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2 Experiences of Federal Agencies Many federal agencies are involved in biosurveillance, but several have lead roles. All federal agencies have complex needs for coordina- tion and communications within their agencies and with other agencies. In the fast-changing context of biohazard response, systems for coordina- tion and communication can be sorely tested. This chapter summarizes presentations from representatives of three agencies: the Centers for Dis- ease Control and Prevention (CDC), the Department of Agriculture (USDA), and the Department of Defense (DOD), to showcase examples of lessons learned. In addition, Matthew Hepburn of the White House National Security Staff (NSS) shared some remarks regarding the importance of biosurveillance, the need for integration, and the desire to find a way to move forward. RESPONDING TO EPIDEMICS AT THE CENTERS FOR DISEASE CONTROL AND PREVENTION1 The response to the 2009 H1N1 pandemic offers many valuable les- sons for biosurveillance, said Stephen Redd, Influenza Coordination Unit, CDC. Comprehensive and targeted response relies on the most ac- curate and timely information provided by successful biosurveillance processes. Most important, the systems and relationships developed be- fore the pandemic were critical in making correct decisions. Technology 1 This section is based on the presentation by Stephen Redd, Influenza Coordination Unit, CDC. 9

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10 BIOSURVEILLANCE INFORMATION SHARING AND COLLABORATION also played a role, and technological systems can be improved, said Redd, but understanding the information generated during an epidemic requires “relationships and trust.” Response to a pandemic flu is based on the systems set up to identify and respond to seasonal influenza, Redd observed. Also, state and local health departments are essential components of these systems, because they both gather information and implement interventions. Finally, labora- tory findings often constitute the lead information for pandemic prepared- ness, which is not necessarily the case for other kinds of emergencies. Redd also emphasized several aspects of situational awareness. De- termining what has happened and what could happen requires detection, characterization, assessment of the burden, and determination of what has changed. Situational awareness also requires knowledge of the tools that can be used to mitigate impacts, including antivirals, vaccines, and nonpharmaceutical interventions, along with knowledge of the effective- ness of those tools. Detection and Early Response Within a few days of detection of the 2009 H1N1 signal cases, the CDC director was receiving a daily briefing on the situation. Preparing the briefing brought people together at CDC and resulted in the prepara- tion of slides that could be distributed within the agency and to other federal agencies. Daily calls were held with the White House, and the Domestic Readiness Group was regularly briefed, said Redd. State health officials, epidemiologists, and laboratory directors also received daily up- dates, which provided these officials with a common picture of what was happening. As pandemic response progressed, daily teleconferences convened by the Department of Health and Human Services chief of staff included representatives from several federal agencies. Weekly videoconferences involved a wider range of agencies, and weekly calls with state and local health officials provided a way to provide them with the latest information. In addition, CDC established liaisons with agencies at the federal, state, and local levels.

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11 EXPERIENCES OF FEDERAL AGENCIES CDC had to make major decisions on the basis of limited infor- mation within the first few days of the epidemic, including the following: • When to publish information about cases • School closure criteria • Recommendations for antiviral drug treatment and prophylaxis • Recommendations for personal protective equipment • Recommendations concerning public health emergency • Distribution of countermeasures from stockpile • Warning on travel to affected areas • Initiation of vaccine candidate development • Arrangement with industry to produce vaccine • Funding to states to plan vaccination programs • Guidance on priority groups for vaccination • Initiation of vaccine production Except for the last three items in this list, these decisions had to be made within about the first 10 days of the epidemic, said Redd, when there were still relatively few cases and when basic information such as the rate of human-to-human transmission, the incubation period, the hos- pitalization rate, the risk factors for the disease, and the fatality rate were still being characterized. Improvements Under Way CDC is undertaking a number of steps to improve its procedures in light of the lessons learned during the H1N1 epidemic, including • developing a systematic method for severity assessment; • enhancing modeling capacity; • developing a nimble and accessible way to visualize available data; • enhancing strategic and scientific virologic surveillance; • expanding and automating syndromic surveillance; and • using serologic data for assessment of population immunity. Redd called particular attention to the need for enhanced modeling capacity and to the expansion and automation of syndromic surveillance. “There is a huge opportunity, with the rolling out of electronic health

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12 BIOSURVEILLANCE INFORMATION SHARING AND COLLABORATION records in meaningful use, to transition our existing methods for syndromic surveillance into something that would be faster than what we have been using,” he said. Roles and responsibilities among agencies need to be clarified and clearly assigned, Redd concluded. During the pandemic, a sense of insti- tutional territoriality faded away because of the importance of the prob- lem, but planning and practice are essential for future crises, especially since H1N1 and other influenza viruses continue to pose a threat. “There are new viruses evolving as we speak. We can’t lose track of this thing.” Discussion In response to a question about new strains of the influenza virus that continue to be detected, Redd pointed to several recent cases involving novel viruses. A critical question, said Redd, is whether these detections are the result of better surveillance or whether they point to new and po- tentially dangerous strains. He also cited the importance of combined investigations between agricultural and health departments in preventing future pandemics, particularly for understanding the epidemiology of swine influenza viruses. With regard to a question about the best ways to disseminate infor- mation in an epidemic, Redd noted that efforts under way to update the website for season influenza could help people customize the infor- mation they receive to reflect their needs. A particular problem during the epidemic was conveying information to the private sector about the actions being taken by the federal government and the actions needed from the private sector. A better way of disseminating that information is needed, he said. Redd’s CDC colleague Christopher Braden observed that one prob- lem during the epidemic was that CDC sometimes released information before state and local health officials were briefed. Redd responded that this was a consequence of so much information being generated so quickly. In addition, it sometimes was difficult to share information with- in states, which led CDC to target different audiences within states to make sure they all had the same information. The relationships and trust that had been established before the epidemic were particularly valuable in enhancing communication with the states, Redd said. In addition, daily calls with state health officers were set up after the pandemic began, when the value of such calls became apparent.

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13 EXPERIENCES OF FEDERAL AGENCIES COORDINATING ANIMAL HEALTH ACTIONS ACROSS THE HUMAN-ANIMAL INTERFACE2 The One Health concept represents a collaborative effort across the interface of disease complexes that affect animals, humans, and the envi- ronment, explained Jere Dick, Animal and Plant Health Inspection Ser- vice (APHIS), USDA. As such, it provides a framework to analyze past events and prepare for future ones. H1N1 Influenza as an Example In 2005, human and animal health officials began collaborating around the emerging H5N1 virus, known as the avian or bird flu virus. The virus had a substantial impact on people who were raising chickens and ducks around the globe as well as on human health, which required that departments of agriculture and the public health arena work together, said Dick. This interagency collaboration led to a number of initiatives, such as a joint effort by the World Organisation for Animal Health and the Food and Agriculture Organization to form a global network of ex- pertise on animal influenzas. In 2008, CDC came to USDA and asked to collaborate on gathering data from the national swine herd. APHIS was initially reluctant to get involved, recounted Dick, because influenza among swine had been han- dled for years by local practitioners and managers and was manageable through the use of vaccines. Also, USDA did not have funding from Congress to do that kind of surveillance. However, CDC agreed to pro- vide the funding if USDA would provide the field force to collect the samples. At that point, APHIS met with the National Pork Board, the American Association of Swine Veterinarians, the National Pork Pro- ducers Council, and a variety of swine industry officials and began to work on a surveillance system. Setting up such a system required answering several questions. What is an influenza-like illness case definition for swine? What is the case definition for people? If the two case definitions were associated, what samples would be taken and under whose authority? Which laboratories would do the tests? How would the data be shared? A Swine Influenza Virus pilot program manual was prepared for field operations, and the 2 This section is based on the presentation by Jere Dick, APHIS, USDA.

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14 BIOSURVEILLANCE INFORMATION SHARING AND COLLABORATION pilot project began in 2009, just a few weeks before the first case of H1N1 appeared in California. The pilot program had several objectives: • Share isolates for research activities. • Monitor genetic evolution and ecology. • Provide isolates for development of diagnostic reagents, diagnos- tic assays, vaccine products, and improved biosecurity. The initial public assumption was that the early cases of H1N1 influ- enza originated from human exposure to pigs, even though the virus was already demonstrating efficient human-to-human transmission. In reality, humans were exposing the pigs to H1N1, and swine transfer of influenza to humans did not occur to any great extent. At that point, the swine in- dustry suspended surveillance efforts, since surveillance was not man- dated. Lessons Learned The experience with H1N1 influenza conveys several important les- sons, said Dick. First, an interdisciplinary team of public health and animal health officials needs to talk with industry representatives to understand the ramifications of even minor decisions. “Public health programs and poli- cies have to address the economic concerns and the public perception. We knew that pork was still safe to eat, and yet there was tremendous impact.” Industry needs to know about the possible consequences of a positive result, and diagnostic results need to be quickly communicated to everyone. Collaboration on common objectives and messages is essential. Yet, obstacles to collaboration can block progress. The animal health community and the public health community have different perspectives in defining a problem, the purpose of collaboration, and overall objec- tives, Dick said. Data confidentiality can be an obstacle, since several laws govern the kinds of information that can be shared. Funding and other resources also can be limited. If USDA does not have a line item funding a particular effort, it does not have the resources to start work on something immediately. APHIS is currently considering the development of a line item for One Health–type activities where staff would be sup- ported to do that work with public health counterparts in all of the states.

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15 EXPERIENCES OF FEDERAL AGENCIES In contrast, several things worked well, Dick observed. Collaboration can be very effective, especially if collaborations and trust are developed in advance of an event. As a result, USDA continues to work hard to de- velop synergies with public health partners. Defining the scope of a col- laboration also improves productivity and reduces cost. For example, collaboration within government and with the private sector on a swine influenza virus vaccine shortened development time and saved money. Future Plans To continue to increase collaboration, USDA has created a One Health joint working group that meets monthly. APHIS also has a liaison who works at the CDC. A strategic plan, four operational plans, a train- ing plan, a communication plan, and a preharvest and zoonotic disease operational plan are all either finished or being developed. USDA is also examining its surveillance policies. For example, the Center for Epidemiology and Animal Health in Fort Collins, Colorado, is developing comprehensive swine surveillance that involves a number of data streams. The department also is working to increase voluntary sample submission. Samples are identified geographically but are not assigned to a farm so that data can be shared without violating individual farmers’ con- fidentiality. In this way, USDA can work with health departments to iden- tify areas of the country where a virus may be spreading. Discussion In response to a question about the tools that state and local health departments can use to collaborate with their animal health counterparts, Dick replied that APHIS has received funds to support positions within each state (though some positions extend across states). The role of these animal health emergency coordinators, whose contact information is on the APHIS website, is to work with state and federal officials in those states to prepare for a variety of emergencies. Dick also commented on the need to expand animal surveillance to protect human health. USDA does not get funding to provide animal samples for human health concerns, but if there are associated animal health concerns, the agency can address those under its direct authority.

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16 BIOSURVEILLANCE INFORMATION SHARING AND COLLABORATION APHIS also acts as a facilitator with state and local authorities, who have much of the authority to gather animal samples. Further, Dick pointed out that APHIS has people stationed not only in the United States but also around the world to serve as subject-matter experts and monitor what is going on in the animal health community. In addition, about 500 specially trained veterinarians in the United States can respond within hours to any private or state veterinary practitioner to assist in diagnoses and getting lab samples to be tested. “It goes back to the earlier comment—this is really all about people, and having them positioned and ready to respond.” INTEGRATING COMPLEX NATIONAL MISSIONS: LESSONS FROM THE NATIONAL COUNTERTERRORISM CENTER’S DIRECTORATE OF STRATEGIC OPERATIONAL PLANNING3 Robert Kravinsky, Office of the Secretary of Defense, described some of the results of a recent study of the National Counterterrorism Center (NCTC) by the Project on National Security Reform. While the study did not focus directly on biosecurity, said Kravinsky, it provides many lessons that are directly applicable to biosurveillance because of similarities involving multiple agencies, needs, and information flows. As well, counterterrorism, like biosurveillance, serves an important role in protecting the nation. Most national security threats require a high de- gree of integration, yet the national security system remains structured along functional lines such as defense, diplomacy, agriculture, food safe- ty, and so on. The only place where integration can occur is at the level of the NSS, but this level does not have directive authority. NCTC, which was established by executive order in 2004 under the office of the Director of National Intelligence, has four core missions: • Analyze terrorism intelligence (except purely domestic terrorism). • Share and store information. • Support U.S. counterterrorism activities using information technology. 3 This section is based on the presentation by Robert Kravinsky, Office of the Secretary of Defense.

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17 EXPERIENCES OF FEDERAL AGENCIES • Conduct strategic operational planning (through the Directorate of Strategic Operational Planning). The Project on National Security Reform focused largely on the fourth of these missions. The mission statement for the Directorate of Strategic Operational Planning (DSOP) calls for it to be the focal point of the national security establishment by orchestrating and harmonizing the appropriate application of instruments of national power (e.g., diplomat- ic, financial, military, and intelligence activities). Interestingly, said Kravinsky, the 2010 Government Accountability Office report on biosurveillance pointed to a lack of a focal point with authority and re- sources to guide and develop national biosurveillance capabilities. The Project on National Security Reform began by examining a con- cept Kravinsky called “Whole-of-Government Collaboration” designed to orchestrate and harmonize a mission. This is a multifaceted concept that could include the following integrating functions: • Capturing and cataloging the range of activities and resources • Developing strategic objectives • Developing policy options • Harmonizing and synthesizing plans • Prioritizing resources • Assigning roles and responsibilities • Resolving impediments • Adjudicating conflicting roles and responsibilities • Gaming and exercising • Assessing performance • Coordinating operations to achieve unity of effort • Directing operations to achieve unity of command The project then broke down the concept of “authority” into various components, including authority over processes, resources, personnel, and enabling procedures. In this way, it could compare the different components of authority for different government entities. For example, entities could have the authority to develop strategy, determine require- ments, approve reprogramming and transfer of resources, establish pro- fessional development standards within the community, and so on. These types of authorities then could be compared to examine the characteris- tics of collaboration.

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18 BIOSURVEILLANCE INFORMATION SHARING AND COLLABORATION The project came to several broad conclusions: • NCTC is involved in a significant breadth of planning activity, and its role as an interagency team continues to evolve and grow. • Departments and agencies have a varying degree of awareness of these activities, and the added value of NCTC planning to its customers is not universally understood. • NCTC’s relationship with the NSS is not formalized (though this step was undertaken after the study was published). • Overlapping authorities have resulted in lack of participation by certain departments and agencies. • The current congressional committee structure is not equipped to oversee interagency mechanisms, resulting in confusion over ju- risdiction and no champion in Congress. • NCTC workforce needs are challenged by the scarcity of plan- ning competencies across the federal government and the uneven participation of agencies. As an example of overlapping authority, Kravinsky observed that in 1998 the State Department was given authority over the overall supervi- sion of international counterterrorism authorities’ activities. However, NCTC had the same mandate. “Through no fault of either NCTC or the State Department, they had authorities that were never reconciled,” Kravinsky said. The project resulted in a number of recommendations and lessons learned: • The President should issue an executive order to address the full scope of the counterterrorism architecture. • Congress should establish a Counterterrorism Working Group in each chamber to look across committee jurisdictional boundaries. • The President should vest the director of NCTC with responsibil- ity to provide advice on the choices of personnel to lead the enti- ties of the departments and agencies focused on counterterrorism. • NCTC should partner with the Office of Personnel Management and others to develop training curricula and programs for strate- gic planners to address the federal government’s need for these skills. • The Office of Management and Budget and the DSOP should de- velop a consolidated interagency counterterrorism budget display.

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19 EXPERIENCES OF FEDERAL AGENCIES • The counterterrorism program and budget guidance should be nested within broader national security guidance. • NCTC should partner with the Department of Homeland Securi- ty to explore opportunities for collaborative planning with non- federal partners. • Create an interagency coordination mechanism below the level of the NSS that allows seamless and institutionalized linkage be- tween customers in the interagency space. • Consider “Center” options for other missions (cybersecurity, bi- osecurity, etc.). • Mandate a reporting chain to the President to obtain the informal authority associated with proximity to the President that is re- quired to lead an effective interagency team. • Untangle overlapping mandates and authorities to ensure that all actors understand the need for, and leadership from, an inter- agency team. • Ensure strong links between policy, strategy, and resources that are critical to turning policy, strategy, and plans into action. • Create a government-wide human capital system that provides personnel with the necessary experience and expertise to form an effective interagency team. • Cultivate champions on Capitol Hill to foster congressional sup- port for the interagency team and streamlined oversight of the national mission. Kravinsky closed by saying that some of these recommendations could be helpful to the biosurveillance community. Discussion Kravinsky made a point regarding resource allocation, noting that such aligning of resources to missions needed to occur within a greater context of prioritization, and not in isolation of other efforts. Similarly, he noted the importance of recognizing territorial issues around duties, responsibilities, missions, and scopes, and finding ways to work around them, potentially by executive order defining exactly who is in which role doing what.

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20 BIOSURVEILLANCE INFORMATION SHARING AND COLLABORATION VIEWPOINT OF THE NATIONAL SECURITY STAFF4 Matthew Hepburn, of the National Security staff, said that the pur- pose of the NSS is to support two advisors to the President: the National Security Advisor and the Homeland Security Advisor. Within the NSS are a series of directorates, including the resilience directorate, which handles preparedness and response. Biosurveillance is a top priority of the directorate. The purpose of biosurveillance is to inform the decisions associated with an event, said Hepburn. Decisions can have major impacts, but there are also low-impact decisions that involve who needs to be notified and what information needs to be conveyed. These decisions vary depending on the target of the information, whether it is the head of a government agency or the public. At all levels, better information creates at least the potential for better decisions. As an example, Hepburn cited recent reports from the United Na- tions Food and Agriculture Organization involving the emergence of new strains of H5N1 influenza. “A senior leader needs to understand what this means. Do we need to take any action? Do we need to ban any im- ports? Do we need to negotiate with foreign governments? Do we need to do something different than we already are based on this report? How do we inform the leadership on that?” A complete picture of the situation on which to base decisions cannot be obtained from any one government agency, said Hepburn, though many agencies are essential to create such a picture. Rather, analyzing the situation requires multiagency expertise. Thus, a process involving multiple agencies is needed to assemble information rapidly. A policy maker may have just 45 minutes or an hour to prepare for a high-impact announcement, such as would follow the report of a serious E. coli out- break. “We need that collective understanding.” Many audiences can benefit from that assembled understanding, from national and international leaders to local communities. The value of biosurveillance is measured in part by its benefits to these many audi- ences, said Hepburn, because these audiences will then participate in the process. For example, “we should figure out how what we do has enor- mous benefit for the private sector. And then they will participate. That is where our creativity and our innovation need to focus.” 4 This section is based on the presentation by Matthew Hepburn, Medical Preparedness Policy, White House NSS.

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21 EXPERIENCES OF FEDERAL AGENCIES Discussion In response to a question about what information should be conveyed to the NSS from agencies, Hepburn noted that biosurveillance has been defined broadly. He advocated setting thresholds for conveying infor- mation lower and then learning by experience where they can be raised. “With that exercise we develop the trust and learn how to work together.” Hepburn said that the NSS reads the daily reports generated by the National Biosurveillance Integration Center (NBIC), along with reports from elsewhere in government. He also reaches out to NBIC when he needs information because of a question he has been asked or an anticipated need. “It is much better for me rather than calling three dozen experts across the U.S. government.” Hepburn also emphasized the importance of building local capabil- ity. A biosurveillance system needs to be valuable to the communities it serves. “How do we make biosurveillance something that absolutely can’t be cut because it is so valuable?”

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