Release Date: July 16, 2008 Cannon House Office Building (Remarks as Prepared) Introduction Mr. Chairman, Ranking Member McCaul, and Members of the Subcommittee, thank you for the opportunity to testify today on the Department of Homeland Security's (DHS) biosurveillance efforts. I serve as the Deputy Assistant Secretary for WMD and Biodefense, a division within the Department of Homeland Security's Office of Health Affairs (OHA). I appreciate your interest in our biosurveillance programs, and trust that my testimony today will provide valuable insight into the Department's biosurveillance initiatives to safeguard the Nation against a biological attack or other biological incidents that threaten the security of the Homeland. The Nation continues to face the risk of a major biological event that could cause catastrophic loss of human life, severe economic damages, and significant harm to our Nation's critical infrastructures and key resources. As you so vividly remember the nation already experienced a form of bioterrorism in late 2001 with the deadly anthrax mailings that cost the lives of 5 individuals, injured 17, and caused severe disruptions to many of our government activities, including operations of the U.S. Postal Service and numerous other functions. The challenges we face in assessing current terrorist capabilities andentifying plots make it unlikely that we will receive actionable, specific warning of an impending bioterrorist attack. Furthermore, many of these deadly biological agents are accessible in nature, relatively easy to procure, develop and transport without an advanced background in the biological sciences. Unlike nuclear weapons, few people with advanced laboratory knowledge in the biological sciences are needed to weaponize many of these deadly pathogens. As such, it is incredibly difficult to predict and prevent a biological attack from taking place. The threat of bioterrorism has not subsided, and the impact of a large-scale bioterrorism event, such as the wide-spread dissemination of an aerosolized form of anthrax or other deadly biological pathogen, would have a serious effect on the health and security of the Nation. A bioterrorist plot may not have detectable signals, thus, there may be little or no warning of an impending biological attack, presenting significant challenges to theentification, detection, and disruption of such plots. Our first indication of a bioterrorist attack will likely be through early detection and warning systems, such as BioWatch and the National Biosurveillance Integration Center (NBIC). Their detection capabilities will drive the subsequent response and significantly influence the number of individuals affected by an attack. In the event that a threat does reach, or occur in, the Homeland, a comprehensive biosurveillance capability can minimize the impact and duration of the event via early detection and characterization, broad situational awareness and by facilitating early intervention and mitigation. Biosurveillance An integrated biosurveillance program is vital to help protect the homeland from bioterrorism: unintentional introductions (e.g. Foot-and-Mouth Disease); and naturally occurring biological events, such as pandemic influenza. Biosurveillance refers to monitoring for potential signs of biological events with the intent of early detection of that event to permit the timely response to mitigate consequences. Should an event occur, biosurveillance and detection allows the monitoring of an outbreak as it happens and provides accurate situational awareness to first responders. Biosurveillance is one of the critical components of our Nation's biodefense strategy, as outlined in Homeland Security Presidential Directive (HSPD) - 10: Biodefense for the 21st Century. Biosurveillance includes many different components that work in complementary fashion to achieve a comprehensive awareness. This takes the form of both traditional and novel methods of early event detection including environmental detection systems, clinical syndromic surveillance, reportable disease and laboratory-based surveillance, monitoring of agricultural and wildlife activity, testing of the food supply, and monitoring mail and open-source analysis to name a few. Each is a necessary and valuable component of a comprehensive biosurveillance strategy. I would like to discuss two biosurveillance programs that the Department is leading as part of the Federal government's larger biosurveillance strategy: NBIC and the Biowatch Early Detection System. National Biosurveillance Integration Center (NBIC) Recognizing the need to create a new biological threat surveillance capability across multiple sectors and domains to provide early awareness and warning of emerging biological events, Secretary Chertoff, in collaboration with the other appropriate Federal Departments and agencies, established the National Biosurveillance Integration System (NBIS), which serves as the platform for information exchange between senior leaders and partners agencies and facilitates the early recognition of biological events, including natural disease outbreaks, accidental or intentional use of biological agents, and emergent biohazards.  Currently, twelve Federal Member Agencies comprise the NBIS community.  Eventually, this community will evolve to include State, local and tribal entities, and potentially the private sector and, international stakeholders. The NBIS community provides situational awareness through the acquisition, integration, analysis and dissemination of information from existing human disease, food, agriculture, water, meteorological, and environmental surveillance systems and relevant threat and intelligence information. In 2007, Congress passed and President Bush signed P.L. 110-53, The Implementing of the 9/11 Commission Recommendations Act of 2007 which formally authorized the establishment of the National Biosurveillance Integration Center (NBIC), which serves as the hub of operations and personnel to which the NBIS community contributes information. The NBIC is located in the DHS Nebraska Avenue Center and is charged with the primary mission to rapidlyentify, characterize, localize, and track a biological event of national concern; integrate and analyze data relating to human health, animal, plant, food, water; and disseminate alerts and pertinent information. NBIC seeks to provide information to allow early recognition of biological events of national concern, both natural and man-made, in order to make a timely response possible. No other entity in government serves to integrate this biological threat information from across the spectrum of public and private, domestic and international, open or protected sources. As an operating center, the vital component parts of NBIC are:

• A corps of highly-trained subject matter experts (SMEs) and analysts, including a 24 hour/7 day OHA Watch Desk within the DHS National Operations Center;
• Tailored customer products resulting from integrative analysis of biosurveillance information;
• A culture of cooperation, trust and mutual support across the Federal government and other partners; and
• A robust information management system capable of handling large quantities of structured and unstructured information.

Developing an Interagency Information Sharing Capability Developing interagency cross-domain biosurveillance capability is a difficult and complicated task that has not been previously attempted. Coordination with our Federal partners to obtain data, personnel, and information sharing agreements requires new processes and procedures. Additionally, building a new IT system to coordinate the information sharing, as well as creating new analytical tools to assist analysts inentifying trends, patterns, and anomalies quickly and accurately as is necessary for forward looking and cueing capability has taken time. However, we are still scheduled to meet our full operational capability (FOC) goals by September 30, 2008. NBIC has formalized its relationship with a number of Federal partners, and continues to make progress on obtaining formal agreements with the remaining relevant Federal Agencies in order to promote a robust interagency biosurveillance capability.  MOUs are in place with Departments of Defense, State, Agriculture, Interior, Health and Human Services, and Transportation. We are also working closely with the Department of Veterans Affairs, FBI, Environmental Protection Agency, U.S. Postal Service, and the Department of Commerce and other components within DHS. While final details of some of these agreements are being resolved, these Departments and agencies are currently contributing to the NBIC mission and providing valuable information on current bio-events. NBIC has established the NBIS Interagency Working Group (NIWG) which meets monthly to provide an open forum among NBIS members to discuss interagency collaboration, develop detailed operational procedures and offer recommendations to enhance the capability of NBIS. The NIWG representatives possess a detailed knowledge of their respective organization's biosurveillance-relevant capabilities, programs and activities that can contribute to the integrated effort. This collaboration has produced the first version of the NBIS Concept of Operations which lays out the details of how the mission of NBIS is being implemented and executed.  This document is significant in that it describes the steps NBIS will take to accomplish the unprecedented task of Biosurveillance cross-domain integration and analysis. Further, NBIC has developed a governance structure to provide senior-level oversight of operations to ensure that interagency goals and objectives are met.  The National Biosurveillance Integration System Interagency Oversight Council is made up of representatives at the Assistant Secretary level from each NBIS member agency and acts as the senior oversight body to provide guidance and direction for the efficient operation and evolution of NBIS. NBIC Information Integration and Analysis To accomplish the biosurveillance mission, the NBIC monitors over 530 information feeds. Monitoring of these information feeds is facilitated by the NBIS 2.0 IT system. These sources include interagency communications and165 open source sites.  These open source sites include 20 organizational sites, 14 federal government sites, 85 State, local, or territorial government health and agriculture sites, 35 foreign government sites, and 2 commercial sites. Using its information feeds, NBIS develops and shares a Biosurveillance Common Operating Picture (BCOP) with the NBIS community. The BCOP is a comprehensive electronic picture with assessments of current biological events, trends and their potential impacts on the Nation's homeland security. The BCOP provides a secure platform for cross domain information analysis by NBIS subject matter experts to learn more about and collectively evaluate current situations. An impact assessment of an event constitutes a major portion of the NBIS BCOP information dissemination. As an example of the NBIC capability, several NBIS member agencies continue to work closely together to provide comprehensive situational awareness to Federal agencies on the current Salmonella stereotype Saintpaul event.  NBIC remains thoroughly engaged in the tracking of this event, and regularly posts Situational Reports (SITREPs) on the BCOP.  Thus far, NBIS has released 11 national SITREPs on this event. NBIC Full Operating Capability NBIC has developed a set of goals to address the highest priority requirements to achieve FOC by September 30, 2008, which assumes the current reprogramming request before Congress. We continue to progress toward the following to achieve full operational capability:

• Install interagency staff and enhanced space resources for NBIC;
• Enhance IT Infrastructure for biosurveillance;
• Expand the NBIS Interagency Community;
• Further develop NBIC Intra-Agency Collaboration;
• Continue NBIC Collaborative Analysis and Production;
• Refine the NBIC Five Year Strategic Plan with modified objectives; and
• Refine the NBIC Contingency Operations Plans with updated strategies.

BioWatch I would also like to discuss the Department's BioWatch Program, which was established in January 2003, and is currently managed by OHA. The BioWatch mission is to deploy and maintain a national 24/7 early warning system capable of detecting the intentional release of select aerosolized biological agents in order to speed response and recovery efforts. The purpose of this early detection and warning capability is to mitigate the consequences of a catastrophic attack, which could affect tens of thousands of people if, for example, aerosolized anthrax were released. The goals of the BioWatch Program include:

• Early detection and characterization of biological attacks against the Nation's cities, high value assets, and mass gatherings to allow for the rapid distribution of life-saving countermeasures;
• Cost-effectively improving bio-aerosol threat monitoring capability and increasing its capacity to cover a greater portion of the general population;
• Providing operational and consequence management guidance and assistance to Federal, State, local, and tribal entities; and
• Integrating BioWatch capabilities into a national bio-threat monitoring and response system.

BioWatch is part of a national biodefense strategy that includes intelligence, law enforcement, bio-monitoring, situational awareness, decision support, response, and recovery activities. Within this strategy, BioWatch is an essential component of bio-monitoring, along with astute clinicians, syndromic surveillance, food and agriculture monitoring, veterinary surveillance, and mailroom monitoring. BioWatch technical and operational capabilities are integrated with military capabilities at installations to the benefit of both the Department of Defense and DHS. Bio-monitoring of infectious agents will enable earlier treatment of affected populations than would otherwise be possible, and contribute to the prevention of secondary transmission, thereby reducing morbidity, mortality, and the associated health care costs from a biological terrorist attack. Each component of bio-monitoring relies on different technologies and techniques that are optimized for their intended purpose.  It is through situational awareness and decision support that bio-monitoring is linked with the public health and medical response communities that must respond in the event of a biological terrorist event. Current BioWatch Capability The current generation BioWatch system, which is operating in over 30 of the Nation's largest metropolitan areas, is composed of aerosol collectors, secondary sampling kits, laboratories, guidance documents, concepts of operation, communications protocols, an internet-based information portal, subject matter experts, and a small number of early-generation indoor detectors. System operation requires the integration and coordination of Federal, State, and local authorities whom all play an active role in the program. The system is tested routinely at each of the local jurisdictions where it is deployed. The BioWatch program has established and strengthened existing local infrastructure.  Laboratory procedures and field operations have been standardized and are reviewed periodically for quality assurance by the BioWatch program. Detailed environmental sampling plans have been developed that could be used to gather information about the viability and distribution of a bio-agent detected by the system. BioWat