDC and state public-health officials have identified as posing a serious public- health risk for which case reports would help inform prevention and control efforts. Diseases on the nationally notifiable list range from sexually transmitted diseases, such as Human Immunodeficiency Virus and syphilis, to potential bioterrorism agents, such as anthrax and tularemia.

Similarly, to help protect the nation’s agricultural sector, USDA has routine reporting systems and disease-specific surveillance programs, which rely on state-collected data, for domesticated animals and some wildlife that can provide information to support the early detection goal of biosurveillance. Many states have a statutory or regulatory list of diseases that animal-health officials are required to report to the state departments of agriculture. State animal-health officials obtain information on the presence of specific, confirmed clinical diseases in the United States from multiple sources—including veterinary laboratories, public-health laboratories, and veterinarians—and report this information to USDA’s National Animal Health Reporting System (NAHRS). This system is designed to provide data from state animal-health departments 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.

For wildlife, USDA’s Animal and Plant Health Inspections Service’s Wildlife Services division is charged with conducting surveillance of wildlife to detect zoonotic or other diseases that may pose threats to agriculture. The division’s National Wildlife Disease Program is charged with conducting routine surveillance for targeted diseases and responding to mortality and morbidity events, particularly those occurring near humans or livestock. The program has wildlife disease biologists in most states that work to coordinate with state, local, and tribal officials to conduct surveillance and respond to events. In addition, DOI’s U.S. Geological Survey’s (USGS) National Wildlife Health Center is charged with addressing wildlife disease throughout the United States. 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, although there is currently no national reporting system for wildlife diseases.

Recognizing that human and animal diseases are interconnected, several organizations—including the American Medical Association, the American Veterinary Medical Association, USDA, and HHS—have taken steps to support the One Health concept, which is a worldwide strategy for expanding interdisciplinary collaboration and communications in all aspects of health care for humans and animals.

Disease-reporting systems help professionals to recognize unusual disease signals and analyze their meaning, but generally have inherent limitations that affect the speed with which their results can be determined, communicated, and acted upon. Many surveillance programs incorporate other methods of surveillance that have the potential to augment and enhance the detection and situational-awareness benefits of traditional disease reporting. For example, syndromic surveillance uses health-related data collected before diagnosis to look for signals or clusters of similar illnesses that might indicate an outbreak. An example of syndromic surveillance data is prediagnostic health-related information like patients’ chief complaints recorded by hospital emergency room staff. However, we 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. Another method used in disease surveillance efforts is sentinel surveillance, in which practitioners monitor for specific disease events in a targeted subset rather than an entire population. Sentinel surveillance can also promote early detection, for example by monitoring sentinel chicken flocks and testing for the presence of antibodies to arboviruses, such as West Nile virus, which could be spread by mosquitoes to humans.

Numerous federal, state, local, and private-sector entities with responsibility for monitoring animal and human health have roles to play both in supporting traditional surveillance activities and in designing systems to focus specifically on enhancing detection and situational awareness.

Biosurveillance Roles and Responsibilities in Nonfederal Jurisdictions

Conducting biosurveillance is a shared responsibility among multiple local, state, and federal agencies, as well as among professionals across various disciplines in state, tribal, local, and insular jurisdictions. However, there is variation in organization and structure among public-health, animal-health, and wildlife functions at the state, tribal, local, and insular levels. For example, as shown in figure 2, a state’s public-health structure may or may not be centralized.

On the other hand, livestock and poultry health is largely centralized within state departments of agriculture, relying on accredited veterinarians across the state for detection. By contrast, wildlife disease surveillance largely lacks structure entirely and is dependent upon chance observations of unusual numbers of sick or dead wildlife, or both, being observed and reported to state or local wildlife agencies. The exception is USDA’s National Wildlife Disease Program, which coordinates national surveillance and reporting of targeted diseases that may pose threats to human health or agricultural resources.

Some of the nonfederal partners with key responsibilities in the biosurveillance enterprise are presented in table 1.

Tribal Jurisdictions. As of October 2010, there were 565 federally recognized tribes—340 in the continental United States and 225 in Alaska. Federally recognized Indian tribes are Native American groups eligible for the special programs and services provided by the United States to Indians because of their status as Indians. Under the Indian Self-Determination and Education Assistance Act, as amended, federally recognized Indian tribes can enter into self-determination contracts or self-governance compacts with the federal government to take over administration of certain federal programs for Indians previously administered on their behalf by the Department of the Interior or HHS.

The Bureau of Indian Affairs, within DOI, and the IHS, within HHS, are the primary agencies that operate Indian programs within those two departments. IHS is charged with providing health care to the approximately 1.9 million American Indians and Alaska Natives who are members or descendants of federally recognized tribes. These services are provided at federally or tribally operated health-care facilities, which receive IHS funding and are located in 12 geographic regions overseen by IHS area offices. These IHS-funded facilities vary in the services that they provide. For example, some facilities offer comprehensive hospital services, while others offer only primary-care services. Although American Indian tribes are sovereign entities, IHS facilities follow disease- reporting regulations and use disease-reporting channels for the state in which tribal patients geographically reside. For example, tribal patients who live within the boundaries of Utah, New Mexico, or Arizona could use the same IHS facility in Shiprock, New Mexico. If a patient whose tribal residence is geographically located in Arizona presents at the Shiprock facility with a disease that the state of Arizona has designated as reportable, IHS would report it to Arizona public health officials. Tribes that manage their own health services use the national notifiable disease reporting system.

Land-based agricultural resources are vital to the economic and social welfare of many tribes. The Intertribal Agriculture Council is an organization of tribal agriculture producers and conducts programs designed to further the goal of improving tribal agriculture by promoting the Indian use of Indian resources through contracts and cooperative agreements with federal agencies.

Insular Jurisdictions. The United States has strategic and economic pacts with two jurisdictions in the Atlantic Ocean and six in the Pacific Basin. These jurisdictions are together referred to as insular areas and include the territories of American Samoa, Guam, and the U.S. Virgin Islands; the commonwealths of the Northern Mariana Islands and Puerto Rico; and the freely associated states of the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau. The pacts with the insular areas include the provision of federal assistance which, for example, can include funding to support public- health preparedness efforts, such as building and maintaining basic public-health capabilities.

According to CDC, some of the world’s most destructive diseases are vector-borne—that is they are transmitted to humans and animals by vectors such as ticks, mosquitoes, or fleas. CDC also contends the United States is at a greater risk than ever from vector-borne diseases—such as West Nile virus, Lyme disease, dengue fever, chikungunya, and Rocky Mountain spotted fever—due to globalization and climate change. separate public-health laboratory—play a dual role in providing both clinical and public-health laboratory services in their own jurisdictions. The laboratories in this network have limited testing capabilities, though, and often medical officials must send specimens to Hawaii, the U.S. mainland, or Australia for additional testing.

CDC officials said that the Pacific insular areas present a challenge to global disease spread and detection, because the region has experienced outbreaks of emerging infectious disease and has lower detection capacity. According to CDC officials, in the age of routine air travel and with the rights granted to foreign nationals of some Pacific insular areas under the Compacts of Free Association, the risk of insular residents traveling to U.S. territories, Hawaii, and the mainland with undiagnosed and potentially dangerous infectious diseases is troublesome. Additionally, according to DOI officials, issues surrounding international travel create challenges to ensuring timely response to disease outbreak events in insular areas.

USDA operates disease-eradication and investigation activities, export certification, and surveillance actions in most U.S. insular areas. In addition, USDA’s National Wildlife Disease Program has an office in Hawaii that supports activities to conduct surveillance for and respond to outbreaks of disease in wildlife that pose threats to human health and agricultural resources.

DOI’s USGS National Wildlife Health Center, located in Madison, Wisconsin, assists state and federal agencies with wildlife health-related issues and has a Honolulu Field Station, which is staffed by a wildlife disease specialist and three biological technicians. The Honolulu Field Station was established to serve state and federal agencies in Hawaii and the Pacific, including the insular areas. The Honolulu Field Station provides training to biologists regarding response to unusual wildlife mortalities and performs laboratory and field investigations to determine the cause of death in wildlife.

Humans, Livestock, Wildlife, and the Spread of Zoonotic Diseases

About 75 percent of the new diseases that have affected humans over the past 10 years are zoonotic and have been caused by pathogens originating from an animal. Many of these diseases have the potential to spread through various means over long distances and to become global problems. As shown in figure 3, these emerging and reemerging diseases transmit between animals—including livestock and wildlife—and humans. In some cases, disease transmission is direct, in others the animals act as intermediate or accidental hosts, while in others transmission occurs via arthropod—for example, mosquitoes or ticks—vectors. Examples of such emerging and zoonotic diseases include: West Nile virus, H1N1, SARS, avian influenza, and rabies. Potential bioterrorism threats also include the use of zoonotic diseases as weapons of mass destruction, such as anthrax, plague, tularemia, and brucellosis.

Habitat loss and human encroachment on rural and wildlife environments are bringing populations of humans and animals, both farmed and wild, into closer and more-frequent contact. Increasingly, wildlife are involved in the transmission of diseases to people, pets, and livestock, and managing wildlife vectors is an integral part of efforts to control the spr of zoonotic diseases. Diseases among wildlife can also provide early warnings of environmental damage, bioterrorism, and other risks to human health. DOI’s USGS National Wildlife Health Center, which is the only federal laboratory in the United States dedicated to wildlife disease investigation, focuses on developing methods to reduce or eliminate the transmission of diseases among wildlife, domestic animals, and humans.

We Previously Recommended That the National Security Staff Develop a National Biosurveillance Strategy

Brucellosis and Feral Swine

In June 2010, we reported that 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. We found that the decision makers responsible for developing a national biosurveillance capability are spread across multiple agencies and departments, and rely on support from state and local authorities. We noted that our prior work on complex undertakings like biosurveillance can benefit from strategic oversight mechanisms, such as a focal point and a national strategy, to coordinate and lead efforts across the multiple federal departments with biosurveillance responsibilities. We recommended that the Homeland Security Council, which was established to serve as a mechanism for ensuring coordination of federal homeland security–related activities and development of homeland- security policies, should direct the National Security Staff to establish a focal point and charge this focal point with the responsibility for developing a national biosurveillance strategy.

Hunting feral swine is a popular sport among hunters, and also serves as a population control method which wildlife agencies support, but there are more than 24 diseases that people can get from feral swine. While most of these diseases are spread by eating undercooked meat, the germs that cause swine brucellosis are spread by swine through birthing fluids and semen. People become exposed to the germs through contact with an infected swine’s blood, fluids, or tissues (such as muscles, testicles, liver, or other organs). Domestic swine are also threatened by brucellosis through contact with infected feral swine.

In August 2011, the National Security Staff reported that it had created a biosurveillance Sub-Interagency Policy Committee, under the guidan the Domestic Resilience Group, to serve as a focal point in order to coordinate the development of a National Strategy for Biosurveillance. They said the strategy, and the implementation guidance to it, will define the overall purpose of the U.S. government biosurveillance effort, and w pay particular attention to the assignment of roles and responsibilities. These efforts are the first steps taken to address the findings in our June 2010 report.

Absent a Strategy and Biosurveillance- Specific Capability Efforts, Existing Federal Activities Help Support State and Local Capabilities

In the absence of a national biosurveillance strategy, the federal government has some efforts, including emergency preparedness, disease-specific surveillance, and laboratory enhancement programs, that provide resources and information that state and city officials say are critical to their efforts to build and maintain capabilities. The federal programs and initiatives that officials identified during interviews as useful for supporting their biosurveillance capabilities generally fell into four categories, which respondents to our follow-up questionnaire ranked in descending order of importance as follows: (1) grants and cooperative agreements, (2) nonfinancial technical and material assistance, (3) guidance, and (4) information sharing. As we reported in June 2010, about federal biosurveillance activities, without a strategic approach to build and maintain a national biosurveillance capability, these efforts continue to be uncoordinated and not specifically targeted at ensuring the most-effective and efficient biosurveillance capability.

Federal Grants and Cooperative Agreements Provide Essential Support for State and Local Biosurveillance Capabilities

Nearly all—26 of 27—of the questionnaire respondents identified grants and cooperative agreements as the most important type of federal assistance they receive. During interviews, state and local officials in multiple agriculture, public-health, and wildlife departments said that they are completely or largely dependent on federal funding for biosurveillance-related activities and that their biosurveillance capabilities would be limited without these federal grants and cooperative agreements.

State and city officials we interviewed noted that grants and cooperative agreements generally serve a dual purpose in that they both provide guidance on federal priorities, goals, and objectives and provide financial support to pursue those priorities. For example, when we asked public- health officials about the federal efforts that support their capabilities, five of nine public-health departments cited the guidance on planning and federal priorities that they receive in conjunction with the Public Health Emergency Preparedness (PHEP) cooperative agreement. At the same time, six of nine public-health departments we interviewed cited PHEP funding as critical for supporting their capability resources, such as additional staff to increase investigation and diagnostic capacity, and for building and maintaining those capabilities identified as priorities. Officials from one public-health department said that the funding they receive for PHEP and another CDC cooperative agreement—Epidemiology Laboratory and Capacity for Infectious Diseases (ELC)—pays the salaries of 70 percent of their communicable-disease staff, including the salaries of their scientists, researchers, physicians, and data analysts. Moreover, these officials said the federal cooperative agreements enable the department to conduct outbreak investigations that were not possible before PHEP and ELC funding was available. Similarly, laboratory officials in one state we visited said that the cooperative agreements enable the department to pay for additional public-health positions, training, and laboratory testing efforts and equipment, and without the cooperative agreements, their laboratory testing capacity would be considerably reduced.

A National Biosurveillance Capability: A national biosurveillance capability is the combination of capabilities of all jurisdictions and entities that constitute the biosurveillance enterprise working in concert to achieve the timely detection and situational awareness goals of biosurveillance, particularly for potentially catastrophic biological events.

In interviews, agriculture officials in five of seven states said that their departments depend on federal funding to conduct surveillance efforts. For example, officials from three of the states said federal grants and cooperative agreements enable their departments to, among other things, collect and test specimens and purchase equipment for surveillance efforts. Similarly, wildlife officials from four states we interviewed said that their dependence on federal funding dictates priorities for certain surveillance efforts—such as the funding for avian influenza and chronic wasting disease surveillance efforts—and they would likely not conduct active surveillance efforts like these without federal support. In follow-up questionnaires, we asked officials to identify the federal grants and cooperative agreements that were essential to their core biosurveillance capabilities. Table 2 shows the federal grants and cooperative agreements most commonly identified as essential to their core biosurveillance capabilities by the 27 officials who responded to our questionnaire, by group. For more information on questionnaire results, see appendix III.

Respondents to our follow-up questionnaire ranked nonfinancial technical and material assistance as the second-most important type of federal support for building and maintaining biosurveillance capabilities. According to state and local officials, the nonfinancial assistance efforts they identified help to, among other things, support biosurveillance capacity by improving state and local capacity to identify and diagnose diseases. For example, state public-health, agriculture, and wildlife officials said that training opportunities sponsored by the federal government help enhance and standardize their laboratory testing methods, epidemiological investigations, and specimen-collection procedures, which helps state and local officials develop more efficient and effective disease diagnostic capabilities. In addition, in interviews, officials from both public health and agriculture said that the chance to work together on concrete projects like avian influenza planning and surveillance projects gave them an ongoing reason to communicate and collaborate.

Public-health officials from five of nine public health departments we visited said, in interviews, that they rely on CDC’s subject-matter expertise to either guide their efforts during an event—such as the 2009 H1N1 outbreak—or to answer questions about a specific investigation. Moreover, public-health officials in three of seven states said that without this and other types of nonfinancial assistance, their department would not be able to conduct as many investigations and the efficiency with which they could diagnose a disease would decrease. In addition, public- health officials from one state said the ability to get CDC’s help confirming results and to send specimens with unusual characteristics, which are difficult to identify, increases the state’s laboratory capacity and improves the efficiency with which the state can diagnose an unusual disease.

Similarly, agriculture officials we interviewed in one state said if they did not have the National Veterinary Services Laboratory (NVSL) to provide confirmation for unusual disease samples, they would be less prepared to handle disease outbreaks. Finally, wildlife officials from one state said working in the field with federal officials to trap animals and collect samples has enhanced their relationships with federal officials, their knowledge of new sampling procedures and surveillance data management, and their ability to work with USDA officials during the grant process. In follow-up questionnaires, we asked officials to identify the federal nonfinancial and technical assistance efforts that were essential to their core biosurveillance capabilities. Table 3 shows the federal nonfinancial and technical assistance efforts most commonly identified as essential to their core biosurveillance capabilities by the 27 officials who responded to our questionnaire, by group. For more information on questionnaire results, see appendix III.

The category of federal assistance ranked third overall in importance by state and city questionnaire respondents is guidance. Additionally, during our site visits, the majority of state and city officials we interviewed—16 of 23—said the primary source of federal guidance related to biosurveillance accompanies federal grants and cooperative agreements and serves the purpose of shaping programmatic goals, objectives, and priorities. For example, the public-health epidemiologists and laboratory director for one city said that the detailed capability guidance that accompanied the most recent round of PHEP funding helped the city perform a gap analysis, the results of which will serve as a planning guide over the next 5 years. In addition, four of nine public-health departments we spoke with discussed guidance that supports their efforts to build and maintain biosurveillance capabilities by supporting specific activities that constitute their capabilities, for example, guidance regarding standardized case definitions, disease-reporting requirements, and sampling procedures for unusual or emerging disease agents. Public-health officials in one state we visited said that guidance on standardization is essential to ensure states are able to move information to CDC more efficiently, and without standardization it would be difficult to exchange information with their partners. Similarly, agriculture officials in one state we visited said federal sampling standards help interpret information about disease occurrence in other states, because the significance of results is uniform nationwide. These officials said that without this guidance, they would need to develop protocols state-by-state to interpret results, which would lead to a loss of efficiency in animal diagnostic laboratory protocols and interpretation of results.

In follow-up questionnaires, we asked respondents to characterize the various types of guidance, which had previously been identified in interviews, as very useful, moderately useful, somewhat useful, or not useful in supporting their biosurveillance capabilities. Table 4 shows the sources of federal guidance the 27 officials who responded to our questionnaire—by group—most commonly identified as very useful for supporting biosurveillance capabilities. For more information on questionnaire results, see appendix III.

Information-sharing tools and analytical products was the category ranked fourth in importance by our 27 questionnaire respondents. In interviews, officials said that without the knowledge they gain through these tools and products they would lack critical information about emerging-disease situations in neighboring states and throughout the nation. For example, public-health officials in one state noted that they would lack context about a health situation in their state without the knowledge they gain through these systems and reports about incidents in neighboring states and throughout the nation. In addition, they said these tools are useful in helping them to better understand baselines for various diseases they observe in their own jurisdictions. Public-health officials in another state we interviewed noted that without the information provided by PulseNet, their ability to detect foodborne outbreaks would be diminished.

Southeastern Cooperative Wildlife Disease Study (SCWDS)

The wildlife agencies of 19 states (shaded on map) and Puerto Rico and the U.S. Geological Survey of DOI fund regional wildlife research and service projects through SCWDS, and USDA’s Veterinary Services provides support for national and international surveillance activities where diseases may spread among wildlife and livestock. SCWDS provides wildlife-disease expertise to state and federal agencies responsible for wildlife and domestic livestock resources. SCWDS aims to detect causes of illness and death in wildlife, characterize the effect of diseases and parasites upon wild animal populations, identify disease interrelationships between wildlife and domestic livestock, and determine the role of wildlife in transmission of human diseases.

Likewise, agriculture officials we interviewed in one state said without the compiled information that federal agencies share with them—for example, disease data on USDA’s Veterinary Service Laboratory Submissions website—they would be operating blindly and would need to spend time contacting other states to know what is happening outside their borders. They said this information is particularly useful when it comes to animal movement across state lines, so that they are aware of those diseases of concern in different areas of the country. Similarly, wildlife officials from one state said that the information shared by federal agencies provides awareness of disease threats in their state and information about how to respond if they encounter the disease in question. They said that the lack of this information could delay the state’s detection of a potentially devastating disease, because outbreak signals—like animal die-offs would have to trigger an investigation in their state—before they had any awareness of looming disease threats. In follow-up questionnaires, we asked officials to identify the types of information sharing tools and analytical products that were essential to their core biosurveillance capabilities. Table 5 shows the types of information sharing tools and analytical products most commonly identified as essential to their core biosurveillance capabilities by the 27 officials who responded to our questionnaire, by group. For more information on questionnaire results, see appendix III.

In June 2010, when we recommended that the National Security Staff lead the development of a national biosurveillance strategy, we noted that an effective national biosurveillance strategy could help identify the resources currently being used to support a biosurveillance capability, additional resources that may be needed, and opportunities for leveraging resources. Although not generalizable to the whole biosurveillance enterprise, our findings suggest that there are existing federal resources that nonfederal officials find essential to their efforts and could provide a starting point for considering how to leverage nonfederal resources.

Because the resources that constitute a national biosurveillance capability are largely owned by nonfederal entities, a national strategy that considers how to leverage existing efforts and resources in federal, state, tribal, local, and insular jurisdictions could improve efforts to build and maintain a national biosurveillance capability.

State and Local Officials Reported Challenges Related to State Policies, Core Capability Resources, and Planning and Leadership to Support Biosurveillance Capabilities

State and city officials we spoke with reported a variety of challenges in building and maintaining biosurveillance capabilities. These challenges generally fell into three different groups: (1) state policies enacted in response to fiscal constraints, (2) obtaining and maintaining resources to support capabilities, and (3) leadership and planning challenges. In the follow-up questionnaire, we asked respondents how challenges identified in the interviews affect their capabilities and to rank the top three challenges they face. For each challenge respondents identified facing, we asked them to indicate whether or not the current combination of resources, leadership, and planning in their jurisdictions were adequate to address that challenge. The challenges reported here are only those that respondents indicated are not currently adequately addressed. For additional information about questionnaire results related to challenges, see appendix IV.

State Policies May Constrain Hiring, Travel, and Information Technology, Even When Federal Funding Is Available

One set of challenges that state and city officials described to us had to do with the state and local budget crises and the policies states have put in place to respond to this challenge. Specifically, in interviews with state public-health, agriculture, and wildlife departments, multiple officials reported barriers that state policies presented for building and maintaining a biosurveillance capability. Among these barriers were (1) an inability to use federal funding for new positions because of state hiring restrictions, (2) an inability to attend national trainings and conferences (even when federal travel funding is available) because of state travel restrictions, and (3) an inability to participate in training and other online forums sponsored by federal agencies and professional associations because of state restrictions on when and how they can use information technology in their offices.

In follow-up questionnaires, 20 of 27 respondents identified these kinds of state policies as a challenge to building and maintaining biosurveillance capability. One respondent who ranked this kind of challenge among the top three challenges noted that state policies on hiring require the use of contractors rather than full-time equivalent personnel. As a consequence, the respondent noted, the knowledge accrued through the course of on- the-job training leaves the agency when a given contract ends.

Although federal agencies who work to help support capabilities in state and local jurisdictions have limited ability to directly affect state policies, CDC officials say they are aware of the issue and agree that it is a challenge—in some cases severely hampering states’ ability to move forward with capability building. The CDC officials said they have discussed the issue with their state and local partners as part of a larger effort to explore various funding options to help better support capability building.

State and City Officials Report Concerns about Resources

A second set of challenges reflected general concerns about the resources that support biosurveillance capabilities, such as appropriately trained personnel, systems, and equipment. Nineteen of 27 respondents to our follow-up questionnaires reported facing workforce shortages among skilled professionals—epidemiologists, informaticians, statisticians, laboratory staff, animal-health staff, or animal-disease specialists. One respondent who rated this particular challenge among the top three noted that noncompetitive salaries had resulted in lack of interest in positions and high turnover. As a consequence, according to the respondent, investments in training yield lower returns and quality of the overall workforce is affected.

Sixteen of 27 questionnaire respondents reported problems with training availability. A state wildlife official who rated training availability as the top current challenge noted that without proper training, staff in the field—who often have duties other than disease surveillance—lack an understanding of the importance of surveillance and reporting, as well as knowledge of the techniques to carry it out. Fourteen of 27 questionnaire respondents indicated issues with workforce competency—hiring and retaining professionals with adequate training and education. One of the respondents that rated this challenge among the top three noted that without properly trained staff to support them, initiatives languish. She also noted that the need for the few skilled personnel to provide on-the- job training and education consumes time and affects workflow.

Fifteen of 27 questionnaire respondents reported that keeping up with ongoing systems maintenance and enhancement needs has been challenging. One respondent who rated ongoing systems maintenance and enhancement among the top three challenges said that public-health informatics, including state-of-the-art database systems and effective electronic linkages, are critical to surveillance, but place demands on resources to attract and maintain public-health informatics expertise and support database applications. Thirteen of 27 questionnaire respondents reported challenges maintaining adequate laboratory capacity. One laboratory official who ranked this among the top three challenges stated that many at the public-health lab are nearing retirement and it has been difficult to attract and retain younger laboratory scientists to work in public health.

State and City Officials Report Leadership and Planning Challenges That Could Be Considered in a National Biosurveillance Strategy

The third set of challenges state and city officials that we interviewed reported included (1) difficulty planning for longer-term capability-building efforts because of uncertainty from year to year about whether project funds would be available; (2) difficulty planning to invest in basic capabilities for multiple disease threats because federal funding has focused on specific diseases rather than strategically building core capabilities; (3) limited leadership and planning—at all levels of the biosurveillance enterprise—to support regional and integrated disease data-surveillance approaches; and (4) differing priorities and other partnership issues. Many of the challenges that state and city officials identified are similar to issues we reported regarding biosurveillance at the federal level. We noted that many of the challenges like these that face the biosurveillance enterprise are complex, inherent to building capabilities that cross traditional boundaries, and not easily resolved. We recommended in June 2010 that a leadership mechanism, such as a focal point, and a strategy could help define the scope of the problems to be addressed, in turn leading to specific objectives and activities for tackling those problems, better allocation and management of resources, and clarification of roles and responsibilities.

In our follow-up questionnaires, by far the single most-commonly reported challenge was funding instability and insecurity, with 25 of 27 questionnaire respondents identifying it as a challenge that has not been adequately addressed. Among those, 23 ranked it as one of the top three challenges and 16 of those ranked it as their top challenge. In interviews, officials in both the human- and animal-health communities noted that they receive little or no support from state budgets for surveillance activities, leaving them largely reliant on federal funding for this type of activity. Moreover, two agriculture officials noted that it is difficult for states to develop long-term plans for building and maintaining capabilities because they do not know how much funding they will receive from year to year. For example, three of the nine visits we made to state public- health departments occurred near the application deadline for the new PHEP cooperative agreements. All three sets of public health officials reported receiving news of a last minute reduction in funding—which according to CDC officials equaled 12 percent—that resulted in the need to significantly revise their PHEP application and accompanying plan for building and maintaining capabilities, in a short time frame.

In interviews, agriculture officials in three of the seven states we visited said they receive little or no funding in their state budgets to support biosurveillance activities and depend on federal funding, which they say has been decreasing. Because of the decreases in funding, the agriculture officials from one state said that their department has decreased its staff level by half over the past 6 years, and these officials noted that without federal funding the department’s biosurveillance capabilities would be minimal. Likewise, wildlife officials in five of the seven states we visited said that they receive little or no funding for surveillance from their state budgets and rely on federal programs to support surveillance.

Federal officials agreed that funding insecurity and instability is a serious challenge affecting states’ ability to plan for and execute capability- building efforts. In October 2010, CDC’s Advisory Committee to the Director—recognizing much of CDC’s effect results from the funds it provides state, tribal, local, and territorial public-health departments— charged its State, Tribal, Local and Territorial Workgroup to produce recommendations to maximize resources and develop capacity throughout this nonfederal community. A subworkgroup was created specifically to consider issues arising from the fiscal challenges facing states and localities.

According to CDC officials, the workgroup has discussed moving cooperative agreements like PHEP and ELC to a 2-year cycle to give state and local public-health departments more time to work within state- imposed restrictions, but they cannot make such a change without legislative action. In addition, CDC officials stated that they attempt to communicate budget decisions to their nonfederal partners in a timely manner. For example, they said that they provided guidance to PHEP applicants to help them plan around funding uncertainty by communicating the minimum funding available and advising them to plan for the next fiscal year using the current year’s funding level with the expectation that it will likely be reduced. However, these officials also noted that when federal agencies have to operate on a continuing resolution, it restricts their ability to plan and obligate funds, which in turn can result in reductions and delays in funding activities at the state and local level.

An official from DOI’s USGS National Wildlife Health Center also attributed funding instability and insecurity to the annual appropriations cycle, because federal agencies also do not know what the budget will be from year to year. Like CDC officials, he said that multiyear appropriations would allow for more long-term planning. USDA officials also acknowledged that their nonfederal partners face challenges planning for and developing capabilities because of funding uncertainty. Officials from USDA’s Animal and Plant Health Inspection Service’s Veterinary Services said they are working to streamline the cooperative agreement process to provide additional flexibility to the states by producing fewer but broader agreements that would allow the states to better prioritize their needs.

Twenty-one of the 27 state and city officials who responded to our follow- up questionnaire reported that the common federal approach of funding capabilities in response to specific diseases or initiatives—for example, West Nile virus—limited their ability to develop core capabilities that could provide surveillance capacity that cut across health threats and for emerging-disease threats. Along these lines, one of the respondents who rated this challenge among the top three said that broad-based surveillance activities are crucial for detecting new and emerging diseases, but funding targeted for specific diseases does not allow for focus on a broad range of causes of morbidity and mortality.

Federal officials agreed that the disease-specific nature of funding is a challenge to states’ ability to invest in core capabilities. CDC officials said this long-standing issue stems from the way CDC receives funding, which is disease-specific and, in turn, awarded to the states that way. According to officials, funding authorized under the Patient Protection and Affordable Care Act (PPACA) has recently offered some authority for flexible biosurveillance capability investments. For example, they said the PPACA program supports additional epidemiologists and laboratory support staff and infrastructure improvements, among other things, at the state and local level. Additionally, CDC officials noted that the all-hazards nature of PHEP grants supports states’ ability to invest in crosscutting core capabilities.

An official from DOI’s USGS National Wildlife Health Center similarly noted that the structure of funding is a challenge for agencies at all levels, and said he would like to see more broad-based funding to allow for long- term investments to retain and develop capacity to address disease issues. USDA officials also acknowledge that stovepiped, or disease- specific, funding presents a challenge for their nonfederal partners when planning for and investing in crosscutting capabilities. Within USDA’s Animal and Plant Health Inspection Service, officials from Veterinary Services said that they are moving away from funding disease- and program-specific items and toward a new funding approach, intended to reduce stovepiping and provide for additional flexibility. USDA’s Wildlife Services officials also find stovepiped funding challenging, but said that they have little control over the issue.

In interviews and follow-up questionnaires, city and state officials also reported challenges with the leadership and planning for integrated biosurveillance approaches. Sixteen of 27 respondents to our follow-up questionnaires reported a lack of leadership and mechanisms to support regional approaches to disease surveillance. Similarly, 17 of 27 respondents reported that integrating information across disease domains is a challenge because of a lack of leadership and mechanisms to facilitate information sharing and data integration among public-health, agriculture, and wildlife disease-control functions. One respondent who ranked integrating human and animal surveillance information among the top three challenges said that the lack of leadership and mechanisms to do so is a barrier to effective and efficient disease response.

Federal agencies with biosurveillance roles have acknowledged that attention to integrated biosurveillance approaches is needed. In response to HSPD-21, CDC created the National Biosurveillance Strategy for Human Health, collaborating with federal and nonfederal partners, to provide a foundation for a long-term effort to improve a nationwide capability to manage human health–related data and information. The strategy lays out six priority areas for attention to address critical gaps and opportunities for improvement. Among the six is integrated biosurveillance, about which the strategy states that, because the responsibility for public health is shared across multiple levels of government, professional practice, and scientific disciplines, the timely exchange of reliable and actionable information is essential. Although the strategy includes goals for enhancing integration of human-health data, these goals have not yet been the central focus of implementation plans for the strategy. However, according to CDC officials, the efforts to establish objectives for enhancing management of human-health information as part of the strategy has been important for larger HHS efforts, such as implementing the National Health Security Strategy. Officials also said these activities are important to the efforts the National Security Staff has underway to guide the biosurveillance enterprise. In addition, CDC officials stated that the BioSense program is being redesigned to improve the ability for jurisdictions to share data with each other during specific events, which could foster more regional data sharing.

An official from DOI’s USGS National Wildlife Health Center said it would be helpful to have a national strategy or framework to guide all of those involved in wildlife health to respond in a coordinated, appropriate, and proportionate way to wildlife disease issues. In addition, he said the framework is needed to outline the shared responsibilities related to threat detection and assessment, policy development, and management actions. According to the official, DOI plans to begin working on such a framework for wildlife surveillance with its partners in the near future. USDA officials also acknowledged that nonfederal partners have faced challenges with leadership and planning for integrated biosurveillance approaches. USDA officials from Animal and Plant Health Inspection Service’s Wildlife Services said they could enhance the integration of biosurveillance capacities for their nonfederal partners by providing access to their existing networks. However, the officials said they would need a source of funding for the increased efforts required to meet the needs of nonfederal partners. Officials from Veterinary Services stated that to address integration challenges, they try to engage their nonfederal partners in planning activities, but are looking to the National Security Staff’s work on the national biosurveillance strategy to help address larger challenges.

Some challenges identified by state and local officials reflected an opportunity for better partnerships between the federal and the state and local governments. Fourteen of 27 respondents to our follow-up questionnaires indicated that competing federal priorities present challenges. For example, in one interview, state officials said that grant guidance can be contradictory with regards to funding streams, and one grant may recommend focusing on a certain priority and then other grants recommend other priorities that do not complement the other grant’s guidance. In addition, 12 of 27 questionnaire respondents reported having vague or insufficient guidance. In interviews, state and local officials who identified this issue noted that there is no user-friendly central repository of best practices for maintaining and enhancing capabilities and that guidance lacks concrete examples for things like developing state planning documents or fostering integrated biosurveillance efforts. Finally, 12 of 27 questionnaire respondents reported federalism challenges, such as conflict between national and local priorities, philosophies, and approaches to conducting biosurveillance. For example, in an interview, public-health officials in one state told us that they have to spend valuable time and resources convincing their federal partners not to overreact to electronic laboratory results of disease that are considered dangerous, such as plague, but are also endemic in low levels within their jurisdictions Officials from CDC stated that they are aware of these kinds of challenges facing their nonfederal partners and of the need to improve federal and nonfederal coordination among programs. These officials said states may have different priorities than those at the federal level due the need to balance their state responsibilities to address health concerns of the state with their other activities conducted with varying federal agencies and programs. According to the officials, they are committed—in national strategy efforts—to building on current capabilities at all levels of government and will take into consideration the issues and challenges states experience in working with their federal biosurveillance partners. They also noted that as they developed guidance for PHEP recipients for the most recent round of cooperative agreements—Public Health Preparedness Capabilities: National Standards for State and Local Planning—they involved approximately 200 stakeholders and experts to help public-health departments better organize their work and determine whether they have the resources to build and sustain all the capabilities. Additionally, they said that they attempted to ensure that their nonfederal partners do not experience continual shifts in PHEP priorities by implementing a new process for reviewing and approving proposed changes to PHEP guidance.

They also described several efforts to coordinate grant guidance within CDC and with other federal partners to improve effectiveness and reduce conflicting activities or redundant reporting. Among these efforts were multiple workgroups and other activities to engage with federal and nonfederal partners, as well as a Memorandum of Understanding with multiple federal departments that fund preparedness activities. According to CDC officials, the memorandum establishes a formal framework that supports joint federal planning and better coordinates emergency public health and health care preparedness consistent with national strategies and priorities.

An official from DOI’s USGS National Wildlife Health Center agrees that partners throughout the biosurveillance enterprise experience federalism challenges. He said that a national strategy or framework that clearly outlines roles and responsibilities could help alleviate these issues. USDA officials also acknowledged that their nonfederal partners have faced these kinds of challenges. Officials from USDA Animal and Plant Health Inspection Service’s Wildlife Services said that they recently created a plan to achieve a more unified cross-program approach to addressing wildlife-disease issues that will affect the agency and its stakeholders. These officials stated that enhanced integration of the USDA resources, expertise, personnel, and infrastructure needed to address issues of wildlife-disease surveillance—among other things—should help their nonfederal partners to mitigate this challenge. Officials from Veterinary Services stated that to address federalism challenges, they seek to proactively engage their nonfederal partners in planning activities, but are looking to the National Security Staff’s work on the national biosurveillance strategy to help address the larger challenge.

In our June 2010 report, we called for a national strategy that could begin to address the difficult but critical issues of who pays for biosurveillance capabilities and how a national capability will be sustained in the future. Our findings about the challenges with planning and investing in core capabilities, while not generalizable to all nonfederal jurisdictions, suggest that there may be some common issues with the structure of funding that affect longer-term planning and investments in core biosurveillance capabilities. We also reported in June 2010 that clarifying the numerous governmental and private-sector entities’ roles and responsibilities for leading, partnering, or supporting biosurveillance activities could help ensure timely disease detection and situational awareness across multiple domains. Our findings similarly suggest that there may be some common issues with promoting integrated biosurveillance approaches at the nonfederal level. As part of a national biosurveillance strategy, considering challenges like these may help partners across the enterprise find shared solutions as they strive to build and maintain an integrated national biosurveillance capability.

Federal Agencies Provide Some Support, but Biosurveillance Capabilities in Tribal and Insular Areas Are Limited by Resources and Infrastructure

As with the state and local jurisdictions, the federal government does not have efforts designed specifically to build and maintain tribal or insular biosurveillance capabilities to support a national biosurveillance capability. However, tribal and insular jurisdictions also receive certain cooperative agreements and technical assistance that federal officials say can help support biosurveillance capacity. At the same time, federal officials reported that limited resources and infrastructure in tribal and insular jurisdictions present challenges to building their capacity.

Federal Agencies Have Provided Financial and Technical Assistance That Can Support Tribal and Insular Capabilities

According to federal and professional association officials that work with tribal and insular jurisdictions, federal agencies provide disease-specific funding and cooperative agreements, as well as training and technical assistance, to support public-health and animal-health surveillance capacity.

Insular areas are eligible for the PHEP and ELC cooperative agreements from CDC. PHEP funds public-health preparedness projects in American Samoa, Guam, U.S. Virgin Islands, Northern Mariana Islands, Puerto Rico, Federated States of Micronesia, Republic of the Marshall Islands, and Republic of Palau. In addition, ELC—which builds epidemiological and laboratory capacity—is awarded to Puerto Rico and the Republic of Palau.

According to officials from PIHOA, federal agencies also provide specimen testing for Pacific insular areas—which have no reference laboratory capacity of their own—for disease agents that the islands’ clinical laboratory network is not equipped or certified to handle. PIHOA developed the Regional Lab Initiative for the transportation of human specimens, and PIHOA serves as a steward for the specimen transportation network by negotiating specimen-transportation contracts with commercial airlines, developing shipping standards for laboratory specimens, and overseeing the Regional Lab Initiative budget. PIHOA officials said that federal funding for this initiative is critical to enable Pacific insular areas to transport specimens for testing to those laboratories with greater capabilities.

According to CDC officials, their Division of Global Migration and Quarantine also works with the insular areas to enhance crosscutting public-health initiatives, with a focus on disease surveillance and help public-health departments tie into various CDC programs. For example, the division has been working with Guam since late 2009 to move towards electronic data sharing of health information to improve timeliness and response to catastrophic events, including better linkages to the National Notifiable Disease Surveillance System. During a 2010 mumps outbreak in Guam and the Federated States of Micronesia, the division also played a coordination role and facilitated the shipment of lab specimens. Officials said that the Guam mumps outbreak helped identify gaps in their surveillance capacity, and the division followed up with targeted training to address the gaps. The division is also working to enhance the quality of American Samoa's public-health records to enhance its ability to submit electronic public-health data into the World Health Organization’s syndromic surveillance system for the Pacific Islands region.

For animal health in the insular areas, USDA has employees and offices in some insular areas. USDA Veterinary Medical Officers in the field interact with producers, respond to reports of potential Foreign Animal Diseases, help administer disease eradication and control and surveillance activities, and assist with export certification out of these field-office sites. DOI provides diagnostic service to determine causes of mortality in wildlife. For example, in American Samoa and Palau, DOI performs necropsy surveys of free-ranging wildlife (both terrestrial and marine) to determine the cause of death. The agency reported that all bird carcasses necropsied are routinely tested for avian influenza. The agency also reported that the ability to ship samples from American Samoa and Palau to Honolulu, Hawaii, has allowed the agency to gain a greater understanding of causes of wildlife mortality in those regions. In case of catastrophic mortality, DOI officials said the agency would probably send someone out to the area to provide on-site assistance and collaborate with local agencies to deal with the issue and resolve it to its logical conclusion. For example, DOI officials have offered response assistance to Palau to help with unusual poultry mortality events in efforts to effect early detection of avian influenza. DOI also provides annual workshops to agencies to communicate findings and provide on-site training on wildlife disease response.

Tribal nations are not eligible for PHEP or ELC funding, but CDC advises states to include tribes in their required all-hazards public-health capability planning for PHEP funding. In addition, IHS has cooperative agreements with Tribal Epidemiology Centers, to support local public health and provide data analyses for the tribes. As shown in figure 4, there are 12 Tribal Epidemiology Centers located around the country. The 12 Tribal Epidemiology Centers typically serve 30-100 tribes in their region. Officials from IHS said that the Tribal Epidemiology Centers may offer a foundation for building tribal biosurveillance capabilities. However, biosurveillance is not the primary job or mission of the epidemiology centers. The priorities of the centers are driven by the needs of the tribes, and the centers help the tribes create a structure for intervention to prevent the major conditions affecting the tribal population.

Federal agencies also provide technical assistance and training to tribal jurisdictions. The Office for State, Tribal, Local and Territorial Support within CDC provides training and technical assistance to improve data and surveillance standards in tribal areas and work to foster public-health workforce development in tribal areas. In addition, IHS provides, without charge, software for automated electronic surveillance that can be implemented by IHS, tribal, and Urban American Indian and Alaska Native sites to help with automated reporting and information sharing. The initial project, IHS’s Influenza Awareness System, focused on influenza-like illness, but according to IHS officials is currently expanding to include other notifiable diseases. IHS also provides technical assistance to tribes, sometimes through the Tribal Epidemiology Centers, and also provides some training, which is available to any American Indian or Alaska Native. The primary focus of the training is not biosurveillance but basic public-health functions, but federal officials who work with these jurisdictions say that any effort to build public-health infrastructure increases biosurveillance capabilities over their existing levels.

Additionally, according to USDA officials, tribes can participate in the same disease-control and eradication programs (such as tuberculosis, brucellosis, scrapie, and chronic wasting disease) as states through grants and cooperative agreements. These officials said these cooperative agreements increase tribes’ biosurveillance capability, particularly with tribes that have more-robust existing infrastructure, like Navajo Nation, which has a full-time veterinarian. USDA officials with responsibility for wildlife said they also provide cooperative agreements and training to support tribal wildlife disease surveillance.

Federal Working Groups and Outreach Efforts Can Help Support Biosurveillance Capabilities

To help build public-health and animal-health surveillance capacity, federal agencies have also created working groups and other outreach efforts to tribal and insular jurisdictions. For example, the Office for State, Tribal, Local and Territorial Support within CDC works with health departments to increase public-health capacity through a working group that helps build capacity across jurisdictions, for example between tribes and corresponding state or local health departments. CDC has developed Pacific working groups to address various issues in the Pacific insular areas, such as the Public Health Preparedness and Response Working Group and an epidemiology working group. According to officials, these working groups help coordinate activities between various CDC departments and the Pacific insular areas.

USDA’s Native American Program Coordinator serves as a tribal liaison, providing assistance to tribes and has developed a relationship with the large land-owning tribes that participate in its programs. The officials said that the tribal liaison has built this relationship over the years by attending the Intertribal Agriculture Council’s Meetings, a gathering of tribal agriculture producers. They noted that because of the tribal liaison’s continuous outreach, they believe that the tribes know whom to call if unusual animal disease symptoms appear in animals on their lands.

Federal Agencies Face Unique Challenges Supporting Tribal and Insular Jurisdictions

USDA’s Traceability Program

Federal officials, as well as officials from professional associations like the Council of State and Tribal Epidemiologists and PIHOA described infrastructure and demographic challenges they face in helping to build biosurveillance capabilities in tribal and insular jurisdictions. For example, CDC officials said that, overall, there is a low capacity to detect and report diseases in both tribal and insular jurisdictions, and that better assurance for detection of potentially catastrophic signs would require enhancement of basic systems and public-health functions. HHS officials said that tribes, insular areas, and states face similar public-health infrastructure challenges, but the challenges are more severe in tribal and insular areas. For example, IHS and CDC officials said some tribes have serious public-health infrastructure limitations—for example, some have minimal or no functioning health-department structure—so officials said the idea of building biosurveillance capabilities is not a realistic pursuit in these areas.

USDA and DOI officials also reported capacity challenges—such as few veterinary and wildlife personnel on the ground in tribal and insular areas—that limit biosurveillance capabilities. Additionally, officials said that the federal cooperative agreements offered by federal agencies do not always provide for the infrastructure enhancement needed for tribal and insular areas, because they assume a basic level of capacity that these jurisdictions often do not have. However, USDA, DOI, and HHS officials also cautioned that despite the limited infrastructure in some of the tribal and insular areas, it would not be practical from a cost-benefit standpoint to invest in complete biosurveillance systems for every tribe and insular area. For example, for small tribal nations and insular areas it may not make sense to expect them to support and maintain separate laboratory facilities, especially when there are other nearby state resources available that could support testing for those populations.

Along the same lines, HHS officials said that tribes and their federal and state partners have historically faced disease-reporting challenges. CDC officials noted that as sovereign nations, tribes typically prefer to work directly with federal agencies, rather than state governments, but because of the nature of public health, it often makes sense for tribes and states to share data or conduct joint investigations with the states. CDC officials said that data sharing between tribes in states is challenging, because tribes may have limited public-health capacity. The officials said that Tribal Epidemiology Centers offer some promise for facilitating information sharing, but some states have been reluctant to share health data with Tribal Epidemiology Centers, because until recently they lacked public-health authority—a legal designation that governs the ability of governmental entities to collect, receive, and share data for public-health purposes under the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Tribal Epidemiology Centers are operated by nonprofit organizations that typically had no legal health authority to handle such data. However, in 2010, PPACA designated these centers public-health authorities under HIPAA. This provision allows the IHS-funded Tribal Epidemiology Centers to access federal and state data sets for research purposes, just as state health departments do. However, these centers still are nonprofit organizations that are competitively selected on a periodic basis and there is no guarantee that the entire nation will continue to have center coverage. HHS officials said the designation of the centers as public-health authorities will likely facilitate more sharing among states and tribes, but it is a relatively new development, so it is too soon to determine the effect.

Federal officials also reported facing demographic and logistical challenges in working with tribal nations. Complications in data collection and reporting arise from the nature of tribal boundaries and populations. Specifically, tribes are not defined by geographic boundaries, tribal members may not live on tribal lands, and tribal lands may cross state boundaries. Officials also said population size and geography vary for tribes and many tribes are in remote locations, including about half of the more than 500 federally recognized tribes located in Alaska. An official from IHS noted that, in general, tribal communities do not have populations large enough to justify building complete, individual surveillance programs and that tribes generally do not have infrastructure or resources to support such an effort.

According to USDA officials, every tribe has a different relationship with the state it is located in and with the federal government. Some tribes have direct relationships with the state agriculture department because most tribes do not have veterinarians. In some cases, the states may take care of the surveillance needs for a tribe, and in other cases, the tribes may have their own surveillance capacity. In general, tribes do not have funding to establish and maintain laboratories. Tribes typically use the state labs that are part of the National Animal Health Laboratory Network (NAHLN), the facilities at Plum Island, the Ames, Iowa lab, or state labs that are not part of NAHLN. (For more information about laboratories, see app. II.) DOI officials said that tribes are interested in wildlife management and disease surveillance, but do not have the resources, as tribes need to build capabilities at the most basic level—like wildlife biologists and management expertise.

Federal agencies, as well as association officials, reported similar resource, demographic, and logistical challenges in insular areas. Officials at the Council of State and Territorial Epidemiologists, PIHOA, and CDC said the Pacific insular areas are challenged in identifying disease outbreaks and emerging diseases. According to PIHOA officials, this is due to workforce shortages for doctors, nurses, epidemiologists, and laboratory officials, and the limited laboratory capacity on the islands. Although the islands can currently depend on laboratories outside Pacific insular areas to conduct testing, and there are currently initiatives and programs in place to improve laboratory capacity on the islands, it may take several days to detect a disease.

CDC officials said timely reporting cannot be ensured in the Pacific insular areas and there is limited ability to build public-health infrastructure in the territories. For example, they said the public-health systems will have to transition to more formal mechanisms of information sharing, because currently events trigger regional partners to respond in an ad hoc and unsystematic way. To address some of these challenges, PIHOA developed the Public Health Infrastructure Initiative, partially funded by CDC’s National Public Health Improvement Initiative, which is supported by PPACA’s Prevention and Public Health Fund, to help improve Pacific insular areas’ public-health systems at every level. Through this initiative, PIHOA is working with Pacific insular areas officials to develop public-health curricula to improve the epidemiological and surveillance capabilities of the islands.

According to DOI officials, aside from Guam, insular areas in the Pacific region have little to no existing veterinary capacity to deal with animal or zoonotic diseases. DOI officials said they would like to get more wildlife disease data from places like Guam and the Commonwealth of the Northern Mariana Islands, but the lack of reliable in-territory contacts there has made it difficult to establish those relationships.

The Federal Government Has Not Comprehensively Assessed Nonfederal Biosurveillance Capabilities

Various federal agencies and professional associations with public-health missions have assessed some aspects of nonfederal biosurveillance capabilities, such as the evaluation of laboratory, epidemiology, surveillance, and other capacities, but the federal government has not systematically or comprehensively assessed state and local governments’ ability to contribute to a national biosurveillance capability. An assessment of capabilities that support biosurveillance is called for in HSPD-10, which states that the United States requires a periodic assessment that identifies gaps or vulnerabilities in our biodefense capabilities—of which surveillance and detection is a key part—to guide prioritization of federal investments. We have previously reported that a national biosurveillance capability depends upon participation from nonfederal jurisdictions and that few of the resources required to support the capability are wholly owned by the federal government. Therefore, assessing the baseline and identifying investment needs for a national biosurveillance capability necessarily involves assessing nonfederal entities’ ability to support a national capability.

No federal, state, local, or association official we spoke to was able to identify a systematic approach—planned or underway—to assessing state and local biosurveillance capabilities and identifying strengths, weaknesses, and gaps across the biosurveillance enterprise. However, certain aspects of public-health capabilities have been assessed by federal agencies and professional associations. For example, CDC’s most-recent round of guidance associated with the PHEP cooperative agreements has begun to define elements, priorities, resource considerations, and metrics for building and assessing public-health surveillance, epidemiology, and laboratory capabilities. According to CDC officials, these national standards are designed to assist states and localities in self-assessing their ability to address the prioritized planning resource elements of each capability and then to assess their ability to demonstrate the functions and tasks within each capability. CDC officials stated that this self-assessment enables states and localities to identify their gaps in preparedness, determine their specific jurisdictional goals and priorities, develop plans for building and sustaining capabilities, and prioritize preparedness investments. CDC officials noted that these data and data collected through the ELC could, with the right attention and resources, offer an opportunity to provide more-cohesive information for a national assessment in the future.

In addition, for the past 4 years the Association of Public Health Laboratories has conducted an assessment of the District of Columbia and the 50 state public-health laboratories’ capacity to respond to biologi- cal, chemical, radiological, and other threats, such as pandemic influenza. Similarly, the Council of State and Territorial Epidemiologists has conducted four assessments since 2001 to assess the epidemiology capacity of state, local, and territorial health departments in the United States. Further, CDC funded a survey of state, local, and territorial syndromic surveillance capabilities that was conducted by the International Society of Disease Surveillance.

According to several federal and state officials, a comprehensive assessment of the biosurveillance enterprise may identify a baseline status, strengths, weaknesses, and gaps across the biosurveillance enterprise and improve the nation’s ability to conduct biosurveillance, but state officials also noted that states would need additional funding to overcome any gaps identified by a federal assessment. For example, officials from one federal agency said that a comprehensive assessment of state and local biosurveillance capabilities would help identify vulnerabilities in the enterprise, assess needs, and help target resources to those areas. Similarly, another federal official who oversees programs for tribal entities noted that knowing more about tribes’ strengths, weaknesses, and gaps would enable their division to better understand where they need to provide additional assistance or focus resources during an event.

State officials we interviewed also discussed how a national assessment could identify best practices in biosurveillance and inform states and federal resource decisionmaking. For example, public health officials from one state said that information about the capability needed to support a national biosurveillance capability would be helpful to support lessons learned and identify best practices. Similarly, wildlife officials from one state said they lack knowledge about the types of wildlife surveillance conducted by other states and other states’ baseline capabilities. They said an assessment of capabilities could determine how their efforts compare to other states, which would provide information to state decision makers to guide resource decisions. According to public-health officials from another state, some gaps in biosurveillance are already fairly well understood—such as electronic lab reporting and workforce sufficiency. These officials said that a formalized national assessment would bring these gaps to the attention of federal agencies and hoped that federal agencies would address these gaps with additional funding, guidelines, and the prioritization of investments.

Although federal, state, and local officials we interviewed generally agreed that a comprehensive national assessment may improve the nation’s ability to conduct biosurveillance, all the officials we interviewed acknowledged that such an assessment would be a complex undertaking. Federal, state, and local officials said the size, variability, and complexity of the biosurveillance enterprise—including federal, state, and local biosurveillance efforts—make it difficult to define precisely what should be measured and identifying the most appropriate assessment participants would be difficult. For example, public-health officials from one state said it would be important to identify definitions and create measurements with which to evaluate capacities, otherwise it would be difficult to maintain a narrow scope for the assessment. They also noted that the development of this type of assessment would require the input of multiple stakeholders. Other officials also noted that it may be difficult to identify the most appropriate parties to provide information for the assessment. For example, agriculture officials from one state said that identifying the most appropriate person to complete the assessment would be difficult, because a state veterinarian will have a different perspective from someone who regularly works in the field. The difficulty in conducting a comprehensive national assessment is exacerbated not only by the magnitude of the undertaking—assessing the capabilities of the states, tribes, insular areas, and the tens of thousands of localities in the United States—but also by the lack of a clear mission and a vision for the desired end state of a national biosurveillance capability. In our June 2010 strategy recommendation, we noted that the National Security Staff and its focal point should define the mission and desired end state.

Until it conducts an assessment of nonfederal biosurveillance capabilities, the federal government will continue to lack key information about the baseline status, strengths, weaknesses, and gaps across the biosurveillance enterprise to guide development and maintenance of a national biosurveillance capability. Officials we interviewed at all levels, as well as federal guidance and directives like HSPD-21, acknowledge that a national biosurveillance capability necessarily rests on the cumulative capabilities of state and local agencies that constitute a large portion of the biosurveillance enterprise. A national strategy like the one we recommended in June 2010—one capable of guiding federal agencies and its key stakeholders to systematically identify risks, resources to address those risks, and investment priorities—may be better positioned to guide development and maintenance of the capability if it takes into account the particular challenges and opportunities inherent in partnering with nonfederal jurisdictions such as state, tribal, local, and insular governments. Moreover, efforts to build the capability would benefit from a framework that facilitates assessment of nonfederal jurisdictions’ baseline capabilities and critical gaps across the entire biosurveillance enterprise.

Conclusions

A key component of preparedness for a potentially catastrophic biological event is the ability to detect a dangerous pathogen early and assess its potential spread and effect. Experts have noted, and our reviews of both federal and nonfederal government biosurveillance activities confirm, that the federal government has undertaken numerous efforts to support timely detection and situational awareness for potentially catastrophic biological events, but these efforts are not well integrated. As we reported in June 2010, current efforts lack a unifying framework and structure for integrating dispersed capabilities and responsibilities across the biosurveillance enterprise. Further we noted that without this unifying framework, it will be difficult to create an integrated approach to building and sustaining a national biosurveillance capability as envisioned in HSPD-21.

Officials at all levels of government, as well as HSPD-21’s vision of a national biosurveillance capability, acknowledge that state and local capabilities are at the heart of the biosurveillance enterprise. According to federal, state, and local officials, early detection of potentially serious disease indications nearly always occurs first at the local level, making the personnel, training, systems, and equipment that support detection at the state and local level a cornerstone of our nation’s biodefense posture. Therefore, to be most effective, a national biosurveillance strategy like the one we recommended in June 2010—one capable of guiding federal agencies and their key stakeholders to systematically identify risks, resources to address those risks, and investment priorities—would address the particular challenges and opportunities inherent in partnering with state and local jurisdictions. Moreover, efforts to build the capability would benefit from a framework that facilitates assessment of jurisdictions’ baseline capabilities and critical gaps across the entire biosurveillance enterprise.

Recommendations for Executive Action

In order to help build and maintain a national biosurveillance capability in a manner that accounts for the particular challenges and opportunities of reliance on state and local partnerships, we recommend the Homeland Security Council direct the National Security Staff to take the following action as part of its implementation of our previous recommendation for a national biosurveillance strategy:  Ensure that the national biosurveillance strategy (1) incorporates a means to leverage existing efforts that support nonfederal biosurveillance capabilities, (2) considers challenges that nonfederal jurisdictions face in building and maintaining biosurveillance capabilities, and (3) includes a framework to develop a baseline and gap assessment of nonfederal jurisdictions’ biosurveillance capabilities.

Agency Comments and Our Evaluation

We provided a draft of this report for review to the National Security Staff, DHS, HHS, DOI, USDA, the Department of Justice; and the state and city officials who contributed to our review. The National Security Staff acknowledged the accuracy of the information contained in the report but did not comment on the recommendation. DHS provided a written response to the draft report, which is summarized below and presented in its entirety in appendix V of this report. USDA provided an oral response that is summarized below. DHS, HHS, DOI, USDA, the Department of Justice, the North Carolina Division of Public Health, and the Utah Department of Agriculture and Food provided technical comments, which we incorporated where appropriate.

In written comments, DHS concurred with our findings. DHS noted that its National Biosurveillance Integration Center has key biosurveillance roles and responsibilities, and stated that to support the Center’s mission, DHS is working with the National Security Staff on the Sub-Interagency Policy Committee on Biosurveillance. DHS further stated that it understands the importance of and supports the inclusion of nonfederal biosurveillance resources in the National Biosurveillance Strategy under development.

In oral comments, USDA concurred with our findings and recommendations. Overall,. Specifically, USDA’s Animal and Plant Health Inspection Service’s Veterinary Services and Wildlife Services supported our recommendation to leverage support, consider challenges, and develop a framework to understand the current capacity and conduct a needs assessment for nonfederal identities to conduct biosurveillance activities. USDA stated that it will continue to work with the National Security Staff in development of the National Biosurveillance Strategy. USDA noted that its Animal and Plant Health Inspection Service has an established national program—the National Wildlife Disease Program— that is currently available to provide the infrastructure and leadership necessary to implement these recommendations, and should be incorporated into an integrated system. USDA noted that the program has a history of providing leadership for national surveillance during various outbreaks, which demonstrates its overall abilities to develop and maintain broad local, state, tribal and private efforts to conduct targeted biosurveillance activities.

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, and the Interior; and interested congressional committees. The report is also available at no charge on GAO’s website 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

To address our objectives, we reviewed key legislation and presidential directives related to biosurveillance, including 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; and Homeland Security Presidential Directives (HSPD) 9, 10, and 21. This report focuses on surveillance efforts for zoonoses— diseases affecting animals and humans—and other emerging infectious diseases with the potential to cause catastrophic human-health effects.

Our work issued in June 2010 on biosurveillance efforts at the federal level explored surveillance for the following biosurveillance domains: human health, animal health, plant health, food, and the environment (specifically, air and water). Given further complexity arising from the number of and variation among states, localities, tribes, and insular areas, we narrowed the disease scope for this report. We focused on zoonotic disease agents, because of the particular threats associated with them and because threats from zoonotic disease agents clearly illustrate the potential benefits of an integrated biosurveillance capability. Given the focus on surveillance for zoonoses and other emerging infectious diseases in humans, certain federal efforts—for example, the Department of Homeland Security’s air-monitoring system BioWatch—are not discussed. Similarly, certain types of waterborne, foodborne, plant, or animal diseases—for example Foot and Mouth Disease—that could have devastating economic consequences or dire human-health effects are not the focus of this report.

At the federal level, we consulted officials at the Departments of Agriculture, Homeland Security, Health and Human Services, and the Interior, which have key missions, statutory responsibilities, directives, or programmatic objectives for biosurveillance activities within the scope of this report, including protecting human and animal health and national security. We also discussed biosurveillance issues at the state and city level with officials from the Department of Justice’s Federal Bureau of Investigation.

To develop background on and contextual understanding of the federal efforts that support state biosurveillance capabilities and the challenges officials face building and maintaining those capabilities, we interviewed officials from 10 professional associations and research organizations and asked for recommendations on factors to consider when selecting states for site visits. We interviewed officials from the following organizations:   Council of State and Territorial Epidemiologists,  Trust for America’s Health,  National Association of State Public Health Veterinarians,  American Phytopathological Society,  Association of Public Health Laboratories,  U.S. Animal Health Association,  American Association of Veterinary Laboratory Diagnosticians,  Association of State and Territorial Health Officials, and  OneHealth.

International Society for Disease Surveillance, On the basis of information collected during interviews with officials from professional associations and research organizations and a review of published reports and studies, we identified several factors that could be associated with variability in approaches, philosophies, and challenges faced by states in conducting biosurveillance. We selected seven states for site visits with the dual goals of capturing variation on each of these factors and accounting for each in commonalities identified across the states we visited. The factors we identified and their application to our site selection are shown in table 6.

Application of factor to selection We visited coastal states in the eastern and western United States, as well as noncoastal states. We also visited states with large urban populations and states with more rural populations. In addition, we visited at least one state that has an international border. We visited at least one state with a centralized public-health structure, at least one with a decentralized public-health structure, at least one with a shared or mixed relationship, and at least one with no local public-health departments. We visited at least one state identified by professional association officials as having strong public-health capabilities as a result of leadership and political will, connections between public and animal health or attention to health security as a public-health and national-security issue. We also visited at least one state that the professional association officials identified as part of a group of states that had chronically struggled with resource issues. According to association officials we interviewed, the extent to which a state has agricultural interest has a bearing on its animal-health resources and programs. We visited at least one state with a large industry presence for one or more of the following types of agriculture: commercial fishing, chickens, turkey, hogs, and cattle. In 2007 and 2008, the Association of State and Territorial Health Officials surveyed the states for their State-by-State Profile of Public Health. As part of that effort, the association asked states to select from a list indicating their top five priorities. Within the list were two priorities particularly relevant to health preparedness generally and biosurveillance capabilities specifically. Respectively these are: (1) assuring preparedness for a health emergency and (2) focusing on early detection or population-protection measures. We selected at least one state that selected neither of the priorities and at least one state that selected one or both. There were no states that selected priority (2) but did not select priority (1) in our sample.

The states selected were California, Colorado, Delaware, Mississippi, New Jersey, North Carolina, and Utah. In every state, we interviewed three groups of officials: 1. Officials in public-health departments, including state epidemiologists, who had responsibility for infectious-disease control, disease monitoring, and emergency response in humans. 2. Officials, generally including the state veterinarian, in state agriculture departments who had responsibility for infectious-disease control and monitoring in livestock and poultry. 3. Officials in various departments that included wildlife infectious- disease control and monitoring in their missions. For example, one of these was a State Department of Wildlife and Fisheries.

We also interviewed public-health officials with responsibility for human infectious-disease control and monitoring in two cities with an increased risk of bioterrorism—New York City and Washington, D.C.—that received direct funding from federal agencies to support preparedness capabilities.

We analyzed the information collected during state and city interviews and developed follow-up questionnaires to confirm and enhance information from the interviews about the federal programs and initiatives that support state and local biosurveillance capabilities and the challenges officials face. We sent follow-up questionnaires to public- health departments in all seven states and two cities and to agriculture and wildlife officials in the seven states. Within each public-health department, we sent separate questionnaires to laboratory and epidemiology officials. In total, we distributed 32 questionnaires and received 27 responses. Of the 27 respondents, 7 were epidemiologists, 7 were public-health laboratory officials, 6 were state agriculture officials, and 7 were state wildlife officials. All of the public-health, agriculture, and wildlife departments represented by the 27 respondents had also been represented in our initial interviews. However, in 7 cases—6 laboratory directors and 1 state veterinarian—the lead officials to whom we directed the questionnaire had not been present at the initial interviews. We pretested the public-health questionnaire with a laboratory official who was not at the original interviews in order to ensue the questions could be understood outside of the context of the interview.

Each questionnaire had two sections: one on federal support to states and cities and one on challenges faced by states and cities. The content of the federal support section varied for human-health and animal-health respondents, but the challenges section was the same for both human- and animal-health respondents. The specific federal programs and challenges we asked about were based on initial interviews with the different groups of respondents. We asked respondents to consider federal efforts over the last 2 years. Because the states and cities in this report were not selected in a probability sample, neither the information derived from interviews with officials nor the questionnaire responses are generalizable across the 50 states or the tens of thousands of localities in the United States. Rather, both the interviews and the questionnaire results offer some perspective on the value of select federal activities to, and challenges faced by, a group of state officials who are actively engaged in efforts to detect and respond to major disease events. In addition, although we interviewed officials responsible for public-health emergency management in most state public-health departments that we visited, we did not administer follow-up questionnaires to the officials responsible for planning and preparing for emergency response, because their response focus was generally not central to our scope. Because this report focuses on detection of and situational awareness of potentially catastrophic zoonotic and emerging infectious-disease events, certain federal efforts that federal agencies consider important in supporting state and local preparedness may not have been identified by state and city officials during our interviews and follow-up questionnaires.

To consider the relationship between our findings at the nonfederal level and our previous findings at the federal level about building and maintaining a national biosurveillance capability, we reviewed our June 2010 findings about the centrality of nonfederal capabilities to a biosurveillance enterprise. We also reviewed our June 2010 findings about the purpose of a national biosurveillance strategy and the benefits it could provide for guiding the effort to support a national biosurveillance capability. We determined that because the federal government relies on nonfederal resources to support a national biosurveillance capability, our June 2010 findings about using the strategy to determine how to leverage resources, weigh the costs and benefits of investments, and define roles and responsibilities were particularly germane to the federal government’s efforts to partner with nonfederal biosurveillance enterprise partners to support a national biosurveillance capability.

To understand how the federal government supports biosurveillance in tribal and insular areas, we consulted officials from components of federal departments with responsibility for working with tribal or insular councils and governments, generally, or on health-related matters. These included: the Department of Health and Human Services’s Indian Health Service; the Department of Health and Human Services’s Centers for Disease Control and Prevention’s (CDC) Office of State, Tribal, Local and Territorial Support; CDC’s Office of Surveillance, Epidemiology, and Laboratory Services, CDC’s National Center for Emerging and Zoonotic Infectious Diseases, the Department of Agriculture’s Office of Tribal Relations and the Department of Agriculture’s Animal and Plant Health Inspection Service; the Department of the Interior’s Bureau of Indian Affairs; and the Department of the Interior’s Office of Insular Affairs. In addition, to develop additional background and context about health infrastructure and surveillance in insular areas, we interviewed representatives from the Pacific Island Health Officers Association (PIHOA), which works in the U.S.-Affiliated Pacific Islands to strengthen crosscutting public-health infrastructure, including health-workforce development, quality assurance, health data systems, public-health planning, and public-health laboratories. The findings in this report about insular areas focus on the U.S.-Affiliated Pacific Islands. With the exception of Puerto Rico and the U.S. Virgin Islands, all commonwealths, territories, possessions, and freely associated states of the United States fall within the U.S.-Affiliated Pacific Islands.

To evaluate the extent to which the federal government has assessed nonfederal governments’ capacity to contribute to a national biosurveillance capability, we reviewed relevant presidential directives and federal-agency documents like the National Biosurveillance Strategy for Human Health, along with our prior work and recommendations on building and maintaining a national biosurveillance capability. We determined that such assessment is called for in HSPD-10 and CDC’s National Biosurveillance Strategy for Human Health and is a critical activity for developing an effective national strategy containing the elements we advocated in prior work on national strategies. To determine what types of assessment activities had been undertaken and whether an enterprisewide assessment of biosurveillance of nonfederal capabilities had been conducted, we reviewed relevant assessments and federal documents like the Council of State and Territorial Epidemiologist’s 2009 National Assessment of Epidemiology Capacity and CDC’s Public Health Preparedness series. In addition, we interviewed federal officials at all five federal departments, state officials in each of the seven states, city officials in the two cities, and officials at 10 professional and research institutions that include public health, animal health, or laboratories in their missions about assessment efforts, including whether they had participated in or had any familiarity with an enterprisewide assessment of nonfederal capabilities.

We conducted this performance audit from August 2010 to October 2011 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: Laboratories, Laboratory Networks, and Their Roles in Biosurveillance

Public-health and animal-health laboratories serve a critical role in both initial detection and ongoing situational awareness of biological events.

Appendix III: Responses to Follow-Up Questionnaire Concerning Federal Programs and Initiatives That May Support Nonfederal Biosurveillance Capabilities

This appendix contains the results of our follow-up questionnaire for each of the four categories of federal programs and initiatives that state and city officials identified during interviews. Presented below are the questions and response totals to the follow-up questionnaires we sent to (1) state and city public-health epidemiology officials (called the Epidemiology group in this appendix), (2) state and city public-health laboratory officials (the Laboratory group), (3) state agriculture officials (the Agriculture group), and (4) state wildlife officials (the Wildlife group) by group, and descriptions of the federal programs and initiatives listed.

Supports Capability Enhancement: Without this support, core functions are adequately maintained, but enhanced biosurveillance methods and mechanisms cannot be built or maintained.

The content of the questionnaire varied for the different respondent groups. For example, public-health officials (the Epidemiology and Laboratory groups) were asked about some information sharing and analytical products, whereas animal-health officials (the Agriculture and Wildlife groups) were asked about others. This was based on earlier interviews with these different groups of officials. Of the 27 officials who responded to these questionnaires, 7 were from the Epidemiology group, 7 were from the Laboratory group, 6 were from the Agriculture group, and 7 were from the Wildlife group. For more detail on the method by which these questionnaires were administered, see appendix I.

Appendix IV: Responses to Follow-Up Questionnaire Concerning Challenges State and Local Officials May Face in Building and Maintaining Biosurveillance Capabilities

Table 16 shows the results of our follow-up questionnaire for the question concerning challenges that state and local officials may face in building and maintaining biosurveillance capabilities. Presented below are the question and response totals to the follow-up questionnaires we sent to (1) state and city public-health epidemiology officials, (2) state and city public-health laboratory officials, (3) state agriculture officials, and (4) state wildlife officials by group, and descriptions for the challenges identified.

Question: How do you classify the following challenges as they currently pertain to your area of responsibility?

Appendix V: Comments from the Department of Homeland Security

Appendix VI: GAO Contact and Staff Acknowledgments

GAO Contact

Staff Acknowledgments

In addition to the contact named above, Edward George, Assistant Director; Amanda Jones Bartine; Michelle Cooper; Kathryn Godfrey; Susanna Kuebler; and Heather Romani made significant contributions to the work. Tina Cheng assisted with graphic design. Amanda Miller and Russ Burnett assisted with design, methodology, and analysis. Stuart Kaufman assisted with design and administration of the follow-up questionnaire. Tracey King provided legal support. Linda Miller provided communications expertise.